"Notes" "VAERS ID" "VAERS ID Code" Adverse Event Description "0909095-1" "0909095-1" "on 12/24/2020 the resident was sleepy and stayed in bed most of the shift. He stated he was doing okay but requested pain medication for his legs at 250PM. At 255AM on 12/25/2020 the resident was observed in bed lying still, pale, eyes half open and foam coming from mouth and unresponsive. He was not breathing and with no pulse" "0910363-1" "0910363-1" "Patient had mild hypotension, decreased oral intake, somnolence starting 3 days after vaccination and death 5 days after administration. He did have advanced dementia and was hospice eligible based on history of aspiration pneumonia." "0913143-1" "0913143-1" "Vaccine administered with no immediate adverse reaction at 11:29am. Vaccine screening questions were completed and resident was not feeling sick and temperature was 98F. At approximately 1:30pm the resident passed away." "0913733-1" "0913733-1" "My grandmother died a few hours after receiving the moderna covid vaccine booster 1. While I don?t expect that the events are related, the treating hospital did not acknowledge this and I wanted to be sure a report was made." "0914604-1" "0914604-1" "Spouse awoke 12/20 and found spouse dead. Client was not transferred to hospital." "0914621-1" "0914621-1" "Resident in our long term care facility who received first dose of Moderna COVID-19 Vaccine on 12/22/2020, only documented side effect was mild fatigue after receiving. She passed away on 12/27/2020 of natural causes per report. Has previously been in & out of hospice care, resided in nursing home for 9+ years, elderly with dementia. Due to proximity of vaccination we felt we should report the death, even though it is not believed to be related." "0914690-1" "0914690-1" "Within 24 hours of receiving the vaccine, fever and respiratory distress, and anxiety developed requiring oxygen, morphine and ativan. My Mom passed away on the evening of 12/26/2020." "0914805-1" "0914805-1" "RESIDENT CODED AND EXPIRED" "0914895-1" "0914895-1" "Injection given on 12/28/20 - no adverse events and no issues yesterday; Death today, 12/30/20, approx.. 2am today (unknown if related - Administrator marked as natural causes)" "0914917-1" "0914917-1" "Death by massive heart attack. Pfizer-BioNTech COVID-19 Vaccine EUA" "0914961-1" "0914961-1" "pt passed away with an hour to hour and 1/2 of receiving vaccine. per nursing home staff they did not expect pt to make it many more days. pt was unresponsive in room when shot was given. per nursing home staff pt was 14 + days post covid" "0914994-1" "0914994-1" "pt was a nursing home pt. pt received first dose of covid vaccine. pt was monitored for 15 minutes after getting shot. staff reported that pt was 15 days post covid. Pt passed away with in 90 minutes of getting vaccine" "0915562-1" "0915562-1" "pt received vaccine at covid clinic on 12/30 at approximately 3:30, pt vomited 4 minutes after receiving shot--dark brown vomit, staff reported pt had vomited night before. Per staff report pt became short of breath between 6 and 7 pm that night. Pt had DNR on file. pt passed away at approximately 10pm. Staff reported pt was 14 + days post covid" "0915682-1" "0915682-1" "Resident received vaccine per pharmacy at the facility at 5 pm. Approximately 6:45 resident found unresponsive and EMS contacted. Upon EMS arrival at facility, resident went into cardiac arrest, code initiated by EMS and transported to hospital. Resident expired at hospital at approximately 8 pm" "0915880-1" "0915880-1" "Patient died within 12 hours of receiving the vaccine." "0915920-1" "0915920-1" "Resident received vaccine in am and expired that afternoon." "0917117-1" "0917117-1" "After vaccination, patient tested positive for COVID-19. Patient was very ill and had numerous chronic health issues prior to vaccination. Facility had a number of patients who had already tested positive for COVID-19. Vaccination continued in an effort to prevent this patient from contracting the virus or to mitigate his risk. This was unsuccessful and patient died." "0917790-1" "0917790-1" "At the time of vaccination, there was an outbreak of residents who had already tested positive for COVID 19 at the nursing home where patient was a resident. About a week later, patient tested positive for COVID 19. She had a number of chronic, underlying health conditions. The vaccine did not have enough time to prevent COVID 19. There is no evidence that the vaccination caused patient's death. It simply didn't have time to save her life." "0917793-1" "0917793-1" "Prior to the administration of the COVID 19 vaccine, the nursing home had an outbreak of COVID-19. Patient was vaccinated and about a week later she tested positive for COVID-19. She had underlying thyroid and diabetes disease. She died as a result of COVID-19 and her underlying health conditions and not as a result of the vaccine." "0918065-1" "0918065-1" "1/1/2020: Residents was found unresponsive. Pronounced deceased at 6:02pm" "0918388-1" "0918388-1" "Resident found unresponsive without pulse, respirations at 04:30 CPR performed, expired at 04:52 by Rescue" "0918418-1" "0918418-1" "Resident became SOB, congested and hypoxic requiring oxygen, respiratory treatments and suctioning. Stabilized after treatment and for the next 72 hours with oxygen saturations in the 90s. On 1/3/2021 was found without pulse and respirations. Resident was a DNR on Hospice." "0918487-1" "0918487-1" "Two days post vaccine patient went into cardiac arrest and passed away." "0918518-1" "0918518-1" "syncopal episode - arrested - CPR - death" "0919108-1" "0919108-1" "Fever, Malaise" "0919537-1" "0919537-1" "Resident exhibited no adverse events during 30 minute monitoring following vaccine administration. Resident found without pulse at 1900." "0920326-1" "0920326-1" "Redness and warmth with edema to right side of neck and under chin. Resident was on Hospice services and expired on 1.1.21" "0920368-1" "0920368-1" "12/30/2020 07:02 AM Resident noted to have some redness in face and respiration were fast. Resident vital signs were abnormal except blood pressure. Temp at the time was 102.0 F taken temporal. Resident respirations were 22 labored at times. Pulse is 105 and pulse ox 94% on room air. Resident is made comfortable in bed. Notified triage of change in condition also made triage aware of resident receiving Covid vaccination yesterday morning. Resident appetite and fluid consumption has been poor for few days. 12/30/2020 07:32 AM Received order from agency to administer Acetaminophen 650mg suppos rectally due to resident not wanting to swallow anything including fluids, medications and food. This writer administered medication as NP ordered. Will monitor for effectiveness and adverse effects if any. 12/30/2020 08:41 AM Received new orders to obtain Flu swab, obtain CBC and BMP, and Chest Xray all to be obtained today. Notified family of resident having temperature and vital signs excluding b/p that was abnormal. Family was thankful for call and inierated to nurse that family does not want resident sent to hospital. Did educate family on benefits of Hospice services, but family persistant on continued daily care provided by nursing staff. Requests visits if decline continues. Family assured if resident continues to decline, facility will accomandate resident family to be able to be at bedside when time comes to do so. NP ordered IVF and IV Levaquin on 12/31/20. Family chose at that time to sign for Hospice services and not have resident provided with IVF or IV Antibiotics" "0920545-1" "0920545-1" ""The resident received is vaccine around 11:00 am and tolerated it without any difficulty or immediate adverse effects. He was at therapy from 12:36 pm until 1:22 pm when he stated he was too tired and could not do anymore. The therapist took him back to his room at that time and he got into bed himself but stated his legs felt heavy. At 1:50 pm the CNA answered his call light and found he had taken himself to the bathroom. She stated that when he went to get back into the bed it was ""abnormal"" how he was getting into it so she assisted him. At that time he quit breathing and she called a RN into the room immediately. He was found without a pulse, respirations, or blood pressure at 1:54 pm. He was a DNR."" "0920815-1" "0920815-1" "Found deceased in her home, unknown cause, 6 days after vaccine." "0920832-1" "0920832-1" "Vaccine 12/30/2020 Screening PCR done 12/31/2020 Symptoms 1/1/2021 COVID test result came back positive 1/2/2021 Deceased 1/4/2021" "0921175-1" "0921175-1" "Resident received Covid Vaccine, noted after 30 mins with labored breathing BP 161/77, HR 116, R 38, T 101.4," "0921481-1" "0921481-1" "Vaccine given on 12/29/20 by Pharmacy. On 1/1/21, resident became lethargic and sluggish and developed a rash on forearms. He was a Hospice recipient and doctor and Hospice ordered no treatment, just to continue to monitor. When no improvement of codition reported, doctor and Hospice ordered comfort meds (Morphine, Ativan, Levsin). Resident expired on 1/4/2021" "0921547-1" "0921547-1" "DEATH ON 1/4/2021, RESIDENT RECIEVED VACCINE ON 1/2/20" "0921572-1" "0921572-1" "Resident had body aches, a low O2 sat and had chills starting on 12/30/20. He had stated that they had slightly improved. On 1/1/21 he sustained a fall with a diagnosis of a displaced hip fracture. On 1/2/21 during the NOC shift his O2 sat dropped again. He later went unresponsive and passed away." "0921667-1" "0921667-1" "LTCF Pfizer Vaccine clinic conducted 12/29/2020 Vaccine lead received a call indicating that a staff member deceased somewhere between 1/3/2021 and 1/4/2021. Cause of death is unknown, and an autopsy is being performed." "0921768-1" "0921768-1" "Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was employed as a housekeeper. About one hour after receiving the vaccine she experienced a hot flash, nausea, and feeling like she was going to pass out after she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours, upon arrival to a friends home she complained of feeling hot and having difficulty breathing. She then collapsed, then when medics arrived, she was still breathing slowly then went into cardiac arrest and was unable to be revived." "0921880-1" "0921880-1" "The resident was found deceased a little less than 12 hours following COVID vaccination, and he had had some changes over the last 2 days. He was 96 and had been on hospice care for a little while. Noone noticed any side effects from vaccine after it was given" "0922977-1" "0922977-1" "Fever, RespDepression & COVID positive REMDESIVIR (EUA) 200 mg x1 then 100 mg daily" "0923993-1" "0923993-1" "Patient was vaccinated Dec 30, 2020. Prime dose of Moderna vaccine. Observed for full 15 minutes post-injection. No complaints when asked during observation. Released. Subsequently, vaccine clinic staff learned from the patient's supervisor that on Jan 4, 2021 that the patient had expired on Jan 2, 2021. By report from the supervisor, the patient was found dead at his home. The patient's primary care provider was unaware of his death when contacted by this reporter today (Jan 6, 2021). Electronic Medical Record without any information since the vaccination." "0924126-1" "0924126-1" "resident expired 1/1/2021" "0924186-1" "0924186-1" "Resident expired 1/3/21" "0924456-1" "0924456-1" "Patient did not display any obvious signs or symptoms; the vaccination was administered at approximately 10:00 AM and the patient continued throughout her day without any complaints or signs of adverse reaction. Patient was helped to bed by the nursing assistant estimated at around 9:00 PM. The facility received notification from the lab around 11:00 PM that the patient's COVID-19 specimen collection from Sunday, 1/3/21, detected COVID-19. When the nursing staff went to the room to check on the resident and prepare her to move to a COVID-19 care area the patient was found unresponsive, no movement, no chest rises, noted regurgitated small amount of food to mouth left side, lying on left side. Pupils non reactive." "0924464-1" "0924464-1" "coughing up blood, significant hemoptysis -- > cardiac arrest. started day after vaccine but likely related to ongoing progression of lung cancer" "0924664-1" "0924664-1" "At approximately, 1855, I was alerted by caregiver, resident was not responding. Per caregiver, she was doing her rounds and found resident in bed, unresponsive, mouth open, observed gurgling noises and tongue hanging out of mouth. This primary caregiver observed resident at baseline and ambulating after dinner at approximately, 1800 less than an hour prior to incident. This PCG called 911 for EMS and gave report of incident. Resident was taken to Medical Center Emergency Department. At ER, CT scan and X-ray was performed. Per report from ER RN, CT scan and x-ray revealed an intracranial aneurysm and fluid in the lungs. Per RN, resident was still unresponsive and was admitted to Medical Center for observation and comfort measures. This primary caregiver reported to RN, resident recently received the first dose of COVID-19 vaccine on 1/2/21. Primary caregiver received a call from Castle RN at 0700, resident expired at 0615." "0925154-1" "0925154-1" "Deceased" "0925556-1" "0925556-1" "Expired 1/05/2021" "0926269-1" "0926269-1" ""Pt last seen at 1200 by nurse for ID band check. No visible signs of distress noted. Pt states ""I just want to be left alone"". 1230 nurse was called to pt room. Pt was noted unresponsive, no pulse and respiration noted. CPR started immediately, at 1239 first shock given. 1245 EMT took over, at 1319 EMT called time of death"" "0926462-1" "0926462-1" "Patient developed hypoxia on 1/4/2021 and did not respond to maximal treatment and passed way on 1/5/2021" "0926568-1" "0926568-1" "patient declined 12/30/2020 and was transferred to hospital where he did not respond to treatment and passed away 1/4/2020" "0926600-1" "0926600-1" "Patient did not report any signs or symptoms of adverse reaction to vaccine. Patient suffered from several comorbidities (diabetes and renal insufficiency). Patient reported not feeling well 01/06/2021 and passed away that day." "0926797-1" "0926797-1" "had a vaccination on 12/31/2020 late morning passed away early morning 01/01/2020. This is a 93 year old with significant heart issues. EF of 20% among other comorbidities. He died suddenly approximately 0430, it is unlikely it was related to receiving the vaccine." "0927189-1" "0927189-1" "Patient was vaccinated at 11am and was found at the facility in his room deceased at approximately 3:00pm. Nurse did not have cause of death" "0927260-1" "0927260-1" "No adverse effects noted after vaccination. Patient with cardiac history was found unresponsive at 16:45 on 1/6/21. Abnormal breathing patterns, eyes partially closed SPO2 was 41%, pulseless with no cardiac sounds upon auscultation. CPR and pulse was regained and patient was breathing. Patient sent to Hospital ER were she remained in an unstable condition had multiple cardiac arrest and severe bradycardia and in the end the hospital was unable to bring her back." "0928062-1" "0928062-1" "vomiting later on 01/05/21. Lethargy and hypoxia in pm of 01/06/21. Hypotension am of 01/07/21. Hospitalized, intubated, cardiac arrest, died 01/07/21." "0928513-1" "0928513-1" "Resident passed away in her sleep" "0928933-1" "0928933-1" "Patient had been diagnosed with COVID-19 on Dec. 11th, 2020. Symptoms were thought to have started on 12/5/2020. Received Moderna vaccine on 12/23. Unexpected death on 1/8/2021. Resuscitation attempts unsuccessful" "0929359-1" "0929359-1" "3:07 pm lung sounds diminished oxygen sats 68%, oxygen applied Oxygen sats remained low for next 36 hours ( patient on Hospice care ) expired 6:22 am 1-8-21" "0929764-1" "0929764-1" "The patient was found deceased at home about 24 hours after immunization. Date of Death:: 12/29/2020; estimated time of death 6:00pm" "0929997-1" "0929997-1" "Patient received vaccine on 1/4/2021. He was in Hospice for CHF and renal failure, but was able to get up in his wheelchair and eat and take medications and talk. On 1/5/2021 am, he was noted to be very lethargic an could only mumble, could not swallow. No localizing neurologic findings. He was too lethargic to get up in chair." "0930154-1" "0930154-1" "Notified today that he passed away. No other details known at this time." "0930431-1" "0930431-1" "Cardiac event, 2 days after vaccination, patient expired." "0930466-1" "0930466-1" "Fever, shortness of breath and chest pain that resulted in a heart attack a few hours after vaccination" "0930487-1" "0930487-1" "Medical docter state patient has a acute cardiac attack" "0930876-1" "0930876-1" "Death" "0930910-1" "0930910-1" "Patient received COVID vaccination around 12:15pm. Patient was monitored for the appropriate amount of time by nursing staff. Patient passed away at 2:15pm." "0932346-1" "0932346-1" "1/7-21 - Received second dose of pfizer covid-19 vaccine 1/8/21 - Fever, dizziness, headache 1/10/21 0250 was found not breathing. EMS performed CPR and patient deceased" "0932787-1" "0932787-1" "RECIEVED VACCINE 1/8/21 EXPIRED UNEXPECTED 1/10/21, NO ADVERSE REACTIONS NOTED" "0932898-1" "0932898-1" "The patient had an apparent cardiac arrest on 12/23/20 and was admitted to the ICU. He was taken off of life support on 12/30/20. He had known cardiac disease." "0933090-1" "0933090-1" "Patient died, I have a copy of his vaccination card" "0933739-1" "0933739-1" ""Staff member checked on her at 3am and patient stated that she felt like she couldn't breathe. 911 was called and taken to the hospital. While in the ambulance, patient coded. Patient was given CPR and ""brought back"". Once at the hospital, patient was placed on a ventilator and efforts were made to contact the guardian for end of life decisions. Two EEGs were given to determine that patient had no brain activity. Guardian, made the decision to end all life saving measures. Patient was taken off the ventilator on 1/9/2021 and passed away at 1:30am on 1/10/2021. The initial indication from the ICU doctor was the patient had a mucus plug that she couldn't clear."" "0933846-1" "0933846-1" ""1-2-2021 10:30 PM Complained Right arm/back hurt - took Tylenol 1-3-2021 Complained Right arm hurt, dizzy 1-4-2021 Felt better - did laundry, daughter found her deceased at 3:30 pm. Dr. at hospital said it was ""cardiac event"" according to death certificate."" "0934050-1" "0934050-1" "Staff reported that patient was found Friday morning (Jan 8) sitting at a table with his head tilted forward and unresponsive to verbal or physical stimuli. Staff lowered patient to floor and started CPR. EMS was called and continued CPR at scene, however they were not able to revive patient. Patient was pronounced dead at the scene. Staff written statements following the death of patient show that he had a fall about 1 hr. prior. It is unknown if this fall contributed to patient's death. An autopsy has been requested." "0934059-1" "0934059-1" "Acute anterior MI with death" "0934263-1" "0934263-1" "The resident resides in an independent living facility/apartment. The reporter at the center was informed by his daughter he was not feeling well on 1/1/2021 (specific symptoms could not be ascertained). He reportedly went to be COVID tested on 1/1/2020 and observed to be deceased in his apartment on 1/2/2020. I do not have confirmation of his COVID results, although the reporter indicates his daughter reports his test was positive." "0934373-1" "0934373-1" "Patient went to bed around 11pm on Saturday PM and sometime between then and 1:30am on Sunday morning got up and went into the living room without waking up her husband (which is normal). At 1:30am, the husband got up to use the restroom and she was out of bed then, but the husband did not know if she was having any problems at this time. When he got up at 7:45am, she was in the recliner and did not move or anything, which is normal for her. At 8:45am, the husband went back into the living room and tried to wake his wife and that is when he noticed there was no pulse and he called 9-1-1 at this time. EMS got on scene and did CPR for 30 mins and she was pronounced dead at 9:21am." "0934507-1" "0934507-1" "Resident died suddenly and expectantly on 01/05/2021" "0934539-1" "0934539-1" "Patient received COVID-19 (Moderna) vaccine from the Health Department on afternoon of January 8, 2021 and went to sleep approximately 2300 that night. Was found unresponsive in bed the following morning and pronounced dead at 1336 on January 9, 2021" "0934745-1" "0934745-1" "Resident had seizure like activity followed by a vagel response with large bowel movement. Resident then began to show signs of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low oxygen levels. Resident not responding to stimuli." "0934966-1" "0934966-1" "COVID-19; COVID-19; Pneumonia; respiratory failure; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Jan2021 for COVID-19 immunization. Medical history included Alzheimer's and others. No known allergies. Concomitant medications included unspecified medications. The reporter's mother in law was tested for COVID-19 at a nursing facility on 25Dec2020 and she was negative. On 02Jan2021, she received the first dose of Pfizer vaccine. On 04Jan2020, she developed a high fever, needed oxygen and was positive for COVID-19. Date of death was 04Jan2021. The cause of her death was listed as pneumonia, respiratory failure and COVID-19. No autopsy performed. No treatment received. No one knew if the vaccination contributed to her death. It was hard to know if her death was due to the administration of the vaccine or it exacerbated the COVID19 symptoms which led to her death. Since this was unknown, it could have been a possibility. The reporter wanted to give us this information because we might want to consider having high risk population, patients with underlying conditions, older population tested for COVID-19 prior to the vaccination, as this is not currently a recommendation or a requirement. All is very new and they are all learning so the reporter wanted to share this information with us. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There are medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was fatal. Information about Lot/Batch has been requested.; Sender's Comments: The association between the fatal event lack of effect (pneumonia, respiratory failure and COVID-19) with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19" "0934968-1" "0934968-1" "he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless; not feeling well; ate a bit but not much; kind of pale; Agitated; Vomiting; trouble in breathing; This is a spontaneous report from a contactable consumer (brother of the patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 04Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes and high blood pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for diabetes, glimepiride (MANUFACTURER UNKNOWN) taken for diabetes, lisinopril (MANUFACTURER UNKNOWN), and amlodipine (MANUFACTURER UNKNOWN). The patient experienced not feeling well, ate a bit but not much, kind of pale, vomiting, trouble in breathing, and agitated on 04Jan2021; body was hyper dried and restless on 05Jan2021; mind just seemed like it was racing on 06Jan2021; and not responsive and he passed away on 06Jan2021 at 10:15 (reported as: around 10:15 AM). The clinical course was reported as follows: The patient received the vaccine on 04Jan2021, after which he started not feeling well. He went right home and went to bed. He woke up and ate a bit but not much and then was kind of pale. The patient then started to vomit, which continued throughout the night. He was having trouble in breathing. Emergency services were called, and they took his vitals and said that everything was okay, but he was very agitated; reported as not like this prior to the vaccine. The patient was taken to urgent care where they gave him an unspecified steroid shot and unspecified medication for vomiting. The patient was told he was probably having a reaction to the vaccine, but he was just dried up. The patient continued to vomit throughout the day and then he was very agitated again and would fall asleep for may be 15-20 minutes. When the patient woke up, he was very restless (reported as: his body was just amped up and could not calm down). The patient calmed down just a little bit in the evening. When the patient was awoken at 6:00 AM in the morning, he was still agitated. The patient stated that he couldn't breathe, and his mind was racing. The patient's other brother went to him and he was not responsive, and he passed away on 06Jan2021 around 10:15 AM. It was reported that none of the symptoms occurred until the patient received the vaccine. Therapeutic measures were taken as a result of vomiting as aforementioned. The clinical outcome of all of the events was unknown; not responsive was not recovered, the patient died on 06Jan2021. The cause of death was unknown (reported as: not known by reporter). An autopsy was not performed. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: not responsive and he passed away" "0935222-1" "0935222-1" "Patient was reported to be deceased at home by law enforcement on 1/7/21" "0935343-1" "0935343-1" "There were no adverse reactions. Resident Died, she had a history of issues with her health prior to the vaccine." "0935350-1" "0935350-1" "Patient was found unresponsive at home with SpO2 20% 1/2/2021" "0935511-1" "0935511-1" "Patient received the 1st dose of Moderna and was found deceased in her home the next day." "0935767-1" "0935767-1" "My mother was given Pfizer vaccine on Thursday and she died 3 days later yesterday on Sunday!!!" "0935815-1" "0935815-1" "Difficulty breathing, death." "0936043-1" "0936043-1" "RESIDENT 1ST DOSE OF MODERNA VACCINE ADMINISTERED ON 01/04/2021 AT 8:30PM, RESIDENT FOUND UNRESPONSIVE ON 01/05/2021." "0936738-1" "0936738-1" "loss of consciousness Narrative: Patient received COVID-19 vaccine dose #1 on 1/6/21 w/o complications. Per 1/6/21- 1/9/21 nursing notes, patient did not experience any injection site reactions, denied pain or tenderness at injection site, no dizziness, no n/v, remained afebrile. Around 1/9/21 @1810, patient became acutely nonresponsive after being helped to the edge of bed. Per nurses, he was previously awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency team called d/t patient's sudden change of condition. Emergency team helped patient into lying position. Per 1/9/21 ICU emergency team note, patient appeared comfortable w/ no palpable radial pulse and had minimal shallow agonal breathing. Pulse ox 94%, HR in 60s per machine. BP unmeasurably low by BP cuffx3. Resident passed at 18:20 pm." "0936805-1" "0936805-1" "Patient received the vaccine on 12/22/20 without complication. It was reported today that the patient was found unresponsive and subsequently expired at home on 1/11/21." "0937127-1" "0937127-1" "The facility had positive cases of COVID when we were able to begin vaccinating residents. Within about a week of vaccination, patient was tested positive for COVID. He was 91 years old and his immune system did not have the time to allow the vaccine to begin working before exposure. His age was a major contributing factor to his death." "0937152-1" "0937152-1" "The facility had positive cases for COVID 19 when the vaccine was received and administered to patient. With her advanced age and chronic conditions, she did not have time to build immunity between the time of vaccination and her testing positive." "0937186-1" "0937186-1" "The facility had a number of positive COVID 19 cases prior to patients vaccination. Due to her advanced age, chronic condition, and exposure, patient did not have the time to build immunity after exposure before becoming positive." "0937434-1" "0937434-1" "Pt expired due to possible cardiac arrest. Unsure if this was vaccine related." "0937444-1" "0937444-1" "Resident was found deceased at approximately 6pm in her apartment" "0937527-1" "0937527-1" "unsure if related to vaccine, but was notified by her next of kin that she died on 1/4/2021. No reports of side effects or hospitalization were reported to the facility prior to the notification of death." "0937569-1" "0937569-1" "patient reported expired 1/7/2021" "0937818-1" "0937818-1" ""This is being reported because of the incident occurring 2 days after the Moderna Covid-19 vaccination. It was reported that the patient expired on 1/9/21, 2 days after receiving the Moderna vaccine. Upon screening of patient prior to administration on 1/7/21, the patient completed paperwork answering NO to the following ""Do you currently have any active infections or acute respiratory illness or fever."""" "0938118-1" "0938118-1" "on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm" "0938974-1" "0938974-1" "Hospice Resident received first Covid 19 vaccine dose on 1/6/21. 1/7/21 resident had decreased appetite noted in am but ate 100% of meal at dinner. 1/9/21 resident had decreased appetite with emesis x 2, loose BM x 2. Call placed to hospice. 1/10/21 5:44 am resident able to take HS meds, ingest 2 cups of shake. No emesis or loose stool noted. 12PM nurse noted resident not eating meals but ingesting milkshake and medications without any problems. Hospice contacted for change in condition. 1:00 pm hospice ordered Phenergan 12.5 mg Q 6 hrs PRN. Labs to be drawn 1/11/21. Hospice notified POA. 1/11/21 12:24am Resident had blood in stool. Resident denies any pain, on 2L of O2 for comfort." "0939050-1" "0939050-1" "Patient vaccinated on 12/28. Approximately one day later, develops cough and on azithromycin x 1 week. On 1/3, patient develops left-sided weakness and aphasia. Taken to the hospital, tested COVID+, required intubation -- acute hypoxic respiratory failure secondary to COVID - on H&P. Patient died on 1/4/21 at 7:20am." "0939270-1" "0939270-1" "Sudden cardiac death" "0939845-1" "0939845-1" "Three hours after receiving COVID 19 vaccination, Patient oxygen level decreased to a critical level and went into cardiac arrest. Staff performed full code but was unable to bring back patient from cardiac arrest." "0940822-1" "0940822-1" "patient passed away after receiving the Covid vaccine; This is a spontaneous report from a contactable nurse. An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular into the right arm on 07Jan2021 at 0.3 mL, single for covid-19 immunization. There was no medical history and no concomitant medications. On 08Jan2021, the patient passed away after receiving the COVID vaccine. The patient died on 08Jan2021. An autopsy was not performed. Investigations indicate that unspecified labs were done, but nothing two weeks prior; no further details were provided. The patient received the first dose the day prior. The reporting nurse discussed it with the medical director, and he thought that he potentially passed away from the COVID vaccine. The relatedness of the event to the suspect vaccine was reported as related by the reporting nurse per The Agency. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender's Comments: Based on the limited information available, it is medically not possible to make meaningful causality assessment, it is unlikely the vaccine could have contributed to the death of the patient based on the known safety profile. However case will be reevaluated when additional information is received during the follow-up The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Stated that the patient passed away after receiving the Covid vaccine" "0940855-1" "0940855-1" "Patient received her vaccination on 1/12/21 administered by pharmacy*+. She expired on 1/12/21 an approximately 7:30pm. Resident did not have any adverse reactions and was a hospice patient." "0940866-1" "0940866-1" ""Patient was found ""acting abnormal"" on 1/9/2021 at 1215. VS HR 20-30's. EMS activated. EMS arrived and patient was found pulseless in PEA/ asystole, CPR and ACLS initiated and then transported to the MC. Unsuccessful resuscitation and expired on 1/09/2021 at 1348. Clinical impression Cardiopulmonary arrest."" "0940955-1" "0940955-1" ""Cardiac Arrest; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 66-year-old female patient (pregnant at the time of vaccination: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via intramuscular at left arm on 11Jan2021 12:15 PM at single dose for COVID-19 immunization. Medical history included diastolic CHF, spinal stenosis, morbid obesity, epilepsy, pulmonary hypertension and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient received medication within 2 weeks of vaccination included amiodarone, melatonin, venlafaxine hydrochloride (EFFEXOR), ibuprofen, aripiprazole (ABILIFY), lisinopril, cranberry capsules, diltiazem, paracetamol (TYLENOL), famotidine, furosemide (LASIX [FUROSEMIDE]), ipratropium bromide, salbutamol sulfate (IPRATROPIUM/ALBUTEROL), buspirone, senna alexandrina leaf (SENNA [SENNA ALEXANDRINA LEAF]), polyethylene glycol 3350 and morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took Penicillin, propranolol, quetiapine, topiramate, Lamictal and had allergy to them. Patient used took the first dose of BNT162B2 (lot number: EJ1685) via intramuscular at right arm on 21Dec2020 12:00 PM at single dose for COVID-19 immunization. Since the vaccination, the patient been tested for COVID-19 (Sars-cov-2 PCR) via nasal swab on 06Jan2021, covid test result was negative. Patient was found pulseless and breathless 20 minutes following the vaccine administration (11Jan2021 12:30 AM). MD found no signs of anaphylaxis. Patient died on 11Jan2021 12:30 AM because of cardiac arrest. No treatment received for the events. Outcome of pulseless and breathless was unknown. the autopsy was performed, and autopsy remarks was unknown. Autopsy-determined cause of death was unknown. It was reported as non-serious, not results in death, Life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.; Sender's Comments: Based on the available information this patient had multiple underlying medical conditions including morbid obesity, diastolic CHF, epilepsy, pulmonary hypertension and COVID-19 diagnosed prior to vaccination. All these conditions more likely contributed to patients cardiac arrest resulting in death. However, based on a close temporal association (""Patient was found pulseless and breathless 20 minutes following the second dose of BNT162B2 vaccine administration, contributory role of BNT162B2 vaccine to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: autopsy remarks was unknown. Autopsy-determined cause of death was unknown"" "0941215-1" "0941215-1" "Actual event and cause of death were unknown; This is a spontaneous report from a non-contactable consumer. A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID Prevention. The relevant medical history included aortic valve replacement from Nov2019. Concomitant medications were not reported. The consumer stated that she was taking the reporting responsibilities to report that a friend of hers, informed that the patient passed away on Friday, and had received the COVID vaccine on Wednesday. The consumer stated that it was unknown to her at this time, if the friend had called to complete a report herself, regarding the incident. Their conversation was very brief. The patient was 90 years old, and it was her friend's mother that was the patient. Actual event and cause of death were unknown. The patient had her vaccine on Wednesday 06Jan2021, and then the patient collapsed in front of the reporter at Friday night on 08Jan2021 and passed away that same day. The autopsy was unknown. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Actual event and cause of death were unknown" "0941561-1" "0941561-1" "Staff walked into resident's room around 10:00am and noted resident's left side of his face was flaccid. Nurse was called and upon assessment resident noted to have an unequal hand grasp with left worse. He was able to talk but was mumbled and hard to understand. Physician, hospice, and family were notified. Resident had a stroke at 10:06 am on 1/8/2020. He lost all ability to use his left side. Resident passed away on 1/11/2020." "0941607-1" "0941607-1" "The patient passed away today, 1/13/2021. She was a hospice patient. She showed no adverse effects after receiving the vaccine on 1/12/2021. This morning she woke up as normal and during her morning shower she had a bowel movement, went limp and was non-responsive. The patient passed away at 7:45 am." "0941743-1" "0941743-1" "This person was found to be deceased on routine rounds during the night, 3am. No symptoms of reaction noted post vaccine. No injection site reaction. No reports of any allergic reaction." "0942040-1" "0942040-1" "little bit of a reaction light headed after 5 minutes. vitals were low, so observed for 30 minutes after being light headed. Patient was found unresponsive and pronounced dead later that day." "0942072-1" "0942072-1" "Death occurred 3 days after vaccine receipt; attributed to complications of her chronic advanced dementia with aspiration at age 87. No evidence of acute vaccine reaction." "0942085-1" "0942085-1" "No adverse effects from vaccination seen on 1/2/21. On 1/6/21 resident was seen by Dr and her baclofen pump was refilled with 20 ml Baclofen 4,000mcg/ml. ITB Rate increased by 6% to 455.5 mcg/day simple continuous rate over 3 days. On 1/8/21 at 0615 resident was shaking, lower extremities mottled, Sa02 70%, pulse 45. Oxygen started at 2 L/m per NC. At 0715 her primary physician was notified as well as her daughter. Oxygen increased to 4 L/min, sats at 83%. SOA noted, reported all over pain. At 0850 when they attempted to reposition the resident, she was not responsive. Licensed nurse assessed her and no heartbeat heard or pulse found." "0942106-1" "0942106-1" "54 y/o M with PMH of HTN, HLD, Alcoholic Cirrhosis, Aortic Valve Stenosis, and angina BIBA as a Medical Alert for cardiac arrest noted PTA. Per EMS, the patient called because he was having constant, diffuse abdominal pain x 1 day that radiated to his chest. On scene, the patient had a witnessed arrest with EMS starting CPR. He was given 3 rounds of epi without ROSC. Pt had no associated shockable rhythm. Of note, pt's wife, had noted pt had received covid vaccine the prior day." "0942290-1" "0942290-1" "Resident received 1st dose on 1/4/2021. On 1/6/2021 resident having SOB, increased weakness with O2 sats at 91% RA. On 8th resident sustained a fall, O2 sats 88-92, dizzy, weakness. Rapid COVID test performed with negative results. Evening of 8th resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the ER on 1/9/2021 with new diagnosis of Leukemia and orders for hospice. Continued with fever, crackles and N/V and loss of appetite from the 9th and 10th of January. Resident expired at 820am on 1/11/2021." "0943266-1" "0943266-1" "Initial pain in back of head and extreme headache. Some vomiting. At emergency, went into coma and was intubated. Hole drilled in skull to relieve pressure. MRI taken. Lot of bleeding in brain - anuerism lead to death approximately 14 hours after initial symptoms." "0943362-1" "0943362-1" "Pt collapsed at home approx 5:30 pm and died" "0943397-1" "0943397-1" "On day due for 2nd dose, Patient was found unresponsive at work in the hospital. Patient pupils were fixed and dilated. Full ACLS was initiated for 55 minutes with multiple rounds of bicarb, calcium chloride, magnesium, and epinephrine. Patient was intubated. Patient continued into V. Fib arrest and was shocked multiple times." "0944282-1" "0944282-1" "resident coded on 09Jan at 8am and expired; This is a spontaneous report from a contactable Other Health Professional. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly in left arm on 05Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included DM2(Type two diabetes mellitus), CHF(congestive heart failure), open wound, wound infection, heart failure. Allergies to medications, food, or other products: none. Concomitant medications included unspecified products (List of any other medications the patient received within 2 weeks of vaccination: yes). If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. The resident coded on 09Jan2021 at 8 AM and expired. The patient died on 09Jan2021. An autopsy was not performed. AE resulted in: patient died. Death cause: unknown at this time. Was treatment received for the adverse event: Unknown. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Serious: Yes. Seriousness criteria-Results in death: Yes. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.; Sender's Comments: The old patient had diabetes mellitus, congestive heart failure, open wound complicated by infection, all these pre-existing medical conditions contribute to the patient death. More information including complete medical history, concomitant medications and event term details especially death cause and autopsy results are needed for a full assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: resident coded on 09Jan at 8am and expired" "0944365-1" "0944365-1" "Resident expired on 12/30/20, dx cardiac arrest." "0944439-1" "0944439-1" "Resident expired on 1/2/21." "0944595-1" "0944595-1" "Cardiac arrest within 1 hour Patient had the second vaccine approximately 2 pm on Tuesday Jan 12th He works at the extended care community and was in good health that morning with no complaints. He waited 10-15 minutes at the vaccine admin site and then told them he felt fine and was ready to get back to work. He then was found unresponsive at 3 pm within an hour of the 2nd vaccine. EMS called immediately worked on him 30 minutes in field then 30 minutes at ER was able to put him on life support yet deemed Brain dead 1-14-21 and pronounced dead an hour or so later" "0944641-1" "0944641-1" "Patient died on 1/21-2021" "0944732-1" "0944732-1" "Resident found unresponsive and without pulse at 05:45am." "0944998-1" "0944998-1" "On 1/11/21 noted with headache, nausea/vomiting, severe melaise. On 1/12/21 resident expired." "0945241-1" "0945241-1" "71yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, VS taken at 10am, B/P 99/60, O2 sats, 95% (trach w/O2). At 11:30am, Patient showed no s/sx of distress, A&Ox3. At 11:50am, a nurse went to perform a COVID test and assessment (the facility is experiencing an outbreak), and found the patient unresponsive on the bathroom floor. CPR was immediately started; no shock advised per AED; 12:15pm EMS arrived and took over. At 12:38pm, EMT called time of death." "0945247-1" "0945247-1" "Has underlying dementia and often with difficulty eating. 1 week after immunization she developed a stroke with left sided weakness and difficulty swallowing. Comfort measures instituted. Not sure if this is related to the vaccine, but thought I should report" "0945253-1" "0945253-1" ""83yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, the patient reportedly got up in the middle of the night with c/o feeling ""blah"", restlessness, and nausea. VS normal, no other s/sx. At 4:15am, the patient was asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do morning VS and found the patient unresponsive, no pulse, no respirations. GNA notified the nurse. At 6:03am, CPR started and EMS called. At 6:15am, EMS arrived and took over. At or around 6:30am, EMT called time of death"" "0945578-1" "0945578-1" "No reactions immediately after vaccine was given. Resident has dementia, has had multiple hospitalizations related to a renal stone recently. Had a tooth that was bothering her, went to see her dentist and it was extracted on 1/6/21. On 1/10 they noted feet and ankles are dark purple with white splotches appears to be mottling. Minimally responsive to voice and touch. Not eating. Compassionate visit with family. Family did not want hospice, did not feel it was needed, said, what more could they do for her than you're already doing? On 1/11 at 1950 was determined to be deceased." "0945603-1" "0945603-1" "Had no immediate issues with the vaccine. He had returned from the hospital on 12/21 and had some concerns about his weight which were shared with his physician on 1/4/21. On 1/5/21 had a visit with his cardiologist for a pacemaker check. On 1/8/21 staff were called to his room, he was on the floor, bluish skin color. No vital signs found, no heart rhythm heard at 2200." "0946225-1" "0946225-1" "At approximately 10:30pm on 1/14/2021, resident was noted to have a rash on her face, hands, arms, and chest. VS:100.2, 113, 20,108/59, 84% room air. applied nasal cannula at 4-L, telephoned Physician orders 6mg Decadron one time order, a second set of Vitals , reads 99.3, 110, 20, 106/60, 90% on 4-L N/C. On coming shift advised. At approximately 2:00am on 1/15/2021, resident congested and coughing. BP 151/70, pulse 124, temp 98.1 forehead, resp 20 and pulse oc 79% on 3L. At approximately 2:30am PRN cough syrup and breathing tx. Resident's condition began to worsen with breathing tx. This LPN updated at 0248 doctor on resident's condition. Doctor gave permission for resident to go to hospital. At 4:19am the Er called to say resident passed away." "0946293-1" "0946293-1" "51 year old M with h/o O2 dependent COPD, Severe pulmonary fibrosis became increasingly hypoxic around 1800hours 1/7/2021. He was transported to hospital for acute on chronic hypoxia respiratory failure. On 1/12/2021 he decompensated further, and after discussing with family and palliative care, He was changed to comfort care. He expired on 1/12/2021@2325 at medical center." "0946959-1" "0946959-1" "Sudden death 18 hours post vaccine ." "0947129-1" "0947129-1" "Resident received Moderna vaccine on 12/23/2020 around 5 pm. At approximately 3:35 am on 12/25/2020, resident had a CVA and died on 1/1/2021 at 3:00 am." "0947642-1" "0947642-1" "died two days after receiving the vaccine; Fever; This is a spontaneous report from a contactable consumer (patient's stepchild). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 07Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included an unspecified statin. The patient experienced fever on 08Jan2021. The patient died two days after receiving the vaccine on 09Jan2021, which was reported as fatal. The clinical course was reported as follows: The patient had a fever the day after getting the vaccine and then he just died in the middle of night. It was reported that it was not clear what exactly happened, but they are looking into this. The clinical outcome of fever was unknown and of died two days after receiving the vaccine was fatal. The patient died on 09Jan2021. The cause of death was not reported. An autopsy was not performed (was reported to be taking place soon). The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: died two days after receiving the vaccine" "0947662-1" "0947662-1" "Accelerated decline in condition with decreased input, decreased responsiveness, somnolence, and death" "0947841-1" "0947841-1" "Patient had no immediate effects from the vaccine, but died approximately 8 hours after receiving first dose of vaccine." "0947891-1" "0947891-1" "Resident experienced an overall decline in condition on 1/8/21 and continued to decline until he passed away on 1/13/21." "0948150-1" "0948150-1" "increase weakness and fatigue, weakness in extremities, incontinent, jerky arm movements, within first 24 hours, continue to decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds diminished, loss consciousness and passed away. 01-12-2021" "0948164-1" "0948164-1" "Abdominal pain, Headaches, chest pain, loss of appetite, confusion, elevated liver enzymes 1/8-1/15/21" "0948228-1" "0948228-1" "Patient reportedly expired the day following receipt of the vaccine." "0948418-1" "0948418-1" "Expired on 1/12/2021; unknown cause of death" "0949474-1" "0949474-1" "Resident had lunch on 01/14/21 and after lunch around 2:00pm, he vomited and stopped breathing. We coded the resident and 911 paramedics came. They pronounced him dead at 2:18pm." "0949523-1" "0949523-1" "Around 00:50am on 01/15/21, C.N.A. reported that the resident looked different and not responding. Initiated Code Blue and started CPR. 911 arrived and pronounced resident dead at 1:01 am." "0949630-1" "0949630-1" "This patient has been under hospice care for over 2 years at the nursing home. She has had a steady decline with gradual weight loss. She was totally dependent in her care needs. She received the vaccine on 1/2/2021 as part of the facility vaccination campaign. No adverse events noted initially. On 1/3/2021 at 6:06 pm, she was noted on vital sign checks (done every 4 hours for first 72 hours after vaccination) with BP 64/52 but otherwise asymptomatic. Subsequent BP improved. On 1/4/2021 at 4:45 am, pt found with respiratory rate of 30 with otherwise normal vital signs. Tachypnea persisted, so she received liquid morphine 2.5 mg without improvement. Supplemental oxygen was applied. Tachypnea persisted. She had poor oral intake after that point had persistent tachypnea and worsening hypoxemia despite clear lungs on exam. She remained under hospice care and comfort measures were continued. No blood testing or imaging tests were done. She required increasing amounts of oxygen, became hypotensive, and died peacefully on 1/8/2021 at 7:45 pm." "0949657-1" "0949657-1" "Veteran was found by family slumped over and unresponsive at the breakfast table on 1/13/21, had expired" "0949965-1" "0949965-1" "Patient 101 years old, nursing home resident, received vaccine 1/11, on 1/13 found on floor without obvious trauma, unresponsive. Brought to ED and was bradycardic, hypotensive, hypothermic and refractory to aggressive medical management. No obvious cause of death found on exam or labs, cxr. Unknown if event could be related to vaccine or not. Medical Examiner accepted case although initially unknown that patient had recently received vaccine. ME updated with that information today as soon as discovered." "0950057-1" "0950057-1" "Patient suffered a cardiac arrest and was unable to give details about her symptoms. Per husband, patient did not complain of any symptoms after vaccine administration. She began seizing without warning which was complicated by cardiac arrest of uncertain etiology" "0950073-1" "0950073-1" ""On 1/15/2021 at 1800, resident noted to be lethargic and shaking, stating ""I don't care."" repeatedly. C/O head and neck pain. T100.6. Given Tylenol with no relief of pain. Order received for Aleve and administered.. Assisted to bed as usual in evening. Monitored during night shift and noted to be resting comfortably/sleeping.. Noted agonal breathing at 4:10 AM 1/16/2021 , T 99.4, Absence of vital signs at 4:15AM 1/16/21 and death pronounced at 4:40AM 1/16/21."" "0950108-1" "0950108-1" """"Moderna COVID-19 Vaccine EUA"" It has been reported to me that pt. had gone into hospital for a heart catheterization on 1/12/2021. It was found during this procedure that pt. had suffered a MI. She was release to home the following day and passed away at her residence on 1/15/2021."" "0950441-1" "0950441-1" "Pt had witnessed arrest by wife. Pt wife started CPR and called EMS. CPR started at 15:12. Continued by EMS. Pt arrived to medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He was unresponsive to verbal and tactile stimulus and had fixed unreactive pupils. He was pronounced at 16:13." "0950893-1" "0950893-1" "Death" "0950979-1" "0950979-1" "Headache after dose was given at 10:00 a.m Died at after 7:30 pm the same night the dose was given." "0951101-1" "0951101-1" "PATIENT GOT HER FIRST COVID PFIZER VACCINE AT 12/31 IN THE AM. HAD GOTTEN FLU LIKE SYMPTOMS AND HAD BEEN SICK FOR A COUPLE OF DAYS. HAD NAUSEA AND VOMITTING DURING THIS TIME AS WELL. ON 1/3 THE CARE GIVER WENT TO CHECK ON HER PT AT HER LTC FACILITY WHERE SHE LIVES AND SHE WASN'T ACTING RIGHT. SHE WAS UNABLE TO DO A STROKE EXAM. PT HAD NO MOVEMNET IN ARMS OR LEGS AND WAS UNABLE TO SPEAK. PT WAS VITALLY STABLE AT THE TIME. EMS RECORDED THAT THEY THOUGHT DIAGNOSIS WOULD BE STROKE, PNEUMONIA OR SEPSIS. AFTER ARRIVAL AT THE HOSPITIAL DETERMED THAT SHE HAD A STORKE, ACUTE KIDNEY INJURY, ABNORMAL LFTS." "0951518-1" "0951518-1" ""Narrative: Patient with severe aphasia and only able to say ""hey, hey, hey"" or ""uh huh"" or shake his head no as a way to communicate. Patient previously able to ambulate with significant limp and hyperextension of right knee, but mostly wheelchair bound over last several years as he had had a slow and steady decline in overall health and mobility. Patient developed aggressive behavior of shouting ""hey"" and grabbing of groin in 2016. This was worked up with CT scans, labs, referral to urology, neurology, and referrals to psychiatry. The exact etiology of this action was never able to be affirmed, but thought to be more psychiatrically related. It improved significantly with addition of antipsychotics, worsened when antipsychotics were reduced, and improved again with addition of injectable antipsychotic on 12-10-2020.Patient suffered from falls on occasion given his significantly impaired physical mobility. His last documented fall was 8-31-2019. Patient began utilizing wheelchair most of time following that fall. No significant injuries noted in documentation of the falls. In the last 3 months, patient would often refuse medications. He would sometimes indicate that they would cause dizziness, and other times he would simply refuse. We attempted to hide medications in his food/fluid (with wife's blessing) and when he detected this he would occasionally refuse to eat. Patient previously on DOAC. After pharmacy review in 12/2020 it was recommended to discontinue this as no clear indication to continue use. He was high fall risk and would often refuse this medication as well since 10/2020. Noted to be in NSR on EKGs and decision made to discontinue the DOAC. Patient had no evidence of adverse effects noted after vaccination on December 28th. Patient seen by provider on the morning of his death (1/4/2021) with no noticeable significant change in health condition. Temperature 36.8Con January 4th at 19:45. During routine bedtime cares, patient suddenly collapsed and death was pronounced January 4, 2021 at 20:05. Autopsy was requested from next of kin and no autopsy was granted. Symptoms: & DEATH Treatment:"" "0951519-1" "0951519-1" "Narrative: Symptoms: Palpitations & Syncope Treatment: EPINEPHRINE 1 MG ONCE ,EPINEPHRINE 1 MG ONCE ,SODIUM BICARBONATE 50 ML ONCE" "0951688-1" "0951688-1" "Resident expired 1/17/21" "0952204-1" "0952204-1" "Patient became sick 3 hours after the vaccine and was found deceased 1 day after his vaccination. He passed away in his sleep." "0952704-1" "0952704-1" "Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home." "0952713-1" "0952713-1" "Weakness, Low O2, death. Positive for COVID on 1/12/21, dies on 1/16/21" "0952799-1" "0952799-1" "On 1/17/2021 at 4:35 am resident found apneic and pulseless, at 4:40am death confirmed" "0952881-1" "0952881-1" "Resident was seen by MD on 1/11/2021 due to increasing in edema and shortness of breath. Lasix 40 mg STAT given. New orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on 11/23/2020. Labs were abnormal. Continued on the lasix 40 mgs. Resident remained short of breath with exertion and on oxygen. He was assisted to the toilet on 1/15/2021 in the morning where he subsequently passed away." "0953129-1" "0953129-1" "Patient presented to our Emergency Department via EMS in full code status; asystole. Patient expired. Per nursing, husband stated patient awoke this AM and reported pain in back between shoulders and in bilateral shoulders. Patient then went unresponsive and husband called EMS." "0953183-1" "0953183-1" "1/11/21 at 8:57 Resident with fever and at 11 am saturation down to 83 O2 to 10 liters. Resident continued to decline until CTB on 1/14/2021 at 1325" "0953348-1" "0953348-1" "Patient was living in a nursing home with positive cases when administered. His age and chronic condition was such that he did not have time after the vaccination to avoid exposure or develop immunity." "0953590-1" "0953590-1" "resident expired; This is a spontaneous report from a contactable healthcare professional. An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0140), intramuscular in the left arm on 05Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included metabolic encephalopathy from, failure to thrive (FTT), diabetes mellitus (DM) 2 , chronic obstructive pulmonary disease (COPD), arthritis, weakness, hyperlipidemia, chronic kidney disease (CKD), dementia. Known allergies was none. The patient took unspecified concomitant medication. On 11Jan2021, the resident expired. The patient underwent lab tests and procedures which included nasal swab: negative on 09Jan2021. There was no treatment given for the event. The patient died on 11Jan2021. An autopsy was not performed.; Sender's Comments: Lacking information on the cause of patient's demise, the Company cannot completely exclude a causal relationship between COVID 19 vaccine, BNT162B2, and patient's death of unknown cause, as a cautionary measure and for reporting purposes. The patient's pre-existing medical condition of metabolic encephalopathy from, failure to thrive (FTT), diabetes mellitus (DM) 2 , chronic obstructive pulmonary disease (COPD), arthritis, weakness, hyperlipidemia, chronic kidney disease (CKD), dementia may have provided the contribution to the event in this 82-year-old male patient. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: resident expired" "0953754-1" "0953754-1" "patient suddenly developed pneumonia 7 days after vaccination and died the evening of developing pneumonia" "0953785-1" "0953785-1" "Death" "0953858-1" "0953858-1" "patient started to decline 1/10/2021, patient seen at facility by medical professional - patient deceased 1/13/2021" "0953865-1" "0953865-1" "REPORTING ONLY AS RESIDENT EXPIRED ON 1/17/2021 3 DAYS AFTER. S/S HYPOXIA/CONGESTED LUNG SOUNDS" "0953922-1" "0953922-1" "The day following the vaccine, the patient complained of throat issues and anxiety. This was not new... however . That evening he reported difficulty breathing and was placed on oxygen; a COVID test was performed and was negative. On 12/30/2020, patient complained of sternal pressure and was transferred to the hospital. The patient died 12/31/2020 and records obtained from the hospital indicated the patient died from a massive myocardial infarction." "0954251-1" "0954251-1" "71 year old woman at rehabilitation center for physical therapy with history of cirrhosis of the liver, asthma, and heart condition was tested for COVID-19 on 01/07/21, received 1st dose of Pfizer COVID-19 vaccine on 01/08/21, positive test result for COVID-19 received on 01/09/21. She was sent to the hospital and admitted on 01/12/21 after O2 was 70% and was in a confused state. Patient passed away on 01/17/21." "0954780-1" "0954780-1" "On 1/13/2021, resident had sudden emesis. Immediately following emesis he was noted without a pulse and pronounced deceased. No acute symptoms noted prior to this episode. Resident does have a significant cardiac history." "0954812-1" "0954812-1" "She had the first dose of Pfizer vaccine at the Campus on Friday 1/15 at 4:30 pm. After the vaccine, she had no new symptoms or signs of vaccine reaction and MD friend reports that he checked her pulse which was not elevated from baseline. On 1/16, she awakened and continued to feel at her recent baseline. However, in the early afternoon, she complained of headache, nausea/epigastric pain, and chest heaviness. These apparently were not unusual symptoms for her to feel intermittently. Per her niece, who has a home O2 sat device, her 02 sat that morning was 97 with a HR of 87 irregularly irregular. She was afebrile. (continue on page 2)" "0955261-1" "0955261-1" "Death" "0955390-1" "0955390-1" "Resident received vaccination on January 15, 2021. She was found unresponsive with shallow respirations on the morning of January 16, 2021 and was sent to ER via ambulance. The resident was admitted to medical center ICU where she passed away later that day." "0955425-1" "0955425-1" "resident had a pressure ulcer to RT hip, was getting treatment on. Was scheduled to have wound debrided and wound vac applied on 1-19-2021. Appetite was poor, not wanting to get out of bed, and decline in alertness. Passed away on 1-16-2021" "0955426-1" "0955426-1" "1120: Drooling, Rt side facial drooping, BP: 60/30; 911 contacted; became unresponsive on toliet; shallow deep breathing; transferred to Wheelchair; EMS arrived and transferred to ED; In hospital cause of death listed Cardiac Pulmonary Arrest; Date of death 1/17/21" "0955436-1" "0955436-1" "patient received vaccine 12/29. Unexpected death 1/5." "0955597-1" "0955597-1" "Death" "0955959-1" "0955959-1" "Patient died 1 week after vaccination. According to family was having very rapid decline in status in recent weeks and they did not think related to vaccination." "0956365-1" "0956365-1" "12/28/2020: generalized weakness and fell twice at home, cough, nausea,1/04/2021: cough, nausea, fever and chronic pain when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on bipap, 1/15/2021: pt was intubated, on TPN, pt DNR, 1/18/2021: was extubated and put on comfort measures and passed away" "0956458-1" "0956458-1" "Patient was vaccinated for SARS-CoV-2 on 6-Jan-21 at his site of employment, a Nursing Home. Patient presented to Urgent Care on 15-Jan-21 complaining of left sided chest pain that started the evening before with an associated slight cough. Pt was afebrile with a heart rate of 88 and an O2 sat on room air of 98% in triage. His EKG showed a sinus tachycardia of 114 with a slightly prolonged QTc of 463 ms. Physical exam was significant for bibasilar crackles and X-ray showed bibasilar infiltrates consistent with COVID pneumonia but bacterial pneumonia could not be excluded. The patients BP was documented as 97/64. He was treated with Zofran for nausea and tylenol. He was prescribed a five day course of Azithromycin, an Albuterol inhaler, guaifenessin with codeine cough syrup, and Zofran. Labs were drawn and he was discharged. His lab results were reported after his departure and were significant for a white blood cell count of 1.33, platelet count of 73, 2% myelocytes, 1% metamyelocytes, an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline phosphatase of 294 and AST of 112 with ALT noted to be within normal limit. His COVID nasopharyngeal swab from the visit was reported as negative and a swab performed at his employment on 13-Jan-21 was also reported to be negative. Patient could not be reached by phone after discharge from Urgent Care about these labs. On the evening of 16-Jan-21, Police Department received a 911 call about an adult at the patient's address who was found unresponsive. Upon arrival on scene, the patient was found to be deceased and a decision was made not to attempt to resuscitate. The death was deemed to be non-suspicious and the patient's body was transported to a funeral home. On 19-Jan-21, I contacted the State Medical Examiner's Office. They have decided to perform an autopsy and have recovered the CBC and chemistry specimens obtained for further testing." "0956761-1" "0956761-1" "Family was told that Patient expired in his sleep during the early morning hours of 1/15. I spoke with him the evening before (on 1/14), which was a day after he had received the Covid vaccine. He was not having any symptoms of allergy or reaction then. He did say that he felt tired, but he often complained of feeling tired over time." "0956843-1" "0956843-1" "Resident was found deceased in his bed at 7:15 am." "0956903-1" "0956903-1" "mi Narrative: patient with asymptomatic covid 19, covid positive 12/10/2020." "0956962-1" "0956962-1" "COVID 19 vaccine, unknown which company Chronically ill in a skilled nursing facility found diaphoretic, hypotensive, hypoxia to 85% arrived to Emergency dept in cardiac arrest Died within 65 minutes of nursing finding patient in distress Wife felt it may have been related to vaccine date of vaccination 1/6/20 hx covid 19 PNA in April 2020" "0956966-1" "0956966-1" "hypoxia, secretions,cough, dyspnea Narrative: ALS patient on hospice with ongoing history of aspiration pna, receiving tube feeds. Developed incr in secretions, hypoxeia, temp and with recently noted clogged feeding tube." "0956994-1" "0956994-1" "The patient had severe shortness of breath resulting in cardiac arrest on the 5th day after the vaccine. Shortness of breath started 12 hours after injection. On the 5th day, the patient was discovered to also have a rash throughout his body, but it is unknown when this rash started." "0957116-1" "0957116-1" "Sudden death without warning symptoms 4 days after vaccine. Many medical problems which most likely explain the outcome but spouse feels it is related and it is a new vaccine. Monitor for pattern?" "0957799-1" "0957799-1" "Presented to Urgent Care for weakness and confusion, transferred to ED, patient had a cardiac arrest and was unable to be resuscitated" "0958069-1" "0958069-1" "Started with cough, mild shortness of breath and feeling terrible in evening of 1/19." "0958072-1" "0958072-1" "Death 3 days after receiving 2nd dose of COVID vaccine, unknown if related to vaccine administration." "0958228-1" "0958228-1" "Patient has end stage renal disease and rapidly worsening dementia, family could no longer care for him at home, and he was admitted for 14-day quarantine prior to admission to inpatient hospice. Received vaccine on 1/12 without apparent adverse reactions. Patient started refusing oral intake on 1/16, and CMP on 1/17 showed hypernatremia 165 (new issue). His BUN 138 CREAT 6.93 K 5.2 were his baseline. He was found to be deceased on 1/18 at 11:18 pm." "0958322-1" "0958322-1" "Shaking and then became unresponsive" "0958443-1" "0958443-1" "death by suicide Narrative: death by suicide; 12/26/20, self inflicted gun shot wound; found deceased by family member" "0958565-1" "0958565-1" "Clients wife reported on 1/18/2021, that her husband died unexpectedly the day after receiving the COVID 19 vaccine. I called and spoke with her. She stated that the client had started experienced some tightness in his chest the evening of 1/11/2021. She stated that it was normal for him to have the tightness in his chest if he got stressed. She stated that she found him on the garage floor on 1/12/2021 at 2120. He was taken by ambulance to the hospital. She stated that the hospital told her that his COPD had caused him to go into arrythmia." "0958745-1" "0958745-1" "Resident was noted to have increase weakness on 1/15/2021. Resident was warm to touch with low grade fever of 99.3 F. Resident was up propelling self in w/c on 1/16/2021 he was pleasant, accepted medications and ate lunch. He was found slumped over in his w/c not responding and vital signs absent." "0958914-1" "0958914-1" "Death on 1/15/2020" "0958935-1" "0958935-1" "Sudden Death within 24 hours of vaccine" "0958971-1" "0958971-1" "Hemorrhagic Stroke, Right Basal Ganglion" "0959001-1" "0959001-1" "Patient woke apx 0200 complaining of nausea to group home staff. Vitals were checked at that time and WNL. Patient went back to bed. When staff went to wake patient apx 0530, he was unresponsive and had no pulse. Chest compressions were started and EMS called." "0959079-1" "0959079-1" "On 1/9/2021 observed with elevated respirations of 38-42 per minute, BP manually 72/50. pulse is jumping rapidly between 110-16 bpm. oxygen sat 76% RA, resident refusing oxygen at first attempt, allowed oxygen to be placed, is now 84% on 4L. resident shaking head yes that he is hurting, and yes that he would take medication for pain. Dr. notified, branch block. Received order for morphine 2mg per hr as needed for elevated respirations and pain. Dr. also gave orders to D/C Tamsulosin and finasteride. Resident continue with decreased O2 sats and elevated respirations. Absence of vital signs on 1/10/21 at 826PM." "0959167-1" "0959167-1" "Patient received COVID 19 vaccine 01/14/2021. Patient died in his sleep 01/16/2021." "0959179-1" "0959179-1" "Patient received COVID-19 vaccination on 1/14/2021. On 1/17/2021, patient was transferred to Hospital s/p multiple cardiac arrests. Patient was hyperkalemic and in acute renal failure at time of transfer. Hyperkalemia was treated, but the patient suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021. Ultimately we suspect that the patients condition was a direct result of his underlying disease states, but wanted to make sure reporting was made available." "0959272-1" "0959272-1" "Patient died 4 days after immunization. Probably unrelated to immunization, as patient has been in poor health and was receiving hospice services. I have no details related to his illness or symptoms. Daughter is the HIPAA/emergency contact and will have all the information needed." "0959356-1" "0959356-1" "Pt passed away the day after the vaccine was given." "0959568-1" "0959568-1" "Patient received her first dose of the Moderna COVID-19 Vaccination on Saturday January 16th 2021 at approximately 12pm. She completed all necessary screening forms and was deemed to be at low risk for serious allergic reactions. She tolerated the vaccination well, and no complications or immediate adverse events occurred. She was observed for a full 15 mins per CDPHE/CDC guidelines and left the Clinic in stable condition after her observation period was complete. On the morning of Tuesday, January 19th, 2021, the patient was found unconscious and unresponsive by her husband. She was transferred by Ambulance to Hospital shortly thereafter. She was diagnosed with a brain bleed that was determined to be inoperable. She was transferred to other Hospital for higher level care. She was seen by neurosurgery and diagnosed with a ruptured aneurysm. She was treated in the ICU for 24 hours, at which point her team determined that the severity of her brain bleed would not respond to treatment. Supportive cares were withdrawn on Wednesday Jan 20th, and she passed away shortly thereafter." "0959591-1" "0959591-1" "Resident has increase weakness and lethargy with abnormal labs. He was transferred to the ER. He was admitted to the hospital and treated for worsening AKI and hypotension." "0959929-1" "0959929-1" ""Narrative: Patient seen in ED 1-17-21 with c/c of ""bloated with epigastric pain"". Patient with complicated medical history including stage 1B pancreatic cancer (was currently on chemotherapy mFOLFIRINOX), and a leadless permanent pacemaker implantation on 1-11-21 for long episodes of SR with complete heart block following symptoms of syncope (other cardiac history: CAD s/p CABG 2009, PAF, and HTN). Regarding ER visit for epigastric pain, nothing notable was found on workup and patient was to discharge home to rest. There were available doses of COVID-19 Vaccine following a vaccine clinic that same day, and patient was offered and agreed to a dose of vaccine. Patient was monitored for 15 minutes post vaccine with no notable issues. The following day, Monday 1-18-21, patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees and that he had been ""feeling kind of bad all day"". Patient was advise to seek urgent medical care and reported back to ED on 1-19-21 at 00:55. Patient wasd admitted for SIRS (tachycardia and febrile) -- patient also reported diffuse myalgia. WBC WNL, CXR unremarkable for infection, UA neg for bacteria, LFTs WNL, blood cultures negative. Procalcitonin elevated at 17.8 -- suggesting inflammatory response. Patient initially reported feeling better on the morning of 1-19-21, but around 13:00 began rapidly declining (confusion, unable to walk) and started experiencing EKG changes (9 beats of SVT). Patient then coded and resuscitation was attempted for approximately 30 minutes. Patient did not survive the code. Coroner has been notified and family is considering autopsy at time of this report."" "0960460-1" "0960460-1" ""died; tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program, Pfizer First Connect. A 97-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 at 97-years-old at a single dose for COVID-19 immunization; administered by the nursing home. Medical history included glaucoma from an unknown date and unknown if ongoing. Concomitant medications included: ""used a sav for skin tears"", and ""eye drops for glaucoma"" from an unknown date to an unknown date. On 07Jan2021, the patient experienced: tested positive for COVID (medically significant). The patient died (death, medically significant) on 17Jan2021. The clinical course was reported as follows: The reporter stated that in regard to the patient's height and weight: ""was probably getting down to about five foot eight. Shrinking."" The reporter stated that If she remembered correctly, they were trying to maintain the patient's weight 135 to 136 pounds. The reporter stated that her father was in a nursing home. The patient received his first dose of the COVID vaccine on 30Dec2020. The patient died on 17Jan2021. The reporter stated that she ""wanted Pfizer to know that the little old people in the nursing might not be strong enough for the vaccine."" The reporter stated that she was ""not calling to complaining."" The reporter stated that there was nothing wrong with her dad. He was elderly with no health issues. ""He was literally on no medications. The only reason he was in the nursing home was because he was afraid to walk."" The reporter stated that she received a call about giving the patient the vaccine and she said yes because she wanted him to have the vaccine. One week after the vaccine, the patient tested positive for COVID ""like all the other people"" (no further details provided). The reporter stated that her dad had no symptoms of COVID. The director of nursing said the patient was doing so well. The patient ate his lunch, he laid down for nap, and at 14:30 he was gone. The patient ""went peacefully in his sleep."" The reporter then again stated that the patient literally had nothing wrong with him. ""They were shocked. They fed him and he took a nap. He was sleeping, but it was eternally."" The reporter stated that, ""it might not have been the Pfizer vaccine, maybe his heart wore out."" In regard to an autopsy: the reporter stated that they would get it done if needed. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 07Jan2021. History of all previous immunization with the Pfizer vaccine considered as suspect: none. It was unknown if there were additional vaccines administered on the same date of the Pfizer suspect, but the reporter doubted it. There were no prior vaccinations within 4 weeks. There were no adverse events following the prior vaccinations. The clinical outcome of the event, died, was fatal. The clinical outcome of the event, tested positive for COVID, was unknown. The patient died on 17Jan2021 due to an unknown cause of death. An autopsy was not performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: died"" "0960552-1" "0960552-1" "At approximately 930am I arrived at Memory Care. I met with the director of the facility and she directed me to where my team would be setting up. My team consisted of (technician), (nurse) and I. As we were setting up, the director asked how she can help. I explained to her that we would need a designated area for patients to be monitored after vaccination for 15 minutes and maybe even longer . I also explained that we would need one of her staff monitoring while we vaccinate. She agreed, and proceeded to designate her staff and the cafeteria area, facing the vaccination station,the monitoring station. Throughout the day, nurse and I were both vaccinating,while the staff of the facility would monitor the vaccinated patients. I would also stop occasionally to mix the vaccine and check the temperature of the aero safe. At approximately 12:50pm, the director rushed in and stated that a patient is not responding, and that she had been vaccinated. At that point, I grabbed epipens and a thermometer and I also instructed nurse to grab an Epipen and come with me. We followed the director to pt's room. Once we got to the room, the patient was in bed and there were 4 staff members standing bedside and one of them turned and stated the patient has passed. At that point I asked the staff how long ago did the patient get the vaccine, they stated about 30 minutes ago. They also stated that the patient was a hospice patient and that the patient had declined, and was rapidly detiorating and had not eaten or drank anything all day . They also stated that the patient had been monitored for 15 minutes post vaccination. I then left the room and grabbed the patients COVID Vaccine intake consent form. I looked at the answered questionaire and all the responses were circled NO. Patient had a temp of 96.5 at the time of vaccination.The vaccine administration information for Immunizer Section was filled out by Nurse. I then proceeded to ask the director once again if there were staff that was monitoring her for 15 minutes, the director stated they had staff monitoring her. She also stated the Hospice nurse has to announce her death, so they waited for the Hospice Nurse to come. I then called Corporate and explained the situation. After speaking to corporate, I also asked nurse, if she remembered the patient. She stated that she did and at the time of the vaccination the patient was not alert, there were two staff members with the patient. She was non oriented and she kept closing her eyes. At that point, Nurse stated that she asked the two staff members with her if this is how she usually is and if its ok to vaccinate her. Both Staff members stated that it its ok,this is how she is. The Nurse then proceeded to vaccinate. At approximately 3:10pm, as I was leaving I spoke to the director, and one of her Staff members. Staff that the patient has actually not eaten/ or drank anything for the past several days, including today(01/18/21). Staff also stated that on Friday, Jan 15th,2021, they had informed the family that the patient was rapidly detiorating. Staff also stated that the family knowingly gave the consent to vaccinate her. She also stated that the hospice Nurse believes that the death was primarily caused by her detiorating state. She also stated that the hospice Nurse informed that the death was not due to the Vaccine. Per Lead Pharmacist at the clinic." "0960752-1" "0960752-1" "Extreme Fatigue" "0960841-1" "0960841-1" "Patient developed 104.4 temp approximately 48 hours after being given the vaccine. I treated him with antibiotics, IV fluids, cooling methods. CXR does show a new right perihilar infiltrate. However, his fever came down within the next 24-48 hours. Unfortunately, he suffered a cardiac arrest on 1/21/21 in the early morning and expired." "0961010-1" "0961010-1" "Resident returned to the memory support unit at 1500. Resident was than toileted and transferred in to bed per his request. At 1515 resident was observed face down beside bed, resident sustained a 1inX1in eccyhmotic/hematoma to the forehead. Neuro Checks with in normal limes Vital signs: 100/52, 100, 97.2, 28. Resident sent to ED for further medical evaluation via EMS." "0961339-1" "0961339-1" "possibly got it at clinic, possibly who administered shot. Pts. daughter said the pts boyfriend denied any symptoms the whole day but that in the middle of the night the pt passed away." "0961434-1" "0961434-1" "This is a 94-year-old male who is brought in by ambulance after being found on the floor with unknown downtime. He was in asystole upon EMS arrival. He remains in asystole. No advanced airway is in place. The patient is getting compressions from Lucas device upon arrival. It was reported that he was last talked to by family at 2 PM. The patient got his SARS-CoV-2 vaccination this morning. The patient is evaluated emergently. CPR was ongoing with 3 rounds of epinephrine given. The patient remains in asystole. He has rigor mortis. The patient's pupils are fixed and dilated. The patient has compressions paused and ultrasound is used to evaluate for cardiac activity. None is detected. The patient has no electrical activity on monitor. The patient's time of death is 2113." "0961705-1" "0961705-1" "approximately 3 hours prior to expiring the patient was experiencing forceful emesis. later was found to have expired, patient was comfort care only." "0961776-1" "0961776-1" "1/13/2021 12:00 PM: Patient received COVID-19 Vaccine. 1/14/2021 21:00: Nurse performed routine rounds and the patient appeared okay. 1/14/2021 22:00: CNA discovered patient unresponsive in bed, began CPR, and called 911. 1/14/2021 23:08: Pronounced deceased." "0961845-1" "0961845-1" "Narrative:" "0962307-1" "0962307-1" "tired; legs felt heavy; stopped breathing; This is a spontaneous report from a Pfizer-sponsored program a non-contactable consumer. A 93-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 11:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received vaccine around 11:00 a.m. About two hours later, he said he was tired and couldn't continue with the physical therapy he was doing. He was taken back to his room, where he said his legs felt heavy. Soon after, he stopped breathing. A nurse declared a do-not-resuscitate order. The patient died on 04Jan2021. It was not reported if an autopsy was performed. Outcome of stopped breathing was fatal. Outcome of tired and legs felt heavy was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: stopped breathing" "0962318-1" "0962318-1" ""Called to schedule second vaccine and daughter reports that he died on01/19/2021 with ""COVID"""" "0962325-1" "0962325-1" ""Patient's wife called this morning stating that her husband has passed away last night. After receiving first dose of Pfizer COVID-19 vaccine at around 0830, patient remained in the Immunizations Department for the 15-minute monitoring period. Per wife, patient's only complaint was pain at the injection site. At 1300, wife states that patient complaint of dizziness which ""dissipated after a few minutes"" followed by a headache which ""dissipated after a few minutes"" as well. Then patient complained of nausea, no vomiting and ""couldn't relax."" Per wife, from around 1400/1500, patient stayed on his recliner while still having a conversation with her--""he didn't get up to eat."" Last conversation they had was around 2000/2100. Per wife, at around 2100/2200, patient was quiet and when she checked on him, ""he wasn't responding anymore."" Wife then called 911, ""but they couldn't revive him."""" "0962390-1" "0962390-1" "Admitted to hospital after vaccination with Acute hypoxemic respiratory failure, Septic shock; Aneurysm of arteriovenous dialysis fistula; expired 1/16/2021" "0962714-1" "0962714-1" "We do not believe that the patient's death was an adverse event from the vaccine. Patient received COVID vaccine from Pfizer Dose #1 12/19/2020 (lot # EK5730) and Dose #2 1/7/2021 (lot # EL1284). No side effects or adverse events noted; lived in 24/7 care facility and monitored twice daily for reaction. Patient died 1/10/2021 from chronic respiratory failure and congestive heart failure after recent aspiration pneumonia requiring hospitalization. Death was anticipated and not sudden. We were told to report his death to VAERS even though his death was anticipated and not related to his vaccination." "0962716-1" "0962716-1" "Patient deceased" "0962764-1" "0962764-1" "Patient did not have any adverse reaction to the COVID vaccine, but we were asked by our health dept to submit a VAERS report since the patient died between his first and second dose. Received Pfizer Dose #1 12/17/2020. No side effects or adverse events noted; lived in 24/7 care facility and monitored twice daily for reaction. Date of death 12/23/2020 from aspiration pneumonia complicated by end-stage heart failure and ischemic cardiomyopathy. Death was anticipated and not sudden." "0962784-1" "0962784-1" "patient expired 1/15/2021; had been treated as outpatient for pneumonia, likely COVID-19 but no positive test result in December 2020. PMH diabetes" "0962827-1" "0962827-1" "Admitted 1/14/21: Patient is an elderly 93-year-old female with multiple medical problems including chronic combined CHF, P 80, diabetes mellitus, HTN, hyperlipidemia, CKD stage 3, has been complaining of generalized weakness, fatigue, decreased appetite for the past few days. She had an outpatient COVID-19 vaccine earlier today. Within 2 hr of admitting the patient to the hospital, condition clinically deteriorated. Patient elected to be DNR/DNI while in the ED. Patient was pronounced dead at 10:30 p.m. earlier today. Preliminary cause of death: Hypoglycemia induced lactic acidosis." "0962940-1" "0962940-1" "Pt received second dose of COVID vaccine on 01/20/2021 at 1430. At 1600 Pt developed a wet productive cough with coarse crackles. Pt ate dinner at 5 pm cough persisted. At 18:30 the nurse went to Pt's room to give him his medications. Pt still had a cough, denied shortness of breath. Pt was in a good mood and joking with staff. Pt asked to be shaved. At 19:45 Pt was sitting in the lounge and a CNA noticed that Pt was pale/white in color and clammy. 02 Sat was 85%. Respirations were labored. Pt was placed on 4 L of 02. Increased to 5 L via face mask and 02 sat was 89-90%. Ambulance was called at unknown time. Pt arrived at Medical Center at 2120 and was pronounced dead at 2127." "0962966-1" "0962966-1" "On Saturday, 1/16/2021, Patient went to the grocery store. Upon her return, she indicated she was experiencing N/V and some throat swelling. Patient subsequently collapsed and expired before she could be brought to an emergency room. During investigation by Coroners Office, it has been reported that Patient may have gotten some takeout food while she was out. Labs are pending and the Coroners investigation is ongoing. Spouse believes that her death was caused by the vaccine." "0962995-1" "0962995-1" "No immediate reaction. Patient-reported deceased four days later on Jan. 19, 2021. As of this date cause of death is unknown to our clinic." "0963016-1" "0963016-1" "unknown. Event occurred after leaving vaccination site" "0963057-1" "0963057-1" "presented to ED 1/9/21 with abdominal pain, progressive worsening weakness and fatigue and new onset A fib with RVR likely due to hypertensive urgency . Patient progressed clinically with severe hypoxia and transferred to ICU and started on BiPAP; progressive decline with decreased urinary output with uremia likely secondary to sepsis. Concern with patient worsening clinical decline, palliative care had been consulted on end of life care. Patient expired 1/17/21" "0963163-1" "0963163-1" "Narrative:" "0963167-1" "0963167-1" "Narrative: Symptoms: & Cardiac Arrest; Death Treatment: EPINEPHRINE" "0963235-1" "0963235-1" "Patient diagnosed with COVID on January 9, 2021 after being exposed to family member that was under quarantine in the same household. Admitted to the hospital and was discharged on January 14, 2021 with home hospice. Patient passed away on January 18, 2021" "0963269-1" "0963269-1" "Patient passed away on 01/18/2021" "0963388-1" "0963388-1" "Patient died unexpectedly 5 days after receiving vaccine (1/10/2021)." "0963610-1" "0963610-1" "Patient deceased on 01/17/2021" "0963902-1" "0963902-1" "Death; This is a spontaneous report from four non-contactable consumers via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 28Dec2020 at a single dose for COVID-19 immunization. Ongoing medical history included Alzheimer's Disease, encephalopathy, hypertension, acute kidney failure, urinary retention and recent urinary tract infection (UTI), all from an unspecified date. Concomitant medication included acetaminophen (MANUFACTURER UNKNOWN), bisacodyl (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN), loperamide (MANUFACTURER UNKNOWN), ondansetron (MANUFACTURER UNKNOWN), senna alexandrina (SENNA PLUS), vitamin d3 (MANUFACTURER UNKNOWN). The patient had no known drug allergies. The patient experienced death on 30Dec2020. The vaccine was given on 28Dec2020 with no adverse events and no issues on 29Dec2020. The patient died on 30Dec2020, at approximately 2:00 AM. It was unknown if an autopsy was performed. It was unknown if the event was related to the suspect drug, the administrator marked as natural causes. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death" "0964401-1" "0964401-1" "Pt died 4 days after vaccine, no known reaction to the vaccination" "0964617-1" "0964617-1" "Death, which I believe is unrelated to vaccination" "0964629-1" "0964629-1" "Death - Hospice patient with metastatic CA admitted to facility and received vaccine during stay. No adverse sequelae noted from vaccine administration, but reporting as required because pt died 7 days later. Narrative: Reporting this event because patient died 7 days after receiving vaccine in the facility where he was in hospice care for metastatic cancer. Vaccine was administered by protocol without complications. The patient had been asked and denied any prior severe reaction to this vaccine or its components and gave permission to receive it. No vaccine adverse sequelae were documented after the immunization as monitored for 15 minutes nor in facility notes for 7 days after the immunization. The patient's death was felt to be due to underlying terminal illness." "0964636-1" "0964636-1" "Pt on hospice in facility for severe cardiomyopathy unable to perform interventions received vaccine without adverse sequelae died 5 days later. Reporting as required. Narrative: Reporting as required patient death 5 days after immunization with Pfizer vaccine. However, no adverse sequelae were noted to the vaccine in the 15minute observation period, nor in the days following the immunization related to the vaccine. The patient denied any prior severe reaction to this vaccine or its components, and the patient gave verbal consent to receive the vaccine. Patient had been in the facility on hospice since 11/18/20 for severe decompensated HF and newly diagnosed cardiomyopathy, unable to perform interventions, also LE ischemic wounds with very poor potential to heal due to advanced PVD." "0964653-1" "0964653-1" "loss of consciousness; respiratory distress Narrative: Patient tolerated his 1st dose of the COVID-19 vaccine well, on 12/16/2020, and received his 2nd dose on 1/6/2021. Patient had some mild clinical decline the past few days prior to 2nd vaccination, with a decreased appetite and some increased fatigue per nursing report, but no significant changes. He experienced nausea on the evening of 1/6/21, which was effectively managed, but by early morning he spiked a fever of 102.9 with a sat of 86.1%. He continued to deteriorate from that point on and died 1/7/21 @13:20. Clinically, the presentation was most consistent with an aspiration pneumonia." "0964671-1" "0964671-1" "Death on 1-5-21" "0964724-1" "0964724-1" "Death 1-15-21" "0964795-1" "0964795-1" "Symptoms of fever (Tmax 102.9), diarrhea, and altered mental status started ~ 24 hours after vaccination. No evidence of septicemia with negative blood cultures Minimal improvement over 3 days, transferred to tertiary care center for MRI brain after which LP was recommended. However family declined as intubation would have been required and was not consistent with patient's goals of care." "0965256-1" "0965256-1" "Found deceased, presumed while exercising" "0965547-1" "0965547-1" "resident coded and expired; This is a spontaneous report from a non-contactable consumer via Pfizer Sponsored Program. A 63-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EH9899) intramuscular at single dose at left arm on 28Dec2020 for Covid-19 immunisation. Medical history included no current Illness, no known allergies, but preexisting conditions: dysphagia, violent behaviors, depressive disorder, schizophrenia, aspiration, gastrooesophageal reflux disease (GERD), hyperlipidaemia, bipolar disorder, rectal bleeding, hypertension. The patient had no birth defect. Concomitant medication included asa (ASA) at 81mg, lisinopril (LISINOPRIL) at 10mg daily, ferrous sulfate (FERROUS SULFATE) at 325 (unit unknown), olanzapine (ZYPREXA) at 20mg, morniflumate (FLOMAX [MORNIFLUMATE]) at 0.4 (unit unknown), famotidine (FAMOTIDINE) at 20mg, ascorbic acid (VIT C), carbamazepine (CARBAMAZEPINE) at 250mg bid, valproate semisodium (DEPAKOTE) at 750mg bid, metformin (METFORMIN) at 1000 (unit unknown) bid, sertraline (SERTRALINE) at 100 (unit unknown) bid, albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), buspirone hydrochloride (BUSPAR) at 10mg tid, polycarbophil calcium (FIBERCON). The patient died on 29Dec2020. The patient had no ER or Doctor visit and was not hospitalized. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: resident coded and expired" "0965548-1" "0965548-1" "passed away; This is a spontaneous report from non-contactable consumers received via a Pfizer-sponsored program An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) via an unspecified route of administration on 30Dec2020 at a single dose (1 dose) in the left arm (LA) (administered by: senior living) as Covid vaccine. Medical history included patient was 14 plus days post COVID and unresponsive. The patient had no listed allergies. Concomitant medications were not reported. The patient passed away with an hour and half of receiving vaccine on 30Dec2020. Per nursing staff, they did not expect the patient to make it many more days. She was unresponsive in the room when shot was given. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: passed away" "0965561-1" "0965561-1" "respiratory distress; fever; anxiety developed requiring oxygen; Passed away; This is a spontaneous report via a Pfizer-sponsored program from a non-contactable consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included anaphylactic reaction (broad), neuroleptic malignant syndrome (broad), anticholinergic syndrome (broad), acute central respiratory depression (broad), hypersensitivity (broad), respiratory failure (narrow), drug reaction with eosinophilia and systemic symptoms (broad), hypoglycaemia (broad), COVID-19 (broad) and chronic obstructive pulmonary disease (COPD); all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium and lorazepam (ATIVAN). Within 24 hours of receiving the vaccine, the patient experienced fever, respiratory distress, and anxiety developed requiring oxygen, morphine and lorazepam (ATIVAN). The patient passed away on the evening of 26Dec2020. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: negative on an unspecified date. The outcome of the event death was fatal, while of the other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Passed a" "0965564-1" "0965564-1" "Cardiac arrest Narrative:" "0965565-1" "0965565-1" "Narrative: Please note that patient is a hospice patient. Death occurred 10 days post vaccination. Providers do not believe that there was a correlation. Facility requires that we reports all death even if we suspect no correlation between death and vaccine. Symptoms: & death" "0965571-1" "0965571-1" "1/13/21 pt came into clinic for vaccine. Had difficulty remembering age. Called me Mon. 1/18/21 stating she was sick. When asked what her sx were, she stated fatigue. She was well the night of the shot, Thur. and Fri. but became tired on Sat. and Sun. I went through other sx with her such as h/a, fever, n/v, muscle aches, weakness and she said she experienced none of those. I questioned her about eating and drinking and she said she ate and drank water. She seemed fine so I told her to call her doctor if she was worse or the fatigue persisted or call 911. She agreed. Two staff from clinic called her Mon. and Tues, (1/18 and 1/19). On Tues. she may have had sl slurred speech. She was found deceased on" "0965807-1" "0965807-1" "began itching within 24 hours, within 5 days couldn't move on her own, by 6th day was having respiratory issues, by day 7 unresponsive, by day 8 dead" "0965831-1" "0965831-1" "Patient received her first dose of vaccine on Monday, January 18th. Two days later on Wednesday, January 18th, she retired to bed early. Later that night when her husband went to bed, he found her in the bed deceased. No other details of the event are know." "0965860-1" "0965860-1" "Patient had increased SOB while at home. EMS was called. Patient coded in the squad" "0965910-1" "0965910-1" "The employee found dead at her home on 1/21/2021." "0965922-1" "0965922-1" "We were alerted that the patient died at home." "0966178-1" "0966178-1" "Pt called son to let him know he couldn't breath around 2 AM. Pts son showed up at his house 10 minutes later and ambulance arrived with in 20 minutes at 2:15" "0966359-1" "0966359-1" "Headache, pain in the injection site, threw up. A few hours later she died." "0966844-1" "0966844-1" ""Patient is reported to have died at home, the day after his COVID test. Family member states that he did good the afternoon and evening after his COVID-19 injection, but that he started not feeling good the next day. The patient ""was having palpitations"". The family tried to convince him to go to the Emergency Room, but he refused. Patient died at home."" "0966856-1" "0966856-1" "Patient is a 90-year-old female. She is a nursing home resident with and ongoing COVID 19 outbreak occurring . She has been diagnosed with corona virus on 1/4/21. She apparently has not eaten or drank anything in about a week. She was being hydrated at the nursing home with normal saline, but has failed to improve. She was sent to the ER and was admitted on 1/8/21 to hospital At no time during the hospital stay has she been more than minimal responsive. She need O2 for Comfort but on CXR and CT cardiopulmonary imagining was clear. Discharge note stated that he was requiring supplemental oxygen, but her chest x-ray on admission actually showed no acute cardiopulmonary disease. She was diagnosed with COVID-19 on 1/4/21. Most likely, this disease set her level of function back to the point that she was no longer eating and drinking, and she just overall rapidly declined after that. There was no evidence of an actual COVID pneumonia or pneumonitis. On 1/12/2021 family made patient a DNR and IVF were stopped and switched to comforted care. Patient expired 1/13/21" "0966888-1" "0966888-1" "At 04:30 on 1/22/2021, facility was notified of employee death at home." "0967240-1" "0967240-1" "Patient unexpectedly died on o1/6/2020. No known signs or symptoms." "0967399-1" "0967399-1" "Sudden death" "0967506-1" "0967506-1" "Died within 5 days of receiving vaccine. Exact cause and day unknown." "0967743-1" "0967743-1" "Possible seizer, unknown at this time, aprox 1hr and 20min after vac given. Passed away aprox 2hrs after vac." "0967747-1" "0967747-1" "Pt passed away evening of 1/13 - unknown reason currently Narrative:" "0967749-1" "0967749-1" "Cardiac Arrest Narrative:" "0967754-1" "0967754-1" "Death - unknown cause, no reported side effects Narrative: Unknown cause of death" "0967830-1" "0967830-1" "Patient was was brought to the ED from facility which he received the vaccine via ambulance with BiPAP, hypoxia, and one dose of Epi of 0.3 mg. He then required intubation, and had struggled with hypoxia, even on increasing PEEP. CODE BLUE called in the ED for PEA. He was medicated for such (please see the code run sheet for details), and he came in and out of the code 5 times. After 95 minutes, with the wife at the bedside, and family conference by phone, the code was called, and he was pronounced at 18:20. He received in total 8 me of Epi, 3 shots of Atropine, 3 amps bicarb. He got lasix 40 mg, lovenox 60 mg subcutaneous once. He had a CVC into the right internal jugular, and levophed was started, then Epinephrine drip was started. Prior to the code he got steroids (solumedrol 125 mg, then later decadron 6 mg iv), benadryl iv, antibiotics (ceftraixone / zithromax), and lasix 40 mg. All this time while in the ED, the Rt was at the bedside, and lots of secretions from the lungs were aspirated, bloody color. Code was the result of PEA secondary to hypoxia (4000 on admission) and notably had been on daily PO dexamethasone 1 mg TID (total daily dose 3 mg, equivalent to 20 mg PO prednisone) since 11/6/20 without any PJP ppx. There was elevated c/f COVID-19 infection in setting of patient's presenting symptoms, especially in conjunction with b/l GGOs on imaging. Has undergone multiple COVID test that have all resulted negative. Discussed radiographic findings with radiology colleagues, and overall, it is difficult to definitively narrow the differential with imaging alone, but overall density of GGOs seem to appear less likely PJP and more in line with chemical pneumonitis vs COVID, although less typical for viral pneumonia as well. Given false-negative COVID tests are not unheard of, especially in the immunocompromised population, patient was kept on isolation precautions as a PUI for abundance of caution. He is now off precautions. In setting of patient having been on prednisone for some time without PJP ppx, he was also started on treatment dose TMP/SMX. Beta-d-glucan has returned positive, and although not the ideal test for PJP, this can certainly support a potential dx of PJP. Unfortunately, DFA from sputum was not performed due to insufficient sample and currently the patient is unable to produce an additional sample for testing. He is tolerating the high-dose TMP/SMX; we adjusted the dose to three SS tablets TID based on his somewhat declining UOP. Other fungal etiologies are pending work-up as well. Lastly, patient's chemotherapy is known to cause pneumonitis, but per pulmonology team, he receives prophylactic dexamethasone with his chemo cycles that should help to prevent drug-induced pneumonitis. Remains on the differential for now and this should also be concurrently treated with the steroids he is receiving."" 1/10/21: Comfort care initiated. All non-comfort measures were discontinued. Time of death: Jan 10,2021@14:56; immediate cause of death per death note is ""hypoxic respiratory failure"""" "0973814-1" "0973814-1" "DEATH Narrative:" "0973820-1" "0973820-1" "Narrative: Symptoms: & DEATH DUE TO COVID 01/13/21 Treatment:" "0973957-1" "0973957-1" "5 days after receiving his COVID vaccination the patient had a spontaneous (nontraumatic) subarachnoid hemorrhage which was fatal. The patient had previously been stable on his coumadin dosing with therapeutic INRs for the past several months per his wife. At time of presentation his blood pressure in the ER was elevated to 223/94 and his INR was risen to 3.1" "0974033-1" "0974033-1" "Resident deceased on 1/26 at 445am. No signs ahead of time." "0974172-1" "0974172-1" "Resident passed away 1/25/2021 at 1048pm after the vaccine was given on 1/24/2021. Resident had been being monitored but death was not expected." "0974422-1" "0974422-1" "Patient developed fever to 102 within 24 hours with decreased mentation. Stopped eating/drinking despite aggressively treating fever. Was DNR B status. Family agreed to a trial of IV fluids on 1/21 but was not successfully started until 1/22 after several attempts. Family wanted only comfort measures with no transfer to hospital. Patient continued to have fevers to 102-103 range. Patient passed on 1/23 . Patient did test positive for COVID in early September without significant illness. She was in usual state of health prior to vaccination." "0974443-1" "0974443-1" "Patient received Moderna COVID vaccine on 12/30/2020 at a Pharmacy clinic where he was a resident. Nurses at the facility reported that he was responsive and showed no signs of any adverse effects until 1/2/2021 when he was observed slightly unresponsive and staring at the ceiling and trembling. He had a fever of 101F at this time. The facility ordered labs and a rapid COVID test (all of which came back normal) and started IV antibiotics. A few hours later, patient began bleeding from his eyes, nose, and mouth and was sent to the local ER. The patient refused being admitted to the ICU for possible sepsis/hemorrhage and died the following day on 1/3/2021. All healthcare professionals involved agreed that this was not likely due to the vaccine, but needed to be reported nonetheless." "0974454-1" "0974454-1" "Patient passed away 23 days after receiving COVID vaccine" "0974489-1" "0974489-1" "No immediate symptoms. No symptoms ever reported. Patient was found dead in her home on 1/25/2021 and last seen on 1/24/2021. Neighbor called for welfare check because they had not seen her and she had not checked mailbox. No evidence of foul play." "0974573-1" "0974573-1" "ON 1/21/2020 RESIDENT WAS EXPERINCING CHILLS AND LOOSE STOOLS. FOLLOWING THIS EPISODE BECAME UNRESPONSIVE, PALE, DIAPHORETIC AND BRADYCARDIC. PALLIATIVE CARE WAS PROVIDED. RESIDENT PASSED AWAY APPROX. 10 HOURS LATER." "0974794-1" "0974794-1" "Patient presented to Vaccine clinic 1/12/21 to receive COVID vaccination. Patient denied any ill feeling, no fever, cleared for vaccination. Is chronically SOB due to COPD, but patient reported no different than usual. Presented to the ED the next day c/o SOB and weakness for the last week. Patients condition ultimately declined over the next few days and died 01/21/21 from pneumonia (not COVID). Patient did admit she lied about her symptoms on the day of vaccination to get the shot." "0974833-1" "0974833-1" "1/24/21 0445- patient presents to the ED with complaints of neck pain, chest pain, and back pain for about a week. States also feels SOB, intermittent fever with temperature 100.3 on arrival. Patient was worked up for his cardiac type symptoms, found to have elevated WBC and CRP with no explanation. D-Dimer was elevated with CT showing no sign of PE. Patient was sent home from the ED with instructions to follow up with primary care and/or return if s/s worsen. 1/24/21 1705- patient is returned to the ED via ambulance after becoming unresponsive and some seizure like activity. Patient was intubated. Head CT showed large brain bleed that was irreparable and not compatible with life. Patient was also found with positive blood cultures x2 with gram positive cocci in clusters growing after 9 hours." "0974855-1" "0974855-1" "decedent had shortness of breath and hypoxia, cardiac arrested in front of the EMS crew, ACLS initiated, arrived in the Hospital ED asystole and pronounced dead" "0974960-1" "0974960-1" "ON 1/14/2021 TYPICAL UTI SYMPTOMS FOR RESIDENT DEVELOPED INCLUDING FEVER AND RIGIDITY. RESIDENT IS NON-VERBAL. IV ANTIBIOTICS WERE STARTED. FREQUENT UTI'S ARE COMMON FOR THIS RESIDENT." "0975002-1" "0975002-1" "on 1/13/2021 at 3:40am Cliff called for assistance. He lost his balance and had fallen. Cliff refused vitals, refused emergency department, denied hitting his head. As the day progressed patient developed a headache, diarrhea, and vomiting. He again declined the offer for the emergency room. At supper time wife and staff found Cliff unresponsive, 911 was called and he was taken to the emergency department. The ER did a CT scan and found an acute subdural hematoma. Patient was placed on comfort cares and expired at 3pm on 01/14/2021. Cliff did not have a history of falls." "0975023-1" "0975023-1" "CARDIAC ARREST THAT LEAD TO DEATH - IT WAS REPORTED BY EMS THAT THE PT HAD RECEIVED THE VACCINE ABOUT 30 MINS PRIOR. HE ARRIVED HOME, BECAME SHORT OF BREATH & COLLAPSED. 911 WAS CALLED AND HE WAS TRANSPORTED VIA EMS TO HOSPITAL (16:17) WHERE HE LATER EXPIRED (23:01)." "0975184-1" "0975184-1" "The patient had a heart attack and died at a local hospital morning of 1/19/2021." "0975206-1" "0975206-1" "1 fall after first dose on 1/8/2021 at 1930; no injuries; 4 falls after second dose on 1/14/21 at 1545, 1/15/21 at 1700, 1/21/21/at 1220 and 1/21/21 at 1330 all falls with no injuries. Started Ceftriaxone 1 GM IM daily for 5 dyas on 1/21/21 for UTI: E. Coli" "0975382-1" "0975382-1" "01/22/20When transferring resident from bed to W/C Resident became unresponsive to voice with eyes fix open and point up to the right. Placed resident back in bed found 82% o2 sats B/P 110/106 pulse 110 resp below 16 placed o2 via non rebreather with 20 l/min 02 up to 90% then stabilized at 89% Resident following all commands encouraged to take do breathing exercises, with some compliance, continues ABT/pneumonia , no s/s adverse 1/23/2021 16:48 Discharge Summary Note Text: Resident found unresponsive with no pulse or respirations in bed with emesis on gown. Time of death verified at 1645 with LPN. Funeral Home called at 1900 and body released at 2000." "0975421-1" "0975421-1" "Resident was discovered deceased in his apartment on 1/23/2021. Family had" "0975434-1" "0975434-1" ""vomiting x3 1/8/21 1/9/21 00:34 - called to resident room by CNAs, staff stated resident was ""different"". Vitals taken and 02 sat was low, O2 in room and applied via NC @3L, O2 sat returned to 98 and all other vitals WNL including BS. Resident asked how he felt, stated he felt ""okay"". Resident exhibiting some shakey movements and clearing throat, states he does not have any phlegm or drainage or trouble swallowing. MD called and updated on situation, voicemail left. 1/9/21 11am- resident has been making a ""growling"" noise this shift. resident also has tremors. resident alert and answers questions appropriately. when asked if resident wants to go to hospital, resident firmly states ""no"". vitals wnl. no emesis noted. will continue to monitor resident. 1/9/21 12p- resident not answering questions appropriately. resident only answering yes or no. resident cannot tell me name, or the year, resident cannot state where he is currently or birthdate."" "0975689-1" "0975689-1" "Resident vaccinated on 01/06/21 she acquired COVID 19 on 01/10/2021. Resident had multiple co morbidities and was declining prior to the vaccine. Resident expired on 01/20/2021" "0975735-1" "0975735-1" "VACCINE ADMINISTERED 01/06/21 ACQUIRED COVID 19 01/10/21 RESIDENT HAD MULTIPLE CO MORBIDITIES AND WAS DECLINING PRIOR TO VACCINE. RESIDENT EXPIRED ON 01/25/2021" "0975744-1" "0975744-1" "See initial report" "0975762-1" "0975762-1" "Pt deceased" "0975918-1" "0975918-1" "death Narrative:" "0975952-1" "0975952-1" "Narrative:" "0976032-1" "0976032-1" "Patient stated he wasn't feeling well on January 25, 2021, wasn't eating and complained of abdominal pain. Patient noted to have indigestion and was constipated. Meds provided and labs ordered. On morning of January 26, 2021, patient became weak, lethargic and hypoxic and was sent to emergency department around 0700 hours on January 26, 2021. At approximately 1100 hours, emergency physician notified this writer that patient was not going to overcome his illness and would be placed on comfort care. At approximately 1130 hours, this writer was notified that patient had passed away from multi-organ failure." "0976111-1" "0976111-1" ""CC:full arrest HPI:HPI and ROS limited due to patient's condition. History is via EMS, medical record, and son. Per Son patient had Covid vaccine on Saturday morning. Slept all day Sunday. Woke up Sunday night a bit ""like coming out of a deep sleep per son, around 10 pm. Shortly after that patient was having a hard time breathing. Emergency called. Arrested around the time EMS arrived. King airway, I/O and CPR initiated. Patient has been in v fib. Was shocked multiple times, given 4 rounds of epi, bicarb and amiodarone. ACLS continued on arrival. Multiple rounds of epi, and attempted defib. Patient given epi, bicarb. Rhythms included fine v fib, asystole, and PEA. Unrecoverable with no cardiac motion. Time of death 11:50 pm."" "0976112-1" "0976112-1" "Resident expired on january 21, 2021" "0976146-1" "0976146-1" "Resident is asymptomatic" "0976166-1" "0976166-1" "ASYMPTOMATIC" "0977319-1" "0977319-1" "Notified by patient's sister on 1/26/2021 that patient died in his sleep on 1/25/2021. She did not know cause of death." "0977320-1" "0977320-1" "about 20+ hours after vaccination resident was having hard time breathing, 911 was called. Resident coded multiple times at the facility after CPR she was taken to ICU. She coded again and was placed on life support. Due to her choice to not be on life support she passed on 11/26/2021." "0977358-1" "0977358-1" "cough congestive heart failure death" "0977426-1" "0977426-1" "Patient has a history of advanced melanoma with brain metastasis. He developed seizure disorder as well and had some mild seizures at home over the prior month. He received the vaccine at 4pm and was monitored in the office for 15 minutes. He then went home with his daughter whom he lives with. He ate dinner with her and read until 8pm when he went to his room. She found him in his room at 9pm unresponsive with seizures. Hospice was alerted and recommend oral valium. He continued to be unresponsive and expired the following day at 7:30 pm." "0977963-1" "0977963-1" "(Report per patients wife ) Patient took his usual nap around 12pm. She found him lying in the bed unresponsvie at 2pm. EMS was not called. Patient's wife called the Funeral home." "0978199-1" "0978199-1" "Arm hurting used his oxygen at time of bed appeared vomited." "0978529-1" "0978529-1" "Patient developed Covid pneumonia dx 1/15/21, patient expired" "0978567-1" "0978567-1" "Resident received the first dose of Moderna Vaccine on 01/12/2021 and Tested for COVID-19 on 01/12/2021. Resident tested positive on 01/13/2021. Resident was transferred to acute hospital on 01/19/2021 due to desaturation. Resident expired at Hospital on 01/24/2021." "0978754-1" "0978754-1" "No symptoms appeared immediately after vaccination, although patient passed away around 6:00 pm unexpectedly. Staff talked with her last time at 5:30 pm and then found her at 6:00 pm passed away. Unknown at this time if death is directly related to receiving the vaccine." "0979081-1" "0979081-1" "Patient found dead in home the next morning. May or may not be connected to vaccination. Instructed to report it from our medical director and director of nursing." "0979101-1" "0979101-1" "cardiac arrest - no warning signs" "0979155-1" "0979155-1" "Jan 3 vaccine administered, jan 4 started headaches, vomiting, pain in the back of the neck, Headaches, chills, loss of speech," "0979223-1" "0979223-1" "Patient developed SOB but reported good O2Sats. Instructed on going to ER if worsening symptoms. Patient eventually expired on 1/22/21" "0979255-1" "0979255-1" "Patient received COVID 19 vaccine the morning of 1/18/21 at Public Health COVID-19 vaccine clinic. I (person completing this report) work for PH. Later that night while in bed, patient reported difficulty breathing to his wife, then turned blue, and became unresponsive. Family report pt was without any symptoms prior to event. 911 called; CPR started by family member 15 min. after pt became unresponsive. EMS performed resuscitation for about 30-40 minutes with multiple defibrillation for V-fib. Between EMS and Medical Center ER, pt had 9 rounds of epi, CPR w/ LUCAS machine, given 2 doses of amiodarone (150 mg and 300 mg). Patient had 3 EKGs, which did not show STEMI, but did show nonspecific conduction delay and sinus arrest with junctional escape vs sinus bradycardia (HR 50's). Pt had return of spontaneous circulation. Pt intubated, and started on Levophed. Pt transferred to ICU, and had central line placed. Family decided to make patient DNR. Pt went into coarse VFib again, and as per wishes of family, code blue not called. Patient expired at 01:53 on 1/19/21." "0979533-1" "0979533-1" "Patient recieved vaccine 1 of covid 19 i 1/19/2021. She felt poorly on 1/20/2021. She felt dizzy and fell at 3 AM on 1/23/2021. She felt poorly and did not know her son's name which was not normal. She went to ER on 1/24. She was assessed as not having fractures. She was going to be transferred to a skilled nursing facility. She was not having respiratory complaints. She was awaiting transfer when her O2 levels started dropping substantially. She declined aggressive intervention and she died within a few hours." "0979773-1" "0979773-1" "Not sure if it has to do with the COVID vaccine but her caregiver reported to me today (1/27/20201) that she passed away on 01/16/2021 from a pulmonary embolism that was 18 days after vaccine" "0979796-1" "0979796-1" "Patient went to hospital with COVID symptoms on 01/10/2021 and passed away on 01/22/2021" "0979818-1" "0979818-1" "Patient arrived at ER with complaints of CPR in progress. Per EMS, patient became short of breath while performing yard work on 1/26/2021. At arrival, patient was in fine v fib with a total of 6 shocks delivered along with 300 mg amiodarone followed by 150 mg amiodarone, 1 amp epinephrine and 2 epinephrine drips adminstered en route to ED. CPR initiated at 1755 and EMS reports asystole at 1829. TOD 1909 pronounced by ED DO Dx: Cardiac arrest" "0979837-1" "0979837-1" "Per EMS, the patient was last seen walking and talking to wife 10 minutes prior to EMS arrival. EMS reports via patients wife, that patient was upstairs to change for his doctor appointment then patient's wife found him down. The patient received his COVID-19 vaccine on 1/25/21. EMS states they gave 5 rounds of EPI then patient moved into vfib then was shocked once but returned to asystole. In ED, the patient initially in asystole CPR was started immediately. The patient was given 3 rounds EPI, 1 round bicarb. The patient stayed in PEA throughout. Patient was given tPA. Patient continued to be in asystole and time of death was called at 11:35 am." "0979841-1" "0979841-1" "Pt likely presented to vaccine appt with asymptomatic/early infection of COVID-19, as he presented 2 days post-vaccination and tested positive for COVID-19 on rapid and PCR test. He was hospitalized where he eventually died of complications from COVID-19 while in ICU. Date of death was 1/15/2021." "0979926-1" "0979926-1" "Pt began experiencing shortness of breath 3 days after vaccine and expired later that day." "0979990-1" "0979990-1" "sudden cardiac arrest" "0980107-1" "0980107-1" "Patient noted to have a change in status at 11:23PM that night. Her oxygen saturation had dropped from normal on room air to 82% and required oxygen. She was also noted to be lethargic with altered mental status and not responding verbally. She then began to mottle. Her oxygen saturation worsened to 51% on 4Liters of oxygen by the next day and she expired on 1/14/21." "0981061-1" "0981061-1" "Patient died 3 days post Moderna vaccine." "0981225-1" "0981225-1" "Patient with inoperable pancreatic cancer received second Pfizer vaccine approximately 12:30 pm on 1/27/21. At approximataely 16:30, patient complained of abdominal pain and was given Levsin 0.125mg and morphine 5mg orally. At approximately 19:30 patient was found on the floor covered in a large amount of emesis, unresponsive without a pulse." "0981406-1" "0981406-1" "Stroke, death" "0981407-1" "0981407-1" "Expired in sleep on 1/24/21" "0981849-1" "0981849-1" "died 01/16/2021" "0981912-1" "0981912-1" "Patient presented to the Emergency Department complaining of chest pain, pale, cool diaphoretic, and hypotensive. The patient was discovered to have a large saddle pulmonary embolism, went into cardiac arrest and expired. Of note, the patient received her second Moderna COVID vaccine on 1/23, which would place her first one approximately 12/25 if she received them at the appropriate interval. This information is from the patient's daughter and the ED record, the information is not available in CAIR. Per the daughter, the patient started feeling ill on 1/21, improved on 1/25, and then acutely worsened on 1/27, resulting in the ED visit." "0981938-1" "0981938-1" "UNKNOWN/ASYTOLE Narrative: Please refer to section 6. 68y/o male with h/o severe peripheral vascular disease with previous left AKA 2/3/20, s/p bilateral bypasses in the past. Pt recently underwent right AKA on 1/12/21. Per Hospital remote data 1/10/21 pt c/o shortness of breath, CXR demonstrated right lower lobe opacity & left basilar infiltrate. Pt s/p >10 days emperic IV abx. Moderna vaccine 0.5ml IM was administered via left deltoid on 1/22/21 around 16:21. On 1/23/21@05:14 code blue was called as pt found to be unresponsive, breathless and pulseless, facial cyanosis noted, CPR started immediately.Pt found to be in asystole. ACLS guideline followed but no return of spontaneous circulation, At 05:32 pt remained pulseless and breathless and was pronounced. Autopsy currently pending." "0981945-1" "0981945-1" "weakness and fallsNarrative: 95 yo male w/ a PMH significant for Afib, legal blindness, Hx of CVA, cognitive impairment, GERD, HTN, pseudogout, BPH, chronic knee infection, and DJD who received his first dose of the Moderna COVID-19 vaccine on 01/08/21. The pt's COVID-19 screening questionnaire prior to receiving the vaccine was negative. The pt presented to the ED on 01/13/21 for weakness and m PCR test on ultiple recent falls (since receiving his first dose of the COVID-19 vaccine). The pt's COVID-19 01/13/20 was positive and he was admitted. He was started on treatment with remdesivir + dexamethasone on 1/14. The pt initially required supplemental oxygen via low-flow NC, however his oxygen requirements increased to 100% NRB. On 01/16/21 his MPOA elected for hospice care. The pt passed on 01/17/21. Unclear if the COVID-19 vaccine attributed to the patient's hospitalization and eventual death, or whether these events occurred from COVID-19 itself, however this case is being reported the FDA since this vaccine is under an emergency use authorization (EUA)." "0982218-1" "0982218-1" "resident was on hospice, chronically ill w dementia, COPD, HTN, failure to thrive, passed away 1/13/21. Not certain injection related as he was declining already." "0982354-1" "0982354-1" "patient received COVID vaccine on 12/29/2020 and passed away on 1/23/2021" "0982370-1" "0982370-1" "Patient died at hospital on j/16/2021 approximately 48 after receiving vaccination. Believe death related to fall at home prior to vaccination." "0982417-1" "0982417-1" "Resident tested positive for COVID on 1/7/2021." "0982472-1" "0982472-1" "Worsening respiratory failure 1/20/2021 death 1/27/2021" "0982495-1" "0982495-1" "Client's sister called crying and said the family just found out yesterday that Client had died some time last week. The last time any family talked to him was on the 19th of January, missed calls show on the phone on the 21st. His last internet search was sternum pain. . She will also call the Agency and report this. The vaccine isn't in Registery at this time, do I don't know the lot number but she said he was due back in one month. She said he was very healthy and ran triathalons." "0982517-1" "0982517-1" "patient received COVID vaccine on 1/11/2021 and passed away on 1/25/2021" "0982541-1" "0982541-1" "36 hours after vaccination, the patient had increased respiratory distress. He was placed on high flow nasal cannula oxygen with mild improvement. He then continued to be hypotensive requiring IV fluids and subsequently IV vasopressors. Patient's BP was stabilized with vasopresor, however he continued to deteriorate clinically with altered mental status and lethargy, concerned for bowel peroration based on physical exam by MD. He was then emergency intubated and placed on mechanical ventilation. He was then transferred to acute care hospital near by." "0982826-1" "0982826-1" "Was at work on 1/26/21 and collapsed, no known complaints a the time. CRP was initiated immediately, transported to ER and pronounced dead" "0982890-1" "0982890-1" "Pt presented to ER via EMS at 1556 3 days after receiving vaccine. pt was breathing approximately 50 times a minutes and o2 sats in the 70's upon arrival. NP decided to intubate, Rocuronium and Versed given. Pt became bradycardic and 1 amp of Atropine was given without improvement. No pulse felt, CPR started per ACLS protocol. 7 Epi's given. Time of death- 1632. After TOD pt was swabbed for COVID-19 and the results were positive." "0982891-1" "0982891-1" "All residents had been in isolation due to multiple cases of COVID in the facility. Resident voiced no health related complaints. He continued to visit with staff and required moderate assist with toileting. Resident had fall 0130 on 1-15-2021, which resulted in laceration with surgical repair. Resident was noted to change in mental status and respirations on morning of 1-16-2021 during morning blood sugar check. Resident had O2 @1.5l/m via n/c and respirations of 10 with periods of apnea and unresponsive to verbal stimuli. Blood sugar was 583. Resident deceased upon re-check after calling PCP to report status change." "0982929-1" "0982929-1" "Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been resolved on the date of her death which occurred 01/27/21, She was found unresponsive by staff, 911 contacted, and paramedics pronounced her deceased at 7:48 AM. After consultation with PCP manner of death was noted as cardiac arrest. PCP was to sign off on death certificate." "0982942-1" "0982942-1" "per recipient spouse - vaccine recipient became ill during the night of 1/21/21 or early morning of 1/22/21 and was deceased in the morning of 1/22/21." "0983169-1" "0983169-1" "Client received the COVID-19 vaccine on 1/5/21 by the Vaccine clinic. Plans were for Hospice services. Client tested positive for COVID-19 by rapid testing on 1/8/21. On 1/10/21 at 0900 Client was unresponsive and without vital signs. Orders were for DNR, and CPR was not initiated." "0983173-1" "0983173-1" "Client recevied the COVID-19 vaccine on 1/5/21 by the Vaccine clinic. Client tested positive for COVID-19 by rapid testing on 1/21/21, with c/o hurting all over and loose stools. She became non-verbal on 1/23/21 with poor intake. On 1/24/21 at 0537 Client was unresponsive and without vital signs. Orders were for DNR, and CPR was not initiated." "0983184-1" "0983184-1" "Patient has been under Hospice services for almost a year. She began to demonstrate a large amount of oral secretions on 1/10/21 at 2130. She was suctioned and a Rapid COVID-19 test was performed, which was negative. The COVID-19 Rapid test was repeated on 1/11/21 and was positive. Oxygen saturation was noted to be 78% on 1/12/21, and oxygen was initiated at 1133 at 3L per nasal cannula. Oxygen was increased to 4L at 1635 d/t shortness of breath. On 1/15/21 @ 0645 patient was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated." "0983187-1" "0983187-1" "Client tested positive for COVID-19 by rapid test on 1/8/21. On 1/9/21 at 1405 his oxygen saturation dropped to 86% and oxygen was initiated at 2L per nasal cannula. A non-productive cough was noted on 1/10/21 and oxygen was increased to 3L. On 1/12/21 Client became non-responsive with 30 second periods of apnea. Dexamethasone was initiated on 1/13/21. Lung sounds were noted with crackles on 1/15/21 at 1158 and at 2120 Client was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated." "0983189-1" "0983189-1" "Patient tested positive for COVID-19 by rapid test on 1/6/21. She began to demonstrate a dry cough on 1/11/21. On 1/12/21 at 1723 her oxygen saturation dropped to 79% and oxygen was applied at 4L per nasal cannula. On 1/19/21 at 2130 Patient was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated." "0983192-1" "0983192-1" "Patient recevied the COVID-19 vaccine on 1/5/21 by the Vaccine clinic #1. Patient tested positive for COVID-19 by rapid testing on 1/6/21. She demonstrated poor appetite and fluid/food intake and an IV of Normal Saline was initiated on 1/7/21. Oxygen saturation was initiated on 1/12/21 at 4L per nasal cannula. for shortness of breath. On 1/22/21 at 0310 Patient was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated." "0983193-1" "0983193-1" "Patient began to demonstrate a cough the evening of 1/5/2021, after receiving the COVID-19 vaccine earlier in the afternoon. A rapid COVID-19 test was performed and was positive. She began to demonstrate shortness of breath with exertion on 1/7/21, and lethargy on 1/12/21. Appetite and oral intake began to decline on 1/12/21, and Oxygen saturation dropped on 1/16/21 to 82%, and oxygen was initiated at 3L per nasal cannula. On 1/19/21 at 0414 patient was unresponsive and without vital signs. Orders were for DNR, and CPR was not initiated." "0983428-1" "0983428-1" "Pt. was admitted to hospital on 1/6/21 with fatigue, weakness. Pt. was Covid positive in November of 2020. Impression upon admission was fatigue may be due to her aortic stenosis and some hypertensive issues with blood pressure changes. She was anemic. WBC was elevated to 19.2, HBG 10.5, NA-131, K+ - 3.1, Rule out bacterial infection. Potential source could be her heart valve. Also noted to have acute renal failure with BUN of 47 and Creatinine of 2.2 noted. Pt. was transferred to Hospital on 1/8/2021 with dx of aortic stenosis, bacteremia, ARF, Dehydration and anemia. Discharged with dx. of sepsis. Pt. expired on 1/18/21 with dx. of severe sepsis, complete heart block, staphylococcus epidermidis bacteremia." "0983720-1" "0983720-1" "Death Narrative: Patient had Parkinson's and advanced Dementia. He was on a palliative care unit and a DNR." "0983721-1" "0983721-1" "Death Narrative: Patient with Severe Dementia and on Hospice for end of life care." "0983766-1" "0983766-1" "Pt started complaining of chest heaviness and shortness of breath on the afternoon of 1/21/21. EMS was called to the patients home and she was found to have an O2 sat in the 70's. She was admitted to hospital and found to have a proBNP of 5000. She tested negative for Covid-19. She was determined to be in acute-on-chronic heart failure and was referred for hospice care. She passed away on the evening of 1/24/21." "0984617-1" "0984617-1" "Patient passed su hospital on 23Jan2021 stopped breathing; complained of not feeling well; had an inflamed gall bladder; This is a spontaneous report from a contactable consumer. A 98-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiry date unknown), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medication reported as has received other medications (unspecified) within 2 weeks. The patient passed in hospital on 23Jan2021 with stopped breathing. Day after vaccine on 17Jan2021, the patient complained of not feeling well, went to hospital where was told she had an inflamed gall bladder. The events caused patient hospitalization for 4 days. The cause of death reported as stopped breathing. It was unknown if autopsy done. Prior to vaccination, the patient not diagnosed with COVID-19. The outcome of the event breathing arrested was fatal, outcome of the other events was unknown.; Reported Cause(s) of Death: Stopped breathing" "0985004-1" "0985004-1" "The week of 1/18/2021 The patient complained of Abdominal pain and called off work (we are also her employer) She was seen for constipation on 1/20/2021. Employee returned to work on 1/25/2021 Had occasional episodes during work where she would sweat and become tired but would rest until she felt better. On the Night of 1/27/2021 she was feeling fine no issues, later in the shift a co worker found her unresponsive, CPR was initiated but unsuccessful." "0985205-1" "0985205-1" "Patient was feeling dizzy and under the weather after the vaccination. The following day he died in his sleep during a nap." "0985367-1" "0985367-1" "TESTED POSITIVE FOR COVID-19 1-7-2021, TRANFERRED TO HOSPITAL ON 1-18-2021. HE READMITTED TO THE FACILITY ON 1-21-2021 WITH HOSPICE SERVICES AND EXPIRED ON 1-25-2021." "0985449-1" "0985449-1" "Patient was an 87 y/o female admitted for septic shock. She was started on and eventually maxed on 3 pressors. CT abd showed colonic obstruction with dilatation of large and small bowel. Patient was made DNR in the ED. Palliative care consulted on case. Family opted for comfort care. Patient was asystole on monitor. No spontaneous breath/cardiac sounds ausculted. Patient did not withdraw to pain. Pupils fixed and dilated. She was pronounced and 1230 on 1/28/21" "0985451-1" "0985451-1" "COVID-19 + 1/11/2021, EXPIRED ON 1-24-2021" "0985501-1" "0985501-1" "family states seemed short of breath since after the covid vaccine. Staff said beginning on 1/22/21 the patient seemed sluggish, more tired, and nausea noted. She stayed in her room more after the vaccine because worried about giving/getting COVID to others. was talking on the phone at 11:30 PM on 1/26/21 to staff person about temperature of room. at 12:15 AM on 1/27/21 staff noted not breathing, started CPR and called EMS. When EMS arrived they stopped the code because she was too long deceased." "0985527-1" "0985527-1" "COVID-19 + ON 1-13-2021, TRANFERRED TO HOSPITAL ON 1-23-2021 DUE TO HYPONATREMIA" "0985715-1" "0985715-1" "Patient received the vaccine on 12/29/20 and presented at the ER at the Hospital on 12/30/20 stating that he wasn't feeling well. It is stated that his health had declined over the past few weeks and currently on hospice. Visit was unremarkable. Patient stated that wanted to stop dialysis. Patient passed away on 01/02/2021." "0985814-1" "0985814-1" "started having generalized weakness on 1/21/21, fatigued., nausea/vomiting. went to doctor on 1/25/21 with complaint of sore throat, cough, and felt congested. Went to ER on 1/25/21 with complaints of increased shortness of breath, worsening nausea and vomiting. started on oxygen for sats of 87%. admitted on 1/25/21. On 1/26/21 needed intubated, CXR showed worsening consolidative change right lung at right hilar level. Echocardiogram showed ejection fraction 35-40%, left atrium is moderately dilated." "0985933-1" "0985933-1" "Died; Increased respirations (22 and labored at times); Pulse 105; 94% O2 on RA; Labored breathing at times; leukocytosis; elevated BUN; left lower lung congestion; elevated creatinine; Temperature of 102.0F; Redness on face; A spontaneous report was received from a nurse concerning a 92-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness on face, increased respirations, labored breathing at times, temperature of 102F, pulse of 105, 94 percent O2, leukocytosis, elevated BUN, left lower lung congestion, elevated creatinine, and death. The patient's medical history, as provided by the reporter, included dementia and reduced mobility. No relevant concomitant medications were reported. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient began to experience redness on her face, increased respirations (reported as 22 and labored at times), pulse of 105, and 94 percent oxygen saturation on room air. The patient had a fever of 102 degrees Fahrenheit. Laboratory tests revealed a negative influenza swab, elevated white blood cell count of 14.1, elevated BUN at 113, and creatinine 2.7. Chest x-ray showed mild, left lower lung infiltrate. On 31 Dec 2020, the patient went under hospice care per her family request.. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 01 Jan 2021, the cause of death was unknown.; Reporter's Comments: This case concerns a 92-year-old, female subject with medical history of dementia and reduced mobility, who experienced the serious unexpected events of death, respiratory rate increased, heart rate increased, oxygen saturation decreased, elevated BUN, elevated creatinine, left lung congestion and dyspnoea and the non-serious events of erythema and pyrexia. The events of respiratory rate increased, heart rate increased, oxygen saturation decreased, dyspnoea, erythema and pyrexia occurred 2 days after the first dose of the study medication administration, and the event of death occurred 4 days after the first dose of the study medication administration. Very limited information regarding the events is available at this time and no definite diagnosis or autopsy report have been provided. Additional information has been requested.; Reported Cause(s) of Death: Died" "0986063-1" "0986063-1" "Resident was vaccinated on 1/13/21. Resident passed away on 1/16/21" "0986123-1" "0986123-1" "passed away-heart attack; This is a spontaneous report from a contactable consumer, the daughter of the patient from a Pfizer Sponsored program Pfizer First Connect. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 19Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 24Jan2021, the patient passed away due to a heart attack. It was not reported if an autopsy was performed. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away-heart attack" "0986200-1" "0986200-1" "Death" "0986672-1" "0986672-1" "Patient tested Covid positive, cough, low oxygen levels, COVID Pneumonia, patient is now deceased" "0986773-1" "0986773-1" "Resident was vaccinated on 12/31/20. Then on 1/14/21 he tested positive for SARS-CoV-2 on routine surveillance PCR testing. Another resident on the same hall was COVID positive on 1/11/21. Results of the PCR test were obtained on 1/16/21. He appeared asymptomatic at that time. Given his COVID positive status, all aerosol generating procedures had to be stopped. Overnight on 1/16/21 into 1/17/21, he had the onset of acute respiratory failure and was transported to the hospital. Per notes, he was put on BiPAP for several hours, but his CO2 level did not improve. Per prior advance directives completed with the resident and his two brothers, he had DNR/DNI orders. The hospital physician spoke with his brother and the decision was made to move to comfort care. He was discharged to inpatient hospice and died around 4pm on 1/18/21. This outcome does not appear to be vaccine-related, but death from COVID-19 infection is listed as a reportable event following COVID-19 vaccination." "0986857-1" "0986857-1" "Extreme bouts of nausea first few days after vaccine. Estimated that patient died at home within 3-4 days after receiving the vaccine. Last phone call to daughter expressed extreme nausea and seemed to have altered mental status. Found dead by daughter on 01/04/2021." "0986869-1" "0986869-1" "Patient noted with respiratory distress on 1/10/2021, transferred to hospital via 911." "0986901-1" "0986901-1" "Patient received vaccine uneventfully with no acute concerns. Left clinic and by report went out with friends. Spoke to father on phone at or around 9:00 pm. Failed to show up to work and was found dead at home. Other details pending" "0986948-1" "0986948-1" "Cardiac arrest on 1/24/21 in the early morning hours then passed away on 1/25/21 around 1:51am in the hospital" "0987029-1" "0987029-1" "Resident passed away at 8:15 am on 1/28/21-found to be without pulse/respirations/DNR order in place." "0987126-1" "0987126-1" "Patient died. Patient had been declining in health rapidly prior to receiving the vaccine" "0987301-1" "0987301-1" "My Mother was given the Covid Vaccine (1st Dose) on 12/28/2020. Later that night we received a call from the nursing facility that my Mother was having uncontrollable seizures and had to be transported to the nearby hospital. The ER doctor confirmed that my Mother had tested positive to Covid. She was treated for Covid and was on life support. A few days later we received a call that my Mother had a major stroke. She passed away on January 4, 2021" "0987469-1" "0987469-1" "emesis bright yellow in color, liquid BM, increased respirations" "0987513-1" "0987513-1" "Note Text: Resident oxygen was going down to 74% during change of shift 3-11, oxygen initiated 3liters via nasal canula per standing order want up to 84-86% NP notified, ordered Prednisone 20mg stat, Rocephin 1gram IM stat administered, Per NP statement if pt's condition worsening sent him to ER, continue monitoring pt and his oxygen going to 82% increasing distress. Notified Nurses supervisor, 911 was called pt left building at 1819 to Hospital alert oriented. Vs bp. 165/60, temp. 98.3,m pulse 109, res 22, 02. 82%. Resident father notified." "0987533-1" "0987533-1" "The patient was observed to be lethargic on 1/29/21 at 1515. BP-80/50, P-75, RR-27, T-100.1. He was given a bolus of NS 150 mlx2. and Rocephin 1 gram IM." "0987636-1" "0987636-1" "Legs started swelling and shortness of breath Thursday January 21 2021 Was rushed to hospital with kidney failure and fluid build up around lungs and entire body Blood pressure dropped and had multiple organ failure" "0987663-1" "0987663-1" "Died" "0987789-1" "0987789-1" "REC'D CALL FROM PT'S DAUGHTER, HER FATHER WAS VACCINATED ON 1/22/21, WOKE UP 1/23/21 WAS SHORT OF BREATH AND DIZZY. PT PRESENTED TO ED OF LOCAL HOSPITAL AND WAS ADMITTED, PT PASSED ON 1/25/21. DAUGHTER STATES THAT FAMILY AND DOCTORS AGREE THAT THE VACCINE DID NOT CONTRIBUTE TOWARDS PT'S DEATH, BUT FELT IT NEEDED TO BE REPORTED. PT'S DAUGHTER CONTACTED THIS RN AT LOCAL HEALTH DEPARTMENT TO REPORT TO VAERS." "0987877-1" "0987877-1" "REC'D CALL FROM PT'S SON, PT HAS BEEN ON HOSPICE CARE AND PASSED 1/26/21. DOES NOT BELIEVE THIS IS RELATED TO VACCINE ADMINISTRATION, BUT WANTED TO REPORT TO US." "0988245-1" "0988245-1" "93 y/o with complex medical history (severe COPD on oxygen, diastolic CHF, CKD3, myelofibrosis, marginal zone lymphoma of spleen with recent progression and no active treatment, chronic anemia, afib, CAD, pulmonary artery hypertension, h/o bladder cancer, hypertension, hypothyroidism, h/o bilateral PE, sick sinus syndrome s/p pacemaker, h/o Hodgkin's disease). Has had multiple hospitalizations over the last 3 months for dyspnea, most recently in 12/2020. Enrolled in palliative care. Has had multiple transfusions (most recently 01/13/21) for his chronic anemia due to myelofibrosis, and recently started on darbepoetin. No documented history of anaphylaxis to medications or prior vaccinations. He received COVID19 vaccine (Moderna) on 01/16/21. He passed away suddenly at home on 01/17/21. Symptoms: & cardiac arrest Treatment:" "0988246-1" "0988246-1" ""Narrative: See ""Other Relevant History"" in Section 6 above Symptoms: ElevatedLiverEnzymes & death, pneumonia, afib Treatment:"" "0988270-1" "0988270-1" "Narrative: Symptoms: & death Treatment:" "0988369-1" "0988369-1" "aspiration pneumonia/death" "0989006-1" "0989006-1" "After being observed for approximately 20 minutes and patient walked to her car without assistance I was called to assess the patient in the parking lot for troubles breathing. EMS was called as I made my way outside. Upon my arrival patient was leaning out of the car and stating that she could not breath. She was able to tell me that she was allergic to penicillin. Oxygen was immediately placed on the patient with minimal relief. Lung sounds were coarse throughout. She then began to vomit about every 20-30 seconds. Epipen was administered in the right leg with no relief. Patient continued to complain of troubles breathing and vomiting. A second epipen was administered in the patients right arm again with no relief. A few minutes later patient was given racemic epinephrine through the oxygen mask. There appeared to be mild improvement in her breathing as she appeared more comfortable, but still complaining of shortness of breath and vomiting. When EMS arrived patient was unable to transport herself to the stretcher. When EMS and clinical staff transferred patient to the stretcher she became unresponsive. She appeared to still be breathing. She did not respond to verbal stimuli. Per ED report large amount of fluid was suctioned from the patients lungs following intubation in the ambulance. When patient arrived to the ED she was extubated and re-intubated without difficulty and further fluid was suctioned. At that time patient was found to be in PEA, shock was delivered. Shortly thereafter no cardiac activity was found and patient pronounced dead." "0989015-1" "0989015-1" "Myocardial Infarction" "0990034-1" "0990034-1" "I helped facilitate scheduling for his COVID vaccine and received notification from his wife that he passed away unexpectedly this morning. She reported he had been experiencing a rheumatoid arthritis flare and was on steroids. His diabetes was not well controlled as a result. He did not have any reactions in the days immediately after the vaccine." "0990780-1" "0990780-1" "patient passed" "0991060-1" "0991060-1" "Fever 101.1, unresponsive episode. Transferred to Hospital on 1/28. Diagnosis there was anemia and CHF, aware that he had vaccine day prior. Transfused with 2 units pRBC's. Transferred back to Nursing Home on 1/30 and passed away 0140 1/31/2021" "0991080-1" "0991080-1" "Patient sudden death reported by family. No further details available at this time." "0991216-1" "0991216-1" "Vaccine given on 01-25-2021. Wife reported on 01-29-2021 that patient had a ran a fever on 01-26-2021, Was better on 01-27-2021. She found him dead when she came home work on the evening of 01-28-2021." "0991622-1" "0991622-1" "Death" "0991677-1" "0991677-1" "got up in the night and stated that she couldn't breath, ambulance was called, pt expired in route to hospital. *relayed to me by Facility staff RN." "0991849-1" "0991849-1" "Congestion, Hypoxia, SOB, Tachycardia, Weakness. Started on O2 @ 3L, HOB elevated, Tylenol supp" "0991859-1" "0991859-1" "Per granddaughter's report, pt became very weak within hours of receiving the first dose of the Moderna COVID-19 vaccine and could not get out of bed the next morning without assistance, reported difficulty seeing, and did not recognize some family members. By Sunday, 1/31, pt was unable to be awakened, would not eat, and had low urinary output. Granddaughter reports that the morning of 2/1 he was awake and ate a small amount and seemed to be improving although still weak and unable to get out of bed. Granddaughter reported he died 2/1 around 10am in the morning." "0991927-1" "0991927-1" "Patient was found deceased at Nursing Home in his room 01/12/2021 at 5:25 AM." "0991997-1" "0991997-1" "Resident c/o nausea evening of 1/29 (nausea common for her post dialysis), had a large emesis at approx 2220, 0030 (unusual for resident to vomit)- received Zofran per order. Skin cool and damp, Blood sugar 147 (checked due to h/o diabetes and poor intake). At approx 230am Blood pressured checked and noted to be 52/29. Resident transferred to ER, intubated and transferred to higher level of care where she passed away on 1/30 at 736pm. Resident's medical notes indicated likely shock, cardiogenic in nature, sepsis (source unknown) along with a multitude of other co-morbidities that resident has." "0992063-1" "0992063-1" "Patient received first dose of the COVID-19 Moderna vaccine on 1/19/2021 at an outside facility (no lot #, route, or site available to me in electronic charting). Pt began having hypoxia, SOB, and a dusky appearance of extremities on 1/29/2021 and was brought by EMS to our hospital. PT is a DNR and family had been looking into a hospice sign up due to dementia and general decline in the weeks prior to hospitalization. Pt tested positive on admission for COVID-19 via PCR test on 1/29/2021. Pt continued to have respiratory decline, was put on comfort care per wishes of family/advanced directives, and he passed away the evening of 1/30." "0992082-1" "0992082-1" "Resident was noted on 1/25 with an increased functional decline as she would not feed herself with utensils, but would eat finger foods if placed in her hand. She was started on Rocephin IM for possible infections. Labs had been obtained on 1/21/21, unremarkable for CBC and CMP. 75,000 colony count on urine. On 1/26/21 she was noted with right sided weakness and further decline. She was sent to Hospital for further evaluation. We were notified that she expired on 1/28/2021. Resident had been noted with a decline in function about 2 weeks earlier when she would not stand or transfer any longer. She was still responsive, taking meds, and feeding herself until 1/26/21. Further information on admitting diagnoses and progress notes from hospital have not been available to date." "0992137-1" "0992137-1" "6 days after vaccine developed bloody diarrhea. Thought to have ischemic colitis but negative evaluation. became hypotensive bradycardic placed on ventilator. Subsequently was poorly responsive and eventually coded once more and succumbed" "0992154-1" "0992154-1" "No adverse events reported post vaccine. 1 st dose on 1/11/21 by public health. Death 1/31/21 Patient was on hospice for gradual decline." "0992209-1" "0992209-1" "Death" "0992237-1" "0992237-1" "1/28/2021- Seen by FNP for indigestion, chest pressure and palpitations. EKG reviewed and referral made to Cardiology. 1/29/2021-1800 Presented to ED in cardiac arrest-onset PTA. Patient was found unresponsive by his wife at their home. The last known well was at 1530 when she called him on the phone. The patient was pronounced at ~1850." "0992238-1" "0992238-1" "Tested positive for COVID19 on 12-30-2020, Admitted to Hospital on 1/5/2021 with active COVID, Patient died 1/29/2021." "0992342-1" "0992342-1" "Shortness of Breath, decreased oxygen saturation, irregular heart rhythm, hypertension, Positive for COVID, bilateral pneumonia" "0992347-1" "0992347-1" "Death" "0992372-1" "0992372-1" ""This is a 73 year old female that received her 1st dose with Moderna vaccine on 1/8/21 at approximately 1600. Within one hour, the patient developed altered mental status and increasing weakness. She was transported to the hospital by the staff at her Assisted Living Facility for concern of a vaccine reaction. On admission, oxygen saturation was found to be 89% on room air, BP=137/86, HR=94. Labs were normal, with the exception of WBC=15 (leukocytes normal, chest xray clear, COVID test negative), and a detectable troponin=63. Head CT negative. Physical exam was only notable for 'slight superficial erythema over distal right forearm and dorsal hand. No significant edema.' The patient was treated for a possible allergic reaction to vaccine with NS bolus, methylprednisolone 125mg, famotidine 20mg, and aspirin 300mg PR. She was admitted for monitoring given continued altered mental status/weakness. The next day, she continued to show no improvement, so a head MRI was ordered. MRI showed "" 1. Numerous acute cerebral and cerebellar infarcts involving both anterior and posterior circulations consistent with a central embolic source. 2. Minimal right parietal petechial hemorrhage. 3. Moderate atrophy and moderate nonspecific white matter signal abnormalities compatible with chronic microvascular ischemia "" Neurology was consulted, who approved the start of aspirin and to continue DVT prophylaxis. The patient's advanced dementia and timeline preclude other intervention. The patient's status was DNR/DNI. The patient was discharged on hospice to her assisted living facility on 1/11/21 (with reports of continued somnolence). It was reported that date of death was 1/24/21."" "0992571-1" "0992571-1" "Patient's wife called the physician's office with increasing SOB. MD advised that the patient go to the ED. While dressing, the patient became unresponsive, 911 called. Patient expired in ED." "0992599-1" "0992599-1" "right arm redness" "0992677-1" "0992677-1" "Low Grade Temp, Persistent low back pain, Projectile Vomiting." "0992734-1" "0992734-1" "1st COVID immunization 1/7/2021, COIVD positive results on 1/16/21, 1/24/21 O2 sats decreased to 78%, 1/24/21 reveived the Bamlanivimab infusion 50 ml/hr. 1/24/20 chest x ray 1/24/21 She was sent to hospital and admitted. 1/27/2021 Expired" "0992846-1" "0992846-1" "Patient complained to wife of not feeling well in evening after the vaccination and expired at home during the night." "0992884-1" "0992884-1" "The next morning after vaccine, patient ran a fever, vomited, and was very tired. Mom laid her down to sleep and when she checked later, patient had passed away." "0992977-1" "0992977-1" "spoke with patient husband on Saturday 1/23 and he said that she had been in the hospital. that she had had a stroke, the MD's at the hospital told him that it was not contributed to the vaccine and that they were unsure even if the stroke had occurred prior to the vaccine or after. spoke with him again on 1-29 and he stated that she had passed away on 1/25/21" "0993028-1" "0993028-1" "On 1/9/21-Diaphoresis, O2 90%, respirations 22, increased weakness, wheezing bilaterally. Send to ER for evaluation and treatment. She was sent to ER, where she was admitted for 2 days, then expired there on 1/11/21" "0993072-1" "0993072-1" "Pt. presented to the ER with abd pain and septic shock. Pt. reported to feel ill shortly after receiving the vaccine." "0993112-1" "0993112-1" "she was injected, sh stopped eating and talking, the doctor watched her for 2 days. had her transported to the hospital. i was told she had tested positive for COVID 2 times once at the home and once at the hospital. with in 2 DAYS at the hospital she wa on a ventilator 2 days later she died. i talked with the rehab center and confirmed she tested negative for COVID on Dec 27th 2020 and was given the Vaccine on the 29th Dec 202 was in the hospital 4 day later, was on a ventilator 4 days after that then died a few day later as her heart stopped beating. all the while i had POA and was not contacted by Hospital staff until after they had made the next step." "0993828-1" "0993828-1" ""Heart stopped; Could not swallow; This is a spontaneous report from a contactable nurse (patient's wife). An 85-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included blood pressure abnormal (verbatim: blood pressure) from an unknown date and unknown if ongoing, neuropathy from an unknown date and unknown if ongoing, weight issue from an unknown date and unknown if ongoing, diabetes from an unknown date and unknown if ongoing, walker user from an unknown date and unknown if ongoing. Concomitant medications included insulin aspart (NOVOLOG) taken for diabetes from an unspecified date to an unspecified date; and he was taking a long acting one as well. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) for immunization on unknown dates (""had flu shots before with no reactions and everything, nothing before""). On 24Jan2021, the patient's heart stopped (death, medically significant), and could not swallow (medically significant). The clinical course was reported as follows: The patient's wife stated the patient was taking insulin aspart (NOVOLOG) and he was taking a long acting one as well. The reporter, the patient's wife and a retired registered nurse (RN) stated, her husband (patient) just died and she thought he died from the COVID vaccine (later clarified the reason of death was-heart stopped). The patient had the vaccine on 21Jan2021, which was on a Thursday, and he was fine. On the following Sunday around 1:30 (on 24Jan2021), the patient was feeling a little weak, however, the patient's wife thought maybe his blood sugar was low. The patient's wife checked, and the patient's blood sugar was 91. The patient's wife went to get some yogurt to feed him in order to get his blood sugar up a little; ""which was a normal thing for him, it was not that low for him."" Then, suddenly, the patient fell, and the patient's wife could not get a pulse or anything. The patient's wife called an unspecified number and she started compressions; however, he was dead. The patient's wife stated the patient just had his heart test, a three hour long one, and it was ""perfect three weeks ago."" The patient had just gone to the doctor the other day and his blood pressure was ""fine and everything."" The patient's wife stated that other than his diabetes, ""which he had for (sentence incomplete)."" Regarding lab tests, the patient's wife stated, ""No, he had it before but not in the last two weeks. He was going for one because we just went to the doctor last week and he was going to call yesterday to make the appointment request to get his blood work done. Blood work has been good except his A1C was always high, but other than that everything was good"" (as reported). Regarding causality, the patient's wife stated, ""I do, because he was fine until about half an hour before he died. He said to me, I feel a little weak today and then I was talking to him that your upper body strength is really good and then I said, we just have to work on your weight a little more because he did have neuropathy. And then, I went out of the room and all of a sudden I just heard him fall and that is when I just went in to check his blood sugar and it was 91 and I got him yogurt and he started eating that and then that was it, he started spitting it out and he said, I could not swallow and that was it, he just died."" The patient's wife further added, ""I just wanted other people to know that things like this happen and I am sure it was from that because he was healthy as could be. He was walking with his walker, the day before outside and he felt fine."" The clinical outcome of the event, heart stopped, was fatal. The clinical outcome of the event, could not swallow, was unknown. The patient died on 24Jan2021 due to ""heart stopped."" An autopsy was not performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart stopped"" "0993998-1" "0993998-1" "passed away; cough; This is a spontaneous report from a contactable consumer, the patient's daughter. A 92-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 13Jan2021 at 11:00 (at the age of 92-years-old) as a single dose for COVID-19 immunization. Ongoing medical history included nursing home resident, admitted to hospice on 13Jan2021 (prior to vaccination), and oxygen supplementation (due to low oxygen levels) from a few days prior to the vaccine (Jan2021). Other relevant medical history included congestive heart failure from Dec2020 and sulfa allergy. Prior to the vaccination, the patient was tested numerous times (as reported) for COVID-19 and was negative. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. A few days before the vaccination, her oxygen level had gone down, and she had been placed on oxygen. Prior to receiving the vaccine, the patient was reported as being 'fine'. On 13Jan2021, the patient received the vaccine at 11:00. The patient coughed maybe 5 or 6 times and then dropped her head. Resuscitation was not performed as patient had a do not resuscitate (DNR) order. The patient passed away on 13Jan2021 at 13:05. The cause of death was not reported. An autopsy was not performed. The clinical outcome of the cough was unknown at the time of death. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away" "0994309-1" "0994309-1" "Got vaccine on 1/15/21. He was tired right away, bedridden the next 3 days. He couldn't breathe so he was taken by ambulance on 1/18/21. He was in hospital for several days. put on remdesivir cocktail for 10 days. Slowly getting worse and died in hospital on 1/30/21." "0994544-1" "0994544-1" "The patient went home around 11 am on 1-31-21 after her vaccine and 15 minute observation period. She was eating breakfast after at home and complained to a neighbor that her teeth hurt and she was nauseated after eating. In the afternoon, she felt dizzy and had diarrhea accompanied with blood. Close to 9 PM, her son went to check on her. The patient was found on the floor--she was unresponsive and had purple lips. Her son called an ambulance and started chest compressions. The patient passed away at the hospital. The doctor has ordered an autopsy, and the results are pending." "0994778-1" "0994778-1" "Resident received the vaccine on 1-22-21 and she was diagnosed with COVID-19 during routine testing on 1-28-21. She didn't have any symptoms except feeling weak and she had a decrease in her appetite. She already had a poor appetite prior. She died on 2-2-21." "0994788-1" "0994788-1" "Patient death on 2/1/2021 at 4:55am at hospital." "0994790-1" "0994790-1" "Resident found unresponsive in room this am at approx. 9:30 am. Resident was observed eating breakfast around 8:45 am. Housekeeper reported seeing resident between breakfast and time found unresponsive. Resident had voiced no complaints. Code was initiated until EMS arrived and transported resident to hospital. Resident expired." "0994913-1" "0994913-1" "patient passed away 2 days after vaccine. patient had temperature, nausea, and vomiting after vaccine." "0994989-1" "0994989-1" "Employee was found unresponsive in floor at her home. EMS arrived and person had expired." "0995146-1" "0995146-1" "Narrative: Patient experienced cardiac arrest with PEA and a witnessed collapse upon arrival to the emergency department on 1/24/21. Patient received his first dose of the COVID vaccine on 01/15/2021and felt poorly thereafter. He was describing shortness of breath to his wife and requiring 5L of O2 at home to maintain saturations in 80s, while he usually was on 3L to maintain saturations in the mid 90s. He had been oriented but more fatigued than normal and described bilateral shoulder pain (which was not new for him) as well as indigestion. Took Tylenol with some relief. He had decreased PO intake and less appetite. The patient's wife encouraged him to come to the hospital daily for a week prior to admission, but the patient did not want to because he felt his side effects were secondary to the vaccine. Symptoms:RespDepression, Palpitations, Syncope & cardiac arrest Treatment: EPINEPHRINE 1 MG ONCE 3 rounds given ,CALCIUM CHLORIDE 1000 MG ONCE" "0995147-1" "0995147-1" "Death Narrative: Patient received the first COVID-19 dose on 12/23. Afterwards, patient complained of localized pain on L deltoid area where the vaccine was administered; his temperature was 98.1 F. On 12/26-27, staff reported that patient appeared more fatigued than usual and was shivering on 12/27, which seized after blanket was given. On 12/28, patient presented with fever (Tmax 100.2 F) and acetaminophen was administered for alleviation of fever. ADR was reported for the fever on 12/29. Patient continued to decline and was placed back on hospice care on 12/29; on 12/30. the symptoms reported on nursing note include erythema and pain on whole L arm. Lidocaine was applied. Patient's family and provider mutually agreed not to administer the second dose of vaccine. He continued to decline and was started on end-of-life care around 1/4 and passed on 1/20 1417." "0995165-1" "0995165-1" "Died in sleep" "0995224-1" "0995224-1" "Cardiac arrest; Pain on her upper right chest; Lot of pain in lower abdomen; Pain underneath arm; Thought it was muscle aches; A spontaneous report was received from a nurse concerning a 92-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed upper right chest pain and underneath the arm, severe abdominal pain, muscle aches and cardiac arrest. The patient's medical history was not provided Concomitant product use was not provided by the reporter. On 14 Jan 2021, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient developed upper right chest pain and pain underneath the arm. They thought it was muscle aches. Sometime later, the patient developed a lot of pain in the lower abdomen. The called emergency services and an ambulance arrived but the patient then suffered cardiac arrest. Treatment for the event included tramadol. Action taken with mRNA-1273 in response to the events was not applicable due to the patient was died. The patient died on 19 Jan 2021. The cause of death was reported as cardiac arrest. Autopsy were not provided.; Reporter's Comments: Company Comment: This case concerns a 92-year-old female patient who experienced unexpected serious events of cardiac arrest, upper right chest pain and underneath the arm, severe abdominal pain, muscle aches. The event occurred 5 days after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Although a temporal association exist between the events and the administration of the vaccine, in the absence of critical details such as the patient's medical history, any diagnostic test or autopsy result, adequate evaluation and assessment cannot be established. Main field defaults to æpossibly related' for all events.; Reported Cause(s) of Death: Cardiac arrest" "0995441-1" "0995441-1" "The vaccine was given on Monday. Tuesday afternoon he developed weakness in both legs and could not stand up. This was a new development; he had neuropathy in one leg but he had been able to stand up and walk three hours before. He was helped to the bathroom. He said he felt better and might want to stand up again. He was helped to bed. He was found dead around 5:30 Wednesday morning. He was 94 years old and had a lot of medical conditions. No one has indicated his death had anything to do with the vaccine. I'm sure it's just a coincidence that he died so soon after receiving the vaccine" "0995460-1" "0995460-1" "Vaccine-1/7 Covid positive-1/10 Hospitalized-1/17 Deceased-1/25" "0995520-1" "0995520-1" "1-12-21 Resident is complaining of heart pain. Resident blood pressure is 228/105. 1-22-21 Dx UTI 1-13-21 His nurse called MD at approximately 0645, reported to him that it was reported to this nurse that resident has not slept in 2 days and night, has an increased blood pressure, reports severe pain in lower back, and appears to be uncomfortable Resident is able to verbalize his pain and where it is at, but is unable to explain the quality of the pain or give a number on the 0/10 pain scale." "0995641-1" "0995641-1" "Resident was hospitalized for confusion, and hypotension and increased weakness; resident proceeded to have a NSTEMI and died on 5th day in hospital on 1/31/2021." "0995649-1" "0995649-1" "Cardiac arrest; Patient transported by EMS to hospital 11:00pm on 01/29/2021. Patient received vaccine on 01/25/2021. Patient expired 01/30/2021 within the hour into the new day after midnight on 01/30/2021. Patient was feeling well prior to and any chronic health conditions were well controlled. Sudden cardiac arrest 4 days after receiving the vaccine. Details given by patients husband/POA." "0995825-1" "0995825-1" "Client unexpectedly collapsed and passed away on 1/13/21 from suspected sudden cardiac death. Prior to her death, she was in skilled care for rehabilitation following hospitalization from 12/21-12/31/20 for an acute lower GI bleed. Her hospitalization and skilled care stay were complicated by delirium and she was being treated for delirium with olanzapine (Zyprexa) at time of death." "0995977-1" "0995977-1" "Lethargy/altered level of consciousness lead to hospital admission. Multiple interventions during hospitalization. Final hospital diagnoses: Acute respiratory failure with hypercapnia, acute pansinusitis." "0996086-1" "0996086-1" "Pt received vaccine on 7 jan. 2021 Twelve days later, on 19 January 2021, Pt developed symptoms of COVID (cough, sore throat, fever, myalgias), on 20 Jan, pt admitted to hospital for worsening symptoms. Pt tested positive for COVID 19. Pt admitted to ICU where pt had complicated hospital course to include ARDS secondary to COVID pneumonia, nonSTEMI, with biventricular heart failure, on multiple pressor, rhabdomyolysis with acute kidney injury, requiring CRRT. Pt was in hospital for 10 days; he passed away on 31 Jan 2021." "0996105-1" "0996105-1" "patient received vaccine on Jan 23, 2021 passed away on Jan 24, she was already on hospice, so unclear if due to vaccine or other issues. Was at her baseline before and after vaccine per facility, had b'fast and passed away at noon on Jan 24" "0996156-1" "0996156-1" ""Client came to nursing station about 2pm to report she ""was not feeling well"". Nurses took vital signs, then referred her to the vaccination clinic that was onsite. She was observed by vaccination team for a period of time. She reported shoulder pain radiating into shoulder blade in arm vaccine was received. Vaccination team offered ice pack to her, observed for a period of time, and released back to work. About 10pm that evening, she sent a text to another coworker that her pain was ""off the charts"" and that she had pain covering her whole left side of her body. She did not come to work in the morning and did not contact work. Well being check was performed at approximately 9am on 2/2/2021 and she was found dead in her home. 911 was immediately called and authorities took over the scene."" "0996259-1" "0996259-1" "Unknown. Was informed that the patient went to E/R on 1/25/21 (6 days after receiving vaccine. Died 1/29/21 ( 10 days after receiving vaccine)." "0996291-1" "0996291-1" "Death" "0996423-1" "0996423-1" "Patient had a CVA and passed away suddenly 1/10/21" "0996591-1" "0996591-1" "patient received vaccine on Jan 23, 2021. developed weakness on Jan 25, 2021. Sent to ED on Jan 27, 2021 with hypoxia requiring 6 L O2, low Bp, declining mental status. Per family request transitioned to hospice and passed away on Jan 30, 2021" "0996959-1" "0996959-1" "Vaccine was administered Thursday and my father Died early Monday morning unexpectedly" "0997145-1" "0997145-1" ""85 year old patient with multiple medical problems. PEA/asystolic arrest 5 days after receiving vaccine, hospitalized. Patient died on 2/1/2021. It is not clear whether the vaccine administration led to the patient's death or not. ""...healthcare professionals are encouraged to report any clinically significant or unexpected events (even if not certain the vaccine caused the event)"""" "0997297-1" "0997297-1" "Death on 1/17/21. Death certificate reports: Septic Shock, UTI, Pneumonia, Chronic Renal Failure" "0997553-1" "0997553-1" "fatigue x 5 days, including day of vaccination, death the night of day 5/early morning of day 6" "0997571-1" "0997571-1" "BRAIN BLEED" "0997642-1" "0997642-1" "We were notified 02/02/2021 of patient's death. Unknown cause at this time." "0997677-1" "0997677-1" "Rapid decline in health status, Elevated BP&P, posturing, loss of consciousness, Glasgow coma Scale 4 starting 2/1/2021, Deceased 2/3/21" "0997783-1" "0997783-1" "patient passed away subsequent to receiving dose on 02/01. Staff does not have reason to believe vaccine was involved." "0998138-1" "0998138-1" "Same day as vaccination given, developed pain went from arm up to shoulder, to back, to neck to head - right side of body; chills/body aches" "0998175-1" "0998175-1" "Resident vaccinated-1/7/21 Resident covid positive 1/11/21 Resident covid PNA-1/12/21 Resident hospitalized 1/16/21 Resident deceased 1/20/21" "0998228-1" "0998228-1" "Found unresponsive" "0998421-1" "0998421-1" "Resident passed away unexpectedly on 1/27/21 from presumed sudden cardiac death." "0998422-1" "0998422-1" "patient developed progressive diffuse muscle weakness, altered mental status including excessive drowsiness, decreased oral intake starting on 1/31/2021. Symptoms continued to worsen overnight and he was evaluated in the emergency room on 2/2/2021 and admitted with dehydration and altered mental status. He was aggressively hydrated overnight, but showed persistent diffuse muscle weakness, altered mental status with decreased responsiveness progressing, but no focal neurological findings noted. CT scan of the head on 3/3/2021 showed no findings other than age-related diffuse cerebral atrophy. The patient did spike a fever to 103 on the morning of 2/3/2021. CBC, CMP, procalcitonin and lactic acid levels remained normal. He remains hospitalized in stable condition as of 2/3/2021 @1300." "0998463-1" "0998463-1" "Resident passed away unexpectedly on 01/19/21 after developing acute hypoxic respiratory failure on morning of 01/19/21. She was transferred to hospital via EMS where she was intubated, coded, and ultimately expired with uncertain underlying cause, potentially ACS." "0998544-1" "0998544-1" "Patient had heart attack. Spoke with spouse on 2/3/2021 stated had multiple health issues including heart and lung issues." "0998576-1" "0998576-1" "Had acute respiratory failure, dysuria NSTEMI after Dose #1 Lot # 025L20A (Moderna) hospitalized same day 12/31/20 administered @ 1040 back to baseline. 2nd Dose on 1/27/21 0950 Lot as above. Unknown exact onset same day, ED by EMS @ 1745, respiratory distress, febrile 39.4 degrees C BP 150/105 RR 29" "0998637-1" "0998637-1" "Patient noted to have irregular breathing in bed and unable to arouse. Provided life saving measures in the field x 30 minutes and transferred to hospital. Noted to have heart arrhythmia which suspected to cause cardiac arrest." "0998770-1" "0998770-1" "Patient had no symptoms or adverse events until the next evening after shot (1/29/21) where daughter reported her having heart palpitations. Family told her to rest and did not seek medical attention. Saturday afternoon (1/30/2021), patient started experiencing labored breathing. Daughter called 911 and before the ambulance arrived, the patient's breathing became more and more shallow. Patient was taken to the local hospital and passed away Saturday evening around 5:30 pm." "1000228-1" "1000228-1" "dead; Collapsed; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; This is a spontaneous report from a contactable nurse. A 40-year-old male patient receive first dose of bnt162b2 (Lot number: EK9231, Brand: Pfizer), intramuscular in left arm on 21Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included immunocompromised w/ reportable conditions from an unknown date and unknown if ongoing, positive for Covid in September from Sep2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced dead, collapsed on 26Jan2021. Therapeutic measures were taken as a result of collapsed. The outcome of collapsed was unknown. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Received Covid vaccine here on 21Jan2021, was at work on 26Jan2021 and collapsed, no known complaints at the time, CPR (cardiopulmonary resuscitation) was initiated immediately, transported to ER (Emergency room) and pronounced dead. Unknown if other vaccine in four weeks. The patient had COVID prior vaccination. Unknown If COVID tested post vaccination.; Sender's Comments: Based on the information currently provided, the patient was immunocompromised and had prior COVID infection. The death and syncope more likely are associated with the patient underlying medical conditions. More information such medical history, concomitant medications, treatment indication and event term details especially death cause and autopsy results are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Dead" "1000665-1" "1000665-1" "Death 2 days later; This is a spontaneous report from a contactable Other HCP. A 97-year-old male patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via intramuscular in the left arm on 18Jan2021 12:00 PM at single dose for covid-19 immunisation. Medical history included prostate cancer, macular degeneration, type 2 diabetes, atrial fibrillation. No known allergies. Concomitant medications included glipizide, warfarin and metformin in two weeks. The patient had no other vaccine in four weeks. The patient experienced death on 20Jan2021 at 09:00 PM. Death cause was undetermined. No autopsy was performed. No treatment was received for AE. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the event was fatal.; Sender's Comments: Event unknown cause of death is assessed as Related until sufficient information is available to confirm an unrelated cause of death or if there is sufficient information to allow an unrelated causality assessment. Case will be reassessed when follow-up information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death 2 days later" "1000670-1" "1000670-1" "she was hurting at her chest/ Chest pain; on her left arm hurt real bad that's what the clot on her left arm; on her left arm hurt real bad that's what the clot on her left arm; She passed away; heart attack; This is a spontaneous report from a contactable consumer. An 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus, for which she was taking a pill like an hour before she would take her meal. On Monday (Jan2021) the patient experienced was hurting at her chest/ chest pain, her left arm hurt real bad as she had a blockage in her left arm/clot on her left arm, and they wanted to put in a stent and after the surgery it went well and she all go home in two days. The patient was hospitalized in Jan2021 due to the events. She had a heart attack and that the chamber between the dividers had a hole in it and her heart tissue was too thin so much thin she couldn't repair it. The patient passed away on 26Jan2021. The patient was tested negative for COVID-19 on unknown date. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: She passed away" "1000709-1" "1000709-1" "Patient with past medical history of CAD, CKD, sCHF, LGL Leukemia admitted to Hospital on 1/19 with pleural effusion. Pt expired on 2/1/2021. Hs of essential HTN, complete heart block, T2Diabetes,thyroid issues, stroke, papillary CA of thyroid, dyslipidemia, anemia, hypercalcemia, pulmonary nodule, hypoparathyroidism, pacemaker, bilat carotid stenosis, afib, pleural effusion, pancytopenia, cardiomyopathy, severe aortic stenosis, sick sinus syndrome, Dressler syndrome, empyema, ESRD" "1000711-1" "1000711-1" "in addition to above, pt had the following diagnosis: portal HTN, abnormal blood chem, essential tremor, depressive disorder, abnormal glucose tolerance test, hyperlipidemia, hypothyroidism, insomnia, localized osteoarthrosis, calculus of kidney, pancytopenia, odule on liver, hepatocellular CA, hyotension, hypovolemia, hepatorenal syndrome additional meds: zoloft, aldactone, thiamine,demadex, ultram, kenalog, vitamins, bactroban ung" "1000739-1" "1000739-1" "Approximately 10 minutes after receiving the COVID- 19 vaccine resident displayed seizure activity, staring straight ahead and strong allover muscle jerking of both the up and lower extremities, color became gray, activity lasted approximately 3 minutes, resident then became relaxed, color returned to normal, BP-140/80, 97.8, 60, 16, sleeping the remainder of the shift,. Resident continued to decline until resident CTB on 1/19/21" "1000752-1" "1000752-1" ""Pt son, reports patient passed away on 2/1/21 in the early hours. Pt wife, told Pt's son that patient started feeling ""bad"" with common cold like symptoms on 1/31/21, had a temp of 99.0. Pt's wife went to take a shower, when she got out patient was unresponsive. She called EMS, they pronounced patient deceased upon arrival. Pt's son also reports patient and Pt's wife both had their 1st COVID-19 vaccine 13 days prior. He was told by EMT on sight to notify the facility where they received their vaccines. He did contact them and was told to notify PCP."" "1000856-1" "1000856-1" ""Myocardial infarction Narrative: PMH significant for aortic valve stenosis, mitral valve stenosis, CKD, CHF, DM, HTN, obesity, hypothyroidism and dyslipidemia. Per report from primary care - the patients wife reports that the patient went on Saturday (1/30/21 - about 1050) morning to receive his COVID vaccine. He returned home and told her about the experience and denied any side effects. He then proceeded to sit in his easy chair for a while and around 1:30, she asked him if he wanted any lunch. The patient's wife reports he ""grumbled"" at her, and then got up to go to the bathroom. She then heard a loud crash and found him lying on the floor of the bathroom, with his head knocking hole in the wall as he fell. She could not detect a pulse. She called 911 and began compressions. First responders to the scene likewise tried to revive him but were not successful in her efforts. Per primary care documentation - Uncertain if related to Pfizer vaccine; vaccine administered on 1/30/21 and approximately 3 hours later suffered fatal MI at home."" "1001488-1" "1001488-1" "Patient died several days after receiving the second dose of the vaccine. See additional information sent. An autopsy has been performed and results are pending." "1001567-1" "1001567-1" "Death "" "1019661-1" "1019661-1" "Patient admitted to hospital evening of 2/7/21 with acute ischemic stroke and received tenectaplase. Diagnosis Left MCA stroke. Reporting event given was just over 24 hours after first COVID vaccine dose." "1019669-1" "1019669-1" "the following morning the patient became unresponsive while taking a shower, became asystolic and died despite about an hour of ACLS and 8 rounds of epi" "1019670-1" "1019670-1" "2/2/2021- seen in Ed with c/o intermittent fever following 2nd dose. Redness to bilateral upper extremities, c/o some pain with urination, weak. V/S stable, afebrile in ED. Assess for infection. No significant abnormal labs (see below), hydrated and discharged. 2/4/2021- arrived in ED with c/o vomiting, seen earlier by PCP that day labs drawn. Shortly after arriving in the ED copious amouts of emesis noted, the patient went into full cardiac arrest and CPR was started. -Please see HPI above, in addition after intubation the patient coded again. More epinephrine and lidocaine were given. CPR was resumed. We did obtain ROSC and targeted temperature management was pursued. He is placed on a lidocaine drip and a right femoral central line was placed by myself. At this time, norepinephrine drip was initiated given his continued hypotension. Post intubation chest x-ray suggests possible abdominal pathology and once the patient was stabilized further, he was sent to the CT scanner where CT head without IV contrast and CT chest, abdomen and pelvis with IV contrast was obtained. He did lose pulses once in the radiology suite. This was brief. IV fluids were initiated and he received over 2 L of crystalloid therapy. He continued to be hypotensive in the emergency department and vasopressin was added. He also had a single dose of Neo-Synephrine and IV push fashion to help bring his blood pressure up. CT scan reveals probable bilateral aspiration pneumonia/pneumonitis and dilated loops of small bowel without a transition point and pneumatosis involving loops in the left upper quadrant. I did try to initiate consult with critical care and possible transfer, however he continued to be unstable and coded requiring CPR multiple times. He was given IV bicarbonate given his prolonged CPR state and pH. Ultimately, the family decided to make the patient comfort measures only given his critical illness. Shortly after making this decision he did pass away in the emergency department. RADIOLOGY DIAGNOSTIC - CHEST PORTABLE 02/04 2051 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2059 IMPRESSION: 1. Findings highly suspicious for portal venous gas which can be seen in the setting of bowel ischemia. Consider CT for further evaluation and/or surgical consultation. 2. Endotracheal tube 3.7 cm above the carina. 3. Low lung volumes with mild patchy perihilar opacities. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 8:55 PM Impression By: MD CT SCAN - CT HEAD WO 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2200 IMPRESSION: Negative for acute intracranial process. No evidence of mass effect, acute hemorrhage or definite acute cortical infarct. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 9:57 PM Impression By: - MD CT SCAN - CT CHEST/ABD/PELVIS W 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2214 IMPRESSION: 1. Ill-defined patchy opacities within the bilateral upper lobes, right middle lobe, in consolidative opacities within bilateral lower lobes which could represent aspiration, and/or multifocal pneumonia. 2. Small right trace left pleural effusions. 3. Diffusely dilated small bowel without a transition point and mucosal hyperenhancement involving the colon with areas of pneumatosis involving loops of small bowel within the left upper quadrant and portal venous air consistent with hypoperfusion complex. There is a small caliber appearance of the aorta and a flattened appearance of the IVC is well. 4. Intravascular air within the IVC and bilateral iliac veins could be secondary to right femoral central lying injection. 5. Somewhat abnormal enhancement pattern of the kidneys with hypoenhancement of the medullary pyramids which may suggest hypoperfusion injury as well. 6. Probable nondisplaced rib fractures on the right at ribs 2 through" "1019850-1" "1019850-1" "HPI Patient is a 77 y.o. male who presents with in full cardiac arrest. Patient is resident of local nursing home. According to nursing home staff, a tech was in his room talking with him as patient was laying in bed. Tech began walking out of patient's room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive. Patient had no spontaneous respirations or pulse, subsequently CPR was started immediately. 911 was called. This occurred around 5:30 a.m.. Upon EMS arrival on scene, they found a male unresponsive with CPR being performed. There was no spontaneous respirations or circulation. Thus, ET tube was placed and ACLS guidelines initiated. Patient was found to be in PEA, and according to EMS, patient was given a total of 6, 1 mg epinephrine IV push and 1, 1 Amp sodium bicarb. Patient was worked on at the scene for approximately 40 min before being transferred to ER. Upon arrival to ER trauma room 1 patient is still in full arrest. ET tube in place with good ventilation. Patient remains in PEA. Chest compressions and ACLS guidelines initiated. In reviewing patient's chart and nursing home notes, patient is a full code. Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG. Patient also has history of 3rd degree heart block and pacemaker placement. Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%." "1019911-1" "1019911-1" "Client was administered the vaccine while symptomatic (01/25/21) although client did not know he was symptomatic for COVID-19. He had been exposed to a family member who had tested positive and should have been in quarantine but wasn't either because it was not felt he was considered a close contact by his family opinion or his family member never notified public health of this close contact...?. Clinet had presented to the ED following day after vaccination for shortness of breath and fatigue and an antigen test showed he was positive for COVID-19. He was sent home that same day 01/26/21. He was back in ED on 01/28/21 for worsening symptoms and admitted to hospital and later placed on ventilator. He passed away on 02/09/2021 (date of death was per his wife)." "1019964-1" "1019964-1" "The resident received his COVID-19 Moderna vaccination on 2/6/2021 2:11 pm and expired on 2/7/2021 at 6:04 am. There were no signs or symptoms of vaccination reaction leading up to death." "1019979-1" "1019979-1" "Patient received the Moderna COVID vaccine 1/28/21. He was tested for COVID 19 on 1/29/31. Results were received 1/30/21, at which time he was evaluated and found to be hypoxic with tachycardia. He was sent to the local ER and returned this same day. On 2/2/21, he was evaluated by the provider, who sent him to the emergency room with acute respiratory distress and poor O2 sats" "1020002-1" "1020002-1" "Given First Moderna covid vacc 1/19/2021. Doing well on multiple contacts from health care providers, then 2/5/2021 was driving, pulled over to the side of the road into a yard, got out of the car and told an observer that he could not breathe, collapsed face down in the snow, EMS called, unable to revive him." "1020018-1" "1020018-1" "Patient reported to be unresponsive on the morning after receiving his second dose of Moderna COVID-19 vaccine. Patient had expired during the night." "1020079-1" "1020079-1" "Received Moderna covid vaccination 1/14/2021. 1/16/2021 received report of cough and difficulty breathing. Proceeded to hospital and was diagnosed Covid+ on testing. Continued to decline, died 1/31/2021." "1020119-1" "1020119-1" "My mother died suddenly on February 3rd. She went into shock/cardiac arrest and appeared to have internal bleeding. No autopsy has been performed. Unsure if it was related to the COVID vaccine." "1020134-1" "1020134-1" ""anxious, restless, weak, dizzy, felt ""horrible"". Continued to C/O symptoms,. At 01:15, patient lost consciousness , then stopped breathing and lost pulse. Narrative: Patient was first vaccinated for COVID 19 on 1/8/21. On 1/24/21: 61 year old presents to E.R. with CC of chest pain/sob, with multiple medical conditions including hypertension, atrial fibrillation on apixaban, cardiomyopathy with poor EF, dyslipidemia, COPD, CVA, lung CA s/p radiotherapy, PTSD, depression, Churg Strauss Syndrome, Sjogren's syndrome presented with chief complaint of chest pain or shortness of breath. He has been having worsening shortness of breath the past few days, also complains of cough productive of yellowish sputum, no hemoptysis. He complains of left upper chest pain with no radiation. There is no diaphoresis, palpitations or lightheadedness. He denies fever or chills. He complains of having fallen a few times recently, thus he passed out. Could not say if there were seizures activity. Admitted to 3D Tele. On 1/27, Pt advises he had episode of substernal CP this am. RN advises pt was in afib w/ RVR at a rate >140 at time of CP. Pt CP improved w/ prn NTG. Pt HR improved after daily medications. Pt sts his CP has resolved. Pt admits to continued dyspnea. Increased trop, transferred. 1/28, struggling with orthopnea and cough. He has no peripheral edema. He does have intermittent chest pain. Patient having periods of A-Fib RVR with non-sustained rates of 140's-150's 1/29 more chest pain at 04:00, relieved with NTG. HR = AF, with RVR 145. At about 08:00, Cardiology sees patient and signs off, ""shortness of breath and cough not due to heart failure as evidenced by orthostatic hypotension and no improvement in symptoms with diuresis. Consider underlying lung disease vs acute pulmonary disease."" No pulmonary consult noted. 1/29 Patient received 2nd dose COVID19 vaccine at about 3:30-4p. No notes from staff on this event. No notes from MD that this was discussed and still part of the plan. 1/29 nurse's note: At around 2240 Pt was able to rest briefly but is now restless and anxious again. Tachypneic, stating he feels so weak and dizzy and overall just feel horrible. Continuing to get up frequently to have small soft bowel movements with assistance. Pt also stated ever since he got ""that shot"" he hasn't felt well. When asked what shot pt replied ""COVID shot."" Pt did receive 2nd dose of COVID vaccine 1/29 at 1530. Around 2250 Spoke w MOD to relay above information and overall concern for pt, asked for MOD to come to bedside to evaluate pt. MOD states he's handing off to oncoming MOD and they will come to bedside to see pt. Around 2300 oncoming MOD called and all above and previous information discussed Around 2310 MOD came to bedside to see pt. Will continue to monitor closely. 01/30/2021 ADDENDUM Around 0115 pt called for help to use bedside commode to urinate and have BM. Assisted x2 to BSC. While sitting on BSC pt's eyes rolled back and pt made postures consistent with a seizure, body became very rigid. Pt was unresponsive still with pulse. Lifted patient back to bed with 3 staff assist. Pt stopped breathing and lost pulse. Chest compressions started immediately and Code Blue called at 0120. 1/30 Hospitalist note: Called for CODE BLUE AGAIN AT 4:53. While on Vent after s/p Code blue for reasons not clear patient went into Asystole and code called second time. Patient had a prolonged CPR and was actually called off at 5:17 but he started having pulse and agonal resp. he was placed on Levophed and D5NS. He got a total of 9 amps of epi, 3 amps od Bicarb and 1amp of D50. Trope bumped from 0.12 to 0.43 prior to this he already was on ASA, Apixiban for afib. Cards are on board for his CHF for his pulmonary edema Lasix ordered. Hid lactic acid is elevated. Blood cultures pending. Started Zosyn and is on Levophed. Continue to monitor. Updated patients Mom and she requested to do everything at this point. Coded again at 5:40, survived, but AOD writes a death note(?) Coded for the 4th time at 08:18. Family at beside, Mother asks for code to be stopped."" "1020135-1" "1020135-1" ""death Narrative: 92 yo male seen in clinic on 12/30/2020 for transfusion, hbg 6.9. PMH includes HLD, CKD, myelodysplastic syndrome, DM, prostate cancer, HTN. Pt also received COVID19 Pfizer vaccine the same day. The patient denied any prior severereaction to this vaccine or its components. Post-transfusion, patient had a mechanical fall (per patient he was seated and used the cane to help him stand. However the cane slipped on the floor causing the patient to fall, patient hit his head and injured his right hip, no loss of consciousness at the time). Rapid response team was called and patient was admitted to the ED. Pt was found to have subcapital right femoral neck fracture, scalp contusion, and TBI (per ED provider's note). Ortho evaluated and said patient wasn't a surgical candidate. During his hospitalization, patient tested positive for COVID19 on 1/12/2021, pt was asymptomatic at the time. On 1/13/2021, pt exhibited mild URI symptoms, no respiratory distress. He was started on cetirizine, Montelukast, albuterol, and inhaled steroids to manage his symptoms. Dexamethasone was started on 1/14/2021. Chest Xray was ordered on 1/17/2021, pt's respiratory was slowly getting worse, resting O2 sats were in the high 80s and low 90s with IS. On 1/18/2021, CXR shows patchy bilateral airspace opacities suspious for pneumonia of bacterial or viral etiology. Pt was started on remdesivir 01/18/2021 (5 doses, from 1/18-1/22/2021). Pt required 5-6 LPM of oxygen at rest. Pt was then transferred to the ICU. His oxygen demand continued to increase and his condition worsened. On 2/14/2021, pt started to desat into the 70s on max high flow. Patient/family agree to comfort care. Medical cause of death was listed as ""acute hypoxic respiratory failure due to COVID19."" Patient expired 1/24/2021."" "1020183-1" "1020183-1" "Death. I actually not sure which Covid Vaccine she took. I just know the date and time she took it at her local school where she worked. Died in her sleep after complaining of a headache. I talked to her around 5pm on sunday through a videochat and she seemed happy and well. But a local friend commented that she had complained of a headache late in the afternoon." "1020195-1" "1020195-1" "Received Moderna #1 on 1/12/2021. 1/15/2021 developed worsening shortness of breath. Went to hospital and diagnosed with anemia, 4 negative fecal tests, neg EGD and colonoscopy. Discharged and readmitted (circumstances unknown for this episode) then readmitted a third time 1/20/2021 for shortness of breath. Diagnosed covid + at third hospitalization and continued to get worse. He died 1/23/2021." "1020227-1" "1020227-1" "This is the patient who passed away 2d after his second COVID vaccine. Of note, the 2/8 telephone note makes it sound like he was hospitalized at time of death - that is incorrect. His daugther listed as EM contact works in the eye clinic here. He had mild illness, completed 10d isolation but missed his scheduled booster dose on 2/2 due to isolation. He was called on 2/5 when there was a booster visit cancellation and received his booster dose on that day. His daugther reported that he was doing fine and looking well on 2/7 AM, ate breakfast, shortly after stood up and just collapsed." "1020443-1" "1020443-1" "For the two days prior to presentation the patient had been complaining of chest pain, his breathing seemed to be labored Monday. He and the family thought the pain was due to shingles as he carried this diagnosis from a month ago. Patient had also received the COVID vaccine 2 days prior to presentation and assumed he was feeling unwell due to the vaccine. Family wanted to take him to the hospital yesterday and earlier today but he refused. She left him in his home earlier this afternoon prior to presentation and returned to check on him finding him unresponsive and apneic at which time EMS was activated. #cardiac arrest -- suspect primary cardiac given collateral from family at home, consider hypoxemia which was corrected with advanced airway and 100% FiO2, patient clinically euvolemic and with soft brown stool in diaper not suggestive of GI hemorrhage, attempt to address acidosis with CPR and bicarbonate, not hypoglycemia, on bedside ultrasound FAST neg and no pericardial effusion suggestive of tamponade and +lung sliding bil not spontaneous pneumothorax Assessment/Diagnosis: -cardiac arrest, cause unspecified" "1020654-1" "1020654-1" "Patient found unresponsive in room with no pulse or respirations. She was pronounced dead by paramedics at 06:25am on 2/5/2021." "1020684-1" "1020684-1" "Patient received vaccine at Public Health Clinic. Patient ended up having a seizure 3 days later and ended up in the hospital. Found to have right lobe pneumonia and low depakote level. Patient noted to have multiple seizures at hospital, issues with stabilizing HR and BP, and passed away on 1/20/21." "1020702-1" "1020702-1" "Passed away the morning of 2/9/21." "1020724-1" "1020724-1" ""Patient sent to the ED or sudden onset of shortness of breath on 02/02/2021. Per documentation by the MD, the patient had COVID19 ""several weeks ago"" and the nursing facility felt like he had recovered. A rapid test done in the ED was negative. When the patient worsened and seemed to be following the same path as other COVID patients, a send out PCR test was done, which was positive. The patient worsened and passed away that same day (02/05/2021) I was not made aware that the patient had the vaccine on 01/21/2021 until Monday 02/08/2021."" "1020749-1" "1020749-1" "Patient had no reaction at the clinic. Patient is a medical doctor whose partner called in this death. States patient had no complaint on 1/13 nor 1/14 while at work. States patient died at home on 1/15 a.m. Physician who stated she was called to the patient's home @ 0157 1/15/2021 and found cyanotic from head to toe. State girlfriend found him sitting in the chair a few minutes before they called her. The Coroner did not order autopsy. Did not sent patient to the hospital. Sent him directly Funeral Home. Death Certificate Number 123-2021-002593 list cause of death as pending. I spoke with the patient's primary doctor who gave me the history of HTN, Diabetes, & High Cholesterol. States he had not seen this patient since April 2020. They were also friends and he was not aware of any medical problems. The Coroner state she thinks patient has a heart attack. Neither the Coroner nor PMD think death was related to COVID Vaccine. Informed both that MSDH would have to complete VAERS. Both voiced understanding." "1020816-1" "1020816-1" "Pt with acute resp failure, COVID PNA, that developed symptoms 9 days prior to admit and ultimately received first vaccine 6 days prior toa admit, then shortly after progressed with other covid symptoms and was admitted. She decompensated while intp and was transferred to ICU for rising O2 needs, ultimately had to be intubated. Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle. Sx and IR consulted and did beside exploration of hematoma. Initially blood pressure responded but overnight continued with refractory hypotension. Maxed out vasopressin and levophed, hemodynamics deteriorated. Pt passed soon after(2/2)." "1020830-1" "1020830-1" "This resident of the assisted living facility received his Covid-19 Moderna (1st) vaccination and he has a leaking Aortic Aneurysm which resulted in hospitalization and he entered into Hospice care on 1.30.2021 and passed away on 1.30.2021." "1021038-1" "1021038-1" "Patient had passed since the first dose was given." "1021040-1" "1021040-1" "Pfizer-BioNTech COVID-19 Vaccine Hospital Emergency Room Provider reported cause of death as COVID vaccine administered 11 days prior to death. Additional information being reported from LTCF." "1021045-1" "1021045-1" "Patient had passed since the first dose was given." "1021052-1" "1021052-1" "Patient had passed since the first dose was given." "1021058-1" "1021058-1" "Patient had passed since the first dose was given." "1021171-1" "1021171-1" "Patient received first dose of Moderna COVID-19 vaccine on 2/3/21. Primary Care physician received call from coroner's office 2/8/21 asking for information contributing to cause of death. Per Primary Care Physician notes, wife states she and patient took turns shoveling snow on 2/4/21. On one trip back into the house she found him unresponsive on the floor and called 911. Paramedics were unable to revive patient and he passed away (2/4/21)." "1021919-1" "1021919-1" "Death; kidney failure (unable to urinate); shortness of breath; required oxygen; A spontaneous report was received from consumer concerning an 87-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, kidney failure and death. The patient's medical history included advanced kidney and heart disease. No relevant concomitant medications were reported. On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 17 Jan 2021, the husband reported that the patient experienced adverse events. Symptoms included shortness of breath and kidney failure (unable to urinate). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath. Action taken with mRNA-1273 in response to the events was not applicable. On 20 Jan 2021, the patient died. The cause of death was unknown. Autopsy details were unknown.; Reporter's Comments: This case concerns a 87-year-old, female patient with the medical history of advanced kidney and heart disease, who experienced fatal unexpected event of dyspnea, renal failure and death. The events of dyspnea and renal failure occurred 12 days and the event of death occurred 15 days after the first dose of mRNA-1273 (Lot: unknown). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath. The cause of death was unknown. Autopsy details were unknown. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the history of advanced kidney and heart disease may remain as confounder. Additional information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1021926-1" "1021926-1" "Passed away; Positive result; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed COVID-19 and passed away. The patient's medical history was not provided. Concomitant product use was not reported. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient had a positive COVID-19 test. On 18 Jan 2021, the patient passed away. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 18 Jan 2021. The cause of death was not reported.; Reporter's Comments: This spontaneous report concerns a female patient who experienced COVID-19 and passed away. The event of COVID-19 occurred 4 days after the first and only dose of the mRNA-1273 vaccine administered and death occurred 14 days after administration of the mRNA-1273 vaccine. Based on the information provided and the known etiology of COVID-19, it is unlikely to be associated with mRNA-1273 vaccine administration. With no definite information on the clinical details of the death, it is difficult to adequately assess a causal association with mRNA vaccine. Main field defaults to æpossibly related'; Reported Cause(s) of Death: unknown cause of death" "1022127-1" "1022127-1" "One week to the day after patient's first vaccine he died of a heart attack; This is a spontaneous report from a contactable consumer and from a contactable physician. A 71-year-old male patient (husband) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose on the right arm for COVID-19 immunization. The patient medical history included past heart conditions. No known allergies. Patient took other medications in two weeks. Facility type vaccine was doctor's office/urgent care. No other vaccine received in four weeks. One week to the day after patient's first vaccine he died of a heart attack on 19Jan2021 18:30. Cause of death was heart attack. No COVID prior vaccination. No COVID tested post vaccination. It was unknown if an autopsy was performed. The physician reported that the patient arrived DOA. Physician signed the death certificate based on the patient's prior diagnosis. Physician would not provide additional cause of death medical background without consent. He was not aware of any adverse events experienced from the time of vaccination to the date of death. Follow-up (05Feb2021): This is a follow up spontaneous report from a contactable physician. This physician reported in response to HCP telephonic follow up activity which the following: patient death and cause of death were confirmed. Follow-up attempts are completed. No further information is expected. Information about Lot number is not available.; Sender's Comments: Based on the temporal relationship, the association between the event fatal heart attack with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: One week to the day after patient's first vaccine he died of a heart attack" "1022160-1" "1022160-1" "24 hours after shot had high fever 101, chills, weakness, became listless, family called 911, client became unresponsive and died in the Emergency room." "1022397-1" "1022397-1" "Death 2/9/21" "1022440-1" "1022440-1" ""The decedent experienced severe chest pain and dyspnea approximately nine days following the first series of the vaccine. He reported to family members that he was having a ""severe reaction"" to the vaccine and believed it was acute pericarditis due to the same symptoms he experienced prior. He reported that on 2/1/21 around 0300 hours, the symptoms were the most severe and he was going to seek medical attention, but did not. He waited till the convenient store opened and purchased OTC Tylenol for relief of symptoms. He continued to have dyspnea and chest pain up until 2/9/21, when he called 911 complaining of chest pain and was found to have a STEMI; subsequently died at Hospital in the ER."" "1022529-1" "1022529-1" "Pt suffered Cardiac Arrest and respiratory arrest on 2/9/21 and passed away at a local hospital. He had multiple health conditions likely contributing to this. he arrested at home and CPR was attempted and unsuccessful. Pt received his Covid vaccine #1 on 1/27/21. No issues were noted after vaccine and was due for his 2nd dose next week. However, we were notified he passed away on 2/9/21. Very likely death not at all related to vaccine but wanted to document as patient was in the middle of the covid vaccine series." "1022552-1" "1022552-1" "Patient died of cardiac arrest on 01/21/2021" "1022685-1" "1022685-1" "Received Pfizer Covid Vaccine in the AM on 2/9/21. Arrived to emergency department later the same day complaining of nausea, weakness, fatigue, Vomiting, Diarrhea. Post operative diagnosis, Ischemic colon/toxic megacolon." "1022902-1" "1022902-1" ""death Narrative: 71 yo male who passed away on 1/29/2021, medical cause of death ""cholangiocarcinoma, interval between onset and death 14 months. Since patient passed away within 42 days of the covid19 vaccine administration, we are required to complete a report to VAERS. Vaccine (Pfizer) was administered without complications. The patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy. Synopsis- 1/23 71 yo male presented to ED with upper GI bleed. PMH: DM, HTN, cholangiocarcinoma of biliary tract requiring recurrent paracentesis, COPD, perigastric and lower esophageal varices (not on beta blockers due to bradycardia). Pt has had 2 episodes of coffee ground emesis. Lactic 2.6, ammonia 52. Rec'd protonix, octreotide, and ceftriaxone in ED. Family has been previously encouraged to speak to palliative care but has never been willing to. GI consulted. 1/24 EGD completed. No signs of active bleed. MDs recommending hospice. CT + for small bowel ileus. 1/26 Requires placement of NG tube to suction. Palliative care consulted. 1/27 Paracentesis completed. 4100mls removed. 1/28 Pt changed to palliative status. 1/29 Pt passed away."" "1022918-1" "1022918-1" ""Resident complained of feeling ""hot"" at supper time. Had emesis an hour or so later. Became hypoxic and was transferred to the hospital emergency room. Her evaluation in the ED revealed continued presence of UTI, leukocytosis (19.8), and renal insufficiency (BUN 22 Cr. 1.3) BP 99/63; P 74; Temp 98.1; RR 16; and O2 sat of 95% with 2 LPNC (she is typically on RA). CXR reported changes most consistent with CHF with cardiomegaly and bilateral pulmonary vascular prominence. Bibasilar pleural effusions greater on the right than left with pulmonary edema. Large hiatal hernia and likely old chronic wedge defromities involving the mid thoracic vertebral body. She was admitted for IV antibiotics. She expired 2/6/2021"" "1023061-1" "1023061-1" "Pt received the vaccine on 1/30/21 Pt reported symptoms of left armpit pain to wife on 2/7/21, went to work 4 am 2/8/21 and found face down, dead at work later that morning. Pt worked at a pet store, per wife he did complete his tasks and generally comes home by 7:30 am. Wife called when pt did not come back home and he was found dead." "1023673-1" "1023673-1" "Patient was vaccinated on 1/14/2021. On 1/22/2021, patient tested positive for COVID-19 and admitted to the hospital for acute hypoxemic respiratory failure, COVID-19 pneumonia, and severe ARDS. Patient was intubated on 1/23/2021 and later died on 2/10/2021 after being extubated and placed on comfort measures." "1023791-1" "1023791-1" "DIED WITHIN 5 DAYS OF RECEIEVING THE 2ND DOSE, EXPERIENCED GENERALIZED WEAKNESS." "1023803-1" "1023803-1" "Was contacted by the person's daughter on 2/5/21. Patient started vomiting 2 days after vaccination. She aspirated and passed away 1/16/21. Patient had history of stroke and swallowing problems." "1023840-1" "1023840-1" "Pt was administered Moderna Covid-19 Vaccine on 2/4/2021. Pt exhbited no symptoms of an adverse reaction of any sort. Pt was ambulating alert and attentive. Pt was observed for the alloted 15 mins by pharmacist and case worker who had escorted pt to vaccination clinic. It was reported that Either on sunday 2/7/2021 or monday 2/8/2021 pt had passed away. Circumstances revolving patient death is still unknown." "1023948-1" "1023948-1" ""02/08/21--2 days after vaccine--Resident stated that she ""didn't feel good"" (She is developmentally delayed and less able to communicate how she feels than those in the community) and stopped eating most foods; also had fatigue. Vitals, coloring, & behavior were normal. 02/09/21--Belly was firm and mildly distended (although she stated it didn't hurt); she coded this evening and CPR was performed before EMT could transport her to the hospital. 02/10/21--Resident passed."" "1023979-1" "1023979-1" "Moderna administered 02/01/21. Patient expired 02/10/2020 unexpectedly" "1024067-1" "1024067-1" "1/15: Pfizer vaccine dose 1 administered 1/16: Fever, chills 1/22: Sore throat, coughing w/white phlegm, taking Tylenol and Mucinex. Fever and chills from 1/16 subsided. Had telehealth consultation with PA. Per her notes, patient said he gets these symptoms annually, requested for an antibiotic. PA referred him for a COVID test. Ordered hydrocodone/chlorphen ER suspension for his cough and an antibiotic. Antibiotic was recommended if symptoms do not subside. 1/23: COVID test administered 1/25: Reported positive for COVID 1/26: Telehealth session w/PA: she informed patient of his positive test, advised to quarantine and seek medical help at hospital if symptoms worsen. Patient reported that his sore throat mostly subsided but is still coughing at night. Said that the pharmacy didn't receive the prescription order for the antibiotic, so this was re-ordered. 1/31: Partner found him dead at 8:18AM on his bed. Death certificate issued by state says cause of death: COVID. Autopsy was not performed. Buried on 2/9/21." "1024157-1" "1024157-1" "7 days after receiving the vaccine, patient suffered excessive diarrhea and slight coughing. 9 days after vaccine, patient was tested for Covid 19, and received positive results. Patient was transported to hospital via ambulance but hospital returned her to the nursing home since chest was clear, no respiratory issues, and no fever. 10 days after receiving the vaccine, patient was turned over to hospice care but still in the nursing home. Hospice was called in to provide better physician advice and access 24/7. 14 days after receiving vaccine, patient began experiencing excruciating body aches, coughing, low oxygen levels, and no appetite. 18 days after vaccine, patient died." "1024226-1" "1024226-1" "New onset dizziness with hypotension, tachycardia, and vomiting blood. Sent to ER - told he went into cardiac arrest and died." "1024325-1" "1024325-1" "Patient passed away on February 5, 2021. There was no reaction after the shot was given, the patient's son said the death was not related to the vaccine. The patient had a bad case of shingles about a month prior to receiving the vaccine which the son said had been hard on the patient, the patient was also 90 years old. Per the son, the patient's doctor had wanted the patient to get the vaccine. Due to the close proximity of the date the vaccine was given and the date Patient passed away we wanted to complete the VAERS form." "1024343-1" "1024343-1" "PATIENT ARRIVED TO ED ON 2/9 IN FULL CARDIAC ARREST" "1024420-1" "1024420-1" "Patient had the first Moderna Covid vaccine on Thursday 1/21/2021. She had a bit of sore arm on that day and the day after. On Saturday 1/23/2021, she had a fever of 100.5 F (11AM), nausea, light headache and chills. The temperature went down after she took ibuprofen. Patient's husband enrolled her to V-Safe to report all the adverse effects she experienced. On Sunday 1/24/2021, her temperature was 98.3F. She still had nausea and no appetite. She and her husband watched a football game in their bedroom upstairs. Husband noticed that his wife was pacing around the room many times. At 7Pm, Husband went downstairs for dinner but she refused to come down to eat. He went upstairs around 8pm, TV was still on. He turned off TV and went down stairs again thinking his wife felt as sleep while watching TV. He went back upstairs for bed around 10:30 PM. Husband said his wife had a deviated septum so she would snore very loudly when asleep. He didn?t hear her snoring so he went to check on her and found her not responsive. Husband called emergency services. Paramedic came at 10:45 and said patient was passed. Husband sent many texts to V-safe after that to report the incident. No response was received from V-safe. Patient?s doctor told her husband that she died due to cardiac arrest." "1024539-1" "1024539-1" "patient tested positive for covid on 1/29/21. was hospitalized on 2/8/21 for shortness of breath, generalized weakness, nausea." "1024592-1" "1024592-1" "No adverse reactions noted. Resident is on hospice for end of life care for terminal diagnosis cerebral atherosclerosis. Experiencing respiratory distress 2/10/2021 r/t to hospice prognosis." "1024626-1" "1024626-1" "DEATH ON 5TH DAY OF 2ND DOSE." "1024627-1" "1024627-1" "covid shot 2/2; feel bad 2/5; covid positive diagnosis - 2/8 s/s cough, fever, shortness of breath , hypertension, afib (in er) - admitted went into DIC per intensivist 2/11 patient died" "1024743-1" "1024743-1" "pt became lethargic, stopped eating. No fever; no nausea" "1024788-1" "1024788-1" "Pt had passed away before second dose given." "1024790-1" "1024790-1" "Pt had passed away before second dose given." "1024795-1" "1024795-1" "Pt had passed away before second dose given." "1024817-1" "1024817-1" "Patient was coded and expired Code Blue: Patient was in dialysis, after 30 minutes his sbp dropped to 60s he was given 4 albumin. Patient who was responsive before that became unresponsive, had seizure like activity, lost pulse and spontaneous breathing. HD stopped. Code called. Cpr started. A few minutes into cpr patient started to profusely bleed - gi bleed and ventilation became very hard., intubation was very difficult and ventilation hard as we suctioned large amounts of aspirated blood. Patient was eventually intubated. More than 8 doses of epi ws given, sodium bicarbonate * 2 given with continuous cpr. It was mostly PEA with one shockable rhythym. And shock delivered for vfib. patient continued to profusely bleed, og insertion was not successful and effective ventilation was very tough due to massive aspiration,. Possible variceal rupture with cpr from his cirrhosis is likely scenario. After 30 minutes of unsuccessful ventilation and acls protocol. Code was stopped." "1024853-1" "1024853-1" "Feb 8 states she had a cold. Feb 9 added stomach ache and nausea. Feb 9 visited urgent care facility for exam and Covid-19 test. Rapid test results were negative. Appeared tired but fine. Told to go home and rest. Feb 10 at 9:00 am found dead on the floor in pool of blood and aspirated. Excessive blood in toilet, pooled on floor and hallway rug." "1025079-1" "1025079-1" "Patient found by family in his home deceased on the morning of 02/10/2021." "1025081-1" "1025081-1" "No reported adverse reactions from 1st or 2nd vaccine doses Patient died on 2/6/2021 at Correctional facility- autopsy was performed at medical examiner's office. The COD was artherosclerotic cardiovascular disease" "1025330-1" "1025330-1" "On 1/26 at breakfast table began vomiting. Continued thru am when at noon a caregiver did his O2 saturation and found it was 75%. This was confirmed, and resent sent to ER ." "1025398-1" "1025398-1" "Patient received vaccine on 2/5. We were told on 2/9 that the patient visited another emergency department on 2/6 but no information was given as to what prompted that visit. She was sent home. Daughter found her on 2/6 or 2/ 7 unresponsive and she died." "1025472-1" "1025472-1" "Patient received COVID19 vaccine at clinic at 11:52 am, discharge post treatment stable. Got home around 2:30 pm went to bed. He usually got tired post dialysis. He did not wake up at 6 pm. His wife went check on him. found patient cold and unresponsive. 911 pulseless PEA. ER Medical hospital. Pronounced death at 7:40 pm" "1025493-1" "1025493-1" "Patient expired on the morning of 2/11/2021. No known adverse events prior to death. Patient was observed for 20 to 25 minutes after administration of vaccine and reported experiencing no signs or symptoms of adverse events at that time." "1025579-1" "1025579-1" "Patient received the vaccine at an outside healthcare facility on 2/11/21. At approximately 1 pm she screamed out and fell out of her chair. EMS was called and patient was found to be in Vfib. ACLS was performed for approximately 42 minutes prior to arrival at ED. At that time the patient had been pulseless for 25 minutes. Patient received 450 mg of amiodarone, epinephrine x7, sodium bicarbonate x2, and 7 AED shocks. In the ED 3 more doses of epinephrine were given, one more dose of sodium bicarbonate, and 5 additional shocks. ROSC was not achieved and time of death was called at 1416." "1025641-1" "1025641-1" "Complained of dizziness on January 18,th seen by MD this date. Passed away on 22nd." "1026045-1" "1026045-1" "On 2/7/21 resident complainted of not feeling well, nausea, vomiting and weakness sent to ER passed away." "1026095-1" "1026095-1" "DEATH 2/12/21" "1026141-1" "1026141-1" "death 2/12/21" "1026233-1" "1026233-1" "patient developed autoimmune thrombocytopenia" "1026270-1" "1026270-1" "At 10:33 am Patient pushed her pendant for staff, staff arrived to her apartment and Patient was found unresponsive in her bathroom. Patient received her second COVID-19 Pfizer vaccine about 75 minuets prior to this, she had no adverse reaction's within the first hour of receiving the second dose. CPR was started until paramedics arrived, they took over and tried to resuscitate. Patient was pronounced dead at 11:33 am at scene." "1026362-1" "1026362-1" "Patient stated he had a migraine after the vaccine. We were advised of a change in appetite on Thursday February 4th. Patient died on February 6th." "1026379-1" "1026379-1" "patient 6 hours post vaccination" "1026396-1" "1026396-1" "Patient experienced loss of taste and lack of appetite. Passed away on 1/23/21." "1026443-1" "1026443-1" "Received first 1/15/2021 with no adverse reaction. Received 2nd dose 2/9 @ 0846 with no adverse reaction or report of feeling ill. Traveled to store and arrived approx. 2 hours after receiving vaccine. Daughter stated patient felt well and had to go to the restroom to have BM. Collapsed in bathroom. Transported by ambulance to Hospital @ 1439 in cardiac arrest. Was in PEA and went in v fib back to PEA. Resuscitation efforts initiated and patient expired with time noted at hospital records at 15:11." "1026451-1" "1026451-1" "Resident expired 2/2/2021 one day after the vaccine" "1026492-1" "1026492-1" "The individual received the vaccine around 12:00pm on 02/11/21. Around 9pm the individual went to lay down on the couch at home and started to have difficulty breathing. Within 30 minutes the individual became week and unresponsive. She was transported to the hospital where she was pronounced deceased at 11:44 pm on 02/11/21." "1026499-1" "1026499-1" "Resident reviewed for incident. Resident received the second dose of the Moderna Covid-19 vaccine lot# 016M20A Exp 5/2/2021 on 2/5/2021 from clinic through pharmacy. Resident had her temp/O2 taken on AM shift and was 98.6/93%, beginning PM shift 98.4/95%. A few hours later noted that resident to have chills and was shaking RN assessment completed and vitals taken resident noted to have temp of 102.2, oxygen 95%, pulse 110. Resident alert and oriented at that time and talking to staff. Reported findings to APNP with order to send to ER. 911 called, residents brother updated. Upon EMT arrival RN went down to residents room with EMT and resident had an emesis as resident was getting cleaned up resident went unresponsive. Pulse noted to still be present at that time, resident did briefly respond to sternal rub and then went unresponsive again. Resident full code and EMT transferred to gurney and said that if they lost a pulse in route that they would transfer to hospital B instead of hospital A being the closest facility. RN called brother and gave update. Facility notified from Hospital that resident had passed away." "1026534-1" "1026534-1" "resident had a stroke, sent to the hospital and died 4 days later" "1026581-1" "1026581-1" "He had sudden death on Feb 4th. Unclear if this could be related to vaccination but since it was close in timing report has been filed. No known immediate reaction to vaccination." "1026671-1" "1026671-1" "The vaccine was administered at the patient's residence in an assisted living facility. The morning following the vaccination staff report that she was very agitated and stated she did not feel well. They called an ambulance and she was transported to a local ER, staff report that it was not at the hospital that the patient is usually seen by when when she has issues and they were concerned that the facility did not have her medical history to treat her properly. The patient's grandson reported back to the assisted living director that the patient was diagnosed with asymptomatic pneumonia, was transferred to the ICU and passed away in the night." "1026699-1" "1026699-1" "Had a stroke 3 days after round one of Covid vaccine and subsequently died the next week due to complications of stroke. Upon admission to hospital, was in afib." "1026752-1" "1026752-1" "Developed vomiting, seizure and cardiac arrest, V Fib" "1026841-1" "1026841-1" "Resident passed away this morning. No signs or symptoms prior to his death of an issue with the vaccine. He was an end stage dementia resident at the nursing home." "1026980-1" "1026980-1" "Patient reported to Emergency room on 01/23/2021 with complaint of nausea. According to ER record patient reported he received a COVID 19 vaccine Pfizer the day before. Work up in the ER (CT ABD PELVIS) reveal a clotted of SMA. CT CHEST REVEALED BILATERAL PULMONARY EMBOLUS. THE PATIENT WAS TRANSFERRED TO THE STATE HOSPITAL. HE WAS SCHEDULED FOR EMERGENT VASCULAR SURGERY WHICH WAS CANCELLED AS THE PATIENT DIED SHORTLY AFTER HIS ARRIVAL." "1027051-1" "1027051-1" "Few minutes post vaccination, after moving to observation area via wheelchair, the patient complained of dizziness. She took glucose tabs she had brought with her. Staff wheeled her to Triage # 1. Her eyes rolled back in her head and she lost consciousness. Staff (paramedics on site) transferred her to gurney and started compressions. AED placed, V- Fib was rhythm, Shock # 1 given, CPR resumed. Shocked again. Fire truck and additional EMT arrived on site and took over care. Epinephrine was given 3 times via intra-osseous route, Amiodarone given intra-osseous route. Additional defibrillation with on site AED for a total of 6-7 times. Patient had good chest rise with ambu-bag, no airway obstruction or peri-oral edema noted. Code called at 12:40 PM." "1027071-1" "1027071-1" "Adverse reaction to the vaccine started with variable weakness beginning 1/29/2021. On 1/30/21 around 8:30pm, he needed assistance in the bathroom related to weakness and had what was later identified as a stroke with left side weakness and slurred speech. In accordance with his wishes, he had care at home. Due to his advanced age and frailty, a CT scan was not pursued. The 325 mg of aspirin that he was previously taking daily was discontinued. After the stroke, he needed total care. Hospice was established at home. Nursing assistant care was delivered by daughter. Death followed 9 days later (2/9/2021)." "1027141-1" "1027141-1" "The patient reported feeling well. I discussed with him the Covid-19 vaccine and he was able to state that he wanted it and to sign his consent form. The facility reported they had discussed this with him and he had agreed prior to my visit." "1027158-1" "1027158-1" ""death. Per son pt was not feeling well after the vaccination ""like her legs were weak."" Son found the mom in her bed 1am on 2/12/2021 unresponsive."" "1027258-1" "1027258-1" "Resident was given the Pfizer vaccine on January 22, 2021, nausea and shortness of breath was taken to the Hospital on the 23rd of January and passed on the 24, 2021" "1027300-1" "1027300-1" "Nausea, vomiting and generalized weakness." "1027502-1" "1027502-1" "My dad received his first COVID vaccine on January 14, 2021. On January 16, 2021 he ate breakfast around 7:00 am and went back to his room. When the staff checked on him around 8:00 am they found my dad unresponsive. His blood pressure was over 220 and his pulse was 43. They began manual CPR until the paramedics arrived, but my dad died." "1027503-1" "1027503-1" "Patient died on 02/08/2021" "1027619-1" "1027619-1" "Swollen leg/pain- taken to urgent care- became unresponsive - CPR initiated- expired" "1027757-1" "1027757-1" "Death" "1027967-1" "1027967-1" "Patient received vaccination on 1/15/2021. Hemorrhagic Stroke on 1/20 , then diagnosed with complicated idiopathic coagulopathy" "1028101-1" "1028101-1" "Pt develops left leg pain The day after vaccination in AM subsequently drove approximately 150 miles On his way back stopped at his brothers place for lunch. He then collapsed coning down the steps, EMS started CPR. took him to ER Resuscitated briefly but went into CardioPulm Arrest again and PEA Resucitaion for aprox 1 hour but was unsuccessful. Noted to have Left leg more swollen than Right by 3 to 4 CM presumed to have died from massive Pulmonary embolism and inferior wall myocardial ischemia" "1028166-1" "1028166-1" "Patient was found unresponsive on her kitchen floor about 9:45 AM on February 10, 2021 approximately 18 hours after receiving her first Covid-19 vaccination. Exact time of the event is unknown. She was known to get up between 6:30 and 7:30 AM. It appeared that she had not eaten breakfast nor taken any medication that morning. She was taken by ambulance to Medical Center where a CT scan showed an unrecoverable massive brain hemorrhage. She died at approximately 3:50 PM after the respirator was removed. She was sent to the local Medical Examiner afterwards." "1028217-1" "1028217-1" "DEATH" "1028476-1" "1028476-1" "She started having breathing problems/heart attack appearance. on 1/22/21 and went to the ER. Upon admittance was told it was an anaphylactic shock from the Covid shot. They kept her in ICU and released her 1/23/21. At 12:45 am on 1/24/21 she passed out and we called the ambulance. Hospital admitted her and worked through multiple organ failure issues and thought her numbers were under control. She was released on 1/27/21 and was driving on 1/28/21 around 4:15 pm and appears to have had heart failure and had a wreck. She passed away that day." "1028596-1" "1028596-1" "*extreme* fatigue. could not awaken for more than few seconds. When briefly awake she was coherent and not confused. slept deeply from 4pm and could not wake to eat or drink. No fever, bp normal, blood oxygen ok. Blood sugar at 11pm was 230. Gave her 15u lantus at 11pm (normally 25u). Was sleeping at 2:30am but had died at next check at 3:30am." "1028778-1" "1028778-1" "On December 17, 2020, my husband, received his first BioNTech BNT162b2 COVID-19 vaccination. On Thursday January 7, 2021, he received this second COVID-19 vaccination. The following three days after his second vaccination, he felt fine. The fourth day, on Sunday January 10, my husband felt extremely fatigued. On Monday the 11th and Tuesday the 12th, he worked a full shift but complained of extreme fatigue and extreme chills to the point that his teeth were chattering while on the phone with me. He decided to work through it. When he got home on Monday night, he started vomiting. On Wednesday January 13, he woke up and had swollen eyes. Once again, he felt extremely fatigued, even after a full nights rest. He had the day off but had an early meeting. After his meeting, he was still tired so he went back to sleep. I left to get lunch, and drop off our kids, and upon my return, I found him on the walk in closet floor, face up, having passed away. He felt as cold as ice. The rapid test done after they called the paramedics resulted in a negative COVID-19 test for him." "1028885-1" "1028885-1" "Patient (now deceased) received 1st dose of Pfizer-BioNTech vaccine around December 21, 2020 and was noticed to be scratching, fatigued, and unresponsive by a family member on December 24, 2020. He received the second dose of the same vaccine around January 22, 2021. Pockmarks and bleeding scratch marks were noted by a family member on the patient's face prior to this second dose. On January 28, 2021 a family member was alerted that the patient was suffering from severe bullous pemphigoid- a skin condition that has never been experienced by the patient, has been reported to be related to COVID-19 viral infection, and to T-cell responses promoted by vaccines. A corticosteroid was given, but did not work. Blisters developed to the point hands had to be dressed." "1028921-1" "1028921-1" "Patient had no energy in the first 24 hours and then began a steady decline that started with vomiting after 48 hours, then an inability to swallow and ultimately the patients death on 2/5/21." "1029003-1" "1029003-1" "I video chatted with her Thursday after receiving the vaccine. My mom was in poor health but she was talking in complete sentences and responded appropriately. She was upright in bed and made eye contact. She smiled and denied pain. By Sunday, she was extremely weak and unable to sip water with a straw. Her health had changed dramatically and rapidly. She moaned in pain and was very fatigued. Her condition continued to deteriorate over the week and she stopped talking and was constantly sleeping. They started antibiotics for the oozing cancer lesion and then morphine for pain and end of life care. She passed away on January 22nd which was 15 days post vaccination." "1029068-1" "1029068-1" "Patient was given vaccine the following day he died ," "1029335-1" "1029335-1" "Cardiopulmonary arrest" "1029374-1" "1029374-1" "On 2/4/21, at around 3:00pm he began feeling very tired and he began burping in the evening. The following morning, he woke up early and was still burping and not feeling well. At around 5:00am, he collapsed. My mother called 9-1-1 and began giving CPR. The parademics arrived and tried to revive him, and transported him to the hospital but at 6:11am, he was pronounced dead of a heart attack. He was healthy." "1029412-1" "1029412-1" "Death" "1029511-1" "1029511-1" "Developed severe shortness of breath." "1029514-1" "1029514-1" "patient deceased" "1029554-1" "1029554-1" "Patient died suddenly on 2/1/21 from unknown causes according to his son." "1029744-1" "1029744-1" "right arm swelling immediately after injection. followed by bilateral lower leg edema, chills and body aches that continued daily at 2 weeks post immunization admin 2/4/21 treated with dexamethasone 6mg PO x 7 days- this resolved his s/s 2/13/21 patient passed away at facility" "1029783-1" "1029783-1" "Shortly after receiving the Moderna COVID-19 vaccine, patient complained of chest and stomach pain, then became very sleepy and fainted. RN was unable to obtain a manual BP; Apical pulse 36. Pulse Ox in the 70s. She was placed in bed and eventually regained consciousness. Her pulse ox improved to the 90s. BP 92/55. Her only complaint was that her hands were cold. Medical Director believes it was vasovagal syncopy due to receiving the vaccine. Patient died on 1/28/2021, due to progressive dementia." "1029790-1" "1029790-1" "Taken to Emergency about 8 hours later and died in ER" "1030273-1" "1030273-1" "Death; A spontaneous report was received from a reporter concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed away. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 on 28 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020, 2am the patient passed away. Administrator marked as natural causes. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was fatal. The patient died on 30 Dec 2020. The cause of death was reported as unknown. The reporter did not provide an assessment for the event, passed away.; Reporter's Comments: This case concerns a patient of unknown age and gender. The medical history and concomitant medication is not provided. The patient experienced Death. The event occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death" "1030323-1" "1030323-1" ""Patient had COVID vaccination on 2/3 with no adverse s/s before leaving unit. Upon coming to treatment Friday 2/5 he reported to the RN that he had fallen on thursday 2/4 due to ""getting up fast"" did not hit head or hurt anything per RN discussion. Began treatment without difficulty. About 3/4 way through treatment was talking with staff and became unresponsive - code was called and pt expired after 30 minute resuscitation efforts."" "1030468-1" "1030468-1" "Pt presents to ER with increased weakness, hypoxia, history of COPD, but not oxygen dependent., hypotension. Acute Kidney failure noted in labs, not previously diagnosed , new hyperkalemia. BP 73/39, HR 67. dopamine initiated, and switched to Levophed. Oxygen Sat 86%, requiring 10 L O2. Transferred from this critical access hospital to another Hospital. Expires later 2-13-2021" "1030586-1" "1030586-1" "This individual's employer informed our facility that he passed away at his home on 2/14/2021. Since he was not brought into our hospital, we do not have information regarding other health conditions or active medications. Since this individual received his second covid vaccine three days prior, this was reported to Moderna in addition to this VAERS report being completed. The coroner for County can be contacted." "1030701-1" "1030701-1" "unknown, husband reported hospitalization 02/12 and deceased 02/15" "1030712-1" "1030712-1" "2/10: Fever, fatigue, tylenol 2/11 @ 1300: pt made DNR, hospice consulted 2/11 @ 1800 decreased LOC, increased RR, fever, chills - 1/5L NS bolus IV, rectal tylenol. Refusing to eat/drink, PO morphine 2/12 @ 16:30, deceased at facility **resident was not doing well prior to vaccination" "1030729-1" "1030729-1" "deceased, 2/1/21" "1030893-1" "1030893-1" "Resident had slight/slow decline in health prior to vaccine but continued to be able to walk around with walker at community. The day of the vaccine she had a fever. 2 days after vaccine resident did not get out of bed all day and refused to eat. She had small amounts of orange juice as her blood sugar level was low due to not eating. Resident was diagnosed with a UTI and began an oral antibiotic. 3 days after and on day 5 after vaccine resident began feeling weak and had a fall on each day. The following day again resident spent the day in bed. The next day she was quite restless, was on the edge of her bed attempting to self transfer often throughout the day. Resident continued to be restless on the 10th of Feb, had further decline on the 11th of Feb. Resident passed away early the AM of Feb. 12th." "1031176-1" "1031176-1" "Death Narrative: Patient received Covid vaccine on 2/2/21, person reports his legs were more rigid with some sweating the day of the vaccination with leg rigidity that was slowly improving. No other adverse effects reported for following 7 days. Person states he had vomiting episode earlier this week, person states he had no other symptoms before or after the vomiting episodes. On morning of 2/12/21, person reports patient got up ready for breakfast with no issues. She says he asked for chorizo and oatmeal but she laughed and said don't you mean chorizo and eggs. He said yes. They got him into W/C and he was rolling himself into dining room got stuck in hallway. She says he took several breaths then 3 very deep breaths and passed away. She called 911 they took his VS but he has passed. She told them to leave him along no resuscitation." "1031189-1" "1031189-1" "COVID 19 symptoms and a positive test was confirmed on 1/6, employee noted previous exposure to positive family members Narrative: Employee noted exposure to COVID prior to presenting for 1st dose of vaccine on 1/5/21. On 1/6/21 employee reported the onset of symptoms and was tested and was confirmed COVID positive that day. Positive result was reported to employee health on 1/8/21. Employee Health continued to track employees progress and was informed of the need for hospitalization on 1/14/21. Course of hospitalization noted the need for intubation and significant issue with comorbid condition (rheumatoid arthritis). Employee died on 2/9/2021. Unable to confirm a direct connection to Vaccine vs. COVID infection, but felt it should be reported." "1031544-1" "1031544-1" "Patient family had been noticing onset confusion for a few weeks prior to vaccine and event. Patient was taken to ED when found unconscious and died of a subdural hemorrhage a few days after vaccine clinic at retirement home." "1031593-1" "1031593-1" "On February 11, 2021 around 10:15 am, patient was given the Moderna brand COVID-19 vaccination. After his vaccination, he was instructed to wait around for 15 minutes after the administration of the vaccine. During this time, there were no reported issues with the patient. On February 15, 2021 around 9:15am, patient's wife called the pharmacy and spoke with the pharmacist informing her that patient had passed away in his sleep on Saturday evening. Patient's wife inquired about whether death may have been caused by an adverse reaction to the vaccine. During the call patient's wife mentioned that patient slept a lot the day of the vaccine and the day after. patient's wife mentioned that patient woke up Saturday to eat breakfast and lunch. She states that later that evening, she found patient asleep and cold which she then realized that he'd passed away." "1031595-1" "1031595-1" "Unresponsive, Increase BP and H. Hospital Dx Renal Failure" "1031629-1" "1031629-1" "Patient became nauseated about 10 minutes after vaccine administered, this subsided but returned several hours after the vaccine was given. She continued with intractable nausea and vomiting for about 24 hours. This patient was enrolled in hospice and she continued to decline and refused to eat or drink. She was taking Ibuprofen due to intractable back pain. Her emesis was coffee ground color. After this her condition continued to decline until her death" "1031767-1" "1031767-1" "1/31/2021 12:50 Nursing Note Note Text: Res had low BP, low O2 sats, 30 breaths per minute, eyes open wide, making confused utterances. Started supplemental oxygen via NC, 2L, then 3L. Sats went up to 93% for a while, Sprvsr called. Unable to auscultate Left lung sounds. Called to update Res daughter. Called to page NP, writer went back to assess Res and O2 sats were 88%, turned O2 to 4LPM, called 911 for transport to Hospital ED. Left around 1030. NP called back afterwards, was updated. Family updated that Res was sent to Hospital ED. Note Text: Received phone call from daughter as well as information from hospital. Resident has pneumonia with septic shock. She is on abx and had thoracentesis performed for large pleural effusion. [linked]" "1031780-1" "1031780-1" "Patient was not seen at our facilities prior to or after COVID-19 vaccination. Patient received first dose on 1/23/2021 and as reported by the family member, patient expired on 2/5/21. Symptoms were reported to have stared on 2/1/2021, 9 days after receiving the first dose with a drop in oxygen levels and fever. He was reported to also have a history of chronic lung disease. Patient's family member to be contacted if necessary." "1031846-1" "1031846-1" ""Patient and her husband are elderly, but healthy and live independently. Patient took blood pressure medicine 'off and on' according to family. She was 5'2"", 120 pounds and slim and healthy and active, so was her husband, though he had pulmonary fibrosis so they had been staying home and not attending church etc, and masking when they did go out to protect against covid disease. They were both vaccinated with covid Pfizer vaccine (dose #1) on Thursday Feb 11. (02/11/2021) Thursday night as they went to bed they checked in with each other on how they each felt. Patient said she felt totally fine, and her husband said his arm was a bit sore. Patient woke before her husband on Friday Feb 12, went downstairs and, from what the family can tell, fixed herself a snack, then sat on the sofa. Patient's husband found her deceased on the sofa. He called 911 and they asked him to do CPR until the paramedics arrived. Because of proximity to covid vaccine, the ME wanted to examine the body in the home and also ordered an autopsy. Autopsy was completed on the same day as death, Feb 12, 2021"" "1031909-1" "1031909-1" "Pt received dose #1 of COVID-19 vaccine (Pfizer-BioNTech) on 12/18/20 and dose #2 ( Pfizer-BioNTech) on 1/8/21. On 1/30, patient was evaluated at urgent care due to back pain. No bloodwork done; metronidazole prescribed for 7 days. On 2/8, patient was admitted to outside hospital due to ongoing symptom progression. At time of admission, hgb 5 g/dL and plt 9k. Per Dr. (hematology/oncology), pt with schistocytes, LDH 1500, and elevated reticulocyte count consistent with thrombotic thrombocytopenic purpura (TTP). SCr >2 mg/dL. Patient immediately treated with plasma exchange and steroids, however continued to decline. Patient expired on 2/14/21." "1031993-1" "1031993-1" "Patient reported mild flu like symptoms from vaccination later that evening. Next morning LTCF staff found pt deceased" "1032161-1" "1032161-1" ""The day after the 2nd shot, patient developed blisters on his lips and mouth. The care facility said that he had a nut allergy -- but he had never been allergic to nuts. He stopped eating and drinking and his BP had dropped to 60/40. By Jan 16th they called to say he was dying and he passed away on 1/18/21. Patient had COVID19 from Oct 29th - early November. By Nov 21st he had lost 40 lbs. He was 6'3"" and had gone from 189lbs to 149 lbs with COVID. By Nov 21st when we could visit, he had recovered from COVID, but was very thin and weak. He could not bathroom alone and kept falling. He didn't seem to have a bad reaction to the 1st COVID shot, But he immediately reacted to the 2nd shot and passed away within 6 days."" "1032163-1" "1032163-1" "Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up to ankles, later rising up to her knees. Pt admitted to hospital on 2/6/21 for symptomatic anemia 2/2 vaginal bleeding. Patient received 4 units FFP, 4 units PRBC, 1 unit cryoprecipitate, and vitamin K 5 mg IV. Also started on medroxyprogesterone 20 mg PO TID. Alectinib d/ced due to worsening liver function. Evalauted by OB/GYN and Hematology. Diagnosed with DIC. Patient with worsening bilateral lower extremity edema and purpura with pain and weakness. Palliative care consulted. Patient passed away on 2/11." "1032193-1" "1032193-1" "Patient received his first dose of Covid vaccine on Jan. 30, 2021. On Jan 31, 2021 at 6:08 AM, patient noted unresponsive per facility. Code blue was called and 911 dispatched. He expired in the ER." "1032252-1" "1032252-1" "Resident tested COVID-19 confirmed positive a few days after covid vaccination." "1032265-1" "1032265-1" "Resident tested NEGATIVE for COVID-19 last 1/25/2021. She was on monitoring for desaturation and low blood pressure on Jan. 27,2021" "1032279-1" "1032279-1" "Resident tested NEGATIVE for COVID-19 on 1/25/2021. She was on monitoring for declining in condition on 1/29/2021." "1032303-1" "1032303-1" "On monitoring for declining in condition, loss of appetite and generalized body weakness on2/1/2021. Was confirmed COVID-19 positive 4/23/2020." "1032321-1" "1032321-1" "Resident has shortness of breath on 1/19/2021 and was transferred to Hospital 1/20/2021" "1032327-1" "1032327-1" "On monitoring for weight loss ." "1032575-1" "1032575-1" "Two days later passed away; difficulty breathing, shortness of breath; difficulty breathing, gurgling; Not feeling well; Achiness; Severe fever; Chills; A spontaneous report was received from a physician concerning a 56-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever, chills, achiness, shortness of breath, gurgling and unresponsive. The patient's medical history was not provided. Concomitant product use was not provided. On 19 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. After receiving the vaccine on 19 Jan 2021, the patient experienced fever, chills, shortness of breath, gurgling and achiness. On 21 Jan 2021, the patient was found unresponsive. Emergency medical services were called to perform life saving measures however, they were unsuccessful. No further treatment information was provided. The patient died on 21 Jan 2021. The cause of death was reported as unknown. An autopsy was planned.; Reporter's Comments: This case concerns a 56-year-old, female, who experienced a serious event of death, with many other events after receiving second dose of mRNA-1273 (Lot# 042L20A). Very limited information regarding these events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1032662-1" "1032662-1" "Death" "1032873-1" "1032873-1" "He had rigors starting 6 pm the day after the vaccination. He was treated with one 500 mg tylenol. He had increased wheezing but did not complain of SOB. At 0400 the next morning, he died." "1032880-1" "1032880-1" "Received Pfizer 1/22/2021. RNA+ 2/4/2021. S/S SOB, cough, confusion. COVID assoc. resp. failure, stage 4 lung cancer, COPD, HTN, former smoker. patient in hospice and died 2/10/2021." "1033102-1" "1033102-1" "Patient received first dose of vaccine on 1/7/21 at a community Public Health clinic. On 1/29/21 he received a second dose at the community Public Health clinic. On 2/5/21, the patient presented to the ED with complaints of shortness of breath worsening over the last 2 weeks. Patient reported that he had decreased exercise capacity and increased coughing with sputum production intermittently. Patient reported that he had been feeling chilled, but no fevers. Patient was admitted and treated with Decadron and Remdesivir. Patient experienced increased oxygen requirement. Patient was a DNI and did not want to be on life support. After discussion with the patient and family, patient was moved to comfort care. passed away on 2/11/21." "1033131-1" "1033131-1" "Patient received initial COVID vaccine on 2/11/2021 at Clinic. Direct observation for 15 minutes and no documentation noting an adverse reaction. On 2/14/2021 was diagnosed with Sepsis secondary to pneumonia, started on antibiotic therapy, cardiac arrested, and expired on 2/14/2021 while at Hospital." "1033155-1" "1033155-1" "Vaccine given in clinic per protocol - patient monitored for 15 minutes, no adverse reactions noted at the time. Patient stated he felt fine following 15 minute monitoring time. Patient left facility- it was later reported that pt had a fall at home. Upon review of pt's medical record - Pt's wife had to initiate CPR and call EMS for transportation and life saving measures enroute to the Emergency Room. Pt was intubated as pt was in asystole upon arrival to the ER, ACLS was continued, pt was noted to have a traumatic brain injury from his fall at home, and pt was pronounced dead at 1620." "1033263-1" "1033263-1" "patient passed away within 60 days of receiving COVID vaccine" "1033323-1" "1033323-1" "patient passed away within 60 days of receiving a COVID vaccine" "1033444-1" "1033444-1" "symptoms of ongoing congestive heart disease just progressed" "1033448-1" "1033448-1" "Fever by the next day, difficulty breathing, pneumonia, and then DEATH within a few days. (Died 02/01/2021)" "1033607-1" "1033607-1" "Vomiting, death." "1033682-1" "1033682-1" "L hand edema, hematoma which burst and caused bleeding sending pt to the ER for pressure dressing and 2 stitches. L hand and arm progressively got more edematous and bruised looking (severely black/blue/purple) and the hand continued to bleed and swell on 2/6/21. Severe arterial and venous issues and apparent blood clots. On 2/7/21 there were also lumps noted on left inner thigh. Pt. stopped eating or drinking on 2/8/21 and expired on 2/12/21." "1033873-1" "1033873-1" "PATIENT PASSED AWAY ON 2-1-2021" "1034055-1" "1034055-1" "Associate developed SOB on 2/12/21. Taken to Hospital on 2/13/21. Reported deceased 2/14/21." "1034116-1" "1034116-1" "Presented from clinic with 3-4 days of extensive rash. There were multiple areas of skin sloughing on bilateral upper extremities and abdominal wall." "1034146-1" "1034146-1" "ARRIVED AT EVENT, CONSENT FORM COMPLETED, DID NOT REPORT HE HAD BEEN ILL, DID NOT REPORT THAT HE TOOK ANY FEVER REDUCING MEDICATIONS" "1034182-1" "1034182-1" "Approximately 2 weeks post vaccination developed rapid AF, CHF. Admitted to Medical Center. Discharged home on hospice. Patient died at home on 2/13/2021. Reported to this reporter at second dose clinic on 2/16/21. Other details not known. Unknown if related to vaccine." "1034192-1" "1034192-1" "Patient presented with spontaneous IVH of small vessel origin with essentially no past medical history. She then acutely developed mesenteric ischemia. Died due to all dead small bowel which also appeared to be small vessel disease and not embolic/thrombotic. This process started one week after" "1034349-1" "1034349-1" "Patient awoke on 2/12/21 with altered mental status, confusion, respiratory distress, was taken to hospital by ambulance. Per ED notes from ED attending Pt presented with hypotension and respiratory distress. DNR status, patient given comfort measures and passed away in ED at 11:24 am on 2/12/21." "1035539-1" "1035539-1" "Fall; fatigued; arm pain; AML; Sepsis secondary to AML; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), via an unspecified route of administration on 19Jan2021 17:30 in right arm at single dose for covid-19 immunization. Medical history included hypertension, hyperlipidemia, OA (osteoarthritis), cognitive impairment. No other vaccine in four weeks was administrated. Concomitant medication in two weeks included atorvastatin, aspirin, calcium, gabapentin, losartan and memantine hydrochloride (NAMENDA). The patient previously took lisinopril and tetracycline and both experienced allergies. The patient had no covid prior vaccination. The patient initially had no symptoms but arm pain in Jan2021, no bleeding or bruising from injection. On 31Jan2021 19:00, patient felt fatigued. Patient suffered fall on 01Feb2021. She was admitted to hospital. All cell lines were down in Feb2021. She was diagnosed with AML (acute myeloid leukemia) in 2021. She expired 07Feb2021. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event) and patient died. The patient received the treatment of blood and platelet transfusions, bone marrow biopsy, cytogenetic testing, antibiotics, intubation for events. The patient died on 07Feb2021 due to sepsis secondary to AML. An autopsy was not performed. Outcome of events were fatal.; Reported Cause(s) of Death: arm pain; fatigued; fall; Sepsis secondary to AML; Sepsis secondary to AML" "1035542-1" "1035542-1" "passed away; This is a spontaneous report from a contactable consumer (patient's granddaughter). An 82-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN9581), via an unspecified route of administration on 08Feb2021 at 14:30 into right arm at single dose for COVID Prevention. Medical history included Heart valve replacement from 5 years before 09Feb2021 (2016), on Oxygen at night (reporter did not know the liter amount that the patient used at night). The patient's concomitant medications were not reported. Patient had no other vaccines on the same day as the COVID vaccine. It was reported that patient received his first dose of the Pfizer vaccine around 14:30 on 08Feb2021 and he was fine before that, and by 16:30, he had passed away on 08Feb2021. Reporter reported that the cause of death was unknown at this time and that the family would be having an autopsy performed but that it had not yet been performed. No investigation assessment could provide. The patient died on 08Feb2021 at 16:30. An autopsy was not performed.; Reported Cause(s) of Death: passed away" "1035546-1" "1035546-1" "Stroke; This is a spontaneous report from a contactable consumer. A 94-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 16Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing hypertension (took medication). Patient did not have COVID-19 prior to vaccination. Concomitant included unspecified medication for hypertension. The patient experienced stroke on 31Jan2021. The patient was brought to the emergency room and hospitalized due to the event on 31Jan2021. No therapeutic measures were taken as a result of the event. The patient underwent lab tests and procedures which included COVID-19 virus test: negative in Feb2021 (a week before report); investigation: brain bleed and discovered she had a stroke (on unknown date in 2021). The patient died on 03Feb2021 due to stroke and old age. An autopsy was not performed. Patient's family did not attribute her death to the vaccine at all. The information on the Lot/Batch number has been requested.; Reported Cause(s) of Death: stroke; Old age" "1035552-1" "1035552-1" "approxmately 1:30 Pm the resident passed away; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported that a female patient of an unspecified age (reported as 85 without unit) received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular at left arm on 29Dec2020 11:29 at single dose for COVID-19 immunization. Medical history included dementia, aphasia, type 2 diabetes mellitus (DM), iron deficiency, asthenia, osteoporosis, polyneuropathy, anxiety, Major depressive disorder (MDD). Concomitant medication included gabapentin, memantine. The patient had allergies to codiene, phenobarbital, penicillin. The vaccine was administrated with no immediate adverse reaction at 11:29. Vaccine screening questions were completed and resident was not feeling sick and temperature was 98F. At approximately 13:30 on 29Dec2020, the resident passed away. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: approxmately 1:30 Pm the resident passed away" "1035553-1" "1035553-1" "Pt passed soon after; shortly after progressed with other covid symptoms and was admitted / acute resp failure, COVID pneumonia; acute resp failure, COVID pneumonia; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; This is a spontaneous report from a non-contactable Pharmacist. A 76-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EL3247), intramuscular on 19Jan2021 at single dose for COVID-19 immunisation. The patient medical history included COVID symptoms from 16Jan2021 and ongoing. Concomitant medications were not reported. The patient with acute resp failure, COVID pneumonia, that developed symptoms 9 days prior to admit and ultimately received first vaccine 6 days prior to a admit, then shortly after progressed with other covid symptoms and was admitted on 25Jan2021. She decompensated while intp and was transferred to ICU for rising O2 needs, ultimately had to be intubated. Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle. Sx and IR consulted and did beside exploration of hematoma. Initially blood pressure responded but overnight continued with refractory hypotension. Maxed out vasopressin and levophed, hemodynamics deteriorated. The patient died on 02Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events death, COVID-19 pneumonia, acute respiratory failure, hypotension, abdominal wall haematoma and abdominal wall haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Pt passed soon after" "1035597-1" "1035597-1" "Death on 1/17/2021. Found at home deceased." "1035641-1" "1035641-1" "Healthcare was advised that this patient expired approximately two weeks after receiving her initial COVID vaccination" "1035841-1" "1035841-1" "Death on 2/8/2021 unknown signs and symptoms at time of death; multiple co-morbidities" "1035845-1" "1035845-1" "We were informed by EMS that the patient was found deceased on 2/11/2021 at her home. EMS states she was dead for some time, no medical care given." "1035850-1" "1035850-1" "Patient woke up on the morning of 2/6 with symptoms of a stroke. Rushed to hospital where clot found in brain. Recovered from initial stroke but then had another major stroke on 2/8 and never recovered." "1035866-1" "1035866-1" "Pt died on 2/15/21. On 2/13/21, pt complained of muscle aches." "1035872-1" "1035872-1" "Patient was found unresponsive at 8 am on 2/12; patient was deceased" "1035878-1" "1035878-1" "Daughter called to report that the patient died on 02/15/2021. No report of symptoms from the vaccine on 02/13/2021" "1035897-1" "1035897-1" "Patient received her vaccine on 2/2/2021 in the morning. She was observed for over 15 minutes and had no history of any anaphylactic reaction of any sort. She felt fine and went home. 2/15/2021 we were notified by her family that she had passed away on 2/7/2021 at home. The cause of death was stated as myocardial infarct secondary to coronary artery disease. We do not think it had to do with the vaccine administration. The patient had many comorbidities." "1035943-1" "1035943-1" "Patient had no reaction at the time of vaccination. Waited the required 15 minutes and was allowed to go home." "1035950-1" "1035950-1" "Patient found deceased at home on 2/15/2021. There was no known cause of death with no significant medical history." "1036047-1" "1036047-1" "Short version The patient has long-standing health issues. The patient received the first dose of Moderna COVID-19 vaccine on 1/16/2021 (unknown location). The patient suffered an event in his home on 1/24/2021. CPR and treatment was begun and he was transported to the ED. He was pronounced dead in the ED at 0846. Long version 70-year-old male with past medical history of CAD with pacemaker, A. fib, COPD, hypertension/hyperlipidemia presenting in cardiac arrest. 911 call at 0724. Per EMS, patient was witnessed by family to have seizure-like activity and then collapsed and became unresponsive. Patient was noted by family to be pulseless and CPR was started right away. Patient received two doses of epi by police were on scene first (AED defibrillation x2) and six doses of epi (plus 6 more AED shocks) by EMS when they arrived. Patient had CPR performed for 45 minutes prior to arriving at the hospital. On route, patient had episodes of paced rhythm and V. fib. Patient received one amp of bicarb and one amp of calcium en route. Patient also received 300 mg of amiodarone en route. Arrived in ED at 0810 Patient received ongoing compressions, shocks and additional medications (epinephrine x6, lidocaine IV, sodium bicarbonate) until time of death called at 0846 in the ED." "1036098-1" "1036098-1" "Patient received the vaccine on 1/31/2021. Patient complained of bleeding 2/7/2021. Went to clinic where labs were conducted. Patient had an INR of 12. Previous INR results were normal prior to vaccination. Patient was also diagnosed with UTI and given antibiotics. Patient was encouraged to go to ER. Patient died on 2/12/2021." "1036182-1" "1036182-1" ""Patient received 2nd dose of the COVID-19 Pfizer vaccine, was observed in office x 15+ minutes, and released home. Pt and his son exited the building and when they got to the car, the pt shouted out ""oh no!"" and collapsed to the ground. The patient was unconscious experiencing agonal respirations, and unresponsive to painful stimuli. There is an Emergency Room at the same location. Their staff came out and helped to transfer the pt to the ED for further evaluation. It was found that the patient had a known Anterior communicating artery aneurysm (7/28/2017) that seemed to have ruptured. The patient was stabilized and transported to our local hospital and upon arrival, he was effectively comatose with a GCS 3. CT Head notated an extensive subarachnoid and intraventricular hemorrhage most probably related to a bleeding anterior communicating artery aneurysm. Neuro-Interventional Radiologist dictation reads ""Hunt Hess 5 Fisher grade 4 extensive subarachnoid hemorrhage with intraventricular hemorrhage and early hydrocephalus secondary to rupture of a known anterior communicating artery aneurysm. Initial ICP after EVD placement noted to be in the 120s now 68 treatment complicated by aneurysm rerupture after admission and increased volume of blood although large volume of hemorrhage was seen on initial scan and no change in the patient's clinical exam on her scale was noted due to this rerupture. Patient's exam and prognosis are poor giving extensor posturing lack of extraocular movements to doll's maneuver and weak pupillary reflex as well as cough and gag. Follows no commands or instructions at this time with no spontaneous movement on ventilator set at 12 overbreathing at 14-16 at this time without any sedation."" The family opted to discontinue any further treatment to include surgical intervention given the findings. The patient was given comfort care with son and daughter at the bedside. The patient was extubated and expired at 1545h on 2/13/2021."" "1036418-1" "1036418-1" "ER visit 1/25/21 patient walked into a prompt care and collapsed, witnessed and pulseless CPR with ROSC after 6-7mins, no shock no meds. Awake and speaking upon arrival to ER. 2 plus pitting edema ble ER diagnosis Anasarca, cardiac arrest, hypotension, elevated troponin I levels, Acute kidney injury and syncope. ER notes reveal a syncopal episode in the shower prior to collapse at prompt care. Central line placed and plan to ship to another facility, patient continued to decline despite dopamine and dobutamine expired in ER prior to transfer." "1036437-1" "1036437-1" "Patient is deceased. Family called the pharmacy on 2-17-21 to let us know he would not be coming for his second appointment. When the pharmacist tried to call the family back for more info, the phone number on file doesn't work." "1036440-1" "1036440-1" "Patient died at home in hospice care from complications of stage 4 bladder cancer" "1036460-1" "1036460-1" "death 2-5-21" "1036479-1" "1036479-1" "Fall 2/4 hospital admission 2/7/21 with death on 2/8/2021. Patient continued to decline on Bipap he was a DNR/DNI and family decided on comfort measures and he expired 2/8/2021." "1036480-1" "1036480-1" "Patient passed away on 2/2/21 after being admitted on 1/31/21 after receiving COVID19 Moderna Vaccine on 1/26/21. On initial report to the hospital patient reported having a cough for over 2 weeks (starting approx. 1/17/21). He had a postive COVID19 PCR on 1/31/21. Intubated on 1/31/21 and passed away on 2/2/21" "1036519-1" "1036519-1" "Received first SARS-CoV2 vaccination yesterday at local store Experienced new symptoms of chills, nausea as well as worsening from baseline dyspnea at night. Wife states he had rough morning breathing and had sudden loss of consciousness and unresponsiveness and failed to respond to bystander CPR. He expired at his home." "1036532-1" "1036532-1" "Patient was found unresponsive the following day and then pronounced deceased" "1036585-1" "1036585-1" ""Patient called EMS approximately 1pm on 2/15 with complaints of generalized weakness. Upon arrival EMS found her to be diaphoretic and she had a witnessed syncopal episode with question of v-fib and seizures. She became unresponsive and had no pulse. CPR was begun and she was transported to ED. She remained asystole throughout. CPR was initially continued in the ED for approximately 30 minutes and then stopped with Time of Death noted at 13:27. ED notes noted ""suspect given history that patient experienced massive MI, PE or ruptured AAA"". Death certificate notes indicate ""signficant conditions contributing to death after cardiac arrest; ASCVD""."" "1036634-1" "1036634-1" "Patient had COVID in Sept. Minimal symptoms. Received 1st dose 1/18 without adverse reactions. Second dose on 2/8-had complaints of arm soreness several days after then appeared in usual state of health. On 2/14 @ 2 hours after having lunch, patient was found unresponsive with Respirations 60, pulse 130, PO 84%, blood pressure 105/68. Patient with lots of white foam coming out of mouth. Temperature to 101.3. Patient DNR B and family deferred transfer, wanted comfort measures only. Nursing received order for MSIR. Patient continued with temps in 99-100 range with tylenol suppositories. Patient passed on 2/16." "1036655-1" "1036655-1" "Death on 1/31/2021 multiple comorbidities" "1036675-1" "1036675-1" "61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%, improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11.07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, Thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 2/8/2021 and then VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM." "1036678-1" "1036678-1" "Resident did not exhibit any side effects from the vaccine. Staff spoke with him in his room at approximately 7:20am and returned to his room just a few minutes later and he was unresponsive. When the RN got to the room he had CTB. Physician documented heart failure and end stage kidney disease on the death certificate." "1036683-1" "1036683-1" "cardiac arrest in the home." "1036697-1" "1036697-1" "Multiple co-morbidities history of COVID-19 6/8/2020 and 12/28/2020. At time of vaccination fighting osteomyelitis. 1st dose 1/13/21, 2nd dose 2/3/2021 expired 2/8/2021." "1036731-1" "1036731-1" "SOB, DOE, oxygen desaturation, nausea. Ems transport to ER for eval" "1036748-1" "1036748-1" "Sent to ER 1/14/2021 due to drop in blood pressure with LOC during dialysis. Imaging revealed right lower lobe pneumonia given script for amoxicillin. According to staff patient was on dialysis had pneumonia and was on hospice, dialysis stopped resulting in death." "1036770-1" "1036770-1" "Feb 10th died in her sleep. No apparent reason." "1036787-1" "1036787-1" "passed away 2 days after vaccine was given" "1036874-1" "1036874-1" "Patient developed pneumonia Admitted to hospital on 12/25. Determined to have pseudomonas bacteremia and passed away on 12/27." "1036881-1" "1036881-1" "Myocardial Infarction" "1036935-1" "1036935-1" "unkown" "1036993-1" "1036993-1" "Patient reported at review of questionnaire had headache that day. Temp was taken, 97.8, okay. proceeded. Conversing customer friend in store afterward. When timer went off, said he was fine, he and his wife left. Daughter called to store Wednesday morning, said Pt had passed away Tuesday, that it was unknown the cause, and just wanted to let us know. We did not take down her phone number and last name. The patient was a long time customer." "1037051-1" "1037051-1" "Diarrhea , fatigue on 2/10 Fall 2/12 out to hospital Resident Expired 2/14" "1037124-1" "1037124-1" "Patient was at a gym watching his daughter. He slumped over unconscious. EMS was called. He was found to be in fine ventricular fibrillation and resuscitation efforts failed. He was brought to Hospital ED where he was pronounced dead. He had underlying cardiac disease but his family requested I report this event as possibly related to the recent COVID vaccination." "1037207-1" "1037207-1" "She had pain in the injection site Tuesday night and then during Tuesday she got worse with nausea and some fever. By Wednesday she was complaining that she could not pee even though she was drinking a lot of fluids. She continued to complain it was the worst she ever felt and then at 0600 Thursday morning she woke us up and said she needed to go to the hospital. We arrived at the hospital just before 0700 and she immediately threw up in the trash can. We went into a treatment room and they took blood and started fluids as she became incoherent. She said she had taken Tylenol so they started a drug to counter that but her liver function was all wrong and they started to look for a hospital that could transplant a liver. She was air evade about 0930 to Medical center and just over 30 hours latter she was dead. There is a pending autopsy. She was a healthy 39 year old mother who got the shots because she worked as a surgical tech and she was the single mother of a 9 year old little girl." "1037865-1" "1037865-1" "respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19; This is a spontaneous report from a contactable physician. An 89-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 10Jan2021 at 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient received one dose of Pfizer vaccine on 10Jan2021. The patient was presented to the ER with COVID symptoms and was diagnosed on 27Jan2021. Patient subsequently died on 09Feb2021 from respiratory failure from COVID19. It was unknown if autopsy was done. The patient was tested for COVID post vaccination via nasal swab: covid-19 virus test positive on 27Jan2021. The events resulted in emergency room/department or urgent care, hospitalization, and patient died. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID post vaccination and respiratory failure with fatal outcome, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. More information on the underlying medical condition in this 89-year-old male patient is required for the Company to make a more meaningful causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death: presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from" "1037878-1" "1037878-1" "Is patient deceased: Yes; Low pulse; This is a spontaneous report from two contactable nurses reporting for a patient. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0140 expiration date Mar2021) intramuscular on 22Dec2020 at 10:30 at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home. Patient age at time of vaccination was 70 years. Patient's Medical History included ongoing Type 2 Diabetes Mellitus Without Complication onset date: admission 22Oct2020, ongoing morbid obesity due to excess calories onset date: admission 22Oct2020, cardiac disorder, essential hypertension, hypertension, schizophrenia, hyperlipidemia, benign prostatic hyperplasia (BPH), Gastrooesophageal reflux disease (GERD), depression, hypothyroid, epilepsy, pain, dry eyes, anxiety, restlessness, 17Jan2020 Slid out of chair to floor, no injury, on 27Jan2020, 28Jan2020, 29Jan2020 diarrhea noted. Concomitant medications included acetylsalicylic acid (ASPIRIN EC) for Cardiac Health, atenolol (ATENOLOL) for Essential Hypertension, atorvastatin calcium (ATORVASTATIN CALCIUM) for hyperlipidemia, finasteride (FINASTERIDE) for benign prostatic hyperplasia, tamsulosin hydrochloride (FLOMAX) benign prostatic hyperplasia, insulin glargine (LANTUS) for diabetes mellitus, lithium carbonate (LITHIUM CARBONATE) for Schizophrenia, losartan potassium (LOSARTAN POTASSIUM) for hypertension, lurasidone hydrochloride (LURASIDONE HYDROCHLORIDE) for Schizophrenia, omeprazole (OMEPRAZOLE) for gastrooesophageal reflux disease, sertraline hcl (SERTRALINE HCL) for depression, levothyroxine sodium (SYNTHROID) for hypothyroid, ergocalciferol (VIT D) for supplement, haloperidol (HALOPERIDOL) for Schizophrenia, levetiracetam (KEPPRA) for epilepsy, paracetamol (TYLENOL EXTRA-STRENGTH) for pain, propylene glycol (ARTIFICIAL TEARS) for dry eyes, lorazepam (ATIVAN) for a anxiety or restlessness. As antipyretic use was reported Tylenol ES (500 mg) Tab, 2 Tabs by Mouth Routine use three times a day given at time of vaccination and after. It was reported the patient was Covid+. He was tested on 21Dec2020 and was not admitted to hospital. Event Onset Date was reported as 24Dec2020 (clarification pending). On 30Dec2020 the patient was started on O2 at 2L for low pulse. O2 was increased over time to eventually O2 at 8L on 03Jan2021. Morphine Sulfate was started on 03Jan2021 at 5 mg sl/by mouth every 2 hours as needed for pain or airhunger. The patient deceased on 03Jan2021. The cause of death was unknown. It was not reported if an autopsy was performed. The AEs did not require a visit to Emergency Room or Physician Office. Outcome of Low pulse was unknown.; Sender's Comments: Based on the information available the events Death (unknown cause) and Heart rate decreased are attributed to patient's multiple underlying medical conditions including Type 2 Diabetes Mellitus, morbid obesity, cardiac disorder, hypertension, epilepsy etc. However, based solely on a vaccine-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the above mentioned events cannot be completely excluded. The case will be reevaluated should additional information, including the cause of death, become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Is patient deceased: Yes" "1038147-1" "1038147-1" "Patient went into new-onset atrial fibrillation, resulting in a catastrophic stroke. Patient passed away on 2/11 as a result of the stroke." "1038225-1" "1038225-1" "Death, 2-17-21 at 1802 hours" "1038253-1" "1038253-1" "Died the next day; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and died the next day. The patient's medical history was not provided. Concomitant medication use was not provided by the reporter. On 12 Jan 2021, approximately one day prior to the event, the patient received one of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021 the patient died. No additional information was provided in regards to the event. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 13 Jan 2021. The cause of death was unknown.; Reporter's Comments: This case concerns a male patient of unknown age. The medical history and concomitant medication were not provided. The patient died approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death" "1038257-1" "1038257-1" "Passed away; tired; nonresponsive; cold; difficulty breathing; swelling; sore arm; feeling weird and funny; A spontaneous report (United States) was received from a consumer concerning a 63 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient experienced limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal and the patient passed away . Medical history included treatment for tuberculosis and dialysis. Concomitant medication included calcium acetate, Renvela, glipizide, omeprazole, aspirin, vitamin D, losartan, furosemide, rifampin, and Sensipar. On 14 Jan 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 030L20A) for prophylaxis of COVID-19 infection. On 13 Jan2021, the patient tested negative for COVID-19). On 16 Jan 2021, the patient experienced a sore arm, and feeling weird/funny. On 17Jan2021, the patient experienced difficulty breathing and swelling. On 18 Jan 2021, the patient declined dialysis, was tired and wanted to lay down. At 8 am, the patient was found nonresponsive and cold and is believed to have passed away around 4 am. The coroner tested the deceased for COVID-19 and the test was positive. No autopsy was reported. No death certificate was issued at the time of the report but the reporter believes it will list cause of death as COVID complications. Action taken with the mRNA-1273 was not applicable. The outcome of the events of limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal, was fatal. On 18 Jan 2021, the patient was died. Cause of death was COVID-19. Autopsy details were not provided.; Reporter's Comments: The events developed on four days after first dose of mRNA-1372. Dyspnea, unresponsive to stimuli, and death were consistent with infection in pandemic set up confounded by age of patient and refusal of dialysis Cause of death was reported as COVID-19. Autopsy details were not provided. Based on reporter's causality the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: COVID-19" "1038290-1" "1038290-1" "Death on same day as vaccination" "1038442-1" "1038442-1" "Death within thirty days of vaccine. Multiple co-morbidities and placed on hospice 12/28/20." "1038489-1" "1038489-1" "The patient experienced a cardiac arrest 2 days after receiving the second dose of the Covid-19 vaccine. He later died on 2-17-2021 with complications including respiratory arrest and acute kidney failure." "1038517-1" "1038517-1" "Pt. received vaccine on 2/3/2021. Coded at home on 2/17/2021." "1038527-1" "1038527-1" "Per EMS/Hospital report patient had difficulty breathing and cardiac arrest with prolonged CPR (greater than 45 mins in the ER) who was resuscitated. Family subsequently arrived including son and daughter and all family members were in the ER room are in agreement that patient would not want further aggressive cares given her extremely poor prognosis in light of chronic debilitation with numerous medical issues and now a very long period of CPR. Hospital Course After updating family they stated patient would not want further aggressive cares given her grim prognosis and chronic severe and debilitating medical issues. She continued to have myoclonic jerking. She was extubated to comfort cares in the ER and did not pass immediately therefore brought to a room. She received comfort cares and passed away at 0450 with family present." "1038561-1" "1038561-1" "(02/15/2021): vaccine (02/16/2021) : severe body aches and weakness, increased congestion and mucous production. (02/16-17/2021) : death possibly during the night" "1038579-1" "1038579-1" "Death" "1038633-1" "1038633-1" "Moderna COVID vaccine administered 2/9/21. Patient expired in home on 2/10/21, at around 2100. Patient had h/o CVA in2001 with long standing sequelae. On day of administration, team attempted to draw lab specimen with vein finder, but patient was possibly Narrative: Moderna COVID vaccine administered 2/9/21. Patient expired in home on 2/10/21, at around 2100. Patient had h/o CVA in2001 with long standing sequelae. On day of administration, team attempted to draw lab specimen with vein finder, but patient was possibly dehydrated. CG/wife reported to APRN on 2/10/21, patient was sleeping and snoring and then began to sleep more quietly. She checked on patient and found that he had no pulse and had passed away" "1038635-1" "1038635-1" "The patient fell the day after receiving the Moderna COVID-19 vaccine. She broke her hip in this fall. During surgery to correct the broken hip, she went in to sudden and unexpected cardiac arrest. The anesthetist did not notice any ST changes or A fib; dysrhythmia was very unexpected. The patient had a DNR. She died at 13:00 on 02/07/2021. Causes of death are listed as 1. Cardiac Arrest 2. Recent hip fracture with hip placement 3. History of Breast Cancer 4. Hypothyroid and 5. Dementia" "1038658-1" "1038658-1" ""86yo female alert, stable with ankle abrasion eating 100% prior to vaccine in assisted living facility. On 2/1/2021, received Moderna vaccine. Starting thereafter, eating 50% on 2/2/21. Temperature was 98 tympanic. On 2/3, the leg abrasion started having moderate bleeding. On 2/4, the caregiver noted patient ""not looking good, unable to talk, arms moving aimlessly, grasping"". BP 95/41, temperature 98, oxygen on room air 92-93%. POA did not want hospital transfer. 2/5 Hospice started, oxygen given, morphine given. 2/5-2/8 comfort care given, patient responsive to tactile stimuli, resting, not taking oral medications or food. 2/8/2021 patient expired."" "1038719-1" "1038719-1" "death attributed to unknown cause" "1038720-1" "1038720-1" "Resident complained about back pain in the middle of the night and when they went to do a blood pressure examination, she passed away at 2:40 am." "1039090-1" "1039090-1" ""The patient came to the Emergency Room at approx 3:30 am on 02/03/2021 with pain in right arm (same arm the COVID vaccine had been administered in approx 12 hours earlier) and feeling generally unwell. Patient was concerned about possibility of gout flare or that something was wrong with her arm. Elevated blood pressure was noted; this was attributed to anxiety. She was evaluated, given 500 mg Tylenol, and discharged since the pain was decreasing and blood pressure was stabilized. Patient instructed to follow-up with physician. The next day, on 02/04/2021, the patient arrived at the Emergency Room by ambulance; cardiac arrest was the chief complaint. The patient's daughter stated the patient had been ""feeling generally poor and then suddenly collapsed."" Daughter described ""gurgling respirations"" and being unresponsive. 911 was called, police arrived within 5 minutes and initiated CPR. Epinephrine, atropine, lidocaine and bicarb administered after arrival to Emergency Room. Shockable rhythm never demonstrated. Patient never recovered spontaneous respiration or movement. The death was called at 23:04. Coronary artery disease with cardiac arrest is the cause from the ER records; the coroner is putting COVID-19 vaccination in Part 1 of the death certificate."" "1039250-1" "1039250-1" "Daughter of decedent reported that he quickly declined within 2 weeks of receiving vaccine and developed shortness of breath. Decedent received vaccine 1/30/2021 and died 2/15/2021. Only received first dose of series." "1039304-1" "1039304-1" "Resident getting rehab therapy in the facility and has a long history of Parkinson's Disease. On 01/29/21, he received the COVID vaccine on left deltoid, resident was recently hospitalized due to Pneumonia and was on antibiotic IV and was recently placed on GT feeding due to severe dysphagia from his Parkinson's disease. On 01/31/21, started having increased congestion. On 02/02/21, started having increased temperature and WBC went up >20,000 on 02/03/21, started on Vancomycin IV on 02/04/21 but was transferred to the hospital. Facility was notified today (02/18/21) that resident expired in the hospital." "1039597-1" "1039597-1" ""Death Narrative: Patient received first dose of COVID vaccine on 1/30/21. Reported by his wife to agency that he passed away at an outside hospital on 2/14/21. By report of his wife: ""due to sepsis (related to bed sores) and aspiration pneumonia"""" "1039922-1" "1039922-1" ""death was from natural causes; collapsed; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Feb2021 at 73-years-old at a single dose for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing (on oxygen as needed, but not every day), oxygen therapy from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) for immunization on unknown dates (Gets flu shot every year around October). On 06Feb2021, the patient collapsed (medically significant) and experienced death was from natural causes (death, medically significant). The clinical course was reported as follows: The reporter stated that his grandmother received the first dose of the Pfizer COVID-19 vaccine on 05Feb2021 and passed away on the morning of 06Feb2021. The patient went to bed and woke up in the middle of the night around 03:00 to use the bathroom and collapsed and died within 10-15 minutes of collapsing. The patient was pronounced dead at the scene. The reporter asked: ""What do you know about the news in the media about reports of death in nursing home elderly patients?"" The reporter wanted to know the ingredients of the Pfizer COVID-19 vaccine. The reporter wanted to know about the use of the Pfizer COVID-19 vaccine in patients with underlying conditions. The patient had COPD and was on oxygen as needed, but not every day. The Medical examiner said the death was from natural causes and the family was not doing an autopsy. The patient had been tested for COVID and was negative. The patient underwent lab tests and procedures which COVID test: negative on an unspecified date. The clinical outcome of the event, death was from natural causes, was fatal. The clinical outcome of the event, collapsed, was unknown. The patient died on 06Feb2021 due to death was from natural causes. An autopsy was not performed. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Reported Cause(s) of Death: death was from natural causes"" "1040005-1" "1040005-1" "Patient was found unresponsive and had passed away." "1040170-1" "1040170-1" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "1040183-1" "1040183-1" ""Patient had swelling around her jaw after her second shot of the covid , Pfizer vaccine ( .5 ml IM) on the Friday morning, January 29th, I took her to a follow up appointment with the cardiologist at 3:00 pm, as a follow up to a small heart attack event with hospitalization two weeks previously, at the cardiologist she was given the ok/all is well. That next morning early, she had a 911 event at her assisted living apartment and was sent back to the hospital, having had another heart attack. Patient died on the following Thursday, February 4, 2021. I do not know if the vaccination had any cause for my mothers death; but I feel it is necessary to report this series of heart attacks after she received the pfizer vaccine. Her Certificate of Death records the cause of death as ""Coronary Artery Disease""."" "1040574-1" "1040574-1" "Patient collapsed and could not be revived. There was no prior warning. She was otherwise in good condition for her age. The death was listed as probable cardiac arrest but no autopsy was performed. Since it occurred so close to the vaccine shot I thought someone may want to know." "1040633-1" "1040633-1" "Death due to hemorrhagic stroke." "1040802-1" "1040802-1" "Toileting and had expired while doing so; Severe abdominal pain; Diarrhea; Vomiting; Mild injection site pain; A spontaneous report was received from a healthcare professional concerning an 88-year-old , female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, toileting and had expired while doing so (death), mild injection site pain, severe abdominal pain, diarrhea, and vomiting. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient felt mild pain at the injection site after receiving the vaccine. On 21 Jan 2021, the patient reported severe abdominal pain, diarrhea and vomiting. These symptoms were intermittent for a week and no other adverse events were noted. On 27 Jan 2021, the patient passed away while toileting. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 27 Jan 2021. The cause of death was unknown. An autopsy was not performed.; Reporter's Comments: The gastrointestinal events were consistent with increased risk associate with elderly age of patient. The cause of death was unknown. Autopsy was not performed. Very limited information regarding the events is available at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death" "1040877-1" "1040877-1" "unknown if related to vaccine. patient received 2nd vaccine at 0830, observed 15 minutes, discharged, arrested at 0915 upon entering her home. vaccine was administered by DOH at their community location. patient was pronounced lifeless in the ED." "1040927-1" "1040927-1" "Patient previously had dizzy spills, but about a week after receiving the vaccine her dizzy spills began to get worse. The whole prior she kept saying I am just not right. On the 2/7/21 she a COVID test done, a nurse came to her house and preformed. On the morning of the 8th patient was on the phone with someone else and patient asked this person to call me and go check on her. Within 5 minutes I was over at her house, and I found her on the floor, she on her belly facedown. It looked like she was on the toilet, and it looked like she fall getting her off, she was still wet, she still felt warm. I called the ambulance and immediately began CPR. When EMS arrived they took over the CPR and transported her to the Hospital. The EMS was there for about 40 minutes and used an machine to preform the compressions. She was pronounced deceased at the hospital. No autopsy was done." "1041064-1" "1041064-1" "CLIENT EXPIRED 1 WEEK FOLLOWING THE VACCINE." "1041185-1" "1041185-1" "Death within 30 days" "1041191-1" "1041191-1" "Decedent had unwitnessed fall out of wheelchair 1/25/21 around 9:43am, denied head strike, pain, discomfort. Around 10:02pm, 1/25/21, decedent noted to have slurred speech and fluctuating HR, transported to Hospital and made cmo." "1041200-1" "1041200-1" "Patient described feeling nervous, anxious the next morning (Wednesday) after the vaccine. He later fell in the bathroom after using the restroom, his legs gave out (his words) and consequently was on the ground for 23 hours before being transported to the hospital. That was Thursday afternoon. He was diagnosed with COVID-19 on Saturday night and died the following Friday morning." "1041230-1" "1041230-1" "Patient received first dose of covid vaccine on 1/22/2021. Patient had no immediate reaction. Patient presented to the Emergency Department on 1/26/2021 c/o shortness of breath and chest pain. ECG showed a ST elevation myocardial infarction. Patient was treated and transferred to a cath lab where he died. Patient had significant coronary artery disease." "1041333-1" "1041333-1" "He developed a fever on 1/8, become unable to swallow and bedbound. He was already end of life and Hospice care at the time of the vaccine." "1041656-1" "1041656-1" "she died 2/12/2021 at close to 2pm" "1041719-1" "1041719-1" "Pt received moderna vaccine #2 at 1:30pm. No s/s of adverse reactions. Ate dinner at 4pm. She was in her room at 430pm and she slid out of her chair and was laying on her Right side. She reported she slid out of her chair because she needed to go urinate per staff. She denied pain. At 630p complained of right hip pain. mobile xray was ordered. At 825pm resident was sleeping x 30 mins in her bed when she was found to have no pulse or respirations. She ceased to breathe. Mobile xray did not make it on time." "1041740-1" "1041740-1" "Patient died on 2-13-21" "1041784-1" "1041784-1" "On the 25th he was home alone, he called 911 and let them know he thought he was having a stroke. EMS arrived and transported him to Hospital. It was massive stroke, he was not able to comprehend anything, he was put into Hospice the following day and passed away on the 27th. There was no autopsy preformed." "1041789-1" "1041789-1" "As per patient daughter - patient had some minor chills on the day of the vaccination - Friday 1/15/21; felt well next day -Saturday, than she was found slumped and lifeless on the couch on Sunday 1/17. Cause of death on death certificate was reportedly put as COPD, Lung Ca and ASHD." "1041832-1" "1041832-1" "Patient was found unconscious without a pulse. Patient remained in asystole without pulse or respirations despite CPR." "1041839-1" "1041839-1" "Death- ~ 7 hours after vaccine" "1041990-1" "1041990-1" "PATIENT WAS ADMITTED TO ER FOR ALTERED MENTAL STATUS / UTI SEPSIS WITH SEPTIC SHOCK / COVID AND COVID PNA PATIENT WAS ADMITTED TO ICU AND DIED . POA WISH TO WITHDRAWL EXTRME MEASURES" "1042012-1" "1042012-1" "Patient died suddenly 2/14/2021" "1042145-1" "1042145-1" "Patient reported feeling weak, fatigue, fever (102), and loss of appetite. Patient subsequently went to the ER 2/6/2021 and tested positive for COVID-19 on 2/7/21 (collection date). See following discharge summary from ED: 82 y.o. female who initially presented to the ED with complaint of generalized weakness, fatigue, fever, and loss of appetite x at least 4 days since receiving Covid 19 vaccine. Her workup in the emergency room was significant for hypoxia with 02 saturation 88% on 2LPM (home nocturnal 02 requirement) with improvement to mid-90s on 4LPM. Blood sugar was 47, Cr 1.61. CXR showed extensive R lung and moderate left lung opacities. She was started on empiric ceftriaxone and azithromycin and admitted to the hospitalist service for further workup and mgmt. During her stay in the hospital, pt did test positive for Covid 19. She developed rapidly progressive respiratory failure, felt to be secondary to ARDS. There was also question of contributing pulmonary edema, however this was refractory to lasix and thus ARDS was felt to be the most significant factor. She had requested DNR/DNI status, thus as her 02 requirement escalated she was transitioned to 15LPM NRB and then to BiPAP support. Unfortunately, she continued to suffer greatly with the BiPAP in place, and therefore made the decision to transition herself to comfort measures only after visitation from her family. Her other medical issues were supported as appropriate during her stay, with dextrose infusion for hypoglycemia and AKI, also hyponatremia felt to be due to IVVF. Unfortunately, am unable to find any documentation regarding how pt was feeling when she received the vaccine compared to her baseline state of health. thus am unable to say whether the severity of her illness represents vaccine¡ enhanced disease or the much more common cytokine release syndrome leading to ARDS. Regardless, she developed ARDS as result of her Covid 19 illness. Time of death: 1408 on 2/9/21. Cause of death: ARDS due to Covid 19 pneumonia." "1042351-1" "1042351-1" "death" "1042967-1" "1042967-1" "Patient called son around 6:30am on 2/18/21. When son tried to contact patient around 8:30am, he was not able to get a hold of patient. Son sent someone over to check on patient. They found patient on the floor. He was coherent at first but then lost consciousness. It believed he experienced a stroke sometime around 8:30-9:00am of 2/18/21. Patient was taken to hospital and then transferred to another hospital. He was put in a medically induced coma. He passed between 4:00 and 4:30 pm on 02/19/21." "1043123-1" "1043123-1" "Death" "1043302-1" "1043302-1" "My dad received the Pfizer vaccination on 2/5/21. He was admitted into the hospital the next day for C-Diff bacterial infection. He had been on dialysis treatments for kidney failure treatment since 2017 and had recently been diagnosed with stage 3 colon cancer in June 2020. He had completed his final treatment of chemotherapy on 2/4/21 and several weeks prior had been determined cancer free. On Tuesday 2/9/21 he was released from the hospital and went home. Early Thursday morning 2/11/21 @ approximately 1:30 am CST his eyes rolled back in head and he stopped breathing and was non responsive. My mother called 911 and attempted CPR. Paramedics arrived and were able to successfully get a pulse then transferred him to the hospital. He was put on a ventilator @ the hospital and then transferred to a different hospital a few hours later. He lost pulse/heartbeat several times @ the 2nd hospital he was transferred to. We were not allowed to travel with him or see him b/c of all of the COVID restrictions. We were communicating with the ICU doctor by phone who ultimately communicated to us that there was nothing further that could be done to save his life. He subsequently passed away @ approximately 8:55 am CST on 2/11/21." "1043690-1" "1043690-1" "Ventricular fibrillation/sudden death" "1043880-1" "1043880-1" "Pt received second Moderna COVID-19 vaccination administered in left arm at her assisted living facility by Pharmacist at 1153 on 2/19/2021. Pt was monitored for vaccine reaction with no known adverse reaction. Approximately 18 hours post-vaccine, she was found deceased in her sleep at 0540 on 2/20/21. Per circumstances/pt history, it is presumed that the patient aspirated while sleeping, perhaps secondary to a seizure. Coroner was notified and declined as coroner's case. VAERS notification being made due to pt death within 24 hours of receiving a vaccine." "1044247-1" "1044247-1" "Moderna COVID 19 Vaccine: Patient started with symptoms of covid 5 days after first vaccine. She was hospitalized and passed due to COVID 19 on 2/6/21. Patients family informed us when she was due for the second dose." "1044352-1" "1044352-1" "Stomach upset, sudden heart failure, death" "1044420-1" "1044420-1" "Please reference separately submitted MIS-A form. He had sore throat, high fever, diarrhea, deteriorating in to multisystem failure and apparent acute myocarditis, notably with relative initial sparing of the lungs. He suffered cardiac arrest in radiology after developing aphasia and was transferred to Hospital after cannulation for VA ECMO; he died there 2/8/21." "1044459-1" "1044459-1" "Grandmother had trouble breathing the night she got the vaccine. She went to the hospital. They found pneumonia and a partial bowel obstruction. The obstruction cleared but she died from the pneumonia on 2/16/21." "1044704-1" "1044704-1" "Light headedness, fatigue, nausea" "1045150-1" "1045150-1" "Patient found in home deceased." "1045635-1" "1045635-1" "Death; Passed out; Stomach was bothering; Constipated; Difficulty breathing; Weakness/Event: Weakness was reported as worsened; a temperature of 99.4 degrees; Sweaty; Cold; Muscle ache; Body Aches; Diarrhea; Nausea; Vomiting; Fatigue/Tiredness; His raspy throat felt like he had mucus stuck in his throat; Cough; Raspy throat/worsened; This is a spontaneous report from a contactable consumer reporting her husband. A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EM9810, Expiry Date: Jun2021) at the age of 74- year-old via an unspecified route of administration on 04Feb2021 09:15 at single dose in Arm, Right for COVID-19 immunisation. Medical history included type 2 diabetes mellitus for about 20-25 years, ongoing kidney disease from 2005, ongoing chronic kidney disease, cardiac pacemaker insertion. The patient was diagnosed with kidney disease in 2005, but it was about 1 to 1-1/2 years ago that his kidney disease progressed to Stage 4 Kidney Disease. She said the Veterans Administration diagnosed her husband with his kidney disease, but her husband saw a private doctor, as well as, a VA doctor for his care. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot Number: EL3248; Expiration Date: Apr2021) at the age of 74- year-old Intramuscularly at approximately 08:45AM on 15Jan2021 in right arm for COVID-19 immunisation and had no reaction. There were no additional vaccines administered on same date of the Pfizer suspect. There were no Prior Vaccinations within 4 weeks. The patient had symptoms start earlier in the day of Tuesday, 09Feb2021, after his second COVID-19 Vaccine shot (04Feb2021). The reporter said she and her husband didn't think anything of his symptoms at first. The patient had a temperature of 99.4 degrees on 09Feb2021. She didn't check her husband's temperature again after that time because the nurse at her husband's doctor's office said her husband's temperature was not at an area of concern. The patient was sweaty, off and on, starting 09Feb2021. She clarified he would be sweaty and the cold, but nothing extreme. The patient developed muscle aches, body aches, diarrhea, nausea, and vomiting on 09Feb2021. She clarified her husband had fatigue, tiredness, and had trouble with a raspy throat. His raspy throat started Tuesday evening (09Feb2021). His raspy throat felt like he had mucus stuck in his throat, and he was unable to clear the mucus from his throat. The reporter called her husband's primary care doctor on the morning of 10Feb2021 because her husband was having trouble with a raspy throat, and difficulty breathing. She said on Tuesday night (09Feb2021) her husband had to sleep sitting up because he couldn't lay down with his breathing. He was able to eat breakfast (clarified as oatmeal and an orange), lunch (clarified as soup and a salad), and dinner (clarified as soup and half a sandwich. She said her husband ate all the meat and half of the bread on the sandwich) on 10Feb2021. Her husband's primary care doctor wasn't available to speak to on Wednesday morning (10Feb2021), but the doctor's nurse said it sounded like her husband was having a reaction to his second COVID-19 Vaccine shot. The reporter said her husband's doctor instructed her later in the day to take her husband to the Emergency Room or Urgent Care if he didn't feel any better. Her husband's throat raspiness got worse in the evening of 10Feb2021. His breathing also became worse after dinner in the evening of 10Feb2021. The patient leaned forward over a couple pillows while sitting on their couch as it was easier for him to breath by doing that. They decided at 11:00PM that her husband should go to the Emergency Room. She said her husband was getting very weak, so she and her husband debated if she should call # for an ambulance, or if she should drive him to the Emergency Room. She said her husband was able to dress himself, but with some difficulty, and she assisted walking him from their house to their car. She said she had turned to walk away from her husband while he was at the side of their car, and then she heard her husband make a noise. He had appeared to have passed out. She clarified in the past, her husband had passed out prior to his pacemaker. She said she dialed #, and the # operator told her how to tell if her husband was still breathing. She said she couldn't tell if her husband was still breathing. She said when the ambulance arrived at her house, the ambulance staff worked on her husband for a long time. The reporter thought her husband had died at the time he had collapsed at the side of their car. The patient took a sugar free cough syrup Tuesday night (09Feb2021), and then again a couple times on Wednesday (10Feb2021) as treatment. The patient had thrown up a couple times, but found that the sugar free cough syrup soothed his cough the night before (09Feb2021). She said her husband had taken 2 TUMS early on Wednesday morning at approximately 2:00AM (10Feb2021). He had said his stomach was bothering him on 10Feb2021. He said he thought he may be constipated, so he took 1 Senokot (Clarified as GeriCare Senna-Plus Natural Vegetable Laxative with Stool Softener) on 10Feb2021. She clarified her husband had diarrhea on 09Feb2021, but felt on 10Feb2021 he may have been constipated. There were no adverse events required a visit to Emergency Room since Patient's wife stated she was getting her husband to their car, so she could drive him to the Emergency Room, when her husband collapsed and died or to Physician Office as they spoke with the nurse at her husband's primary care doctor's office. Weakness was reported as worsened. The outcome of events Sweaty, Cold, Muscle ache, Body Aches, Fatigue/Tiredness, Raspy throat/worsened, Difficulty breathing, Weakness was not recovered; and of the remaining events was unknown. The patient died on 11Feb2021. The patient's official time of death was Thursday, 11Feb2021, at 12:08AM. Cause of death was unknown. An autopsy was not performed and it would take 3 weeks for a death certificate to be issued. The reporter stated she thought it was important to notify Pfizer of her husband's passing because his side effects fell within the expected time period after receiving his second COVID-19 Vaccine.; Reported Cause(s) of Death: Death" "1045803-1" "1045803-1" "Patient was found with no pulse no heart rate by a staff member around 11 pm. Earlier that day seen by myself for fatigue, sorethroat, nausea." "1045842-1" "1045842-1" "A few days after the vaccination my father had a sore throat and slight cough. This progressed into pneumonia like symptoms and he died on 2/11/21." "1045894-1" "1045894-1" "COVID infection, death" "1045895-1" "1045895-1" "He was found deceased in his home by Sheriff and paramedics evening of 2/21/21." "1045972-1" "1045972-1" "patient passed away within 60 days of receiving a COVID vaccine" "1046179-1" "1046179-1" "patient was not vaccinated at hospital. Caregiver reports that patient was vaccinated with second dose on Monday 2/15/21. Tuesday patient experienced n/v/d. Went to an ED on Wednesday and was cleared and sent home. Thursday reported shortness of breath to her caregiver and then collapsed. Patient was brought to as PEA arrest and ultimately died." "1046230-1" "1046230-1" "Death. My father-in-law was found unexpectedly deceased in his home Saturday morning. He worked the previous day." "1046265-1" "1046265-1" "Received 2nd dose of COVID19 Pfizer vaccine at 1103 am on 2/19/21, was last seen at 1159, found around 1615 by kitchen staff who were serving dinner." "1046317-1" "1046317-1" "Patient passed away from chronic respiratory failure with cardiogenic shock 24 hours from 2nd dose of vaccine. Patient with longstanding history of pulmonary HTN and heart failure with desire for comfort care only. Entering into VAERS out of abundance of caution." "1046347-1" "1046347-1" "When family members came to receive the second dose of their COVID vaccine, they informed us that the above patient had passed away." "1046397-1" "1046397-1" "Death" "1046447-1" "1046447-1" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "1046542-1" "1046542-1" "patient passed away with in 60 days of receiving a COVID vaccine" "1046613-1" "1046613-1" "patient passed away within 60 days of receiving a COVID vaccine" "1046666-1" "1046666-1" "Patient had no adverse events during the observation period after vaccine. He was conscious and having conversation with facility staff. He was observed for 15 minutes at least. When the facility staff returned later, approximately 60 to 90 minutes, patient had passed away." "1046698-1" "1046698-1" "patient passed away within 60 days of receiving a COVID vaccine" "1046722-1" "1046722-1" "No symptoms or signs on the day 1st dose of vaccine was received (2/11/2021). 3 days later, (2/14/2021) patient experienced chills for approximately 6 hours, followed by severe (visible) chest spasms, and then cardiac arrest. 911 was called upon witnessing chest spasms, but cardiac arrest/death occurred before patient could be transported to the hospital." "1046752-1" "1046752-1" "Pt was hospitalized Jan 18, 2021 after he had fallen outside overnight and lay there approximately 12 hours until he was found. Hypothermic & rhabdomyolis diagnosis. Gradually improved w/ strength & mental status - was in swing bed @ hospital. He got his first Covid 19 shot on 2-8-21. Was fine @ 0300 on 2-9-21 and @ 0430 he was found unresponsive. Dx: probable arrythmia & pronounced dead @ 0454. Noted on pain scale @ 2/8/21 @ 21:11, clients pain was a 7/10 They offered pain med & he refused They repositioned & distracted him @ 2047 on 2/8/21 Pain had decreased to 3/10 and nothing given. Then @ 0300 check he was sleeping and @ 0430 unresponsive." "1046763-1" "1046763-1" "1/23 - Mild injection site discomfort. Appetite loss compared to previous day. Beginning loss of mental acuity compared to previous day. 1/24 - Continued loss of appetite. Near complete loss of ability to move. Continued decline of mental acuity. Very little speaking. 1/25 - Stopped speaking completely. Loss of bowel control in the evening and continued until death. Complete loss of appetite. 1/26 - Near complete loss of ability to swallow. Moved to hospice 4:00pm. 1/27 - Died 4:00am" "1046795-1" "1046795-1" "Per ED note: Brought in ED by EMS at 1945 for acute shortness of breath and hypotension. Patient was placed on supplemental oxygen and covid test completed. Patient was placed on BiPAP to maintain oxygen greater than 90%. Found to be in metabolic acidosis. Patient became unresponsive and pulse could not be palpated. Chest compressions were initiated. ACLS medications given and pulses regained. Patient lost pulse 30 mins later and never regained pulse. Per ED noted; likely developed a PE. Passed away at 2127" "1046845-1" "1046845-1" "Deceased 02/18/2021 with an unknown cause of death" "1046881-1" "1046881-1" "Code blue called at 11:00pm. Patient had code status of Do Not Resuscitate." "1046915-1" "1046915-1" "Resident received the 2nd dose of the Covid vaccine approximately around 1105 by pharmacy through the pharmacy LTC partnership vaccination program. Resident had no adverse effects until around 8:00 pm she began complaining of body aches, and chills, Tylenol was given at this time. Around 9:30pm resident was sleeping in bed. Around 12:00 am the CNA called nurse into room to assess resident as the resident stated she did not feel good. Temperature at that time was 102.2, and vomiting. RN came to assess @ 1220 am She was noted to be vomiting, diaphoretic, pale and having trouble breathing. Temp was 97.3 after vomting, Pulse 53, Resp 20, o2 sats were 40-45%, unable to obtain Blood pressure, Applied 5 L of oxygen at this time and had LPN call 911 immediately. Resident was repsonsive and able to follow staff members instructions but was only answering yes or no simple questions at the time time of assessment. Paramedics arrived at 0040 and resident was sent to Hospital. @ 0130 ER nurse called to nursing facility to notify resident had coded in the ER and passed away @ 0110." "1047072-1" "1047072-1" "Patient had sore arm on the day of vaccination. Per patient's nephew , the next morning patient experienced body pains, aches, headache . Onn Tuesday patient had fever. Patient's condition progressively got worse. He had difficulty breathing by Wednesday night. He had low oxygen levels at 80 per pulse ox reading. Patient was coughing up blood. Family took him to hospital on Thursday morning due to breathing difficulty and patient died 2.18.21 at 10 am" "1047169-1" "1047169-1" "jaundice->hemolytic anemia-> hemorrhagic shock->multi organ failure->death pt admitted to ICU 2/16 with Hgb=3.4, treated with steroids, supportive care , pressors, pt died 2/20/21" "1047183-1" "1047183-1" "Pt had expired before second dose was delivered." "1047197-1" "1047197-1" "death" "1047282-1" "1047282-1" "Patient felt fine on Friday afternoon and evening after shot. Felt fine on Saturday until the afternoon when she started feeling fatigued and chilled. Decided to take a warm bath at about 6pm. Was found dead in bathtub at approximately 7pm with blisters on arms, legs, and face." "1047326-1" "1047326-1" "According to patient's caregiver, patient presented with symptoms of fever (101.6 F) and purple blotches all over the body within an hour. Since patient was in hospice , caregiver called Hospice and a pharmacy and was told to give patient Benadryl and Tylenol. Patient was given both medications and the fever subsided in a few days but the purple blotches never went away. Patient passed away at the facility a week later." "1047351-1" "1047351-1" "Patient was tested for covid on 2/2/21 with positive resulted. Presented to Hospital ER on 2/10/21 with c/o of abdominal pain. Diagnosed with gastritis, prescribed metoclopromide and famotidine and dc home. Returned to ER on 2/13/21 with c/o of weakness, diarrhea, foot ulcer, and loss of appetite. Diagnosed: 1) Dyspnea and hypoxia secondary to Covid-19 2) Extensive bilateral lung infiltrates secondary to Covid-19 3) Increased Cr 4) Increased LFTs, ferritin, d-dimer, troponin secondary to Covid-19 5) Elevated procalcitonin placing the patient at high risk for sepsis 6) Chronic appearing Right foot wound without signs of secondary infection Patient transferred to a different hospital in another city." "1047434-1" "1047434-1" "Patient died 3 days after receiving his first dose of the Covid vaccine. He saw his doctor 2 weeks prior to his death with absolutely no complaints, very healthy. He had no prior heart conditions and was pronounced dead of a heart attack." "1047455-1" "1047455-1" "Resident deceased" "1047571-1" "1047571-1" "Death after stroke ." "1047634-1" "1047634-1" "Patient was admitted to hospital on 2-9-21 for urinary tract infection and tested positive for Covid. Developed pneumonia and expired on 2-12-21." "1048688-1" "1048688-1" "My mother had a stroke on 28Jan2021 sometime after 9:30 AM the morning after getting the first dose of the Pfizer Covid vaccine; Cerebral infarction; This is a spontaneous report from a contactable consumer (reporting for mother). A 94-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown as not available or provided to reporter at the time of report completion) via an unspecified route of administration on 27Jan2021 in right arm at single dose for COVID-19 immunization. Medical history included coronary artery disease and hypertension. There were no concomitant medications. The patient was not pregnant. No other vaccine was received in four weeks. The patient did not have covid prior vaccination and not have covid tested post vaccination. The patient had a stroke on 28Jan2021 sometime after 9:30 AM the morning after getting the first dose of the Pfizer Covid vaccine and was hospitalized due to stroke for 6 days from Jan2021. The patient then experienced cerebral infarction in 2021 and died due to it on 04Feb2021. Treatment received for events stroke and cerebral infarction included tPA injection. The outcome of events stroke and cerebral infarction was fatal. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cerebral infarction" "1048690-1" "1048690-1" "presumed cardiac failure; This is a spontaneous report from a contactable nurse. An 89-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular at arm left on 10Feb2021 (at the age of 89 years) at single dose for COVID-19 immunization. The patient medical history included congestive heart failure, coronary artery disease, hypertension, hyperlipidemia, osteoarthritis, presence of prosthetic heart valve and allergies, all from an unknown date and unknown if ongoing. The patient's concomitant medication included amlodipine besilate/benazepril hydrochloride, amlodipine, acetylsalicylic acid (ASPIRIN E.C.), atorvastatin, benazepril, carvedilol, ubidecarenone (COQ10), furosemide, acetaminophen and potassium chloride. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular at arm left on 20Jan2021 at single dose for COVID-19 immunization. The patient experienced presumed cardiac failure on 12Feb2021 at 03:30 with fatal outcome. The patient died on 12Feb2021. An autopsy was not performed.; Sender's Comments: Based on the current available information, the event Cardiac failure is most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2. The patient medical history of congestive heart failure, coronary artery disease, hypertension, and hyperlipidemia provide plausible explanations for the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: presumed cardiac failure" "1048745-1" "1048745-1" "Death on February 12, 2021 acute cardiac tamponade" "1048786-1" "1048786-1" ""Was given vaccine around 1:30Pm on 2-11-2021. He and his wife waited in the building for 15 minutes and then left. he denied complaint. (He was waiting to have both Covid shots before he went to cardiologist Re: CAD.) He had an alarm going off in his house, was going to basement to check it out. Police officer heard alarm, came into house, & heard a thud when Doc fell. He was in PEA (Pulseless Electrical Activity) when brought into ER. Given 5 ""rounds of Epinephrine with no response."" "1048882-1" "1048882-1" "Vaccine was administered 2/1/2021 at approximately 9am. Due to self reporting of allergic reaction (hives) to Augmentin, patient was monitored on site for 30 minutes. After the monitoring period, she was cleared to go with no issues reported at the time. We were later informed that the patient passed away from a pulmonary embolism on 2/12/2021." "1048917-1" "1048917-1" "Resident yelling for assistance in apartment. Nursing personnel found resident on floor at 6:10 AM on 2/18/2021. Resident was transported to Hospital on 2/18/2021. Status update on 2/18/2021 from son, resident CT & X-rays were done all normal. Labs done and WBC count was elevated and awaiting results. Resident stable and admitted to hospital for observation. Resident passed away on 2.21.2021." "1048947-1" "1048947-1" "Patient experienced an episode of emesis and loss of consciousness several hours after vaccine on 2/16/21. He was taken by EMS to the hospital and was noted to be hypoxic and hypotensive. He was admitted to the hospital and subsequently intubated. He was also found to have a small bowel obstruction and a nasogastric tube was placed to decompress the bowel. He required pressor support as well. He expired on 2/17/21." "1049012-1" "1049012-1" "Patient was given vaccine on friday, one week later she passed away. The family called the pharmacy to inform us on Saturday, Feb 20, 2021. After the phone call was over, we saw in her pharmacy profile that she had received the vaccine one week prior" "1049389-1" "1049389-1" "Patient passed away Saturday at 14:04pm. Patient's wife reports his death was sudden, he passed away sitting in his chair his heart just stopped she said. They tried to perform CPR, 911 was called and paramedics arrived at the scene and he was given medication but never had any return of vital signs and so his death was called at the scene. Wife reports he was not ill, did not have any symptoms prior to the event. They are not going to be doing a autopsy. She wanted us to know based on timing that there may be some possible correlation with his COVID19 vaccine. He obtained the vaccine on 02/09/2021 - wife reports he had no symptoms, not even arm soreness after the vaccine. Had no fever, shortness of breath. Did not complain of chest pain. We can update chart to reflect the patient is deceased and lets make a card for the family." "1049406-1" "1049406-1" "Patient rcvd 1st covid 19 vaccine on 1/26/2021. Patient had house guests on 1/30/21. Those house guests tested positive for covid on 2/1/2021. Patient started getting symptoms on 02/2/2021. Patient tested postivie on 2/4/2021. Patient was hospitalized 2/7/2021. Patient passed away on 2/21/21." "1049428-1" "1049428-1" "2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-graded x 2 with poor appetite and recent 6lb weight loss. 2/8/21-APRN updated regarding poor appetite and difficulty chewing as well as downgraded texture of diet. Also informed of increased s/s of discomfort and increased use of PRN Oxycodone for pain. 2/9/21- elevated temp 100.7. 2/9/21 Covid pcr test negative. 2/9/21-N.O.?s APRN BMP, Albumin and Pre-albumin Level in am. 2/11/21-elevated temp 100.4. Covid rapid test negative. 2/12/21- CBG recorded at 517 at 5:20 am. Resident also has an elevated temp of 100.9. Tylenol administered per order. Vital signs include resp 24, radial pulse 134, O2 sat 83%. Supplemental oxygen administered via nasal cannula. Head of bed elevated. DR. notified at time via telephone. Order given for sliding scale for CBG. Guardian updated regarding changes in residents condition, poor prognosis. Guardian requests Hospice eval and admit. Guardian requests comfort care no hospitalization, no IV's, no G-tubes, no labs etc, D/C of Palliative services. ARNP informed. 2/12/21 Acute Telehealth visit with APRN due to increased lethargy, elevated CBG?s despite poor appetite and insulin administration. Resident unresponsive to verbal and noxious stimuli at time of visit. N.O. Morphine sulfate 20mg/ml, give 2.5mg PO/SL Q4hr PRN pain/shortness of breath. 2/12/2021-Admitted to Hospice, Lethargic, diaphoretic, T 98.1 P 130's R 18 O2 high 80's to low 90's via O2 mask at 3L. 2/12/2021- Resident legs and arms noted to feel cool this afternoon, 02 sat was 97% with 02 on @ 3L with mask Noted resident with sob and increased pulse. Prn morphine 0.25ml sl. given with good effect. Resident was less restless and quiet in her bed. Checked on resident several times this shift for needs. Resident noted to not move in her bed @ 8:15pm and noted she was not breathing. Supervisor called and pronounced resident deceased." "1049648-1" "1049648-1" "I was notified on 2/22/21 that this patient passed away over the weekend. I do not know the details, nor can I confirm anything beyond what I was told. I believe the death occurred on 2/20/21 due to a massive stroke." "1049724-1" "1049724-1" "Emergency room 1/11/21 Patient is a 72 year old female who presents with decreased level of consciousness. The patient is a nursing home patient and had an episode of choking yesterday that was treated with a Heimlich maneuver. Nursing staff at the nursing home reports that she seems to be a bit less responsive today. However, the patient has been for the most part unresponsive for 3-4 months time following a COVID-19 infection. Of note, her oxygen saturation on room air is 72%. The patient is also febrile to 100.8¦. She was unable to provide any information and the aforementioned information is gathered from nursing home staff report." "1049852-1" "1049852-1" "When calling to get billing information we were notified that patient had passed away. Patient's daughter said patient was having cvd a/s on 2.1.2021 got vaccine 2.2.2021 and passed away 2.5.2021. Cardiologist said not related" "1049864-1" "1049864-1" "1/27/21 Emergency room: HPI Patient is a 77 y.o. male who presents after a syncopal episode with cyanosis and shortness of breath. Patient came from rehab where they stated he was sitting on his bed, his oxygen saturation dropped down to 76% on 4L and he became cyanotic. By the time EMS arrived, patient was back to 95% on 4 L. On arrival to the ER, he is 98-100% on 4L. He has a history of COPD and has a chronic cough due to this.Currently, he has no pain, no shortness of breath, no weakness, no cyanosis. He is afebrile and sitting comfortably in bed. 2/10/21 emergency room HPI Patient is a 77 y.o. male who presents with in full cardiac arrest. Patient is resident of local nursing home. According to nursing home staff, a tech was in his room talking with him as patient was laying in bed. Tech began walking out of patient's room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive. Patient had no spontaneous respirations or pulse, subsequently CPR was started immediately. 911 was called. This occurred around 5:30 a.m.. Upon EMS arrival on scene, they found a male unresponsive with CPR being performed. There was no spontaneous respirations or circulation. Thus, ET tube was placed and life support guidelines initiated. Patient was found to be in PEA, and according to EMS, patient was given a total of 6, 1 mg epinephrine IV push and 1, 1 Amp sodium bicarb. Patient was worked on at the scene for approximately 40 min before being transferred to ER. Upon arrival to ER trauma room 1 patient is still in full arrest. ET tube in place with good ventilation. Patient remains in PEA. Chest compressions and life support guidelines initiated. In reviewing patient's chart and nursing home notes, patient is a full code. Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG. Patient also has history of 3rd degree heart block and pacemaker placement. Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%." "1049963-1" "1049963-1" "Found lying face down without respiration or pulse, believed to be within 5 minutes of event. ACLS procedures unsuccessful. Unable to get autopsy. Believed to be heart attack secondary to COVID infection, but unconfirmed. Relative contribution of recent vaccination unknown." "1049997-1" "1049997-1" "Vaccine was administered at Nursing Facility. Patient is an 89-year-old female with prior medical history of CVA with dysphagia, history of possible dementia, GERD, hyperlipidemia, and a pacemaker. She is a resident from town. She was sent for hypotension with a blood pressure of 90/52, tachypnea respirations of 54, possible aspiration pneumonia. Status post Covid vaccine earlier today. History is limited as patient is nonverbal on my exam. Death within 24 hours of vaccination" "1050137-1" "1050137-1" "Pt received second Moderna Vaccination on 2/21/21 at 1:00 pm at Pharmacy. Pt present on 2/22/21 to ER via ambulance at 1940. Upon presentation C/C hypotension Post COVID vaccine. Nurse notes states that Home Health nurse sent patient to ER secondary to hypotension and hyperglycemia. Pt states back ached and was holding his head. Nurse noted pt had random petechiae over body and bruising to abdomen following injections received during recent hospitalization. (unknown hospitalization). Patient was treated with IVF bolus in addition to initiating Dopamine for hypotension, patient became agonal and daughter at bedside presented Adv. Directive, pt was DNR. Pt pronounced time of death was 2110pm. (Pt only reported a sore shoulder secondary to vaccine)." "1050158-1" "1050158-1" "Resident is a Hospice patient. On 1-23-2021 am shift resident was observed by nursing have chest congestion and had a emesis times 1 with SOB, Zofran 4 mg was given. HOB (02 sats 88%) was elevated resident on 02 via nasal canula with 02 sat now @ 90% . no respiratory distress noted. MD was called with response pending for orders. @ 1400 resident with no signs of life. vs 90%-24-97/71-97.6. Hospice on site and time of death 1436" "1050172-1" "1050172-1" "Individual developed severe body aches, severe shoulder discomfort, high fevers (documented max temp. 103.7 F). Daughter reported that she became non-responsive with high fevers, and when the fevers decreased she was more lucid. Her condition rapidly progressed to nausea vomiting, diarrhea and patient died on 2/9/2021." "1050201-1" "1050201-1" "Died 7 days after receiving 2nd dose of Moderna vaccine. Had underlying hx Lung CA w/mets." "1050281-1" "1050281-1" "Per family, patient has been feeling sick since he was vaccinated, patient went to ER on 02/15/2021, and after few hours at ER patient passed away." "1050431-1" "1050431-1" "Since I was not with my husband I can only tell you what was told to me. He walked out of the store toward our car. Someone watched him, concerned, because he was walking very slowly (normally has a slow gait because of leg braces and toe amputations so I don't know if it was unusually slow). The woman saw him fall and she ran to help-administered CPR immediately-and told me he died instantly. Medics tried to resuscitate and failed to bring a pulse. (My husband left our home around 11:15 to drop a package off at store. The store is one mile from our home. At around 12:30 a deputy came to my door and when I saw him my knees buckled. I knew something horrible happened." "1051263-1" "1051263-1" "Passed away; Found unconscious; Coma; Lack of oxygen to the brain; A spontaneous report was received from a consumer, concerning his mother, a 71-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away, prior to death, patient experienced lack of oxygen to the brain and was found unconscious and went to coma. The patient's medical history reported included seizures. Concomitant medications included phenobarbital, lamotrigine and levetiracetam. On 27 Jan 2021, approximately six days prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 01 Feb 2021 at 4 am, the patient was found to be unconscious on the couch, hence she was rushed to the hospital with lack of oxygen to the brain. Later, she went into a coma, hence she was in hospital for 30 hours and then was transferred to a different hospital for a second opinion on 06-Feb-2021, where she was passed away at 02:20 PM. Treatment information was not provided Action taken with mRNA-1273 in response to the events were not applicable. The outcome of events, lack of oxygen to the brain, found unconscious and coma were considered unknown. The outcome of event passed away was fatal as she died on 06 Feb 2021 at 2:20 pm. The cause of death was not provided. Plans for an autopsy were unknown.; Reporter's Comments: This is a case of 71-year-old female subject with a history of seizures who died 6 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Passed away" "1051267-1" "1051267-1" "Passed away; Slight soreness in arm; A regulatory report was received from a pharmacist concerning a 72-year-old male patient who received Moderna covid-19 vaccine and death occurred 4 days after the vaccine and also experienced soreness in his arm after the vaccine administration. The patient's medical history includes diabetes mellitus, Hypertension, Hypercholesterolemia, CVD, previous stroke and Depression. No relevant concomitant medications were reported. No information on allergies. On 4-FEB-2021 at 10:43 am, prior to the onset of events, the patient received his first of two planned doses of covid-19 vaccine for the prophylaxis of covid-19 infection. He had soreness in his arm the day following the shot, but he had no other symptoms. He passed away on 08-FEB-2021 at 10 am. As per his wife, they never made it to the hospital, and he had poor health prior to vaccination. Action taken with 2nd dose of Moderna Covid-19 vaccine was not applicable. The outcome of the event death is fatal.; Reporter's Comments: This is a 72 year old male with hx of diabetes mellitus, hypertension, hypercholesterolemia, and CVD who died 4 days after the vaccine was administered. No autopsy report provided. No further information is expected in this regulatory report case.; Reported Cause(s) of Death: Unknown cause of death" "1051445-1" "1051445-1" "chest x-ray shows numerous bilateral patchy opacities; catastrophic brain bleed; Brainstem reflexes were lost; Patient died; shortness of breath; nausea; diarrhea; worsening shortness of breath/numerous bilateral patchy opacities; immunosuppressed status; This is a spontaneous report from a contactable pharmacist and a contactable other health professional. A 61-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular at arm right on 28Jan2021 (at the age of 61 years) at single dose for COVID-19 immunization. The patient medical history included bilateral lung transplant on 23Jun2017, lymphangioleiomyomatosis, hepatocellular carcinoma, antibody mediated rejection of lung transplant , bronchiolitis obliterans syndrome, grade 0P, major depressive disorder, RLS (restless legs syndrome), chronic insomnia, long term current use of systemic steroids OSA (obstructive sleep apnea), iron deficiency anemia, bilateral sciatica, hoarseness of voice, memory change, laryngeal stridor, pure hypercholesterolemia senile nuclear cataract, bilateral myopia of both eyes, osteoporosis without current pathological fracture, alopecia, immunosuppressed status, all from an unknown date and unknown if ongoing. Concomitant medication included acyclovir (formulation: capsule, strength: 200 mg) oral at 200 mg twice daily, salbutamol (ALBUTEROL HFA) as needed (MCG/ACT inhaler take 2 puffs by inhalation every 4 hours as needed) for wheezing (shortness of breath), atorvastatin (LIPITOR, formulation: tablet) oral at 80 mg once a day, azithromycin (ZITHROMAX, formulation: tablet)oral at 250 mg (every Monday, Wednesday, Friday), bupropion hydrochloride (WELLBUTRIN XL, formulation: tablet, strength: 150 mg) oral at 150 mg once a day, calcium citrate/cholecalciferol (CALCIUM + VITAMIN D, formulation: tablet) oral at 2 dose form once a day (every morning), everolimus (ZORTRESS, formulation: tablet, strength: 1 mg) oral at 2 mg twice a day, fluticasone propionate/salmeterol xinafoate (ADVAIR, strength: 500 ug/ 20 ug) twice daily (1 puff by inhalation), gabapentin (NEURONTIN, formulation: capsule, strength:100 mg) oral at 300 mg daily (by mouth nightly), loratadine (CLARITIN, formulation: tablet, strength: 10 mg) oral at 10 mg as needed, metoprolol tartrate (LOPRESSOR, formulation: tablet, strength: 25 mg)oral at 50 mg twice daily, minoxidil (ROGAN, strength: 5%) topical apply 1 cap full every other day to affected area on scalp for alopecia, ondansetron (ZOFRAN, formulation: tablet, strength: 4 mg) oral at 4 mg as needed for nausea, pantoprazole sodium sesquihydrate (PROTONIX, formulation: tablet, strength: 40 mg) oral at 40 mg once a day, prednisone (DELTASONE, formulation: tablet, strength: 5 mg) oral at 5 mg daily (every morning), sertraline hydrochloride (ZOLOFT, formulation: tablet, strength: 100 mg) oral at 100 mg twice a day (every morning), sulfamethoxazole/trimethoprim (BACTRIM) 400-80 mg per tablet (1 tablet by mouth every Monday, Wednesday, Friday), tacrolimus (formulation: capsule) at 3 mg daily (2 mg every morning and 1 mg at night), salbutamol sulfate (PROVENTIL HFA) as needed for wheezing (shortness of breath), salbutamol sulfate (VENTOLIN HFA) as needed for wheezing (shortness of breath) , salbutamol sulfate (PROAIR HFA) as needed for wheezing (shortness of breath), ascorbic acid/ferrous fumarate/folic acid/ retinol (PRENATAL, formulation: tablet) oral daily. The patient previously took NSAIDs and voriconazole and experienced drug allergies. It was reported that the patient presented to emergency department (ED) on 04Feb2021 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine. Full viral panel including COVID-19 was not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 08Feb2021 and then VV ECMO cannulation on 13Feb2021. Acute pupil exam changes in the early am hours of 15Feb2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. The events were all serious. The patient outcome of the events was fatal. The patient died on 15Feb2021. It was not reported if an autopsy was performed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. However, the reported event may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Chest x-ray shows numerous bilateral patchy opacities; Catastrophic brain bleed; Brainstem reflexes were lost; shortness of breath; nausea; Diarrhea; Worsening shortness of breath/numerous bilateral patchy opacities" "1051637-1" "1051637-1" "2/9 received 2nd vaccine in series. 2/10 mild headache and fatigue. 2/11 worsening headache, extreme fatigue, and general malaise. In bed except for bathroom use and minimal food consumption starting 2/11 until hospitalization on 2/17/2021." "1051651-1" "1051651-1" "Abdominal pain, nausea and vomiting, shortness of breath, acidosis, hypoglycemia, death. Onset of abdominal pain was 30 minutes after administration of the vaccine followed by 20+ episodes of vomiting and dry heaving." "1051666-1" "1051666-1" "Pt presented to ER with SOB on 01-29-2021. He was admitted to Healthcare with acute CHF exacerbation, elevated lactate, anemia and elevated d-dimer. Pt reports getting SOB getting up to go to the bathroom. Pt was intubated. He developed pulmonary edema. Pt expired on 02-02-2021 at 10:13 PM." "1051675-1" "1051675-1" ""Patient passed away on 2/1/21 at the Health System. She was there for congestive heart failure (CHF) which had been a problem for her since contracting COVID-19 (symptoms began 10/29/20 and tested positive 10/30/20). She had been to see her medical provider several times after her isolation period as well as a few trips to the hospital for, what they called ""CHF flare-ups"". Her last hospitalization began on January 30, 2021. Her social worker reported on t1/31/21 that ""she would likely be returning in another day or two""."" "1051699-1" "1051699-1" "Death on 02.15.2021." "1051803-1" "1051803-1" "unknown, was informed by Health Director that person had passed away" "1051923-1" "1051923-1" "Patient passed away within 60 days of receiving a COVID vaccine" "1051942-1" "1051942-1" "Hepatorenal syndrome- Death" "1051975-1" "1051975-1" "Patient passed away within 60 days of receiving a COVID vaccine" "1051993-1" "1051993-1" "Notified on 2/24/2021 that patient passed away on 2/14/2021. Other cause of death - non-covid -19 related" "1052014-1" "1052014-1" "Extreme difficulty breathing upon exertion, collapsed shortly after walking started, loss of conciousness, and death" "1052045-1" "1052045-1" "Patient passed away with in 60 days of receiving the COVID vaccine series" "1052049-1" "1052049-1" "Patient was into the clinic on the afternoon of 2/23/21 for a COVID-19 vaccine. He had a podiatry clinic visit after his vaccine same day. It was reported by the patients family physician that patient stated he didn't feel well and suddenly collapsed at home at approximately 4:45 pm. Emergency medical personnel were not able to revive him. Patient died at approximately 4:45 pm on 2/23/21." "1052070-1" "1052070-1" "2/22/2021 10:09 pm resident reported 1 episode of being nauseous and having dry heaves, no temperature, MD notified and nurse was told to continue to monitor, no new orders, daughter made aware. Vital signs being done every 4 hours. 2/23/2021 3:04am resident complains of nausea, scant BM amount x 2, MD notified and no new orders, continue to monitor and encourage fluids, vital signs continue every 4 hours." "1052106-1" "1052106-1" "While at counseling appointment on February 17 patient had witnessed sudden cardiac arrest and was not able to be resuscitated. She was pronounced dead at 12:09. At the time of death her glucose was about 500." "1052108-1" "1052108-1" "Patient passed away within 60 days of receiving the COVID vaccine series" "1052164-1" "1052164-1" "911 called to patients house for trouble breathing and abdominal pain. Patient coded, wife presented DNR paperwork. Patient presented to Hospital DOA at 0958." "1052172-1" "1052172-1" ""Agency contacted 2/19 In evening by employer representative- client Died Suddenly after work"""" "1052179-1" "1052179-1" "Patient passed away within 60 days of receiving a COVID vaccine" "1052217-1" "1052217-1" "Elevated heart rate, flushing of the face and ears, vomiting, trouble breathing, pulmonary edema" "1052226-1" "1052226-1" "Patient discovered unresponsive in cell, blue coloration to skin, vital signs, undetectable. CPR initiated, Ambulance summoned. Following EMS arrival with additional unsuccessful attempts to revive patient, patient was determined to have expired." "1052273-1" "1052273-1" "Patient admitted to the hospital the day after receiving a COVID vaccine x 5 days. Patient passed away on 2/23/2021." "1052645-1" "1052645-1" "Cardiogenic shock occurred on 2/10/2021, approximately 12 hours after patient received her 12th dose of pemetrexed/pembrolizumab and 4 days after COVID vaccine. Coronary angiography was done on 2/10/2021 and no significant coronary narrowing or blockage were noted. Baseline troponin on 2/10/21 was 0.02 and later on 2/10/21, troponins were 9.99 & 25.27. Creatinine increase from 1.2 to 3.4 within 24hours, and AST/ALT increased from 23 & 31 to 4,220 & 4,786 respectively on 2/11. Patient expired on 02/11/2021." "1052738-1" "1052738-1" "He vaccine on 2/5/2021 I went to see my husband the next day he was shaking and his mouth was open shaking, and he had fever of 105, they gave him Tylenol suppositories and he passed away 2 hours later. They should not have given him should not have given him the vaccine that is on hospice, it was not the right decision. I am worried about the elderly and those very sick." "1052809-1" "1052809-1" "Patient passed away" "1052820-1" "1052820-1" "Approximately 2 weeks after the first COVID vaccine she developed shortness of breath that was much more significant than she had previously. This was the first time she had expressed this symptom to me as being something she was concerned about and difficult for her to manage (we have spoken almost daily for many years). Within 24 hours of the second dose of the mRNA vaccine, they called an ambulance to get her and she was taken to the hospital and diagnosed with bacterial pneumonia. The doctors said it was unrelated, but I found a study with a different vaccine (LAIV) that also seemed to increase the incidence of bacterial pneumonia. They hypothesized through diverting the immune system. So while I don't think the vaccine gave her the bacteria, I do think it may have caused her immune system to be temporarily compromised allowing the bacteria to grow out of control. I feel this is important to report to look for these types of patterns as perhaps it can help others avoid the death spiral that happened to my mother. There were also intervening events between her hospitalization and her death including two successful surgeries (one for a broken hip and another to put in stents in her leg). So to summarize, the first vaccine was within about 2 weeks of the onset of her breathing problems. Within 24 hours of the second vaccine she was hospitalized and diagnosed with bacterial pneumonia. As she was battling bacterial pneumonia in the hospital she broke her hip and was found to have reduced peripheral circulation and had 2 surgeries to correct those. They were successful according to the surgeons, however she died within a week or so of the surgeries. She had other comorbidities as well which I'm sure predisposed her such as diabetes, hypertension and cancer for many years." "1053191-1" "1053191-1" "Vaccine administered 02/08/2021 , by Thursday 02/11/2021 patient almost nonverbal, by Monday 02/15/2021 patient went to the hospital with bruising, sores on her stomach and clots reported as thrombocytopenia, deceased by Friday 02/19/2021." "1053322-1" "1053322-1" "Pt had passed away before second dose" "1053393-1" "1053393-1" ""Patient felt achy, tired starting the day after the vaccine. Per his wife, he was very tired and ""losing stamina"". On 2/13/21, he woke up feeling dizzy and weak. His wife asked him if he wanted to go to the doctor and he declined. He ate breakfast and went to rest in his easy chair. He passed away an hour later."" "1053694-1" "1053694-1" "Sudden Death on 2/17/2021" "1053788-1" "1053788-1" "Received call that patient is now deceased" "1053879-1" "1053879-1" "Shortness of breath - related to chronic comorbidities" "1053978-1" "1053978-1" "pt woke up at 0400 with fever, chills, and body aches progressing over 4 hours to the point when she became unresponsive. husband called 911, pt was declared dead at the time of EMS arrival around 1200" "1054080-1" "1054080-1" "cardiac arrest, death: 2/21/21" "1054114-1" "1054114-1" "Patient was hospitalized 15 days after receiving vaccine. Admission was not due to vaccine and was admitted for acute ascites and patient had reported fever and hypoxia. Patients admission resulted in death 7 days after being admitted to hospital." "1054160-1" "1054160-1" "2/12/2021 woke up with sore arm and back. 2/13/2021 woke up with headache around 1am. Headache and nausea all morning. Mid-late afternoon started having seizures. Admitted to Hospital 2/15/2021 expired. Reported per wife on 2/25/2021." "1054171-1" "1054171-1" "Resident found unresponsive in his room. CPR performed and patient expired." "1054175-1" "1054175-1" "Resident found unresponsive, CPR initiated and EMS called. EMS called time of death after arrival." "1054192-1" "1054192-1" "Pt's wife reports death 2/23/2021" "1054337-1" "1054337-1" "FOUND DEAD IN HIS OWN BED" "1054434-1" "1054434-1" "Patient reported to emergency room on 2/20 with increasing of shortness of breath, quantitated unable to walk from room to room in his house. Patient was admitted." "1054435-1" "1054435-1" "Patient passed on 01/28/2021 per family member." "1054551-1" "1054551-1" "Resident expired on 2/29/21." "1054592-1" "1054592-1" "Resident expired on 2/24/21, under hospice care." "1054694-1" "1054694-1" ""Pt received vaccine on 1/29/2021 and died on 2/13/2021. Wife called agency and noted the pt received his 1st dose of vaccine and was having ""side effects and began declining"". It is unknown what side effects he was having."" "1054698-1" "1054698-1" "THE RESIDENT WAS ROUTINELY TESTED FOR COVID ON 1/29/21 AND POSITIVE RESULTS RETURNED ON 1/30/21; WAS ASYMPTOMATIC AT FIRST, BUT DEVELOPED SYMPTOMS ON 1/31/21 THAT PROGRESSED AND THE RESIDENT DIED ON 2/7/21" "1054699-1" "1054699-1" "Patient was found at 6 AM on 01/21/2021 - he passed away during his sleep" "1054813-1" "1054813-1" "Chest clear - Hospitalized for a UTI" "1054859-1" "1054859-1" "No details - patient died on 1/22/2021" "1054966-1" "1054966-1" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1055009-1" "1055009-1" "Patient deceased 2/9/2021 when called for second dose vaccine appointment" "1055027-1" "1055027-1" "patient deceased no show to 2nd appointment notified by family" "1055070-1" "1055070-1" "Client died on 02/21/2021 and had received the second dose of the vaccine series on 02/19/2021." "1055107-1" "1055107-1" "No documented vaccine reaction Hospitalized due to co-morbities" "1055122-1" "1055122-1" "Pale, Short of Breath, Hypoxic, Lethargic within minutes became unresponsive and died." "1055149-1" "1055149-1" "This is a hospice patient under the care of Hospice at an affiliated nursing home. Pt received the vaccination around noon on 2-16-21 by a representative from Pharmacy. The following afternoon 2-17-21 at 14:45 the pt started to experience severe SOB resp rate 36, audible wheezing and use of respiratory accessory muscles. BP180/80, 113 pulse temp 98. Pt was given morphine and ativan. The respiratory distress was eased however pt never returned to baseline and died 2-22-21 around 4am." "1055203-1" "1055203-1" "Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632." "1055267-1" "1055267-1" "Death" "1055290-1" "1055290-1" "Death occurred 02/14/2021" "1055298-1" "1055298-1" "Emergency Room HPI: The patient is a 71 y.o. female with a PMH notable for COPD, hypertension and anxiety and depression who presented on 2/6/2021 for evaluation of shortness of breath. Patient presented to our emergency room yesterday morning from local nursing facility rehab nursing staff reported that she had had a increased shortness of breath for the last 3 days she has been diagnosed with COVID-19 on 2-2-2021. Patient has also received both COVID-19 vaccines. Patient presented to the emergency room with labored respirations conscious awake and was on a non-rebreather at 15 L. upon arrival to our emergency room patient's temperature 101.6¦, pulse 169, respirations 40 to blood pressure 142/91 and oxygen saturation 100% on 15 L non-rebreather. Patient received a chest x-ray that showed chronic emphysema and fibrotic changes in the lung no acute processes identified. Patient's white count 12.8, glucose 197, creatinine 1.2, lactic acid 4.6, cardiac enzymes negative, D-dimer 1180, patient has urine culture pending. Patient has received about 3 L normal saline boluses patient was having hypotension 86/52. Patient also received IV acetaminophen a 1000 mg IV in the emergency room along with Decadron 10 mg IV piggyback. Patient was admitted acute care for the need of IV fluids and IV antibiotics for COVID-19 and sepsis 2/12 admit Brief history and initial physical exam: Patient is a 71 year old long-term resident of Rehab and Healthcare. Unfortunately, she contracted coronavirus (COVID-19) at the nursing home. Her respiratory status started to decompensate and so she was brought into the hospital. Initial workup showed significant bilateral pleural effusions and ground-glass opacity of both lungs. She had a significant supplemental oxygen requirement. She was admitted for further evaluation and treatment. Hospital course: The patient was admitted and started on IV Remdesivir. She was given IV Decadron. She was given immune support vitamins. Despite this, her sepsis worsened. When it became apparent that the patient was not going to recover, her daughter did make her comfort care only and hospice was consulted. The patient was found to be appropriate for general inpatient hospice and was made comfort care. Her requirement for morphine and Ativan did slowly rise. Eventually, the patient did succumb to her respiratory failure. Time of death was called at 10:00 p.m. on February 15, 2021 Discharge Condition: expired. Presume cause of death with cardiopulmonary arrest secondary to acute respiratory failure secondary to coronavirus (COVID-19) pneumonia Disposition: Deceased" "1055341-1" "1055341-1" "Sudden death two weeks after first dose of vaccine was administered. No previous symptoms or signs. Family opted not to do an autopsy so cause of death (stroke or heart attack) not known." "1055418-1" "1055418-1" "Patient suffered a stroke and passed away" "1055563-1" "1055563-1" "Pt tested positive for COVID-19 on 2/10/2021 and died from illness related to COVID-19 on hospice at home on 2/18/2021, per care facility." "1055588-1" "1055588-1" "Pt tested positive for COVID-19 on 2/10/2021 and was hospitalized on 2/15/2021 and deceased on 2/18/2021 at the hospital of admission, per caregiver." "1055613-1" "1055613-1" "Pt tested positive for COVID-19 on 2/10/2021 and was deceased on 2/16/2021 per the caregiver." "1055618-1" "1055618-1" "Pt tested positive for COVID-19 on 2/10/2021, and was deceased on 2/16/2021 at." "1055629-1" "1055629-1" "Pt tested positive for COVID-19 on 2/10/2021, and deceased on 2/12/2021, per caregiver at." "1055691-1" "1055691-1" "Massive ischemic stroke with aspiration, unable to arouse on the morning of 1/21/2021 and placed on Hospice with death 1/24/2021" "1055791-1" "1055791-1" "Was given without consent from POA patient got severely sick and never recovered later passed away only live 1 month POA did not allow second vaccine to be given just wanted to report this vaccine was given illegal without POA knowledge" "1055819-1" "1055819-1" "On January 1, 2021, patient was admitted to Medical Center with COVID. Tested positive on January 2, 2021. Spent 10 days in hospital. Once recovered from pneumonia and fever gone, on January 10, 2021, she was transferred to Rehabilitation Center for continued treatment. She spent 16 days there. She developed UTI and CDIF infections and was on/off oxygen. She started physical therapy. She was scheduled to be released to go home on January 27, 2021. On January 26, 2021, the day before going home, Rehabilitation Center gave her the Moderna vaccine. On January 27, the day she went home, she started feeling very weak and couldn't walk. My dad tried lifting her and they both fell to the ground. My dad called 911 and she was taken to Medical Center, with high fever and possible stroke symptoms (which later was negative). Two days later, she had difficulty breathing and was put on a ventilator. She was on a ventilator for about three days. They took it off and she slowly started recovering. The doctors did all kinds of tests (blood clot in lung, heart, etc.) and all was negative. The only thing they could trace it to was an adverse reaction to the vaccine. After spending 11 days at hospital and treating her for various infections, her heart stopped and she passed away suddenly." "1056011-1" "1056011-1" ""My grandpa had a stroke on the 15th of February. He claimed he had been feeling ""off"" for a few days, but didn't say anything. A blood clot had formed in his brain. He was doing better and about to go to rehab to strength his right side of his body. On the 22nd he took a turn for the worst. He was having trouble breathing and they sedated and partially paralyzed him to put a tube in his mouth. I believe another blood clot had formed and oxygen wasn't properly going through his body. They could not stabilize him, and he passed away the same day."" "1056196-1" "1056196-1" ""He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; his cardiac arrest was caused by an arrhythmia; This is a spontaneous report from contactable pharmacist via Pfizer Sales Representative. A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. Patient had a long history of congenital heart issues. He had been stable and closely monitored for the past 20 years. He had no history of arrhythmia. The patient's concomitant medications were not reported. Patient collapsed due to a cardiac arrest on Friday 15Jan2021 and passed away on 19Jan2021. The doctors feel that his cardiac arrest was caused by an arrhythmia. Reporter reported this through the v safe app. And received a message stating reporter would be contacted by the cdc. After patient passed away reporter replied stop to v safe. But still had not been contacted by anyone. This may or may not be related. Reporter have no way of knowing. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported ""collapsed due to a cardiac arrest"", ""cardiac arrest was caused by an arrhythmia"" and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association. The patient's pre-existing long history of congenital heart issues might have provided alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death: He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; his cardiac arrest was caused by an arrhythmia; He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan"" "1056518-1" "1056518-1" "The coroner said it was some type of heart attack; A spontaneous Report Received from a Health care professional concerning a 84 year old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced a heart attack / myocardial infarction. The patient's had undergone triple bypass surgery years ago. Concomitant medications were vitamins. On 18-Jan-2021 prior to onset of events the patient received his first of first two planned doses of (mRNA-1273) COVID-19 vaccine of unknown batch no, unknown route and unknown site of administration for prophylaxis of COVID-19 infection. On 13-Feb-2021 the patient experienced death 27 days after the first dose of the vaccine. The coroner said it was some type of heart attack and think he expired sometime Saturday 13-Feb-2021. On 16-Feb-2021 the patient was supposed to have his second dose of (mRNA-1273) COVID-19 vaccine. The event, heart attack, was fatal.; Reporter's Comments: This is a case of death to heart attack in a 84-year-old female subject with a hx of triple bypass surgery, who died 27 days after receiving first dose of vaccine. Very limited information has been provided at this time. No death certificate provided. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of Death" "1056660-1" "1056660-1" "Cardiac Event MI or Stroke; Cardiac Event MI or Stroke; This is a spontaneous report from a contactable consumer (Son in law). A 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 17Feb2021 14:00 at single dose for covid-19 immunisation. Medical history included atrial fibrillation (AFib), prostate cancer Survivor. Concomitant medication included alirocumab (PRALUENT), escitalopram oxalate (LEXAPRO), apixaban (ELIQUIS), nitroglycerin and Ca channel blocker. The patient received the first dose of BNT162B2 on an unknown date for covid-19 immunisation. The patient experienced cardiac event myocardial infarction (MI) or stroke on 17Feb2021. Adverse event result in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The patient died on 19Feb2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. The reporter didn't know if this was associated or not. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardiac Event MI or Stroke; Cardiac Event MI or Stroke" "1056842-1" "1056842-1" "The medical facility did not treat patient as her primary care, but were informed that she passed away on 15 February 2021 of a stroke. I do not have further information on the medical aspect of this as we were not her treating provider but did administer the vaccine on 12 February." "1056845-1" "1056845-1" "Three days after second COVID-19 vaccine, patient became lethargic. Due to advance directive that instructed that no life saving interventions to take place, patient continued to decline and expired on 29 January 2021." "1056972-1" "1056972-1" "5-6 days after receiving first Moderna covid vaccine pt. began not feeling well. On 02/10/2021 she saw a provider in an office for eval of abdominal pain and diarrhea and sent home. On 02/15/2021 she presented to a local ED with continuing symptoms, transferred to Medical Center. She is currently an inpatient there with a diagnosis of multiple blood clots in abdomen and brain and antiphospholipid syndrome." "1057082-1" "1057082-1" "Pt admitted to Hospital on 2/8/21 with 2-3 days of SOA and cough. His wife was diagnosed with COVID-19 at approximately the same time when the patient received 1st COVID-19 vaccine. Pt had not felt well since receiving the vaccine and had some changes in taste or smell. He became acutely worse 2-3 days p/t admission with DOE, productive cough, H/A, N/V, profound weakness and bilateral infiltrates on CXR. He was hypoxic on room air. During hospitalization, has gone back and forth from BiPAP to HFNC. Unable to prone. Pt and wife discussed goals of care and decided on comfort measure approach. Pt expired on 2/19/21." "1057281-1" "1057281-1" "patient's husband reported her death that happened after first COVID-19 vaccine" "1057348-1" "1057348-1" "Extreme Fatigue, slurring speech, unable to stand, eat. Death on 2/5/21" "1057363-1" "1057363-1" "Patient with severe dementia in Hospice Care" "1057704-1" "1057704-1" "High grade MDS; Multiorgan failure; Pancytopenia; shortness of breath; Inflammatory marker increased; Chills; Fever; Fatigue; A spontaneous report was received from a healthcare provider concerning a 71Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced chills, fever, fatigue, pancytopenia, shortness of breath (dyspnoea), multi organ failure, and myelodysplastic syndrome (MDS). The patient's medical history was reported to include Breast Cancer and mastectomy. No relevant concomitant medications were reported. On 16 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unkown) intramuscularly for prophylaxis of COVID-19 infection. On 16 Jan 2021, The patient experienced events like chills, fever, and fatigue. On an undisclosed date, the patient was admitted to the hospital for shortness of breath. Laboratory details include Bone Marrow biopsy with abnormal results such as showed high grade MDS with 19% blasts. Blood work done with normal results. Body temperature results came out 103 degrees Fahrenheit. On 30 Jan 2021 the patient experienced worsening shortness of breath and was intubated. Her IL-6 was very high, and she had profound liver failure. She ended up needing pressors and requiring continuous renal replacement therapy. Treatment included steroids. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 12 Feb 2021. The cause of death was reported as high grade MDS. An autopsy was planned.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death" "1057750-1" "1057750-1" "Started feeling unwell; Headaches; Body aches; Chest pain; Didn't had wishes to eat; Diarrhea; COVID-19 pneumonia; A spontaneous report was received from a consumer concerning a 69-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID-19 pneumonia, feeling unwell, headaches, body aches, chest pain, decreased appetite and diarrhea The patient's medical history high blood pressure which was controlled with medication. Concomitant product use included nifedipine and fenofibrate. On 20-JAN-2021, approximately a week and a half or two prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. A week and a half or two later the patient stated feeling unwell, headaches, body aches, chest pain, decreased appetite and diarrhea for which patient was hospitalized on 06-FEB-2021. Since everything seemed to be fine the patient was discharged on an unknown date in FEB-2021 however, patient's family was not notified that it was a late reaction to the vaccine's first dose. Later, due to shortness of breath he was hospitalized again on 08-FEB-2021 and was diagnosed for pneumonia and was intubated on the same day. Due to COVID-19 situation patient's family could not be in the facilities and that there wasn't any follow up of the patient given to the family, so family did not have much information. During the first hospitalization(06-FEB-2021) the patient had a blood test which showed a normal result and was tested for COVID-19 and Influenza, both were negative. During second hospitalization (08-FEB-2021) the hospital said that the patient was stable. The patient's family did not know the results of the tests conducted at the time. The action taken with the vaccine in response to the events is not applicable. The outcome of COVID-19 pneumonia was fatal. The patient died on 14 Feb 2021 The cause of death was reported as COVID-19 related pneumonia. The autopsy was not done.; Reporter's Comments: Very limited information regarding this event has been provided at this time. The cause of death was reported as COVID-19 related pneumonia. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events are assessed as unlikely related. Further information has been requested.; Reported Cause(s) of Death: COVID-19 pneumonia" "1057802-1" "1057802-1" "Patient was transferred from hospital for further evaluation and care by pulmonologist. He started having symptoms a week before with fatigue, emesis, decreased p.o. intake, shortness of breath, vomiting and diarrhea. The two previous takes before death required increasing oxygen and family wanted everything done including intubation. He was transferred to ICU." "1057828-1" "1057828-1" "Patient unexpectedly died on 2/17 after 14 days of receiving first dose of COVID-19 vaccine. EMS presumed it could be from possible myocardial infarction." "1057853-1" "1057853-1" "on 2/218/2021 the patient was at home and developed chest pain. Patient was transported by family to urgent care then to the ED where the patient later died." "1057956-1" "1057956-1" "Heard through a family member had some feeling badly and some respiratory symptoms. We do not have any real information. This is a coroners case." "1057997-1" "1057997-1" """"Feeling Hot"" without fever and nausea 10 hours post vaccine and resolved within 1 hour. Seizure, Hypotension, Unresponsive followed shortly by cardiac arrest and pulseless electrical activity 21 hours post vaccine. Pronounced dead 22 hours post vaccine"" "1058033-1" "1058033-1" "Patient had a stroke two days after vaccine. Recevied TPA for treatment of stroke due to acute onset of altered mental status. Had a history of afib, not on anticoagulation, which is likely cause of stroke. Family opted for comfort measures given poor neurologic status. Passed awaiting hospice placement" "1058160-1" "1058160-1" "Resident expired on 2-25-21" "1058171-1" "1058171-1" "Death" "1058190-1" "1058190-1" "On the evening of 2/23/221 at 9:00 pm, resident reported feeling SOB, BP 80/44, Pulse 53, O2Sat 95% on 3L oxygen, hands cold, pulse weak. Temp 92.5F MD notified. EMS activated. EMS arrival and HR 20. Family refused transport to ER. Resident expired at 2:40 am on 2/24/21 Meds continued: duloextine, VITd2,hydralazine, synthroid, lisinopril, mag ox, folplex, pantoprazole, potassium chloride, ellipta, ensure, hydrocortisone cream, boost, deprox, xanax, morphine, lorazepam, tylenol, albuterol inhlation, ventolin inh." "1058192-1" "1058192-1" "2/24/21 Patient Died. 02/23/21. Patient came to ED for weakness/falls. Patient had fallen on 02/21 and 02/23. UA was done in LTC, and he was started on ciprofloxacin 02/22/21. Treatment was to put patient on comfort cares (morphine + lorazepam)" "1058266-1" "1058266-1" "Pale, not eating, no urine output" "1058464-1" "1058464-1" "Pt tested Covid positive 2/8/2021." "1058569-1" "1058569-1" "PATIENT DIED IN HIS SLEEP NIGHT AFTER ADMINISTRATION" "1058793-1" "1058793-1" "Pt had only complained of a sore arm after receiving the vaccine- pt died on 2/25/21 from what they feel was a massive heart attack- unsure if related to vaccine at all" "1058845-1" "1058845-1" ""Pfizer-BioNTech COVID- 19 Vaccine EUA Patient received COVID-19 Vaccine dose #2 on February 24, 2021. On February 25th at 10:36 AM,Patient's son called physician to report some side effects to second dose of Covid vaccine. She had diarrhea when she came home yesterday. Son has been up all night with her as patient has had a ""hacking cough,feels terrible, and now has had diarrhea x2"". Patient has taken Advil and will be taking tylenol periodically through out the day for her side effects. Patients son notified physician at 09:55 AM on February 26 that the patient has expired."" "1058963-1" "1058963-1" "2/182021: Witnessed cardiorespiratory arrest with PEA arrest upon EMS arrival" "1059001-1" "1059001-1" "Patient had declining health for the past 6 months, dementia and unable to walk. Patient had decreased appetite starting 1/1/21. After 1st vaccine shot patient appetite decreased further. After 2nd vaccine shot patient fatigue increased to the point where she could not get out of bed and had minimal appetite. Patient passed away 10 days after receiving 2nd shot on 2/22/21. Patient did not go to ED and was not hospitalized." "1059048-1" "1059048-1" "Fever, chills, fatigue, muscle aches, nausea, death 48 hours after injection" "1059207-1" "1059207-1" "Unknown symptoms overnight. Appears patient passed away sometime after waking up next morning after receiving vaccine." "1059344-1" "1059344-1" "death 2/25/21" "1059356-1" "1059356-1" "Pt fell within 24 hours after vaccine. was sent to hospital. pt was found to be hypoxic with multifocal opacities on CT scan" "1059360-1" "1059360-1" "Cardiac arrhythmia, EMS on site within minutes, outcome of death." "1059421-1" "1059421-1" "After the second vaccine dose she reported not feeling well with unspecified symptoms for a few days. On February 18th, 2021 she visited her doctor with numbness in her hand. They thought it may be carpal tunnel and sent her home. The morning or March 18th , 2021 she had a severe stroke and was transferred to Hospital and then to other hospital. She was in the hospital until Tuesday March 23rd when she was transferred back to her home for hospice care. She died on March 26th, 2021." "1059621-1" "1059621-1" "1/14/21 - Resident complained of SOB. SPO2 66% on RA, vs 105/66-96-20 T98.2 O2 administered Pox 97% Binax test revealed (+) COVID results. Resident transferred to COVID wing. Family (HCP) updated and declined transfer to hospital Resident continued with fever, hypoxia and lethargy. Family elected CMO and Hospice notified. Resident died on 1/16/2021 @ 930AM." "1059623-1" "1059623-1" "Possible Stroke per Medical examiner but Reported symptoms after covid vaccine 2/11 therefore being considered poss Covid vaccine related also. No hospitalization prior to death. (Symptoms reported to office 2/17) Fatigue, decreased appetite-" "1059745-1" "1059745-1" "Per Patients Wife - Same day - Flu like symptoms, Nausea, Headache. Restless that night. Next day - Weak, shortness of breath. Wife called squad to get him out of his wheelchair but patient refused hospital as it gets him agitated. Patient passed away around 11 AM the day after vaccination." "1059825-1" "1059825-1" "30 hours after the first Covid vaccination, the resident was lethargic, non responsive with shortness of breathe." "1060080-1" "1060080-1" "Death" "1060190-1" "1060190-1" "Patient received Covid Vaccine Moderna at 1145, multiple syncopal episodes at pharmacy, sent to ER. Outcome Death" "1060520-1" "1060520-1" "Pt expired 11 days after receiving vaccine. No indication his passing was related to the vaccine. Narrative: No updated notes regarding cause of death. Patient's wife called to notify the facility of his passing on 1/26/2021" "1060521-1" "1060521-1" "Pt passed away 15 days after vaccine, no indication death was related to vaccine. Narrative: Patient was a 64 yr old female with stage 4 serious ovarian cancer with extensive lung metastases no longer on treatment with severe CAD, HFpEF who was transitioned to comfort care on 1/23/21." "1060522-1" "1060522-1" "death Narrative: 86 year old MALE with PMH of Afib s/p AICD/PPM, HFrEF (EF< 20% 10/2019), DM2, HTN, HLD, BPH, Depression. Was stable and feeling well when he was administered Covid-19 vaccine on 02/17/2021- Pfizer COVID-19 Vaccine 0.3 ml IM. MVX (Manuf); PFR; Lot#; EL9267; Exp Date:05/31/2021 Administration Anatomic site: Right Deltoid; Pt was monitored for 30 minutes after administration and had no adverse effects. He was called later in the day and reports he feels well and has had no adverse reactions, he endorsed his arm is a little sore at injection site. ON 02/19/2021- his dghter found him on the floor, next to his bed, dead. She reported on 2/19/2021- that she was out with him to dinner on 2/18/2021, and he stated he did not feel well, that his insides did not feel right. He proceeded to have dinner and 2 drinks. HE was doing ok, when she took him home." "1060523-1" "1060523-1" "contracted covid after first dose Narrative: First covid vaccine dose 12/31/2020, tested positive for covid 1/7/2021, died from complications 1/25/2021" "1060524-1" "1060524-1" "Death, unknown cause Narrative: Patient received COVID19 vaccine on 2/23/2021 at 14:27. On 2/24/21, patient's family found patient deceased at 12:08am. The local coroner had called the MC to let us know on 2/24/21 at 12:55am. Coroner did not suspect foul play." "1060525-1" "1060525-1" "death Narrative: This was reported to VAERS by another entity and records were requested." "1060527-1" "1060527-1" "loss of consciousness;febrile Narrative: Patient received his 2nd vaccine at 10am 2/17. That evening he felt subjectively febrile and then suffered a ground level fall at 0400 on 2/18. He did not lose consciousness or injure his head. EMS was contacted and assisted him into bed. At 0600, wife noted increased work of breathing, which prompted another EMS call, who found him hypoxic with fever of 106. He was transported to a community hospital, where he was found to have temp 102.9 and blood pressure in 70s-80s systolic. He was transferred to hospital at 1300 on 2/18/21, requiring norepinephrine for pressure support after fluid resuscitation. He c/o stiffness and soreness all over but presenting ROS was otherwise negative. Patient was treated with 4L IV fluids and vancomycin and piperacillin/tazobactam at the outside ER. Here at the hospital he was treated with vancomycin, piperacillin/tazobactam and levofloxacin along with IV fluids and norepinephrine. Despite this he had several fevers with Tmax 103.5F the night of 2/18-2/19 and he required norepinephrine plus vasopressin overnight to maintain blood pressure. Piperacillin/Tazobactam was discontinued in favor of meropenem. His last fever was at 6am on 2/19. ID consult was obtained 2/19/21 and vancomycin and levofloxacin were weaned off. Ultimately his blood pressure improved and he was weaned off of all vasopressors the morning of 2/20. Notably, he never developed severe hypoxemia at rest while in the ICU, but did require BiPAP non-invasive ventilation at night instead of his usual CPAP to keep his oxygen levels > 90% while sleeping and additionally had desaturations into the low 80% range with exertion from which he was slow to recover. His oxygen saturation was >90% on 30-40% FiO2 via aerosol mask overnight and 3L (his current baseline) NC during the day. He was transferred out of the ICU on 2/21 based on hemodynamic improvement, stable oxygenation, and improved mentation and symptoms. Unfortunately, on the morning of 2/22/21, patient had an abrupt change in status and was found to be unresponsive with hypercarbic respiratory failure and hypotension. ABG during this event was 7.16/121/65. BiPAP was initiated as patient's code status was DNR/DNI. CXR with no significant change from 2/18/21. CT of head without contrast was negative for acute processes. Based on lack of rapid improvement, the decision was made by wife to transition to comfort care. Patient died at 1446 on 2/22/21. **Of note: patient was admitted for 1 week for covid 19 pneumonia November 2020. During this hospitalization he was found to have chronic R sided PE, no acute PE." "1060528-1" "1060528-1" "Death due to underlying condition for hospice pt. Narrative: This was a 95 yo patient residing at home with daughter. Patient reported to PCP on 1/4 c/o poor appetite and weight loss. Daughter reported that patient was very frail and requested a hospice referral. Outside medical records indicate that patient was dx with pneumatosis of the cecum and peritonitis. Patient also had severe atherosclerotic disease with near complete occlusion of the infrarenal abdominal aorta. Due to age and frailty, patient was placed in hospice care where he passed away on 1/22/21." "1060529-1" "1060529-1" "Hypoxia, Decreased responsiveness, Narrative: 86yo male with PMHx HTN, Afib not on AC after head trauma, CVA, and colon cancer who was brought to the ED by his family on 2/17. Per documentation the pt was in his usual state of health until 2/16. Received Moderna covid vaccine #2 on 2/16/21 at 0900, and was monitored for 15 minutes following immunization no noted issues. Later that night, had myalgias and took Tylenol. Per the family he slipped on the ice and fell on his butt. Overnight, had several dark stools and vomitus. was brought to the ED by his family because he was being less responsive. Pt arrived to the emergency department in extremis. No pulse identified. CPR immediately initiated for several rounds lasting about 25-30 minutes. ROSC unable to be achieved. Patient expired on 2/17 at 1941. Of note, per previous documentation had waxing and waning mental status at baseline. No symptoms noted with 1st dose of Moderna vaccine, which was administered on 1/16/21." "1060833-1" "1060833-1" "Severe headache, nausea and vomiting" "1060858-1" "1060858-1" "had lack of appetite before second dose. When received the second dose, he started vomiting on the way home. Was sick on and off for the next few days. Died suddenly on 2/23/2021" "1061040-1" "1061040-1" "Text message from patient : 2.37 pm Saturday 02/20/2021 had the vaccine , waiting for 15 minutes & 2nd dose due 3/18/2021 Test message 9.44 am Sunday :feeling little sick with stomach ach No answer to phone calls on Cell/ Landline on Sunday No answer to phone call/ or text message No further communication." "1061059-1" "1061059-1" "Do not know if patient informed her physician that she received vaccine on 1/29/2021. She had appt at 3:15 pm on 1/29 and afterwards stated she received the Moderna vaccine. Reporter is uncertain if this was at a health office or clinic. She drove herself to the ER at about 3am on 1/30/2021 with increased cramping and pain." "1061064-1" "1061064-1" "Unable to breathe and died. Doctors unable to save her upon arrival" "1061077-1" "1061077-1" "Day after second dose decedent had fever and tremors, subsided on day three (less than 72 hours) after dose with exterem wekness followed by death less than 72 hours after second dose" "1061184-1" "1061184-1" ""Possible heart attack on 2/5/21. Complaint: "" On Feb 5th l believe l experienced a mild hear attack"" (Comment: He said he felt ""clammy, sweaty, excruciating pain on my left side - including his left arm, and left leg, dizzy, exhausted."" This happened after work, and after taking a shower. He said that was the first time he's experienced it, and that it has not happened since then. He said he has constant headaches, ""It just went away yesterday."""" "1061226-1" "1061226-1" "death" "1061303-1" "1061303-1" "Death. Patient was found unresponsive in the morning hours after her shot." "1061434-1" "1061434-1" "I am the patient's daughter as well as an RN-BSN. My mother was given the Moderna vaccine on Feb 11, 2021 and on Feb 15, 2021 she had a CVA and MI. She was found on her apt. floor unconscious. She was transferred to the Hospital by ambulance where a CT scan and other tests were done. It was determined she had a stroke and heart attack. My mother was in great health, took no medications, and lived alone in her apt. before this incident. The medical professionals determined she would not recover so she was admitted to hospice and died on Feb. 21, 2021. I believe there is a relationship between the vaccine and the CVA and MI." "1061909-1" "1061909-1" "Massive stroke; A spontaneous report was received from a consumer (patient's daughter), concerning an 85-year-old female patient, who received Moderna COVID-19 vaccine and death occurred in two days. The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies. She states that her mother was physically and mentally healthy before vaccination. On 29-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of covid-19 vaccine for the prophylaxis of Covid-19 infection. There were no complaints on any side effects from the patient for 6 hours after vaccination. Next day, she was found unresponsive on her bed by her neighbor after they were sent to check on her by her daughter. Her heart was beating, and she was breathing at that time, but did not have consciousness. According to her daughter, the patient had a massive stroke in her sleep sometime between 8:pm on 29-JAN-2021 and 9:30 am on 30-JAN-2021. Her life saving measures were taken out at 1:15 am on 31-JAN-2021 and she died approximately at 1:45am. No information available on hospitalization and treatment received with this event. It is not known whether autopsy was done. Action taken with 2nd dose of Moderna Covid-19 vaccine was not applicable. The outcome of the event stroke is fatal.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stoke, a causal relationship cannot be excluded. Patient's elderly age is considered a risk factor.; Reported Cause(s) of Death: Massive stroke" "1061911-1" "1061911-1" "Died at home; Gasping for air/difficulty breathing; Soreness; A spontaneous report was received from a physician concerning a 45 years-old, female patient who experienced soreness/MedDRA PT: pain, gasping for air/difficulty breathing/MedDRA PT: dyspnoea and subsequently died/MedDRA PT: death. The patient's medical history included blood pressure (disorder not specified), thyroid disorder, depression and anxiety. Concomitant product use included blood pressure medication, thyroid medication and possibly depression and anxiety medication. On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot #007M20A) (route of administration and injection site not provided) for prophylaxis of COVID-19 infection. On 28 Jan 2021, following the vaccination, the patient was fine but had experienced some soreness. Per patient's coworker, the patient did not take any medication as it made the patient sick. The physician was not aware of any complaints from the vaccine. On 13 Feb 2021 at 3:31am, the patient called 911. Per the 911 call, the patient was gasping for air on the call and having difficulty breathing. The patient subsequently died on 13 Feb 2021 at home. The physician inquired whether Moderna gets involved with the autopsy and logistics of the death of patients and wanted to know the time frame for reporting a death of a patient who received the vaccine. The physician did not know who administered the patient's vaccine. Action taken with mRNA-1273 in response to the events was not applicable as the patient deceased. The event died was fatal. The outcome for the events soreness and gasping for air/difficulty breathing was unknown. The patient died on 13 Feb 2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding the event of dyspnea and death has been provided at this time. Further information has been requested. Patient's medical history of blood pressure is considered a risk factor. Based on the current available information and temporal association between the use of the product and the onset of the pain, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Died at home" "1062260-1" "1062260-1" "Developed acute facial droop and slurred speech 2h after 1st dose of the vaccine on 2/17, found with R MCA stroke. Then became unresponsive on 2/27 and was found with an acute L MCA stroke. Was transferred from another hospital, was not a candidate for intervention, and was made comfort and died on 2/28" "1062350-1" "1062350-1" "Death; A spontaneous was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine and who died. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23-Jan-2021, prior to the onset of the event, patient received their first of two planned doses of mRNA-1273 (Lot number:013620A) intramuscularly for prophylaxis of COVID-19 infection. On 25-Jan-2021, approximately 2 days after injection, patient Died. On 26-Jan-2021, neighbor Reporter called in to report a potential AE death. She shared that she lives in a condo building with other elderly. She shared that she and 2 other neighbors went to a vaccination site in Miami at a fire department. She shared that she is fine but that her neighbor died two days after shot. She shared that she didn't know if he had symptoms and that she knows that he had a lot of medical issues and was on about 15 medicines. She shared that she didn't know his age but guessed 70. She said we can contact his wife, but it must be a Spanish speaking agent because she speaks little English. She is concerned because they all received the vaccine at the same time. She wanted to reiterate that she was fine but believed we should know about the neighbor's death. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event death is not applicable. The patient died on 26-Jan-2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. The cause of death was not provided.; Reported Cause(s) of Death: Unknown" "1062550-1" "1062550-1" "Patient's daughter called to report that about 30 hours after receiving the vaccine he passed away at home. She said she didn't know the cause of death but she felt like she should let us know about it." "1062666-1" "1062666-1" "2-24-21 patient with development of cough, fatigue, increasing on chronic disability worsening debility and falls. scheduled for office visit 2-25.21 0900 call from spouse 0210 am patient was not breathing and lvad alarming low flow alarm on arrival of ems confirm asystolic not breathing and dead" "1062830-1" "1062830-1" "92 yo female who received her first dose of Moderna vaccine on 1/11/2021 with no known adverse effects. Admitted to the hospital on 1/17/21 with a spine compression fracture. Discharged and readmitted on 1/19 /21 with nausea and vomiting. Found to have new atrial flutter and elevated troponin attributed to NSTEMI. Discharge on Aspirin and Plavix. No cath. Second dose of Moderna vaccine 2/25/21. No immediate reaction. One hour later began to feel progressively weak. EMS called shortly after getting home. Intubated in the field. Died at 0658 on 2/26/21 s/p PEA arrest without ROSC." "1062895-1" "1062895-1" "patient passed away within 60 days of receiving a COVID vaccine" "1062962-1" "1062962-1" "[COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)" "1063000-1" "1063000-1" "Patient passed away within 60 days of receiving a COVID vaccine" "1063174-1" "1063174-1" "Narrative: Patient received COVID/Pfizer #1 2/10/21 in L deltoid. (Patient home bound). On 2/12/21 reported left flank rash. 2/13 rash spread to entire abdomen/chest and UEs. Continued with fluctuations in BP/HR, fluid retention. On 2/16 labs ordered and Medrol dose pack. seen in home on 2/19 by MD - RUE swelling; diffuse rash over entire body; additional labs ordered (order to home infusion company). Patient passed in AM of 2/20/21. Reported no urine output the prior evening. Additional labs not performed due to death of patient prior to lab company arrival." "1063201-1" "1063201-1" "The recipient was feeling well immediately after the vaccination, all day on 2.8 and in the morning of 2.9. His daughter in law text him at 0930 and he did not respond to the text (atypical) and then he missed a morning meeting. His wife was downstairs in a meeting herself and after the meeting was over she called to him and he did not respond. She found him with no pulse and was not breathing. She called 911 and attempted CPR. They did not complete an autopsy, they stated that they believe the cause of death was either an embolism, Heart attack or aneurism. The wife stated that she does not believe the death was due to the vaccination; however, there were no tests completed to prove or disprove." "1063457-1" "1063457-1" "On date on second dose, 2/27/2021, the pt began have fatigue and diarrhea at around 10:30 am. This continued to the following day. On 2/28/2021, the patient was last seen around 4:20 pm by his wife in their residence. She found him unresponsive at 5:30 pm in their bedroom. EMS was called and the decedent was declared deceased. The pt had his first dose on 2/9/2021. Both doses were given at the hospital. Per family, the pt had no adverse affects following the first dose." "1063522-1" "1063522-1" "1. Fatigue ? day 1 - Tuesday 2. Loss of appetite ? day 1 Tuesday 3. Fever 102.0 ? day 2 - Wednesday 4. Chills ? day 2 - - Wednesday 5. Weak ? day 2 - - Wednesday 6. Non-ambulatory (unusual) ? day 2 - - Wednesday 7. Two emergency service ambulance assessment ? day 2 - - Wednesday 8. Symptoms improved ? day 3 - Thursday 9. Ambulatory - day 3 - Thursday 10. Symptoms worsened ? day 4 - Friday 11. Chills ? day 4 - Friday 12. Non-ambulatory again ? day 4 - Friday 13. Fever 102.0 ? day 4 - Friday 14. Left side flank pain ? day 4 - Friday 15. CPR and declared decease at home by paramedics - day 5 - Saturday morning @ 1:32am" "1063561-1" "1063561-1" "Patient was a Resident on our LTC wing. Per the LTC Manager: Resident had hx of CVA with deficits in speech and extremities. Hx of decreased circulation to BLE's which resulted in wounds to bilateral feet on and off that needed treatment. Average meal consumption 25-50% of meals, started refusing more often in December and January. Would consume small amounts 60-120mL of fluids here or there. Vaccinated on 1/7/21. Stopped eating 1/18/21. Attempted bolus NS fluid 1/25/21. Resident refused all treatment afterwards. Went hospice on 2/3/21 and passed away on 2/7/21." "1063674-1" "1063674-1" "EMS responded to a call at his home; he was found unresponsive by family slumped over in a chair" "1063681-1" "1063681-1" "Pt got his vaccine 1/27 and was found dead at his residence on 2/7/21. I heard from our county health officer who talked to the coroner who said that they estimated that the patient had been deceased for 2-3 days prior to when they were found. No apparent cause of death was found." "1063727-1" "1063727-1" "Called pt for Dose 2 appt. Pt had passed away." "1063758-1" "1063758-1" ""Patient died on 2/25/21 in the AM after receiving his COVID-19 Moderna vaccine #1 at approximately 2:30P on 2/24/21. I do not have a time of death. I contacted the County Medical Examiner's office who stated that they received his body after he was determined to be deceased at the shelter. No autopsy was performed and his body was released to a funeral home on 2/26. The ME's office said that ""permit for burial/cremation is pending"" and no other information on COD was available. Per staff, he was also tested for COVID as part of shelter protocol on 2/24 and PCR was negative. He arrived to the shelter on 2/19/21."" "1063812-1" "1063812-1" "Resident had severe CAD, DM type 2, and hx of RBKA and left 5 digits on foot amputation. Hx of osteomyelitis post surgical. After last surgery, resident did not have a good appetite, more restless, increased confusion with dementia. Significant other passed away on 12/30/20, resident began refusing meals, decreased eating. Vaccinated on 1/13/21. On 1/25/21 Resident labs showed kidney failure. Dr. spoke with family and transitioned to Comfort care, on 2/5/21 went hospice. Patient passed away on 2/13/2021." "1063846-1" "1063846-1" "Hx dementia, CVA, CAD. 2-3 year history of only consuming 25% of 1-2 meals daily. All meds d/c early 2020 because of refusing to eat or drink anything. Suddenly began drinking april/may, gained weight back. Vaccinated on 1/7/21 & 2/4/21. On 2/22/21 had significant changes in respiratory status. Passed away 2/23/21." "1063863-1" "1063863-1" "Resident had Hx of DM T2, Hx of prostate CA. Started having swallowing difficulties in November. Increased c/o nausea and decreased appetite. 25% per meal average. Decreased energy to participate in activities and refused getting out of bed or meals. Was vaccinated on 1/13/21. Hospice care started on 1/25/21. Resident passed away 2/23/21." "1063903-1" "1063903-1" "NO SPECIFIC ADVERSE EVENT DUE TO THE VACCINE BUT THE PATIENT PASSED AWAY 02/10/2021 DUE TO COVID" "1063980-1" "1063980-1" "1/26 /2021 - pt went to ER for chest pain 2/9/2021 - pt received Pfizer COVID vaccine 1st dose 2/17/2021 - cardiac arrest with death" "1064265-1" "1064265-1" "Death" "1064294-1" "1064294-1" "Death on 2-28-21. Not felt by this provider to be likely related to vaccination." "1064433-1" "1064433-1" "Cardiac Arrest" "1064646-1" "1064646-1" "Minor arm pain on 2nd day of each vaccine Diarrhea 3 days after 2nd vaccine Massive heart attack (left ventricle) 8 days (2/24/21) after vaccine Home hospice 3:30pm 2/24/21 Stopped breathing 5:45 am, pronounced dead at 8:22 am on 2/25/21" "1065158-1" "1065158-1" "death; severe headache; This is a spontaneous report from a non-contactable consumer from a Pfizer-sponsored program. A male patient of an unspecified age (Age: 83, unit: Unknown; as reported) received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:EH9899), intramuscularly in the left arm on 20Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history included sulfonamide allergy from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously took azithromycin [MANUFACTURER UNKNOWN] and experienced allergy on an unspecified date. On 22Jan2021, the patient experienced severe headache (non-serious). On 28Jan2021, the patient experienced death (death, medically significant); 8 days after receiving the vaccine. The patient died on 28Jan2021 due to unknown cause of death. It was unknown if an autopsy was performed. The clinical outcome of the event, death, was fatal. The clinical outcome of the event, severe headache, was not recovered. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Unknown cause of death" "1065434-1" "1065434-1" "Patient died; This is a spontaneous report from a contactable consumer (parent's patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route on 13Feb2021 (at the age of 47-year-old) at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 18Feb2021 the patient died. The cause of death was unknown. An autopsy was not performed. No COVID prior vaccination. The patient had not been tested for COVID post vaccination. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Patient died" "1065435-1" "1065435-1" "blood clot; death cause: Heart Problems; tired; nauseous; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3248), via an unspecified route of administration at single dose in the left arm on 19Jan2021 14:00 for covid-19 immunisation. Medical history included heart problems, pacemaker. Concomitant medication included heparin. The patient experienced death cause: heart problems on 20Jan2021, blood clot on an unspecified date with outcome of unknown that required hospitalization, tired on 19Jan2021 with outcome of unknown, nauseous on 19Jan2021 with outcome of unknown. The patient was hospitalized for blood clot from 16Jan2021 to 18Jan2021. The patient died on 20Jan2021. An autopsy was not performed. The events were described as follows: The patient was tired and nauseous about 3 hours after her vaccine. She had been in the hospital 16Jan2021 to 18Jan2021 for a blood clot. The patient died at her home on 20Jan2021 between 4 and 7 pm. No treatment required. The vaccine was administered at Hospital Facility. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.; Reported Cause(s) of Death: death cause: Heart Problems" "1065507-1" "1065507-1" "EXTREME PAIN, STOPPED EATING/DRINKING -- STARTED MORPHINE" "1065543-1" "1065543-1" "It was reported to staff that this gentleman suffered thrombocytopenia following his vaccine, a platelet infusion was done and he expired on 2-14-21" "1065551-1" "1065551-1" ""Pt received 2nd Pfizer BioNTech Covid 19 EUA vaccine @1:50 pm; Pt released from Observation @2:09 pm. Approximately 2:18 pm RN called to parking lot and observed pt having difficulties. Called for EMS & crash cart. Vitals taken 2:20 BP 83/55, no respirations noted, pt unresponsive. AED attached. EMS arrived 2:22 and took over care of pt. and transported @2:40 pm to Hospital. Per wife, pt has history of PE in Oct. 2020, HTN, diabetes with insulin pump, obesity, gastroparesis, home oxygen and uses motorized scooter. Wife also said pt had allergy to iodine not previously reported, and MD had stopped Zarelto subsequent to 1st Pfizer vaccine 2/8/21 ""due to breathing difficulty"". Patient was unable to be resuscitated. Time of death 14:59."" "1065719-1" "1065719-1" "My grandpa got his second covid vaccine on Thursday. Saturday he complained of stiff neck. Sunday he had low grade fever, nausea and vomiting, chills, and mild headache. He was feeling bad enough to call squad at 3 pm. The paramedics did evaluation and thought he was just experiencing normal side effects from vaccine and felt no need to transport to hospital so my grandpa decided to stay home and just rest. At 2 am that same night he went into cardiac arrest and was not able to be brought back" "1065920-1" "1065920-1" ""never woke up after arrival; Suffered with vascular dementia; Death cause: Covid/Tested positive to Covid 31Jan, tested due to increased lethargy; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient received the vaccine at nursing home/senior living facility. Medical history included dementia, hypertension, past strokes. The patient was exposed to asymptotic staff member on or prior to 25Jan2021. The patient had no known allergy. No COVID prior vaccination. Concomitant medication included lisinopril. No other vaccine was received in four weeks. The patient was tested positive to COVID on 31Jan2021, tested due to increased lethargy started from 26Jan2021. The patient suffered with vascular dementia. She was ambulatory up to 31Jan2021. The patient was sent to hospice that evening on 31Jan2021 to quarantine, never woke up after arrival. Palliative Care started 02Feb2021, the patient expired 12Feb2021. Cause of death was COVID. The patient did not receive treatment for events. The autopsy was not performed. The outcome of events ""never woke up, vascular dementia"" was unknown. Information on Lot /Batch Number has been requested.; Reported Cause(s) of Death: Death cause: Covid"" "1066093-1" "1066093-1" "No known side effects; however, on 1/20 the decedent suffered lethargy. On 2/12/2021, the decedent had a possible seizure and was transported to emergency department where shortly after arrival, he was pronounced dead." "1066107-1" "1066107-1" "death" "1066118-1" "1066118-1" "Patient had an unwitnessed cardiac arrest while outside walking his dog. AED in the field initially advised shock and was shocked 3 times without effect. At the time EMS ALS arrived, patient was in PEA arrest. He was transferred to Hospital with CPR in progress. Time of death called at 1857." "1066126-1" "1066126-1" "death" "1066178-1" "1066178-1" "Caller is nephew of patient. Patient was admitted to Hospital on 2/15/21 with Covid like symptoms and decreased O2 sat. He tested positive for Covid 2/15/21. Treated with Remdesivir. Patient status continued to decline and he passed away in hospital 2/22/21 0612." "1066199-1" "1066199-1" "Patient had gotten up to the bathroom and collapsed in the hallway after using the restroom. Patient was unresponsive upon EMS arrival with vomitus coming out of the mouth per the report when they rolled patient over onto his side the emesis was pouring out of his mouth. ER course: Examination. Epinephrine 1 mg IO x4 CBC, CMP, cardiac panel MDM: 1447 patient arrival, per EMS report patient had been sick and vomiting all morning. Bradycardia noted at arrival with rates in the 30s, CPR was initiated patient had received 3 rounds of epi prior to arrival. 1450 CPR continues via the Lucas device, 1 mg epinephrine given IV push 1451 CPR pause rhythm check. CPR resumes 1453 CPR paused for rhythm check. No central pulses, CPR resumed, glucose of 99 per fingerstick 1454 King tube removed. Oral airway placed respirations by BVM. 1 mg epinephrine IV push 1455 CPR pause for both pulse and rhythm check. No central pulses noted. CPR resumes via Lucas 1456 pupils are fixed and dilated bilaterally 1457 CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed via Lucas. 1 mg epinephrine IV push 1459 warm blankets applied. CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed 1501 CPR pause for pulse and rhythm check. No central pulses. CPR resumes 1502 1 mg epinephrine given IV push 1503 CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed via the Lucas device 1506 resuscitation is ceased at this time. Time of death recorded at 1506" "1066209-1" "1066209-1" "[COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): He presented 10 days after first COVID-19 Vaccine with Progressive neurological deficits with bulbar manifestations - dysarthria, dysphagia and bilateral arm weakness and incoordiantion, worse on right. MRI brain was negative for acute stroke and MRI cervical, showed degenerative changes. Transferred from community hospital to tertiary center where the diagnosis was made of AIDP. He was intubated at that time in Neuro ICU. Given Steroids and IVIG but no improvement and was either will need to have Trach and PEG vs CMP and family honored the patient's wishes and made him CMO. signs of severe demyelination and AIDP was diagnosed." "1066274-1" "1066274-1" "death" "1066289-1" "1066289-1" "death" "1066322-1" "1066322-1" "Patient was vaccinated approx 9a. Later that evening, patient was having trouble breathing so they called son who lives down the road to come, 20 mins after the call the patient has passed. Per medical examiner, pt died due to possible PE, MI, or his aortic aneurysm ruptured." "1066332-1" "1066332-1" "death" "1066484-1" "1066484-1" "Received vaccination at 14:20 2/26/21. Was observed until discharged at 15:15. Discharged per wheel chair to lobby in alert/stable condition, to wait on bus to take him home. At 18:00 his neighbor heard him fall, could not get patient to answer phone, found him unresponsive. Neighbor called 9-1-1, ambulance personnel could not revive patient. Coroner's office ruled his death as Natural Causes due to Hypertension, Cardiac disease, Diabetes, ESRD. There were no indication of anaphylactic reaction noted when I questioned the coroner's office. The Coroner's office/EMS were aware the patient had received the Moderna COVID 19 vaccination that day." "1066715-1" "1066715-1" "epistaxis." "1066770-1" "1066770-1" "died" "1066852-1" "1066852-1" "History of terminal cancer, entered hospice care 1/2021, expired 2/28/2021. No reported adverse events from patient or family after receiving vaccine" "1066906-1" "1066906-1" "92 year-old male with PMHx of vascular dementia, BPH, MDD, sleep disturbance , basal cell carcinoma of neck, osteoarthritis, BLE edema, Guillain-Barre syndrome 30 years prior, s/p COVID positive on 1/11/21 and received IV Bamlanivimab. Sent to hospital on 2/2/21 for altered mental status, generalized weakness with inability to lift bilateral UE and difficulty moving his BLE. He was treated for UTI with 7 days of Cefepime for Morganella Morganii. He was followed by neurology with MRI of the brain and CT of the spine without acute findings. Lumbar puncture unable to be obtained. He received 5 day course of IVIG for presumed Guillain-Barre . EMG showed generalized sensory motor polyneuropathy both axon loss and demyelinating type severe in degree. However, he did not recover from his GBS symptoms, was transferred back to the nursing home and died on 2/15/2021." "1067036-1" "1067036-1" "Patient received dose 1 of Moderna Vaccine on 1/14/21 administered by pharmacy. Patient was hospitalized on 1/31/21 due to shortness of breath and diminished O2 sats down to 88%. Patient was in atrial fibrillation. Patient discharged from hospital on 2/25/21 to home. Patient received dose 2 of Moderna Vaccine on 2/25/21 prior to discharge from hospital. Last hospital note stated that patient was pleasant and cooperative with good motivation. Patient passed away after discharge from the hospital on 2/26/21. Patient's son called the hospital to report his passing." "1067090-1" "1067090-1" "within 24 hours after her second injection she developed chills, had a syncopal episode and had, difficulty breathing. this progressed over the next day when she had a second syncopal episode and her dyspnea and confusion worsened EMT was called and she was brought to the hospital. she was in flash pulmonary edema and with her history of severe aortic stenosis she was admitted to the cardiac icu. she had no prior history up to that time of pulmonary edema and was functioning without distress in her home. she had a history of covid in early april, manifesting primarily as severe confusion, from which she recovered." "1067125-1" "1067125-1" "was reported to staff at Health Department that client passed away hours after receiving Moderna vaccine, also reported that client had multiple health conditions." "1067177-1" "1067177-1" "Patient had sudden death 1 week after 2nd COVID vaccine. Had complained of dizziness throughout the week leading up to it." "1067358-1" "1067358-1" "1-25-2021- Phone call: pt had cold and cough prior to vaccine. cough worsened 1-28-2021 Phone call: pt requesting provider visit, cough is same and taking tessalon pearls 1-29-2021 Provider in office visit: pt complain of cough and SOB for 6 days. Getting worse. Temp 101.2, pulse ox 87%, BP 128/70. level of distress- leaning forward to breath. appeared ill. diffuse rales throughout both lung fields, more at bases. Diagnosis Pneumonia due to COVID 19 virus. Sent to ER" "1068304-1" "1068304-1" "died; This is a spontaneous report from a contactable consumer reporting for a patient. An 86-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 10Feb2021 at single dose for COVID-19 immunization. Concomitant medications were not reported. Relevant medical history included bacterial infection, the patient was being treated for bacterial infection and had spent 1 week in hospital within one month prior to being dosed with vaccine. On 17Feb2021 the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: death" "1068306-1" "1068306-1" "heart attacks; Collapse of lung; pulse was in the 130s/140s; passed away; nose and fingers turned gray and were cold to the touch; nose and fingers turned gray and were cold to the touch; his big toe had turned gray; his right foot was swollen; low grade fever; Shaking; extremely cold; This is a spontaneous report from a contactable consumer. An elderly male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 18Feb2021, at single dose, for COVID-19 immunisation. Medical history included ongoing blood magnesium decreased (went to the hospital on 17Feb2021). Concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), on 27Jan2021, for COVID-19 immunisation and experienced arm soreness. The patient experienced passed away (death, hospitalization, medically significant) on 23Feb2021, heart attacks (caused hospitalization, medically significant) on 20Feb2021 with outcome of unknown, collapse of lung (caused hospitalization) on 20Feb2021 with outcome of unknown, pulse was in the 130s/140s (caused hospitalization) on 19Feb2021 with outcome of unknown, low grade fever on 18Feb2021 with outcome of recovered on 23Feb2021, shaking on 18Feb2021 with outcome of unknown, extremely cold on 18Feb2021 with outcome of unknown, nose and fingers turned gray and were cold to the touch on 19Feb2021 with outcome of unknown, his big toe had turned gray on 19Feb2021 with outcome of unknown, his right foot was swollen on 19Feb2021 with outcome of unknown. The events his big toe had turned gray and his right foot was swollen required physician visit on 19Feb2021. They were reported as a result of the magnesium deficiency. On 19Feb2021 evening his fever increased and his nose and fingers turned gray and were cold to the touch. On 20Feb2021 he collapsed at home and was taken to the hospital by ambulance. He had several heart attacks prior to the collapse. They decided to put him in a medically induced coma and reduce his body temperature that evening and started dialysis on 21Feb2021. They returned his body to normal temperature on 23Feb2021, his pulse was in the 130s/140s. They were starting to reduce the sedatives on 23Feb2021. The patient passed away on 23Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: passed away" "1068308-1" "1068308-1" "cardiac arrest due to pericardial effusion; cardiac arrest due to pericardial effusion; On 21Feb he went to the ER after vomiting and passing out; On 21Feb he went to the ER after vomiting and passing out; On 19Feb, he began to feel ill again with a fever. He felt worse on 20Feb; On 19Feb, he began to feel ill again with a fever. He felt worse on 20Feb; fever; headache; stomach upset; This is a spontaneous report from a contactable consumer reporting for the father: A 75-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EL3428) at single dose at left arm on 03Feb2021 for Covid-19 immunisation. Medical history included type 2 diabetes mellitus. No known allergies. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included amitriptyline hydrochloride (manufacturer unknown) 10 mg, atorvastatin (manufacturer unknown) 20 mg, dutasteride (manufacturer unknown) 0.5 mg, linaclotide (LINZESS) 290 mcg, gabapentin (manufacturer unknown) 300 mg, montelukast (manufacturer unknown) 10 mg, ramipril (manufacturer unknown) 5 mg, insulin degludec (TRESIBA) 100 unit/ml, liraglutide (VICTOZA) 18 mg/3ml solution. No other vaccine in 4 weeks. The patient experienced cardiac arrest due to pericardial effusion on 21Feb2021 14:15, fever on 13Feb2021, headache on 13Feb2021, stomach upset on 13Feb2021, on 19feb, he began to feel ill again with a fever, he felt worse on 20feb on 19Feb2021, on 21feb he went to the ER after vomiting and passing out on 21Feb2021. Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of cardiac arrest due to pericardial effusion. Course of events: In Feb2021, 10 days after his 1st injection, the patient developed fever, headache, and stomach upset. He went for a rapid Covid-19 test (nasal swab) and it was negative on 11Feb2021. The doctor told him he might be having a delayed reaction to the vaccination. After a couple of days, he improved. On 19Feb2021, he began to feel ill again with a fever. He felt worse on 20Feb2021. On 21Feb2021 he went to the ER after vomiting and passing out and received treatment: IV fluids, diagnostic testing at ER. Rapid Covid test (nasal swab) at ER came back negative again on 21Feb2021. His heart arrested suddenly and he could not be resuscitated. CT scan results, that came back after death, showed Covid like pneumonia and pericardial effusion. The patient died on 21Feb2021 14:15. Cause of death was cardiac arrest due to pericardial effusion. An autopsy was not performed. The outcome of cardiac arrest due to pericardial effusion was fatal, of fever, headache, stomach upset was recovering, of he began to feel ill again with a fever, he felt worse was not recovered, of he went to the ER after vomiting and passing out was unknown.; Reported Cause(s) of Death: cardiac arrest due to pericardial effusion; cardiac arrest due to pericardial effusion" "1068357-1" "1068357-1" "No pulse and no heart beat; couldn't wake him up; passed away; A spontaneous report was received from a daughter concerning a 84-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced no pulse or heartbeat, couldn't wake him up and passed away. The patient's medical history, as provided by the reporter, included high blood pressure and prostate cancer. No relevant concomitant medications were reported. On 19 Jan 2021, the patient had a blood pressure reading of 133/84 at a cardiology visit. On 13 Feb 2021, approximately 3 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number 031M20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 Feb 2021 at 3:30 pm, the patient could not be woken up and was found with no pulse or heartbeat. Action taken with the drug in response to the events was not applicable. The outcome of the events, no pulse or heartbeat and couldn't wake him up, were not provided. The patient died on 13 Feb 2021. The cause of death was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. The patient's medical history of high blood pressure and prostate cancer remains the risk factors. The cause of death was unknown. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1068549-1" "1068549-1" "2/13/21 Patient had covid like symptoms 2/15/21 Patient admitted to Hospital with covid like sx and decreased O2 sat; tested positive for Covid on 2/15/21; treated with Remdesivir and convalesent Plasma. Sx worsened and patient died 2/26/21.." "1068564-1" "1068564-1" "On 3/2/2021, clinic was notified by patient's family that patient had deceased on 2/28/2021 from a heart attack. Unsure of any relation to the Moderna vaccine but reporting for due diligence." "1068700-1" "1068700-1" "Patient passed away 24 hours after receipt of 1st Dose Pfizer vaccine. Provider does not feel death was due to vaccination. but underlying conditions. No immediate side effects noted from vaccination." "1068761-1" "1068761-1" "DEATH Narrative: patient was placed on hospice care following vaccine, unclear cause of death, not documented" "1068762-1" "1068762-1" ""DEATH Narrative: patient's wife reported he had gone in an outside hospital, had held his brilinta as advised anticipating shoulder surgery ""and he threw a big clot and died."""" "1068814-1" "1068814-1" "9 days after vaccination, the patient was found deceased in his home, sitting on his couch. Determined to be due to pulmonary embolism." "1068850-1" "1068850-1" "Pfizer-BioNTech COVID- 19 Vaccine EUA: Wife of patient called Primary Care Physician to inform that patient had received dose #2 of Pfizer COVID vaccine, and later that evening experienced a seizure and expired." "1068882-1" "1068882-1" "DEATH Narrative: Son stated that patient was doing well, still working and driving places. He stated that he called his son and stated that he wasn't feeling well and died shortly after that." "1068883-1" "1068883-1" "DEATH Narrative: PATIENT PASSED AWAY WHILE ON HOSPICE CARE" "1068884-1" "1068884-1" "DEATH Narrative: Presented to ED via EMS c/o increasing shortness of breath, O2 sat mid to high 80s on 4L. When EMS arrived , pt was in distress, intubated by EMS and transported to ED. Pt had a PEA arrest en route but resuscitated w/ return of spontaneous circulation after receiving a dose of epinephrine and chest compressions. Pt was hypotensive on arrival to ED. He was started on sepsis protocol , volume resuscitation and empiric antibiotics. Once stabilized, he was admitted to icu at hospital. Removed from respirator 2/22/21" "1068886-1" "1068886-1" "DEATH Narrative: Pt he reports he developed chills SOB body aches the same night as receiving the COVID vaccine on 1.26.2021-pt is currently reporting CheSt tightness and SOB Admitted to hosp: ICU with Bilateral Pulmonary Emboli, LLE DVT, NSTEMI, Arrhythmia." "1068887-1" "1068887-1" "DEATH Narrative: UNSURE DETAILS OF EVENT, NO DOCUMENTATION IN PROGRESS NOTES" "1068888-1" "1068888-1" "DEATH" "1068889-1" "1068889-1" "death Narrative: no other details available, as nothing documented in record" "1068890-1" "1068890-1" "death Narrative: unclear of details, s/p spine surgery on 2/2/21 and discharged on 2/6/21" "1068901-1" "1068901-1" "ER admit for CP and Jaw pain, exhaustion, Aortic arteritis normal SED rate found on CT scan hospital admit IV medications required Solumedrol and Actemra questionable how much medications received d/t IV's not working. Released from care on 2/19 with prednisone . Symptoms still present off and on. 2/21 922pm CP Jaw Pain severe EMT's called EKG done reported no heart attack, pain better, EMTs left. 10/15 severe Pain collapsed with no pulse and no breathing, EMTs returned unable to obtain a shock-able rhythm time of death pronounced. reason for death on certificate Aortitis - hospitalist thinks aortic dissection d/t severe inflammation" "1068931-1" "1068931-1" "Case passed away on 2/28/21. During post vaccination monitoring, case did not have any adverse reactions. When writer spoke to him on 2/26/21 to schedule his second dose, he sounded well." "1068963-1" "1068963-1" "approximately 24 hours post vaccine Patient developed a low grade fever of 99.5 and had increased fatigue. 48 hours later she had decreased neurological functioning. 02/23 she had difficulty swallowing. 02/23 She was admitted to hospice services. 02/26 she passed just before 10 am." "1068993-1" "1068993-1" "Spontaneous intracerebral hemorrhage and death on 2/20/2021" "1069009-1" "1069009-1" "Several days after vaccination his left arm turned red. He was taken to the hospital where he was evaluated and admitted with a diagnosis of left axillary vein thrombosis. A chest X-ray was taken and he presented bibasilar atelectasis and pneumonia with pleural effusions." "1069026-1" "1069026-1" "Death Narrative: Family was able to be present at bedside shortly after patient was extubated. Fentanyl bolus given 10-15 minutes prior. Patient passed away soon after endotracheal tube removed. Time of death 10:14am." "1069118-1" "1069118-1" "Within 10 minutes following the second vaccination, patient reported dizziness and nausea, had an episode of vomiting but recovered within 30 minutes. It was reported to our clinic that the patient was found deceased on March 1, 2021 at approximately 10 pm. Cause of death is not determined at this time." "1069140-1" "1069140-1" "The day after the administration of the vaccine, the fever began, the patient claim that he had no blood pressure problems. He was given acetaminophen every 4 hrs. and vitamin C and D. On February 11, he was stabilized, he had his regular meals without any problem but in the afternoon his temperature rose again and they put him to bed. The patient died that same afternoon around 4:00 pm" "1069235-1" "1069235-1" "Death" "1069263-1" "1069263-1" "DIED" "1069316-1" "1069316-1" "death" "1069560-1" "1069560-1" "Hospital course 1/31 ? 2/20/21 1/31 in ED pt was at home when children noticed his lips were blue, ems arrived and found him to be 50% on RA, on Non-rebreather pt got to 78%, covid on 01/26 Shortness of Breath 61-year-old male presents with EMS for evaluation of shortness of breath hypoxia. History is limited due to the patient's current clinical condition and so is primarily obtained from EMS. EMS reports that he tested positive for COVID-19 5 days ago. He began developing shortness of breath yesterday and his family called because his lips and fingers were blue today and he appeared short of breath. On EMS arrival he had a room air saturation of less than 50% so he was placed on nonrebreather with improvement in his saturation to 70% and he was transported to the emergency department. Patient does admit to shortness of breath. He denies any chest pain. He is noted to have a cast on his left ankle and said that he broke his left ankle on 23 December but has not had surgery. He denies any new pain or swelling of the leg. In the ED he was placed on 15L nasal cannula and NRB mask with improvement in SPO2 to low 90s. Additional work up revealed troponin of 1.35, lactic acid 5.8, and d-dimer 14.4. He received dexamethasone and was placed on heparin gtt. 1/31 admitted to ICU Acute hypoxic respiratory failure due to COVID-19 vs heart failure vs PE. CXR with bilateral hazy infiltrates more pronounced in the bases and left periphery and suspected multifocal pneumonia. At risk for PE given LLE immobility in the setting of COVID-19 with significantly elevated d-dimer. RISK of CTA outweighs benefit given AKI and iodine allergy. Continue with empiric treatment with heparin gtt. Admitted to ICU with SO2 in 60s-70s on 15L and NRB. Attempted 50L 95% FIO2 high flow and nasal cannula. Given lasix 40mg IV with good diuresis however SPO2 still remained low 80s with RR 40s and PO2 42 so the decision was made to intubate. Oxygenation improved following intubation, with further improvement following recruitment maneuver and increase in PEEP. FIO2 weaned to 90% with SPO2 remaining in mid 90s. Will continue to wean FIO2 as able. ARDS net protocol as much as possible. Consider prone ventilation and/or epoprostenol if unable to improve . VAP Bundle: HOB >30 degrees; Oral care per nursing standard and on DVT/PPI prophylaxis Sedation: Target Richmond Agitation and Sedation Scale (RASS) of 0 to -2 with propofol and fentanyl. Check baseline TG levels. COVID - 19: Convalescent plasma: Not indicated Steroids: Dexamethasone 6 mg / day for 10 days Remdesivir: Not indicated d/t AKI IL-6 inhibitor: Meets criteria for tocilizumab Systemic AC: Heparin gtt. No signs of bleeding (Platelets and Hb stable). Antibiotics: Start 3 and 7 day course of azithromycin and ceftriaxone, respectively. Elevated troponin Suspect demand ischemia d/t hypoxia; EKG does not show any ischemic changes AKI: Suspect d/t hypoxia in the setting of COVID infection. Urine output and electrolytes acceptable. Closed fracture of left ankle Suffered fracture following a fall on ice in December. Cast was placed on 12/30 by SOS. He was due to be re-evaluated this week for possible cast removal. Inhaled epoprostenol started Considered for ECMO but not initiated due to not a candidate Vasopressors required at times Antihypertensive infusion required at times severe hypoxia with position changes switched from heparin drip to enoxaparin prophylaxis 2/20 discharge summary 61 y/o male admitted to Hospital on 1/31 with hypoxia. He was diagnosed with COVID 19 5 days prior to admission, and had worsening respiratory status. He was intubated after arrival, and was on ventilator for the entire intervening time, until he was extubated on 2/20 at the time of transition to Comfort measures only. Prior to developing COVID 19, he had received his first dose of the Pfizer vaccine, as a member of the school system. He had a fractured L ankle after a fall on 12/31/20, and had a cast in place at the time of admission. He received Tocilizumab on 1/31, and underwent several cycles of prone positioning, beginning on 2/2. He completed a course of Decadron, he received Ceftriaxone and azithromycin beginning on admission, and completed a course of these. Anticoagulation with enoxaparin was utilized due to coagulopathy associated with COVID 19. Vasopressor support was required at times, as well as diuresis for fluid management. He required high levels of sedation to maintain ventilator synchrony, and high levels of ventilator support with high oxygen levels throughout his stay. Tracheostomy was being considered, but family decided that since he was not going to have good recovery, withdrawal of support, and allowing death was the appropriate choice for the patient and for them. He was extubated at 2100 on 2/20/2021. Death was pronounced at 2123 on 2/20/2021. Children were at bedside." "1069647-1" "1069647-1" "Beginning in the evening 2/19/21, fever/chills/fatigue; worsening of symptoms 2/20/21 with lethargy/lack of appetite/weakness; unable to arouse on 2/21/21 then breathing stopped, patient's spouse called 911 performed CPR, EMS continued for 15 min then while in ambulance to hospital where he was pronounced dead. Official time of death 2:20pm" "1069728-1" "1069728-1" "Patient Started having dizziness, feeling faint at around midnight on 3/3/2021. He then lost consciousness, had seizure-like activity and was taken to hospital via EMS. In the hospital patient was unresponsive and received resuscitation attempts unsuccessfully. Per family, after about 45 minutes, code was called and patient expired." "1069743-1" "1069743-1" "Cardiac arrest- death" "1069830-1" "1069830-1" "From CT Scan in ED at 7:40 pm on 1/25/2021 -- There is a large intraparenchymal hemorrhage with Surrounding vasogenic edema within the left occipital lobe. There is additional subdural hemorrhage layering along the left frontal, temporal and parietal convexity which may be decompressing from the area of intraparenchymal hematoma. No visualized intraventricular hemorrhage.There is some trace hemorrhage layering along the left tentorium cerebelli. Severe associated mass effect with left-to-right midline shift of 2.1 cm. There is subfalcine and downward transtentorial herniation with complete effacement of the basilar cisterns. Evaluation of the craniocervical junction is limited due to beam hardening artifact. Near-complete effacement of the left lateral ventricle. No head trauma or fall. Deceased 1/26/2021" "1069876-1" "1069876-1" "Vaccinated 2/20. At that time, had symptoms of incarcerated hernia, went to ED for evaluation. Not felt to warrant hospital admission. Returned two days later with agitation, altered mental status, and incarceration. Went to OR, uncomplicated hernia repair. Postoperatively, did not recover mental status. Went into arrythmias POD 4, hypotension ensued, had multiple interventions and evaluations without satisfying answers for clinical course." "1069938-1" "1069938-1" "expired at Hospital" "1070038-1" "1070038-1" "Client passed away 8 days after being vaccinated. It is unknown if it occurred from the vaccine or other comorbidities." "1070040-1" "1070040-1" "Admitted to hospital 2/22/21" "1070562-1" "1070562-1" "The coroner called Dr. on 3.2.2021 to advise that he had a witnessed collapse and Mr. was taken to the ED where he was pronounced." "1070770-1" "1070770-1" "Maternal exposure during pregnancy; Fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected; This is a spontaneous report from a contactable consumer (parent). This consumer reported information for both mother and fetus. This is a fetus report. A patient of unspecified age and gender (fetus) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), transplacental on 04Feb2021 at 14:00 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included ergocalciferol (VIT D), folic acid (FOLATE), ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/ nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide (PRENATAL VITAMINS) and sertraline hydrochloride (ZOLOFT) at 25 mg, all transplacental. It was reported that OB exam on 03Feb21 showed healthy baby at 7weeks 5days heartbeat detected 152 bpm; no abnormalities identified via ultrasound; labs and hormone levels all within normal ranges. No issues detected. Mother received 1st dose of vaccine on 04Feb2021. Per ultrasound on 20Feb2021, fetus stopped growing on 09Feb2021 (8 weeks 4 days); no heartbeat detected. Miscarriage occurred on 22Feb2021. The fetus died on 22Feb2021. It was not reported if an autopsy was performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021204433 same drug and reporter, different patient and event; Reported Cause(s) of Death: Fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected; Mother received 1st dose of vaccine 04Feb21. Per ultrasound on 20Feb21, fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected. Miscarriage occurred 22Feb21." "1070937-1" "1070937-1" "Unwitnessed Cardiac arrest. ACLS protocols were performed. Cessation of resuscitation was called in the field by Dr." "1071117-1" "1071117-1" "Passed away; UTI; Abnormal bleeding; A spontaneous report was received from a healthcare professional concerning a patient who received the Moderna COVID-19 Vaccine (mRNA-1273) and experienced abnormal bleeding, UTI, and passed away. The patient's medical history included a long term history of anticoagulation therapy. Concomitant product use included anticoagulation therapy. On 31Jan2021 prior to the onset of the events the patient recieved their first dose of mRNA-1273 (Lot number:not reported) intramuscularly for prophylaxis of COVID-19 infection. On 07Feb2021, the patient complained of abnormal bleeding. Patient was seen at clinic on 10Feb2021 and was diagnosed with a UTI and given antibiotics. An INR was also completed that day due to patient having a long term history of anticoagulation therapy. Results of that showed the INR to be 12. Prior to vaccination, patient's INR was normal and no changes to medications and diet were made after vaccination and prior to complaint starting. On 12Feb2021 the patient passed away. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 12Feb2021. The cause of death was unknown. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns an 82 year old male patient, with history of long term anticoagulation therapy (unknown indication), who experienced a fatal event of death and abnormal hemorrhage, 13 days after receiving second dose of mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death" "1071120-1" "1071120-1" "Atrial fibrillation; Feeling fluttery; Heart rate was racing and was increasing, went up to 175 just sitting; A spontaneous report was received from a consumer concerning a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation, feeling fluttery, and heart rate was racing and was increasing, went up to 175 just sitting. The patient's medical history was not provided. Concomitant medications included Travatan for glaucoma. On 12 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021, five hours after vaccination, the patient experienced a fluttery feeling, heart rate was racing and was increasing, heart rate went up to 175 just sitting. She took an EKG on her watch and it was atrial fibrillation. When she was sleeping, her heart rate was at 102 or the 90s, normally it would be in the 60s. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events, atrial fibrillation, feeling fluttery, and heart rate was racing and was increasing, went up to 175 just sitting, was unknown.; Reporter's Comments: This case concerns a 64 year old female patient, who was on hospice care experienced a fatal event of death, 1 day after receiving second dose of mRNA- 1273 (Lot# 030M20A). Very limited information regarding this event has been provided at this time. Further information has been requested." "1071128-1" "1071128-1" "Unresponsive; A spontaneous report was received from Pfizer concerning a 32-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 DEC 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 04 JAN 2021, at 7:20 am, the patient died. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 04 Jan 2021. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: This case concerns a 32-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The cause of death was unknown. Plans for an autopsy were not provided. Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death" "1071129-1" "1071129-1" "Unresponsive; A spontaneous report was received from Pfizer concerning a 43-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 08 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 09 JAN 2021, the patient died. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 08 Jan 2021. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death" "1071130-1" "1071130-1" "Unresponsive; A spontaneous report was received from Pfizer concerning a 45-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Dec 2020, approximately 24 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 29 Dec 2020, the patient was found deceased at home. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 29 Dec 2020. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: unknown cause of death" "1071131-1" "1071131-1" "Unresponsive; A spontaneous report was received from Pfizer concerning a 50-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscular for prophylaxis of COVID-19 infection. On 31 Dec 2020, the patient died. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 31 Dec 2020. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: This case concerns a 51 year old, female patient, who experienced an unexpected event of Death, after receiving 1st dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. There is no contact information and no further follow up information is expected.; Reported Cause(s) of Death: unknown cause of death" "1071132-1" "1071132-1" "chronic hypoxia respiratory failure; Unresponsive; A spontaneous report was received from Pfizer concerning a 51-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had developed hypoxia a sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 07 Jan 2021, around 6:00 pm, the patient became increasingly hypoxic. He was transported to the hospital for acute on chronic hypoxia respiratory failure. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 12 Jan 2021 at 11:25pm. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death" "1071133-1" "1071133-1" "Unresponsive; A spontaneous report was received from Pfizer concerning a 52-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 08 Jan 2021, approximately 2 hours prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient was monitored for the appropriate amount of time by nursing staff, following vaccination. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 08 Jan 2021 at 2:15pm. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: This case concerns a 52-year old, female patient, who experienced a sudden death 1 day after administration of first dose of mRNA-1273. The cause of death was not provided. Plans for an autopsy were unknown. Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death" "1071134-1" "1071134-1" "Death; A spontaneous report was received from a reporter concerning a 56-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had experienced death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Dec 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient died. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 08 Jan 2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death" "1071135-1" "1071135-1" "Unresponsive; A spontaneous report was received from Pfizer concerning a 56-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 09 Jan 2021, the patient was found deceased in her home. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 09 Jan 2021. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death" "1071136-1" "1071136-1" "sepsis; respiratory failure; Fever; Unresponsive; A spontaneous report was received from Pfizer concerning a 56-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced respiratory failure, sepsis, fever and sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient began to have a fever. She was sent to the emergency room for evaluation. That evening, she died. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 11 Jan 2021. The cause of death was reported as respiratory failure and sepsis. Plans for an autopsy were unknown/not provided.; Reporter's Comments: This is a case of 56-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sepsis, fever, respiratory failure and sudden death. Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Respirtory Failure; Sepsis" "1071137-1" "1071137-1" "Unresponsive; A spontaneous report was received from Pfizer concerning a 58-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 04 Jan 2021, the patient died. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 04 Jan 2021. The cause of death was unknown/not reported. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death" "1071138-1" "1071138-1" "Sudden death; A spontaneous report was received from Pfizer concerning a 60-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient died. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 08 Jan 2021. The cause of death was unknown/not reported. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death" "1071139-1" "1071139-1" "Sudden death; A spontaneous report was received from Pfizer concerning a 60-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient was found to be deceased at 3:00 am. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 13 Jan 2021. The cause of death was unknown/not reported. Plans for an autopsy were unknown/not provided. .; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death" "1071367-1" "1071367-1" "Blood pressure went down until he died; Couldn't hear his heartbeat; neck was sweating; He was cold; Couldn't get up; Death; Sick; immediately very tired; he was tired; Hands were shaking; Slept for too long; A spontaneous report was received on 18 Feb 2021 from a consumer concerning a 81-years-old, male patient who received Moderna's COVID-19 vaccine and developed immediately very tired, hands were shaking, neck was sweating, was cold, sick, couldn't get up, couldn't hear his heartbeat and blood pressure went down until he died. Patients' medical history, as provided by patient's spouse, was emergency room(ER) admission in November 2020 because he had a congested chest (he had fluid around his heart). At that time, they gave him pills for kidney function. Other concomitant medication reported was Coumadin, blood thinner. Two weeks before receiving the vaccine, patient's EKG was normal. On 11 Feb 2021, in the morning, patient received their first of two planned doses of mRNA-1273(BATCH/LOT # 007M20A) probably in the right arm for the prophylaxis of COVID-19 infection. On 11 Feb 2021, approximately after 15 minutes of receiving vaccine, they left and patient was immediately very tired, his hands were shaking. So, patient's spouse made them down sleep for too long. On Friday, 12 Feb 2021 she tried to pick him up, but he was tired, exhausted, and sick. On Saturday, 13 Feb 2021, she brought him a coffee and he couldn't hold it because his hands were shaking, so she gave him the coffee and then made him pee on the bed because he couldn't get up. At lunch time she made him eat something and he fell sleep again. His wife was hanging around him all day and around 7:30pm she realized that he was cold, and his neck was sweating, she couldn't hear his heartbeat. So, she called emergency services and when they arrived, her husband's blood pressure went down until he died. Treatment for the events were not provided. Action taken with mRNA-1273 was not applicable. Patient was pronounced dead on 13 Feb 2021 20:00. The cause of death was not provided. The plans for an autopsy were not provided. The events of blood pressure went down until he died and couldn't hear his heartbeat were fatal. The outcome for the remaining events were unknown.; Reporter's Comments: This case concerns an 81 year old, male patient, who experienced a serious event of death among others, 2 days after receiving mRNA- 1273 (Lot# 007M20A). Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1071618-1" "1071618-1" "Chills; headache; extreme fatigue; gas or chest pain that was thought to be gas and went away Died 4 days later" "1071741-1" "1071741-1" "He started vomiting 2 days later. we suspect he was having stool issues as well. he vomited blood at some point over the weekend. there was black vomit right before he passed. from 2am-6am he was wheezing and rattling and then he passed at approximately 6am 3/1/2021 at home. EMS did come and try to revive him and were unsuccessful." "1071863-1" "1071863-1" "Patient, age 101, was having a period of declining health prior to vaccine administration. This continued after the vaccine to include increased pain, inability to swallow and ultimately Patient passed away on 1/9/2021. The physician does not believe this is due to vaccine administration, however family asked that this information be reported for record keeping." "1071903-1" "1071903-1" "No reported adverse effects after vaccine was administered. Someone reported to our clinic that patient was found dead at home on Sunday" "1071935-1" "1071935-1" "Patient received the vaccine around 11 am. He hadn't been feeling well (headache, dizziness) per report and initially called in to work. He then decided to come to work and was found down in a patient bathroom during his shift on our Facility while taking care of a patient (he was a nurse aid). Patient was coded and the team and was transferred to our Facility ED. He expired 3/3 2112" "1072113-1" "1072113-1" "Death" "1072156-1" "1072156-1" "Vaccine manufacturer and lot number unknown, vaccine given at alternate location. 2/23/21 8:27 PM: The patient is a 68-year-old male comes to the emergency department by paramedic ambulance for altered mental status that, began at around noon in association fever temp 102.9. PMH of myelofibrosis (on Jakafi and hydroxychloroquine), depression, anxiety, OSA, and history of AVR. Given history of myelodysplasia and Jak inhibitor predisposing to some opportunistic infections most notably viral reactivation with history of HSV and possible bacterial endocarditis he was admitted to the ICU for further monitoring and pressors. Patient has a MOS procedure 14 days prior - Status post MOSs procedure with large wound deficit on forehead -- Does not appear to be overtly infected at the time of admission. ED physician indicated mild facial cellulitis. 2/23/21- WBC 16.1 on admission. ECHO 2/26 indicated - no vegetation visualized. Of note second COVID vaccine 2 days prior to admission. Dr. felt incident was possible cardiogenic shock secondary to COVID vaccine. He did not feel the patient has a source of infection upon admission. Questionable given wounds on forehead Dr. (CMO) review of case- his impression was septic shock with and underlying case of chronic cardiac compromise making the hemodynamics worse" "1072166-1" "1072166-1" "Patient hospitalized with shortness of breath and pneumonia (from 2/15/2021 to 2/21/2021) and patient died at another facility on 3/2/2021." "1072218-1" "1072218-1" "Patient hospitalized for NSTEMI (from 2/18/2021 to 2/20/2021) and discharged on hospice/comfort care. Patient died 2/21/2021." "1072709-1" "1072709-1" "3 days after receiving his first dose, patient had 102 fever and contracted COVID Pneumonia and is now hospitalized in the ICU" "1072763-1" "1072763-1" "The same day that the person was vaccinated he started feeling dizzy and had difficulty breathing. He was hospitalized from February 5 to February 23. Patient died in the hospital on February 23, 2021" "1072993-1" "1072993-1" "Day After - severe headache, 2 days after headache continues, itchy scalp, day 3 rash visible at hair line headache continues, more confusion than normal, day 4 on site nurses check rash and think it is dermatitis, day 5 continues to get work nurse practitioner was to visit next day, day 6 NP thinks that she has UTI and sends her to hospital (2/11/21). Hospital determines - Rash is Shingles, UTI present, - MRSA is now present in shingles which is on right back of head and right neck and face. Next Sepsis is diagnosed. Since 2/11/21 patient was not conscious. 2/20/21 famiy is notified that she should be moved to Hospice. Moved to hospice on 2/20/21. The patient, my mother, died on 2/23/21 official cause of death is UTI." "1073092-1" "1073092-1" "The decedent reported a continuous headache since receiving the vaccination. On March 3rd he suffered a cardiac arrest and was pronounced deceased." "1073128-1" "1073128-1" "Expired within 30days of vaccination. Received vaccine 1/22/21 did not have any complaints, during a bed check she was found on the floor with no apparent injury, no pulse or respirations." "1073167-1" "1073167-1" "She passed away 2/24/2021" "1073225-1" "1073225-1" "Death within 30 days: Admit 2/8/21-2/13/21 s/p fall with left hip fracture (repaired), severe debility with recurrent falls discharged to SNF. Not doing well postop at the SNF, brought to ED due to failed foley insertion with bright red blood upon arrival to ER febrile, hypotensive, tachycardic, severe sepsis. Gran negative bacteremia likely from chronic ascites, family decided on comfort care and he expired within hours of admission." "1073252-1" "1073252-1" "Death within 30 days of vaccine" "1073283-1" "1073283-1" "Death within 30 days of vaccination" "1073344-1" "1073344-1" "patient died." "1073361-1" "1073361-1" "passed away" "1073435-1" "1073435-1" "Patient received dose 1 and dose 2 of the COVID 19 vaccine, 2/2/21 (Lot EL9265, Pfizer) and 2/24/21 (Lot EN6202, Pfizer), on 2/28/21 patient presented to the Emergency Department at our facility. CBC lab test was abnormal, possible Leukemia, patient transferred to Medical Center for further evaluation and treatment. Patient expired on March 2, 2021." "1073682-1" "1073682-1" "pulmonary edema; Low heart rate; chest pain; This is a spontaneous report from a contactable pharmacist. An 80-years-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 28Jan2021 at single dose for COVID-19 Immunisation. Medical history included dementia, high blood pressure, COVID prior vaccination. He had no known allergies. Concomitant medication included diltiazem hydrochloride (CARDIZEM), anastrozole (ARIMIDEX), simvastatin and lorazepam. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 (at the age of 80-years-old) at single dose for COVID-19 Immunization. There was no other vaccine received in four weeks. The patient experienced pulmonary edema, low heart rate and chest pain on 26Feb2021. The events resulted in hospitalization and patient died. The patient was hospitalized from 26Feb2021 for 1 day. Treatment received for the events included Epinephrine, morphine, nitroglycerine. The patient underwent lab tests and procedures which included Covid test Nasal Swab post vaccination on 26Feb2021 indicated Negative. The patient died on 26Feb2021. An autopsy was not performed. information on the lot/batch number has been requested.; Sender's Comments: Pulmonary edema, low heart rate, and chest pain, all reported as fatal, are deemed unrelated to BNT162B2 vaccine, being rather accidental occurrences, likely favored by the patient's age and by the mentioned high blood pressure, known risk factor for cardiovascular diseases. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Low heart rate; pulmonary edema; chest pain" "1073773-1" "1073773-1" "Patient was found deceased later in the afternoon." "1073808-1" "1073808-1" "Prt was found deceased" "1073812-1" "1073812-1" "DEATH Narrative: PT WAS PLACED ON HOSPICE ON 1/21/2021" "1073813-1" "1073813-1" "DEATH Narrative: UNCLEAR WHY PATIENT WAS HOSPITALIZED AS LIMITED INFORMATION IN RECORD" "1073814-1" "1073814-1" "DEATH Narrative: NO ADDITIONAL DETAIL PROVIDED OTHER THAN PATIENT DIED AT HOME" "1073815-1" "1073815-1" "DEATH Narrative: NO DETAILS PROVIDED, NO NOTE REGARDING DEATH" "1073816-1" "1073816-1" "RESPIRATORY FAILURE Narrative: PT PASSED AWAY WHILE IN THE HOSPITAL" "1073895-1" "1073895-1" "Patient passed away after getting the 1st dose of COVID vaccine. He seemed otherwise very healthy." "1073902-1" "1073902-1" "Patient seemed otherwise healthy before the vaccination. Patient was hospitalized then shortly passed after getting the 1st dose." "1074067-1" "1074067-1" "Patient received Moderna COVID-19 vaccine on 2/25/2021. Patient found dead by family the morning of 2/26/2021. Family requested an autopsy." "1074271-1" "1074271-1" "altered mental status, acute on chronic thrombocytopenia, death" "1074361-1" "1074361-1" "General malaise, acetaminophen was given every 6 to 8 hours" "1074401-1" "1074401-1" "General malaise, acetaminophen was gives every 6 to 8 hours" "1074599-1" "1074599-1" "Death; A spontaneous report was received from a other health care professional concerning a 57-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and died. The patient's medical history included chronic obstructive pulmonary disease (COPD). Concomitant product use was not provided. On 02 Feb 2021, prior to onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 043L20A) in the left arm for prophylaxis of Covid-19 infection. 03 Feb 2021, it was reported that the patient died. The patient was not experiencing any symptoms prior to death. He was on hospice care, not hospitalized. No further information was provided. Treatment information was unknown. The cause of death was not reported. Plans for an autopsy were unknown. Action taken with the mRNA-1273 in response to the event was not applicable.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown" "1074753-1" "1074753-1" "Pt. had a cardiac arrest and expired on 2/20/21." "1074784-1" "1074784-1" "Nurse called clients' son to remind her of the second dose needed and was informed that client had passed away from Pneumonia the Sunday after she received the vaccine 1/17/2021." "1074873-1" "1074873-1" "Patient had COVID pneumonia in January 2021. Readmitted 2/10 for nausea/vomiting found to be in DKA. Treated with IV insulin, fluids, pressors and admitted to ICU. DKA resolved but continued to have ongoing nausea and dysphagia. EGD showed possible candidiasis, GI symptoms started to improve and was discharged home 2/24 with O2, life care, home health care. Patient recorded deceased 02/26/2021." "1074894-1" "1074894-1" "Patient became ill with pneumonia on 1/29/21 and then recurrent pneumonia on 2/10/21. Pt's plan of care was subsequently changed to comfort-focused on 2/11/21 and patient was deceased that same day." "1074903-1" "1074903-1" "caller (son) stayed w/ the pt for about an hour after he received the vax and the pt stated the only symptoms at that time was some achiness on the arm around the injection site. Son went home after that. He tried to contact him on 3/1/2021 but wasn't able to reach him. On 3/2/21 the brother tried to contact him and wasn't able to reach him. They contacted the police dept on 3/2/2021 around 8:00 AM to do a well check. Pt was found on the couch like he had fallen asleep but was deceased. They suspect he probably expired on 3/1/2021. No autopsy will be conducted per the son." "1074955-1" "1074955-1" "at midnight client got up to go to the bathroom. His legs became weak and he fell and hit his head on the wall. He called for his wife and said he didn't feel right. He denied any pain. She called EMSA and he stopped breathing while she was waiting on them. She gave him CPR with instructions from the dispatcher. He was pronounced dead at 1:30am. She has tried to call the clinic 3 times and left messages and no one has called her back, Her PCP told her this needed to be reported ." "1074982-1" "1074982-1" "death" "1075017-1" "1075017-1" "death" "1075024-1" "1075024-1" "Death" "1075035-1" "1075035-1" "sudden cardiac arrest and death" "1075042-1" "1075042-1" "Patient passed away within 60 days of receiving a COVID vaccine" "1075057-1" "1075057-1" "death" "1075090-1" "1075090-1" "death" "1075097-1" "1075097-1" "Pt received initial dose on 1/5/21, diagnosed with COVID-19 on 1/8/21, treated with monoclonal antibodies on 1/13/21. Pt experienced CHF exacerbation, anasarca, and renal failure during acute illness. Pt also treated for pneumonia during this time. Pt was considered terminal status on 1/25/21. She received second COVID-19 vaccine on 2/15/21. Pt then experienced increased difficulty eating and taking medications this same day, in addition to hallucinations she was experiencing. Patient subsequently died on 2/16/21." "1075211-1" "1075211-1" "2/9/2021 Expired at facility. Several weeks prior with several medical and mental health issues as noted prior. 2/4 began with increased lethargy and somnolence. Medications being held per MD. 2/5 CBC WNL, BUN/Cr 38/1.23 GFR 41 2/5 Admitted to Hospice services on 2/5." "1075296-1" "1075296-1" "Patient was found dead this morning." "1075298-1" "1075298-1" "Pt had worsening altered mental status, tachypnea, and low-grade fever on 1/13/21. Pt considered terminal status previously and comfort-focus care pursued. Suspected pneumonia vs. TIA/CVA. PO meds D/C'ed as patient could no longer swallow." "1075349-1" "1075349-1" "death" "1075354-1" "1075354-1" "Patient passed away within 60 days of receiving a COVID vaccine" "1075363-1" "1075363-1" "Death due to Moderna 2nd dose, pulmonary thromboembolism" "1075388-1" "1075388-1" "The day after the shot she developed fever for 2 days as high as 101. She developed a pruritic burning rash to posterior right leg extending down the lateral lower leg. She had fatigue and myalgias. Diagnosed with shingles on 2/23. and informed to not receive the 2nd vaccine. She presented to the Emergency room on 2/27 with fatigue, numbness right side of the face, no reports of shortness of breath or chest pain. Ambulated in to ER. After her work up she was discharged home - she present back to the ER within 30 minutes. PTA arrival at the ER for the 2nd time - she complained of left neck and arm pain - then went unconscious. She arrived to the ER in full arrest - pronounced deceased after resuscitation efforts were not effective" "1075407-1" "1075407-1" "Patient passed away within 60 days of receiving the COVID vaccine series" "1075412-1" "1075412-1" "Pt with underlying COPD and chronic respiratory failure requiring BIPAP. Pt had cardiopulmonary arrest on 2/24/21 and died as a result. Pt was overall palliative-focused plan of care." "1075608-1" "1075608-1" "Patient waited 15 mins after covid vaccination on Wednesday 3/3, cleared by EMT to leave. I was notified by nurse at the senior building where patient resides that she had expired Thursday evening at home. Paramedics were called. No other additional information." "1075620-1" "1075620-1" "Patient became acutely ill on 1/15/21 with recurrent pneumonia, treated with Augmentin. Pt became progressively worse on the next 48-72 hours, treatment goals changed to palliative-focused, and all treatments withdrawn. Patient died on 1/22/21." "1075636-1" "1075636-1" "1/21/2021 During Covid 19 outbreak on the unit, resident contracted the virus. 1/21 MD updated on increased weakness, twitching, fatigue noted today. 2 rapid covid-19 tests done today, both negative. new orders cbc with diff, BMP, d. dimer stat and swab for covid and Influenza. 1/21-Covid and Influenza swab results received. PCR-Influenza negative, covid-19 positive. Palliative care updated. 1/21-Labs drawn cbc, BMP, d. dimer Results WNL. Temp 101.2 and Occ dry cough. 1/22 Palliative MD and APRN visited. Family preference for no hospitalizations, no IV's and do not intubate. DNR. Admitted to Hospice services on 1/25. 1/21-1/29. Symptomatic with lethergy, occ cough, off and on temp and began refusing meals and meds at times. 1/31 periods of apnea. 2/1 precautions ended for Covid 19. Continued with Hospice care and with ongoing refusal of meals, condition declining and comfort maintained. Meds slowly discontinued. Expired at facility on 2/18/2021." "1075639-1" "1075639-1" "Patient is a 53 year old man with a past medical history of follicular lymphoma diagnosed in 2008, more recently with DLBCL with CNS involvement (involving hypothalamus; dx 8/2018; s/p HD MTX, s/p BMT- followed by Dr.), autoimmune hepatitis, obesity, adipic DI, central hypothyroidism and type 2 DM who presented to Hospital via EMS after a fall at home with multisystem organ failure leading to intubation in the ED and subsequent transfer to Oncology ICU for further management. He was in his usual state if health until Sunday. On Saturday he got COVID vaccine at 4pm, that evening he had no issues. Sunday night around 10pm he didn't make complete sense and his wife was concerned because of his history of DM and treated CNS lymphoma. BG was 320-340 at that time. Monday he was good and Monday night he started to have shaking of his left hand. Tuesday he had one episode of diarrhea. Later he was more shaky in the shower and he started to fall and his wife was unable to grab him and he slid down the wall and could not get up. Family was called to help and he was not making sense so they called EMS. Wife reports that he was down approximately 3 hours before EMS was able to get him up. In EMS he was noted to have a large area of skin desquamation from the right posterior knee to the ankle. His GCS was 15. He had stable blood pressure and heart rate. He was hypoxia to the 50s and oxygen was applied. In the ED he was found to be in multisystem organ failure and was intubated and had rapid progression of shock requiring Epinephrine, Levophed and Vasopressin. Crash lines were placed and he was sent to hospital. Upon arrival he was noted to have a cold pulseless right lower extremity and surgery was called. He was evaluated by Trauma Surgery, Orthopedic surgery and Vascular surgery and eventually underwent above the knee amputation. Unfortunately they were not able to remove all nonviable tissue and he continued to deteriorate. He was taken level 1 back to the OR and an additional 10 cm of nonviable tissue was removed. Unfortunately upon arrive he suffered cardiac arrest in the setting of severe lactic acidosis and hyperkalemia." "1075657-1" "1075657-1" "Resident was having back pain but did have previous back pain prior too." "1075710-1" "1075710-1" "2/6/21 Sent to ER for evaluation of agitation and returned a few hours later on 2/7/21 with no acute findings. 2/7/21 continued with agitation and restlessness and had psychoactive medication changes 2/8/21 Had head CT with no acute findings 2/11/21 MRI of lumbar spine with compression fx T10 2/17/21 UA and KUB done with no acute findings Multiple falls within this time frame with escalating agitation, restlessness, and insomnia. Dx psychosis and started on Seroquel 2/25/21 3/2/21 Patient died" "1075725-1" "1075725-1" "Resident started have chest pain on 3/02 and on 03/03 he was lethargic and wasn't eating or drinking Resident was on Hospice" "1075871-1" "1075871-1" "She was vaccinated on 2/2/21 and started feeling bad on 2/4/21. She was treated by her doctor, improved somewhat, got worse, then went to the hospital on 2/16/21. She died on 2/20/21." "1075917-1" "1075917-1" "WE CALLED PATIENT ON 3/2/21 BECAUSE HE HAD NOT SHOWED UP FOR HIS 2ND DOSE. THE PERSON WHO ANSWERED THE PHONE NOTIFIED US THAT PATIENT PASSED AWAY AT MEDICAL CENTER ON 2/13/21." "1076017-1" "1076017-1" "elderly diabetic man with AFib/RVR who presented with multiorgan failure few hours after receiving his 2nd COVID shot today and ultimately expired. he did well after the 1st COVID shot and subsequently developed this multiorgan failure after the 2nd shot. had his second COVID vaccine shot around 4 pm, went home and collapsed, lay on the floor for a few hours refusing to call paramedics, eventually wife called 911, he arrived to ED and was dead a few hours later. -on arrival the pH was 6.7, agonal breathing, low BP, lactate 18, but no MI, no stroke, no apparent infection/sepsis. important to note that he had a covid vaccine just a few hours from collapsing and dying." "1076158-1" "1076158-1" "Patient was found dead at his home on 2/25/2021. He was last seen at home by his sister at 8:30pm on 2/24/21." "1076162-1" "1076162-1" "Patient received vaccine on 1/11/2021. Patient passed away 1/15/2021, cause not reported, unaware if related." "1076188-1" "1076188-1" "Out of hospital cardiac arrest and refractory shock, acute kidney injury, shock liver, respiratory failure leading to death" "1076911-1" "1076911-1" "passed away shortly after her vaccine; started dealing with signs that are common with a stroke; developed swelling in her arms; This is a spontaneous report from a contactable consumer report for grandmother. A 101-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EM9809) via an unspecified route of administration in left arm on 08Feb2021 04:30 AM at single dose for covid-19 immunisation. Medical history included elderly. No covid prior vaccination. No other vaccine in four weeks; No other medications in two weeks. On 12Feb2021 12:00 AM, patient passed away shortly after her vaccine. She started dealing with signs that are common with a stroke. Event considered Life threatening illness (immediate risk of death from the event). She also developed swelling in her arms. No treatment received, patient not recovered from stroke and swelling arm. The patient died on 12Feb2021. No covid tested post vaccination. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: passed away shortly after her vaccine" "1076915-1" "1076915-1" "(name) is now dead 2 days after receiving a COVID mRN shot; This is a spontaneous report from a non-contactable other non HCP. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient is now dead 2 days after receiving a Covid mrn (as reported) shot in Jan2021. She died two days later, according to her mother. 28 year old daughter took the vaccine on a Tuesday (on 19Jan2021) and was dead by Thursday (on 21Jan2021). Outcome of event was fatal. Autopsy shows no other red flags (as reported). The reporter has assured us he will get to the bottom of this vaccine crap. Anything attached should be red flag (as reported). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: (name) is now dead 2 days after receiving a COVID mRN shot" "1076949-1" "1076949-1" "Patient admitted on 2/21/21 and died in hospital on 2/22/2021. Patient had a significant, lifelong underlying medical condition." "1077008-1" "1077008-1" "Per patient's daughter the patient had severe flu like symptoms, shaking, extreme pain in wrists/fingers/feet. Patient collapsed at home and pronounced dead at scene." "1077014-1" "1077014-1" "Death" "1077021-1" "1077021-1" "Patient passed away three days after receiving the vaccine." "1077079-1" "1077079-1" "Patient was alert and oriented with no signs or symptoms of sickness prior to immunization for 2nd dose of Pfizer COVID19 vaccine. Temperature 98.7. Patient under hospice care and DNR status for wound care (coccyx). Patient has no recollection of first dose, but no adverse reactions to first dose per her caregivers. Patient did not appear to have any adverse reactions to the vaccine after the 15 minute observation period. About 1 hr after vaccine administration, patient was reported deceased. No signs of swelling or allergic reaction at site of injection." "1077148-1" "1077148-1" "It was reported to us that at @1822 the patient sustained a Seizure at home. EMS was called and arrived to initiate CPR. CPR was performed but the patient was declared deceased by EMS at his home." "1077227-1" "1077227-1" "nausea and diahhrea" "1077236-1" "1077236-1" "Family states patient had been coughing and was weak after the vaccine. Patient walked to the bathroom and then fell striking her head found in PEA with agonal breathing. Despite aggressive CPR medications patient remained in asystole. Unknow if Moderna or Phifzer" "1077275-1" "1077275-1" "At about 11:00 am which was about 22 hours after receiving 2nd dose of Moderna patient exhibited difficulty breathing and soon breathing became more difficult to point where her shoulders were lifting to breathe. At 6:45 pm she passed away." "1077297-1" "1077297-1" "He collapsed and went into cardiac arrest" "1077452-1" "1077452-1" "Death felt a little sick 1 day after shot 2/28/21, felt worse next day 3/1/21 was weak, she was found dead am 3/2/21 on the floor in her bedroom 1/2 way between bathroom and bed." "1078002-1" "1078002-1" "Fever, tiredness, headache, body ache and chills and cough. Patient passed away at homeThursday, March 5 around 5:00 a.m." "1078239-1" "1078239-1" "Death. Ruptured myocardial infarction." "1078246-1" "1078246-1" "Death. Ruptured myocardial infarct." "1078352-1" "1078352-1" "Developed fatigue, body aches, headache 1 day after vaccination on 3/3. The morning of 3/5 complained of chest pain. Took Tylenol at 8:30 am. At 10:30 am his family found him unresponsive. EMS was called and he was pronounced dead in the home." "1078618-1" "1078618-1" "She was week, fell, wouldn't eat, drink or get out of bed. Died after being sent to hospital 3 times and ended up on hospice" "1079251-1" "1079251-1" "Patient died the day after she received her vaccine" "1079904-1" "1079904-1" "SUBJECT WAS FOUND DECEASED ON 22 FEB 2021 AT AROUND 11:30 PM" "1079958-1" "1079958-1" "Pt found down and pulseless in home by husband. EMS called, Pt found to be in PEA arrest. Pt achieved ROSC with CPR and Epinephrin. Pt Passed away on 09/07/2021 at 1330. Pt was in multisystem organ failure." "1079976-1" "1079976-1" "12/23/20 (Moderna #1) - Malaise, cough on 12/24, went to walk-in on 12/25 c/o cough, malaise, rx'd Augmentin x14d, Rapid covid negative (and PCR resulted negative). 12/27 slept all day, 12/28 back to work. 1/12/21 metallic taste in mouth, severe GI sx, malaise, aches, headache. 1/14 seen at walk-in and covid swabbed Negative. 1/21/21 exposed to parents who found out they were covid + on 1/22/21. 1/25/21 (Moderna #2) - Continued with persistent cough and GI sx. Then also developed urinary frequency and urgency. Seen at urgent care 2/1 c/o cough, dx URI, rx'd augmenting. Woke up morning of 2/2/21 abruptly, stood up, said something was wrong, and collapsed. CPR attempted immediately, EMS brought him to ER where he was pronounced dead." "1080033-1" "1080033-1" "COVID symptoms started within 8-9 days of vaccination. No fever, general not feeling, chills. Turned into very difficult breathing, low oxygen levels and pneumonia. Tested positive for COVID at Hospital ER on Wednesday, January 27. Died in the hospital Saturday morning, January 30, 2021." "1080075-1" "1080075-1" "Hemorrhagic stroke. = Death" "1080404-1" "1080404-1" "Severe fatigue, lethargy observed by family members on date of discharge from sub-acute nursing care to home 02/03/2021 and subsequently on 02/04/21 with complaint of shortness of breath. Continued lethargy and shortness of breath on 02/05/21, 02/06/21. Lethargy, shortness of breath and loss of appetite, chills, on 02/07/21. Less lethargic on 02/08/2021 but worsened shortness of breath and loss of appetite. Patient requested 911 call on afternoon of 02/09/2021 for shortness of breath. Rapid Covid screen at ER was positive and staff reported beginning treatment with dexamethasone and remdesivir. Hospital staff reported to family that patient had pneumonia, congestive heart failure, confusion on 02/10/2021. Nursing staff reported patient was getting antivirals and antibiotics. Patient was transported for care by pulmonary specialist at Hospital on 02/13/2021." "1080424-1" "1080424-1" ""Narrative: above in section ""Other relevant history"""" "1080425-1" "1080425-1" "Narrative: Patient with h/o ESRD on HD MWF, HTN presented to ER on 2/20/21 with worsening dyspnea and GI symptoms; tested positive for COVID-19. Patient had received first COVID vaccination approx. 9 days prior. Patient admitted to ICU for treatment of COVID+ PNA. During admission, patient often could not tolerate removal of fluid during HD d/t tachycardia. He received dexamethasone, convalescent plasma for COVID. Patient underwent TTE which was notable for septal wall motion abnormalities and grossly reduced EF. Admission also c/b acute liver injury, possible cholecystitis, thrombocytopenia, SVT, encephalopathy. Patient then developed progressive shock and hemodynamic instability on 3/2 and passed away on 3/2/21." "1080427-1" "1080427-1" ""Narrative: above in section ""Other relevant history"""" "1080428-1" "1080428-1" ""DEATH Narrative: 73 y.o. male with pmh severe COPD, CAD, HTN, hypothyroidism, OSA treated with CPAP, obesity. Noted to have engaged with Pulmonary clinic in December 2020 for worsening respiratory status. No PFTs since 2015. Was found slumped over deceased in his home on the afternoon of 2/24/2021. Medical Examiner notified. Request sent to ME office for report if one exists. No drugs or alcohol were found on the scene andno sign of trama. Hypertensive cardiovascular disease were reported as an adequate cause for death. ""pathologist"" reported that Covid vaccine does not need to be listed as it was ""more than 24 hours since the shot""."" "1080429-1" "1080429-1" "DEATH Narrative: no documentation regarding any immediate reaction after vaccine administration. 83 y.o. male with pmh severe pulmonary hypertension, s/p TAVR last year, severe asbestos related lung disease on chronic oxygen, recently started on palliative care. Was found by daugher deceased on the morning of 2/11/2021. Autopsy declined by family." "1080430-1" "1080430-1" "Death Narrative: Death was not determined to be related to COVID vaccination. COVID vaccination (dose 1) occurred on 1/27/21 with no noted side effects. Death occurred on 2/14/21." "1080431-1" "1080431-1" "Narrative: 67 year-old male received his 1st COVID vaccine dose at a clinic on 2/25/21 at ~ 11:45am. No known prior COVID infection. No history of vaccine allergies or allergies to any component of the COVID vaccine. Does have history of allergic reactions including hives, angioedema or anaphylaxis to some medications (neomycin, Neosporin, bacitracin) and environmental allergens (yellow jackets, fir trees). Patient reported previously daily use of diphenhydramine (2 caps every morning) and kept an epi-pen on hand. The afternoon of 2/26/21, patient presented to his neighbor's house requesting assistance with an epi-pen. Neighbor reported significant swelling around tongue and lips, and ability to faintly speak. Neighbor administered epi-pen, but unsure if it worked, so administered a 2nd epi-pen. Within a minute or two after the 2nd dose, patient slumped over and became non-responsive. EMS was called and neighbor began CPR. EMS reported that patient was non-responsive upon arrival. A King airway was placed and a Lucas device used for chest compressions. Three rounds of epinephrine were administered during transport to the local emergency room. Patient remained unresponsive with evidence of PEA during transport. Arrival at the ER occurred ~ 4:25pm. On arrival patient noted to be unresponsive with CPR in progress. Dose of epinephrine administered ~ 3 minutes after arrival in ER. No femoral pulse palpable, cardiac monitor did show some electrical activity. Evaluation of oral cavity showed significant swelling of tongue. Additional dose of epinephrine given. Patient remained with no palpable central pulse and showed continued evidence of PEA. Patient was estimated to have been down > 45 minutes. Patient pronounced deceased at 4:59pm." "1080432-1" "1080432-1" "Death Narrative: On 3/3/21 an MSA from the Decedent Affairs Office received a call from the Office of the Chief Medical Examiner. The ME office informed the MSA that an autopsy was conducted on 3/2/21 and is pending results. No further information was given. A clinical review was conducted by the PCP but no conclusions could be made until autopsy results are received. The Office of Decedent Affairs will be reaching out periodically to the ME's office to retrieve these results. This Issue Brief will be updated by 3/17/21." "1080433-1" "1080433-1" "unknown cardiovascular event" "1080434-1" "1080434-1" "Death Narrative: Patient passed away on 3-2-21, patient received the vaccine on 2-24-21. Patient was obese and had several co-morbid conditions." "1080435-1" "1080435-1" "DEATH Narrative: 61 y.o. male with pmh afib, substance dependance, renal failure, recent admissions in the community for acute hypotension and acute kidney injury (11/2020 & 2/2021). Was found deceased in his apartment on the afternoon of 03/01/2021. Request sent to ME office for report if one exists. Patient was listed as having no known allergies." "1080538-1" "1080538-1" "Unexpected Death. No details known at this time." "1080620-1" "1080620-1" "Information provided by facility director. Resident told medical provider on 3/3/21 at routine visit that he had not felt right since receiving vaccine on 2/11/21. No specific complaints and no findings reported by provider. No specific complaints reported prior to nurse at facility finding resident unresponsive and breathing at approximately 6AM on 3/5/21. 911 initiated. EMS, police and coroner responded." "1080671-1" "1080671-1" "Patient received vaccine 1/26/2021, complained of fever and chills post vaccine. Daughter reported worsening symptoms to confusion, decreased appetite, N/V and chest pain. Dry cough and SOB. Patient admitted to facility for Chest pain, AMS on 2/2/2021. Expired 2/2/2021." "1080716-1" "1080716-1" "On day three after vaccine administration patient expired. quite an active man, no signs led up to his death until maybe a half hour prior to the event." "1080932-1" "1080932-1" "DIAGNOSED WITH COVID 1/21/21; RECIEVED BAMLANIVUBAM INFUSION; HOSPITAL ADMISSION 1/23/21 WITH ACUT RESPIRATORY FAILURE DUE TO COVID. INTUBATED X 10 DAYS" "1081009-1" "1081009-1" "there were no signs of adverse reaction at the time of injections and she waited 15 minutes at the site to watch for side effects. and none were evident or reported. We were notified that she passed away on Saturday, March 6." "1081033-1" "1081033-1" "Patient expired 2 days after receiving the vaccination. Patient had other signs of deterioration over the course of the previous month with worsening edema and difficulty breathing. Unlikely to be related according to our assessments, but wanted to err on the side of caution." "1081132-1" "1081132-1" "Severe thrombocytopenia approx. 10 days after vaccine administration." "1081155-1" "1081155-1" "Pt died on 3/6/2021. Received Vaccine on 2/12/2021. Unknown cause of death." "1081279-1" "1081279-1" "Patient seen by physician for weakness, tired, increase SOB, falls, increase confusion and then subsequently hospitalized . Patient then expired on 3/7/21." "1081304-1" "1081304-1" "patient passed away within 60 days of receiving a COVID vaccine" "1081305-1" "1081305-1" "Sudden death approximately 24 hours after receiving 2nd COVID vaccine - symptoms unknown - autopsy revealed cardiac disease as the cause of death" "1081308-1" "1081308-1" "Death 3 days afterards, undetermined cause at this time." "1081416-1" "1081416-1" "Pt. presented to ED via EMS for emergent coma. EMS intubated patient in field due to respiratory failure. Pt. was severely hypertensive with nearly total loss of brainstem reflexes. Patient had known L MCA cerebral aneurysm with appointment to undergo intervention to address in the near future. NCCT reported massive multifocal brain hemorrhage, SAH, SDH, and parenchymal hemmorhage with midline shift and subfalcine herniation. Due to dismal/poor prognosis, family requested withdrawal of support approximately 4 hours after presentation and patient expired shortly thereafter." "1081426-1" "1081426-1" "Death on the way home after receiving vaccine." "1081471-1" "1081471-1" "This individual received the first dose of the Covid-19 Pfizer vaccine on 3/4/21 and a few days later passed away on 03/07/21." "1081547-1" "1081547-1" "NO IMMEDIATE ADVERSE EVENTS PRESENT FOLLOWING IMMUNIZATION. RESIDENT WAS ALERT, RESPONSIVE, TALKATIVE, WITHOUT COMPLAINTS, AND ENGAGING IN NORMAL ACTIVITIES AFTER IMMUNIZATION, AS WELL AS THE FOLLOWING DAY. HE WAS FOUND IN BED THE SECOND MORNING AFTER VACCINATION (AT 6:25AM) WITHOUT VITAL SIGNS AND HAD EXPIRED PEACEFULLY IN HIS SLEEP. HE WAS A DNR, NO LIFE SUSTAINING MEASURES WERE PERFORMED." "1081762-1" "1081762-1" "Pfizer-BioNTech COVID-19 vaccine treatment under Emergency Use Authorization(EUA): Male received his second vaccine on February 28, 2021 and had been following the vaccine. Symptoms included nausea, vomiting, hypotension, and bradycardia. He was admitted to the hospital on March 1st. Medical history included Coronary Artery Disease, A-Fib, and a previous CABG procedure." "1081763-1" "1081763-1" "Pfizer-BioNTech COVID-19 vaccine treatment under Emergency Use Authorization(EUA): Female died 27 hours after receiving second dose of vaccine. Immediately after vaccine she had rapid breathing, almost hyperventilating. Medical history included Dementia and Parkinson's Disease." "1082172-1" "1082172-1" "THE RESIDENT STARTED HAVING SYMPTOMS OF COVID 19 ON 2/3 (COUGH AND SHORTNESS OF BREATH). RAPID TEST WAS NEGATIVE, BUT PCR TEST WAS POSITIVE. SHE RECEIVED TREATMENT FOR COVID WITH IVERMECTIN, DEXAMETHASONE, ALBUTEROL MDI, MUCINEX, AND Z-PACK. SYMPTOMS PROGRESSED AND SHE PASSED AWAY ON 2/15/21." "1082190-1" "1082190-1" "Patient hospitalized 2/18/21, second dose was scheduled for 2/23/21. Patient expired in hospital 2/27/21." "1082345-1" "1082345-1" "This patient developed a severe pneumonia, clinically diagnosed as COVID-19 pneumonia, with hypercapnic and hypoxemic respiratory failure, and expired. I am not sure if it was related to the vaccine, but the rapid antigen for Sars-CoV2 was positive and the PCR was negative. I am reporting this event because of the lack of clarity on this issue and the positivity of the Sars-CoV2 was beyond the parameters of 14 days in the phase three trials." "1082400-1" "1082400-1" "Patient developed COVID after vaccines. There was an outbreak at her facility . She ended up with pneumonia and expired on 03/07/2021" "1082467-1" "1082467-1" "Pt passed away on 3/6/21." "1082707-1" "1082707-1" "death" "1082717-1" "1082717-1" "Patient dropped dead 24 hours after receiving the vaccine. The vaccine killed her. She received the vaccine 2/16/2021 and died 2/17/2021" "1082759-1" "1082759-1" "Death" "1082787-1" "1082787-1" "Death on 3/7/21" "1082804-1" "1082804-1" "Patient committed suicide the morning of March 2, 2021. He stepped in front of a truck on a highway. I consulted with pharmacy and they said that I should report even if the 2 most likely have nothing to do with each other." "1082850-1" "1082850-1" "pt became nauseated and vomiting 1 day after getting vaccine, reported on Mon 2/22/21 but states was getting better, received call from sister on 2/25/21 that pt could not get out of bed on own - was sent to ER at that time" "1082985-1" "1082985-1" "Patient had been feeling dyspneic for 1.5 weeks to 1 month prior to his death on 2/28/21. He received vaccine on 2/25/21. On his family found him leaning on the couch with eyes rolled back and foaming at the mouth. He was making noises (like grunting sounds?). EMS was called. He had cardiac arrest while in ambulance enroute to EMS. Resuscitation efforts continued in ED. Family was informed about his status and resuscitation efforts were stopped." "1083117-1" "1083117-1" "Pt. received his second moderna vaccine on 03/05/2021 and his son reported that the pt. passed away after receiving his vaccine." "1083728-1" "1083728-1" "Dead on the bed with his legs dangling off one side of the bed; Complained about an upset stomach; A spontaneous report was received from a nurse concerning a 70-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273). The patient's medical history included hypertension and diabetes. No concomitant medications were provided. On 20 Feb 2021, Saturday, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection. On 21 Feb 2021, Sunday 9:36 AM the patient's experienced an upset stomach and attributed it to dinner last night and later on 22 Feb 2021, Monday he was found dead on the bed with his legs dangling off one side of the bed. The cause of death was unknown. Treatment information for event upset stomach included half a spoon of an Indian thing. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event upset stomach was fatal and patient died on 21 Feb 2021.; Reporter's Comments: This is a 70-year-old, male patient, who received Moderna's COVID-19 vaccine and history of risk factors for CAD such as hypertension and diabetes, was found dead 2 days after vaccination. Very limited information regarding this events has been provided at this time. Further information has been requested; Reported Cause(s) of Death: Unknown cause of death" "1084036-1" "1084036-1" "Profoundly weak by Saturday the day after the injection (2/6/2021), hospitalized by Monday (2/8/2021), on a ventilator by Wednesday (2/10/2021) and died the following Monday, (2/15/2021) She was treated for HLH (hemophagocyticlymphoistiocytosis)" "1084145-1" "1084145-1" "At home Care Hospice Patient" "1084180-1" "1084180-1" "Patient came with husband to Vaccine clinic today 3/5 for 2nd dose of vaccine. Did well during and immediately after vaccine. Husband states patient has c/o severe chest pressure and pain for several weeks but has refused to come to ER for evaluation. Today, after getting vaccine dose and going to local bank, patient was in passenger side of truck when chest pain started again. Husband begged patient to let him take her to the ER but she said no, I?m fine and I don?t want to go. She then went unresponsive. At a stop light, he was next to a couple of cops who he was able to wave down and proceed to escort them in to ER. Upon arrival to the ER, patient was unresponsive and pulseless. CPR was initiated, 1 defib, and 1mg of epi was given. Return of pulse was obtained, but husband asked for no life support and only comfort measures. Patient was admitted for comfort measures. I do NOT think this was related to her vaccine, but rather the unfortunately end to a sub-acute chest pain patient that declined multiple urgings to seek care. Patient then expired on 3/5/21 at 2037." "1084187-1" "1084187-1" "At Home Care Hospice Patient" "1084203-1" "1084203-1" "Pt was visiting dr for routine checkup. Pt began to experience difficulty breathing, 911 called. I showed up to pt apneic, pulseless. CPR initiated. Return of spontaneous circulation in ambulance (without Rx). Pt intubated, ventilations continued throughout contact. Pt still had spontaneous pulse upon delivery ti ED, placed on vent in our presence. Pt later transported to Level 1 hospital on vent." "1084287-1" "1084287-1" "Death" "1084390-1" "1084390-1" "1/29 /21 Increased fatigued, congestion, BP elevated Stat CBC/BMP/CXR. CXR. CXR-CHF with superimposed bilateral infiltrates and bilateral pleural effusions. N.O. Rocephin 1gm IM QD x 7 days. CBC am. Consult with cardiology. 2nd covid vaccine not given. 2/2-2/5 Sent to ER for ongoing significantly elevated BP's. Remains on Rocephin. Hospitalized 3 days for Acute on Chronic Diastolic and Systolic Heart Failure-Diuresed with IV Lasix, Multiple changes in medications by cardiology for poorly controlled HTN. Head CT negative, Covid negative. 2/5 Readmission from Facility-Followed closely by cardiology. Losartan was increased, Hydralazine was increased, Norvasc was increased. Continue Atenolol. Monitoring daily weights and vital signs. Resident with increased lethargy and then behaviors at times, and refusing meds. Oral intake poor. Continued on Coumadin for A-Fib with monitoring of INR. Palliative consult ordered. Continued to be followed by Mental Health and APRN in addition to PCP. 2/6 CBC/BMP/CXR-BUN/Creatinine elevated 44/2.2 and upon readmission to facility. MD changed from Lasix to Demadex. CXR-Continued PNA. Started on Rocephin 1gm IM x 7 days. 2/8 MD visit. Palliative consult ordered 2/11 Critical labs with elevated BUN/Creatine and Na level. MD ofered hospitalization to ADPOA who declined and wanted to pursue Hospice instead. Resident was seen by APRN from Home Health and Hospice Services who discussed plan of care with ADPOA requested comfort care and no further hospitalizations. 2/12 Resident admitted to Hospice Services. Compassionate visit with ADPOA 2/14 resident with further decline, periods of apnea evident, comfort maintained. 2/18 Passed at facility with Hospice services in place and compassionate visits with ADPOA" "1084419-1" "1084419-1" "EMS reported sudden onset of shortness of breath, patient grabbed his chest and collapsed. He stopped breathing. Wife began CPR with chest compressions at 5:00. Fire dept. arrived resumed CPR and attached AED but there was no shock advise. They placed an OPA as well (inserted an airway) and started ventilation. Asystole was confirmed, they continued CPR. After 5:25 they gave 3 rounds Epineferin and ended CPR at 5:46. They also checked his blood sugar and it was 136. Possible reaction to covid vaccine. Possible death due to history of cardiac issues. His PCP is requesting an autopsy" "1084685-1" "1084685-1" "We received a phone call stating that the patient passed away overnight." "1084793-1" "1084793-1" "Hypotension in the 70s/40s despite IV fluid replenishment. Per our MD DC/transfer note: PEG displacement, ongoing sepsis, hypoglycemia. Assess for other reason for hypotension including sepsis, cardiogenic shock, acute abdominal processes. patient was transferred to the Hospital ER where she expired" "1084800-1" "1084800-1" "Death. EMS called to residence 9 hours later for cardiac arrest. Pt pronounced at Emergency Room. Pt sent to ME office for autopsy." "1084949-1" "1084949-1" "Patient dies suddenly 4 days after the vaccine" "1084965-1" "1084965-1" "Injection in left arm at 4:15 pm. on Friday 3/5/2021. At 9pm, 3/5/2021 he complained of chest pain and was taken by ambulance to Medical Center Emergency Room. He was diagnosed with gallstones and discharged at approx 4:00 am on 3/6/2021. He found non responsive at home shortly thereafter." "1085019-1" "1085019-1" "Had vaccine on 3/3/2021 at approximately 1 PM. She was found on her couch deceased on 3/8/2021. Possible death on 3/5/2021. She called her sister and told sister that back hurt worse than usual and she would lay on the couch and rest. This is where she was found. Unknown if from vaccine, but due to vaccination on Wednesday proceeding her death, report is being filed." "1085032-1" "1085032-1" "Patient received dose #2 of her Moderna COVID vaccine on 2/25/21. Patient called in to work the next day 2/26/21 because she was not feeling well. Patient did not show up to work on Monday 3/1/21 and her supervisor, called the PD to check in on her and she was found deceased in her home." "1085185-1" "1085185-1" "testing positive for COVID; Fever for 3 hours after the vaccine/ High temperature; Joint pain; Severe upper back pain; Headache; A spontaneous report was received from a nurse concerning a 44-year-old female patient who experienced fever for 3 hours after vaccination, headache, joint pain, and severe upper back pain. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included dulaglutide, metformin, empagliflozin, losartan, amlodipine, levothyroxine, simvastatin, allopurinol, estrogen, colchicine, calcium, zinc, multivitamin and vitamin C. On 05 Jan 2021, the patient received mRNA-1273 (Lot number 026L20A) intramuscularly for prophylaxis of COVID-19 infection. On 05 Jan 2021, patient experienced fever for 3 hours after vaccination. The patient also experienced headache, joint pain, and severe upper back pain. The patient stated her temperature was high from 05 Jan 2021 until 09 Jan 2021 when it went down. Treatment information was not provided. Follow-up received on 21 Feb 2021, from the patient's husband, included that the patient tested positive for Covid-19 on 09 Jan 2021 and was hospitalized on 11 Jan 2021. The patient never recovered from her symptoms and the patient died on 02 Feb 2021. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events Coronavirus test positive was fatal and for headache, joint pain, severe upper back pain and temperature were unknown. The cause of death was reported as Coronavirus test positive and autopsy details was unknown.; Reporter's Comments: This case concerns a 44-year-old female who was hospitalized with a serious unexpected event of COVID-19 with fatal outcome along with NS unexpected back pain and NS expected fever, headache, arthralgia. Event onset was 5 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes fatal. Autopsy results unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Testing positive for COVID" "1085193-1" "1085193-1" "Unconscious; Felt a bit sore at the injection site; A spontaneous report was received from a consumer and healthcare facility staff member concerning a 69 years old, female patient who experienced little bit sore at the injection site, unconscious and passed away. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. The patient experienced sore at the injection site and unconsciousness both since 22 Feb 2021. The husband of the patient performed CPR as instructed by 911 and EMT's and police performed medical procedure which included injections and electrical shock both on 22 Feb 2021. The patient died on 22 Feb 2021. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The patient died on 22 Feb 2021. The cause of death was unknown. Plans for an autopsy were not provided.; Reporter's Comments: This is a case of death of a 59-year-old, female patient who experienced injection site sore and became unconscious on the same day after mRNA-1273 administration and subsequently expired. Although critical details such as the patient's medical history and actual cause of death is lacking, based on the current available information which shows a strong temporal association with the product use, thus, a causal relationship cannot be excluded. injection sore is consistent with product safety profile and cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death" "1085254-1" "1085254-1" "Severe abdominal pain unable to eat or sleep for 36 hours. He went by ambulance to the Hospital emergency room. They tried to pump his stomach but he aspirated and and went into cardiac arrest. He was revived but never regained consciousness. (The ICU Dr said that he had blood clots in his abdomen from a recent stroke. We were unaware of him having a stroke other than in 2026. The same Dr. said that he had necrosis in his lungs from aspirating. The necrosis was from his bowel dying) He was put on a ventilator and given drugs to increase his heart rate. On 3-5-21 the heart drugs were reduced and he died. I was with him when he recieved the vaccination and he was healthy, just old. I think that the shot killed him." "1085302-1" "1085302-1" "Patient was admitted to Hospital on 3/1/21. Blood Sugar of 758. Patient diagnosis with Acute respiratory failure with hypoxia and acute heart failure and Metabolic encephalopathy. Patient put on ventilator and passed away on 3/2/21 at 17:04." "1085375-1" "1085375-1" "Patient presented to medical center emergency room on 02/21/2020 at 19:00, patient complained of shortness of breath and feeling fullness of her throat. Patient stated that she had Motrin 800 mg TID and Flexeril PRN due to her back pain. Patient also stated that she ate a banana after she took her medications. Her systolic blood pressure was 50, and her HR was 109, patient also stated that she had her 2 shots of Moderna Vaccine, her first shot was on 01/06 and her second shot was on 02/02. Patient was treated with: 1 Duoneb, 0.3 ML IM of epinephrine, Solumedrol 125 mg, Benadryl IV 50 mg, Normal Saline infusion IV 1000 ml/hr, and Pepcid IV 20 mg. Patient lactic acid was 10.6, WBC 24.2 and Temp 97 F, patient was diagnosed as sepsis shock and patient received: Piperacillin-tazobactam 3.375 g in D5W 50 ml IVPB (3.375 g once) Vancomycin 1 g in D5W 200 ml IVPB (1 g once). Patient pH was < 6.780 and PCO2 was 55 and bicarbonate level was 5.0, patient received Sodium bicarbonate IV 50 mEq once. Patient was not stable as her BP and HR were fluctuating patient received DilTlazem IV 2.5 mg for 2 doses. Patient received Levophed 16 mg /NS 250 ml IV. At 23:13 patient was intubated, patient received a local anesthesia through a central line of lidocaine 2% without epinephrine, and patient was transferred to the ICU to be monitored. At 00:33 CODE BLUE was called and patient became unresponsive and lost pulse while patient was brought to ICU. Patient was coded twice before ROSC, during intubation patient patient noted to have coffee-ground drainage." "1085413-1" "1085413-1" "patient was on treadmill at home on 3/4/21 and became shortness of breath, collaspsed, hitting head on floor. Family started CPR, Downtime prior to ED arrival 30 minutes. Arrived at ER at 8:48AM. Intubated by EMS. initially shocked 1x but otherwise was in asystole. Eventually after about 70 minutes of CPR at ER patient had no ROSC, pupils dialted and fixed and at this point pronounced dead." "1085478-1" "1085478-1" "Patient has been feeling fatigued since the vaccine. On 3/8 he went to play Hockey, first time since pandemic started. He reported feeling to his friends that he felt unwell and left the ice. He was found dead, CPR started, EMS called-> had shockable rhythm (VF), shocked 10 times pre-hospital. Brought to Hospital ER and placed on VA ECMO. He is currently in the ICU setting; echo suggests possible MI but formal cath pending. Has anoxic brain injury, splenic laceration, pulmonary hemorrhage/contusions, rib fractures all related to CPR (received over an hour prior to ECMO placement). Patient may ultimately expire, he is critically ill." "1085673-1" "1085673-1" "Patient died 2/26/2021" "1085783-1" "1085783-1" "Sudden Unexpected Death - No signs or symptoms" "1085788-1" "1085788-1" "My grandpa was very lethargic after his 2nd vaccine. The following day he started acting more awake, he had a better appetite but seemed to be breathing a little funny. He was labored a bit. He went to sleep on 2/24/21 and at 230 am was dead." "1086206-1" "1086206-1" "Four days of feeling sick with aches, pains, upset stomach. On day 2 he was so sick he thought he would die. Sudden death on day 7." "1086868-1" "1086868-1" "Passed away; Severe hypotension; Hemodialysis shunt bleeding; A spontaneous report was received from other health professional concerning a 72 years old, male patient who experienced hypotension, removal and replacement of hemodialysis shunt (procedure), hemodialysis shunt bleeding and death. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 29-DEC-2020, the patient received their first of two planned doses of mRNA-1273 (Batch number [LOT/BATCH: 039K208] intramuscularly in the right arm for prophylaxis of COVID-19 infection. The patient was hospitalized for severe hypotension and Removal and Replacement of hemodialysis shunt from 17-JAN-2021 to 21-Jan-2021. On 26-01-2021 the patient was sent to hospital due to his hemodialysis shunt bleeding. On 27-01-2021, the patient passed away at the hospital . Treatment information was unknown. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 27 Jan 2021. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1086901-1" "1086901-1" "His oxygen dropped too low to 76; Pneumonia; something with toxins; he couldn't eat or swallow; he couldn't eat or swallow; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is the 1st of 2 reports. This consumer (wife) reported for a 75-year-old male patient that received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 31Jan2021 (at the age of 75-years-old) for COVID-19 immunization. Medical history included dialysis for approximately 2.5 years, a lung problem, blood pressure. Concomitant medications included carvedilol and warfarin and other unspecified medications. The patient experienced pneumonia and died on 11Feb2021 03:00 AM. An autopsy was not performed. The cause of death was reported to be pneumonia. Clinical course was the follows the next day on 01Feb2021 at 9:30AM the patient was dressed and ready to go to dialysis. His oxygen dropped too low to 76. He wanted an ambulance called. He went into the hospital. The patient was confused, and he was not normally confused. In the hospital the physicians said he had pneumonia, but it wasn't that bad. The doctors were baffled. He also was in the hospital for something with toxins. He had a lung problem for a long time. If he didn't go to the bathroom the toxins were hitting the liver and then the toxins were going to the brain. When he was in the hospital he couldn't eat or swallow. The first day he did eat a bit, but he had dialysis in the hospital, and it knocks him out. They were giving him antibiotics IV. He couldn't swallow any of his pills. He was in there for 11 days and had not eaten. He couldn't swallow any pills. He started going to sleep and they started giving him Morphine drip at the end. They couldn't get any medicine in him because he couldn't swallow. The patient died of pneumonia, the outcome of the other adverse events was unknown. Information on lot number/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021247875 Same report, different patient/event; Reported Cause(s) of Death: Pneumonia" "1086933-1" "1086933-1" "Pneumonia; Unresponsive at times; Weak; Diarrhea; Feeling Punky; Body aches/muscle aches; Fever; Chills; Nausea; Vomiting; Sore arm at site of injection; A spontaneous report, was received from a nurse (caregiver), regarding a 96 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced pneumonia, unresponsive at times (unresponsive to stimuli), weak (asthenia), diarrhea, feeling punky (malaise), body aches/muscle aches (myalgia), fever (pyrexia), chills, nausea, vomiting, sore arm at site of injection (vaccination site pain), and vomiting. The patient's medical history was not reported. Historical vaccine reported was flu shot. Concomitant medications included insulin, unspecified medication for pulmonary hypertension and heart failure. On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A), intramuscular for the prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient experienced the sore arm. On 07 Feb 2021, the patient experienced body aches, sore arms, felt punky, weak, fevers with a body temperature of 103.7 (unknown units), chills, nausea, vomiting, diarrhea and muscle aches. Treatment medication included acetaminophen. On 08 Feb 2021, the patient continued with high fever, unresponsive at times, and all other symptoms. On 09 Feb 2021, the patient's fever was control, very weak and passed away on the same day at 04 45 pm. The death occurred and death certificate stated that pneumonia was the cause of death. Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcome of the event, pneumonia was considered as fatal, and that of other events unresponsive at times, weak, diarrhea, feeling punky, body aches/muscle aches, fever, chills, nausea, vomiting, sore arm at site of injection, and vomiting were considered as unknown. The patient died on 09 Feb 2021. Plans for an autopsy was unknown. The cause of death was reported as pneumonia.; Reporter's Comments: This case concerns a 96 year old, female patient, who experienced a serious unexpected event of Pneumonia (fatal) among others, 5 days after receiving 1st dose of mRNA- 1273 (Lot# 013M20A). Very limited information regarding these events has been provided at this time. The subject's con meds included insulin, unknown medications for pulmonary HTN and heart failure. The cause of death was determined to be pneumonia. Advanced age and co-morbidities may remain as risk factors.; Reported Cause(s) of Death: Pneumonia" "1087735-1" "1087735-1" "On 3/5/21 at approximately 0200 became congested suddenly. Doctor was notified with N.O. Torsemide 20 mg tab via PEG-tube NOW, IM Rocephin 1 mg QD x7 days for possible aspiration, Chest X Ray, CBC/BMP in morning, and may suction resident if tolerated PRN. Received both Torsemide and the Rocephin and then deceased at 0350." "1087763-1" "1087763-1" "Difficulty breathing leading to organ failure and death" "1087885-1" "1087885-1" "Patient was found deceased in garage one day post vaccination" "1087949-1" "1087949-1" "3/6/2021 Expired at facility receiving Hospice Services since 8/1/2020. Hx Covid-19 June 2020. Prior to death: Resident began refusing meals and failing overall. On, 2/18 began with jaundiced skin, no other symptoms. ADPOA, Hospice APRN and MD updated. Comfort measures maintained as resident continued to have slow decline." "1087952-1" "1087952-1" "Resident fell out of her chair and was transferred to the ER with a diagnosis of a Mio cardial infarction and passed away in the ER." "1088112-1" "1088112-1" "03/05/2021: Increased SOB, DOE, increased HR and RR, pain on inhalation, agitation 3/06/2021: increased work of breathing, using accessory muscles, sweats, low-grade fever 3/07/2021- death" "1088175-1" "1088175-1" "death within 30 days of vaccination" "1088180-1" "1088180-1" "Patient was admitted to Hospice on 8/11/20. He experienced normal progression of his diseases until his death on 3/9/21." "1088184-1" "1088184-1" "Pronounced dead on 3/9/21 approximately 72 hours after receiving vaccination. Unknown symptoms prior." "1088216-1" "1088216-1" "Death within 30 days of vaccination" "1088287-1" "1088287-1" "The caregiver on duty tells the nurse in charge that on 5/3/2021 she proceeds to bathe the resident and he was disoriented, so she goes to bed at around 5:00 a.m. The resident expresses that he feels bad, when the caregiver goes to look for things to take vital, when he returns she finds him without vital signs and was presenting respiratory problems." "1088320-1" "1088320-1" "Pt tested positive for COVID on 2/6/2021. Deceased on 2/15/21. Not marked COVID death on death certificate." "1088328-1" "1088328-1" "The caregivers in their rounds indicates that resident was well, ate his meals and her vitals were taken. In their next 7:30 pm rounds they find that the resident was not breathing. Home physician certifies death as Congestive Heart Failure." "1088338-1" "1088338-1" "Case received vaccines 12/23/2020, and 01/13/2021. Public Health received notification that patient died 3/5/2021. Not really sure if her death is related to vaccine administration but I was instructed to fill out this form." "1088365-1" "1088365-1" "Pt tested positive for COVID on 02/29/2021. Passed away on 02/25/2021. COVID listed on death certificate." "1088367-1" "1088367-1" "Person of contact spent around 10 minutes in the room, spoke with the resident, left the room. When the caregiver came into the room with the resident lunch the resident was without vital signs. Dxn: Atherosclerotic Heart Diseases" "1088401-1" "1088401-1" "Pt tested positive for COVID on 2/15/21. She passed away on 02/23/21. Not listed as COVID death on death certificate." "1088539-1" "1088539-1" "He was found unresponsive, cold and with rigor mortis present after family requested welfare check. He had not been seen for 36 hours." "1088615-1" "1088615-1" "Death within 30 days of vaccination, vaccinated on 3/5/2021 pronounced dead on 3/6/2021. Unknown if any side effects from vaccine. No ER visit found at local hospital." "1088686-1" "1088686-1" "Pt found deceased in home on 03/07/2021" "1088723-1" "1088723-1" "Patient had 2nd COVID vaccine on 2/21/2021. He started having a temperature on 2/24/2021. Patient then started having trouble breathing. We took him to hospital. He was admitted on 2/25/2021. He steadily declined and was sent to ICU and died on March 1, 2021." "1088741-1" "1088741-1" "Patient found unresponsive approx 16 hours after vaccination. Death listed as Cardiac arrest secondary to stenosis. Patient had inoperable cardiac issues and was reportedly in a terminal state." "1088815-1" "1088815-1" "PER MEDICAL RECORDS PATIENT PRESENTED TO ER VIA EMS REPORTING INTERMITTENT CHEST PAIN, FEELING LIKE HIS HEART WAS STOPPING." "1088830-1" "1088830-1" "Patient died after feeling unwell for about ten minutes." "1088837-1" "1088837-1" "Patient received first vaccine dose on 3/10/21, waited for approximately 1 hour in Pharmacy after. Was walking to her vehicle and became short of breath. Patient got to her vehicle and called 911 due to severe shortness of breath. Rescue arrived on scene at approximately 11:00am, found patient in distress and administered epinephrine, methylprednisolone, and diphenhydramine. Patient placed on CPAP in rescue en route to ER, became unresponsive, frothing pink sputum. Intubated by paramedics en route with iGel device. Patient arrived to ER at 11:22am, went into cardiac arrest at 11:24am. Patient continued to be unstable, had multiple rounds of cardiac arrest and ROSC. Patient ultimately did not survive arrests, and pronounced dead at 2:37pm. Medications received during course in the ER - epinephrine 1mg x18 doses, sodium bicarbonate 50mEq x4 doses, calcium chloride 1g, insulin regular 10 units x1, furosemide 80mg x1, epinephrine titrated infusion, sodium bicarbonate infusion." "1088956-1" "1088956-1" "Tested positive and had symptoms for Covid-19 . Admitted to hospital on 2/14/21 in the icu and died in 2/28/21" "1089038-1" "1089038-1" "Patient died 2 days after COVID vaccination, concern for vaccine related death. Autopsy showed bilateral pulmonary emboli. No evidence death was vaccine related." "1089215-1" "1089215-1" "Syncopal episode followed by death. Unable to be revived. Coroner's case." "1089349-1" "1089349-1" "Patient had an adverse reaction to her first shot, unreported, mostly local to the injection. For this 2nd dose, she was not feeling well the day after the shot, but was at work. She did not show up for work on Friday and was found dead. Time of death was undetermined. She lived alone. An autopsy was not performed." "1089441-1" "1089441-1" "Sunday, Feb 21, 2021. Patient told her husband she didn?t feel well and she lay down next to him. She was tossing and looked like she was trying to get up. He was talking to her and she wasn?t answering him. She was having trouble breathing. Took her to the hospital right away at 7:30 pm. They put her into a comma with a respirator. Finally went from emergency room to ICU on Monday. Then on Wednesday they took the respirator out and I spoke to her ? told her we all love her and she could only say hoarsely ?terrible, terrible.? They said she might get moved to regular floor. But then Wednesday night couldn?t breathe again and put the respirator back in. Thursday morning husband had it removed and she died that evening at 10:51 on February 25." "1089536-1" "1089536-1" "Moderna COVID-19 Vaccine EUA Heart attack Death" "1089759-1" "1089759-1" "Death" "1090239-1" "1090239-1" "she passed away on 19Feb as she had a HGB of 5; O2 sats were in 70s; she had a HGB of 5; on the same side the patient hand started swelling; lymphedema from L breast; swelling all over; This is a spontaneous report from a contactable consumer reporting on behalf of the mother. An 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 at 13:45, at single dose, in left arm, for COVID-19 immunization. No other vaccine was given in four weeks. Medical history included chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). Known allergies: none. The patient had no COVID prior vaccination and was not tested after vaccination. Concomitant medications were not reported, however, the patient received other medications in two weeks. On 05Feb2021 at 09:00, on the same side the patient hand started swelling and doctor gave her some furosemide (LASIX). One week from vaccination she started having lymphedema from L breast and started noticeably swelling all over. On 18Feb2021 she was taken to the hospital as O2 sats were in 70s. She passed away on 19Feb2021 as she had a HGB of 5. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization for 1 day. No treatment was received. No autopsy was performed. Low oxygen saturation, hand swelling, lymphedema from L breast and swelling all over final outcome was unknown. Information on Lot/Batch number has been requested.; Reported Cause(s) of Death: she passed away on 19Feb as she had a HGB of 5; she had a HGB of 5" "1090240-1" "1090240-1" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090322-1" "1090322-1" "MY WIFE DIED UNEXPECTEDLY 4 DAYS AFTER HER SECOND DOSAGE SHOT, ON FEBRUARY 17, 2021. SHE HAD BEEN HEALTHY AND HAD A RECENT CHECKUP AT WHICH THE DOCTOR GAVE HER A CLEAN BILL OF HEALTH. SHE WAS ALERT AND IN GOOD SPIRITS JUST THE NIGHT BEFORE WHEN WE WATCHED A MOVIE TOGETHER. I SAW NO INDICATION THAT SHE WAS FEELING POORLY OR OTHERWISE. I FOUND HER IN BED, DECEASED, UPON COMING HOME FROM WORK THE NEXT DAY." "1090369-1" "1090369-1" "Patient showed reaction to vaccine almost immediately, began having chills and nausea. Patient ultimately succumbed to cardiac arrest." "1090417-1" "1090417-1" "Error: Wrong Dose of Vaccine - Too High" "1090464-1" "1090464-1" "Feb. 10: Moderna Vaccination #1 Administered (arm) Feb. 11-Feb. 19: Developed a cough which worsened, weakness, confusion, could not follow instruction, fell, no appetite, fever of 102.8 on Feb. 19, no taste Feb. 20: Emergency Room with diagnosis of Covid pneumonia. Given usual Covid treatment. Became very confused, combatative, etc. Feb. 21: Placed on ventilator Mar. 1: Ventilator removed. Patient expired." "1090801-1" "1090801-1" "Rapid decline. Patient was reportedly vaccinated (unknown location / brand of vaccine) on 3/4/2021. On 3/5/2021, patient suffered fever of 104, nausea/vomiting, lethargy, loss of appetite, and patient expired unexpectedly." "1090862-1" "1090862-1" "DEATH-My Mother received her second Pfizer vaccine on Thursday, February 18, 2021 and died three days later on Sunday, February 21, 2021, after being admitted to the intensive care unit at Hospital. After developing an adverse reaction that started with nausea and then got progressively worse, including vomiting blood, Mom was rushed to the emergency room where she was tested for Covid-19 due to hospital policy (neg. result) and admitted to the intensive care unit. Mother died on Sunday, February 21, 2021. NOTE: Mother was doing well with her heart and renal conditions until she received the second dose of the Pfizer Covid-19 vaccine on February 18, 2021, directly or indirectly causing her death three days later on February 21, 2021. It is unfortunate that we are all advised (sometimes ill advised), particularly those with underlying conditions, to get vaccinated without the benefits of knowing when the vaccine can cause more harm than good. For obvious reasons, the approval of covid vaccines was rushed and thus the Pfizer and Moderna Studies are not thorough and lack in data to support an all call for everyone to get vaccinated in the name of herd immunity. Without the appropriate data, My Mother is DEAD! Sadly, there are probably more unreported deaths caused by the vaccine. While you have immunity from liability, you still have a moral obligation to collect data and advise accordingly. My goal is to save lives by sharing my mother?s personal experience and death after receiving the vaccine with everyone I know through every available resource. It is unconscionable that I have to shoulder the burden of getting the facts out about your vaccine so that individuals with underlying conditions can make a proper, informed decision about getting vaccinated. Sadly, I receive over 100 questions a day via social media from individuals inquiring about whether or not they or their loved ones should opt for the vaccine. I am not a medical professional?this is your job! Until you assume responsibility, I will continue advising anyone with heart and/or renal conditions to stay away from any and all covid vaccinations. Instead of the massive all call for vaccinations, we need further information and data from additional studies that will give more insight as to when the vaccine can cause more harm than good, as in My Mother?s case." "1091138-1" "1091138-1" "pt returned to his skilled nursing facility after his 2nd covid vaccine and at approx 10:45 pm he was in cardiac arrest. CPR was started and transported to Hospital. Pt was pronounced dead at 1:06 am on 3/11/21" "1091158-1" "1091158-1" "patient passed away with in 60 days of receiving the COVID vaccine series" "1091269-1" "1091269-1" "A home dialysis patient who received his first COVID-19 (Moderna) vaccine on 2/4/2021. He was screened prior to admission into the clinic and reported no signs of symptom of COVID-19. This patient was diagnosed with COVID-19 on 2/12/2021 and hospitalized on 2/16/2021 with COVID pneumonia. The patient's spouse and son (who lives with them) also tested positive for COVID-19. This patient developed COVID-19 complications while inpatient including stroke and mechanical ventilation was required. The patient was made a DNR by family and removed from mechanical ventilation and expired on 2/26/2021." "1091327-1" "1091327-1" "Death" "1091337-1" "1091337-1" "This is a hospice patient. She died on 2/13/2021 from her underlying medical conditions. I just received notification of the death 3/11/2021 and am reporting this immediately." "1091357-1" "1091357-1" "Patient died suddenly and unexpectedly on 2/21/2021 one week after receiving first vaccine on 2/20/2021." "1091439-1" "1091439-1" "fell/passed out (unknown) at home, taken by ambulance to local hospital, small bleed noted on CT scan, transferred to tertiary care center, f/u scan after 6 hours unchanged. Sent home. next morning unresponsive, transported back to tertiary care center. required ventilation en route.. massive cerebral hemorrhage noted on CT scan in different area. due to advanced dementia and unresponsiveness life support removed around 9pm that night. passed away at 9am on 3/1." "1091538-1" "1091538-1" "According to his daughter, patient did not appear to have any ill effects from his second COVID-19 vaccine on 03/09/2021. However, on 03/11/2021, he suffered what is suspected to be a fatal arrhythmia/myocardial infarction. It is unknown if there is any correlation to the vaccine." "1091560-1" "1091560-1" "On January 26, patient lost his balance and fell, no injury. On January 28, patient, fell, no injury. In both cases falls were observed and were not to the head. On January 29 patient could not maintain his balance. Taken to hospital. MRI revealed large subdural hematoma. Craniotomy on January 30, by Dr. Approximately 10 days later, Hbg, was down to 7, unexplained internal bleeding." "1091695-1" "1091695-1" "patient expired 2/10/2021. Unknown whether the death was even related to the vaccine. Pt did not have any problems during 15 min observation period and no issues reported to HD after vaccination. reported because the person expired within 7 days of vaccination." "1091753-1" "1091753-1" "observed for 15 min after both vaccines and no reported issues after vaccination. Patient did expire 2/25/2021 but cause of death unknown." "1091799-1" "1091799-1" "Became COVID-positive, pneumonia, ARDS, hospitalized for hypoxia 2/21/2021, death 2/25/2021" "1091894-1" "1091894-1" "The patient presented to the off complaining of feeling weak in the legs on Monday, March 1, 2021. She had been moving over the weekend and was over-exerting herself and stated she had fallen on a rug at the old house and then had lain down on the floor to sleep with her dog in the new home, had difficulty getting up and needed help. No symptoms of fever, chills, sweats, headache, myalgias. The next day she passed away at her home, sitting in her chair." "1091928-1" "1091928-1" "Pt was given Moderna COVID-19 vaccine on 2/11/21 with no adverse reactions. Pt later died on 3/08/2021 with lung cancer being cause of death." "1091957-1" "1091957-1" "I'm still not sure which COVID19 vaccine my dad received (It made me fill it out--I'm not sure if he got Moderna or Pfizer). Nursing home would know. He received his 2nd shot on Jan 19. On Feb 17 all was fine and they were planning on getting him crowns at the dentist. On Feb. 19 everything went poorly. He started to suddenly have seizures and was not responsive. When I arrived on Feb 21 he didn't say much and had seizures that night. On Feb 22, he responded a little bit and had a big black eye from a seizure the night before. On Feb 22 he had at least 4 seizures and he passed that afternoon around 1:20 pm" "1092016-1" "1092016-1" "Per son and employee, patient's health had been declining since she was hospitalized for a severe UTI in Dec 2020. The evening of 02.09.2021 she vomited, then was found to be unresponsive the morning of 02.10.2021. Patient passed away later in the day on 02.10.2021." "1092047-1" "1092047-1" "patient passed away within 60 days of receiving a COVID vaccine" "1092108-1" "1092108-1" "Patient's wife reports patient never reported feeling unwell. He had been working on painting the basement all week and on 02.12.2021 came in from outside, ate, and they sat down to watch TV. Around 9:30 patient reported being extremely tired and went to bed. Was found unresponsive the following morning, 02.13.2021. Patient's wife reports the doctor said it was a heart attack." "1092110-1" "1092110-1" "Patient passed away within 60 days of receiving a COVID vaccine series" "1092168-1" "1092168-1" "Patient passed away within 60 days of receiving a COVID vaccine" "1092214-1" "1092214-1" "Patient received his first COVID vaccine on 3/2 and then passed away 3 days after receiving Moderna vaccine. Provider presumed he died from sudden heart attack, this occurred at home." "1092328-1" "1092328-1" ""Patient appeared alert, oriented and completed everyday normal activates 3 days after receiving vaccine on a Wednesday afternoon, Jan 27th 2021 at 4:00 p.m. . Went to bed as usual on Sunday night Jan 31st 2021 at 9:30 p.m., husband found patient on couch sitting upright, unresponsive at 4:00 a.m. Patient's daughter came over to the house approx. 8 minutes later. Preformed CPR for 3-5 minutes, pt had a pulse. The ambulance was called prior to daughter arriving at the house. Ambulance arrived at 4:40 a.m. took pt to Hospital by 5:00a.m. Pt declared ""brain dead"""" "1092477-1" "1092477-1" "Pericardial effusion; multiple blood clots in portal vein." "1092483-1" "1092483-1" "Both patient and spouse we given their Moderna prime dose on 2-10-21. Both patient and spouse agreed to observe the post vaccination waiting period and reported no concerns. On 3-10-2021, they returned for their boost dose at 12:30 PM. Prior to administration of their second dose, they reported only mild headache and fatigue that presented approximately 12 hours after their first dose was administered. Once again, spouse and patient observed the post vaccination waiting period and reported no issues. On 3-11-21, I was notified that patient had passed away at home. In speaking to spouse, he stated that they both went to bed that evening with with a mild headache and fatigue. Spouse stated that he woke up early that morning with a more pronounced headache and had difficulty sleeping. He noted that at approximately 5:18 AM patient seemed to breathing heavily and may have gasped a bit. He checked on her again around 6:40 and determined that she had passed away. He contacted EMS and the technician confirmed that she had passed away. Spouse reports that the state will perform and autopsy in the next few days at the direction of Medical staff." "1092485-1" "1092485-1" "Patient felt generally unwell, tired and unable to walk well. Said his feet felt numb. He could not get up and slid to the floor. He did not have the core strength to even help him sit up. Sometime after he was assisted back on the couch around 4:30 am he must of got back up and attempted to go to restroom because he was found on the floor with his arm and face resting on the love seat which looked as if he was trying to pull himself up. His wife found him in the morning around 11:00 am and he had been died for some time according to EMS. His death was unexpected. Even when contacting his doctors they were confused as to why he had passed away. No autopsy was done but as of this moment he has not been cremated yet and is at Funeral Home." "1092651-1" "1092651-1" "DEATH" "1092653-1" "1092653-1" ""Patient received the vaccine on the evening of 03-09-2021. R.N. states she was ""fine "" at 440 AM bed check. At 0830 03-10-2021 patient was found slumped over on her bathroom toilet having expired sometime between 440AM and 830 AM"" "1092737-1" "1092737-1" "Sudden death. Alone at home, found on floor 4 hours after last phone contact" "1092883-1" "1092883-1" "Death. Patient lived alone, was found dead at 11:04 the morning following his second dose of vaccine. Actual time of death is unknown. Time of vaccine administration the previous day is estimated." "1092941-1" "1092941-1" "Extreme fatigue, shortness of breath. Stopped eating within 2 days, stopped fluid intake 3 days later. Family notified on March 3. ery little fluid intake until Sun, when fluid intake stopped as well. Death occured on mon, Feb 8 2021." "1093418-1" "1093418-1" "After pt received first dose of Moderna on January 27, 2021, he experieced continuous increased decline in his health , with symptoms of increased difficulty swallowing, increased coughing, at least one episode of choking with expulsion of food; increased difficulty walking with walker, increased shortness of breath. On Wednesday, Feb. 24, at 7:50 a.m. , Pt was in wheelchair exiting home, on way to detached garage, being pushed by his daughter, when he slumped over, stated that he couldn't breathe, and went unconscious. Pt. did not have a detectable pulse . EMT was called and upon arrival performed CPR and obtained a pulse. Pt was transported to local hospital, where, again he lost pulse and was resuscitated again with mechanical CPR. Pt was supported with blood pressure medicine and ventilator until 7:53 p.m. when his heart stopped again. Pt. passed at that time." "1093666-1" "1093666-1" "Client Passed away on 1/28/2021" "1093762-1" "1093762-1" "3/12/2021-EXPIRED AT FACILITY ON HOSPICE SERVICES" "1093791-1" "1093791-1" "Unknown" "1093843-1" "1093843-1" "patient's daughter reported patient passed away 2 days after first dose of vaccine" "1093857-1" "1093857-1" "According to the patient's wife, the patient had flu like symptoms 2/11/2021. Complaints: Thirsty, sweaty and seizure with no prior history. Died at home. Not sent to hospital. Pronounced by coroner" "1093939-1" "1093939-1" "No report of negative event after 15 min wait past receipt of vaccine. Notified by Coronor, on 3/11/2021 that this patient expired on 3/11/2021 at home. Not sent to hospital. Pronounced at home. Sent to Funeral Home" "1093961-1" "1093961-1" "Death" "1093986-1" "1093986-1" "Received a phone call stating that the patient complained of not feeling well on 3/11/21 while at work and that the patient died that night while at home." "1094102-1" "1094102-1" "NO ADVERSE EVENT NOTICE RECEIVED ON DATE OF VACCINE. RECEIVED NOTICE FROM CORONOER THAT THIS PATIENT EXPIRED 2/28/2021. COLLECTED URINE, BLOOD, AND TOXICOLOGY SCREEN. NOT SENT TO HOSPITAL. SENT TO FUNERAL HOME" "1094110-1" "1094110-1" "unknown. Patient is deceased" "1094138-1" "1094138-1" "D= decedent D received the second dose of the COVID vaccine on 3/10/21 @ 10:45AM. His daughter, ************, transported him to the Pharmacy appointment. She notes that D did not have any complaints before or after the appointment?specifically she denies observing any weakness, dizziness, cough, and fever. D went on to have an uneventful day with normal appetite and bedtime. ************ also mentions that there were no adverse reactions following the first dose either. The next morning (3/11/21) at 6am the decedent?s wife found him in bed ?looking around the room? with gurgling agonal breathing. No seizure activity reported." "1094146-1" "1094146-1" "2nd dose administered on 2/20/21, on 2/23/21 the patient fell and sustained a facial injury" "1094164-1" "1094164-1" "deceased" "1094165-1" "1094165-1" "Patient received her first dose of the Mederna Covid vaccine at the Health unit on 03/10/21. Her family states she began experiencing nausea and vomiting last night (03/11/2021) and then started having chest pain at around midnight. This morning (03/12/2021) she was still experiencing vomiting and chest pain. She collapsed at approximately 07:30 and her family initiated CPR and EMS was called. She was brought the Hospital via Ambulance at 08:18 in cardiac arrest. The emergency department was unable to resuscitate her and she was pronounced dead." "1094187-1" "1094187-1" "ABDOMINAL PAIN BACK PAIN death" "1094197-1" "1094197-1" "DEATH - PT'S WIFE CALLED 3-11 TO TELL US PATIENT WAS FEELING BAD, AND TO ASK WHAT TO DO. WE SENT A PULSEOXIMETER, AND ADVISED TO CONTACT DR. - ON MORNING OF 3-12, PT'S WIFE CALLED TO TELL US HE HAD PASSED AWAY DURING THE NIGHT." "1094208-1" "1094208-1" "ALTERED MENTAL STATUS Death" "1094242-1" "1094242-1" "Fall, fever, head injury, body aches, weakness, death" "1094290-1" "1094290-1" "Patient died on March 10th 2021 and received the vaccine on February 23 2021. Patient had health issues. Spoke with coroner and patient did die at home. Patient was taken straight the the funeral home afterwards." "1094300-1" "1094300-1" "death" "1094322-1" "1094322-1" "2nd dose given on 2/24/2021, deceased on 3/2/2021" "1094343-1" "1094343-1" "ABDOMINAL PAIN death" "1094402-1" "1094402-1" "death" "1094421-1" "1094421-1" "cardiac arrest death" "1094441-1" "1094441-1" "death" "1094468-1" "1094468-1" "Hospitalization after a fall resulting in femoral neck fracture. Patient deceased 3/4/21." "1094490-1" "1094490-1" "Patient was vaccinated with her second dose on Wednesday, February 24th. A family member contacted us to let us know she was sitting in a casino exactly one week later and passed out, going into cardiac arrest. The patient did pass away." "1094512-1" "1094512-1" "Emesis 3/4/2021 03/05/2021 Pneumonia" "1094638-1" "1094638-1" "Exposure to Covid 19 either on the date of vaccine (2/13/21) or shortly thereafter. Symptoms of Covid started on Monday (2/15) early morning following shot. Dr. ordered Covid test on Weds. (2/17). Taken by ambulance to Hospital, approx. 7 pm on Saturday (2/20) with dehydration, low oxygen levels, confusion, shaking and cough. Admitted to hospital with threats of ventilator up until Weds (2/24) when he was intubated, proned and FINALLY given hydration via IV fluids. He went into kidney failure on Thursday (2/25) and put on dialysis. Other organs began shutting down and was taken off the ventilator on Friday (2/26) and did not recover. He passed away just before 4:00 p.m. on 2/26/21." "1094719-1" "1094719-1" "Patient reported as deceased 3 days after vaccination by son." "1094868-1" "1094868-1" ""Started having confusion at 3#0 a.m. Sunday morning. Unstable gait and hypoxia at home. More congested than usual. Had 2nd COVID vaccine 4 weeks ago. Had visual hallucinations with seeing ""bugs"" Admitted with positive COVID and Influenza B diagnosis."" "1094979-1" "1094979-1" "Death within 60 days of COVID vaccine administration. Dose 1 on 12/23/2020 Dose 2 on 01/13/2021" "1094990-1" "1094990-1" "Death within 60 days of COVID vaccine administration" "1094993-1" "1094993-1" "2nd vaccine dose given on 02/16/2021, admitted to hospital on 02/24/2021 CARDIAC ARREST RECTAL BLEEDING died on 03/03/2021" "1095001-1" "1095001-1" "Death within 60 days of receiving COVID vaccine" "1095020-1" "1095020-1" "Passed out then was brain dead . Death" "1095025-1" "1095025-1" "shortness of breath 3 days after 2nd dose injected. admitted on 2/19 shortness of breath admitted on 2/26 shortness of breath admitted on 3/2 cardiac arrest, neck mass, seizure like activity, acute respiratory failure died on 3/06/2021" "1095038-1" "1095038-1" "death" "1095053-1" "1095053-1" "death" "1095070-1" "1095070-1" "SHORTNESS OF BREATH Respiratory distress Hypoxia Pneumonia due to COVID-19 virus Death" "1095081-1" "1095081-1" "Death" "1095111-1" "1095111-1" "Admitted on 2/17/2021 2nd dose injected on 2/20/2021 Shortness of breath died on 03/04/2021" "1095124-1" "1095124-1" "Chest pain DOE (dyspnea on exertion) Pneumonia of both lungs due to infectious organism, unspecified part of lung Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present Death" "1095140-1" "1095140-1" "death" "1095149-1" "1095149-1" "death" "1095160-1" "1095160-1" "death" "1095170-1" "1095170-1" "patient status started to decline within a few hours of receiving her covid vaccine she was weak, developed increased shortness of breath and went to the emergency room were she was diagnosed with STEMI and within 2 days expired." "1095174-1" "1095174-1" "Cardiac arrest Acute respiratory failure with hypoxia Death" "1095183-1" "1095183-1" "Death" "1095184-1" "1095184-1" """"Pfizer-BioNTech COVID-19 Vaccine EUA"" Patient was discovered deceased this morning by her family members."" "1095236-1" "1095236-1" "death" "1095238-1" "1095238-1" "Patient at the time of vaccination on 3-8-21 has having issues with shortness of breath and edema consistent with congestive heart failure, the following day on 3-9-21, he was having more issues with shortness of breath, tachycardia, low O2 saturation. He was given meds in the clinic and monitored until he was feeling better with increased O2 sats. He was found unresponsive on his housing unit one hour later and failed to respond to resuscitation efforts and was pronounced expired at 1047." "1095254-1" "1095254-1" "Shortness of breath Death" "1095300-1" "1095300-1" "According to Medical Center's report, patient was brought to ED deceased upon arrival via EMS on 03/12/2021 at 8:57am. Patient had been seen on 3/11/2021 at same ED complaining of a heavy type of chest pain in the mid chest, also noting body aches, headache, and nausea." "1095327-1" "1095327-1" "I was alerted on 3.11.21 by the patient's wife that patient had passed away the night after having received the vaccine. The wife informed me that she did not wake up the next morning." "1095360-1" "1095360-1" "SHORTNESS OF BREATH Bradycardia Hypothermia Cardiomyopathy Elevated troponin Acute renal failure (ARF) Death" "1095392-1" "1095392-1" "Received shot 02/04/2021, sudden Cardiac Arrest 2/8/2021, found 2/10/2021" "1095393-1" "1095393-1" "Cardiac Arrest" "1095406-1" "1095406-1" "death" "1095424-1" "1095424-1" "death" "1095435-1" "1095435-1" "Headache, nausea on 1/25 progressed to SOB 1/26 and death 1/27" "1095437-1" "1095437-1" "2nd dose injected on 02/19/2021 death on 2/24/2021" "1095456-1" "1095456-1" "date of injection 01/30/2021 CARDIAC ARREST 1/30/2021 Death 1/30/2021" "1095536-1" "1095536-1" "2nd injection given on 02/16/2021 Altered Mental Status admission on 3/3/2021 Intracranial bleeding Unresponsive Intracranial bleed Death on 3/6/2021" "1095545-1" "1095545-1" "death" "1095555-1" "1095555-1" "Death" "1095562-1" "1095562-1" "death" "1095571-1" "1095571-1" "death" "1095589-1" "1095589-1" "death" "1095596-1" "1095596-1" "cardiac arrest death" "1095605-1" "1095605-1" "death" "1095634-1" "1095634-1" "2nd injection given on 2/19/2021 death 2/27/21" "1095636-1" "1095636-1" "death" "1095642-1" "1095642-1" "death" "1095659-1" "1095659-1" "death" "1095666-1" "1095666-1" "Patient received his 2nd dose of Moderna COVID-19 vaccine yesterday. He was found dead at his home today. After speaking with the County Coroner, an autopsy is not planned. Patient had COPD, Type II Diabetes, cardiovascular disease, and a pacemaker. The coroner does not believe vaccination was contributory to his death." "1095668-1" "1095668-1" ""62 yo M with no known medical history awoke 12:15 am on 3/11/2021 and told his wife he had ""pain all over"". When she asked if it was chest pain, he said he didn't know. He went downstairs, vomited, slumped over against the wall behind the couch, and became unresponsive. Wife called 911 and was instructed to begin CPR. EMS crew arrived shortly after that and performed prolonged resuscitation efforts as per ACLS protocol. Pt pronounced at 3:15 am. Patient had not seen a physician in many years, had not had any vaccines in over 20 years, took no medications, and had no known medical history. He did have a strong family history of heart disease and had told his wife the week prior to his death that he had suffered a several-hour bout of chest pain that resolved spontaneously 2-3 days prior to his telling her about it. He refused to seek medical evaluation despite her urging."" "1095695-1" "1095695-1" "death" "1095725-1" "1095725-1" "death" "1095737-1" "1095737-1" "Shortness of breath Acute on chronic renal failure Abnormal LFTs Death" "1095748-1" "1095748-1" "death" "1095757-1" "1095757-1" "Death" "1095765-1" "1095765-1" "death" "1095771-1" "1095771-1" "death" "1095779-1" "1095779-1" "death" "1095791-1" "1095791-1" "Hip pain death" "1095798-1" "1095798-1" "death" "1095862-1" "1095862-1" "received a phone call from the daughter of the patient. On 01/21/2021, patient came in and got his first Covid Vaccination. 3 days after the vaccination, the patient experienced really bad diarrhea, and was sleeping for 22 hours a day. 2 weeks later he perked up a little bit. On 02/23/2021, patient received his booster. Daughter states that 2 days later, patient shut down completely, not eating or drinking. The patient ended up passing away on 03/05/2021." "1096197-1" "1096197-1" "Low pulse, lethargy, labored breathing. Oxygen was administered." "1096461-1" "1096461-1" "Patient received vaccine at 10:35am, was observed for 15 minutes then returned home with family. Patient began to not feel well, experienced cardiac arrest as witnessed by son, was taken to hospital Emergency Department where she expired at 12:50pm." "1096497-1" "1096497-1" "Notified by police department that patient was found dead at his home on 3/12/21. Per the officer, the family reports patient reported diarrhea on 3/11/21 and fatigue on 3/12/21. The family found him in his home deceased later in the day on 3/12/21" "1096600-1" "1096600-1" "Per the patient's spouse and Hospital: The patient received a rapid COVID test at clinic prior to vaccination, which read negative. The patient received vaccination on 2/23/21 and the following day (2/24/21) began to experience breathing difficulties. The patient was admitted to the emergency room at Hospital on 2/26/21 and diagnosed with hypoxic respiratory failure d/t COVID-19 (oxygen saturation < 50%). Patient was intubated on 3/2/21. Per Hospital pharmacist, patient expired on 3/12/21 at 6:40pm." "1096602-1" "1096602-1" "Hospice nurse reported patient started experiencing fatigue, nausea, dizziness, decreased appetite and shortness of breath immediately following vaccination. Hospice medications were ordered and patient began receiving morphine and nebulizer treatments. She then started having dysphasia. She then died on 3/5/21 from presumed respiratory failure." "1096913-1" "1096913-1" "My father passed away on February 10th, 2021. On Monday, January 25th 2021, he said he is feeling very uncomfortable in his chest area. He thought it was severe acid reflux. He took Gas X for Acid Reflux and told us that he does not want to go to the hospital. On Tuyesday, January 26th, he felt that his Acid Reflux symptoms got worse, he still did not want to go to the hospital. He took Tums. On that evening, he started having shortness of breath. We took his BP at home and it was very low. We begged him to go to the hospital, he still did not want to go. On Wednesday, January 27th, his shortness of breath got worse and we convinced him that he has to go to the hospital. We took him to ER. Doctor said that he had a heart attack on Monday morning and that is why he was not feeling well since Monday morning. While at the hospital, while the cardiologists were monitoring him, his heart condition got worse. By Friday, February 5th, cardiologists said that he is very fragile, his heart condition is very fragile and he won't survive any procedure. They said that something triggered the heart attack. We told them about the vaccination on 1/13/2021. They sent him home on hospice on Friday, Feburary 5th, 2021. He was on supplemental oxygen when he came home. He passed away due to a heart attack on February 10th, 2021 around 9pm." "1096952-1" "1096952-1" "Patients cancer progressed quicker than expected. Resulting in his passing" "1097000-1" "1097000-1" "No adverse events were immediately reported, but patient died on 7th day following vaccine" "1097244-1" "1097244-1" "Death within 7 days of vaccine. COD Cardiac Arrest" "1097283-1" "1097283-1" "Death within 7 days of vaccine" "1098028-1" "1098028-1" "Cardiac arrest, death approx 12 hours later" "1098119-1" "1098119-1" "in the early am she had bad diarrhea , she went to work and then started having really bad stomach pains and before noon she had to go home because she started puking. She laid down to take a nap around 3:30pm and never woke up." "1098178-1" "1098178-1" "2nd dose of covid19 vaccine administered on 1/25/21 AM. First dose was about 12/28/2021. Patient had a change in condition noted same day PM, which included worsening mental status with increased confusion such as disorientation and decreased functional status, as well as opening of pressure ulcer on coccyx. Patient became lethargic. Patient condition worsened over the next few days. Patient decreased oral intakes, including medications. Care and comfort measures were in place. Patient expired on 2/4/2021." "1098299-1" "1098299-1" "Husband returned for second dose of COVID-19 vaccine and reported that wife, expired the day after her first dose of the COVID vaccine. Medical team did not feel that there was a correlation so we were not notified prior to that date" "1098473-1" "1098473-1" "My mother had the shot on January 25. On the 30th, she became confused and was having trouble swallowing. I took her to the hospital on the 31st (Sunday). She was admitted with pancreatitis and was unable to drink water. She was then admitted to the ICU. She became septic and her mental status declined. By Tuesday, she was placed on a ventilator. She then had renal failure and died on February 18th." "1098680-1" "1098680-1" "Pt completed 2 covid vaccine morderna doses Feb 18, 2021. Pt with increasing weakness and short of breath for 3 days PTA on 3/6/2021." "1098856-1" "1098856-1" "Four hours after vaccine shot, she began with a headache then severe vomiting. She became in coherent and when brought to the hospital she had a brain hemorrhage. She passed away on 3/3/2021 at 3:05pm." "1098902-1" "1098902-1" "Death" "1099216-1" "1099216-1" "PATIENT'S SISTER REPORTED PATIENT PASSED AWAY 03/07/2021" "1099326-1" "1099326-1" "A few days after vaccination patient had an unusual dry cough/ and then a pain in his chest, He called our Doctor she said call your cardiologist now, patient called Dr and told him he wanted to go to his office, explained the pain he was experiencing - the doctor told him said he couldn't see him wanted to do a telemed exam. and proceeded to tell patient to see an gastro entomologist, take Tums, no tomatoes, no coffee and a few other foods and that patient was suffering from Acid Reflux and to call him back net week." "1100562-1" "1100562-1" "She died 5 days after her second vaccine; This is a spontaneous report from a contactable consumer. An 83-year-old female patient (Not pregnant) received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number not provided), via an unspecified route of administration in the left arm on 12FEB2021 at 03:00 PM (at the age of 83-years-old) at single dose for covid-19 immunisation. The subject had a history of Heart condition and thyroid. Relevant concomitant medications included calcium, fish oil, multivitamin and potassium. The patient died on 16Feb2021 (12:00 PM), 5 days after her second dose of vaccine (as reported). The cause of patient's death was unknown. She had no adverse effects until her death. It was unknown if autopsy was performed. Information on batch/lot number was requested.; Reported Cause(s) of Death: She died 5 days after her second vaccine" "1100650-1" "1100650-1" "Patient died two days after receiving vaccine. Death certificate said respiratory failure." "1100685-1" "1100685-1" "Death 1 week later. No other information available." "1100865-1" "1100865-1" "Patient died within 24 hours of vaccine. Unknown at this time if related." "1100951-1" "1100951-1" "Patient was found unresponsive by family members in the early morning on 2/23/2021. Patient passed away." "1100963-1" "1100963-1" "High temperature second day after vacination. Tylenol treatment to drop the high temperature. Passed away by pulmonary embolism suddenly." "1101239-1" "1101239-1" ""Patient had been slowly declining over the past year due to dementia and age. On the date of her second vaccination, Feb. 17, she was getting around with her walker. On Friday, Feb. 19, she was so weak she was no longer able to walk with her walker, and she declined every day thereafter. On Monday, Feb. 22 she began crying and saying ""help me"". That lasted approximately a week. her health declined every day until Saturday, March 6, when she passed away at 6:15a."" "1101286-1" "1101286-1" "Large Stroke" "1101602-1" "1101602-1" "Later that day after receiving the shot, patient reportedly became very ill with fever, vomiting, and diarrhea. He was found deceased the next day when friends went to check on him." "1101662-1" "1101662-1" "PATIENT PASSED AWAY BEFORE THEY COULD RECEIVE THE SECOND DOSE OF THE SHOT. WE ARE NOT SURE IF IT WAS VACCINE RELATED OR NOT." "1101690-1" "1101690-1" "THE PATIENT HAD PASSED AWAY AND WAS UNABLE TO GET HIS SECOND SHOT TO COMPLETE THE SERIES. WE ARE UNSURE IF THE VACCINE WAS RELATED TO HIM PASSING." "1101718-1" "1101718-1" "Patient was taken by ambulance to E.R. 3 days after injection with bleeding from the nose and blood in stool. Spent 10 days in hospital. Returned to ER a few days later with fluid leaking from arms and legs. Diagnosed with congestive heart failure. Sent home under Hospice. Returned to ER, by ambulance, 36 hrs. later. Still weeping from skin and placed in ICU. on Bipap machine . Transferred that evening to medical Care Center where she passed away on March 3, 2021." "1101761-1" "1101761-1" "Trouble breathing. Taken to ER. Diagnosis Congestive Heart Failure. No Previous such diagnosis. Admitted for 6 days with Metropolo benign only new prescription. After 2nd shot on February 2 had follow up visits but started experiencing light headless. On February suddenly went limp with loss of pulse and breathing. Taken to Hospital ER, admitted without neurological responses. Died on February 22." "1101780-1" "1101780-1" "Resident expired the next day" "1101837-1" "1101837-1" "The patient became ill two days after the vaccination, and was hospitalized. He was diagnosed with COVID pneumonia on the 15th, and subsequently died." "1101884-1" "1101884-1" "History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on 2/17/21 Unsure if any relation but patient was treated in our urgent care on 3/8/2021 18 day post receipt of 2nd COVID-19 vaccine unresponsive. Patient received ACLS support for unknown cause with suspected neurological/respiratory/cardiac complications. Patient was transferred to higher level of care." "1101959-1" "1101959-1" "He passed on 02/06/2021" "1101991-1" "1101991-1" "In ED on 2/25/21 Chief complaint: Patient's daughter present at bedside stating patient was not vocalizing this morning when she woke up. Patient's daughter was talking to her and she would orient to her but not answer any of her questions. EMS called and by the time they arrived patient was acting her normal self. Daughter states she has had a very difficult time managing patient's behaviors over the last several weeks and it has been getting more difficult. Daughter states that over the last several weeks her behaviors have been worsening and been more difficult to deal with. These include her getting up at night and sundowning as well as yelling and screaming during the day. Daughter states that she gets in the shouting matches with the patient during the day. Daughter breaks down and starts to cry when discussing that she thinks her mother will need long-term placement as she is having a difficult time dealing with her behaviors. Of note patient did receive second dose of Covid vaccine yesterday. -Patient has not been complaining of any symptoms over the last several days and daughter has not noticed cough or congestion or other signs of URI/illness -No focal neurologic deficits on exam -Received 1L IV NS in ED 2/26/21 Covid positive, incidental finding ? tested so she could go to nursing facility -Patient asymptomatic -Vital signs stable, afebrile -She does not need treatment at this time -She will need a repeat Covid test 14 days after the original Covid test prior to going to SNF -Plan- discharge to skilled nursing facility Discharge summary Principal Problem: Comfort measures only status Active Problems: Chronic atrial fibrillation Essential hypertension Dementia with behavioral disturbance Recurrent falls Dysphagia COVID-19 Resolved Problems: Cough with hemoptysis Leukocytosis Dehydration Inadequate oral intake Patient is a 97-year-old female with a past medical history of dementia, likely combined vascular/Alzheimer's, hypertension, chronic A. Fib, who presented to the ED on 2/25/2021 due to behavioral disturbance as well as need for long-term care placement due to progressive dementia. She did have an incidental positive Covid test on 2/26/2021 and was planned for discharge to COVID recovery ward of SNF. She did not require medication or oxygen treatment for COIVD-19. She developed tachycardia/tachypnea and cough later productive for blood after suctioning attempts overnight on 2/28-3/1, which did not recur. Unfortunately, patient's overall function declined after, and she was refusing/unable to eat or drink. She was transitioned to comfort care status on 03/03/2021. She eventually slipped into persistent sleep with lack of responsiveness on 3/4/2021. Comfort care was provided. She had decreased urinary utput and respiratory function indicating expected progression. She was noted to not have a heart rate on 03/08/2021. Auscultation did not reveal any breath sounds or heart sounds; unable to palpate pulse; no pupillary response to light was seen; and patient did not respond to painful stimuli. Death was pronounced on 03/08/2021, 02:58am. Deceased 3/8/21" "1102082-1" "1102082-1" "Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia" "1102244-1" "1102244-1" "Patient expired on 02/26/2021 from a Myocardial Infarction" "1102308-1" "1102308-1" "Pt received Pfizer COVID Vaccine 3/9/21 at 13:25 At Clinic. Lot #EN6205 Exp 6/21 to right deltoid. No issues noted while patient dialyzing. Pt came off treatment 16mns early due to concerns of transportation. Pt a/o, VSS, pt in W/c no issues noted at discharge. Pt's comorbid conditions per hospital discharge records: <20% EF, deteriorating health status, physician recommended hospice care but pt refused. On March 11th, significant other notified facility that patient had passed away in his sleep and was found by workers at the rehab facility he was in." "1102443-1" "1102443-1" "On 2/18/2021 the resident spiked a fever of 101.7 and had decrease oxygen saturation down to 86% with a cough. The resident was transferred to the ER for evaluation. Per Advanced Directives resident was not treated with antibiotics and returned to the Nursing Home on 2/19/2021. The resident had several episodes of emesis and was placed on comfort measures. He dised on 2/25/2021." "1102572-1" "1102572-1" "Was notified by a third party that patient died on morning of 3/15/2021. No other information available." "1102698-1" "1102698-1" "Death 5 days after 2nd Pfizer vaccine" "1102722-1" "1102722-1" "Patient presented to Hospital ED on 3/14/21 with respiratory distress. Patient was tested for COVID-19 and found to be positive on 3/14/21 in the hospital ED. Patient was a DNR. Hospice was consulted (this writer is employed by Hospice). The patient passed away on 3/15/2021. Per family patient had recently received COVID-19 vaccine. Vaccine information verified in portal." "1102736-1" "1102736-1" "Spouse of an existing client signed up for a COVID-19 vaccination and received his first injection of Moderna on 03/07/21 by ARNP. He denied any symptoms of illness, including COVID-19, on the vaccination date. He was educated re: possible side effects and adverse effects and was asked to report any such effects; no interim contact received. This provider's office called the existing client on 03/15/21 with a routine matter and was advised that this individual had passed away the preceding day. This provider spoke to the existing client, who reported that the cause of death is unknown. The existing client did not believe that her spouse's death and the vaccination were related. She was asked to notify this provider if any further information is discovered and agreed to do so." "1102754-1" "1102754-1" "Patient contacted her employer 2 days after vaccination with complaint of new onset rash. Was seen by her PCP and was reportedly being treated for Shingles. Missed work week of 8-12 March for same. When didn't report to work today (3/15/21), supervisor went to home to conduct a safety check and found the patient dead in her home." "1102800-1" "1102800-1" ""Patient received a covid vaccine on 03/05/2021. Daughter reports there were no side effects that night or the following days. The next Saturday, March 13, 2021, the daughter was at her parents house checking up on them. Her father was in the bathroom as she passed in the hall. He came out of the bathroom and proceeded to the living room, she stated dad are you ok? He said he couldn't breath. Giving his history of COPD and being short of breath sometimes, she didn't think anything of it. She proceeded to follow him to his chair and was checking his oxygen tank that he had been using with ambulation. It still had some in the tank. She raised her head to tell him he still had some in the tank and saw that he had started ""agonal breathing"". Daughter is a nurse and knew he needed help. She phone for an ambulance and with the help of her mother got patient to the floor and started CPR. Paramedics arrived on scene, continued CPR and administered meds and also intubated, but were unsuccessful in their efforts."" "1102815-1" "1102815-1" "Patient presented to hospital on 3/11 with shortness of breath. History of chronic oxygen dependency at night. Became more sob over last several days and was not able to make it to md appointment. Had a recent abnormal stress test. Family states she was febrile at home. Was low on oxygen level on 2LNC, placed on non-rebreather and then BIPAP. Positive for Rhinovirus. Chest xray showed bilateral lower infiltrates. Patient detiorated through the night and was intubated and placed on vasopressors for septic shock. Patient was made DNR and family refused hemodialysis. Family then made decision to withdraw care." "1103055-1" "1103055-1" "Patient wife called on 3/11/21 to state that she would like us to cancel her husband second dose appointment for his COVID-19 Moderna vaccine. Wife stated that 24 hours after receiving vaccine patient died. Hospital told patient wife that it could be due to receiving COVID-19 vaccine. Unable to get anymore pertinent information from patient representative." "1103106-1" "1103106-1" "Patient died on 01/24/2021. Began exhibiting symptoms similar to Covid 1 day after vaccination." "1103186-1" "1103186-1" "Patient was vaccinated with the Pfizer vaccine in early February. On February 19th, she was diagnosed with Acute Myeloid Leukemia" "1103192-1" "1103192-1" "Patient passed in his sleep 5 days after receiving first dose of Moderna" "1103241-1" "1103241-1" "On 01 February 2021 a 97 year old male was administered the Pfizer COVID vaccine. Side effects began as fatigue and difficulty communicating. On 08 February 2021 the male became bedridden and developed a fever with chills. Over the next few days he struggled to eat, drink, and eventually to breath. The 97 year old died 25 February 2021." "1103347-1" "1103347-1" "At 2 PM Friday, March 12, patient was cleaning house and began speaking incoherently. Due to the aphasia, her daughter called 911. The ambulance delivered her to Hospital by 2:20. She presented with a brain hemoragh. Hospital called for medivac which took her to another Hospital. The bleeding continued and the docs ruled out surgery. They were unable to slow the bleed. Patient was put on a ventilor shortly after arriving at hospital. Patient passed at 6:55 PM March 13." "1103656-1" "1103656-1" "Patient was found deceased in garage. Neighbor who is a nurse did CPR until ambulance got there and took over, started IVs and pushed medicine and did CPR as well. Patient was pronounced deceased over th ephone with the JP and Police due to the icy weather conditions on Feb 16th 2021" "1103708-1" "1103708-1" "Diarrhea, Stiff Neck, Overall feeling not well, Loss of strength" "1103748-1" "1103748-1" "Cardiac Arrest/Death" "1103750-1" "1103750-1" "DAY AFTER, PT COMPLAINED OF PAIN IN LEFT COLLAR BONE. PATIENT DECLINED IN FUNCTION OVER NEXT 11 DAYS. HOSPICE WAS CONSULTED AND PT PASSED ON 2/23/21" "1103813-1" "1103813-1" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103821-1" "1103821-1" "Weakness Death" "1103826-1" "1103826-1" "chest pain, acute heart failue death" "1103831-1" "1103831-1" "death" "1103837-1" "1103837-1" "shortness of breath, dizziness death" "1103847-1" "1103847-1" "weakness fever death" "1103876-1" "1103876-1" "shortness of breath, cough, nausea, diarrhea death" "1103885-1" "1103885-1" "death" "1103943-1" "1103943-1" "unexplained death" "1103955-1" "1103955-1" "No adverse reactions at the time of vaccine. Was admitted to hospital 5 days later with BLL pneumonia and passed away on 03/10/2021" "1103970-1" "1103970-1" ""Reported by EMS per report from wife that he was ""sick after shot"" and got worse during the night. Wife found him the following morning cold and pale, pulseless. Dispatch called at 719AM. Pt pronounced on the scene and taken to Funeral Home. Uncertain if Medical Exam is planned"" "1104031-1" "1104031-1" "Patient died of cardiac arrest at hospital 3/12/2021" "1104080-1" "1104080-1" "death" "1104175-1" "1104175-1" "She received the 2nd Dose on 3/9/2021. On 3/10/2021 She complained of a headache. On the morning of 3/11/2021 she complained of abdominal pain and had no appetite. We then found her unresponsive, called 911 and the medics pronounced her at around 1300." "1104177-1" "1104177-1" "first vaccine (Moderna) was injected on 02/03/2021, second vaccine (pfizer) was injected on 03/02/2021, my Mother was dead on 03/08/2021. with no symptoms on 03/07/2021." "1104252-1" "1104252-1" ""Death Narrative: On 2/12/21, patient was hospitalized at Medical Center with ""leaking and swollen legs."" Patient was transferred to hospital 2/13/21 for a vascular surgeon consult, where patient was diagnosed with lower extremity ischemia and acute diastolic heart failure. A bilateral, common endarterectomy with bovine angioplasty and bilateral iliac stent placement was performed on 2/17/21. Patient was discharged to a skilled nursing facility on 2/26/21. Patient had received first covid vaccination on 1/29/21. He was due to receive his second dose on 2/26/21, however, the appointment was moved to 3/10/21 since patient was hospitalized. Patient received his second dose on 3/10/21. Patient was hospitalized again (reason for hospitalization unknown) where he passed away 3/11/21 at hospital."" "1104257-1" "1104257-1" "Death Narrative: 1st Dose of COVID Vaccination" "1104258-1" "1104258-1" "Deceased Narrative: Patient was a 79 yr old male with a PMH of metastatic rectal cancer with colostomy s/p chemo with RT in 2015-16 with recurrence in 2020, was on holiday from palliative chemo since 9/23/20 due to chemo-related toxicity. Patient was admitted back to Facility on 10/08 for RLE pain ins/o increased weakness and functional decline. Patient decided to transition to hospice care and was admitted to Facility 10/13 for end life care, where he continuously showed signs of functional decline." "1104337-1" "1104337-1" "On 3/23 at 0730 resdient non responsive with saliva foaming from mouth. BS 500. All vitals initially Ok then sats dropped to 75. (11 was called immediately upon finding resident. Taken to hospital. Completed course there and later on to rehab. She expired 3/11/2021" "1104364-1" "1104364-1" "Death within 24 hours of receiving vaccine" "1104384-1" "1104384-1" "Being in the Mall, accompanied by her cousin, felt a severe headache and pain in both shoulders followed immediately by fainting, cardio-respiratory arrest that required call 911 for emergency transfer to Hospital. She was intubated in the emergency room treated by the doctors, Cardiologist and Intensive care where she was subjected to hypothermia and other treatments due to the serious neurological damage that she presented. No other organ seemed compromised. Never came out of the coma, passing away on February 26, 2021." "1104428-1" "1104428-1" "Deceased Narrative: Patient was outpatient, there is no information about reactions, underlying or active conditions between the time they came in for their first Pfizer dose and their death." "1104429-1" "1104429-1" "Death Narrative: Patient with medical history significant for malnutrition and end stage COPD. Patient was on 5 to 6 liters/min of oxygen. On 3/10/21, patient received his first COVID-19 vaccination. On 3/12/21, patient was admitted to Hospice for home hospice care due to worsening of COPD. Per medical examiner, patient passed away on 3/13/21." "1104430-1" "1104430-1" "Death Narrative: Patient has been admitted to a home hospice program since approximately 11/12/20 with an initial terminal diagnosis of dysphagia which was later changed in February 2021 to vascular dementia. Patient with significant past medical history of several CVA's which led to aphasia and vascular dementia." "1104431-1" "1104431-1" "Cardiac arrest Narrative: An 82 year old, male, resident of a facility, received his first dose of the Pfizer COVID vaccine on 12/30/20 (time of dose not known). On 12/31/20, patient was reported to be febrile with increased lethargy and UTI was suspected so patient received a dose of ceftriaxone and levofloxacin. Within 30 minutes he became wheezy and short of breath, developed hives and tongue swelling. He required intubation and admission for treatment of acute respiratory failure, acute kidney injury and significant lactic acidosis. Treatment included epinephrine, H1 and H2 blockers, and steroids. He recovered and was extubated on 1/3/21 and discharged back to the facility on 1/6/21. Attending physician noted that antibiotics were most likely contributor to event, but recommended that patient not receive the 2nd COVID vaccine dose. Patient was referred to an allergist to assess this event, with an outpatient visit on 1/14/21. Patient expressed interest in receiving the 2nd dose. Allergist determined that the antibiotics were the cause of anaphylaxis, and recommended skin testing to take place 6 weeks after his reaction. Allergist determined the reaction was not due to the COVID vaccine and advised patient that he could receive the 2nd dose. Patient received the 2nd dose of the Pfizer COVID vaccine on 1/9/21 (time not known). Notes from the facility indicate patient was lethargic and running a fever the morning of 1/20/21. At 1500 on 1/20/21 patient was noted to be lying supine in bed, visiting with aides. At 1508 nurse entered room and noted patient to be lying on floor supine and nurse was unable to get patient to respond to shaking or calling his name. Breathing was noted to be labored, and nurse was unable to detect a pulse. At 1509, 911 was called and CPR initiated. Spontaneous pulse and breathes resumed just before ambulance arrived at 1522. On arrival at the ED patient was responsive and breathing spontaneously, however, hemodynamically unstable. Patient went into cardiac arrest and code blue called at 1535. Received treatment with epinephrine, methylprednisolone, diphenhydramine, amiodarone, atropine. Patient was intubated. EKG obtained and showed acute MI. At 1622 he again went into cardiac arrest and time of death was called." "1104666-1" "1104666-1" "Patient presented with dyspnea and found to have COVID 19 infection. Treated with steroids and oxygen but clinically deteriorated and died" "1104671-1" "1104671-1" "Patient has a long history of seizures. He has seizures on a daily basis. He lives with his family, who are his primary caregivers, they family provides all of his activities of daily living. Patient received vaccine on Friday morning, feeling well throughout the day according to the father. Went to bed, during the night in bed he had seizures which is typical for him, and during the episode the father noticed that he had stopped breathing. called 911 who came to the house and the patient died in the house. I do not believe he went to the hospital." "1104698-1" "1104698-1" "RESPIRATORY DISTRESS Death" "1104699-1" "1104699-1" "Patient had been admitted to hospice care on 11/3/20. He reportedly declined in health and died 2/12/21." "1104720-1" "1104720-1" "death" "1104815-1" "1104815-1" "Seen in ED for positive COVID symptoms - discharged with instructions. Death 1/26/2021" "1104845-1" "1104845-1" "Deceased received second Moderna dose on 3/11/2021 at unknown location and unknown time. Complained of 'side effects' which are unclear at this time. Had a sudden witnessed cardiac event on 3/14/2021 and was rushed to a local emergency department. Diagnosed with ST elevation MI and could not be fully resuscitated." "1105115-1" "1105115-1" "Resident did not express having any symptoms, the only thing that the POC observed abscesses in the arm, groin, thigh and knees after the first vaccination. After the second dose, he was hypoactive. On 2/27 at about 3:30 am he asked him to turn on his side, between 4 am and 5 am POC went to the room I notice it strange, because his head was wrapped in the sheet. When the POC removed the sheet, she observed that her mouth and nose were full of secretions. So he turned it and he himself did not react. He called the emergency who certifies that he had no vital signs. (emergency arrives within 5:45 am to 6:00 am)" "1105125-1" "1105125-1" "Patient had a hemorrhagic stroke" "1105146-1" "1105146-1" "1/19 began vomiting and was hospitalized. On 1/30 he was discharged and later received the vaccine. It begins with weakness and a lack of appetite. He started coughing up foul-smelling secretions. He makes the arrangements to take him to the emergency room again, he called 911 to be transported, when they are taking the information from the POC, he is under oxygenation to 44. They take him in the ambulance, he receives CPR, they transport him to the facility where he arrives lifeless." "1105193-1" "1105193-1" "Death due to pulmonary fibrosis" "1105261-1" "1105261-1" "The patient was admitted to hospice because she stopped eating and deteriorated. He was being given food through the tube and then he has no vital signs." "1105300-1" "1105300-1" "He went to the hospital for cardiovascular problems and cholecystitis and was under treatment after the first dose. 2/26/2021 at around 11:00 pm she was complaining of high blood pressure, uncontrolled vital signs, uncontrolled sugar, at 6:00 am she has passed away. They certify respiratory failure." "1105408-1" "1105408-1" "Death" "1105600-1" "1105600-1" "Death on Feb 14, 2021" "1105679-1" "1105679-1" "My father complained of heartburn the evening he received his vaccine. He told my mother he need to sit down and relax. My mother walked into the other room to watch some TV while she allowed my dad to relax. During that time, my mother fell asleep. She woke up after an hour when she realized my dad was not sitting next to her. She went to the living room where he was sitting and discovered he was not breathing and passed away. EMT was called and they said they could not do anything for my dad since he was already gone." "1105749-1" "1105749-1" "Patient died on 2/28/2021" "1105772-1" "1105772-1" "My mother died on February 19, 2021. She had her 2nd dose vaccine on 2/11, on 2/12 it was noted that she was not able to walk, on 2/13 she was walking at 30%, on 2/14 she was walking with difficulty, on Monday 2/15 she was throwing up violently and her blood pressure dropped, so she was sent to Clinic. My sister was told she was just constipated and she had A Fib (never reported before to us). My sister was then told on 2/16 early a.m. that she had a blood clot that destroyed her colon. Due to age surgery would likely not be successful. She then died on the Friday. We are reporting in the event that the Pfizer vaccine was somehow a contributing factor to the A fib or to the Clot. She has no history of A fib or clotting prior to this incident. She was 93, and did have dementia, but was able to eat normal foods prior to this. What was unusual was the challenge in walking the day after the shot. Other than that no difference was observed until the day she was admitted to the hospital emergency room. She was a resident at Assisted Living, Memory Care, and that is where she received the vaccine. The mailing address I provided is her mailing address prior to death." "1105820-1" "1105820-1" ""Patient seen and evaluated by PA-C. with myself. We agreed on the clinical findings and implemented our plan together. Please see PA's note for details. All relevant procedures supervised. Patient arrived to the emergency department due to respiratory symptoms, hypoxic, reported that Wednesday he received his 2nd dose of COVID vaccine. His initial workup was concern for NSTEMI with elevated troponin and peaked T-waves, his chest x-ray concerning for COVID/pneumonia. Patient initially tolerated oxygen by nasal cannula and sepsis protocol was started including IV fluid resuscitation that was done cautiously due to the concern of COVID with respiratory failure. The biotics were given. PA-C readdressed code status with patient who confirmed that his DNR DNI, she so contacted his daughter. Patient had multiorgan failure including acute kidney injury, and pneumonia with respiratory failure +/- respiratory failure. Due to the concern of NSTEMI patient was initially going to be transfer to was hospital and transfer was started. Patient respiratory status started deteriorating and his blood pressure dropped slightly but improved after 500 cubic centimeters of IV fluid and he was also placed on a NIPPV. Around 6:00 p.m. patient has significantly desaturation and he discontinued himself NIPPV. Due to inability to intubate patient, he was ventilated with BVM, patient is slowly improved saturation levels and was opening his eyes, he was placed on a non-rebreather. At this point there is high concern of ARDS and due to inability to intubate or give for the respiratory support His daughter was at bedside and updated of current medical status and poor prognosis. Patient continued deteriorating and at this point he had agonal breathing. His daughter was at bedside and she was made aware of the futile prognosis of patient due to his respiratory failure. Patient rapidly became bradycardic and went into cardiac arrest. No CPR was done due to the DNI DNR status of the patient. Critical Care Procedure Note Authorized and Performed by: MD Total critical care time: Approximately 30 minutes Due to a high probability of clinically significant, life threatening deterioration, the patient required my highest level of preparedness to intervene emergently and I personally spent this critical care time directly and personally managing the patient. This critical care time included obtaining a history; examining the patient; pulse oximetry; ordering and review of studies; arranging urgent treatment with development of a management plan; evaluation of patient's response to treatment; frequent reassessment; and, discussions with other providers. This critical care time was performed to assess and manage the high probability of imminent, life-threatening deterioration that could result in multi-organ failure. It was exclusive of separately billable procedures and treating other patients and teaching time. Please see MDM section and the rest of the note for further information on patient assessment and treatment. PE: VITAL SIGNS: BP: 126/75 Pulse: (!) 122 Resp: (!) 40 SpO2: (!) 82 % Temp: 98.1 ¦F (36.7 ¦C) Height: 5' 8"" (172.7 cm) Weight: 152 lb (68.9 kg) General: Alert, nontoxic, in no acute distress. Lungs: Clear to auscultation bilaterally. CLINICAL IMPRESSION: 1. Sepsis with acute hypoxic respiratory failure and septic shock, due to unspecified organism (HCC) 2. Suspected COVID-19 virus infection 3. NSTEMI (non-ST elevated myocardial infarction) (HCC) 4. Multifocal pneumonia 5. ARDS (adult respiratory distress syndrome) (HCC) 6. Acute kidney injury (HCC) Further care and disposition otherwise as outlined by PA. ED on 2/14/2021 Revision & Routing History Detailed Report Note filed date Mon Feb 15, 2021 8:46 AM"" "1106554-1" "1106554-1" ""She received vaccine on 12.28.21. On 12.30.21 she went to the ER and was subsequently sent to Hospital. Not sure what the findings were, but she was discharged after several hours. I spoke with her on the phone on 1.1.21,, She wasn't feeling well. I asked her what was going on because she had been doing really well for a few months. She stated ""Every since I took the vaccine, I have felt really bad."" She died on 1.5.21. Timeline: 12.28.20 Vaccine 12.30.20 ER 1.1.21 Continues to feel bad and reports feeling worse and worse since vaccine. 1.5.21 Died at home."" "1106581-1" "1106581-1" "Patient was discovered deceased in her apartment at 3pm on March 12, 2021." "1106603-1" "1106603-1" "100 year old patient in reasonable health (reading, socializing, doing Zoom calls, etc.) took second Pfizer vaccine on February 5, 2021. On the morning of February 22, 2021 the patient suffered a major hemorrhagic stroke. He suffered severe paralysis, could not speak, and suffered from severe pain. Within 24 hours he was moved to Hospice Care. A day later on February 24, 2021 he died." "1106667-1" "1106667-1" ""Information here obtained from daughter: on Thursday patient had an uneventful fistulagram with angioplasty. Patient got vaccine at end of usual Friday am dialysis treatment. He was observed for about 30"" and no untoward event noted, vitals usual. At home on Saturday morning, seemed not quite himself by wife as reported by daughter, from whom i got his information. He gets up late as hemodialysis starts at 515 am. No reported problems on Friday. On Saturday morning, he seemed not himself but sat down and ate breakfast around 9 am. On getting up from table he got suddenly weak, his head rolled back and his eyes rolled up. 911 called and he was given resuscitation efforts of unknown duration which were unsuccessful. He was pronounced dead at 11 am and the mortuary was called. No premortem labs, et al."" "1106684-1" "1106684-1" "Resident on palliative/comfort care services since readmission to facility on 2/9/2021. Received first dose of Moderna COVID-19 vaccine on 1/7/2021. Received second dose of Moderna COVID-19 vaccine on 3/8/21. G-tube feeding discontinued on 2/14/21. Resident expired 3/10/2021." "1106719-1" "1106719-1" "Her daughter informed pharmacy staff that pt passed away on sunday 3/14/21" "1106733-1" "1106733-1" "First dose of Moderna COVID-19 vaccine given 1/7/21. Second dose of Moderna COVID-19 vaccine given 3/8/21. No adverse effects noted after vaccination. Resident was on hospice care since 2/27/2021 with poor food and fluid intake prior. Admitted to hospice with hypokalemia, failure to thrive." "1106737-1" "1106737-1" "weakness/malaise per daughter, death on 3/14 (did have underlying medical conditions)" "1106834-1" "1106834-1" "Patient apparently expired 3/09/2021, no other information known, unknown if linked." "1107265-1" "1107265-1" "white blood cell count was very high; death; This is a spontaneous report from a contactable consumer (ex-spouse) via medical information team. A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 02Mar2021 at a single dose (at the age of 52-years-old) for COVID-19 immunisation. Medical history included back pain: At some point before the vaccine was administered, he had a telehealth visit for reported back pain. Concomitant medications were not reported. The patient died on 05Mar2021 at his home. The patient received the first dose of COVID vaccine at a hospital on 02Mar2021. The patient was a fairly healthy active 52-year-old. At some point before the vaccine was administered, he had a telehealth visit for reported back pain. He was instructed to get blood work/labs done. A letter was received the day of his death that states his white blood cell count was very high and with it a recommendation that he seek medical attention. She (ex-spouse) reports the autopsy results won't be complete for a few months. The cause of death is unknown. The outcome of white blood cell count was very high was unknown. Information on the lot/ batch number has been requested.; Reported Cause(s) of Death: Death" "1107445-1" "1107445-1" "Site: Pain at Injection Site-Mild" "1107648-1" "1107648-1" "Developed leukemia and kidney failure. Died in 6 days." "1107656-1" "1107656-1" "Patient was found dead on 3/15/2021" "1107735-1" "1107735-1" "Death on March 8 due to a large blood clot at the base of his brain. This was 16 days after innoculation." "1107885-1" "1107885-1" "Patient presented to the ER on 3/2 for urinary frequency and lower abdominal pain. He was hospitalized at Medical Center- on 3/2/2021 for small bowel obstruction and acute kidney injury. Patient passed on 3/2/2021." "1107898-1" "1107898-1" ""5 days post-vaccination (1st dose of Moderna), patient started developing lethargy, and difficulty swallowing. 7 days post-vaccination patient looked ""ashen"". 12 days after vaccination patient was improving, but 14 days after vaccination patient was found to have (on lab work) critical hypernatremia (sodium level of 180 mmol/L), patient was re-referred back to hospice, and 17 days post-vaccination patient died."" "1107923-1" "1107923-1" "Patient died 2/6/21" "1108261-1" "1108261-1" "death Narrative: Patient received 1st dose of Moderna COVID-19 vaccine on 03/08/2021. Patient died 03/09/2021. Medical examiner received report that patient was alert before a fall on the night of 03/08/2021. Death certificate will report death likely due to arrhythmia due to underlying CHF. Contributing factors include diabetes." "1108262-1" "1108262-1" "Patient passed away unrelated to covid vaccine Narrative: The patient had hypertension, diabetes, hyperlipidemia and sleep apnea. Patient received first dose of Moderna vaccine 1/15/2021 and no adverse reaction was recorded. Clinical staff called to review patient's intent for second dose, patient is not interested and has elected to not receive second dose following clinical discussion of the risks and benefits of the COVID-19 vaccination. Patient was called on 2/17/2021 and his son stated patient passed away on 2/6/2021.Cause of death not documented. No indication that death was related to COVID 19 vaccination." "1108263-1" "1108263-1" "Death Narrative: Patient died at home on 2/11/21, two days after receipt of the Pfizer COVID19 vaccine. Reviewed death certificate and cause of death is listed as chronic systolic heart failure and pulmonary hypertension. That is all the information that I have." "1108264-1" "1108264-1" "DEATH Narrative: No information available in the record other than date of vaccine on 1/7/2021 with no adverse effects or complications noted during observation period. Patient was not known to have had COVID infection prior to death. Had last received medical care at facility in 2012 except received audiology care up to 12/2/2020. No recent hospitalizations known. No death note or autopsy noted. Only indication of death is the updated banner/date of death in demographics. Death most likely due to advanced age (84 y/o) in addition to comorbidities." "1108265-1" "1108265-1" "Death Narrative: 83 y.o. male with pmh of heart failure admitted on 3/9 for shortness of breath and weight gain. Had Vfib arrest on 3/12 and was intubated/xfer to ICU. Continued to require increasing levels of pressors. He suffered VF arrest in the setting of metabolic, septic and cardiogenic shock. He had end stage heart failure and required 4 pressors. Was made CMO and passed away. Noted to have not received 2nd does of Moderna likely due to hospitalization at the time that the second dose would have been due. Patients history of adverse drug reactions included: lisinopril, dabigatran, and penicillin." "1108267-1" "1108267-1" "Deceased Narrative: Patient was a 79 yo male with a hx of HTN, ETOH and tobacco use, PVD, HLD with no contact with health care since 2014. Patient presented to facility on 9/30 with worsening bilateral leg pain and SOB. During that hospitalization he dx with severe decompensated HF (EF 20-25%) and cardiomyopathy. Cardiac cath with severe CAD, however unable to perform interventions. Upon goals of care discussion, patient no longer wished to go to facility or aggressive medical management. Patient was transitioned to hospice for comfort care." "1108279-1" "1108279-1" "deceased Narrative: Patient was a 68M with advanced ALS, long-term need for mechanical ventilation, total care, TF, who developed worsening respiratory failure increasing difficulty with mech ventilation, unresponsive to COPD exacerbation treatment, in the setting of persistently abnormal CXR findings concerning for malignancy or other processes. After discussion with family, they did not want to patient to suffer any more and asked for mechanical ventilation be stopped after adequate comfort medications were administered. Patient was allowed to pass away naturally from his underlying advanced ALS." "1108312-1" "1108312-1" "Severe exacerbation of idiopathic capillary leak syndrome 48 hours following administeration of Janssen vaccine leading to profound vasodilatory shock, renal failure and DIC and death" "1108365-1" "1108365-1" "She had breathing problems, bowel movement problems, sharp pain -site unknown No appetite and nausea. Went to the Doctor on wednesday and they gave her a prescription for nausea (promethazine) 12.5mg She Passed away 03/12/2021 at 8:54pm waiting to be picked up by a friend that was going to take her to the emergency room/hospital." "1108469-1" "1108469-1" "Deceased Narrative: This was a 77 yo F with h/o HFpEF, afib (warfarin), COPD, obesity hypoventilation syndrome, OSA on BiPAP, T2DM, RA, L-sided follicular bronchitis and newly diagnosed probably malignant pulmonary process. Patient was admitted to facility 9/26-10/15 for acute on chronic hypercarbic respiratory failure with persistent O2 requirement despite treatment for CAP, COPD and CHF exacerbation. Patient then underwent high dose steroid taper per Rheum. Patient presented an overall poor state of health and was at high risk of complications with any procedures and was not a candidate for systemic therapy for a malignancy based on functional status. Patient was accepting of terminal diagnosis and transitioned to comfort measures at home." "1108470-1" "1108470-1" "Pulmonary Embolism Narrative: Patient was hospitalized with acute pulmonary embolis on 2/12/2021. Was started on Eloquis and discharged on 2/15/2021, with primary diagnosis of acute PE and BLE DVT. Secondary diagnosis of acute systolic heart failure with bilateral pleural effusions. On 2/17 we got notification that patient was placed on hospital." "1108471-1" "1108471-1" "death Narrative: Pt received 1st moderna covid vaccine 2/12/2021 and passed away of unknown causes 2/12/2021 Pt 76 year old with AAA,HTN,CKD,COPD" "1108472-1" "1108472-1" "cardiac arrest Narrative: Per medics, Patient was gardening when he stated he felt dizzy and collapsed. Wife started CPR until medics arrived. Patient arrived at the hospital after 20min of pulseless V tach and 10 min of PEA." "1108475-1" "1108475-1" "death Narrative: Patient received COVID vaccine # 1 on 1/6/2021, on 1/23/21 his wife reported to the facility that he passed away. Notes in database do not mention cause of death or where death occurred. There are no scanned records in database with any detail either." "1108476-1" "1108476-1" "Narrative: Dose #1 of vaccine was administered 2/6/21, per daughter's report patient became ill 3 days later (cough) and was taken to local hospital and was discharged with diagnosis of CAP, NSTEMI and acute on chronic CHF exacerbation. Discharged home on hospice where he passed away at home on 2/20/21." "1108477-1" "1108477-1" "Patient died unrelated to covid vaccine Narrative: The patient had advanced Alzheimer's disease and severe dementia. Patient received the first dose of Moderna vaccine on 1/7/2021 and no adverse reaction was reported. Placed in hospice care and passed away on 1/29/2021. Cause of death not documented. No indication that death was related to COVID 19 vaccination." "1108478-1" "1108478-1" "Death Narrative: Patient was outpatient. There was no information or document notes about reactions, underlying or active conditions between the time patient came in for the first Pfizer dose and their death." "1108588-1" "1108588-1" "After vaccine (2nd dose) on 3/04, patient resumed normal activities, running errands, etc. In the evening of 3/05, patient complained of extremely sore arms (not alleviated by painkillers) and nausea. Additionally, patient felt extremely cold. She went to bed early, at 7:00 pm, and was found dead the next morning 3/06 at 7:30 am. She had vomited. The coroner (not a medical examiner) declared cause of death as 1) cardiac arrest 2) hypertension and 3)hypercholesterolemia, based solely on medical records. There was no autopsy. Due to or despite medications, patient's blood pressure readings were typically low (last one 118/70), pulse normal (89), BMI 25.29, cholesterol levels normal (166/LDL 82), blood sugar 95." "1108595-1" "1108595-1" "senescence, hypotensive reaction to COVID-19 vaccination, COPD" "1108609-1" "1108609-1" "Patient was found unresponsive the morning of March 14, 2021. She was pronounced dead at 5:33 AM. The medical examiner quoted natural cause of death." "1108623-1" "1108623-1" "Fatigue, Body aches, loss of appetite, 100 degree fever for a short time. indigestion, nausea for about 3 days Fatal Heart attack 2/28/2021" "1108762-1" "1108762-1" "Patient without previous cardiovascular history with complaints of chest tightness and diaphoresis. Contacted the doctor's office and sent advise to go to ER for possible cardiovascular event. Witnessed cardiac arrest at home with unsuccessful resuscitation." "1108766-1" "1108766-1" "Family reported today 3/17/2021 that patient passed away 3/12/2021, they did not indicate that it had anything to do with the vaccination or give medical history." "1108959-1" "1108959-1" "Stroke resulting in death. Admitted to hospital 2/21/21 as transfer from first Hospital after found collapsed in his hotel room. Left M1 occlusion, thrombectomy performed, then had hemorrhagic trnasformation. Developed worsening respiratory status after extubation, was reintubated. Given poor neurologic status, was extubated and started on palliative morphine drip. Pt died 0100 3/1/21." "1109087-1" "1109087-1" "Pt expired in Community Hospital ED on 3-10-21. This was 5 days after receiving his second Moderna covid vaccination. Hospital nurse says ED report says multiple system problems." "1109309-1" "1109309-1" "After vaccine was administered patient was seemingly fine until a loss of consciousness/mini stroke on Jan 16 (5 days after vaccine) causing a fall and massive stroke on Jan 22 (11 days after vaccine) that left patient unresponsive and on life support until family decided to stop services and begin hospice care with no fluids or food until death" "1109346-1" "1109346-1" "When patient didn't show up for her second COVID-19 vaccine today 3/17/21, we couldn't reach her so we contacted her Dr. office. They informed us that patient visited the emergency department on 2/22/21 and passed away while in the hospital on 2/23/21." "1109350-1" "1109350-1" "unexplained death on 3/15/21" "1109418-1" "1109418-1" "sudden death, while sleeping 2 days after injection Vaccine 3/12/21 last seen conversant and comfortable at 3a 3/14/21 Found nonresponsive and not breathing at 8:30a 3/14/21" "1109427-1" "1109427-1" "Moderna Covid-19 Vaccine EUA After receiving the first vaccine, started making gasping noises at night, lethargy, fit bit would not register sleep at night, some breathing issues during waking hours. HR observed to decrease to under 40 over the last week of his life. 5 days after 2nd vaccine had extreme fatigue, nightmares, forgot to take regular meds in the morning, 6 days after he woke up very confused and had nightmares and 7 days after vaccination woke up late, exhausted, with shortness of breath all day and refused to go to ER. Went to bed early and died in the night with his CPAP machine on." "1109535-1" "1109535-1" "My Father had a hemorrhagic stroke. He passed away 13 days after receiving the second Modern?s vaccine." "1109552-1" "1109552-1" "Family call Clinical Lead to car for elderly woman in backseat of car who had become unresponsive. Patient lying on side. Wearing portable NC o2. Unresponsive to verbal/sternal rub. No pulse, No resps. Called AMR to car side who called 911. Transferred patient to a gurney and began CPR as we transferred to AMR rig. EKG - showed PEA - CPR continued - patient intubated by AMR - epi is given. Pt transported by AMR/Fire to hospital. Pt was a full code on Hospice - she passed away 3/11/21 with the following cause of death: 1.Acute-on-chronic hypoxemic/hypercarbic respiratory failure, multifactorial in origin. 2. Possible aspiration pneumonia, present on admission. 3. Bronchiectasis, chronic, secondary to asbestosis. 4. Acute combined metabolic and toxic encephalopathy, present on admission. 5. Out of hospital pulseless electrical activity arrest. 6. Hyperkalemia. 7. Cardiogenic shock. 8. Acute kidney injury. 9. Lactic acidosis. 10. Acute diastolic congestive heart failure. 11. Severe protein-calorie malnutrition." "1109578-1" "1109578-1" "Patient died at nursing home." "1109696-1" "1109696-1" "Pt presented to the ER on 1/4 2021 with worsening sob, found to have acute ST elevation MI and new rapid atrial fib with RVR. He tested positive for covid 19 requiring new oxygen and received his first pfizer vaccine on 12/31. He was acutely transferred to rochester general hospital. He progressed to multiorgan failure, sepsis, mrsa bacteremia and died on 1/14/2021" "1110099-1" "1110099-1" "3/12/21 Sudden cardiac arrest at home; unable to be resuscitated at scene (Brother) Caller is a family friend who was asked by family to call and report incident. If f/u is needed, please contact him first. Current Medical History: unknown by caller Current Medications: unknown by caller" "1110152-1" "1110152-1" "This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was seen at care now urgent care with the complain of epigastric pain associated with nausea vomiting and intermittent diarrhea. Patient received her initial COVID vaccine 2 days ago. History is obtained from urgent care chart. As per notes patient started nausea vomiting 6 hours post COVID vaccine administration. Patient was seen in urgent care for epigastric pain and nausea vomiting. Patient was found unresponsive at 0902 by tech. No carotid pulses palpated. CPR was started. Patient was brought into the emergency department with Lucas on. Patient was given 5 epinephrine prior to arrival. CPR was in progress. Patient was asystole. Resuscitation was continued in the ED. Patient was intubated in the ED by physician assistant 5 epinephrine 2 bicarb and 1 calcium chloride was given in the ED. Cardiac Ultrasound didn't show any cardiac activity. Asystole on the monitor. No corneal reflex people are fixed and dilated. Patient was pronounced at 1007 am" "1110160-1" "1110160-1" "Phone call from patient' s 2 daughters on 3/10/2021. Patient was found dead in bed with a remote in his hand. He had not been sick. He had received Moderna SARS vaccine 2/27/2021= 11 days earlier, but did not have any adverse reactions. He had recovered from lumbar spine surgery several months earlier. He was pronounced dead by the fire chief." "1110232-1" "1110232-1" "DizzineS, sweating,weak, chilling, diarrhea, shortness of breath, death" "1110311-1" "1110311-1" "patient passed away within 60 days of receiving a COVID vaccine" "1110329-1" "1110329-1" "Patient passed away within 60 days of receiving the COVID vaccine series" "1110388-1" "1110388-1" "On 2/1/2021 they performed CBC, the result was aseptic bacteria so it came out and she was taken to the hospital. They removed the tube in the hospital, (she remained in the hospital) First she was hospitalized and then she was transferred to the Medical Center Hospital to auscultate bleeding in the stool and to be evaluated by the Gastroenterologist. This specialist performs the necessary studies, they do not give a diagnosis and in the process she dies. The hospital indicated that she had a blood drain and heart failure." "1110437-1" "1110437-1" "Since the vaccine was administered on 1/30/2021 the resident was complaining of tiredness. On 2/9/2021 she complains more than usual with fatigue, a lot of fatigue so they make the decision to transfer her to the hospital. In the hospital she was informed that the pain was from a gallbladder stone, also that she has a lung condition and a compromised kidney. A Dr. from Hospital tells POC that the patient was not responding to treatments and was compromised thus prolonging the hospital stay." "1110439-1" "1110439-1" "Tolerated Well without complications" "1110462-1" "1110462-1" "Patient passed away within 60 days of receiving a COVID vaccine" "1110537-1" "1110537-1" "Pt was found to be having stroke like symptoms 3/15 in the morning at nursing home. he was evaluated and was transported by ambulance from one hospital to another hospital as the CT scanner was down. patient had an injury on march 1 with a cabinet falling on him breaking his femur and family not sure if at that time he had hit his head. Patient was intubated in the ER CT scan showed a massive cerebral bleed with midline shift and transtentorial herniation" "1110581-1" "1110581-1" "Withing 24 hours of vaccine admin developed nausea, chills, aches, dyspnea, elevated heart rate. Saw PCP on 2/15 and was sent to ER and then admitted to hospital for 5 days-continued extreme nausea and atrial fibrillation after diuresis for CHF. HR 120s had to be put on multiple meds to bring ratedown. Discharged on 2/19. Cont worsening nauaea/chills/aches. Passed away on 2/23" "1110641-1" "1110641-1" "Patient passed away within 60 days of receiving a COVID vaccine" "1110654-1" "1110654-1" "Constipation Shortness of Breath Death" "1110673-1" "1110673-1" "shoulder injury death" "1110693-1" "1110693-1" "death" "1110696-1" "1110696-1" "Patient passed away within 60 days of receiving a COVID vaccine" "1110712-1" "1110712-1" "death" "1110732-1" "1110732-1" "death" "1110878-1" "1110878-1" "Only received 1st round dosage of COVID vaccination, he seemed to handle vaccination okay. On January 17, 2021, he tested COVID positive on a resident screening test done in response to an employee positive case in days previous to the residents testing. Fifteen days after his first innoculation,his AM nurse found him non-responsive on early vital checks. Vitals at that time were normal range. The facility physician was contacted and advised that he should be taken to Emergency Room at local hospital for further evaluation. Blood work was taken and ER DR diagnosed Heart enzymes elevated indicating a heart attack. Advised additional testing should be done, and that monoclonal antibody treatment wasn't an option due to time lapse since diagnosis of COVID, The option of comfort care was chosen as the treatment plan." "1111039-1" "1111039-1" "patient passed away within 60 days of receiving a COVID vaccine" "1111042-1" "1111042-1" "RHC 3/15/21. No significant reaction from vaccine. Had sore arm." "1111300-1" "1111300-1" "patient died of complications of pneumonia related to COVID-19; patient died of complications of pneumonia related to COVID-19; This is a spontaneous report from a contactable consumer. A 92-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Jan2021 at 13:00 (at the age of 92-years-old) as a single dose for COVID-19 immunization. Medical history included melanoma, chronic obstructive pulmonary disease, diabetes mellitus, and diminished kidney function; all from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was vaccinated on 06Jan2021 during an existing hospitalization. On 22Jan2021, the patient developed pneumonia related to COVID-19. The patient did not receive any treatment. On 03Feb2021, the patient died of complications of pneumonia related to COVID-19. It was not reported if an autopsy was performed. The events were serious for hospitalization prolongation, being life-threatening and death. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: patient died of complications of pneumonia related to COVID-19" "1111389-1" "1111389-1" "Cough started on 3/5. Hospitalization on 3/7, Expired 3/16. Doctor's Death Diagnosis: acute on chronic respiratory failure." "1111406-1" "1111406-1" "02/28/2021 @ 12:00 PM - sore arm, more than normal, at sight of injection; not feeling right 03/01/2021 @ AM - arm so sore that she could hardly move whole arm to hold stair rail; fatigued; not feeling right 03/04/2021 - diarrhea 6 x; fatigued; not feeling right 03/05/2021 - still had diarrhea; fatigued 03/06/2021 - 1/6 cup of urine only when she woke up in the morning; fatigued; diarrhea during AM; seemed to stop diarrhea PM and urinated maybe 2/3 cup urine more; found an almost unnoticeable bulge between the 2 collar bones above the sternum, still not feeling right 03/07/2021 - after waking up to go to the bathroom approximately 6:00 AM, incontinent wit BM, vomited" "1111546-1" "1111546-1" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111574-1" "1111574-1" "Passed away 4 days after second dose, complained of not being able to breathe in the middle of the night, and passed minutes later." "1111624-1" "1111624-1" "expired on 02/09/2021" "1111645-1" "1111645-1" "Patient was a resident on a LTC wing. Received Covid-19 vaccine on 1/13/21 & 2/10/21. Pt stated she felt phlegm in her throat 3/14/21. On 3/15/21 patient started having trouble swallowing, and started needing supplemental oxygen for low oxygen saturation and needing suctioned for c/o being unable to swallow.. ST eval showed no gag reflex and inability to swallow effectively or safely. Pt needed 5L/O2 and unable to hold saturations above 90%. Patient became ?comfort care?, and passed away 3/18/21." "1111683-1" "1111683-1" "Patient's niece reported that the patient's arm became sore, had stomach upset, fever the day after the vaccine. The following day the patient died." "1111699-1" "1111699-1" "Patient developed symptomatic COVID infection with symptoms starting 3/13, was admitted to the hospital for respiratory failure on 3/16 and expired on 3/18/21" "1111726-1" "1111726-1" "Patient was reported by adult care home to have passed away 3/12/21" "1111831-1" "1111831-1" "Died 3-2-21" "1111924-1" "1111924-1" "Patient found demised at home on 3/17/2021" "1111957-1" "1111957-1" "Received vaccine on 3/3/2021 then was found dead in bed by her husband on 3/7/2021." "1112104-1" "1112104-1" "Patient passed away within 60 days of receiving a COVID vaccine" "1112117-1" "1112117-1" "Patient was a patient on hospice, had terminal dx of frontal lobe dementia. NP visited with patient on 03/10/2021, notable decline/flank pain, fever 101. Patient passed away on 03/12/21, Medical Director wanted this reported to VAERS d/t the vaccination was within 72hrs of the pts death." "1112122-1" "1112122-1" ""Patient was admitted for Multi drug resistant UTI (for which he has been admitted many times before). Was hospitalized for 3 days while awaiting cultures, hemodynamically stable, with no lab abnormalities. On the day of discharge (sensitivities to UTI came back, pt to be discharged on cefepime, had PICC line) pt got up from bed, sat on the edge of the bed and was being given belongings by the nurse, alert and oriented and in a pleasant mood, when suddenly pt grabbed at his chest and stated ""I can't breathe"" and became combative and altered when O2 was attempted to be placed on pt's face; then pt had PEA arrest x3 and unable to achieve ROSC."" "1112123-1" "1112123-1" "This patient was on hospice, we are reporting this to VAERS at the Medical Directors request d/t patient's death within 48 hours of the second dose vaccine. The death occurred the morning following his second dose of the Moderna COVID-19 Vaccination, vaccine received on 03/11/21 and patient date of death 03/12/21 at 9:41 am. This was a hospice patient with a terminal dx of CKD. This is being reported at the request of the Medical Director for the hospice team, d/t the patient's death occurred within 48 hours of receiving the second dose of this vaccine. The nurse case manager stated the pt was declining as they were on hospice for a terminal condition and had co-morbidities, Pt did show more decline after receiving COVID-19 vaccination and patient passed away within 48 hours of receiving second vaccination dose." "1112136-1" "1112136-1" "Patient passed away within 60 days of receiving a COVID vaccine" "1112164-1" "1112164-1" "lndividual Suddenly passed away on 3/7/21.....His Psychiartrist stated that there could be an adverse effect with COVID, the COVID Vaccination and medications, with an emphasis on Clozapine" "1112185-1" "1112185-1" "Patient passed away within 60 days of receiving the COVID vaccine series" "1112223-1" "1112223-1" "Patient passed away within 60 days of receiving a COVID vaccine" "1112264-1" "1112264-1" "death" "1112370-1" "1112370-1" "The patient got the Moderna vaccine on 3/2/2021. On 3/3/2021 he suffered a dissection of the ascending thoracic aorta and died." "1112420-1" "1112420-1" "Patient was contacted about coming in to receive second dose and family member had informed us that she had passed away from COVID two weeks after vaccine was given." "1112517-1" "1112517-1" "My mother died of a brain hemorrhage 5 days after receiving the vaccine." "1112585-1" "1112585-1" "patient diagnosed with covid on 2.18.2021 and died of covid 3.6.2021" "1112701-1" "1112701-1" "Pt received COVID19 shot on 3/12/2021. Pt passed away on 3/15/2021. Dr called us to inform us that our patient had passed away but he did not believe it was caused by the vaccination at this time." "1112743-1" "1112743-1" "PATIENT PASSED AWAY ON 3/14/2021 @ 6:10 PM" "1112773-1" "1112773-1" "Moderna #1 vaccine given at 130pm March 11th 2021. Pt had history of asthma and frequent nebulizer use and had it in car with her for drive-thru vaccine clinic we did at location, which has a large parking lot. We gave 80 doses. Pt checked off anaphylaxis on the intake form so Dr spoke to her and she changed it to no history of anaphylaxis and only has history of asthma. So we gave her the vaccine. About 5 minutes later in car parking lot she started to use her personal nebulizer. I saw her in passenger side of car using a personal nebulizer so I talked to her and her daughter to find out what was going on. They said she has exacerbations all the time and this was not out of ordinary for her. I checked pulse ox and did a lung exam, etc, and she was stable. She seemed baseline according to history by her and her daughter. As she seemed at baseline and clinically was comfortable and conversant whole time, and she felt better after her nebulizer, I told them to have a low threshold for going to ER or calling 911 if her asthma was worse or different than her usual symptoms. They agreed. According to daughter, she did well until about 24 hours the next day. The daughter said she was fine and she went to store and when she returned EMTs were intubating patient and apparently the patient used her epipen and called 911 herself. Approximate time of expiration was 230pm on March12th 2021." "1113563-1" "1113563-1" ""2/25/21 - sore arm, profound fatigue 2/26/21 - chills, fatigue, runny nose (cold-like sx) 2/27/21 - dry throat 3/02/21 - lost voice 3/03/21 - 3/04/21 - chest congestion, difficulty breathing, sounded like water in lungs 3/05/21 - became pale, eyes rolled back, shaking, immobile, caregiver called ambulance, taken to Hospital ER 3/06/21 - death, Hospital dx him with ""pneumonia"" but I believe that hospital medical staff were unaware of his sx following the COVID vaccine #2 shot."" "1113647-1" "1113647-1" "Patient died 3 days after vaccination" "1113713-1" "1113713-1" "My mother called me when she was going to get her second vaccination. She was alive and well and living independently at her home. She could walk, talk, make her own food, wash and dry her own clothes and take her own baths. After taking the second vaccination she went down hill. She became sicker and sicker and eventually she started coughing up blood. She decided to go to the hospital, another Hospital of facility. I don't know what the treatment was at that hospital but she was soon transferred to facility and that is where I was notified she was in the hospital and visited her there. After arriving they intubated her and said she had blood clots in her brain and heart. When I saw her after she transferred from Hospital to the Hospital I noticed one arm was swollen. Her legs were as they have been for the last 20 years and looked okay to me--no discoloration other than her regular discoloring at one right ankle and the same old same old slight swelling in the left ankle. The doctors and nurses were putting the blame on her legs but you could tell things were happening else where. But as she got worse and worse at the hospital her right arm become more and more swollen with dark bruises appearing--the hospital staff took pictures. The left arm continued to swell and did not look normal at all. She apparently had bleeding in her left lung from a blood clot. She had three areas of her brain that add clots and some bleeding. She was constipated and gaseous when they cleaned her. They didn't treat her constipation which made being intubated worse because I feel that caused her intestines to swell, thus she also had bleeding in her intestines. My mother died on March 17, 2021 at hospital in ICU. I was told they could not treat the blood clots because of the bleeding in her lung, intestines and brain." "1114257-1" "1114257-1" "fever; chills; headaches; excruciating generalized body aches like he had just be ran over by a truck; nausea; patient has passed away; A spontaneous report from was received from a Consumer concerning a 74 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, headaches, chills, fever, excruciating generalized body aches like he had just be ran over by a truck, patient has passed away. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23-02-2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, The patient experienced nausea, headaches, chills, fever, excruciating generalized body aches like he had just be ran over by a truck. The patient had a cardiac angiography on 24-02-2021. The result was unknown. The patient was found dead on 06-03-2021. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events nausea, headaches, chills, fever, excruciating generalized body aches like he had just be ran over by a truck was recovering. The patient died on 06-03-2021. The information about the autopsy was unknown. The cause of the death was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. The patient must have been in some form of cardiac issues before death, that's reason why cardiac angiography was done. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death" "1114382-1" "1114382-1" "Baby stop growing 3 days later (7 weeks 3 days per sono); Baby stop growing 3 days later (7 weeks 3 days per sono); This is a spontaneous report from a contactable Other HCP. This Other HCP reported events for herself and fetus. This is a fetus report. A 40-year-old mother received bnt162b2 (BNT162B2), dose 2 administered in Arm Left on 20Feb2021 (Batch/Lot Number: El9266) as SINGLE DOSE, dose 1 administered in Arm Left on 27Jan2021 (Batch/Lot Number: El3248) as SINGLE DOSE for covid-19 immunisation. The mother medical history included allergies: Shellfish. No other vaccine in four weeks. No COVID prior vaccination. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The mother was pregnant. Last menstrual date: 04Jan2021. Due Date: 11Oct2021. The mother was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono) on 24Feb2021 08:00 AM. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient died on 24Feb2021 08:00 AM. It was not reported if an autopsy was performed.; Sender's Comments: Based on provided information and temporal association the reported events causal relationship with the suspect drug cannot be excluded. However there is very limited information provided in this report. Additional information is needed to better assess the case, including complete medical history and diagnostics workup. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021277400 Same reporter/drug, different patient /event (mother case); Reported Cause(s) of Death: Baby stop growing 3 days later (7 weeks 3 days per sono); Baby stop growing 3 days later (7 weeks 3 days per sono)" "1114448-1" "1114448-1" "He was sent to the hospital two weeks earlier for Pulmonary Edema, he was discharged and sent to hospice. When the caregiver takes her rounds, she finds the resident without vital signs, prior to that he had not manifested any symptoms. Certification of cardio-respiratory failure secondary to Alzheimer's disease" "1114454-1" "1114454-1" "On 2/1/2021 he vomited and his pulse began to drop. A doctor from the hospice visited him days before and found him in good health and pressure. Patient was in the Home Care hospice." "1114496-1" "1114496-1" "Impaired emotional state, the abdomen began to inflate, 8/2/2021 is taken by ambulance to the hospital where corresponding studies were carried out. He was having complications from cirrhosis. Then you are discharged on the same day 8/2/2021. On 2/18/2021 he was complaining of generalized pain, they call hospice to be evaluated, caregivers when they proceed to take vitals he was without vital signs." "1114511-1" "1114511-1" "Chills, presenting discomfort . Then they give him a bath. When they went to report to the nurse of each of the residents, they found him without vital signs." "1114735-1" "1114735-1" "Acute mesenteric ischemia; shock secondary to necrotic bowel." "1114752-1" "1114752-1" "12/31/2020: vaccine given 1/17/2021: symptom onset and subsequent hospital course: dyspnea, hypoxic, tachypnea, afib w/RVR, septic, NSTEMI" "1114806-1" "1114806-1" "Diagnosis: Cortical vein thrombosis, massive intracerebral hemorrhage with tentorial herniation, thrombocytopenia. Clinical Presentation and Course: 1 week after receiving Janssen COVID19 vaccination, patient developed gradually worsening headache. On March 17th, patient presented to Hospital with dry heaving, sudden worsening of headache and L sided weakness. Evaluation with head CT revealed a large R temporoparietal intraparenchymal hemorrhage with 1.3cm midline shift. She ended up getting intubated for worsening mental status. On evaluation at arrival in Medical Center, she was noted to have extensor posturing. Repeat imaging revealed worsening midline shift to 1.6cm. CTA showed cortical vein thrombosis involving the right transverse and sigmoid sigmoid sinus with tentorial herniation. Patient developed brain herniation and brain death was pronounced on March 18th, 2021." "1114822-1" "1114822-1" "Diagnosed with COVID (confirmed with a positive COVID test) the say after her vaccine. Eventually died from complications of COVID. Because vaccine was administered prior to her illness, I am putting this in the VAERS system. Symptoms included SOB, coughing, muscle aches. headache, fever." "1114885-1" "1114885-1" "Asthenia; Nausea; Vomiting; A spontaneous report was received from a Pharmaceutical Company concerning a 90 Years-old male patient who received Moderna' s COVID-19 vaccine (mRNA-1273) and experienced nausea, vomiting, generalized weakness with a fatal outcome. The patient's medical history is aortic aneurysm, aortic stenosis, coronary artery disease, hypertension, cardiac heart failure, atrial fibrillation, HLD, ischemic heart failure, pacemaker, ventricular fibrillation, peripheral vascular shunt, palpitations, hypotension, and small bowel obstruction. No concomitant medications were provided. On 06 FEB 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. On 11 FEB 2021, the patient experienced the events, nausea, vomiting, generalized weakness. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 12 FEB 2021. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1115045-1" "1115045-1" "Death; A spontaneous report was received from a consumer concerning a 57 years old male patient who received mRNA-1273 for prophylaxis of COVID-19 infection and had died (death). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 2 Mar 2021, approximately three hours prior to the onset of the symptoms, the patient received hia second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. It was reported that the patient died three hours after receiving the 2nd dose in the ER. Treatment information was not provided. The cause of death was unknown. Plans for an autopsy were unknown. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event of death was considered as fatal.; Reporter's Comments: This is a case of sudden concerning a 57 year old male who died three hours after receiving the second dose of the vaccine. Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: unknown cause of Death" "1115126-1" "1115126-1" "His breathing problem worsened on 02/23/2021, short of breath and tired. He died of a pulmonary embolism and heart attack in the hospital on 3/9/21 after being there for 9 days." "1115216-1" "1115216-1" "NA Patient hx COPD,CAD," "1115348-1" "1115348-1" "death; A spontaneous report was received from a HCP concerning about a 86 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and died. The patient's medical history was not reported. Concomitant medications were not reported. On 05 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026A21A) via intramuscular in left deltoid for prophylaxis of COVID-19 infection. On 06 Mar 2021 the patient died next day after vaccination, who left quite well after vaccination from the facility, the reason for death is not known. Treatment information was not provided. Action taken with mRNA-1273 in response to the event is not applicable. The outcomes of all the event is not applicable.; Reporter's Comments: This is a case of death in a 86 years old female patient, with unknown past medical hx or current co morbid conditions and concomitant medications, who died one day after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death" "1115451-1" "1115451-1" "Home care treatment History of COPD" "1115581-1" "1115581-1" "Unattended Death, symptoms and timeframe unknown, death occurred approximately 1 week post vaccination" "1115715-1" "1115715-1" ""Family, daughter, reports that patient felt ""a little sick"" on 2/24/21 and ""sick"" on 2/25/21. She reports that approximately 1 week later her father had weakness and and frequent falls, was evaluated in the E.D. and ultimately admitted to hospital (3/4-3/15) Patient was discharged to nursing home where he died on 3/16/21."" "1115756-1" "1115756-1" "NA 90 year old Heart Disease" "1115838-1" "1115838-1" "NA History - CAD,CKD-Stage 3 DMII HTN" "1115944-1" "1115944-1" "1-2 hours after receiving Moderna vaccination patient began complaining of chest pain to family members but refused to seek medical attention. He was found deceased this morning (03/19/21) by his family. Medical Examiner determined time of death was around 8:40pm on 03/18/21." "1115994-1" "1115994-1" "03/02/21 the patient was visited by nurse. No signs of distress. Normal vitals. No GI concerns according to staff. Her appetite was her usual described as fair. She received her 2nd Moderna vaccination on 03/08/21. Within hour she because very ill according to facility staff. She began to vomit up to 5 times. Her stools because loose. She became more lethargic. She was started on compazine for the vomiting. Her oral intake was minimal. Her symptoms did not resolve and she was visited by the nurse again on 03/11/2021 where she was not very responsive. Her vitals included an irregular pulse and apnea noted in her breathing up to 15 seconds. She died on 03/12/21" "1116006-1" "1116006-1" "Patient passed away within 60 days of receiving a COVID vaccine" "1116073-1" "1116073-1" "Patient passed away within 60 days of receiving a COVID vaccine" "1116094-1" "1116094-1" "Attempted Suicide Narrative: 93 year old received his 2nd dose of moderna vaccine on 3/11/21 in his home (nurse went there to give it). He attempted to take his life via gunshot wound to the head on 3/13/21. Sent to an outside hospital and passed away 3/16/21. He recently was diagnosed with cancer. Had an appointment with oncologist on 3/11/21 and found out cancer was limited to lung only and discussed treatment options. No Mental Health issues in the past. Cancer diagnosis and covid vaccine timing may have contributed." "1116095-1" "1116095-1" "Patient passed away unrelated to covid vaccination Narrative: The patient had rectal cancer with metastases and stage 4 chronic kidney disease. Has been placed on palliative care. Patient received his first dose of Pfizer vaccine on 12/22 and second dose of Pfizer on 1/12. No adverse reaction related to vaccination was reported. Patient passed away on 1/17. Patient's daughter had concern that his rapid decline over the past few days may have been related to COVID vaccine. Attending explained that patient's clinical changes are more consistent with decline due to an end of life status. No indication that death was related to COVID 19 vaccination." "1116096-1" "1116096-1" "Death Narrative:" "1116097-1" "1116097-1" "Death Narrative:" "1116098-1" "1116098-1" "Death Narrative:" "1116099-1" "1116099-1" "Cardiac Arrest Narrative: Patient received vaccine at 1209 on 3/13/2021, observed for 15min no reaction noted. Later that evening patient was not feeling well presented to ER where he was admitted. Had cardiac arrest during hospitalization on 3/16/2021 where patient passed away. Had a Hx of CHF, A-Fib, had a cardiac stent placement in 2020.." "1116100-1" "1116100-1" "extreme fatigue then patient passed away while asleep Narrative: Unclear if the vaccine is connected to his death. Chart reviewed. He has medical conditions which could have caused his death. Unclear who completed his death certificate. Death was close to a month ago. Whether he had an autopsy or not is unclear. We can report as a suspicious death after vaccination." "1116101-1" "1116101-1" "Death Narrative:" "1116102-1" "1116102-1" "Death Narrative:" "1116103-1" "1116103-1" "Death Narrative:" "1116104-1" "1116104-1" "Death Narrative:" "1116105-1" "1116105-1" "Death Narrative:" "1116107-1" "1116107-1" "Death Narrative:" "1116108-1" "1116108-1" "Death Narrative: Patient received dose 1 of COVID vaccine on 1/27/21. Was observed x15 minutes, no reactions noted. Later that day patient's spouse reports patient has been acting out (reports behaviors the night before) and that she cannot care for him any longer. Patient falls sometime in the 48 hours after vaccine and is admitted to the hospital with an unknown diagnosis. Not certain of patient's history after this hospitalization until 2/9 when patient is admitted again to the hospital with hepatic encephalopathy. Patient is switched to hospice status by 2/12, and passes on 2/21/21." "1116236-1" "1116236-1" "Hospice patient passed away within 60 days of receiving a COVID vaccine" "1116259-1" "1116259-1" ""Death; not able to stand up or walk; extreme weakness; he did not feel well; not able to stand up or walk; A spontaneous report was received from the patient's wife concerning a male (age not provided) who experienced extreme weakness/asthenia, did not feel well/malaise, unable to walk/gait inability, and unable to stand/dysstasia. The patient's medical history included lung disease which required oxygen support. Per patient's wife, no concomitant products were in use within two weeks of the event. The patient's wife also stated he does not take any daily medications. On 21 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 ( Batch number 029L20A) by injection into his left arm for prophylaxis of Covid-19 infection. After receiving the vaccine, the patient's wife stated he did not feel well. He experienced extreme weakness. He was not able to stand up or walk for the first few days after getting the shot. ""He could not walk even 3 steps and get in the car"". On 09 Feb 2021, the patient felt a little bit better and could walk from one bedroom to another. No Medications were used to treat the patient's symptoms. No relevant medical tests were provided. The patient had an appointment with his healthcare provider (date and time not provided) and was told he could not get the second dose of vaccine unless he got better. The patient's wife stated she is not blaming the vaccine because her husband had a lung disease prior to getting the vaccine. His doctor said, (per his wife) this lung disease had weakened him to the point he could not drive his car anymore. His brain was fine before the vaccine. On 03 Mar 2021, the patient's wife called to say that the patient had finally passed away on 13 Feb 2021. The second dose of mRNA-1273 was withheld in response to the events while waiting for the patient's condition to improve however; it was never given due to the patient's death. The events of did not feel well, extreme weakness, unable to walk, and unable to stand were not resolved (presumably) prior to the patient's death. The patient died on 13 Feb 2021. The cause of death was not provided. Plans for an autopsy were not provided. Company Comment: The reported events, death, malaise, asthenia, gait inability, and dysstasia were considered possibly related to mRNA-1273.; Reporter's Comments: This is a case of death in a male subject with a hx of lung disease requiring oxygen, who died 23 days after receiving first dose of vaccine. Very limited information is available and based on the reporter's causality assessment the event is considered unlikely related to the vaccine""; Reported Cause(s) of Death: cause of death unknown"" "1116353-1" "1116353-1" "Patient passed away within 60 days of receiving the COVID vaccine series" "1116377-1" "1116377-1" "91 yo father received vaccine, was mobile and alert before first shot, but required wheelchair by second vaccination due to being weak. After second vaccination, was not able to stand or move after 36 hrs, at which point he was taken to the hospital. At hospital, all vital signs were good except an MRI showed cancer in spine. Shot was given 3/1 and my father passed on 3/18. Obviously this shot did not cause metastatic cancer, but I believe it did induce an inflammatory response of some kind that caused it to progress extremely quickly." "1116386-1" "1116386-1" "Patient developed nausea and vomiting 3/14/21. was seen at clinic by this provider 3/16/21 and reported at that time continued fatigue but overall symptom improvement. Vital signs were stable. pt was advised to orally hydrate and routinely monitor blood sugars and f/u as needed. On 3/18/21 patient was found down in his motel room by shelter staff unresponsive. 911 was called. pt transported to hospital by EMS receiving BLS. Clinic staff was advised by family that patient was pronounced dead that date." "1116400-1" "1116400-1" "Patient passed away within 60 days of receiving the COVID vaccine series" "1116407-1" "1116407-1" "Patient got sick over the weekend. Went to facility on 03/02/2021 and then passed on 03/18/2021" "1116408-1" "1116408-1" "severe internal bleeding fluid build up around lungs/heart high heart rate low blood pressure low oxygen liver failure death" "1116436-1" "1116436-1" "Patient passed away within 60 days of receiving the COVID vaccine series" "1116540-1" "1116540-1" "DEATH- PHARMACY NOTIFIED 3/19/21 OF PATIENT DEATH ON 3/18/21, NO OTHER DETAILS KNOWN" "1116594-1" "1116594-1" "Patient called EMS from for respiratory distress. EMS arrived, noted severe distress and hypoxia. Patient transported to Hospital Emergency Dept. Patient deteriorated to respiratory arrest and cardiac arrest. Per ED note, after 30 minutes of aggressive resuscitation (including approximately 19 minutes in the ED), no ROSC was achieved. Patient expired" "1117078-1" "1117078-1" "Patient died approx. 5 hours after shot was administered. Cause of death reported is Atherosclerotic Cardiovascular Disease. The death certificate was signed by the county coroner without autopsy, based on the report by the onsite deputy coroner. No doctors or hospitals were involved. This report is FYI only; there has been no direct connection made between my mother's death and the vaccine other than one followed shorty after the other." "1117213-1" "1117213-1" "Case tested positive for COVID-19 on 3/1/2021 by rapid antigen and then again on 3/3/2021 by PCR. Case was admitted to hospital on 3/3/2021 for shortness of breath and occult infection. Case was previously admitted and discharged from hospital on 2/22/2021 after a lumbar compression fracture. Case had monoclonal antibody infusions; was afebrile and denied chills, but had a dry cough. Case was a previous smoker, quit 2 years prior. Case developed pneumonia. Case required supplemental oxygen." "1117316-1" "1117316-1" "Sister in law called on 3-19-2021 to report that had died a day after receiving his Moderna vaccine. She stated he was found in his driveway and was unable to be resuscitated after being rushed to the hospital." "1117431-1" "1117431-1" "Found in chair lethargic less than 48 hours after her first civid vaccine by facility staff where she lives in an independent living facility. Nursing staff felt she had a stroke with right sided weakness. Slurred speech, weak, unable to walk without two person assistance. Patient was under hospice care so hospitalization was given." "1118229-1" "1118229-1" "Sudden Death" "1118314-1" "1118314-1" "She received the Johnson and Johnson vaccine on Wednesday and died on Sunday 3/14/2021. Her autopsy is pending." "1118953-1" "1118953-1" "Patient passed away unrelated to covid vaccine Narrative: The patient had end stage COPD and placed in hospice care. Patient received first dose of Moderna vaccine on 1/20 and second dose of Moderna vaccine on 2/16. No adverse reaction was reported. Patient passed away at home on 2/24/2021. Cause of death not documented. No indication that death was related to COVID 19 vaccination." "1118954-1" "1118954-1" "Patient passed away unrelated to covid vaccine Narrative: 87 YO male has relapse lung cancer and was on radiation therapy and chemotherapy in hospital. Patient received his first dose of Pfizer vaccine on 1/28/2021 (as advised 1.5 weeks after administration of chemotherapy in between cycle) and no adverse reaction was reported. Cause of death not documented. No indication that death was related to COVID 19 vaccination." "1118955-1" "1118955-1" "Patient passed away unrelated to covid vaccine Narrative: The patient had Alzheimer dementia and acute on chronic renal failure. Patient received first dose of Pfizer vaccine on 1/13/2021 and second Pfizer vaccine on 2/2/2021. No adverse reaction was reported. Patient was recently admitted for LE edema and increasing SOB. Patient passed away on 3/8/2021 in hospital. No indication that death was related to COVID 19 vaccination." "1118956-1" "1118956-1" "Patient passed away unrelated to COVID vaccine Narrative: The patient has COPD and congestive heart failure. Patient received first dose of Moderna vaccine on 1/11/2021 and no adverse reaction was reported. Patient's son reported patient had a minor car accident and was taken to ER where he was tested positive for COVID pneumonia and he passed away in his sleep on the morning of 2/4/2021. Patient's son stated due to his COPD, he was not able to survive the COVID pneumonia. No indication that death was related to COVID 19 vaccination." "1118957-1" "1118957-1" "DEATH Narrative: Patient passed away approximately 1 month after receiving first COVID-19 vaccination. No report of a significant reaction to this vaccine, so unlikely a correlation." "1118958-1" "1118958-1" "Death Narrative:" "1118959-1" "1118959-1" "Death Narrative:" "1118960-1" "1118960-1" "Death Narrative:" "1118961-1" "1118961-1" "Death Narrative:" "1118962-1" "1118962-1" "Death Narrative:" "1118963-1" "1118963-1" "Death Narrative:" "1118964-1" "1118964-1" "Death Narrative:" "1118965-1" "1118965-1" "Patient passed away unrelated to covid vaccine Narrative: The patient had new onset of CHF,A.fib and hx f COPD. Patient was admitted to hospital on 1/21 and Patient discharge against medical advise on 1/22. Patient aware of risk including early death and increased morbidity but patient still wanted to leave. Patient received the first dose of Pfizer vaccine on 1/19 and no adverse reaction was reported. Patient presented to ER for shortness of breath and chest pain and was admitted on 1/29. Patient passed away on 1/31. No indication that death was related to COVID 19 vaccination." "1118966-1" "1118966-1" "Patient passed away unrelated to covid vaccination Narrative: The patient had hx of chronic heart failure on palliative milrinone with hospice. Patient received his first dose of Moderna on 1/11 and patient had a prior positive PCR on 1/12/2021. Patient passed away on 1/27/2021. Family member stated patient didn't seem to be struggling for breath, any pain or other discomfort. Cause of death is not related to COVID 19 vaccination." "1118967-1" "1118967-1" "Patient passed away unrelated to covid vaccine Narrative: The patient had worsening COPD and cognitive deficits. Patient's last hospital visit is 2/2021 for COPD exacerbation. Patient received his first dose of Moderna on 1/13 and second dose of Moderna on 2/9. Patient passed away at home on 3/3. No indication that death was related to COVID 19 vaccination." "1118968-1" "1118968-1" "Patient passed away due to cardiac arrest Narrative: The patient had with PMH of CAD and multiple PCI, HFpEF, HTN. DM2, ESRD on HD, COPD and home O2 and other co-morbidities. Patient received his first dose of Pfizer vaccine on 1/21 and no adverse reaction was reported. Patient had a cardiac arrest on 2/1 and he was admitted to hospital. Patient passed away naturally on 2/1. Cause of death is not related to COVID 19 vaccination." "1119002-1" "1119002-1" "Day 1-Confusion and weakness Day2-Increase in weakness, inability to swallow, confusion, fatigue Day 3-Weakness, confusion, incontinence, hospitalized for hypoxia, pneumonia Day 20- Deceased" "1119393-1" "1119393-1" "Systemic: Death. Unknow cause as of reporting date. -Severe, Additional Details: PT caregiver called to report that the Pt passed away on 3/8/21 2 days post vaccince, Caregiver was distrot and not very able to provided more details due to reccent nature of report." "1120315-1" "1120315-1" "After about 30 minutes he said his throat felt weird. That night. Later he said he didn?t feel good and he said these are just normal reactions. I with pneumonia, or he thought he was catching pneumonia from me. Not possible he had the vaccine. Then the next morning he was still having difficulty breathing. Then Saturday 03/20/2021. afternoon he couldn?t catch his breath. I ran to get my phone and came back and he was dead. Called 911 and did CPR. They arrived and got a heart beat and put him on a breathing machine. He is in a medical induced coma. With a 50/50. Chance of survival." "1120493-1" "1120493-1" "Cardiac arrest five days after administration of the 2nd dose at 9pm, ambulance was called and EMTs attempted resuscitation, but no pulse was detected after 1 hour of compressions and CPR; time of death was recorded at 10:06pm" "1120523-1" "1120523-1" "Hemorrhage/Bleeding" "1120756-1" "1120756-1" "On Friday night, 3/19/21, patient spiked a fever, had shortness of breath, and had blood coming out of his nose and mouth per patient's daughter-in law. 9-1-1 was called, paramedics arrived at the home at 5AM on Saturday, 3/20/21 per patient's daughter. Patient died." "1120816-1" "1120816-1" "Death. No autopsy performed." "1120842-1" "1120842-1" "this is all per family, 4 to 5 days after 2nd COVID vaccine he was acting unusual and was taken to the hospital. He had a clot in his brain and underwent brain surgery. He experienced seizures after the surgery, but it was ultimately reported the surgery went well. He remained intubated and on a ventilator after surgery. He developed complications of his lungs and kidneys while on the ventilator. Ventilator was removed 3/16/2021 and he passed away that day. The hospital providers thought the clot in the brain may have been from hitting his head over a month ago. From my understanding he was A&O, independent with ADLs, and lived in his private residence prior to these complications." "1120952-1" "1120952-1" "NOTHING LOCALLY AT TIME OF IMMUNIZATION. NO PROBLEM 15-30MINUTES LATER. WAS INFORMED SHE WAS FOUND DEAD THE NEXT MORNING." "1120979-1" "1120979-1" "NO IMMEDIATE LOCAL REACTION, NO REACTION 30MINUTES LATER. FOUND FOAMING AT THE MOUTH NEXT MORNING. PRONOUNCED DEAD AT HOSPITAL." "1121695-1" "1121695-1" "The patient, who has no significant past medical history including diabetes, presented with very severe diabetic ketoacidosis one week after receiving the vaccine. He developed severe metabolic encephalopathy, aspiration pneumonia, and was placed on mechanical ventilation. At the time of this reporting, he is brain death (awaiting apnea test confirmation). He is expected not to survive." "1121906-1" "1121906-1" "Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: Coroners Office contacted Pharmacy on 3/21/21 to report a patient who had recieved a dose of the covid vaccine on 3/18/21 and was founded deceased on 3/20/2021" "1122080-1" "1122080-1" "Patient's received 2nd dose of Moderna vaccine Friday 3/12. Her husband reported she had not unexpected fatigue, malaise, and fever for 1 day but better after that. On Monday she began complaining of shortness of breath. This progressively worsened and she started having presyncopal episodes. On Saturday she was unable to come down the stairs in the house so husband planned to take her to the hospital but she stood up and passed out and woke up quickly. He decided to call EMS. By the time she presented to our hospital she was cyanotic and agonal breathing. On moving her from EMS stretcher to ED bed she had PEA cardiac arrest. She underwent mechanical device CPR with only brief (<1 min) ROSC x1. She at some point did have a shockable rhythm. Cath lab was notified and she was taken emergently to the cath lab with ongoing mechanical device CPR. Peripheral VA ECMO was placed after about 1.5 hours. Pulmonary angiogram was done which showed massive saddle PE with near complete obliteration of the right pulmonary tree and some filling defects in the left tree as well. At that time she had severe mixed respiratory and metabolic acidosis with a lactate of 24. She also had no gag or corneal reflex, minimally responsive pupils, and no response to noxious stimuli. Mechanical thrombectomy was attempted with some result. She was transferred to the SICU with increasing pressor requirement, and DIC. Ultimately, the venous catheter of the ECMO circuit malfunctioned thought to be secondary propagating IVC thrombosis. Family decided to withdraw care and she passed away." "1122172-1" "1122172-1" "Moderna COVID-19 (mRNA-1273) vaccine treatment under Emergency Use Authorization(EUA): The decedent received the shot at 4:30pm and was found deceased at 10pm the same day." "1122318-1" "1122318-1" "Received second dose of Pfizer Covid vaccine on 3-15 and he passed away 3 days later on 3/18/21" "1122392-1" "1122392-1" "Patient passed away related to covid vaccination Narrative: The patient had CHF, cardiomyopathy, A-fib and COPD. Patient received his first dose of Moderna on 1/20. No adverse reaction was reported. Patient was found unresponsive and confirmed dead by Sheriff on 2/10. Cardiologist was notified of his death and suspect patient's death is related to ventricular arrhythmia. He also has a history of noncompliance. Cause of death is not related to COVID 19 vaccination." "1122393-1" "1122393-1" "Death Narrative: Around the end of January 2021, patient was admitted to a home hospice program due to worsening of patient's Parkinson's Disease and Dementia. It was noted on the hospice programs Plan of Care that patient had severe, progressive dysphagia due to disease. Patient lost 20 pounds over the last 2 months prior to admission to hospice program. Patient had severe tremors, dystonia, and was dyspneic with minimal exertion. Patient received Moderna's Covid vaccine on 3/3/21. On 3/13/21, patient got progressively worse. He stopped eating and drinking and started to exhibit Cheyne-Stokes breathing. Hospice nurse noted that patient only had a few days remaining. On 3/18/21, patient passed away." "1122394-1" "1122394-1" "Patient passed away unrelated to covid vaccination Narrative: The patient with PMHx significant for afib s/p failed ablation, chronic hep B, heart failure and skin cancer. Patient received his first dose of Pfizer on 1/14 and second dose of Pfizer on 2/4. Patient's wife notified facility that patient had passed away at his residence on 3/9 due to metastasized cancer. Cause of death is not related to COVID 19 vaccination." "1122441-1" "1122441-1" "Patient passed away unrelated to covid vaccine Narrative: The patient had with a history of ischemic cardiomyopathy and multiple PCI's, CABG history of acute renal failure and hypokalemia and decompensated heart failure. Patient received his first dose of Pfizer dose on 2/18. Patient passed away on 3/8 due to cardiac arrest upon arrival to ER. Cause of death is not related to COVID-19 vaccination." "1122468-1" "1122468-1" "Patient passed away unrelated to covid vaccine Narrative: The patient had prostate cancer, Merkle cell carcinoma and clear cell carcinoma of kidney. Patient has been placed on hospice care. Patient received the first dose of Pfizer on 2/1 and no adverse reaction was reported. Patient passed away on 2/5. No indication that death was related to COVID 19 vaccination." "1122501-1" "1122501-1" "Patient expired next day" "1122640-1" "1122640-1" "Death 3/11/21" "1122643-1" "1122643-1" "Massive Hemorrhagic stroke 24 hours after receiving first Pfizer vaccination. Suffered bleeding of kidney 6 days later, followed more brain bleeds and blood in stomach area. Vessels are leaking blood, Dr's were could find no reason for the bleedings, have not seen this before." "1122741-1" "1122741-1" "suspected pulmonary embolism; shock; cardiac arrest; This is a spontaneous report from a non-contactable consumer (patient's wife). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 04Mar2021 at 11:45 AM at a single dose for COVID-19 immunization. Medical history reported as none. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced a suspected pulmonary embolism on Monday 08Mar2021 at 11:30 AM. Embolism led to shock and cardiac arrest. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient received unspecified treatment for the events. The patient died on 08Mar2021 at 11:30 AM. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: suspected pulmonary embolism; shock; cardiac arrest" "1122742-1" "1122742-1" "He died around 5 o clock; This is a spontaneous report from a contactable consumer (patient's wife). An 89-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 12Mar2021 13:00 at a single dose (lot number was reported as NEEU200, the reporter did not know if its 2 or Z) for COVID-19 immunization. Medical history allergic to Penicillin, has a long list of allergies, neck pain and sleep disorder (sleep aid). Concomitant medications included diphenhydramine hydrochloride (BENADRYL), clopidogrel bisulfate, calcitriol, melatonin (MELATONIN) taken for sleep aid, Phillips Laxative tablet Magnesium (not appropriately paraphrased and clarified, as reported), simvastatin, terazosin hydrochloride, tizanidine hydrochloride (TIZANIDINE HCL) for when he had the pain in neck (he didn't take that hardly ever), vitamin C [ascorbic acid] and Multivitamin one a day. On Friday 12Mar2021, the reporter and the patient went to get the Covid shot. Their appointment was at 12:30 but they were in line long time before they got the shot. They got the shot around 13:00 and then they have to wait 15 minutes before they could leave. They drove up, they were ready to shoot us with the needle and they asked the patient, asked was he allergic to anything and the reporter answered for him and said yes, Penicillin and other long list and then they gave him the shot. They never did go over his allergies. They got home about 13:30, so which would take us about that long to get home. The patient died around 5 o clock and the reporter didn't know if this was connected or not with his death. The patient died on 12Mar2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: This case of death was provided with minimal details and autopsy results not available. However, drug causality cannot be completely excluded for BNT162B2 injection, only due to plausible chronological relation. Otherwise, information received was so limited to prevent a thorough medical assessment for patient death. The impact of this report on the benefit/risk profile of the Pfizer drugs is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: He died around 5 o clock" "1122969-1" "1122969-1" "Resident Expired at facility on Hospice services on 3/21/21" "1123065-1" "1123065-1" "CHF death" "1123066-1" "1123066-1" "Death" "1123078-1" "1123078-1" "mass on right lung fall, arm fracture arm pain leg pain death" "1123165-1" "1123165-1" "generalized weakness respiratory failure" "1123167-1" "1123167-1" "Stroke" "1123229-1" "1123229-1" "Patient received Moderna Dose #1-01/08/2021 and Dose #2-02/05/2021. He was admitted to Medical Center on 03/08/2021 with confusion and decreased O2 sats; date of death was 03/12/2021." "1123247-1" "1123247-1" "Our agency was alerted that the patient passed away on 3/16/2021" "1123294-1" "1123294-1" "Shortness of breath, chest tightening, nausea, lightheadedness. Chest pain while in the ER. Intubated after cardiac arrest. Transferred to ICU. Life support removed 3/22/21. Pt expected to expire today." "1123329-1" "1123329-1" "Presented to Emergency department in cardiac arrest. Pt's family reports patient complaining of indigestion throughout the night. Awakened this morning but returned to bed. Family noted his breathing became loud and then stopped. EMS called. Patient in PEA arrest when they arrived. Patient's family reports he received COVID-19 vaccine day before via facility. I have notified the vaccine clinic and received the Lot number of the vaccine use when I called." "1123405-1" "1123405-1" "None stated." "1123532-1" "1123532-1" "Dose given at 1649hrs. At 2030hrs, complaints of headache and diarrhea. At 0100hrs on 03/21, family noticed patient unresponsive and not breathing. Fire rescue called out and pronounced her at 0210hrs." "1123737-1" "1123737-1" "PATIENT PASSED AWAY ON 3.20.2021" "1123768-1" "1123768-1" "PATIENT DIED AT HOME ON 03/19/2021" "1123805-1" "1123805-1" "Admitted on 2/17/2021 with acute respiratory failure with marked hypoxia. Noted to have fever & chills, weakness and acute confusion ~ 3 days prior to admission. Placed on NIPPV, steroids, convalescent plasma and antibiotics. Patient died 2/24/2021" "1123847-1" "1123847-1" "Patient had no reactions to first vaccine post dialysis. The morning after the patient received the vaccine, patient expired at home. Police stated that the death was vaccine related." "1123927-1" "1123927-1" "NA CAD, Chronic Abd pain with Opioid treatment - Chronic Pancreatitis" "1123977-1" "1123977-1" "Not even 20 hrs after she received the vaccine she couldn?t breathe, she?s been fine nothing wrong at all. 7am she was awake sitting up in bed doing crosswords told her great granddaughter to have a good day at work and would see her shortly . 739 I walked out the room to take my kid to work was gone till 751 not even 12 minutes and I came in and my gram couldn?t breathe was yelling for me saying she couldn?t breathe. It sounded like my gram had come over with upper respiratory problems in a matter of 10 minutes she was gasping for air called 911 spoke to operator my gram was talking saying she couldn?t breathe she was trying to breathe, my grams last words were if they don?t hury I?m going to die I?m 100% sure my gram was dead in my arms before EMS arrived. Yes she was 95 but she is a healthy lady have had no issues of health problems lately. We?ve done everything to keep her save from the virus and then she gets her 2nd moderna shot and she?s dead 20 hrs later there?s a huge problem old age or not" "1124100-1" "1124100-1" "NA - Reaction Age 103.dementia" "1124121-1" "1124121-1" "DECEDENT WAS NOTED TO BE COUGHING FOLLOWING THE ADMINISTERING OF THE VACCINE. FAMILY INTERVIEWED COULD NOT RECALL WHETHER THE DECEDENT WAS COUGHING PRIOR TO RECEIVING THE VACCINE." "1124195-1" "1124195-1" "Abdominal pain, nausea, diarrhea, headache, muscle aches, and fatigue1-2 days after vaccination prompting transport via EMS to ER from home. Had cardiac arrest while in the ER x2, subsequent anoxic brain injury and death following removal of ventilator support." "1124259-1" "1124259-1" "No adverse reactions reported by family" "1124281-1" "1124281-1" "79 yo with HFpEF, CKD, neurogenic bladder with chronic indwelling Foley admitted to Facility 01/21/21-01/28/21 with recurrent c. difficile/sepsis. Received COVID vaccine on 2/3/21 as outpatietn. Readmitted to Facility on 02/16/21 with sepsis with E. coli BSI from GU source, recurrent/persistent c. difficile colitis. Worsening sepsis. Family transitioned goals from full code to DNR/DNI and then to CMO. Patient expired 02/18/2021." "1124307-1" "1124307-1" "The patient was found dead in his home on 3/18/2021, 8 days after vaccination. Due to the remoteness of where the individual lives and his lack of housemate, it is unknown how long he had been dead, but it is not believe that he was dead for more than 1-2 days. He had no adverse reactions in the 15-30 minutes that he was observed post-injection. He also reported only a sore arm to the public health nurse in an email a few days after his vaccination." "1124363-1" "1124363-1" "patient died at home. apparently he awoke in the middle of the night and asked for help, then collapsed. CPR failed. patient and family did not want an autopsy. suspect sudden cardiac death" "1124382-1" "1124382-1" ""Death Narrative: Patient received first COVID vaccine does on 3/13/21 at 07:53 without complications. Home telehealth nurse informed by family member on 3/18/21 the patient passed away on 3/13/21 at approximately 1300. Per medical record documentation, ""Patient had been at facility getting COVID vaccine that morning at 0800, came home and was taking out his garbage when he started to stumble and fell to his knee, a neighbor saw and assisted patient up and was walking with him back to the apartment when ""...he stopped breathing and feel over, dead."" Per medical record review, patient had several co-morbidities including hypertension, hyperlipidemia, chronic hyponatremia, alcohol abuse, alcoholic fatty liver, chronic thrombocytopenia, and GERD."" "1124383-1" "1124383-1" "DEATH Narrative: Events surrounding patient's death are unknown- nothing is documented in medical record regarding event. Causality of death is unknown. This event is being reported due to the timing of the death in relation to the receipt of vaccine (4 days)." "1124577-1" "1124577-1" "My father received the first Covid shot 3/2; he woke up 3/3 with severe body aches and weakness, which we thought nothing of. However, every day, he got weaker and weaker. He has been treated for Liver cancer, he received his first infusion of Opdivo almost 4 weeks before the vaccination. About 7 days after the shot, he was having trouble swallowing so he went to the ER to get a CT scan. He was found to have greatly elevated troponins, the DR was baffled he wasn?t having any chest pain; they were apparently not trending either., he has never had a heart attack or any other heart problems, takes Nadolol for high blood pressure. The CT scan showed significant growth of his tumors which had been stable for a year and the last CT scan was the end of January; liver enzymes were also significantly elevated whereas they were stable before. My father deteriorated rapidly, and died on 3/18/21. The day he got the shot just prior, he was hauling wood, shoveling snow and living a normal life feeling good. The day after the shot he could barely get out of bed he was so weak, until he finally died 16 days later." "1124604-1" "1124604-1" "Pt presented SOB several days prior to receiving vaccine. His sister reported he had severe COPD and was getting progressively worse. On the day pt was vaccinated, his sister picked him up for the appointment and pt refused a wheelchair. Pt walked into the clinic on his own and recevied his vaccine. Sister reported pt walked to the car after his vaccine and was winded. She dropped him off at his house and called him later to check up on him. Pt stated he was feeling fine but his arm was sore. Pt's sister called the next morning and reported that he sounded terrible. He was strugging to breathe and was SOB. His sister went over to his house to check on him and wanted to take him to the doctor's office or the hospital. Pt refused at that time. Pt agreed to make a doctor appointment for later in the afternoon. Sister left at noon. She stated her brother had made a doctor appointment for 4:00 at Family Practice. Upon arriving, pt started walking towards the entrance and became SOB. His significant other asked the doctor's office for a wheelchair and was denied. Pt coded in parking lot of Doctor's Office and passed away at 4:31 p.m." "1124671-1" "1124671-1" "3 days after vaccination, person was somewhat disoriented. 4th day after vaccination, patient fell, hit head and developed subdural hematoma from which he subsequently died." "1124688-1" "1124688-1" "Sudden death March 20, 2021" "1124794-1" "1124794-1" "Extreme head ache, chest pain, fever 101 F. Gave 1000 mg Tylenol, albuterol via nebulizer Q4hr. Died 3/20/2021 approx 11:00 am from Cardiac Arrest." "1124826-1" "1124826-1" "Patient had a mini stroke (TIA) approximately 14 hours after the 1st Moderna COVID vaccine which is when the doctors put him on Plavix, the blood thinner and an aspirin. The patient had a massive stroke with brain hemorrhage within 24 hours of the 2nd Moderna COVID vaccine which resulted in his death." "1125070-1" "1125070-1" "He past away on 28Feb2021 from a heart attack; A spontaneous report was received from a consumer concerning a 80 year old male patient who received Moderna's COVID-19 vaccine and the patient died due to heart attack. The patient's medical history, as provided by the reporter, included diabetes, congestive heart failure, hypertension and high cholesterol. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) intramuscularly in the right arm on 21 Jan 2021. On 26 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 024M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 28 Feb 2021 the patient passed away due to heart attack. No treatment information was provided. The seriousness criteria for the event passed away from a heart attack were death and medically significant. Action taken with mRNA-1273 in response to the event was not applicable. The outcome for the event, he passed away from a heart attack was fatal.; Reporter's Comments: This case concerns a 80 year old, male patient. who died due to myocardial infarction. Very limited information regarding this event has been provided at this time. The patient's medical history of diabetes, congestive heart failure, hypertension and high cholesterol remains the risk factor for myocardial infarction. Further information has been requested. The cause of death is Myocardial infarction.; Reported Cause(s) of Death: Heart Attack" "1125079-1" "1125079-1" "Patient passed away; Found him non-responsive; A spontaneous report was received from a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced unresponsiveness to stimulus. The event was followed by his death. The patient's medical history included Covid-19 and experienced dehydration prior to testing positive for Covid-19. Concomitant product use was not provided by the reporter. The patient was diagnosed with COVID-19 at the skilled facility after becoming dehydrated. He was transported to Hospital on 23 Dec 2020 then discharged to skilled facility on 03 Jan 2021 for physical therapy. On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 02 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The anatomical location were not reported. On 03 Mar 2021, the patient was found non-responsive and the staff at skilled rehabilitation tried to resuscitate. Death was the outcome. Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not applicable. The outcome of the event non responsive to stimuli was fatal. The patient died-on 03 Mar 2021 and the cause of death was not provided. It is not known whether autopsy done on this individual. No results were provided.; Reporter's Comments: This is a case of death in an unknown aged male subject with unknown medical history of recently recovered covid-19 infection before first dose, who died one day after receiving second dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1125144-1" "1125144-1" "Death unknown. Patient caregiver reported that it may be related to broken heart syndrome due her family member's passing." "1125283-1" "1125283-1" "Systemic: Patient passed away-Severe, Additional Details: Patient passed away on 3/9/2021" "1125300-1" "1125300-1" "Patient had no known ill effects or complaints directly after receiving his first COVID-19 vaccine on 02/19/2021. However, on 03/21/2021, he was found deceased on his bedroom floor due to a suspected cardiac arrhythmia. It is unknown if there is any correlation." "1125377-1" "1125377-1" "Patient began to complain about secretions on 2/1 and phlegm for days post vaccine. Following that she complained of upset stomach upset and large mucus. Loose stool followed on day 6 post vaccine, with continued large amounts of mucus." "1125469-1" "1125469-1" "PER FAMILY PATIENT PASSED AWAY 2/28/2021" "1125494-1" "1125494-1" "He was found deceased in his home 7 days after receiving the 2nd vaccine," "1125507-1" "1125507-1" "Death within 60 days of vaccination" "1125778-1" "1125778-1" "3/20/21 06:22 pm Resident c/o Nausea and feeling full- Tube feeding placed on Hold- Resident started vomiting- Zofran 4 mg given- Positive outcomes. 03/21/2021- 0430 Resident found unresponsive on morning rounds- w/ weak pulse, shallow breathing. O2 via NC increased to 5 L, NP, Family ( Code Status DNR)- Power of attorney ordered to send out- MR notified- Upon arrival no rhythm detected- Death pronounced at 0445" "1125891-1" "1125891-1" "Patient died with an unknown cause. He was found on the kitchen floor with no blood present. We requested an autopsy but because the County Coroner said there was no foul play suspected, that they would not perform an autopsy on the body to determine the cause of death even though the family had requested an autopsy. The Funeral Home stated to us that it had the looks of a heart attack, but he was not qualified to make that determination. He stated that the way the blood had stopped and purpled in his neck, gave him the indication that the heart was unable to pump all the way." "1125903-1" "1125903-1" "Patient stayed in health center under routine observation for 15-20 minutes after vaccine injection and showed no symptoms and was subsequently released to go home. A friend drove her home after her injection. On 3/19/21 at 09:09 a.m. a medical assistant from our facility called pt. to inform her of normal lab results. On 3/21/21 at approximately 05:43 p.m. the on call provider took a call from Deputy from the Sherriffs office informing us that pt. was found deceased in her bed on the afternoon of 3/21/21." "1125936-1" "1125936-1" "3-21-21 at 5:35am - Intermittent coughing during HS. Afebrile. Upper lung fields noted congestion; clearing when coughing/turned repositioned per staff, Afebrile. 3-21-21 at 9:30am - In residents room repositioning him, resident vomited tube feeding. Turned him on his side and swept out his mouth. Tube feeding pump turned off. Breathing became labored. Second nurse placed non-rebreather mask on him. Called 911 to take resident to hospital. 3-21-21 9:45am EMS now at bedside. Pulse palpable, Cheyne Stokes respirations. O2 on per non-rebreather mask. EMS assessed resident- now in VT/VF CPR initiated. Code cart placed outside of door. 3-21-21 10:00am Resident transferred out to Rig with an organized heart rhythm. Dr. ( on call for Dr.) notified of event and transport to hospital." "1126004-1" "1126004-1" "When attempting to schedule dose #2, was advised by the family that the patient passed away on 3/13/2021." "1126012-1" "1126012-1" "Death within 60 days of vaccination" "1126015-1" "1126015-1" "Unknown adverse event from vaccination. 3/14/21 Informed by caregiver that client was sent by ambulance to ER and diagnosed with bilat pneumonia. She developed difficulty breathing on 3/13/21. She was seen at Walk In on 3/12/21 for toenail eviscerated and INR, and had been giving tylenol for pain control for toe. 3/15/21 Informed by caregiver client was in ICU, septic, bilat pneumonia, and low oxygen levels. 3/16/21 Informed by caregiver client not doing well authorized indwelling cath due to low blood pressure and ventilator. Client transfered by med flight to ICU. 3/17/21 Informed by caregiver client death last night." "1126060-1" "1126060-1" "death 2 and half hours after receiving the first Moderna vaccine; A Spontaneous report was received from a health care professional concerning a 61 year old male patient,who received Moderna's COVID-19 vaccine (mRNA-1273) and reported death. The patient's medical history as provided by the reporter included diabetes, history of shortness of breath, cardiac history. Concomitant medications included metoprolol, metformin and glipizide. On 05 Mar 2021, prior to the onset of events the patient received his first dose of their two planned doses of mRNA-1273 (Batch N0: 030a21a) intramuscularly for prophylaxis of covid 19 infection. On 05 Mar 2021,it was reported that the patient died 2 and half hours after receiving the first Moderna vaccine. The patient had no symptoms during observation 15 minutes after receiving fist Moderna vaccine.The patient's PCP ordered an autopsy. Treatment information not included. Action taken with mRNA-1273 in response to the events was not applicable. On 05 Mar 2021, it was reported that the patient died.; Reporter's Comments: This is a case of sudden death in a 61-year-old male subject with hx of diabetes, history of shortness of breath and cardiac history, who died 2 1/2 hours after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death" "1126135-1" "1126135-1" ""I am writing this on behalf of my mother. She received the first round of the vaccine (Pfizer/EL9269) on 2/18/21. That evening she reported not feeling ""right"". Over the next two days after receiving the vaccine on Thursday she reported to family that she didnt feel well. She had no fever but muscle aches, an earache and sore throat (this was on Friday and Saturday). On Sunday her breathing became a bit labored. She still had previous symptoms reported and labored breathing -- she stated she thought she would have to go to the Dr the next day (Monday, Feb 22, 201) if she did not feel better. Sometime in the night of Feb 21st and Feb 22nd my mom passed away. My mom had many health problems. Heart disease, diabetic, she was on dialysis and had sleep apnea. However, she definitely seemed to be having some difficulty with the affects of the first vaccine. Please let her life be counted."" "1126293-1" "1126293-1" "Death 10 days after receiving first moderna covid vaccination. Was not told by patients family cause of death, unclear if there is a link between vaccination or not." "1126550-1" "1126550-1" "Death; A spontaneous report was received from a consumer concerning a 66-year-old, female patient, who received Moderna's covid-19 vaccine (mRNA-1273) and died. The patient's medical history included covid-19 infection on 04 Nov 2020. No relevant concomitant medications were mentioned. On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:unknown) intramuscularly for prophylaxis of COVID-19 infection. On 09 Mar 2021, the patient died. CT was done and did not find any atherosclerosis but found her lungs were whited out,heavily filled with fluid which he described could've been pulmonary edema. She had tested Covid positive back on 04 Nov 2020. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was fatal. The patient died on 09 Mar 2021 and the cause of death was unknown. An autopsy was planned on 11 Mar 2021.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1126563-1" "1126563-1" "Death; Kidney shutdown; This is a spontaneous report from a contactable consumer reporting for the mother. An 83-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm, on 28Feb2021, as single dose, for COVID-19 immunisation. Medical history included unspecified ailments. Concomitant medications were not reported. The patient experienced kidney shutdown (medically significant) on 02Mar2021 with outcome of unknown and death (death, medically significant) on 14Mar2021. The cause of death was unknown. It was not reported if an autopsy was performed. The information on the lot/batch number has been requested.; Reported Cause(s) of Death: Death" "1126609-1" "1126609-1" "CARDIOPULMONARY ARREST 2 DAYS AFTER RECIEVING SECOND MODERNA DOSE" "1126619-1" "1126619-1" "His vitals signs was stable after vaccine was administered, but the resident was expired in 85mins after given 1st dose of Covid Moderna vaccine." "1126639-1" "1126639-1" "@ 6:50 pm- Resident lying in bed with signs of apnea also has o2 in progress per Nasal cannula. Call bell in reach. v/s 53/20, 12, 101.5, o2 is 92%. Family choice not to send out to hospital bc resident had HX of periods of apnea @ 9:30 pm- resident had no means of life, vitals wasnt reading at this time." "1126643-1" "1126643-1" "Death within 30 days of vaccination" "1126681-1" "1126681-1" "Family notified facility of death when we contacted to confirm second dose appointment" "1126683-1" "1126683-1" "Death within 60 days of vaccination. Tested positive for COVID-19 2/8/2021, admitted outpatient to Hospital 2/8-2/10 readmitted 2/13-2/14 with transfer to Medical Center in with death on 3/2/2021." "1126721-1" "1126721-1" "Patient experienced severe vomiting and fatigue 24 hours after receiving vaccine. This occurred throughout 48 hours after and patient was found d/c on 03/20/2021." "1126724-1" "1126724-1" "Death within 30 days of vaccination." "1126732-1" "1126732-1" "The decedent had significant medical conditions. The wife stated, the appointment for the vaccine shot was made on-line. Dept. of Health visited their home on 3/16. The shot was administered into the decedent's left arm at 0930hrs. The decedent expressed no health complaints and had no visible indications of adverse affects. The decedent was found not breathing supine in bed at 2347hrs 3/16 (same day as vaccine shot)." "1126810-1" "1126810-1" "Patient suffered AMI within 24 hours after dose was administered." "1126834-1" "1126834-1" ""vaccinated 1/13. presented for COVID screening on 1/14 due to a + exposure. Test was +. Patient came to ED on 1/16 with weakness, congestion, poor appetite, coughing. Previous headache and sweating had resolved by the time she presented. Discharged with isolation instructions. Returned to ED late on 1/22 with "" right-sided chest pain described as sharp constant 6/10 nonradiating pain localized to the right side of upper chest, shortness of breath with exertion since this afternoon. She does endorse subjective fevers, with associated increased coughing which is productive in nature, shortness of breath."" Admitted to ICU early 1/23, transferred to Medical Center on 2/4/21."" "1126863-1" "1126863-1" ""Patient was vaccinated in her home (COVID J&J) on 3/8. Vaccinator obtained consent and confirmed throughout the process that patient as at baseline since patient was nonverbal and bedbound. Later that same day she experienced an emergency and was take to the hospital and subsequently admitted to ICU. She died on 3/10, family present, on comfort care. Per HPI, ""Patient is a 85 y.o. female with advanced dementia (non verbal, wheelchair bound at baseline), chronic aspiration, recurrent UTIs, voiding dysfunction currently self-straight cathing, has suspicious bladder and gallbladder masses (being worked up), has right sided hydronephrosis, BIBEMS for acute hypoxemia, difficult to bag en route, ED had difficulty intubating and so performed cricothroidotomy. Patient had brief PEA arrest due to hypoxia. ED provider noted ""excessive pulmonary edema in airway, unfavorable anatomy, and airway swelling."" Suspected insult stemming from J&J COVID vaccination reaction."" "1126876-1" "1126876-1" "Patient passed away in the early morning of 3/13/21." "1126882-1" "1126882-1" "Patient's wife states that he reported a bad headache about 3 hours after vaccination, that had improved by the next morning. The afternoon of 1/27/21, within 24 hours of receiving the vaccine, patient suffered from a stroke." "1126917-1" "1126917-1" "N/a" "1127080-1" "1127080-1" "He developed very labored breathing on Tuesday night. By Wednesday morning , upon waking it was severly worse. I would have taken him to the ER had I been home. When I returned home around 11am, he was having a very hard time breathing. I got him a rescue inhaler to use. He had a dailysis treatment that day, during the treatment they kept him on oxygen. I called Dr office to inform them, they ordered a new inhaler and told me if the symptoms did not decrease by 72 hours to inform them. His breathing did get somewhat better but he did not have his enegry levels that he had previously or his appeatite. 12 days after his 2nd dose of the Moderna vaccine he went into cardiac arrest in the home with myself and husband present." "1127148-1" "1127148-1" "Death" "1127157-1" "1127157-1" "Death" "1127175-1" "1127175-1" "Death" "1127245-1" "1127245-1" "Vaccine given Dec 27th 2020, patient couldn?t swallow eat or drink the next day, patients family notified Dec 29th 2020 and patient passed away on Dec 30, 2020 at 1 pm EST." "1127402-1" "1127402-1" "Pt recieved 1st Pfizer vaccine on 2/25/21 and her 2nd one on 3/18/21 Pt went to the ER on 3/23 via 911 in full cardiac arrest Per daugher, she c/o lightheaded this A< she came out of her room snad fell down, was vomitting and labored breathing paramedics were called, she went to Hospital and later died" "1127444-1" "1127444-1" "Sudden onset of shortness of breath early morning 3/15/2021. EMS called, transported patient to Adventist to ER code blue in asystole. Asystole on arrival, no response to resuscitative efforts, pronounced dead in ER." "1127466-1" "1127466-1" "Received call from his exwife that patient had passed away. Death Certificate states date of death as March 14, 2021. Causes of death are listed a. Cardiac Pulmonary Arrest. b. Myocardial Infarction" "1127468-1" "1127468-1" "Severe lethargy after receiving the shot. Constant sleepiness and malaise, nausea, confusion, loss of appetite, dizziness, Blood vessels/clots formed in her eyes. Acute renal failure and eventually death on March 18, 2021." "1127472-1" "1127472-1" "Fever, low oxygen saturation, severe encephalopathy, kidney failure, bilateral pulmonary infiltrates, sepsis, tachycardic, acidotic, intubated on ventilator since admission, paralyzed/sedated, ABG results showed high CO2 and O2 retention, edema, electrolyte imbalance, ARDS, low hemoglobin and hematocrit levels, blood transfusion needed" "1127653-1" "1127653-1" "Death by Hemorrhagic Stroke" "1127657-1" "1127657-1" "Cardiopulmonary arrest at home @ 1 hour after vaccine administration. CPR by EMS to today hospital for asystolic cardiac arrest. Pt. Intubated then terminally extubated" "1127847-1" "1127847-1" "Participant felt flushed, feverish, fatigued with general aches and dry cough over the weekend after receiving injection, took acetaminophen and cough syrup on Monday. He became short of breath on 1/20/2021 and was hypoxic on oximeter check, was sent to the ER. He was intubated in ER and went into respiratory failure with sepsis due to COVID19. He was treated with tocilzumab, became paralyzed and DVT in left lower extremity was found. HE required pressors and diuresis, he developed AKI and hyperkalemia. On 2/21 he was in multi-organ failure. His level of cognition decreased until he was no longer responsive and he died on 2/24/2021." "1127860-1" "1127860-1" ""Not sure if covid vaccine caused this, but this is what happened - Received covid vaccine. two days later had violent shakes in the night. Immediately went to get a covid test out of precaution. Tested negative for covid, but positive for ""flu b"". Went home to treat flu with fluids and rest. Got no better. Went to heart doctor out of precaution, full work up...everything checked out great. Went home, got no better. Went to primary care physician, full work up...found a ""spot"" on left lung. Was given antibiotics and steroids, go home and in a few days will be getting better. 3 days later became incapacitated and had to be rushed to ER. Was admitted into hospital for 6 days to treat ""pneumonia"". Also possible UTI and sepsis. Also while in hospital found out that a mini stroke had happened. Treatment went well, oxygen levels were good. Was released with glowing reports. 24 hours later at home had to be rushed to ER again after becoming incapacitated.. Was admitted again 7 more days. During this time everything took a nose dive in succession. Lungs were failing, multiple unexplained strokes were happening (while on blood thinners, had been on blood thinner 15 years...after first stroke they changed to another blood thinner...only more strokes). After so many strokes and compounding of strokes, his neuro function started failing. He was put on life support. While on life support his organs started failing. He had to be put on comfort mode and was dead within 8 hours. A perfectly healthy 77 year old man who had never been sick a day in his life (literally) got his 2nd covid shot, two days later he fell ill. From that point on his health spiraled out of control until his death on March 19th. Every doctor (pulmonologist, cardiologist, neurologist, and all attending doctors said that it was ""atypical and abnormal"" what was happening. It should not have happened. 180 degrees from normal."" "1127866-1" "1127866-1" "Patient died in his sleep the night of getting dose 1 COVID -19 he had a massive heart attack and died" "1128052-1" "1128052-1" "Chest pain; felt really bad; Death; Vomited that night; Sore arm and pain in both arms; A spontaneous report was received from a consumer concerning a 83-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and pain in both arm /pain in extremity, felt really bad/feeling abnormal, chest pain and the patient died. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 04 Mar 2021, patient experienced sore arm and felt bad. The patient vomited that night. On an unknown date patient reported chest pain and pain in both arms. On 05 Mar 2021, at 12:46pm the patient died. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 05 Mar 2021. The cause of death was reported as unknown. Plans for an autopsy were unknown.; Reporter's Comments: This is a case of death in an 83-year-old male subject with unknown medical history, who died 2 days after receiving first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death" "1129005-1" "1129005-1" "death" "1129069-1" "1129069-1" "Patient had no known immediate ill effects or complaints directly after receiving his second COVID-19 vaccination on 03/11/2021. However, on 03/22/2021, he suffered a fatal cardiac arrhythmia while exercising on his home elliptical machine." "1129117-1" "1129117-1" "Patient passed away in her sleep 8 days after receiving 2nd dose of Moderna vaccine. Patient's family reports they believe it was a massive heart attack. They do not believe this was related to the vaccine." "1129413-1" "1129413-1" "Death" "1129427-1" "1129427-1" "Pt received vaccine on Friday, March 19th. On Monday, March 23rd, t was hiking with boy scout troop, became short of breath, collapsed and went into full arrest. BLS done on scene, transported to local ER where pt was pronounced dead." "1129706-1" "1129706-1" "Patient presented to SJMC in Brainerd by private car, 3/23/21 DOA. Family with patient wanted no resuscitation. Patient pronounced deceased 2:49 pm." "1129801-1" "1129801-1" "RECEIVED REPORT THAT TWO WEEKS AFTER HIS SECOND DOSE, HE DIED OF A MYOCARDIAL INFARCTION." "1129805-1" "1129805-1" "Death; unconscious; in and out of consciousness; weak, very weak; blood pressure was very low; little light headed; A spontaneous report was received from consumer concerning a 88 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a little light headed/ dizziness, weak, very weak/asthenia, blood pressure was very low/ hypotension, in and out of consciousness/depressed level of consciousness, unconscious/ loss of consciousness and passed away. The patient's medical history was reported as heart issues. Concomitant medications taken by the patient included levothyroxine, isosorbide, acetylsalicylic acid, metoprolol, furosemide, warfarin, antibiotics. On 3 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 3 Mar 2021, when the patient got home the night, after getting the shot, patient was a little lightheaded, she seemed to be okay on 04 Mar 2021 and 05 Mar 2021. Patient had complained of being weak and her blood pressure was very low on 08 Mar 2021. She was progressively started getting weaker. On 09 Mar 2021, she was very weak and was in and out of consciousness. Patient was taken to the hospital, and she became unconscious and then passed away. Patient passed away on 09 Mar 2021. The patient died on 09 Mar 2021. The cause of death was unknown. Plans for an autopsy were unknown. Treatment activities for event was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events, unconscious, a little light headed, weak, very weak, blood pressure was very low, in and out of consciousness was unknown. The outcome was considered fatal.; Reporter's Comments: This is a case of sudden death in a 88-year-old female patient with a history of heart issues, who died 6 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death" "1129838-1" "1129838-1" "chest pain, vomiting, death" "1129851-1" "1129851-1" "Family reported patient passed away 3 days after injection by MI" "1129860-1" "1129860-1" "Died January 21 after she received an mRNA shot; A spontaneous report was received from a consumer via social media concerning a 28-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and died two days later (death). The patient's medical history was not provided. No relevant concomitant medications were reported. On 19 Jan 2021, per social media post, the patient received one of their two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. The reporter stated that the patient was dead on 21 Jan 2021. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 21 Jan 2021. The cause of death was reported as unknown. An autopsy was done. The reporter stated that the autopsy showed no other red flags, otherwise, no additional autopsy results were reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death" "1129951-1" "1129951-1" "72 y/o with hx of HTN, Aortic valve replacement, venous stasis and venous insufficiency of both lower extremities, CAD, AAA, and s/p squamous cell carcinoma excision in 2019 Upon reviewing the history, here is what we found. 1. 2/27 -- Received send-out covid swabbing/testing- Patient did not disclose this information when screened for his covid vaccination at the clinic. 2. 3/2, 10:00 AM ? Presented to Covid Vaccination Clinic and received 1st dose of Moderna. Results of pending covid test were not back at this time, nor did he disclose this information when screened by nurse prior to vaccination. 3. 3/2, 10:30 PM ? Covid result came back to lab as positive SARS Co-V 2019 4. 3/3 ? patient called and notified of result per ED nurse 5. 3/3 ? Pharmacy recommended patient for mAB infusion (patient did not receive it) 6. 3/6 ? patient presents to ED in severe respiratory distress, DX of Covid-19 pneumonia & transferred to ICU 7. 3/21 ? patient dies after 15 day hospitalization in ICU (pt. had received convalescent plasma x 2 and remdesivir there)" "1129993-1" "1129993-1" "Family stated she felt fine after shot. Had upset stomach night before her death. Took tums. Died in sleep." "1130105-1" "1130105-1" "Kidney failure and death. Patient heart labs were good." "1130109-1" "1130109-1" "Patient passed away unrelated to covid vaccination Narrative: The patient received his first dose of Pfizer vaccine on 1/20. Patient was on hospice and passed away at his home with family on 1/26. Cause of death not documented. No indication that death was related to COVID 19 vaccination." "1130110-1" "1130110-1" "Patient passed away unrelated to covid vaccination Narrative: The patient had diabetes, hypertension and coronary atherosclerosis. Patient received his first dose of Moderna on 1/7/2021. Patient elected to not receive 2nd dose vaccination following clinical discussion with provider. Patient was diagnosed with pancreatic cancer and ws place on hospice care. Patient passed away on 2/21.No indication that death was related to COVID 19 vaccination." "1130111-1" "1130111-1" "Patient passed away unrelated to covid vaccine Narrative: The patient received his first dose of Moderna on 1/14 and he was rushed to the hospital at 4 am on 1/15. The patient tested positive for COVID and is hospitalized in the hospital. The patient passed away on 2/8. Cause of death not documented, possibly due to COVID complication. No indication that death was related to COVID 19 vaccination." "1130112-1" "1130112-1" "Patient passed away unrelated to covid vaccination Narrative: The patient had COPD and history of prostate cancer. Patient was placed on hospice care. Patient received his first dose Moderna on 2/9. Patient passed away on 2/16. Cause of death not documented. No indication that death was related to COVID 19 vaccination." "1130113-1" "1130113-1" "Patient passed away unrelated to covid vaccination Narrative: The patient had Alzheimer's disease and was placed on hospice care. Patient received his first Pfizer vaccine on 1/16. No adverse reaction was reported. Patient passed away on 1/30. Cause of death not documented. No indication that death was related to COVID 19 vaccination." "1130250-1" "1130250-1" "Patient tested positive for Covid on 3/12/21 per hospital admission notes. Patient was admitted to the hospital on 3/16/2021 with Covid pneumonia. She passed away on 3/22/21." "1130251-1" "1130251-1" "Sister reports that she was fine, the day before I took her to the dentist. Sister on 5/3/2021 called her and did not answer, so she goes to the nursing home where she resides. She finds her sister cold in the apartment's furniture. Massive heart attack" "1130306-1" "1130306-1" "It began on 2/3/2021 to present low saturation, pressures rose and fell (unstable). They gave him therapy, since he could not breathe. On 02/04/2021, POC reports that caregivers took their rounds and he was without vital signs. Doctor certifies that it was due to respiratory failure." "1130327-1" "1130327-1" "died in sleep" "1130340-1" "1130340-1" "2/25/2021 She was taken to the hospital for aspiration. 03/09/2021 was discharged, but relatives were informed that she was unwell. 3/13/2021 When they went to take the rounds she was without signs, she was sleeping. He refers that the patient died of Aspiration Pneumonia and was tested at the Hospital with negative results. They certify death due to cardiovascular arrest" "1130386-1" "1130386-1" "syncopal event. 911 was then called. Once EMS arrived he was found unresponsive and was in V fib.; transferred to the cath lab where he was found to have a proximal LAD occlusion deceased 3/17/2021" "1130567-1" "1130567-1" "received vaccine on 2/11/2021, stopped eating on 2/18/2021, expired on 03/06/2021" "1130616-1" "1130616-1" "Community partner reported that they found her unresponsive on the 17th (so she may have died on the 16th) from what they believe was a heart attack. The family has requested an autopsy." "1130720-1" "1130720-1" "Tiredness Death 03/19/2021 Cause of death: Ruptured Myocardial infarction" "1130777-1" "1130777-1" ""1st vaccine on 2/20 and reported feeling ""lousy"" afterwards. On the evening of 2/23 felt like she was going to pass out. Felt worse when she woke the next morning. Presented to the ER on 2/24 with chest pain and ""indigestion"". Found to be in A.Fib with RVR. Vomited in ER triage. On 2/25 developed altered mental status, hypotension, hypoxemia. She was intubated and transferred to the ICU with severe lactic acidosis/shock/multiorgan failure. Had Right lower lobe infiltrate and right pleural effusion. Diagnosed with pneumonia and possible ischemic bowel. Died on 2/26. Family requested autopsy."" "1130955-1" "1130955-1" "Atrial fibrillation, respiratory distress, acute renal failure" "1131084-1" "1131084-1" "My sister died in her sleep six days after receiving the J&J vaccine in her sleep." "1131274-1" "1131274-1" "Patient had unexplained asystolic cardiac arrest 3 days after second Pfizer shot was administered. No recent illnesses or complaints, no fevers." "1131280-1" "1131280-1" "On 3/23/2021, Patient became ill, vomiting uncontrollably, throughout the day. On 3/24/2021, he continued his vomiting episodes, and developed a fever with chills. At about 2100 hrs, patient was extremely weak, he went to the bathroom, urinated, and attempted to crawl back to his bedroom, less than 10 steps away. His wife, called 911, and went down stairs to allow entry for the fire department, The fire department, found patient unresponsive, not breathing, and no pulse. He was pronounced dead in his home." "1131328-1" "1131328-1" "Severe GI symptoms followed by death" "1131386-1" "1131386-1" "death" "1131556-1" "1131556-1" "Diagnosis?s with TTP on March 12. Passes away on March 19 2021" "1131557-1" "1131557-1" "COVID-19 disease, symptoms started 3/5/21, deceased of COVID-19 on 3/14/21" "1131585-1" "1131585-1" "death" "1131606-1" "1131606-1" "death" "1131617-1" "1131617-1" "Pt c/o of left arm pain after injection and for several days after. Pt was in bed for 2 days after injection c/o generalized malaise and weakness. Pt c/o of feeling of funny heart rhythms and feeling of constant anxious feeling. Pt started having episodes of SOB and was very labored doing simple tasks such as using the toilet. Pt started using o2 for the first time and had to recover for any activity for several minutes. Different medications were tried to help control symptoms such as Morphine for SOB and ativan for anxious feelings. Symptoms were never well managed after vaccine. Pt eventually died from worsening symptoms on 3/20" "1132062-1" "1132062-1" "Had multiple hospitalizations for COPD prior to COVID-19 infection in December 2020. Had been admitted to Hospice for further decompensation after COVID diagnosis. Limited oral intake and hospice began using morphine and Ativan. Was on comfort medications only prior to 1/26/2021" "1132159-1" "1132159-1" "Death, adverse event occurred outside of the hospital and outside of observation window. Event was reported via employee to hospital." "1132299-1" "1132299-1" "Unstable vitals" "1132313-1" "1132313-1" ""Patient got vaccine dose #2 on 3/23/21 (Tues) approx 10am. Per family reports patient went to hospital 3/24/21 (Wed) for unspecified pain and temp of 102f. Family states a ""scan"" was done and came back with nothing. P was treated for UTI and sent home. Patient was reportedly laying down at home about 8:15 or 8:30am complaining of a bad headache. Patient was found later that am deceased in her bed."" "1132327-1" "1132327-1" "They proceed to take the round and at that moment they realize that she was not breathing, she was already compromised . He dies of heart failure." "1132360-1" "1132360-1" "She was being treated for kidney failure, at one point her body was not responding to the treatments and they put her in Hospice. She was in hospice for some 5 days. She had been dying for days and in one of the rounds around 6 am on 2/2/2021, the caregivers accompanied her until she no longer had vital signs." "1132458-1" "1132458-1" "He was in Hospice. He died as a veteran. He had a constant lack of appetite. Has no additional information" "1132667-1" "1132667-1" "She was transferred to the hospital on 3/4/2021 due to low blood pressure, she understands that due to heart failure. The death certification information is unknown." "1132713-1" "1132713-1" "2/16/2021 He was transferred to the Regional Hospital of due to low pressure (systole), received CPR in the ambulance on the way to the hospital. He died on 2/19/2021 due to various complications, including pneumonia." "1132752-1" "1132752-1" "Decedent began noticing symptoms on 3/17/2021. He c/o worsening back pain, joint pain, headache and stiffness last Sunday (3/21/2021). Today (3/25/2021), he c/o chest pain. The decedent received his COVID-19 vaccine on 3/16/2021." "1132786-1" "1132786-1" "Death" "1132800-1" "1132800-1" "Wife found husband dead two days after2nd dose. This Health Department was made aware of the death by the the Kidney Center. The patient failed to show up for a scheduled dialysis appointment on 03/24/2022. The clinic obtained information of the passing from the wife. The patient received his SECOND dose of COVID-19 vaccine on 3/22/21, reported feeling ill 3/23/21 and then passing on 3/24/21. The clinic called the health department to report the death of the patient on 3/24/2021." "1133044-1" "1133044-1" "Ventricular tachycardia; This is a spontaneous report from a contactable physician and consumer. A 73-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: UNKNOWN) via intramuscular in left arm on 10Mar2021 (at the age of 73-years-old) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient did not receive other vaccine in four weeks prior to vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included carvedilol (COREG), apixaban (ELIQUIS), enalapril(MANUFACTURER UNKNOWN), furosemide (LASIX), dofetilide (TIKOSYN), allopurinol (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date for Covid-19 immunization. On 13Mar2021, the patient experienced ventricular tachycardia. Seriousness criteria was considered as emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for 1 day and died on same day (13Mar2021). The patient was not tested for covid post vaccination. The patient received treatment for the event. An autopsy was not performed, and the reported cause of death was ventricular tachycardia. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a causal association between the reported event ventricular tachycardia and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available including medical history data. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Ventricular tachycardia" "1133552-1" "1133552-1" "Unknown - Documentation not available" "1133564-1" "1133564-1" "It was sent for low pressure on 02/12/2021 to the Hospital Medical Center. He died of respiratory arrest." "1133604-1" "1133604-1" "She was taken to hospital 03/02/2021 where she died at 4 am from a heart attack." "1133650-1" "1133650-1" "Patient presented to the emergency department of Hospital on 1/16/21 with severe hypoxia to 70s% on room air and was found to have COVID-19 infection with pneumonitis. Patient is a resident where received Covid Vaccination on 1/15/21" "1133712-1" "1133712-1" "reported bad headaches on the day following the vaccine--did not see the doctor--later died. the coroner reported that the preliminary autopsy showed an enlarged heart and liver" "1133748-1" "1133748-1" "Death Narrative: admitted to hospital on 12/29/20 due to Covid-19 PNA. PMH includes MRSA+, CHF, COPD, HTN, HDL, Meniere's. 1/12 DC to NH where he rec vaccine. 2/7 pt passed away at NH 2/7/21." "1133750-1" "1133750-1" "Death Narrative: Pt was at rehab hospital where he rec his vaccine. No info for Lot or site. Was under Hospice for COPD, CHF, MDD. Passed at rehab center. No other info." "1133939-1" "1133939-1" "Acute hemolytic anemia of unknown cause - may/may not be related to vaccination" "1133940-1" "1133940-1" "Patient was found deceased at home on 2/20/2021, 8 days after receiving the 1st dose of COVID-19 vaccine." "1134002-1" "1134002-1" "Death 4 days after vaccination" "1134021-1" "1134021-1" "Patient death within 60 days of receiving the COVID vaccine series" "1134054-1" "1134054-1" "Hospitalization within 6 weeks after receiving vaccine" "1134070-1" "1134070-1" "Patient death within 60 days of receiving the COVID vaccine series" "1134252-1" "1134252-1" "1/15 through 1/19 Pt was hospitalized for COVID symptoms and diagnosed COVID +. received remdesivir and plasma on 1/15. 1/19 discharged home and doing well until 2/12 2/11 received pfizer vaccine 2/12 readmitted to hospital after being found unresponsive at home, sats 35%, rales, temp 103.8, CXR infiltrates, placed on PR mask then BIPAP- diagnosed with cytokine storm possibly from vaccine. 2/13 sats 78% on BIPAP, sweating, rapid response called and stabilized 2/16 pt found with left sided weakness, droop and left arm flaccid. CT scan revealed ischemic stroke 2/17 6L salter lab remain weak on left side 2/19 increased to 10L salter lab 2/20 possible aspiration - worsening sats 2/21 continues to have decreased sats PR mask at 15L. then back on BIPAP 2/22 discussion with family about poor prognosis. DNR comfort. 2/23 Pt passed away" "1134376-1" "1134376-1" "Patient passed away from cardiogenic shock after a CABG" "1134398-1" "1134398-1" "She had been in her usual state of health until tonight. Assisted living facility staff called. He mentioned that the facility staff had earlier noticed that she was dragging her right foot and and has been needing more assistance with activities. The patient was walking and did not feel well. She was lowered to the ground and had a witnessed cardiac arrest. The ambulance was called and she was reportedly found to have pulseless electrical activity. She was given Epinephrine and Amiodarone with return of pulse. The patient was brought to the Emergency Room and was evaluated by ER physician. EKG showed atrial fibrillation, ventricular rate = 66, RBBB with Brugada pattern. She was emergently brought to the Cath Lab. Cardiac catheterization showed normal coronary arteries but EF 35-40%. Repeat EKG showed atrial fibrillation with rapid ventricular response = 110, RBBB. Therapeutic hypothermia was initiated. The patient was admitted to the ICU on mechanical ventilation with TV 350 RR 14 PEEP 5. She is sedated with Propofol and Fentanyl IV. She is on Levophed IV. ABG showed pH = 7.22, pCO2 = 53, pO2 = 66, O2 sat = 88%. Lactate level = 9.5. WBC 8.8, Hgb 13.4, Hct 46, Platelets 138. Na 138, K 3.2, Cl 102, bicarb 20, BUN 16, Crea 1.19, estimated GFR = 44 mL/minute. Magnesium 2.7. Glucose levels have ranged from 273-312. Pro-Calcitonin = 0.26. Albumin 3.7. SGOT 262, SGPT 294. Troponin elevated at 47. Pro-BNP = 600. Urinalysis showed large blood. Chest x-ray showed vague peripheral pneumonitis. Endotracheal tube is in place. COVID-19 test by PCR is negative (2/5/21). COURSE IN HOSPITAL The patient was admitted to the ICU and was followed by Pulmonary/Critical Care. Patient was maintained on mechanical ventilation, sedated with propofol and fentanyl IV. Vasopressors were administered (Levophed IV). She was managed with therapeutic hypothermia. She was followed by Cardiology. Foley catheter was inserted for close input/output monitoring. Neuro checks, vital signs, daily weights, pulse oximetry, cardiac telemetry and fingersticks were monitored. She was given sodium bicarbonate IV due to metabolic acidosis. She was also given insulin IV drip. Potassium chloride IV was administered due to hypokalemia. The patient was given amiodarone IV. Platelet count was noted to be low but stable. Glucose levels were within acceptable range. Metabolic acidosis resolved. Hypokalemia resolved. Hypomagnesemia resolved. There were elevated LFTs which improved. Elevated CPK also improved. She was taken off hypothermia protocol. Sedation was decreased and she was able to open her eyes with verbal stimulus but unable to follow commands. Ammonia level was normal. Neurology evaluated the patient. EEG showed left periodic epileptiform discharges consistent with severe diffuse encephalopathy. Chest x-ray revealed right upper lung and left mid lung increasing opacity for which meropenem IV was started. Levophed was discontinued. Initially she had peripheral cyanosis, but this resolved upon discontinuation of vasopressors. Brain MRI was done demonstrating diffuse bilateral small and moderate-sized ischemic foci throughout the cerebellum and cerebellar region suggestive of embolism. There also was chronic marked atrophy and moderate small-vessel gliosis. CIRCUMSTANCES SURROUNDING DEMISE Based on neurologic evaluation, her prognosis for meaningful neurologic recovery was thought to be extremely poor. The patient was evaluated and followed by Palliative Care. She does not have family members and had designated her neighbor friends as her power of attorney. They have known the patient for a ling time and they know that she does not want to live like this. A decision was therefore made for comfort care measures only. Compassionate extubation was performed on February 12, 2021. The patient passed away on February 12, 2021, at 6:39 p.m." "1134432-1" "1134432-1" "Pt went unresponsive at home per wife, was transported to hospital by EMS and died after getting to the hospital. This is not a suspected allergic reaction to the COVID Moderna vaccine at this time." "1134477-1" "1134477-1" "Resident found unresponsive found at 1545, CPR done, EMS responded and resident Pronounced Dead at 1615" "1134616-1" "1134616-1" "Patient death within 60 days of receiving the COVID vaccine series" "1134647-1" "1134647-1" ""81 y/o male patient was vaccinated 3/3/21 and died 3/6/21. Patient's wife reported he was having ""some trouble breathing"" but could not remember whether this problem started before or after being vaccinated."" "1134651-1" "1134651-1" "The patient had a hemorrhagic stroke approximately 3 days after receiving the vaccine and died." "1134697-1" "1134697-1" "Patient reportedly passed away on 3-24-21 on the day after the vaccine was given. We have no further information at our facility regarding the event." "1134751-1" "1134751-1" "Patient was hospitalized within 4 days of getting the vaccine and passed away 6 days after getting the vaccine" "1134819-1" "1134819-1" "She developed a large pulmonary embolus, and she died on 3/17 at Hospital. She developed symptoms of SOB on 3/11, and was admitted to the hospital. She was initially stable and not requiring oxygen and was sent home on anticoagulation. However she returned the same day with worsening symptoms, troponin now elevated, and ECHO showing signs of right heart strain. Embolus on imaging had increased in just over days from previous CT scan. She became pulseless and died despite resuscitative efforts. It is my opinion (Dr.) that she died of a pulmonary embolus, and an autopsy is pending." "1135281-1" "1135281-1" "Passed away; A spontaneous report was received from a Healthcare Professional concerning a 57-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away/death. The patient's medical history was not provided. However, the patient had some serious chronic health condition. No relevant concomitant medications were reported. On 21 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: LOT: 011L20A Exp: 03July2021) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. He did not experience any symptoms right away and nothing within the next 15 mins under observation. On 22 Jan 2021, the patient passed away. Treatment details was not reported. Action taken with mRNA-1273 in response to the event passed away, was not applicable. On 22 Jan 2021, the patient died. It was unknown if an autopsy was performed.; Reporter's Comments: Very limited information regarding the event of death has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Passed away" "1135351-1" "1135351-1" "2/03/2021 Death. No treatment. Deceased." "1135483-1" "1135483-1" "Patient got 2nd vaccine, waited 15 minutes for observation and collapsed when getting into car" "1135587-1" "1135587-1" ""died yesterday; This is a spontaneous report received from Medical Information from a contactable other health professional. A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 17Mar2021, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient died in Mar2021 (reported as ""yesterday""). The outcome of the event was fatal. The cause of death was not reported. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: Event unknown cause of death is assessed as related until sufficient information is available to confirm an unrelated cause of death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: died yesterday"" "1135730-1" "1135730-1" "Patient found dead two days after vaccination; A spontaneous report was received from a healthcare provider concerning 48-year-old, male patient who received Moderna's COVID-19 vaccine (mrna-1273) and died. The patient's medical history includes bipolar disorder, colon polyps, hypertension, benign tremors & other Comorbidities. Concomitant product like iron sulfate, Fluticasone, Gabapentin, Lamotrigine, Methocarbamol, Propranolol hydrochloride was reported by the reporter . On 11 mar 2021, approximately 2 days prior to the event, the patient received their first dose of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 13 Mar 2021, the patient died. No other details were reported. Treatment information was unknown. The patient died on 13 Mar 2021. The cause of death was not provided. Plans for an autopsy were unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1135778-1" "1135778-1" "Breathing issues; Death; A spontaneous report was received from a consumer concerning a 78 years old, female patient who experienced breathing issues/dyspnoea. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 08 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. The patient experienced breathing difficulty on 12 Mar 2021. The patient died on 12 Mar 2021. Treatment information was not provided. Action taken with the drug in response to the events is not applicable. The patient died on 12 Mar 2021. The cause of death was not reported. The reporter wanted to conduct a autopsy to find out if the death was caused by the vaccine.; Reporter's Comments: This is a case of death in a 78-year-old female subject with unknown medical history, who died 4 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1136004-1" "1136004-1" "Patients representative notified pharmacy today to cancel patients second appointment as the patient had died this morning due to a staff infection in hospital. Representative did state they did not believe it was related to vaccination as patient has been having difficult time with underlying conditions (pulmonary fibrosis and atrial fibrillation)." "1136479-1" "1136479-1" "PATIENT HAD THE FOLLOWING SYMTOMS AFTER RECEVING THE PFIZER COVID VACCINATION. MORNING OF MARCH 23RD HE WAS NOT WELL AND STATED HOME FROM WORK. SYMTOMS WERE AN UPSET STOMACH, UPPER BACK SORENESS, AND SORENESS OF ARM. DURING THE AFTERNOON HE TOLD HIS WIFE HE NEEDED TO LAY DOWN AND NEVER REGAINED CONCIOUSNESS BEFORE AND AFTER EMS WAS CALLED @7PM. SPECIFIC DETAILS OF EMERGENCY MEDICAL CARE CAN BE GATHERED FROM THE HOSPITAL. UPON VISITING PATIENT AT POST MORTUM, STAFF NURSE INFORMED ME THEY WORKED ON HIM FOR OVER AN HOUR BUT THEY NEVER GOT A PULSE. FURTHER DETAILS SUCH AS LOCATATION OF VACCINE ADMINISTRATION MAY BE GATHERED BY THIS AGENCY FROM HIS WIDOW." "1136547-1" "1136547-1" "92 y/o - Severe dementia. Hospice" "1136624-1" "1136624-1" "N/A 98 y/o with dementia and heart disease" "1136657-1" "1136657-1" "NA 74 y/o several comorbidities. Stroke" "1136716-1" "1136716-1" "The patient referred that has no symptoms. POC was with her, until she died. She died of Alzheimer's, diabetes and a sacral ulcer that she brought when she was admitted." "1136862-1" "1136862-1" "Had his vaccine, he had some reaction but not aware of what it was. On 3/20/21 they found him slumped over the toilet where he had died. His brother had spoken with him the day before and was supposed to see him on Saturday. Brother is not aware if he had taken anything for his symptoms, probably just took some Tylenol." "1136867-1" "1136867-1" "headache started about 12 noon on day of, texted a friend at 5:47pm to say wasn't feeling well, hurting all over mostly in chest, shoulders and head." "1137069-1" "1137069-1" "57yo Male, resident, declared dead 01/11/2021 , following a period of ill health related to diabetic ulcers." "1137286-1" "1137286-1" "Brought in from ED, family concerned for altered mental status, hyperthermia, Tmax in 105. The patient stated that after the covid-19 vaccine on Friday, he experienced acute onset of R shoulder pain, constant, associated with decreased ROM. On PM Monday, he noticed first episode of chills, that lasted a few minutes, accompanied with sweating. This episode recurred 4 times over the week, then the family started noticed the patient was unable to answer questions and was somnolent. Blood Cultures in the ED were positive for MRSA 2:2. He was positive for endocarditis (previous dental work). Acute metabolic encephalopathy due to severe sepsis most likely 2/2 MRSA bacteremia complicated by NSTEMI and AKI in setting of newly diagnosed aortic valve endocarditis complicated by septic emboli to the bilateral cerebral hemispheres" "1137449-1" "1137449-1" "He returned from the hospital through a PEG tube, he was stable. On 7/3/2021, caregivers give a round of vitals at 7:30 am, he was stable, when he was going to receive food he was without vital signs. Cause of death respiratory cardiac arrest." "1137529-1" "1137529-1" "See started having shortness of breath on the night of 8/2/2021. He sends her to do tests, and she was taken to the hospital. She died in the hospital due to kidney and heart failure." "1137579-1" "1137579-1" "? Maderna vaccine #1 on 3/16 at clinic ? Provider visit 3/22 dx bronchitis due to COVID-19, z pak and steroids ? ED 3/25 syncopy, full arrest and patient expired patient states she had COVID in February" "1137994-1" "1137994-1" "Patient passed away on Monday (March 22nd, 2021)" "1138065-1" "1138065-1" "Pt came into Emergency Department with resuscitation efforts in progress. Patient spouse states no known health concerns but was feeling unwell after 2nd dose of vaccine on Monday." "1138291-1" "1138291-1" "Severe headache, fatigue, very sleepy about two hours after injection. Woke about 1:00 a.m. with severe headache. Gave two Tylenol and cold wash cloth for forehead. Started tossing and turning about five minutes later. Sat up in bed, fell over and struck bedside table. EMT said he suffered stroke around 1:30 am. He passed away on the 5th." "1138309-1" "1138309-1" "Death - unattended" "1138368-1" "1138368-1" "Injection SUNDAY. within 2 hrs of the 2nd injection, he was amazed to no longer feeling the chronic pain throughout his shoulder. MONDAY: The following evening (after supper) he experienced severe light-headedness, followed by violent, prolonged projectile vomiting, during which, his eyes rolled back and he passed out while continuing to vomit. Low BP. transported to hospital; CT scan showed perforated esophagus, air in chest lining. 2nd CT: air and fluid spread to neck area, bowel obstruction/infection. TUESDAY: 5am: Transferred to hospice ward, unresponsive. Tuesday, 2:20pm: died." "1138370-1" "1138370-1" "he started feeling sick day after vaccine with flu like symptoms, seen in ED 5 days after vaccination, diagnosed with COVID19, About 1 week after that, he was found dead at home on his couch." "1138403-1" "1138403-1" "patient showed no signs or symptoms after but was found deceased the following day." "1138695-1" "1138695-1" "expiration" "1139029-1" "1139029-1" "Progressively following vaccine on 3/4/21 became more fatigued until taken to hospital on 3/13/21. Found to have lesions on liver and in lungs on scans. Told to follow up with Oncologist on 3/16 but instead had to go to ED due to worsened fatigue and confusion. Liver enzymes noted to be very elevated on admission and progressively deteriorated in to liver failure and subsequent kidney failure over 3 day hospitalization. Unable to biopsy lesions due to risk of bleeding. Discharged to hospice facility on 3/19/21 and died 3/20/21 early AM." "1139039-1" "1139039-1" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139056-1" "1139056-1" "****I want to note that I am submitting on behave of my mother who passed away yesterday. The medical examiner has declined 2x for an autopsy to be done. My mother was healthy and was absolutely fine besides the rash (dr diagnosed her with cellulitis week of March 14). I do not agree with the rule of death being ?natural causes? neither does her doctor." "1139186-1" "1139186-1" "Hospice of Compusus nurse called and reported that patient passed away. She reported no adverse reaction and that patient had no complications before going to bed and patient did not wake up from his sleep." "1139599-1" "1139599-1" "Patient was found deceased in his own home on Monday, March 15, 2021. He was found on the floor in a sitting position with three fingers of his right hand on his right carotid. It appeared that he was getting ready for church, which was a routine event. Although patient was a diabetic, he never had episodes that were life threatening, and was always able to manage to remediate with insulin or food. Patient last spoke to a neighbor at 2:30 a.m. on Sunday, March 14th, who said he appeared to be just fine and they scheduled a date with their dogs on Sunday afternoon. A sheet of instructions found on the kitchen counter at the home informed us that he had a COVID vaccine at the VA Hospital on Wednesday, March 10th. He was documenting side-effects of very sore right arm and low blood sugars. that was unusual because if he was able to manage he wouldn't have noted it. It was apparent that something sudden happened such that he was unable to get to help and his heart rate must have been of concern. We believe that patient suffered onset of some sort of cardiac event, blood clot, high heart rate, or heart attack, that was associated with the vaccine on Wednesday and 4 days later he was suddenly gone, unable to call for help (he has family close by in this community). We want healthcare providers and individuals to be able to make informed decisions about giving/taking the vaccine when there is another health issue such as diabetes to consider. We lost a brother, a father, a friend and a dedicated veteran unnecessarily." "1139653-1" "1139653-1" "Patient reported to hospital ER department the day following second vaccination. Patients issues at ER was: breathing difficulty, Respiratory arrest, Cardiac arrest, aspiration vomit. The patient died while in ER. It should be noted patient had been on hospice prior to vaccination." "1139677-1" "1139677-1" "Per family pt became more somnolent, gaining weight, jaundiced after 2nd covid vaccine dose. Pt was admitted to the hospital on 3/23 with decompensated cirrhosis and ecoli bacteremia and died on 3/25." "1139812-1" "1139812-1" "Patient was found expired in his home on 3/20/2021." "1139999-1" "1139999-1" "Daughter-in-law called earlier this week to report that has passed away on March 10, 2021." "1140050-1" "1140050-1" ""Patient received his first dose of Pfizer COVID-19 vaccine on 02/03/2021. He has significant medical history, but presented to the hospital on afternoon of 02/08/2021 with report of three days of nausea and vomiting. He thought this attributed to a new cholesterol medication. He also reported some shortness of breath, mild cough, no fever. reported some epigastrium pain the day prior but since resolved. Significant other reported some significant swelling and that pt complained of feeling like he had a ""blockage in his throat"". Workup showed concerns of pneumonia so pt was started on antibiotics and Vitamin K. Shortly after meds started pt started complaining of itching arm and trouble breathing. He became bradycardic and lost consciousness. Resuscitative efforts initiated but unsuccessful. Time of death called on 02/08/2021 at 1737. Hospital notes report ""cause of death is anaphylaxis"", and pt would be an OME case."" "1140258-1" "1140258-1" "Patient contacted 911 complaining of not feeling well and difficulty breathing. Upon arrival patient was found by EMS in cardiac arrest. EMS was unable to get return of spontaneous circulation." "1140696-1" "1140696-1" "Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and Hemorrhagic; strokes, Ischemic and Hemorrhagic; AML; Leukemia; Blood clot diagnosis; Sore lower leg; RDW Stand. Dev. H/RDW Coeff Var H; Platelet Count L, Platelet Vol L; Neutrophils L; Band Neutrophils H; Monocytes H; Metamyelocytes H; Myelocytes H; Absolute Neutrophils L; Other Cell Type Blast Like Cells H; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9261, via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:30 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer (8 years ago no chemo just radiation). Historical vaccine included first dose of BNT162B2 (lot number: EL0140) on 11Jan2021 for Covid-19 immunization. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium citrate, colecalciferol (CALCIUM CITRATE + D3), glucosamine, magnesium citrate, docosahexaenoic acid, eicosapentaenoic acid, tocopheryl acetate (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]) and curcuma longa (TURMERIC [CURCUMA LONGA]). On 04Feb2021, the patient's blood work result showed red cell distribution width (RDW) stand. dev. high; RDW coeff var high, platelet count low, platelet vol low; neutrophils low; band neutrophils high; monocytes high; metamyelocytes high; myelocytes high; absolute neutrophils low; other cell type blast like cells high. On 15Feb2021, the patient experienced sore lower leg. On 16Feb2021, the patient was diagnosed with blood clot. On 19Feb2021, the patient was diagnosed with leukemia. On 20Feb2021, the patient was diagnosed with acute myeloid leukemia (AML). On 21Feb2021, the patient had tow types of stroke, ischemic and hemorrhagic, the patient was intubated. On 23Feb2021, the patient was extubated and died due to multifocal intracerebral hemorrhage, disseminated intravascular coagulopathy, acute myeloid leukemia with blast crisis. The patient received chemotherapy and leukapheresis as treatment. The patient died on 23Feb2021. An autopsy was not performed.; Reported Cause(s) of Death: Disseminated Intravascular Coagulopathy; Acute Myeloid Leukemia With Blast Crisis; Multifocal Intracerebral Hemorrhage" "1140716-1" "1140716-1" "Approximately 30 minutes after vaccination the patient experienced a cardiac arrest. He was brought to the hospital where resuscitation efforts were continued but ultimately proved to be unsuccessful. The patient was pronounced deceased." "1140772-1" "1140772-1" "Chills, fever and tremors began around 2100 on night of vaccination, was reported symptoms subsided the following day. Found early morning of 2/22/2021 deceased in bed by live-in caregiver" "1140864-1" "1140864-1" "My mom received her second covid shot at 10:05 AM on 3/26 and experienced no adverse symptoms. At around 6 am the following day, on the morning of 3/27 she was found on the floor, and presumably suffered from a heart attack. After devastation to our family, we called her physician and he himself was also surprised. Although she is a type 2 diabetic with high blood pressure she has maintained great health and kept her conditions under control with her medications. This, unfortunately, seems too coincidental to not have been in some way or completely caused by the second dose of the shot." "1141262-1" "1141262-1" "Moderna vaccine administered. Death resulted 48 hours later." "1141402-1" "1141402-1" "Dad had a heart attack either on February 19th or 20th. He was found dead on the morning of February 20th." "1141569-1" "1141569-1" "patient experienced heart attack and subsequently passed away approximately 2 weeks following vaccination. it is not believed to be related to the vaccination." "1141968-1" "1141968-1" "My husband died of a sudden massive heart attack. He was one of two teachers who died after the moderna vaccine, second dose. A third teacher had a stroke." "1141989-1" "1141989-1" "Patient received Johnson and Johnson vaccine at approx 1:30 pm and passed away on 11:03 pm - May 24, 2021. Was told around 10;20 pm, the patient was experiencing trouble breathing, cold, clammy, non-responsive ." "1142047-1" "1142047-1" "Patient received the injection on May 2nd. Following the injection, we noticed an increased weakness and general achiness. On the 8th she was so weak that we purchased a gait belt to assist her. We were not super concerned as we were expecting the second shot to cause body aches or flu like symptoms based on what we had heard from others who had received both vaccine shots. She continued to be unsteady and we found that she has a mild UTI which we had begun treating with prescribed antibiotics. Late afternoon on the 11th, mother suffered a major stroke. we did not take her to the hospital because we had already been told that they would not be able to do anything at her age should she suffer a stroke. On the 12th I called the doctors office and asked for them to send Hospice to the house as we could tell that she was dying. Mother died on the 13th. Just a week prior to her death I had spoken with Dr. and we had discussed how that she was declining in health but that she was not even close to needing Hospice, yet she is dead a week later. Less than 2 weeks after getting her second Covid Shot." "1142078-1" "1142078-1" "Patient was a high functioning 97-year-old female with a history of CLL diagnosed 1 year ago on no treatment prior to arrival, chronic stable thrombocytopenia, chronic kidney disease, past history of breast cancer and bladder cancer in remission, transfusion dependent anemia of chronic disease, covid 19 vaccination on 3/5/2021, who presented to the emergency room on 3/25/2021 unresponsive found by the family and emergency services was called. The paramedics found her temperature to be 101.6 and her room air sat was 87%. In the ER CT of the head revealed acute subarachnoid hemorrhage. There was no trauma. CT the abdomen and pelvis showed lymphadenopathy and splenomegaly consistent with her known CLL and new bilateral lung infiltrates. Patient's white blood cell count was 124,000 consistent with her known CLL. Patient prior was high functioning and still drove herself to her doctor's appointments. The day prior she told her son she was feeling slightly nauseous and ill and went to bed early. She was admitted with a subarachnoid hemorrhage which was felt to be spontaneous and not traumatic. She was not on any anticoagulation prior to arrival. She was also admitted with severe sepsis felt possibly due to aspiration pneumonia or pneumonia in general and she did have fever and bilateral infiltrates on imaging. covid 19 and influenza neg. The decision was made to place her on comfort care after discussion with family. She ultimately expired on 3/28 At 14:48 PM in the presence of her family" "1142674-1" "1142674-1" "She developed chills she couldn't control and fell asleep all afternoon, evening and through the night. I spoke with her twice and my uncle and aunt checked on her three times, all three she was freezing cold and too tired to get up. In the morning, she was dazed, cold and walked to the bathroom, where she collapsed to her death. Paramedics could not revive her. My mom died Saturday morning - within the 24-hour period of her vaccine. She was feeling so great leading up to it, active, stripping the guest bedroom sheets, bubbly, and excited for us to be able to finally visit her soon." "1142724-1" "1142724-1" "PATIENT RECIEVED FIRST SHOT ON FEBRUARY 18TH AND SHOWED NO OBVIOUS SIGNS, SYMPTOMS, OR ISSUES. PATIENT RECIEVED THE SECOND SHOT ON MARCH 11TH SHOWED NO IMMEDIATE SIGNS OR SYMPTOMS UNTIL A DAY AND A HALF LATER ON MARCH 13TH WHEN PATIENT SUDDENLY STOPPED BREATHING AND WENT INTO CARDIAC FAILURE FOR NO APPARENT REASON." "1142806-1" "1142806-1" "altered mental status cardiac arrest hyperglycemia death" "1142950-1" "1142950-1" "ALTERED MENTAL STATUS Bradycardia Elevated troponin Non-traumatic rhabdomyolysis Death" "1142953-1" "1142953-1" "death" "1142957-1" "1142957-1" "SHORTNESS OF BREATH Pleural effusion Acute renal failure superimposed on chronic kidney disease, unspecified CKD stage, unspecified acute renal failure type (CMS/HCC) DEATH" "1142965-1" "1142965-1" "Following the vaccination, individual ate lunch and then returned home. Later found deceased in chair in home ~8 hours after vaccine. No known symptoms. However no one was at home with individual for prolonged period of time during this time frame." "1142969-1" "1142969-1" "Thrombocytopenia (CMS/HCC) Prostate cancer (CMS/HCC) Pain VOMITING DEATH" "1142975-1" "1142975-1" "Death" "1142982-1" "1142982-1" "Cold symptoms (cough with phlegm) Weakness Low oxygenation" "1142995-1" "1142995-1" "Death" "1142999-1" "1142999-1" "Patient have generalized weakness for the last few months, she stop chewing. On 3/4/2021 he stopped reacting to stimuli and had dilated pupils. Certified Alzheimer's deseases, cerebral aneurysm." "1143017-1" "1143017-1" "Low BLP, dies at Hospital" "1143040-1" "1143040-1" "During the last month she was losing weight, reflux due to having PEG, low blood pressure, lack of tension. They notified relatives and hospice, she lost mobility, stopped urinating. Respiratory cardiac arrest and end-stage Alzheimer's certified" "1143063-1" "1143063-1" "POC alleges that the resident was eating days before but, on 3/24/2021 he did not want to eat in the afternoon, he took a Pediasure around 4 pm, at 6 pm, caregivers on their rounds found him foaming at the mouth. It was heard with phlegm. They refer him to the hospital, they take a chest plate and indicate that everything was fine. Dies by aspiration, due to cardiac respiratory arrest." "1143222-1" "1143222-1" "CHEST PAIN WEAKNESS - GENERALIZED Hyperkalemia Lactic acidosis Hyponatremia SEPSIS EKG abnormalities Acute kidney injury (CMS/HCC) Neutropenia (CMS/HCC) DEATH" "1143239-1" "1143239-1" "He was taken to hospital 2/27/2021 for respiratory problems, diagnosed with pneumonia and died in hospital." "1143240-1" "1143240-1" "Acute renal failure (ARF) (CMS/HCC) Septic shock (CMS/HCC)" "1143254-1" "1143254-1" "Death" "1143266-1" "1143266-1" "Death" "1143277-1" "1143277-1" "Altered mental status Intracranial hemorrhage (CMS/HCC) Hypertension Cerebral brain hemorrhage (CMS/HCC" "1143334-1" "1143334-1" "The doctor diagnosed the death as aspiration pneumonia." "1143356-1" "1143356-1" "Breathing difficulties, not taken to hospital, managed at home. Certifies respiratory arrest." "1143393-1" "1143393-1" "Before receiving the vaccine, she was deteriorating, but relatives agreed to vaccinate her. Last week she began to have swallowing problems, she was not eating. They started with serum, supplements, and nasogastric." "1143613-1" "1143613-1" "He was going to be discharged from Hospice on Monday 2/15/2021. The patient was in Hospice due to a stroke. The nurse indicates after the vaccine she started with stomach pain and vomiting. Hospice evaluated her, she was given Pedialyte and then she died on 2/19/2021" "1143895-1" "1143895-1" "13th of January received first Moderna shot. 18-19th began to have headaches 22nd headaches worsened 25th at the doctor's (tested negative nose swab) home till 28th (28th tested positive for corona after having her first shot at Advent) stroke symptoms at school 28th Advent did CT scan MRI venous thrombosis diagnosis, from front to back, hemorrage in the northern hemisphere 29th blood thinner administered to attempt to drain clot, seizures 31st passed away" "1143912-1" "1143912-1" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1144095-1" "1144095-1" "The patient started having breathing issues and increased heart rate 5 hours after vaccine administration. He was transported to Hospital where he later passed away." "1144220-1" "1144220-1" "Bacteremia - strep epidermidis, developed respiratory distress required intubation for hypercapnic respiratory failure. Developed PEA on 3/28 died." "1144235-1" "1144235-1" "Patient deceased on 3/23/2021." "1144355-1" "1144355-1" "no details provided, informed patient died on 3/21/21" "1144356-1" "1144356-1" "Pfizer COVID -19 Vaccine EUA Patient's wife reported to facility, upon contacting for 2nd dose appointment, that the patient passed away from COVID-19. This patient did not pass away at facility, as there are no records of this patient in our EHR. Per patient?s wife, patient was vaccinated on 2/3/21 at the clinic with the initial Pfizer COVID-19 vaccine. The patient passed away on 2/22/21 from COVID-19 (3 weeks after the initial dose, but prior to the booster dose). Pfizer/BioNtech NDC# 59267-1000-2 Pfizer/BioNtech Lot # EL9269 Lot Exp: 05/30/2021 Site: left Deltoid Time of vaccination: 2/3/2021 6:15:53 PM" "1144468-1" "1144468-1" "NAUSEA, VOMITING AND DIARRHEA 48 HOURS AFTER VACCINE." "1144499-1" "1144499-1" "pts arm was bothering her after taking the covid vax. On 3/10/2021 pt went to Hospital to have a Echocardiogram procedure. Pt was sent home. The next day pt was vomiting and heaving. Her blood pressure was high and she was having symptoms of a heart attack. 911 was called. First Responder was first to arrive so pt was put on gurney and put on a flight to Hospital. Pt was loaded for the heart flight but perished in flight to the hospital due to cardiac arrest." "1144617-1" "1144617-1" "Patient was found deceased in her home by her daughter 9+ hours after receiving the vaccine. The was no indication of how long the patient had been deceased prior to being discovered." "1144818-1" "1144818-1" "Patient death within 60 days of receiving a COVID vaccine" "1144826-1" "1144826-1" "received word that the patient passed away on 3/5/2021. Do not know the cause of death, nor where he passed away. He does not have any significant medical history at Health Care Corporation, but did get his first vaccination here on 2/17/2021." "1145005-1" "1145005-1" "Patient presented to the ED on 3/4/2021 with left facial droop, left-sided weakness, and dysarthria that started upon awakening that morning. Patient found to have an ischemic stroke and ultimately admitted to hospice. Patient expired on 3/10/2021." "1145054-1" "1145054-1" "patient received 2nd dose of Moderna on 3/13/2021; reported by Police Department as having passed away on 3/14/2021. No other details available." "1145135-1" "1145135-1" "My mom received her first Moderna Vaccine on 1/22/21. Late on 1/23 her face began to swell so the staff called the ambulance to come take her to the hospital for what they thought was an abscessed tooth. ER doctor said there was an infection and that she needed to be seen by an oral surgeon. On 1/25/21 I took my mom to Dr., her oral surgeon and after the examination he advised that there was no abscess but an allergic reaction to the Moderna vaccine. He suggested Benadryl. I gave her benadryl and the swelling started subsiding. From this point on her gums and teeth hurt. Her eating habits started to decline. She received her 2nd Moderna vaccine on 2/19/21 and from that point on she could no longer chew or brush her teeth because the pain was so severe. She passed on 3/19/21." "1145183-1" "1145183-1" "25 hours after receiving Covid vaccine, patient began seizing and went into cardiac arrest. Daughter began CPR and continued until EMS arrived. Patient subsequently passed away at Hospital." "1145196-1" "1145196-1" "Patient was found deceased by her son 2 days following vaccination. Coroner stated heart attack was the likely cause of death. However, a autopsy was not performed before the body was cremated." "1145219-1" "1145219-1" "Left-sided weakness, slurred speech" "1145251-1" "1145251-1" "Ppt collapsed at home on 3/27/2021 late morning. Presented to ED on 3/27/21 from home around 11am with altered mental status. Was found to have a hyper acute stroke per CT head (intracranial hemorrhage). Ppt was pronounced on 3/28/2021 at 1:45pm. UNSURE IF DEATH RELATED TO VACCINE." "1145320-1" "1145320-1" "Patient reviewed vaccination at 1:20pm. She was observed for one hour per MD. At 5:18, she became unresponsive in her wheelchair and became blue with no palpable pulse. Patient had a DNR status and was not revived." "1145423-1" "1145423-1" "3/26/21 ER to Inpt Admission: Patient was admitted to the hospital for comfort measures after patient suffered MI and did not want any life-prolonging therapies. Patient was started on comfort medications and symptoms were monitored closely. The patient passed peacefully before she could be fully assessed" "1145434-1" "1145434-1" "Acute onset shortness of breath approximately 11-12 hours post second dose of Moderna covid vaccine. EMS responded and briefly performed CPR before DNR was produced and life saving measures were discontinued. Patient subsequently expired." "1145479-1" "1145479-1" "Patient received vaccine at 10:18am and then went home with no reaction in the vaccination POD. EMS was called to the patients home shortly before 2:30 that afternoon. When EMS arrived patient was posturing with lower extremities extended in plantar flexion. Last seen normal 30 minutes prior. she was also tachycardic and in respiratory distress with sonorous respirations. Cranial nerve deficit present GCS 3.She was unresponsive and intubated. Airlifted after CT to hospital. She died at 1647 at Hospital from hemorrhagic stroke." "1145488-1" "1145488-1" "Death" "1145508-1" "1145508-1" "Patient presented to the ED 2/6/2021 with increasing SOB and found to have abnormal labs as an outpatient. Patient was found to be COVID positive on 2/6/2021 as well. Patient was discharged on 2/9/2021 for acute decompensations diastolic HF. At 2/19/2021 visit with Nephrology, patient found to have hypervolemic hyponatremia, not responding to oral diuretics and decision was made to manage as an inpatient. Patient found to have cardiomegaly, mild pulmonary vascular congestions with small bilateral pleural effusions, EF 59%, severely elevated pulmonary artery systolic pressure, and had a AKI. Patient did not improve with diuretic therapy. Hospice and comfort care measures were pursued and patient expired on 3/1/2021." "1145526-1" "1145526-1" "3/13- First shot of Moderna vaccine received. 3/14- Sore arm, chills and a headache. 3/15- Shortness of breath and rapid heartbeat. 3/16- Went to ER because of more severe shortness of breath and rapid heartbeat. 3/17- COVID test with negative result. 3/19- Patient messaged her PCP explaining persisted symptoms. 3/23- Chest pain and shortness of breath developed and she died at ER in PEA. 3/25- Autopsy showed pulmonary embolism with no evidence of peripheral vascular disease. Double check COVID test with negative result." "1145531-1" "1145531-1" "Pt diagnosed with COVID-19 despite 2 COVID vaccines (first given 1/15/2021. Pt developed respiratory symptoms, including dyspnea, which progressed over 3.5 weeks and then systemic symptoms of myalgias, malaise. He was admitted 3/21/2021 and had positive NP swab for SARS-CoV-2 x 2. He required admission to ICU and died of respiratory failure on 3/28/2021." "1145552-1" "1145552-1" "Patient expired 3/8/2021 at home. Coroner pronounced time of death at 0415 and assumed cause of death was history of transplant and cardiac." "1145662-1" "1145662-1" "Pfizer-BioNTech COVID-19 Vaccine treatment under Emergency Use Authorization(EUA): The decedent received their vaccine and had no reaction. He was found dead in bed the next morning." "1145887-1" "1145887-1" "She received the vaccine on March 23. On March 28 she felt unwell and early on March 29, 2021 developed severe headache and came to the Medical Center ER. She had a large intracranial hemorrhage. Platelet count was 4,000. She had a normal platelet count in December 2020. She had not received chemotherapy for her breast cancer, only radiation. The hemorrhage rapidly expanded. She was intubated and admitted to the ICU under my care. Her husband opted for palliative extubation and she died soon after." "1145916-1" "1145916-1" "Extreme rigors, fever, shortness of breath/hypoxemia within hours of receiving vaccine according to staff at the care home. leukopenia, pulmonary edema, death" "1145918-1" "1145918-1" ""As reported by the patient's mother, the patient received the vaccine on 1/19/21, ""got sick"" on 1/20/21, and died in the early morning hours of 1/21/21. No further information was offered."" "1146022-1" "1146022-1" "on 3/24, she had decreased level of alertness, eating less, but continued to drink. On 3/25, appeared a bit better, but still not at baseline. drinking fluids but not eating. she vomited up black material and then passed away on 3/25." "1146141-1" "1146141-1" "My mother didn't feel well after the 2nd shot. She died in her bathtub overnight 3/12 into 3/13" "1146282-1" "1146282-1" "On 3/23/2021 he had respiratory problems and high blood pressure, for which he was transferred to the hospital and days later he died." "1146288-1" "1146288-1" ""Vaccine administered at 1816. Patient walked to the observation area and while in the observation area, got up to use the restroom. Patient exited the restroom and said she needed assistance. She indicated to the observation nurse that ""this ain't good"" or ""this ain't right"". Patient reported seeing spots and having chest pain. The time was approximately 1830. She was assisted to the floor. Help was summoned and 911 called at approximately 1834. Upon being lowered to the floor patient was breathing, she was not cyanotic, her eyes were open and she was not responsive. The patient had a pulse. Sometime after 1830, but before 1835, the patient was observed to have seizure like activity as bilateral"" "1146320-1" "1146320-1" "Flu symptoms 14 hours after injection. Respiratory failure within 22 hours after injection leading to dealth" "1146461-1" "1146461-1" "Death Shortness of Breath A-fib COPD exacerbation Pneumonia" "1146467-1" "1146467-1" "NA- patient refused second dose of vaccine - Patient condition at time of death Chronic Conditions Renal failure Advanced age 100 y/o Cardiopulmonary arrest secondary to Covid 19" "1146678-1" "1146678-1" "Patient received 1st dose Pfizer COVID vaccine on 2/5/2021 and second dose on 2/26/21. She had no adverse reaction to either dose. Around 3/2/2021, she saw her physician complaining of pain in her arm, which was attributed to gout. At the time, she also had a nonproductive cough, generalized weakness and one episode of loose stool. She presented to the emergency room on 3/7/21 with significant hypoxia. She tested positive for COVID 19 by both rapid test and PCR. A quantitative test for COVID antibodies was sent out to a reference lab on 3/7/2021 and resulted on 3/11/2021 as >250 U/mL. Pt. required CPAP, BiPAP, High Flow Oxygen and ultimately intubation. Was not oxygen dependent before hospitalization. Pt. treated with dexamethasone, 2 doses of Remdesivir (then held due to acute kidney injury), tocilizumab X 1 dose, 1 unit COVID-19 convalescent plasma. Pt. expired on 3/19/2021. Sample sent for genome sequencing to check for variants of interest in joint effort between pathology and infectious disease. Report not yet available." "1146708-1" "1146708-1" ""not feeling; Patient was found deceased; Stiffness in neck; Extreme fatigue; A Spontaneous report was received from a consumer concerning a 65-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stiffness in neck/ musculoskeletal stiffness, extreme fatigue and patient was found deceased/Death. The patient's current condition included obesity and diabetes. Concomitant medication was not reported. On an unknown date, the patient received his first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 14 Mar 2021, prior to the event, the patient received his second of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 14 Mar 2021, after receiving the second dose of the vaccination the patient began to complain of not Feeling. On 16 Mar 2021, the patient began to complain of stiffness in neck and extreme fatigue. On Wednesday 17 Mar 2021, the patient was found deceased in their home. The event deceased was reported as serious. The family member states they would hate to link the Moderna vaccination to their uncle's death but the vaccination was the only alteration of the patient normal diet and medications. Treatment medication was not reported. The patient died on 17 Mar 2021. It was unknown if autopsy was performed. Action taken with the drug in response to the events was not applicable. The outcome of the event patient was found deceased was fatal whereas outcome of other events stiffness in neck, extreme fatigue was unknown.; Reporter's Comments: This is a case of sudden death in a 65-year-old male subject with a hx of obesity and diabetes who died 3 days after receiving the second dose of vaccine. Very limited information has been provided at this time."" Further information is requested.; Reported Cause(s) of Death: Death"" "1146761-1" "1146761-1" """"widow maker"" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; ""widow maker"" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; ""widow maker"" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; Cardiogenic shock; Anterior myocardial infarction; This is a spontaneous report from a contactable consumer. An 81-years-old female patient received BNT162B2, dose 2 via an unspecified route of administration, administered in left arm on 06Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included very sensitive to medication effects (usually takes only 1/2 dose with strong efficacy to avoid side effects). Breast cancer survivor (2014 onset, 2019 declared permanent remission) and mild blood pressure treated successfully with medication for about 10 years. Concomitant medications included spironolactone and valsartan, both taken for blood pressure. The patient previously received first dose of BNT162B2 on 16Jan2021 in left arm for COVID-19 immunization. The reporter's mother died 3 weeks and 6 days after having received the second dose of the Pfizer covid vaccine. The cause of death was a ""widow maker"" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; the event began about 11:45pm on 04Mar2021. The blockage was confirmed via cardiac cath procedure performed within 2 hours of the onset by Doctor, he removed the clot and placed a stent. However her heart was too damaged and could not recover. Doctor confirmed to us that she did not have excessive or evidence of any prior blockage and not excessive plaque. The blood clot likely came on and caused the cardiac event within roughly an hour, he explained. The patient had no prior symptoms and no comorbidities for blood clotting and was full of life and energy on 05Mar up to when she went to bed that night. She died 06Mar at 4:04 am at hospital. The strat date of the events was reported as 04Mar2021 at 11:45 PM. AE resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient died on 06Mar2021. An autopsy was not performed. The death cause: Triggered by the sudden 100% blockage of the LAD by a blood clot, the cause of death is listed as (A) Cardiogenic shock (B) Anterior myocardial infarction. Treatment was received for the events which included multiple resuscitations and angioplasty surgery. No covid prior vaccination, no covid tested post vaccination. The outcome of the events was fatal. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: ""widow maker"" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; ""widow maker"" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; ""widow maker"" type heart attack where the LAD artery"" "1146768-1" "1146768-1" "Death" "1146787-1" "1146787-1" "death Narrative: Pt has been declining prior to starting COVID vaccine doses; then he got COVID after first dose (VAER reported); and then was admitted to hospice for dyspnea, chronic pain, pressure ulcers, urinary incontinence with foley catheter in place, bedbound, dysphagia." "1146788-1" "1146788-1" "patient passed away Narrative: Family member reported patient passed away day after receiving the covid vaccine" "1146789-1" "1146789-1" "death Narrative: Pt received COVID vaccine dose #1 on 2/27 at facility. Pt admitted to Hospital d/t COPD exacerbation and severe hypoxia. Pt with longstanding hx respiratory complications including air hunger, use of continuous oxygen, panic attacks and pain requiring narcotics (also impacted respiratory drive). Pt evaluated by palliative care/hospice services at Hospital and was deemed appropriate for end-of-life care. Pt unable to discharge home for home hospice services, therefore remained at Hospital where he later passed away. Pt's wife called facility 3/29 to report the death of patient, exact date of death was 3/13. Anticipated cause of death includes respiratory failure d/t severe COPD, hypoxia and narcotic use. Was pt previously covid positive? No Are there any predisposing factors (i.e. PMH, HPI, allergy history etc) for patient experiencing adverse drug event? No Any occurrence of an ADR at time of administration or during time of observation? No Was there and ADR between observation period and date of death? No Was patient hospitalized prior to vaccination? No Was patient hospitalized between vaccination and date of death? Yes - d/t severe hypoxia and COPD exacerbation Was hospitalization attributable to ADE ? No Was patient hospitalized prior to death Yes What are the possible cause of death? severe COPD, hypoxia, reduced respiratory drive d/t narcotic use (chronic pain)" "1146940-1" "1146940-1" "Patient died on March 7th 2021 exactly one week after she received the vaccine. The only symptoms she exhibited was pain at the injection site." "1147151-1" "1147151-1" "Received email from Public Health Nurse that patient had passed away on 3-16-21. The coroner did not believe it was associated with the vaccine, just reporting the death. Requested VAERS form still be filled out." "1147210-1" "1147210-1" "Massive heart attack, yelled for help to wife, 10 seconds later no pulse, called EMT, could not revive, DOA at hospital" "1147303-1" "1147303-1" "Patient death within 60 days of receiving a COVID vaccine" "1147326-1" "1147326-1" "Patient received 1st vaccine on 3/24 with no issues reported. Patient returned on FRiday for routine treatment and was afebrile, BP within normal limits and no compliants. Left the unit stable post treatment. Patient passed away on Saturday morning. There was no hospitalization. Patient went straight from home to the funeral home. Daughter states that patient had been feeling warm since Wednesday." "1147354-1" "1147354-1" "Patient death within 60 days of receiving a COVID vaccine" "1147392-1" "1147392-1" "Death--Patient woke up in morning and c/o not feeling well. Died in route to hospital." "1147393-1" "1147393-1" "Died 20 days after first vaccine." "1147418-1" "1147418-1" "Patient died 6 days after 2nd Moderna vaccine." "1147428-1" "1147428-1" "Patient hospitalization and death within 60 days of receiving a COVID vaccine" "1147433-1" "1147433-1" "Decedent received first Covid-19 vaccination on 03/16/2021, has not been feeling well the past week. This past week the decedent stated she had been more tired and was experiencing shortness of breath." "1147469-1" "1147469-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1147518-1" "1147518-1" "Patient death within 60 days of receiving a COVID vaccine" "1147527-1" "1147527-1" "Pt. died due to natural causes at home" "1147576-1" "1147576-1" "HE HAD A RECTAL BLEED AND WAS ON ELIQUIS, SO THEY STOPPED ELIQUIS, THEY SAID THE CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE" "1147591-1" "1147591-1" "Patient received vaccine on 3/26/2021. Was found deceased on 03/27/2021" "1147618-1" "1147618-1" "cardiac arrest" "1147625-1" "1147625-1" "Patient death within 60 days of receiving a COVID vaccine" "1147758-1" "1147758-1" "headaches, coughing, fatigue, fever, chills, nonapeptide, vomiting" "1147783-1" "1147783-1" "Had 2nd COVID shot died next day physician advised me to notify." "1147793-1" "1147793-1" "she got couple episodes of vomiting next day of vaccine and by the day after morning she became unresponsive and took to ER and found benign meningioma ( not known before ) and uncle herniation, thalamic infarct and followed by went for the decompressive surgery at the and brought home after 2 week and at the 3 rd week put on hospice and diet on 03/18/2021. She would be alive today if she hasn't received vaccine." "1147848-1" "1147848-1" "Approximately 3-4 days after her first immunization, patient became ill. She contacted our triage line 6 days after immunization with report of chills and weakness. She presented to Medical Center Emergency Room where she was admitted for hypoxia. She was subsequently diagnosed with COVID by PCR. She developed respiratory failure, worsening kidney failure necessitating dialysis, c diff colitis, GI bleed, and acute heart failure. Despite maximal efforts by the ICU/hospitalist team and specialists her conditioned worsened. She was made comfort care and died on 2.26.21" "1147948-1" "1147948-1" "Received Vaccine 1/20/21 1/21/2021 Morning: Nursing staff noted decreased O2 Saturation and put her on an oxygen mask 1/21/2021 Night: Patient found unresponsive, not breathing. DNR. Pronounced Expired" "1148091-1" "1148091-1" "Hospice Care. End of Life. Expired." "1148157-1" "1148157-1" "Hospice Care, Crisis Care, Expired." "1148204-1" "1148204-1" "My husband died on Feb 5. 2021. I do not know if the vaccination had any effect but he died of heart attack from Coronary Artery Disease which was unknown." "1148215-1" "1148215-1" "Death" "1148224-1" "1148224-1" "on 2/27 patient's wife called and stated that he had fatigue, body aches, low grade fever, and poor appetite. on 3/4, patient's wife called and stated he had some shortness of breath and extreme fatigue. on the evening of 3/4, he experienced sharp back pain and shortness of breath and was taken by ambulance to the hospital, where he was diagnosed with CHF exacerbation and NSTEMI and worsening CKD. he developed cardiogenic shock and renal failure. on 3/10 he was started on milrinone, then on 3/11 he went into pulseless VT and expired." "1148250-1" "1148250-1" "3/28/21 ER HPI 66 y.o. male who presents with cardiac arrest. Wife said patient went to load machines in the truck between 6:30 p.m. to 7:00 p.m. and about 745 p.m. when she did not see him, she went searching for him and found him about 8:15 p.m. without pulseless and cold. EMS was called and they got there about 8:23 p.m. and started CPR and brought the patient to the emergency room at at 9:05 p.m. and he was certified dead at 2110 p.m." "1148285-1" "1148285-1" "Death" "1148354-1" "1148354-1" "Patient felt ill afterwards, did not regain typical activity level, found deceased in home on day 5 after 2nd dose" "1148390-1" "1148390-1" "Diarrhea, Pulmonary embolism resulting in death" "1148451-1" "1148451-1" "Described patient feeling fine the day after the vaccine (3/4/21), but by 3/5 she wasn't feeling well and was on the couch all day. By 3/8 she couldn't get out of bed, then was subsequently admitted to the hospital. Patient remained in hospital for ~2 weeks before passing away on 3/29/21." "1148527-1" "1148527-1" "Overall decline, Hospice, Crisis Care, Expired" "1148585-1" "1148585-1" "Overall Decline, Hospice Care, Crisis Care, Expired." "1148826-1" "1148826-1" "Overall Decline w/congestion and ABT tx, Hospice Care, Crisis Care, Expired" "1148858-1" "1148858-1" "UNKNOWN. PT'S WIFE CALLED US TODAY 3/30/2021 TO INFORM US THAT PATIENT PASSED AWAY ON 3/29/2021 DUE TO MASSIVE HEART ATTACKED" "1149202-1" "1149202-1" "Per ED Provider Report, the patient collapsed while outside on 3/25/21. Ambulance was called to the scene where patient was found unresponsive. Patient was transferred to Hospital. Patient was in full cardiac arrest upon arrival. CPR was initiated. Patient deceased. Patient's mother stated the patient had been feeling badly for 2-days, but refused to seek medical treatment." "1149401-1" "1149401-1" ""Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: CAREGIVER REPORTED PATIENT STOPPED EATING AND HAD FEVER OF 101, FEVER WENT DOWN AFTER A DAY OR SO BUT CONTINUED NOT TO EAT-Severe, Additional Details: CAREGIVER REPORTED PT HAD FEVER AND LOSS OF APPETITE AFTER FIRST DOSE, QUESTIONED IF SECOND DOSE IS APPRORPIATE. PER THE CDC GUIDELINES THE PATIENT DID NOT HAVE A SEVERE ALLRGIC REACTON TO THE VACCINE AND THEREFOR SHOULD PROCEED WITH SECOND DOSE. CAREGIVERS STATES TOOK A WHILE FOR PT TO REGAIN APPETITE AFTER THE FIRST DOSE. SECOND DOSE HE HAD FEVER OF 101 FOR ABOUT 1 DAY BUT LOST APPETITE AND NEVER REGAINED. PASSED AWAY ON THE 24TH OF MARCH. CAREGIVER STATES PT WAS \""STRIVING\"" PRIOR TO 2ND DOSE"" "1149448-1" "1149448-1" "Covid vaccine monitoring documentation. 90 yof patient presented to ED 3/4/21 at 1233 unresponsive via EMS due to cardiac arrest. BP documented 82/43 at 1233, pulse 49. Prior to arrival, patient had been in bathroom and had syncopal event. Patient lived with family. EMS began CPR and administered doses of Epi. Documentation also stated patient?s family member said patient received their 2nd covid vaccine 5 days prior and has not been okay since. After arrival to ED, patient was intubated, cardiac ultrasound showed no cardiac activity and no pericardial fluid. Patient received sodium bicarbonate and calcium chloride. Patient expired in the ED department at 03/04/2021 12:51. Per Death Summary Form clinical diagnosis cardiopulmonary arrest, clinical impression of cause of death or terminal events leading to death, possible myocardial infarction. Pfizer EL9265 on 1/30/21, Pfizer EL9266 on 2/20/21." "1149492-1" "1149492-1" "Patient death within 60 days of receiving the COVID vaccine series" "1149497-1" "1149497-1" "Patient death within 60 days of receiving the COVID vaccine series" "1149704-1" "1149704-1" "Patient received Moderna vaccine on 3/12 and passed away on 3/14. Patient had multiple chronic and acute conditions and was in overall poor health." "1149770-1" "1149770-1" "Aches, fevers, chills-within 24 hrs Nausea and vomiting-within 48 hrs Heart attack and death on third day" "1149813-1" "1149813-1" "PT RECEIVED MODERNA #1 ON 3/26 AND PASSED AWAY ON 3/28 AT HOME." "1149826-1" "1149826-1" "Patient took the Pfizer Corona Virus shot does 1 on march 1, 2021. He passed away on march 20, 2021. Reported being fatigued and exhausted after taking does 1. Was sleeping up 10 hours a day. On the day he passed, he reported being light-headed and struggling to breath. The paramedics worked on him for 40 minutes to try and revive him." "1149835-1" "1149835-1" "Patient received her first Moderna COVID-19 vaccination on 03/11/2021. She did not have any ill effects directly afterwards. However, starting on 03/27/2021, she began complaining of left arm pain in the area of the injection. She continued to complain of pain in the injection site on 03/28/2021. On 03/29/2021, her roommate found her deceased on her bed due to a probable cardiac event." "1150089-1" "1150089-1" "Suicide, no vaccine symptoms" "1150107-1" "1150107-1" "received vaccine on 01/20/21. 02/06/21vomiting, difficulty eating, hypotension, sent to hospital and admitted with hypotension and hypothermia, placed on Bi-pap, 02/15/21 resident returned to facility under hospice care, expired on 02/24/2021" "1150577-1" "1150577-1" "Got the shot Saturday patients arm was hurting Saturday and the people at shot clinic told the patient to take Tylenol for pain, Sunday the patient was extremely tired and clammy told the daughter his joints and body was hurting so badly. Sunday the patient woke up with allergy symptoms so patient was waiting it out to see dr until his appointment. The patient finally woke up on 3-31-21 around 5 am and the patient had cold chills and clammy the patient put on his robe then told his wife that he was too hot shortly after. The wife was leaving for work at 6am and the patient was curled around toilet stating he felt nauseous, wife left for work around 6am and then she stated about 15-20 minutes later the husband called her asking her to come back home she stated he sounded very short of breath and just not right, she turned around and got home around 645am and found her husband pale and in his recliner with his mouth open and unresponsive. The wife called 911 and she stated the told her pull him into floor and EMS arrived as soon as she got in the floor to start CPR." "1151270-1" "1151270-1" ""Unknown what if any adverse event may have occurred. This report is being submitted following a periodic review of death certificates . Death certificate for this individual indicates ""recent COVID vaccine"" in ""PART II. OTHER SIGNIFICANT CONDITIONS contributing to death but not resulting in the underlying cause"""" "1151500-1" "1151500-1" "Found unresponsive by family member after falling asleep. Started CPR .Rescue squad arrived. Transported to Hospital. Cease resuscitation order at 1:32 am." "1151636-1" "1151636-1" "My father received his first Pfizer vaccine on 02/03/21. On 2/12/21 I rushed him to the ER. He was vomiting uncontrollably and had shortness of breath. Once arrived at ER, they immediately put him on oxygen. Vomiting lasted several hours. They tested him for Covid and did a chest x-ray. Tested positive for Covid. Chest x-ray showed Covid pneumonia. Was admitted. Stayed in hospital for 5 days and was then released to nursing home for physical and occupational therapy. He was very weak and on days experienced what they called Covid fog. After 2 weeks of therapy, he was released on 03/06/21 to go back home to his apartment, with extended visiting nurse therapy. On 3/10/21, was the first visiting nurse appointment. At 12:00 an RN came to his apartment from Home Health Care. She checked his vitals. She said his blood pressure was good, lungs sounded good and oxygen level was 98. She said he was doing good and that she would not need to continue to come out and check on him weekly. She left. At 2:30 the same day, a Physical Therapist from Home Health Care came. She asked him lots of questions and adjusted my fathers' walker for him. He showed her how he was doing using the walker. Walked approximately 15-20 feet in his apartment. She checked his vitals before she left. His oxygen level was now at 91. She had him take a few deep breathes until his oxygen level was up to 93. She left and said she would be back on Friday the 12th to begin the actual physical therapy then. Within 10 minutes after she left my father started shaking uncontrollably and was having difficulties breathing. I called 911. Paramedics arrived. My fathers' oxygen level was all the way down to 74. They took him to the ER. When getting him out of ambulance he began vomiting. Vomiting lasted for hours just like when he went to the hospital back in February. They tried 3 different drugs to control the nausea. They did EKG, chest and abdomen scans. Was found that he had multiple blood clots and inflammation in his lungs and a bacterial infection in his blood. After testing, bacteria was found to be E Coli. Treated him with heparin for clots and antibiotics for infection and had him on oxygen in nose. Every day thereafter, he felt worse. They switched him to a high flow oxygen mask to keep his oxygen levels up. By Saturday night (early morning Sunday) on 03/14, they had taken the high flow oxygen mask off and hooked him up to a BiPap oxygen machine because his oxygen levels were dropping too low. We were then told by the lung doctor, that the damage to his lungs was extreme and that the next step would be to put him on a ventilator and feeding tube. My father did not want this per his will and his discussion with Dr earlier in the week. Dr indicated that he would not get better just being on the BiPap machine and we then chose to have them take him off of the machine because he did not want to go on life support. My father passed away on Sunday, March 14th around 6:30pm." "1151679-1" "1151679-1" "Patient received 2nd Moderna Covid-19 vaccine on 3/4/21. Patient was admitted to hospital on 3/14/21 with a stroke. The patient fell the night before and laid on the floor until family found him and then was taken to the ER. Prior to falling he experienced left arm weakness." "1151697-1" "1151697-1" "DEATH Narrative: No information about patient's death in record, patient received most of his care outside the clinic with only 2 ambulatory care notes in clinic total. Had diagnosis of CLL and was no longer on chemo. No documentation of: prior COVID infection, immediate ADR to COVID vaccine, prior hospitalizations for covid or anything else, death note, autopsy Unlikely that covid vaccine resulted in this patient's death, but was due to advanced age and diagnosis of CLL." "1151699-1" "1151699-1" "DEATH Narrative: NO INFORMATION AVAILABLE IN RECORD OTHER THAN DATE OF DEATH VACCINE GIVEN 02/10/2021 DATE OF DEATH 03/11/2021 PT DID NOT RECEIVE CARE AT CLINIC SINCE 2013 (AUDIOLOGY ONLY AT THAT TIME) NO DOCUMENTATION OF PREVIOUS COVID INFECTION NO IMMEDIATE ADR FOLLOWING VACCINE NO DOCUMENTATION OF HOSPITALIZATIONS (RECENT OR AFTER VACCINE) NO DEATH NOTE OR AUTOPSY Likely that vaccine did not contribute to this patient's death." "1151700-1" "1151700-1" ""Narrative: Patient received dose 1 of Moderna COVID-19 vaccine on 3/11/21 from clinic. Vaccine was administered to patient without complications and patient was observed for 15 minutes post-vaccination without any adverse effects. No documentation as to any adverse effects following the 15 minutes post-vaccination. 11 days later on 3/22/21, EMS was dispatched to patient's home and patient was found lying supine, unconscious, and unresponsive to stimuli. Patient was noted to have shallow breathing per EMS staff, and was subsequently brought to the hospital. Per family, patient lives alone and was feeling well - they had spoken to her two days prior to the event. Per family patient did not have recent fevers, vomiting, diarrhea, or cough. Also no recent medication changes or trauma. PMH includes stroke approx. 8 years ago, gout, HLD, HTN, and RLS. BP upon admission was 126/93, HR 123, temp 37.1 degrees Celcius, RR 28. Patient noted to smell of urine. CT showed large completed right sided infarct consistent with MCA stroke. Per neurology the lesion was not recoverable and patient would be unlikely to regain any function. Family was notified and poor prognosis was discussed. Patient has been very clear in the past that she would prefer ""to go when her time came"". She had a DNR And DNI as well. Daughter requested to pursue comfort measures for patient, therefore she was transferred to hospice care. Patient passed away the following day on 3/23/21. Death very unlikely due to COVID-19 vaccination since CT imaging clearly showed cerebral infarct and patient had a PMH of stroke."" "1151701-1" "1151701-1" ""COUGH, WEAKNESS, INSOMNIA, ACUTE ON CHRONIC CKD, ACUTE ON CHRONIC CHF, EMESIS, DEATH Narrative: 1/12/21-PT REPORTED FEELING TIRED, UNABLE TO SLEEP AND EXPERIENCING DYSPNEA ON EXERTION THAT HE FEELS MAY BE RELATED TO RECENT COVID VACCINE 1/17/21-patient admitted to hospital due to 'severe abdominal pain;' received 1 unit PRBC due to symptomatic anemia and weakness (Hgb 8.4->7.1); dx: acute on chronic CHF exacerbation and difficulty breathing, acute kidney injury-CKD Stage IV; HPI includes chief complaint ""weakness/sob since last night, cough x 2 weeks since covid vaccine;"" HPI includes ""pt states that for 2 weeks he has had SOB, cough, chills, body aches, and weakness, symptoms not improved over the last few days, more weak as of late"" 1/28/21-transferred to facility 2/12/21-transferred back to hospital due to SOB, abnormal labs, pleural effusion 2/16/21-episode of coffee ground emesis 2/19/21-EGD showed ulcerative esophagitis and gastritis 2/24/21-transferred to SNF 3/9/21-admitted to hospital d/t multiple episodes of vomiting 3/10/21-pt passed away at hospital Possibility that acute inflammatory process triggered by vaccine resulted in patient's eventual death, but difficult to ascertain due to patient's various comorbidities. Patient never tested positive for COVID. Did not experience immediate ADR following 1st dose of vaccine. Did not received 2nd dose due to illness. Hospitalized multiple times following 1st vaccine dose."" "1151915-1" "1151915-1" "presents to the ED via EMS in cardiac arrest. EMS report patient was in agonal respiration upon arrival and has had no pulse since 2109. Patient had a syncopal episode on the toilet prior to EMS call. EMS notes they gave patient 4 epinephrine, 1 bicarbonate, and 1 Narcan. Patient arrived with a lucas machine in place and intubated. Patient's intubation was verified to be a 7.0 ETT and 23 cm at the lip. Cardiac Activity noted in ED at 2150. See nurses notes for times medications were administered. Further history limited due to unstable vital signs. Pt hypotensive, started and maxed on levophed, epinephrine infusions and additional push dose epi given. Right femoral central line placed. Pt began to brady down, was given atropine, ultimately again became pulseless and CPR resumed. After 2 further rounds of ACLS, total down time approached 1 hour without return of pulse. On echo, there were occasional agonal beats, but no organized cardiac activity. EKG and case had been discussed with Dr. Friday and decision was to attempt therapeutic hypothermia prior to second cardiac arrest as EKG showed inferolateral STEMI" "1151937-1" "1151937-1" ""Unknown what if any adverse event may have occurred. This report is being submitted following a periodic review of death certificates . Death certificate for this individual indicates ""recent COVID vaccine"" in ""PART II. OTHER SIGNIFICANT CONDITIONS contributing to death but not resulting in the underlying cause"""" "1152051-1" "1152051-1" ""Unknown what if any adverse event may have occurred. This report is being submitted following a periodic review of death certificates . Death certificate for this individual indicates ""COPD - Decline Acutely After COVID Vaccine 1st Dose"" in ""PART II. OTHER SIGNIFICANT CONDITIONS contributing to death but not resulting in the underlying cause"""" "1152164-1" "1152164-1" "Deceased 2/26/21" "1152267-1" "1152267-1" "The patient was a Hospice patient that passed away." "1152288-1" "1152288-1" "Death" "1152421-1" "1152421-1" "hospice patietn passed away" "1152513-1" "1152513-1" "Employee had a heart attack and past away around 3/17/21." "1152648-1" "1152648-1" "Cardiac arrest resulting in death. I actually do not know the name of the vaccine or which type it was it was her 2nd one and it occurred today at 1:30 pm" "1152674-1" "1152674-1" "Patient hospitalized with shortness of breath" "1152686-1" "1152686-1" "Respiratory distress, Atrial fibrillation, Acute Kidney Injury, COVID 19 positive High flow nasal cannula, BiPAP machine, antibiotics" "1152693-1" "1152693-1" "Patient received dose #1 of Moderna COVID-19 vaccine 2/13/2021. Family member reported patient death 3/12/2021" "1152698-1" "1152698-1" "stroke -venous thrombosis" "1152757-1" "1152757-1" "vaccine recieved 3/29/21, on 3/30/21 patient expired in his home. cause of death assumed to be cardiac related. Pt. was not feeling well after covid vaccination, therefore refused to go to dialysis (3/30/21). Collapsed in basement and was found by spouse 30 minutes later. Patient was DNR. spouse stated she feels death was not directly related to vaccine because he had several health conditions in which he has been noncompliant with and has not been following his medical providers treatment plans." "1152765-1" "1152765-1" "The patient has passed away 3 days after receiving the 2nd dose of the Moderna Covid vaccine. They were pronounced dead Friday March 19. The patient lived alone and was on unreachable Thursday March 18th. The patient was found deceased the next day at their residence." "1153162-1" "1153162-1" "Death; Trouble in breathing; chills; sweating; his body was really cold; A spontaneous report was received from a consumer concerning a 79 years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events death, trouble in breathing/dyspnoea, chills, sweating/hyperhidrosis and his body was really cold/hypothermia. The patient's medical history included blood clotting, blood pressure and diabetes. The relevant concomitant medications reported were provided as medications for blood thinner, blood pressure medication and diabetes medication. On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number: unknown) through intramuscular route of administration for prophylaxis of COVID-19 infection. On 03 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA (Lot number: unknown) through unknown route of administration for prophylaxis of COVID-19 infection. On 04 Mar 2021, after second dose patient experienced sweating, his body was really cold. His wife called ambulance and paramedics had quoted that these were usual symptoms of second shot and if they want, they can take him to hospital for monitoring. The patient doesn't want to go hospital and wanted to take rest in bed. On 05 Mar 2021, at 2am, four hours after first ambulance call, his wife noticed that he was still sweating, had chills and also had trouble in breathing. She called the ambulance second time and while it arrived at home it was too late and he was already passed. All the events were provided as intervention/medically important. No laboratory data was provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The events trouble in breathing, chills, sweating and body was really cold were not recovered. The patient died on 05 Mar 2021, due to unknown cause of death but On 19 Mar 2021, his wife talked with primary care physician and he mentioned that vaccine is one of the contributing factors to his death and it is noted on his death certificate. Plans for autopsy was unknown.; Reporter's Comments: This is a case of sudden death in a 79-year-old fmale patient with a history of blood clotting, abnormal blood pressure and diabetes, who died 2 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death" "1153527-1" "1153527-1" "Suffered massive stroke 24 hours after Pfizer vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a (age- 86; unit- unknown) female elderly patient with no pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jan2021 13:45 PM at single dose for covid-19 immunisation. No pregnant at time of vaccination. No illnesses or chronic health conditions, no family history of strokes, heart disease or high blood pressure, very healthy prior to vaccine. No other vaccine in four weeks. She suffered massive stroke 24 hours after Pfizer vaccine on 30Jan2021 13:00 PM. Event resulted in Emergency room/department or urgent care, Hospitalization for 27 days, Life threatening illness (immediate risk of death from the event), Disability or permanent damage, Patient died on 18Mar2021. Treatments were received for the event. Outcome of the event was fatal. No autopsy was done. lot/batch number has been requested.; Reported Cause(s) of Death: Suffered massive stroke 24 hours after Pfizer vaccine" "1153540-1" "1153540-1" "He had not been experiencing any issues or symptoms of his chronic illnesses, but within 1 day had CHF symptoms and died; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included chronic kidney disease, Congestive heart failure (CHF), hypertension, diabetes mellitus. The concomitant drugs included other unspecified medications in two weeks. There were no covid prior vaccination, and no covid tested post vaccination. The patient had not been experiencing any issues or symptoms of his chronic illnesses, but within 1 day had CHF symptoms and died in Mar2021, which resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), died. The patient was hospitalized for 1 days. Treatment was received. The patient died in Mar2021. The event was listed as complication of Covid 19 vaccination. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: He had not been experiencing any issues or symptoms of his chronic illnesses, but within 1 day had CHF symptoms and died" "1153969-1" "1153969-1" "Brain bleed; Platelet count droppped to 40; Bruises all over the body; Organs shut down; A spontaneous report was received from a consumer concerning a 64-year-old female patient, who experienced bruises all over the body (contusion) , brain bleed (cerebral haemorrhage), platelet count dropped below 40 (platelet count decreased) and organs shutdown (multi organ failure). The patient's medical history included bacterial infection 2 days prior to receiving vaccine dose. Product known to have been used by the patient, within two weeks prior to the event, included antibiotics (not specified). On 02 Mar 2021, the patient received her first of the two planned vaccine doses of mRNA-1237 (Lot # unknown) for prophylaxis of Covid-19 infection. On 03-Mar-2021, the patient developed severe bruises all over her body. On 04 Mar 2021, within 2 days after receiving the vaccination, the patient was rushed to the hospital where it was determined that she had sustained a brain bleed. She had all her organs shutdown and her platelet count had dropped below 40. On 04 Mar 2021, it was reported that the patient died. The cause of death was reported as organ failure. Plans for autopsy were not provided. Action taken with the mRNA-1273 in response to the events was not applicable. The outcome of the events, bruises all over the body(contusion), brain bleed(cerebral haemorrhage), platelet count dropped below 40(platelet count decreased) were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's underlying history of bacterial infection could be a contributory factor. Awaiting further clarification.; Reported Cause(s) of Death: Organ Failure" "1153971-1" "1153971-1" "Patient passed away; Heavy breathing; Shortness of breath; Low temperature; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (Patient passed away) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced BODY TEMPERATURE DECREASED (low temperature) and FATIGUE (tired). On 20-Mar-2021, the patient experienced DEATH (Patient passed away) (seriousness criterion death), DYSPNOEA (heavy breathing) and DYSPNOEA (shortness of breath). The patient died on 20-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (heavy breathing), DYSPNOEA (shortness of breath), BODY TEMPERATURE DECREASED (low temperature) and FATIGUE (tired) outcome was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death" "1154140-1" "1154140-1" "DEATH Narrative: LIMITED INFORMATION PROVIDED IN MEDICAL RECORD OTHER THAN SON CALLED TO REPORT PATIENT HAD BEEN TRANSFERRED OUT OF ICU TO HOSPICE CARE ON 03/02/21. No documentation regarding hospital admission or ICU care. Son called on 3/3/21 to report patient passed away peacefully and without pain. No previous COVID infection, no recent hospitalizations known, no immediate acute reaction to COVID vaccine. Unlikely that vaccine contributed to death, as patient was on hospice with advanced age of 91 years." "1154141-1" "1154141-1" "loss of appetite, abdominal pain, weight loss, death Narrative: 02/12/21: GI VISIT-ASSESSMENT: 1-R/O Gastric or Cecal Cancer with Peritoneal Carcinomatosis is most the cause of his weight loss and early satiety. Liver and Pancreas on CT Scan unremarkable. 2- Weight loss and early satiety may be due to Gastric Mass with metastasis or Colon Mass. 02/17/21: ED VISIT AND ADMISSION w/ CC 4 weeks of poor appetite and 2 weeks of inability to hold down food and abdominal pain, decreased BM and decreased urination Assessment on admission: acute kidney insufficiency, Possible partial Gastric outlet obstruction 2/2 malignancy, GI malignancy with peritoneal carcinomatosis as per CT scan 2/11, asymptomatic bacteruria hyperkalemia and AKI during admission 02/21/21: pt signed out of hospital AMA due to 'personal problems' 02/22/21: pt returned to hospital for continuation of care and was readmitted with same c/o 02/24/21: pt tachycardic and hypotensive w/ altered mental status; rapid response team called, transferred to icu; impression: acute severe sepsis with uremia; during procedure to place nephrostomy tubes, pt goes into wide complex vtach then vfib and ACLS done w/ compressions, ROSC @ 2255 w/ BP 70-41, Norepi started; pt intubated 02/25/21: pt extubated 02/25/21@2106: pt with inferior lateral stemi 03/01/21: pt w/ sudden deterioration with decreased LOC and increased WOB., intubated, found to be profoundly hypoxemic, developed severe metabolic acidosis and hyperkalemia, severe refractory hypotension 03/02/21: pt unresponsive without pulse or respirations, NOK declined autopsy no prior covid infection noted, no immediate reaction after covid vaccine, pt was hospitalized leading up to death with unrelenting abdominal pain, AKI, metabolic abnormalities. It is unlikely that vaccine led to patient's death." "1154142-1" "1154142-1" "cardia arrest Narrative: 76 yo with CAD, carotid artery stenosis, abdominal aortic aneurism, history of MI, DM. Patient was given both COVID vaccinations with the 2nd and most recent on 2/27. On 3/20, patient was admitted to an outside local emergency room with cardiac arrest and passed away at the facility. They were unsure if this had anything to do with his covid vaccinations but thought we should at least report it." "1154143-1" "1154143-1" "weakness, fatigue, body ache Narrative: 67-year-old male with past history of diabetes type 2, hyperlipidemia, left BKA, who presented to hospital 2/14/21 with generalized weakness, fatigue, body aches and left leg pain for the past 5 days. He reported it started after receiving his COVID-19 vaccine on 2/09/21. He also had associated nausea, vomiting, diarrhea. He denied fever, chest pain, shortness of breath, abdominal pain. Labs showed mild leukocytosis 12k, AKI with Cr 4.6, K 3.2, Bili 2.9, trop 0.01, lactate 2.2. He was given 3L IVF, vanco blue in ED at 18:35. Asystole on monitor. ACLS initiated and once eventually stabilized he was transferred to ICU. Pt again coded 2 more times while in ICU with were halted due to medical futility." "1154145-1" "1154145-1" ""NASAL CONGESTION, COUGH, FATIGUED, WEAK, NO APPETITE, DEATH Narrative: 02/02-VACCINE GIVEN 02/22-pt not feeling well, dry cough, nasal congestion, weakness, loss of appetite, fatigued and weak; pt was exposed to ""non-covid"" virus through caregiver 02/23-caregiver called telecare to report pt with 3 days fatigue, admitted to hospital 02/25-alerted that pt passed away; they thought he might have been having a mild MI and later placed him on a ventilator and was told he had Pneumonia. He passed away on 2/24/21 at 1030AM confirmed by Daughter; no record of autopsy or death note no documentation of prior covid infection, acute adr to covid vaccine, teste negative to covid on 12/28 (exposed to daughter who have covid) hospitalized 09/23-09/29/2020 due to vomiting and diarrhea, found to have elevated troponins and abnormal kidney function, discharged home; was result of working in the sun and getting dehydrated not likely that covid vaccine contributed to patient's death, but death d/t advanced age and potential exposure to non-COVID virus shortly prior to death"" "1154150-1" "1154150-1" "DEATH Narrative: NO INFORMATION AVAILABLE AS PATIENT DID NOT RECEIVE CARE AT THE FACILITY ALL EXCEPT AUDIOLOGY CLINIC WITH THE LAST VISIT IN 2019 NO DEATH NOTE, NO AUTOPSY NOTED, PT HAD ONE AMBULATORY CARE NOTE IN 2012 NO DOCUMENTATION OF PREVIOUS COVID INFECTION, NO HOSPITALIZATIONS, NO ACUTE REACTION AFTER VACCINE. Most likely cause of death was advanced age, not related to vaccine." "1154151-1" "1154151-1" "FALLS, CHEST PAIN, HEMORRAHAGIC CONTUSION, COVID, PNEUMONIA, HYPOXIC RESPIRATORY FAILURE Narrative: 2/22/2021 Patient presented to hospital with multiple complaints. He was reporting falls, chest pain, his wife was diagnosed with Covid. While he was there, he was found to have hemorrhagic contusion in the right frontoparietal region with minimal surrounding edema, Covid, pneumonia, elevated troponin. He was accepted in transfer by trauma surgeon Dr. and arrives with no complaints. 2/26/2021 Patient died after code blue was called Death Diagnosis: s/p fall with head trauma Focal area right intracranial hemorrhage per initial CT - serial CT head showing stability Acute hypoxic respiratory failure secondary to COVID-19 viral illness COVID-19 viral illness Acute chest pain, improved Elevated troponin, suspected type 2 NSTEMI Elevated D-dimer - V/Q scan with intermittent probability PE Acute kidney injury on CKD, improving unlikely that vaccine contributed to patient's death." "1154152-1" "1154152-1" ""death Narrative: Patient was a 71 y/o gentleman with PMHx schizoaffective-bipolar, major neurocognitive disorder, hx covid- 19 in 12/15/20, chronic insomnia, BPH s/p LUTS, OA/DJD at unspecified joint, and acquired hypothyroidism who presented to the clinic for hospital follow up and monitoring while on clozapine. Pt received covid19 vaccine on 2/16/2019 while inpatient, right before his discharge on 2/17/2021.Of note, pt was put on hospice care at the time of discharge to patient's home. He passed away on 2/26/2021. I could not find the death notice in the chart (which usually contains the medical cause of death). This was reported to us from an staff. The following describes his hospitalization: At facility, was noted to be dehydrated and reported to not have been taking his medications or having good PO intake. Per reports from nursing home, patient wasnoted to have difficulty swallowing"" and spit up meals and medications. SLP evaluation with concerns for mastication and dysphagia. At time of hospitalization his Na was at 153, also noted to have AKI2. His hypernatremia, aki, and dehydration resolved with fluid replacement. His potassium was also replaced. His constipation resolved with laxatives which also improved his abdominal discomfort. Also, his olanzapine was changed to disintegrating tablet which helped with his intermittent agitation. Currently, he was calm, amenable, and with medication compliance. To help with his poor appetite, his mirtazapine dose was increased to 30 mg from 15 mg. Pt was discharged on 2/17/2021 when family decided to place him under hospice care."" "1154154-1" "1154154-1" "death Narrative: 88 yo male with PMH CAD, aortic valve stenosis, sensorineural hearing loss, impaired fasting glucose, thrombocytopenia, obesity, GERD, and mixed hyperlipidemia was found to have passed away when staff did an outreach on 3/8/2021 for patient to come back for his second vaccine dose. Per family member, patient passed away on 2/24/2021. Patient has no prior positive for COVID19, no recent hospitalization (none found within the facilities record). Patient received the vaccine on 2/8/2021 with no complications. We have no other records to review. Pt was not hospitalized prior to vaccination or post vaccination. Possible cause of death unknown, no death note found in chart." "1154155-1" "1154155-1" "DEATH Narrative: 66 yo male with PMH of HTN, HFpEF, COPD, T2DM, CKD, tobacco use disorder and bipolar disorder was found dead in his home on 2/16/2021 after police did a wellness check per request of patient's sister. Patient received the covid19 vaccine (Pfizer) on 2/9/2021, vaccine was administered without complications. No prior positive for covid19. After patient received his covid19 vaccine, he was seen at same day access for increased SOB/DOE, worsened orthopnea. Per progress notes, at this last appt, patient had expressed a number of medications which he was not willing to take, attributing his worsened health to their effects. Pt has continued spironolactone despite being advised to stop it by his medical provider. At the time of visit, provider noted that this kidney function was declining (patient does have CKD). Provider discussed the importance of medication adherence and patient was started on torsemide. Hctz was discontinued, minoxidil was increased due to patient preference. Prior to this same day access/express care visit, patient was hospitalized from 1/26 through 1/28/2021 for hypertensive urgency (211/105) and that at that time, pt already had orthopnea, SOB, and dyspnea. Patient was also admitted from 1/7 to 1/8 and left AMA. While inpatient, his MRI revealed a pontine lacunar infarct that was found to be chronic. It was recommended that patient be treated with aspirin/plavix for 21 days then aspirin alone but patient declined." "1154290-1" "1154290-1" "The patient apparently woke up in the morning and told his wife that he was tired and went back to bed and did not wake up." "1154465-1" "1154465-1" "NA MS End Stage Vascular disease COPD" "1154501-1" "1154501-1" "Within days symptoms of likely CVA. Within one week diagnosis of shingles." "1154639-1" "1154639-1" "Patient began having seizures about four hours post vaccine while at a friends house and passed away" "1154856-1" "1154856-1" "My sister died due to allergic reaction 45min after taking the Moderna Vaccine" "1155002-1" "1155002-1" "Patient died between late afternoon 3/9/21 and morning of 3/10/21. Found at a well-being check by police 3/10/21. Medical examiner declined autopsy." "1155311-1" "1155311-1" "NA Lymphoma - Hospice Care" "1155464-1" "1155464-1" "Patient passed away 2/23/21" "1155594-1" "1155594-1" "Patient death within 60 days of receiving a COVID vaccine" "1155633-1" "1155633-1" "cardiac arrest/vfib arrest" "1155752-1" "1155752-1" "Patient death within 60 days of receiving a COVID vaccine" "1155785-1" "1155785-1" "NA Advanced age PVD, Heart failure ,respiratory failure" "1155829-1" "1155829-1" "Cardiopulmonary arrest and death at 0822 4/1/21" "1155891-1" "1155891-1" "Pt was given 3rd dose of Moderna Covid Vax in error on 3/11/2021 at the rehabilitation center. 3/12/2021 - according to nursing home pt was acting strange around 7:30 am. Pt was scheduled to be picked up by family members at 9:00 am. When family got there the pt was unresponsive and 911 was called. He was transported by ambulance to Medical Center ER. Pt was intubated. He had fever so was given 3 different types of antibiotics. He was given for blood pressure medicine and Chest X-ray. He was moved to ICU and considered critical. Family was called in to make final decisions. His organs were failing. He was on ventilator at 100%. On 3/16/2021 the family made the decision to remove him from the ventilator. He passed around 7 AM on 3/16/2021." "1155893-1" "1155893-1" "pt was at his normal baseline of health the Monday of vaccine. Per sister, he had a fever of 104F, chills and myalgias hte following Saturday. he was not heard from on Sunday therefore on Monday his sister did a forced entry and found him on the ground." "1156029-1" "1156029-1" "Patient death within 60 days of receiving the COVID vaccine series" "1156076-1" "1156076-1" "Patient received her 2nd dose of the COVID-19 maderna vaccination on February 4, 2021. By the evening of February 4, 2021 her husband reported her health to decline rapidly. Her symptoms and complains included overall generalized body weakness and fatigue. She was reportedly unable to get out of bed on February 5, 2021. She continued to decline and became short of breath in the early morning hours of February 6, 2021. She went unresponsive and was pronounced deceased at 0615 by (medicolegal death investigator)." "1156224-1" "1156224-1" "Patient has a renal transplant; developed fever and seen in Emergency Ctr.; tested positive for COVID." "1156250-1" "1156250-1" "Patient recieved his second dose of the COVID-19 vaccine on February 4, 2021. His complains consisted of overwhelming exhaustion. He was found dead in his hotel room on February 10, 2021." "1156266-1" "1156266-1" "pt presented in ER 3/17/21 with SOB and back pain; felt bad since vaccine given; UTI diagnosis-given keflex 500 tid and rocephin shot pt presented to clinic 3/19/21 with continuing back pain dx low back pain and candidia given methocarbamol, diflucan, and ibuprofen pt presented to clinic 3/26/21 with continuing back pain, difficulty urination. given ceftin and rocephin shot pt presented to ER 3/27/21 renal failure and expired within 10 min of arrival no fever documented at any visit" "1156284-1" "1156284-1" "Cerebral stroke on 3/23/21" "1156328-1" "1156328-1" "Death on 03/29/2021" "1156352-1" "1156352-1" ""Patient's wife returned for second Pfizer CoVid vaccine on 4/1/2021 she told the vaccinator, that her husband, died two days after he received the first Pfizer vaccine. Date of Death - 03/13/2021. Wife states that husband had a ""massive stroke."" EEG indicated no brain activity and it was decided to remove him from life support."" "1156365-1" "1156365-1" "Client has history of COPD and CHF. Three days after the 1st COVID Vaccine, client had some SOB and he called 911. When the ambulance arrived they had to do CPR on him and got him to the hospital and at the hospital they got him breathing on his own. From the ER they transferred him to Facility. He spent 23 days in the hospital and Rehab. He was told he could take the vaccine. He was out of the hospital for one week before his 2nd COVID Vaccine. His friend/neighbor is the historian and she states that since he was out of rehab that he was having a lot of extremity swelling. He then came to the Health Services on 03/29/2021for his 2nd COVID Vaccine. On 3/30/2021 at 5:45 pm, client went to Pharmacy to pick up his medications, and after 9 pm was found by friend deceased in his car at Pharmacy. This information was received from friend/neighbor, no local family available." "1156392-1" "1156392-1" ".Mandatory EUA Reporting - Received 2nd Moderna Covid vaccine on 2/26. Admitted to hospital on 3/10 with pneumonia and COVID positive. Patient's son was living with him and Covid positive. Failed treatment with abx, steroids, oxygen. Transitioned to comfort care and passed away on day 8 of hospitalization." "1156450-1" "1156450-1" "Patient received his second dose of the COVID-19 vaccine on February 17, 2021. Per family, he complained of feeling chilly and cold. He was found deceased in the early morning on February 18, 2021." "1156579-1" "1156579-1" "Per Hospital medical records patient was admitted to hospital 3/14/2021 at 1021. Notes from 3/14/21 indicate patient presented with 1 week of nonproductive cough. Received chemotherapy 4 days ago. 3 days ago developed fever, chills, dyspnea, anorexia." "1156595-1" "1156595-1" "Mandatory EUA Reporting - Patient received Moderna COVID-19 vaccine on 1/4. She was living with someone who was diagnosed with COVID-19 on 1/11. Patient was tested on 1/11 and was negative for COVID-19. Then about 4-5 days later developed symptoms and tested positive. She was admitted to hospital on 1/20/2021 to medical floor, transferred to ICU on 1/27, and died on 2/5/2021." "1156620-1" "1156620-1" "Mandatory EUA Reporting - Patient received COVID-19 vaccine on 1/12/21 and then tested positive for Covid the same day. Was admitted to hospital from rehab (resides in rehab for chronic respiratory failure). Patient deteriorated throughout hospitalization, was transitioned to comfort care, and expired on 2/10/21." "1156845-1" "1156845-1" "Patient received COVID vaccine 3/23/2021. The family called the vaccination clinic to inform that the patient died on 3/27/2021. Family believes the vaccine caused the death. I have no other information on this chart." "1157033-1" "1157033-1" "Per family patient reported c/o nausea and vomiting at home post treatment on 3/30/2021, he went to bed and was found unresponsive on 3/31, EMS was contacted and pronounced deceased at home on 3/31/2021. (exact time unknown)." "1157040-1" "1157040-1" "The patient received vaccine on 3/25 (2nd dose in series). The patient was a 911 call 3/31 with death at home (natural causes) 6 days after vaccine receipt" "1157133-1" "1157133-1" "pt deceased approx 36 hours after vaccination" "1157561-1" "1157561-1" "Died; Unresponsive; Shortness of breath; Not able to eat; Sick; Nauseous; Vomiting; Passed out on kitchen floor; Blood sugar increased; A spontaneous report was received from a consumer concerning an unspecified age, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced raised blood sugar/blood sugar increased, passed out on kitchen floor/loss of consciousness, nausea, vomiting, sick/illness, not being able to eat/decreased appetite, shortness of breath/dyspnea, unresponsive/unresponsive to stimuli and died/death. The patient's medical history included diabetes. Products known to have been used by the patient, within two weeks prior to the event, included unspecified insulin. On 11 Feb 2021, the patient received their first planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient had a rise in her blood sugar (blood sugar 208, 212, 199 up until her bedtime of 9:45PM). On 12 Feb 2021, the patient passed out on the kitchen floor and the patient's blood sugar took a dive (blood sugar was 304 9:00AM, blood sugar was 260 10:30AM then stayed over 200/280 all day even with insulin). That evening, the patient experienced nausea and vomiting. On 13 Feb 2021, the patient's blood sugar was up and had nausea and vomiting throughout the night. The patient spoke with her doctor, who told her to regulate it with insulin if she needed too. Per the report, the doctor informed the patient that there have been studies that say the vaccine has shown to mess with blood sugars. The patient's blood sugar remained between 144-179 all day even with insulin. The patient had nausea and vomiting. On 14 Feb 2021, the patient reported still being sick. The patient reported a weight loss of 5 pounds and reported not being able to eat. Blood sugar was 174-292 all day even with insulin. On 17 Feb 2021, the patient's blood sugar was bouncing between 53-151 all day even with insulin. On 18 Feb 2021, the patient reported shortness of breath and was using Vicks to help clear the nasal passage. On 19 Feb 2021, approximately at 6:00AM, the patient's spouse found patient breathing but unresponsive. At approximately 7:25AM, the patient died. Treatment information included, unspecified insulin and Vicks. Action taken with the drug in response to the event is not applicable. The outcome of event, passed out on kitchen floor/loss of consciousness, was considered resolved on 12 Feb 2021. The outcome of events, raised blood sugar/blood sugar increased, passed out on kitchen floor/loss of consciousness, nausea, vomiting, sick/illness, not being able to eat/decreased appetite, shortness of breath/dyspnea, were considered unknown. The outcome of events, unresponsive/unresponsive to stimuli and died/death, were considered fatal. The cause of death was not provided. Plans for autopsy was not provided.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Patient's history of uncontrolled diabetes with recent fluctuations may have been contributory for the occurrence of the death. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1157683-1" "1157683-1" "Patient had his Vaccine on 2-28-2021. Patient passed away on 3-3-2021. Do not know the cause, just found out from our tech and thought we should report it in case." "1157733-1" "1157733-1" "Patient experienced a brain hemorrhage and was hospitalized on Monday, March 15. Despite numerous tests, doctors could not find the source or cause of the bleeding. Over time, the bleeding spread to other areas of her brain including her brain stem. Damage from the bleeding was so severe that she would not recover. She passed away on March 24 after being removed from life support." "1157805-1" "1157805-1" "Patient had the 2nd Vaccine on 3-25-2021 and Passed away on 3-28-2021. our tech found out. No clue if it is related to the vaccine or not." "1158952-1" "1158952-1" "Death of patient reported to have happened on 3/30/2021" "1158955-1" "1158955-1" "Deceased" "1159084-1" "1159084-1" "Patient was found deceased on 4/2/21" "1159101-1" "1159101-1" "My Father was ill for approx 3-4 days after first vaccine with fatigue and some minor chest pressure, this start approx 3 days after injection and had made a complete recover, he then recieved his 2nd vaccine shot and again 3-4 days later he again stated began having severe fatigue and mobility issues, ( he stated his legs felt like jello ) , no chest pains and no breathing issues were associated. 3 days later he was still feeling the same with symptoms and on the 4 day he was found deceased in his home." "1159118-1" "1159118-1" "Patient died at home in the night of 03/30/21 to 03/31/2021. Time of death unknown." "1159365-1" "1159365-1" "My father received his second dose of the moderna vaccine on 3/27/2021. Around 5PM he started to feel unwell and went to lay down. My mom found him unresponsive at 10PM and called an ambulance. She was told at the hospital that he had a massive brain bleed. He passed away the following morning around 10AM." "1159535-1" "1159535-1" "Patient described myalgias, headache and dyspnea at ER visit on 4/1/21 at 2:37 am. Patient was discharged. Patient returned the same day at 15:40 cyanotic, altered, hypoxic and hypotensive. The patient was found to have profound metabolic acidosis, liver failure, renal failure. She went into cardiopulmonary arrest, was revived, rearrested and died. Patient was treated for possible sepsis, shock, liver failure." "1159573-1" "1159573-1" "He received his vaccine, had soreness in his arm. Went to bed and around 2:00 AM his brother got a call from his dad (he lives upstairs from him in the same house) who said that something was wrong and he needed to go to the hospital. The brother found him sweating profusely, it appeared that the right side of his body was stiffening up, and they started to go out to the car to go to the hospital. He started to go limp and he collapsed and tried to revive him, they called 9-1-1 and they tried to revive him as well without success and he died." "1159900-1" "1159900-1" "CVA (stroke) around 2:00 p.m., was immediately transported to hospital. Meds were given (I believe Alteplase, but would need to confirm.) 3 brain bleeds after medications. Patient passed away at 5:40 p.m." "1159988-1" "1159988-1" "Death" "1160180-1" "1160180-1" "Long term care patient death within 60 days of receiving a COVID vaccine" "1160227-1" "1160227-1" "death 5 days later" "1160235-1" "1160235-1" "Death Narrative: Pt passed away ~3 weeks after dose 1 of COVID vaccine (Moderna). Daughter was home with pt and after he went to the bathroom she reports pt was out of breath, however that has been chronic/ongoing for him due to his diagnosis of COPD, pulmonary HTN and metastatic lung cancer. After sitting and resting in a chair, she states patient became unresponsive. She called 911 who told her he had no pulse and was not breathing. She states that they were not able to resuscitate him. Pt had been suspected to be positive for COVID as he had symptoms of increased cough, congestion and rhinitis. Daughter (that is primary caregiver and lives in home with patient) tested positive for COVID on 1/31/21. She started having symptoms on 1/25/21. Patient started having symptoms on 1/31/21. No COVID test confirmed prior to pt's death. Patient had a definitive diagnosis of metastatic adenocarcinoma in October 2020. History of multimorbidity. He did have a 60 pack year history of smoking. Most likely cause of death from available records is metastatic lung cancer, with other serious diagnoses contributing." "1160236-1" "1160236-1" "covid+ Narrative: Patient with diagnosis of chronic respiratory failure with hypoxia secondary to COPD, dependent on oxygen/steroid, GERD, Rosacea secondary to long term steroid use, CAD, HLD, HTN, Diet controlled DM, Granulomatous disease of the lungs, Hx Abnormality Imaging of the lungs early 1990's- further imaging resolved without treatment, Vitamin D/B12 deficiency, Chronic rhinitis, Adjustment disorder with anxiety, Osteoarthritis of multiple joints. Patient admitted 3/19/21 with +COVID symptoms/test. Transferred to facility 3/27/21 with new onset Afib/further respiratory decompensation requiring NRB/Amiodarone gtt. Was made comfort care for Patient request and placed on MSO4 gtt. Patient passed away 3/31/21 at 1640 of Acute on Chronic respiratory failure secondary to COPD/COVID with daughter at side." "1160237-1" "1160237-1" "COVID+ Narrative: Patient administered COVID-19 vaccine (Moderna) dose #1 2/18/2021. On 3/17/2021, Patient developed a cough and fever and was brought by ambulance to tertiary care facility with diagnosis of COVID-19. Patient on BIPAP as of 3/22/2021. On 3/26/2021, Patient was initiated on morphine drip for comfort care and BIPAP was discontinued. Patient passed away 3/26/2021." "1160240-1" "1160240-1" "Hospice Patient death within 60 days of receiving the COVID vaccine series" "1160361-1" "1160361-1" "Respiratory distress, led to heart failure, and ultimately death of patient" "1160365-1" "1160365-1" "Death" "1160669-1" "1160669-1" "Fever, Weakness, Chills, Body aches Stared on 3/9/21" "1160713-1" "1160713-1" "DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Cardiac arrest (HCC) [I46.9] HOSPITAL COURSE: Patient is a 74 year old female who receives care through healthcare clinic and second healthcare clinic with past medical history of HTN, CKD, cardiomyopathy/congestive heart failure, atrial fibrillation on Pradaxa who presented to the ED 3/16 after suffering an out of hospital cardiac arrest at her dentist's office. Per report, patient had SBP in the 80s on arrival but was asymptomatic. Prior to start of any procedure (no reports of being given sedative medications), she became unresponsive. CPR was initiated and was found to be in asystole. She received 3 rounds of CPR with ROSC. CT head without acute abnormality. Chest XR showing mild vascular congestion and interstitial edema. Initial labs showing AKI, elevated liver enzymes, BNP >29,000, troponin 39, lactic acid of 11, INR of 6.6, PTT 62, APTT 87. UA with protein, nitrite, moderate blood. Urine culture ordered. Blood cultures ordered. In ED, patient was hypotensive requiring addition of vasopressors. Targeted temperature management was started. Ceftriaxone and flagyl started for possible urinary tract infection and aspiration. Patient with profound coagulopathy, INR increasing to 12.0 on arrival to the ICU. Two units FFP and vitamin K were given. Patient with escalating pressor requirements at this time so CT t/a/p was ordered showing multiple bilateral rib fractures, nondisplaced sternal fracture with small anterior mediastinal retrosternal hematoma, small right sided hemothorax, right chest wall hematoma, patchy bilateral airspace disease consistent with atelectasis/infiltrate/aspiration, diffuse GGO consistent with interstitial edema, enlarged pulmonary arteries consistent with pulmonary hypertension, cholelithiasis. FDP elevated and 2 units of cryoprecipitate given 3/16. Hemoglobin decreased to 5.9 3/17 with INR of 5.4. Two additional units of FFP and additional dose of vitamin K ordered. Two units RBCs ordered. CTA thorax and abdomen 3/17 re-confirmed hemothorax and chest wall hematoma but no active bleeding noted. CT bilateral LE showed no evidence of hematoma. Trauma consulted who recommended chest tube placement. Overnight 3/16-3/17, patient also noted to have seizure activity on EEG and patient loaded with Keppra. Head CT 3/17 negative for hemorrhage or other acute processes. Patient remained in status epilepticus 3/17am and additional Keppra load was given and neurology consulted. Received Praxbind for continued bleeding/coagulopathy. 3/17pm went into PEA arrest with 10 minutes of CPR with ROSC. Bronchoscopy following ROSC noted evidence of bleeding from multiple areas, clots removed. MRI brain showing diffuse anoxic brain injury. Propofol stopped 3/19am. After goals of care discussion this morning, all first degree relatives (daughter and son) all in agreement to transition to comfort care measures. I received call from bedside RN that patient had passed away. On exam, no heart or breath sounds appreciated upon auscultation for 2 minutes. No spontaneous movement or chest rise noted. No pulse palpated for two minutes. Pupils fixed and dilated. No response to noxious stimuli. Time of death 1400 3/20/2021." "1160722-1" "1160722-1" "Patient diagnosed with COVID on 2/21/2021 and subsequently expired" "1160839-1" "1160839-1" "Hospice patient death within 60 days of receiving the COVID vaccine series" "1160874-1" "1160874-1" "Patient was seen in ED on 03/12/2021. Symptoms included fatigue and weakness, she was flown out to hospital. She passed away on 03/14/2021 in hospital." "1161011-1" "1161011-1" "Immediately following vaccination no adverse reaction noted. April 1, 2021 patient went into cardiac arrest and passed" "1161015-1" "1161015-1" ""Per RN at Group Home where patient worked, on 3/19/21 he called the RN with complaints of a ""low grade"" fever (99-100 degrees) but otherwise reportedly felt fine. He was advised to stay home, was offered Covid testing but refused. On 3/22/21 the RN received an email from patient's supervisor that he still felt unwell and reported vomiting and diarrhea. Was offered a Covid test but refused. -Per patient's friend (a nurse who informed us of the case) various friends spoke with patient up until the morning of 3/25 and he reportedly had no respiratory or cardiac complaints. They were unable to reach him the evening of 3/25, nor the morning of 3/26 so sent the police for a well check and patient was found dead. He lived alone. -Per OSME. Patient did not receive an autopsy but did have an ""inspection"" which includes an external exam, toxicology and other testing including Covid testing which was positive. The specimen has been sent for sequencing. -Of note, Patient worked in a group home that had an outbreak of Covid in Jan/early Feb. His last exposure to a + person was likely 2/8/21 but possibly 2/10/21. He had a Covid test 2/15/21 that was ""inconclusive"". The test was re-run (same assay) and was also ""inconclusive"""" "1161042-1" "1161042-1" "PATIENT CONTRACTED COVID, DATE OF COLLECTION 3/18/2021, DIED ON 3/21/2021" "1161106-1" "1161106-1" "CONTRACTED COVID, CONFIRMED 3/17/21, PATIENT DIED ON 3/23/21" "1162124-1" "1162124-1" ""Death; Heart attack; Shortness of breath; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 72 years, at single dose on 23Mar2021 at 10:00 (Lot number was not reported) for COVID-19 immunisation. Medical history included asthma, penicillin allergy and she was diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient experienced death, shortness of breath and heart attack on 23Mar2021 at 20:30. And it was reported that the adverse event result in ""Emergency room/department or urgent care"" and patient was treatment with CPR. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not been tested for COVID-19 since the vaccination. Event outcome of events shortness of breath and heart attack was not recovered. The patient died on 23Mar2021 at 20:30. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Death"" "1162419-1" "1162419-1" ""Failing health since vaccine; she does not want to eat; She slept probably five hours during the day; She got up and she does not want to eat, she took a nap, she changed chairs and she took a nap; Her health has declined each day; She has more fatigue every day; In constant pain; Lost 20 LBS.; became weak and lightheaded; became weak and lightheaded; her immune system began to shut down; The initial safety information received was reporting only non-serious adverse drug reaction, Upon receipt of follow-up information on 26Mar2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm on 04Feb2021 at 12:30 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. Medical history included ongoing diabetes, arthritis and thyroid, all three for 10 plus years; and bladder. Concomitant medication included ongoing methotrexate and meloxicam taken for arthritis; metformin taken for diabetes; mirabegron taken for bladder; and levothyroxine taken for thyroid, all from an unspecified start date and ongoing. The patient received the vaccine on 04Feb2021 (reported as last Thursday afternoon) and everyday since then her health has declined each day. She has more fatigue every day and lightheaded. Her immune system began to shut down (several blood draws taken). She just wanted little afternoon nap. On Saturday, she wanted to do very little 'aero' (word not clear), very little just the minimum. She get up, she had a little breakfast, and as I live near a little pond, she watched the water and birds. And then yesterday, she slept probably five hours during the day and today that is all she has done, she got up and she does not want to eat, she took a nap, she changed chairs and she took a nap. She is now in her bedroom and taking another nap and this is not my mother. The patient was still alive but in failing health since the vaccine. The patient is now bedridden, lost 20 pounds (lbs) and was in constant pain. The patient was fine, walking and even dancing prior to vaccine. The outcome of the events ""Her health has declined each day"" was not recovered while unknown for the other events. The patient died from vaccine on 15Mar2021. The autopsy was not done. Follow-Up (02Apr2021): Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Failing health since vaccine"" "1162753-1" "1162753-1" "Tongue swolle so large he had to be put on a vent for 10 days, passed away after 2 weeks" "1162930-1" "1162930-1" "Patient died of a cerebral hemorrhage on 3/15/2021 at 11:30 AM." "1163093-1" "1163093-1" "On the morning of 3/31/2021 patient had chills, she seemed to develop a cold, she was achy and not wanting to eat. She was very sleepy and by 6:00 P.M. she passed away." "1163141-1" "1163141-1" "Tongue swelling, feeling hot (no temperature taken)" "1163369-1" "1163369-1" "Blood clots" "1163428-1" "1163428-1" "Began with weakness of March 24th and stroke- like symptoms despite a clear CT Scan and EKG. Trouble walking or staying awake. Heart stopped on March 28th. Deceased." "1163843-1" "1163843-1" "It was reported that patient died on 3/14/2021. This may have had nothing to do with the vaccine." "1163967-1" "1163967-1" "Felt crummy on day one and two better on day three and on day four developed four blood clots on Coumadin with an INR of 4.5 and died the next day on 3/31/2021." "1164535-1" "1164535-1" "The patient presented for his second Pfizer Covid-19 vaccination on 28MAR2021. On his way into the Vaccination Center, he was blown over by high winds sustaining a blow to his right forehead with small abrasion and a 3x4cm subcutaneous hematoma. He was assisted to a wheel chair and brought into the EMT booth for further assessment. He was awake and alert and oriented during his time with us. He never lost consciousness . He vigorously requested to receive the Covid-19 vaccination which we complied with. Due to the mechanism of injury and use of an anticoagulant, he was subsequently transfered to Hospital for further assessment and care. We heard on 4/3/21 of his death." "1165014-1" "1165014-1" "My dad had the first shot of the covid vaccine and less then 24 hours later he went into cardiac arrest. He spent 10 days in ICU and we had to remove him from life support and he survived another 6 days suffering until he past in April 3rd" "1165132-1" "1165132-1" "Death; had vomited and was found unresponsive and covered in stool, intubated and then went in to PEA in the field and passed despite lengthy resuscitation." "1165154-1" "1165154-1" "My husband died 18 days after the shot" "1166062-1" "1166062-1" "Patient received second dose of Pfizer vaccine on March 17, 2020 while at work. March 18, 2020 her 5 month old breastfed infant developed a rash and within 24 hours was inconsolable, refusing to eat, and developed a fever. Patient brought baby to local ER where assessments were performed, blood analysis revealed elevated liver enzymes. Infant was hospitalized but continued to decline and passed away. Diagnosis of TTP. No known allergies. No new exposures aside from the mother's vaccination the previous day." "1166300-1" "1166300-1" "Note: I AM reporting this because I strongly believe that patient's death was caused by his second COvid-19 vaccine. The exact date of the vaccine is unknown. His girlfriend told me he got his second Vaccine at the end of February. I also don't know what vaccine (Moderna or Pfizer) he got, so the Pfizer is just a guess. Patient started feeling bad and looking bad after his second vaccine. He complained that he wasn't feeling well and missed appointments saying he wasn't feeling well during the two weeks or so between the time of his second vaccine and his death." "1166447-1" "1166447-1" "Pfizer-BioNTech COVID-19 Vaccine EUA Pt received 1st dose vaccine 2/17/2021, 2nd dose vaccine 3/10/2021. Had been on warfarin since 2015, unclear if pt had been taking atorvastatin (last refill was 2019 according to Dr, Adult Primary Care clinic). Pt was last seen normal by his wife at approximately 1030am, out in the yard. She went out at approximately 1130 am and found him down on the ground. Pt was brought in by paramedic to ER. IN ER, score =22, aphasic, R hemiplegic, CT scan of head showed large parenchymal hematoma in L basal ganglia with small SAH plus 2 mm L to F subfalcine midline shift. Pt was intubated in ER for airway protection after an episode of vomiting. In ER, pt was given - Vitamin K 10 mg IV x1, Levetiracetam 1500 mg IV x1, Nicardipine infusion, 4-factor PCC (KCentra) 3500 unitsx1, Sodium chloride 3% infusion, pantoprazole 40 mg IV x1, Ondansetron 4 mg IVx1. After intubation, pt also received propofol infusion, and admitted to CCU. 3/15 Repeat CT head showed expansion of hematoma associated with midline shift. 3/16-3/17 transfer to hospital was arranged, pt remained unresponsive. 3/18-3/19 comfort care" "1166778-1" "1166778-1" "Patient had chills the night after the vaccine and throughout the night pulse ox dropped to 88, given 3L O2. Pt had little sleep and the next day had no appetite pulse ox between 88-90. After dinner had severe chills, no fever ,extreme SOB , pulse ox down to 79, coughing up blood tinged sputum, fluid in lungs, anxious. EMT called sent to hospital confirmed to have had an MI and new onset CHF, enzymes elevated, creat 1.8. Transferred to hospital and was stable. The next day still SOB, enzymes lessening, trying to wean from O2. The nurse attempted to get the pt to the bathroom he became extremely SOB and became unresponsive. They attempted CPR and the pt expired shortly thereafter due to another MI." "1166865-1" "1166865-1" "After first vaccination mom was tired in bed flu symptoms for a few days. Had MG symptoms come back and talked to her Dr. Went for 2nd vaccination and very tired &had Severe MG symptoms dr said to take then stop taking Mestinin as she continued getting sicker he called and said not to get any therapeutic drugs called Solaris not to see a dr and she died few days after." "1167042-1" "1167042-1" "Severe tiredness/lethargy started on 01/28/2021. Died at home around noon on 01/29/2021." "1167363-1" "1167363-1" "On December 30th my father tested positive for COVID. He was reported asymptomatic by the care facility staff. He was given vaccine on Jan 14th and began feeling ill that evening. The morning of the Jan 15th the nursing facility had my father admitted to emergency and then to ICU. He stayed in the hospital for 10-14 days and then was released on hospice at the senior care facility. He passed away on Jan 31st. I'm not sure if the sudden change in my father's health was due or made worse due to the COVID vaccine as the hospital was treating several symptoms, but the timing seems suspicious. I have also not been able to get an explanation for why he was given a vaccine if he tested positive. I do not know which vaccine was given, but needed to select one to submit the form." "1167407-1" "1167407-1" "Patient was involved in a single plane crash on the evening after receiving second vaccine dose" "1167886-1" "1167886-1" "Patient vaccinated against COVID-19; received COVID-19 Janssen vaccine on 3/10/2021. Patient developed symptoms last week of March. Called Provider with symptoms and then presented to the hospital (admitted on 4/1/2021). Tested for COVID and found to be positive. 4/1/2021. Patient declined, admitted to ICU on 4/3/2021. Patient died on 4/4/2021. Chief Complaint: HPI: Patient is a 79 y.o. yr. old female who presents today for COUGH (has had cough for a little over a week) and FEVER (on and off for about a week)Patient was seen due to feeling ill for over week. Patient states that she was trying to fight it on her own but symptoms have been progressing. Patient has felt feverish no known fevers. Has had a persistent now worsening cough. Patient is feeling very tired and weak due to being sick for over week. Patient does live alone. Patient is coughing which is productive with sputum. Patient is eating and drinking well. No N/V/d. No loss of taste or smell. No recent ill exposure.; Has had covid vaccine. Patient did get the Johnson and Johnson vaccine over a month ago. Patient is feeling very fatigue; Having feverish/chills. Patient is taking OTC nightquil which is no longer helping. Patient does see oncologist for her CLL. DISCHARGE DIAGNOSIS: 1. Deceased 2. COVID-19 with hypoxia 3. Asthma 4. Anemia DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 HOSPITAL COURSE: Patient is a 79 year old female who was admitted on 04/01/2021 for COVID-19 pneumonia with complications of hypoxia. Patient's symptoms of cough and shortness of breath have been present for approximately 2 weeks. It was noted that 1 month ago she did receive the Johnson & Johnson vaccine. Upon admission patient was treated with azithromycin, Rocephin to cover for secondary bacterial infection. She was not a candidate for remdesivir due to the length of her symptoms. She was started on Decadron, as well as gentle fluids due to tachycardia for approximately 12 hours. During the night of 4/2-4/3 patient progressively declined requiring more oxygen she was transferred to the intensive care unit. Patient was a do not resuscitate continued decline and after exacerbating all treatment options patient was switched to comfort care earlier this evening. Pronounced dead at 6:45 a.m." "1167892-1" "1167892-1" "After 2nd vaccine my husband started getting confused. Worse and worse. Had him get a fasting blood draw and was supposed to see his dr the following Monday. His 2nd shot was 2/11/2021. He Died 2/27/2021. Took away my life and husband of 35 years! Would?ve been 70 years old today!" "1167899-1" "1167899-1" "Patient death within 60 days of receiving the COVID vaccine series" "1167930-1" "1167930-1" "Patient death within 60 days of receiving the COVID vaccine series" "1167965-1" "1167965-1" "Patient called PCP office 3/5 w/ c/o N/V/D, weakness and lightheaded when she stood up. Was advised to hold blood pressure medication. On 3/8, was feeling much worse and called 911. Upon arrival (8:55), patient A&O x 4 with poor oxygen saturation (O2: 88%). Given nebulized albuterol/ipratropium. BG: 247mg/dl. Patient has episode of dry heaving after which she vagaled down with HR in the 40s. Recovered on her own. Once the nebulizer treatment ended, she was place on nasal O2 at 3 liters/minutes. Given 4mg ondansetron. Lost consciousness and respirations became agonal. Pt was bagged via BVM and noted to be in PEA. CPR initiated, including intubation. Given 1mg epinephrine. NSR obtained after two rounds of CPR. Pt arrested again shortly after arrival to ED. ACLS initiated once more. Patient expired at 10:40 am." "1168104-1" "1168104-1" "Pfizer COVID Vaccine treatment under Emergency Use Authorization(EUA): Vaccination received 3/2/2021. On 3/16/2021, maternal cardiac arrest, terminal fetal bradycardia, emergent C-section. Likely amniotic fluid embolism and DIC." "1168142-1" "1168142-1" "ER 3/17 HPI: 72 y.o. female who presents with generalized weakness and not feeling well. Patient states that she had her 1st dose of COVID-19 vaccine about a week ago and since then has not felt well. She denies fever or chills, she denies any arthralgias or myalgias, she has had some nausea and vomiting but none in the last couple of days. There has been no diarrhea. There have been no urinary symptoms. 3/22/21 Inpt Admission hpi 72 y.o. female who presents with shortness of breath and hemoptysis. Patient has known history of COPD and also has a history of squamous cell carcinoma of the lung that is in remission. Patient reports she has noticed increasing shortness of breath for the past several weeks. She states the got worse around the noon time today. Patient reports she began having some hemoptysis today. Patient denies any chest pain or palpitations. Patient denies any fevers or chills. Patient denies any sinus congestion or nasal drainage. Patient denies any headaches, myalgias, or loss of sense of taste and smell. Patient does report a 4 day history of intermittent diarrhea. She denies any nausea or vomiting. Patient has had COVID-19 vaccination. Of note, patient's family reports she has lost 10 lb in the past 30 days. 3/30/21 Deceased" "1168198-1" "1168198-1" "Patient was hospitalized x 3 and died within 60 days of receiving a COVID vaccine series" "1168221-1" "1168221-1" "ER HPI: 78 y.o. female who presents with respiratory distress. Patient is transported to the emergency room via emergency medical services from local long-term care facility. Patient is unable to give any history due to acuity and severity of current condition. On arrival to the emergency room patient is in obvious distress she is hypertensive with a blood pressure of 74/51 she is tachycardic with a rate of about 140 she is tachypneic with a rate of the 29th at 30 her oxygen saturation on a non-rebreather are 82% and her temperature is 102.9¦. FINAL IMPRESSION ICD-10-CM ICD-9-CM 1. Septic shock (HCC) A41.9 038.9 R65.21 785.52 995.92 2. Aspiration pneumonia of right lower lobe due to gastric secretions (HCC) J69.0 507.0 3. Acute hypoxemic respiratory failure (HCC) J96.01 518.81" "1168240-1" "1168240-1" "Patient deceased 3/23/21 due to suicide." "1168254-1" "1168254-1" "Patient was given vaccine on 03/25/21. On 04/01/21 patient found in yard and brought to ER, then transferred via air to ER. Patient had concussion due to fall, pneumothorax, and PEA episode. Chest tube placed in the ER, Comfort cares then administered per family request with patient passing that day." "1168291-1" "1168291-1" "3/22/21 Admission HPI: 71 y.o. male with a history of poorly controlled diabetes mellitus and COPD. He presented to my office today acutely with a several day history of increasing shortness of breath. He has increased his prednisone at home recently and been increasing the frequency of his DuoNebs. Despite this, he states that his oxygen saturations have been staying in the low 80s. He has a hard time walking due to the shortness of breath. He states previous to about a week ago he was doing very well. He denies any fever. He denies any known exposure to coronavirus (COVID-19). In the office today his oxygen saturations were 88% on 4 L. Because of his failure of outpatient therapy, he will be admitted to the hospital for further evaluation and treatment. This patient has a history of severe respiratory decompensation that happens very quickly. Therefore, it is medically urgent we get him into the hospital. 3/25/21 Admission HPI71 y.o. male with a known history of severe COPD and type 2 diabetes mellitus. He came to my office with a several day history of increasing shortness of breath. He had increased his oral steroids and breathing treatments at home and despite this was still having oxygen saturations in the low to mid 80s on 2-4 L of supplemental oxygen. In my office he was extremely diminished and had basically failed outpatient therapy. Therefore he was admitted to inpatient status for acute treatment of a severe COPD exacerbation requiring IV antibiotics and IV steroids. He was admitted and treated with IV treatments. He did recover nicely. However, he was found to be extremely physically deconditioned. Because of this he was thought to be an excellent candidate for swing bed and is being transitioned to swing bed. 4/5/21 ER Practitioner Note: Upon arrival to ED trauma room I found patient to be in cardiac arrest, CPR in progress. History is that EMS was called to the scene for a patient with chest pain. Shortly after arrival at his home patient developed a cardiac arrest. They followed standard ACLS protocol and the patient was intubated. Blood sugar normal. As CPR was given, medications were administered consisting of epinephrine and 1 mg in 2 different doses along with 1 amp of bicarb. IV access via an IO. Patient was then transported to the emergency department. Upon arrival, CPR was continued and oxygen supplied via endotracheal tube with good tube placement verified by auscultation and good sat readings. Monitor was placed and patient demonstrated initially a sinus rhythm but there was no pulse. Therefore, diagnosis was PEA and no reversible causes were identified. ACLS protocol was followed with epinephrine 1 mg IV every 5 min. He received a total that including EMS, 5 mg of epinephrine and 1 amp of bicarb. Monitor at this point revealed the rhythm changed to an agonal rhythm. When CPR was given, there was good results from the CPR. However, CPR discontinued and there is no pulse and patient had an agonal rhythm for several minutes, pupils were fixed but not dilated year. Lungs demonstrating clear bilateral breath sounds when he was bagged via the endotracheal tube. No external signs of any trauma noted. The patient's sister is here and she is a registered nurse. We had discussed management at this point with her and all were in agreement that the code be terminated. At 1015, patient was pronounced deceased.. ACLS protocol was followed. See nursing record for medication and vital sign details. Code outcome: Deceased CC time 20 minutes." "1168352-1" "1168352-1" "Started feeling ill a few hours after vaccination. Became increasingly ill over the next few days with nausea and vomiting, severe diarrhea, leg cramps that progressed to where he was not able to ambulate, flushed, confused." "1168503-1" "1168503-1" "reports death due to age and dementia" "1168598-1" "1168598-1" "Patient passed away the morning after receiving her second COVID vaccine." "1168622-1" "1168622-1" "Pt started late in the day w/ CP and SOB, was transported to Hospital by EMS . Pt passed away once at the facility. Time of Death was: 2011 on 4/1/21; pt was discharged from ER on 4/2/21" "1168641-1" "1168641-1" "Death." "1168645-1" "1168645-1" "Patient death within 60 days of receiving the COVID vaccine series" "1168691-1" "1168691-1" "Patient death within 60 days of receiving the COVID vaccine series" "1168793-1" "1168793-1" "Death Narrative: Death on 03/07/2021. 2nd dose administered 6 days before serious event. No data about cause of death available. Pt was dx Iron deficiency anemia and had been scheduled to have a diagnostic colonoscopy. No indication that death was related to the vaccine." "1168794-1" "1168794-1" "Death Narrative: Death on 03/21/2021. 2nd dose administered 46 days before serious event. Patient had been admitted to the hospital for AMS of unknown etiology concerning for sepsis with multiple sources and was on comfort care measures only. There are no indications that death was related to the vaccine." "1168795-1" "1168795-1" "Death Narrative: Death on 12/22/20. 1st dose administered 5 days prior to serious event. Patient passed of chronic illness while in facility. There are no indications that death was related to the vaccine." "1168799-1" "1168799-1" "Death Narrative: Death on 02/10/2021. 2nd dose 28 days prior to serious event. Patient was admitted to facility for ALS and was on mechanical ventilation at time of death. No indications that death was related to the vaccine." "1168815-1" "1168815-1" "Death Narrative: Death on 01/25/2021. 2nd dose administered 19 days prior to severe event. Patient had diagnosis of malignant pulmonary process with a terminal prognosis. There are no indications that death was related to the vaccine." "1168833-1" "1168833-1" "Death Narrative: Death on 12/27/20. 1st dose 10 days before serious event. Patient was admitted for hospice care at the facility with bladder cancer with mets to liver, lung, and bone. There are no indications that death was related to the vaccine." "1168851-1" "1168851-1" "Death Narrative: Death on 03/04/21. 2nd dose of the vaccine was given 2 months before severe event. There is no indication that death was related to the vaccine. Patient was admitted to facility for hospice care when he passed." "1168978-1" "1168978-1" "hypertrophic cardiomyopathy; he just suddenly fell; lost his sense of taste; excruciating pains all over his body; General body aches like he got ran over by a truck/excruciating pains all over his body; Headache; Chills; Fever; Nausea; Pain; Based on the current available information which includes a strong temporal association between the use of the product and onset of the events, and excluding other etiologies, causal relationship cannot be excluded..This spontaneous case was reported by a consumer and describes the occurrence of hypertrophic cardiomyopathy in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 007M20A) for COVID-19 vaccination. The patient's past medical history included Angiogram (Was told they had an excellent heart and no surgery was needed) Concomitant products included acetylsalicylic (E.C.) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced pain, headache, chills, fever and nausea. On 24-Feb-2021, the patient experienced lost his sense of taste, excruciating pains all over his body and myalgia (general body aches like he got ran over by a truck/excruciating pains all over his body). On 06-Mar-2021, the patient experienced hypertrophic cardiomyopathy (seriousness criterion death) and he just suddenly fell.. An autopsy was performed. Consumer reported on behalf of spouse. Ambulance was called and patient was pronounced dead. Awaiting toxicology report. Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Major narrative update - outcome of events, additional events reported; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of pain, headache, chills, fever , nausea, loss of sense of taste, excruciating pains all over his body and myalgia and excluding other etiologies, causal relationship cannot be excluded. There is not enough details to assess the fatal event of hypertrophic cardiomyopathy and the administration of the product. Additional information has been requested.; Reported Cause(s) of Death: hypertrophic cardiomyopathy" "1169170-1" "1169170-1" ""3/30/21 AM = (Patient's notes) ""Chest/breast PAIN throughout night and (previous) day. Pain continuously in back last two (2) days. Nauseated, weak bladder every hour or so. No appetite. 1st Covid shot 3-27."" "1169181-1" "1169181-1" ""Wife reported that no side effects from vaccine noted until 3/16/2021 when patient had arm and back pain and wanted to go back to bed and she noted he was extremely sweaty at that time. He was lifted back to bed and was reportioned several times because he could not get comfortable. She went to get him a drink from the kitchen and heard a guttural sound and rushed back to find him unresponsive and blue in color. She called ""911"" and patient was dead upon arrival (and a DNR) so the Medical examiner arrived and pronounced him dead. She states sx started at about 4pm and he was pronounced dead at about 5pm. Medical examiner determined a heart attack cause of death. The family not sure that the vaccination had anything to do with death but wanted it to be reported."" "1169518-1" "1169518-1" ""This report is being submitted following a periodic review of death certificates . Death certificate for this individual indicates ""recent COVID vaccine"" in ""PART II. OTHER SIGNIFICANT CONDITIONS contributing to death but not resulting in the underlying cause"""" "1169584-1" "1169584-1" "Patient appeared in no distress the day after vaccination other than complaint of nausea. It is unclear but patient expired sometime the night of 4/3/21 or early morning of 4/4/21" "1169650-1" "1169650-1" "DIFFICULTY BREATHING, SEVERE CHEST PAIN, STOMACH ACHE, HEADACHE, JOINT PAIN WENT TO EMERGENCY ROOM THAT EVENING ON 3/15/2021 WENT TO BED WITH CHEST PAIN AND DID NOT WAKE UP THE NEXT MORNING PARAMEDICS WERE UNABLE TO REVIVE HIM, PRONOUNCED HIM DEAD AT THE SCENE." "1169683-1" "1169683-1" "Within 5-10 hours of the second dose: nausea, vomiting, chills, fever, fatigue. Chills, fatigue and nausea continued for 10 days until death" "1169796-1" "1169796-1" "4/2020 presumed COVID-19 (not formally diagnosed, not hospitalized) 2/07/21 Moderna vaccine #1 (date per pt's daughter) 2/21/21 onset SOB/DOE, fever 2/24/21 Seen at Urgent Care: RML crackles and infiltrate on CXR, given azithromycin and Augmentin 2/27/21 Presented to ED with progression of SOB/DOE, fatigue, diarrhea. Hypoxemic requiring low-flow NC, B/L basilar crackles noted; started on CTX/azithro (2/27-3/3) for presumed CAP 3/08/21 Required HFNC; first seen by me personally: diffuse, distinct velcro crackles, lower > upper fields 3/12/21 Started on high-dose steroids without improvement; unable to wean from HFNC with progressively worsening hypoxemia; pt declined intubation. 03/22/21 Patient died in Palliative Care Unit Diagnosis: Interstitial lung disease of uncertain etiology, acute interstitial pneumonitis vs. undiagnosed connective tissue disease" "1169895-1" "1169895-1" "Death; 48 hours after vaccine" "1169913-1" "1169913-1" "none noted or reported after the injection" "1170447-1" "1170447-1" "Patient fully recovered from natural SARS-COV-2 infection in early December 2020. Patient was doing quite well between mid December and mid January. Patient was hospitalized with congestive heart failure in late January 2021. Received first dose of Moderna COVID19 vaccine shortly before being discharged around February 1 (not sure of exact date). Patient was feeling well at that time. Patient became quite ill within 24 hours of Moderna COVID19 vaccine. Patient steadily worsened during February 2021. Was hospitalized in mid February (unsure of date) and diagnosed with kidney failure and liver disease. Congestive heart failure rapidly worsened and previously stable leukemia flared up. Patient was discharged from hospital February 19 and was placed in quarantine at Care Center. Patient was considered terminal and was to go into hospice care. Patient was administered second COVID19 vaccine on February 25, rapidly deteriorated, and died on March 1." "1170462-1" "1170462-1" ""Presented with rash and malaise ""since I got my COVID shot"". Rash red raised macular t/o body"" "1170822-1" "1170822-1" "Patient was found deceased on arrival in his living quarters after not showing up for work. This was approximately 14 days after his second pfizer vaccination. We have no reports of previous signs or symptoms in the days preceding his death. Patient had not visited the clinic since receiving his second shot in the series" "1171118-1" "1171118-1" "Patient received his first dose of Pfizer vaccine at around 10:15am on Friday April 2, 2021. His family reports he waited 15 minutes after vaccination and then proceeded home and reported no other issues. Patient collapsed at his home on Saturday April 3, 2021 around 11am. Family did CPR and called 911. Upon arrival of EMS they determined he was deceased and did not do anything further." "1171191-1" "1171191-1" "Patient was found dead in his apartment. I'm not clear on details, but he was having some issues the week prior to being vaccinated. He was in acute distress when his attendant care worker came to give him his medications the day before." "1171204-1" "1171204-1" "Patient fell while on the job on Friday March 26th, slurred talking. Later slumped over in the car while driving and had to be taken to the Emergency room where he later passed away. Cause of death on the death certificate per the coroner is Pulmonary Embolus. Patient was just seen my his family physician in January and was in good health no medications taken other than eye drops." "1171278-1" "1171278-1" "No adverse events reported while client observed after vaccination. Received voice message on 4/6 from daughter that client had died several hours after receiving vaccine. Also reported he had underlying health issues so unsure of cause. I made telephone call to daughter on 4/6. Daughter was wanting report made and plans to do so with additional health information included. I informed daughter I would be making a report also." "1171391-1" "1171391-1" "Death on 3/24/21 reported to vaccination clinic by family member. No additional details given." "1171601-1" "1171601-1" "Loss of appetite, malaise, nausea, falls, mental fog, death." "1171887-1" "1171887-1" ""Notified by pt's family member that pt stated at the dinner table he was not feeling well and went to lay down. Pt then later called out for his family member stating he was bleeding from his dialysis access in his leg. Pt's family member called EMS, pt was transported to the hospital. Pt member stated the pt passed away that evening ""because of all the blood he lost from his access."" Pt's nephrologist and NP were notified. Pt's death per nephrologist was felt to be due to blood loss from his graft and not related to the vaccine."" "1172610-1" "1172610-1" "Fever of 102 degrees Fahrenheit discovered by me when I went to awaken my husband on Saturday February 13, 2021. Two days later I discovered that he had died when I went to keep him a dose of liquid Tylenol at 4 am on February 15, 2021." "1172620-1" "1172620-1" "My father, who at 80 was walking 2 miles a day and had just had a check up within the month consisting of an MRI, cardiac monitor and lab work which gave him essentially a clean bill of health felt fatigued after his second Moderna shot. 11 days after his second dose he took an afternoon nap and was found dead by my mother and myself. We are devastated. The time frame so close to his second moderna shot can not be ignored. We want no one to suffer a loss such as this if the vaccine was a catalyst. Full autopsy is ongoing, no know cause with initial results." "1172648-1" "1172648-1" "Cardiopulmonary arrest, D-Dimer 55,000, TNKase administered, ACLS, needle thoracostomy, persistent PEA arrest, decompensated into asystole , pronounced" "1172708-1" "1172708-1" "No acute symptoms after vaccine except a mildly sore arm. Patient died 4 days later" "1172711-1" "1172711-1" "@nd dose Pfizer on March 27 without immediate problems. Had sudden collapse on March 29, found to have large intracerebral hemorrhage; at local hospital after discussion placed on comfort measures only; died 04/02/2021" "1172767-1" "1172767-1" "Patient presented 4/3 stating received Pfizer COVID-19 vaccine on Monday and began having sympoms about Wednesday. Developed fever by Thursday and cough/nausea/vomiting by Friday. Cough ongoing and feels like he should have production but is not able sputum out. The pain is chest is described as not being able to fully expand his lungs when he tries to inhale. Patient presented 4/6-DOA" "1172840-1" "1172840-1" "She received vaccination at 1430 hrs on April 2. Died in her sleep that night...sometime between 2200 hrs April 2 and 0600 hrs April 3." "1172981-1" "1172981-1" "Pt developed dyspnea and decompensated due to underlying metastatic adenocarcinoma of lung and large pericardial effusion which caused cardiac tamponade ultimately causing him to succumb." "1173602-1" "1173602-1" "Passed away on the sleep; A spontaneous report was received from a pharmacist concerning a 73-years-old male patient who received Moderna's COVID-19 vaccine and passed way on the sleep/death. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (lot number: 024M20A) on 23 Jan 2021. On 23 Mar 2021, patient received second of two planned doses of mRNA-1273 (lot number: 047A21A) intramuscularly for COVID-19 prophylaxis. On an unknown date in Mar 2021, the patient passed away on the sleep. The patient received both scheduled doses of mRNA-1273 prior to the event therefore, action taken with the drug in response to the event was not applicable. The patient died on the sleep on an unspecified date in Mar 2021. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: This case concerns a 73-years-old, male patient, who died. The cause of death was unknown. Plans for an autopsy were unknown. Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1173746-1" "1173746-1" "Received first dose 2/27/21 and received second dose 3/20/21 and died 3/26/21." "1173788-1" "1173788-1" "had second vaccine on 4/1/21, expired 4/2/21" "1173826-1" "1173826-1" "Pt received the vaccine on 3/9/2021 reports to ED on 3/19/2021 s/p fall while transferring from wheelchair no fractures on x-ray, sent home at 2246. started to c/o chest pain and shortness of breath. Went into cardiac arrest at home approximately 4 hours after leaving ER. Pt was pronounced DOA 3/20/201 @ 0343" "1173977-1" "1173977-1" "after receiving his initial dose the next day he seemed to have suffered a TIA that took almost a week for him to recovery from. He was confused, no appetite, weak, and generally not himself. Prior to receiving his second dose he was alert, eating, no complaints of any discomfort or issues. The next day following his second dose he passed away from what we think was a massive heart attack. As a family we feel his weakened state contributed to this and not the fault of the vaccine but felt it important to notify you in case individuals such as patient should be monitored in a different way or use a different vaccine." "1174109-1" "1174109-1" "Death" "1174338-1" "1174338-1" "Patient died 12-15hrs after vaccination.; This is a spontaneous report from a contactable Consumer. A 40-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 25Mar2021 12:45 (Batch/Lot Number: ER8727) at the age of 40-year-old as single dose for covid-19 immunisation. Medical history reported as none. Concomitant medication included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient patient died 12-15 hours after vaccination. The patient died on 26Mar2021. An autopsy was not performed. No treatment received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19.; Reported Cause(s) of Death: Patient died 12-15hrs after vaccination." "1175146-1" "1175146-1" "Patient became weak within 24 hours and declined daily until she died on 4/5/21. Family wanted no intervention except comfort care given patient's wishes." "1175454-1" "1175454-1" "Died on 2/12/2021; diagnosed as a COVID-19 related death; 1st vaccine dose on 12/22/2020, 2nd vaccine dose on 1/14/2021. Hospitalized for acute respiratory failure with hypoxia and pneumonia due to COVID-19 infection." "1175492-1" "1175492-1" "Janssen vaccine given on 3/9/2021; Admitted to the hospital on 3/16/2021 for COVID-19 infection, pneumonia, new onset a-fib, and COPD exacerbation." "1175722-1" "1175722-1" "Family member reported patient deceased. Was found on 3/21/21. She had told a friend she wasn't feeling well on the night of 3/19/21." "1175952-1" "1175952-1" "Patient death within 60 days of receiving the COVID vaccine series" "1176003-1" "1176003-1" "Patient death within 60 days of receiving a COVID vaccine" "1176010-1" "1176010-1" "He got his vaccine, and mother had talked to his girlfriend said that he felt fine other than a sore arm. He called his mother and told her that he was sick to his stomach with cramps and that he was throwing up blood. The girlfriend found him on the floor on the 21st dead on the floor in his hotel room at 8:00 AM. The girlfriend said she had spoken with him around 10:00 PM and that he said he was going to sleep on the floor in the bathroom as he was throwing up and the floor was cool. She subsequently found out that he was throwing up blood, and autopsy report showed that his stomach was full of blood and further testing is being done to see what has caused the bleeding." "1176064-1" "1176064-1" "Patient death within 60 days of receiving a COVID vaccine" "1176120-1" "1176120-1" "Patient died of expected causes 5 days post-vaccine. Patient was known to have advanced colon cancer. Patient's COD was metastatic cecal cancer, admitted to hospital on 3/22/21 for palliative treatment, PEG tube placement for decompression, and pain control." "1176121-1" "1176121-1" "Patient death within 60 days of receiving a COVID vaccine" "1176131-1" "1176131-1" "Patient died." "1176215-1" "1176215-1" "Patient was admitted to the hospital on 03/27/2021. He was symptomatic and died at the hospital on 04/06/2021." "1176234-1" "1176234-1" "Patient death within 60 days of receiving the COVID vaccine series" "1176274-1" "1176274-1" "Patient became SOB 911 called patient arrested in ambulance and died" "1176278-1" "1176278-1" "Patient within 60 days of receiving a COVID vaccine death" "1176372-1" "1176372-1" "Narrative: Per law enforcement report, patient's death appears to be natural causes. Wife found 91 yo patient on the floor having seizures. Patient was treated for seizure disorder and had recent Primary Care visit with updated labs. Seizure medication lab monitoring was monitored with no concerns." "1176373-1" "1176373-1" "Death Narrative: Patient with gastric cancer received COVID-19 vaccine, first dose on 2/8/2021 and second dose on 3/9/2021. Chart note indicates that patient passed away on 3/26/2021 while on home hospice. Patient has never tested positive for COVID. Patient had metastatic cancer and was referred to hospice on 3/5/2021, note from provider indicates patient likely had only weeks to live. Patient had no documented reaction from COVID vaccine administration. Patient had no hospitalization around time of COVID vaccination. The patients most likely cause of death was the metastatic cancer, with date of death closely aligning with cancer providers' estimations of remaining life span on 3/5." "1176806-1" "1176806-1" "OBJECTIVE: Patient found deceased on March 26, 2021, less than one week post vaccination with Pfizer-BioNTech COVID19 vaccine dose #1. Found by daughter who is also RN and caregiver. Patient found with black tongue protruding slightly from open mouth. Three days post vaccine date and for three days patient found mouth-breathing heavily. When patient?s attention was called to his breathing he immediately resumed normal breathing. Also three days post vaccine date and for three days patient had loosened waist belt and offered complaint of feeling full. Also, Patient was more talkative during the week following vaccination. SUBJECTIVE: Perhaps related to anxiety. OBJECTIVE: Patient had eaten only one avocado per day for his remaining two days of life. Patient had history of stoicism and was known to downplay or deny deviations in physical well-being." "1176896-1" "1176896-1" "Patient died of an apparent Cardiac Arrest." "1177058-1" "1177058-1" ""Family reports that patient had her 2nd dose of COVID-19 vaccine on 4/1, approximately 3 weeks after her first dose. Patient had one week history of ""allergy type"" symptoms. Evening of 4/1 developed ""GI symptoms and diarrhea"". Morning of 4/2 her ""neighbor came by to check on her and she stated that she was not feeling very well last night but thought she just needed some Gatorade of something...He stated that as he gave her the alka-Seltzer he told her that there was aspirin in it which apparently she has an allergy to. He stated that her response was I should be fine I do not think I'm that allergic to aspirin...5 to 10 minutes later she started to have some issues...Patient stated to her neighbor that she was having a hard time breathing and thought she needed to go to the hospital, and that maybe she was more allergic to the aspirin than she had thought...Over the 15 miles between her house and the hospital patient condition deteriorated to the point where they arrived at the hospital she is in full cardiac arrest...given ACLS protocol including epinephrine and was intubated."" ""They achieved ROSC after approximately 10 minutes."" Patient was then flown, MT emergency department to Hospital. Patient was cared for in the ICU. Patient herniated her brain the night of 4/5-4/6. ""After meeting the clinical and imaging criteria at 1605 on 4/6/2021 she was declared brain dead. Medical team suggests that patient had Samter's Triad/Triad Asthma with history of asthma, nasal polyps and allergy to aspirin. Anaphylaxis secondary to ingestion of aspirin via Alka-Seltzer."" "1177076-1" "1177076-1" "On Saturday, April 3rd, patient told her son she was tired and was going to take a nap. Her son tried to wake her the next morning since she had not come out of her room from the day before. He was unable to wake her." "1177173-1" "1177173-1" "Husband and wife came in 4/5 and received their COVID vaccines at 11am. They waited the 15 minutes to check for reactions and were unsymptomatic when time was up. The pharmacy did a courtesy call around 3:15 pm on 4/7 to check in with them and see how they were feeling. The wife stated that her husband had passed away the night of 4/5. Wife stated that they were getting ready to go to bed and husband felt hot and shaky so he laid in front of a fan. Wife eventually had to do CPR and stated that she thinks that he passed away during the time while they were waiting for EMS, which took about 45 minutes. Patient was pronounced dead night of 4/5. Wife stated that patient has a history of heart problems including hypertension and multiple stents place and that she does not think the vaccine had to do with her husband's death." "1177248-1" "1177248-1" "Family reports general malaise post treatment, followed by fever and chills 4/3/2021, and cardiac arrest 4/4/2021." "1177384-1" "1177384-1" "4:30pm slight nausea; arm pain; mild headache 5:00 pm headache more severe; up the back of head, described as unusual pain; thought a migraine was coming on. 5-7:00pm headache continues to worsen; chills; research on line side effects of Pfizer vaccine and they coincide with symptoms; 7:05 gets up to urinate (no assistance needed); screams out in pain 3 times while on toilet; starts to vomit; right side of face (eye and cheek and mouth droop like a stroke; left hand starts to curl. Loses consciousness immediately thereafter. 911 call; paramedics on the way; airway was swept and clear; gurgled breathing. Rushed to Hospital and assessed as having massive brain bleed. Pronounced dead at 10:22pm. Acute Hemorrhagic Stroke on Death Certificate." "1177548-1" "1177548-1" "On the evening of 4/3/2021 the patient was at home, prone in bed, gasped suddenly and became unresponsive. EMS was called and unable to resuscitate. She expired." "1177616-1" "1177616-1" "Patient death within 60 days of receiving the COVID vaccine series" "1177800-1" "1177800-1" "Rapid onset in fever and myalgia. Dyspnea and hypoxia developed over days, and eventually patient was hospitalized with bilateral pneumonia consistent with COVID-19, however patient had multiple negative tests for SARS-CoV-2, both antigen and PCR. Patient eventually diagnosed with interstitial lung disease prior to expiring on 4/7/2021." "1178071-1" "1178071-1" "Patient found expired at home about 12 hours after administration of vaccine" "1178158-1" "1178158-1" "Pt came to the ER via ambulance with SOB, difficulty breathing, confusion and combativeness which had gotten worse over the day 4/3/21. He had a rash all over his body.. After the respiratory treatments failed, pt was intubated and transferred to a higher level of care and expired on 4/4/21" "1178304-1" "1178304-1" "died/cancer; collapsed on the floor; eyes rolled back; stopped breathing for a very short.; This is a spontaneous report from a contactable consumer. A 70-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: en6100, expiry date not reported), via an unspecified route of administration, administered in right arm Right on 06Mar2021 11:00 at a single dose for covid-19 immunization.Medical history included stage 4 esophagis cancer and mushroom allergies (known allergies to mushrooms). The patient had no covid prior vaccination; not diagnosed with COVID-19. The patient had other medications (unspecified) that the patient received within 2 weeks of vaccination. The most COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (lot number: el9267) for covid-19 immunisation in the right arm on 13Feb2021. The patient was not tested for covid post vaccination. Since the vaccination, the patient has not been tested for COVID-19. On the afternoon of 06Mar2021 (16:00), patient collapsed on the floor, eyes rolled back, stopped breathing for a very short. The patient was revived and carried to bed. She died at 4 am on the 13Mar2021. She told the reporter she did not want to go to the hospital and she said she wanted to die at home. The reporter stated that the cause of death was cancer since an unknown date. The events were reported as serious resulting in death. No treatment received for the adverse events reported. The patient died on 13Mar2021. The causes of death were cancer, collapsed on the floor, eyes rolled back, and stopped breathing for a very short. An autopsy was not performed.; Reported Cause(s) of Death: collapsed on the floor; eyes rolled back; stopped breathing for a very short; died/cancer" "1178307-1" "1178307-1" ""She died 23 hours later on 28Feb/Her cause of death on her death certificate was stated to be cardiac arrest; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 27Feb2021 at a single dose for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient died 23 hours later on 28Feb2021 after first dose on 27Feb2021. She did not show any adverse symptoms after being vaccinated. The questionnaire before the vaccination asked ""if you have a chronic health condition such as heart disease"". It was stated that she has heart disease; still the vaccination was given. Her cause of death on her death certificate was stated to be cardiac arrest. The patient died on 28Feb2021. It was unknown if an autopsy was performed. Information about Batch/Lot number has been requested.; Reported Cause(s) of Death: She died 23 hours later on 28Feb/Her cause of death on her death certificate was stated to be cardiac arrest"" "1178531-1" "1178531-1" "Death within 12 hours" "1178537-1" "1178537-1" "Pt was found deceased at home on 3/10/21. He had had a cough prior to, recent hospitalization for pneumonia/acute on chronic resp. failure." "1178571-1" "1178571-1" "Pt was found deceased at home, 4/2/2021." "1178887-1" "1178887-1" "Death" "1178909-1" "1178909-1" "He complained Fever and after that shortness of breath, and when I tried to see a Doctor he suddenly collapse and died" "1179434-1" "1179434-1" "She felt. Ad the evening of her 2nd vaccine. The morning after she felt worse. Nauseous, pale, achy. She said she had not ever felt that bad. I read possible side effects. It said flu like symptoms, so we thought it would pass. Then around 4 she called for me & when I got there she had an event that caused her to be unable to speak & her eyes widened & pupils were dilated. I called 911. They got here quick. She had at least three of those stiffening wide eyed events. The emt said they thought it was her blood sugar. When checked it was 350 even though she had taken her insulin that day. They said she had a massive heart attack on the way to the hospital." "1179444-1" "1179444-1" "Systemic: Unknown, patient found deceased at home evening after receiving vaccine.-Severe, Additional Details: called pharmacy inquiring about vaccine for patient. She received her COVID vaccine on 4/6/21 and later that evening was found at home deceased. Called to gather information on the patient/vaccine. Caregiver stated that the patient did not have a PCP, therefore they do not have much medical history on her. There were no notes on adverse reaction during post-vaccine observation. It is unknown at this time if vaccine played any role." "1179974-1" "1179974-1" "pt was diagnosed with covid on 3-29-21 , hospitalized for pneumonia and respiratory failure and expired on 4-6-21 at Hospital" "1180036-1" "1180036-1" "Patient tested positive for COVID on 12/30/2020. She did not experience COVID symptoms; however, at that time her dementia and weakness progressed. She passed away on 02/12/2021 at the nursing home facility." "1180051-1" "1180051-1" "Was hospitalized (unsure dates on hospitalization); has no known pre-existing conditions; symptom onset was 3/3/2021 with fever, chills, rigors, myalgia, rhinorrhea/congestion, sore throat, cough (wet productive), nausea/vomiting, headache, loss of smell and taste, and fatigue. Was a household contact to a known COID-19 case." "1180107-1" "1180107-1" "Death within 30 days of vaccination" "1180145-1" "1180145-1" "Low Magnesium levels 2/24 Mag 1.5, 3/4 received 4gm Mag Sulfate, 3/8 Mag 1.6 (obtained from Hospital. Death within 30 days of vaccination" "1180189-1" "1180189-1" "Hospitalization within 30 days of vaccination. Death within 60 days of vaccination" "1180245-1" "1180245-1" "Death within 30 days of vaccination" "1180291-1" "1180291-1" "Hospitalization x 2 within 30 days of vaccination; Death within 60 days of vaccination" "1180374-1" "1180374-1" "Death within 60 days of vaccination. Unwitnessed cardiac arrest, CPR attempted and unsuccessful." "1180530-1" "1180530-1" "Death due to massive basal ganglia hemorrhage" "1180533-1" "1180533-1" "wife of the patient called came in for her COVID-19 vaccine appointment on 4/8/2021 and explained that her husband passed away in his sleep suddenly after a wonderful evening on 3/25/2021. She expressed that physician said it was not COVID related. Wife did not want to discuss the death of her husband at this time so the information is limited for this report." "1180565-1" "1180565-1" "04/07/2021 cold hands, alternating hot and cold sweats, arm stiffness, shaking, aphasic and blank stare. Date of death 04/07/2021." "1180587-1" "1180587-1" "Acute Hemorrhagic CVA resulting in eventual death." "1180640-1" "1180640-1" "4/4/21 woke up more tired than usual. Progressed from there, prominent fatigue for the next couple days, slept on the couch on and off for a couple days which was unusual for him. Mild SOA and weakness 4/7/21. Died in his sleep into the morning of 4/8/21." "1180688-1" "1180688-1" "Patient was vaccinated on 4/6/21 at 9:05 am. Report received that patient was in the car on the way home from the vaccination and had chest pain and shortness of breath. Patient called their primary care doctor who requested reporting to the nearest emergency room immediately. Patient became unresponsive in the car. Patient arrived in cardiac arrest (arrival time noted to be 4/6/21 at 10:54 am, CPR began. Patient was intubated in the ER, and received epinephrine, amiodarone, and was defibrillated several times per ACLS protocol. Patient did not have return of spontaneous circulation and was subsequently pronounced. Per report, it was noted that patient was short of breath prior to receiving vaccination earlier in the day." "1180818-1" "1180818-1" "Recipient of vaccine is a family member (father) of employee of Hospital. Recipient was vaccinated with Dose 2 Pfizer Covid vaccine on 3/19/2021 and observed on-site for 15 minutes after vaccination with no apparent concerns. On 3/23/2021, his daughter (our employee) notified clinic that on 3/22/2021, recipient had died. 4/7/2021 his daughter (our employee) states the medical examiner indicated his autopsy showed evidence of cardiac arrest." "1180840-1" "1180840-1" "3.5 hours after receiving the vaccine, the patient was killed in a head-on collision. The patient was driving when her vehicle crossed the centerline and struck a second vehicle head on. It is unknown if the COVID19 vaccine contributed to the collision and death." "1180886-1" "1180886-1" "Patient contracted COVID during an outbreak. Patient went to the ED on 2/28 and was sent home. Patient returned to the ED on 1/2 and was admitted. Patient expired on 1/3" "1180894-1" "1180894-1" "respiratory arrest, cardiac arrest Narrative: Patient died 1 day after receiving 2nd dose of COVID vaccine in his bed at home. Paramedics arrived but were not able to resuscitate." "1180895-1" "1180895-1" "death Narrative: Pt with hx substance use disorder (on suboxone), depression, PTSD, SI and grief following her son's suicide. Pt received COVID vaccine 3/14/21. Clinic notified of pt's death on 4/6, for which it HAS NOT BEEN VERIFIED but reported death date of 4/3. Pt was scheduled for MH f/u appt 4/5, but no-showed it. Unclear report or cause of death, however, suspected via suicide or drug overdose given risk factors and worsening of mental illnesses. Was pt previously covid positive? No Are there any predisposing factors (i.e. PMH, HPI, allergy history etc) for patient experiencing adverse drug event? No Any occurrence of an ADR at time of administration or during time of observation? No Did patient recover from event? N/A - pt died but does not appear related to vaccine Was there an ADR between observation period and date of death? No Was patient hospitalized prior to vaccination? No Was patient hospitalized between vaccination and date of death? No Was patient hospitalized prior to death No What are the possible cause of death? Suicide, illicit drug overdose" "1180896-1" "1180896-1" "Narrative: Patient received second dose of Moderna COVID vaccine on 3/11. per caregiver, was diagnosed with a stroke at hospital ~ 3/17/21. He was transitioned to hospice and expired last week." "1181914-1" "1181914-1" "Patient entered Drug store to get his second Moderna COVID shot on 4/8/2021 at approx. 12:30pm. (First dose was 3/11/2021) He filled out his Pre-Vaccination Checklist for COVID-19 Vaccines and signed the consent. His form was reviewed and he was given his vaccine in his left deltoid. He then was given his CDC card and waited at least 15 minutes and then exited the building. At 1p.m he was in an accident on the main highway. He was conscious after the accident, but later did pass away. This information came from a Police Officer as no one at the pharmacy witnessed the accident." "1181925-1" "1181925-1" "Patient started complaining of extreme back pain and trouble walking within days after receiving the vaccine. His pain got increasingly worse. On the 23rd he had to be taken into the hospital in an ambulance. He said he felt as if his lower body was separated from his torso, and visible was having trouble walking. They prescribed him Valium, preformed an x-ray, and sent him home. On the 27th he was taken back to the hospital due to leg weakness, tingling in his hands and feet, and extreme pain. He was diagnosed with Guillain-Barre Syndrome. He passed away April 6, 2021 after spending 11 days in the hospital, and 6 days on a ventilator." "1182018-1" "1182018-1" "Death from cardiac arrest" "1182101-1" "1182101-1" "Completed Moderna series on 02/12/2021. Diagnosed with COVID-19 on 04/06/2021 and expired from COVID-19 pneumonia on 04/06/2021" "1182258-1" "1182258-1" "UKNOWN - SAW ON SOCIAL MEDIA THAT PATIENT PASSED AWAY ON 4/1/2021" "1182611-1" "1182611-1" "My father became weak and non-responsive in week following vaccine. Could not communicate and passed 11 days after receiving vaccine." "1183418-1" "1183418-1" "Vaccine breakthrough hospitalization - SOB with O2 sat 50% when EMS arrived. On non-rebreather satting 70%. Chills, fever, cough, and chest pain. BP 152/79, HR 93, RR 20, SpO2 91%. Had been scheduled to receive COVID mAb day of admission, but clinical course worsened. Admitted to Medical ICU for acute respiratory failure with hypoxia and ARDS secondary to COVID-19. Placed on BIPAP and Rx with Remdesivir, dexamethasone, & tociluzumab. Treated for presumed pulmonary embolism with full-dose anticoagulation. Pt expressed wishes to remain DNR/DNI, ultimately she elected to transition to comfort measures only given worsening hypoxia." "1183806-1" "1183806-1" "Went down hill after receiving the 2nd shot and stopped breathing; Went down hill after receiving the 2nd shot and stopped breathing; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY ARREST (Went down hill after receiving the 2nd shot and stopped breathing) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Went down hill after receiving the 2nd shot and stopped breathing). On 24-Mar-2021, the patient experienced RESPIRATORY ARREST (Went down hill after receiving the 2nd shot and stopped breathing) (seriousness criteria death and medically significant). On 24-Mar-2021, GENERAL PHYSICAL HEALTH DETERIORATION (Went down hill after receiving the 2nd shot and stopped breathing) outcome was unknown. The patient died on 24-Mar-2021. The reported cause of death was stopped breathing. It is unknown if an autopsy was performed. Reporter wasn't sure if patient received Pfizer or Moderna vaccine. The patient was in hospice care and reporter thought the patient received the vaccination from a local pharmacy. Concomitant medications and treatment medications were not provided.; Reported Cause(s) of Death: Stopped breathing" "1183985-1" "1183985-1" ""Fluid in his bottom right lobe of his lung where the cancer is; Inflammation in the bottom of his lung; in lower right lobe of lung; Blood pressure isn't stable; going up and down; Blood pressure issues; Exhausted; fatigue; Trying to control his blood pressure and his pulse issues, pulse incomplete; Muscle weakness was severely progressing; Bad reaction to the Covid vaccine; Blood clot on his lung; Raspy voice; the patient had been sick; Moderate headaches; Passed away; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from Pharmaceuticals (Manufacturer control number 2020CAT00505). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation. Co-suspect drug included amifampridine phosphate (FIRDAPSE) orally, from 18Sep2020 to an unspecified date at 10 mg thrice daily, from 02Oct2020 to an unspecified date at 20 mg thrice daily, for Lambert-Eaton myasthenic syndrome. Medical history included Lambert-Eaton myasthenic syndrome (he could not walk without FIRDAPSE), migraine ever since he was a kid, small cell lung cancer (in liver and lymph nodes; brain metastases), metastases to liver, metastases to lymph nodes, radiotherapy of his head and lung for his cancer, gait disturbance from an unknown date and unknown if ongoing, muscular weakness from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole, acetylsalicylic acid (ASPIRIN (E.C.), furosemide. The patient experienced blood clot on his lung in Jan2021 with outcome of unknown, fluid in his bottom right lobe of his lung where the cancer was on an unspecified date with outcome of not recovered, inflammation in the bottom of his lung; in lower right lobe of lung on an unspecified date with outcome of not recovered, raspy voice in 2021 with outcome of recovered, blood pressure not stable; going up and down; blood pressure issues on an unspecified date with outcome of not recovered, exhausted; fatigue on an unspecified date with outcome of not recovered, sick in 2021 with outcome of unknown, trying to control his blood pressure and his pulse issues, pulse incomplete on an unspecified date with outcome of unknown, moderate headaches from 19Sep2020 with outcome of recovered, muscle weakness severely progressing on an unspecified date with outcome of unknown, 10 mg 3 times a day wasn't enough (therapeutic product effect incomplete), on an unspecified date with outcome of unknown, he'd switch and do a couple doses of 15 mg and it was better but not enough (intentional product use issue) on an unspecified date with outcome of unknown, after he received the COVID vaccine, he experienced a bad reaction (unspecified) on an unspecified date with outcome of unknown. The events were reported as serious as involved hospitalization. The patient passed away on an unspecified date in Feb2021. It was not reported if an autopsy was performed. The clinical course of the events included the following information. On 21Sep2020, a spontaneous report was received from a consumer, via a company representative, regarding a 74-year-old male who was being treated with FIRDAPSE 10 MG (amifampridine). On 22Sep2020, additional information was received from a consumer. On 02Oct2020, additional information was received from a consumer and chemotherapy was added as a co-suspect. On 01Feb2021, additional information was received from a consumer via a company representative. On 09Feb2021, additional information was received from a consumer, and this case was determined to be the master case for cases 2021CAT00039 and 2021CAT00052 (both invalid, duplicate cases) and the information was merged into this case (2020CAT00505). This case was re-assessed as serious/unexpected, and COVID vaccine was added as co-suspect. On 18Feb2021, additional information was received from a consumer via a company representative. On 19Feb2021, additional information was received from a patient ambassador via a company representative. Medical history included LEMS (Lambert-Eaton myasthenic syndrome) and migraines. Concomitant products included: an unknown statin, pantoprazole, and acetylsalicylic acid (ASPIRIN) 81 mg. On 18Sep2020, the patient started treatment with FIRDAPSE 10 mg at 10 mg, 3x/day orally for LEMS. On 19Sep2020 and 20Sep2020, after starting the product, the patient experienced moderate headaches. On 21Sep2020, the patient did not experience a headache. On 22Sep2020, the patient experienced a headache that was ""4/10."" He had taken acetaminophen; aspirin; caffeine (EXCEDRIN) and ibuprofen as treatment and it ""helped."" The patient had not spoken to his HCP (health care provider) about the event but was going to call his HCP and ask to increase his dose of FIRDAPSE. The product was working and he was walking better, but he had heard people taking up to 80 mg a day. As of 22Sep2020, product use was ongoing and headaches were improved. On 02Oct2020, it was learned that his medical history included being prone to headaches (also reported as migraines ever since he was a kid) and ""chemo"" for small cell lung cancer stage 4 which was in his liver and lymph nodes. Concomitant products included furosemide. It was noted that the patient had been on the product for 4 to 5 days when he experienced his moderate headaches. He had the headaches for just a couple days, but he wasn't sure if it was due to the FIRDAPSE or it was the chemo. He took ""a couple"" of ibuprofen and he was ""alright."" On an unspecified date, the patient was in contact with his HCP and he was told to ""keep an eye on it"" (presumed headaches) and see if it got worse. They agreed that it could have been the chemo or a ""fluke"" thing. He also spoke to his HCP about his FIRDAPSE dose of 10 mg, 3x/day not being enough. He would switch and do a couple doses of 15 mg and it was better, but not enough. His HCP thought he should be taking 20 mg 3x/day, so he was working with the patient's insurance and pharmacy to get it changed. As of 02Oct2020, FIRDAPSE and chemo treatment were ongoing and moderate headaches were resolved (reported as he'd been good for a few days). On 01Feb2021 and 09Feb2021, it was learned that on 02Oct2020, the patient's FIRDAPSE dose increased to 20 mg, 3x/day. On an unspecified date, the patient received the COVID vaccine at an unreported dose, route, and frequency of administration for an unreported indication. After the patient received the COVID vaccine, he experienced a bad reaction (unspecified). Since 27Jan2021 (reported as since Wednesday, relative to 01Feb2021), the patient had been sick. On 31Jan2021, the patient went to the emergency room, and they thought he had a blood clot on his lung. Subsequently, he was admitted to the hospital. Initially, when the patient was in the hospital, they took all his medications away, including his FIRDAPSE, as the pharmacy was managing his medication. The patient wife was able to get the doctors to let the patient keep his FIRDAPSE in his room with him before he missed any doses because he could not walk without his FIRDAPSE. On an unspecified date in 2021, the patient had radiation of his head and lung for his cancer (previously reported medical history), and ""they"" (presumed his medical provider) said he could have a raspy voice and headache, which he did experience but then resolved. While in the hospital, the patient's blood pressure was not stable. It went ""up and down, up and down."" He had fluid in the bottom right lobe of his lung, where the cancer was, and they could not ""tap it"" due to the blood pressure issues. They were trying to get the fluid out every other way they could. The doctors said he had inflammation in the bottom of his lung. He was given a ""good dose"" of prednisone, but he was just exhausted. They were trying to control his blood pressure and his pulse. When they got one of them ""up,"" the other went ""down."" The doctors said that the patient's LEMS had nothing to do with why he was in the hospital. His wife expressed her gratitude for the FIRDAPSE and how it had helped him. As of 09Feb2021, treatment with FIRDAPSE was ongoing. The patient was still in the hospital and not doing well, also reported that he was still the same, he had not improved but he had not worsened. The blood clot on his lung, blood pressure fluctuation and pulse issues, fluid in the bottom right lobe of his lung, inflammation in the bottom of his lung, and exhaustion were not resolved. The status of the bad reaction to the COVID vaccine was not reported. No additional information was provided. On 18Feb2021 and 19Feb2021, it was learned that the patient's medical history included: muscle weakness and lung cancer with brain metastases. On unspecified dates, after starting FIRDAPSE, the patient's muscle weakness began severely progressing, and he experienced fatigue. The weakness was worsening significantly, even after being on the medication (presumed FIRDAPSE). On 14Feb2021 or 15Feb2021, the patient was discharged from the hospital. On 18Feb2021, the patient took his last dose of FIRDAPSE. On 18Feb2021 or 19Feb2021 (reported as last night, relative to 19Feb2021; yet also reported as either 18Feb2021 or 19Feb2021), the patient passed away. The cause of death was unknown. A 74-year-old male, with a history of migraines and chemotherapy for metastatic small cell lung cancer, was taking an unknown statin, furosemide, pantoprazole, and Aspirin. He added FIRDAPSE for LEMS on 18Sep2020 and experienced headaches for a couple days, but he wasn't sure if it was due to the FIRDAPSE or chemo. After COVID vaccine, he experienced a bad reaction (unspecified). Since 27Jan2021, he was hospitalized with a blood clot on his lung. He had brain and lung radiation for cancer. While in the hospital, he had fluid and inflammation in the bottom right lobe of his lung, where the cancer was, which count not be drained due to labile blood pressure. His muscle weakness began progressing and he experienced fatigue. In Feb2021, he was discharged on FIRDAPSE. A few days post-discharge, he died. Based on the information provided, the events were assessed as unrelated. Information on the batch/lot number has been requested.; Reported Cause(s) of Death: Passed away"" "1184531-1" "1184531-1" "Weakness Confusion Falling down Vision impairment Legs really weak All of the above symptoms started on March 14, 2021 On March 18,2021 she was not out of bed except for just a few minutes. On March 19, 2021 she was on the floor laying beside of the bed and my father noticed blood looking stuff on her shirt and bed covers. She was really confused and lethargic. She was really weak and could not stand. She was extremely fatigued. At around 10:30 she fell again on the floor and my father and sister in law was able to get her back up and put her in a chair and she went to sleep. At 12:55 my father noticed she was not breathing and called 911. When they did CPR blood was coming from her mouth and nose. When the ambulance arrived they immediately took her to the hospital where she was pronounced dead at around 3:30 pm." "1184784-1" "1184784-1" "Approximately 3 hours after vaccine administration, patient experienced the following: Nausea, Vomiting, Abdominal pain, and the following day: Bloody Bowel Movements. Patient went to the emergency department the day after vaccine administration. Patient was made NPO, started on IVF and Zosyn. Patient was seen by GI who agreed with supportive management of ischemic colitis. Around 1730 on 2/6, patient unresponsive and rapid response was called. Patient responded to Narcan. On 2/8/2021, 0358, patient was seen as not breathing and code blue was called. Interventions were unsuccessful and patient was pronounced dead at 0439am." "1185061-1" "1185061-1" ""On 04/08/2021 pt. was found passed away in her bath tub. Pt. received her 2nd dose of the Covid vaccine on 04/07/2021 at 2:00 p.m. Family choice not to have an autopsy performed and death certificate was completed with cause of death ""sudden cardiac arrest"". Note on 2/20/21 Pt. was transferred to Hospital with dx. of acute pancreatitis with elevated lipase and wbc."" "1185193-1" "1185193-1" "within 2 weeks of receiving the covid vaccine patient became weak, stopped eating, more lethargic and became bedbound and was started on hospice. She died on 3/31/2021" "1185219-1" "1185219-1" "Patient was vaccinated on 3/30/2021. Found DOA on 4/8/2021. Last time anyone spoke with the patient was on 4/3/2021." "1185285-1" "1185285-1" "Pt received vaccine on march 11, 2021 went into E.R at Hospital and admitted 3/16/2021 Positive COVID-19 Pneumonia" "1185996-1" "1185996-1" "My father complained of chest pains and then died two days after receiving the vaccine." "1186039-1" "1186039-1" "On 2/27/2021 at 12:46 pm, the patient developed chest pain. Not helped by nitroglycerin x 2. He was transported to the hospital where he died." "1186275-1" "1186275-1" "Died of Heart Attack unexpectedly day following vaccine" "1186348-1" "1186348-1" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "1186471-1" "1186471-1" "Complaints of diarrhea, sweating, weakness suffered sudden cardiac arrest. CPR, AED, Lucas device applied ACLS protocol initiated by EMS. Efforts terminated. Patient pronounced deceased at 1003am." "1186943-1" "1186943-1" "55-year-old male with no diagnosed past medical history presents emergency department after cardiac arrest. Per patient's daughter, patient was feeling at baseline today. He got his COVID vaccine at 5 PM this evening. He was running some errands and called his daughter at 8:40 PM. He told his daughter he was not feeling well. She reports he sounded out of breath and sounded as if he was slurring his words. Daughter told him to pull over and she called 911. She met him on the side of the road and he was gasping for air. She arrived at the same time as EMS. Upon arrival of EMS patient was in ventricular fibrillation. He was defibrillated 3 times. He also had one episode of ventricular tachycardia. He was given 300 mg of amiodarone and 3 rounds of epinephrine with had return of spontaneous circulation. King airway was placed and patient was brought to the emergency department." "1187052-1" "1187052-1" "Patient is an 82-year-old female who came to the emergency department today complaining of shortness of breath. Patient also reports that she has cough, low oxygen and recently received her second Covid shot and when EMS picked her up she was 83% oxygen saturation on room air. Patient has what sounds like pooling secretions in her throat and patient had suctioning done by respiratory which caused her to bleed blood noted in teeth and around mouth. Patient reports that her throat has been hurting her and that is why she has been unable to eat. Patient's daughter is at bedside and is historian for majority of the assessment. Patient's daughter reports she has not been eating or drinking for the last 2 days. Labs in ER showed WBC 11.61, lactate level 3.3, creatinine 2.0, procalcitonin 5.33, magnesium 1.5, BNP 2100, glucose 474. Chest x-ray showed no acute findings." "1187758-1" "1187758-1" "PATIENT WAS GIVEN JANSSEN COVID 19 VACCINE AT AROUND 12PM WHEN PATIENT WAS ACCOMPANIED BY HIS SON. HE WAS OBSERVED FOR 15 MINUTES AFTER THE VACCINATION AND LEFT PHARMACY WITHOUT ANY PROBLEM. PATIENT'S DAUGHTER CALLED AROUND 6PM AND REPORTED HER FATHER JUST DIED. SHE REPORTED HER FATHER ALL OF SUDDEN WAS SHAKING AND DIED RIGHT AFTER." "1188040-1" "1188040-1" "nontraumatic subcortical hemorrhage of left cerebral hemisphere resulting in death" "1188126-1" "1188126-1" "Patient was on hospice for general debility for about 2 years. Patient was eating 100% and propelling self in wheel chair while living in nursing home. Received Covid vaccine #1 on 2/2/21 and #2 on 3/2/21. No other significant events occurred until starting 4/7/21 when patient started vomiting food. Then on 4/8/21 patient vomited large amount of coffee ground emesis. Then on 4/9/21 patient expired." "1188262-1" "1188262-1" "Patient was stable with ongoing care prior to incident. On 3/2/2021 patient had Covid vaccine number 2. On 3/9/2021, patient started to have dark brown emesis and was transferred to the hospital. On 3/12/2021, patient returned to nursing facility with hematemesis and melena due to GI bleed. Patient was started on comfort care. Had ongoing esophageal cancer with radiation therapy prior to incident. Patient expired on 4/8/2021. Of note, patient was covid positive on 12/14/2020 without any signs of infections. He had covid #1 vaccine on 2/2/2021 and #2 on 3/2/2021. Of note, his wounds worsened after covid vaccines per nursing notes." "1188278-1" "1188278-1" "Patient collapsed & died 48 hrs. after receiving vaccine. He was shopping at local CVS store & collapsed without warning. Two nurses on scene at Clinic performed CPR immediately & applied AED. EMS arrived within 5 min. There was never a heart rhythm & after 35 min. of CPR was DOA at hospital ER. He had gone to the gym earlier at 7am & was having a normal day. He had not mentioned any complaints of not feeling well." "1188311-1" "1188311-1" "Major Complex Seizure with post-ictal period of 2 hours, occurring 3 hours after receiving injection. 16 days later on March 6, 2021 was unable to void, sustained breathing difficulty with peripheral edema. Received diuretic from Nurse,. Indwelling Catheter was inserted. On day 17, after receiving Corvid Vaccine, DECEASED on March 7, 2021 at home. Sustained Complex Seizure 6 hours prior. Death Certificate ruling Cause of Death as Cardiac Arrhythmias." "1188345-1" "1188345-1" "Patient's wife came into our clinic today for her second Moderna dose and reported to us that her husband (the patient) had died on March 28, 2021 of a NON-COVID cause. She did not specify how he died. She gave us his vaccine card in case we needed to do anything with it. This RN is reporting as the client died roughly two weeks after administration of the 1st dose and it was reported directly to the facility, although the death is not COVID related according to the patient's wife." "1188497-1" "1188497-1" "After two days: severe nose bleed. After eight days: vomited blood; followed by endoscopy to fix stomach bleed. After 17 days days, lung hemorrhage." "1188519-1" "1188519-1" "On 3/29/21 at 11:00pm my dad began having chills and uncontrollable shaking. My mother contacted Pfizer who instructed us to alternate Tylenol and Motrin. Tylenol given and Motrin given 4 hours later as instructed by Pfizer. On 3/30/21 around 11:10am my dad was found unresponsive, not breathing and did not have a pulse. My mother immediately called 911 and my aunt began CPR. When EMS arrived he was found to be in cardiac arrest and after 25 min of efforts by EMS my father passed away less than 24 hours after receiving his 2nd covid vaccine." "1189015-1" "1189015-1" "Patient was given the vaccine without incident at or near 0924a. He previously was diagnosed, through PCR test to have COVID-19 back in December 2019. Outside of supportive therapy at home, he was not treated and was not hospitalized and he recovered within a few weeks. At or near 930-10p, on April 9th, approximately 12 hours after the vaccine was given, while out at a restaurant with family, the patient experienced a medical event, (what appears to be an acute coronary event) and died." "1189199-1" "1189199-1" "Stomach cramps, vomiting (coffee ground emesis), diarrhea that started on 04/06/2021 and lasted for 2 days." "1189843-1" "1189843-1" "Fell three times in home on May 15th. Was taken to Emergency Room by Ambulance. In hospital for two days and then released. Ordered Home Physical Therapy and Walker. Cleaned the wounds from the fall. Difficulty breathing and swallowing. Released and told to schedule echocardiogram with Primary Care to follow up on heart's pumping function. Still had difficulty breathing when home and walking. Started diarrhea on Monday 22 had appointment on the 24th with doctor, but died at home before she could make appointment." "1190541-1" "1190541-1" "RECEIVED VACCINE ON 2/5/21 AND WAS FOUND DEAD MORNING OF 2/7/21. SHE HAD NO SIDE EFFECTS OTHER THAN SLIGHTLY SORE ARM UP TO THAT POINT. ED MD FELT SHE HAD SIGNIFICANT CARDIAC HISTORY AND LIKELY HAD MI. MEDICAL EXAMINER DID NOT ORDER AN AUTOPSY AND SHE WAS CREMATED. I FELT THAT I SHOULD JUST REPORT IT SINCE IT WAS SO CLOSE TO RECIVING THE VACCINE." "1191410-1" "1191410-1" "3 days after the covid-19 vaccine, she had a seizure and was taken to the hospital. She was diagnosed with sepsis and died 02/22/2021." "1191920-1" "1191920-1" "Sudden Death; The first and second dose of vaccine was administered on 28Mar2021 12:00 PM.; The first and second dose of vaccine was administered on 28Mar2021 12:00 PM.; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN6199) and second dose (lot: ER8730); both via an unspecified route of administration into the right arm on 28Mar2021 12:00 for COVID-19 immunization. Medical history included coronary artery disease (CAD), hypertension, parkinson's disease, abdominal aortic aneurysm, cerebral aneurysm and arthritis. Concomitant medications included paracetamol (TYLENOL) taken for arthritis and a pill for his hypertension. It was reported that the first and second dose of vaccine was administered on 28Mar2021 12:00 PM. The patient's sudden death on 30Mar2021 15:30 was also reported. An autopsy was not performed. The patient was not diagnosed with COVID-19 prior to vaccination. Further information has been requested.; Reported Cause(s) of Death: Sudden Death" "1191979-1" "1191979-1" "Started with intense headaches right after the 2nd dose of the Moderna vaccine on 03/06/2021. Had the headache for over two weeks, and eventually went to the hospital with loss of speech and movement on her left side of her body. They at first said it was strokes, then after the CT scan results came back they found multiple abscess in her brain. She does not have a history of strokes or brain abscess. Speech and motor functions never returned, and one abscess was so large that it caused a brain shift ( the two hemispheres separated) they performed brain surgery and it was not successful. She passed away on 3/31/2021 at 431 am." "1192036-1" "1192036-1" "Death; This is a spontaneous report from a contactable consumer received from the Pfizer-sponsored program, COVAX US Support. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 04Mar2021 11:30 (At the age of 73 years) (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 via intramuscular on an unspecified date for COVID-19 immunization and experienced pain in her arm, bloating and pain. The patient died on 11Mar2021. AE required visit to emergency room, physician office and intensive care unit. The patient was admitted to the ICU for 1 day. It was reported that the patient received treatment for the event. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Death" "1192099-1" "1192099-1" "Reported cause(s) of patient death: Heart failure; chills; fever; This is a spontaneous report from a contactable consumer (patient's spouse). A 59-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) at the age of 59-years-old, via an unspecified route of administration in left arm on 17Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included congestive heart failure, diabetes, and high blood pressure. He has no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included olmesartan medoxomil, furosemide, repaglinide, metformin, amlodipine, atorvastatin, carvedilol, hydrochlorothiazide, and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was reported as other. The patient experienced chills, fever, and heart failure on 18Mar2021. The events resulted in emergency room/department or urgent care, doctor or other healthcare professional office/clinic visit, and hospitalization for 8 days from Mar2021 to Mar2021. He eventually passed away on 31Mar2021. Treatment received for the events was reported as unknown. The patient underwent lab test and procedure which included nasal swab for COVID which was negative on 20Mar2021. The outcome of the events chills and fever were unknown. The patient died on 31Mar2021. The cause of death was heart failure. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Heart failure" "1192116-1" "1192116-1" "Had his first vaccination of the Pfizer and 8 days later he passed away; This is a spontaneous report from a contactable consumer. A male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. It was reported that the patient had his first vaccination on 20Mar2021 and 8 days later (on 28Mar2021) the patient passed away. It was unknown if an autopsy was performed. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Had his first vaccination of the Pfizer and 8 days later he passed away" "1192426-1" "1192426-1" ""Owner emailed the following message on 03/23/2021, ""Patient was feeling not good after the vaccinations and we call 911. She refused to go to hospital . Today she did do good and we call 911 and they took her because her oxygen dropped down . As of now she passed away"""" "1192660-1" "1192660-1" "My father received the vaccine on Friday 3/5/21. He noted that he wasn?t feeling well following the vaccine. On 3/7/21, he passed away from a heart attack." "1192930-1" "1192930-1" "Patient developed generalized weakness with peripheral neuropathy four days after getting second injection. Patient had a right MCA distribution infarct on 3/24/21. Last injection was on 2/25/21. Patient died on 4/7/21 from consequences of infarct." "1192987-1" "1192987-1" "Death" "1194264-1" "1194264-1" "Patient found deceased. Unwitnessed death." "1194290-1" "1194290-1" "my mother collapsed in the kitchen she was rushed to hospital via ambulance she passed away, doctor said her heart was having a hard time he said there was a blood cot by lung" "1194540-1" "1194540-1" "on 2/8 developed cough on 2/13 to Hospital Emergency Room, diagnosed viral pneumonia on 2/15 back to ER, admitted, diagnosed with pulmonary embolism on 2/20 to ICU, intubated and put on ventilator on 3/3 died from pneumonia due to COVID-19 per death certificate" "1194600-1" "1194600-1" "Death She was found Saturday Apr 10th deceased at her home." "1195054-1" "1195054-1" "Received 1st Pfizer vaccine on 3/06/2021 since receiving shot she slept up to 12 hours a day. passed away 9 days after receiving vaccination. She had no pre existing conditions." "1195645-1" "1195645-1" "COMPLETE WEAKNESS, FULL BODY ACHES, CHILLS. PATIENT UNABLE TO GET OUT OF BED." "1195850-1" "1195850-1" "Death by clot" "1196099-1" "1196099-1" "DEATH OF PATIENT REPORTED ON 04/07/2021 AT 11:25PM" "1196346-1" "1196346-1" "Unknown" "1196401-1" "1196401-1" "My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and diarrhea throughout the weekend. By Sunday (48 hours later), she was having black outs and ended up passing away on Monday, March 22, less than 72 hours later. She was fine without symptoms prior to the shot." "1196478-1" "1196478-1" "MASSIVE HEART INFARCTION" "1196666-1" "1196666-1" "Pt. Expired" "1196846-1" "1196846-1" "Patient within 60 days of receiving a COVID vaccine death" "1196941-1" "1196941-1" "My father awoke the day after vaccine with a fever of 100 and his blood oxygen level at 82, he was shaking, weak. We called 911 and he was taken to hospital, he was given oxygen in er and then transferred to a room. On Friday he suffered a heart attack and was put on life support . On Tuesday, April 6th we discontinuing all life saving measures and my father died." "1196968-1" "1196968-1" "Patient found unresponsive at home 04/04/21 at 11pm per child. Sent to hospital via 911. Deceased 4/6/2021." "1197016-1" "1197016-1" "patient was hospitalized with COVID-19 on April 6, 2021" "1197086-1" "1197086-1" "The individual complained of severe stomach pain - called 9-1-1 was unable to be revived." "1197095-1" "1197095-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1197251-1" "1197251-1" "She had trouble breathing within days of the second vaccine. She went to the hospital 9 days after the vaccine. Her breathing continued to decline where she had to be placed on a ventilator. She stayed on that for almost 3 weeks. The doctors had no hope of her recovery and we chose to end life support exactly one month after her second shot." "1197393-1" "1197393-1" "Died Narrative: Pt has a diagnosis of: Parkinson's Disease, severe AS, heart failure Symptoms include: dyphagia, aphagia, excessive secretions. Agency patient has been referred to: Hospice Code Status:DNR/DNI 90M with PMH notable for Afib, chronic aspiration, and dysarthria, severe aortic stenosis who presents3/5 with 2 weeks of generalized weakness and in ED noted to be in AFib w/ RVR to 130s, CT findings suggestive of volume overload with exam supporting this at time of admission, and also noting nonspecific generalized weakness. DC Home 3/9 Hospice" "1197394-1" "1197394-1" "Death Narrative: Death on 03/22/2021. Patient was a 69 year-old male with history of lung cancer treated with radiation. Recently presented with a right suprahilar lesion Stage III for which he received radiation therapy in 2/2021. He developed a strong cough after radiation treatment and passed from a massive hemoptysis per physician note. He received the 1st dose of vaccine on 03/20/2021 2 days before his death. There is no indication that the event was the result of the vaccine." "1197395-1" "1197395-1" "Death Narrative: Patient received his first dose of the Moderna COVID-19 vaccination on 3/4/2021. He presented to facility 03/05/2021 for shortness of breath. He was originally treated for COPD exacerbation and COVID-19 was ruled out by negative testing. He was then found to have blood cultures positive for E. Faecalis. He was treated with broad spectrum antibiotics. His lack of improvement in respiratory status was the cause of discharge to hospice after which he died on 3/30/2021." "1197396-1" "1197396-1" "Death Narrative: Patient received the first dose of Moderna COVID-19 vaccination on 3/11/2021. He had not received any vaccines within 4 weeks prior and did not have any contraindications to the vaccine listed in his chart. He did not have a positive COVID-19 test within the facility system. Cause of death: Patient was transported to facility on 4/3/21 after complaining of shortness of breath. It was noted that he had some GI bleeding and was hypertensive. The documentation from facility indicates that death was of natural causes." "1197397-1" "1197397-1" "Death Narrative:" "1197398-1" "1197398-1" "Death Narrative: Patient with h/o metastatic lung CA-he was already on hospice at time of 1st and second COVID-19 vaccines." "1197555-1" "1197555-1" "death Narrative: 70 yo male received COVID19 vaccine on 2/16/2021 (first dose) without complications. Patient was admitted to the facility on 3/12/2021 and transferred out to a hospital on 3/15/2021. Patient died on 3/24/2021 due to acute respiratory failure at a medical center. This report is being written because patient received Pfizer covid19 vaccine, Facility requires we report to VAERS if death occurs within 42 days of vaccination. Prior to his hospital admission, his previous one was 5/11/2020-5/14/2020. Please see below for hospital course at the Facility: 70 yo male with PMHx of COPD, CHFrEF 20%, CAD s/p MI and CABG in 1999, HLD, HTN, DM2, GERD, Anxiety and Depression who presented with increased shortness of breath to facility. Transfered on 3/13 to the facility. Noted increased SOB without CP, palpitations, cough, orthopnea or PND. No history of home O2 use but required 2-3L O2 during this hospital stay. Was noted on admit to Facility to have troponin elevation with unchanged EKG. Was started on NSTEMI protocol with heparin ggt, ASA, BB, and statin. Initially received one dose ceftriaxone/azithro for possible PNA. On admission, primary team held home BB. On arrival to Facility, troponin at 3.998 trended to 4.442 and then trended down. underwent CTA to evaluate for PE that was negative. CXR and CT showed pulmonary edema consistent with HF exacerbation and a proBNP 8613. Patient was given 40mg IV lasix x2. RRT was called twice, once for BP 80/50 treated with 500ml IVF, and second for CP that resolved with NTG and tramadol. Cardiology was consulted with goal to cath patient, however some concern for medication adherence going forward so they will reevaluate. Patient began to have tachycardia with rates in the 150s sustained and hypotension. EKG showed likely sinus tachycardia with wide QRS similar to prior EKGs. Patient has ICD in place that was interrogated and showed good function. IV metoprolol 5mg given x3 with rated decrease to upper 120s. Patient remained asymptomatic, awake, and alert. Per discussion with wife after transfer, patient BP has been in the 50s systolic at home for the last month. Cardiac cath was performed showing 99% stenosis of LCX. Did not tolerate procedure with nausea, vomiting, and altered mental status. RRT was called after cath procedure. He is nauseous, diaphoretic. He complained of chest pressure. STAT EKG obtained. Noted ST depressions in the septal leads significant from before. Cardiology concerned pt was having an inferior MI. STEMI call was activated and hospital cath lab was called and report given to the cardiologist on call. Pt was then transported to the Facility and he passed away on 3/24/2021." "1197556-1" "1197556-1" "cardiac arrest Narrative: Patient received dose 2 series of Moderna COVID-19 vaccine. First dose was received on 1/17/21 and second dose received 2/14/21. After both doses patient was observed for 15 minutes and did not have any adverse reaction per administering RN. No data in database or database as to any other adverse events occurring 15 minutes post-vaccination. On 3/20/21, EMS was called to patient's home who was discovered on the floor with an unknown breathing status and pulse. AED was attached to the patient. A very weak pulse was found and patient had agonal respirations. Cardiac monitor was attached to patient with a HR of 32. 1mg of atropine was administered and patient's rhythm changed to PEA with no respirations or pulse. Per patient's wife and son, he was a DNR, therefore all resuscitation attempts were stopped (patient was never admitted to the hospital). Patient was never known to be previously positive to COVID. PMH that may have predisposed patient to this adverse event leading to death include h/o DVT on chronic anticoagulation, COPD, and abdominal aortic aneurysm. There is insufficient information to determine the exact cause of death or what led to the cardiac arrest given that the time from last vaccination to the adverse event was almost a month apart." "1197557-1" "1197557-1" "Death Narrative: already reported VAER for hospitalization on 3/3; the patient subsequently died once transferred to SNF" "1197611-1" "1197611-1" "Massive heart attack; Death; vomiting; Stroke; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Massive heart attack), CEREBROVASCULAR ACCIDENT (Stroke) and DEATH (Death) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011m20a and 013a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included LOSARTAN POTASSIUM (COZAAR) for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DEATH (Death) (seriousness criterion death) and VOMITING (vomiting). In March 2021, the patient experienced MYOCARDIAL INFARCTION (Massive heart attack) (seriousness criteria hospitalization and life threatening) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). On 11-Mar-2021, MYOCARDIAL INFARCTION (Massive heart attack), CEREBROVASCULAR ACCIDENT (Stroke) and VOMITING (vomiting) had resolved. The patient died on 11-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Echocardiogram: unknown (Inconclusive) unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information also included inhalers, non specified and eye drops non specified. No treatment information was reported. Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death" "1197691-1" "1197691-1" ""The weeks following vaccination, the patient felt lethargic, dizzy, unstable on his feet. Mental cognitive ability was unchanged, and he seemed to still be sharp. Up until the day of death, the patient was still active, able to drive, speak, make jokes, eat, and do everything normally. The morning of death, he had a bad fall, but couldn't recall what happened. It's assumed that a low blood pressure event, syncope, partial aneurysm, something of that nature causing temporary loss of consciousness occurred. We attended a funeral that afternoon, ate lunch, and dropped him off at his home. Sometime during that evening, he fell and died. The cause is unknown and still ""undetermined"" on the death certificate. (Heart attack or brain aneurysm is what I'm guessing)"" "1197766-1" "1197766-1" "Patient was vaccinated at Pharmacy with 2nd dose Moderna 03/28/2021, patient called dialysis clinic that she was coughing up blood and she is going to Hospital in the afternoon. Pt's daughter called the clinic informed staff that pt passed away 4/3/2021 due to internal bleeding." "1197795-1" "1197795-1" "Patient expired at some point after infection; not in the immediate time period of injection" "1197923-1" "1197923-1" "He was found down in cardiac arrest- EMS called CPR done and taken to Emergency room, unsuccessful CPR, patient died" "1197984-1" "1197984-1" "This was the 2nd Moderna Shot on 2-18-2021. She received the first shot on 1-22-2021. Patient verbally reported to me that about 4 hours after the shot, she began experiencing severe shocks all over her face and into her left neck and chest area. This quickly worsened to include her left arm. That all resolved after a nap. But when she woke up, and went to the mirror, she noted that her left face was slow and drooping. She went to the ER. It was noted that she was having a severe problem with swallowing. She also was noting severe pain in left external ear canal. She had obvious severe breakout in the left ear canal - and the immediate area. She was sent home - and came to my office the next day. By that time, the symptoms had become much much worse. She was unable to swallow. The outbreak in the left ear was much more pronounced. And her entire left face and left tongue were paralyzed. She was diagnosed with the Ramsay-Hunt Syndrome - she was unable to talk or swallow. She was readmitted back into the hospital." "1198028-1" "1198028-1" "None stated." "1198032-1" "1198032-1" "Patient has had L leg blood clot and multiple mental co-morbity-Anemia, hypertension, heart disease, hypokalemia, liver enzyme off per MD, poor nutrition, tremors, hypothyrodism, COPD, small vessel disease of the brain" "1198102-1" "1198102-1" "Nausea ,shortness of breath during the day . Heart stopped 7:45 pm. Death declared at 12:45 am March 09 2021." "1198157-1" "1198157-1" "Hospice patient death within 60 days of receiving the COVID vaccine series" "1198162-1" "1198162-1" "My sister received the Janssen vaccine on March 13, 2021. One week later, March 20, 2021, she started complaining of severe headaches, dizziness and vomiting. This continued so she visited the ER on Wednesday, March 24, 2021, where she suffered a cerebral venous sinus thrombosis. She was pronounced brain dead on March 27, 2021, which is also the same day she was pronounced dead." "1198196-1" "1198196-1" "On 3/10/2021 around 2 pm reported more fatigue, low-grade fever, and weak; treated w/ Tylenol; 3/13/2021 refused medications; 3/16/2021 became constipated; 3/20/2021 gait unsteady and reported feeling as though she'd fall; more fatigued; 3/20/2021 refused medications and slept excessively; 3/20/21 vomited in bed; 3/22/2021 restless and exit seeking; 3/25/2021 packed belongings and exhibited exit seeking; 3/26/2021 transported to hospital 5:15 am due to falling while attempting to pick up something off of the floor; 3/29/2021 hospital reported she had a brain bleed and had chosen hospice care at her daughter's home; resident passed away on 3/30/2021." "1198199-1" "1198199-1" "62-year-old male with number of medical problems that include history of hepatitis-C, history of cirrhosis, history of alcohol abuse, cocaine abuse, history of diabetes hypertension who has initially presented to EMS with increasing shortness of breath. Patient suffered cardiac arrest during his transportation to the emergency room. A CPR was initiated and was given 3 rounds of epinephrine. Most of the history is taken from the ER physician chart review. ACUTE RESPIRATORY FAILURE SECONDARY TO HYPOXEMIA, COVID-19 , cardiac arrest, possible anoxic brain damage : Patient is 62-year-old male with complicated history with history of hepatitis-C, cirrhosis, alcohol use, cocaine abuse diabetes who presented after having cardiac arrest and possible anoxic brain damage. Patient was intubated after the arrest. Patient stayed in the hospital for number of days. Patient was found to have COVID-19 positive. Patient was found to have diffuse bilateral infiltrate. Patient was started on broad-spectrum antibiotics including cefepime Flagyl and Decadron. Due to patient's cardiac arrest patient was started on hypothermia protocol. Patient was rewarming after that. There was no purposeful movement or neurological recovery. After long discussion with the family, patient has been made comfort care. Patient was extubated. Patient expired promptly after that. Family is notified." "1198211-1" "1198211-1" "The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre-existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination." "1198227-1" "1198227-1" "SON REPORTED THAT PATIENT WOKE UP 4/7/21 WITH FLU LIKE SYMPTOMS AND STAYED IN BED ALL DAY. PT DID NOT DRINK ANYTHING OR TAKE INSULIN ON 4/7/21. WHEN DAUGHTER ARRIVED AT PTS HOME THAT EVENING, PT WAS INCOHERENT. SHE CALLED 911 AND PT WAS TRANSPORTED TO THE HOSPITAL WHERE HE PASSED AWAY ON 4/9/21." "1198387-1" "1198387-1" "Found dead in her home on Saturday morning" "1198400-1" "1198400-1" "Sudden Death" "1198405-1" "1198405-1" "Pt with Advanced PD underwent surgery on 3/1/21 and 3/8/21 to explant a malplaced DBS device and re-implant with a new DBS device. She struggled to recover following the surgeries and did not respond to her medications or the new device. She received her COVID vaccine on 3/15/21. No significant change following the vaccine but no improvement as expected as device settings and medications were titrated. We received a call from her husband that she died during the night of 4/1/21. She had seen her PCP on 3/31/21 without any concerns on vitals etc." "1198540-1" "1198540-1" "Unknown if the vaccine has any correlation to event. Patient was found unresponsive and not breathing on 4/11/21 @ approximately 3:45 PM outside on the grounds of the campus. A rented scoter was next to him. There was no sign of trauma. 9-1-1 was called and CPR initiated by passerby (there were no witnesses). He remained unresponsive and was intubated when the paramedics arrived. He was transported to hospital where he was pronounced dead." "1198617-1" "1198617-1" "Adverse Event: Death Treatment: Rest & Cold Pack On Arm At Injection Site (Not Effective) Symptoms: Arm Pain At Injection Site, Diarrhea, Fatigue, Dizziness, Low Appetite, Light Headedness, Fever & Chills" "1198737-1" "1198737-1" "Patient passed away on 4/1/21. 4 days after getting his second moderna vaccine. He was is good health" "1198782-1" "1198782-1" "As described to me by her son: 04-01-2021 received vaccine , no issues, waited the 15 min and said she felt fine. Left with no issues. had been to see her MD that morning for routine visit and everything was fine. 04-02-2021: No issues - felt fine. Went shopping and out to eat. Was a bit tired that evening. Son left her home at 6pm and all was good. 04-03-2021: son text her in the morning and no answer. Thought she might be in the shower and text again and no answer. He called her and no answer, so he went over and found her non-responsive laying on her back on her bed with the same clothes she left her with the prior evening. sheriff's office pronounced her dead on 04-03-2021 with what appeared to have been a heart attack." "1198798-1" "1198798-1" "Began feeling unwell, had urinary urgency, and was itching shortly after 2nd dose of Pfizer COVID-19, then found obtunded due to pulmonary embolus resulting in death within 24 hours of receiving 2nd dose" "1198939-1" "1198939-1" "Per Medical Examiner, fourteen hours after receiving vaccine presenting symptoms were fatigue and muscle aches, went to Hospital Emergency Room and was released. Six hours later family stated symptoms had worsened, fever, shortness of breath and fatigue, admitted to Medical Center, diagnosed with sepsis and died within 48 hours of vaccination, deceased 4/7/2021, cause of death neutropenic sepsis with multi-lobar pneumonia, autopsy scheduled 4/13/2021." "1198967-1" "1198967-1" "Cardiac arrest, death" "1199143-1" "1199143-1" "Headache and vomiting starting one week later (4/3/2021); seizure due to hemorrhagic stroke 04/ 5/2021; continued bleeds 04/06/2021, 04/07/2021; life support removed 04/08/2021." "1199323-1" "1199323-1" "Patient's Wife reported that patient did not experience any side effects from the vaccine. She reported they did their daily chores after receiving the vaccine and patient did not complain about having any health issues on that day even before going to bed. She reported that patient did not wake up from his sleep the next morning." "1199349-1" "1199349-1" "102 fever, chills, loss of appetite,extreme body weakness, loss of taste, vomiting" "1199382-1" "1199382-1" "1/30/2021- he was found to be confused by family and taken to the ER where he was found to have bilateral pneumonia, symptoms of decompensated heart failure. he did not improve with interventions and ultimately was placed on comfort care and passed away in the hospital 2/2/2021" "1199402-1" "1199402-1" "She was found deceased after likely sudden cardiac death" "1199415-1" "1199415-1" "she was found unresponsive by family and taken to the ER on 4/1 where she was found to have a massive subdural hematoma. she was placed on comfort measures and passed away at the hospital. she had had a fall out of bed in the week before her ER admission." "1199422-1" "1199422-1" "Patient passed away from blood clot, did not feel well after 2nd shot" "1199446-1" "1199446-1" "admitted to the hospital with recurrent hypoxemic and hypercarbic respiratory failure. discharged home. passed away at home after discharge." "1199455-1" "1199455-1" "Patient reported difficulty breathing and chest pain; suffered cardiac arrest and death" "1199543-1" "1199543-1" "Facility manager informed us that patient had a seizure on 3/17/21, which was 2 days after the vaccine was given (3/15/21) which then lead to a stroke. Patient passed died on 3/17/21." "1199575-1" "1199575-1" "Death" "1199594-1" "1199594-1" "There were no noted adverse signs or symptoms at the time of vaccination. Fiance of patient called Public Health on 4/12/21 to report the patient died in her sleep overnight on 4/7 or 4/8. Autopsy not performed, body embalmed prior to Public Health's knowledge of client death. Pfizer BioNTech COVID-19 Vaccine EUA" "1199642-1" "1199642-1" "Patient was not present for 2nd dose clinic today. Manager of facility reported that patient died in his sleep on 4/6/21" "1200514-1" "1200514-1" "Death on 4-5-21 the day after the shot. Bloody nose during that day" "1200519-1" "1200519-1" "Death" "1200541-1" "1200541-1" "Death" "1200569-1" "1200569-1" "Death Abdominal pain Abnormal CT scan Partial gastric outlet obstruction Disorder of common bile duct Hyperbilirubinemia Colon cancer (CMS/HCC) Obstructive jaundice" "1200573-1" "1200573-1" "She had a slight fever after administering vaccine. On Mar15 till 10:30PM she is doing good, working on household chores. All of a sudden she complained about a pain behind ear that creeped to her Head (Unbearable pain). With in a minute she became unconscious and we called 911, they took her to Medical Center and moved her to another Medical Center Neurosurgeon is available. As per doctors, cause of death as per Death Certificate are as follows: Cerebral Herniation Malignant Cerebral Edema Anoxic Brain Injury Aneurysmal Subarachnoid Hemorrhage" "1200591-1" "1200591-1" "Death SHORTNESS OF BREATH Hyponatremia Atrial fibrillation (CMS/HCC) Generalized weakness SIADH (syndrome of inappropriate ADH production) (CMS/HCC) Pleural effusion on right Syndrome of inappropriate secretion of antidiuretic hormone Sick sinus syndrome" "1200619-1" "1200619-1" "Death Sepsis abdominal pain" "1200658-1" "1200658-1" "Bell's palsy Altered Mental status Death" "1200724-1" "1200724-1" "Death" "1200805-1" "1200805-1" "FEVER VOMITING ISOLATION-INFECTIOUS DISEASE Death" "1200807-1" "1200807-1" "Died within five days of receiving" "1200851-1" "1200851-1" "Acute hypoxemic respiratory failure (CMS/HCC) Chest pain sepsis Death" "1200921-1" "1200921-1" "Chills, tiredness. DEATH." "1200923-1" "1200923-1" "Patient died of a heart attack" "1200939-1" "1200939-1" "Massive PE, patient died. No history of DVT, we did a COVID test here and it was negative. She had no PMH, we suspect the vaccine made her hypercoagulable. Had pleuritic CP, tachycardia, tachypnea." "1200959-1" "1200959-1" "death" "1201114-1" "1201114-1" "Due date 4/18/2021. Pt presented in labor on 4/10/21. Her labor was uncomplicated and progressing appropriately. She had sudden onset of coughing following by loss of consciousness. Code blue was called. Emergency bedside C/S was performed. Despite resuscitative efforts of 1 hour and 15 minutes, the patient expired." "1201130-1" "1201130-1" "Death on 03/25/2021 ruled as cardiac arrest." "1201182-1" "1201182-1" "Sudden death - found by paramedics" "1201226-1" "1201226-1" "She was taken to the hospital for respiratory distress, she was turning purple. She dies arriving at the hospital." "1201247-1" "1201247-1" "Paralysis (CMS/HCC) death" "1201277-1" "1201277-1" "Death" "1201283-1" "1201283-1" "Had a fatal heart attack" "1201361-1" "1201361-1" "Patient passed away between 3/30/21 and 4/1/21 at home." "1201475-1" "1201475-1" "WE RECEIVED A TELEPHONE CALL AT 4:45 PM ON 1/27/21 THAT WAS NON RESPONSIVE AND A FOLLOWING CALL AT 5:00 PM THAT SHE HAD PASSED." "1201528-1" "1201528-1" "My Father had been in his usual state of health when he received his first Pfizer Covid-19 shot on 1/12/2021 and his second dose on 2/2/2021. He complained of being tired and chills on 1/13/2021 and again on 1/20/2021. He was diagnosed with a UTI and placed on antibiotics on 1/27/2021. After the second covid-19 shot on 2/2/2021 my father had a change in his condition on 2/4/2021. He became very lethargic, more confused and unable to speak and was send to the Hospital. He spent from 2/4/2021 to 2/12/2021 in the hospital being treated for a UTI and also was said to have had a Transient Ischemic Attack. He went to a rehab facility for Physical Therapy from 2/12/2021 to 2/19/2021 after which he returned to the Assisted Living Facility. He had another episode of lethargy/unresponsiveness on 2/26/2021 and was once again sent to the hospital where they did not show any new findings. He spent a few days in the hospital before returning to his facility where he continued to have periodic episodes of increased lethargy/confusion and decreased eating. He was placed on Hospice and passed away on March 29th." "1201543-1" "1201543-1" "Death" "1201682-1" "1201682-1" "PATIENT HAD DIZZINESS, WENT TO DR, THEN NEXT DAY ER AND ENDED UP DYING 4-2-2021" "1201691-1" "1201691-1" "developed fluid in lungs difficultly breathing." "1201835-1" "1201835-1" "Low grade fever, aches & chills on 3/13/21 & 3/14/21. Felt better 3/15/21 through 3/18/21. Side effects ( fever, aches, chills ) returned on 3/19/21 & 3/20/21. Suffered stroke on 3/21/21 at 3:30 AM due to blood clots. Passed away on 3/22/21." "1201889-1" "1201889-1" ""I am an investigator with the coroner's office. We have a death that occurred on 4/12/2021 that we ruled a natural death due to atherosclerotic cardiovascular disease. The family is concerned that the decedent was doing ""fine"" until she took the J&J COVID-19 vaccine on April 9, 2021. We DO NOT KNOW if the J&J vaccine caused this death, but are reporting it due to the close proximity of the vaccination to the death itself."" "1201981-1" "1201981-1" "7 days after the COVID vaccine, patient went into resp. arrest and died in the ER" "1201993-1" "1201993-1" "DEATH Narrative: Patient passed away after Covid Vaccine. 2/8/21: brought to the ER for evaluation for leg weakness and a recent fall associated. He was in a facility- per patient he fell when standing from the bed, he though he could do it and did not ask for help. He has been with hip and pelvic pain since then. The CT/XR shows evidence of lytic lesions, an IR bone biopsy was done and came positive for metastatic bladder carcinoma. 02/17/21: transferred to the facility for PT and pain management, originally for short stay rehab then changed to hospice care. 02/19/2021: received covid vaccine 03/05/21: discharged from facility on home hospice 03/23/21: pt passed away at home Patient with prior covid infection; tested positive last on 9/25/2020. Vaccine did not likely contribute to patient's death, as he was on hospice due to malignant cancer. No evidence of reaction immediately after vaccination or before date of death." "1202019-1" "1202019-1" ""This patient was under hospice care at home with Nursing Service and Hospice. He received the J&J vaccination at noon by local public health nurse on Mon 4/12/21. The patient's wife, reported to hospice team that he had been sleepy during the day and had received a dose of Ativan earlier that morning (PRN medication at 0750). The primary hospice nurse reported wife noted he became more lethargic throughout the day after vaccination with his condition worsening at 1720; at that time his blood sugar levels were noted to be low at ""47"" but patient was alert enough to drink orange juice, eat ice cream. The patient continued to deteriorate so MD was consulted and he was transported to the ED where he later expired at 1930."" "1202257-1" "1202257-1" "Brother called pharmacy on 04.13.2021 at approximately 10am and informed pharmacist that his sister had passed away due to a pulmonary embolism about 2 weeks after receiving her first dose of the Moderna COVID vaccination at our pharmacy. He mentioned that healthcare provider was looking at possible gene mutation in family that may have contributed." "1202320-1" "1202320-1" "Acute stroke" "1202366-1" "1202366-1" "pt recieved vaccine at 1135 on 4/9, pt reported tongue swelling around 1130 the next day (4/10, 24 hrs after), presented to ED via EMS 1518, was diagnosed with angioedema likley due to ramipril, was intubated by 1624. pt had difficult intubation, was transferred to ICU, in critical condition on a ventilator, days later, after multiple cardiac arrests and multiple rounds of ACLS were performed, the pt was pronounced dead at 0127 on 4/12" "1202386-1" "1202386-1" "Multiple comorbidities - Cardiogenic/septic shock, Acute Respiratory failure, AKD stage 3" "1202456-1" "1202456-1" "Death. My mother passed away 3/18/2021 from pulmonary arrest." "1202463-1" "1202463-1" "Patient was hospitalized x 2 within 60 days of receiving a COVID vaccine series" "1202478-1" "1202478-1" "This is a 61 year old female, with history of hypertension, who presents to the ED via EMS for evaluation of cardiac arrest prior to arrival. Patient's husband came from anouther [sic] room and found patient take a big gasp then suddenly became unresponsive. EMS gave patient a total of 4 rounds of Epi, 1 Narcan, and 2 shocks en route. EMS reports with glucose level of 92. Unknown if patient is on any anticoagulation. Patient presents in asystole. Epi and bicarb given. Compressions performed. Lungs equal with bagging. Bedside US performed which did not reveal any meaningful cardiac activity. Code called. Discussed with family, they state she had been having some cardiac issues and her daughter died of cardiac problems in her 30s." "1202482-1" "1202482-1" "blood clots" "1202561-1" "1202561-1" "CVA with residual hemiparesis - C-Diff, diarrhea, weakness. AKI" "1202616-1" "1202616-1" "Patient death within 60 days of receiving the COVID vaccine series" "1202649-1" "1202649-1" "Blood clots then death" "1202683-1" "1202683-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine" "1202719-1" "1202719-1" "Death of patient within 24hrs of vaccine" "1202725-1" "1202725-1" "Advanced age, Hospice" "1202967-1" "1202967-1" "Death Narrative: Patient had Pfizer COVID vaccine dose #1 on 3/20/21. He called his provider on 3/30 to report known exposure to COVID that occurred on 3/27 and 3/28. On 4/1 he tested positive for COVID swabbed at the facility and sent to the main facility for processing. He was notified of positive result on 4/1 at 4pm. He was advised to quarantine and to call facility call center/triage should he develop any fever, shortness of breath, and other Covid-related symptoms. Provider received a phone call from PD on 4/8 notifying of patient unattended death. According to EMS report neighbors were aware of patients COVID positive status. No one had seen or heard from the patient in 3 days so they contacted PD for wellness check. Entry was forced into apartment and patient was found deceased, sitting on the couch. Not breathing ashen color. Pt has ringer and no Pulse. PMH: Quit tobacco 5-15 yrs ago Hyperlipidemia Hyperglycemia Obesity Allergic rhinitis, stable Hx AAA and Right ICA aneurysm, S/P Open repair in 2013 Patient had no prior history of COVID before 4/1 diagnosis. He was not having any symptoms between 4/1 when he tested positive and he did not call to report any symptoms between 4/1 diagnosis and death. There was no communication after 4/1 positive covid test. Patient was scheduled for a phone call with RN on 4/8 the date he was found deceased. Cause of death is not mentioned, but suspected to be due to COVID infection. There were no reported side effects to COVID Vaccine administration." "1202968-1" "1202968-1" "death Narrative: I was told that the patient expired 3 days after his 2nd dose of Moderna vaccine." "1202969-1" "1202969-1" "death Narrative: Patient with consistent decline over the last year; March 2021- increased confusion related to dementia, falls, hospitalizations wt loss. Enrolled in home hospice on 3/26 family's goal was to keep patient home and comfortable. Patient received J&J vaccine in the home through agency on 4/6/2021, Patient had a fall on 4/7/2021, Patient with rib pain after the fall no other injury noted. Patient passed away on home hospice on 4/11/2021." "1203159-1" "1203159-1" "Metastatic Lung cancer" "1203198-1" "1203198-1" "Second vaccine received on 4/6/21. Pulmonary Embolism on 4/11/21. Death on 4/13/21." "1203240-1" "1203240-1" "My husband had fever of 102.6 the morning after he received the vaccine. He continued to run high fever. He had gi symptoms with diarrhea. He was up all Saturday night with generalized body aching and diarrhea. On Sunday night he coded in the bathroom at home. CPR was started when EMS arrived he was in full cardiac arrest. He was coded for 1 hour without any return of heart function. I found my husband on the bathroom floor on that Sunday night about 1140pm performed CPR and activated 911." "1203337-1" "1203337-1" "Brought to the ER as a code blue, 50 minutes down. CBC, CMP, and HIV screen completed. Deceased despite attempts of revival. Wife reports patient reported not feeling well, c/o feeling short of breath, started having foaming at the mouth, loss consciousness. He had pink sputum on arrival." "1203406-1" "1203406-1" ""Patient's spouse called on 4-13-21 to cancel second dose appointment due to her husbands death on 4-9-21. Spouse states unsure of cause awaiting autopsy results. He received the vaccine on Wednesday 4-7-21 and his wife said he was fine that night and worked in the yard the following day in the morning and early afternoon. Thursday night/Friday morning she noticed he was thrashing in his sleep and making ""weird sounds""."" "1203475-1" "1203475-1" "Advanced Age, Likely Sudden Acute MI" "1203510-1" "1203510-1" "Unknown on any adverse events or symptoms" "1203534-1" "1203534-1" "NA Hospice Care" "1203542-1" "1203542-1" "Unknown if pt had s/s at time of vaccination on 1/29/2021 and 2/19/2021. From 3/1/2021-3/6/2021, pt hospitalized w/ covid, resp insufficiency, acute on chronic diastolic HF, dyspnea, ele. D-dimer, acute pulm edema and acute on chronic renal insufficiency. Dcd to home. Six hrs later, readmitted w/ worsening multifocal airspace opacities, enlarged cardiac silhouette, sob, cough. No PE on CXR. Recd O2, cefepime, remdesivir, vanco, Lasix, heparin, rivaroxaban, dexamethasone, tocilizumab. On 3/8/2021, pt had onset R weakness, CT w/ distal R MZ occlusion, Intubated for decline. Not TPA candidate. Per neuro, CVA r/t either a fib hx or hypercoagulability r/t covid. Pt died." "1203575-1" "1203575-1" "Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family." "1203603-1" "1203603-1" "Diarrhea, fever, stomach pain for 7 days. She died on the seventh day." "1203631-1" "1203631-1" "Flu like symptoms from the time received, patient passed away 03/11/2021" "1203679-1" "1203679-1" "Pericardial effusion" "1203711-1" "1203711-1" "patient did not show up for dose 2 - we called her and family informed us she had entered hospice and passed away since we last saw her for the covid vaccine" "1203732-1" "1203732-1" "Patient had history of COPD, MS. Treated for pneumonia in February. Recently discharged from the hospital 2/24/2021 for pneumonia. Seen in the office on 3/1/2021 as a follow up. Given Covid vaccine on 3/15/2021. Patient was reportedly feeling well the day of vaccine. Patient collapsed on 3/19/2021 and died." "1203799-1" "1203799-1" "Patient developed chills and fatigue Saturday and Sunday (April 3rd and April 4th) . Patient developed diarrhea and lack of appetite Monday, April 5th. Patient was reported to be bedridden Wednesday, April 7th. Patients husband stated hat patients eyes were halfway closed, experiencing shallow breathing, and had a soft pulse. Husband call 911 while instructed to do chest compressions until EMTs arrived on site. First responder were reported to perform resuscitation efforts on the patient for 35 minutes until transporting the patient to the hospital." "1203902-1" "1203902-1" "Blood Clot which led to Pulmonary Embolism, Pneumonia, and death." "1203939-1" "1203939-1" "NA Septic shock Aspiration pneumonia Acute encephalopathy Pancytopenia Seizure" "1203976-1" "1203976-1" "Patient death within 60 days of receiving the COVID vaccine series" "1204016-1" "1204016-1" "HE DIED SUDDENLY !!!!! JUST COLLAPSED !!!!" "1204069-1" "1204069-1" "Death Acute kidney injury COVID-19 virus infection COVID-19" "1204133-1" "1204133-1" "came in with chest pain ,coded and died. Family believes it was because of COVID vaccine" "1204162-1" "1204162-1" "Pt developed respiratory illness requiring hospitalization on 3-8-21. She expired on 3-31-21 while still hospitalized." "1204227-1" "1204227-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1204266-1" "1204266-1" "Patient expired day after receiving second dose of Pfizer COVID-19 vaccine" "1204272-1" "1204272-1" "Per EMS patient's husband reports she was using the push mower in the front yard and suddenly collapsed. EMS brought the patient in with active CPR in progress and the patient was pronounced deceased in the Emergency Department." "1204313-1" "1204313-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1204429-1" "1204429-1" "From golfing on 02/23/2021 to dimentia suddenly going into overdrive and death on 03/31/2021 All tests and care was taken to understand rapid/ unexplained decline." "1204479-1" "1204479-1" "Initially 2 to 5 days just fatigue. Evening of March 26th unusual fatigue and lower back to middle back discomfort low pain level." "1204502-1" "1204502-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1204616-1" "1204616-1" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204680-1" "1204680-1" "Suddent Death approximately 75 hours after second dose of Moderna Vaccine" "1204726-1" "1204726-1" "Patient vaccinated on 3/7/21, on 4/2 presented pain in left leg and some redness, on 4/3 some dizziness, lightheadedness, difficulty with vision in right eye, some slurred speech; on 4/5 his health agravated and EMS was called and taken to hospital; spouse informed that patient had a blood clot in stem of brain; on 4/6 patient died. No autopsy performed" "1204876-1" "1204876-1" "Death" "1205036-1" "1205036-1" "On March 30th started with headaches then progressed to shortness of breath while moving. Then on April 4th transport to hospital via EMT was tested for Covid 19 results was negative. It was determined that blood clots where found in Right leg & Left leg and both lungs and now blood clot was found in heart. PT has low platelets, low blood pressure. While in the hospital pt was given herapin . Patient has remained in ICU since the 4th to present time." "1205071-1" "1205071-1" "On February 18, 2021 between hours 18:20-18:40 and a week after taking the second shot, patient lost balance (fainting) at home, fell, bruised a rib and fractured skull, causing subdural hematoma (bleeding outside of the brain). Bleeding stopped and several CT scans were performed. Under medical supervision, an anticoagulant medication was stopped to allow for healing. On February 20, 2021, moved from ICU to regular hospital room and on February 23 moved to another hospital for intense rehabilitation. Within days a thrombus developed causing a minor Cerebrovascular Accident, which was immediately identified by a medical doctor and nursing staff. On March 2, 2021 at 10:30 am moved to a Medical Center for further treatment. An endovascular thrombectomy for the removal of a thrombus was performed by a doctor. After recovery in the Neurosciences Critical Care ICU, under amazing care by the doctors, further thrombi developed on patient's lungs and around the bowel. Patient expired at 8:01 on March 4, 2021 due to Ischemic Complications of Thrombi/Thromboemoli." "1205121-1" "1205121-1" "twelve hours after getting the shot my wife woke up with an upset stomach; her blood sugar was also slightly elevated; within ~the next two hours she became disoriented and confused; I called 911 and within a couple of minutes of the first 911 call she stopped breathing and could not be revived." "1205124-1" "1205124-1" "Witnessed cardiac arrest with death as the outcome" "1205249-1" "1205249-1" "Died from cardiac arrest; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 24Mar2021 as single dose for COVID-19 immunization. Medical history included heart disease, kidney issues, and physical disability from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included atorvastatin; spironolactone; lisinopril; and ubidecarenone, vitamin e NOS (COQ10 COMPLEX) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 on 03Mar2021 11:00 AM, on Left arm, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was reported to have died from cardiac arrest on 26Mar2021. The reporter did not know if it was related to vaccine. The patient died on 26Mar2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: It appears he died from cardiac arrest." "1205282-1" "1205282-1" "Patient had a stroke 11 days later(on 4/6/21) and expired" "1205305-1" "1205305-1" "3-11 didn't feel well, passed away later that day" "1205392-1" "1205392-1" "blood clots in left leg and both lungs diagnosed on 2/22, died 2/24" "1205421-1" "1205421-1" "On April 8, 2021 patient received his second dose of Moderna COVID-19 vaccine at pharmacy at 1:08pm. Patient waited the appropriate 15 minutes, and then left pharmacy. He reported no adverse reactions to our staff during that time, and did not call afterward to report any adverse reactions. At approximately 4:30pm on April 10, 2021, I received notification that patient was found DOA at his residence. No other information is available at this time." "1205423-1" "1205423-1" "Patient's physician reported this adverse event by phone to Medical Center administration on 4/13/2021. Per the physician, the patient received his 2nd Pfizer COVID19 vaccination dose on Friday 4/9/2021 at the drive through vaccination clinic. On Saturday 4/10/2021 the patient told to his wife that he felt ill, continuing through Sunday. On Sunday, 4/11/2021, at his home, the patient told his wife that he felt ill and went to sleep. The patients wife found him not breathing, called 911 and started CPR. The patient was pronounced deceased at his home and was not transported to hospital." "1205518-1" "1205518-1" "Resident was inoculated on 04/09. According to family members, he began to feel unwell that evening, cold sweats, high fever, dehydration. According to family members, he refused to get medical attention. After not hearing from him for a few days, family members called for a wellfare check on 04/12 at which time he was found deceased." "1205632-1" "1205632-1" "My MOTHER had a health condition, diabetes and heart problems, she was at home with palliative care, due to her condition, she was fine in the last month she was able to walk, shower, eat alone, she felt happy to be able to recover, she got the vaccine because the doctor advised her, the same day she got fever, and began to feel fatigued, 3 days later my mother died, she had heart attack from shortness of breath." "1205684-1" "1205684-1" "Blood Clot blocked oxygen to the brain. Suffered a severe stroke Was hospitalized Suffered brain swelling Lost brain function Died." "1205714-1" "1205714-1" "She was found unresponsive by her husband on 4/11/2021 and pronounced dead at the scene. She had been to the emergency room for recurrent syncope several weeks prior to any vaccinations. No cause was determined." "1205863-1" "1205863-1" "Died from Pulmonary Embolism. No leg pain, no leg swelling to indicate DVT in leg. Also was thrombocytopenic at the time of emergency/ER visit/treatment. He suddenly complained of very bad chest pain, could hardly speak to tell symptoms. Immediate resuscitation was started by family member and 911 was called. Ambulance detected tech, tried to electroconvert, but was not successful. Chest compression and bagging was done until patient got the hospital. There full resuscitation effort. Unsuccessful. Troponin normal, D-dimer sky high." "1205982-1" "1205982-1" "On 1-27-21 my mother received her first dose of the Moderna COVID-19 vaccine (031L2A). The next day she felt something in the back of her left knee. The following day (2 days) after the injection she saw her primary care physician for the discomfort in the back of her knee. She was treated for what was believed to be a soft tissue injury. She received her second dose of the Moderna COVID-19 (14M20A) vaccine on Friday 2-26-21. The next day the back of her knee started to bother her again. She saw her doctor on Monday3-1-21 and had an x-ray. On Tuesday the doctor's office called and said her x-ray was clear. Friday morning, 3-5-21 my father heard a loud noise (thud) and found my mother unresponsive on the bathroom floor at approximately 8:30am. He called 911. She was transported to the hospital via ambulance. The emergency room physicians worked on her for over an hour and were unable to get her back. Her time of death was 10:12am. The primary cause of death listed on her death certificate is pulmonary embolism." "1206085-1" "1206085-1" "She got sick, pain in the arm and neck the day after the vaccine. I called her doctors office on the 19th of Feb and I did not get a call back. She was sick to her stomach, really tired and lost her appetite. On the 22nd I called her doctor again... no response, on the 23 I called again. On the 24th finally someone spoke to me.. they stated they had called my mom and spoke with her. They are suppose to call me, my mom could not remember by the time she would hang up. They said to let her rest and give her electrolytes and Vit. B6. On the 26th when I called the doctor and said she is lethargic they said to take her to the ER. She flat lined at the hospital and her body went into shock. She ended up having Kidney, Heart and Liver Failure. She was still driving and doing all of her cooking, banking, shopping, showering, walking every day on Feb 18th. She died on March 5th." "1206219-1" "1206219-1" "Patient was at this hospital for brain scans to determine why a sudden exacerbation of Alzheimer's symptoms were occurring." "1206330-1" "1206330-1" "Death" "1206428-1" "1206428-1" "Presented with 2-3 weeks of fatigue and acute on chronic leg swelling (h/o chronic venous disease, phlebitis) 13 April; treated for dehydration and prescribed ASA. Tachycardia on exam, resolved with resuscitation. Asymptomatic 4 hours later, and expired overnight in his sleep. Found unresponsive in the morning, time of death 09:57." "1207001-1" "1207001-1" "Intracerebral hemorrhage" "1207096-1" "1207096-1" "Death Acute blood loss anemia Pleural effusion GI bleed NSTEMI (non-ST elevated myocardial infarction)" "1207097-1" "1207097-1" "According to hospital records, patient presented to the ER in full cardiac arrest with ongoing CPR in progress." "1207106-1" "1207106-1" "CARDIAC ARREST DEATH" "1207139-1" "1207139-1" "Death Cardiac arrest Hyperkalemia NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) ESRD needing dialysis (CMS/HCC)" "1207198-1" "1207198-1" "Death Anemia GI bleed Lactate blood increased CKD (chronic kidney disease) Jefferson fracture" "1207214-1" "1207214-1" "Death day after vaccine" "1207228-1" "1207228-1" "death" "1207237-1" "1207237-1" "Death Hypokalemia LBBB (left bundle branch block) Pneumonia Anemia Hypoxia Fever Multifocal pneumonia Pneumonia due to COVID-19 virus2.82 Sepsis" "1207254-1" "1207254-1" "Deceased complained of abdominal pain and was taking aspirin for a headache. He died within less than a day of initial complaints." "1207286-1" "1207286-1" "Death" "1207340-1" "1207340-1" "Covid like symptoms within days of vaccine. Outcome: death." "1207377-1" "1207377-1" "Patient had vaccine on 03/15/2021. Started complaining of extreme pain in RLE by that evening. Patient contacted health agency and portable x-rays came out to view RLE. No fractures were seen. Pain continued and was unmanageable by 03/20/2021 and patient was transported to the ER. Patient was found to have blood clot in RLE and admitted to ICU. Patient further declined while admitted having multiple system failure and passed away on 03/25/2021." "1207395-1" "1207395-1" "On 1/24/2021 the patient was discharged from the hospital due to swelling in the body, when they proceeded to infuse medications. She herself had passed away." "1207401-1" "1207401-1" "SUDDEN DEATH - PULMONARY EMBOLUS DUE TO DEEP VEIN THROMBOSIS RIGHT POPLITEAL VEIN" "1207428-1" "1207428-1" "Patient declared deceased the day after receiving second Moderna COVID vaccine. not her regular pharmacy to our knowledge. Have attempted to contact last known PCP with no response. Son notified pharmacy of patient passing away." "1207600-1" "1207600-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1207687-1" "1207687-1" "My husband became very sick the day after recieving the shot. He was freezing cold. No matter what he did he could not get warm. He experienced flu like symptons for about 24 hours. This was on Saturday. On Tuesday he died. They said it was a heart attack. He was in excellent health. We had gone to the gym 3 days a week for years. He was doing Cardio on the bike and treadmill for over an hour each time. He never experienced shortness of breath and before the shot was 100 % healthy" "1207773-1" "1207773-1" "2nd maderna vaccine was given to my dad on 02/26/2021 and on 03/15/2021 my dad was visiting me all day and he acted fine and normal. At the end of our visit between 8 & 9 pm we went to the store where he started to gasp for breath. He had to keep stopping and said he couldn't breath. I had him sit several times because I didn't know how bad it was. By the time we reached the doors to leave after a short trip he almost fell over and he became confused and said he couldn't breath. I had another customer get my dad a wheel chair close by while I called 911. The ambulance came quickly but at the hospital my dad went into cardiac arrest and his heart stopped 2 or 3 times and it had to be restarted. When I was able to get to the hospital my dad was on a ventilator and sedated. They had put him on medicine to blast the blood clots they had found. They said he had 2 very large blood clots with one on each lung. Later his kidneys started failing him and they said he would need to go on dialysis as soon as the next day. Later that night they told me my dads heart was shutting down and he had developed pneumonia. My dad died that night and I had to watch him take his last breath. If you want further information please contact Medical center would be the ones to contact for all information and my dad was in the critical care unit." "1207822-1" "1207822-1" "No adverse symptoms from vaccination. Decedent died day after 2nd vaccination, death not related to vaccination" "1207863-1" "1207863-1" "Patient death within 60 days of receiving the COVID vaccine series" "1207869-1" "1207869-1" "Presented to the ER on 3/19 at 23:57 with 2 days of worsening shortness of breath. HR 60, Pulse Ox: 85% on Room air. Placed on BiPAP. could not maintain oxygen, intubated. The patient rapidly decompensated and went into cardiac arrest with PEA. ACLS performed for 35 minutes without the ability to reverse. Patient expired at 0222 on 3/20/21." "1207928-1" "1207928-1" "Shortness of breath" "1207946-1" "1207946-1" "Pt c/o abdominal pain that began 5 min after vaccine administration, per pt's son. Pt main complaint in the ED was abdominal pain. On exam pt's abdomen was tender diffusely. Within minutes of initial evaluation the pt lost consciousness. Minutes later the pt was apneic and pulseless. Resuscitative efforts were initiated per ACLS protocol. During resuscitative efforts the pt received several rounds of code-dosed epinephrine. In addition, the pt received 1 dose of IV Benadryl in addition to medications standard for ACLS protocol. Benadryl was administered specifically to treat the possibility of anaphylaxis." "1207989-1" "1207989-1" "The decedent was last seen alive at approximately 0130 when the decedent's next of kin (NOK) heard the decedent walking around the residence. The decedent complained of arm soreness and indigestion; the decedent received a second COVID-19 vaccination (Moderna) on 04/12/2021. The decedent went to the living room to sleep on the couch due to the health and soreness complaints. At approximately 0750, NOK entered the living room and found the decedent unconscious and not breathing." "1207994-1" "1207994-1" "Blood Clot on back of leg" "1208082-1" "1208082-1" "Pt had AFIB and was on ELIQUIS 2.5 mg BID. He began to bleed, a lot. We stopped DOAC, disussed possibility pt might die form blood clot without the DOAC. He had vaccine after stopping DOAC (stopped DOAC 2/24/21). On 3/8 he had the Janssen Vaccine. On 3/15 he awoke w weakness, inability to speak. Transferred to hospital where he was diagnosed w having major stroke, admitted to hospital. They decided NOT to use anticoagulant because he had too great a risk of bleeding." "1208248-1" "1208248-1" "Had a general over all weakness especially affected his swallowing." "1208360-1" "1208360-1" "Patient was hospitalized X 5 and died within 60 days of receiving a COVID vaccine" "1208419-1" "1208419-1" "Patient described throwing up, pale in skin, sweating prior to passing away." "1208477-1" "1208477-1" "Received Moderna vaccine on 2/29/21 and 3/19/2021. Health began declining 2 weeks later and died on 4/13/2021 (26 days post vaccination) with heart failure listed as cause of death." "1208484-1" "1208484-1" "3hrs after the patient's vaccination, she fell to the floor and was unable to get up, noted to have R sided facial droop, inability to speak, R sided weakness. Found to have a large stroke with left sided M2 MCA clot noted on CT angiogram." "1208505-1" "1208505-1" "Patient passed away due to metastatic cancer in esophagus and liver." "1208579-1" "1208579-1" "Developed blood clot in heart -- > went into Atrial Fibrilation with no prior history of A FIb -- > Large clot was thrown from the heart into the brain splitting into two clots, one blocking brain stem and one blocking right hemisphere -- > Death on 2/10/21" "1208583-1" "1208583-1" "Chills, Fever,fatigue. Tested positive for COVID on 3/22 and died on 3/29" "1208628-1" "1208628-1" "It was reported by the Sheriff's Dept. that patient was found expired on 4/13/21 - sitter reported that patient went to take a nap and the sitter went to check on him and found him unresponsive and called 911; patient was DOA on arrival" "1208670-1" "1208670-1" "death" "1208709-1" "1208709-1" "The information was presented by his granddaughter. He was scheduled to come in for his second vaccination with his granddaughter on 4/14/21, however, he passed away on 4/13/21. His granddaughter stated he experienced a severe nose bleed just under a week post vaccination (1st dose/Pfizer). The nose bleed lasted a few hours and had to be controlled by the Hospital. The incident reoccurred a week later and again, the bleeding had to be controlled by nasal clamp and lasted for a few hours. The patient began having pain in his stomach and feet, and stayed pale and nauseous. On 4/13/21 the patient was found in his bed saturated in blood and had soiled himself. His family called EMS and the patient went to Hospital. The patient coded and was not revived. The granddaughter stated that he had an enlarge prostate that was discovered during one of his hospital visits in the past 3 weeks." "1208718-1" "1208718-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1208724-1" "1208724-1" "death" "1208744-1" "1208744-1" "Death" "1208762-1" "1208762-1" "Death" "1208779-1" "1208779-1" "Death" "1208807-1" "1208807-1" "Death Anasarca Hyperammonemia Altered mental status Pulmonary edema Hypermagnesemia ARF (acute renal failure) Anemia" "1208905-1" "1208905-1" "Patient felt fatigue, malaise, SOB and chest pain 2-4 days after vaccine" "1208945-1" "1208945-1" "The patient received the vaccine on 3/31/2021. On 4/7/2021, patient developed weakness that continued until 4/14/2021. Patient also developed shortness of breath on 4/14/2021. The patient presented to the ER for weakness and shortness of breath. Patient had labwork, EKG, and an Xray. Troponin, BNP, and D-Dimer were elevated. Sodium was low. Chest xray showed congestive heart failure. Pt required intubation and then coded. Cardiac life saving procedures were started but the patient succumbed to death. Patient death pronounced per MD." "1209081-1" "1209081-1" "Cardiac Arrest Death Sepsis due to methicillin susceptible Staphylococcus aureus" "1209096-1" "1209096-1" "Death" "1209119-1" "1209119-1" "Death Dehydration Community acquired pneumonia Closed head injury, initial encounter Fall at home, initial encounter Acute hypoxemic respiratory failure" "1209139-1" "1209139-1" "Death Shortness of breath Sepsis" "1209158-1" "1209158-1" "Death Sepis Acute Kidney injury" "1209172-1" "1209172-1" "Death" "1209252-1" "1209252-1" "On 4/13 patient's daughter in law called public health department to report that patient was found by EMS on 3/12/21. They believe patient had passed away over night. No autopsy was done. Family member reported that EMS believed the cause to be heart attack or pulmonary embolism." "1209341-1" "1209341-1" "Received Vaccine 1/15/21 and 2/5/21. Transitioned to Hospice care. Expired 4/13/2021." "1209415-1" "1209415-1" "Patient experience flu like symptoms and body aches the same evening after receiving vaccine. On 4/1/21 the patient experienced nausea, high blood pressure, and a headache. Around 7:00 pm that night the patient threw up and became unresponsive. The patient was then transported to the hospital by ambulance. A CT scan showed a brain bleed and the patient was intubated and transferred to another hospital." "1209422-1" "1209422-1" "Per the patient's husband, on 03/26/2021, the day after vaccination, the decedent complained of nausea with vomiting, and had difficulty driving. On 03/27/2021, her nausea continued and she complained of shortness of breath while walking. On 03/28/2021, she was short of breath before vomiting a small amount. She then became unresponsive. Death was pronounced a short time later. Per her treating physician who signed the death certificate, the cause of death is felt to be probable myocardial infarction due to electrolyte abnormalities due to complications of her diabetes mellitus." "1209441-1" "1209441-1" "My mother and I received the Moderna vaccine on January 20th. About two weeks later on January 31st, she complained about her leg. It was swollen. Later on that day, she collapsed, was rushed to the hospital. Died on February 4th due to anoxic brain injury due to DVT that caused a massive pulmonary embolism." "1209447-1" "1209447-1" "Sudden death No reported symptoms 24 hours after vaccine" "1209462-1" "1209462-1" "NA" "1209498-1" "1209498-1" "Pt received the vaccine on 3/24/21. On 4/12/21 pt died of cardiac arrest" "1209647-1" "1209647-1" "Acute brain hemmorhage" "1209724-1" "1209724-1" "Hospice patient received Janssen vaccine on Friday and passed away peacefully on Monday. We don't think the death is related to the vaccine but reporting it since it happened less than a week after receiving vaccine" "1209804-1" "1209804-1" "Timeline of events: o No concerns in the past month. o Usual state of health on Friday 4/9/2021 o Received Pfizer vaccine at event on 4/9/2021 o Fatigue, poor PO intake and myalgia on Saturday, 4/10/2021; Received Tylenol at 1 pm o Texted Primary Community Nurse (PCN) (not on call), on Saturday, to share above. PCN followed up Sunday morning and reassured them. o Last seen alive Sunday night, not well from vaccine but does not seem like family was concerned enough to page on call team o Monday morning- found dead in rigor mortis o Cause of death: deemed sudden cardiac death. Etiology unclear. o Unexpected death." "1209825-1" "1209825-1" "Hospitalized 03-13-2021, Diagnosed with Thrombotic Thrombocytopenic Purpura, Died 03-16-2021" "1209873-1" "1209873-1" "The day after receiving the first dose of the Pfizer vaccine, she developed a headache behind her right eye that never went away. Then on Wednesday morning, March 31st (two weeks after receiving the first dose), she was found in bed by my mother, unable to walk or talk, her face was drooping, she was very sweaty, and had defecated on herself. My mother called the ambulance. She was transported to Hospital where it was determined she had suffered a massive hemorrhagic stroke. She was immediately transported by ambulance to another Hospital. She spent one day in ICU and then was put on palliative care. She died around 12/N on Friday, April 2nd, two days after the stroke." "1209903-1" "1209903-1" "I DON'T KNOW THE EXACT EVENTS FOR THE CASE, BUT WAS ASKED TO FILL IN THE INFORMATION THE BEST I COULD WITH THE INFORMATION I HAD ON HAND. THIS YOUNG LADY, RECEIVED A COVID-19 VACCINE ON 3/6/2021 AND EXPIRED ON MARCH 13, 2021. THIS IS MOST OF THE INFORMATION THAT I HAVE. YOU WOULD NEED TO CONTACT THE MEDICAL EXAMINER'S OFFICE, THAT WILL BE ABEL TO PROVIDE YOU WITH MOST DETAIL FOR THIS CASE." "1209906-1" "1209906-1" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1210133-1" "1210133-1" "Patient had her Johnson and Johnson Covid 19 vaccine on Friday April 9, 2021. Prior to the vaccine patient displayed no noticeable signs of deteriorating health. Over the next two days, friends of the patient attempted to contact her with no success. Finally after several hours of no contact, the grandchildren of the patients friend went to her apartment and found the patient lying on the couch unresponsive. When the patient was found, her leg was swollen. She was cold and not breathing. She passed away after receiving the Johnson and Johnson vaccine." "1210267-1" "1210267-1" "Dad became very sleepy the day after. He quickly declined and died on Feb. 7 th. I feel the vaccine may have had something to do with his death." "1210317-1" "1210317-1" "We both got our shot at the same time on March 17, 2021. Then on March 22, 2021 at 9:20 PM my husband suffered cardiac arrest and a seizure. His heart was revived however, due to lack of oxygen to his brain he suffered brain damage and never regained consciousness and passed on 4/3/21 with acute respiratory failure." "1210441-1" "1210441-1" "I spoke to patient by phone on Saturday morning around 9:20am. He was concerned about the fatigue, nausea, headache, chills, and muscle aches he had the night before. He felt better when I spoke to him. He wanted to know when those side effects would go away finally. Since I had the Moderna vaccine I said 24 to 36 hours. But I didn't know about the J&J vaccine. We disconnect the call at 9:40am Saturday morning. After the call at some point he fixed lunch or dinner and stopped eating before finishing his meal. He had left the food on the table and in the pans he fixed it in. Very unusual for him. The patient then went to his room where is was found Monday 3/22/21 around noon in his bed laying on his chest (he hated to lie on his chest) by the police and the HR officer from his work. The HR officer had called my other brother around 11:15am on 3/22 /21 to ask if we had heard from the patient because he had not reported to work or phoned in. He has passed sometime between noon on Saturday till Sunday evening alone at his residence. He had towels and a trash can beside his bed when he was found. The coroner call it death by natural causes and would not do an autopsy when even asked by his PCP." "1210581-1" "1210581-1" "Patient's daughter in law called to report the adverse event and will be submitting a VAERS as well. Pt rcvd first dose of vaccine 03/03 and 16 days later on 03/19 he was hospitalized for respiratory unrest, cause unknown. It was not suspected to be caused by the vaccine at that time. Doctors encouraged him to rcv the second dose and pharmacy staff was informed pt had been given the go ahead to do so. Pt marked that he was not currently ill on his informed consent form and that he had not had a previous reaction to the vaccine. 5 days after rcving his second dose (03/30) he arrested again resulting in hospitalization later death on 4/4." "1210630-1" "1210630-1" ""Mother called health department today, 4/14/21, to report reactions son experienced after receiving vaccine 3/4/21. She stated that on 3/6/21 he started having headaches, weakness and leg cramps. He went to the hospital two times with complaints. On 3/15/21 he was unable to walk/drive because headaches were severe. On 3/30/21 he passed out, squad was called. He was not responsive and was put on a vent at the hospital. A ""scan"" showed blood clots in brain and heart. This individual passed away on 4/4/21."" "1210673-1" "1210673-1" "patient experienced a massive brain stem stroke on the morning of Friday, April 2, 2021. He was found minimally responsive on the floor at home and rushed to Medical Center which has a comprehensive stroke center. Imaging and testing determined there was no chance of recovery that would restore meaningful quality of life. The family removed life support on Saturday, April 3, 2021. Of note ,Patients sister, also, similarly suffered mild stroke shortly after receiving her 2nd Pfizer COVID-19 vaccine. Her recovery is ongoing and her family has been encourage to also report to VAERS." "1211001-1" "1211001-1" "Patient is deceased. Had a blood clot travel to her brain and causes an un recoverable stroke" "1211052-1" "1211052-1" "My father received his shot on March 13, 2021. He drove to move home and on March 28th started having his right arm go numb but did not tell us. He asked to go the ER March 29th at 6:45am saying his chest hurt and was having a hard time breathing, this has happened before since having Covid in September. I called 911 after he became dizzy and could not walk. While at the ER suffered a massive stroke that paralyzed him from his nose down over a course of 3 days. His brain stem was affected and he lost the ability to swallow. After being on a ventilator for 72 hours he was removed from it and died less then 30 mins later from drowning in his own saliva on April 1, 2021." "1211110-1" "1211110-1" "Death" "1211224-1" "1211224-1" ""Patient came in for vaccine with his son. During the screening, the patient's son answered all of the questions regarding the patient. The patient's son denied any previous serious reactions to medications including the components to the vaccine. Only medical condition the patient's son mentioned was hypertension. The patient was vaccinated, and appeared fine. Once he got to the waiting area, he stated, ""I feel hot."" His coat was removed, the manager was notified,. We gave the patient something to drink, a snack, and a cold icepack. Once the patient's condition continued to decline, vital signs were assessed. Blood pressure was 140/110, pulse oximetry was 87% on room air, and patient was placed on oxygen. I notified the manager to go grab the doctor as I was helping the patient. The doctor brought a glucometer to make sure the patient was not hypoglycemic, and the result was 117 mg/dL. At this point the patient was diaphoretic, and complaining of pain in his abdomen. He also complained of nausea. The squad was alerted, and came to get the patient. At this point the patient's pulse ox was 53% on 6L of oxygen. Patient's family was present with the patient, and the patient was then transported to the hospital via EMS."" "1212176-1" "1212176-1" "Death Metastatic adenocarcinoma Intertrochanteric fracture of left femur" "1212182-1" "1212182-1" "Death" "1212194-1" "1212194-1" "Death R06.02 - Shortness of breath J18.9 - Pneumonia" "1212220-1" "1212220-1" "Death SHORTNESS OF BREATH WEAKNESS - GENERALIZED" "1212227-1" "1212227-1" "death Narrative: Patient received COVID vaccine #1 on 1/13/2021. On 1/19/2021, notes from primary care indicate advancing dementia and a urinalysis suggestive of a UTI, he was ordered a course of cefdinir and PCP at that time suggested long term care. On 2/1/2021, he was admitted to a facility for acute kidney failure and was also noted to have frequent falls at home, no scanned records from that hospitalization are available. On 2/7/2021, he discharged from that facility with home hospice. On 2/11/2021 at 0140, Patient passed away at home. No autopsy results available." "1212233-1" "1212233-1" "death Weakness Fever Sepsis" "1212251-1" "1212251-1" "Fall and stroke" "1212295-1" "1212295-1" ""Patients mom states 12 hours after vaccination dev: fever, chills, stiff neck. Symptoms got progressively worse throughout the day. on the evening of 4/8/21 patients mom describes patient talking ""out of her head"", fever, chills, leg pain, ""bad"" headache. On 4/9/21 patient woke up around 5:30 AM, sister helped to bathroom. reported leg pain, neck pain, headache. Laid back down. Sister found patient unresponsive around 9:00 AM. Sister performed CPR. Pronounced dead at patient's home by EMS."" "1212373-1" "1212373-1" "The patient had an uneventful post-operative course and was discharged on post-op day 2. By report, on post op day 4-5, the patient began complaining of headache, back pain and abdominal pain. Continued home meds for post-op pain and constipation. On POD 8/9, the patient notified her daughter that she woke up short of breath. She was transferred by EMS to Hospital where she reportedly expired (this event was reported by the patient's daughter to doctor's office, the spine surgeon who managed her while inpatient at Hospital" "1212390-1" "1212390-1" "Within 4 days of the vaccine she became weak, nauseous, body pain and developed a fever. She was unable to get out of bed at all. One week after vaccine she suffered a stroke." "1212418-1" "1212418-1" "death Narrative: Patient received his COVID #1 vaccine on 1/4/2021. He is noted to be a dialysis patient and on 1/21/2021 was given a RX for treatment of a UTI. On 1/24/2021, he was admitted to a facility with a syncopal episode. He remained there until 2/2/2021 when he discharged to home. On 2/4/2021, notes indicate that he passed away in his sleep that night. No autopsy reports available. 31 days from time of vaccine #1 and date of death, does not appear that he received vaccine #2." "1212474-1" "1212474-1" "Death R05 - Cough J96.90 - Respiratory failure R55 - Syncope R41.82 - Altered mental status I95.9 - Hypotension M25.551 - Right hip pain Z79.01 - On apixaban therapy" "1212489-1" "1212489-1" "CARDIAC ARREST Death" "1212567-1" "1212567-1" "he died while on his routine daily run; medical examiner agreed he should have an autopsy which showed coronary artery disease/likely an acute cardiac event" "1212771-1" "1212771-1" "an 87 year old male with ESRD on PD, pAfib, CAD, HTN, HLD, hypothyroidism, who was brought in after a witness cardiac arrest. Patient apparently received the first dose of the Covid vaccine (pfizer) at around 11 am. He was doing fine the rest of the day until later in the evening when he had shortness of breath without chest pain, abdominal pain, nausea, vomiting. Upon EMS arrival, the patient appeared to have some agonal breathing and then went down, was in PEA arrest, received CPR with 1 dose of calcium, 1 dose of bicarbonate, and 3 doses of epinephrine with return of spontaneous circulation. Upon arrival in the ED, patient had an intraosseous line, on dopamine for soft blood pressure. Patient has been successfully intubated." "1212788-1" "1212788-1" "Patient's wife notified our corporate office on 4/15/21 that her husband received a J&J COVID vaccine from our pharmacy on 3/23/2021 and that he passed away one week later, 3/30/2021, in their yard after having a heart attack. Phone number provided is the wife's." "1212820-1" "1212820-1" "Unexpected death 3 days after vaccination" "1212869-1" "1212869-1" "Patient expired on 4/3/2021 after refusing dialysis x 2 weeks" "1212969-1" "1212969-1" "Patient Expired" "1213032-1" "1213032-1" "D69.6 - Thrombocytopenia (CMS/HCC) U07.1 - COVID-19 D72.819 - Leukopenia R77.8 - Elevated troponin I level J18.9 - Multifocal pneumonia U07.1, J12.82 - Pneumonia due to COVID-19 virus" "1213047-1" "1213047-1" "This is the patient's spouse reporting. The day following the vaccination, wife began to suffer mild, common vaccination symptoms such as fatigue, hills, and joint pain. In the days following, in addition to those symptoms, she began to cough and had a sore throat. By March 8th, she had lost her sense of taste and sense of smell. We realized we needed to have her tested for COVID-19. We went to a testing area. She was seen and tested. She tested positive for COVID-19 (as did I). The belief was that our illness was uncomplicated and we were sent home with instructions to monitor our symptoms. On 03/14/2021, I took her to the hospital because her condition was worsening." "1213081-1" "1213081-1" "Fever, Sick on stomach, aches, fatigue, extreme weakness. Symptoms were extreme. Generally felt terrible after being very stable and active. No improvement and condition worsened daily with loss of appetite. Death occurred on March 13, 2021." "1213085-1" "1213085-1" "End Stage dementia, overall decline, hospice care, expired" "1213115-1" "1213115-1" "cardiac arrest at approximately 4:35pm, patient expired." "1213131-1" "1213131-1" "PATIENT DIED FROM BLOOD CLOT 3/29/2021 - AUTOPSY PERFORMED AND CONFIRMED" "1213217-1" "1213217-1" "Death - no symptoms, signs or treatment provided" "1213285-1" "1213285-1" "Death Narrative: Patient received his first COVID-19 vaccination 2/27/2021 and received his second COVID-19 vaccination 03/27/2021. Patient had not been tested for COVID per chart review and had no contraindications to receiving the vaccine. Patient did not experience any adverse events to the COVID-19 vaccine between time of vaccination and the time of death 12 days later. Of note, patient was receiving home hospice at the time of his death (04/08/2021) for his advanced acute myeloid leukemia." "1213286-1" "1213286-1" "death Narrative: Patient received Moderna COVID vaccine #1 on 1/10/21, he was seen by his PCP for a routine 6 month check up on 1/14/21. Notes at that time indicate he had a left great toe, he wound and was receiving home health and IV daptomycin through a PICC line. On 2/7/21, he received vaccine #2. Notes then indicate that on 3/9/21, he was found passed away in his home by family. No autopsy results available. 30 days form date of vaccine #2 to date of death." "1213287-1" "1213287-1" "Death. Narrative: Patient received Moderna COVID vaccine #1 on 3/3/21. He is noted to be a dialysis patient. On 3/24/21, his wife took him to a facility ER due to intermittent shortness of breath over the previous week. He was admitted for fluid overload. On 3/27/21, he was found unresponsive and CPR was initiated and a code blue was called. He received defibrillation, epinephrine, IV calcium, sodium bicarb and amiodarone and was intubated; however he did not survive and time of death is recorded as 3/27/21 at 0138. No autopsy results available. 24 days from time of vaccine to date of death." "1213288-1" "1213288-1" "death Narrative: Pt received second Moderna COVID vaccine dose on 2/9/21. Pt enrolled in hospice house for end-of-life care 4/8, however, diagnosis was not available in database for enrollment in hospice. Pt's son emailed affairs to report the passing of the patient 4/11/21 with no additional details or reasoning; death has not been verified. Was pt previously covid positive? no Are there any predisposing factors (i.e. PMH, HPI, allergy history etc) for patient experiencing adverse drug event? Yes, CHF potentially a contributing factor to hospice status and death Any occurrence of an ADR at time of administration or during time of observation? No Was there an ADR between observation period and date of death? No Was patient hospitalized prior to vaccination? No Was patient hospitalized prior to death No What are the possible cause of death? unknown, pt enrolled in hospice services outside of the facility." "1213289-1" "1213289-1" "death Narrative: Patient received Moderna COVID #1 on 2/4/21 and #2 on 3/4/21. He was seen by his PCP via telephone visit on 3/2/21 for a routine follow up, no acute issues noted and follow up was planned for 6 months. On 3/12/21, he passed away, no notes in medical records or scanned records to indicate what happened. No autopsy results available. 8 days from date of last vaccine and date of death." "1213302-1" "1213302-1" "He received his first COVID19 shot (Pfizer) reportedly on 3/2/21, then began a new chemotherapy regimen on 3/10/21. On 3/18, he fell to the floor and could not get up. He was admitted to the hospital for sepsis, pneumonia, and chemotherapy-induced neutropenia, treated on IV antibiotics and discharged on PO antibiotics. His home insulin was also decreased but continued to have hypoglycemic to hyperglycemic events. Insulin was decreased in clinic afterward and was compliant on antibiotics. Returned to hospital again a few days later for sepsis and pneumonia/effusion. He later went to a nursing facility / on hospice. He ultimately required supplemental oxygen and breathing increasingly became labored. Patient ultimately died on 4/9/21." "1213304-1" "1213304-1" ""death Narrative: Patient received Moderna Covid #1 on 3/11/21 in his home by nurse. On 3/25/21, a note was entered to indicate that is wife had called EMS the day before as ""his heart stopped"" and he passed en route to the hospital. No further details available. No autopsy results available. 13 days between date of vaccination and date of death."" "1213306-1" "1213306-1" "blood clotting in legs, lungs, resulting in hospitalization. Second clotting event resulting in stroke and hospitalization, ongoing treatment and evaluation" "1213364-1" "1213364-1" "death Narrative: Patient received Moderna COVID #1 vaccine on 1/28/21. On 2/3/21, he was admitted to a facility for fever, weakness, chills and rigor. Noted history of B cell lymphoma not on chemotherapy at the time. He also had reports of productive cough with thick brown/green sputum. He was admitted to the hospital and given 1 round of methotrexate and Rituxan. Hospital course was complicated with bacteremia (given vancomycin and cefepime), A fib, AKI, HTN, neutropenia (received Neupogen), acute popliteal VT (unable to anticoagulated due to thrombocytopenia - platelets as low as 20). No bleeding issues noted. On 2/18/21, family opted to change his status to DNR with hospice/comfort care and he passed on 2/19/21. No autopsy results available. 22 days from date of vaccine to date of death." "1213431-1" "1213431-1" "Patient admitted with massive portal vein thrombosis and low plt in setting of infection. Symptoms started one week prior" "1213551-1" "1213551-1" "DEATH, ABDOMINAL DISTENTION, CHF EXACERBATION. Narrative: Pt died after completion of COVID vaccine series. Pt in CLC at time of both vaccinations. Hospitalized for CHF exacerbation 01/05 COVID vaccine dose #1 01/01 c/o abdominal distention, diarrhea 01/08 c/o increased SOB and continued diarrhea/abdominal distention, sent to ED, low potassium, borderline elevation troponin, gaseous distention on CT, admitted to hospital, states SOB and leg swelling for a few weeks now (likely unrelated to vaccine) 01/21 discharged from hospital to CLC; during course, found to have severe hypokalemia and renal failure, abd ileus, treated for electrolyte imbalance 01/26 admitted to hospital with c/o coffee ground emesis & abdominal distention 01/27 COVID vaccine dose #2 moved to critical care mid hospitalization with like aspiration PNA and numerous complications 02/06 patient passed away after withdraw of care Unlikely that vaccine contributed to death but death likely due to comorbidities and advanced age. Patient did not have acute specific ADR at time of vaccine or between vaccinations and date of death that could be attributed to vaccine. Hospitalized prior to and after vaccinations. Numerous comorbidities including acute on chronic HF and kidney failure pre-disposed patient to death." "1213566-1" "1213566-1" "death Narrative: Patient received his COVID #1 Moderna vaccine on 2/3/2021. On 2/9/21, he reported to our ER with severe upper back pain x 2 weeks, notes indicate that he fell 12/2020 and sustained a fracture to T5, he denied shortness of breath but did report a cough. He was given morphine 10mg IM x 1 dose, ondansetron 4mg SL x 1 dose and an outpatient RX for Norco and discharged. On 2/11/21, his wife reported that he fell out of bed and he was taken to a facility via EMS. No records from that visit are available. On 3/9/2021. it was reported that he passed away. No autopsy reports available. 34 days from time of vaccine to date of death." "1213567-1" "1213567-1" "Narrative: On 1/11/21, patient received Moderna COVID vaccine #1 and on 2/8/21, she received dose #2. No notes record any adverse events to vaccine. There is a scanned document from 2/24/21 where patient agreed to home hospice care. Date of death is recorded as 3/1/21. No documentation of any events from time of vaccines to date of death. No autopsy results reported. 21 days from date of vaccine #2 and date of death." "1213568-1" "1213568-1" "death Narrative: Patient received Moderna covid vaccine # 1 on 2/26/21. Per scanned records on 3/18/21, he presented to the ER with reports of shortness of breath and was subsequently admitted and treated for acute CHF, NSTEMI and sepsis (ceftriaxone and azithromycin). He later developed AKI and surgery was consulted for placement of a Trialysis catheter. After placement of this catheter, he developed increasing respiratory distress and confusion and was transferred to the ICU where he received vasopressors, intubation and unsuccessful resuscitation after a code blue. Autopsy reports not available. 22 days from date of vaccine to date of death." "1213569-1" "1213569-1" "death Narrative: Patient received COVID vaccine #1 on 2/4/21. On 3/1/21, it was reported to the facility that patient had passed away on 2/24/21. No notes on file with respect to what happened around the time of his passing. No autopsy results available. 20 days from time of vaccine to date of death." "1213570-1" "1213570-1" "death Narrative: Patient received Moderna Covid vaccine #1 on 2/12/21. On 2/17/21, his son contacted the clinic social worker to inquire about home health services as he thought Patient had had a stroke (no longer able to walk and slurred speech). Patient refused to go to the hospital and son agreed to not have him admitted for fear that he would die alone in a hospital. Patient receives primary care from a provider and social worker suggested that he contact his PCP regarding home hospice services. No further notes of what occurred after that conversation and his date of death is reported as 3/21/21. No autopsy results available. 37 days from date vaccine to date of death." "1213571-1" "1213571-1" "Death. Narrative: Patient received Moderna COVID vaccine #1 on 3/1/21. On 3/17/21, he was admitted to a facility for a CABG. Per notes, after his CABG, he developed Pseudomonas pneumonia, AKI requiring dialysis and ultimately became oliguric. He required epinephrine, dobutamine, dopamine, amiodarone and went through two code blues prior to pronouncement of death on 3/25/21 at 2305. No autopsy reports available. 24 days from time of vaccine to date of death." "1213572-1" "1213572-1" "death Narrative: Patient received COVID vaccine #1 on 12/30/20 and #2 on 2/1/21. He was an inpatient in the facility and had been under hospice care since 12/9/20. No adverse events to vaccine found per notes. On 2/27/21, he began to have short and rapid respirations and was unresponsive. He was given morphine, atropine sublingual, lorazepam and nebulizers per hospice care orders and was determined to be imminent. On 2/28/21 at 2230, he passed. No autopsy results available. 27 days from date of vaccination to date of death." "1213955-1" "1213955-1" "My brother is now dead, less than one month after his second shot" "1213958-1" "1213958-1" "PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021." "1213993-1" "1213993-1" "Abdominal pain, transferred to ER 2/24/21, admitted to hospital, Expired at hospital 3/21/21" "1214135-1" "1214135-1" "unknown, death at home, with no one in attendance. Pt with mulitple medical conditions, when RN adminstered 2nd dose on 4/07/2021. They dicussed how the first one went. Pt states, besides sore arm nothing. She did have acid reflux, (common for her) which she took regular medication which took care of it. But denied any other problems with first dose. Seccond dose given with no reaction during 15 min observation time. EMS was called to scene on 4/08/2021 at approx 1630 hrs, to find pt deceased, spine in bed. approx down time 2-3 hrs. Pt's primary Dr. contact as well as corner. With pt's medical history no further investigation was done." "1214139-1" "1214139-1" "Cardiac Event" "1214277-1" "1214277-1" "After resident received vaccine there continued to be a decline in her overall health. Resident died on 2/26/21 at the age 102. The County Health Department requested that her information be forwarded to VAERS. There is no evidence that resident had a adverse reaction to the vaccination." "1214325-1" "1214325-1" "Severe anxiety, Kidney Failure, Hypoglycemia, ER visits, Overall decline, Hospice care, Expired" "1214482-1" "1214482-1" "Not feeling well according to mother the night before he passed away. 11 days after vaccination." "1214500-1" "1214500-1" "Patient at 27 weeks of pregnancy, reported to midwife at regular visit on 4/14/21 that she was experiencing SOB but all blood work normal - assumed normal SOB with pregnancy. Night/morning of 4/15 started seizures, transported to ED. Diagnosed with massive pulmonary embolism. Emergency C-section prerformed by Dr. Pt. did not survive." "1214501-1" "1214501-1" "DEATH" "1214516-1" "1214516-1" "Client was monitored after being Vaccinated for 15 minutes and staff observed no symptoms. DHS CRT was made aware of the death two days prior to 2nd dose Vaccine Clinic." "1214544-1" "1214544-1" "Patient died of a brain stem bleed on 4/11/21. It is unknown if the vaccine received on 3/8/21 is in any way related to his passing." "1214640-1" "1214640-1" "After receiving the J&J vaccine on Sunday afternoon, when my husband got up on Monday morning he passed out in the bathroom and was unresponsive. The EMTs arrived and were able to revive him in the ambulance. When they reached the hospital he was put on life support. After he coded again in the Emergency room they told me he was without oxygen for too long and was taken off the respirator. He passed away at 4:10 PM." "1214705-1" "1214705-1" "Patient passed away on April 4 2021" "1214783-1" "1214783-1" "unknown details of event as pt was in LTC facility where medical records would be located. Pt is reported to have expired at the facility." "1214800-1" "1214800-1" "Patient per tracking received 2nd COVID vaccine on 4/5/2021 from Health Department. Patient to Hospital Emergency department via EMS 4/6/2021 with cardiac arrest and death" "1214882-1" "1214882-1" "unknown" "1214997-1" "1214997-1" "Patient was terminal when he received the vaccine" "1215033-1" "1215033-1" "Patient sister contacted Pharmacy on 4/09/2021 about 4:30pm to report that her sister had passed away on 4/1/2021 approximately 7 hours after receiving her first Covid-19 vaccine at our clinic. The sister reports that she spoke with her the evening of 3/31/2021approximately at 7:45pm. The sister, indicated that her sister had been drinking and drank frequently. Stated her sister was an unhealthy person, drank everyday and could have been taking Alprazolam but wasn't sure. The sister stated that the patient's son had spoke/seen mom in the house around 8:30 pm. Patient was found in the household bathtub at around 1:00am, 911 was called and she was reported to be deceased upon arrival." "1215095-1" "1215095-1" ""Received her first COVID vaccine on Thursday, March 18. On 3/23/21 she started to have new onset of generalized muscles aches and weakness. She started feeling some pain in her back, which then spread to arms and legs. She is now beginning to feel weakness in her core and extremities. Having difficulty lifting arms above head. She is still able to walk without difficulty but legs do feel weak. Increase in SOB as well. Myalgias and chest pain resolved within a week, however she continued to feel weak, tired, and had DOE. She developed ""brain fog"" and talked to her boss about taking short-term disability as it had been hard to work. No appetite. On 4/1/21, she presented to the ED with 2 weeks of worsening generalized weakness, SOB, lightheadedness, dizziness and found to have acute anemia. Was admitted for further workup. Hgb at admission was 5.4. This admission diagnosed her with a new warm autoantibody hemolytic anemia. This is new since the COVID vaccine was administered. Upon admission there was no thrombocytopenia, so there was low suspicion for microangiopathic hemolytic anemia, TTP/HUS, or DIC. Peripheral blood smear at that time suggested a leukoerythroblastic blood picture (could be Bone Marrow recovery post chemo) but with marked normocytic, normochromic anemia, and with increased circulating erythroid precursors and increased red blood cell regeneration; spherocytes and fragments are present supporting hemolysis. DAT positive (both IgG and C3) along with other hemolysis lab including elevated LDH, Bilirubin, haptoglobin 3, and PBS c/w hemolysis; no evidence of MAHA. So warm autoantibody hemolytic anemia is the most likely explanation. She had negative cold agglutinin antibodies <1:32 on 4/9. Started on methylprednisolone on 4/2/21, but Hgb continued to steadily decline despite treatment. Continued on methylprednisolone 87.5mg daily. Rituxan 375mg/m2 was started on 4/6/21 with plans for weekly infusions for a total of 4 weeks. there was concern for a GI bleed on 4/10-4/11 due to bright red fluid appearing like blood in the toilet after a stool. This led to her receiving roughly 5 units of pRBCs. After these 5 units she started urinating red urine and we became highly concerned for hyperhemolysis. She did not have any further stools so we did not think a GI bleed was likely. She was given 1 dose of Eculizumab (Soliris) (4/12). This treatment is for complement mediated intravascular hyperhemolysis. Unfortunately it did not appear to help her. On 4/14, we were thinking TTP could be contributory with numerous schistocytes on peripheral smear. Her T bili was up to 7.8, and her hemoglobin plasma was trending up, in the 380 -- > 610 and in the 800s today. Cr was worsening. Platelet count was dropping. With her worsening condition and concern for both hyperhemolysis and possible TTP, we decided to start her plasma exchange followed by her second dose of Rituximab. Unfortunately she became disoriented/confused following line placement and while receiving plasmaphoresis. CT head returned without acute findings. She then had an allergic reaction with a rash during PLEX which was stopped (4L completed with a goal of 5L). Improved with benadryl. She was then administered rituximab. Then she developed worsening sinus tachycardia and HTN. Her respiratory status deteriorated and she eventually required high-flow oxygen to maintain saturations > 90%. CXR showed bilateral opacities, not drastically changed from previous films. Rituximab was stopped halfway through its infusion in case this was an adverse effect to the drug. She was given 20 mg IV Lasix per the nighttime sign-out. She was initially given ceftriaxone and azithromycin IV to cover CAP but later ABx were broadened to vanc and Zosyn with rising lactate of unknown source. Ultimately she had acute respiratory failure with hypoxia and need BiPAP. She was eventually intubated and a code blue was called. She unfortunately died shortly after intubation."" "1215373-1" "1215373-1" "The pt missed her scheduled appointment for COVID vaccine #2, so I called her to reschedule. Today I reached her mother, who informed me that pt passed away last Tuesday. I did not ask for any details of her death at this time." "1215380-1" "1215380-1" "no symptoms" "1215401-1" "1215401-1" "PATIENT'S SISTER CALLED THIS AFTERNOON STATING HE HAD RECEIVED THE JANSSEN COVID VACCINE 4/05 AND THEY FOUND HIM DEAD THIS MORNING. THEY ARE NOT CERTAIN IF IT WAS FROM VACCINE. THEY CLAIM HE HAS NO OTHER HEALTH ISSUES AND IS NOT ON ANY OTHER MEDICATIONS. THEY HAVE NOT PERFORMED AUTOPSY. SHE WAS MORE RELAYING INFORMATION RATHER THAN BLAMING THE DEATH ON THE VACCINE. SHE REQUESTED WE SUBMIT REPORT TO VAERS; SHE HAS NO WAY TO AND DOES NOT KNOW HOW." "1215403-1" "1215403-1" "1 week post vaccination - patient, not responding to albuterol HFA, called 911, he passed out, was unresponsive, pronounced dead." "1215435-1" "1215435-1" "Patient began experiencing back pain on March 14 and on or around March 18 he started coughing up blood clots according to a coworker. Patient lived alone and was unable to be reached on Sunday March 21. I went over to his house and found him deceased in his bed. Patient had a trashcan beside his bed and it appeared to have some blood in it. Patient had thick mucus coming out of his mouth and blood coming out of his nose. According to paramedics he had passed a few hours before finding him. Unfortunately Patient has been cremated so there is no way to say that this was related to the Covid 19 shot from Johnson and Johnson, however there are new reports that blood clots have been a side effect. I would like to speak with someone from the Department of Health to discuss this further. I feel this could be related to the vaccination and I would to know how long the Health Department knew about this possible side effect. If patient would have known sooner that the blood clots were a side effect I feel he would have gone to the Emergency Room. Patient had no health insurance and he was trying to prevent getting Covid. This has caused our family so much heartache and we are all very apprehensive about getting the Covid Vaccine ourselves. Please contact me as soon as possible, I am also patient's executor so I am able to speak to you on behalf of patient and our family. Thank you." "1215882-1" "1215882-1" "fatal pulmonary embolism from RLE DVT" "1216091-1" "1216091-1" "Patient at gym working out and had a seizure, when 9-1-1 crews arrived patient was post-ictal, while treating the patient he had another seizure, during transport patient went into cardiac arrest, crews provided ACLS care and transported patient to hospital for treatment. Resuscitation efforts were terminated by physician in emergency room." "1216134-1" "1216134-1" "Cardiac arrest...death" "1216189-1" "1216189-1" "78 year old woman admitted with severe back pain, inability to ambulate and leukocytosis on 3/31/21. History of hypertension, CHF, obesity, chronic kidney disease, and back pain. Work up included multiple consults. The patient was placed on SQ heparin for VTE prophylaxis. Acute L5 fracture was found along with emphysematous changes. Neurosurgical evaluation- no surgery was necessary. During the first 24 hours (before receiving the vaccine), the patient's Hg dropped 9.3 to 6.8 and platelets dropped 130K to 61 K with no apparent bleeding source. PRBC transfusion was given. GI consult was obtained the patient was scheduled to have EGD the following morning (day 3). Cardiology was obtained for elevated troponin and hypoxia. An echo obtained on day 2 showed moderate elevated pulmonary artery pressure, mild to moderate tricuspid regurgitation, and normal sized right atrium and ventricle. The patient received the Janssen vaccine upon request the morning of hospital day 2 (4.1.21 at 11:02). At 11:37PM on 4/1/21 the patient received 5mg IV metoprolol for elevated HR of 132 (BP 129/67). At 0128 on 4/2/21 the patient's heart rate dropped into the 60's and then declined further requiring cardiac resuscitation. The attempt was unsuccessful and the patient expired at 01:43 on 4/2/21. An autopsy was conducted (results available on 4/13/21) showed a 4 cm clot in the patient's right atrium and a mural thrombus in her femoral artery." "1216240-1" "1216240-1" "Massive stroke Death 4 Days later" "1216264-1" "1216264-1" "Patient admitted 3/28/2021 with severe COVID 19 pneumonia. She progressed to acute respiratory failure and was intubated. During her hospitalization she was diagnosed with acute myeloblastic leukemia. Her family withdrew care and she died on 4/7/2021" "1216355-1" "1216355-1" "At 5 AM on 3/21/2021 my father was in bed sleeping and started to gurgle, he was unresponsive, 911 was called he was unresponsive and taken to the Hospital and died at 3:22 PM on 3/21/2021. from a C V A." "1217813-1" "1217813-1" "deceased on 4/13/21" "1218454-1" "1218454-1" "Patient's sister, spoke to Public Health staff to say that he passed away suddenly on 4/3/21 from a cardiac arrest, he had no underlying health conditions she states but did take some medications, she believes for blood pressure." "1218464-1" "1218464-1" ""EMS was dispatched to patient's home for ""non breathing."" EMS found patient on the floor in the kitchen with sheet already over her. No pulse, patient cold to the touch, jaw was locked shut. Patient's family members stated the last time they saw the patient alive was around 2:30 am on the same day. Patient pronounced dead on arrival at 6:20 am. No evidence of foul play noted."" "1218467-1" "1218467-1" "Patient hospitalized Hospital Admission Diagnoses: Severe sepsis (CMS/HCC) [A41.9, R65.20] Discharge Diagnosis: Patient Active Problem List Diagnosis Date Noted *Elevated troponin 03/30/2021 *B12 deficiency 03/30/2021 *Acute systolic heart failure (CMS/HCC) 03/25/2021 Discharge Diagnoses: Patient Active Problem List Diagnosis Date Noted *Elevated troponin 03/30/2021 *B12 deficiency 03/30/2021 *Acute systolic heart failure (CMS/HCC) 03/25/2021 *Acute respiratory failure with hypoxia (CMS/HCC) 03/24/2021 *Acute pulmonary edema (CMS/HCC) 03/24/2021 *IVH (Intraventricular hemorrhage) (CMS/HCC) 06/06/2018 *Brain edema (CMS/HCC) 06/06/2018 *Brain compression (CMS/HCC) 06/06/2018 *Benign essential HTN *Coronary artery disease * Type 2 diabetes mellitus with hemoglobin A1c goal of less than 7.0% (CMS/HCC) *Nontraumatic right thalamic hemorrhage (HCC) 06/05/2018 Consults: IP CONSULT TO PULMONOLOGY IP CONSULT TO CARDIOLOGY INPATIENT CONSULT TO PHARMACY INPATIENT CONSULT TO PHARMACY IP CONSULT TO NUTRITION SERVICES IP CONSULT TO NUTRITION SERVICES Procedures: Intubation Catheterization Significant Diagnostic Studies: Cardiac Catheterization" "1218469-1" "1218469-1" "death Narrative: Patient passed away on April 13, 2021 at home at 1810 He was 72 years old had severe aortic stenosis and hypertension and had an aortic valve replacement (TAVR) at hospital on Jan 20, 2021. He was readmitted to hospital for shortness of breath which was evaluated from Feb 19 - Feb 21, 2021 I spoke with his daughter today. She was with him at home when he went to the bathroom and since he had not come out for some time, she knocked on the door and found him collapsed in the bathroom. She called 911, who did CPR, however he had passed away. He was referred to the coroner. He had his first Moderna vaccine on March 15, 2021 after which he had not had any side effects. He received his second dose on April 12, 2021 and had not mentioned any side effects other than mild abdominal discomfort. Daughter said his shortness of breath had been improving after his discharge from the hospital. He had not complained of chest pain, cough, fever, diarrhea, in the last few days. I paid condolences to daughter and told here we would be reviewing the case to see if there was any relationship to him receiving the Covid19 vaccine and that the case had already been referred to the coroners office." "1218602-1" "1218602-1" "colonic necrosis 62 yo woman history of prior L occipital CVA and DVT on Xarelto presented to Hospital on April 6 with mental status changes. Patient was noted to be in severe metabolic acidosis, renal failure and shock. Chest x-ray showed interstitial infiltrates and she tested positive for SARS-CoV2. She required intubation and mechanical ventilation. CT brain showed encephalomalacia and atrophy, no new changes. She was transferred on April 8. She was given IV bicarb for persistent metabolic acidosis. Initially she was only treated with steroids, then antibiotics were added for fever and persistent hypotension. She started to spike fevers up to 40. Abdominal CXR ordered prior to MRI, showed possible pneumatosis. A follow up CT April 13 abdomen/pelvis was done which shows colonic pneumatosis, with air in the SMV, portal vein, air in the liver. No thrombocytopenia; platelets on April 13 were 310k, as low as 260 on April 8." "1218764-1" "1218764-1" "Patient with Hx of AML received 1st dose COVID vaccine 2/10/2021, 2nd dose 3/4/2021. She developed DVT of the right leg, AML relapse. The patient has been diagnosed with AML back in 2016 and underwent several lines of therapy including chemotherapy with 7 and 3 and the last treatment was decitabine with maintenance treatment with ivosidenib. Having severe leukocytosis and right-sided leg edema with DVT raised concern about blast crisis and leukostasis. Patient was admitted to hospital and received. ceftriaxone and azithromycin for possible pneumonia. She underwent leukophoresis on the 4/6/2021, 4/7/2021. Patient received IV heparin gtt for DVT but later on was on hold given worsening thrombocytopenia. She was transferred from one hospital to another hospital. I do not think the development of DVT was due to COVID vaccine. But prior to COVID vaccine, patient was in AML remission." "1218779-1" "1218779-1" "Death" "1218848-1" "1218848-1" "Angioedema on 4/2/21 leading to death" "1218987-1" "1218987-1" "Date and time of vaccination: (list both if they received both shots): 02/02/21 1100, 02/23/21 1200 Date and time adverse event started: 02/05/21 1100 SOB AFTER FIRST SHOT ,FATIGUE , WAS ADMITTED TO HOSPITAL FOR 7 DAYS , RELEASED AND THEN RETURNED TO THE HOSPITAL , SENT BACK TO , SAW THE DOCTOR 24TH OF MARCH , DOCTOR ADVISED WATER REDUCTION AND THE PATIENT HAD DEVELOPED CHF , PATIENT PAST ON THE 29TH" "1219000-1" "1219000-1" "Patient was alert and verbally responsive in usual state of health on 1/11/2021 received Moderna vaccination dose 1. Patient seemed stable until 2/6/21. Then on 2/6/21, patient was noted with slight elevated temp of 99.2, pulse 100, spo2 94%RA at 2:15am. By 5:20am, patient was pronounced dead." "1219100-1" "1219100-1" "This patient was at work two days after her vaccine and went to the bathroom. When she did not come back to work after around 20 minutes, she was found unresponsive and an ambulance was called. The patient was declared deceased at the ER with the cause of death initially as cardiac arrest however a full autopsy was performed and Coroner's office is awaiting that report at this time. We did not know of the death until we went back this week to complete the second round of vaccinations. Since the death happened in such close proximity to the vaccination date we felt it prudent to report." "1219229-1" "1219229-1" "Pt. c/o symptoms of fatigue and dizziness on 3/2. On 3/3 pt. presents to ER, afebrile, c/o fatigue, feeling of being lightheaded, reports syncope and falling x's 2. Pt. according to MD documentation was in good health. Denies any recent illness. Pt. was found to be bradycardic, sick sinus syndrome, r/o MI. Pt. was transferred to higher level of care hospital on 3/3. Pt. had emergency pacemaker insertion. She became hypotensive and hypoxic post-op and was found to in lactic acidosis. Pt. expired on 3/3/21." "1219334-1" "1219334-1" "Death on 3/22. Unknown cause. Family found him unresponsive. Did not pursue autopsy." "1219402-1" "1219402-1" "Homebound visit complete 4/14/21 around 1230-1300, monitored for 15 minutes, left attended with home health nurse. Patient was found dead per EMS and had passed sometime during the night." "1219404-1" "1219404-1" "Pt was admitted with COVID-19 pneumonia on 4/15 that has progressed to COVID ARDS, DKA, AKI on CKD, NSTEMI" "1219505-1" "1219505-1" "STARTING HAVE SEVERE PAIN IN LOWER NECK UP INTO LEFT SIDE OF HEAD SEVERAL DAYS AFTER VACCINE. ER ON 3/15/21 SHOWED ARTHRITIS IN C-3. SENT TO DR FOR FOLLOW UP. 3/17/21 PUT ON ORAL PREDNISONE, PAIN SHOTS X4 IN AREA. 3/19/21 RETURN TO ER, INCREASED PAIN AGAIN, LOSE OF SIGHT IN LEFT EYE, CT SHOWED POSSIBLE VERTEBRAL ARTERIAL OCCLUSION WITH POSSIBLE DISECTION. ADMITTED. ALSO SAW MICRO VASCULAR CHANGES AND ATROPHY. NEURO CONSULT FOR THROMBECTOMY VS MEDICATION MANAGEMENT. PER FAMILY, PAIN MEDS, NO FURTHER MRI OF BRAIN, COMFORT CARES. PT DIED 3/22/21." "1219577-1" "1219577-1" "3/27/2021- @3 AM resident with increase in SOB with unresponsive episodes. Pt states she has history of unresponsive episodes related to cardiac issues, declined hospitalization." "1219667-1" "1219667-1" "Patient had a Hemorrhagic stoke and passed away." "1219772-1" "1219772-1" "Patient died 1 month after vaccination, cause of death is failure to thrive" "1219816-1" "1219816-1" "Resident passed on 3/23/2021. Resident continues to decline medically. 2/22 He was admitted to nursing home with worsening pressure injury." "1219828-1" "1219828-1" "Patient received his first Moderna vaccine 3-19-21. He was due for his 2nd dose 4-16-21. We followed up with his sister due to missed appointment and was informed that he passed away 4-15-21 due to a blood clot." "1220012-1" "1220012-1" "02/21/21- Resident has been refusing meds and meal with continued poor PO nutritional intake, and lethargic. She continue to have periods of medication refusal and continued poor PO intake. 3/8 She developed shingles to her R buttock and was started on Acyclovir cream x7 days. She continues to decline medically. Admitted to Hospice on 3/12, poor PO intake and weight loss. 3/23 Resident passed." "1220155-1" "1220155-1" "Internal bleeding resulting in death." "1220223-1" "1220223-1" "None stated." "1220264-1" "1220264-1" "Patient was scheduled for second dose on 4/14/21. Wife called that morning to say that patient passed away on 4/6/21. Wife Callie stated he saw the neurologist on 4/1/21. On 4/6 he was doing very well in the am and pm. She put him to bed, he woke up and called to her, gasped and passed away. She reports he tolerated the 3/17 vaccination well. I called the doctor on 4/16/21 for more information but he has not returned my call as of yet." "1220532-1" "1220532-1" "On 4/16/2021 I received a phone call from public health informing us that the patient died on 3/31/2021." "1220590-1" "1220590-1" "- In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restlessness, pallor, R arm pain. - Telephone visit 4/14/21 complained of chills, nausea, vomiting, abdominal cramping, diarrhea. Fluids and rest recommended. - 4/15/21 presented to Kaiser with chest pain, shortness of breath, abdominal pain. Diagnosed with late presentation of acute coronary syndrome / anterior ST elevation MI. Echo with low EF < 25%, LV apical thrombus - 4/16/21 heart catheterization showed 100% occlusion of LAD treated with PCI / DES x 2, IABP. Endotracheal intubation for respiratory failure." "1220723-1" "1220723-1" "36 year old male with hx of hypertension , asthma, schizophrenia . he recieved Janssen vaccine on 4/6/2021. he started to fell unwell on 4/14 and on 4/15 he was found by his father unresponsive then sent to the hospital. Pt was diagnosed with massive pulmonary embolism, severe shock, acute renal failure ,Diabetic ketoacidosis , hyperglycemic hyperosmolar nonketotic coma, acute respiratory failure, patient expried from massive pulmonary embolism within 48 hours after admission." "1221106-1" "1221106-1" "Eleven days after receiving the dose, he died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Eleven days after receiving the dose, he died) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The patient's past medical history included COVID-19. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 21-Feb-2021 The patient died on 21-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Unknown Action taken with mRNA-1273 in response to the event was not applicable. Prior to the patient's receiving his first dose of the Moderna Covid-19 vaccine series, wife reported that he was hospitalized for Covid-19 infection for three weeks. While hospitalized, he was treated for Covid-19 infection with medications unknown to her and was very sick on a ventilator in the ICU. He was then discharged to a rehab facility for several weeks and moved to a nursing home for additional rehab. Eleven days after receiving the dose, he died on 21 Feb 2021. He had been getting along well and working on coming home prior to receiving the first dose. Limited information regarding the patient's death has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the patient's death has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death" "1221127-1" "1221127-1" "Died of clots in brain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRAIN STEM THROMBOSIS (Died of clots in brain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medically reported history). On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced BRAIN STEM THROMBOSIS (Died of clots in brain) (seriousness criteria death and medically significant). The patient died on 30-Jan-2021. The reported cause of death was Brain stem thrombosis. It is unknown if an autopsy was performed. This is a 76 year-old, who received mRNA-1273 Vaccine) and died 8 days after receiving first dose of vaccine and subsequently experienced brain stem thrombosis. No medical hx or conmeds were provided. The reported cause of death was brain stem thrombosis. Very limited information has been reported at this time. Further information is expected. This case was linked to MOD21-075103, US-MODERNATX, INC.-MOD-2021-075124 (Linked Report).; Sender's Comments: This is a 76 year-old, who received mRNA-1273 Vaccine) and died 8 days after receiving first dose of vaccine and subsequently experienced brain stem thrombosis. No medical hx or conmeds were provided. The reported cause of death was brain stem thrombosis. Very limited information has been reported at this time. Further information is expected. MOD21-075103: US-MODERNATX, INC.-MOD-2021-075124:Patient's brother in law case; Reported Cause(s) of Death: brain stem thrombosis" "1221137-1" "1221137-1" "My my grandma got them a derma vaccine on January 22 she died on February 11 she was admitted to the hospital with a blood clot in her leg they tried to do surgery but when they put her under the anesthesia she never woke back up. She was 93 years old and had many other health conditions but when I called the doctors office to ask them if they reported my grandma they just kept giving me the runaround I tried to call hospital as well and I got the same thing they told me to go back to the doctor. I think someone should know and I think it?s way too difficult for family members to try to report adverse side effects it took me all day to find someone that could help me get to this website. I think there may be a lot more adverse side effects but people don?t know how to report them." "1221145-1" "1221145-1" "My uncle unexpectedly passed away during the early morning hours of April 13. He had reported to my aunt that he was having shortness of breath, headaches, and in general not feeling well. She found him sitting up with a clear liquid pouring out of his nose and then he fell over dead." "1221163-1" "1221163-1" ""heart attack; couldnt walk; couldnt get out of bed; body ache and pains; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 033A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Neurological disorder NOS, Diabetes, peripheral artery disease, Disabled spouse (100% disable) and COPD. Concomitant products included GABAPENTIN for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 21-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criterion death), GAIT DISTURBANCE (couldnt walk), BEDRIDDEN (couldnt get out of bed) and PAIN (body ache and pains). The patient died on 21-Mar-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, GAIT DISTURBANCE (couldnt walk), BEDRIDDEN (couldnt get out of bed) and PAIN (body ache and pains) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient had a medical condition of ""agent orange"". The patient was a veteran. Treatment included for the events was acetaminophen (Tylenol). Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-075051 (Linked Report).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-075051:Case for second dose; Reported Cause(s) of Death: Heart attack"" "1221176-1" "1221176-1" "he died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (he died) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 03-Apr-2021 The patient died on 03-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the event was not applicable. Very limited information regarding this event has been provided at this time. Further information has been requested; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested; Reported Cause(s) of Death: Unknown cause of death" "1221329-1" "1221329-1" "My Dad was healthy no symptoms on first shot . On Second shoot just slight pain in arm , he felt sick on Sunday the 4 of April at around 7pm he had a upset stomach. He got worse at night. in the morning Monday the 5 April we decided it was time to take him to the hospital. Due to the covid 19 restriction we were not able to go in with him He was stable until 1 pm when he suffered 4 heart attacks . He Died . He was healthy he exercise and was active every day . We were told to report this because it was close to dates of vaccination." "1221425-1" "1221425-1" ""Patient felt ok the day of the shot, next day got very sick. Said he felt terrible, felt like the vaccine was going to ""do him in."" He complained of weakness and shortness of breath. He was dehydrated and worried about his kidney function. Said he had a hard time going to the bathroom with stomach pains. On Mar 31, 2021, said he had fever, but didn't go to doctor. Was taken by ambulance April 3 to ER, admitted that night, transferred to ICU on April 4, on ventilator, proceeded to experience multiple organ failure and died on April 11, 2021"" "1221521-1" "1221521-1" "Patient reported after 1st vaccine experiencing some itching. Patient also reported an increase in his BS after vaccine 1. Provider prescribed Atarax to patient for this, patient had previously been prescribed this as he has had a similar reaction to other vaccines and medication changes. Patient was seen by provider for high BS, patients insurance stopped paying for his insulin and they were transitioning him to Trulicity. Patient came to vaccine clinic on 4/13/2021. Patient was given 2nd dose of vaccine and monitored for appropriate period of time post vaccination. Patients family reports that patient had been feeling SOB for the past several weeks and more fatigue than usual. 4/14/2021, patient triggered an alert thru the monitoring system, nurse reached out to patient to discuss and schedule appointment for further DM education and appt with provider. Nurse had difficult time reaching patient, but patient did call back same day and scheduled appt on 4/23/21. Family reports they went to bed on 4/14/2021, brother went upstairs for bed checked on patient and he was unresponsive. 911 called, paramedics and fire department responded, but CPR was unsuccessful. Patient pronounced dea 4/15/2021 @ 12:26am." "1221576-1" "1221576-1" "Death" "1221916-1" "1221916-1" "blood clot in his brain; Patient collapsed on the floor at night 2 days after receiving 2nd dose; brain was dead; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRAIN DEATH (brain was dead), CEREBRAL THROMBOSIS (blood clot in his brain) and LOSS OF CONSCIOUSNESS (Patient collapsed on the floor at night 2 days after receiving 2nd dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0021B21A and 001821A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history reported). On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Patient collapsed on the floor at night 2 days after receiving 2nd dose) (seriousness criterion hospitalization prolonged). On 30-Mar-2021, the patient experienced CEREBRAL THROMBOSIS (blood clot in his brain) (seriousness criteria death and hospitalization prolonged). The patient died on 08-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, LOSS OF CONSCIOUSNESS (Patient collapsed on the floor at night 2 days after receiving 2nd dose) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, X-ray: blood clot (Positive) x-rays revealed blood clot in his brain. No concomitant medications were reported. After the 2nd dose, On 29Mar2021, at night, he collapsed on the floor and was taken at the hospital on same night by ambulance. So he was hospitalized on 30Mar2021 and upon doing tests and x-rays, they found blood clot in his brain. He stayed in hospital through out and transferred to hospice center on 06Apr2021 where he passed away on 08Apr2021. His brain was dead and never recovered from the clot. Unknown treatment medications were given at the hospital. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death" "1221918-1" "1221918-1" "Died; The initial case was missing the following minimum criteria: Reporter with no first-hand knowledge. Upon receipt of follow-up information on 13Apr2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported that a 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Jan2021 (at the age of 66-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 for COVID-19 immunisation. The patient died on 11Jan2021; the cause of death was unknown. On 11Jan2021, the patient experienced cardiac arrest and breathless with outcome unknown. The patient was found pulseless and breathless 20 minutes following the vaccine administration. MD found no signs of anaphylaxis. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Died" "1222020-1" "1222020-1" "Patient became unresponsive in his chair at home. CPR was attempted by patients wife and paramedics without success. Patient is deceased." "1222021-1" "1222021-1" "Client became ill approximately one hour after COVID immunization. Symptoms include weakness, light headed, general malaise. Client refused wife's offer for medical assistance." "1222285-1" "1222285-1" "Hospice patient, started with dysphagia. POC of the home refers death by asphyxiation" "1222324-1" "1222324-1" "From 3/11/2021 until 3/29/2021 the patient was in the hospital due to lack of appetite and kidney failure. The doctor certifies that the cause was more natural" "1222366-1" "1222366-1" "Died a natural death" "1222399-1" "1222399-1" "POC alleges that she observed that resident began to swell and retain fluids and the nurse noticed that he was not urinating, felt a lot of tiredness and had swollen legs. He was evaluated by the doctor and sent for several studies (EKG) and his heart was weakened. He was sent to do another study, because snoring was heard. He was transferred to the hospital to the ER, he had the fluid in his lungs. He is placed intensive and dies on 3/23/2021 from heart failure." "1222469-1" "1222469-1" "REPOERTED BY FAMILY MEMBER THAT THEY FOUND PATIENT DEAD IN SLEEP, NOT BREATHING SUSPECTING HEART ATTACK...AUTOPSY WILL BE PERFORMED" "1222565-1" "1222565-1" "Resident was in Hospice and began to stops wallowing. Respiratory cardiac arrest" "1222742-1" "1222742-1" "This patient was admitted to Hospital, and subsequently transferred with acute coronary syndrome and cardiogenic shock two days after receiving a COVID-19 vaccination. He died of complications of acute coronary syndrome on April 17, 2021." "1222817-1" "1222817-1" "Patient called me Wednesday April 14,2021 at 12:44 pm explaining that she was having a hard time breathing that day. Due to her chronic lung health, I didn?t think much of it. She passed away in the early hours of Thursday April 15,2021 in her sleep." "1222837-1" "1222837-1" "On 3/25/2021 POC alleges that the resident begin to develop fever and urine infection. He was transferred to the hospital on 3/26/2021 where he had white secretions in his mouth. On 3/28/2021 he died in the hospital from respiratory cardio failure." "1222851-1" "1222851-1" "12 hrs after receiving, did not feel well headache , nausea, 48 hrs later had seizure during sleep ,affecting her speech , speech got worse over the day drs were running test , then had another seizure causing them to resuscitate, hospital was giving he4 seizures medications , she was giving 5 and a small amount of sedation, 1# days later they had them almost to a halt , ran several test to determine what could have caused the seizures and could find no reason , she never regained consciousness, she passed away 18 days later . I would like to know if the vaccine caused the seizures ." "1222852-1" "1222852-1" "The manager says the patient lost her appetite, presented a cough with difficulty swallowing" "1222868-1" "1222868-1" "According to POC the resident was transferred to the hospital on 4/8/2021, due to low pressures, high pulse and cough. They certify death by COVID 19, because it affected the lungs." "1222886-1" "1222886-1" "Massive aneurysm - deceased 04-15-2021" "1222901-1" "1222901-1" "Patient had started peritoneal dialysis at home with me, his wife, 8 days before the second shot. All was going well. We got his second shot on the morig of March 18. His only reaction seemed to be soreness at injection site. At 11 pm we started dialysis as usual, with the cycler. At 12 pm he was having trouble breathing after just having been filled with 1500 ml of dialysate. This was the first time this happened. I gave hi nitro glycerine and had the cycler take out the 1500 ml of dialysate, and stopped the therapy for the night. He then felt better, and apologized for waking me up. In the morning he was dead. I believe it is possible that the vaccine tipped the balance of patients already taxed system. As I know that people who have serious diseases and are older are encouraged to take the vaccine, this outcome should be known to the CDC." "1223056-1" "1223056-1" "My wife started to fall and pass out had no strength to get up this happened two to three times cinch she got the shot the last time she past out in the shower and i rushed her to hospital were she pasted away from blood clots to the right side of the neck and stated bleed on the brain" "1223167-1" "1223167-1" "My father received the first dose on 2/13, and started to rapidly decline thereafter. He started having neurological issues, memory issues, and balance issues and eventually collapsed and was hospitalized on 3/5, intubated twice in two weeks, with his death occurring on 3/31/21." "1223371-1" "1223371-1" "Patients First dose 01/13/2021 and second dose of Moderna Covid 19 vaccine was administered on February 11th. Patient developed pulmonary embolism in both lungs and hospitalized February 25th. Patient later developed PCP Pneumonia and died March 23rd." "1223378-1" "1223378-1" "please find attached document provided by spouse." "1223630-1" "1223630-1" "Nausea vomiting throughout the day and continuous the next night, sense on impending doom" "1223644-1" "1223644-1" "Not feeling well, malaise, fatigue, intermittent upper stomach pain (sharp) beginning day after vaccine administration lasting 8 days resulting in death on 4/10/21" "1223650-1" "1223650-1" "In the evening on March 15th, she began having shortness of breath and chest pain. She asked her boyfriend for her blood pressure cuff so she could take her blood pressure. As he was getting it she told him to call 911 and then her eyes rolled back in her head and she stopped breathing. Paramedics attempted to revive her but were unsuccessful. She was taken to the hospital and pronounced dead. Cause of death listed as heart disease." "1223669-1" "1223669-1" "60 year old male died unexpectedly at home, found 04/11/2021. Last known contact was by phone with his brother on 04/10/2021. Cause of death was determined to be MI due to ASCVD due to tobacco dependence, cigarettes. Autopsy was not requested. This medical examiner was later contacted by the daughter of the decedent to report that he had received the Johnson & Johnson COVID vaccine on 04/08/2021, 2-3 days prior to his death." "1223683-1" "1223683-1" "Patient reported severe headache on 2/12/21 at approximately 3:30 pm followed by vertigo, nausea, vomiting. Patient became unconscious and EMS was called, found patient on floor and she was brought to ED where CT revealed intracranial hemorrhage. Patient was admitted and supportive care given. She had worsening status on 2/17/21 with pupillary reflexes no longer present and withdrawal of care was performed on 2/21/21. Patient expired on 2/22/21." "1223714-1" "1223714-1" "This information is second hand, I have not been in contact with next of kin- I am reporting this because I don't know if anyone else including a medical examiner or his PCP would know that he was recently vaccinated. I was told that this patient was feeling sick for a couple of weeks. A friend visited him within the last couple days and he had a migraine headache. When they went to check on him today they found him deceased in his chair. Further investigation would be needed." "1223800-1" "1223800-1" "resident unresponsive verbally and favoring L side with R side flaccid unable to take AM med. The writer obtained BS 90. The resident has R side face drop with drooling noted. The resident responded to painful stimuli only. Pupils dilated. Supervisor at bedside BS 102 rechecked. The family opted for comfort measures only. Age 68 On 2/15/2021 Z51.5: ENCOUNTER FOR PALLIATIVE CARE, Patient expired 2/23/2021" "1223941-1" "1223941-1" "Death 4/17/21" "1223971-1" "1223971-1" "4/4/21 at 11:30 pm the patient started to make snoring-like sounds in her sleep and could not be woken up. 911 was called and in the hospital a CT scan identified extensive large right-sided intraparenchymal hemorrhage within the frontal, parietal and temporal regions, extending into the ventricular system. The patient was put on the ventilator and administered blood pressure medication. A-line was inserted to read blood pressure. 4/11/21 at 8:11 pm the patient passed away due to cardiac arrest" "1224121-1" "1224121-1" "My Husband and I received the same day a strong pain in our left arms. The next day my husband complained about pain in his entire body and weakness, and I had the same. In the evening he collapsed falling out of his wheelchair. He tried for an hour to sit down back in his wheelchair with my help, but he couldn't. He agreed that I call 911. Two nurses took him to Emergency Room at Hospital and didn't allow me to go with him. In the morning on Saturday, he was transferred to Room at Hospital and the next day to the Intensive Care Room, where he sadly passed away on Tuesday April 13 at 4:22 am." "1224144-1" "1224144-1" "Developed fever, nausea and vomiting about 24 hours later. Symptoms lasted two days and began to subside, at which time shortness of breath began. Patient drove himself to the hospital for evaluation and treatment on Saturday, March 27th where he collapsed in cardiac arrest. he was resuscitated and stabilized on life support. He died of multiple organ failure on Monday March 29th. The official diagnosis was Severe Septic Shock. It is unclear if any infective agent was identified. It should be noted that sepsis is a condition in which immune dysregulation is inherent and includes cytokine storm activity. The possible correlation between vaccination and the subsequent development of sepsis should be investigated." "1224177-1" "1224177-1" "Blood clot blocking blood flow to brain - 1st episode: ( 3/12/21) stabilized, minor limited movement left side - 2nd episode: (3/24/21) no blood flow to brain, death (maintained on life support for organ donation)" "1224884-1" "1224884-1" "Shock; Reduced Central pulse volume; Loss of consciousness; potential anaphylactic reaction; found unresponsive in a swimming pool; This is a spontaneous report received from a contactable Physician. An 81-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included cardiac arrest, congestive heart failure, difficult breathing and arrhythmia. Concomitant medications included metoprolol; omeprazole; propranolol; duloxetine; fosinopril; pravastatin; hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ); levothyroxine sodium (SYNTHROID); insulin glargine (BASAGLAR); asa and ranitidine hydrochloride (ZANTAC). The patient previously minocycline for swelling and the patient had a historical vaccine of shingrix on 11May2020. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 for covid-19 immunisation. The reporter stated that the patient was found unresponsive in a swimming pool on 18Feb2021. The patient also experienced shock, reduced central pulse volume and loss of consciousness and potential anaphylactic reaction on an unspecified date. The patient did not received any recent vaccines for SARS-CoV2 other than Pfizer_BioNtech COVID-19 Vaccine prior to the event being reported. The patient died on 22Feb2021. It was not reported if an autopsy was performed. Outcome of the events was fatal. Information on Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: found unresponsive in a swimming pool; Shock; Reduced Central pulse volume; Loss of consciousness; potential anaphylactic reaction" "1224923-1" "1224923-1" ""My uncle died three days after taking the vaccine; he felt strange and he felt like something was in his throat; he felt like he wasn't doing well; This is a spontaneous report from a contactable nurse reporting for her uncle. A 73-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation . Medical history included psoriasis , cardiac pacemaker insertion on an unknown date (He recently had a pacemaker implanted several months ago) , hypertension from an unknown date. The patient died three days after taking the vaccine on 09Apr2021 , he felt strange and he felt like something was in his throat on 09Apr2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 150/90 on 09Apr2021. It was not reported if an autopsy was performed. Course of the event: The reporter's uncle died three days after taking the vaccine. He was at home getting ready to watch a basketball game with the reporter's aunt when he began to complain that he felt strange and he felt like something was in his throat. Both the patient and the reporter's aunt are also RN's. My aunt checked his BP and the first time it was 150/90. His BP was taken a second time but the reporter cannot remember what the 2nd reading was. He then said he was going to the bathroom and asked her to call # because he felt like he wasn't doing well. The reporter's aunt called #, and assisted the reporter's uncle to lay down in bed. She remained on the phone with #who arrived at the scene shortly thereafter. They performed CPR at the scene and he was transported to the hospital. The reporter believes the patient was pronounced dead at home. The patient was about 5""10, heavy set stature. He recently had a pacemaker implanted several months ago and has a history of psoriasis and HTN. There is additional concomitant medical history I will have to confirm. Information about lot/batch has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment for the reported patient's sudden death. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: My uncle died three days after taking the vaccine"" "1225566-1" "1225566-1" "Patient had a sudden change in status one week after receiving his first Moderna Covid 19 vaccine. He had sudden onset of tachypnea RR = 40/min, apparent severe pain, greatly elevated blood pressure, with normal heart rate (on beta blocker), diaphoresis. had been enrolled in hospice for 14 months prior to this episode, but had experienced only slow decline prior to this acute event. He died at home under hospice care on 2/27/2021." "1225829-1" "1225829-1" "Extreme weakness & Fatique Dizziness Fainting Death 04/09/2021" "1225854-1" "1225854-1" "Death, 04/16/2021" "1225903-1" "1225903-1" "Brain Bleed - Hemorrhaging Stroke" "1225942-1" "1225942-1" "Patient was a 16yr female who received Pfizer vaccine 3/19/21 at vaccine clinic and presented with ongoing CPR to the ED 3/28/21 after cardiac arrest at home. Patient placed on ECMO and imaging revealed bilateral large pulmonary embolism as likely etiology of arrest. Risk factors included oral contraceptive use. Labs have since confirmed absence of Factor V leiden or prothrombin gene mutation. Patient declared dead by neurologic criteria 3/30/21." "1226135-1" "1226135-1" "My mother died in the hospital after being in the ICU for a week with severe breathing problems. Her symptoms matched that of a Covid patient but she tested negative for Covid twice (once was the 24 hour test)." "1226196-1" "1226196-1" "Patient arrived to Hospital in cardiac arrest 48 hours after administration of the Pfizer Vaccine." "1226364-1" "1226364-1" "Patient developed unspecified pneumonia which led to extremely high troponin levels. Patient died due to cardio pulmonary disease due to complications from COVID vaccine." "1227279-1" "1227279-1" "heart attack; stopped breathing; This is a spontaneous report from a contactable consumer. A 67-year-old female patient (mother) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Mar2021 (67-year-old) as single dose for COVID-19 immunization. Medical history included Hypothyroid, Sleep Apnea, Known allergies: Shellfish, Sulfa, Possible Tree Nut allergy. Patient is not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID); apixaban (ELIQUIS); senna [senna alexandrina]; valsartan; clopidogrel; metoprolol; atorvastatin; macrogol 3350 (MIRALAX). The patient previously took vitamins, Claritin , first dose of bnt162b2 on 24Jan2021 01:00 PM (67-year-old) for COVID-19 immunization and exactly 3 weeks after the first dose, the patient had a heart attack and stroke. Exactly 3 weeks after the second dose (04Apr2021), the patient stopped breathing and died. It was reported that death cause was unknown but also likely heart attack (unspecified date). Ae resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage, Patient died]. Number of days hospitalization is 10. Patient had no covid prior vaccination. The patient was covid tested post vaccination. The patient underwent lab tests and procedures which included covid test (Nasal Swab): negative on an unspecified date. The patient died on 04Apr2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: stopped breathing; death cause: likely heart attack" "1227320-1" "1227320-1" "about 2 days after the 1st dose of the moderna vaccine, felt very tired and unwell for several days. He felt okay for about 2 weeks then on January 29, 2021 he felt intense chest pain. Concerned it was a heart attack, he was brought to the hospital. He stayed one night and the hospital ran several tests like EKG, stress test and others. Found his results to be normal and was released on January 20, 2021. Even the moment he was released, he felt very dizzy but hospital was not concerned and thought maybe side effect of medication. He continued to feel dizzy, fuzzy brain and hard time staying awake during the day and sleeping through the night for the rest of the week. He passed sometime in the early hours of February 6, 2021. Doctor's suspicion is a blood clot. He has no history of blood clots, heart problems or any health issues." "1227451-1" "1227451-1" "presented to Emergency room with complaints of approximately 5 days of progressively worsening shortness of breath with a dry nonproductive cough, increased weakness, and wheezing. Symptoms not controlled with increased use of rescue inhaler albuterol. Patient's daughter reached out and spoke with patient's pulmonologist Dr. today who ordered oral steroids however patient reports she had not started taking them yet. Patient was initiated on 15 L non-rebreather and received 2 duo nebs EN route to the hospital. It was reported she did have some intermittent chest tightness although on my review, she denied this. Upon arrival to the emergency room, patient was initiated on BiPAP and receive 40 mg of IV Lasix at 125 mg of IV Solu-Medrol. Patient expired 4/19/2021" "1227470-1" "1227470-1" "My uncle started feeling unwell the evening he got his 2nd Covid 19 vaccine. By the next evening, he started vomiting violently, trembling and sweating. He lived in country and his caregiver didn't think to take him to the hospital. The symptoms calmed down after a while, but he was not able to hold any food or liquids down. Eventually, he fell asleep and his caregiver left for the night. He returned on Easter Sunday at 9:30 am and found my uncle deceased." "1227962-1" "1227962-1" "suddenly passed away; This is a spontaneous report from a contactable healthcare professional reporting on behalf of friend's husband. A 43-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Apr20201, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient suddenly passed away on 11Apr2021. It was unknown if an autopsy was performed or not. The patient passed away at home and he was otherwise healthy. The reporter stated there was not a way to know if it was related to the vaccine as of right now. Information on lot number/batch number has been requested.; Sender's Comments: Limited information precludes a medically meaningful assessment of the case. A possible contributory role of the suspect product BNT162B2 to the development of event Sudden death cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: suddenly passed away" "1227970-1" "1227970-1" "Mom died of a Brain Stem stroke; This is a spontaneous report from a contactable consumer (who reported for the mother). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 03Mar2021 at 11:30 (at the age of 88-year-old) (Lot Number: EN6198) as single dose for COVID-19 immunisation. The patient was not tested for COVID-19 after vaccination. Relevant medical history included COVID-19 prior of vaccination. Concomitant medication included atorvastatin (LIPITOR) taken for an unspecified indication, start and stop date were not reported. On 09Mar2021 at 09:45, the patient experienced a brain stem stroke; the event required emergency room visit, the patient was hospitalized on 09Mar2021 and the event was considered serious also as life-threatening and causing disability. The patient received unspecified corrective treatments. The patient died due to brain stem stroke on 11Mar2021. An autopsy was not performed.; Reported Cause(s) of Death: Brain stem stroke" "1227977-1" "1227977-1" "Pulmonary embolism/ blood clot/ passed out; This is a spontaneous report from a contactable consumer (patient's daughter). A male patient of an unspecified age received BNT162B2 (Pfizer COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in arm, side unknown, on 24Mar2021 14:30 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Vaccination facility type was clinic. Medical history included colon cancer in 2011. He had cancer in 2011 but resolved that year without chemotherapy or radiation. His lab work was good. There were no concomitant medications. No prior vaccinations (within 4 weeks). No family medical history relevant to AE. The patient experienced pulmonary embolism on 26Mar2021 with fatal outcome. The reporter was reporting on the Pfizer COVID vaccine that her father received. She stated he died from a blood clot after receiving the first dose. Stated she needs help because he had no health issues and he died. She just wanted this information to be out there and for people to be aware. This morning they had been reading on the news that the Johnson and Johnson vaccine is on hold. It seems to be put on the market without research. She felt like her father was a guinea pig. Her mother didn't want to get her second dose. Stated there seems to be an issue with Pfizer too. Her father had no issues whatsoever. His death certificate stated the cause of death was a pulmonary embolism, but he had no history of blood clots. Passed away Friday 26Mar2021 at 11:33 am. The reporter stated when he went to Emergency Room they thought he was having a heart attack. All physicians were wondering what happened because he had no health issues. The event required a visit to the emergency room that day because he passed out at his job. The patient underwent lab tests and procedures which included lab work: good in 2011. The patient died on 26Mar2021. An autopsy was performed that revealed pulmonary embolism.; Reported Cause(s) of Death: Pulmonary embolism; Autopsy-determined Cause(s) of Death: Pulmonary embolism" "1227980-1" "1227980-1" "Blood Clot/The Blood clot was in the legs and went to his lungs; Blood Clot/The Blood clot was in the legs and went to his lungs; fell; Leg pain; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included thrombosis from 2020 to an unknown date, it was Months ago in 2020, He was prescribed a medicine for blood clots, but since then he has had no issues, anxiety from an unknown date and unknown if ongoing. Her brother in law had anxiety about even getting the vaccine. The patient experienced leg pain on Mar2021 , pulmonary thrombosis, leg thrombosis and fall on an unspecified date. The patient died on 02Apr2021. An autopsy was not performed. The clinical course was the following: The Blood clot was in the legs and went to his lungs, his leg never got red or anything and it was a blood clot. He was having such bad leg pain, it's too bad, had there been some sort of warning, he would have thought to wait till next year. There was nothing the day he got vaccine, but that night his leg started hurting, his girlfriend said let me go get a cold wrap and she wrapped it, he's a farmer. He wakes up the next day and his leg is still hurting, the 3rd day it goes on, his leg still hurting and no one is thinking it a blood clot, he calls the doctor and tells the doctor his leg is hurting, they suggest ibuprofen for inflammation, the next day thought maybe it's better, by Friday he was making breakfast, fell and died. With his girlfriend she said what's going on, and he went straight to hospital, they said the clot in his leg went to the lung. The Blood clot when it was in the leg it never got hot, red, or anything like that. He had the vaccine in the morning and on that same day the leg pain started later that night. It Started out with Leg Pain, she does not know if it was right or left but it was just one leg.; Reported Cause(s) of Death: Thrombosis pulmonary; Thrombosis leg; Fall; Leg pain" "1228009-1" "1228009-1" "respiratory and cardiac arrest Narrative: Patient with PMH of esophageal cancer, larynx cancer, liver cancer, PTSD, A. fib, and alcohol abuse. He received his COVID-19 vaccines on 2/14/21 and 3/14/21. Both vaccines were administered without complications and patient was observed for 15 minutes post-vaccination without adverse effects. No other adverse events noted between time of last COVID-19 vaccinations and death. On 4/11/21, patient's wife called 911 in which EMS found patient unresponsive with abnormal breathing. Wife reported that patient was breathing up until 5 minutes prior to EMA arrival, but had been unresponsive. Wife reports that patient suffered from multiple forms of cancer, PTSD, and alcohol abuse. Wife believed that patient quit smoking and drinking but the morning of death found vodka and cigarettes in his coat. Wife reports that patient asked for help getting up from the stairs and then laid down in the bed, and went unresponsive afterwards. EMS attempted to revive the patient with CPR but were unsuccessful. Per EMS note patient suffered from respiratory arrest, cardiac arrest, then cardiac death. Patient was not brought to the hospital prior to death. It is very unlikely that the COVID-19 vaccinations contributed to this patient's death due to his extensive PMH with substance use disorder and cancer." "1228010-1" "1228010-1" "Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient died of a drug overdose and had a UDS positive for fentanyl and alcohol on 3/8/21 patient tested positive for Chlamydia due to high risk sexual behavior and substance use disorder. Patient was admitted to facility on 2/26/21 to detox from alcohol." "1228011-1" "1228011-1" "Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors (PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did no occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 90 yo and admitted on 2/10/21 for SOB and a fall resulting in a femur fracture. Patient was on Eliquis and has h/o CABG x5, dementia, bradycardia s/p pacemaker. Patient was discharged to a rehab facility where his condition declined ultimately resulting in transfer to inpatient hospice. He eventually required care in ICU where he eventually deceased." "1228012-1" "1228012-1" "Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 78 and receiving home based primary care prior to COVID vaccination for multiple conditions including CKD, T2DM, w/ complications, and CHF." "1228013-1" "1228013-1" "Death. Narrative: Patient was not previously COVID positive and did not have any predisposing factors (PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 74 but no cause of death listed or notes of recent care. Patient was hospitalized with chest pain in 6/2020 and has h/o of severe multivessel CAD, HFrEF, and polysubstance abuse." "1228014-1" "1228014-1" "Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient was 84 and receiving palliative care for metastatic prostate cancer. Comorbidities include T2DM, HTN, MI s/p PCI, and CKD." "1228015-1" "1228015-1" "Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was admitted to hospital from 11/18/20-1/26/21 for Dx: generalized weakness. Previously admitted 10/21/20-11/17/20 for a pulmonary embolism. Patient did not last long after being discharged from short term rehab and passed away at home on 2/2/2021" "1228016-1" "1228016-1" "Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient was 92 and a resident at facility when he passed away. Patient has been LTC resident since 2/15/2019 and received hospice services prior to receiving first Pfizer vaccine dose. Patient receiving hospice care for terminal colon cancer." "1228018-1" "1228018-1" ""Deceased 3/28/21 ""natural causes"" Narrative: Per notes ""Pathologist was informed that he died of natural causes"". PCP indicated that death cert will only show HTN as cause of death."" "1228019-1" "1228019-1" "Narrative: 2/8/2021 UTI, sepsis, hyperglycemia, staphylococcus, MRSA infection-discharged to hospice care from Medical Center 2/9, passed 2/11." "1228351-1" "1228351-1" "He died unexpectedly early in the morning. He woke up suddenly, said he needed help, and then was gone." "1228372-1" "1228372-1" "Patient's wife called in mid March 2021 letting us know that the patient, needed to re-schedule his 2nd dose of Moderna Covid-19 vaccine - he had missed his scheduled 2nd dose date due to being hospitalized - doctors had thought he might need a defibrillator but then discharged him without one. Patient's wife called back on 4/16 to let us know that he passed away on 4/14." "1228448-1" "1228448-1" "Received vaccine 04/08/2021. Was admitted to the hospital later in the day with cardiac arrest. Deceased 4/9/2021" "1228481-1" "1228481-1" "The patient had previously been diagnosed with COVID-19 in November 2020, but did no require hospitalization and had recovered. He received his first dose of the Pfizer COVID vaccine on 2/25/2021, and on 3/15/2021, collapsed suddenly at home and was unable to be resuscitated. An autopsy was performed at the request of the family, and a massive pulmonary embolus was found in the main pulmonary artery and extending far into the segmental pulmonary arteries of both lungs." "1228594-1" "1228594-1" "Contacted Veteran's son. He did mention that his father was not healthy, but also that his father did not voice any specific changes to his health as recently as Tuesday (4/13) when they last spoke after receiving his second dose of vaccine on 4/10. He did mention that the coroner had declared his father?s death ?natural? and was not planning to do an autopsy." "1228761-1" "1228761-1" "Note from 3/25/2021: PMH of asthma, PVD, Diabetes Mellitus type 2, Diastolic CHF , Aflutter , hypothyroidism , and allergies, who presents to facility with after her home provider saw her and concerned for pneumonia and worsening respiratory status. Lab work-up showed elevated WBC of 20.61, low potassium 3.2 , and BNP of 764. Her troponin was also elevated 0.147. Chest CTA done showed atypical infectious process with consolidation at the left lung base and secondary to pulmonary mycobacterium avium complex infection in the bronchiectatic form .Patient is a 91 year old female with PMH of asthma, PVD, Diabetes Mellitus type 2, Diastolic CHF , Aflutter , hypothyroidism , and allergies, who presents to facility with after her home provider saw her and concerned for pneumonia and worsening respiratory status. Lab work-up showed elevated WBC of 20.61, low potassium 3.2 , and BNP of 764. Her troponin was also elevated 0.147. Chest CTA done showed atypical infectious process with consolidation at the left lung base and secondary to pulmonary mycobacterium avium complex infection in the bronchiectatic form ." "1228798-1" "1228798-1" "a few days after his congestive heart failure got worse and continued on a down ward spiral. He refused to go to hospital and last few days hospice was brought in. He died not being able to breath. Autopsy was not done." "1228875-1" "1228875-1" "woke up with trouble breathin like couldn't get enough air into lungs, happened when sleeping for several nights" "1228903-1" "1228903-1" "patient had massive intracerebral hemorrhage 3 days after vaccination. family claims patient was doing well until vaccination. there is a suspicion that patient might have had sinus venous thrombosis that lead to the the ICH." "1228974-1" "1228974-1" "PATIENT GOT FIRST DOSE OF MODERNA ON 03/11/21 AND PASSED AWAY ON 03/28/2021" "1228976-1" "1228976-1" "Death SHORTNESS OF BREATH" "1228986-1" "1228986-1" "Death" "1229005-1" "1229005-1" "Death" "1229034-1" "1229034-1" "Pt. had hx of SOB prior to vaccination and Dx with hear failure Woke up day after vaccination with being very tired. Admitted to hospital with UTI, Sepsis" "1229053-1" "1229053-1" "PATIENT RECEIVED FIRST MODERNA DOSE ON 03/04/2021 AND PASSED AWAY 03/12/2021" "1229059-1" "1229059-1" "Patient diagnosed with COVID-19 on 3/24/2021 after receiving her first dose of Moderna COVID-19 vaccine on 3/19/2021" "1229079-1" "1229079-1" "Death" "1229092-1" "1229092-1" "PATIENT GOT FIRST MODERNA DOSE 03/11/2021 AND SECOND DOSE 04/08/2021 AND PASSED AWAY ON 04/14/2021" "1229152-1" "1229152-1" "101.5 fever Friday night, followed by a seizure at 3am. She was found unresponsive late Saturday afternoon, and was pronounced dead at the hospital. Sudden cardiac arrest." "1229211-1" "1229211-1" "hemorrhage in the brain" "1229214-1" "1229214-1" "WE RECEIVED A CALL ON TUESDAY AFTERNOON THE 13TH OF APRIL FROM THE MEDICAL EXAMINER REQUIRING INFORMATION ON HOW TO CONTACTB THE PATIENT'S DOCTOR. WHEN ASKED AS TO WHAT HAPPENED WE WERE TOLD THAT THE PATIENT WAS FOUND DEAD IN HER APARTMENT ON TUESDA.Y. WE DID INFORM THEM THAT THE PATIENT HAD RECEIVED THE JANSSEN VACCINE AT THE PHARMACY ON FRIDAY THE 9TH. WE DONT KNOW THE CAUSE OF ADVERSE EVENT." "1229218-1" "1229218-1" "My mom had a brain aneurysm 45 minutes after receiving her second Covid vaccine on Wednesday, March 31st, 2021. She was rushed to Medical Center. After her CT Scan she was put on Life support that morning. After consulting with Doctors we took her off Life Support at 4:00 pm on Friday April 2nd and she passed away 29 hours later at 9;00 pm on Saturday, April 3rd." "1229270-1" "1229270-1" "Fever and diarrhea following a couple days after the vaccine Being administered. The day prior to hospital emergency admission uncontrollable throwing up extreme side/Stomach/chest pain. Was taken by ambulance to emergency." "1229366-1" "1229366-1" "Hospitalization and death within 6 weeks of receiving COVID vaccination." "1229390-1" "1229390-1" "Pt found unresponsive in hospital room with large amount of vomit. Patient pronounced dead shortly after with cause of death noted to be aspiration pneumonia with hypoxemia leading to cardiac arrest. Pt received vaccine 1 month prior so I wanted to report this." "1229396-1" "1229396-1" "Death R41.82 - Altered mental status N39.0 - Urinary tract infection N17.9 - Acute kidney injury (CMS/HCC) A41.9 - Sepsis (CMS/HCC)" "1229552-1" "1229552-1" "We administered the second dose of the Moderna COVID-19 vaccine on Friday, April 16th. We were contacted by the patients family to report that the patient began a fever and chills the night of 4/16, she subsequently began having nausea, vomitting, and sweating followed by a seizure, and was taken to the emergency department where she died the following day. She was encouraged to receive the vaccine at the encouragement of her oncologist." "1229733-1" "1229733-1" "PATIENT DIED THE DAY AFTER GETTING VACCINE" "1229734-1" "1229734-1" "Death" "1229797-1" "1229797-1" "Paient was vaccinated on 3/29/2021 with dose 1 of Moderna. Patient developed COVID symptoms on 4/4/2021 and passed away on 4/16/2021." "1229805-1" "1229805-1" "Death" "1229810-1" "1229810-1" "No adverse reactions" "1229825-1" "1229825-1" "Death" "1229878-1" "1229878-1" "Dissection of the right ICA with occlusion of tthe right ICA, right MCA and portions of A1 segmenet of the ACA" "1229917-1" "1229917-1" "4/3/21 at 0052 during Q15 rounds the patient was found laying awake on the floor next to his bed. He denied falling. Vitals showed BP 95/57, Temp 96, O2 sat 77%. He was evaluated and transferred to an acute care hospital with cardiac specialty. He was found to have elevated triponin and chest x-ray showed lung infiltrates; COVID test was negative. Diagnosis was MI and pnuemonia. He received a right coronary artery stent. The patient was intubated on full ventilation support. On 4/4/21 the patient went into cardiac arrest 3 times and was resuscitated. On 4/5/21 his condition declined and he went into cardiac arrest again and was resuscitated around noon. The patient died in acute care on 4/7/21 at 0608." "1230008-1" "1230008-1" "Patient presented to ER on 4/16/21 complaining of chest pain. Patient stated she had the J&J vaccine a month ago and had been having problems. She was also being seen by a cardiologist." "1230024-1" "1230024-1" "Shortness of breath, hypoxia, Pulmonary Embolism, intubation death." "1230054-1" "1230054-1" "Pfizer COVID-19 Vaccine EUA Patient received vaccine dose #1 on 1/14/2021 and Dose #2 on 1/31/2021. Patient presented to ED on 2/1/2021 with complaints of acute mental status change. He was recently diagnosed with enterocoal/pseudomonas UTI four days prior to presenting to ED and was being treated with Augmentin and Levaquin. Patient screened positive for COVID-19, with the sample analyzed using PCR or equivalent. Patient suffered a cardiac arrest on 2/7/2021 x3, developed three pressor shock, and required maximum ventilator settings. Patient subsequently expired." "1230079-1" "1230079-1" "My husband passed away two weeks and one day after getting his last vaccine" "1230230-1" "1230230-1" "Fatigue, dizziness, heart attack and death" "1230246-1" "1230246-1" "My husband developed severe COVID symptoms, despite testing negative for COVID via pcr tests on Sunday 3/21 /21 and Tuesday 3/23. He was hospitalized on 3/28 due to low blood oxygen levels. Was diagnosed with COVID and pneumonia. Treated with remdesivir and a steroid, then monoclonal antibodies. Despite making progress to the extent doctors were cautiously optimistic on 4/9/21 he would be discharged on 4/16/21, he instead was transferred to ICU on 4/10/21, placed on a ventilator on 4/11/21 and died on 4/15/21." "1230324-1" "1230324-1" "Fatigue, , Body aches, Swollen hands (noted on the 27th), Death (31st)" "1230357-1" "1230357-1" "On the morning of Friday 4/16/21, patient came to vaccine clinic to let us know that his wife passed away the night of her second dose of her Pfizer covid vaccine. He states that she complained of arm pain at the injection site that evening (4/14/21) and went to bed around 9:30pm because the pain was excruciating. He said around 2:00am, she woke up stating she couldn't breathe. This has happened before, so she went and sat up in the living room which helped her last time. For whatever reason, she then went into her bedroom where he said she fell out. He noticed foam coming from her mouth and called 911. EMS was unable to revive her. She passed away at home." "1230371-1" "1230371-1" "Patient passed away on 4/13 after presenting to local hospital with near syncope and AKI. Records from local hospital are unavailable, unclear regarding cause of death and circumstances thereforth." "1230389-1" "1230389-1" "High fever, severe night sweats, blood clots in lungs" "1230493-1" "1230493-1" "Patient had just been advised that his cancer had stopped growing and would be able to resume his immunotherapy drug Tagrisso. After receiving his first dose he went downhill very quickly. On the evening of 2/23 he had an unexplained seizure and went to the ER through 2/26. He was discharged to Hospice and passed away on 2/28." "1230868-1" "1230868-1" "My dad took vaccine 4/1 5pm, he had arm pain 4/2 morning, felt like fever in the afternoon. After 5pm, he compliant with joint pain. He was found on the floor dead 4/3 at 1am at home." "1230879-1" "1230879-1" "Heavy lethargy followed by death." "1231112-1" "1231112-1" "Patient was admitted to the hospital approximately 2 days after receiving the Moderna vaccine. She was under Hospice care before receiving the vaccine." "1231272-1" "1231272-1" "PATIENT RECEIVED THE WND INJECTION APPROX 4:00PM. DAY OF - INITIAL COMPLAINT CHRONIC FATIGUE AND REDNESS & TENDERNESS AT THE INJECTION SITE. NEXT DAY CHRONIC FATIGUE, REDNESS AND TENDERNESS AT THE INJECTION SITE. APPROX 9:30 PM PATIENT COMPLAINED OF A POUNDING HEADACHE AND FATIGUE. SHE DIED A FEW HOURS LATER. CORONER'S OFFICE PROCLAIMED TIME OF DEATH APPROX MIDNIGHT THURSDAY NIGHT/FRIDAY MORNING." "1231384-1" "1231384-1" "Sharp Chest Pain resulting in Death 2 hours later, 03/13/2021 @ 12:08" "1231568-1" "1231568-1" "Unknown onset of adverse events. PT received second COVID vaccine on 3/26/21. She was found deceased in her residence (where she lives alone) by family on 3/28/21. She was found in bed, appropriately covered with blankets. Son last spoke with PT around 17:30 hours on 3/26 after receiving the vaccine, and reported the PT did not complain of any symptoms, did not sound short of breath, and did not complain of any breathing difficulty. Based on postmortem presentation, believed PT died late night of 3/26/early morning of 3/27. Suspect death is likely due to PT's heart disease, Medical Examiner agreed with the assessment.I spoke with the clinic that administered the second dose, and was informed that the PT did not exhibit any signs/symptoms during the observation period immediately following the vaccine being given. PT's PCP was contacted, and agreed to certify DC based on known medical history. PCP also agreed that the death did not sound related to the vaccine based on lack of symptoms as reported by the administering clinic and family." "1231694-1" "1231694-1" "suffered a massive heart attack the morning following his first dose of Moderna vaccine. He was hospitalized for 21 days, first at Hospital and then . He passed away on February 11, 2021, at ." "1232096-1" "1232096-1" "2/17/2021 He was transferred to the hospital because he was having respiratory problems and died in the hospital due to respiratory arrest." "1232109-1" "1232109-1" "On 2/28/2021 while having lunch at noon he suffered an apparent heart attack." "1232115-1" "1232115-1" "Resident was in Hospice and was presenting with an infection. On the morning of 3/14/2021 in the round of caregivers they found him without vital signs." "1232138-1" "1232138-1" "Resident began coughing then complained of abdominal pain and was taken to the Hospital. He began to vomit and breathed in. Had a heart attack" "1232171-1" "1232171-1" "resident with acute SOB on 4/13 sent to ED dx with pneumonia. Sent to rehab. Passed away in her sleep on night of 4/20/21" "1232413-1" "1232413-1" "beginning the day after the vaccine Patient experienced dairrhea, extreme nausea, cramps, coughing and weakness. This persisted for 3 days. Patient suffered a stroke or multiple strokes either 5 or 6 days after administration of the vaccine. She has since died as a result of the strokes." "1232416-1" "1232416-1" "Loss of apatite to the point of no ingestion through mouth. During hospitalization, the medical staff identified a mass at the abdomen." "1232447-1" "1232447-1" "Dies at long term care facility doe to a stroke." "1232456-1" "1232456-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1232541-1" "1232541-1" "Patient found unresponsive at approximately 12:00 am 10/11. EMS called and patient was pronounced dead at scene." "1232551-1" "1232551-1" "Patient was administered dose 2 of Moderna vaccine on 2/22/2021 and on evening of 2/23/2021 patient experienced a witnessed cardiac arrest, was transported to the ED and expired" "1232635-1" "1232635-1" "Patients husband was bringing his daughter to a vaccine event. Spouse spoke of concern over his wife having a Pfizer COVID-19 vaccine in January and withing 24 hours being found unresponsive. Patient details that she did not show symptoms of distress after this second vaccination. He went to check on her in the morning on 1/28/21 at different points in the morning but when checking on patient at around 11:00 AM she was found laying on her side unresponsive, not breathing. Emergency medical profesisonals arrived but resuscitation efforts were unsuccessful." "1232673-1" "1232673-1" "Patient was admitted to the hospital with pneumonia the evening after her received the vaccine in the morning. He had been struggling with his COPD/ pneumonia since 3/1/21. He was hospitalized and died 8 days later" "1232707-1" "1232707-1" "Patient died at home per medical examiner, suspected cardiovascular event" "1232709-1" "1232709-1" "Mother had a stroke 2 days later." "1232759-1" "1232759-1" "SAW OBITUARY FOR PATIENT IN PAPER SHE HAD JUST RECEIVED VACCINE NOT TO LONG AGO SO WANTED TO MAKE SURE THIS WAS REPORTED" "1232799-1" "1232799-1" "No information really known. Office was notified yesterday by county coroner that patient was found deceased in his home on 4/9/19. Coroner was requesting patient records. Unknown if death related to the Moderna Covie-19 vaccine but reporting this as death occurred 3 days after the vaccine and coroner gave office no information. You can contact the coroner involved with this case." "1232805-1" "1232805-1" "Patient had several ED visits and was admitted to the hospital, all within 6 weeks of receiving COVID vaccination. ED visits 3/5/21, 3/18/21, and admissions on 3/22/21." "1232936-1" "1232936-1" "Taken to the Hospital due to a fracture, severe UTI and sepsis. Dies at the Hospital." "1232938-1" "1232938-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1232970-1" "1232970-1" "Patient passed away." "1232988-1" "1232988-1" "Taken to the Hospital due to COVID-like symptoms (strong cough). At the Hospital she is diagnosed with COVID-19, problems with kidney and hemoglobin levels. Dies at the Hospital due to COVID-19." "1232994-1" "1232994-1" "Patient death within 60 days of receiving the COVID vaccine series" "1233186-1" "1233186-1" "The patient is a 73yr old female with multiple comorbidities including but not limiting to ESRD on dialysis, DM, COPD on home oxygen, OSA not compliant with CPAP at home, pulmonary hypertension, tachy-brady syndrome s/p pacemaker in March 2021, with multiple admissions (?6) this year already, admitted with septic shock, NSTEMI on 4/13/2021. She underwent R foot debridement and amputation on 4/16/2021. ID team treated with Vanco/Cefepime. On 4/18 afternoon, she developed PEA and coded for about 25min. Since ROSC, she never regained consciousness. This morning, at the beginning of my shift at 7am, she's on bicarb drip, maxed Levophed 100, Epi 100 drips and full vent. However, she was getting paced and BP stayed in 40s. I discussed with ICU pharmacist and gave her stress dose Solu-cortef. Checked serum cortisol level, turned out to be appropriate later. Lactic acid 22 and bicarb was only 2 despite being on Bicarb drip. I called Shauna/daughter to inform her about guarded prognosis (imminent death) and asked to bring husband to come see her asap. Before family arrived, she developed another PEA and code blue was called. She was given Epi, bicarb pushes and CPR started immediately. Code blue was unsuccessful. At 8:13am, she was pronounced dead. I called daughter again to notify her of patient's death. Family arrived around 10am. I met both daughter and husband at bedside and offered emotional support. Chaplain was consulted. Disposition - critically ill patient with multi-organ failure, septic shock from R foot osteomyelitis, ESRD on dialysis, DM, COPD on home oxygen, OSA not compliant with CPAP at home, pulmonary hypertension, tachy-brady syndrome s/p pacemaker in March 2021 - Patient coded and did not survive" "1233229-1" "1233229-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1233385-1" "1233385-1" "Pt presented with abd pain, dark stool, altered mental status, febrile, hypotensive, septic, cardiogenic shock, progressed to multi organ dysfunction." "1233445-1" "1233445-1" "Patient found in pulseless arrest on stairwell of her apartment building on the night of 4/2/21. Patient transported via ambulance to hospital where she passed away." "1233510-1" "1233510-1" "Death. Multiple pulmonary thrombi." "1233587-1" "1233587-1" "Patient received two dose Moderna series of vaccinations for COVID 19 (1/21/2021 and 2/18/2021). Patient reported to ED feeling weak on 2/20/2021, but was not tested for COVID at that time. Reportedly, patients family were all tested for COVID and were positive on or about 2/21/2021. The patient was later admitted to the hospital on 4/13 with COVID. She subsequently expired on 4/14." "1233604-1" "1233604-1" "Patient was in ED x 2 and died within 60 days of receiving a COVID vaccine series" "1233606-1" "1233606-1" "52 m active alcoholic with lab abnormalities c/w heavy etoh including pancytopenia (anemia to 7s, throbocytopenia to 70s, mild leukopenia-since 12/20); 2 recent admissions (feb march 2021) with likely etoh-induced pre-renal AKI; DM; who received 2nd dose of moderna 4/8/21. After not being in contact with his family for several days, family sought him at his residence where he was found pulsless and apneic on the floor with some scant blood near his face. CPR-- >transported to hospital where upon attempting to intubate profuse bleeding into larynx/pharynx noted. Despite ongoing cpr and mechanical ventilation team in ER was unable to re-establish pulse. He was pronounced dead at about 8 PM 4/9/21." "1233617-1" "1233617-1" "5:30 pm 3/29/21 received phone call from aunt that ems had taken dad to hospital because he was feeling unwell. he vomited prior before and just didn't feel right. ems showed up and observed him, glucose was 139..not out of range...vitals stable..2nd moderna vaccine 5 days prior...ems said that is was probably side effects...asked if he really wanted to go in...said yes, took him to hospital...5:45 daughter called hospital to get status check....she is poa for medical...er doc said he was intubated and on vent.....er doc said he was very sick...6:50 pm daughter got to er and room he was on vent and knocked out...he had antibiotics, sleeping meds..meds to rise bp in iv.....er doc came in daughter asked why he was on vent...asked about o2 doc said he was fine just unresponsive...labs were being done at time...had him on dextrose, propofol, dexmedtominine,..asked to have him transferred to own hospital..8:10 dr. comes in with lab results...kidneys and livers were showing multi organ failure...triponin was high as well..red flags were: creatine 9.93, gsr-5, hemoglobin-7, liver lft-500, triponin 14, covid test was negative, white count was in range, daughter mentioned vaccine again and doc said nothing nor did she mention heart being in trouble, no answers regarding what the cause of this was...for the record he only had kidney issues due to type 2 diabetes, was not at dialysis level...9:30 ems shows up to take dad to another hospital were not ready from him yet...9:41 dad heart started to drop on monitor withing 15 secodes iit flatlined in front of daughter......med staff did cpr...brought in epi pens and manual cpr for heart...a little after 10 heart was started it ran for 4 minutes then crashed again..10:05 continued cpr until 10:28, dr showed that walls i heart not squeezing very damaged, brought in echo during process, 10:28 time of death" "1233672-1" "1233672-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1233769-1" "1233769-1" ""According to death certificate patient died of ""blunt force injuries from a motorcycle accident"""" "1233795-1" "1233795-1" "Information obtained from the Hospital. Began to not feel well the next day, SOB, diarrhea and fatigue. Was admitted to hospital on 4/9/21, diagnosed with COVID, placed on a vent and died on 4/19/21." "1234046-1" "1234046-1" "Received a Janssen vaccination on 4/7/21 from a home visiting nurse from the County Health Department. On approximately 4/13/21, the family noticed slight signs of an issue, with patient slumping towards the right, and showing some signs of weakness on right side of body. Family contacted the PCP, who advised to take her to the ED. Family was hesitant to do that because patient had been bedridden for past few years. She seemed to improve somewhat on 4/15/21. Then the morning of 4/16/21, the family found her on the floor of her bedroom. She appeared to have had a moderate to severe stroke. Right side of body paralyzed, cannot speak. Uncertain whether mental faculties further deteriorated. PCP ordered a hospice facility for care. Stroke likely caused by blood clot but unsure if related to JJ vaccine. She has not been evaluated in person by her health care providers." "1234064-1" "1234064-1" "Husband stated wife had a severe stroke on 4/19" "1234152-1" "1234152-1" "Pt. had (what we think) a small seizure on Thursday, March 18th and then again on Saturday, March 20th. On Sunday, March 21st, 911 had to be called as his seizure did not end. He had a grand male. He was seizing for several hours. At the time this was all occurring he has been on anti seizure meds for a few years Divalproex 1000 mg am and 1000 mgs pm daily). He passed 1 week later, March 28 at approx 6:45pm at the Clinic. I am unable to get any information on his medical report for that week. Statement from his Nurologists is on second page. Additional information for Item 18: Statement: 47 year old gentleman who passed away on March 28 from aspiration pneumonia secondary to status epilepticus and on a history of multiple sclerosis / additional leukoencephalopathy of unknown etiology (both treated with rituximab), prior seizures (on valproic acid) and pulmonary embolism (on apixaban). The key reason for reaching out is in light of the announcement about the side effects of the Johnson & Johnson vaccine specifically cerebral venous sinus thrombosis. While he had a known history of seizures, he had no clear trigger for these seizures; including that his valproic acid level was therapeutic (83.0 mcg/mL) at time of presentation. He had, however, received the Johnson & Johnson vaccine on March 12 before having what in hindsight appeared to be repeated seizures between March 18-21; he had a more significant one on March 21 that hospitalized him. This time frame appears consistent with the reported cases of central venous sinus thrombosis associated with the Johnson & Johnson vaccine. Equally, he was taking apixaban at that point in time and his PLT (173) / INR (1.1) / PTT (36.6) at time of presentation were all normal and stable. He did have an elevated ProBNP (552.0) at presentation; nasopharyngeal swab was negative for COVID / Influenza A/B / RSV and non-contrast head CT did not show any clear new abnormalities. His only D-dimer was obtained on March 23 and was 226. He did not have a CT angiogram or venogram. Overall the link between the vaccine and pt. seizures is not definite. At the same time, the similarity with the reported cases has led to me wanting to report it in case of the possible link. If you require further information then please don't hesitate to email me Pt. med list at the time of this incident Modifinil - 100 mg/1per day/AM Sertraline - 100 mg/1per day/AM Vitamin D3 - 50 mg/1per day/AM Divalproex - 500 mg/2per day/AM Eliquis - 5 mg/1per day/AM Furoseminde - 20 mg/1per day/AM Metroprolol - 100 mg/1per day/AM Lisinopril - 10 mg/1per day/AM Divalproex - 500 mg/2per day/PM Eliquis - 5 mg/1per day/PM Metroprolol - 100 mg/1per day/PM Melatonin - 5 mg/1per day/PM Quetiapine - 50 mg/3per day/PM" "1234428-1" "1234428-1" "PFIZER-BIONTECH COVID-19 VACCINE EUA. Patient received vaccination on 2/10/21. No adverse reactions reported following vaccination. Patient had unplanned weight loss x 1 month of 14.1% and 6 month loss of 20.8% according to nursing nutrition notes. HT: 60in Wt 122lb. Patient died on 2/12/21." "1234488-1" "1234488-1" ""Patient had an undiagnosed/unknown UTI at the time of her second vaccine on 3/2/21. She was admitted to Hospital on 3/3/21 with organ failure; she passed away on 3/5/21. Her cause of death is listed as Sepsis, and UTI. The vaccine was not listed as a cause of death, but might have been a ""tipping point"" in her inability to recover with antibiotic treatment."" "1235191-1" "1235191-1" "my sister had a ruptured brain aneurysm on 3/25/2021" "1235449-1" "1235449-1" "Laboring to breath. Hospitalized." "1235472-1" "1235472-1" "My mother never had a reaction with the 1st shot and after the 2nd shot doing fine Thursday afternoon and Friday. She began having sx Saturday and passed Sunday early morning" "1235806-1" "1235806-1" "diabetic coma; blood sugar kept dropping; This is a spontaneous report from a contactable consumer (patient's neighbor). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diabetes and coronary artery disease, and back surgery. The patient's concomitant medications were not reported. They think the patient went into a diabetic coma from low blood sugar dropping on 01Apr2021 and the patient passed away in his sleep. Reporter does not know if it had anything to do with the shot or anything but he thought they may want to know that. The patient started having problems with his blood sugar on Thursday 01Apr2021. The patient's blood sugar kept dropping and he went to bed that night and died. Patient was found deceased Friday morning 02Apr2021. Information about batch/lot number has been requested.; Reported Cause(s) of Death: Blood glucose decreased; diabetic coma" "1235811-1" "1235811-1" ""COVID pneumonia; Hematological; bleeding; having hemoxysis; slight troponin increase; GI bleed; headaches; COVID-19 test was positive; COVID-19 test was positive; nauseous; abdominal discomfort; body aches; This is a spontaneous report from a contactable physician. A 52-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age 52-year-old on 12Mar2021 at single dose for COVID-19 immunisation. Medical history included hemodialysis for many years, adherent to medical care, multiple DVTs and Pes (On anticoagulants), morbid obesity, Patient was on dialysis for renal failure and had lupus anticoagulant (positive), Afib, allergic to shellfish. Family history included renal failure and had lupus anticoagulant. Concomitant medications included warfarin sodium (COUMADIN); metoprolol; amitriptyline; calcitriol; ergocalciferol (VIT D); calcium; calcium acetate (PHOSLO); amiodarone; albuterol. The patient previously allergic to Cipro, clindamycin, doxycyclin, Lyrica, tetracycline. The patient previously was non-responder to hepatitis B vaccine. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 for COVID-19 immunisation. The patient hasn't been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient wasn't smoker/ former smoker. There was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. A nephrologist who reported patient in her hemodialysis unit who were vaccinated with BNT162b2 but were recently diagnosed with COVID-19. More detail is below on each patient. The patient COVID results were sent to the local health department for genetic sequencing (pending) and SARS titers were drawn (pending). Unfortunately, the HD unit does not have B/L information (although the B/L # was put on the patient's COVID vaccine cards, a record was not kept in the HD unit). Day she came in for dialysis she was already short of breath she said she'd had body aches for 5 days, got short of breath on 05Apr2021. The day before, started getting cough, nauseous, chills, abdominal discomfort on 04Apr2021. The patient was sent to the ER from dialysis and was admitted for SOB on 05Apr2021 and passed away on 09Apr2021 due to a GI bleed. Patient is over 500lbs so was unable to fit into hospital imaging equiment for CT scans or weight measurements. COVID-19 test was positive on 05Apr2021; the patient experienced COVID pneumonia on 05Apr2021. The patient admitted on 05Apr2021 to regular floor. The patient was moved to an Intensive Care Unit on 06Apr2021. The patient experienced short of breath on 05Apr2021 and required much more O2 than normal. Sometimes required BP support while on Dialysis and BP was 113/61 in ER. Pressure dropped to 100/70 and required mitrodrine after fluid was removed. The patient needed 4 liters supplemental O2 vs. only needing 2 liters at home. The patient experienced tachypnea and hypoxemia and no Respiratory failure. Respiration was 22. After 5 litres of O2 improved. Pulse 93 in ER. Cardiovascular: There was no heart failure, cardiogenic shock, Acute myocardial infarction, arrhythmia and myocarditis. The patient Had chest pain which resolved when O2 was administered. Gastrointestinal/Hepatic: There was no Vomiting, Diarrhea. The patient experienced nausea but no vomiting or diarrhea and complained of abdominal pain. There was no Jaundice and acute liver failure. Neurological: There was no altered consciousness, altered consciousness, encephalopathy, meningitis and cerebrovascular accident. The patient had headaches a couple days before admitting to ER. Hematological: There was no Thrombocytopenia, Disseminated intravascular coagulation. INR was 3 due to large dose of coumadin, and platelets were 180 and white count 6.8. Slight troponin increased at 0.37 at admittance, BNP 39. The patient started coughing up blood, having hemoxysis and bleeding on unspecified date. Laboratory test or diagnostic studies was reported that test for SARS-CoV-2 by PCR, or other commercial or public health assay. Xray showed vascular congestion with superimposed infiltrate which could represent pneumonia. Blood count was 11 and 36.7% at ER. Clinical chemistry: Sodium was 133; BUN was 68; Creatinine was 10. Evidence of hypoxemia: Pulse oO2 was 90 in ER. CT scans: unknown results. Urinalysis: On dialysis so does not make urine. The patient had received Remdesivir, from 06Apr2021, Hydroxychloroquine/chloroquine, Azithromycin from 06Apr2021 and Corticosteroids from 06Apr2021 for COVID-19. The outcome of event ""GI bleed"" was fatal, the event ""chest pain"" and ""body aches"" was recovered and other events was unknown. The patient died on 09Apr2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of the suspect drug cannot be excluded for the events vaccination failure, COVID-19, COVID-19 pneumonia, and sepsis. However, the patient's multiple medical comborbidities including renal failure requiring dialysis, lupus, and morbid obesity along with the risk of COVID-19 infection in light of the current pandemic are the more likely explanations for the development of these infections. The events gastrointestinal hemorrhage, hemorrhage, hemolysis and troponin increased are attributed to intercurrent medical conditions, and are considered unrelated to the suspect drug. The patient is currently on warfarin which may increase the risk for bleeds. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: GI bleed"" "1235815-1" "1235815-1" "stroke; Brain bleed; Brain blood clot; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program named Corporate (Pfizer) Social Media Platforms. A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:15 as single dose for covid-19 immunisation. Medical history reported as none. The patient's concomitant medications were not reported. The patient experienced brain blood clot on 25Mar2021 08:00 , stroke and brain bleed on an unspecified date. The patient was hospitalized for brain blood clot, stroke, brain bleed for 7 days. Therapeutic measures were taken as a result of brain blood clot, stroke, brain bleed included Ventillator. The patient died on 02Apr2021. An autopsy was not performed. The outcome of events was fatal. No other vaccine in four weeks; No covid prior vaccination. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Brain blood clot; stroke; Brain bleed" "1235817-1" "1235817-1" "My mother passed away/death cause: natural causes; This is a spontaneous report from a contactable consumer for patient (reporter's mother). A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 74 years old, via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:15 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. Medical history included Stage 4 metastatic lung cancer, Diabetes type 2, Hypertension. Other medications in two weeks was Yes, while unspecified. The reporter reported that my mother passed away/death cause: natural causes on 05Apr2021 07:00. 4 days after receiving this vaccine. No treatment received. An autopsy was not performed. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information on batch/lot number has been requested.; Reported Cause(s) of Death: My mother passed away/death cause: natural causes" "1235822-1" "1235822-1" "microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with coagulopathy; thrombotic microangiopathy; jaundice; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable physician. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 29Mar2021 13:45 (Batch/Lot Number: ER8733) as single dose for covid-19 immunisation. Patient was not pregnant. The COVID-19 vaccine was administered at Doctor's office/urgent care. Medical history included Metastatic breast cancer. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant Therapy included Clinical trial oral drug - ARV-471 on 22Mar2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient presented to the hospital on 05Apr2021 complaint of (c/o) 1 week of jaundice, nausea, vomiting, and diarrhea, which started on an unknown date in Mar2021, and on 05Apr2021 found to have evidence of microangiopathic hemolytic anemia, thrombocytopenia, and severe hyperbilirubinemia/cholestasis with coagulopathy. Work-up revealed like thrombotic microangiopathy although etiology unclear. ADAMTS13 level 29 with no inhibitor not suggestive of Thrombotic thrombocytopenic purpura (TTP). Patient eventually died of this acute presentation. She also had a history of metastatic breast cancer and had also just started taking a phase 1/2 oral clinical trial drug ARV-471 on 22Mar2021. Unclear if the drug, COVID vaccine, or breast cancer may have contributed to current illness. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Patient died. Patient hospitalized for 5 days. Date of Death was on 09Apr2021. Death cause: Death certificate stated metastatic breast cancer. No autopsy performed. Therapeutic measures were taken as a result of events included plasmapheresis, steroids, antibiotics. The patient underwent lab tests and procedures which included Nasal Swab: negative on 05Apr2021. The outcome of the events was fatal.; Sender's Comments: Based on temporal association and the limited information available, the causal association between BNT162B2 vaccine and the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: severe hyperbilirubinemia/cholestasis with coagulopathy; jaundice; nausea; vomiting; diarrhea; microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with co" "1235829-1" "1235829-1" "Drowning; He didn't feel well; This is a spontaneous report from a contactable consumer (patient's wife). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in left arm on 05Mar202113:00 (Lot Number: En6198) as single dose for COVID-19 immunisation. Medical history included hypertensive cardio disease, remote myocardial infraction. No COVID prior vaccination. No known allergies. No COVID was tested post vaccination. There were no concomitant medications. No other vaccine was received in four weeks. The patient didn't feel well Saturday on 06Mar2021 12:00 AM, went surfing Sunday morning on 07Mar2021 as usual for the last 60 yrs. He was in excellent shape and surfed every day. At about 7am the reporter received a phone call that the patient had been pulled from the water unresponsive. But what the reporter didn't understand was he had his arm over his board. But his face was in the water. The reporter realize he drowned but something happened before that. The events resulted in Emergency room/department or urgent care. It was unknown if patient received treatment for events. The patient died on 07Mar2021. An autopsy was performed that revealed drowning. The outcome of event didn't feel well was unknown.; Reported Cause(s) of Death: Drowning; Autopsy-determined Cause(s) of Death: Drowning" "1235915-1" "1235915-1" "My father complained of soreness and body aches from the shot Sunday night to my mom and Monday morning to his boss at work. My sister found him that afternoon in my parent's home unresponsive and call proceeded to call 911 and start CPR. But it was to late and he was already gone." "1236405-1" "1236405-1" ""Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 82 and had a PMH significant for parkinsonism w/ dementia, difficulty walking and performing daily tasks, CAD, afib, and osteomyelitis. Patient was authorized for home health aide on 3/18/21 after wife overwhelmed with his care. Listed cause of death on death certificate says ""unknown-history of dementia and heart conditions"""" "1236406-1" "1236406-1" "death Narrative: pt had first vaccine on 1/26; caregiver declined second dose due to concerns of side effects; pt died 3/29/21 (not from COVID)" "1236407-1" "1236407-1" "Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 81 and presented to the ED w/ altered mental status on 2/18/21 after receiving COVID vaccine on 2/16/21. Patient was also previously admitted earlier that month for a retroperitoneal hemorrhage that had similar presentation of altered mental status. CT this admission showed a new CVA. He was eventually transferred to the ICU for nonconvulsive status epilepticus and eventually transitioned to hospice care after further decline in status. Wife elected to stop dialysis and he passed away on 3/23/21. Comorbidities include ESRD on dialysis, CVA, DM, prostate cancer." "1236408-1" "1236408-1" "Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient was hospitalized in early 02/2021 at Medical Center in the ICU for a bleeding ulcer. Was inpatient for over a month, but do not have records due to it being outside facility. Received a colonoscopy report which showed. diverticulosis and CT of abdomen showing pleural effusion, umbilical hernia and gallstones. Notable comorbidities include emphysema, CKD, CAD, ICM, and T2DM." "1236409-1" "1236409-1" "Death Narrative: Patient was not previously COVID positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 97 and admitted to Hospital on around 2/20/2021 due to a fall at home. He later passed away on 3/5/21." "1236410-1" "1236410-1" "Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient found decreased at home on 3/3/21. No apparent cause of death. Telephone appt on 2/10/21 was unremarkable other than patient having mild shortness of breath and chest discomfort. Comorbidities include COPD, HTN, HLD, and age of 74." "1236411-1" "1236411-1" "Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 90 and suffered cardiac arrest at home on 2/25/21. Patient had afib w/ a pacemaker, cardiomyopathy, CKD4, and PVD." "1236412-1" "1236412-1" "Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 95 and admitted to ED on 2/26/21 with leg edema and diarrhea. Had periods of bradycardia in the 40s during admission. Diagnosis was heart failure exacerbation which caused a significant decline in his condition resulting in eventual palliative care before his death. Notable comorbidities include CAD s/p cabg, T2DM, HFrEF, CKD, HTN, recurrent UTIs." "1236413-1" "1236413-1" "Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was hospitalized in 02/2021 at facility for unknown reason until his passing on 3/7/2021. He had dx of HCV in 01/2021 that was cured but left him with cirrhosis s/p TIPS procedure. Was not liver transplant candidate due to home O2 needs. Other major comorbidities include COPD and diabetes." "1236414-1" "1236414-1" "death Narrative: Patient received Moderna covid #1 on 1/9/21 and #2 on 2/8/21. On 2/24/21, he was sent to the ER at a facility from a nursing home where he was admitted for skilled nursing care. He was sent to the ER due to fever, decreased mental status, renal failure, possible UTI and possible pneumonia. He was admitted and received IV fluids, Zosyn and Solu Medrol. On 2/26/21, a consult was placed for hospice care and he was accepted for hospice care at a contract nursing home. Upon review of scanned records, it appears he had a stroke/intercranial hemorrhage on 2/10/21 and that is why he was admitted to the nursing home for skilled nursing services. A date of death of 3/18/21 is recorded. No autopsy results recorded. 38 days from vaccine #2 and date of death." "1236415-1" "1236415-1" "death Narrative: Patient received Moderna covid vaccine #1 on 3/25/21. No notes entered after this time and date of death is recorded as 3/30/21. No scanned records. No autopsy results available. 5 days from date of vaccine to date of death." "1236416-1" "1236416-1" "death Narrative: Patient received Moderna covid vaccine #1 on 1/22/21 and #2 on 2/24/21. On 3/4/21, he was admitted to a facility for shortness of breath x 1 week. Upon admission, he was found to be in heart block and was admitted to the ICU and placed on pressors. He did have a negative COVID PCR test on 3/4/21. He has a noted history of COPD, CHF and OSA. On 3/6/21, he underwent a new pacemaker placement. His course was complicated by the development of AKI, paroxysmal V tach and new aflutter and was initiated on apixaban. He was discharged on 3/18/21. No further records available and a date of death was recorded as 4/3/21. No autopsy results available. 38 days from time of second vaccine to date of death." "1236417-1" "1236417-1" "death Narrative: Patient with noted history of ALS was given Moderna covid vaccine #1 on 2/27/21. On 3/5/21, notes were entered in system for family requesting a specialty bed as he was having difficulty sleeping as it was hard to breath when he laid down. He was sleeping sitting up in his wheelchair. On 3/8/21, a note was placed that he was planned to have a trach placed on 3/12/21 and that he was now under hospice care. No further notes entered and a date of death was recorded as 3/17/21. No autopsy results available. 18 days from date of vaccine to date of death." "1236418-1" "1236418-1" "death Narrative: Patient received Moderna covid #1 on 1/14/21. On 1/29/21, a social worker note was placed that indicated that patient was now under home hospice care. No scanned records on file. No further notes regarding events from this time to date of death on 2/10/21. No autopsy results available. 27 days from date of vaccine to date of death." "1236419-1" "1236419-1" "death Narrative: Patient, that is a facility resident, received his Moderna covid vaccine #1 on 12/28/20. On 1/14/21 due a continued decline in status, he was changed to hospice care. On 1/25/21, he received covid #2. He was noted to have a decline in oral intake and increase in somnolence over a few weeks prior to his date of death on 2/9/21. No autopsy results available. 15 days from date of second vaccine to date of death." "1236785-1" "1236785-1" "Resident found unresponsive and without vital signs the morning on April 17, 2021 at 6:35am. The nurse started CPR, called a code, 911 called, AED applied. Local EMS responded, took over the code. EMS had contact with the local hospital ER, code called at the facility. Resident expired." "1236916-1" "1236916-1" "On 4/16 at around 10:24AM, patient presented to emergency department via EMS status post a witnessed cardiac arrest. After the witnessed cardiac arrest, EMS was called and reported that the patient was unresponsive. Per EMS, patient was immediately intubated and chest compressions started. EMS reports an initial cardiac rhythm of VFib and shocked patient once. Patient was given 3 epinephrine and brought into the ED. After prolonged CPR and resuscitation for more than hour and a half, the patient was made DNR/DNI and was pronounced dead at 11:45AM." "1237069-1" "1237069-1" "Spouse reported that patient was taken to The Hospital after unresponsive in the home on 4/2/2021. States was told that cause of death was heart failure." "1237089-1" "1237089-1" "Father received 2nd vaccine and died two days later of heart failure. Was not in critical condition prior to the vaccine." "1237092-1" "1237092-1" "Massive pulmonary thromboemboli" "1237104-1" "1237104-1" "Pt received vaccine on 4/20/21 at 1:00pm, observed 30 mins post injection with no adverse reaction noted. Pt collapsed at home early morning on 4/21 & transported to ED via ambulance where he later expired." "1237427-1" "1237427-1" "Arm soreness 1-3 days post vaccine flu like symptoms 4-7 days post vaccine Severe back pain 4-10 days post vaccine Death 11 days post vaccine" "1237434-1" "1237434-1" "Patient discovered down and unresponsive with immediate declaration of death. Pronounced dead 4/6/2021 11:45 PM" "1237478-1" "1237478-1" "6-8 hours following the vaccine, the patient developed a severe head ache, SOB and fatigue. Patient took an unknown OTC medication, this did not help her symptoms. Her headache receded on 04/08, and her symptoms improved, but never fully resolved (per patient's son)." "1237511-1" "1237511-1" "Patient brought in by ambulance after cardiac arrest witnessed by patient's wife at 4/19/21 1:37AM. Per ED, the wife reports he had complained of feeling weak over the last few days without clear reason, then this morning patient had episode of emesis after which he told wife to call 911 and then suddenly became unresponsive. In ED was intubated, started on hypothermia protocol, Patient sedated on Propofol and started on a heparin drip, clopidogrel, aspirin and empiric antibiotics for aspiration Pneumonia" "1237530-1" "1237530-1" "Mom was feeling fine the day of the vaccine. Last spoke with her at 6:30 PM and she said she wasn't feeling anything but would go to bed early. I said OK I will check on you in the morning. She never woke up!" "1237672-1" "1237672-1" "Presents with dyspnea for a few days. Pt was tested positive for COVID 19 one wk ago (outside health system). Pt also c/o L arm numbness. Pt denied f/c, CP, n/v/d, abd pain, HA, syncope. In ED, Pt was found to have hypoxic O2 sat at 89% and was put 2L NC. Pt got loading dose of ASA and dexamethasone (7 day course), completed 5 day course of remdesivir and received tocilizumab due to increased oxygen requirements. Pt also has mildly elevated troponin and cardiology was consulted in ED. St elevation noted 4/20 AM, heparin bolus given for acute coronary syndrome and ticagrelor LD. Left heart cath on 4/20/21 showed 3 vessel disease but due to difficulty revascularizing LAD in setting of worsening K+, Bicarb, S no further revasc attempts were made. Upon return to MICU, pt found to be hypotensive and bradycardic. PEA arrest. Family contacted during code and in agreement to transition to comfort measures." "1237704-1" "1237704-1" "Death, blood clots in liver" "1237709-1" "1237709-1" "Patient deceased" "1237837-1" "1237837-1" "This is a possible breakthrough COVID case. The patient had right-sided weakness for two weeks prior to 4/20/21. She then developed weakness and confusion in the few days leading up to hospitalization on 4/20/21. The patient tested positive for COVID on 4/20/21. The patient was also previously COVID positive on 11/6/2020." "1237878-1" "1237878-1" "This 70 year old white female received the Covid shot on 2/25/2021 and died of a heart attack on 4/13/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1237884-1" "1237884-1" "Resident have had multiple PNA tx with IM Rocephin and IV Zosyn, Difficulty in swallowing, Elevated HCV RNA, 02/15 PCR Quant, ER visit following weakness and involuntary UE movements/jerking. Elevated amonia levels controlled with use of Lactulose. 02/22/2021 RUE and RLE extensive DVT. Worsening pressure wound and development of arterial wounds. Admitted to Hospice on 03/31/2021. Resident deceased on 04/03/2021." "1237890-1" "1237890-1" "This 93 year old white female hospice patient received the Covid shot on 1/20/2021 and went to the ED on 3/12 for COPD exacerbation, shortness of breath and extremity weakness. She returned to the ED on 3/13/21 and was admitted for generalized weakness and dehydration. The patient subsequently died on 4/13/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1237923-1" "1237923-1" "This 85 year old white male received the vaccine on 2/19/21 and went to the ED on 4/05 and was admitted with generalized weakness, hyponatremia, fever and elevated bilirubin. On 04/16/21, he went to the ED and was admitted to the hospital on 4/17 with poor appetite and hospital admission dx of ketonuria, leukocytosis, renal insufficiency, elevated troponin, hematuria, generalized weakness and died on 4/19/2021. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1237947-1" "1237947-1" "Patient admitted 4/12/21 with fatigue and abdominal pain. Found to have UTI but no definite sepsis, and acute renal failure. Treated with iv antibiotics and iv fluids. Over next 48 hours developed worsening encephalopathy and thrombocytopenia. MRI/MRA/MRV showed no acute findings. Hyperammonemia noted, with no known Hx of cirrhosis; US did not show portal vein or hepatic vein thrombosis. Encephalopathy worsened, no clear etiology; EEG just showed generalized encephalopathy. Renal function worsened. Patient became obtunded and was intubated 4/16/19. Platelet nadir of 31k. Dialysis started. Left common femoral DVT developed. Patient had DIC type picture. Respiratory failure worsened, hypotension developed, patient passed away 4/20/21. No clear etiology of encephalopathy and thrombocytopenia identified, unclear if related to J&J vaccine received 2 weeks prior." "1238123-1" "1238123-1" "4/14-Resident c/o not feeling well and declined scheduled dialysis. c/o bilateral shoulder pain and fatigue. AP- 44, BP- 80/45, c/o headache, no chest pain and no SOB. Sent to CMC ER- patient deceased on 4/14/2021." "1238126-1" "1238126-1" "4/1/2021 routine lab work done for follow up Dr. visit, 4/2/2021 Dr.office called stated platelet count is 14,000 go to ER. Patient was admitted to the hospital and as of this entry still a pt. because the Drs can not get his platelet count up or to stay up ( range has been from approx. 7,000 to 30,000) Patient is in declining health. As I understand it labs from Jan /2021 the platelets were 77,000. He has been treated with IVIG, prednisone, NPlate, platelet infusions-please contact Drs. and the hospital Patient displayed NO outward bleeding of any kind. He had only1 small bruise about the size of a dime on the base/web of his left index finger" "1238170-1" "1238170-1" "Found dead at home 10 days post vaccine administration. Unclear correlation." "1238185-1" "1238185-1" "Received 2nd COVID vaccine on 4/19/21. Apparently hadn't been feeling well since. Presented to the ED on 4/21/21 with hypotension, bradycardia, hypoxia and a GCS of 3. Does have a history of ESRD on HD, but no missed dialysis sessions. Found to have a potassium of 8.7. There was concern for pulmonary embolism but was not hemodynamically stable enough to undergo imaging. Went into PEA arrest x 3 in the ED and ultimately died. Of note, patient did have a recent ankle fracture recently and apparently has been non-ambulatory for at least the past few days." "1238188-1" "1238188-1" "The decedent suffered fever and malaise after the second dose on 04/13/2021." "1238235-1" "1238235-1" "Information received by wife. Patient was fatigued 4/10/21 after vaccination. His wife stated that she talked with him and he seemed fine. When his wife went to bed early that evening, the patient was sitting in the recliner in the living room. On the morning of 4/11/21, patient's wife found him unresponsive in the recliner. She called an ambulance but patient was deceased. Patient's wife stated that she noted a trashcan next to the chair the patient was sitting in. The trashcan did not have emesis in it but patient's wife assumes he had been nauseated that evening before he passed away." "1238254-1" "1238254-1" "This 85 year old male received the Covid shot on 2/23/21 and subsequently died on 4/15/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1238268-1" "1238268-1" "This 91 year old white male received the Covid shot on 2/19/21 and subsequently died on 3/21/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.." "1238270-1" "1238270-1" "Patient was already in hospital for severe COPD. While there, he was given J&J Covid-19 vaccination. Approximately 11 days after vaccination, patient developed vomiting that could not be controlled. He later developed abdominal pain that worsened and also could not be controlled. Intravenous pain killers eventually hastened his passing." "1238276-1" "1238276-1" "This 58 year old white male hospice patient received the Covid shot on 3/22/21 and died on 4/15/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1238280-1" "1238280-1" "The decedent was visiting family. There are no reported adverse effects known." "1238286-1" "1238286-1" "This 85 year old white male hospice patient received the Covid shot on 2/16/21 and went to the ED on 2/21/21 and was admitted on 2/22/21 with altered mental status, pneumonia, severe sepsis, bladder cancer, UTI, dementia and died on 4/19/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1238302-1" "1238302-1" "This 75 year old white female received the Covid shot on 3/23/21 and died on 4/4/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1238316-1" "1238316-1" "Suffered a fall, stopped eating, on February 28, 2021 was found without vital signs." "1238326-1" "1238326-1" "This 82 year old male hospice patient received the Covid shot on 3/6/21 and went to the ED on 4/6/21 and was admitted on 4/6/21 with respiratory distress, acute hypoxemic respiratory failure, anasarca, atrial flutter, hypothyroid and died on 4/15/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1238342-1" "1238342-1" "This 72 year old white male hospice patient received the Covid shot on 2/20/21 and went to the ED on 3/27/21 and was admitted on 3/27/21 with shortness of breath, pneumonia, hyponatremia, anemia, bilateral pleural effusion, metastatic cancer and died on 4/17/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1238356-1" "1238356-1" "This 69 year old female received the Covid shot on 3/10/21 and went to the ED on 3/14/21 and was admitted on 3/14/21 with weakness, lack of appetite, malignant neoplasm of brain and lung and died on 4/18/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1238418-1" "1238418-1" "3/30- Resident was sent to ER was found to have acute CVA, R vertebral occlusion, carotid stenosis, 17mm lung mass suspicious for malignancy, family opted for palliative and or Hospice. 4/03-re-admitted to the facility. 4/14 Admitted to Hopsice. Resident deceased on 4/16." "1238440-1" "1238440-1" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1238478-1" "1238478-1" "He was healthy before vaccine. After vaccine a small amount of chills for a couple days. He was sicker and was exposed to COVID 19, so went to hospital 4/14/2021 tested neg for influenza and + Coronavirus. Died on 4/15/2021" "1238566-1" "1238566-1" "On April 18, 2021, nine days after the person got his second dose of Moderna vaccine, he committed suicide using a gun in the presence of his family." "1238623-1" "1238623-1" "Patient was asymptomatic and was vaccinated on 1/22/2021. A facility caregiver tested positive for COVID, so patient was tested and received results on 1/27/2021 indicating positive for COVID-19. Patient expired early morning of 2/1/2021, still completely asymptomatic. Patient's physical condition had been fairly stable for the previous few years." "1238733-1" "1238733-1" "Resident was found kneeling over walker with face down in the bathtub right before 1700. Code called and initiated. Resident pronounced dead at 1721 by EMS." "1238843-1" "1238843-1" "per patient's family report: patient complained severe leg pain a few days before she was found dead in her apartment on 2/18./2021. It was likely she had sudden death as she did not activate her neck alert or call button in her apartment. Family request we report the incident, she was last seen on 12/15/2020 for pacemaker check, she also had medical message communication with me on 2/8 to request refill on her Percocet that she takes occ for her joint pain only at bed time. family suspect possible DVT with PE after getting more informed about vaccine side effects. however no autopsy was done." "1240013-1" "1240013-1" "not feeling well and short of breath on 2/11/21, 2/12/21 more short of breath ambulance came. Went into PEA in ambulance with CPR. They gave TPA for suspected blood clot. He initially improved. He did not recover and died 4/4/21. He spent the entire time in hospital or TCU with complications. We brought him home 4/2 to die at home." "1240133-1" "1240133-1" "Recipient was found deceased the next day after receiving 1st dose pfizer vaccination." "1240207-1" "1240207-1" "Symptoms of tiredness and head sinus pressure came on throughout the day monday 3-29-21. Symptoms were unchanged tues morning 3-30-21. She died Tuesday 3-30-21 between 10:34 am and 12:00 pm. She was found unresponsive at 12:07 pm when husband returned home for lunch. Autopsy results still pending." "1240254-1" "1240254-1" "Monday night pt. became ill, threw up and had a fever. He went to bed, but around 11 pm he woke up disoriented, unable to walk. Was helped to the bathroom, but was unable to get back to bed on his own. Fell on his bottom. I had to call our son to come pick him up and help him back to bed, unable to hold his own weight.. Had trouble sleeping. Abt 1 pm needed help getting up again, same disorientation, also fell off the toilet and needed help getting back to the bed, unable to hold his own weight. Finally fell asleep. Next day seemed fine enough. Tuesday night, became ill again, went to bed. Got up to go to the bathroom, was wobbly, but able to make it. Was helped back, wobbly but able to walk. Trouble falling asleep, fever, chills. Finally fell asleep at 3 am Wed morning. I had to go to the doctor early, so left him sleeping in bed. When I came back around 11 am, he was still sleeping, snoring loudly. Became concerned. Wouldn't wake up. Called Paramedics. CT scan at the hospital revealed a brain bleed. Transported to hospital. Put on support for almost 2 weeks. No progress, no response. Finally support was discontinued and he died April 19th at 7:52 pm." "1241383-1" "1241383-1" "Death Narrative: 80 yr old metastatic lung cancer, had stopped eating, still wanted vaccine, Died on hospice service. no vaccine complications reported." "1241384-1" "1241384-1" "Death Narrative: Patient was 96 yr old, prostate cancer, peg tube placed, Died on Hospice service, No vaccine complication reported." "1241386-1" "1241386-1" "EXPIRED Narrative: 86 y/o male who received first dose of COVID-19 vaccine (Moderna) 1/22/21 and never returned for second dose. COVID-19 clinic alerted the pharmacist that patient expired prior to receiving second dose. Unknown reason." "1241387-1" "1241387-1" "DEATH" "1241388-1" "1241388-1" "Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 76 and presented to the ER on 2/20/21 with altered mental status, weakness, and persistent diarrhea after just being discharged previous week for bacteremia. Hospital progression included a GI bleed requiring blood transfusions, esophageal varices, and unrecoverable mental status. Care was transitioned to hospice where he passed on 2/28/21. Comorbidities include cirrhosis, CKD, DM, pancytopenia, frequent paracentesis for ascites." "1241389-1" "1241389-1" "Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient presented to the ER on 3/8/21 after being sick the prior 2 weeks with loose, bloody/tarry stools, frequent falls, and hypotension. Hospital course progressed to worsening encephalopathy secondary to decompensated alcoholic cirrhosis. Developed pneumonia that did not improve with antibiotics and progressed to palliative care with him passing away on 3/24/21. Comorbidities include COPD, alcoholism, Takotsubo cardiomyopathy, HTN, cirrhosis, HLD, former smoker." "1241390-1" "1241390-1" "Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 94 and receiving hospice care for end life care in the months leading up to his passing on 3/9/21. In addition to his advanced age, the patient had chronic afib on anticoagulation, hypothyroidism, HTN, HLD, COPD, depression, and increasing cognitive and memory issues towards the end of his life." "1241391-1" "1241391-1" "Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 86 but did not have a lot of history of receiving medical care in the system. There is note mentioned his death in the chart. His possible contributing comorbidities are advanced age, HTN, HLD, DM, mitral valve insufficiency." "1241392-1" "1241392-1" "Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH,allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. No notes detailing the circumstances the death of the patient. Patient had issues controlling his blood pressure in the prior 6 months with an average BP of 150/68 and systolic blood pressure readings >200 at times, Other comorbidities include anemia, DM2, Afib on pradaxa, cardiac pacemaker, and HLD." "1241393-1" "1241393-1" "Death Narrative: The patient did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. Patient transported to ER on 1/14/21 after receiving first COVID-19 vaccine earlier that day. He was reported to have a reaction to the vaccine including diaphoresis, new onset afib, and hypotension(vasovagal reaction). He was discharged the next day with no signs of afib. Patient was later hospitalized around 1/28/21 for COVID pneumonia. He later passed away on 2/5/21 due to hypoxic respiratory failure secondary to COVID-19. Comorbidities include advanced age, obesity, HLD, atherosclerosis, DM2, HTN." "1241394-1" "1241394-1" "Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 90 but not receiving frequent care from facility and circumstances regarding his cause of death not certain. His comorbidities include advanced age, afib, cardiac pacemaker, HTN, Barrett's esophagus, HTN, and hypothyroidism." "1241395-1" "1241395-1" "Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 80 and discharged on 2/17/21 with hospice after falling and suffering a subdural hematoma. Patient was likely reaching end of life from metastatic prostate cancer before fall." "1241396-1" "1241396-1" "Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 81 and brought to the Hospital ER on 3/4/21 w/ a STEMI. He did not recover and later passed away there on 3/10/21. Comorbidities include diabetes, HLD, HTN, cardiac murmur." "1241397-1" "1241397-1" "Death Narrative: 91 yr old Arterial ulcer on toe, not surgical candidate, patient opted palliative care, hospice enrolled, Died on hospice service. No vaccine complications reported." "1241399-1" "1241399-1" "Death Narrative: 95 yr old Renal failure, renal anemia, Died on Hospice service. No vaccine complications reported." "1241400-1" "1241400-1" "Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient was a resident at an assisted living facility and by 3/11/21 he had several falls within the last week, one of which he hit his head and need to be evaluated by the ER due to him being on warfarin. Patient had dementia and psychosis and told wife he was falling intentionally. He deceased at the rehab facility on 3/30/21 after requiring hospitalization 4 times over the last for not getting blood flow to his brain per wife." "1241401-1" "1241401-1" "DEATH Narrative: Patient died after COVID vaccine dose #1. 01/14 COVID vaccine dose #1 04/13 pt died Patient with advanced ALS, progressive respiratory difficulty and passed away while on hospice. Vaccine did not likely contribute to the patient's death, but was due to advanced ALS. Patient was not hospitalized prior to vaccine or immediately after vaccine. No adverse event following vaccine. No previous COVID diagnosis known." "1241402-1" "1241402-1" "DEATH. Narrative: Patient died after receiving COVID vaccine dose #1. 07/18/20: admitted to hospital for weakness/lightheadedness causing legs to give out and fall backwards, resulting in hematoma 12/15/20: seen by PCP, stable 02/03 seen in ID clinic for HIV follow up, nothing out of the ordinary 03/02 COVID vaccine dose #1 03/14 Pt died Cause of death unknown and undocumented at this time. Patient did not have an ADR immediately after vaccine or hospitalized before or after vaccine. Last hospitalization was July 2020 due to fall and associated hematoma. Death not likely due to vaccine, but due to comorbidities, including active HIV infection with detectable viral load. No known previous COVID infection." "1241403-1" "1241403-1" "Death Narrative: Patient tested positive for COVID-19 on 1/25/21 after receiving her first vaccine on 1/8/21. He was discharged from hospital on 1/26/21 with admitting diagnosis of COVID pneumonia. He did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient had made it through the COVID infection period but suffered complications including pneumonitis, lung, heart, and kidney failure requiring high flow oxygen. He required readmission to hospital for the complications in 3/2021 but ultimately passed away on 3/24/21 likely due to the multi organ failure complication of COVID" "1241404-1" "1241404-1" "WEAKNESS, SHORTNESS OF BREATH, NASAL CONGESTION, DEATH Narrative: Patient died after COVID vaccine dose #1 01/07 visit for chemo, stable 01/21 visit for chemo, stable 01/27 hematology visit d/t rash, likely heat rash 02/09 chemo for multiple myeloma, reports fatigue but no dyspnea 02/10 COVID vaccine dose #1 03/02 chest xray with concern for bilateral pneumonia, treated with antibiotics 03/08 pt having pain in back of the neck 03/09 pt having shortness of breath, transported to hospital with persistent generalized weakness with body ache and shortness of breath; diagnosis: atypical pneumonia, viral vs. bacterial, acute dyspnea with hypoxia, nonproductive cough, chest congestion, headache, and malaise 03/25 pt passed away COVID vaccination not likely contributor to patient's death, but is more likely due to advanced age (83 y/o) and comorbidities, especially active multiple myeloma, receiving chemo. No immediate reaction after first vaccination. Hospitalized a month after vaccine and illness persisted, leading to patient's passint. No COVID infection documented." "1241405-1" "1241405-1" "Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Circumstances surrounding his death are not documented in chart. Comorbidities include Hepatitis C, HTN, T2DM." "1241587-1" "1241587-1" "She was a healthcare worker. It was reported to me by her immediate supervisor that she tested positive for COVID-19 the day after her first vaccination. She became symptomatic around January 21, 2021. She was scheduled to return to work on January 29, 2021 but did not come in. She died on February 2, 2021." "1241639-1" "1241639-1" "Two days after the 2nd dose, the patient presents the following symptoms: 75% oxigenation, 35% Puls, 153 sugar, HBP 64/44 and vomiting." "1241676-1" "1241676-1" "The patient was with respiratory difficulties, low pressure and low pulse." "1241805-1" "1241805-1" "Patient experienced a headache within 4 hours of vaccination. Took recommended dose of Tylenol. 4 hours after that (8 hours after vaccination) he was still experiencing extreme headache and also vomiting and took another dose of Tylenol. Was still feeling poor at 1am but coherent and talking, not thinking that it was serious enough to warrant going to hospital, as he believed it was just a bad headache and the vomiting was from the headache. At 6am, he was found blue/dead in his bed." "1241873-1" "1241873-1" "Patient received her first dose of Pfizer vaccine on 4/1/21. Patient has a stroke 4/6/21 and passed away on 4/10/21." "1241936-1" "1241936-1" "acute respiratory failure 12 days post vaccination, emergency room visit, death of patient." "1242022-1" "1242022-1" "Patient care coordinator on PCP team learned of patient death, as documented: TC to pt family for a welfare ck d/t co-worker mentioned saw in social media pt had passed? PCC-spoke with pt daughter states father passed on 4/18/2021 in the PM unknown exact time of death at home. PCC gave family condolences for their loss. Patient reports father got covid-19 vaccine on 4/13/2021 and he started having severe HA's on this day. Sx increased for the next few days, he had dry cough,sore throat,chest pain,SOB. States father declined for family to called an ambulance while sx were increasing. States ambulance was called on Sunday 4/18/2021 to take body to the morgue. States they are awaiting for autopsy results,and death certificate. States father's body will be taken to his family. On what date did they pass away? 418/2021 unknown time, at home Do you know what the cause was? Family is not sure of cause of death" "1242079-1" "1242079-1" "diarrhea. No fevers. Occasional cough. No loss of taste or smell." "1242117-1" "1242117-1" "Healthy male, no substance use, no symptoms reported made plans to go hiking with a friend the following Sunday (4/18/21) on 4/16/2021 in afternoon. This was last known contact, patient stopped responding to phone after text and was found deceased in home on 4/22/2021, appearing to have passed away in sleep, likely 4/16/2021 in evening." "1242118-1" "1242118-1" "Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9." "1242160-1" "1242160-1" "CALLED TO TRANSFER PATIENT FROM 2C ADMITTING AREA TO ENDOSCOPY UNIT AROUND 1410. UPON ARRIVAL IN 2C TO TRANSFER PATIENT, PATIENT WAS ALERT AND RESPONSIVE TO NAME. WHEN WHEELED TO BEDSIDE IN ENDOSCOPY UNIT PATIENTS RIGHT ARM SLUMPED AND HE BECAME UNRESPONSIVE. RAPID RESPONSE CALLED. PATIENT TRANSFERRED TO STRETCHER, CODE BLUE CALLED, AND CPR STARTED. DR. ANESTHESIA AT BEDSIDE MANAGING AIRWAY. CODE TEAM RESPONDED. REFER TO ARREST RECORD." "1242205-1" "1242205-1" "8 days after the 2nd Pfizer shot sudden vomiting including blood and then collapse and died. No other symptoms of sickness leading up to this." "1242376-1" "1242376-1" "Vaccine on 04/10/21.Shortness of breath, dizziness, nausea 04/13/2021. Death on at hospital on 04/14/2021 Autopsy found Bilateral pulmonary thromboemnbolus" "1242520-1" "1242520-1" "35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour." "1242546-1" "1242546-1" "Patient found deceased at home 19 days after first dose of Pfizer vaccine. No reported side effects after vaccine. Patient did not have regular medical care. Autopsy performed due to lack of medical history and recent vaccination. Autopsy revealed marked pre-existing cardiac disease (hypertensive and atherosclerotic cardiovascular disease), which is the determined cause of death. Autopsy also revealed marked thyroid gland enlargement with Hashimoto thyroiditis diagnosed on histologic exam. It is unknown if this is pre-existing, as patient did not seek medical care and did not complain of symptomatology." "1242573-1" "1242573-1" "Heart failure" "1242607-1" "1242607-1" "Ankle swelling with extreme foot pain(has neuropathy) No symptoms in 15 minutes after injection on both injections After the second injection had complaints of being shaky, not feeling well with generalized weakness" "1242654-1" "1242654-1" "NA Comfort Cares-acute hypoxic respiratory failure in the setting of bilateral pulmonary extensive infiltrates due to ARDS, pneumonia and possible component of CHF exacerbation. Non-ST elevation myocardial infarction." "1242660-1" "1242660-1" "Patient has a long standing chronic history of CHF which he was recently hospitalized for, returning from an overnight stay at the hospital as a DNR/DNH/DNI." "1242850-1" "1242850-1" "Received #2 Moderna on 3/5/2021. Started to not feel well the next day. By 3/9/2021, he was too sick to get out of bed. Friends stayed with him the previous night and opted to call 911 for hospital transport on 3/9. He was admitted to a Medical Center and diagnosed with pneumonia. He died on 3/18/2021 in patient." "1242858-1" "1242858-1" "Patient contracted COVID 19 and subsequently expired from respiratory distress, following completion of the serious of two vaccination shots. She received her Moderna vaccinations on 1/7/21 and 2/4/21. I do not have access to the lot # info- would have to contact vaccination site to obtain" "1242906-1" "1242906-1" "Pharmacy was contacted by an aunt, who is also a healthcare provider. This contact was requested by the family. Per nurse practitionar who is the aunt of the deceased), patient passed away on Monday, 4/19/2021. He was found unresponsive on a jogging trail, where he had been jogging, by a third party person. They had called an ambulance and could not revive him. Family requested a VAERS report due to the proximity in time to his 2nd Pfizer vaccination. He had received his vaccination at 9:56am on 4/14/21 (lot ER8730) and per father the only side effect he indicated was a sore arm. Autopsy pending per family." "1242950-1" "1242950-1" "Receiver of vaccine was reported dead on 04-22-2021 TOD 0809 to Medical Examiner's Office Report # 052-EMF-79-21" "1243053-1" "1243053-1" "Patient was hospitalized x 2 and died within 60 days of receiving a COVID vaccine" "1243206-1" "1243206-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1243300-1" "1243300-1" "Started feeling bad two=three days after shot, became fatigued, lost 15 pounds and could not go to work. On morning of 4/21 was found unresponsive and rushed to hospital where he died 2 hours later" "1243301-1" "1243301-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1243346-1" "1243346-1" "Pt received vaccine on 03/17/2021. Pt's wife stated that pt never felt well after receiving the vaccine. Per hospital notes, pt lost his balance and fell at home approximately 12 hours prior to admission. By report, he laid on the floor for around 12 hours before emergency services were activated and he was brought to the ED. Primary diagnosis was a closed left hip fracture with other hospital problems of the fall at home, bradycardia, coronary artery disease, hypokalemia, protein calorie malnutrition, type 2 myocardial infarction and essential hypertension." "1243358-1" "1243358-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine" "1243360-1" "1243360-1" "Patient received first Moderna Vaccine on 02/26/2021 and second Moderna Vaccine on 03/26/2021. Health Department was notified of patients death on 03/27/2021, today 04/22/2021. Any further information is unknown by the health department for patients cause of death that occurred on 03/27/2021." "1243461-1" "1243461-1" "My father passed away on the 5th day and was in pretty good health." "1243487-1" "1243487-1" "Patient Committed Suicide with a firearm." "1243574-1" "1243574-1" "Cause of death is believed to be a fatal arrhythmia resulting from advanced old age and aggravated by sepsis due to COVID-19 infection along with gastroenteritis. The death was natural and not unexpected. Tobacco is not believed to have contributed to t" "1243588-1" "1243588-1" "not sure if related, but he passed away on 4/18/2021" "1243648-1" "1243648-1" "headache on 4/8/21, sudden death 4/11/2021" "1243650-1" "1243650-1" "Unexpected death; found unresponsive 04/20/21 morning and pronounced dead after unsuccessful resuscitative efforts" "1243715-1" "1243715-1" "Report received from co-worker of patient. Patient received J&J vaccine on 3/13/21. Patient was at work and collapsed 11 days after vaccination. Was intubated at work site and taken to local hospital - the patient was then airlifted to a Medcial Center. Diagnosed with a brain bleed and subsequently died on 4/6/21." "1243791-1" "1243791-1" "Per the father, the deceased received his first shot of Moderna vaccine on Saturday, 4/10/2021 at a local church. He did not work on 4/11/2021. Worked on 4/12/2021. The deceased was found dead at 6:43 p.m. at his home." "1243832-1" "1243832-1" ""4.21.2021- I spoke with (patient's husband) related to spouse. Husband stated the patient has a history of 2nd Degree Type 2 heart block, pacemaker placed at the age of 14, and she currently has issues with an eating disorder dx with anorexia. Patient is reported to be approximately 68-70 pounds at the time of vaccination. March 8.2021- Husband states he and his wife came to receive the vaccine around 1630. After, receiving the vaccine the patient stated to her Husband ""my arm really hurts."" She begin experiencing s/s at approximately 1900 including: fever, chills, runny nose, fatigued and tired - reportedly temperature was 100.0 and the patient began to drink Gatorade and take Tylenol. Monday, 3.15.2021 patient continued to have symptoms therefore, (husband) contacted Moderna Representatives from the safety team, to determine if it would be safe for the patient to get the 2nd vaccine dose - advised everyone that does not have contraindications should be vaccinated-advised to reach out to PCP. Husband stated that the patient did not want to go to her PCP because of her eating disorder. The patient worked from bed during the week per the husband and spent 90-95% of her time in the bed after receiving the vaccine. Husband states on Saturday 3.20.2021 the patients fever had subsided however, she continued to feel poorly and remained bedbound most of the time. Husband is an Pilot 3.23.2021 stated once, he had landed he began trying to contact wife but she was not answering the phone, after several attempts to contact wife - Husband called a neighbor to check on wife. Upon, entering the residence the neighbor found wife lying on the floor unconscious and not breathing. The neighbor notified Husband and called 911. EMS arrived at the scene and pronounced the patient as a DOA. Husband states that the death certification list cardiac arrest, electrolyte imbalance, and heart block, as causes for death. Husband is concerned that the vaccine may have contributed in some way demise of his wife as he stated ""she was never the same after the vaccination."""" "1244303-1" "1244303-1" "Flu like symptoms, diarrhea, vomiting, weakness, no appetite and trouble drinking fluids for the first several days. Took him to the hospital due to concern over dehydration and not eating, but still having daily diarrhea. ER doc said that the electrolytes were fine and heart was ok, so, no reason to keep in hospital. That night he was I not able to get out of bed or even sit up. Monday called primary care doctor and decided to call hospice for more help. They provided 24/7 monitoring and care for several days. He just got worse every day until he died Tuesday early morning at about 1:10am at home." "1244814-1" "1244814-1" "Dizziness off and on for 2 weeks along with muscle weakness and developed a cough about a week after this injection. My mother passed away." "1244990-1" "1244990-1" "After receiving the second dose of the vaccine, my husband experienced left arm pain which he thought was from the injection. About a week later, the pain got worse and moved toward his chest. It got so bad, he had to be taken by ambulance to the hospital to find out he had been having a heart attack. He spent nearly three weeks in the hospital before he died on 4/15/21" "1245000-1" "1245000-1" "Blood clots in the lungs, pulmonary embolism" "1245299-1" "1245299-1" "Patient developed swelling of his upper and lower lip on 4/11 and was given 25 mg benadryl at the care home. Swelling subsequently worsened and 911 was called, with EMS noting SpO2 at 88%. He was transported to the ER and found to have CHF/pulmonary edema and NSTEMI. Comfort care measures were implemented and he died 4/15." "1245370-1" "1245370-1" "very tired and sleep 18 hours; passed away; severe flu-like symptoms; chest pain; Soreness at injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (passed away) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dermatomyositis, Polymyositis, Osteoarthritis, Degenerative bone disease, Osteoporosis, Muscular dystrophy, Rheumatoid arthritis, Immune disorder (NOS) and Raynaud's phenomenon. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Asthma, PILOCARPINE for Dry mouth, IRBESARTAN for Hypertension, DILTIAZEM HYDROCHLORIDE (CARDIZEM CD) for Hypertension and Chest pain, SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, TIZANIDINE for Muscle spasms, PROCHLORPERAZINE EDISYLATE (COMPAZINE [PROCHLORPERAZINE EDISYLATE]) and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, GABAPENTIN (NEURONTIN) for Nerve pain, OXYCODONE for Pain, LEFLUNOMIDE and UPADACITINIB (RINVOQ) for Rheumatoid arthritis, ZOLPIDEM TARTRATE (AMBIEN CR), ACETYLSALICYLIC ACID (BAYER ASPIRIN), LANSOPRAZOLE (PREVACID), DIAZEPAM (VALIUM), CANNABIDIOL (CBD OIL) and IRON (IRON COMPLEX [IRON]) for an unknown indication. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). On 31-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (severe flu-like symptoms) and CHEST PAIN (chest pain). On an unknown date, the patient experienced FATIGUE (very tired and sleep 18 hours). On 02-Apr-2021, INFLUENZA LIKE ILLNESS (severe flu-like symptoms), CHEST PAIN (chest pain), FATIGUE (very tired and sleep 18 hours) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown. The patient died on 02-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. On 02-APR-2021 at 1: 30 AM mother found her daughter lying on the floor unresponsive. Paramedics and police came to the house. Paramedics tried to revive her and she was pronounced dead at the scene. This is a 54 year-old, female patient who received mRNA-1273 Vaccine) (batch no. 020B21A) and died 3 days after receiving first dose of vaccine and experiencing Influenza like symptoms. Medical hx of several auto immune disorders were provided. Conmeds include Hypertensive and Chest pain meds. The fatal outcome may be related to the patient's pre-existing comorbidities Very limited information has been reported at this time. No further information is expected.; Sender's Comments: This is a 54 year-old, female patient who received mRNA-1273 Vaccine) (batch no. 020B21A) and died 3 days after receiving first dose of vaccine and experiencing Influenza like symptoms. Medical hx of several auto immune disorders were provided. Conmeds include Hypertensive and Chest pain meds. The fatal outcome may be related to the patient's pre-existing comorbidities Very limited information has been reported at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death" "1245371-1" "1245371-1" "irritated her heart condition; Clot blood; weakness in legs, couldnt walk with legs; Coma; couldn't breathe; stroke/massive stroke in left side of her brain; Irritated her heart condition, rapid heart beat; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke/massive stroke in left side of her brain), CARDIAC DISORDER (irritated her heart condition), DYSPNOEA (couldn't breathe), THROMBOSIS (Clot blood), COMA (Coma) and MUSCULAR WEAKNESS (weakness in legs, couldnt walk with legs) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Covid-19 Vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart disease, unspecified, Hypertension and AFib. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) for Hypertension, METOPROLOL for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tiredness). On 12-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weakness in legs, couldnt walk with legs) (seriousness criterion hospitalization). On 13-Mar-2021, the patient experienced CARDIAC DISORDER (irritated her heart condition) (seriousness criterion hospitalization), THROMBOSIS (Clot blood) (seriousness criterion hospitalization) and HEART RATE INCREASED (Irritated her heart condition, rapid heart beat). On 15-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke/massive stroke in left side of her brain) (seriousness criteria death and medically significant). On 16-Mar-2021, the patient experienced DYSPNOEA (couldn't breathe) (seriousness criterion hospitalization prolonged) and COMA (Coma) (seriousness criterion hospitalization prolonged). The patient was hospitalized on 13-Mar-2021 due to CARDIAC DISORDER, COMA, DYSPNOEA, MUSCULAR WEAKNESS and THROMBOSIS. The patient died on 17-Mar-2021. The reported cause of death was massive stroke in left side of her brain. It is unknown if an autopsy was performed. At the time of death, CARDIAC DISORDER (irritated her heart condition), DYSPNOEA (couldn't breathe), THROMBOSIS (Clot blood), COMA (Coma), MUSCULAR WEAKNESS (weakness in legs, couldnt walk with legs), HEART RATE INCREASED (Irritated her heart condition, rapid heart beat), HEADACHE (Headache) and FATIGUE (Tiredness) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. This case concerns an 95 year old female patient, with medical history of A Fib, Heart disease, Hypertension who experienced a serious unexpected event of Death 8 days after receiving 1st dose of mRNA- 1273 . Very limited information regarding these events has been provided at this time. However, the patient's advance age, multiple co-morbidities, may remain as risk factors. Further information is requested. This case was linked to MOD-2021-074814 (Patient Link).; Sender's Comments: This case concerns an 95 year old female patient, with medical history of A Fib, Heart disease, Hypertension who experienced a serious unexpected event of Death 8 days after receiving 1st dose of mRNA- 1273 . Very limited information regarding these events has been provided at this time. However, the patient's advance age, multiple co-morbidities, may remain as risk factors. Further information is requested.; Reported Cause(s) of Death: massive stroke in left side of her brain" "1245985-1" "1245985-1" "This 80 year old white male received the Covid shot on 4/8/21 and died on 4/18/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1246110-1" "1246110-1" "Lethargy, weakness, headache; ultimately pronounced on 4/3/2021 at 1310 hours" "1246210-1" "1246210-1" "NA Hospitalization for Acute Resp Failure with Hypoxia secondary to acute and chronic CAD" "1246223-1" "1246223-1" "Hospitalization - comfort measures -acute on chronic combined CHF caused by ischemic cardiomyopathy with Cardiorenal syndrome + acute hypoxic respiratory failure, major decline, failed CABG" "1246256-1" "1246256-1" "Hospice Care Sepsis associated hypotension Discharge Diagnoses: acute on chronic hypoxic/hypercapnic resp failure requiring intubation, acute on chronic CHF, severe COPD with likely exacerbation, possible CAP, likely medical non compliance" "1246484-1" "1246484-1" "Patient received her first Moderna dose on 03/12/21 at 1:24pm in the Right Deltoid, Lot# 036A21A, no reaction after 15 min. No reaction was reported 15 min. after her second dose which was in the opposite arm. See was being watched by her family members that evening, family members did not report anything at that time. Her temperature on 4/16/21 was 97.1" "1246486-1" "1246486-1" "Patient reported to onsite health clinic to see nurse at 1930. Complaints of not feeling well. Vomited then dyspnea. Went into cardiac arrest, AED used x1. EMS called at 1945. CPR, intubation until 2055. Time of death 2055." "1246534-1" "1246534-1" "Patient felt initially well, but later in that afternoon her arm started hurting and she felt increasingly nauseous and started vomiting at 10:49pm, two hours later she was pronounced dead at approximately 12:30am." "1246604-1" "1246604-1" ""Patient presented to ED on 04/18/2021 with cardiopulmonary arrest, per ED ""He was receiving CPR with EMS for arrival to the emergency. Two rounds epi. Asystole and then went into V-tach. Got shocked once. Then after that has been strip PA asystole."" ED called time of death on patient 04/18/2021 at 05:14AM."" "1246863-1" "1246863-1" "Shortness of breath, blood clot in lungs" "1246956-1" "1246956-1" "Stroke and blood clot in right leg." "1247144-1" "1247144-1" "Patient complained of chest heaviness and fatigue at bedtime 6 days after receiving the first dose of the Pfizer COVID vaccine. Patient planned to go to the doctor in the morning, but died while sleeping." "1247180-1" "1247180-1" "Patient passed away suddenly and unexpectedly at home the morning of April 4, 2021. The ER doctor was unable to ascertain a cause. The preliminary autopsy conducted by the medical examiner within 24 hours of death was inconclusive, but I'm told tests of samples are ongoing." "1247222-1" "1247222-1" "Patient collapsed when being helped out of her son's car. EMS promptly on scene. Patient in PEA and was transported to Hospital, where she died. Was reported to be in usual health before event." "1247290-1" "1247290-1" "He found dead after 2 days he got the vaccine." "1247315-1" "1247315-1" "Death less than 24 hours after vaccine administration" "1247318-1" "1247318-1" "Death" "1247401-1" "1247401-1" "Patient received Moderna Vaccine on Friday 4/16/2021 12:00pm in dialysis clinic. Over the weekend family called and left a message stating that patient CTB on Friday 4/16/2021 around 8pm." "1247465-1" "1247465-1" "Patient received vaccine on 4/15/21 2nd dose of 2 dose series. He woke up the morning of 4/22/21 at 6:15am with vomiting. His temperature spiked to 104.2 and his O2 sat dropped to 98%. He developed shaking chills, and a loose wet sounding cough. He had chest xray and labs. Started on treatment for pneumonia with rocephin, zithromax and solumedrol. Declined throughout the day and had increasing requirements for O2 and patient passed away at 1355 on 4/22/21." "1247588-1" "1247588-1" "Shortness of breath in early March, hospitalized on 3/17/2021, was COVID positive and was found to have pulmonary emboli" "1247741-1" "1247741-1" "received second covid vaccine on 3/2/2021. Admitted to hospital on 3/27/21 with shortness of breath and expired on 4/12/2021." "1247816-1" "1247816-1" "patient called EMS with pain crisis and noted that she had lost vision in both eyes. was transported to Emergency room by EMS and had cardiac arrest and died." "1247832-1" "1247832-1" "patient was vaccinated with second covid vaccine on 2/12/21. Patient was admitted to the hospital on 03/04/2021 with fatigue and diagnosed with COVID 19 (positive lab test on 2/26/21 and 3/4/21). Case expired on 3/8/21." "1247865-1" "1247865-1" "One week and 6 days after second vaccine fatal heart attack" "1247898-1" "1247898-1" "Patient had second covid 19 vaccine on 2/2/21 at pharmacy. Was admitted on 4/6/21 to hospital with Shortness and Breath, Vomiting, and COVID-19 (tested positive on 4/6/21). Patient expired on 4/8/21 @ 1954." "1247997-1" "1247997-1" "Per his parents, patient started feeling nauseous an hour or two after the vaccine and at night around 10pm it worsened where he felt nauseous, had shivers and he vomited in the middle of the night. He then vomited again the next day and continued to not feel well the next couple of days. On 4/20/2021 at around 4:20pm he called his mother, his girlfriend and his mentor that he was not feeling well, was nauseous and dizzy and had shivers and was going to pull over on his car to get something to drink. He then stopped answering his phone and was found dead in his car later on that day. Police is investigating the case." "1248051-1" "1248051-1" "Patient was admitted with ischemic colitis and hypoglycemia. She also tested positive for C.diff during her hospitalization, unclear if this was from prior antibiotics in March. She did not receive DVT prophylaxis for 2 days. She developed a nonocclusive DVT in the right internal jugular and subclavian veins and a Nonocclusive superficial thrombosis in the right basilic vein on 4/18. She went into PEA and was revived, intubated, and transferred to the ICU. She went into PEA again and was revived after 5 rounds of CPR. The family decided to make the patient comfort care and expired on 4/19" "1248086-1" "1248086-1" "Moderna COVID-19 Vaccine EUA: patient underwent L1-2 corpectomy, pedicle subtraction osteotomy, and extension of fusion from T4 to the pelvis two months after vaccination. During surgery patient became thrombocytopenic and required massive transfusion. Thirteen days after surgery found to have bilateral pulmonary embolisms and deep vein thromboses and placed on anticoagulation. Patient subsequently suffered cardiac arrest and was unable to be resuscitated." "1248554-1" "1248554-1" "PATIENT RECEIVED THE VACCINE ON 3/15, HE PASSED AWAY ON 3/29" "1248748-1" "1248748-1" "Pt in previously good health received J&J vaccine 04/09 and felt well until 04/21 when she developed lower extremity weakness and incoordination which became progressively worse and was accompanied by slurred speech on the afternoon of 04/22. The pt's husband helped her into bed and she apparently died during the night of 04/22-04/23." "1248842-1" "1248842-1" "Pt received his 2nd moderna covid vaccine on 4/16/2021. admitted on 4/22/2021 from his long term care facility due to concerns for a chf exacerbation and acute on chronic respiratory failure. Pt was given IV Lasix. chest x ray showed mild pulm vascular congestion. there was no hypoxia, tachycardia and pt was on eliquis so pe was felt to not be a possibility. abg showed acute respiratory acidosis with hypercapnia which improved with bipap administration. His troponins and ekg were negative. vitals on arrival were stable. He was admitted. Labs were otherwise unremarkable. Pt began to have pauses on telemetry and was last seen awake and alert but when nursing staff went back to check on him minutes later he was found deceased" "1248862-1" "1248862-1" "Patient flew from city to city through another city on Tuesday 3/16/21. He had a reaction on the flight where he coughed for 1.5 hrs and was hot in the airplane. He could not go to work and was required to get Covid tested on 3/18. Still coughing and having trouble sleeping (laying down). Rapid Covid test negative on 3/18. PCR test results negative on 3/21 from hospital. He continued to grow weak and cough from 3/16-3/21. At 3am on 3/22 he called and said that his feet were 2X their size and having difficulty breathing. Taken to hospital via ambulance. When transfered to ER bed, Dr said that he lost pulse. They intubated and got his pulse back. Died at 5:15am. Autopsy said cardiac arrest. Dr said that they could not maintain a heart beat. He asked me if the patient had a history of blood clots? No he did not ever has a blood clot that I know of. He had a chest xray post mortem showing fluid in his lungs from low circulation of blood." "1249366-1" "1249366-1" "pt received her 2nd pfizer covid 19 vaccination on 4/1/21. she presented to the er on 4/16 with family with c/o 3 days of poor oral intake, diarrhea, weakness and confusion. family reported deterioration over the last 2 weeks. she was initially hemodynamically stable in the ER initially then became bradycardic and hypotensive. oxymask was placed. blood work revealed neutrophilia, anemia, mildly elevated ast and a markedly elevated troponin. she was admitted with non ST elevation MI, acute encephalopathy which ultimately progressed to coma, acute renal failure, progressive thrombocytopenia. cardiology saw her. she was started on a heparin drip. infectious cause for her symptoms was not found. her ef was 40% on echo. she expired on 4/20/2021." "1249581-1" "1249581-1" "Died in sleep. Not sick when he went to bed. Not breathing when found. No sign of puke, blood, urine or BM." "1249616-1" "1249616-1" "MY HUSBAND DIED WITHIN 24 HOURS OF RECEIVING THE VACCINE. I WANT TO CONFIRM THAT YOU KNOW ABOUT THIS. PLEASE CALL ME ON MY CELL PHONE , THANK YOU," "1249652-1" "1249652-1" "Patient died in his sleep 2 days after receiving 1st dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Patient died in his sleep 2 days after receiving 1st dose) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. Death occurred on 12-Feb-2021 The patient died on 12-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. The patient's wife went to wake him up but he was found dead in his sleep. She was hearing impaired and was not able to give any other information. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. This is a case of sudden death in a 84-year-old male, who died 2 days after receiving ffirst dose of vaccine. Very limited information has been provided at this time.; Sender's Comments: This is a case of sudden death in a 84-year-old male, who died 2 days after receiving ffirst dose of vaccine. Very limited information has been provided at this time; Reported Cause(s) of Death: Patient died in his sleep 2 days after receiving 1st dose" "1249681-1" "1249681-1" ""Found dead; Felt crappy; Wasn't feeling well; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Found dead) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure abnormal (""Patient was on blood pressure medications for the last 20 years"") and Anticoagulant therapy (""Patient started on a blood thinner in January 2021""). On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced FEELING ABNORMAL (Felt crappy) and MALAISE (Wasn't feeling well). On 18-Apr-2021, FEELING ABNORMAL (Felt crappy) and MALAISE (Wasn't feeling well) outcome was unknown. The patient died on 18-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. The patient was on blood pressure medications (unspecified) for the last 20 years. She was started on blood thinner (unspecified) in January 2021. Treatment information leading up to the patient's death was not reported. Action taken with mRNA-1273 in response to the events was not applicable. A case of death of a 75-year-old, female patient 3 days after the second dose of mRNA-1273 (Lot # 040A21A). Patient had developed abnormal feeling and malaise 2 days after vaccine use and based on temporal association cannot be excluded. However, causality cannot be established for the death as cause of death is unknown. Further information is being requested.; Sender's Comments: A case of death of a 75-year-old, female patient 3 days after the second dose of mRNA-1273 (Lot # 040A21A). Patient had developed abnormal feeling and malaise 2 days after vaccine use and based on temporal association cannot be excluded. However, causality cannot be established for the death as cause of death is unknown. Further information is being requested.; Reported Cause(s) of Death: Found dead"" "1249748-1" "1249748-1" "At first my mother had a headache. Then My mother was feeling weak and could not breathe. She continued to suffer so went to the doctor to get a check up but continued to suffer and finally died on 2/8/21 due to a couple of reasons which include hypertension" "1250784-1" "1250784-1" "My mother was found deceased in her home two days after receiving the first dose of Pfizer vaccine of unknown causes." "1250851-1" "1250851-1" "She had a lymph tissue lumps fever chills muscle aches headache. She said she felt about 50% better the following day. She eventually succumbed and passed away." "1250966-1" "1250966-1" "Per family, patient received 2nd vaccination and began experiencing swelling and shortness of breath the following day. This progressed over the course of 2 weeks until this today when he suffered a cardiopulmonary arrest and could not be resuscitated. Death resulted on April 24th 2021." "1251028-1" "1251028-1" "Death by suicide sometime between late evening Wednesday, April 21st, 2021 and early morning April 22nd, 2021. He was found at about 8am that morning." "1251507-1" "1251507-1" ""Department of Health received a call from her sister, in response to a call/letter/text sent out to all recipients of the Janssen vaccine. She stated that her sister received the J and J vaccine on 3/12/21 (confirmed in State vaccine system) at the hospital where she receives her oncology care. She reported the following: ""She had a massive stroke on MARCH 27TH, 2021 leaving her paralyzed on the right side with the inability to speak, swallow, or see. She was initially diagnosed with Ovarian cancer approximately three and one half years ago. She was chosen for a study with Pharmaceuticals and her diagnosis was changed to a vary rare form of cancer called clear cell carcinoma which originates in the gynecological area. She did have a previous stroke approximately three years ago, (just after original diagnosis) but she was on a different course of treatment at that time...Oncologists have explained that this most recent stroke event would not be considered a side effect of her current treatment routine. She wanted to bring it to the attention of the health department in case it needs to be looked at more closely by the J&J research/scientific team. She passed away on 4/5/21. Her current treatment consisted of palliative chemo only. "" Decedent was a resident but was vaccinated in another state. After the CVA she was brought to the hospital and subsequently transferred to the Medical Center where she died on 4/5/2021. Sister is willing to speak with any investigators if deemed necessary."" "1252137-1" "1252137-1" "Stoke 6 days after vaccine. Death 5 days after stroke." "1255612-1" "1255612-1" "Heart attack and death; This is a spontaneous report from a contactable Nurse. A 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Ej1685) intramuscular in left arm on 18Dec2020 at 11:00 AM at single dose for COVID-19 immunisation. Medical history was none, no known allergies. No other concomitant medications in two weeks. No other vaccine in four weeks. The patient experienced heart attack at 05:30 pm on 06Apr2021 and the event caused patient death. No treatment for the event. Autopsy results was available. Autopsy remarks: heart attack. No COVID prior vaccination, no COVID tested post vaccination. The patient died on 06Apr2021. An autopsy was performed and the reported cause of death was heart attack.; Sender's Comments: Myocardial infarction occurred 3 months and 19 days after BNT162B2 vaccine administration. The event is considered unrelated to suspect drug being rather an incidental occurrence. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Heart attack and death; Autopsy-determined Cause(s) of Death: Heart attack" "1255708-1" "1255708-1" "SOB; Sepsis; aspiration pneumonia; This is a spontaneous report based on the information received by Pfizer. A contactable Other HCP reported that a 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration at the age of 59-year-old on 31Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included chronic UTI, and splenectomy for unknown reason, RMS (Rhabdomyosarcoma). Concomitant medication included ocrelizumab (OCREVUS). On 02Apr2021, it was reported that patient experienced: Went into hospital due to SOB (Shortness of breath) on 02Apr2021, died on 07Apr2021 related to aspiration pneumonia on an unspecified date. Patient developed Sepsis as well on an unspecified date. Patient became a DNR on 06Apr2021 then passed on 07Apr2021. The patient was hospitalized for SOB from 02Apr2021 to an unknown date. The patient died on 07Apr2021. It was not reported if an autopsy was performed. The outcome of event aspiration pneumonia was fatal. The outcome of events SOB and Sepsis was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available and known drug safety profile, the reported events more likely represented intercurrent illnesses, but not related to Bnt162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: aspiration pneumonia" "1255719-1" "1255719-1" ""My father had a massive stroke and brain hemorrhage that took his life.; My father had a massive stroke and brain hemorrhage that took his life.; This is a spontaneous report from a contactable consumer. A 65-year-old male patient (reporter's father) received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration at the age of 65-years-old on 15Mar2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history was not reported. No known allergies. Not diagnosed with COVID prior vaccination. There were no concomitant medications. No other vaccines in four weeks. No other medications in two weeks. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The reporter stated that, ""My father had a massive stroke and brain hemorrhage that took his life"" on 15Apr2021 09:30 PM. No treatment received for the events. The events resulted in Emergency room/department or urgent care. The patient died on 18Apr2021. It was not reported if an autopsy was performed. Unknown if tested for COVID post vaccination. Information about lot/batch number has been requested.; Reported Cause(s) of Death: My father had a massive stroke and brain hemorrhage that took his life.; My father had a massive stroke and brain hemorrhage that took his life."" "1255746-1" "1255746-1" "heart arrhythmia; cardiac arrest; This is a spontaneous report from a contactable consumer who reported for his wife. An 81-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number EM9810) via unspecified route of administration on 02Feb2021 (at the age of 81-year old) at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medication included metoprolol from Jan2021 for congestive heart failure. The patient received the first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number) on 12Jan2021 and on 15Jan2021, she had such trouble breathing diagnosed in the Urgent care as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. On 18Feb2021 she collapsed, went limp and went into the hospital and she was neurologically unresponsive. They tried to revive her and did bring her back with 5 epi shots, he was told that they did bring her back. When she got to the ER she went pulseless again and they gave her two more epi shots and got her back but she never did come out of a coma-like state. They admitted her to ICU. She stayed there until she passed away on the 22Feb2021. CT scans, X-rays, images of her heart, echocardiograms were performed. She was tested for COVID in Feb2021 and it was negative. They did a brain scan and there was no activity because she had been too long without oxygen. The consumer reported that the week before the cardiac arrest, she was feeling faint but she never passed out. Death certificate stated cause of death was heart arrhythmia and cardiac arrest. No autopsy was done.; Reported Cause(s) of Death: heart arrhythmia; cardiac arrest" "1255836-1" "1255836-1" "Presented to ED on 1/12/21 slowly worsening constant myalgias, generalized weakness where she couldn't walk, dry cough. Per daughter not acting herself and more confused. Clinical impressions included hypoxia, COVID-19. Pt is s/p her first dose of vaccine and this precludes plasma. Supportive care steroids and doxy. Family faxed DNR on 1/12/21 at 2225. Remdesivir given 1/13/21 at 1am. 1/13/21 note at 1:30am: Pt's O2 sat fluctuating btw 80%-90%. Increased NC success pt O2 sat continues to decrease. NRB 15L in place O2 Sat 90%. Pt became pulseless and expired at 0451." "1256000-1" "1256000-1" "Pallor, Fatigue, loss of vitality, diarrhea, profuse rectal bleeding, coughing up blood, death 25 days after vaccine" "1256112-1" "1256112-1" "My husband received the shot on the 22nd. He died in his sleep on the 24th. He was complaining how the second shot really was giving him a lot of trouble, but nothing that would indicate life-threatening symptoms" "1256666-1" "1256666-1" "Patient started complaining of being short of breath, weak and dizzy a day or two after receiving the shot. He started taking the asthma inhaler constantly rather than just once in months. He lay down for a nap and never woke up exactly 3 weeks after getting the shot. (more exact details will need to come from his wife)." "1256737-1" "1256737-1" "Died blood clot in brain" "1256806-1" "1256806-1" "My Sister was found dead on 4/27/2021. She had been dead aprx. 0ne week. She received her 1st Moderna shot on March 25th." "1256946-1" "1256946-1" "Unknown if any immediate reaction. The patient passed away on 3/28/21 approximately 2 weeks from the first dose of the vaccine." "1257062-1" "1257062-1" "The patient developed high fevers, profound watery diarrhea up to 13L/day, requiring IV administration of replacement fluids. He ultimately developed ARDS and succumbed to this illness." "1257197-1" "1257197-1" ""Patient died sometime between Sunday evening, April 4 and Monday morning, April 5. I looked at the browser history in her cellphone and on the night of April 4, she googled ""Heart attack symptoms in women"" and ""Moderna vaccination side effects."" I think she didn't go to the doctor because she figured her symptoms were related to her vaccine -- even though it had been a week. I wanted to report her death because I don't trust her doctor to do it. It took him two weeks and a call from me to complain before he signed her death certificate. He listed April 9, 2021 as the official date of death because that's when she was found, even though the deputy coroner told me she died on either the 4th or the 5th."" "1257204-1" "1257204-1" "Patient began experiencing pain and difficulty walking on Tuesday, March 23. Later that afternoon she was taken to an Urgent care, who sent her to the ER for evaluation. She was diagnosed with a very large blood clot in her leg, spanning from just above the knee to her groin area. They admitted her and began treating her with blood thinners. While undergoing that treatment, her heart stopped 3 times and she had to be resuscitated. They discovered a pulmonary embolism. While removing a large clot from her lungs, the doctor found that her lungs were riddled with hundreds of tiny blood clots. They also said that she was bleeding internally, very heavily, from an unknown location. In all, they gave her 20 units of blood, and none of it stayed in her veins. The doctor said it seemed to just disintegrate. At that point, her brain and organs had begun shutting down and family made the decision to remove her from life support. She passed away Thursday evening, March 25, 2021." "1257426-1" "1257426-1" "Heart stopped suddenly after 18 days probably due to presence of Potassium Chloride in the injection. Outcome DEATH within 2 hours thereof as medics unable to regain consciousness after CPR." "1257772-1" "1257772-1" "Patient started not feeling well and told friends and family that he was not feeling well and that his doctor believed he was having a side effect to the 2nd dose of his COVID-19 Vaccine. He died 11 days after receiving his vaccine." "1257832-1" "1257832-1" "Hospitalized +Covid post vaccination with decreased mental status" "1257932-1" "1257932-1" "Witnessed sudden cardiac arrest" "1258054-1" "1258054-1" "Stroke, hospitalized 5 days, sent to skilled care (nursing home), death 2 weeks after stroke" "1258114-1" "1258114-1" "Death 1 week after 2nd dose of Phizer COVID vaccine, this person developed shortness of breath and was found passed away by his roomate." "1258236-1" "1258236-1" "resident was hospice she was afebrile day of vaccine on 4/20. on am of 4/21/21 0600 nurse stated no c/o of pain or discomfort. Resp were even and unlabored. That morning at 1145 charge nurse stated she was extremely hard to rouse. Vs were ok. SHe had some weakness in right side. they notified hospice. She had labs done. She was diagnosed with PNA and started on Abt. That night she was unresponsive to verbal commands and couldn't get po med. she received gentamicin im. on 4/22/21 charted she was vommiting small amount. She expired late that night. MD doesn't believe the vaccine caused the death, but thinks it has the potential." "1258269-1" "1258269-1" "This pt came in to see me in her normal state of health and then received moderna #1 here on 4/1. Developed SOB 2 hrs after vaccination. Presented to ER on 4/2 with hypoxia (80%) and was + for covid. The ER triage notes states ?C/O SOB, Nausea, vomiting, diarrhea that started yesterday 2 hours after he first COVID Vaccine?. Notes quote her saying ?I got my vaccine yesterday and I started to feel short of breath.? She died from covid respiratory failure on 4/23." "1258334-1" "1258334-1" "My Father starting experiencing all the side affects - chills/shaking/loss of energy /fever and passed away - the day after having the shot." "1258453-1" "1258453-1" "my auntie, who was trying to be supportive and to get vaccinated just passed away like this is not worse it. My auntie, passed away the next two days after she got her Pfizer Covid vaccine. My auntie, who is 65 years old, got her Pfizer vaccine the the morning of April 22 2021. She told us he was completely find on the day of the vaccine. But the next morning around 9 am, she told us she has severe abdominal pain, has the need to have a bowel movement, but she was defecated. She also told us that she vomit couple times already, then she has no more energy to talk. She got into the hospital and she was announced right after midnight at 12:04 April 25th. The reported death reason is due to Bowel Ischemia with Perforation and it has nothing to do with Pfizer vaccine that she got. But I believe it is her post Pfizer covid vaccine reaction that result in Bowel Ischemia with Perforation. My auntie lived with a very healthy life style. She walked every morning, and has a shorter walk in the evening. She has no blood pressure, no blood sugar, everything is fine with her medical check. My auntie had a kidney transplant 20+ years ago and she is on the track for monthly doctor visit. When she asked her general doctor if she could get the vaccine, her general doctor asked her to consult her kidney doctor. She then went to ask her kidney doctor and her kidney doctor call her general doctor to discuss her health conditions. Both of her doctor decided that she could take the vaccine and one of the doctor registered her for the vaccine on April 15 2021. The she nurse told her to came in for vaccine on Apr 22, and she is now death after the Pfizer vaccine. I only read about people with recent organ transplant is not recommended to take the Covid vaccine. But there is no information about people that ever had kidney transplant shouldn?t take the vaccine. My auntie, who was trying to be supportive and to get vaccinated just passed away like this is not worse it without a clear explanation. I would like you to contact health department to follow up on this case and find out the real root cause. If the vaccine is not recommended for people that ever got kidney transplant, CDC should publish the information so that there won?t be more victims. Please take necessary action ASAP. Thank you!" "1258483-1" "1258483-1" "Death on 4/4/2021 from subdural hematoma" "1258524-1" "1258524-1" "Patient passed away in between dose 1 and 2. Cause unknown." "1258614-1" "1258614-1" "Patient presented to ED for 2 syncopal episodes and went into cardiac arrest 5 minutes prior to ED arrival in ambulance. She received ACLS measures and alteplase was mixed and administered for pulmonary embolism concern." "1258763-1" "1258763-1" "On April 23,2021 patient was at her home and started complaining of shortness of breath and chest pain. She called 911 and they responded to her residence at 0500 a.m. While being assessed, patient collapsed. She was asystolic. CPR was started but to no avail. She was transported to the coroner's office where an autopsy was performed. She had bilateral pulmonary thromboemboli. There were not deep vein thromboses found in her legs." "1258858-1" "1258858-1" "Patient died on 4/22/21. Vaccinated with 2nd dose of Moderna on 3/31/21. Vaccinated with Shingrix on 4/15/21." "1258867-1" "1258867-1" "This 72 year old female received the Covid shot on 03/15/2021 and went to the ED on 4/3/2021 and was admitted on 4/3/2021 with abdominal pain, nausea, chest pain, NSTEMI and died on 04/24/2021 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1259030-1" "1259030-1" "Per my aunt (uncle's wife), my uncle complained of severe headache especially on the right temple area, nausea, and dizziness at around 6am on 4/11/2021. Soon afterward, she noted my uncle has left side weakness and drooling when drinking." "1259240-1" "1259240-1" "PATIENT DID NOT SHOW FOR SECOND DOSE OF VACCINE WHEN CALLED WE WERE TOLD BY HIS WIFE THAT HE HAD A HEARTATTACK AND PASSED AWAY ON 04/13/2021" "1259253-1" "1259253-1" "This 76 year old female received the Covid shot on 2/27/2021 and went to the ED on 4/13/2021 and was admitted on 4/13/2021 with hortness of breath, abnormal lab, and returned to ED on 4/16/2021 and admitted on 4/17/2021 with vomiting, elevated troponin, dehydration and returned on 4/23/2021 and admitted on 4/24/2021 with rapid heart rate and acute respiratory failure and died on 4/24/2021. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1259280-1" "1259280-1" "This 71 year old male received the Covid shot on 2/27/21 and went to the ED and was admitted on 4/5/2021 and died on 4/25/2021. Lumbar radiculopathy, spondylolisthesis of lumbar region, lumbar stenosis with neurogenic claudication, lumbar spinal stenosis. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1259316-1" "1259316-1" "This 83 year old female received the Covid shot on 1/28/21 while under hospice care and went to the ED and admitted 2/4/21 and again on 3/3/21 and again on 3/25/21 and 4/15/21 died on 4/24/21. GI bleed, duodenal ulcer with hemorrhage, SIRS (systemic inflammatory response syndrome, shortness of breath, acute heart failure, acute respiratory failure, cough, pleural effusion. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1259340-1" "1259340-1" "This 70 year old male received the Covid shot on 3/24/21 and was found deceased at home by the Sheriff sometime between 3/24/21 and 4/16/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1259351-1" "1259351-1" "This 84 year old male was a hospice patient and received the Covid shot on 2/24/21 . The patient died on 4/1/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1259591-1" "1259591-1" "Congestive Heart Failure decline, AFib w/RVR, hospitalization, Respiratory decline, Cardiac decline, possible UTI, Hospice Care, continued decline, expired." "1259703-1" "1259703-1" "DEATH, HAEMORRHAGIC STROKE" "1259763-1" "1259763-1" "Fever, chills, headache, and tiredness (2nd day of receiving the 2nd dose) Feeling good on the 3rd day Headache, stomach burn, throwing up, and heart attack (4th day of receiving the 2nd dose) Passed away on April 2, 2021" "1260018-1" "1260018-1" "Was sweaty, unresponsive, and breathing shallow a few mins after administration. BP 97/68. Within a few mins, patient became responsive and BP 146/81. Patient chose not to go with EMS and walked out of store after they were feeling better. Today (3 days later) received report from medical examiner that patient passed away." "1260071-1" "1260071-1" "FOUND DECEASED, COLD IN VEHICLE" "1260537-1" "1260537-1" ""Patient (per family member) received 1st dose of Pfizer COVID vaccine on 4/24/2021. On 4/26/2021 at 6 AM patient presented to hospital with chest pain for 2 hours. EKG showed inferior ST segment elevation myocardial infarction (a ""heart attack"") and the patient was brought emergently for cardiac catheterization. Catheterization showed an occluded right coronary artery, and angioplasty/stenting was performed. Following brief restoration of blood flow to the heart, the artery re-occluded and the patient arrested. After 90 minutes of CPR, the patient expired."" "1260729-1" "1260729-1" ""She had diareah and nausea for a few days with 1st shot but it got better. She complained about ""feeling off"" after the 2nd shot. Went to bed to try to sleep it off and she never got up again. We think she died Wednesday night or Thursday morning by how she stopped responding to texts. She was found deceased on Friday. They won't do an autopsy here. funeral home has her for now."" "1260747-1" "1260747-1" "Patient received notice of her vaccination appoint shortly before her AV Fistulogram, with angioplasty surgery on Tues, 2/2/21. She was nervous about getting the vaccine just days prior to her scheduled surgery. We called her primary doctor and was told to contact the surgeon. After multiple attempts to reach the surgeon and speaking with hospital staff, assuring us it was fine to get the vaccine prior to surgery. I still wanted to confirm with the surgeon and was finally able to speak to him. He assured me and to inform patient that it was fine to get the vaccine prior to surgery. On Sat, 1/30/21, patient received her Covid-19 Moderna vaccine. On Sun, 1/31/21, she got a covid-19 test to prepare for her surgery on Tues, 2/2/21. Her vaccine injection site was sore and she was tired, so she rested and took naps. On Mon, 2/1/21, she went to dialysis as usual. On Tues, 2/2/21, she had her surgery in morning. On Wed, 2/3/21, her dialysis facility could not perform treatment due to swelling of her arm. On 2/4/21 she rested, her arm still bothering her but had been assured to rest. On Fri 2/5/21, she went for her usual dialysis treatment but the facility was not able to perform dialysis and shortly after starting treatment, the facility called 911 to take patient to the hospital. Patient died with the next few hours without her family at her side." "1261483-1" "1261483-1" "Diagnosed with shingles; passed away suddenly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (passed away suddenly) and HERPES ZOSTER (Diagnosed with shingles) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication. On 28-Dec-2020 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced HERPES ZOSTER (Diagnosed with shingles) (seriousness criterion hospitalization). The patient died on 13-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HERPES ZOSTER (Diagnosed with shingles) outcome was unknown. Treatment included antiviral medication valtrex 1 mg. The action taken with mRNA-1273 with events was not applicable. Cause of death was unknown. Plans for an autopsy were not provided. This case concerns a 75-year-old, male patient, who experienced herpes zoster 5 days after and died 1 month 15 days after receiving the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The cause of death was not reported. It is unknown if an autopsy was performed. Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2021: Follow-up included fatal event.; Sender's Comments: This case concerns a 75-year-old, male patient, who experienced herpes zoster 5 days after and died 1 month 15 days after receiving the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The cause of death was not reported. It is unknown if an autopsy was performed.; Reported Cause(s) of Death: Unknown cause of death" "1261526-1" "1261526-1" "Type 2 Diabetes; Hypotension; heart started to drop; Renal failure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (heart started to drop), RENAL FAILURE (Renal failure), TYPE 2 DIABETES MELLITUS (Type 2 Diabetes) and HYPOTENSION (Hypotension) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Multi organ failure (Kidneys and liver are VERY messed up showing multi-organ failure.) and Type 2 diabetes mellitus. On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced CARDIAC FAILURE (heart started to drop) (seriousness criteria death and medically significant) and RENAL FAILURE (Renal failure) (seriousness criteria death and medically significant). On an unknown date, the patient experienced TYPE 2 DIABETES MELLITUS (Type 2 Diabetes) (seriousness criterion death) and HYPOTENSION (Hypotension) (seriousness criterion death). The patient died on 29-Mar-2021. The reported cause of death was Renal failure, type 2 diabetes, Hypotension and heart started to drop. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatine: 9.93 (Inconclusive) Inconclusive. On an unknown date, Glomerular filtration rate: 5 (Inconclusive) Inconclusive and 5.0 (Inconclusive) 5.0. On an unknown date, Haemoglobin: 7 (Inconclusive) Inconclusive. On an unknown date, Liver function test: 500 (Inconclusive) Inconclusive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative. On an unknown date, Troponin: 14 (Inconclusive) 14.0. On an unknown date, Troponin increased: 500 (Inconclusive) Inconclusive. On an unknown date, White blood cell count: normal (normal) normal (in range). The action taken with mRNA-1273 in response to the event was not applicable. He was feeling unwell. He had vomited prior and felt sick. His blood sugar was 136 or 139, nothing bad. Treatment details included antibiotics going into him, sleeping meds, meds to rise his blood pressure,Dextrose, Propofol, Dexmedtominine. Company comment: This is a 69-year-old, patient of unknown gender who received mRNA-1273 Vaccine who experienced cardiac failure and died, 6 days after receiving second dose of vaccine. Medical history includes Type 2 diabetes mellitus and Multi organ failure. No conmeds were provided. Very limited information has been reported at this time. No further information is expected.; Sender's Comments: This is a 69-year-old, patient of unknown gender who received mRNA-1273 Vaccine who experienced cardiac failure and died, 6 days after receiving second dose of vaccine. Medical history includes Type 2 diabetes mellitus and Multi organ failure. No conmeds were provided. Very limited information has been reported at this time. No further information is expected.; Reported Cause(s) of Death: renal failure; type 2 diabetes; hypotension; heart started to drop" "1261766-1" "1261766-1" "increased body temperature, seizure, death" "1261821-1" "1261821-1" "unknown bleeding; nausea; lightheaded; GI bleed; cardiac arrest; bleed in small intestine; This is a spontaneous report from a contactable consumer (patient's daughter). A 70-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Right on 26Feb2021 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. Vaccine Administered at Military Facility was no. Patient received the first dose of vaccine on 05Feb2021 at age of 70 years old for covid-19 immunization and experienced rash on face, loss of blood found to be from small intestine, hemoglobin low, cardiac arrest, going into shock. The patient medical history and concomitant medications were not reported. The patient experienced unknown bleeding (death, hospitalization, medically significant) on 10Mar2021, nausea (hospitalization) in 2021 with outcome of unknown, lightheaded (hospitalization) in 2021 with outcome of unknown, gastrointestinal (GI) bleed (medically significant) in 2021 with outcome of unknown, cardiac arrest (medically significant) in 2021 with outcome of unknown, bleed in small intestine (medically significant) in 2021 with outcome of unknown. Patient went to the hospital on 10Mar2021 with nausea and lightheaded. Endoscopy found GI bleed in 2021. Received blood went into cardiac arrest. Sent to another hospital found bleed in small intestine. Patient experienced unknown bleeding on 10Mar2021, which required visit to Emergency room/ intensive care unit on 18Mar2021 and received treatment, it resulted in death. The patient died on 18Mar2021. An autopsy was not performed.; Reported Cause(s) of Death: unknown bleeding" "1261833-1" "1261833-1" "died; administered in Left leg; This is a spontaneous report from a contactable consumer reported for patient (mother). A 93-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Mar2021 administered in Left leg at single dose for COVID-19 immunisation. No other vaccine in four weeks. Medical history included COPD, aortic stenosis, mild dementia, no known allergies. Concomitant medications in two weeks included donepezil, acetylsalicylic acid (ASPIRIN), ascorbic acid/ergocalciferol/nicotinamide/retinol/riboflavin/thiamine hydrochloride (VITAMINS), Blood Pressure Meds. Historical Vaccine included the first dose of BNT162B2 (lot number EL1283) in the right arm on 26Jan2021 09:15 (at the age of 93-years-old) as a single dose for COVID-19 immunization and experienced prolonged tiredness, increased weakness, dragging right foot when walks, little more trouble swallowing pills than before on 27Jan2021. The patient died three weeks later on 29Mar2021, she received treatment included ambulance. Care providers thought rapid decline after vaccine. The death cause was unknown, no autopsy was performed. No COVID prior vaccination, no COVID tested post vaccination. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died" "1261857-1" "1261857-1" "He died the same day he received the shot" "1261865-1" "1261865-1" "Death after experiencing blood clot to the lung" "1262151-1" "1262151-1" "After 1st dose of Pfizer: Nausea, and trouble breathing (Oxygen went up and down from 90 to 95) - Took to Dr and advise to watch oxygen levels After 2nd dose of Pfizer: Nausea, Dry heaves, Stomach Pain, Head Aches, Back Pain, Loosing Control of Bladder (Kidney Failure), Trouble Breathing (Oxygen went under 90) - Took to her Dr and she said to take her to the Emergency Room due to her Oxygen going below 90. I took her to Hospital." "1262218-1" "1262218-1" "Pt received dose #1 of Moderna on 1/20/2021 at clinic. On 1/24/2021, developed self reported fatigue and sleep disturbances with pruritis. Sought no medical care. Routine labs were obtained on 2/23 which demonstrated new-onset transaminitis and hyperferritinemia (ALT 2366, AST 1260, alk phos 362, ferritin 32,000) and was admitted to hospital for evaluation. No etiology for acute liver failure identified, including comprehensive evaluation for viral hepatitis and other common causes of hepatitis common after transplant. Concern raised for hemophagocytic lymphohistiocytosis (HLH) due to extreme hyperferritinemia, although bone marrow biopsy negative. Ultimately transferred to another hospital for further care at patient's request. No specific treatment was given and transaminitis ultimately resolved. Soluble IL-2 receptor (CD25) level checked on 3/2, at time of admission, markedly elevated at 2338.6, consistent with diagnosis of HLH. Pt discharged on 3/5. Ultimately readmitted on 3/9 and found to have rapidly progressive Legionella pneumonia and died on 3/16. Two events felt to be unrelated and pneumonia not felt to be cause of HLH due to patient's status at time of initial admission." "1262319-1" "1262319-1" "Per Review of Charge Nurses Notes. Please see Below Called in to residents room by CNA, resident without respirations or pulse, resident placed on floor and CPR initiated at 0725, EMSA notified and called time of death at 0751. Specialists on call for Dr. notified. daughter notified. cremation services notified." "1262349-1" "1262349-1" "Pt came in with positive D-dimer, coded and passed" "1262410-1" "1262410-1" "Heart Attack 2 days after 2nd dose of moderna vaccine - followed by death" "1262415-1" "1262415-1" "Information obtained from clients wife. patient received his first dose of Moderna 2/24/21 lot 024M20A with no reported issues except for a sore arm. patient received his second dose of Moderna on 3/24/21; Lot# 006B21A. No immediate effects from the vaccine. On day 2 post vaccination, patient became to have chills, per wife; did not check temperature and denied any symptoms such as flu-like symptoms. Day 3 post vaccination; patient began to have weakness in the legs. March 31st; patient was unable to stand and the rescue squad was called. patient was taken to the Hospital; where he was evaluated and released home. Pt collapsed at 1am 4/1/2021 and died 4/1/21." "1262580-1" "1262580-1" "Patient died on April 12th 2021. Not sure exactly what the cause of death but that he was losing blood in in his somewhere. He resided in a nursing home, and was taken to the hospital where he later died" "1262780-1" "1262780-1" "Patient found unresponsive in home, attempted CPR and provided epi x 3 in transport to ED. ACLS continued at the ER, but RSC unable to be achieved. Death pronounced at 0925 AM" "1262914-1" "1262914-1" "pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated." "1263539-1" "1263539-1" "With in one hour patient experienced severe Vomiting and Diarrhea. She had called her Doctors office. She saw a PA which told her to drink more water. She experienced Uncontrollable Diarrhea For 18 days. She was sent to Hospital by ambulance on Monday March 15, 2021. She was was treated with an IV and sent home discharged with Weakness. She continued to have Uncontrollable Diarrhea to were she was wearing Diapers. She fell from Weakness on March 16, 2021 to the point where she laid on the floor for an hour and half before she could drag herself up. She went to Hospital on March 18, 2021. Her blood pressure dropped and was admitted to ICU on the March 18th. She started suffering from a Heart attack and was taken back to have a stent put in her wrist to help with possible heart blockage. She went into cardiac arrest and passed away." "1263560-1" "1263560-1" "Per patient's Daughter the patient developed blood clots in his small intestine on 4/13/2021 and died 4/22/21 with physicians unable to explain how or why he developed these clots while on apixaban. She requested his case be reported and reviewed in hopes it helps make the vaccines safer if that was what caused the clots." "1263575-1" "1263575-1" "Patient had received the vaccine day prior to coming to ED. Presented to ED with family due to n/v/chills with shaking. She was able to dress self into gown and answer history questions. Then when she laid supine she became cold/clammy with loss of pulse. CPR was started with eventual decision by family to cease." "1263591-1" "1263591-1" "Within 12 hours of vaccine patient complained of being short of breath and asked his wife to call 911, he then stopped breathing and she did CPR until rescue squad arrived. Pt was unable to be revived and died." "1263713-1" "1263713-1" "3/30/2021 Patient received 1st dose of Moderna vaccine at 11:35AM and subsequently discontinued dialysis treatment 58 minutes early due to being cold. 3/31/2021 Patient went to hospital at 2:28PM with admitting diagnosis of acute encephalopathy due to intra-cranial hemorrhage. 4/1/2021 Patient expired at 3:35AM with cause of death reported as intra-cranial hemorrhage." "1263795-1" "1263795-1" "11;45 Mom put her light on had shortness of breathe, needed a Nirtro pill. Didn?t give much relief. Was given Ativan for anxiety & Diltiazm for blood pressure.. not much relief, was given oxygen. Then LASIK for fluid build up. Passed about 6;20 A.M. on the 9th." "1263989-1" "1263989-1" "Nausea, vomiting, burning in stomach, high blood sugars- symptoms started the day after the vaccine. Found obtunded 3 days after vaccine given. 911 called in route to the hospital had a cardiac arrest, resuscitated, arrested again and resuscitated. Upon admission to the hospital diagnosed with diabetic ketoacidosis and died the next day- 4 days after the vaccine was administered" "1264003-1" "1264003-1" "Patient received 1st COVID vaccine 4/12/2021 at medical center. Per ER report: 4/14/2021 patient was in bed with significant other and was noted to not be responding. EMS was called. Patient was found without a pulse and apneic. CPR began, PEA converted to Vtach, received 8 total epi and 1.5gm lidocaine by EMS. Down 50-55 minutes prior to ER. In ER given 2 additional epi, 2 sodium bicarb, intubated and was PEA then asystole. Pronounced deceased in ER." "1264171-1" "1264171-1" "Pt Deceased prior to dose 2. Reported by home health agency as unrelated to vaccination." "1264244-1" "1264244-1" "Expired in between Dose 1 and 2. Non-vaccine related. Death Certificate indicates, COPD, Type 2 Diabetes & hypertension" "1264249-1" "1264249-1" "chills, dizziness. shortness of breath developed a few hours later ." "1264579-1" "1264579-1" "I was notified that patient passed away at Hospital 10:37 am today. Per message to medical office from Coroner, it was reported that patient collapsed this morning while walking his dog. Patient was brought in by ALS complaint of FULL ARREST to Hospital 10:10 am and pronounced at 10:37 am 4/24/2021 by Dr. at Hospital." "1264618-1" "1264618-1" "103 fever 2 days after the vaccine. Then became afebrile. Then found deceased on 4-26-2021" "1264707-1" "1264707-1" "death; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (death) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Cirrhosis of liver. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 17-Apr-2021 The patient died on 17-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Limited information regarding the patient's death has been provided at this time and a causal relationship cannot be excluded. It is not clear if the patient was hospitalized at the time of their death, only that they died in hospital; Sender's Comments: Limited information regarding the patient's death has been provided at this time and a causal relationship cannot be excluded. It is not clear if the patient was hospitalized at the time of their death, only that they died in hospital; Reported Cause(s) of Death: Unknown cause of death" "1265810-1" "1265810-1" "sweating; felt cold/intense cold even in his bones; He was told by the professional health care that he had small clots in his blood; death cause: Medication; arm started to sore; Doctor identified he had DVT; her husband during that night was not able to sleep; He started having fever; This is a spontaneous report from a contactable consumer (patient's spouse). A 61-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 21Mar2021 09:00 (Batch/Lot number was not reported) as single dose f(at the age of 61-year-old) or COVID-19 immunisation. Medical history included dialysis, diabetes mellitus, known allergies: A7, Penicillin, Aspirin, Iodine, Povidone, Pepcid, dyes, iodine allergy. The patient's concomitant medications were not reported. The patient previously took Aspirin, povidone and pepcid ac and experienced drug hypersensitivity with all. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced death cause: medication on 18Apr2021, he was told by the professional health care that he had small clots in his blood in Mar2021, felt cold/intense cold even in his bones on 21Mar2021, sweating on 26Mar2021, her husband during that night was not able to sleep on 21Mar2021, he started having fever on 21Mar2021, arm started to sore and DVT on 29Mar2021. The patient was hospitalized for he had small clots in his blood, felt cold/intense cold even in his bones, sweating for 27 days. The event DVT was medically significant. The course of events was as follows: After getting the vaccine in 21Mar2021 her husband during that night was not able to sleep. He started having fever and felt cold. Days later he continued with the symptoms. On 26Mar2021 after vaccination he had dialysis same day in the afternoon. When arriving home the person notifies symptoms of intense cold even in his bones and then he started to sweat excessively on 26Mar2021 (Friday). The reporter decided to take her husband to the emergency room on 28Mar2021 (Sunday) where he had a general checkup. He was told by the professional health care that he had small clots in his blood. After some time he had health complications where they had suggested to amputate some of the limbs because of this, the reporter alleges those complications were due to the vaccine. On Monday 29Mar2021 same symptoms reappeared and he was admitted to Hospital. Had a blood test and notified to health professional that blood presents small clots. His arm started to sore severely after the sample. Doctor identified he had DVT. Doctor decided to proceed with various medications. Patient received treatment and he was injected: Percose, Morphine, Benadryl, Triphetarin for blood clot reduction. The patient underwent lab tests and procedures which included blood test: blood clot in Mar2021, Sars-cov-2 Nasal swab test: negative in Mar2021 post vaccination. The patient died on 18Apr2021. It was not reported if an autopsy was performed. The outcome of death cause: medication was fatal, of the other events was unknown. Information about the lot/batch number has been requested.; Reported Cause(s) of Death: death cause: Medication" "1266074-1" "1266074-1" "fever; feeling weak; unable to walk independently; no appetite; This is a spontaneous report from a contactable consumer via social media. A 73-year-old male patient received the second dose of (lot number: EW2243), via an unspecified route of administration on 12Apr2021 09:45 (at the age of 73-years-old) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The other medications that the patient received within 2 weeks of vaccination were insulin and for blood pressure. Prior to vaccination, the patient was not diagnosed with Covid-19. The patient previously received the first dose of bnt162b2 (lot number: ER4812), via an unspecified route of administration on 16Mar2021 (at the age of 73-years-old) as a single dose for covid-19 immunisation. The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced fever, feeling weak, unable to walk independently and had no appetite. The adverse events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received for the events. The outcome of the events was fatal. The patient died on 19Apr2021. Cause of death were fever, feeling weak, unable to walk independently and had no appetite. An autopsy was not performed. Since the vaccination, the patient hasn't been tested for covid-19.; Reported Cause(s) of Death: fever; feeling weak; unable to walk independently; no appetite" "1266361-1" "1266361-1" ""April 22, 2021 morning my auntie got her first dose of Pfizer vaccine. She happily shared here vaccine experience with family member and relative. April 23 morning, she told us she has severe abdominal pain, has the need to have a bowel movement, but she was defecated. She also told us that she vomit couple times already, then she has no more energy to talk. She got into the hospital and she was announced death right after midnight at 12:04 April 25th. Reason of death given is ""septic shock secondary to ischemic bowel & intra-abdominal sepsis"". But it is the blood clots issue that is causing it. I was told that after my auntie got into hospital the very next day after Pfizer vaccine, hospital later found out that my auntie has blood blockage issue that is causing blood couldn't flow to her intestines. The acid in her blood was very high, 6+. After more than 6 hours without blood to her intestines, her intestines tissues start dying and turned black color. Doctor found out about this at the night of April 23, 2021 nighttime. April 22, 2021 morning is the day my auntie got her Pfizer covid vaccine. There is a very high chances of the Pfizer vaccine is causing the blood clots that lead to blood blockages."" "1266384-1" "1266384-1" "Patient with dementia NOS received COVID-19 vaccination first dose (as reported) on 3/30/2021. Family reported she was feeling unwell with vague complaints thereafter. Found dead on 4/27/2021. Autopsy performed on 4/28/2021 revealed ischemic bowel with an acute superior mesenteric artery thrombosis. She had little other cardiovascular disease to account for the thrombosis." "1266405-1" "1266405-1" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266427-1" "1266427-1" "Patient presented to the ED and was subsequently hospitalized twice within 6 weeks of receiving COVID vaccination. First visit was 2/23/2021 and second visit was 3/14/2021. Patient died on 4/8/2021" "1266493-1" "1266493-1" "Family friend of the wife, called our pharmacy on 04/28/2021 and reported that wife's appointment would need to be canceled for 04/29/2021 because her spouse passed away the previous night. This prompted our staff to look further and it was noted that her spouse, received his first Moderna vaccine on 4/26/2021 at our pharmacy. Friend was not reporting his death due to the belief that the injection was the cause. Only to report, so upcoming appointment for his wife could be canceled. It was reported to our Medical staff that Patient n has Chronic COPD and had difficulty breathing on the evening of 4/27/2021 and was taken to the hospital where he later passed away. Patient was on portable oxygen and resembled shortness of breath while ambulating at the time of his vaccination appointment on 4/26/2021. Patient immediately recovered from Shortness of Breath once seated in exam room for injection for a few minutes." "1266554-1" "1266554-1" "Received 2nd shot on April 14. He was functioning normally until he woke up on April 25. Symptoms were chest pain, trouble breathing, lethargic, very pale, cold to the touch, vomiting with blood in vomit. PT was taken to the ER where he passed away later that night." "1266609-1" "1266609-1" "Death" "1266615-1" "1266615-1" "Death" "1266624-1" "1266624-1" "Acute respiratory failure with hypoxia Death" "1266821-1" "1266821-1" "Pt was seen in Family Medicine on 4/23/2021. Was given her first Moderna vaccine that day. On-call doctor received phone call on 4/24/2021 that pt had expired. Death certificate states cause of death: seizure due to possible complication of COVID 19 vaccine. Conditions if any, leading to immediate cause: cerebellopontine angle tumor of brain" "1266936-1" "1266936-1" "Employee developed a fever and chills on 01-Apr-21 which he managed with Tylenol. Symptoms resolved as per patient who contributed the symptoms as a result of the J&J vaccine. On 10-Apr-21 he developed a cough and requested a day to rest. On 11-Apr-21, he went to Hospital to be evaluated by the physician who ordered some labs which were normal. He was then advised to complete PCR swab and was notified on 12-Apri-21 that his test is positive. As per the protocol, all COVID-19 positive individuals must report to the Health Center within 24 hours of notification and complete 10 days home isolation. During isolation, on 17-Apr-21, patient developed hemoptysis and difficulty breathing a breathing and notified his supervisor who called 112 for an ambulance. He was transferred to Hospital. Evaluated and started treatment for pneumonia and was transferred to Hospital on 18-Apr-21. His condition started declining on 21-Apr-21 as he became hypoxic and tachypneic and was subsequently sedated and intubated. As he became HD unstable, Levophed and Vasopressin were started and reached maxed doses. On 25-Apr-21 Dr. from the hospital called and stated that patient expired at 0830." "1266953-1" "1266953-1" "It was reported that patient had been experiencing difficulty breathing, walking and delusions as per his fiancT . Fiance notified Manger that they sought medical attention earlier in the morning on 1-Apr-21 at the Clinic and they refused to evaluate patient beyond performing a PCR swab test so, they went back to their apartment. An SMS notification was sent on 1-Apr-21 indicating that patient was COVID-19 positive which was not seen by patient or fiance who reported the result to Mgmt. on 6-Apr-21. He was contacted by patient's friend and advised him the patient was sick, not able to walk, and having difficulty." "1267074-1" "1267074-1" "#1 = 011J20A on 1-6-21 #2 = 028L20A on 2-3-21 patient presented after sudden onset of chest pain early in morning and found to be covid +. ECG demonstrated diffuse ST elevation, troponins negative. CT without contrast didn't have much in it. He was found to be COVID rapid test+ and IGG negative. He was admitted into isolation, no oxygen needs. DDIMER was over 2000 and friction rub noted on physical exam. Cardiology ruled out STEMI, thought maybe viral pericarditis - but wanted echo done after out of isolation. CTA was planned for AM on 4-28-21, but patient died 4-27-21 PM after being found down in room. ROSC was not able to be achieved despite aggressive resuscitation efforts" "1267143-1" "1267143-1" "Veteran died on 4/21/2021" "1267192-1" "1267192-1" "Patient received her shot and felt very weak within 24 hours. The week of 4/4/2021 began to feel dizzy and stated she felt unwell. Her blood pressure and heart rate were taken and she was having an elevated heart rate. Her normal heart rate is around 50 BPM and her heart rate jumped to over 100 BPM. This continued on and off for a couple of weeks. The week of 4/18/2021, began having shortening of breath. On 4/25/2021, was found in her home unresponsive. Suffered a stroke and was taken to a hospital. She was transferred to a hospice unit on 4/26/2021. She passed away on 4/28/2021" "1267278-1" "1267278-1" "Patient passed away 4/12/2021 suddenly, found by family on couch. Was having shortness of breath day before. Per mom, patient had been laughing and talking the morning before patient passed away." "1267350-1" "1267350-1" "Shortness of Breath Fever Body Pains - Shoulder, Hand pain" "1267444-1" "1267444-1" "multiple er/admissions from february through april 27. pt deceased on 4/27/21 2/25/21 known past medical history of hypertension and hypothyroidism. Status-post spinal decompression due to stenosis. The patient then developed worsening issues with a surgical site infection. Patient has had numerous bouts of C diff. Staff notes patient is to have GI consult in the near future. Patient is seen today in her room. Patient was once again diagnosed with C diff and is currently being treated with antibiotics. Patient notes no bowel movements today. Patient has not had any issues with intake recently. The patient's weight has declined partially due to likely diarrhea. Patient's blood pressure continues to be monitored closely as it has been on the lower side of normal. Patient's potassium 2.9 on CMP. Patient's other care and therapies were reviewed. 2/28/21 Patient was admitted the hospital after found to be anemic at skilled care facility where she is being treated for C diff infection recurrent Lea. Patient was transfused. Patient was also found to have pneumonia/lung mass. Patient has struggled with electrolyte dysfunction. Patient had to be transfused a second time. Patient did well with second transfusion. Patient was found to be hypokalemic. Patient did well with potassium replacement. The patient was advised will have to do outpatient PET scan. Patient was found to have positive blood cultures as well 4/26/21 68 y.o. female who presents from nursing home with complaints of elevated white blood cell count. According to nursing home records patient had CBC checked on Saturday 04/24/2021 and her WBC count was found to be 50,000. At that point in time no other orders were given and patient was not sent in for evaluation. CBC was repeated this morning and WBC count found to be in the 70,000s. Patient was sent in for evaluation this morning. In talking with the patient, she denies any runny nose, sinus drainage or cough. Patient does report shortness of breath. Patient denies any chest pain or palpitations. Patient denies any dysuria, hematuria, fevers, or chills. Patient denies any nausea or vomiting. Patient does report diffuse pain across the lower abdomen. She does report chronic diarrhea. Patient had C diff stool checked on 04/13/2021 and was negative. (4/26 cdiff positive) Of note patient does have known lung mass that was seen on chest x-ray and PET scan. Patient reports that she does not want anything done and understands it could be cancer. And continuing to question patient, she reports she wants to be a DNR and does not want any aggressive measures." "1267468-1" "1267468-1" "patient received her covid vaccine per her record: 1/3 and 1/24/21. Patient presented to Facility 4/20/21 diagnosed with COVID, patient died 4/23/21 due to hypoxic respiratory failure/ bilateral pneumonia due to covid." "1267487-1" "1267487-1" "Cough and diarrhea the day after receiving vaccine. The next day, had difficulty breathing and collapsed." "1267587-1" "1267587-1" "patient woke up on 04/22/2021 with shortness of breath and weakness. On exam, she was hypotensive, tachycardic and edematous" "1267593-1" "1267593-1" "Headache, Increasing fatigue and difficulty breathing over two weeks before 2nd dose -- exacerbated by 2nd dose. Worsening condition led to visit to Primary Care In office tests indicated presence of blood clots and need for emergency hospital treatment. Emergency surgery to remove blood clots throughout her body and attempt to put her on ECMO were unsuccessful and patient succumbed at 12:06 AM 3/3/21." "1267641-1" "1267641-1" "Shortness of breath" "1267665-1" "1267665-1" "4/8/21 pt had brain fog like he was in a haze and felt strange being very relaxed like he had taken a tranquillizer he felt better next day. pt seemed to be fine at this point. 4/22/21 pt seemed to be fine and went to the store where he went shopping. He put shopping bags in car. He was found in his car after and hour and 20 minutes by a couple of bystanders unresponsive. 911 was called and he transported to ER. He was intubated but patient died. Unknown is any test were performed." "1267721-1" "1267721-1" "Per family and health department report, patient died at home. No treatment or assessment performed. Patient family reports death caused by complications r/t bladder cancer. No further details released." "1267753-1" "1267753-1" "Case tested positive for COVID-19 on 12/7/2020; vaccinated on 1/8/2021 and 2/5/2021 with Moderna; re-tested positive for COVID-19 on 4/1/2021. Case was admitted to hospital on 4/2/2021 for surgery due to a previous fall. Case had altered mental status and fever. Case was found to have an acute CVA." "1267794-1" "1267794-1" "Approximately 3 weeks after Moderna Covid-19 vaccine administration, patient began to experience dizziness, transferred to Hospital, diagnosed with ischemic stroke, discharged, returned within days with worsening, diagnosed with new ischemic stroke (contralateral side), transferred to Medical Center, patient's condition worsened, presumably additional new ischemic stroke, patient ultimately died on 3/5/2021. Diagnosis was acute infarction of the brainstem/pons as well as acute bilateral cerebellar/occipital infarctions." "1267795-1" "1267795-1" "After receiving the initial dose, the decedent had complaints of extreme weakness and lethargy." "1267822-1" "1267822-1" "Admitted to hospital on 9/30/2020 and discharged on 10/28/2020." "1267883-1" "1267883-1" "Cardiac Arrest about an hour after being injected." "1267948-1" "1267948-1" "Exact time of symptom onset unknown. Clinic was notified by family at 10am on 4/21 that patient had expired at home. Family member reported that patient was tired and achy and was found deceased on the floor in his room. Patient had a history of Covid-19 in January, 2021." "1267950-1" "1267950-1" "This 97 year old female received the Covid shot on 2/06/21 and went to the ED and was admitted on 2/17/21 with AMS, UTI, Sepsis from e.coli, and subsequently on 3/10/21 and again on 3/24 and recevied the 2nd Covid shot on 4/9/21 and died on 4/19/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1267987-1" "1267987-1" "? Patient never had a COVID positive test result ? The narrative seemed to shift over time, with the most recent hospital notes stating the headaches started after the vaccination, so I wanted to include a more in depth timeline on this ? General timeline gathered from notes o 01/11/2021: Constant headache ongoing for 3 weeks; discussed scheduling his COVID vaccine, directed to website o 02/02/2021: acknowledges patient has had first dose of COVID vaccine; denies ever being sick or around anyone with COVID o 03/01/2021: patient states he has had a headache since the COVID vaccine 1/19/2021 o 03/03/2021: patient has had both COVID vaccine shots o 03/12/2021: patient has had a headache for a couple months that waxes and wanes, no cause was identified. His headache first began at the end of January after his COVID vaccine" "1268019-1" "1268019-1" "This 83 year old female received the vaccine on 2/26/21 and went to the ED on 4/22/21 and was admitted with Thrombocytopenia, acute renal failure, fall with subdural hematoma, clavicle fracture, anemia, head injury, anascara, hyperkalemia and died on 4/27/2021. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1268038-1" "1268038-1" "Fiance reports 24 hrs after receiving the COVID-19 J&J vaccine pt passed away" "1268039-1" "1268039-1" "This 73 year old white male received the 2nd Covid shot on 4/23 and died on 04/24/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1268044-1" "1268044-1" "Clinic was informed that patient patient went unresponsive at home at 2pm on 4/21/21 and patient expired." "1268049-1" "1268049-1" "Fall Death" "1268064-1" "1268064-1" "This 76 year old female received the 2nd Covid shot on 3/19/21 and died on 4/25/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1268137-1" "1268137-1" "Cause of Death A: Acute encephalopathy Cause of Death B: COVID 19 IMMUNIZATION FOLLOWING COVID 19 VIRUS INFECTION Cause of Death Other: Chronic Schizophrenia" "1268162-1" "1268162-1" "My mom received the first does of the shot on April 14, 2021 around 10:15 am. Her friend that took her told me that she was having a reaction to it when he took her home that day. He said she had the chills really bad that he had to turn the heat on in the car and give her a coat. He said later she was sweating. She didn't make any calls on her phone after 5:20 pm. Her sister found her dead inside her home the next day." "1268212-1" "1268212-1" "Patient died on 4/23/21" "1268351-1" "1268351-1" "Died of heart attack" "1268373-1" "1268373-1" "Patient collapsed and became unresponsive 24 hours after receiving second dose of vaccine." "1268424-1" "1268424-1" "The decedent was found in her bedroom by her daughter. Medical history only includes previous blood clots. Decedent has been complaining of coughing and shortness of breath the past few days. There is no history of drug use. The decedent had a foam cone when found." "1268440-1" "1268440-1" "Death due to cardiac arrest on 4/26/2021" "1268636-1" "1268636-1" "Patient received the vaccine, no adverse reactions while at the facility/post observation time period. Patient's niece came into the facility on 4/28/2021 and stated that patient was sick and couldn't move out of the bed after getting the shot. After three days, patient went into Hospital and later expired on 4/27/2021." "1269178-1" "1269178-1" "Received Moderna Dose #2 on 3/10/2021. About 1-2 weeks after, he started experiencing swollen leg (unsure if left or right), had shortness of breath, and looked pale on 4/22 he was seen by a provider and was prescribed oxygen, later that night he passed." "1269219-1" "1269219-1" "The Patients leg gave out and he fell. Per doctors at hospital, he did not hit his head. He could not get up and he vomited. Ambulance was called and he was taken to the Hospital. The family was told that he had a brain bleed near the thalamus. A few hours later the patient was unresponsive. He was intubated and taken to neuro ICU. Within less then 24 hours from first symptom the patient died." "1269224-1" "1269224-1" "My partner felt pain overnight. Then, felt flu like symptoms- plus chills- the next day and night. The following morning at 7:00 am, Patient said that she felt real sick. She also, complained of having a real bad Headache, Not long after that, she felt like throwing up. She tried to throw up. Except, nothing came out and she felt very nauseous because of the vaccine. When she came call to bed, I offered to make her some breakfast to help her feel better. Unfortunately, she felt, too, I'll to try and eat an food because of the way she felt. So, I laid next to her with the hope that all would be well. Because, the pharmacist who administered the second dose. Assured my partner, that it was normal to feel flu like symptoms the next day. So, we never doubted what the pharmacist advised. All of sudden, she suffered a cardiac arrest in my presence and died in front of me." "1269282-1" "1269282-1" "Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COPD. Concurrent medical conditions included Immunocompromised. Concomitant products included OXYGEN for an unknown indication. On 12-Apr-2021 at 12:45 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 12-Apr-2021 The patient died on 12-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No treatment information were reported.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death" "1269415-1" "1269415-1" "? Tuesday, April 6th ? Patient receives the 2nd Pfizer vaccine shot ? Thursday, April 8th ? Patient is sick with vomiting and diarrhea ? Friday, April 9th ? Patient is delirious and still sick with vomiting and diarrhea. She is also has pain in her stomach. An ambulance is called to take her to the hospital. The hospital determines her white blood count is elevated, indicating an infection. Blood sugar is very high ? approximately 400. Covid test is negative. She is restless upon arrival. She tries to climb out of bed continuously. She is restrained. o Saturday, April 10th ? Patient is running a fever and is in pain. She is also confused and doesn?t recognize her oldest sister. Meds are administered to handle both items. (Toradol?). Blood sugar around 200. She continuously counts and calls for Mother and Father. Patient continues to be restless o Sunday, April 11th - at request of family, a CT scan is done of her stomach and abdomen. Nothing is found. Potassium was at 3.2 (normal is 3.5) so she received an IV drip to help with potassium levels. Sugar ? 206. Later drops to 176. Patient calms down some. She is still confused and doesn?t recognize her oldest sister. ? Monday April 12th ? the hospital attempts to do an MRI, but patient panics. This is a closed MRI and her 1st husband died in one. The MRI isn?t done. ? Tuesday, April 13th ? she is asked by the doctor to state her name and wiggle her toes. She complies. Doctor orders speech therapy. She is sedated for an MRI and a CT scan. Both are successfully completed. She sleeps for the rest of the day. Blood sugar ? 274 @ 5:09pm. ? Wednesday, April 14th ? Patient was asleep all day. Most of the day she isn?t responsive when nurses come in and do things like take blood. She normally responds even if she is asleep. Around 5pm she starts to respond and make noises; she briefly opens her eyes then falls asleep. She continues to run a temperature. ? Thursday, April 15th ? Patient is asleep most of the day. She is responsive when nurses do things like take blood. A spinal tap is performed. There was mention of dementia. Hospital is sharing little information, varying from she is retreating into herself vs. something worth isolating is going on. Temp was 102.3 at 7:37, but later dropped to 99.3 without meds. Dr. (neurologist) provides an update to the family. Tests so far are negative. EEG showed sleeping brain (she was asleep during test). MRI showed nothing. Spinal tap negative so far. No infection or anything has shown up. Orders another EEG and MRI ? Friday, April 16th ? Patient tried to open her eyes. ? Saturday, April 17th ? a met code was called on her and she was moved to ICU. A circulation issue was found in right leg. Occlusion was really bad. Initially the doctor was concerned about blood clots. None were found, just swelling. Pressure was relieved. Blood pressure issues. She was put on 2 blood pressure meds, at least. She was dehydrated and acidic. Diabetic ketoacidosis was mentioned. A cytokine storm was expected. ? Sunday, April 18th ? blood pressure not stable. She was put on dialysis. Peripheral circulation was worse. ? Monday, April 19th ? she coded around 5am. Doctors were trying to save her. She passed away about 30 minutes later ." "1269763-1" "1269763-1" "died on 14Apr2021 01:30 pm of a sudden death; first dose of BNT16B2 on 15Mar2021 09:00 am/ second dose via an unspecified route of administration on 02Apr2021; first dose of BNT16B2 on 15Mar2021 09:00 am/ second dose via an unspecified route of administration on 02Apr2021; This is a spontaneous report from a contactable healthcare professional (patient's spouse, nurse practitioner). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 02Apr2021 (lot number: EW0150) as single dose (at the age of 47-years-old) for COVID-19 immunisation, vaccinated at a hospital. Medical history included hypothyroidism, anxiety, and chronic migraine (ongoing). The patient had no known food and drug allergies. Concomitant medications included levothyroxine sodium (SYNTHROID); sumatriptan for migraines; and clonazepam for anxiety. The patient received the first dose of BNT16B2 on 15Mar2021 09:00 am (lot number: EN6708) (at the age of 47-years-old) for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient died on 14Apr2021 01:30 pm of a sudden death. She was found at home unresponsive and pulseless. Efforts at resuscitation were unsuccessful. Her medical history of hypothyroidism, anxiety and chronic migraines do not appear to be contributory. The patient did not receive treatment (as reported). The reporter considered the event to be a serious adverse effect (SAE). A full autopsy has been performed; the results were pending.; Reported Cause(s) of Death: died on 14Apr2021 01:30 pm of a sudden death" "1269770-1" "1269770-1" "seizures; dizziness; fatigue; passed away; This is a spontaneous report from a contactable Consumer. This Consumer reported for a 33-year-old male patient (friend) who deceased who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number unknown), via an unspecified route of administration on an unknown date in Mar2021 at a single dose for COVID-19 immunization. The reporter wanted to know if there were any reports or information on patients having severe seizures or blood clotting, he was trying to find out for some information on similar adverse events that occurred with the Johnson & Johnson COVID vaccine, but from receiving the Pfizer-BioNTech COVID-19 vaccine the person that had the severe reaction went to the doctor and the doctor said it was highly unlikely from the vaccine. The reporter tried to look online for potential side effects, to help the family provide some type of (information about this). The reported stated the patient was very healthy, young 33 years old, never had a history of seizures, he had no past medical issues. He received second dose middle of march, he passed on 13Apr2021. On the third week after receiving second dose, he started experiencing dizziness and fatigue that later progress into seizures, he was admitted into the hospital, and was no longer under control. Doctors said was highly unlikely it was from the vaccine however every test came back negative; X-Rays, biopsies, everything negative. The patient deceased and outcome of the events was unknwon. Information on the Lot/Batch number has been requested. ; Reported Cause(s) of Death: passed away" "1269804-1" "1269804-1" "nose bleeds, black and blue marks weeks later," "1269848-1" "1269848-1" "Death Narrative: Patient was admitted to facility from 1/11/2021 to 1/13/2021 for treatment of Covid 19 with symptoms of fatigue and poor oral intake. Admission was uneventful and follow-up notes post discharge from both Cardiology APRN and Primary Care Physician that the Patient was recovering well post admission. Patient received first of Covid Pfizer Vaccine on 4/2/2021 and second dose of Covid Pfizer Vaccine on 4/22/2021. Patient had been observed for 15 minutes after administration of each dose. No reaction was noted during the post vaccination observation period of either dose. Notice of death was received 5 days after second dose of Covid Vaccine from funeral home. There were no reports of an ADR occurring between observation period and death. There were no progress notes in patients chart between second Covid 19 Vaccine note 4/22/201 and death notice 4/27/2021. Cause of death is unknown at this time." "1269849-1" "1269849-1" "Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient was transferred to behavioral health unit at an outside nursing home on 2/15/21 after hospitalization for psychiatric evaluation on 1/29/21 w/subsequent Law for erratic behavior w/ delusions/hallucinations. Patient passed away on 4/12/21 at an outside facility with details surrounding death unknown. PMH significant for CKD, AAA, PVD, anemia, CAD, Dm, HTN, COPD, advanced age." "1269850-1" "1269850-1" ""death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient has PMH significant for neoplasm of liver, stage 4 esophageal adenocarcinoma congestive cardiomyopathy, AF, htn. Seen 3/22, per not ""states that for the past three days he has had constant chest heaviness and shortness of breath along with productive cough with dark sputum."" Discharged 3/24. Deceased 4/2/2021 however no notation or death certificate noted."" "1269851-1" "1269851-1" "Death Narrative: Patient was previously tested COVID-19 positive on 3/2/2021, but did not have any other predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was admitted with afib with RVR on 2/17/21 and was having a HFrEF exacerbation. HR was controlled during admission and he was discharged on 2/19/21. Patient was hospitalized 4 more times over the next two months for cardiac symptoms with last hospitalization occurring 4/12/21 for hypotension/tachycardia and decompensated heart failure. Patient never recovered and transitioned to hospice before passing on 4/16/21. Patient had a PMH significant for afib s/p DCCV on eliquis, CKD, HFpEF on home O2 2L, PMR on prednisone, known R pleural effusion, Covid PNA in 11/2020 and chronic foley" "1269852-1" "1269852-1" ""Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 93 and receiving home based palliative care. On 3/30/21 his home nurse reported he was having bilateral lung wheezing. On 4/16/21 patient's wife stated he passed away at home after suffering an ""asthma attack."" PMH significant for dementia, malnutrition, reduced mobility, bedbound, Alzheimer's, DM, afib, CAD, NSTEMI"" "1269853-1" "1269853-1" "death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for amyotrophic lateral sclerosis, AF, HTN. No notation regarding death, or cause of death. Patient deceased 4.16.21" "1269854-1" "1269854-1" "death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient has a PMH significant for T2DM, CAD, hyperlipidemia, Parkinson's disease, HTN, Diffuse interstitial Pulmonary fibrosis. No cause of death listed or any notation. Patient deceased on 4/10/202. 2nd dose of Pfizer given 3/13" "1269855-1" "1269855-1" "Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug adverse event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was admitted on 2/27/21 with acute encephalopathy and suffering progressively worsening mental status. He was admitted for over a month through 3/31/21 where he was eventually discharged on hospice before passing on 4/5/21. His hospital course consisted of treating community acquired pneumonia/bacteremia from hemodialysis catheter placement. Patient continued to have positive cultures despite antibiotics due to a found vegetation on the aortic valve. He experienced functional and cognitive decline over his admission. Comorbidities include vascular dementia, h/o stroke, ESRD on HD, HTN, DM2, HLD" "1270105-1" "1270105-1" "This 86 year old male received the Covid shot on 2/17/21 and went to the ED on 4/20 with abnormal lab of hypercalcemia and again on 4/25 with altered mental status and was admitted on 4/25 and died on 4/25/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1270114-1" "1270114-1" "Presented to Emergency Dept in full arrest. Patient was working outside when she began having a severe headache and lost responsiveness. CT head in ED revealed large subarachnoid hemorrhage." "1270247-1" "1270247-1" "Patient presented to the ED on 3/1/2021 and was subsequently hospitalized. She died on 3/25/2021." "1270366-1" "1270366-1" "cardiac arrest 5 days post vaccination." "1270605-1" "1270605-1" "His brother reporting that he got the vaccine, the following day he was coughing. The coughing caused him not to be able to sleep and was weak due to that. He could feel his throat closing and he was having a hard time breathing and he called his brother who told him to call 9-1-1. He was taken to Medical Center 4/17/2021, diagnosed with possibly COVID. He was admitted to the COVID ward and he died on 4/26/2021. The doctor that pronounced him was . Cause of death diagnosis. Hypoxic respiratory arrest, COVID 19" "1270690-1" "1270690-1" "Patient developed shortness of breath 3 days post injection. Death due to COVID-19 pneumonia 4/27/21" "1270749-1" "1270749-1" "HYPOTENSION (SARASOTA EMS RESPONDED TO PHARMACY); CLAMMY/SOB, EXTREMITY TINGLES; DEATH WITHIN 6-7 HRS" "1270832-1" "1270832-1" "Beginning the day after the inoculation, my husband began feeling worse in terms of his difficulty in breathing. He used the Albuterol inhaler more than usual. It progressively got worse over the next 2 weeks, ending with my husband?s sudden collapse and death exactly 2 weeks later on April 5, 2021. The inoculation may or may not have been directly linked to his unexpected death, but I feel it may have exasperated his condition, which led to his death. And I feel it is important to report this to you. I later heard that he should not have been using his Albuterol inhaler one week prior to receiving the Pfizer vaccine. I don?t know if that is true, but that information was never told to my husband, if it is." "1270844-1" "1270844-1" "Per pt's daughter, pt suddenly died at home with no known cause 23 days post second dose of the COVID vaccine. He had no terminal, chronic, or acute health conditions." "1270907-1" "1270907-1" "Sweatting and seizing" "1270973-1" "1270973-1" "vaccine administered 4/8 at 1429 patient had a cardiac arrest on 4/8 at 2209 patient expired 4/10/21" "1270988-1" "1270988-1" "After 2nd Vaccine on 3/6/21, she became ill on 3/8/21, fever and chills was in bed all day on 3/9/21 with the same symptoms. Woke up on 3/9/21 with shingles, Her PCP was treating her with Famciclovir and Gabapentin for pain. She no longer had the fever or chills but still didn't feel well. On 3/17/21 she was admitted at Medical Center which she was treated for a blood clot in her lung and for pericardial effusion. She was put on blood thinners which then caused a bleed in her hip bone. She had a surgery to put a filter in to stop more blood clots and to drain the fluid from her heart. She died on 3/27/21 around 3:30pm." "1271190-1" "1271190-1" "Contracted COVID-19 on 4/4/2021, Pt. demise 4/15/2021" "1271213-1" "1271213-1" "Patient is a 80 y.o. male with significant PMHx of CAD, HTN, HLD, CKD who is admitted to ICU as a transfer from hospital for acute liver failure and cardiac arrest. Pt presented to hospital on 04/28 w/ complaints of nausea and vomiting. He stated that he had recently gotten his COVID vaccine. Pt was found to be in acute liver failure in the ED w/ AST and ALT > 1000. Lactate > 15.0. BMP showed AKI on CKD and BG >500. Pt did have cardiac arrest while undergoing CT Scan and ROSC was achieved after CPR x 20 mins. Pt was hence transferred to the ICU for higher level management and admitted for cardiac arrest and acute liver failure. Upon arrival, Pt was intubated and sedated. He was non-responsive to verbal and physical stimuli. Pt was acidotic. ABG: 6.99 / 28 / 165 / 7. 1 amp of HCO3 was given upon arrival. Pt was started on insulin gtt for DKA and was started on Levophed for low BP. Pt underwent cardiac arrest shortly after arrival to the ICU. CPR was performed for > 20 mins without ROSC. Family arrived at bedside and decision was made to stop CPR at 0205 on 04/29/2021." "1271243-1" "1271243-1" "Symptoms of fever, nausea, and weakness started 3 days following vaccination. Denies any exposure to COVID positive person. Presented to local emergency department on 3/27/21 with nausea, fever, chills, dizziness, and confusion. Due to patient's condition, he was transferred to larger facility for further management. Patient was admitted to hospital and subsequently transferred to ICU on 4/17/21. He was intubated at that time. Patient went into multisystem organ failure and died on 4/18/21." "1271305-1" "1271305-1" "Death within 60 days of vaccine" "1271382-1" "1271382-1" "Patient was admitted to facility 2/25 and passed away 3/4." "1271626-1" "1271626-1" "SPOUSE REPORTS THE FOLLOWING FOR PATIENT 4/21/2021 @ 9PM GENERAL MALAISE 4/22/2021 APPROX 4AM SEVERE HEADACHE TOOK IBUPROFEN 4/23/2021 AFTER LUNCH, PATIENT WAS UNABLE TO WALK AS PREVIOUS AND HAD 4 FALLS, ALSO COMPLAINED OF A SORE THROAT. 4/24/2021 DID NOT FEEL WELL, TEMP UP TO 100.4, NAUSEA AND VOMITTING X 1 AND CHEST PAIN, CALLED EMS AND WAS TRANSPORTED TO MEDICAL CENTER ER. 4/26/2021 PATIENT WAS DISCHAGED HOME AFTER TREATMENT FOR RHABDOMYOLYSIS AND RETURNED TO THE HOSTPITAL AGAIN ON 04/27/2021 WITH RHABDOMYOLYSIS AS PRIMARY DIAGNSOSIS. RESIDENT DISCHARGED TO SNF ON 04/28/2021." "1271674-1" "1271674-1" "Death within 60 days of vaccination" "1271726-1" "1271726-1" "Death within 60 days of vaccination" "1271737-1" "1271737-1" "Patient presented to the ED and was subsequently hospitalized with sepsis, respiratory failure and pneumonia on 3/2/2021. Patient presented to the ED and was subsequently hospitalized with pneumonia on 3/22/2021. Patient presented to the ED and was subsequently hospitalized with sepsis on 3/31/2021. He died on 4/4/2021." "1271757-1" "1271757-1" "Death within 60 days of vaccination" "1271786-1" "1271786-1" "Patient came to pharmacy for 1st Moderna Covid-19 vaccination on 4/21/21. Spouse reported she died on 4/25/21. Our pharmacy does not have information about her medications or health conditions as she wasn't a regular customer of ours." "1271827-1" "1271827-1" "lungs shut down from 95 to 0 in a blink of an eye" "1271846-1" "1271846-1" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271865-1" "1271865-1" ""Patient spouse came to our clinic on 4/29/2021 to report that on 3/18/2021 patient had a ""brain bleed"" and required emergency treatment. Patient died on 3/20/2021. Death certificate list cause of death as subarachnoid hemorrhage due to ruptured aneurysm"" "1271898-1" "1271898-1" "Patient was found unresponsive on 4/15/2021. Patient seemed to pass in his sleep per family member. The coroner deemed myocardial infarction. No autopsy completed." "1272012-1" "1272012-1" "Arm became sore at 5:25 pm (03/31/2021) developed chills, could not sleep for shaking, headache and joint pain (03:08 pm on 04/01/2021) ***this is what she texted to me and my other sister and the 03:08 pm text was the last text she had texted***" "1272058-1" "1272058-1" "Death on April 28, 2021 1AM" "1272138-1" "1272138-1" "PFIZER-BIONTECH COVID-19 VACCINE EUA. PATIENT RECEIVED FIRST DOSE OF VACCINE ON 2/8/21. PATIENT REPORTEDLY PASSED AWAY ON 2/13/21 AT 7AM IN NURSING FACILITY. Record of death states CHF as principle cause of death and Stage IV CKD as contributory cause of death." "1272140-1" "1272140-1" "PFIZER-BIONTECH COVID-19 VACCINE EUA. PATIENT VACCINATED WITH SECOND DOSE ON 2/8/21. PATIENT REPORTEDLY DIED ON 2/15/21 AT 5:02AM. RECORD OF DEATH FROM NURSING FACILITY STATES CHF AS PRINCIPLE CAUSE OF DEATH AND CONTRIBUTORY CAUSES: FRACTURED HIP, A-FIB, STAGE 3 CKD." "1272201-1" "1272201-1" "Pulmonary embolism; died - autopsy showed multiple blood clots all over his body - pelvic area, hearts,arteries, lungs; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (died - autopsy showed multiple blood clots all over his body - pelvic area, hearts,arteries, lungs) and PULMONARY EMBOLISM (Pulmonary embolism) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 003A21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Prostate cancer and Memory loss. Concomitant products included METFORMIN for Diabetes. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced THROMBOSIS (died - autopsy showed multiple blood clots all over his body - pelvic area, hearts,arteries, lungs) (seriousness criterion death). On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion death). The patient died on 04-Apr-2021. The reported cause of death was Pulmonary embolism. An autopsy was performed. The autopsy-determined cause of death was multiple blood clots. Action taken with mRNA-1273 in response to the event was not applicable Other concomitant medications were reported included unspecified medications for memory loss and diabetes. No treatment information was provided.; Sender's Comments: This is an 83-year-old, male patient who received mRNA-1273 Vaccine who experienced multiple thrombosis and died, 2 days after receiving second dose of vaccine. Medical history includes Diabetes, and Prostate cancer. Conmeds including some unspecified medications for memory loss and diabetes. The autopsy-determined cause of death was multiple blood clots. Very limited information has been reported at this time. Further information is expected,; Reported Cause(s) of Death: Pulmonary embolism; Autopsy-determined Cause(s) of Death: multiple blood clots" "1272225-1" "1272225-1" "Confusion 6 days after shot. Within a week lost ability to walk, became urinary incontinent. Major chest congestion, slept all the time. Rushed by ambulance at day 12.. Diagnosed with pneumonia amd uti. Cardiac arrest at day 14, never woke up. Taken off life support 3/20/21." "1272342-1" "1272342-1" "Developed shortness of breath within 12hrs of 2nd Moderna dose along with heart palpitations and nausea. Admitted to hospital 3 days after shot and quickly developed pnemonia and died 4 days later after blood O2 fell below 80%. Had periods of mild improvements followed by more severe declines each time." "1272393-1" "1272393-1" "Her conditions (leg swelling, coughing) get deteriorated after the vaccination. She was found pericardial effusions and plural effusions 2 weeks after the second dose. She stayed in ICU for 6 weeks and passed away." "1272476-1" "1272476-1" "She was quite sick, dizzy, went to ER three times between Saturday and Sunday, they sent her home each time, she died Monday morning." "1272543-1" "1272543-1" "The following evening after the shot, he had severe pains in his back and shoulders, headache, nausea (vomited). 2 days later, felt severe pain in his stomach, along with pain in his shoulders and back, with a headache, also vomited." "1273174-1" "1273174-1" "From one of the nurse vaccinators: the man who had a laryngectomy who gave me a hard time about an id when we first started..I was so happy to see his name on my list this morning. I saw that no one could contact him..I got into the building ..no answer at the door ..phone disconnected ..found the super..he died 3 weeks ago..he didn?t know cause..just emergent situation to hospital and passed." "1273324-1" "1273324-1" "The day before the first vaccine she was up and acting normal, laundry, housework and knew what to do. She has severe dementia but was doing OK and knew where she was. She got the first vaccine on 1/29/21, and the 3rd and 4th day they noticed she was having hallucinations and saying things that weren't there. She could hear baby's crying but there were no baby's present. Within 7 days she had what the son described as a stroke. He said that she was watching television and he was on a conference call and he noticed she walked into a wall and he asked if she was okay and starting stumbling across the room and when he touched her she felt very heavy and said that one side of her face was drooping. He got her back into the chair and called 9-1-1. She was so agitated at the hospital that the husband does not know what they gave her and they kept her for a week. They finally got her under control. They discharged her from there and she that was all that they could do with her. They brought her home with nurses assistance and her paranoia was evident, hallucinations were very evident. They said that they tried to do a CAT Scan and an MRI and they said that she did not have a stroke. Restless was very adamant, talking strange things and wanting to go to her son's house when she was there. Before that vaccination she knew where she was and after that she did not know where she was thinking she was at one location and just confusion. She then got her 2nd vaccine and then her husband went out of town and took her back home on 2/24/21 as he was able to get her in a car and travel and able to eat and knew somewhat what was going on. On 2/25/21 when he brought her home to a long term care facility. She was chanting constantly, had irritability, anger, cognition completely eroded. She was very agitated, very combative. Drugs would not calm her down, and tried to get CAT scans or MRI's but were unsuccessful due to her combativeness. She was screaming and yelling 24 hours a day to the top of her lungs and gave her Ativan which had the adverse effects of what they were supposed to do. Had biting, hallucinations, paranoia. She had a couple of falls, they had her in a wheelchair and tried to feed her and she would fall down. They took her to the hospital a few times and she progressively got worse. On 4/19/21 she shut down and quit eating, quit drinking, closed her eyes, and lasted a week like that and then she died on 4/24/21 @ 2:30 AM. None of her doctors could figure out what had happened. They were finally able to get a CAT scan and felt that she may have a stroke. Finally they memory care facility told them to come a take her to the hospital and they had moved their hospice patient's as she was screaming and disruptive and they could not handle her anymore. They thought she was suffering from Lewy body dementia at one point. They were going to have her tested for that and they could not do it on Saturday when she passed for genetics and missed those timelines and could not do it." "1273409-1" "1273409-1" "Resident CTB" "1273475-1" "1273475-1" "on 04/29/2021 Resident was checked at 1830 and found to be at baseline status. At approximately 1855, resident was found pulses and apneic. CPR initiated and resident transferred to medical center. Resident expired 1939." "1273483-1" "1273483-1" "Medical team dispatched to the residence of the the name person on April 10, 2021 at 2327. Pt assessed by medic on scene and determine patient with obvious death. Pt found halfway on the couch and to be pulseless, apneic, and with rigor mortis. Unknown down time and when further assessed, patient death determine by EMS. pt had fixed and dilated pupils, non-responsive to painful stimuli, absent breath sounds, no heart sounds auscultated. Pt was also placed on the monitor and found to be in asystole in 2 contiguous leads. CPR with held and no resuscitative measures performed." "1273487-1" "1273487-1" "Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10" "1273511-1" "1273511-1" "Patient recieved Moderna dose 1 02/23/2021, dose 2 03/25/2021. Nausea and vomitting after 2nd dose, found unresponsive by son on 04/17/2021, taken to ER and diagnosed with new onset Afib with RVR, sepsis with shock. Deceased 04/18/2021" "1273570-1" "1273570-1" "Patient reported dyspnea that began about 1 week post 2nd shot in Covid vaccination series. Patient deceased on 3/18/2021" "1273671-1" "1273671-1" "Husband stated that she died of an aneurysm on March 28, 2021. He will provide details later." "1273691-1" "1273691-1" "Patient tested positive for COVID 19 on 03/21 after a symptom onset of 03/19/21. She was admitted to the hospital on 03/24 and passed away 04/19. Cause of death is listed as multi-organ dysfunction secondary to hemorrhagic shock, other contributing factors: COVID-19 pneumonia." "1273804-1" "1273804-1" "GI Hemorrhage Covid + Respiratory Failure" "1273868-1" "1273868-1" "Sudden death (Patient's son should have access to COVID-19 vaccination card with lot numbers and location where vaccine was administered.)" "1273940-1" "1273940-1" "Heart Attack at 7:10 am( 4/9/21), CPR, CCU, CPR, Death(4/11/21) 9:15pm" "1273988-1" "1273988-1" "Patient had vaccination 4/7/2021 and started having symptoms 04/25/2021 arrived at the ER today with hypoxia" "1274103-1" "1274103-1" "This 77 year old white female received the Covid shot on 03/13/21 and went to the ED on 4/10/21 and was admitted on 4/10/21 with hyponatremia with excess fluid volume, acute respiratory failure with hypercapnia, transient confusion, acute heart failure, shortness of breath and went to the ED again on 4/18/21 with cerebral infarction and died on 4/29/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1274185-1" "1274185-1" ""This was a 58 year old female who received her 1st dose Pfizer on 4/6/21 (Lot# EW0175) and 2nd dose Pfizer on 4/27/21 (Lot# EW0151). Of note, the patient was in a motor vehicle accident on 4/12/21 with a diagnosis of concussion and cervical/thoracic strain/sprain (see history under patient information). On 4/29/21, the patient's sister contacted the patient's primary care clinic with the following documented concern: ""Pt's sister calling to report that two days ago pt got 2nd dose Pfizer vaccine and has been sick. This morning they found her passed out against the her bedroom door. Pt reports that she can't remember much other than going to the bathroom. Pt's sister states that patient totaled her car a week ago, and that it was determined she had a concussion. ""She hasn't been herself since the wreck and I am very concerned."" This caller recommenced the Ed or UC but caller denied stating that either needs to see her today. This writer is reaching out to nurse to see if they can advise from here."" A RN assessed the patient virtually with the following documentation: ""RN note: Call transferred from patient's sister. Pt noted to be found on her floor this morning. Pt unsure if she hit her head. Spoke to patient. She reports body aches, and feeling weak. Pt is slow to answer questions, and had a lot of difficulty hearing me (sister did not have any difficulty hearing me). Pt is noted to have more rapid breathing, and some slight wheezing. Speech is clear when she is speaking. Sister gave patient water to drink. She drank out of bottle and was able to hold on her own (though had difficulty with this at first). Sister noted some water dripping down face, but was able to swallow okay. Sister also noted that patient's lips seem to be pursed. Plan: Given recent concussion, and patients change in behavior per sister (pt more irritable, speaking more slowly, moving slowly, breathing faster, and wheezing), recommended patient be taken to the ED today--recommended ambulance since it took 2 men to help patient back to bed this morning. Sister states patient is not agreeable to going to ED at this time. Advised to try to encourage her to drink more fluids, and continue to monitor her sxs, and if any worsening, to call for ambulance transport. Sister agreeable to plan, and will discuss with sister, and recommend ED visit today."" On 4/30/21, the patient's sister contacted the clinic to inform them that the patient was found dead that morning. The medical examiner is completing the further investigation. If additional information is needed from the primary care physician for this patient."" "1274247-1" "1274247-1" "This 86 year old white male received the Covid shot on 4/10/21 and died on 4/22/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1274263-1" "1274263-1" "This 86 year old female received the Covid shot on 2/07/21 and went to the ED on 2/12/21 and was admitted on 2/13/21 with a cerebrovascualar accident, weakness, encephalopathy and UTI and went to the ED a 2nd time on 2/24/21 and admitted on 2/26/21 with and went to the ED again on 3/22/21 with altered mental status and died in 4/2021. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1274273-1" "1274273-1" "This 86 year old white male received the Covid shot on 03/06/21 and died on 04/26/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1274296-1" "1274296-1" "This 68 year old white female received the Covid shot on 3/3/21 and went to the ED on 3/22/21 and was admitted on 3/22/21 with shortness of breath, pneumonia and died on 4/10/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1274367-1" "1274367-1" "Approximately 1 week after vaccine, patient began shaking /trembling per caregiver and son. Less shaking 2 days before she died. Following vaccination, appetite decreased and then appetite disappeared 2 days before she passed. History of infection in her foot per caregiver. noted to have a blister on her right toe that became purple/ dark color. MD was notified and was started on an antibiotic. Patient was on palliative care due to advanced age and bedridden status. MD - No autopsy was done." "1274396-1" "1274396-1" "Patient was not vaccinated at our site however was admitted approximately 7-10 days post vaccination and expired." "1274456-1" "1274456-1" "received vaccine on 3/24/21 at another site. Was admitted to the hospital thru the ED with worsening shortness of breath." "1274462-1" "1274462-1" "Resident developed and was being treated for pneumonia on or about February 14, 2021, He was admitted to hospital on March 6, 2021 for low potassium and returned to the facility about March 11,2021. He returned with a diagnosis of pneumonia. He was admitted hospital on 4-1-2021 and returned to the facility on 4-7-2021 with a diagnosis of CVA. He was admitted to hospital again on 4-12-2021 with a diagnosis of aspiration pneumonia. He returned to the facility on 4-21-2021 and expired at the facility on 4-26-2021" "1274675-1" "1274675-1" "Vaccine was administered at 1215, patient was monitored for 15minutes per CDC guidelines with not adverse reactions noted. Approximately one hour after administration of vaccine patient noted to be moaning, fingerstick BS at 59mg/dL, Dextrose administered, pt proceeded in to cardiac arrest, CPR was initiated and EMS activated. Pt expired approximately 4 hours after incident at ER." "1274722-1" "1274722-1" "Pt presented to the hospital after a cardiac arrest. Work up showed renal artery thrombosis b/l causing renal failure and hyperkalemia. ROSC was achieved and pt coded multiple times after. We were unable to obtain CT A 2/2 to pt being unstable so only U/S imaging with doppler was used for diagnosis. Pt was treated with heparin gtt., hematology work up was sent but cause not identified. ECHO did not show thrombosis in the heart. CCRT was attempted but pt expired." "1275048-1" "1275048-1" ""Patient was a healthy 75 year old male when he got the shot. Within 5 hours, he began to feel TIRED, which was an expected side effect. He felt tired for several days. Nine days later he went to Memorial Hermann ER in Kingwood, and they said he had pneumonia. They also said he had a ""small mass"" at the bottom of his lung and might want to get it checked out. On March 20, he developed a cough. On March 21 we went to a different ER and a CT scan showed he had plureal effusion. On the next day he was short winded. He went back to the ER and they admitted him and transferred him to hospital by ambulance. On March 23, 1.7 liters of fluid was drained from his lung and sent to be tested. On March 26 he was diagnosed with malignant plureal effusion. He passed out at the doctor office and tranferred to to another facility by ambulance. He remained there for 4 days for tests, and a port was put in to drain the fluid. On March 29 he was transferred . They repeated many tests and did a bronchoscopy. On April 1 they told him he had squamous cell carcinoma. He came home on April 2. The doctor called and said they made a mistake he had small cell carcinoma. He remained home until April 11, when he was taken back to by ambulance. He had gone from a healthy appearing individual on March 17 to a critically ill individual and he died on April 15. Doctors had never seen cancer overtake a man in 28 days. 28 days!!!! On March 22, he had a small mass at the bottom of his lung, and one week later, it was a mass so large, his lung could not be seen and his lung had collapsed. Doctors assumed that the cancer was dormant and that the vaccine did something to wake it. It attacked my husband with a vengeance. He never smoked."" "1275726-1" "1275726-1" "massive Pulmonary embolism causing cardiac arrest" "1275910-1" "1275910-1" "Patient presented to ED on 3/28/21 with the following information: patient reports home daughter was diagnosed with COVID-19 infection a few days ago. For about a week now the patient herself has had severe fatigue, loss of taste, loss of appetite, nausea, vomiting and diarrhea. She denies fevers. She has however had a persistent cough and over the last few days has been short of breath. Tested positive for COVID-19 on 3/27/2021 at outside facility. Last night patient had multiple episodes of diarrhea making her fatigue significantly worse today. Has been drinking a lot of free water. Additionally noted increased cough and shortness of breath. Patient was admitted to the hospital with COVID-19 pneumonia on 3/28/21 and expired on 4/13/21." "1275915-1" "1275915-1" "On 3/25/21, patient presented to the ED with several days history of nausea, vomiting, and upper abdominal pain, and 1 day history of shortness of breath and wheeze. Patient recently received her first dose of Moderna COVID vaccination on March 10. Patient's daughter first developed COVID symptoms approximately 1-2 weeks prior, and was tested positive. Patient developed nausea, vomiting, and upper abdominal pain 6 days prior on March 19. She was tested positive for COVID several days prior to admission (either the 22 or 23rd, patient not sure). On the morning admission, patient had significant worsening of shortness of breath and wheeze. Patient also became significantly more weak and fatigued, and was eventually brought to ED. Patient reported chills, but denied headaches, chest pain, or diarrhea. Patient admitted to the hospital on 3/25/21 with main diagnosis COVD-19 pneumonia and patient expired on 4/13/21." "1275922-1" "1275922-1" "On 3/8/21, patient presented to the ED with cough, fever > 103, chills, SOB, all starting 9 days ago (2/27/21) about 3 days after 2nd dose of Pfizer vaccine. Patient was admitted to the hospital with main diagnosis COVID-19 pneumonia and patient expired on 4/8/21." "1277679-1" "1277679-1" "Death on 04/30/2021" "1277990-1" "1277990-1" "Patient passed away, was notified by Coroner" "1278019-1" "1278019-1" "On 4/9/2021 patient suffered from a Hemorragic Stroke on the left side of the brain making him unable to move his right leg and toes, right arm and hand, slight droop of right lip, and responding mostly in one word answers with delays at times. He was hospitalized in the am hours, sent to ER and then to Neuro ICU for 3.5 days and then moved onto a neuro floor for 1.5 days. On 4/13/2021 he was transported to an acute rehabilitation center to receive OT, PT and Speech Theraphy. On 4/19/2021 patient suffered from Ischemic Stroke on the right side of the brain, he became unresponsive. He was intubated on 4/19/2021, placed into ICU and was removed from intubation, due to poor life outcome from the 2 strokes having affected his body, on 4/21/2021." "1278030-1" "1278030-1" ""27 year old male with Down's Syndrome and no other past medical history received second COVID-19 vaccine on 4/27/2021. On 4/30/2021 began ""feeling poorly"" with nausea/vomiting and possible chest discomfort. Originally presented to ED on morning of 4/30 - EKG completed demonstrated diffused ST elevation. Patient was transferred to Medical Center for heart catheterization. Left heart catheterization demonstrated normal coronary arteries and LVEDP of 25. Stat ECHO demonstrated pericardial effusion and concern raised for myopericarditis. Patient subsequently transferred to a different Medical Center for higher level of care. Upon arrival to Medical Center plan was to intubate and take to cath lab for heart biopsy and PA catheter placement. However, upon intubation patient began to decompensate and subsequently developed cardiac arrest. During ACLS, VA ECMO was placed and therapeutic hypothermia was initiated. Following VA ECMO placement patient received IVIG, high dose methylprednisolone (1000 mg), anakinra 100 mg, and broad spectrum antibiotics (vancomycin and Zosyn). Despite these efforts the patient continued to have hemodynamic instability and was on high dose vasopressors (epinephrine, norepinephrine, dopamine, angiotensin II, vasopressin). Patient subsequently suffered another cardiac arrest, briefly regained pulse with high dose vasopressors, but subsequently lost pulse despite best efforts and died on 5/1/2021 at approximately 13:00."" "1278349-1" "1278349-1" "Patient suffered a seizure and pulmonary edema four days after receiving second Pfizer shot. He was pronounced dead several hours later. Patient had no health issues and was 45 years old." "1279431-1" "1279431-1" "Unspecified Cardiac Event; This is a spontaneous report from a contactable consumer (Patient's Daughter). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EK4176), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. The patient also received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EK4176), via an unspecified route of administration on 05Feb2021 at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease from an unknown date to 21Feb2021, brain aneurysm, smoker. Family medical history included States her Grandfather had skin cancer, but it was benign, moles and then freeze them off. No cardiac events. Grandma passed away infection from knee surgery. The patient received a Prior Vaccinations within 4 weeks has received both doses of the Pfizer Covid Vaccine. Concomitant medication was not reported. On 21Feb2021, patient experienced unspecified cardiac event. Caller stated that she was calling in regards to her mother regarding the Covid19 vaccine. States she was instructed by the pathologist to call Pfizer directly, rather than just report on VAERS. States this was not the same pathologist as the one that did the autopsy. Caller states does have a copy of the autopsy. States she called several pathologist to get the autopsy done. Dr. called her back after it had been done, and the caller discussed with him, the patient passed away after some cardiac event. States it is not clear what cardiac event. States she passed away 16 days after receiving her second dose of the vaccine. States the patient's physician would be happy to talk to Pfizer about it. Reporter states her mom was an LPN there and they all know her. States anyone there is fully aware of who she is. States some people in the office are taking it hard, and they may get sentimental. States it helps if people get things business and not talk about feelings. Reporter states it was 8:50am when the EMTs arrived and she had already passed. Caller states was who did the autopsy. She has been speaking with a lady, but she goes by (university name). States (Hospital Name) is a hospital, it used to be (University name). Hospital. Reporter states (phone number) is a direct line to (university name). Reporter states when the autopsy results came back she had the original and they are sending another because of the cause of death. Reporter states the autopsy showed no Pulmonary Obstruction, which made them question, well did she have COPD? States it was interesting because her mom was a smoker but her lungs were pink, and there was no fluid or obstruction in her lungs. States her mom taught her a little bit growing up. Reporter states she was going to be a nurse too but she lost her grant because she got married, now she doesn't qualify. Caller stats an autopsy was done; however they did not do a toxicology report. Caller states that patient was an organ donor. States she received a letter from them stating the patient will be helping a lot of people with skin grafts. Reporter adds, the patient was negative for Covid, she had to be tested for the autopsy. States she died from some type of cardiac event. States the patient did have COPD but on the autopsy, her lungs were clear and there were no pulmonary obstructions. States the liver showed possible hypertension, but the patient did not have hypertension. Reporter states there are some interesting things with her autopsy report and the patient's PCP could go over it medically if necessary. Reporter states this morning she saw several articles that state heart inflammation has been linked to the vaccine. Caller asks if she still needs to report it through VAERS? States she should have done it in the beginning but her mom was a big supporter of the vaccine. Reporter states her mom was on Facebook, and someone stated they weren't sure about getting the vaccine and her mom had commented, well she just got her second one, let's see what happens and then she died 16 days later. States that is why she was hesitated to report it. States the Pathologist encouraged her to call in and report it. Caller states she does not know if her mom had any other adverse events. States she will not say a word about things unless it gets really bad. Reporter states the only person that would know is Dr. meant a lot to her mom and she would be willing to tell her doctor, but not her daughter because she wouldn't want her to worry. Caller states the patient never used her inhaler, it is still full. States she took her mom's purse because her mom lived out of her purse, everything she needed was in there. Reporter states the patient had Tylenol, Sudafed, Advil, and Prednisone in her purse. Reporter states she knows she wasn't taking Prednisone. States the pill box is locked and it looks like it hasn't been open in a while. Reporter states she does not know if she was taking any medication, Dr. may have more information. Reporter states no, she didn't go to the doctor or the ER. States the patient's dog woke up her stepdad and she had already passed away. States they have her dog and he is going through a lot, when she first passed the dog had aggressive tendencies, and when she would lay with him, he would nudge her to get up. He doesn't like it when people go to sleep and that makes it harder. States the dog ended up getting an eye infection, because his tear ducts were clogged, states he did that a couple weeks, and now he is getting better, not as fearful or aggressive. Reporter states when her mom had the brain aneurysm, it takes a little bit longer for anesthesia to wear off. States it was an extremely strong anesthesia that she had never had before. States she wouldn't let anyone take care of her except for her. States when she was under anesthesia, she would call her mom. States they would know when she said mom, she was talking about her daughter. States her mom said she looks like her grandma when she was younger. Consumer adds the patient's husband's contact information, in case it is needed. On 21Feb2021, the patient died due to cardiac event secondary to COPD. Autopsy was perfomed. Autopsy details was available. The outcome of the event was fatal.; Reported Cause(s) of Death: Cardiac Event Secondary to COPD" "1279639-1" "1279639-1" "Sudden fatal heart attack. Patient went from a medically well person of 69 and died suddenly of PES within 2 weeks of dose. Patient reported arm pain, fatigue, and coldness to extremities" "1279801-1" "1279801-1" "Death. Autopsy was done. Awaiting results" "1280064-1" "1280064-1" "4/13/2021 heartburn like symptoms started. 4/20/2021 admitted to emergency room, received diagnosis of 3 blood clots in the heart, 4/27/2021 died as a result of blood clots in heart" "1280396-1" "1280396-1" "The day after first shot , patient was more paranoid, increase hallucinations, angry and started to lose ability to stand up straight, by day 8 she had total loss of leg control and torso, could not feed herself, dress herself and she was very combative and hallucinating constantly. We had to hospitalize her and she died March 6 in the hospital." "1280622-1" "1280622-1" "On 4/13 Patient underwent aortic root replacement with saphenous vein graft reconstruction of the right coronary artery. He had no prior coronary disease. This operation was done for an enlarging aortic root aneurysm in the setting of Marfan syndrome. The right coronary was anomalous and needed vein extension for reimplantation. He recovered very well and was seen in our clinic on 4/23, with no unusual findings. He had a normal echo, EKG and DVT study performed. On 4/28 he had his first Moderna COVID19 dose. on 5/1, he developed malaise, myalgias, painful lymph nodes, chills, and chest pain. He called my clinic and was instructed to go to the ER, but then felt better and didn't go. He was then found unresponsive later that afternoon and was pronounced dead on arrival of EMS." "1280657-1" "1280657-1" "Patient tested positive for COVID back in December 2020. She passed away at the nursing home facility on April 1, 2021." "1280682-1" "1280682-1" "Patient admitted on 03/25/2021 through the emergency department for complaint of shortness of breath she was a resident of a Nursing Facility. Her oxygen saturations were into 80%. Patient was poor historian her daughter at the bedside provided most history. Patient with recent admissions for coronavirus on 03/03/2021 and then again on 03/05/2021 for post coronavirus pneumonia. Throughout hospitalization patient with poor appetite, on 03/28/2021 noted to be somnolent, additional blood cultures and labs checked. Patient continue to decline, refused medications. Minimal responsiveness on 04/01/2021. Had episode of PAF on 4/1/21, renal dosed Eliquis per Cardiology. Service discussed with family multiple times about code status, he continued to be on decided home willing to change code status. Patient remained on high-flow oxygen and not eating. Patient very anxious increase work of breathing. Patient died on 04/03/2021." "1280718-1" "1280718-1" "Because patient had a severe adverse reaction to the first injection, he stated to me that he would not be getting the second injection. Two workers (from the mental health day program, he went to before the covid lockdown) both advised him to get the second injection, however, and he complied. After injection he had episodes of difficulty breathing and vomiting for several nights. Soon after that, he started having to go to the emergency room for blood sugars over 500 (prior to injection his diabetes had been controllable at care home). When he went to ER (for high blood sugar) March 18th, his heart stopped and could not be re-started. He died." "1280996-1" "1280996-1" "Had average Saturday at home, no illness. Layed in bed talking. Became nauseated, got up to vomit. Went back to bed, talking again. Said something wasn't right. Massive Heart Attack and Immediate Death. Police arrive in 2 minutes to begin CPR. Medic soon after. Efforts to resuscitate unsuccessful." "1281046-1" "1281046-1" "Arthralgia; Chills; Cold sweat; Dyspnoea; Fatigue; Feeling of body temperature change; Nausea; Pain; Pain in extremity; Pallor; Unresponsive to stimuli; This case was received via FDA VAERS (Reference number: 1150577) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021. This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (Arthralgia), CHILLS (Chills), COLD SWEAT (Cold sweat), DYSPNOEA (Dyspnoea), FATIGUE (Fatigue), FEELING OF BODY TEMPERATURE CHANGE (Feeling of body temperature change), NAUSEA (Nausea), PAIN (Pain), PAIN IN EXTREMITY (Pain in extremity), PALLOR (Pallor) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 014M20A) for COVID-19 vaccination. Concurrent medical conditions included Lactose intolerance. Concomitant products included DIPHENHYDRAMINE, VITAMIN D3 and ZINC. On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced ARTHRALGIA (Arthralgia) (seriousness criterion death), CHILLS (Chills) (seriousness criterion death), COLD SWEAT (Cold sweat) (seriousness criterion death), DYSPNOEA (Dyspnoea) (seriousness criterion death), FATIGUE (Fatigue) (seriousness criterion death), NAUSEA (Nausea) (seriousness criterion death), PAIN (Pain) (seriousness criterion death), PAIN IN EXTREMITY (Pain in extremity) (seriousness criterion death), PALLOR (Pallor) (seriousness criterion death) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) (seriousness criterion death). 27-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feeling of body temperature change) (seriousness criterion death). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. The patient died on 31-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood chloride: 104 (Inconclusive) 104. On an unknown date, Blood creatinine: 1.4 (Inconclusive) 1.4. On an unknown date, Blood glucose: 421 (Inconclusive) 421. On an unknown date, Blood lactic acid: 9.7 (Inconclusive) 9.7. On an unknown date, Blood potassium: 4.1 (Inconclusive) 4.1. On an unknown date, Blood sodium: 139 (Inconclusive) 139. On an unknown date, Blood urea: 13 (Inconclusive) 13. On an unknown date, Calcium ionised: 1.18 (Inconclusive) 1.18. On an unknown date, Haematocrit: 42 (Inconclusive) 42. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Paracetamol was taken for the treatment of pain. Patient's wife called 911 and she stated the told her pull him into floor and EMS arrived as soon as she got in the floor to start CPR. Action taken with the mRNA-1273 in response to the event is not applicable.; Sender's Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information required.; Reported Cause(s) of Death: Death" "1281242-1" "1281242-1" "Weakness loss of appetite 1wk after trouble breathing body hicups heart attack death (almost 2 wks after)" "1281531-1" "1281531-1" "Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism" "1281533-1" "1281533-1" "Blood clot in the lungs, Death" "1281552-1" "1281552-1" "I cannot confirm the type of vaccine the pt received as it didn't occur in our health system. Pt experienced out of hospital cardiac arrest a few days after vaccination. Pt resuscitated; however never regained consciousness. Coronary angiogram revealed normal coronary arteries." "1281673-1" "1281673-1" "stroke leading to death" "1281690-1" "1281690-1" "Death Non-STEMI (non-ST elevated myocardial infarction) (CMS/HCC) Chronic renal failure" "1281713-1" "1281713-1" "This 73 year old black female received the Covid shot on 2/27/21 and went to the ED on 4/29/21 and was admitted on 4/29/21 with respiratory distress, cardiac arrest and other symptoms and died on 5/1/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1281744-1" "1281744-1" "This 68 year old female received the Covid shot on 4/7/21 and died on 4/13/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1281748-1" "1281748-1" """"Janssen COVID-19 Vaccine EUA"" 3/18 twitching of foot...severe leg pain 7:45 PM 3/19 involved in a motor vehicle accident with cardiac arrest and a dissecting aortic aneurysm 12;45 PM"" "1281778-1" "1281778-1" "This 73 year old female received the Covid shot on 2/27/21 and went to the ED on 4/29/21 and was admitted on 4/29/21 with respiratory distress, cardiac arrest and other symptoms and died on 5/1/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1281798-1" "1281798-1" "This 83 year old black male received the Covid shot on 03/22/2021 and went to the ED on 4/5/21 and was admitted on 4/8/21 with CHF, bilateral lower extremity edema, chronic kidney disease and died on 5/1/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1281824-1" "1281824-1" "Pt. in cardiac arrest on 04/13/2021. Pt. was pronounced dead at Hospital on 04/13/2021." "1282259-1" "1282259-1" "Death" "1282517-1" "1282517-1" "Patient visited his doctor/pulmonologist on 3/18/21 and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a serious cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating, lifting his arms and communicating. He was diagnosed with Covid Pneumonia. Patient had underlying conditions (heart, lung and kidney disease)" "1282520-1" "1282520-1" "62F with stage 2 mycoises fungoides, peripheral neuropathy, HTN, HLD, admitted from hepatology clinic on 3/25/21 for worsening liver injury and URI symptoms, found to be COVID positive. Liver biopsy with evidence of severe hepatitis with bridging necrosis. Course complicated by increase encephalopathy 3/31/21 concerning for acute liver failure, requiring stay in COVID ICU, transferred to hepatology service on 4/2/21. DDx remains viral hepatitis, autoimmune hepatitis, and drug-induced liver injury now on steroid therapy as of 3/31/21 and NAC. Pt. had worsening ALF and encephalopathy, transitioned to comfort care. Pt died early morning of 4/4/21" "1282523-1" "1282523-1" "Pt received first COVID Pfizer vaccine on 3/2/21 and second vaccine dose of Pfizer on 3/23/21 and tested positive for COVID 3/24/21 was admitted through the ED on 3/24/21 with decreased oxygen levels (50%) and SOB. Admitted to the floor on 3/25/21, Patient was never intubated but was put on continuous BiPap. Patient treated with acetaminophine, albuterol, solumedrol, and remdesivir. Patient expired on 4/15/21. Cause of death was secondary COVID pneumonia and acute respiratory failure." "1282776-1" "1282776-1" "March 22 had a stroke, admitted, respiratory entire time, then rec'd death certificated Death Certificate" "1282830-1" "1282830-1" "Early in the around 10am on Feb. 24, 2021 my mother was found dead on the floor of the bathroom. She was found with dried blood coming from her nose." "1282946-1" "1282946-1" "The patient passed away." "1283068-1" "1283068-1" "Hi, my name is, I'm a RN and am submitting this report about my grandpa. I took him into the VA to get his second covid vaccine on 2/17/21. At that time my grandp lived semi-independently in a house between my parents and my uncle . He didn't get out very much but with some help of grocery shopping and organizing his medication he was still able to live alone and function well independently. My mother reported to me on 2/18/21 that my grandpa was confused, weak and tired. My grandpa has never had any signs of dementia. At this time he developed a delerium that waxed and waned. He complained of headache, no appetite and extreme weakness. On 2/23/21 he fell down in his house and we decided to move him into my uncles spare bedroom to keep better eyes on him. The delerium persisted and on 3/5 he was taken to Hospital for a workup for his delerium and weakness. There he saw Dr. an internal medicine doctor at hospital. The workup showed an elevated BNP (probably baseline but I'd have to look at previous lab results) but nothing further. We opted not to do further imaging and instead take him home. It became obvious to me that this was the end of his life and so I requested a hospice referral from Dr. My grandpa died on 3/24/21." "1283082-1" "1283082-1" "HAD LITTLE WEAKNESS AND TIREDNESS SINCE NEXT DAY AFTER TAKING VACCINE ON 4/7/2021 ON 4TH DAY, MORNING, 8.00 AM, 4/11/2021, WHEN I CHECKED AFTER WAKING UP, PATIENT WAS NOTICED NOT RESPONDING, NOT BREATHING, NO HEART BEAT. 911 WAS CALLED AND ARRIVED AT 8.20 AM. THEY TRIED VARIOUS MEASURES FOR 1 HOUR, AND THEN THEY CONCLUDED THAT THE PATIENT IS NO MORE." "1283093-1" "1283093-1" "Tired, headache." "1283204-1" "1283204-1" "Per the nursing home facility patient received her second dose of vaccine on 01/14/2021 but it was not listed on KYIR. Patient tested positive on 04/14/2021 and died on 04/16/2021." "1283410-1" "1283410-1" "Patient had a stroke on March 15, 2021 as described as a blood clot in her brain. Medical personnel were unable to correct it surgically and she passed away that evening in the hospital. Death was the final result." "1283686-1" "1283686-1" "Patient discovered by caregiver to have passed away on the morning of 4/24/21" "1283733-1" "1283733-1" "on April 2nd patient woke up at around 4:30 am and complained of pain in his back. I rubbed his back and he wondered if it was just something he ate. He then tried to calm down and got back into bed . He was holding my hand when suddenly his hand felt cold. I turned on the light to find his eyes rolled back and he was gasping his last breath . This was about 5:20 AM . Patient was a healthy active man." "1284252-1" "1284252-1" "patient suffered from a massive right ICA stroke on 4/22 (2 days after vaccine). stroke progressed to cerebral edema with evidence of herniation. she was intubated and unfortunately expired. not a neurosurgery candidate due to her age and signs of herniation." "1284449-1" "1284449-1" "Approximately 40 hours after second Pfizer vaccine, patient complained of pain in lower right leg, and a cold foot, lethargy, weakness, feeling unwell. 3 days later, shortness of breath, difficulty breathing, rapid heartbeat, and confusion began. Went to Medical center on 4/20/21, diagnosed with DVT, PE and clots in and around the heart and passed away on 4/21/21 of cardiac shock in the setting of pulmonary and arterial thrombosis." "1284727-1" "1284727-1" "heart attack; Bood clot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) and THROMBOSIS (Bood clot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria death and medically significant) and THROMBOSIS (Bood clot) (seriousness criterion death). The patient died on 23-Mar-2021. The reported cause of death was Heart attack and Clot blood. It is unknown if an autopsy was performed. Not Provided No concomitant medication were reported. No treatment information was provided.; Reported Cause(s) of Death: Heart attack; Clot blood" "1284864-1" "1284864-1" "blood clot in her leg; blood clot in her leg; Cardiac arrest; Heart attack; This is a spontaneous report from a contactable consumer (patient's daughter). A 96-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 29Jan2021 (Lot Number: EL9265) as SINGLE DOSE for COVID-19 immunization. Medical history included blood clots in her legs from an unknown date and unknown if ongoing , diabetec, bone infection, surgery and anemic; all from an unknown date and unknown if ongoing; and a family history of gangrene from an unknown date and unknown if ongoing of her mother. Concomitant medications included apixaban (ELIQUIS) taken as blood thinner and furosemide (FUROSEMIDE) taken for an unspecified indication; both start and stop date were not reported. The patient previously had BNT162B2 (Lot Number: EL1283) dose 1 on 08Jan2021 for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was in the military facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, the patient died due to a heart attack and cardiac arrest. The patient developed a blood clot in her leg and had to have her leg taken off. The date of surgery was 05Feb2021, not early Mar2021 like was originally stated at the hospital. The patient was admitted either on 01Feb2021 or 02Feb2021 and discharged on 23Feb2021. They had a bunch of bad weather and then they put the patient in the nursing facility for about a month and when she was brought home she had a heart attack and died due to cardiac arrest. She doesn't know about the blood clot and this being related to the COVID vaccines but the patient had surgery a week after she had her second shot. The heart attack was on 15Mar2021. The patient had a history of blood clots in her legs before and she had problems with that so that might of made it worse but she doesn't know for sure. The patient died on 15Mar2021. An autopsy was not performed. The outcome of the event blood clot in her leg was unknown. No follow-up attempts are possible; information about lot/batch number has been obtained.; Reported Cause(s) of Death: heart attack; cardiac arrest" "1284937-1" "1284937-1" "passed away(death); temperature 99.7F; tired; left arm swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (passed away(death)) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetic and Asthma ((but everything was under control).). On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PERIPHERAL SWELLING (left arm swelling) and FATIGUE (tired). On 31-Jan-2021 at 10:30 AM, the patient experienced PYREXIA (temperature 99.7F). The patient died on 25-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PERIPHERAL SWELLING (left arm swelling), PYREXIA (temperature 99.7F) and FATIGUE (tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Body temperature: 99.7 f (abnormal) elevated. On 31 Jan 2021, the patient was tired and went to bed early. At 10:30 pm, the patient's wife reported the patient's temperature as 99.7 degrees Fahrenheit and was given acetaminophen. The patient's left arm had swelling. The patient's son (doctor) prescribed antibiotic for treatment. On 01 Feb 2021, the patient was taken by ambulance to hospital. He was at hospital for 24 days and was on a ventilator. Treatment included Tylenol antibiotic. Company comment: Very limited information regarding the events has been provided at this time. Further information has been requested..; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested..; Reported Cause(s) of Death: Unknown cause of death" "1284956-1" "1284956-1" "My mom was found dead at home 24 hours after having vaccine" "1285193-1" "1285193-1" "Multiple Blood Clots in Right Lung, clots passed through his heart and caused his death" "1285303-1" "1285303-1" "Patient admitted to Hospital on 4/16/2021 with 2 weeks of generalized weakness, chills, poor oral intake and nonproductive cough. Chest x-ray shows consolidation. Patient tested for covid-19 which returned positive on 4/18/21. Patient remained hospitalized and started on steroids and vitamin c/e after covid testing returned positive. Patient respiratory status worsened requiring high flow nasal cannula and BiPAP as needed. Patient did not want to be intubated and decided to go to comfort care. Patient passed away on 5/3/21 in the hospital." "1285361-1" "1285361-1" "I am unsure if this illness was related to his recent vaccination. However, after seeing reading this article about possible link between covid vaccination and the development of myocarditis, I felt compelled to report: https://www.reuters.com/world/middle-east/israel-examining-heart-inflammation-cases-people-who-received-pfizer-covid-shot-2021-04-25/. The patient in question is a 53 year old man with a history of previous carotid artery dissection and hyperlipidemia transferred to our hospital from an outside facility for presumed myocarditis. He rapidly decompensated, required intubation, multiple vasopressors, was initiated and ultimately expired." "1285387-1" "1285387-1" "From what I understand the night of the dose she had chills and a headache. She had several bad headaches since that vaccine up until her death on April 21st. She was given the J&J vaccine on April 8th at the CVS. Died on April 21. at home. I just saw an article today, May 4th that about 1-2 hours from her death, another female in her 30's got the J&J vaccine on the SAME DATE April 8 and she died on APRIL 19th. Pretty close in deaths and same vaccine. IS IT CONNECTED?" "1285510-1" "1285510-1" "60 yo male with BMI 30 and vodka x 2-3 bottles per day. In hospital 4/9-14 for obstructive uropathy of undetermined origin. In hospital on 4/12 and got J & J there. 4/13 with no prior history developed a DVT. D/C'd on 4/14 on Eliquis. Found unresponsive 4/19. At autopsy, found pulmonary thromboemboli" "1285561-1" "1285561-1" ""The patient presented with chest pain around 5 pm on 4/4/21. Patient reported ""pain came out of nowhere."" Patient reported pain was non-exertional and non-positional. He described it as ""a constant burning sensation"" located in the center of his chest with radiation upwards toward his jaw and shoulders, bilaterally. He was transferred to COVID unit, became hypotensive, hypoxic was seen by house MD. Lung exam crackles bilaterally. IV fluids stopped, patient was given 40 mg Lasix, Morphine 2 mg and started on a small dose nitroglycerine drip. POX 70s, low 80s so Bipap ordered. Patient developed v tach and arrested, resuscitated, defibrillated, received multiple meds, intubated by anesthesia, transferred in ICU on Levophed and Epinephrine. Arrested in ICU. Lines were placed by ICU team, arrested again in ICU. Was maxed out on 4 pressors, despite CPR, pulse could not be obtained, patient was pronounced dead 4/6/21 at 3:31am. 1. Triple vessel CAD 2. Moderately severe LV dysfunction with and EF 30% 3 The recent NSTEMI is secondary to the occlusion of the SVG-OM1. There is a large thrombus in the SVG which makes PCI of this vessel unlikely to be successful. 4 The native OM1 is chronically occluded. It may be possible to attempt to open this with CTO techniques, however, at this time continued medical treatment. 5. Perclose"" "1285713-1" "1285713-1" "Died unexpectedly in my arms. On the 15th. Could not breathe We tried to use inhaler and did not work." "1285872-1" "1285872-1" "80 yo woman with hx of HTN, anxiety dneies any other conditions, presented to ER due to epigastric pain, vomiting x1. In Er presented with elevated heart rate, EKG with sinus tachycardia, regular rythm. CXR with COPD changes. There are bibasilar infiltrates suspicious for pneumonitis in the appropriate clinical setting. PAtient admitted to unit for further treatment and workup. WBC 16.91 4/27/2021" "1285906-1" "1285906-1" "Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine." "1285947-1" "1285947-1" "Hospitalized and died of COVID-19 after being fully vaccinated." "1286074-1" "1286074-1" "We were notified by company on 4/28/21 that patient had died between the afternoon of 4/23 and Saturday morning 4/24/21. No other information was given to us." "1286085-1" "1286085-1" "Patient had a brain hemorrhage on April 20th and died on April 25th." "1286108-1" "1286108-1" "Hospitalization 4/8/2021-4/16/2021 with discharge home on hospice and death 4/28/2021. Admitting diagnosis: Acute respiratory distress, COPD, acute hypercapnic hypoxic respiratory failure, Hypomagnesemia; HTN; probable UTI with concerns for Severe Sepsis; Altered mental status with concerns for metabolic encephalopathy along with dementia." "1286114-1" "1286114-1" "At 11:30am on April 6th my dad had a type A Aortic Dissection. He was rushed in an ambulence to Hospital. 4 hours later, they evaluated him and sent him by medivac to Hospital for emergency open heart surgery. Dr. performed the surgery which my dad survived. He continued to have additional complications in the ICU including a right brain stroke which may have happened during surgery. While in the ICU, he contracted pneumonia and his lungs and kidneys began declining. 20 days after the aortic dissection he died in the hospital." "1286144-1" "1286144-1" "Shortness of breath followed by sudden collapse followed by death." "1286158-1" "1286158-1" "Pt had an appointment with her cardiologist 4/15/2021 and no changes in patient's health noted states daughter. Patient performed yard work at noon 4/16/2021 and developed chest tightness that was relieved by rest. After patient's nap at noon no more chest discomfort occurred. Patient went to bed that night and husband noted she was sleeping comfortbly with no breathing difficulties at midnight. At 3 am husband found patient cold and she had expired." "1286213-1" "1286213-1" "Presented to ED on 4/23/21 with weakness, malaise, poor appetite and nausea; elevated temperature, tachycardia, lactic acidosis, chest XRAY patchy infiltrates. COVID test positive. Respiratory failure and COVID19 pneumonia. Patient referred to hospice." "1286232-1" "1286232-1" "patient passed away before second dose" "1286275-1" "1286275-1" "Death due to a Subarachnoid hemorrhage" "1286303-1" "1286303-1" "patient passed away" "1286341-1" "1286341-1" "Patient was very ill and homebound. Her son has to physically carry her to move her from one place to another and she is considered homebound." "1286431-1" "1286431-1" "Patient reported to ER on 4/23/21 with complaint of chest pain. Symptoms started that morning. Felt fine the evening before. No fevers, chills or productive cough. He also had associated shortness of breath." "1286457-1" "1286457-1" "Received first dose of Pfizer vaccine in left deltoid on 4/8/21 at 7:30 am. At 10:00 am, she called her niece and complained of extreme fatigue. At 12:00 pm, she complained of worsening fatigue and blurry vision. At 3:40 pm, she complained of loss of appetite but denied fever and chills. The niece was unable to reach her by phone after 4 pm, so she came over to the decedent?s residence at 6:15 pm to check on her. The niece found her lying face up in bed ?gasping for air.? She then became unresponsive and EMS was called. The decedent was pronounced at 8:11 pm after unsuccessful resuscitative efforts. Autopsy showed hypertensive and atherosclerotic cardiovascular disease with marked partially calcific coronary atherosclerosis; marked pulmonary edema; and pleural effusions. The brain was saved for neuropathology given the history of blurry vision." "1286592-1" "1286592-1" "received both of his doses of the Pfizer COVID vaccine . Had a migraine after the first dose, and a mild headache after the second dose. Unclear whether or not he suffered chronic migraines, although there was paperwork at the death scene stating that he had an appointment for a MRI on 3/1/21. No recent influenza-like symptoms are reported. He was found dead in his home on 2/22/21, seated at a chair at his desk. Autopsy findings include an enlarged and dilated heart, granular kidneys, with the right kidney very shrunken and about half the size of the left kidney, and prostate hypertrophy. There is no trauma. The airway is not edematous. Ancillary studies that are pending include microscopy, toxicology (basic testing plus vitreous chemistries), a COVID swab, a respiratory viral panel swab, HIV testing, and neuropathology. The cause and manner of death on the death certificate will both be ?pending further studies? until these studies are completed." "1286629-1" "1286629-1" "had second dose of Pfizer vaccine on 2/4 at 15:00, had back pain, nausea and vomiting around 18:00, went to the ER around midnight with abdominal symptoms and stable VS, and went unresponsive and was pronounced on 2/5 at 6:23 am. Dr. did the autopsy over the weekend. At autopsy, he has remote myocardial infarcts and what appears very recent myocardial infarct. Quick tox was negative for drugs. No hemorrhage or signs of inflammation in the injection site (right shoulder). No other findings. Cause and manner of death are currently pending for extensive histology and viral testing. F/u from OCME on 2/22/2021: histology slides and decedent has myocardial infarct. He will be signed out as such. Covid swab is negative" "1286659-1" "1286659-1" "Shortness of breath, hypoxia, + COVID-19" "1286679-1" "1286679-1" "Neck pain and stiffness starting shortly after vaccine admin of 2nd dose" "1286760-1" "1286760-1" "fever, shortness of breath, respiratory distress, pneumonia, liver failure, death." "1286795-1" "1286795-1" ""Patient reported feeling ""shaky"" day of 2nd vaccine dose. Patients family reports that patient wasn't feeling well the night of and called EMS to her home. Patient passed away this morning around 5am."" "1287685-1" "1287685-1" "WEEKNESS IN THE RIGHT SIDE OF BODY" "1287846-1" "1287846-1" "The person who received the vaccine got very sick 5 days after the receiving the vaccine. The patient was talking at 2:00 pm on the 28th and he was on a ventilator a few hours later. The doctors were never able to determine why he got so sick suddenly. He passed away on April 6th." "1288450-1" "1288450-1" "Feeling Tired; Headaches; Passed away; found dead in her bed; Was not feeling well; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 11Apr2021 (lot number: ER8729) at the age of 49 years old, as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included naproxen sodium (NAPROSYN) taken for an unspecified indication from 05Apr2021 to an unspecified stop date; and benzonatate taken for an unspecified indication from 05Apr2021 to an unspecified stop date. The patient previously received first dose of BNT162b2 on 21Mar2021 (lot number: EP6955) at the age of 49 years old, for COVID-19 immunization and experienced fatigue, legs were hurting, dry cough, and really bad headaches. No other vaccines received in four weeks. The caller's friend (patient) got her second dose on a Sunday (11Apr2021). Monday, (12Apr2021), the patient went to work, but left because she wasn't feeling well. The reporter stated that the reporter did not speak to her friend (patient) directly on this day but was told that her friend (the patient) was feeling tired and having headaches. The reporter stated that her friend died early Tuesday morning 13Apr2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 05Apr2021. The patient died on 13Apr2021. An autopsy was performed, and results were not provided. Outcome of events 'was not feeling well', 'feeling tired', and 'headaches' was unknown.; Reported Cause(s) of Death: Passed away; found dead in her bed" "1288839-1" "1288839-1" "Systemic: Blood Disorder (diagnosed by MD)-Severe, Additional Details: Patient passed away on 4/23/21 and had blood clots throughout body. Patient did not have any other symptoms that were reported. Patients family requested a VAERS report be submitted." "1289022-1" "1289022-1" "Patient passed away on 4/29/2021. A member of our staff noticed his name on the obituary section of our local news. We do not know of any other details." "1289201-1" "1289201-1" "Patient is a 66-year-old female with complicated past medical history including uncontrolled diabetes, colovaginal fistula status post resection with end ileostomy in 2017, open cholecystectomy 2019, chronic pain, CAD status post stents on Plavix and COPD that presents to the hospital today complaining of abdominal pain. Patient states that her abdominal pain began a few days ago. Is been in the middle of her abdomen. Is worsened over time. She states that all her operations were done by the Dr. Postoperatively she had no complications. She was told that she could not have her ostomy reversed and has been doing with the end ileostomy since then. She states that she just emptied her bag again this morning. She has been having trouble eating secondary to the abdominal pain. This prompted her visit to the emergency room today. Upon evaluation by the ED physician she underwent a CAT scan which showed a small bowel obstruction. For this were consulted. Of note patient was also found to have a UTI and was made a septic alert by the ED. I met the patient upon my arrival into the emergency room. Upon my arrival into the emergency room patient was sitting upright in bed. She is squirming around in the bed stating that she is having abdominal pain. States that she does not know her medications. Her husband usually takes care of this for her. She is able to relate her surgical history to me. ED physician spoke with the Dr. He is unavailable to come see this patient. According to the ED physician the Dr. asked us to take care of the patient while he is away." "1289324-1" "1289324-1" "Generally not feeling well after first shot. Shortness of breath the day after getting the second shot. The patient died the day after getting the second shot." "1289333-1" "1289333-1" ""March 2 - second Moderna March 3 - spontaneous bruising appears March 4 - visit with primary care doctor, blood work shows significant drop in platelets March 9 - first visit with oncologist/haematologist & hospitalized March 9-19 - hospitalized for tests, treatment to increase platelets, & many blood panels. No official diagnosis, treat as ITP. Follow up visits with oncologist/haematologist to keep an eye on platelets as they increase. March 30-Apr 4 - ER visit due to swelling of ankles, feet, and left arm. Tests show superficial blood clot, fluid on lungs, and pneumonia. Oncologist said that ""we have no official diagnosis"", that she's being treated for ITP. April 6-14 - follow up visit to oncologist/haematologist show elevated kidney enzymes, then later liver enzymes, low sodium. April 14 - decision to move to short term rehab for regular PT and OT. Continued swelling (fluid in third spaces.) April 21 - visit to cardiologist to perform cardioversion, successful (during first week of hospital stay, heart rhythm med had to stop). April 23 - facility nurse discovered significantly low Hemoglobin and a blood transfusion was ordered. April 24 - returned to short term rehab facility. April 25 - discovered my mother on O2 and state of health was different, extremely weak and not moving, arm hurting badly. I insisted that her oncologist is contacted. Transported to ER. Discovered her blood work abnormal. After stabilizing her, rushed to the hospital ICU. April 26 - Discussed with her ICU doctor the history of what you have read above. He explained that the covid-19 vaccination has a tendency to affect three proteins specifically that clot and thin blood. I begged him to ""get it out of her system."" Her bleeding was significant and platelets dropped, again. Still has her mental facilities. Responding well to aggressive treatment: albumin transfusion, plateletpheresis, and CRRT. Pleural catheter to remove fluid from the lungs. Mention of Sepsis. April 27 - Lifted her head up today, opened her eyes, making doctors very happy. Her cardiologist and the ICU doctor both said they were ""confused"" and everything happening to my mom was ""a mystery."" Though going in to the evening, her nurse expressed to me that she's worried. The ICU oncologist called me at home in the evening. He asked me if she had been having a fever on a regular basis. He said he thought it could be TTP or a rare disease called HTH, but both results wouldn't be back for one week. He planned to consult with a doctor. He explained to me that the blood was attacking itself and ""confused,"" and that her organs were shutting down. He indicated that the blood work wasn't indicating significant infection. He referenced how the vaccination has made her auto immune system ""go crazy."" April 28 - I get a call very early from the nurse that she has been fighting with my mother's blood pressure all night, trying to keep it elevated. She told me to come to the hospital, because she had taken a turn for the worse. I arrive to find my mother's eyes wide open, breathing shallow, and blood pressure steady, but drops without assistance from medication. She continues to have her mental facilities. She passed away, organs shutting down, and blood pressure dropped."" "1289375-1" "1289375-1" "Hospital Course: Patient admitted to the ICU in cardiogenic shock. Intra-aortic balloon pump. Multiple vasopressors. Intubated-mechanical ventilation. Appropriate sedation. EMD arrest 5/2 spontaneous recovery. Family meeting wife and daughter agreed to A1 designation. 0725 recurrent hypotension nonresponsive to vasopressors, calcium, serum bicarbonate. Pronounced dead at 0754. _________________" "1289378-1" "1289378-1" "Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination." "1289387-1" "1289387-1" "Patient had a subarachnoid hemorrhage and died at hospital on the afternoon of saturday April 10" "1289390-1" "1289390-1" "Patient hospitalized and died of pneumonia caused by COVID-19 after being fully vaccinated." "1289414-1" "1289414-1" "Patient tested positive on 04/20/2021 via PCR. Upon arriving to hospice care, patient tested positive via rapid on 04/29/2021. She died in hospice care on 05/01/2021." "1289450-1" "1289450-1" "Hospitalized and died due to COVID-19 after being fully vaccinated." "1289460-1" "1289460-1" "Only information known is what is in the obituary, Obituary states died suddenly on 5/1/21 after an illness." "1289604-1" "1289604-1" "Patient was found deceased in her home the next morning after getting her vaccine the day before" "1289664-1" "1289664-1" "2/4/21 Woke with bad headache continued all day 2/5,2/6 Bad headache continued-Tylanol no help 2/8 AM Loss of conshance. Loss of ability to speak. Taken to hospital. Briefly gained conshanceness. Still unable to speak. 2/27 Died." "1289681-1" "1289681-1" "I63.9 - Stroke (CMS/HCC) R53.1 - Acute left-sided weakness" "1289723-1" "1289723-1" "Death. Approximately 12 hours after administering the vaccination shot, patient experienced a medical emergency and lost her pulse. Paramedics attempted to resuscitate her for about 80 minutes. Her heart was unable to be restarted. She was declared deceased at 3:00 AM locally." "1289756-1" "1289756-1" "Patient passed away before receiving second dose, husband states not COVID related death." "1289866-1" "1289866-1" "On 4-15-21, patient started having breathing problems and shortness of breath. He had a cough that he had productive phlegm. He continued to get worse. On 4-18-21, he fell getting out of the shower and slumped onto the floor, stating that he couldn't breathe. His wife and neighbor took him to the local ER. His condition improved with oxygen. He was admitted on 4-18-21 and then was transported by Air Evac to ICU. He was placed on the ventilator prior to leaving on 4-21-21 and transferred to hospital. His condition continued to deteriorate and he passed away on 4-25-21." "1290096-1" "1290096-1" "4/20/21: patient arrived to ER per EMS status post PEA arrest. Per ER records, patient became unresponsive while sitting in bed witnessed by husband at home. According to husband, they had come home, she sat on the bed and complained she was not feeling good. She then fell back on the bed and began to seize. Subsequently she had intermittent episodes of alertness and was able to speak to the husband followed by unresponsiveness. At time of EMS arrival pt. was unresponsive. EMS noted BS 120s, SBP 50s. En route to hospital, pt. had a CP arrest for which epinephrine was given, CPR initiated with ROSC. Pt. arrived to the ER on a NRB mask attempting to speak. Subsequently, pt. had several CP arrests with asystole, and" "1290128-1" "1290128-1" "Patient collapsed at home with cardiopulmonary arrest. He had been complaining of shortness of breath 1 week prior to the event, starting when he received his covid vaccination. The differential diganosis was pulmonary embolism, myocardial infarction or arrythmia. CPR was started immediately and patient received tPA during ACLS without return of spontaneous circulation." "1290186-1" "1290186-1" "Vaccine was administered at 12:10pm The patient was observed for 15 minutes and sent over to her oncologist for an appointment. A CT scan was ordered- CT done (no contrast) in the same building with daughter transporting. Daughter states mother became unresponsive after CT scan. She alerted the doctor and staff who responded. They moved her to an exam room. Noted agonal breaths on vital signs. CPR started. CPR stopped shortly after per the families request. Death pronounced at 2:34pm." "1290195-1" "1290195-1" "Covid19 vaccine: The patient received her second dosage of Moderna on 3/23.Patient called family medicine triage on 4/1 regarding arm/shoulder pain from her vaccine site that was not improving. Pain started out near injection site but last couple days has been spreading to shoulder, some possible swelling, per patient. Finding it hard to sleep. Denies redness, warmth. Feels warm but no chills, doesn't have thermometer at home. The patient refused to call the COVID hotline. She was calling for an in-person appointment and was triaged for her symptoms. The next in-person appointment was not until Saturday 4/3, and it was given to the patient. She did not want to go to the ED. She suffered a witnessed massive heart attack the same day in her home and her partner called 911. Per parnter's report, walked around a little that day, in discomfort. Then came home and laid down with more arm pain. She had acute L arm pain and then agonal breathing - passed in order of 2-3 minutes. Likely cardiac arrest after MI for few days. She was BIBA the EMTs continued CPR for ~20 minutes but was unable to revive patient. She was pronounced dead on 2023." "1290197-1" "1290197-1" "Cardiac arrest, seizures death" "1290282-1" "1290282-1" "04/04/2021 - Assessed at start of shift. Family at bedside and aware of condition. Left after assessment. Unable to arouse. BP 97/64 P 71 R 30 and shallow 02 sat 80% with 02 per NC in place at 2 LPM. Afebrile at 97.7. MS given at this time. Upon entering room at 2245 Pulse faint and R very shallow at 4. Resp. and pulse ceased at 2300." "1290360-1" "1290360-1" ""Statement from health worker from Mobile Vax Team: ""We arrived at the patient's home and daughter explained patient was on hospice, had difficulty breathing and was on fentanyl and morphine but they definitely wanted to go ahead with the vaccination. Nursing student, who gave the vaccine said she saw the patient breathing. She wasn't blinking from my observations. We left after 15 minutes. I left my purse there by mistake so about 40 minutes later we called and the daughter informed us that her mother had passed away. Death verified by hospice nurse."""" "1290421-1" "1290421-1" "Fever, Diarrhea, chills, sweating, weakness beginning 7 hours after injection. Hospitalized due to these symptoms on March 10, and died on March 13." "1290448-1" "1290448-1" "5/4 : Resident with PICC line following course of IV ABX for osteomylitis. Resident was administered Jassen vaccine at 1100am. Resident had PICC line and PIV removed at aprox 1700. He was followed up by nursing staff at 2000 at which time he complained of swelling, redness, and heat to the PICC site. On-call provider was notified and ordered transportation to Emergency Department for evaluation. Facility was notified of passing at 0200 on 5/5" "1290733-1" "1290733-1" "Found unresponsive but still breathing at assisted living. Sent by ambulance to the hospital" "1290874-1" "1290874-1" "Shortly after receiving this first dose,my husband's breathing went downhill, two months later he was dead. They could not find the cause. I told them I knew the cause. It was the Covid shot! I reported it to his pulmonologist and to the hospital staff. He was stable with all other conditions until he got this shot!" "1290894-1" "1290894-1" "My sister died on 4-28-2021" "1291385-1" "1291385-1" "Three days after vaccination, the patient was working outside when he suddenly died. Specific events are not known as he was alone at his work site. No bodily injuries were found. He was simply passed out and unresponsive when found. He had been deceased for hours upon his discovery." "1291811-1" "1291811-1" "day one threw 3 dizziness, day 4 throwing up, diarrhea, then death" "1291923-1" "1291923-1" "I had a patient come in at 10:05am for a Moderna Covid vaccine. Just before 11am we received a call from the patient's roommate that the patient arrived home and collapsed, it was also mentioned her blood pressure was high. We explained that they needed to call 911 but the patient did not want to go to the hospital. We explained that this patient must go to the hospital and get evaluated. They did end up calling 911. Approximately 45 minutes later I received another call from the patient's roommate that EMS did not believe this was a reaction from the vaccine. The roommate mentioned that she was in fact mistaken about the blood pressure and it was actually low (92/54 mmHg). She also mentioned that the patient was vomiting. Around 1:45pm I received a call from the roommate to tell me that the patient had died." "1292046-1" "1292046-1" "Same day as when patient received the 2nd vaccine, she was overcome with generalized fatigue and nausea. By the 4th day, her legs would not hold her when she tried to stand getting out of bed. She was nauseous to the point of not being able to eat or drink. Infact, she did not have the strength or desire to eat or drink. By the 5th day post vaccine (02/20/21), I took her to the Emergency room because she was so fatigued, she just slept, and couldn't stay awake to eat or drink. She was able to get to the car with a walker, but that was the last time she walked. After time at hospital and then Skilled nursing, she passed away on 03/21/21. She never regained the ability to toilet herself, eat on her own, failed to eat and drink, and eventually was put on hospice because she lost 30 pounds over the month from failure to eat or drink, even though I was there or the nurse was there to feed her every meal, and try to get her to take fluids. Her fatigue was just overwhelming. When she first arrived at the emergency room, she: ? Presented with 2 days of weakness and AMS; fever, nausea and generalized fatigue ? Word finding difficulty; without stroke or acute abnormal on CT or MRI; according to the Hospital" "1292206-1" "1292206-1" "Extreme blood clots in lungs and legs" "1292213-1" "1292213-1" "DEATH. My sister took the vaccine on April 28th and DIED on May 3rd." "1292411-1" "1292411-1" "Death resulted two days after 2nd dose in series." "1292810-1" "1292810-1" "hallucinations, CHF, Pleural effusion, bilateral" "1292940-1" "1292940-1" "tested positive for covid" "1293194-1" "1293194-1" "I63.9 - Acute CVA (cerebrovascular accident) (CMS/HCC) I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC)" "1293211-1" "1293211-1" "J18.9 - Pneumonia I95.9 - Hypotension R09.02 - Hypoxia I48.91 - Atrial fibrillation with rapid ventricular response (CMS/HCC) A41.9 - Sepsis, unspecified organism" "1293257-1" "1293257-1" "J96.01 - Acute respiratory failure with hypoxia (CMS/HCC) R57.9 - Shock (CMS/HCC) A41.9 - Sepsis, unspecified organism" "1293272-1" "1293272-1" "This 61 year old white female received the covid-19 vaccine on 4/21/21 and died on 5/5/21." "1293404-1" "1293404-1" "Altered mental status R77.8 - Elevated troponin N39.0, R31.9 - Urinary tract infection with hematuria, site unspecified D64.9 - Anemia, unspecified type R40.2431 - Glasgow coma scale total score 3-8, in the field (EMT or ambulance) (CMS/HCC)" "1293409-1" "1293409-1" "Started feeling sick day of 2nd dose of the Moderna vaccine. never felt good. personal journal entries testify of this. never felt good before she died. Had a massive thrombophlebotic stroke 10 days later causing death." "1293449-1" "1293449-1" "This 81 year old white male received the Covid shot on 3/11/21 and went to the ED on 4/2 and was admitted on 4/4 with shortness of breath, pericardial effusion, pulmonary edema, CHF and again to the ED on 4/30 and admitted on 4/30 with abdominal pain, hypoatremia, renal insufficiency and again to the ED on 5/1 with pericardial effusion and died on 5/4/21." "1293454-1" "1293454-1" "he felt tired the day of but continued doing his daily activities, on april 6 morning a friend couldn't reach him by phone and went to his home and found him on the floor, the hospital said he had a brain bleed, acute hypoxia, the bleed was on the left side of his brain, the doctor stated it was a cerebral bleeding that cause him to fall." "1293462-1" "1293462-1" "This 64 year old male received the Covid shot on 3/29/21 and went to the ED on 3/29/21 and was admitted for left-sided nontraumatic intracerebral hemorrhage and died on 5/4/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1293523-1" "1293523-1" "This 79 year old female received the Covid shot on 2/18 and went to the ED on 2/26 and was admitted on 2/26 with chest pain and abdominal pain and again to the ED on 3/14 and admitted on 3/14 with hyperkalemia, acute renal injury, chest pain and died on 05/04/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation." "1293530-1" "1293530-1" "death" "1293657-1" "1293657-1" "34 y/o male with no PMHx presenting in cardiac arrest from home. Per pt's wife, he received 2nd dose of the Pfizer vaccine roughly 24 hours prior. He complained of arm soreness yesterday afternoon and some chills this morning, took Tylenol for these symptoms. She found him unresponsive in bed after speaking to him roughly 2 hours earlier. Per EMS, patient was in asystole upon their arrival. He received ~ 30 minutes of prehospital ACLS and an additional 20 minutes in the ED and remained in asystole throughout." "1293909-1" "1293909-1" "Per family, pt reported fatigue and elevated glucose, nausea and diarrhea 3-4 days after immunization. She was seen by her PCP following week and again was experiencing elevated blood glucose." "1293944-1" "1293944-1" "Patient suffered cardiac arrest today" "1294116-1" "1294116-1" "Five days post vaccine patient had a massive cerebral hemorrhage resulting in death." "1294303-1" "1294303-1" "Vomiting and diarrhea starting 4/28/21 (day after vaccine). Came to ED today for these symptoms, feeling weak, had a cardiopulmonary arrest and died." "1294370-1" "1294370-1" "Patient received the COVID-19 vaccine on Thursday, March 25, 2021. On Tuesday April 6, 2021 he had a massive stroke, blood clot to left side of his brain. On Friday morning April 9, 2021 doctor's advised he had another stroke due to bleeding in the brain (paralysis on right side and racing heart beat). He died on Saturday, April 10, 2021 @ 5:45 AM." "1294857-1" "1294857-1" "Five days after receiving the Covid-19 vaccine, patient suddenly began having trouble breathing. We called 911 right away but, by the time EMS arrived, she was unconscious and didn't appear to be breathing. Patient was not sick at the time this occurred but she was hospitalized in December of 2019 and was diagnosed with pulmonary fibrosis and pulmonary hypertension which required her to go home with and continue on supplemental oxygen. However, she never experienced pulmonary distress after coming home and her SPO2 levels consistently ranged between 96 and 99% with supplemental oxygen. Patient's death was very sudden and unexpected." "1295072-1" "1295072-1" "Acute renal failure, admitted to the hospital on 4/6/21. Underlying source never identified, died on 4/9/21." "1295164-1" "1295164-1" "Patient's wife called today to inform us that her husband passed away on 04/17/2021. Patient experienced some side effects after receiving both doses of Moderna vaccine such as body ache and feeling of lethargy. Patient was taken to the hospital around 04/16/2021. Exact cause of the death is not known as wife did not want to get autopsy done." "1295200-1" "1295200-1" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295555-1" "1295555-1" "Patient found dead" "1295648-1" "1295648-1" "Patient DIED 10 days after 2nd dose of Covid vaccine." "1295712-1" "1295712-1" "cough, body aches, fever--COVID +, afib, tachycardia, acute coronary syndrome" "1295875-1" "1295875-1" "Presented to urgent care on 5/1/21 with dry cough which started about 4 days prior. Symptoms worsened and presented to emergency department on 5/5/21. Was found to be COVID-19 positive and was admitted for further management. Patient had been exposed to COVID-19 positive person prior to presentation. Patient is currently admitted at time of writing." "1295905-1" "1295905-1" "The medical investigator was contacted regarding the death of this 80 year old man within hours of receiving his first dose of the Pfizer vaccine for COVID-19. Little information is known about the facility and actual vaccination administered at the time of this report. However, patient was reported by his next-of-kin to be an otherwise healthy 80 year old without COVID-19 symptoms. He did have a tobacco smoking history. By postmortem computed tomography scans, patient was found to have evidence of catastrophic complications of cardiovascular disease, with apparent aortic dissection and large blood collections in the left chest cavity as well as the pericardial sac. In my medical opinion, these findings were most consistent with a complication of his underlying cardiovascular disease." "1295932-1" "1295932-1" "Aspirating severe" "1296012-1" "1296012-1" ""Arrived to emergency department via ambulance from nursing home with complaints of ""looking like he was about to have a seizure"". Patient became unresponsive and a code was called. ACLS performed but the patient did not recover from cardiac arrest."" "1296016-1" "1296016-1" "My father died, 20 days after his 2nd vaccination. Not sure if it is related to the vaccine, but a sister reported Arthritis pain, 3 times as bad, after the 2nd vaccination and recommended I report this. My father started having severe back pain, 3 days after the second immunization. I took him for an XRay and the hospital said he had Compression Fractures of the vertebrae, but they could not tell if they were new or old, so needed to do an MRI. Said it also looked like he had a Bowel Obstruction, but I told them he had been having normal BM's up to the previous day. He lived until the 17th of April and never had another BM. They said bring him to the ER. The ER decided to do a CAT Scan, but Dad was not interested in any further treatment. He just wanted to go, so we put him on palliative care and he passed away, 20 days after the 2nd vaccination." "1296030-1" "1296030-1" "Unknown cardiac event. Found on sidewalk down. Revived but resulted in extensive neurological damage. Was put in life support. Never came to. Passed away 05/05/2021." "1296067-1" "1296067-1" "Patient completed 2-dose Pfizer series on 1/31/21 and passed away on 2/13/21. Pt presented to ER on 2/11/21 with SOB, weakness, diffuse abdominal pain and diarrhea that started that day. Pt tested positive for COVID and was transferred out to a higher level of care. 1st dose: 1/5/21, 2nd dose: 1/31/21" "1296113-1" "1296113-1" "Stroke lead to death" "1296193-1" "1296193-1" "HOSPITALIZATION AND DEATH" "1296197-1" "1296197-1" ""Wife reports patient was vaccinated on 3/30/21. She stated patient only had blurred vision following vaccination which lasted a about 2 days. On 4/4 family members visited and it was noted that 1 member tested positive for Covid on 4/5/21 and her spouse was home sick on 4/4/21 and was later positive on 4/5/21. Around 4/5/21 patient began having more frequent episodes of delusion and confusion. Speech slurred and slouched in chair. Patient would be demanding when asking for water when water was in his hand. Talking to her but looking at the ceiling. She stated she thought he was having ""mini strokes."" Increased weakness with standing. Slid to floor multiple times from chair. She reports loss of appetite and trembling. Saw MD on 4/12. ""Could hardly breathe."" MD ordered doxycycline and an inhaler. Patient to Hospital on 4/13/21. Diagnosed with Covid on 4/13/21 via PCR. Discharged from hospital to Skilled Nursing Facility on 4/16/21. Sent back to Hospital on 4/18/21 and passed away on 5/1/21. Wife states that death certificate indicates ""Utonic Hypercapnic respiratory failure, acute/chronic CHF, hypoxemic respiratory failure and HTN, DM, prostate CA and COVID PNA. No autopsy performed. Medical PCP."" "1296253-1" "1296253-1" "ACUTE HYPOXIC RESPIRATORY FAILURE, ATYPICAL PNEUMONIA, MULTIPLE MYELOMA" "1296284-1" "1296284-1" "Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine." "1296304-1" "1296304-1" "History 59-year young lady with history of COPD coronary artery disease CHF was evaluated at a local hospital and transferred with diagnosis of pneumonia. Patient O2 sat was in the 70s she was placed on CPAP. In route patient complained of chest pain abdominal pain and back pain subsequently had a cardiorespiratory arrest. Patient was being bagged after ET intubation in the field by EMS with chest compressions. Breath sounds well equal on arrival. Glucose was greater than 100 on fingerstick. Providers were initially able to obtain a pulse with return of spontaneous circulation but blood pressure was at best 50 systolic. Patient was begun on an epinephrine infusion and norepinephrine ordered. The patient then deteriorated into V-tach, All additional heroic measures failed and the patient expired." "1296384-1" "1296384-1" "Client admitted to the hospital on 4/26/2021 with Covid symptoms, body aches, SOB and chest pain. Diagnosed with Covid -19 pneumonia. Antigen test positive for Covid-19 on 4/26/2021. Subsequent admission on 5/4/2021 with cardiac arrest secondary to hypovolemic shock from UGI bleed, likely variceal. Client died 5/5/2021." "1296394-1" "1296394-1" "Hospitalization and Death" "1296415-1" "1296415-1" "The nurse was called by the family letting us know that the patient had passed away at home. No further details were provided," "1296477-1" "1296477-1" "Case had COVID-19 in November 2020 as part of an outbreak in the SNF she lives in. She recovered then received her first COVID-19 vaccination on 1/4/21. She received her 2nd dose of Moderna on 2/1/21. On 4/11/21 she became ill and was transferred to the hospital where she tested PCR positive for COVID-19. She continued to decline and was intubated. She died on 4/28/21 while still in the hospital. The diagnosis on her death summary from the hospital is COVID-19 pneumonia." "1296636-1" "1296636-1" "Started getting achy and feverish. Diarrhea, vomiting. Told me, I'm as sick as I've ever been in my life. Died. Just want to know if he died from Covid or an adverse reaction from Johnson and Johnson vaccine he received in jail. No one wants to test his blood. He's at the mortuary awaiting cremation, and I thought it best if some government entity drew some blood to determine if he's a Covid or vaccine reaction fatality. Before they cremate his body." "1296678-1" "1296678-1" "April 8, 2021- Vaccinated with the Johnson and Johnson vaccine. April 10, 2021 ? Fever, strong headache, unable to hold on, diarrheas, respiratory difficulty. April 14, 2021- She lost her balance and fall, hitting her face. Had a CT scan and no mass nor bleeding was found, only sinus. Discharged home. SARS-CoV-2 test ? Negative results April 18, 2021- Found dead in her sofa. No thromboembolism nor bleeding" "1296807-1" "1296807-1" "In the hours following the first dose on 3/19/2021, sustained fever between 100 - 102 degrees, headaches, chills, clammy. The symptoms continued all day on the 3/20/2021. Sometime after 5:30 am on the 3/21/2021 she could not breathe. Pulse oximeter registered 57. contacted ambulance, within their arrival 10-15 minutes later, pulse oximeter was down to 43. Lips were blue skin was pale and clammy. At hospital she received high doses of oxygen and was treated for other symptoms." "1296823-1" "1296823-1" "According to facility representative on 1/27/2021 at approximately 7:15 am, pt was discovered not breathing with no pulse. Resident was pronounced dead at 7:44 am on 1/27/2021. Resident was previously tested positive for COVID-19 on 12/9/2020." "1297262-1" "1297262-1" "The patient had developed a rash, fatigue, difficulty breathing, stomach pain, possible fever and began to cough up blood. He took Tylenol and a Chinese herbal medication called Lianhua Qingwen Jiaonang on 5/5/21. It is unclear when his symptoms began, as he did not share that information with his wife until 5/5/21." "1297282-1" "1297282-1" "Confusion Lethargic In mobile Memory loss Motor skill loss" "1297350-1" "1297350-1" "My father in law died one day after his COVID vaccine. His doctor did not seem to care. She ruled it natural causes. She did not order an autopsy. He did have underlying heart conditions, but the timing of his death was suspicious." "1297569-1" "1297569-1" "Extreme exhaustion, weakness. Ultimately death on 4/29/2021" "1298020-1" "1298020-1" "She had no pain from the initial shot but then that night she stated she felt horrible, aches and pains and her cough worsened. a week later she said that the symptoms were just as bad, she was extremely tired also. Nauseated as well. She did not believe that she had a fever." "1298885-1" "1298885-1" "Was not eating; Hematuria; became extremely fatigue/ not improving extreme fatigue/he could hardily make it to the grocery store door back to the car without total exhaustion; weak/he could hardily make it to the grocery store door back to the car without total exhaustion; Pancytopenia; father who passed away; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DEATH (father who passed away), PANCYTOPENIA (Pancytopenia), HAEMATURIA (Hematuria), DECREASED APPETITE (Was not eating), FATIGUE (became extremely fatigue/ not improving extreme fatigue/he could hardily make it to the grocery store door back to the car without total exhaustion) and ASTHENIA (weak/he could hardily make it to the grocery store door back to the car without total exhaustion) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The patient's past medical history included Atrial fibrillation and Heart failure. Concomitant products included RIVAROXABAN (XARELTO), FUROSEMIDE, PRAVASTATIN and CARVEDILOL for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced FATIGUE (became extremely fatigue/ not improving extreme fatigue/he could hardily make it to the grocery store door back to the car without total exhaustion) (seriousness criterion hospitalization) and ASTHENIA (weak/he could hardily make it to the grocery store door back to the car without total exhaustion) (seriousness criterion hospitalization). On 29-Mar-2021, the patient experienced PANCYTOPENIA (Pancytopenia) (seriousness criterion hospitalization). On 01-Apr-2021, the patient experienced HAEMATURIA (Hematuria) (seriousness criterion hospitalization). On 09-Apr-2021, the patient experienced DECREASED APPETITE (Was not eating) (seriousness criterion hospitalization). On 31-Mar-2021, ASTHENIA (weak/he could hardily make it to the grocery store door back to the car without total exhaustion) had resolved. The patient died on 15-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PANCYTOPENIA (Pancytopenia), HAEMATURIA (Hematuria), DECREASED APPETITE (Was not eating) and FATIGUE (became extremely fatigue/ not improving extreme fatigue/he could hardily make it to the grocery store door back to the car without total exhaustion) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Full blood count: low (Low) lowplatelets, low wbc and low hemoglobin. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable as the patient passed away.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, this patient's advanced age and underlying medical conditions (Atrial fibrillation and heart failure) remains a confounder. Further information can't be requested.; Reported Cause(s) of Death: Unknown cause of death" "1299352-1" "1299352-1" "Patient was admitted to the emergency room the morning after receiving the vaccine and died on 07Apr2021; Nasal swab Positive; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) (at the age of 86 years old) as single dose for COVID-19 immunization. Medical history included gastro-intestinal problem. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was admitted to the emergency room on 31Mar2021 the morning after receiving the vaccine. The patient was hospitalized for two days. It was unknown if treatment was given. This event (Patient was admitted to the emergency room the morning after receiving the vaccine and died on 07Apr2021) resulted in emergency room/department or urgent care, hospitalization and life threatening illness (immediate risk of death from the event) and patient died. The patient died on 07Apr2021. The patient's nasal swab was positive on 31Mar2021. The outcome of the event nasal swab was positive was unknown. It was not reported if an autopsy was performed. Information on batch/lot number has been requested.; Reported Cause(s) of Death: Patient was admitted to the emergency room the morning after receiving the vaccine and died on 07Apr2021" "1299650-1" "1299650-1" "COVID-19 infection with pneumonia: Present on admission. Patient was treated with remdesivir and convalescent plasma." "1299850-1" "1299850-1" "He became very ill and died this past Wednesday because he was told to get the shot even though he wasn't feeling well. There is no excused for perpetuating the myth that everyone should get the shot no matter what. A negative covid test and thorough physical should be required before people take this vaccine." "1300070-1" "1300070-1" "Pt. arrived the hospital on 5/1/21 c/o SOB. Within a few hours, she went into cardiac arrest and was resuscitated. Pt. was placed on a Ventilator. She expired on 5/4/21." "1300291-1" "1300291-1" "Passed away in home days after vaccine, was in perfect health as far as can be expected by 93 year old, before vaccine." "1301096-1" "1301096-1" "32 hours after the vaccine, he suffered a massive heart attack due to a blood clot and a massive clot in the right arm. He went to the hospital and under went surgery at 12 am on Saturday. The coronary surgeon mentioned that this was not from heart disease as all vessels were clear. Rather, this was due to an embolism due to an unknown origin. A further work up concluded that he also had blood clots throughout his body (both lungs, one kidney, heart, liver, legs, arms, and possibly brain). By 12 p.m. we were asked back to the hospital as he was worsening. Treatment options included a heparin drip, which caused a brain hemorrhage. He was just at the doctors two times this week, on Tuesday and Wednesday and was fine no issues found. They went through with the 2nd dose and came to our home on Thursday." "1301355-1" "1301355-1" "She began having shortness of breath after getting her second shot. He parents found her dead in her bed this afternoon. No other known comorbidities." "1301797-1" "1301797-1" "Renal failure; Liver failure; Unresponsive; Died; Stomach pain; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UNRESPONSIVE TO STIMULI (Unresponsive), DEATH (Died), RENAL FAILURE (Renal failure) and HEPATIC FAILURE (Liver failure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Primary biliary cirrhosis. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea). On 08-Apr-2021, the patient experienced UNRESPONSIVE TO STIMULI (Unresponsive) (seriousness criterion hospitalization). On 23-Apr-2021, the patient experienced DEATH (Died) (seriousness criterion death), RENAL FAILURE (Renal failure) (seriousness criterion hospitalization) and HEPATIC FAILURE (Liver failure) (seriousness criterion hospitalization). On 23-Apr-2021, RENAL FAILURE (Renal failure) and HEPATIC FAILURE (Liver failure) had resolved and NAUSEA (Nausea) outcome was unknown. The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, UNRESPONSIVE TO STIMULI (Unresponsive) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown. The concomitant medication included liver medications, as reported by the reporter. On 07Apr2021 around 1230pm, the patient experienced stomach pain and nausea which the family attributed to her liver medications. The patient went to sleep later that evening. The next day, 08Apr2021, the patient was found to be sleeping around 8am but was unresponsive around 1:30pm. She was taken by ambulance to the local hospital. The patient was eventually placed on life support and passed on 23Apr2021. No other treatment medication were reported. Company comment: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: unkown cause of death" "1301919-1" "1301919-1" "Death; This case was received via FDA VAERS on 04-May-2021 and was forwarded to Moderna on 04-May-2021. This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 01-Apr-2021 The patient died on 01-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Symptom Text : Death reported to Health department from Medical Examiner office, no further details provided Company comment:This is a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) who died 3 days after the second dose of vaccine. No Med history and no concomitant medication were provided. Very limited information has been reported at this time. Further information is not expected.; Sender's Comments: This is a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) who died 3 days after the second dose of vaccine. No Med hx and no conmeds were provided. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death" "1302134-1" "1302134-1" "Patient had several ED visits within 6 weeks of receiving COVID vaccination. He first presented to the ED on 4/8/21, was admitted on 4/9/21 for 2 days. He was admitted again on 4/20/21 for 6 days. He presented to the ED on 5/8/21 with cardiac arrest and died." "1302209-1" "1302209-1" "death from covid 3 months after completing series" "1302213-1" "1302213-1" "Short of breath, died March 20, 2021" "1302239-1" "1302239-1" "Patient developed paroxysmal atrial fibrillation. Upon date of death- pt husband reported SOB, incontinence, gasping for air, slumped forward and died upon 911 arrival." "1302294-1" "1302294-1" "fever and generalized weakness bilateral pneumonia secondary to COVID-19 infection Failure to Thrive, Severe Sepsis antibiotics: Levaquin, ceftriaxone and Remdesivir, insulin: Humalog and respiratory therapy: O2" "1302383-1" "1302383-1" "He felt very bad the night he received the 2nd shot of Pfizer covid-19 vaccine on April 27. He even joked he probably would die that night. He also complained that despite his protest, the person who administered the shot insisted to inject on his shoulder joint. He developed a bigger-than-quarter-size bruise on his right inner arm the next day. He was feeling tired the following days. On May 4 around 3:30, I heard he was making loud noises. I came to his side immediately. At the time I thought he was making louder than usual snores. I nudged him gently but he didn't respond. After about 15 seconds, the sound stopped, and he had no breath. I then called 911 within 10 seconds, tried to do CPR on him. It took EMS 6 minutes to arrive even though we live very close to a fire station in a well-accessed urban area. EMS worked on him for about 30 minutes before transported him to hospital. They continued to work on him for a while. He never regained breath." "1302428-1" "1302428-1" "The patient was last seen well at 3:30 PM. He was found unresponsive, face down in his own vomit, cyanotic, apneic by family. Patient was unable to be resusitated. He was pronounced dead at 6:51 PM." "1302438-1" "1302438-1" "Patient received the first Pfizer immunization on 4-22-2021. She passed away on 4-30-2021. Her husband notified the pharmacy. Patient had been hospitalized for a period of time before the vaccination for 'bleeding internally' due to an unknown cause." "1302490-1" "1302490-1" ""On 4/26/21 The patient presents to our clinic with concerns for back pain, fever, shortness of breath, fatigue and coughing. We performed a covid19 antigen test which resulted positive. Based on this and his history and examination we recommended he go straight to the hospital for further evaluation and treatment. He was admitted to medical center where a PCR was performed and confirmed positive. He was discharged on 4/29. Per his wife, they felt he was discharged too soon and he went to another hospital. He passed away 5/10/2021. This report is being made in regards to the claim by the CDC that ""no one that has been infected with covid19 4 weeks after having the janssen vaccine has been hospitalized."" This patient was not only hospitalized but passed away."" "1302513-1" "1302513-1" "Death listed as a heart attack. No symptoms, but took an abnormally long nap just prior to the attack." "1302631-1" "1302631-1" "This 86 year old male received the Covid shot on 1/20/21 and went to the ED on 1/23/21 and was admitted on 1/23/21 and again went to the ED and admitted on 4/4/21 and again to the ED on 4/26/21 with the diagnoses listed below and died on 5/4/21. D50.0 - Blood loss anemia I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC) S09.90XA - Closed head injury, initial encounter W19.XXXA - Fall, initial encounter S01.01XA - Laceration of scalp, initial encounter S06.5X9A - Subdural hematoma (CMS/HCC) S06.5X9A - Traumatic subdural hematoma (CMS/HCC) Z74.09, Z78.9 - Impaired mobility and ADLs" "1302667-1" "1302667-1" "This 82 year old female received the Covid shot on 3/31/21 and went to the ED on 4/8 /21 and again to the ED and admitted on 5/7/21 with the diagnoses listed below and died on 5/9/21. J90 - Pleural effusion, not elsewhere classified N18.6 - ESRD (end stage renal disease) D61.818 - Pancytopenia A41.9, R65.20 - Severe sepsis" "1302677-1" "1302677-1" "This 71 year old male received the Covid shot on 3/29/21 and died on 5/6/21 with the diagnoses listed below Covid-19" "1302683-1" "1302683-1" "This 70 year old female received the Covid shot on 3/17/21 and died on 5/1/21." "1302689-1" "1302689-1" "This 87 year old male hospice received the Covid shot on 2/16/21 and died on 5/4/21." "1302705-1" "1302705-1" "This 49 year old female received the Covid shot on 4/6 /21 and went to the ED on 5/5 /21 with the following diagnoses listed below and died on 5/5/21." "1302712-1" "1302712-1" "This 70 year old female received the Covid shot on 4/9/21 and went to the ED on 5/5/21 died on 5/5/21." "1302793-1" "1302793-1" "Hospitalization and Death" "1302844-1" "1302844-1" "Lethargy began the day of vaccine and shortness of breath along with abdominal and chest pain followed the next day. Decedent was found deceased the next evening." "1302958-1" "1302958-1" "Hospitalization and Death" "1303031-1" "1303031-1" "This 68 year old black male received the Covid shot on 3/17/21 and died 5/21." "1303041-1" "1303041-1" "This 77 year old male received the Covid shot on 2/22/21 and went to the ED and admitted on 4/28/21 with the diagnoses listed below and died on 5/5/21. cause of death unknown at time of report" "1303069-1" "1303069-1" "This 75 year old female hospice patient received the Covid shot on 3/24/21 died on 5/6/21." "1303074-1" "1303074-1" "1st dose in series on 03-18-2021; 2nd dose in series on 04-08-2021 2 days after 2nd dose, he developed severe pain in both legs. He was taken to the hospital where clots were diagnosed in both legs and groin area. A previously undiagnosed lung nodule was found and he was given a cancer diagnosis. He was discharged home on apixaban (Eliquis) and comfort measures 2 days after admission. Over the following weeks, he had a permanent lung drain placed. He died on May 5th or 6th at home. No autopsy performed." "1303119-1" "1303119-1" ""The morning after Mom's first dose of the Pfizer shot, Dad woke up and found Mom lying on the floor next to the bed. Mom said, ""I can't move my arm."" Dad called paramedics who checked her. They said her vital signs were normal and left. On 2/9/21 in the morning my da awoke to see that Mom had large amounts of bubbly saliva pouring from her mouth onto her pillow. Dad called paramedics, who said this was a diabetic reaction. Mom had NEVER had anything happen like this before. Mom was very sleepy, could not be aroused, and made only gurgling noises. She was admitted to the hospital for care and therapy. She pulled her own IV out. Mom had to be restrained in the hospital and sedated, due to confusion and worsening dementia. By 2/18 when we spoke by phone mom's speech was abnormally slow and very repetitive. ""I'm very tired today"" was spoken many times. In morning time mom was able to follow basic conversation. Not so later in the day. Mom came home from rehab on 2/26/21. She was able to walk steadily and independently at home after her therapy. After a week or so, Mom began hitting the in-home caregiver. Dad's presence would calm her. In a short time Mom seemed not to know dad anymore, and would hit him and the caregiver when they helped her. She also pulled all covers off the bed and pulled clothes out of the closet, throwing them all over the room during the night. Mom was usually walking around the house during each night. On 4/16/21 Mom and dad were napping sitting up on the couch in the morning. Mom fell forward and hit her head on the hearth. Dad and caregiver gave first aid and called paramedics, who took her to the ER. Mom came home on 4/17/21. On 4/18/21 Mom pulled her catheter out in the early morning. In the afternoon Mom's appearance was concerning, so Dad called paramedics. They said that Mom's BP had dropped very low and took her to the ER. Mom was combative the next day in the hospital. Dr. adjusted her medications periodically to ensure that mom's care would be manageable when she would eventually be sent home. Minimal therapy was done due to dementia. By 5/3/21 doctor said that Mom is bed bound and needing total care. Her blood sugar spiked high despite special diet. Staff waiting for insulin order from doctor. 5/4/21 Doctor called Dad to say that Mom had died during the night."" "1303145-1" "1303145-1" "This 98 year old female received the Covid shot on 2/13/21 and went to the ED and admitted on 4/30/21 with the diagnoses listed below and died on 5/9/21. J44.9 - COPD (chronic obstructive pulmonary disease) S72.002A - Left displaced femoral neck fracture W19.XXXA - Fall, initial encounter S09.90XA - Head injury, initial encounter" "1303162-1" "1303162-1" "This 77 year old female received the Covid shot on 4/1/21 and went to the ED on 4/11/21 and admitted on 4/12/21 and again to the ED on 4/24/21 with the below listed diagnoses and died on 5/9/21. J18.9 - Pneumonia, unspecified organism" "1303175-1" "1303175-1" "This 60 year old black male received the Covid shot on 4/15/21 and went to the ED on 4/23/21 with the following diagnoses listed below and died on 4/27/21. K92.2 - Gastrointestinal hemorrhage, unspecified" "1303190-1" "1303190-1" "This 74 year old female received the Covid shot on 3/12/21 and went to the ED on 4/11/21 with the diagnoses listed below and died on 5/3/21. ABDOMINAL PAIN VOMITING" "1303196-1" "1303196-1" ""per medical report from hospital- ""presented to emergency room at outside facility secondary to worsening shortness of breath. The patient states that about 1 week ago she started feeling ill directly after receiving her first covid vaccine. the patient states her medical issues actually began approximately 2 months ago when she developed sudden onset positional urinary retention as well as urinary incontinence and constipation. She states that she thought maybe her known spinal stenosis had worsened causing her bladder dysfuntion.She states she tries to sit on a commode or a toilet and is unable to void however when lying flat she has to wear adult briefs as she has no control over her bladder at all. There is no p"" "1303208-1" "1303208-1" "Recieved obituray on patient. Called pt. ER contact and she stated that she was unaware how patient died. Pt. died at home but states that pt. had been having flu-like symptoms in bed with chills after vaccination. Pt. ER contact is unaware of pt. medical history or current medications. Pt. ER contact that pt. PCP was not us but another medical facility. Called funeral home and spoke to employee and she stated that the coroner cause of death listed was acute MI. Employee stated that she does not have a certified copy of death certificate at this time." "1303327-1" "1303327-1" "Hospitalization and Death" "1303474-1" "1303474-1" "Death. Date of death unknown" "1303655-1" "1303655-1" "Fever, chills, nausea the morning After vaccine. Took out the trash and had a cardiac arrest and fell. 911 called went to hospital 3 1/2 days no change. 2 Dr.s said no improvement brain dead. Had a living will disconnected after 48 hrs. Disconnected at 7:00 pm died 8:17 pm. 2/7/21" "1303694-1" "1303694-1" "Pt started feeling weak within hours of vaccine progressive weakness ensued and pt began to have falls and Rapid decline in general status and Died 3- -2021" "1304120-1" "1304120-1" "Pt c/o not feeling well and very weak right after receiving injection, and fell less than 3 hours later, would/ could not eat/drink or walk as usual, became confused and bedbound the same day of vaccination and appetite further deteriorated while weakness and confusion increased." "1304434-1" "1304434-1" "Patient found dead after receiving vaccine. At 11:44 on 3-30-2021 Medical Investigator was able to return call after leaving scene where there was no phone service. Police were on the scene requesting Medical Investigator Contact was made between Medical Investigator and member of the police force. Narrative was that the patient, who is handicap with considerable health issues which he was born with, and his parents had been to healthcare facility to receive COVID vaccination. Returning they had traveled in order to arrive at their residence. The decedent had asked to be dropped off close to parents home. The parents arrived at the residence and after waiting ten to fifteen minutes walked searching for the decedent. He was located unresponsive and 911 was initiated." "1304689-1" "1304689-1" "Blood clot" "1306318-1" "1306318-1" "Went back to sleep and never woke up; Arm soreness; Feeling bad; very flushed/looked red; very tired/fatigue/nappy women taking a lot of naps; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Went back to sleep and never woke up) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C2117) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Neurofibromatosis, type 2 (acoustic neurofibromatosis) (Diagnosed at age 11, had tumor on nerves and all over body.), Blindness (All blind in left eye), Allergy NOS (unspecified allergy), Walker user and Feeding tube user. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced DEATH (Went back to sleep and never woke up) (seriousness criterion death), PAIN IN EXTREMITY (Arm soreness), VACCINATION COMPLICATION (Feeling bad), FLUSHING (very flushed/looked red) and FATIGUE (very tired/fatigue/nappy women taking a lot of naps). The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PAIN IN EXTREMITY (Arm soreness), VACCINATION COMPLICATION (Feeling bad), FLUSHING (very flushed/looked red) and FATIGUE (very tired/fatigue/nappy women taking a lot of naps) outcome was unknown. The patient was on a feeding tube, lived independently but had a caretaker who came in every day. The patient had long list of medications for her conditions but concomitant medications were not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. Regarding the events of Pain in extremity, Fatigue, Flushing, Vaccination related malaise, based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, regarding the event of Death,Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Regarding the events of Pain in extremity, Fatigue, Flushing, Vaccination related malaise, based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, regarding the event of Death,Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1306337-1" "1306337-1" ""Patient death certificate lists ""natural"" causes, with the Immediate Cause of Death of Cardiopulmonary Arrest."" "1306733-1" "1306733-1" "On March 2, he woke up feeling bad and had a fever of 102.7. He took tylenol and liquids all day and the fever came down to around 100. The next morning he woke up complaining of excruciating pain in his left arm (site of the injection). He couldn't stand to have anything touch it, couldn't move it and couldn't sleep because of the pain. The next morning he woke up very weak, wasn't able to speak clearly, wasn't making sense. He had a telemedicine appointment scheduled that morning for another matter. The doctor took one look at him and said we should have him evaluated asap. I took him to the emergency room at Hospital. They did some tests and said he was septic and immediately put him into the ICU. He was started on IV antibiotics while the blood cultures were growing out. It was determined that the bacteria was Strep G but they were unable to identify the source. He was put on a ventilator and an echo cardiogram was done. It was believed that the source of the infection was his pacemaker and I was told the pacemaker would have to be removed. They couldn't do it at that hospital. He was transferred to another hospital. The doctors at that hospital determined the pacemaker was not the source. It was believed by some doctors that the source of infection was the injection site. The infection was cleared from his body and the ventilator was removed after 2 weeks. He lived another 2 weeks but never was able to recover. Until the day he was put on paliative care, he expressed pain in the arm where he had received the vaccination. He died at 5:30 a.m. on April 1, 2021." "1306869-1" "1306869-1" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306940-1" "1306940-1" "Hospitalized and died due to COVID-19 after being fully vaccinated." "1306986-1" "1306986-1" "Patient expired of probable aneurysm at Hospital on 5/10/2021" "1307516-1" "1307516-1" "Hospitalized and died due to COVID-19 after being fully vaccinated. From vital records: ACUTE RESPIRATORY FAILURE WITH HYPOXIA, PNEUMONIA DUE TO COVID-19" "1307636-1" "1307636-1" "diabetic ketoacidosis on 5/8/21" "1307637-1" "1307637-1" "Patient received dose 1 on 2/12/2021 and dose 2 on 3/15/2021 from community pharmacy. Tested positive on 4/7/2021. Hospitalized for COVID on 4/19/2021. Discharged on 4/29/2021 to hospice. Passed away on 5/1/2021." "1307657-1" "1307657-1" "Death by suicide." "1307897-1" "1307897-1" "The decedent experience nausea, headache, and chest pain approximately 72 hours after receieving her second shot. She was found deceased later that day." "1308207-1" "1308207-1" "#2 Moderna Vaccine given on 4/20/21 On 5/7/21 patient became SOB before syncope to cardiac arrest, event was witnessed and CPR started immediately. Patient expired 45 min later at Medical Center." "1308208-1" "1308208-1" "Patient died from methamphetamine/opiate overdose" "1309418-1" "1309418-1" "Patient started 18-24 hours with loss of strength- inability to bear weight, and confusion with inability to communicate- both expressive and receptive, moaning and complete loss of awareness. The initial episode lasted approximately 4 hours. These episodes repeated for the next 3 days. She was taken to the Emergency Room by ambulance 3 days after the vaccine and a workup was completed. It was negative at the time of exam. She did have a mild anemia, but CT and laboratory work were otherwise negative. She had recovered strength and her memory. Later that evening she was again unresponsive except to painful stimuli and was like that over night. She was fatigued but was repulsive the next day. She never gained her full strength back. Over the next 4 weeks, she had progressively more of the periods of unresponsiveness and amnesia that stayed progressively longer and recovery was even less in-between the periods of unresponsiveness. She was placed on Hospice Care and succumbed on March 9, 2021, 1 month after her first vaccine." "1309766-1" "1309766-1" "Pt. developed emesis, vomiting blood afternoon after covid vaccine. She died within a few minutes. Resuscitation not attempted due to DNR status. Had recovered from covid months before." "1310067-1" "1310067-1" "Death - Within 24 hours of receiving the vaccine the patient died." "1310163-1" "1310163-1" "Patient died at nursing home facility. Patient had COVID back in 09/2020." "1310174-1" "1310174-1" "Death on 2 May 2021" "1310197-1" "1310197-1" "Patient presented to the ED on 4/2/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Patient presented to the ED on 4/9/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. He also presented to the ED on 4/21/21. He died on 4/24/21." "1310308-1" "1310308-1" "Patient hospitalized on 4/15/2021 after being fully vaccinated. Tested positive on 4/19/2021. Patient died on 4/27/2021." "1310493-1" "1310493-1" "The son came on 05/06 to receive the 2nd dose of Pfizer vaccine and informed us that his mother passed away on 04/18 after 3 days of post vaccination. A home hospice patient with Stage 5 Chronic kidney disease and Stage 4 COPD (Oxygen dependent) came in on 04/15 around 4:30 pm to receive a first dose of Pfizer. After 15 mandatory waiting in the pharmacy, she went home. Around 5:00 pm, patient told her son that she is feeling nauseated. Hospice nurse was contacted. On 4/16, patient experienced hallucination. She told her son that her fingers were disappeared. Hospice nurse was contacted. Please note that vaccine adverse event is not clearly related to vaccine, since patient was on hospice, stage 5 CKD and stage 4 COPD." "1310557-1" "1310557-1" "Cardio respiratory arrest. During rounds, patient was found without vital signs" "1310622-1" "1310622-1" "Developed symptoms around 4/25, presented to ED with complaints of chest pain and something being stuck in his throat. Subsequently died on 4/27." "1310651-1" "1310651-1" "Patient received Moderna vaccine 3/2/2021 0.5 ml LD IM Lot: 029L20A and Moderna vaccine 3/30/2021 0.5 ml LD IM Lot: 019B21A. The patient was exposed to an infected person with Covid about 1 week after her second vaccine. She was admitted to the ICU with severe covid on 4/13/21. She was eventually transitioned to comfort care and died on 5/6/2021." "1310681-1" "1310681-1" "Cardiac arrest." "1310729-1" "1310729-1" "Patient stopped breathing five days after the vaccine (5/29/21) He was taken to Hospital by paramedics and was put on ventilator in Intensive Care. They took him off the ventilator and he died 6 days after (5/5/21)." "1310799-1" "1310799-1" "Died of respiratory arrest." "1310855-1" "1310855-1" "Pneumonia." "1310861-1" "1310861-1" "Cardiac Arrest, Death" "1311196-1" "1311196-1" "FEVER COUGH FATIGUE HEADACHES" "1311276-1" "1311276-1" "Pneumonia due to COVID-19 virus ED to Hosp-Admission Discharged 4/14/2021 - 4/22/2021 (8 days) Last attending ? Treatment team Maxillary fracture Principal problem Final Summary for Deceased Patient Admission Date: 4/14/2021 Discharge Date: 4/22/2021 Final Diagnosis Principal Problem: Maxillary fracture (CMS/HCC) Active Problems: Pneumonia due to COVID-19 virus Demand ischemia (CMS/HCC) Dyslipidemia Essential hypertension Acute kidney injury (CMS/HCC) Glomerulonephritis, IgA Lactic acidosis Septic shock (CMS/HCC) Cytomegalovirus (CMV) viremia (CMS/HCC) Acute respiratory failure with hypoxia (CMS/HCC) Left femoral vein DVT (CMS/HCC) Malnutrition (CMS/HCC) Hypothermia DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Hypoxia [R09.02] Acute respiratory failure with hypoxia (CMS/HCC) [J96.01] Fall, initial encounter [W19.XXXA] COVID-19 [U07.1] COVID-19 virus infection [U07.1] Hospital Course Patient is a 72-year-old female with past medical history of hypertension, hyperlipidemia, recent hospitalization due to CMV viremia and an AKI and myelosuppression. Who presented to the emergency room after a fall in her house on 4/14. She had significant face pain and was hypoxic with an O2 saturation of 68% on room air on presentation. She was then found to be Covid positive. Initially admitted to the medical floor however required increasing amounts of oxygen and was ultimately transferred to the ICU on 4/16. She was maintained on nonrebreather oxygen until the evening of 4/21 when she was intubated and increasing vasopressor requirements. Given her worsening condition, her husband elected to palliatively extubate and pursue comfort care. Time of death was 10:02 AM on 4/22/2021. Disposition of the body: morgue" "1311327-1" "1311327-1" "I63.9 - Acute CVA (cerebrovascular accident)" "1311363-1" "1311363-1" "Developed a cough after an unknown amount of time. Ultimately died on 5/12/21 at 1631 hours." "1311665-1" "1311665-1" "Subject suffered a massive heart attack while mowing the law . May be attributable to the Covid vaccine as the subject had been to the cardiologist prior to both vaccine and EKG and Stress test were perfectly normal" "1311693-1" "1311693-1" "Patient was giventhe Janseen covid vaccine on 5/5. Apparently the patient 6 days later was reportedly aggitated had hallucinations and trouble breathing. The patient proceeded to lay down to rest. The patient never awoke." "1311975-1" "1311975-1" "After my father received the second COVID vaccination he started complaining of headaches. He had lung cancer, but he was in good condition. Within weeks his health deteriorated and when we bought him for a scan the beginning of March he had two small brain bleeds. The cancer had spread to the brain and he had a mass. They put a shunt in on March 18th because they said he had fluid, and this was the only treatment. Ten days later he was back in the hospital and after a week we had to take him home on hospice. I think the vaccine could of escalated his cancer this rapidly. Especially because he had two brain bleeds." "1312036-1" "1312036-1" "Death" "1312219-1" "1312219-1" "Patient was feeling fatigue, unwell the night after getting the vaccine. The next day he stayed home, did not go to work as he was not feeling well. Two days after getting the vaccine, he had trouble breathing, an ambulance was called and he was pronounced deceased hours later. He had a heart attack." "1312456-1" "1312456-1" "Death. While driving patient passed out and was found by County Sheriffs Office. EMT was called and could not save patient. M.E. Declared patient dead at 7:20 PM on May 4, 2021" "1312481-1" "1312481-1" "My husband stated that he did not feel good after the vaccine the next morning, later he went to pick up hay and died on someone's property from the acute coronary syndrome." "1312649-1" "1312649-1" "On 5/12/2021 patient was complaining of generalized body aches, later in the morning when going to a pain management clinic, patient subsequently became nauseous and vomited several times during the course of the day. Reportedly had episode of dark emesis as well. Patient was then found by family around 10pm unresponsive, pale, w/ difficulty breathing, EMS was called, patient was found to be in cardiac arrest in asystole. Patient possibly had v-fib during transport and was defibrillated twice before becoming asystolic again. Patient was subsequently pronounced dead in the Emergency Department on 5/12/21 at 11:04pm." "1313560-1" "1313560-1" "I21.3 - STEMI (ST elevation myocardial infarction) (CMS/HCC)" "1313575-1" "1313575-1" "J18.9 - Left lower lobe pneumonia I48.91 - Atrial fibrillation with RVR (CMS/HCC) N17.9 - Acute kidney injury (CMS/HCC) N30.01 - Acute cystitis with hematuria" "1313585-1" "1313585-1" "K72.90 - Hepatic encephalopathy (CMS/HCC)" "1313593-1" "1313593-1" "death" "1313600-1" "1313600-1" "K92.2 - Acute lower GI bleeding D64.9 - Anemia Z79.01 - Anticoagulated" "1313673-1" "1313673-1" "4/2/21 Vaccination #2 given, 4/3 fatigue, decreased appetite and energy, increased confusion. 4/6/21 PCP ordered CT angiogram of chest-no PE but suspicious infiltrates in upper lung for Covid-19 pneumonia. DVT negative. 4/7/21 Hospital ER CT of head/neck -no stenosis, no intercranial abnormalities, Covid test negative, RIDP positive for rhinovirus and entrovirus. Neuro consult, full admit. Treated with Rocephin, zithro and oxygen, eventually vented then transferred to another location on 4/11/21. Acutely ill and in shock, Extensive workup showed no other identifiable source of infection. Died 4/18/21." "1313691-1" "1313691-1" "Following the vaccination patient didn?t feel well. Fever, chills, cold symptoms, incredibly irritable. 5/1 she awake with a terrible headache which continued all day. Around 9:30 pm she laid down and shortly after was unable to move her body. 5/4/21 at 4:19pm her time of death was called. Cause; brain death due to aneurysm and stroke due to passing blood clot in brain." "1313803-1" "1313803-1" "Received vaccine on 5-6-21. On 5-8-21, complained of headache, bloating, fever, and constipation. Last seen alive at 9 PM on 5-8. Found dead at home at 7 PM on 5-9." "1313837-1" "1313837-1" "He died 24 hours later after receiving the vaccine!" "1313860-1" "1313860-1" "patient received Covid 19 vaccine Johnston and Johnston on 03/13/2021, became positive for covid on 04/13/2021, went to hosp, admitted" "1313888-1" "1313888-1" "Health Department was notified of patient death. Health Department was not informed of cause of death. VAERS report completed." "1313922-1" "1313922-1" "PT NO SHOW FOR APPT 5/11 FOR 2ND DOSE -CHECK OF agency system SHOWS PT REPORTED DECEASED 5/14- CHECK OF database SHOWS PT FOUND DECEASED AT HOMEN 5/14/21- AUTOPSY Completed" "1313931-1" "1313931-1" "ED Discharged 4/4/2021 (4 hours) Hospital Emergency Department Last attending ? Treatment team Generalized weakness +4 more Clinical impression Weakness - Generalized ? Chills Chief complaint ED Provider Notes Emergency Medicine Expand AllCollapse All HPI Chief Complaint Patient presents with ? Weakness - Generalized ? Chills HPI 79-year-old female, history of COPD for which she wears oxygen at night and as needed, also with a history of leukemia and obesity who presents to the ED complaining of generalized body aches, fevers up to 103, feeling generally unwell and weak, poor sleep, onset 3 to 4 days ago. Patient reports that she received her second COVID-19 vaccine approximately 1 week ago. Tolerated this without any particular symptoms. She has had 2 days of watery/nonbloody diarrhea. Does admit to nausea with several episodes of vomiting earlier today. She is denying any particular abdominal pain. Does believe she felt her urine burning earlier today but has had no gross hematuria. Denies any flank pain. No ill contacts although her husband has been at home with a slight cough. Patient does have a cough presently but it is nonproductive. She is denying any particular chest pain or subjective shortness of breath. No rash or unusual lower extremity pain, swelling, or redness. ED to Hosp-Admission Discharged 4/6/2021 - 4/17/2021 (11 days) Hospital Last attending ? Treatment team Severe sepsis (CMS/HCC) Principal problem Discharge Summary Internal Medicine Inpatient DeathSummary BRIEF OVERVIEW Admission Date: 4/6/2021 Discharge Date: 4/17/2021 DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Patient is an 79 y.o. female morbidly obese with past medical history of chronic lymphocytic leukemia follow-up that was initially scheduled oncology follow-up for April 7 now postponed to the next 2 weeks, COPD on 2 L oxygen support at home, GERD, depression and anxiety. She was recently seen in the ED on April 4, 2021 with complaint of shortness of breath, nonproductive cough, fever, chills, nonbloody diarrhea, vomiting and weakness and subsequently diagnosed with COVID-19. She had however received a second dose of COVID-19 a week before and was discharged home due to lack of significant findings on imaging chest x-ray and lack of requirement for higher oxygen support. She presented to the emergency via EMS for evaluation of progressive shortness of breath with associated with fever, chills, headache, persistent shortness of breath, cough productive of thick clear sputum, nausea, vomiting and diarrhea. She denies abdominal pain, chest pain, or dizziness. Denies recent antibiotic usage or recent travel. Apparently, she thought she was getting better upon discharge after being kept for about 12 hours in the last ED visit, however she was not feeling well after going to bed last night and asked the husband to call 911. Upon EMS arrival patient was saturating in the 80s and in respiratory distress. She received 1 DuoNeb and was eventually placed on 10 L oxygen support. She was noted to be in significant respiratory distress during speech. Hospital Course Patient was admitted to hospital due to shortness of breath, and was found to have severe sepsis on presentation due to COVID-19 pneumonia. She had evidence of acute on chronic hypoxic respiratory failure as well. She was started on IV antibiotics, as well as remdesivir and Decadron at high dose. Unfortunately she continued to have clinical deterioration, and ultimately required high flow oxygen therapy. She was then transferred to the ICU, and ultimately required intubation due to severe profound ongoing hypoxia despite optimal medical treatment. She did not respond to remdesivir or steroids or antibiotics. Post intubation, she also developed acute renal failure during the course of her admission. Multiple discussions were had throughout the hospitalization regarding goals of care, and initially patient and family wish to be continually aggressive. She received full medical treatment, including life support, with minimal improvement. Despite being on ventilator for roughly 5 days, she continued to have severe hypoxia. She was proned, and was unable to sustain oxygen saturations when supine even for short period. Her renal function continued to decline as well, and at that point discussion was had with family regarding goals of care again. They were explained that symptoms continue to be persistent, and her illness continues to progress despite aggressive medical therapy. Ultimately decision was made to not pursue dialysis, and to allow the patient to be kept comfortable and pass away naturally from this infection. She was terminally extubated on 4/17 and passed away at 11:16 AM due to COVID-19 and acute on chronic hypoxic respiratory failure. Operative Procedures Performed X-ray Abdomen 1 View Result Date: 4/13/2021 Narrative: Single view portable abdomen INDICATION: Nasogastric tube placement, encounter initial Supine portable view of the lower chest and abdomen demonstrates nasogastric tube with tip and side-port in the gas-distended stomach. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/16/2021 Narrative: XR CHEST 1 VW IMPRESSION: No significant change from the previous examination. END OF IMPRESSION: INDICATION: Worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/13/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central venous catheter are unchanged. Right-sided chest tube is unchanged. There is a small left pleural effusion. There is diffuse bilateral hazy airspace opacification. No change from prior. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/15/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Tubes and lines as described. Small left effusion. Unchanged patchy bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/14/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central venous catheter are unchanged. The right-sided chest tube is unchanged. There is no pneumothorax. There is a small effusion. There is diffuse bilateral patchy airspace consolidation. There is no significant change. Cardiac silhouette is normal size. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View - Daily Result Date: 4/14/2021 Narrative: Chest radiograph HISTORY: Covid 19 infection. Mechanical ventilation. Comments: Frontal radiograph of the chest was obtained and compared to the prior study dated 4/13/2021. The heart is at the upper limits of normal. The mediastinum is within normal limits. Interstitial alveolar opacities are demonstrated bilaterally consistent with pneumonia. There is an endotracheal tube with the distal end approximately 4.3 cm from the carina. Nasogastric tube is noted directed towards the stomach. There is a right jugular central catheter. A right-sided pigtail catheter is seen. IMPRESSION: 1. Persistent bilateral interstitial alveolar opacities consistent with pneumonia. 2. Lines and tubes in place as described. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View, Portable Result Date: 4/14/2021 Narrative: PROCEDURE INFORMATION: Exam: XR Chest Exam date and time: 4/13/2021 11:46 PM Age: 79 years old Clinical indication: Hypoxia; Covid+ TECHNIQUE: Imaging protocol: XR of the chest. Views: 1 view. COMPARISON: DX XR CHEST 1 VW 4/13/2021 10:50 AM FINDINGS: Tubes, catheters and devices: Endotracheal tube tip located at the level of the carina. Pigtail drainage catheter tip remains superimposed over the lateral right mid lung zone. Nasogastric tube enters the stomach but tip not included on the image. Tip of right internal jugular central venous catheter in SVC. Cardiac leads superimposed over the chest bilaterally. Lungs: Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new consolidation and/or atelectasis in the left lung base. No significant interval change in scattered patches of ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. Pleural spaces: Small right apical pneumothorax (12 mm). New small left pleural fluid collection. No right pleural fluid collection. Heart/Mediastinum: Stable cardiac silhouette Bones/joints: Unremarkable for age. IMPRESSION: 1. Endotracheal tube tip located at the level of the carina. 2. Pigtail drainage catheter tip remains superimposed over the lateral right mid lung zone. 3. Small right apical pneumothorax (12 mm). 4. Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new consolidation and/or atelectasis in the left lung base. 5. New small left pleural fluid collection. 6. No significant interval change in scattered patches of ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD X-ray Chest 1 View, Portable Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT INDICATION: verify placement of right chest tube. Encounter: Subsequent. TECHNIQUE: AP portable erect projection of the chest is acquired. COMPARISON: Earlier today. FINDINGS: The left thoracostomy tube terminates near the lateral right midlung. No other change. Extensive pulmonary infiltrates. Stable life support lines. The previous right pneumothorax has predominantly resolved, only a thin crescent of air caps the right apex. END OF IMPRESSION: This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View, Portable Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Lines as described. There is a small right-sided pneumothorax. Unchanged bilateral airspace consolidation. END OF IMPRESSION: INDICATION: verify placement of CVC and post intubation. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/11/2021. FINDINGS: There is a right IJ central venous catheter. Tip is projected over the SVC. There is a small right apical pneumothorax. Endotracheal tube terminates 2 cm superior to the carina. The nasogastric tube passes beneath the diaphragm. Multifocal areas of patchy airspace consolidation bilaterally. Findings do not appear significantly changed from prior. The cardiac silhouette is normal size. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/11/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Mildly worsened bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening respiratory failure, covid pneumonia worsening respiratory failure, covid pneumonia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/8/2021. FINDINGS: The left costophrenic angle is partially excluded. The lungs are adequately expanded. There are large areas of patchy airspace consolidation bilaterally. Findings have mildly increased in severity. There is no effusion or pneumothorax. The cardiac silhouette is mildly enlarged. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/8/2021 Narrative: XR CHEST 1 VW PORT INDICATION: Worsening hypoxemia, Covid pneumonia. Encounter: Initial. TECHNIQUE: AP portable erect projection of the chest is acquired. COMPARISON: 4/4/2021. FINDINGS: Scattered pulmonary infiltrates is developed bilaterally, greatest in the right upper and right lower lobe. No change in the heart, mediastinum, or bony thorax. IMPRESSIONS: Developing pulmonary infiltrates. END OF IMPRESSION: This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View - Portable Result Date: 4/4/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: No evidence of acute pulmonary disease. END OF IMPRESSION: INDICATION: SOB, weak, cough SOB, weak, cough. TECHNIQUE: Portable AP projection of the chest is acquired. COMPARISON: 6/5/2020 FINDINGS: Heart size appears unremarkable. There is mild prominence of pulmonary arteries. This is stable. There is no focal consolidation or effusion. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. Transthoracic Echo (tte) Complete Result Date: 4/11/2021 Narrative: Gender: Female Age: 79 Procedure Date: 4/11/2021 10:19 AM Study Quality: Fair Ht / Wt / BSA: 66.00 in / 218.00 lb / 2.07 m2 Heart Rate: 77 bpm BP: 181 / 81 mmHg Indications: Arrhythmia Transthoracic 2D, Color Flow, and Doppler Echocardiogram Conclusions: The left ventricle is normal in size. Ejection Fraction 55% (normal range 50-70%). All wall segments showed normal motion. Mild concentric LVH. Trivial aortic regurgitation. No additional significant valvular abnormality. No prior study for comparison. Presentation and History: Indication: The patient presents for evaluation of arrhythmia. The patient has a history of obesity and chronic obstructive pulmonary disease. Findings: Procedure Information: Contrast agent, definity, is being given per protocol without apparent complications. Due to technical limitations in the assessment of the left ventricle, imaging was performed after the administration of intravenous Definity echocontrast, as per protocol. Left Ventricle: The left ventricle is normal in size. There is mildly increased left ventricular wall thickness. The left ventricular systolic function is normal. The visually estimated ejection fraction is 55% (normal range 50 70%). Wall Motion: All wall segments showed normal motion. Right Ventricle: RV not well visualized. RV grossly normal in size and function by subcostal view. Atria: The left atrium is borderline dilated. The right atrium is normal in size. Aortic Valve: Sclerotic appearing aortic valve with no significant aortic stenosis. Trivial aortic regurgitation. Mitral Valve: There is trace mitral valve regurgitation by color flow and doppler analysis. There is no mitral valve stenosis by color flow and doppler analysis. Pulmonic Valve: There is no evidence of significant pulmonic valvular stenosis or insufficiency by color flow and doppler analysis. Tricuspid Valve: There is trace tricuspid valve regurgitation by color flow and doppler analysis. Great Vessels: All visible segments of the aorta are normal in size. Venous: The inferior vena cava is normal in size and collapses greater than 50% with inspiration. Pericardium/Pleural: There is no evidence of pericardial effusion. Prior Study Comparison: No prior study for comparison. Measurements: Left Ventricle: IVSd: 0.85 cm (0.6-0.9/0.6-1.0) LVIDd: 5.10 cm (3.9-5.3/4.2-5.9) LVIDd Index: 2.46 cm/m2 (2.4-3.2/2.2-3.1) LVIDs: 3.56 cm (2.0-3.6) LVPWd: 0.95 cm (0.7-1.1) Ao Root: 3.30 cm (2.1-3.5) LV Mass: 203.25 g (67-162/88-224) LV Mass Index: 98.19 g/m2 (43-95/49-115) LVOT Diam: 1.90 cm (3.0+(-)1.3) LVOT Pk Vel: 0.91 LVOT Mn Vel: 0.63 LVOT VTI: 0.20 LVOT Pk Grad: 3.00 LVOT Mn Grad: 2.00 LVOT Diam: 1.90 LVOT Area: 2.84 MV Pk E: 0.66 MV Pk A: 0.66 E/A: 1.00 E'Medial: 5.33 E/E' Med: 12.30 E' Laterial: 10.60 E/E' Lat: 6.20 Mitral Valve: MV Pk E: 0.66 MV PK A: 0.66 MV Decel Time: 209.00 E/A: 1.00 E'Lateral: 10.60 E'Medial: 5.33 E/E' Med: 12.30 E/E' Lat: 6.20 PHT: 61.00 MVA PHT: 3.61 Decel Slope: 3.14 Aortic Valve: AoV Pk Vel: 1.65 AoV Mn Vel: 1.22 AoV VTI: 0.39 AoV Pk Grad: 11.00 Aov Mn Grad: 7.00 AVA Cont.VTI: 1.42 Tricuspid Valve: TR Pk Vel: 2.89 TR Pk Grad: 33.00 RA Press: 10.00 RVSP: 43.00 Great Vessels: Ao Root-2D: 3.30 cm (2.0-3.7) Ao Asc: 3.30 cm (2.1-3.4) Updated on 4/11/2021 5:10:04 PM with Status of Final electronically signed on 4/11/2021 5:10:04 PM with status of Final Ct Covid Chest Low Dose Without Contrast Result Date: 4/6/2021 Narrative: PROCEDURE INFORMATION: Exam: CT Chest Without Contrast; Diagnostic Exam date and time: 4/6/2021 4:21 AM Age: 79 years old Clinical indication: Cough and shortness of breath; Patient HX: +covid; Additional info: Cough. Shortness of breath, covid TECHNIQUE: Imaging protocol: Diagnostic computed tomography of the chest without contrast. 3D rendering (Not supervised by radiologist): MIP and/or 3D reconstructed images were created by the technologist. Radiation optimization: All CT scans at this facility use at least one of these dose optimization techniques: automated exposure control; mA and/or kV adjustment per patient size (includes targeted exams where dose is matched to clinical indication); or iterative reconstruction. COMPARISON: CT CHEST WO CONTRAST 3/8/2021 2:28 PM FINDINGS: Lungs: There are patchy peripheral ground-glass opacities which can be seen with atypical pneumonia. Pleural spaces: Unremarkable. No pneumothorax. No pleural effusion. Heart: No cardiomegaly. No pericardial effusion. Aorta: Atherosclerotic changes of the aorta. Lymph nodes: Unremarkable. No enlarged lymph nodes. Bones/joints: Unremarkable. No acute fracture. Soft tissues: Unremarkable. IMPRESSION: Patchy peripheral ground-glass opacities which can be seen with atypical pneumonia. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD" "1313933-1" "1313933-1" "Dizzy weak breathing a lil heavy" "1314069-1" "1314069-1" "DEATH" "1314135-1" "1314135-1" "PATIENT'S SPOUSE REPORTS PATIENT WAS ADMITTED TO HOSPITAL ON 031421 FOR SEVERE SEPSIS WITH ACUTE ORGAN DYSFUNCTION, ACUTE METABOLIC ENCEPHALOPATHY, BILATERAL PNEUMONIA AND ACUTE HYPOXEMIC RESPIRATORY FAILURE THEN PASSED AWAY ON 3/27/21." "1314186-1" "1314186-1" "? Sore Throat ? Cough ? Abdominal Pain Diarrhea Sinus congestion" "1314214-1" "1314214-1" "after first dose of the Moderna vaccine she became very ill and was hospitalized on 3/13 - 3/23. After 2nd dose of the vaccine she seemed to be doing ok but gradually declining and less and less to be able to do for herself, it slowed down greatly after the vaccine. There was a gradual decline, but on May 2 she woke up and was semi conscious and said she thought she was dyeing and was in pain and discomfort and was taken into the ER and she was DC'd and started hospice and two days before she passed she got the hospice care. My mother was in a semi coma and could not communicate properly. Many test were done at the hospital during her stay even though they never identified what the cause was. At the last ER visit they diagnosed her with pneumonia" "1314224-1" "1314224-1" "Patient was vaccinated with Moderna Covid Vaccine on Thursday, May 6, 2021. We were informed the following Monday that the patient had passed away unexpectedly on Friday, May 7, 2021. Family members did not reach out to us to ask any questions or to let us know what had happened. We do not know that this patient passed away due to vaccination with the Moderna Vaccine." "1314308-1" "1314308-1" "Fever and respiratory problems." "1314342-1" "1314342-1" "He died. He got the shot then several hours later he was found DEAD in his sleep. We are still awaiting coroners reports." "1314352-1" "1314352-1" "Vomiting." "1314395-1" "1314395-1" "Fever, body aches, respiratory difficulties, had a cardiac arrest." "1314461-1" "1314461-1" "Passed away in his sleep 28 hours after vaccine. No illness prior." "1314511-1" "1314511-1" "had severe headaches that started a week after his 2nd covid shot., he was seen by NP on 2/25/21, was instructed to take ibuprofen short term, labs were drawn and were normal. On 3/8/21 suffered tonic clonic seizures, was unresponsive and taken to ER by EMS. remained unresponsive following the seizures and was placed on hospice care and died on 3/12/21." "1314513-1" "1314513-1" "Low arterial pressure, low saturation pressure." "1314542-1" "1314542-1" "Death" "1314603-1" "1314603-1" "Illness set in either the day of the vaccination being administered or the day after, according to phone records. Signs include: nausea/vomiting, back aches, fever, chills, passing out, lack of appetite, extreme fatigue and low energy, bitter taste in the mouth and water tasting bitter." "1314742-1" "1314742-1" "Patient's body was found on May 1st. Since the shot , he was complaining of tinnitus, sore legs, dizziness (passed our several times), loss of bowel control, and unable to maintain a stream of thought, which are stroke symptoms. He has had surgery for blood clots in the past. He seemed to get worse in the weeks following the Jansen shot." "1314761-1" "1314761-1" ""Patient DOD 4/19/21 Death Certificate Line A ?Adverse effect of Covid19 vaccine-5 day interval onset and death? Line B ?Anorexia nervosa? Line C ?Recurrent Major Depressive Disorder? Received her second Moderna dose from our Mobile team on 4/14/21 Since then I spoke with Dr. (Mobile); clients PCP, several times regarding this event. His nurse got an email from client on 4-12-21 that client had vaccination planned on 414 and may need to reschedule medical appointment planned 4-16 if she felt bad. The client was encourage to get vaccine and to keep appointment for Friday April 16th. The client emailed the office at approx 0300 Friday morning April 16 to cancel appointment because she felt to poorly from vaccination shot to come in (fevers; body aches). Dr next heard from police officer on Monday April 19th that she was found dead in her home. He requested the Medical Examiner (ME) evaluate but this request was denied. The client lived alone. Dr contacted family members but they did not have much interaction with the client and had no significant information to contribute. Dr said he speculates that the patients underlying anorexia nervosa likely put the client in a critical nutritional deficiencies / electrolyte imbalance condition and the side effects of vaccination were too much. He felt compelled to complete the death certificate as he did because the ME declined the case. From vaccine mobile team notes: team was there2-3:30pm. All the answers to the health screening questions for the patient were ""no"" except for ""have you ever had a severe allergic reaction to something?"" To that question the answer was ""yes. Immunization Information System record - lot # is underlined: Coronavirus COVID-19, mRNA,LNP-S,PF, 03/17/2021 1 of 2 100 mcg/0.5mL Full 022M20A IM LA Coronavirus COVID-19, mRNA,LNP-S,PF, 04/14/2021 2 of 2 100 mcg/0.5mL Full 006B21A IM LA"" "1314801-1" "1314801-1" "Death: CHRONIC COMBINED SYSTOLIC -CONGESTIVE- AND DIASTOLIC -CONGESTIVE- HEART FAILURE, COVID-19" "1314846-1" "1314846-1" "5/07 general ill feeling; runny nose, watery eyes. continued until 5/10. Wife denied fever or cough. continued until 5/10. 5/11 at work, patient collapsed. Was awake but non-responsive, breathing on his own, vomited shortly before EMS arrived. EMS arrived, patient stopped breathing, was bagged until arrival at hospital where he was intubated. 5/12 Patient was extubated and died in early AM 5/13. Medical records state cerebral brain hemorrhage." "1314864-1" "1314864-1" "She was found dead in her home one week after the injection. She died the day of the injection according to the coroners office. There was blood on the bed and down her chest." "1314985-1" "1314985-1" "The 2nd dose of Moderna was administered on 05/12/2021 at 9:40 am, patient waited for 15 minutes he was feeling well and left the pharmacy at 09:50 am. The patient-caregiver contacted us at 12pm on 05/13/2021 stating that the patient passed away today. She stated he was feeling fine yesterday and had his breathing treatment at night and in the morning he didn't wake up." "1314994-1" "1314994-1" "Heart Attack May 7, 2021, Death May 8, 2021" "1315198-1" "1315198-1" "My Mom had headache, body pain, chills and fever and very weak on the 29, and 30 of April. On May the 3,2021 I found my Mom Dead in Bed. My Mom was a very active lady for her age." "1315815-1" "1315815-1" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1316583-1" "1316583-1" "Couldn't Breath, Died due to Blood Clots on Lungs, Bilateral Pulmonary Embolism, Bleeding on the Brain." "1316645-1" "1316645-1" "Patient received dose 1 of the pfizer covid vaccine on 1/22/21 and dose 2 on 3/4/21. Patient was diagnosed with COVID on 4/22 at outside clinic after presenting with about a week of cough, nausea and fatigue. On 5/2/21 she presented to our emergency department with persistence of the above symptoms and hypoxia to the 70s on room air and again tested positive for COVID. Initially required BIPAP then HFNC. She was treated with broad spectrum antibiotics for 7 days and dexamethasone for 10 days. She was offered tocilizumab and remdesivir but refused. She clinically improved and was weaned down to 2L NC w/saturation of 93%. However on 5/13 she acutely desaturated and was found pulseless. Patient was DNR/DNI so was pronounced dead." "1316707-1" "1316707-1" "Patient became suddenly short of breath, unresponsive, attempted CPR unsuccessfully and patient expired." "1316960-1" "1316960-1" "ADMITTED TO HSOPITAL, EXPIRED" "1316962-1" "1316962-1" "Cause of Death: SENILE DEGENERATION OF THE BRAIN, CHRONIC SACRAL PRESSURE ULCER, DEPRESSION" "1317011-1" "1317011-1" "death" "1317043-1" "1317043-1" "Spontaneous Cortical Non aneurysmal subarachnoid hemorrhage with diagnostic suspicion but not confirmation of cortical venous thrombosis, and spontaneous ventricular tachycardia." "1317164-1" "1317164-1" "Upon reviewing patient's need for 2nd dose, we learned that patient died on 4/25/21." "1317203-1" "1317203-1" "Started having lain in right home on 4/15/2021. On 4/16/2021 complained more about right hip, said feels like he got hit by a truck, and that he felt like he was starting to get a cold. Then he died the night of 4/16/2021." "1317355-1" "1317355-1" "deatb" "1317359-1" "1317359-1" "death" "1317367-1" "1317367-1" "U07.1, J12.82 - Pneumonia due to COVID-19 virus U07.1, J96.00 - Acute respiratory failure due to COVID-19" "1317378-1" "1317378-1" "This 99 year old female received the Covid shot on 4/9/21 and died on 5/8/21." "1317389-1" "1317389-1" "Z79.01 - Chronic anticoagulation J18.9 - Left lower lobe pneumonia R29.6 - Multiple falls A41.9 - Sepsis (CMS/HCC) R09.02 - Hypoxemia J44.1 - COPD exacerbation (CMS/HCC) I50.9 - CHF exacerbation (CMS/HCC) R79.89 - Elevated brain natriuretic peptide (BNP) level" "1317401-1" "1317401-1" "Upon reviewing patient's need for 2nd dose of Moderna, patient's power of attorney informed me that the patient passed away on 5/11/21 without any further information disclosed." "1317417-1" "1317417-1" "Cardiac arrest at home Patient found down at home by son; son found patient drooling; initially thought she was sleeping but found her with her eyes open sitting in a recliner unresponsive at home. EMS arrived and CPR was initiated; patient was intubated and transferred to local hospital. CPR was performed approximately 10 minutes. Per family, patient was in normal state of health prior to incident" "1317481-1" "1317481-1" "Received vaccine 1/27/21, passed away in his sleep 1/29/21." "1317744-1" "1317744-1" "Death" "1318046-1" "1318046-1" "Per report from family, pt had been feeling unwell for 3-4 weeks prior to event on 4/27 where he collapsed and suffered a cardiac arrest. No interventions were performed until EMS arrived 10-15 mins later (again, per family report). Pt was revived following CPR, and suffered a 2nd episode of cardiac arrest (possible in the ED). Pt was noted to have PEA at that time. Pt was intubated and vented in ICU. Pt was cooled x24 hours (unsure of protocol name) and rewarmed over 24 hours more. Pt was weaned from all paralytics, etc. Per RN reports, pt failed all neuro tests except R eye went from 3 > 2 mm (4/29 +). Pt was transitioned to comfort care on 4/30 and passed within 5 minutes." "1318152-1" "1318152-1" ""(Information gained secondhand from patient's close friend as patient was intubated and sedated at the time that potential relationship between events and vaccine administration recognized). 77 yo F with no known significant PMH (was independent in ADLs, active, line-danced twice/week) who developed nausea, headache, fatigue on first day after first dose of Moderna vaccine. Friend reports that patient complained of ""just not feeling right"" following vaccine administration. Complained of poor sleep, poor appetite, dyspepsia and began complaining of lower extremity swelling in the weeks following vaccine administration. Was no longer able to line-dance, etc. Was fatigued. Her friends became concerned and encouraged her to seek medical attention, patient reported that she had was prescribed ""water pill"" and told to ""lay off salt,"". Friends later found out that she had lied about doctor's visit and was self-medicating with over the counter ""water pills"" for all of the water weight she was gaining. Eventually developed worsening shortness of breath. Admitted to hospital on 5/4 with shortness of breath and worsening abdominal pain. Found to have systolic heart failure (EF 20-30%) and was in SVT. Also diagnosed with UTI and SMV thrombus. Grossly anasarcic on exam. Treated for heart failure with diuretic and for her UTI with antibiotics, was started on Heparin drip for SMV thrombus. Underwent left heart catheterization at OSH that was negative for significant CAD. Developed worsening septic shock and was transferred to our hospital for higher level of care. Unfortunately had ongoing decline, found to be fungemic. Eventually succumbed to her septic shock, passed away on 5/14/21. Patient had second dose of vaccine on 3/18/21 according to vaccine card in her purse. Friend states that because of symptoms she developed after first dose of vaccine, she was fearful of getting second dose. Friends insist that she was well before the vaccine---knee pain was limiting factor for her activity level, never shortness of breath. Of note, several friends tested positive for COVID on 2/11/21, the week prior to patient receiving her vaccine. Patient tested negative and reportedly got tested at frequent intervals and was always negative."" "1319357-1" "1319357-1" "Died of cardiac shock one week after second dose" "1320312-1" "1320312-1" "first dose on 21Jan2021 and second dose on 01Feb2021; passed away; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's wife). A male patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Feb2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced a terrible reaction. The patient passed away (death) on 09Apr2021. It was unknown if an autopsy was performed. The information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away" "1320378-1" "1320378-1" "DVT was twice as bad; death/natural process; This is a spontaneous report from a contactable Nurse reporting for reporter's husband. A 78-year-old male patient received bnt162b2 (reported as COVID vaccine), dose 2 via an unspecified route of administration on 20Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as 2nd dose, single (at the age of 78-year-old) for COVID-19 immunisation. Medical history included diabetes, Liver cirrhosis, thrombocytopenia, Kidney stone, sarcoidosis, blood pressure abnormal, high cholesterol, pacemaker and they putted the IVC filter for blood clot. Concomitant medications included insulin, simvastatin, hydrochlorothiazide and omeprazole (PROTONIX), all taken for an unspecified indication, start and stop date were not reported; and carvedilol (COREG) taken for blood pressure, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (Lot Number: EN6201; Expiration Date: 30Jun2021) on 27Feb2021 at the age of 78-year-old for COVID-19 immunization and experienced pulmonary embolism and deep vein thrombosis (DVT) on 12Mar2021, and went into the hospital 12Mar2021. Then the patient had the second COVID shot on 20Mar2021 and the reporter had taken him right back into the hospital couple days later because the DVT got twice as worst. The patient experienced DVT was twice as bad on an unspecified date in Mar2021, which required hospitalization on 22Mar2021. The patient underwent lab tests, he had lab tests on 22Mar2021 when he went in and he probably had them on 23rd and 24th of Mar2021. The reporter didn't know what all the lab tests were done in the hospital. The patient died on 12Apr2021. The reporter stated they put Reason of death as natural process because she sent him in the Hospice. An autopsy was not performed. The outcome of event DVT was unknown. The reporter considered there was a causal relationship, when he got his second COVID shot on 20Mar2021 and then he went back in the hospital on 22Mar2021 and the DVT was twice as bad.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported DVT. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death/natural process" "1320726-1" "1320726-1" "One week after receiving the injection, patient went into complete kidney failure. Patient died on May 14, 2021" "1321140-1" "1321140-1" "My mom, got her first Moderna shot on Feb. 4th, 2021 and developed trombosis in the legs about a week later. She went to the doctor, who at first didn't want to see her and told her to elevate her leg. Pt. had a scheduled eye appointment on Feb. 12th with an other doctor and when she asked if she had any other issues, pt. showed her her leg. The eye doctor immediately told her to go to urgent care. When she did she received blood thinners and started injections in her stomach for 5 days. Feb. 18th pt. suffered a mini stroke and went to the hospital emergency room. She was transferred over to another facility in the afternoon and kept overnight. She had a phone appointment with the Dr. on Feb. 24th and on the 26th she received a heart monitor to wear for 2 weeks. She also had a check up about her leg, which was still swollen. On March 4, pt. received her second Moderna shot and she was feverish and very tired for days and weeks after. By March 18th her condition didn't improve at all and in fact she was felling really bad over night, so on March 19th she was admitted again to the hospital. She was monitored and kept over night, but during the early morning she suffered a stroke and a heart attack and passed way the next day." "1321161-1" "1321161-1" "Patient was vaccinated on May 6,2021. On Friday May 14 ,2021 a relative of the patient report that the patient died on May 9,2021..She report that the patient doesn't take the prescriptions needed for a vascular condition he have and was suppose to received medicines by mail on tuesday before vaccination" "1321401-1" "1321401-1" "Pt presented with coffee ground emesis and acute st elevation myocardia infarction. She was DNR. She was admitted and expired in a few hours." "1321517-1" "1321517-1" "He did not told me about any symptoms. He just died the next day of the vaccine. Still today doesn?t know why he died. He appeared to be in good health." "1321835-1" "1321835-1" "Almost immediated weakness within 3 or four hours, collapsed the next day, repeated falls, taken to Emergency Room on Thursday, March 25, 2021--admitted to Heart Hospital with heart failure, lung failure ( no history of lung problems), and severe sepsis, placed on ventilator until Saturday, March 27, 2021. Died on March 28, 2021." "1321898-1" "1321898-1" "patient died aprox 1 week after the 2nd dose . presumed cause of death stated by son was GI bleed. Not confirmed to be caused by the vaccine. Autopsy not performed according to the son." "1322176-1" "1322176-1" "patient passed away ~24-48 hours after time of vaccination" "1322255-1" "1322255-1" ""At approximately 8 pm pt. sucked in a deep breath, head began to roll and he began twitching on the right side of his body. Pt. only has muscle function in the right side of his body due to his stroke damage. His wife immediately approached him in his chair and asked him what was wrong and all he was able to state was ""I don't know"" before loosing consciousness and stopping breathing. 911 was immediately called and due to his wife being frail herself she was not able to remove him from his wheelchair to perform any CPR. EMS arrived and begin performing CPR until the DNR papers for pt. were located. Medical examiner came to the home and stated she did not feel that an autopsy was needed even though family had told her NUMEROUS times that pt. had received his second Covid vaccine the day prior. He was pronounced dead by the medical examiner and taken directly to the funeral home due to the DNR papers being present."" "1322292-1" "1322292-1" "Complained of chest pain at 3:50 pm may 15th. He went and layed down across his bed was coherent and talking, suddenly passed out. 911 was called and chest compressions were started. Ambulance arrived his condition was 60/40 bp and heart rate of 40. Taken to hospital where he never recovered and passed away." "1322310-1" "1322310-1" "Death. Coroner said collapsed of unknown cause. Autopsy performed. Awaiting final report and toxicology report." "1322484-1" "1322484-1" "About a week after his first dose he developed a skin reaction at the injection site. Redness, swelling, itching. The affected area was about 10 inches by 6 inches. The day following the second dose of the vaccine he developed chills, sweats, aches, and a low grade fever. He also developed the same skin reaction. He had these symptoms for 2 days (Thurs and fri). By Saturday his condition was improving. Sunday was even better, Monday evening he died. He was 37 with no known medical issues. He just died out of nowhere." "1322807-1" "1322807-1" "Patient was seen by an outpatient provided and was referred to emergency department due to hypoxis and respiratory distress on 4/27/21. He was found to by COVID-19 positive at that time. He was admitted to the hospital for further management. on 4/28/21, his condition declined. He was intubated and transferred to the ICU. Patient went into severe acute kidney injury and eventually into multi-system organ failure. He was placed on comfort measures on and was pronounced dead on 5/15/21." "1322956-1" "1322956-1" "Patient got second dose of the vaccine on 2/4/2021. He was diagnosed with COVID 19 on 5/15/2021 (he was negative on 3/19/2021). He was hypoxic, developed changed in mental status. Died on 5/16/2021" "1323057-1" "1323057-1" "Death" "1323098-1" "1323098-1" "This 83 year old black woman received the 2nd dose of vaccine on 3/24/21 and died early May 2021" "1323102-1" "1323102-1" "Death J98.4 - Cavitary lesion of lung R50.9 - Fever, unspecified fever cause" "1323109-1" "1323109-1" "Death A41.50 - Gram-negative sepsis, unspecified K81.0 - Acute cholecystitis E86.0 - Dehydration E83.42 - Hypomagnesemia N39.0 - Urinary tract infection E87.2 - Respiratory acidosis R06.89 - Hypercarbia T85.518A - Cholecystostomy tube dysfunction, initial encounter D72.829 - Leukocytosis, unspecified type" "1323120-1" "1323120-1" "Death Acute Kidney Failure E87.5 - Hyperkalemia M54.9, G89.29 - Chronic back pain N17.9, N18.9 - Acute on chronic renal failure VOMITING DIARRHEA BACK PAIN DIZZINESS LEG SWELLING" "1323124-1" "1323124-1" "This 73 year old female patient received the Covid shot on 3/26/21 died on 5/4/21." "1323163-1" "1323163-1" "Patient was admitted to the hospital on 4/5/2021 for severe AKI with hyperkalemia. Patient had a prolonged hospital course due to kidney failure and AIDS. The patient developed acute respiratory failure on 5/1/21 and was transferred to the ICU, where he was found to be in septic shock. Patient passed away on 5/4/21 at 9:59am" "1323178-1" "1323178-1" "Worsening shortness of breath since the vaccination; collapsed in bathroom on day 10 post-vaccination" "1323208-1" "1323208-1" "SYNCOPE FATIGUE" "1323260-1" "1323260-1" "Patient did not show for 2nd dose appointment scheduled for 5/15/21. Clinic staff contacted caregiver who notified that patient had expired 10 days after her first dose of Moderna." "1323351-1" "1323351-1" "Death within 30 days of vaccination." "1323372-1" "1323372-1" "Patient received both doses of Pfizer vaccine (#1 on 2/9/21, #2 on 3/2/21) and was fully vaccinated when he presented to the ED on 5/9/21 w/ 3 week h/o cough, shortness of breath,. Tested positive for COVID19 by PCR on 5/10/21. Patient treated w/ Remdesivir, Dexamethasone, and convalescent plasma. Was on ventilator. Expired on 5/16/21 due to Acute Respiratory Failure with Hypoxia, Pneumonia due to COVID-19." "1323392-1" "1323392-1" "None reported" "1323514-1" "1323514-1" "Son came into Health Dept this morning to report that his father began throwing up and having diarrhea Saturday morning(05/15/2021) which progressed through the day. States did not want to go to the Hospital but wanted to wait to see his MD at the Dialysis center on Monday (05/17/2021). On Sunday(05/16/2021) nausea and vomiting and diarrhea was worse and now with cough noted. States was washing his hands and fainted, EMS was called and he died that morning." "1323550-1" "1323550-1" "Patient received Moderna COVID vaccine on 2/1/2021 and 2/22/2021. Pt. presented to Medical center within Health system with weakness and arm and leg swelling on 3/4/2021. Admitted for observation, tested negative for COVID and discharged on 3/5. Pt. presented to Medical Center, also within Health system on 5/2/2021 complaining of SOB. Stated that she has had non-productive cough for months, but felt it had worsened lately. Pt. found to be COVID positive with bilateral infiltrates. Pt. required 6L O2. Pt. was DNRCCA. Pt. not intubated but expired from cardiac arrest/COVID on 5/16/2021." "1323593-1" "1323593-1" "Family reported patient passed away in the evening." "1323599-1" "1323599-1" "Sudden death due to heart failure (patient without any underlying heart conditions or experiencing any symptoms prior to death). Called 911 when family noticing patient being unconscious; 911 arrived detecting weak heart beats and took the patients to the nearest emergency room. Heart stopped beating when arriving at emergency room." "1323654-1" "1323654-1" "My mom died one month after the second maderna shot it made her very sick and she never recovered . Headache stomach ache chills fever shaking and death" "1323673-1" "1323673-1" "Subsequently developed respiratory distress and pneumonia after testing positive for COVID. Pt died due to illness." "1323719-1" "1323719-1" "Patient is a 41 y.o. female, reported history of asthma, obesity, polysubstance use, is transferred to the hospital via EMS in cardiac arrest. Per EMS report, the patient was found in an apartment complex by a neighbor unconscious. The initial report was that she was breathing however EMS was called back and then told that she was not breathing and not responsive. Estimated downtime was between 5 and 8 minutes before paramedics arrived and initiated CPR. Due to the patient's body habitus, it did take approximately 15 minutes to get the patient transported to the hospital. 3 rounds of epinephrine were given in the field. Her rhythm has been asystole prior to getting to the emergency department. Intraosseous access is obtained. There is an OPA in place." "1323752-1" "1323752-1" "Clinic contacted patient date of death: 05/09/2021. No other information on symptoms, signs experienced prior to time of death." "1324012-1" "1324012-1" "Acute trouble breathing followed by fainting/loss of consciousness. Chest compressions were started as paramedics were on the way. Paramedics worked on my dad for over 30 minutes but were unable to revive him. They stated he went into cardiac arrest." "1324154-1" "1324154-1" "5/2/2021 - productive persistent cough and poor appetite. Received physician order to transfer to Hospital for evaluation." "1324268-1" "1324268-1" "Lethargy, Exhaustion, Inability to Walk, Heart Attack and Death from Acute Cardiac Arrest" "1324469-1" "1324469-1" "Pt received vaccination on 05/13. The following day developed fever. On 05/15 she developed sore throat and vomiting. Her sore throat progressed where she could not speak or talk. She was seen in the ER and in respiratory failure. She was intubated and developed septic shock. Labs notable for WBC 0.1, platelets 32. INR elevated at 2.2. She had renal failure and shock liver and evidence of DIC. Blood cultures grew gram negative rods. She eventually died from septic shock." "1324523-1" "1324523-1" "Witnessed Cardiac arrest at home. No bystander CPR; +30 min transport time, unsuccessful resuscitation. Code called upon arrival to hospital" "1325015-1" "1325015-1" "Severe headache nauseous" "1325911-1" "1325911-1" "stated that her mother in law died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (stated that her mother in law died) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 07-May-2021 The patient died on 07-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided Concomitant medications and treatment information was not provided. A 61-year-old female patient who received mRNA-1273 died 2 days after the first dose of vaccine. No medical condition or conmeds were provided. The cause of death was not reported. Very limited information has been reported at this time. Further information is being followed up.; Sender's Comments: A 61-year-old female patient who received mRNA-1273 died 2 days after the first dose of vaccine. No medical condition or conmeds were provided. The cause of death was not reported. Very limited information has been reported at this time. Further information is being followed up.; Reported Cause(s) of Death: Unknown cause of death" "1326063-1" "1326063-1" "Died February 12, 2021" "1326251-1" "1326251-1" "she passed away last night; She reported no side effects other than being tired.; This is a spontaneous report from a contactable consumer. A 96-years-old female patient (reporter's mother) received second dose bnt162b2 (BNT162B2), via an unspecified route of administration on 07May2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included high blood pressure, heart disease, stent in heart. The patient was not pregnant. There was no known allergy. Concomitant medications included blood pressure and other medications. The patient previously received first dose bnt162b2 (BNT162B2) on an unknown date for COVID-19 immunisation. Patient received her second Pfizer vaccine on 07May2021. She reported no side effects other than being tired. It may not be related to the vaccine, but she passed away last night. Note that she had heart issues. The adverse events resulted in Emergency room/department or urgent care. Treatment for the adverse events included CPR and other life saving measures. There was no Covid prior vaccination. The patient was not Covid tested post vaccination. Death cause was unknown; may be listed as heart attack (as reported). The outcome of event Tiredness was unknown. The patient died on 09May2021. An autopsy was not performed. Information about lot/batch has been requested.; Reported Cause(s) of Death: she passed away last night" "1326284-1" "1326284-1" "Pt. passed away 2 days after vaccination. At time of vaccination pt. already in moribund state related to long term diabetes mellitus1 with ESRD, chronic foot wound since 2017, severe osteoarthritis. In March 2021 pt. hospitalized d/t severe pain. Findings were acute encephalopathy likely multifactoral, abnormal EEG and NSTEMI. Pt. refused further diagnostic in the hospital and resumed home hemodiaysis with help of her spouse. Hospice care was considered by the couple shortly before the time of vaccination." "1326498-1" "1326498-1" "5 minutes after vaccination, patient suffered cardiac arrest in clinic. CPR started immediately, shocked, EPI given. EMS transported to hospital patient expired in ED." "1326587-1" "1326587-1" ""Wife came in for second dose appointment and handed over husbands vaccination card. Wife reported patient died on Saturday after waking up in the morning and deciding to sleep in for a bit longer. She reported getting out of bed and he was breathing and when she went back to wake him up he wouldn't wake. She called 911 and he was pulseless, she reported emergency aid ""Shocked him"" and worked on him for 45 minutes before asking her for permission to stop. Site will destroy vaccine card as the wife did not wish to keep it."" "1326611-1" "1326611-1" "Systemic: patient died-Severe, Additional Details: patient expired at the hospital not in the nursing home per, director of nursing, at Nursing Home." "1326764-1" "1326764-1" "First vaccine dose administered on 4/20/21. Patient was admitted on 4/29/21 with shortness of breath and pleuritic chest pain. CT scan revealed pulmonary embolism and doppler showed vascular access (Hero graft) thrombosis. Patient was treated with heparin and warfarin, and was discharged on 5/5/2021 after being converted to apixaban. Patient missed scheduled dialysis treatment (no call/no show) on 5/8/21 and 5/11/21. Subsequent welfare check found the patient expired at home." "1326951-1" "1326951-1" "She been feels ill slightly ill ever since the shot. Always short of breathe. Now she died of a blood clot / heart attack while at night in her chair." "1327132-1" "1327132-1" "Cardiac Arrest" "1327444-1" "1327444-1" "seizure, encephalopathy, death" "1327446-1" "1327446-1" "Patient's friend called office on 3/29/21 to notify PCP that patient had passed away on 3/26/21." "1327468-1" "1327468-1" "She did not have control of her bowels when sneezed or coughing. She complained of trouble breathing and in a lot of pain. She passed away on April 3 with pneumonia" "1327551-1" "1327551-1" "Second vaccine 5/14/21 and death on 5/16/21" "1327598-1" "1327598-1" "EMS dispactched to scene of home with CPR in progress. Pt. was in VTACH and shocked X1, Epinephine X 2, Bicarb X 1. Return of circulation which was lost enroute to ED. CPR started again. Blood/Frothy sputum noted from tube and mouth. pupils 3 mm, sluggish. mottled skin in exremities. Glasgow coma score of 3. In the ED Epi, bicarb, Ketalar, Lasix, CaCL, norepi Pt. transfered by helicopter to higher level of care," "1327629-1" "1327629-1" "Pt with history of recovered Covid, developed sudden absominal pain, distention, emesis, diagnosed with bowel infarct and pneumonia, one day after 1st covid vaccine. Died 1/5/21 in hospice." "1327652-1" "1327652-1" "Approximately 48 - 72 hours after vaccine was administered, she was found deceased in am of 05/16/2021" "1327666-1" "1327666-1" "Patient received second Pfizer vaccine on 2/8/2021. Became symptomatic with COVID like S/S on 4/30/2021. Was admitted to Hospital on 5/4/2021 and tested positive for COVID 19 upon admission. Patient was intubated on 5/12/21 and expired while still admitted to the hospital on 5/17/21." "1327727-1" "1327727-1" "She went to the hospital, had a stroke" "1327755-1" "1327755-1" "Hospitalized for COVID-19 pneumonia on 4/23, ICU on 5/3, passed on 5/17 of 2021" "1328720-1" "1328720-1" "Patient was admitted to the hospital on 04/15/2021. He was in the ICU and on a ventilator for majority of the time." "1328722-1" "1328722-1" "Was told she died in her sleep. This is one of 3 nurses in the medical center that passed away suddenly. Vaccine roll out was December 2020, unknown exact date or type" "1328751-1" "1328751-1" "He is a co worker and he passed away in his sleep I heard. One of 3 nurses that died in the medical center since the vaccine roll out" "1328936-1" "1328936-1" "pt. daughter called pharmacy on May 18, 2021 (approximately 5:00pm MST) stating pt. passed away and wanted info on reporting incident to authorities=Technician gave pt. daughter phone # to report incident." "1329227-1" "1329227-1" ""My mother was in generally good health for her age, known as the strongest woman to many. She defied covid for over a year, despite living in an assisted living facility in one of 2020's ""hot zones"". After taking the vaccine, she died within 2 months. I definitely believe 100% the vaccine in the very least hastened her health as she began declining immediately after the first dose, with on/off flu like symptoms until her death."" "1329587-1" "1329587-1" "death; This is a spontaneous report from a consumer. A 39 years old male patient (brother in law, sister's husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05May2021 (Batch/Lot number was not reported) as 2nd dose, Single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death on 06May2021. He received his second pfizer vaccination shot less than 24 hours before his death. Official cause of death hasn't been determined. He simply never woke up the next day and reporter's sister found him cold and blue in their bedroom. The patient died on 06May2021. An autopsy was performed and results were not provided. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: unknown cause of death" "1329905-1" "1329905-1" "Died due to respiratory cardiac arrest." "1329933-1" "1329933-1" "Deterioration of condition." "1329965-1" "1329965-1" "Deterioration of condition." "1330021-1" "1330021-1" "Patient was vaccinated on 1/22/2021 and 2/12/2021 and had out of hospital cardiac arrest on 5/5/2021 where he was tested for COVID-19 and was positive. He had previously tested negative on 4/19/2021." "1330030-1" "1330030-1" "Loss of apatite." "1330155-1" "1330155-1" "Difficulty to breath, pain in the lungs, patient was rushed to the hospital and after addition, patient goes to cardiac arrest." "1330206-1" "1330206-1" "Died of missive hart attack." "1330231-1" "1330231-1" "Decay, irregular pulse, cardiorespiratory failure are observed." "1330240-1" "1330240-1" "Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. This occurred on 3/7/21, 4/1/21, 4/3/21, 4/24/21 and 4/29/21. The patient died on 4/30/21" "1330319-1" "1330319-1" "04/02/2021 - 04/21/2021 fever (100.5-105.9), chills, fatigue, night sweats ibuprofen" "1330410-1" "1330410-1" "Rash presented several days after 2nd dose of vaccine. Seen in urgent care on 4/28 for this. On 5/8/21, patient had left weakness and numbness, dizziness, and loss of balance. Alteplase given,. Transferred to Medical Center, medical intensive care unit. Transferred to medical/surgical unit 5/9/21. Intermittently Febrile - T-max 39.5. CT for mild lethargy 5/9/21. 5/11 - mild respiratory distress and minimally responsive. Continued decline. TOD 1644 5/13" "1330411-1" "1330411-1" "Within 12-24 hours, patient noted to have altered mental status - transferred to ICU where it was later discovered that patient had an intracranial hemorrhage" "1330552-1" "1330552-1" "Blood clot in brain causing stroke then death" "1330697-1" "1330697-1" "Patient died 4/28/2021" "1330712-1" "1330712-1" "Family considers patients demise 5/8/2021 a result of vaccination with COVID-19 series given 2/3/2021 and 3/3/2021. He died from respiratory acidosis yet never had breathing problems prior tom vaccine." "1330750-1" "1330750-1" "ED to Hosp-Admission Discharged 3/8/2021 - 3/9/2021 (14 hours) Hospital MD Last attending ? Treatment team Dementia without behavioral disturbance (CMS/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine Inpatient Discharge Summary BRIEF OVERVIEW Admitting Provider: MD Discharge Provider: MD Primary Care Physician at Discharge: CRNP Admission Date: 3/8/2021 Discharge Date: 3/27/2021 Discharge Diagnosis Hospital Problems POA * (Principal) Dementia without behavioral disturbance (CMS/HCC) Yes Aortic stenosis Yes Atrial fibrillation (CMS/HCC) Yes Chronic obstructive pulmonary disease (CMS/HCC) Yes Congestive heart failure (CMS/HCC) Yes Coronary artery disease with history of myocardial infarction without history of CABG Not Applicable Depression Yes History of aortic valve replacement Not Applicable Hyperlipidemia Yes Hypertension Yes Peripheral vascular disease (CMS/HCC) Yes Ambulatory dysfunction Yes Dementia (CMS/HCC) Yes CKD (chronic kidney disease) Yes History of TIA (transient ischemic attack) Not Applicable Dementia with behavioral disturbance (CMS/HCC) Unknown DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission AKI (acute kidney injury) (CMS/HCC) [N17.9] Dementia with behavioral disturbance (CMS/HCC) [F03.91] Generalized weakness [R53.1] Patient is an 87 y.o. male with past medical history of hypertension, hyperlipidemia AFib not on anticoagulation, sick sinus syndrome status post pacemaker, aortic stenosis status post valve replacement.Coronary artery disease status post CABG, CHF, history of peripheral vascular disease, history of carotid stenosis, severe vertebral artery stenosis, diabetes, CKD, dementia, chronic respiratory failure on 2 L nasal cannula post COVID-19 pneumonia 11/2020 was brought to the emergency room by the family due to worsening confusion and agitation, as per wife after the patient was discharged back in November in few weeks patient dementia started to get worse, more confused, more agitated and few times he was violent to his family members, well for the last few days patient's wife reported that his confusion was very bad so she decided to bring him to the ED for further evaluation management. Hospital Course -For the above presentation patient was admitted to the hospital services, patient was started on oxygen supplementation, Covid repeat test continue to be positive, started on IV antibiotics, IV hydration due to worsening kidney function, in the evening of 3/8 patient was found without any spontaneous respiration, patient was pronounced dead by the RN and CRNP finished the discharge defecate, please refer to RN documentation for more details." "1330767-1" "1330767-1" "Patient presented to the ER on 3/28/2021 with shortness of breath and lower extremity edema and complaining of lower back pain. O2 sat high 80s on room air. Worsening renal failure since last discharge from hospital on 3/23/2021. Patient was readmitted to hospital from skilled care facility after being discharged 5 days prior with acute on chronic stage IV kidney disease as well as acute on chronic diastolic heart failure and had slowly worsening with renal dysfunction and growing concern for dialysis. Patient had developed a cough, a fever up to 101, and 1 questionable sewed of either hemoptysis or hematemesis since being discharged to skilled nursing facility on 3/23/2021. Patient was transitioned to the hospice team and expired on 4/2/2021." "1330914-1" "1330914-1" ""PT deceased on 1/6/21 from ""complications of CHF"" Unknow if it is in fact related to the vaccine."" "1330956-1" "1330956-1" "on 4/20/21, 9 am (24hrs after receiving the second shot, he complained that the couldn't breath and his throat hurt, we gave him some tylenol,) then we call 911 by 3pm because he looked pale. by 6pm we were told that he was going uptown, because he might need a ventilator. Then at 12:30 a.m. on 4/21/21 we were told he was alert and in emergency diaylsis and he should be okay. Then they called us at 8 a.m. to say that he had passed away due to a heart attack." "1331018-1" "1331018-1" "admitted 5/5/21 with increased sob/cough/aches and pains. Dx with COVID 19 pneumonia on 5/1 . temp 98.3" "1331122-1" "1331122-1" "Patient was vaccinated on 3/31/21. Noted to be positive for Covid on 4/19/21 and passed away on 5/8/21. Per the lab report, this is the information for the ordering provider: He had an emergency contact but no number. Phone number for patient is no longer operational." "1331183-1" "1331183-1" "Death occurred outside of pharmacy 22.5 hours post vaccination. Cause of death being the vaccine is unknown." "1331243-1" "1331243-1" "Lightheaded, nausea resulting in heart attack" "1332656-1" "1332656-1" "bilateral leg pain, diarrhea, flu like symptoms, death" "1332841-1" "1332841-1" "Body chills; Body aches; Blindness; Septic shock due to serratia infection (not sure how the infection came to be); Septic shock due to serratia infection (not sure how the infection came to be); Kidney failure; This is a spontaneous report from a non-contactable consumer. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Feb2021 (Lot Number: EL9266) as single dose for COVID-19 immunisation. Medical history included type 2 diabetes, stage 4 kidney disease, high blood pressure. Concomitant medications included unspecified drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. On 14Feb2021, the patient experienced body chills, body aches, blindness, septic shock due to serratia infection (not sure how the infection came to be), kidney failure. The events required a visit to the emergency room. No treatment required. The patient was hospitalized due to the events for 18 days and condition was life threatening. The final outcome was fatal. The patient died on 06Mar2021. An autopsy was not performed. Cause of death was septic shock. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Septic shock" "1332849-1" "1332849-1" "passed away from COVID (positive test on 24Apr2021); passed away from COVID (positive test on 24Apr2021); This is a spontaneous report from a contactable physician. A 37-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 37-years-old, via an unspecified route of administration on 20Mar2021 (Lot Number: EP7534, also reported as EPT534) as single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Patient received first dose of bnt162b2 at the age of 37-years-old on 27Feb2021 (Lot Number: EN6205) for covid-19 immunisation. Patient with no comorbidities passed away from COVID (positive test on 24Apr2021) in the ICU on 09May2021. Autopsy is still pending. Patient's family members provided vaccination card and she would like to verify if the lot numbers are from Pfizer Covid-19 vaccine. Added that it is freighting as the patient developed fatal Covid a month after being fully vaccinated. Additionally, she would like to verify if it is possible to know where the vaccines were shipped or any other distribution or facility information she could get from these lots. Stated that the vaccination card has something written on a box from the right hand side. Reporter seriousness for Tested Positive for Covid was Hospitalization, Death. Cause of death: Autopsy Pending, they assume Covid. Autopsy performed, Autopsy details not available. Events outcome was fatal. The patient died on 09May2021.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded in a context of LOE. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: passed away from COVID (positive test on 24Apr2021)" "1333192-1" "1333192-1" "Acute kidney injury; acute myocardial infarction; cardiac failure congestive; Confusional state; dyspnea; Respiratory distress; Sepsis; cardio-respiratory arrest; This case was received via VAERS (Reference number: 1213568) on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CARDIO-RESPIRATORY ARREST (cardio-respiratory arrest), ACUTE KIDNEY INJURY (Acute kidney injury), ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction), CARDIAC FAILURE CONGESTIVE (cardiac failure congestive), CONFUSIONAL STATE (Confusional state), DYSPNOEA (dyspnea), RESPIRATORY DISTRESS (Respiratory distress) and SEPSIS (Sepsis) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CARDIO-RESPIRATORY ARREST (cardio-respiratory arrest) (seriousness criteria death and medically significant), ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria hospitalization and medically significant), ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction) (seriousness criteria hospitalization and medically significant), CARDIAC FAILURE CONGESTIVE (cardiac failure congestive) (seriousness criteria hospitalization and medically significant), CONFUSIONAL STATE (Confusional state) (seriousness criterion hospitalization), DYSPNOEA (dyspnea) (seriousness criterion hospitalization), RESPIRATORY DISTRESS (Respiratory distress) (seriousness criteria hospitalization and medically significant) and SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant). The patient died on 20-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient presented to the ER and was treated for acute CHF, NSTEMI and sepsis with ceftriaxone and azithromycin. After placement of Trialysis catheter, he developed increasing respiratory distress and confusion and was transferred to the ICU where he received vasopressors, intubation and unsuccessful resuscitation after a code blue on 20-Mar-2020. Company comment: This is a case of death in a 76-year-old male subject with unknown medical history, who died 22 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Concomitant medication use was not provided by the reporter.; Sender's Comments: This is a case of death in a 76-year-old male subject with unknown medical history, who died 22 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death." "1333218-1" "1333218-1" "No event description for this event." "1333421-1" "1333421-1" "3/18, admiteed 2 days after covic vaccine with SOB, rib pain, emesis. Patient had metastatic ovarian cancer on chemotherapy who was admitted to the intensive care unit with severe sepsis with septic shock and acute hypoxemic respiratory failure requiring intubation mechanical ventilation. She was started on broad-spectrum antibiotics, but did not have an obvious source of infection. She remained on mechanical ventilation, with profound metabolic acidosis. She required high doses of norepinephrine and vasopressin drips, but on arterial blood gas had a pH of 6.98. The patient had a cardiopulmonary arrest in the intensive care unit. 1 round of ACLS protocol was performed, with return of spontaneous circulation. After discussion with the patient's mother by phone, she opted for DNR status, comfort care, and to allow for natural death. The patient was kept on mechanical ventilation, and she passed away." "1333518-1" "1333518-1" "He had a stroke and bleeding on the brain" "1333650-1" "1333650-1" "passed away sometime after 2/16/21 and before 2/20/21 in her home. Cause of death ruled by Corner as Myocardial infarcation and congestive heart failure. Sometime between 11 and 15 days after receiving dose 1. did not receive dose 2 due to her passing before she could receive it." "1333734-1" "1333734-1" "Approximately two weeks after vaccination I noticed his left foot and leg swelling. Patient advised me that he needed to go to the hospital because he was not feeling well and his oxygen level was low. We called 911 and was taken to the hospital. After at the hospital I advised a male nurse that I was concerned about his leg being swollen cause he had been given the Jansen Covid vaccine and I was concerned about blood clots. Everyday I would tell someone in the hospital (never saw a doctor I could talk to) about his swollen leg but did not really get anyone interested. Before he was moved to a Veteran?s State Home, I overheard someone saying they were going to give him his anticoagulant. I?m filing this report in case the swollen leg was a result of blood clots due to the vaccine." "1333759-1" "1333759-1" "My mom, patient was a health 79 year old women, only two health issues were COPD and moderate dementia. She had even gotten her annual labs done recently which came back all with in normal range, she as far as we knew did not have any issues with her heart. After her first vaccination in March she started to lose interest in things and didn't have energy to be as active as she was. After the second shot with in two days she started to report pain in chest and head and trouble breathing, She went to her PCP on 5/12 and he wanted her to go to a cardiologist, this referral was made but by the 16th she was in the ER due to extreme chest pain and trouble breathing, a stent was placed in her heart on 4/17/21 my mom's 80th birthday. with in 4 days she died. Her heart just deteriorated. i feel that if she didn't get this shot she would be alive today, she was healthy, now she is dead." "1333939-1" "1333939-1" "The resident was administered his second COVID vaccine (Moderna) on 5/19/21 at 9:30am. Per nursing, the resident tolerated the vaccine well and no problems were documented throughout the day. At 10:00pm the nurse who administered the vaccine recorded the resident's vitals as follows: BP 118/68, HR 72, Respiration 18, Temperature 97.0 F. At 10:20am the resident's CNA discovered him lifeless with vomitus around his mouth and neck. The resident was not breathing, bluish in color, and cool to the touch. Vital signs were checked and no pulse was detected. CPR was attempted with not effect." "1333991-1" "1333991-1" "Blot clot followed by fatal aortic thrombosis" "1334038-1" "1334038-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1334068-1" "1334068-1" "Patient was provided with the COVID-19 vaccine outside of the hospital and begain having shortness of breath approximately 15-20 minutes after receiving the vaccination. In route home, the patient could not catch his breath. The patient was found slumped over at home. EMS arrived and the patient received ACLS and ROSC was achieved. Days later, the patient arrested again and passed away on 5/13/21." "1334174-1" "1334174-1" "Health department received notification that patient expired unexpectedly while operating a vehicle. No known link to vaccination at this time, but reported as it occurred on day 13 post-vaccination." "1334199-1" "1334199-1" "NIECE CALLED TO LET US KNOW PATIENT EXPIRED 3 DAYS POST VACCINE SHOT. NIECE STATED PATIENT HAD BREATHING ISSUES AND NOTES MENTION HEART ISSUES." "1334283-1" "1334283-1" "Patient felt very weak, body aches, shortness of breath and was found deceased at home on 5/10/2021" "1334284-1" "1334284-1" "According to patient's daughter, patient only complained of nausea the day of the immunization. Patient received 2nd dose of Moderna vaccine at 4:05pm and passed away around 8:30pm that same day per daughter's account. She had no pulse upon arrival to hospital. Autopsy was not performed." "1334527-1" "1334527-1" "My brother got the Pfizer 5/4 and started getting sick with a cough on the 7th and by the 10th he was getting more and more sick and ye was taken to the ER on the 14th and he started coughing up blood, he was out of it and pale and not able to move much. On 5/15 in the hospital he was having a hard time breathing and they were trying to give him meds to make him better, they gave him antibiotics because his blood work showed infection, and Precedex to help him rest, and he passed away the same day, he was in good health before. They also said his heart rate was 201/123 and the doctors said pulmonary anema. It escalated so quickly." "1334600-1" "1334600-1" ""Patient passed away on 4/30/21. Wife reports that on 4/29/21, she found him in the garage in a ""pool of blood, face down"" after a fall. Upon finding him on 4/29/21, she took him to the emergency room where he had a CT scan. Patient was diagnosed with a ""concussion"" and sent back home, and was instructed to follow-up with his primary care provider on 4/30/21. On 4/30/21, patient was ""sleepy all day."" On his way out of the house around 3:30, he suddenly put his hand on his wife and proceeded to collapse. The wife also fell, and by the time she gathered herself and went to check on her husband, he had passed away. An ambulance came to the house; CPR was performed for 40 minutes but ""they could not get him back."" He was not transported to a medical center. An autopsy was not done, but the coroner informed patient's wife that he likely died from a ""clot, maybe a PE."" Wife wonders how this could be, since he was on Plavix for 5 years. Wife does not feel that the COVID vaccine is to blame, but thought she should report the issue just in case. This writer is assisting wife of patient to fill out electronic report."" "1334684-1" "1334684-1" "Systemic: death (unknown cause)-Severe, Additional Details: Patient was found deceased roughly an hour and a half after receiving Moderna vaccine. He waited 20 minutes at the pharmacy and left however later died. Details are unknown. Sister may have more information." "1334827-1" "1334827-1" """"severe reactions""; very weak; Felt Bad; shortness of breath; Fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (""severe reactions"") and ASTHENIA (very weak) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Reporter stated that the patient had a history of ""health problems."" No specifics were provided. Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and MELATONIN for an unknown indication. In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced VACCINATION COMPLICATION (""severe reactions"") (seriousness criterion death), ASTHENIA (very weak) (seriousness criterion death), FEELING ABNORMAL (Felt Bad), DYSPNOEA (shortness of breath) and PYREXIA (Fever). On 06-May-2021, FEELING ABNORMAL (Felt Bad), DYSPNOEA (shortness of breath) and PYREXIA (Fever) outcome was unknown. The patient died on 06-May-2021. The cause of death was not reported. An autopsy was not performed. Patient had no symptoms or side effects after the 1st dose. Patient was never hospitalized for the reported events. A 71-year-old male patient who received mRNA-1273 experienced Pyrexia, Feeling Abnormal, Dyspnea, Asthenia and Vaccination Complication and died on an unknown days after the second dose of vaccine. Patient had a history of unspecified health problems which may confound the event. Unlikely that the events are related to the vaccine. Very limited information has been reported at this time. Further information is not expected.; Sender's Comments: A 71-year-old male patient who received mRNA-1273 experienced Pyrexia, Feeling Abnormal, Dyspnea, Asthenia and Vaccination Complication and died on an unknown days after the second dose of vaccine. Patient had a history of unspecified health problems which may confound the event. Unlikely that the events are related to the vaccine. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death"" "1334834-1" "1334834-1" "Caller stated his wife passed out and hit her head on the floor; hit her head on the floor and split it open; transferred to hospital due to cardiac complications; fall; His wife passed away; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of DEATH (His wife passed away), LOSS OF CONSCIOUSNESS (Caller stated his wife passed out and hit her head on the floor), SKULL FRACTURE (hit her head on the floor and split it open), CARDIAC DISORDER (transferred to hospital due to cardiac complications) and FALL (fall) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Caller stated his wife passed out and hit her head on the floor) (seriousness criteria hospitalization and medically significant), SKULL FRACTURE (hit her head on the floor and split it open) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (transferred to hospital due to cardiac complications) (seriousness criterion hospitalization) and FALL (fall) (seriousness criterion hospitalization). On 04-Apr-2021, LOSS OF CONSCIOUSNESS (Caller stated his wife passed out and hit her head on the floor), SKULL FRACTURE (hit her head on the floor and split it open), CARDIAC DISORDER (transferred to hospital due to cardiac complications) and FALL (fall) outcome was unknown. The patient died on 04-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment information was not provided. On 03 Apr 2021, the reporter stated approximately 45 minutes after receiving the COVID-19 vaccine, the patient passed out in the parking lot and hit her head on the floor which caused it to split open. The patient was taken to a hospital but had to be transferred to another hospital after experiencing cardiac complications. On 04 Apr 2021 at 4:00 am, the patient passed away. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1334843-1" "1334843-1" "Informed of patient recently passing within 24 -36 hours of vaccine administration. patient had no signs of adverse side effects while at pharmacy." "1334884-1" "1334884-1" "Dad had been feeling dizzy and tired much of the time when he first knew something was not right and went to his primary doctor and his heart doctor. From the date of 02/13/2021,the first COVID-19 vaccine shot, Dad?s condition worsened but once he was administered the second dose of the COVID-19 vaccine it quickly accelerated. One month and one day after the second vaccination shot he was dead from internal bleeding, an excellerated decrease in hemoglobin, red blood cells, platelets, and the complications this caused after surgery which removed a portion of his colon to stop the bleeding. Following is a chronological list of occurrences to the best of my recollection: 1) 2/25/2021 NP, received lab results which she had ordered earlier. Red blood cells 2.21 MIL/uL, hemoglobin 6.7 GM/DL, platelets 92 THOUS/uL. 2) 2/28/2021 admitted to the hospital to receive 3 units of blood and a bone marrow biopsy. Discharged 3/2/2021. 3) 3/3/2021 diagnosis: anemia, unspecified Melena, and ocult blood in stools. 4) 3/5/2021 Dr. with lab results: red blood cells 2.7 MIL/uL, hemoglobin 8.6 GM/DL, platelets 56 THOUS/uL. 5) 3/10/2021 Video Capsule Endoscopy. 6) 3/12/2021 Outpatient blood transfusion. 7) 3/15/2021 Dr. with bone marrow report. Diagnosed with Myelodysplastic Syndromes. Received first shot of ARANESP with orders to receive the ARANESP shot every two weeks and see a specialist at Hospital. 8) 3/16/21 transported to ER by ambulance with GI bleed. Received blood transfusions and admitted. Received several more tests and blood transfusions. Diagnosis: Arteriouvenous Malformation in descending colon. Treatment: 4 clamps in bleeding veins. Discharged: 3/19/2021. 9) 3/29/2021 Dr. office visit, labs, and second ARANESP shot. Ordered transfusion, no blood match. 10) 3/29/2021 Taken from Dr. office to ER and admitted to Hospital. Transfusions and additional tests performed. Test showed additional bleeding in colon. A colonoscopy was performed and several areas in the colon were sealed. 11) 4/2/2021 Discharged 12) 4/4/2021 Hemorrhaging from colon. Transported by ambulance to Hsopital. More transfusions and tests. 13) 4/5/2021 Performed surgery to remove part of colon. My dad continued to worsen over the next 9 days. 14) 4/14/2021 My dad died." "1334886-1" "1334886-1" "Patient died 72 hours after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient died 72 hours after receiving the vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination. No Medical History information was reported. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 26-Apr-2021 The patient died on 26-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant medication was not provided, Treatment medication was not reported. A 79-year-old female patient who received mRNA-1273 died 3 days after the first dose of vaccine. No medical conditions or concomitant medications were reported. Very limited information has been reported at this time. Further information is being followed up.; Sender's Comments: A 79-year-old female patient who received mRNA-1273 died 3 days after the first dose of vaccine. No medical conditions or concomitant medications were reported. Very limited information has been reported at this time. Further information is being followed up.; Reported Cause(s) of Death: Died 72 hours after receiving the vaccine." "1334899-1" "1334899-1" "Grand mal seizure; encephalopathy" "1336097-1" "1336097-1" "Vfib arrest" "1336534-1" "1336534-1" "NA Acute Systolic AFIB Pancreatic cancer Heart Failure" "1336582-1" "1336582-1" "NA PAD, Coronary Artery Disease" "1336695-1" "1336695-1" "Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses were pneumonia, A-fib and hyponatremia. Patient died on 4/21/2021" "1336774-1" "1336774-1" "Patient developed fever, dyspnea and headache on 5/12/2021; tested positive for COVID-19 on 5/12/2021; patient died on 5/20/21" "1337019-1" "1337019-1" "unknown" "1337058-1" "1337058-1" "The patient had Covid 19 from approximately January 28, 2021 through early February 2021. He received the first dose of the Pfizer Vaccine on March 26, 2021. On March 27, 2021 at approximately 7:30 PM, the patient suddenly became unable to speak clearly and walk normally. The ambulance was called at approximately 7:45 PM. The patient was evaluated and placed in the ambulance by approximately 8:15 PM. He stopped breathing in the ambulance. He was resuscitated and placed on a ventilator at some point. After evaluation at the hospital, it was found that he had suffered a pontine hemorrhage. He was kept alive until his heart stopped on March 29, 2021." "1337097-1" "1337097-1" "pt received Johnson and Johnson vaccine on 5/21/2021, PT had been complaining of shortness of breath since getting the vaccine yesterday and today, pt collapsed at home, wife started CPR, EMS continued compessions and ACLS protocol when they arrived to ED he was in Vfib, After multiple shocks, Epinephrine, bicarb, lidocaine and multiple other life saving medications were administered to no avail, pt expired on 5/21/2021 at 1729" "1337198-1" "1337198-1" "Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day." "1337251-1" "1337251-1" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337366-1" "1337366-1" "Resident received vaccine at 10am and was observed for 15 minutes post vaccine with no reaction noted. Pre and post vitals were at baseline. Upon rounds at 12pm, nurse noted resident with increased respirations and an elevated temperature (Resp 40, Temp 103.5). Nurse notified nursing supervisor and MD called. Patient was transferred via 911 to Hospital at 12:25pm." "1337439-1" "1337439-1" "ACCORDING TO DAD, HE GOT THE VACCINE ON 4/28/21. ON MAY 11 HE WAS COMPLAINING OF N/V, LATER HEADACHE AND ALTERED VISION, ENCEPHALOPATHY, CARDIAC ARREST AND DEATH.... AFTER MULTIPLE LOCAL ER VISITS. HE NEVER HAD FEVER. I WAS CALLED ON HIS CASE DUE TO CONCERN FOR CNS INFECTION. HE WAS ADMITTED ON 5/18 AND DIED ON 5/20 THIS MAY OR MAY NOT BE RELATED TO THE COVID VACCINE, BUT IT IS IMPORTANT IT IS REPORTED JUST INCASE IT IS AND MAY HELP SOMEONE." "1337481-1" "1337481-1" "Resident had been experiencing cognitive decline over approximately the last month. Resident was treated for UTI on 4/29/21, labs were obtained on 5/3/21 and were unremarkable. Resident had seizure like episode at approximately 0830, resident was DNR Comfort Measures and resident's family did not want resident sent to hospital. Resident expired at 0920 on 5/21/21." "1337502-1" "1337502-1" "Death, code blue at home, received COVID vaccine 5/20/21. No known health issues" "1337556-1" "1337556-1" "Stage IV Pancreatic Cancer" "1337585-1" "1337585-1" "NA COPD, MALT lymphoma, HTN" "1337619-1" "1337619-1" "NA End Stage Kidney disease DM Neuromuscular disease" "1337634-1" "1337634-1" "had second dose on 5/14/21, passed away during the night of 5/15/21. Found dead on 5/16/21 morning" "1337675-1" "1337675-1" "NA Left Upper Lobe Lung CA COPD" "1337689-1" "1337689-1" "Health district notified by Police Dept. that a homebound resident who received first dose of Moderna on 4/26/21 and was due for second dose moderna on 5/24/21 was found deceased at home on 5/21/21." "1337701-1" "1337701-1" "64 y.o. female who presented with SOB. She has a history of CAD, diabetes, CHF, CKD and DVT presents to the ED in respiratory distress. Patient was brought in by EMS from nursing home. Patient had reported onset of shortness of breath and respiratory distress over the last 6-7 hours. Patient has O2 sat of 90% on 6 L. Patient only uses 2 L nasal cannula oxygen all day long. Patient is coherent and initially was placed on BIPAP but then stated she wanted to go back, now after ER doc spoke to her she is ok with being admitted but does not want BIPAP or to be placed in the ICU. She is DNR/DNI. She is working hard to breathe currently. Patient is unsure if she is making urine at this time. Workup in the ER revealed AKI on CKD and covid + pneumonia. Patient elected hospice and expired 5/20/2021. It was reported that patient had received vaccines at Walmart." "1337723-1" "1337723-1" "PATIENT WAS IMMUNIZED 5/13. PATIENT WAS FOUND DECEASED IN THEIR APARTMENT ON 5/18. FAMILY LAST SAW HIM ON 5/16 WHEN THEY DROPPED HIM OFF AT HIS APARTMENT. MEDICAL EXAMINER HAS NOT YET DETERMINED CAUSE OF DEATH OR EXACT DATE OF DEATH." "1337728-1" "1337728-1" "Intestinal distress ending in dead gut sundrome" "1337755-1" "1337755-1" "Person died on 5/9/2021, with death note listing acute and chronic respiratory failure with hypoxia, COVID-19, paroxysmal atrial fibrillation, chronic heart failure with reduced ejection fraction, follicular lymphoma, history of CABG, hyperglycemia, and type 2 diabetes." "1337780-1" "1337780-1" "Person died on 5/7/2021 with death note stating acute respiratory failure with hypoxia, thrombocytopenia." "1337824-1" "1337824-1" "foaming at the mouth and had a heart attack" "1337918-1" "1337918-1" "Unaware of any adverse events between administration and death. Reporting agency became aware of patient's expiration on 05/14/2021." "1337951-1" "1337951-1" "patient expired 1 day after receiving 2nd dose of Moderna vaccine" "1338341-1" "1338341-1" "Resident was found deceased in the evening of 5/11/21." "1338394-1" "1338394-1" "Death N17.9 - Acute kidney failure, unspecified FATIGUE CHEST PAIN NAUSEA" "1338572-1" "1338572-1" "Death E87.1 - Chronic hyponatremia N17.9 - AKI (acute kidney injury) (CMS/HCC) J18.9 - Pneumonia of right lower lobe due to infectious organism" "1338590-1" "1338590-1" "Death Thrombocytopenia Subdural bleeding HEADACHE DIZZINESS" "1338605-1" "1338605-1" "Death Acute kidney injury" "1338610-1" "1338610-1" "Death J18.9 - Pneumonia, unspecified organism" "1338617-1" "1338617-1" "Death of patient two days after second injection." "1338618-1" "1338618-1" "death N17.9 - Acute kidney failure, unspecified" "1338625-1" "1338625-1" "Outcome: unexpected/unexplained death Had first dose Moderna Vaccine 3/31/21. She described body aches and mild fever ? ?like I had COVID again for a day? ? lasting about 36 hours, and then felt fine. Had dose # 2 Moderna vaccine about 6:50 PM at Community vaccination site. She was driver, received left deltoid injection from Doctor. During observation period reported no symptoms, was happy and talkative with family and staff. Family reports later that evening she did not feel well ? ?just not hungry? and wanting to lie down. Slept well, then woke up feeling better except for left arm achiness at injection site. Did not report redness, rash, or any difficulty breathing. Was talkative, walking around, took a shower, and was planning to drive to the grocery store later that day. Mid morning ? maybe beginning about 11 AM, family said she went in and out of bathroom several times. She told them she had vomited three times and was feeling shaky. Her oral temperature was 101.3. About 1:30 PM, she was in her room and called out for her mother. When family went into the room, she was shaking ?like she was having a seizure? and then her eyes rolled back and she fell to her side and stopped breathing. Family called 911 and started CPR. CPR was continued by EMT?s once they arrived, but they were not able to resuscitate her." "1339062-1" "1339062-1" "Patient appeared to have had suffered a stroke. Admitted to hospital, tests determined no stroke. Patient had pneumonia, and severe inflammatory response. Sepsis." "1339098-1" "1339098-1" "Massive stroke from huge clot right of brain. Never regained con.." "1340339-1" "1340339-1" "Baby stopped growing 5 days after shot, confirmed with ultrasounds on 4/26 and 5/6; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable consumer (fetus's mother). This consumer reported information for both mother and fetus. This is the fetus report. A patient (fetus) mother (35-years-old ) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 09:15 (Batch/Lot Number: EW0164) at the age of 35-years-old as single dose, dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 15:00 (Batch/Lot Number: Er8732) at the age of 35-years-old as single dose for covid-19 immunisation. Route of the administration for fetus was provided as Transplacental. The patient's mother medical history was not reported. The patient's mother's concomitant medication included estradiol (ESTRACE) taken for an unspecified indication, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported. The patient's mother did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The baby experienced maternal exposure during pregnancy, first trimester from 28Mar2021 15:00. On 23Apr2021, 14:00, the mother experienced miscarriage, the baby stopped growing 5 days after shot 23Apr2021 14:00, confirmed with ultrasounds 26Apr2021 and 06May2021, the event resulted in doctor or other healthcare professional office/clinic visit, there was no treatment for event. Mother's Last menstrual date was 10Mar2021. The outcome of the events was fatal.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021509131 mother case; Reported Cause(s) of Death: Baby stopped growing 5 days after shot, confirmed with ultrasounds on 4/26 and 5/6; Maternal exposure during pregnancy, first trimester" "1340500-1" "1340500-1" "She aspirated and she was dead within week on respirator; she aspirated and she had pulmonary problem to begin with; 3 convulsions within 24 hours of having her first Pfizer / three grand mal compulsive seizures; This is a spontaneous report from a contactable physician. A 55-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported, vaccinated at the age of 55 years old) as single dose for covid-19 immunisation. Medical history included epilepsy, myocardial metabolism disorder. She has a myocardial metabolism disorder, very specific one and it is A467T mutation in the polymerase gamma gene and that is because of her epilepsy. It was because of that it's a progressive disease get involved with many part of the body that is all so causes seizure. Concomitant medications included clobazam; lamotrigine; escitalopram; amitriptyline; calcium folinate (LEUCOVORINE); lorazepam; mesalazine; butalbital, caffeine, paracetamol (FIORICET); vitamin b2 [riboflavin] (VITAMIN B2 [RIBOFLAVIN]); ubidecarenone (COQ10 [UBIDECARENONE]); l-carnitine [levocarnitine]; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]); vitamin a [retinol]; vitamin c [ascorbic acid], all taken for an unspecified indication, start and stop date were not reported. The patient previously took sulphur, nepatop, dilantin [phenytoin], prednisone, and lidocaine and all experienced hypersensitivity. The patient had received 3 convulsions within 24 hours of having her first Pfizer and she had epilepsy like she has been suffering from years and she aspirated and she was dead within week on respirator. She had three grand mal compulsive seizures and because of the seizures; she aspirated and she had pulmonary problem to begin with. She was put on a respirator and she was on respirator from the day she was admitted and she probably died within about two days. when the vaccination was, precise 24 hours later she had three grand mal compulsive seizures and because of the seizures she aspirated and she had pulmonary problem to begin with. She had 3 convulsive seizures that stayed for about 10 minutes and she had not, she normally would have the focal seizure just in her left arm. She has not had it big seizure in probably 20 years. The physician stated that don't know what killed her was not seizure when she wasn't he hospital she was intubated and she was alive. What killed her was she was aspirated and they could not get her off the respirator and she did not have COVID. When she was admitted to the hospital they did a lot of blood test. Before that, her cortisone level usually runs about 200, with metabolize of 700, and her lamotrigine level runs about between 4 and 8.5 of all other routine her Full blood count (CBC) routine is quite normal. It was not reported if an autopsy was performed. Outcome of events Grand mal seizure and Pulmonary disorder was unknown. Information on batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported seizures along with the consequent aspirations which lead to death and the use of BNT162B2 cannot be fully excluded. However, it is noted that the patient has multiple comorbidities which confound the reported drug event pairs. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: She aspirated and she was dead within week on respirator" "1340513-1" "1340513-1" "lose his life after the vaccine; Passed out; swelling and pain in his side of his arm; swelling and pain in his side of his arm; asthma trigger; allergies; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history included bad allergies and has asthma. Concomitant medications were not reported. He lose his life after the vaccine in Apr2021. He took the vaccine in Apr2021. After 3 days he took the vaccine on Tuesday, then Friday he was gone, that first dose. That day he died, he had like the asthma trigger like 10 minute after then he passed out but Thursday he was saying that he had like swelling and pain in his side of his arm. He had night shift and then morning came, Friday came home and then he ate and then he slept and then he woke up at 10 am just to go to kitchen and thought he was saying like having had allergies and 10 minutes then he passed out and then that was it. The reporter was just wondering how come, he still passed. Seriousness for lose his life after the vaccine was reported as death. The outcome of event lose his life after the vaccine was fatal and other events was unknown. The patient died in Apr2021. The cause of death was unknown. It was unknown if an autopsy was performed. Information on the Lot/Batch number has been requested.; Reported Cause(s) of Death: lose his life after the vaccine" "1340672-1" "1340672-1" "Patient went to ER 4/4/21 with severe headache, inability to stay awake. CT scan of the head revealed multiple areas of SAH (unexplained no head injury) and a very large ruptured MCA aneurysm. Patient was COMPLETELY asymptomatic prior to vaccination. The aneurysm was repaired with success but the cerebral hemorrhages kept appearing - unexplained. Cerebral edema became so severe (midline shift up to 9-10mm) neurosurgery ended up performing a burr hole craniotomy to relieve pressure as well as placement of a ventriculostomy. This patient later ended up with severe vasospasms which results in an ischemic stroke of the L frontal lobe. Patient later died in a rehabilitation facility, all of this secondary to the Janssen vaccine. This vaccine should not be administered until further studied. This was a healthy 63 year old woman. Vitals always WNL labs WNL very active, BMI WNL. Absolutely NO comorbidities. A lifelong nurse who raised 2 nurses of her own. These events took place for over a month. The trauma not only the patient has experienced but her family is unforgivable." "1340758-1" "1340758-1" "My dad started having breathing problems and heart fluttering shortly after getting his first covid vaccination on April 9, 2021. He had contracted Covid back in October 2020. He never told us he was getting the vaccination until we got a call on his cell phone from Public Health the day after he died of a pulmonary embolism. When he started complaining of symptoms, his doctor referred him to a cardiologist at a Clinic. He had an appointment with them a few days before he died. Apparently, they didn't find any blood cllots, possibly because they were looking for heart issues. Either way, I believe that my dad died from side effects of the Moderna vaccine. My dad died on May 1, 2021 of a pulmonary embolism. The coroner and County Sheriff both said it was one of the biggest blood clots they had ever seen. Since he had no history of blood clots, I thought it important that I report it." "1340773-1" "1340773-1" "Pulmonary Embolism, Died on way to hospital, medical examiner report pending" "1340821-1" "1340821-1" "Please check with her doctors. I know she mentioned Myocarditis. She was vaccinated I am correct, on March 8 and April 6, 2021" "1341218-1" "1341218-1" "Within hours of receiving the second Moderna vaccine, the patient began experiencing excruciating pain in his lower back and sciatica. Consensus among the health professionals he saw is that the second vaccine triggered an inflammatory response. The pain did not respond to medication physical therapies." "1343001-1" "1343001-1" "Went to er on March 3rd around 2am with discoloration on body with confusion and pain. Was told possible ttp. Condition quickly declined and was transferred to hospital main campus around 12pm. Condition continued to rapidly decline and passed away on March 4th at 11am. There is much more to tell about this. To much to write down. I have called several times no one has called me back." "1343241-1" "1343241-1" "Outcome : patient died Cause : cardio respiratory arrest Had previously tested for any heart problem but his heart was in excellent conditions" "1343266-1" "1343266-1" "On 4-18-21, 17 days after 1st dose of Moderna, he developed upper abdomen pain, chest discomfort. He thought it was indigestion and treated it as such. When he got no relief he went to Emergency room where a cardiac alert was initiated. After he died I was told he had developed myocarditis,/pericarditis and they had to remove a liter of blood from the sac around his heart, but that his heart had gone into cardiogenic shock and that he died. They were prepared to insert a stint thinking he had a blocked coronary artery, but his arteries were clear and they had no idea what had caused this to happen. When he died so soon after the vaccine there were people who wanted to blame the vaccine but I checked into it and there were NO links between the vaccine and myocarditis, pericarditis or cardiogenic shock. Within a few weeks of his death, there began to be possible links between the vaccine and myocarditis. I know 55 is older than what is being looked at, but he had absolutely no previous cardiac history prior to this and this case should e looked at as well" "1343315-1" "1343315-1" "left MCA infarct" "1343387-1" "1343387-1" "Patient died of a myocardial infarction." "1343436-1" "1343436-1" "2-27-21 Heart pain, transported to ER 2x in 2 days. Within 2 days, her Liver and Kidney function failed. and Acute Hypoxic Respiratory Failure and Cardiogenic Shock were listed as cause of death on 3-3-21" "1343471-1" "1343471-1" "Death within 90 Days" "1343488-1" "1343488-1" "Death within 90 days" "1343500-1" "1343500-1" "Death within 90 Days" "1343514-1" "1343514-1" "Death within 90 Days" "1343527-1" "1343527-1" "Death within 90 days" "1343543-1" "1343543-1" "Death within 90 Days" "1343571-1" "1343571-1" "Patient received their J&J vaccination on 4/7/2021. The patient's wife tested positive on 4/12/2021. The patient tested positive on 4/23/2021. The patient presented to the ER with a severe progressive cough (starting one week prior), worsening shortness of breath, a high fever, chills, myalgias, and malaise. The patient was diagnosed with COVID pneumonia and ARDS with hypoxia and given Lovenox, remdesivir, and dexamethasone, tessalon, and Brovana. The patient was admitted on the 23rd and continued to decline until their eventual passing on 4/28/2021." "1343614-1" "1343614-1" "presented to ED dept confused, incr n/v, weakness. Received palliative carex4 days. deceased 05/24" "1343926-1" "1343926-1" "Patient presented to the ED on 5/7/21 with CVA. He was hospitalized on 5/8/21 for 12 days, and died on 5/20/21." "1344052-1" "1344052-1" "Complicated young elder with AICD for recurrent Vtach who was found unresponsive around 20 hours after vaccine; Based on the defibrillator interrogation she had sustained ventricular tachycardia that was properly identified and treated by the device but which did not respond to device discharge, degenerated into ventricular fibrillation and unfortunately could not be terminated by her ICD. Not clear related to vaccine" "1344055-1" "1344055-1" "one week after 1st vaccine shot, mom started to feel sick around lunch. Took mom to hospital she had a heart attack. They dissolved the blood clot and found out she also had pneumonia with no symptoms. She died 2 weeks later. She had dementia but health was fine until she received the covid 19 vaccine." "1344282-1" "1344282-1" "received the vaccine as an inpatient in our hospital on 5/21/21. Patient went into cardiac arrest on 5/22/21 at approximately 9:00am" "1346604-1" "1346604-1" "death J18.9 - Bilateral pneumonia" "1346657-1" "1346657-1" "Found deceased in bed, no known symptoms, undetermined cause and manner of death" "1346714-1" "1346714-1" "death J18.9 - Pneumonia, unspecified organism shortness of breath chest pain" "1346723-1" "1346723-1" "Patient contracted covid 2 months after receiving the full vaccine series. He was admitted the hospital and subsequently passed away. Variant testing was conducted (results are pending) and antibody testing was done. Antibody testing showed no antibodies were produced in response to the vaccine." "1346731-1" "1346731-1" "death R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) N17.9 - Acute kidney failure, unspecified SHORTNESS OF BREATH LEG SWELLING ASCITES" "1346738-1" "1346738-1" "death E87.1 - Hypo-osmolality and hyponatremia N17.9 - Acute kidney failure, unspecified" "1346804-1" "1346804-1" "death N17.9 - Acute kidney injury WEAKNESS - GENERALIZED" "1347081-1" "1347081-1" "Patient complained of exhaustion and malaise within 24 hours of receiving the dose. This never resolved. Three weeks later he complained of the same exhaustion and malaise. Jaw pain was reported on 5/23/2021. Patient found deceased 5/24/2021 at age of 53." "1347105-1" "1347105-1" "Found dead on May 3, 2021. Question day of death 05/01/2021. Medical examiners case. Cause pending, possible SUDEP." "1347148-1" "1347148-1" "Heart pain/ chest pain. Hard to breathe Lack of energy Swollen legs Erratic heart rate Outcome: death 3 days after. Heart failure" "1347160-1" "1347160-1" "fall on May 19 and admitted to ER May 22 with subacute R MCA stroke resulting in obtundation and left sided hemiparalysis. Complicating his presentation is acute COVID 19 infection with pneumonia along with acute on chronic systolic congestive heart failure." "1347172-1" "1347172-1" "Unexpected Death" "1347211-1" "1347211-1" "Dies at the Hospital do to a respiratory arrest." "1347521-1" "1347521-1" "Starting having trouble breathing 1 week later 2 weeks later diagnosed with pneumonia 10 days later admitted to hospital with interstitial lung disease (never before diagnosed with that) Needed 24/7 oxygen Passed away May 10/21" "1347530-1" "1347530-1" "5 days after COVID-19 vaccine, patient had a sudden unexpected cardiac arrest and died at his home after long resuscitation attempts by EMS." "1347547-1" "1347547-1" "The injury that led to the death occurred within 1 day of the decedent receiving the vaccine" "1347634-1" "1347634-1" "3/5, admitted 3 days after covid vaccine and died. Patient presented to ED feeling very weak and had fallen and could not get up. He was brought to the emergency room, and a trauma evaluation was negative. He was found to have a severe junctional bradycardia with a heart rate in the 20s and systolic blood pressures in the 60s. In addition, he was found to have a creatinine now of greater than 5 when his previously had been in the low 1s. Patient admitted with junctional bradycardia, acute renal failure, hypotension, cardiogenic shock, and acute hypoxemic respiratory failure with high O2 needs. PMH significant for CAD, pulmonary HTN, aortic stenosis, obstructive lung disease, and chronic hypoxia. This patient has been made DNR/DNI over the weekend which is quite appropriate. Patient was found to be unresponsive with fixed/dilated pupils, absent heart and breath sounds, no respiratory effort, absent pulses, and no response to painful stimuli. Patient was pronounced deceased on 03/10/2021 at 0405." "1347808-1" "1347808-1" ""started with c/o ""feels weird in my chest like a pulled muscle"", few days later slight short of breath with fatigue, May 2 11:45 cardiac arrest when paramedics placed O2, rounds of CPR and med's, pronounced dead at hospital after attempts of CPR. Out come on death certificate Bilateral Pulmonary Thromboemboli. Coroner stated there were multiple PE's in bilateral lungs. Positive for Covid 19 (Had in Feb, vaccine in April 20)"" "1347815-1" "1347815-1" "passed away suddenly a day after getting his first Moderna covid vaccine. He got the vaccine said he felt fine other that having a sore arm he has in good spirits and joking around according to his coworkers. He died suddenly a day later circumstances are unknown ,He had passed before he was discovered. No autopsy was done. Aneurysm is suspected." "1347843-1" "1347843-1" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1348060-1" "1348060-1" "My father in law suffered a heart attacked on the day he received his second shot. at the time of this he was staying in our house where he wasn't found until two days later when we received a call from his work saying he never showed up or called in to work. The medical examiner told us that prior to the second vaccine in the last few weeks he had suffered some sort of heart issue that damaged his heart, but wasn't big enough for him to notice or think anything of it. The timeline the medical examiner gave us would have been after receiving the first vaccine. He then received his second Vaccine on a Thursday which was the last time anyone heard from him and he didn't show up to work Friday and was found Saturday after we were notified he didn't show up to work and we called 911. The medical examiner said he suffered a heart attack. The medical examiner said they had to write the death date on Saturday because that was when he was found, but the last anyone heard of him was prior to getting the vaccine and then he missed work the very next day(which was Friday)." "1348290-1" "1348290-1" "The patient received the vaccine, but uses the other pharmacy in town for his medications. The pharmacist called me to relay the info he got from the patient's family. He said that the patient had a headache and body aches on Saturday 05/22/2021 and went to bed but did not wake up the next morning." "1348474-1" "1348474-1" "Patient Died of Heart Failure unexpectedly." "1349127-1" "1349127-1" "found dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (found dead) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032m20a) for COVID-19 vaccination. Concurrent medical conditions included Traumatic brain injury, Movement disorder, Seizures (since she was a baby at 11 months old) and Speech loss. Concomitant products included CLONAZEPAM, OXCARBAZEPINE (TRILEPTAL) and GABAPENTIN for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 04-Apr-2021 The patient died on 04-Apr-2021. The cause of death was not reported. An autopsy was not performed. Reporter stated that death certificate said the cause of death was natural causes. She did have her yearly physical exam after her first dose with her physician prior to her death and no other health issues were noted at the time of the exam. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Natural causes" "1349711-1" "1349711-1" "Symptoms: & cardiopulmonary arrest Treatment: EPINEPHRINE 8 MG Unknown during code" "1349910-1" "1349910-1" "Symptoms: & Death" "1349979-1" "1349979-1" "Deceased Narrative: Patient was a 82 yo male with multiple co-morbidities consisting of AF (on warfarin), prio PE, HFrEF, CAD, HTN, mixed CSA/OSA, hypothyroidism, COPD and GERD. Patient was admitted to facility on 7/12/20 after he was found down in his home for 3 days, dx with right MCA ischemic stroke with hemorrhagic conversion. Etiology of CVA was presumed to be secondary to AF/warfarin failure. No treatment with tPA or thrombectomy was initiated as he was outside the window for intervention. Patient was also found to have bilateral DVTs. Patient was then admitted to facility 08/14/20 for end of life care." "1350433-1" "1350433-1" "Presented 5/13 to Hospital. Presented to Hospital on 5/13 with one week of symptoms including cough, dyspnea, diarrhea. COVID-19 testing was positive on 5/8. Treatments prior to arrival included remdesivir and dexamethasone, started 5/13. She was also placed on pulse dose steroids 1000 mg/day methylprednisolone given her history of ground glass lung opacities in 2018. Progressed to high-flow nasal cannula, then BiPAP on 5/14, and was intubated on 5/17. Paralysis and proning initiated. Transferred to another hospital for possible VV ecmo candidacy. Patient with severe acute respiratory failure d/t covid who has failed treatment with the ventilator despite paralysis and proning. CTS asked to place patient on VV ECMO. 5/20/21 1135am initiated ECMO Patient is a 50yr old female with past medical history of hypertension, asthma, OSA and obesity BMI 41.5 who presented to hospital on 5/13 with progressive cough and shortness of breath for about a week. Of note, patient also has a history of respiratory failure presenting with ground glass opacities on CT scan in 2018 with unclear etiology despite bronchoscopy and serologic studies which resolved with high dose corticosteroids. Patient recently tested positive for COVID on 5/8 and received johnson and johnson vaccine in April. Patient was admitted on 5/13 and treated with decadron, remdesivir and tocilizumab. Course complicated by progressive respiratory failure requiring HFNC followed by Bipap and ultimately intubation on 5/17. Due to elevated d-dimer, lower extremity dopplers were obtained which were negative, however a heparin gtt was initiated. Course further complicated by cold left lower extremity; arterial duplex demonstrated distal popliteal artery thormbus extending into the peroneal, anterior tibial and dorsalis pedis arteries. therefore heparin was switched to argatroban and a HIT panel was sent. On 5/19 patient continued to decline despite paralytic and pronning. Patient transferred to ICU for further level of care and VV ECMO evaluation. On arrival patient was started on veletri; however due to continued respiratory decline a shock call was placed for VV ECMO and patient cannulated for VV @ 1200. Cannulation was difficult and patient was felt to have an IVC thrombus as clot was seen going into the ECMO circuit during cannulation. Post cannulation she developed worsening septic shock and DIC. She received 2uprbc, 1unit cryo, 1 platelet, 2 FFP, 5 liters crystalloid and 1L albumin. Blood cultures positive for GPC in clusters. Escalating vasopressors (Epi/NE/vaso) and ongoing hypoxia family opted to change code status to DNR. Patient then continue to have worsening hemodynamic instability and went into PEA and ultimately asystole. She was pronounced deceased at 1815. Family was en route already due to her instability thus will be notified of her passing once they arrive. Dr. was notified of patients death." "1350509-1" "1350509-1" "unknown" "1350521-1" "1350521-1" "Patient was hospitalized 5/7/2021 after testing positive for COVID-19 on 4/30/2021. Patient was fully vaccinated. He died 5/18/2021." "1350545-1" "1350545-1" "Patient brought to the ED with generalized weakness worsening over prior 2-3 days, states she started experiencing after receiving 2nd dose of Covid vaccine. Found to have a positive troponin, hyponatremia. Stress test revealed reversible myocardial ischemia of the inferior and lateral walls of left ventricle with a large defect size but mild defect severity. Patient underwent PCI with DES placement and was placed on triple therapy with aspirin, clopidogrel and eliquis. Patient presented to ED again on 5/23/21 outcome: patient is brought to ED after a fall and loss of unconsciousness, hit her head with large laceration at back of head, 2 episodes of vomiting, leading to terminal events: brainstem compression and rapid deterioration and CS of 2T preclude meaningful survival" "1350631-1" "1350631-1" "Per daughter, patient, after uneventful vaccine administration and 15 minute observation period, returned home, and father had lunch with wife and daughter. At 1:30, father remained home while daughter and wife went grocery shopping. Upon return from grocery store, approximately 1 hr. 45 minutes later, daughter found father unresponsive in bathtub with small amount of water, faucet off, and father partially clothed. Per daughter, the shower chair had been removed from the tub by her father. Per daughter, an autopsy was planned. Results are pending." "1350670-1" "1350670-1" "After first dose her mental status become slightly altered and she leaned to the left a bit when standing up and walking.. From the day of second dose my sisters appetite decreased. She started sleeping more, got weaker to the point I had to bathe her, she had to start using a wheelchair. Mental status much more altered. She was to weak to go to dialysis on Monday March 22 2021 hospice was called in Tuesday March 23 2021 and she passed away at approximately 4:00 P.M. March 24th 2021." "1350766-1" "1350766-1" "Hospitalization and death" "1350875-1" "1350875-1" "My mother, was found deceased on March 19, 2021. Last seen and spoke to on March 18, 2021 around noon or before. After first injections, Pt reported being extremely tired around day 4 and laid down for a nap in the afternoon and woke up the next day in the morning. On the day she was found, it appears she had taken a nap on the couch and never woke up from the nap. This occurred within 10 days after the shot. Possible 9 days if she passed on the 18th. She was found deceased on 3/19/2021 after she didn't answer he apartment door for her meal being delivered." "1350953-1" "1350953-1" "During vital sign inspection, patient presented low saturation, and was taken to the Hospital." "1350978-1" "1350978-1" "78y.o. male with a past medical history of COPD, DM II, and HTN who presented to the hospital's emergency department from an extended care facility. Patient was recently hospitalized and treated with IV antibiotics for HCAP. Patient tested positive for COVID on 3/24/2021. EKG was negative for ischemic signs but patient had an elevated troponin. CXR showed right pleural effusion. Patient was admitted with COVID-19 pneumonia and severe respiratory failure. Patient's oxygenation continued to deteriorate despite Remdesivir, decadron and lovenox. Patient went into respiratory failure and expired from progressive respiratory failure." "1351018-1" "1351018-1" "Loss of apatite, when the time for diaper change arrived, patient was found without vital signs." "1351084-1" "1351084-1" "75 y/o female w/ PMH significant for COPD, diabetes, GERD, HLD, HTN, CAD, CVA who presented to the hospital ED on 4/2/21 for fever, dyspnea. Pt reports being exposed to COVID 1 week ago, her entire family at home had it. She called her PCP and was placed on multivitamins and prednisone taper when she became symptomatic ~3/27/21. Throughout the week, pt had worsening dyspnea, worse with exertion, as well as dry cough, fevers and chills. Reports her temperature was 102 at home. Pulse ox was 85% at home and pt was instructed to come into the ED. On arrival, O2 82% on RA and pt having some respiratory distress. Patient was intubated and placed on full vent support, but could not be extubated. Patient's diabetes continued to be uncontrolled because of IV steroid. Patient's lactic acidosis improved with IV hydration. Patient continued to be difficult to extubate because of COVID pneumonia with ARDS. Family opted for the patient to be transitioned to hospice care and comfort care. Expired on 4/26/2021." "1351091-1" "1351091-1" "Onset urticaria 3/12/21. ED visit 3/14/21. Syncopal episode in context of rash 3/17/21 leading to hospitalization 3/17-8/21. Benadryl, loratadine, famotidine, cephalexin for UTI. 2nd Moderna shot 3/27/21. 4/2 Office visit dizzy, weak, headaches, nausea, loss of appetite since 2nd vaccine Na 127. 4/16 Office visit for Headache, neck pain. 4/25 ED visit for dizziness. MRI head NL, labs mild hyponatremia. Given meclizine. 4/27-8 Hospitalization for dizziness, orthostasis, URI symptoms. OC43 Coronavirus, orthostasis. Alb 2.7 Globulin 5. New cervical and axillary Lymph adenopathy. 5/8/21 admitted to hospital w/ new diagnosis of lymphoma (pathologic diagnosis Nodal peripheral T cell lymphoma w/ follicular helper phenotype. Large axillary lymphadenopathy, thrombocytopenia, elevated total protein, acute kidney injury, anemia. 5/15/21 patient passed away from acute hypoxic respiratory failure in the setting of new lymphoma diagnosis." "1351119-1" "1351119-1" "Patient presented to the ED on 4/23/21 and was subsequently hospitalized for Acute on chronic respiratory failure with hypoxia and hypercapnia. Patient presented to the ED on 5/5/21 and was subsequently hospitalized for hypertensive urgency and CVA. Patient died on 5/9/21." "1351172-1" "1351172-1" "Death on 2/18/21. Pulmonary embolism found on autopsy." "1351207-1" "1351207-1" "73 year old male with PMHx of AFib, CAD, and HTN who presents with c/o dyspnea that started 4/6/21. Patient states it got to the point where he could not walk in his house without severe dyspnea. States he was diagnosed with COVID-19 one week prior. Per chart review he was in our ER 4/3/21 and diagnosed with COVID-19. At the time he was 95% on room air. His only other symptom has been diarrhea. He states he received the Johnson and Johnson vaccine one month ago. He denies any dizziness, chest pain, abdominal pain, n/v, weakness, or numbness. In ER patient was hypoxic and improved only with BiPAP. Per chart review patient had cardiac arrest on 11/2020 for 17 minutes. He has a significant cardiac history consisting of stemi, fem-pop bypass surgery, PVD, CABG x4, AFib post ablation 2017, V-tach. He was started on therapy with steroids, anticoagulation, and Remdesivir. He failed to improve and had increasing oxygen requirements. He was eventually intubated. Due to failure to improve patient was made DNR and eventually expired." "1351287-1" "1351287-1" "11am Resident vaccinated. 2pm Chest congestion, STAT dose of Solumedrol and non rebreather applied. Resident had small amount of emesis and was suctioned. Was being monitored and expired at 2:30 pm" "1351301-1" "1351301-1" "Resident was given the vaccine on 05/19/21 and has been doing well until 05/25/21 around 10:01 am, he was found very congested, lungs with crackles, O2 saturation went down to 60-70 %, placed on 100% non-rebreather masks. Resident suctioned as ordered. Resident was placed on Hospice care. Resident expired at 11:58am." "1351445-1" "1351445-1" "Slight malaise after first dose. After second dose, she complained of body aches throughout the rest of the day until she was transported to the hospital." "1351466-1" "1351466-1" "88-year-old male with lymphoma that received a transfusion of 2 units of packed red blood cells prior to admission. The patient has a history of pleural effusions and he states after the blood transfusion, he became increasingly more short of breath and could not catch his air. He was dyspneic at rest and exertion. There is no cough. No fevers. He also has a history of cardiomyopathy and chest x-ray is suggestive of increasing sizes of his pleural effusions. Tested positive for COVID on 4/20/2021. Moved to hospice and expired on 4/22/2021." "1351475-1" "1351475-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1351511-1" "1351511-1" ""dead two weeks later, is that good enough for your ""adverse event""? Are you using the data to be sure it's killing like you want? What do you want from me here?"" "1351527-1" "1351527-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1351556-1" "1351556-1" "Patient was hospitalized multiple times and died within 60 days of receiving a COVID vaccine series" "1351564-1" "1351564-1" "Pulmonary embolism that resulted in death" "1351581-1" "1351581-1" "Complaint of cramping in legs on April 26. 2021. Resolved for a short period of time. Earlier in May 2021 Complaint of Left Flank pain with Radiating pain to Left Thigh. Appointment with Orthopod cancelled due to inability to drive with pain. On May 15, 2021 complaint of continued Left Flank Pain Radiating to to Left thigh with burning and discoloration. Unresponsive on May 16, 2021. Pronounced Dead at 1:52pm by County Coroner. Cause of death noted as CV. Nature of death :Natural This is being reported in case another patient complains of these same symptoms. There may or may not be a Correlation with this Death and The Jassen Covid-19 Vaccine" "1351679-1" "1351679-1" "Difficulty Breathing, Pain" "1351907-1" "1351907-1" ""My mother described feeling ""off"" from the moment after the second vaccination of COVID19 (Pfizer-BioNTech). She Continued to feel strange weeks after the vaccine. My mother passed away at age 55 completely healthy and had a check-up with her primary care physician prior to any vaccinations. My mother did not die of natural causes at the time of her age and health."" "1352518-1" "1352518-1" "My father had a reaction soon after the first dose in which he vomited violently. The vomiting continued over the next several months but less frequent along with dizziness and fatigue. On April 10 he was admitted to the emergency room with low hemoglobin numbers. Things quickly escalated from there. He was admitted to the ICU and diagnosed with autoimmune hemolytic anemia. After a month in the ICU, over 60 blood transfusions, 20 dialysis, multiple pharmaceutical treatments and a splenectomy, my father died on May 13." "1353752-1" "1353752-1" "He received both doses March 2021. second dose on 3/26. on 4/26 presented to ER with Epistaxis, came to about a month after Pfizer series pt went to Hospital ER 3 times that week for care of what was thought nose bleeds from picking, and later ENT for care that required travel. Pt stopped Plavix use and 6 days later on 5/1 returned to Hospital ER with serious symptoms, developed multiple thrombotic events that lead to clotting of leg/bowel/coronary. Transferred to Hospital on 5/1/2021. Multiple MI events and expired at Hospital on 5/3/2021" "1354136-1" "1354136-1" "Patient had been complaining of worsening LE edema 3 days prior to event. She was seen at the clinic and given medication for it. Patient apparently developed high BP at home ( worsening HTN ?) and passed away at home 5 days after vaccination (05/11). No further info." "1354152-1" "1354152-1" "Eleven days after getting the shot, my mother in law was experiencing severe back pain and was not able to get comfortable or sleep at night. Before we could take her to see a doctor, she fell while trying to get out of bed at 7am the next morning. She had trouble getting up and exerted a lot of energy trying on her own. She called for my husband and I to help her get up. I grabbed her around the waist and my husband held her walker for her as support. Upon rising (mostly of her own ability) she was so exhausted that we had her sit on her walker and rest a moment. My husband went to check on her twice over the next 15-20 minutes, but when he returned again she was showing classic stroke signs and EMS was called. They arrived quickly and agreed. She was taken immediately to the ER, where they also agreed that it looked like a stroke. She was admitted as they continued to run tests, but she continued to decline more and more each day at the hospital losing motor skills and ability to speak. She was not able to move her right side at all and the left side was fidgety and had uncontrollably flailing that left her bruises on her arm and leg. She was also excessively sleepy. After loads of testings and images, the MRIs finally showed that the brain stem was extremely inflamed and it was an auto-immune response. By this time, she was already a vegetable in the ICU ward under incubation, IVs and a feeding tube. They continued to run more tests and brought in infectious diseases, but they ultimately said her body was fighting an infection that she did not have. They attempted a hemoglobin treatment with an oncologist to shut down her immune system but never consulted with her renal doctor, even through they were very concerned about renal failure. She could not complete the treatment and only received 4 out of the 5 doses they wanted to give her because of her kidney counts. They said that the auto-immune attack was very aggressive and they could not shut it down. In the early morning of 4/28/21, they finally contacted her kidney doctor and she was put on dialysis as a last effort to try to save her, but it was too late and all her organs were failing. She passed at 1:56 pm. Patient was homebound during the pandemic and did not leave the house unless she was visiting her doctor's office. My husband and I have limited contact at our jobs, as we work in small offices, and our children (that also lived with her) were being schooled virtually. There is nothing that I know that could have caused her immune system to go into overdrive, except for the vaccine that was administered less than 2 weeks (which is considered the time frame for vaccine immunity) prior to her symptoms." "1354172-1" "1354172-1" "PATIENT REPORTED DIFFICULTY BREATHING UPON EXERTION AND CHEST PAIN STARTING AROUND 05/08/2021. PATIENT WENT TO MD ON 05/12/2021 WHERE MD FOUND EKG ABNORMAL. PATIENT PASSED AWAY THAT EVENING" "1354193-1" "1354193-1" "Patient received second COVID 19 vaccine on 4/13/21 at Site. Patient tested positive for COVID on 5/16/2021. Patient had worsened short of breath on 5/25/2021 and was admitted to Medical and placed on a vent. Patient expired on 5/26/2021." "1354321-1" "1354321-1" "Hospice patient death within 60 days of receiving a COVID vaccine" "1354336-1" "1354336-1" "Patient was hospitalized multiple times and died at home within 60 days of receiving a COVID vaccine" "1354359-1" "1354359-1" "Patient presented to this facility on 5/12/21 as transfer from hospital for treatment of acute hypoxic respiratory failure secondary to COVID pneumonia requiring intensive care unit treatment. Patient did receive a J&J COVID vaccine on 4/7/21. Patient was intubated on arrival. Patient was treated with remdesivir, tocilizumab, steroids, and antibiotics. Patient's ARDS progressed. He developed septic shock, recurrent pneumothoraces, and acute kidney injury on chronic kidney disease. Patient did not improve. Patient was transitioned to comfort care on 5/23/21 and patient expired." "1354490-1" "1354490-1" "Was found deceased in bed this morning" "1354548-1" "1354548-1" "No adverse symptoms reported. Death following a fall while at home alone." "1354601-1" "1354601-1" "cardiomegaly, with significant bilateral lung abnormality. in addition, pulmonary edema with extensive bilateral multifocal pneumonia" "1354616-1" "1354616-1" "Difficulty breathing, coughing, congestion, dies of cardiac arrest." "1354660-1" "1354660-1" "Patient spouse reports to me the following: patient felt normal most of the day, later in the evening he felt extreme fatigue went to bed around 9pm. She found him deceased around 2am." "1354740-1" "1354740-1" "Death" "1354796-1" "1354796-1" "According to the family, he had symptoms of weakness, nausea, headache, difficulty breathing beginning May 15, 2021. They spoke with him on Sunday, May 16, 2021 and he was continuing to have symptoms. On Monday, May 17, he called one of his daughters, but she missed the call. The family tried to call him on May 18- and May 19, but they couldn't reach him. A welfare check was initiated on May 20; however, the police didn't enter the residence. He was found dead in his bed on May 21, 2021, with changes of decomposition." "1354811-1" "1354811-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1354838-1" "1354838-1" "71 y.o. male with history of leukemia who presents accompanied by his son with complaints of 6 week history of generalized weakness worsening over time accompanied by loss of appetite and weight loss. He reports receiving his initial COVID vaccine 6 weeks ago and symptoms began immediately following this. He denies pain or SOB. Pt with severe protein calorie malnutrition and AML presented with dehydration from MRSA Sepsis. Pt had weakness from dehydration, malnutrition and sepsis. He had a progressive downhill course. His family elected for comfort measures. He died of his illness and was pronounced dead at 4:13AM April 13, 2021" "1354848-1" "1354848-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1354872-1" "1354872-1" "Patient was hospitalized multiple times and died within 60 days of receiving a COVID vaccine series" "1354898-1" "1354898-1" "My brother had his second vaccine shot on 4/30. When I talked to him on 5/5 he told me he'd had a lot of joint pain and fatigue but thought he would go into work the next day. Thursday he left work feeling sick with a lot of 'rib pain'. At some point that night he passed away. We still do not have an autopsy report, but the timing seems odd." "1354899-1" "1354899-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1354932-1" "1354932-1" "Patient was hospitalized multiple times and died within 60 days of receiving a COVID vaccine" "1354957-1" "1354957-1" "On 3/27/21 at around 9pm He felt tightness in chest which lead to heart attack and death" "1354959-1" "1354959-1" "Muscle ache, loss of smell and taste The PUI started feeling ill on 4/29/21 with minor symptoms. The patient is having body aches and a loss of appetite due to his loss of taste/smell. The patient is currently undergoing chemo therapy and is most likely the reason why he still got sick with COVID-19 even though he is fully vaccinated. Cause of Death: ACUTE HYPOXIC RESPIRATORY FAILURE, COVID 19 PNEUMONIA" "1354978-1" "1354978-1" "He received the vaccine and had a heart attack on May 3, 2021 and passed away on May 4th. They did an full autopsy" "1355014-1" "1355014-1" "Patient on hospice d/t Stroke. She had a history of CVA's. She died 5-26-2021." "1355032-1" "1355032-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine" "1355039-1" "1355039-1" "Cardiac Arrest" "1355052-1" "1355052-1" "She received her vaccine. The next few days, she was extremely tired and slept a lot. A couple days after the vaccine, she complained that her stomach hurt slightly. Days went by and the pain slowly got worse. She didn't feel like eating. Then on 2/8/21 in the middle of the night, she woke up in excruciating pstomach pain and her husband called ambulance. They rushed her to ER. The determined that her colon had ruptured near her stomach and they took her in for emergency colonoscopy. The surgery was a success, but a couple days after, she was weak and said she didn't want to fight any longer. They put her on hospice measures and she died 2/15/21. We feel that she was doing fine before the vaccine, and then all of a sudden this occurred. Seems to be too much of a coincidence. Finally taking the time to report it, in case there are others having colon and or stomach issues." "1355095-1" "1355095-1" "Daughter reporting after her mother's death . She got her vaccine and called her daughter in the afternoon around 2:00 and told her that she got it. At 6:00 she received a VM where she said that she was having joint pain and wanted to know if she could call her doctor to get her joint pain medicine. Later that evening her daughter told her that was why she was put on the Hydroxychloroquine and they wanted her to see the rheumatologist. She complained of pain a lot, but she specifically asked for joint pain medicine. On the 22nd on another VM her daughter noticed that she sounded raspy hoarse sounding and congested and had a cough. Then subsequent messages after that the hoarseness was there that didn't go away. Her daughter took her to the dentist on 4/15/21 and she remembered that the caregiver told her that she did not want to go to the dentist as she did not feel good. She did not like to get out of the apartment. Then on 4/19/21 she was admitted to the hospital and that she had pneumonia. They were going to discharge her home and she was going to pick her up on 4/22/21, and then they called her back and told her that she sounded junky and they were going to keep her another day. She made arrangements to pick her up on Friday and then her oxygens dropped and would discharge her on Monday. She normally gets oxygen 1 liter of oxygen only at night, and when she was admitted her oxygen levels were low and they put her on 6 liters when she was admitted. Then she was weaned off oxygen completely, and her daughter informed them that she slept with oxygen and that's when they were talking about going home. On Friday she dropped her oxygen level into the 60's On Saturday 4/24/21 she was on 9 liters of oxygen and the doctor came in and said that she was on 14. By Saturday night she was on the Critical care Unit, but her on Vancomycin and was on Vapotherm on high-flow oxygen and she had maxed out at 40 liters at 100% oxygen. They talked to the daughter about putting her on ventilation and thought it was toxicity to Vancomycin and other things and couldn't figure it out and said that it was some sort of inflammation of her lungs. They put her on high levels of steroids and was then taken off of high-flow oxygen and then was still on 20% liters. They recommended hospice and palliative care. They decided to bring her home on Hospice with 15 liters of oxygen. It was up and down levels. She was given steroids when she came home on Hospice and was given steroids. She then started to decline and hospice nurse came and she was admitted to Hershey and they repeated her chest x-ray and COVID testing, and that her lungs were so scarred there was nothing that they could do for her. They tested her for COVID multiple times, the CAT Scans came back that it was worsening and consistent with COVID but tested negative twice while was there. She was then sent to Hospital and tested again and was negative, and she passed on 5/10/2021. HOSPITAL ADMISSIONS: She was admitted to on 4/19/21 discharged home on hospice on 5/6/21. She was admitted to Medical Center on 5/6/21 and she died on 5/10/21 at 5:48 PM." "1355126-1" "1355126-1" "Difficulty breathing and pain in the chest." "1355128-1" "1355128-1" "Fainted in apartment parking lot, on morning of April 3; transported to ER,, via ambulance. Hospital stay for several days, moved to Rehab, sent back to ER with a cough, trouble breathing, and swallowing. Diagnosed with pneumonia. Went into coma on 4/18. Passed away on 4/22/2021." "1355174-1" "1355174-1" ""On 5/20/21 the patient was at home with his mother when he had acute nausea, light-headedness, and abdominal pain. He presented to the ED by ambulance. Excerpt from ED notes od MD follows: ""Initial ED interventions: iv fluids, low dose iv ativan, iv toradol, iv zofran. ED course: patient arrives very anxious, writhing on bed, difficult to redirect. With chronic tonicity, not seizing. Mother arrives, and he recognizes her, seems to be consoled somewhat by her presence, but she is unable to direct him, and describes his behavior as irregular, and events acute this evening at her home. Patient rests, and then HR decrease to 50s on monitior and patient found to be pulseless - I immediately start chest compressions, and achieve ROSC after PEA arrest with administration of EPI/compressions. Patient intubated per procedure note without complication. L femoral central attained per procedure note without complication. CPR performed over ED course intermittently (always PEA arrest) with ROSC achieved with administration of EPI, EPI drip started in addition to sedation meds, and iv fluids. No obvious STEMI on ECG to administer lytics, with suspicion of dissection and AAA prominent. I am able to stabilze and accompany patient to CT suite, where I recognize B/L massive PE immediately. I discuss with Dr. of Cardiology, who agrees with admininstration of alteplase. I disucss risks with mother who consents verbally. Patient without response to alteplase, and with continued pattern of PEA arrest following bradycardia. I discuss etiology of presentation with mother,and that patient is with very poor prognosis of survival, and likely poorer prognosis of neurological status, and patient is made comfort care, and fentanyl drip increased, patient is taken off of ventilation and drips. Pronounced deceased at 22:00. MDM: Initial concern for but not limited to appendicitis, AAA, diverticulitis, renal stones, pyelonephritis, musculoskeletal pain, pancreatitis, toxic ingestion, ACS, obstruction, perforation, sepsis (2/2 PNA, UTI, meningitis, intra-abdominal infection), AAA, dissection, PE - as ED course progresses, differential narrows and consider more likely PEA arrest secondary to ACS, PE, dissection, AAA, necrotic pancreatitis, tension PNX (less likely). Considered but do not suspect seizures, stroke. Imaging studies reviewed - CXR with ETT in place, no acute pathology. CTA chest/A/P remarkable for massive proximal B/L PE. Labs reviewed. ECGs without STEMI, with sinus tach initially, LBBB after initial ROSC, and then AFib in RVR on subsequent ECG. Per above, patient suffered massive B/L PE, with subsequent cardiac arrest, despite heoric efforts including thrombolysis. Death called art 22:00. Diagnosis: massive B/L PEs, PEA arrest. Disposition: deceased."""" "1355185-1" "1355185-1" "Patient found dead" "1355384-1" "1355384-1" "Admitted to the hospital with weakness, fever on 4/14/2021. Transferred to ICU on 4/17/21 requiring bipap. Intubated 4/25/2021. covid + 4/2/21. Last vaccine dose completed 3/3/2021. Pt died on 5/15/2021" "1355794-1" "1355794-1" "My mother has never had any heart issues, and suffered a heart attack on Thursday April 15. She had 2 stints put in late Thur evening. The surgery went well, but there was too much damage to her heart and she passed away on Sat April 17, 2021" "1355806-1" "1355806-1" "My father received his vaccines through the hospital, on 1/23/21 and 2/13/21. The week of April 17, 2021, he started with diarrhea and cough. He spoke with his PCP and was told to quarantine and report any worsening symptoms. Wednesday or Thursday he began with vomiting and unable to hold down any fluids. His cough was nonproductive. On Saturday 4/17/21 he reported to Hospital ER with SOB, cough, vomiting & diarrhea. He was diagnosed with COVID PNA. He passed away 5/7/21 of COVID PNA, respiratory failure. He tested positive the week of 5/7/21 again of COVID 19. I feel this needs to be reported as he had both PFIZER vaccines in January & February and still ended up intubated and deceased from COVID 19." "1355831-1" "1355831-1" "Site pain Vomiting fever death" "1356045-1" "1356045-1" "Death. Patient died on 5/3/2021; two days after receiving vaccine." "1357112-1" "1357112-1" "Patient developed COVID after vaccination; She is now deceased; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (She is now deceased) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cancer (previously had cancer twice). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), NIFEDIPINE (PROCARDIA [NIFEDIPINE]), TICLOPIDINE HYDROCHLORIDE (TICLID), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient developed COVID after vaccination). The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, COVID-19 (Patient developed COVID after vaccination) outcome was unknown. It was reported that the patient previously had cancer twice, and her immune system was not what it should have been. The patient got really, really sick and had COVID at some point after receiving the vaccine. No corrective treatment was provided. Action taken with the drug in response to the events was not applicable. Company comment: Very limited information regarding this event has been provided at this time. Noting the subject had received 1st dose of vaccine prior to COVID. However, based on the mechanism of action of mRNA1273, the event COVID is unlikely related to vaccine.; Sender's Comments: Very limited information regarding this event has been provided at this time. Noting the subject had received 1st dose of vaccine prior to COVID. However, based on the mechanism of action of mRNA1273, the event COVID is unlikely related to vaccine.; Reported Cause(s) of Death: Unknown cause of death" "1357338-1" "1357338-1" "her mother's body was full blown with leukemia/she wasn't responding/leukemia was back; Second dose: breathing heavy; Second dose: screaming in agony and pain because her sides were blowing up in pain; Second dose: She had no red blood cells that could provide oxygen to her organs; Second dose: weak; Second dose: overproducing of her white blood cells; Second dose: wasn't acting like herself; Second dose: more tired; Second dose: she could hardly talk; Second dose: she couldn't stand up; Second dose: she lost control of her bowels; Second dose: hollow cough; This is a spontaneous report from a contactable consumer. A 96-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Mar2021 (Batch/Lot Number: EP6955) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Leukaemia in 2018, High blood pressure with 40 years, Diabetes in 2016, Atrial fibrillation in 2018.The patient's concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (Batch/lot number: EN6199) in left arm on 07Mar2021 for COVID-19 immunization. She had just had her blood drawn in Feb2021 and her blood was ok. So on 07Mar2021 she received her first Covid 19 vaccine. At 96 years old, after the Covid 19 vaccine, her mother's body was full blown with leukemia. Radiation wasn't an option to stop the overproducing of her white blood cells. The Covid 19 vaccine just accelerated it. Maybe there are others out there in this condition and should be double checking to see if they should get the Covid 19 vaccine. On the 12Apr2021 or 13Apr2021 her mother started having a hollow cough. She wasn't congested but she continued to cough. She noticed her mother was breathing heavy and fighting to breathe on Friday, on16Apr2021. It wasn't getting any better and she thought her mother would have more trouble so she took her to the emergency room. She reported she took her mother to the hospital on 16Apr2021.She was admitted on 16Apr2021 and discharged on 18Apr2021. They gave her some oxygen and did some tests. They asked her mother if she had chronic obstructive pulmonary disease and she did not, they suggested that it was her atrial fibrillation. She has had atrial fibrillation in the past, her doctor did leave her on her atrial fibrillation medication. She can't recall the name of the atrial fibrillation medication. She was discharged home on 18Apr2021 and she was breathing ok on her own. But by that next Tuesday, 20Apr2021, she noticed her mother was declining. She wasn't acting like herself. On Wednesday, 21Apr2021, she was more tired and her difficulty breathing started back up. On Thursday, 22Apr2021, she called the ambulance to take her mother to the hospital. She could tell that her mother wasn't herself, she could hardly talk on 22Apr2021 , she couldn't stand up, she lost control of her bowels. She wasn't responding to her. The caller knew something was going on. They put oxygen on her mother and they transferred her to a cancer specialist hospital. That's when the doctor realized it was a leukoblast. Clarified with caller, leukoblast. Then her mother died. She died on 28Apr2021.The caller knows the hospital was doing tests to see what was causing her mother's pain, but she doesn't have that information. She heard the screams from her mother and there was no consoling her mother. The hospital gave her mother morphine and it didn't work. She has no product information for the morphine, it was given in the hospital. She was screaming for murder, screaming for help and was given the morphine. Within a month of receiving the Covid 19 vaccine her leukemia was back and her mother was screaming in agony and pain because her sides were blowing up in pain. Whatever the Covid 19 vaccine did in her body, her body thought it was fighting off something. She had no red blood cells that could provide oxygen to her organs. She was weak. Overproducing of her white blood cells on an unspecified date. The lab data included White blood cell count abnormal and Red blood cell count decreased. Outcome of her mother's body was full blown with leukemia/she wasn't responding was fatal, of remaining events was unknown. Treatment received for all events. The seriousness of event breathing heavy and fighting to breathe were reported as hospitalization from 16Apr2021 to 18Apr2021. The seriousness criteria of she wasn't responding was reported as hospitalization from 22Apr2021 to 28Apr2021.; Reported Cause(s) of Death: Fatal Neoplasm progression" "1357346-1" "1357346-1" "she slowly declined with pneumonia; Woozy/Dizzy; Sleeping all the time; Not eating; Running a fever off and on; Her blood pressure was a bit low, 105 over something; suspected COVID-19 with symptoms; Heart attack; This is a spontaneous report from Pfizer from a contactable Consumer reported for mother. A 65-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05May2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The cancer doctor told her that she needed a Covid vaccine since she has cancer and a lowered immune system. Medical history included Metastatic rectal cancer from Jul2019 to 17May2021, Osteoporosis from unknown date to 17May2021 (She had it for maybe 10 years or something), Fibromyalgia from unknown date to 17May2021 (She had the fibromyalgia for 20 years). She had rectal cancer, osteoporosis, fibromyalgia, and a couple other things that the caller can't think of off hand. Her mother was diagnosed with the rectal cancer in Jul2019. The caller has no idea when she was diagnosed with the osteoporosis. She had the fibromyalgia for 20 years, and the caller is sure it was the same for the osteoporosis, maybe 10 years or something. They were being managed. There were no concomitant medications. The patient did have metastatic rectal cancer, but it was managed. She was not on hospice or terminal, and they hadn't exhausted all of the treatment plans yet. It was being controlled. She was under the surveillance of a cancer doctor who was completely shocked by her sudden death. It seemed like there was no reason. She was fine and drove herself to her appointments all the time. She had just driven herself to her last appointment. She passed away yesterday morning. She was slowly declining since she got the vaccine. The coroner was playing guessing games and assumed it was pancreatic cancer. Well, she didn't have pancreatic cancer, and the doctor already said the cancer didn't kill her. The doctor said if he had to guess it could have been some kind of pneumonia or a reaction to the vaccine. All of it made her heart stop. The coroner couldn't get the city to approve an autopsy to see the real cause of death because there was no foul play. The caller took it upon herself to discover if maybe Pfizer could help, and she needs to alleviate the vaccine as an option if it contributed. She is so tired and hasn't slept. It is devastating. This woman was everything in her life, and the caller is probably going to go next with how she feels. She feels responsible. Her other guess is if she gave her mother Covid and she slowly declined with pneumonia. The caller couldn't get her sister to take her mother to the ER. Her sister was there Sunday night. On Monday morning her sister called to say her mother was gone. On 05May2021 the patient had the first dose of the Covid vaccine. The caller could have gone there or called an ambulance when her mother wasn't answering the phone. She knew something was wrong. She called her sister who said their mother wasn't feeling good. Her mother was woozy, dizzy, and sleeping all the time. On day 3, Sunday, the caller couldn't get her mother on the phone. She thought she had some level of peace because her sister was there and could keep her updated. Her mother often gets sickly, but she always answers the phone even if she is deathly sick. The caller thought enough is enough and she needed to be put on the phone on speaker with her mother. The caller's sister said her mother was sleeping. The doctor said to probably bring her mother to the ER. The caller told her sister who just didn't take her mother to the ER. The caller could have called an ambulance. She feels incompetent. They are assuming the cause of death was a heart attack. If her mother had gone to the ER on Sunday night they may have found out. Her mother became woozy last weekend because the caller was there on Thursday and her mother didn't look good. She had her chemo bag because she brings it home. It was her first new chemo treatment, and the caller had never seen her mother respond like this. It was strange. Any other time when she was getting chemo she felt great because there is so much stuff in there like steroids to prevent a reaction. It was surprising because she was only sick on chemo once and she had been on this one before. She was just off. Then she continued to decline from there. It started before the chemo. She got on chemo that Thursday before Mother's Day, she was on her first chemo treatment at that time. She was sick a couple of days before that. She had the chemo on 06May2021. She started feeling sickly the day she got the injection on 05May2021. When the caller was there she was thinking it was from the chemo. The caller calls her mother every day and she was sounding worse and worse. On Thursday 13May2021 her mother took herself to her chemo follow up appointment and was telling the doctor that she was woozy, dizzy, and not eating. The doctor gave her fluids, and he didn't give her chemo because she was not scheduled for it that day. It was just a follow up appointment. He sent her home. The caller talked to her mother on Thursday evening and she didn't sound good and told her she was woozy and dizzy. On Friday, Saturday, and Sunday she didn't answer the phone. The caller's mother is totally against vaccines, and she had been begged to get the pneumonia and flu vaccine and denied them. She had never responded well to them in her life. Even as a cancer patient they would say she needed it and she wouldn't. She did get the Covid vaccine even though she didn't want to. The caller thought her mother was trying to convince herself it was because of the vaccine because she is so against them, but now she doesn't know. The doctor said he didn't think it would have been Covid because she didn't have a fever. Her mother told her that she had been running a fever off and on, which is not unusual for her mother. The doctor didn't think it would have been Covid. Her mother started sleeping all the time mid week last week. She started not eating at the end of last week. The caller has no idea when her mother had a fever. She hadn't gotten to talk to her mother all weekend. At some point last week her mother had said in a conversation that she had a fever off and on. Then on Thursday when she went to the chemo doctor she had no fever it shows it was 97 something. Her oxygen was fine. Her blood pressure was a bit low, 105 over something, which is low for her. She didn't have a fever last Thursday. Prior Vaccinations within 4 weeks no other vaccinations. Blood work on 13May2021 with unknown result. The patient passed away on 17May2021 after receiving the first dose of the Pfizer Covid vaccine. The caller expresses concern that her mother may have had Covid. No autopsy done. Cause of death was Heart attack. Information on Lot/Batch number has been requested.; Reported Cause(s) of Death: Heart attack" "1357362-1" "1357362-1" "Patient went to sleep and died within 12 hours of vaccination; feeling sick; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at the age of 45-year-old on 20May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 45-year-old healthy male patient received Pfizer Covid vaccine in the morning, reported feeling sick by the evening on 20May2021. Patient went to sleep and died within 12 hours of vaccination on 20May2021. Event took place after use of product. The patient died on 20May2021. It was not reported if an autopsy was performed. The outcome of event feeling sick was unknown. The outcome of event 'Patient went to sleep and died within 12 hours of vaccination' was fatal. Information on lot number/batch number has been requested.; Reported Cause(s) of Death: Patient went to sleep and died within 12 hours of vaccination" "1357369-1" "1357369-1" "Passed away from a Pulmonary Embolism; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 39 years old, on 11Mar2021 (Lot Number: EN6208) as single dose for covid-19 immunisation. Medical history included wolff-parkinson-white syndrome from an unknown date to 15Mar2021. The patient was diagnosed with this later in life, but was told he probably had it his entire life it just hadn't caused any issues for him. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously got the flu vaccine for immunization every year with no issues. The patient passed away from a pulmonary embolism on 15Mar2021. The patient was not hospitalized prior to his death. He died from the pulmonary embolism in his sleep. The reporter denied any medications, labs, testing, or treatments for her husband relevant to these events. The patient died on 15Mar2021. There was a private autopsy performed and they said that the Pfizer Covid Vaccine was one of the contributing factors to the patient's death. The autopsy said the vaccine was a contributing factor. The reporter stated she told them since they said it was the pulmonary embolism that killed him, then that's what it should say. The Medical Examiner was saying that the science for the vaccine is so new, they just don't have the data that they need.; Reported Cause(s) of Death: Pulmonary embolism" "1357679-1" "1357679-1" "3 days after 2nd dose of moderna patient presented to our er in cardiac arrest; lacking extensive cardiac history other than a-fib; he had reported anginal like symptoms to his wofe during the day and then collapsed in v-fub and was unrecusitatble; no autopsy or further information; unclear if vaccine is contributory but within 3 days i agreed with patient's wife in that the temporal relation should be reported" "1357990-1" "1357990-1" "Patient hospitalized. Patient died after testing positive for COVID-19. Admitted to hospital 4/2/2021 for right flank pain. Tested positive on 4/1/2021. Died 4/29/2021" "1358044-1" "1358044-1" "Resident was not having any complaints after injection, Vitals were being monitored Q-shift for 72 hours and up to the time of incident vitals were stable, Administrator received phone call approximately 120am stating resident was complaining of SOB and Chest pain, RN supervisor came to assess resident and determined that she needed to be sent out. EMS was called and in route and resident was having conversation with night shift staff member and suddenly ceased talking and had passed away. Resident was a DNR at the time of incident." "1358087-1" "1358087-1" "There were several serious GMO-associated injuries resulting into hospitalization: 90 (ninety) people, at least 2 (two) of whom died, but possibly even 25 (twenty-five) died (hospital/officials do not disclose the exact number) - Non of the injured/dead had noticable flu-like symptoms, but they had serious non-flu symptoms, e.g. transient ischaemic attack, acute myocardial infarction, neuronal stroke/hemorrhage, autoimmunal petecchial thrombocytopenia etc." "1358091-1" "1358091-1" "My husband died on May 1st after receiving the vaccine on April 27th." "1358130-1" "1358130-1" "Made home visit for the 2nd dose of the Moderna COVID Vaccine and the daughter reported patient had died on 5/9/2021. No other information was given." "1358345-1" "1358345-1" "My husband died May 1st, 3 weeks after his last vaccine April 10 . He had a saddle pulmonary emboli. He did not have any symptoms that I knew of prior to May 1st. Entering info for research data." "1358491-1" "1358491-1" "patient called 911 with shortness of breath and chest pain. When squad arrived, he was still oriented and awake and told squad he had Pfizer vaccine the previous day. Thought was a pulmonary embolism had occurred. Then he lost consciousness and pulses. EMS started CPR. Despite aggressive ACLS maneuvers, the patient ultimately died." "1358542-1" "1358542-1" "The spouse reported onset of symptoms on 5/20/21 including lethargy. He reported that on 5/27/21, her speech became slurred and she died. Per spouse, an autopsy is pending." "1358781-1" "1358781-1" "death" "1358813-1" "1358813-1" "Kidney failure/ death" "1359313-1" "1359313-1" "My husband had a stroke on 01/25/2021, with one large blood clot and many small blood clots. He was put on a ventilator until 02/06/2021 when I asked to have it removed. I died within 5 minutes after it being removed." "1359916-1" "1359916-1" "Death; This case was received via VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13L20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 10-Feb-2021 The patient died on 10-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. It was reported that Patient had no scanned records on file and no further noted regarding events from this time to date of death. No autopsy results were available. 27 days from date of vaccine to date of death. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Very limited information regarding this event has been provided at this time. Further information cannot be requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information cannot be requested.; Reported Cause(s) of Death: Unknown cause of death" "1360114-1" "1360114-1" "Soarness, low blood pressure and then death." "1360403-1" "1360403-1" "Maternal exposure during pregnancy, second trimester; Meconium Aspiration; baby died 2 hours; severe prematurity; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 24May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other HCP (parent). This other HCP reported information for both mother and fetus/baby case. This is the baby report. This 38-year-old female patient was pregnant of a male fetus and received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 24Feb2021 08:15 (Batch/Lot Number: EL9261) and the second dose on 17Mar2021 (Batch/Lot Number: EL9261), both as single dose for COVID-19 immunisation. Relevant medical history of the mother included atopic dermatitis. Concomitant medications included crisaborole (EUCRISA) taken for dermatitis atopic from an unspecified start date and ongoing and loratadine taken for hypersensitivity, start and stop date were not reported. First day of last menstrual period: 29Oct2020. Estimated date of conception: 12Nov2020. Estimated delivery date: 05Aug2021. Gestational period at time of initial exposure: 16 weeks and 5 days. Second trimester. The male fetus had a premature birth on 30Mar2021 and experienced meconium aspiration on an unspecified date. The fetus died on 30Mar2021, 2 hours after the delivery. The mother went into preterm labor on 29Mar2021 which was 12 days after second Pfizer vaccine. She delivered on 30Mar2021 at 21 weeks and 5 days. She was diagnosed with chorioamnioitis due to a staph aureus infection. Leading up to the hospital admission and after first and second vaccines she had frequent headaches, fatigue which she related to the vaccine. She also had chills and body aches. On admission she had a fever. Results of serology tests, e.g., rubella, toxoplasmosis, etc: HIV negative, Rubeola immune, HBSag negative, VISRL no reactive. Ante-natal check-up (specify dates and results) e.g., fetal ultrasound, serum markers, etc: 20 wk fetal surgery, 25Mar2021, normal growing, normal anatomy, male fetus. The mother presented ruptured membrane with chorioamnionitis, treated with antibiotics, and changed postpartum day. Mode of delivery: Vaginal delivery. Outcome of pregnancy: Premature live birth: Baby lived 2 hours. Date of Outcome of Pregnancy: 30Mar2021. Gestational age at birth in weeks: 21 weeks and 5 days.; Sender's Comments: Based on the information currently available, there is not a reasonable possibility reported events were related to BNT162B2 vaccine administration. It was noted that patients mother was diagnosed with chorioamnionitis due to a staph aureus infection which could be contributory. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021392327 Mother/Fetus baby case;US-PFIZER INC-2021390010 Mother/Fetus baby case; Reported Cause(s) of Death: Unknown cause of death" "1361035-1" "1361035-1" "3 days post vaccine, patient developed progressive DOE. Ultimately dx with microagiopathic hemolytic anemia and severe pulmonary HTN thought to be pre- and post capillary. TTP ruled out with normal ADAMTS 13, attempted IV vasodilation but ultimately died." "1361131-1" "1361131-1" "s/p 2 doses of Covid-19 vaccine. Pt presented for weakness, SOB, fatigue progressive over the past month prior to admission. Found to be pancytopenic with bone marrow biopsy consistent with MDS. He was started on chemo but stay was complicated by neutropenic fevers, epistaxis, retinal hemorrhage, AKI, fluid overload, hypoxic respiratory failure, atrial fibrillation with RVR, and shock. He ultimately had a heart attack while admitted and was transitioned to comfort care after medical interventions could not stabilize hemodynamics." "1361137-1" "1361137-1" "Death" "1361366-1" "1361366-1" "Death - 03/26/2021" "1361447-1" "1361447-1" "Patient developed cough about one month after the second dose of his vaccine. He does not have history of underlying lung disease. His CT scan showed diffuse ground glass appearance. Developed progressive and rapid respiratory failure. He was admitted to hospital on 5/13 and expired 5/30." "1361481-1" "1361481-1" "Rapid decline in ability to perform respiratory gas exchange and build up of carbon dioxide in the blood to life-threatening levels, ultimately leading to death. Rapid decline began about 2 weeks after receiving vaccine. Death would likely have occurred on 5/6/2021 or 5/7/2021 but for hospital intervention via use of a BiPAP machine. Patient had been exhibiting more mild, non-COVID respiratory distress for some time, back to at least late 2020, and likely at even lower levels for several years prior. Signs and symptoms included shallow breathing, extreme fatigue, difficulty or inability to lie down, occasional lightheadedness, etc. Oxygen saturation levels in April, as measured by a pulse oximeter, ranged from about 87%-96%. On May 6, it measured 65% just prior to ER visit." "1361500-1" "1361500-1" "Patient received vaccine on Thursday evening. He began to feel very tired Monday and Tuesday. Wednesday he woke up in alot of abdominal pain. We went to healthcare facility at 4:30pm. He was diagnosed with Acute Pancreatitis. He was sent home at 10:30pm We went back to ED at 1:30 am Thursday. He was admitted during the day. In the early morning of Friday May 28th his blood pressure tanked and he became unresponsive. His heart stopped and they did compressions for 8-9 minutes. He was put into ICU. By 3am we were told he may not survive. By 5 am we were told his organs were shutting down. He passed around 7:45am. In researching the vaccine we discovered the SARS virus used in vaccine can attack the pancreas. We believe he died as a result of the reaction to the vaccine and his body and organs could not fight." "1361723-1" "1361723-1" "Weaknesses. Dizziness. Headaches. Blurry vision both eyes. Sleepiness. Strokes. Hospitalization. Death" "1361818-1" "1361818-1" "Death" "1361857-1" "1361857-1" "DEATH, lethargic, migraines, tired" "1361961-1" "1361961-1" "profound exhaustion, unable to stay awake even with stimulation, severe anorexia - unwilling to eat pleural effusion +4 leg edema UTI felt like she was shaking internally (found it painful) felt hot (not common) body aches outcome=death" "1362130-1" "1362130-1" "Acute onset stroke symptoms the afternoon of 4/13/21 after returning home from room. EMS transported pt to local hospital. Dx with aortic arch/proximal subclavian artery thrombus, migration into axillary artery. Treated at local hospital with TNK for aortic arch clot & ischemic stroke. Transferred to tertiary medical center. Pt had massive stroke (left & right side) with brain stem herniation. Pt CMO after 16hrs and expired on 4/14, <32 hrs after symptom onset." "1362251-1" "1362251-1" "Upset stomach and vomiting. Shortness of breath. Pressure in chest. Heart attack and DEATH." "1362271-1" "1362271-1" "Death" "1362287-1" "1362287-1" "Stroke, ending in death" "1362305-1" "1362305-1" "Massive heart attack. He was in Icu with a ECCMO and Impella machine. The highest life support was going to get a heart transplant but hes life ended with a stroke while under sedation for 5 days" "1362402-1" "1362402-1" "death N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia" "1362465-1" "1362465-1" "chest pain, fatigue, death" "1362511-1" "1362511-1" "Skin hurting/sensitivity (Day 1 forward), severe chills (day 2 forward), headache (day 1 forward), fatigue (day 1 forward), mild cough on/off, eye pain (? day 4 forward), achey (day 1 forward), chest rash (? day 3 forward), fever (? day 5 forward 101.9 day 5), back pain (? day 5 forward), labored breathing (? day 5 forward), diarrhea (? day 5 forward), sore throat (? day 5 forward) vomit (day 7). Symptoms of chills and miserable feeling increased day 4 on. Tylenol, Albuterol on day 6, Day 8 hospitalized, antibiotics and oxygen, Sepsis and shock, less than one day in hospital - passed on 3/2/21 am." "1362518-1" "1362518-1" "Death (found down in home ) having died the night before, and he received his COVID vaccine <24 hours before his death." "1362534-1" "1362534-1" "Within 24 hours after the vaccine his blood pressure escalated out of control, 200's over 100's . He went to see his PCP and cardiologist Nephrologist ended up in the hospital in February and his aortic graphic had broken loose and they felt it was because of the escalation of the blood pressure which the doctor felt was a possibility caused by the vaccine. February 7 he was in the hospital for 4 days. On march 10 he went to the hospital to repair the aneurism that had broken loose, the doctor thought it could have broken loose from the hypertension of the blood pressure. He stayed in the hospital for 48 day and was transferred to a rehab center in anther hospital he was in the hospital for a total of 78 days . He came home on the 26 of May and had home health care, he also was ended up with pneumonia. he came home on antibiotics . He ended up passing away yesterday, May 30th, 2021" "1362539-1" "1362539-1" "Pt presented to the hospital with abdominal pain and shortness of breath May 28, 2021 Noted to be thrombocytopenic - had normal platelet 20 days prior Had bruising, melena" "1362566-1" "1362566-1" "mostly unknown, but partner said patient was unresponsive the next morning the day after receiving her Covid vaccine" "1363989-1" "1363989-1" "Liver cancer (It was in his ducts & everything)/ had the cancer, but this vaccine accelerated it; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC CANCER (Liver cancer (It was in his ducts & everything)/ had the cancer, but this vaccine accelerated it) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 013A21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEPATIC CANCER (Liver cancer (It was in his ducts & everything)/ had the cancer, but this vaccine accelerated it) (seriousness criteria death and medically significant). The patient died on 17-May-2021. The reported cause of death was liver cancer. It is unknown if an autopsy was performed. No concomitant medications was reported. No treatment medications was provided. 03-Mar-2021: Husband was diagnosed with liver cancer. It was in his ducts and everything. He had cancer at the time we took both vaccines. He died 10 weeks after being diagnosed with liver cancer. Caller felt the vaccine escalated the process. Company comment: Very limited information regarding the event has been provided at this time. Further information has been requested. This case was linked to MODERNATX, INC.-MOD-2021-019697 (E2B Linked Report).; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested. MODERNATX, INC.-MOD-2021-019697:Wife's case; Reported Cause(s) of Death: Liver cancer" "1364018-1" "1364018-1" ""Cardiac Arrest (38 days after second vaccine); This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Cardiac Arrest (38 days after second vaccine)) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC ARREST (Cardiac Arrest (38 days after second vaccine)) (seriousness criteria death, medically significant and life threatening). The patient died on 08-May-2021. The reported cause of death was cardiac arrest (38 days after second vaccine). It is unknown if an autopsy was performed. It was reported that Lot number 023M20A was the only lot on the vaccination card. Caller was not sure if this lot is from first or second vaccine."" Treatment information was not reported but it was reported ""Paramedics were there at home and they could not resuscitate him."" Concomitant medication was not reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Cardiac Arrest (38 days after second vaccine)"" "1364021-1" "1364021-1" "Had his second shot on 5/13 and passed away on that night or morning; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Had his second shot on 5/13 and passed away on that night or morning) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 13-May-2021 The patient died on 13-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No relevant concomitant medications were reported. It was reported that patient passed away on that night of vaccination or next morning. The patient's autopsy might be scheduled on 24-MAY-2021. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable. Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death" "1364631-1" "1364631-1" ""This is reported by his mother. Around 10:00 AM he got his vaccine. Mother met him at 12:30 and went to lunch, said he felt OK. She stayed with him a couple of hours, went home and apparently he went to sleep. The next day he texted his mother and said that he felt yucky. She told him to give it a couple of days, and he went to work all week, but said that after he ate he felt ""funny"". Then on Sunday, Mother's day on 5/9/21 and they face timed and was supposed to meet him at 5:30. At 12:45 he had finished eating, ate some enchilladas and said that he felt weird. He said that he was going to be ok to meet him at 5:30. At 4:37 PM she texted him to say that she was on her way to meet him. She got at the meeting place at 5:30 and he was usually there before her, this is a normal weekend ritual to exchange his dog. She waited 9 minutes and she tried to facetime him thinking he was in traffic, and he didn't answer. She thought he was just not answering. She then waited 9 more minutes and then called his phone and local Hospital answered the phone and asked who she was, and she answered the questions, and she told her to get to the hospital. She went to the hospital and the doctor came in and told her that he had the car running and he went to the gas pump to get gas and he stepped out of the car and collapsed. The person who saw him told the attended that he had collapsed and they called 9-1-1 and he was pronounced dead. He worked in a warehouse and was doing well and about to be certified to be a forklift driving. They said that they worked on him and that they could not get his heart started again. They had to do an autopsy which is against her religion and she will not find out those results for 3-6 months. She said that he was healthy and looking forward to get tested at work. They told her that he had an enlarged heart and an enlarged spleen, and had never had any heart issues in the past. He walked 20,000 steps a day in the warehouse. He was living in a sober man's facility, he has been clean for 18 months. He had an addiction to pain pills and Xanax. She feels that there was something in the vaccine that had something to do with it as he was perfectly healthy before the vaccine."" "1364724-1" "1364724-1" "Patient received second COVId 19 vaccine on 4/9/21 @ Health Department. Was admitted to hospital on 5/18/2021 with SOB, Nausea, Vomiting, and Headache. Diagnosed with COVID 19 infection and COVID 19 Pneumonia. Patient expired on 5/19/2021 at hospital." "1364761-1" "1364761-1" "Please note the patient did not receive the vaccination at state Medicine so the lot # and site of administration information is NOT available. Unclear if vaccine contributed to patient condition or outcome, but reporting due to timing of events. Patient received her 2nd Pfizer COVID vaccine around 2 pm on 5/19. She felt fatigued and had some localized arm pain in the arm she received her shot. She returned home and took a long nap from 3:30 pm to 11 pm at her daughter's house. She was playing with her grand-daughter and lifting her up when all of a sudden the daughter and her daughter's husband noticed the patient made a grunting/choking noise. She all of a sudden became unresponsive, had fixed pupils and a blank stare and found to be in PEA arrest with acute respiratory failure. Patient was initially admitted 5/20 to Medical Center and then transferred to state Medicine on 5/21. Patient passed on 5/31/21." "1364855-1" "1364855-1" "Dizziness, blurred vision, headache, nausea" "1364886-1" "1364886-1" "Death after fall and hospitalization." "1365007-1" "1365007-1" "I do not know the individuals medical hx or illness/complications. Due to new information circulating related to mRNA vaccines and myocarditis/pericarditis and being made aware that this person had suffered cardiac arrest after being admit to the hospital following complications with their health it warrants being reported regardless of prior health conditions." "1365034-1" "1365034-1" "unknown" "1365075-1" "1365075-1" "Patients father said his son began throwing up 2 days after injection. They took him to the ER and patient was given some medication to stop emesis. Two days later patient was still throwing up and the ER told him to give the medication a couple more days to work. The father said the throwing up was not constant and patient was able to eat and keep it down. The emesis was reported as dark brown mucous with no food particles in it. Patient was reported to throw up everyday until his death on day 9." "1365222-1" "1365222-1" "Received the shot 5/6 and very unexpectedly died 5/15, autopsy was not performed because foul play was not suspected and family could not pay to have it done" "1365322-1" "1365322-1" "death Pneumonia, unspecified organism Cerebral infarction, unspecified" "1365328-1" "1365328-1" "death Non-ST elevation (NSTEMI) myocardial infarction Acute kidney failure, unspecified" "1365365-1" "1365365-1" "Resident received Janssen Covid 19 vaccination on 5/25. On 5/29, the resident died." "1365404-1" "1365404-1" "My husband past away" "1365410-1" "1365410-1" "ON 3/15/21 patient was found unresponsive by spouse. EMS was called. Patient was found to have cardiac arrest Was given Epinephrine, Amiodarone and External Ventricular defibrillation Patient passed away on 3/15/21" "1365485-1" "1365485-1" "On 05/27/2021 the decedent began complaining of shortness of breath, cough, fever, chills, and pain at the injection site. On 05/28/2021 the decedent complained of the same symptoms." "1365516-1" "1365516-1" "my friend died from this vaccine" "1365530-1" "1365530-1" "Patient passed away 3 days after receiving vaccination" "1365695-1" "1365695-1" "After the first dose my father got what the eye doctor thought was pink eye. After treating him it didn't clear up. It was later diagnosed as herpes of the eye and he became blind in one eye. Shortly afterwards I read an article from researchers who stated they had found fragments of the herpes virus in the vaccine. After the second vaccine he was fine one day and 2 days later started having seizures. He was hospitalized for the seizures. His personality totally changed. He no longer recognized my sister. He also became hostile which is not the person he was. He was released from the hospital and brought to a new facility. Then the lights went out. he just stared off into space. A day later he was dead." "1365754-1" "1365754-1" "PT'S wife reported to the pharmacy that he was very tired after the vaccine on thursday and friday, he did not wake up on saturday, he passed away." "1365932-1" "1365932-1" "Patient passed away on April 27, 2021, which was two weeks after receiving second dose of Moderna Covid-19 vaccine." "1366129-1" "1366129-1" "Abrupt syncope with cessation of pulse and respirations at 11:15AM at main office. CPR was started by the workers present. 911 activated and code was activated by EMS and continued during transport and arrival at ER. All resuscitation efforts failed to restore breathing and cardiac activity. A large amount of blood was encountered upon intubation, so Dr. informed next of kin that cause of death was likely a large pulmonary embolus." "1366154-1" "1366154-1" "Death" "1366320-1" "1366320-1" "He died" "1366333-1" "1366333-1" "Death" "1366598-1" "1366598-1" "Onset acute blood loss due to internal bleeding on approximately 05/09/21, upper GI bleeding and anemia. Hemoglobin dropped to 5.2 resulting in death. Hospitalization on 05/12/21 discharged to Hospice Care 05/15/21 loss of life on 05/22/21." "1367547-1" "1367547-1" "death D69.6 - Thrombocytopenia, unspecified Respiratory failure Intercranial mass" "1367840-1" "1367840-1" "death vision loss Acute cerebrovascular accident acute hyponatremia" "1367844-1" "1367844-1" "death weakness E87.1 - Hyponatremia" "1367997-1" "1367997-1" "Massive Heart Attack resulting in death." "1368008-1" "1368008-1" "4/28/21 Pt presented to the ED with complaints of a cough that started 2 weeks ago and was getting worse and weakness with several falls. She also admitted to intermittent diarrhea. She was found to be febrile with a temp to 101.1, tachypneic w/RR of 20. Sats were in the low 90's. NP was was positive for SARS-CoV-2. CXR showed bilateral opacities and she was admitted for PNA and sepsi. She was given Rocephin and Z-max in ED and both were discontinued upon admission. She was started on Decadron in ED 4/30 she had increasing hypoxemia and was placed on a non rebreather. She was transferred to critical care and given tocilizumab. Her respiratory status continued to worsen and she was intubated. She subsequently developed a pneumothorax that persisted despite 2 chest tubes. She developed a large air leak and she was not a surgical candidate. Family ultimately decided to w/draw care on 5/15/21" "1368159-1" "1368159-1" "Resident became hypoxic and supplemental oxygen did not bring oxygen saturation up to normal levels. The physician ordered resident be sent to the emergency room for evaluation." "1368271-1" "1368271-1" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "1368325-1" "1368325-1" "Reaction began within a few hours of vaccination. Patient had fever, chills and diarrhea within a few hours of receiving the vaccine. By 4:30am on 3/31 she could not walk and her legs went numb. An ambulance was called and the EMTs had to carry her out of the house. She was taken to Hospital where they started treating her for an infection but her fever went up over 103F so they ventilated her to try to control the fever. They did blood tests during that time and got the infections disease unit trying to figure out what was causing her symptoms. Doctors diagnosed sepsis. They continued to do blood test and cultures but could not determine the cause. They did MRIs as follow-ups because she was not responding. The fever never went down. She was awake for a few days (ventilator still in) and then started getting worse again. This is about 1.5 weeks post vaccination. They did an MRI and found a bleed on her brain and the infection had spread to her heart valves. Symptoms began within hours of vaccination. She was take to the hospital the morning after the vaccine and never came home. Patient died after 2 weeks in the ICU." "1368553-1" "1368553-1" "5/16- symptoms started- cough, fever body aches. admitted 5/19 with SOB in addition. COVID pnuemonitis, 5/23-sudden decrease in saturation - placed on BiPAP and transferred to the ICU. further decline and arrested on 5/27. PEA and agonal breathing. intubated and ACLS meds given. Coded a second time and family elected to halt heroic measures." "1368648-1" "1368648-1" "Died on 1/31/2021." "1368651-1" "1368651-1" "Patient's daughter came to the pharmacy today and said patient died of a heart attack. Patient thought that she was sick from the vaccine. Did not get help until five days after" "1368670-1" "1368670-1" "Admitted to hospital on 5/2/2021 due to hypoxia and ultimately intubated. Family moved to comfort care and he died on 5/2/2021 at 10am." "1368764-1" "1368764-1" "Cardiac arrest at home, EMS performed CPR. Return of spontaneous circulation in the field after 2 rounds of epinephrine, In ED unresponsive, placed on a ventilator, required high doses epi to maintain perfusing blood pressure. Has acute kidney injury with hyperkalemia, shock liver and severe metabolic acidosis with arterial pH 7.04. CT of the head showed early findings of anoxic brain injury. Admitted to ICU and treated with aggressively with vasopressors, bicarbonate drip, heparin drip and empiric broad spectrum antibiotics. Very poor medical and neurologic prognosis, discussed with family and patient was transitioned to comfort care and passed away on 03/21/21 at 1626" "1368779-1" "1368779-1" ""After receiving second dose of vaccine, complained of stomach pain and feeling ""bloated."" Later had muscle pain, insomnia, and nausea. Found dead at home on 6/1."" "1369287-1" "1369287-1" "Sudden cardiac death. After vaccine patient experienced headache, chills, fatigue, chest pain and did not seek medical care. He had a witnessed cardiac arrest less than 3 days after vaccine #2." "1369340-1" "1369340-1" "My brother took the day off work on May 12, 2021 to receive his 2nd dose of the Moderna vaccine. He communicated with friends later that same day saying he was tired and needed to rest. On May 13, 2021, a work colleague followed up with a text message to see how he was doing to which my brother did not respond. This same colleague went to his house a few days later to find him dead lying on his couch." "1369811-1" "1369811-1" "Patient went swimming at a fitness center the day after he had his 2nd COVID-19 vaccine and was found unresponsive at the bottom of the shallow 4.5 deep pool while exercising. He was not able to be revived. The death certificate says that the immediate cause of death was Arrhythmia resulting from Hypertensive Atherosclerotic Cardiovascular Disease." "1369968-1" "1369968-1" "Fatigue on 6/2/21 followed by cardiac arrest & death" "1370350-1" "1370350-1" "Heart problems; Breathing problems; Lymph nodes swollen; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart problems), DYSPNOEA (Breathing problems) and LYMPHADENOPATHY (Lymph nodes swollen) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024m20a and 029I20a) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Lung cancer (in remission since November) and Liver disorder (liver problems). On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced CARDIAC DISORDER (Heart problems) (seriousness criterion death), DYSPNOEA (Breathing problems) (seriousness criterion death) and LYMPHADENOPATHY (Lymph nodes swollen) (seriousness criterion death). The patient died on 15-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No relevant concomitant medications were provided. Daughter of the patient reported that the patient passed away after his lymph nodes swollen, had breathing problems, and hart problems. She stated that the patient was in remission of lung cancer since November, and that he was diabetic and had liver problems. They wanted to be part of the trials for the vaccine. She wanted his cases to be research because his lymph nodes were swollen, and that for her means there's a correlation between the vaccine taking and his demised. No treatment information was provided. Very limited information regarding these events has been provided at this time. Further information has been requested. The patient's medical history of diabetes, liver disorder and lung cancer are confounding factors that may play possible contributory roles.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. The patient's medical history of diabetes, liver disorder and lung cancer are confounding factors that may play possible contributory roles.; Reported Cause(s) of Death: passed away" "1371177-1" "1371177-1" "Patient hospitalized and died after testing positive for COVID-19. Tested positive on 5/3/2021." "1371338-1" "1371338-1" "32 year old female received vaccines while pregnant with her 3rd child. Pt has asymptomatic Factor V Leiden. She delivered on 5/27/2021 and passed away on 5/31/2021." "1371354-1" "1371354-1" "Patient developed dizziness, chills, fever, body ache, sore throat, difficulty breathing, and stopped eating beginning April 26, The adverse effect is the belief that a breakthrough case of Covid-19 will be less severe if you had the shots. A false sense of security." "1371420-1" "1371420-1" "patient expired 3 days after first vaccination. Did not present to our facility for care after vaccination; did not have any adverse reactions during vaccination waiting period. Per the Medical examiner, patient passed away at his residence, and his death was not related to the COVID vaccine." "1371438-1" "1371438-1" "Clinet was vaccinated on 2/16/21 and on 3/9/21" "1371446-1" "1371446-1" "Admitted for syncopal episode on 5/14/21, found to have lung lesion with necrotizing granulomatous inflammation, deceased 5/20/21" "1371516-1" "1371516-1" "PASSED AWAY AT THE HOSPICE HOUSE" "1371537-1" "1371537-1" "Received shot Tuesday afternoon Died Friday Mourning" "1371594-1" "1371594-1" "cardiac arrest (V fib) treated: with amiodarone, magnesium, 6 doses of epi, calcium, bicarb. Achieved ROSC. outcome: withdrawal of care" "1371720-1" "1371720-1" "Death, cardiac arrest. Patient was found deceased in home, no hospitalization, no autopsy" "1371740-1" "1371740-1" "Resident was found in his bed to be passed away. He had been on Hospice." "1371745-1" "1371745-1" "Was informed by the husband on Thursday May 27, 2021 that his wife had passed away 10 days after the first moderna vaccine and that her physician said it was contributing factor to her death. The husband was waiting for the death certificate." "1371818-1" "1371818-1" "Death with 24 hours of second vaccine - per autopsy Myocarditis" "1371859-1" "1371859-1" ""COVID -19 Vaccine, Primary care MD. Wife, 5/23/2021 patient admitted through ED for chief complaint of 5 days shortness of air, tested positive for COVID-19; patient vaccinated 3/30/2021 at 'local church'. 5/24/2021 admitted to ICU - Attending, 5/26/2021 rapid response due to vitals, 5/27/2021 patient intubated due to respiratory failure/distress/hypoxia; identified in septic shock. 5/31/2021 went to surgery for left forearm and hand compartment syndrome. 6/3/2021 Code blue called, 6/3/2021 date of death. Allergies: Losartan (other) and Verapamil (intolerance) Date of Vaccination: 3/30/2021, Dose: 2, Vaccine Manufacturer: Moderna Lot #: Clinic Administering Vaccine: ""local church"" - no specific name was provided, Injection site: Description of event/reaction: Patient does not have vaccination card and reports not knowing date of first vaccine or exact clinic location. Date of Hospitalization: 5/24/2021 Reason for clinic visit or hospitalization: Shortness of air COVID-19 positive test result: Yes or No; if Yes, date 05/23/2021"" "1371905-1" "1371905-1" "Adverse Event was Death within 48 hours of vaccine." "1371933-1" "1371933-1" "On May 19th at approximately 10-1030 pm. My father suffered a heart attack with no warning and died instantly. He was fine all day long, fine since the second shot. We don?t believe the vaccine was the cause but maybe it jumpstarted something. We wanted to alert someone for knowledge or research. We did not have an autopsy." "1372049-1" "1372049-1" "PASSED AWAY 06/01/21" "1372096-1" "1372096-1" "Patient died abruptly 2-3 hours after receiving shot." "1372112-1" "1372112-1" "Pt died of massive pontine hemorrhage and then cardiac arrest two weeks after vaccination." "1372120-1" "1372120-1" "Pt called 911 for shortness of breath The following is the paramedic narrative patient found at home, sitting on floor. alert, speaking. Patient with sob, saying she can not breath , states it came on suddenly about a half hour ago and pt has not been feeling ill prior to this. No trauma, no pains or other complaints. pt went unconscious then into pea cardiac arrest, witnessed. Laid pt down and check for heart beat and breathing, became pulseless and apneic Initial treatment CPR, IV, BVM. Family states no medical history other than anemia. no drug use, no respiratory or cardiac issues. Pt was given J and J covid 19 vaccine recently. Pt also just returned from a trip and noted to not have gone diving. 2 epinephrine IV given on scene with no change to heart rhythm. Pt loaded into the ambulance and cpr continued while transporting. pt with copious amounts of vomit, suction enroute to ed. Pt w/o shockable rhythm throughout transport. Continue cpr and bvm via king airway , cap at 9. unable to get capnography higher. no change in heart rhythm. while enroute to er. At ED pt did get pulses back however it was reported that pt loss pulses and was pronounced" "1372122-1" "1372122-1" "Patient was hospitalized Feb 18th to the 21st and passed away on Feb 28, 2021." "1372151-1" "1372151-1" "My father suffered an Ischemic stroke on March 2nd and died on March 9th. He was was healthy and fit up to this point and walked several times a day." "1372338-1" "1372338-1" "Death" "1372601-1" "1372601-1" "Noticeable decline after 2nd Moderna vaccine, patient could no longer get out of bed, stopped eating and was unable to communicate verbally" "1373090-1" "1373090-1" ""Patient had received his first Moderna Covid vaccine on 4/8/21 (time unknown). He left the pharmacy after wait period of 15 minutes. Wife said that he complained of sore throat later in the day. Wife said ""he started having fever almost like COVID symptoms"". Wife said he went to the doctors office and received prescription for ibuprofen. on 4/10/21 at 10am. Wife said he didn't get any better so he was hospitalized at the Hospital 8 days later and he passed away."" "1373283-1" "1373283-1" "The patient is deceased; Nausea while eating; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (The patient is deceased) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced NAUSEA (Nausea while eating). The patient died on 11-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, NAUSEA (Nausea while eating) outcome was unknown. No concomitant medications were reported. It was reported that nausea would go away for a few hours and would come back while eating again. The patient was already in supplemental oxygen but was using more since he received the vaccine. The patient had been experiencing the events for four days. Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal cannot be ruled out for the event of Nausea and is unlikely for the event of Death. The event of Oxygen therapy is invalid as it is a pre-existing condition. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25 May 2021 includes serious event death.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal cannot be ruled out for the event of Nausea and is unlikely for the event of Death. The event of Oxygen therapy is invalid as it is a pre-existing condition.; Reported Cause(s) of Death: unknown cause of death" "1373292-1" "1373292-1" "drained fluid off her liver; they thought she was dehydrated; Throwing up; Small headache; Not eating; Not drinking; Not peeing; Sore feet; Sepsis; Death; Screwed up kidneys; Fluid overload; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (Death), SEPSIS (Sepsis), RENAL DISORDER (Screwed up kidneys), LIVER DISORDER (drained fluid off her liver), FLUID OVERLOAD (Fluid overload), DECREASED APPETITE (Not eating), FLUID INTAKE REDUCED (Not drinking), ANURIA (Not peeing), PAIN IN EXTREMITY (Sore feet), VOMITING (Throwing up), HEADACHE (Small headache) and DEHYDRATION (they thought she was dehydrated) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis (shoulders and knees), Hypertension, Acid reflux (esophageal), Penicillin allergy, Drug allergy (Lyrica), Drug allergy (cymbalta) and Drug allergy (ibuprofen). Concomitant products included AMLODIPINE for Blood pressure management, AMITRIPTYLINE for Sleep disorder, HYDROCODONE, POTASSIUM and PARACETAMOL (TYLENOL) for an unknown indication. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced DECREASED APPETITE (Not eating) (seriousness criterion hospitalization), FLUID INTAKE REDUCED (Not drinking) (seriousness criterion hospitalization), ANURIA (Not peeing) (seriousness criterion hospitalization), VOMITING (Throwing up) (seriousness criterion hospitalization) and HEADACHE (Small headache) (seriousness criterion hospitalization). In April 2021, the patient experienced RENAL DISORDER (Screwed up kidneys) (seriousness criterion hospitalization prolonged), FLUID OVERLOAD (Fluid overload) (seriousness criterion hospitalization prolonged) and PAIN IN EXTREMITY (Sore feet) (seriousness criterion hospitalization). On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criterion hospitalization prolonged), LIVER DISORDER (drained fluid off her liver) (seriousness criterion hospitalization) and DEHYDRATION (they thought she was dehydrated) (seriousness criterion hospitalization). The patient was treated with DULOXETINE HYDROCHLORIDE (CYMBALTA) in May 2021 at a dose of UNK dosage form. The patient died on 21-May-2021. It is unknown if an autopsy was performed. At the time of death, SEPSIS (Sepsis), RENAL DISORDER (Screwed up kidneys), LIVER DISORDER (drained fluid off her liver), FLUID OVERLOAD (Fluid overload), DECREASED APPETITE (Not eating), FLUID INTAKE REDUCED (Not drinking), ANURIA (Not peeing), PAIN IN EXTREMITY (Sore feet), VOMITING (Throwing up), HEADACHE (Small headache) and DEHYDRATION (they thought she was dehydrated) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood potassium: abnormal (abnormal) abnormal. Additional concomitant products used included a non-specific acid reflux pill. Treatment information includes fluids, medications NOS, diuretic NOS, dialysis, a catheter, duloxetine (Cymbalta) and antibiotics NOS. Very limited information regarding these events have been provided at this time. However age of patient can be a confounding factor. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received 25-MAY-2021 included no new information.; Sender's Comments: Very limited information regarding these events have been provided at this time. However age of patient can be a confounding factor. No further information is expected." "1373776-1" "1373776-1" "bleed on her brain; the infection had spread to her heart valves; she could not walk; legs went numb; sepsis; fever / fever went up over 103 F; chills; diarrhea; This is a spontaneous report received from a contactable consumer. A 61 years old female received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7533) on 30Mar2021 (at 61 years of age), in right arm, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on 09Mar2021 (lot EN6202), at 61 years of age, in right arm. No other vaccines were given within 4 weeks prior to the COVID vaccine. Medical history included connective tissue disorder - scleroderma. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included methotrexate. On 30Mar2021, within a few hours of receiving the second vaccination, she had fever, chills and diarrhea. By 4:30 AM on 31Mar2021 she could not walk and her legs went numb. An ambulance was called and the EMTs had to carry her out of the house. She was taken to hospital where they started treating with antibiotics her for an infection but her fever went up over 103 F, so they ventilated her to try to control the fever. They did blood tests during that time and got the infections disease unit trying to figure out what was causing her symptoms. Doctors diagnosed sepsis. They continued to do blood test and cultures but could not determine the cause. They did Magnetic Resonance Imaging (MRIs) as follow-ups because she was not responding. The fever never went down. She was awake for a few days (ventilator still in) and then started getting worse again. They did an MRI and found a bleed on her brain and the infection had spread to her heart valves. She died on 14Apr2021 after 15 days of hospital care and Intensive Care Unit (ICU) care. The events were reported with a fatal outcome. It was unknown if autopsy was performed. Since the vaccination, the patient had not been tested for COVID-19.; Reported Cause(s) of Death: chills; diarrhea; she could not walk; legs went numb; sepsis; bleed on her brain; the infection had spread to her heart valves; fever / fever went up over 103 F" "1374104-1" "1374104-1" "Died 2/26/2021" "1374110-1" "1374110-1" "death N17.9 - Acute renal failure, unspecified acute renal failure type" "1374114-1" "1374114-1" "death Pneumonia heart murmur weight loss" "1374122-1" "1374122-1" "death J18.9 - Pneumonia, unspecified organism" "1374131-1" "1374131-1" "death I46.9 Cardiac Arrest J18.9 - Multifocal pneumonia" "1374138-1" "1374138-1" "death - Non-ST elevation (NSTEMI) myocardial infarction" "1374169-1" "1374169-1" "became unresponsive, intubated in the field with CT images revealing a diffuse SAH, IVH, cerebral edema, brain compression, possible aspiration pneumonia o Admit to NICU s/o Doctor o Consult Doctor for CC o Neuro checks q1h o SBP < 110 o Mannitol 50g IV x1 stat than 3% HTS for NA goal 145-155 o EVD placement ASAP o Amicar 5g stat o COVID PCR negative o Labs/ medications as ordered o SAH protocol o Plan for cerebral angiogram and possible coiling in am with Doctor." "1374180-1" "1374180-1" "My Brother was found dead at home - Not sure it's vaccine related - but he did not have major or urgent health issues ." "1374461-1" "1374461-1" "Hospitalization and death within 30 days of vaccination. Obituary stated that he died at Hospital." "1374481-1" "1374481-1" "Patient presented to the ED and was subsequently hospitalized for peripheral artery disease on 4/15/2021. She also presented to the ED and was subsequently hospitalized for sepsis & VT on 5/22/2021. She died on 5/27/2021." "1374761-1" "1374761-1" "COVID vaccine on 2/27/2021 & 3/27/2021 (Moderna); tested positive for COVID-19 by PCR on 5/28/2021; Medical records mention pneumonia, hypoxia, non-sustained ventricular tachycardia, altered mental status, cardiomyopathy, septic shock, and multiorgan failure; also tested positive for haemophilus influenza." "1375050-1" "1375050-1" "Client was screened as per CDC guidelines and had no contraindications for receiving the vaccine on 4/14/2021. LCHD had no notice of any adverse issues. He did not present to the 2nd dose clinic and follow up phone calls revealed that he had died on 4/28/2021." "1375369-1" "1375369-1" "Cardiac Arrest, DVT, AKA, Stroke" "1375603-1" "1375603-1" "Received vaccine at on 5/24/2021. Patient is a 40 y/o male with no significant PMH who initially presented to the hospital after being found down at a restaurant. Was found to have ST segment changes on EKG, somnolent, and hypotensive requiring pressors. Taken to the cath lab where he had equalization of diastolic pressures and subsequently received pericardiocentesis due to concern for tamponade from pericardial effusion. 350 ccs of fluid was drained and his hemodynamics immediately improved and he came off vasopressors. Pericardial drain was placed. Over the next several days he had ongoing workup for the etiology of his pericardial effusion. His pericardial drain output dropped off, was clamped 5/31 and repeat echocardiogram 6/1 did not show significant effusion. Unfortunately, patient went into PEA arrest in the afternoon and was coded for ~40 minutes without return of ROSC. Unclear etiology at this time, no evidence of significant effusion on echocardiogram" "1375673-1" "1375673-1" "Patient passed away 4/14/2021" "1375797-1" "1375797-1" "Sepsis/Bacterial Meningitis" "1375926-1" "1375926-1" "Patients wife stated he was found dead on floor the morning of 6/1/21 and exact time of death was unknown. It sounded like cause was unknown." "1375943-1" "1375943-1" "Patient passed away 4/29/2021" "1375966-1" "1375966-1" "Patient was hospitalized and eventually passed away." "1375972-1" "1375972-1" "Symptom onset began on 4/29/2021. Tested (+) on 4/29/2021. Symptoms included fatigue, congestion, cough. Case was interviewed by public health department on 5/3/2021 and family reported he was in hospital and was admitted on 4/30/2021. Deceased as of 5/14/2021. Unknown if in ICU or mechanically ventilated." "1376548-1" "1376548-1" "Pt developed GI upset and weakness on 6/2, followed by chills and emesis 6/3. Was found deceased on the toilet on the morning of 6/4/21." "1376634-1" "1376634-1" "81 year old male who presented to Medical ER 6/4/21 with possible seizure like activity at home after having his second dose of COVID vaccine on 6/3/21. His first dose of COVID vaccine was given on 5/4/21. After the patient arrived to the ED he was able so my questions. The patient had an EKG performed was not concerning for ACS. He was given a total of 1 mg of Ativan IV. CT head CTA head and neck were negative for any acute findings. He was started on IV lactated Ringer's. CBC was reassuring. CMP showed a sodium of 125 and potassium 3.3. The patient was started on a liter of NS. Magnesium was found to be 1.7 was given 2 g of magnesium IV. Ammonia level blood alcohol level were negative. Initial lactic acid level was 5.9. Repeat lactic acid level is down to 1.9. I had spoke with on-call neurology felt that seizure is most likely due to the patient's electrolyte abnormalities. Did not recommend antiepileptics at this time. I spoke with Dr. who is willing accept the patient for admission to the ICU. When Dr. came down and spoke with the patient he started having another seizure. After the seizure he continued to not breathe. The patient was bagged and started having some spontaneous respirations however continued to have a low O2 sat if he was not bagged. We were able to speak with the neurologist again who recommended giving Keppra 1500 mg IV. Dr. was able to speak with the patient's next of kin his son and the patient's brother who both recommend the patient not be intubated or any other life-saving measures. Would like the patient be kept comfortable. The patient passed away shortly thereafter time of death was 2044." "1376795-1" "1376795-1" "On June 3 he developed a sore throat. His voice sounded like he had a frog in it. Early on June 4 he had to urinate about 10 - 15 times overnight in about a 6 hour timeframe. Later on Friday he left home and a short time later called 911 saying he couldn?t breath. When the paramedics arrived they couldn?t revive him and he died." "1376953-1" "1376953-1" "After second dose, individual became weaker and needed to use of cane to walk around. Became progressively weaker over course of a few weeks, then on May 14th had chest pressure, nausea, and dizziness. This continued, Wednesday May 19th complained of trouble breathing, shortness of breath, but felt better Friday, May 21st, until Saturday May 22nd at 6:00 AM individual complained of more severe chest pressure. Taken to hospital, determined heart attack and kidney failure." "1377302-1" "1377302-1" "PATIENT WAS FOUND DECEASED 3 DAYS AFTER THE SHOT WAS GIVEN." "1377674-1" "1377674-1" "Sudden Cardiac Arrest . Resuscitated and transferred to the hospital. Never regained consciousness and died on 5/11/21." "1377765-1" "1377765-1" "My mother was the patient in question She had a Moderna Covid Vaccine in Feb/March of 2021. She then had 2 doses of Rituxan on April 28th of 2021. After her second dose of the medication, she tested positive for covid 3 days later. She was hospitalized on May 8th and was not able to recover. She passed away on May 20th. The Drs at the Hospital in told me the rituxan essentially wiped the vaccine from her body. The reason I'm reporting this is to warn others in her position about the possible side effects. My mom had a very false sense of security." "1378118-1" "1378118-1" "Decedent passed 06/05/2021 at 1042 hours. Exam showed bilateral pulmonary emboli." "1378167-1" "1378167-1" "The night after receiving the vaccine, the patient began having continuous fevers and coughs. It was later discovered that there were blood clots in the lung and legs. Patient health rapidly declined during hospitalization period. Mobility, apetite and overall strength and energy decreased. Patient was fully bedridden and soon lost eye sight." "1378431-1" "1378431-1" "Open 24 hours of receiving the vaccine, the patient was noted to be fatigued and increasingly confused. Had some response to IV fluids but within 72 hours became progressively hypertensive and transferred to hospital" "1378451-1" "1378451-1" "Unsure, Department followed up on her positive COVID results in 10/2020 and 11/2020. It came to our attention last week that the reason stated for her death on 5/28/21 was due to COVID. Due to having 2 positive tests late last fall and then seeing that she had been vaccinated for COVID in March and April 2021, I was instructed to complete a VAERS." "1378531-1" "1378531-1" "Ventricular tachycardia with a pulse. Cardioversion x 3, Amiodarone 300mg IVP, Lidocaine 100mg IVP, Amiodarone drip & Levophed drip started." "1380716-1" "1380716-1" "Missed second dose; Heart attack; heart was racing; stomach bothering him; 101.4 degrees fever; chills; some headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 22-year-old male patient who received mRNA-1273 (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Flu in February 2020. Concurrent medical conditions included Muscular dystrophy. On 21-Apr-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 01-May-2021, the patient experienced TACHYCARDIA (heart was racing), ABDOMINAL DISCOMFORT (stomach bothering him), PYREXIA (101.4 degrees fever), CHILLS (chills) and HEADACHE (some headaches). On 16-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. The patient died on 16-May-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, PRODUCT DOSE OMISSION ISSUE (Missed second dose), TACHYCARDIA (heart was racing), ABDOMINAL DISCOMFORT (stomach bothering him), PYREXIA (101.4 degrees fever), CHILLS (chills) and HEADACHE (some headaches) outcome was unknown. No Concomitant product use was provided This is a case of product dose omission issue. Very limited information regarding this patient's death has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Significant follow up received :- Patient died, Reporter email and phone number added, patient's medical history added,events updated; Sender's Comments: This is a case of product dose omission issue. Very limited information regarding this patient's death has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Heart Attack" "1381212-1" "1381212-1" "Hypoxic respiratory failure; pneumonia; Stomach cramps; Could not breathe well; She had back problems; COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (patient's husband). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Lot Number: EN6206) at the age of 65 years, as single dose for covid-19 immunisation. Medical history included back disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Previously the patient received the first dose of bnt162b2 on 14Feb2021 at the age of 65 years, lot number: ENG201, injection in arm, possibly in left arm: patient had no problems with the first shot. The patient experienced covid-19 (death, medically significant) on 07Mar2021, hypoxic respiratory failure (death, hospitalization) on 08Mar2021, pneumonia (death, hospitalization) on 08Mar2021, stomach cramps (non-serious) on an unspecified date with outcome of unknown, could not breathe well (non-serious) on an unspecified date with outcome of unknown, she had back problems (non-serious) on an unspecified date with outcome of unknown. Patient went to Emergency Room (ER) 8 hours later administration of the second dose and on 08Mar2021 was admitted to hospital. Patient was in hospital from 08Mar2021 till she died. Patient was positive for covid 19 on unknown date. She was diagnosed with covid when she went to ER. Patient was on a ventilator. The patient underwent lab tests and procedures which included endoscopy: gerd or abdomen problem on unspecified date, COVID test: positive on unknown date. Therapeutic measures were taken as a result of hypoxic respiratory failure and pneumonia (on ventilator). The patient died on 16Apr2021. An autopsy was not performed. It was stated that cause of death on death certificate listed as Covid 19, pneumonia, hypoxic respiratory failure. Follow attempts are needed. Further information is expected; Reported Cause(s) of Death: COVID-19; Drug ineffective; pneumonia; Respiratory failure" "1381465-1" "1381465-1" "death Narrative: not thought to be associated with the covid vaccine, had clear other reasons for demise" "1381705-1" "1381705-1" "First shot Lot# ER 8732 administered 04/03/2021 Death" "1381906-1" "1381906-1" "Vaccine recieved 5/11/21 5/19/21 Presented to ED with respiratory failure. Noted bilateral ground glass opacity, respiratory failure 5/25/21 Intubated for respiratory failure with ARDS 5/30/21 Deceased" "1381998-1" "1381998-1" "death J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia" "1382202-1" "1382202-1" "During rounds at 10pm, CNA observed resident unresponsive. Nurse was immediately called, who in turn call the code. Nursing staff responded and started CPR. A total of 16 rounds of compressions and shocked x 2, prior to Paramedics taking over 10 minutes later. They continued CPR for another 10 minutes before resident was pronounced dead." "1382252-1" "1382252-1" "Patient found deceased in his room on 5/19/21 at approximately 9:35am" "1382262-1" "1382262-1" "Patient received first dose of Moderna on 4/15/2021. Patient tested positive on 4/19/2021 for Covid. Patient admitted to hospital on 4/25/2021. Patient expired 5/14/2021" "1382330-1" "1382330-1" "Case is a vaccine breakthrough case of interest who died of COVID-19 pneumonia on 6/2/2021 after an approximately 2 week hospitalization. Whole genome sequencing resulted in identification of B.1.1.7." "1382347-1" "1382347-1" "COVID Infection post immunization" "1382410-1" "1382410-1" "Patient was hospitalized and passed away" "1382449-1" "1382449-1" "patient was hospitalized and passed away. **2nd vaccine dose 3/15/2021" "1382468-1" "1382468-1" "Per discharge summary, patient presented to BHL with his wife with increased shortness of breath, diarrhea and hematuria. Found to be COVID +. Patient tested positive for COVID 5/21. He has received both Pfizer vaccinations. Patient was admitted and started on treatment for Covid with remdesivir and steroids. He was continued on his home dialysis schedule. He continued to have intermittent confusion and then for the last 3 to 5 days was very confused and more unresponsive. Reviewed goals of care with wife at length and palliative care was consulted. Decision was made not to pursue feeding tube due to patient having clearly outlined his wishes and his advanced directive. Upon further discussion with family hospice was consulted and patient was transitioned to inpatient hospice" "1382493-1" "1382493-1" "headaches, nausea, tired , all over run down, not able to eat" "1382535-1" "1382535-1" "Case was hospitalized and passed away. **2nd dose given 2/6/2021." "1382578-1" "1382578-1" "case was hospitalized and passed away. **2nd dose 2/8/2021" "1382602-1" "1382602-1" "Altered mental status, stroke, death" "1382612-1" "1382612-1" "case was hospitalized and passed away." "1382624-1" "1382624-1" "Sudden Cardiac Death" "1382638-1" "1382638-1" "Patient received his second dose of the Moderna vaccine on 5/21/21. On the morning of 5/22/21, patient started having issues with mobility, heavy sweats, body aches, and headache, although he had no fever and maintained his sense of smell and taste. Patient was later hospitalized and tested positive for COVID on Thursday, May 27, 2021. Patient passed away on Friday, May 28, 2021." "1382641-1" "1382641-1" "Pt had an occipital stroke on the 13th of March. She lost half of her vision in both eyes. We went to the hospital after the eye doctor told her she had had a stroke. Eventually, after 4 trips to the hospital, 2 trips to rehab, we discovered the strokes apparently triggered non-convulsive seizures which they could never end up getting under control. She passed away on 31 May 2021." "1382650-1" "1382650-1" "Case was hospitalized and passed away. **2nd dose of vaccine was 2/5/2021" "1382701-1" "1382701-1" "stroke like symptoms, eye pain, unresponsive episode. brain bleed, death" "1382716-1" "1382716-1" "Family called to report patient passed away within 24 hours upon receipt of first vaccination. Patient was ambulating to the bathroom when they heard him fall. Upon going to check on him he was already deceased." "1382906-1" "1382906-1" "Unexplained death within 48 hours" "1383413-1" "1383413-1" "Sudden death in sleep" "1383801-1" "1383801-1" "RAPID DECLINE IN HEALTH; LACK OF INTEREST IN LIVING; REQUESTED HOSPICE AT AGE 72 WITH NO MAJOR TERMINAL ILLNESS; STOPPED SOCIALIZING, INTERACTING WITH ANYONE; LACK OF APPETITE; VERY WEAK AND FRAIL; DEATH FOLLOWING 2ND SHOT" "1384860-1" "1384860-1" ""Pt rec'd 2 doses Pfizer/BioNTech, 2nd dose May 9,2021 at outside facility. Presented to hospital on 06/08/21 after cardiac arrest, sudden collapse at home, refractory PEA with ongoing CPR >4hrs, cardiogenic shock (EF20%), refractory DIC, MOSF and coma. Uncertain antecedent history, pt had tolerated vaccine well w/o untoward reactions, was possibly ""sick"" in the 2 days prior to admission 06/08, but limited history available. SARS2 PCR and resp path PCR panels negative, no clear bacterial source of shock/collapse initially identified, thus concern for primary myocarditis resulting in refractory shock (perhaps also with ischemic CVA); Tpn not c/w type I ACS/MI. Workup negative for PE, hemorrhagic stroke, PTX/tamponade, etc. 6hrs after death (in evening 06/08/21) BCx x2 resulted Grp A strep, thus pt may have had TSS at home then collapsed in PEA, however source of TSS is uncertain. Notably patient usually healthy, active, no medications, favorable lipid panel, no illicits; + EtOH binge-drinking last several months but no cirrhosis/ESLD previously doubt primarily Etoh-related process. Pt had ongoing PEA arrests with brief ROSC for approx 7 hrs in field -> ED > ICU until death declared."" "1384989-1" "1384989-1" "Admitted to hospital 4/12/21 for acute hypoxic respiratory failure due to COVID-19 pneumonia. Treated with remdesivir (full course) and dexamethasone 10mg x1 then 6mg daily x 9 days. DVT treated with heparin IV Ibrutinib held -- CBC at baseline (WBC ranged 23.5 - 35.1) Infectious Disease MD ruled out other infections, including pneumocystis pneumonia Hypoxemia progressed to severe -- 60L high flow oxygen, unable to wean - patient does not want to be intubated On 4/22 the patient desired for comfort measures only and weaning of oxygen. The patient died on 4/25/21." "1385038-1" "1385038-1" "Patient stopped breathing at 6:15pm on 04/22/2021. Fire dept was called. He went into cardiac arrest and they took him to ICU. He died on 04/26/2021 in ICU." "1385230-1" "1385230-1" "Became a bit dizzy, BP dropped significantly, and he fell while walking into the doctors office (he had no ambulatory issues before this). Legs became weak, couldn?t walk on his own, could barely walk with a walker, legs were beginning to get atrophied, arms began to shake. He had 5 falls total after receiving both Moderna shots. While in hospital, received IVIG for possible Guillan-Barre Syndrome." "1385311-1" "1385311-1" "Initially sore arm; severe headache. positive COVID test on 1/21/2021 - doctors assume he was positive at time of vaccination but we didn't know it yet; severe covid pneumonia; supraventricular tachycardia; diabetes; iron deficiency anemia" "1385337-1" "1385337-1" "Was living happily and independently in a retirement community. After the second dose because losing his memory, focus, depression, followed by 2 strokes, brain bleed, blood clots, seizures, and a Dx of Parkinson's and Parkinson's dementia. He saw doctors monthly and never had any signs of any of these things." "1385401-1" "1385401-1" "Patient received Pfizer COVID-19 vaccine on 1/24/21 (first dose) and 2/5/21 (second dose). Patient tested positive for COVID on 5/22/21, hospitalized on 5/22/21 for acute respiratory failure with hypoxia and passed away on 5/29/21: Preliminary cause of death: Respiratory failure with hypoxia Diagnoses contributing to death: SARS-CoV-2 respiratory infection COVID-19 vaccination breakthrough infection (Pfizer vaccine) Rheumatoid arthritis on methotrexate Anemia Hypertension Obesity" "1385476-1" "1385476-1" "Resident passed away at 12:40pm on 05/24/2021 at Care and Rehab ." "1385652-1" "1385652-1" "-Resident was admitted to facility on 4/14/2021 from hospital. Resident had been vaccinated prior to admission to facility on 3/10/21 and 3/29/21 which was given at another clinic/facility. Resident had history of (+) COVID-19 test results on 1/2021 and 4/9/2021 (Test done at facility). Facility is still doing a weekly routine COVID-19 Testing/Surveillance and on 4/21/20, resident was incidentally found to be still (+) COVID-19 (PCR Test). During that positive result (test date:4/21/21) the resident was asymptomatic at that time, and, Quarantine period completed 5/6/21. Resident expired on 5/19/2021" "1385943-1" "1385943-1" "04/28/2021: Patient transferred from Hospital with shortness of breath, COVID-19 Positive 4/30-5/16: Patient condition deteriorated. Had repeated episodes of hypoxemia and hypotension - was intubated on mechanical ventilation, eventually switched to pressure control inspiratory pressure, extubated, had to be reintubated. Developed A-fib, leukocytosis worsened, Xray showed tension pneumothorax on right side - chest tube placed. 5/17: Family counseled - patient placed on comfort care, remained on ventilator. Time of Death: 05/17/2021, 16:00 Causes of Death: Bilateral Pulmonary infiltrate, Acute hypoxic type 1 respiratory failure, ARDS, Right Pneumothorax, Acute COVID-19 viral pneumonitis with probable bacterial superinfection, Atrial fibrillation with rapid ventricular response, Septic Shock, Bleeding rom lung/ETT - resolved, Possible Mucor in mouth, Candida tracheobronchitis, Previous history of prostate cancer status post radiation, dyslipidemia, hypertension present at admission." "1385984-1" "1385984-1" "Second dose of Moderna COVID-19 vaccine administered 5/25/2021 at ~1300 h. Was last seen alive later that day and seemed to be in her usual state of health. Was then found dead at home on 5/28/2021. Unknown when death actually occurred." "1386054-1" "1386054-1" "DEATH FROM BLOOD CLOT" "1386097-1" "1386097-1" "patient died of cardiac arrest that night in hospital" "1386215-1" "1386215-1" "Death within 60 days of vaccination" "1386331-1" "1386331-1" "There are two adverse events. First is that the skilled nursing facility (SNF) clinical staff incorrectly listed the patient as unvaccinated when requesting SNF patients be vaccinated by the local health department. The patient was previously vaccinated with Moderna on 1/26 (Lot # 004M20A). This should be listed as a vaccine administration error. Second- Approximately, 1 week after being vaccinated with Janssen on 3/24/2021, the patient tested positive for COVID-19 (4/1/21). At the time, the patient was documented to have an asymptomatic infection, picked up on weekly surveillance testing due to a large outbreak at the nursing facility. I was informed on 6/9/21 that the patient had been referred to hospice on 5/4/21 and died on 5/6/21. The medical records are not yet available (pending from the SNF and hospice agency) but the referral was made due to her COVID illness leading to worsening of her general health status. During this period from 4/1 to 5/4, she remained at the SNF. Notably, she was not hospitalized and did not present to the emergency department for care." "1386585-1" "1386585-1" "06/08/2021-Received vaccine at Urgent Clinic. Pt found down at home. Brought to Hospital ED, with cardiac arrest (STEMI), where she later died." "1386631-1" "1386631-1" "My father had an acute myocardial infarction. He was perfectly fine the Sunday before and earlier the day of. On Monday April 26th he had sudden onset of c/o a headache didnt feel well that then led to c/o jaw neck pain. He sat down eyes rolled back 911 EMS dispatched" "1386841-1" "1386841-1" "Prodrome of headache and gastric upset over 2 days following second dose. Then felt fine. Found the following day dead in bed. Autopsy pending" "1387032-1" "1387032-1" "Dizziness, loss of memory, fatigue, and death 10 days later" "1387202-1" "1387202-1" "Inital Fever followed by severe fatigue for 2-3 weeks followed by death" "1387512-1" "1387512-1" "Dizziness; Aches; Weak; Fever; Nausea; DIED; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (DIED) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), PAIN (Aches), ASTHENIA (Weak), PYREXIA (Fever) and NAUSEA (Nausea). The patient died on 18-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DIZZINESS (Dizziness), PAIN (Aches), ASTHENIA (Weak), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that the vaccine was not the cause, he had other medical issues too. This is a case of sudden death in a 62-year-old male patient with unknown medical, who died 12 days after receiving first dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: New event (death) and narrative was updated.; Sender's Comments: This is a case of sudden death in a 62-year-old male patient with unknown medical, who died 12 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death" "1387779-1" "1387779-1" "HEART... SUDDEN DEATH 20 DAYS AFTER; BREATHING ISSUES; This is a spontaneous report from a contactable consumer (patient). An 85-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL1284, expiry date not provided) via an unspecified route of administration, administered in left arm on 02Feb2021 as first dose, single dose for covid-19 immunisation. Medical history included diabetes, bipolar, seizure disorder and COPD (chronic obstructive pulmonary disease), all from an unknown date and unknown if ongoing. The patient's concomitant medications included unspecified medications reported as patient received within 2 weeks of vaccination. The patient previously took buproprion hydrochloride (WELLBUTRIN). Patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. Prior to vaccination, the patient was diagnosed with COVID-19. On 10Feb2021 10:00, the patient experienced heart (also reported as sudden death 20 days after), and immediately had breathing issues, no arrhythmia, no adverse defibrillator reading recorded. Family saw decline immediately after injection, did not request autopsy and adverse medical decline reported to doctor following injection. The events resulted to doctor or other healthcare professional office/clinic visit. Treatment receive in response to the events and treated with cardiologist. The patient died on 10Feb2021. The causes of death were heart (heart disorder) and breathing issues. An autopsy was not performed. Since the vaccination, the patient has been tested for COVID-19.; Reported Cause(s) of Death: HEART... SUDDEN DEATH 20 DAYS AFTER; BREATHING ISSUES" "1387983-1" "1387983-1" "- Acute kidney failure, unspecified - Hypo-osmolality and hyponatremia" "1387996-1" "1387996-1" "Non-ST elevation (NSTEMI) myocardial infarction RESPIRATORY DISTRESS" "1388002-1" "1388002-1" "Nontraumatic intracerebral hemorrhage, unspecified" "1388005-1" "1388005-1" "J18.9 - Pneumonia, unspecified organism" "1388011-1" "1388011-1" "J18.9 - Atypical pneumonia" "1388057-1" "1388057-1" "Admitted 5/26 from outside facility for GI bleed, cardiac arrest and severe sepsis. COVID+. Treated with tocilizumab, vit C, vit D, alinia, zinc. Family opted for comfort care and W/D life support. Expired 6/5." "1388182-1" "1388182-1" "Two weeks after receiving the final injection, my father was admitted to the hospital with pneumonia. He had poor oxygen saturation which prompted a visit to the ER. Upon x-ray he was found to have a large pneumonia in his left lung. After 10 days at the local hospital, and being placed on a ventilator, he became septic and was air lifted to one of our area's larger hospitals. There, he was diagnosed with necrotizing pneumonia caused by pseudomonas aeruginosa. He also had heart rate accelerations that would climb into the 150s and they could never figure out why. He was treated aggressively with antibiotics and was successfully weaned off the vent. However, his body was unable to fight off the infection and he ended up passing away from necrotizing pneumonia that caused his respiratory system to fail. My father had underlying COPD that was well-managed at home and he did not require oxygen. I was questioned several times as to whether he'd gotten into or been around anyone or anything different from his usual, but he had not. The only thing out of the ordinary he had was the Moderna injections." "1388287-1" "1388287-1" "vomiting, confusion" "1388373-1" "1388373-1" "Pt was unable to get out of bed within 12 hours, and needed assistance to use the restroom until her death" "1388528-1" "1388528-1" "Only reporting to VAERS as patient received covid-19 vaccination under EUA and was hospitalized and is now deceased from illness deemed UNRELATED to prior covid-19 vaccination. She was a 69 yr old female who was transferred to hospital on 6/8 at 0141 from outside hospital with severe shock, acute hypoxemic respiratory failure, who had a cardiac arrest on arrival here for 5 mins, during arrest CPR was done and 2 doses of epinephrine were administered prior to ROSC and targeted temperature management was initiated. She was found to have a massive PE, alteplase was given and a heparin continuous infusion was started on 6/8 at 0154 and 0345, respectively. She later underwent a thrombectomy on 6/8 at 1640. She showed signs of poor neurological status. Went into MSOF despite aggressive supportive care. Family requested to make her comfortable and the patient expired on 6/10 at 0449." "1388553-1" "1388553-1" "Death" "1388572-1" "1388572-1" "At around 5:30 a.m. on the day after 2nd Moderna dose, resident was found non-responsive with no vital signs. CPR was performed. Time of death 6:20 a.m. There were no acute illnesses or changes in condition noted prior to receiving vaccine." "1388903-1" "1388903-1" "The vaccine was administered at 12:30 pm on Saturday, March 6, 2021. That night around 7:00 pm he called to tell me that his arm was hurting. That was the last time anyone heard from him. Two days later on the evening of Monday, March 8, 2021, he was found unresponsive in his home. When the ambulance arrived they found he had a temperature of 115 degrees. He was taken to the emergency room and placed in the critical care unit. It was determined that he suffered an anoxic brain injury and would never recover. He passed away on March 21, 2021." "1388920-1" "1388920-1" "Contracted COVID-19 ~1 month later, tested positive on 5/16/21. Died 6/9/2021 at 94 years old. Had CLL diagnosed during final hospitalization, thought to have caused poor vaccine response and susceptibility to COVID." "1389518-1" "1389518-1" "Flu like symptoms with vomiting and nausea for 2 weeks following the second shot" "1389545-1" "1389545-1" "Death occurred 8 days after vaccination - pulmonary thromboemboli found on autopsy." "1389554-1" "1389554-1" ""Message received from the daughter of the patient, daughter states that the 3-4 days after the administration of the vaccine that she reported to feel unfocused and ""out of it"", falling asleep more, and was seen by physician who advised to keep an eye on her, then was later found slightly unresponsive, transported to hospital and found to be suffering from stroke. Patient later discharged from hospital to nursing home and stayed there until 3/28/2021, where she was later transferred to the care of the family and passed away on 4/6/2021. Daughter of patient"" "1389821-1" "1389821-1" "Death" "1390027-1" "1390027-1" "The day after the vaccine, reported typical reactions including aches and pains, which improved the following day. The Monday after noted snoring, which was atypical but consistent with the ear infection and seasonal allergies. Sometime on midday Monday 5/24 Pt died. Was found in his bed at approximately 6pm with rigor already set." "1390921-1" "1390921-1" "half cm tumor in her fallopian tube/1.5cm tumor in the fallopian tubes; Paraneoplastic cerebellar degeneration; meningitis; Severe headache; eyes would move back and forth involuntarily; severe vertigo; This is a spontaneous report from contactable consumer (sister) from Medical Information Team. An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at the age of 81-year-old in Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included bladder cancer. The patient's concomitant medications were not reported. Caller states ''My sister and I both received the Pfizer COVID-19 vaccine. My sister developed Paraneoplastic cerebellar degeneration two weeks after receiving the Pfizer vaccine. They did find a half cm tumor in her fallopian tube. Her doctors have reported the side effect but at that time she was not fully diagnosed. They thought at that time it was meningitis .'' Caller wants to know if Meningitis or Paraneoplastic cerebellar degeneration has been associated with the Pfizer COVID-19 vaccine. Response: Spoke from the attached document. These two disorders have not been listed as side effects associated with the vaccine. However we may not have the list of all the possible side effects associated with the vaccine. Caller was reporting side effects for her sister related to the Covid 19 vaccine. Her sister had received the Pfizer Covid 19 vaccine and 2 weeks later developed a disorder called Paraneoplastic cerebellar degeneration. They had found a tumor in the fallopian tube that was a tiny half centimeter tumor. Said that the doctors had reported the side effects but at the time it was not yet diagnosed as paraneoplastic cerebellar degeneration. At the time, they thought she had meningitis. The event happened about 2 weeks after the vaccine, so about 11Feb2021, was about 2 weeks before or 2 and a half weeks before 11Feb2021 that she got the vaccine. She was in the hospital 10 and a half weeks (about for 74 days). She contacted Pfizer, she believes in Mar2021. Since Feb2021 she had been in 3 different hospitals. They did send her some paperwork but she has not completed it yet. At that point in Mar2021 her diagnosis was meningitis. As it later turns out, it turned to a new diagnosis of the Paraneoplastic cerebellar degeneration. Her sister lives in PRIVACY, she does not even know where she went for the vaccine. She hasn't filed the written report yet. She was not diagnosed with the Paraneoplastic cerebellar degeneration until the very end, 10 days before she died. She died on 24Apr2021. Cause of death: They had removed her ovaries and fallopian tubes had the suspicion that this might have been the diagnosis without ever seeing the tumor. She had multiple CT scans (2021) and never saw the tumor until they removed the fallopian tubes. They found a 1.5cm tumor in the fallopian tubes which is what the cause of death was. She was calling to see if this has happened to anyone else. They say the tumor was the cause because it would have been so odd that it came on so suddenly, 2 weeks after the vaccine. The caller is terrified to get the vaccine, since she had bladder cancer. She had asked if anyone had reported this because that was the diagnosis at the time. They did not do an autopsy, probably because that was up to her brother in law and can understand why an autopsy was not done. They also say when her sister was having all of these bizarre symptoms, it was an auto immune reaction. She was perfectly fine and had come home from a bird watch. She had severe headache, eyes would move back and forth involuntarily in 2021. That never went away. She had severe vertigo in 2021, and it all happened in one day, it didn't go away. They did an immunoglobulin infusion treatment, she had very good treatment. They put her on steroids. The immunoglobulin treatment was for five days and nothing touched those symptoms. They had moved her from one hospital to a rehab facility in PRIVACY. The rehab doctor reported all of these symptoms to Pfizer. At that time, they were still calling it meningitis. He said that the elephant in the room was the vaccine. Felt the vaccine is not totally what caused it but accelerated what ever was going on with her, these bizarre disorders. Maybe this would have happened without the vaccine. They will never know. She wishes that someone can tell her whether or not she should get the vaccine. She asked her doctor who said he was not going to tell her to not get the vaccine. She was calling to see if this has happened to anyone else. They say the tumor was the cause because it would have been so odd that it came on so suddenly, 2 weeks after the vaccine. She had asked if anyone had reported this because that was the diagnosis at the time. The patient was hospitalized for events for 74 days. Therapeutic measures were taken as a result of events. The patient died on 24Apr2021. An autopsy was not performed. The outcome of event half cm tumor in her fallopian tube/1.5cm tumor in the fallopian tubes was fatal. The outcome of events Paraneoplastic cerebellar degeneration and meningitis was unknown. The outcome of other events was not recovered. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: half cm tumor in her fallopian tube/1.5cm tumor in the fallopian tubes" "1390953-1" "1390953-1" "ITP; Brain dead; Brain hemorrhage; Blood in the mouth; Patches on legs; Back pain; D Dimer Very high; Her husband couldn't talk; bruise on arm; This is a spontaneous report from a contactable Nurse (patient's wife). A 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 17Mar2021 16:00 (Batch/Lot Number: EL3247; Expiration Date: 31May2021) as 2ND DOSE, SINGLE (at the age of 72 years) for covid-19 immunisation . The patient received the first dose of BNT162B2 (Lot number: EL3246, Expiration date: Unknown) on 25Feb2021 16:30 in Arm (side not specified) as single dose (at the age of 72 years) for Covid-19 immunisation. Medical history included blood cholesterol from an unknown date and unknown if ongoing, vascular graft from 2013 to an unknown date. Had flu shot and pneumonia shot. No problems. The patient received no other vaccine other than BNT162B2 within 4 weeks. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for vascular graft from 2013 to an unspecified stop date; metoprolol (METOPROLOL) taken for vascular graft, start and stop date were not reported. 6 weeks after the second vaccine, he had patches on legs and back pain. He went to hospital. They found generalized bleeding and ITP, and he passed away immediately. The patient experienced brain dead (death, hospitalization) on 09May2021 , brain hemorrhage (death, hospitalization) on 04May2021 , ITP (immune thrombocytopenia) (death, hospitalization) on an unspecified date , blood in the mouth (death, hospitalization) on 03May2021 , back pain (death, hospitalization) on 2021 , patches on legs (death, hospitalization) on May2021 , D Dimer very high (death, medically significant) on an unspecified date , her husband couldn't talk (Her husband couldn't talk. She was calling his name. She asked him why he was not talking. She squeezed his hand and he squeezed back. He couldn't talk.) (death) on an unspecified date, bruise on arm (death) on 2021. The patient was hospitalized from 03May2021 to 09May2021. The patient underwent lab tests and procedures which included computerised tomogram abdomen: no active bleeding, no mass on 03May2021, computerised tomogram head: hemorrhage on 04May2021, fibrin D Dimer: very high on unspecified date. Therapeutic measures were taken as a result of ITP, back pain. With ITP, they started to do plasmapheresis. Wife stated that the doctor gave him medication Aleve, for back pain. He took 5 tablets only. Then she saw the spots. She told her husband not to take anymore and he did not. The patient died on 09May2021. An autopsy was not performed. Wife said that the doctor was not sure if they were related. The wife stated that she did feel that they were related. The reporter stated events back pain, ITP, blood in the mouth, brain Hemorrhage, Patches on legs, were related to the suspect product. Wife stated that before this, her husband did 2 miles running every other day or twice a week. He was healthy. He ate healthy foods. Her husband's cholesterol was always under 200. He had no issues. His bloodwork was done, and all was OK. He constantly went to the doctor. This case is not related to a study.; Sender's Comments: Based on the information currently available, the reported events are attributed to intercurrent or underlying medical conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Brain dead; Brain hemorrhage; ITP; Blood in the mouth; Back pain; Patches on legs; bruise on arm; Her husband couldn't talk; D Dimer Very high" "1391006-1" "1391006-1" "Ruptured aneurysm with in 12 days of vaccine with no previous symptoms and patient deceased due to brain dead after the surgery due to rupturing.; Ruptured aneurysm with in 12 days of vaccine with no previous symptoms and patient deceased due to brain dead after the surgery due to rupturing.; This is a spontaneous report from a contactable reporter consumer wife reporting on behalf of her 35-year-old husband (patient) received the second dose of BNT162B2 (lot number: ER 8731) at single dose for COVID-19 immunisation on 14Apr2021 at 05:15 PM. Relevant history included was unknown. Relevant concomitant drug was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: ER 8727) at single dose for COVID-19 immunisation on 22Mar2021 at 04:45 PM. The patient experienced ruptured aneurysm on 26Apr2021 at 09:00 PM, within 12 days of vaccine with no previous symptoms and patient deceased due to braindead after the surgery due to rupturing. The event was assessed as serious due to Hospitalization (7 days), Life threatening illness (immediate risk of death from the event), Patient died on 30Apr2021 due to brian anuerysm. No autopsy was performed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Reported Cause(s) of Death: brain dead; Brian Anuerysm" "1391226-1" "1391226-1" "My brother started with some swelling in the legs/feet, followed by chest pains that led him into a heart attack, followed by cardiac arrest. He was shocked back to life where he lay in a coma. His kidneys stopped functioning followed by his lungs and liver?he was kept alive on life support and dialysis, he died after having 4 more heart attacks back to back on June 4, 2021." "1391273-1" "1391273-1" "Went unresponsive at home after experiencing diarrhea. Pulses were lost at home and regained by EMS prior to transport to the emergency room. Pulses lost again in the emergency room. ACLS performed for approximately 40 minutes before pronouncement of death was made." "1391469-1" "1391469-1" "Slurred speech, loss of use of limbs, confusion, heart inflammation and liver failure" "1391483-1" "1391483-1" "Outcome: Patient Death CHIEF COMPLAINT in ER: chest pain, SOB History of Present Illness: Patient is a 66 yo with PMH of chronic afib on chronic anticoagulation who presented to the ER with a chief complaint of shortness of breath and increased fatigue over the past several weeks that has progressively become worse. Patient denies orthopnea or PND but does have some palpitations and occasional chest pain associated with increased fatigue with exertion. On evaluation emergency room patient was noted to be tachycardic consistent with chronic atrial fib, also acute renal insufficiency likely secondary to dehydration. Patient is admitted to the medical service for further treatment and evaluation. DEATH SUMMARY Date of Admission: 04/07/2021 Time of Death: 04/10/2021 at 0737 Final Diagnoses: 1. Sudden Cardiac Death 2. Acute Renal Impairment Secondary to Hypovolemia, A TN 3. Chronic Atrial Fibrillation w/ RVR, Resolved 4. Atypical Chest Pain, Resolved 5. Hypokalemia, Resolved 6. Obstructive Sleep Apnea 7. Chronic Diastolic Heart Failure Hospital Course: Patient is a pleasant 66yo admitted for acute renal impairment secondary to significant o hypovolemia resulting in ATN as well as atrial fibrillation w/ RVR after presenting to ER with complaints of chest pain, dyspnea, malaise, and anorexia that began after receiving his second COVID vaccine on 4/01/2021. Please see H&P for full details. Patient reported that on the day after his COVID #2 vaccine, he lost his appetite and was not able to eat or drink. He continued to take his home medications as prescribed including losartan, chlorthalidone, and meloxicam. After experiencing progressive worsening of symptoms for 5 days, patient presented to ER for further evaluation. Upon arrival to ER, patient was noted to be hypotensive and tachycardic. EKG showed atrial fibrillation w/ RVR. Routine labs were obtained and were remarkable for elevated creatinine and mild hypokalemia w/ normal BNP and negative cardiac enzymes. CXR showed enlarged cardiac silhouette, but no evidence of pulmonary edema or other acute abnormalities. Patient was subsequently admitted for further evaluation and medical management. He was staited on aggressive IV hydration for his hypotension and hypovolemia w/ PRN IV metoprolol as needed for HR> l lObpm. He was continued on anticoagulation. Serial cardiac enzymes were obtained and were negative. TIE report from Dr's office that was performed recently was obtained and showed EF of 55-60% with Grade 1 diastolic dysfunction. Patient's wife brought his CPAP from home and patient wore his CPAP while sleeping during his hospital stay. During the course of hospitalization, patient's blood pressure & HR improved, though he remained in atrial fibrillation. His creatinine continued to trend up consistent with ATN, but patient continued to produce adequate urine and he had no signficant electrolyte derangements. IVF were adjusted based on urine output and volume status. Patient had no recurrence in his presenting complaint of chest pain and he overall reported feeling better throughout his course of hospitalization despite reporting that he continued to have little appetite. Patient was monitored closely on telemetry throughout his hospital stay. On the morning of 4/10/2021, lab tech and nurse walked into the patient's room to obtain specimen for AM labs. Patient reportedly tried to get out of the bed independently, grabbed at his chest & pulled off his telemetry, and fell to his knees. Staff called Code 99 and patient was placed back in the bed. He was noted to be in asystole. ACLS was performed and despite maximal efforts, patient subsequently expired at 0737. I personally called the patient's cardiologist & personal friend, to discuss the events leading up to the patient's death. Upon review of the patient's course of hospitalization, it was felt that patient most likely experienced sudden cardiac death. Of note, Dr reports that the patient frequently contacts him via text message with concerns or complaints. He states that the patient did not message him during the hospitalization to report any chest pain or other concerns. Disposition: Patient Expired" "1391500-1" "1391500-1" "Patient had his 2nd Moderna vaccine at pharmacy at 2:00 and was struggling to breathe a few hours later. We were at the emergency room around 6:00pm and he was placed on a ventilator between midnight and 1:00am. He died 10 days later after experiencing clots that led to seizures and congestive heart failure. I have a death certificate if needed." "1391630-1" "1391630-1" "3 days after vaccination, patient was found down in his home. Admitted to ICU from the ER with severe sepsis, bilateral pneumonia, acute kidney injury and rhabdomyolysis. Patient deceased day after hospitalization." "1391671-1" "1391671-1" "Her surgery in the morning went very well according to her doctor. Later in the afternoon, pt. had a massive stroke. Next day pt. died at Hospital ." "1391681-1" "1391681-1" "brain bleed/aneurysm" "1391711-1" "1391711-1" "Death Certificate 4/22/2021 Cause of Death - Hypertensive Cardiovascular Disease" "1391864-1" "1391864-1" "About 14 days after the first vaccine dose ( Pfizer) patient presented to the ER with severe chest pain. He was sent home after labs, EKG and CT chest were reported as normal. He was told that he had a hiatal hernia. One week later he was found by his wife expired in his bedroom late morning. Patient had no medical problems such as hypertension and never smoked. He was very active and played sports such as pickle ball." "1391995-1" "1391995-1" "Died of unknown cause 2 weeks after receiving vaccine." "1392054-1" "1392054-1" "He died after being diagnosed with Lymphoma. Double hit , B cell. He was fatigued a couple weeks after vaccine, fatigue worsened, then developed severe pain. Diagnosis to death was 11 days." "1392406-1" "1392406-1" "On April 7, my husband received the J&J COVID vaccination. On April 17, he started to feel ill and developed severe abdomen and back pain, which were not normal symptoms of his other health conditions. He ate very little on that date (and that was the last food he had). At 3:30 a.m. on Monday, April 19, I took him to the ER because of severe pain. They gave him multiple tests, including CT scan, labs, EKG, ultrasound, and others. He was admitted to the hospital, and multiple other tests were performed during his stay. During his stay, his sodium and other electrolyte levels dropped to dangerously low levels, he experienced major swelling, his pain persisted, his swallowing ability diminished, he didn't eat, and his heart consistently ran at a high rate. He was transferred home (with comfort care/hospice) on Tuesday, April 27, and died on Wednesday, April 28, at about 9:30 p.m." "1394136-1" "1394136-1" "This is a spontaneous report from a non-contactable nurse. An adult male patient of unspecified age received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Jun2021, for COVID-19 immunization. The first dose of BNT162B2 vaccine was administered on an unknown date. Medical history and concomitant medications were not reported. The patient took the second dose of Covid 19 vaccine and died sometime in the same week, on an unspecified date in Jun2021. Cause of death was unknown. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Event unknown cause of death is assessed as related until sufficient information is available to confirm an unrelated cause of death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: The patient took the second dose of Covid 19 vaccine and died sometime in the same week" "1394137-1" "1394137-1" "Her husband passed away; Sepsis; Shock due to bilateral pulmonary acute disease syndrome; Shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar damage; misery and feeling horrible; Severe chills; Headache; Shortness of breath; Fever; Fatigue; Diarrhea; Muscle aches; Skin sensitivity and rash; Skin sensitivity and rash; Sore throat; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm on 22Feb2021 at 10:00 (Lot Number: EN6202) (at the age of 57-year-old) as single dose for COVID-19 immunisation. Medical history included high cholesterol from 2017 to an unknown date, seasonal allergy from an unknown date and unknown if ongoing and arteriosclerosis from 2017 to an unknown date. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Feb2021 (Lot Number: EL9264) (at the age of 57-year-old) as single dose for COVID-19 immunisation; the patient previously received ZYRTEC (10mg almost daily) for seasonal allergy, ibuprofen (ADVIL, 200 mg) and TYLENOL both for pain. Caller stated that the patient passed away on 02Mar2021 which was 8 days after the 2nd dose of the Pfizer COVID Vaccine. On 26Feb2021 the patient went to urgent care and then on 01Mar2021 he went to the hospital emergency room (ER). It was reported that an autopsy was performed on 06Mar2021 and the cause of death listed sepsis and complications from sepsis and shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar damage. The manner of death was natural and the lung presentation is highly suggestive of diffuse alveolar damage due to COVID-19 although the patient had several negative tests for COVID. The patient tested negative for influenza AB, negative for valley fever, negative for Legionnaire's disease and was in the hospital for less than 24 hours. The patient went back to urgent care on 28Feb2021 and was feeling miserable and asking for blood tests and urine tests, stated at that time his platelets were low at 122, glucose was high at 105, sodium was low at 134, calcium was low at 8.3, urine was negative and the patient did not get these labs til Monday when he was on the way to the emergency room and it was all different when he got to the hospital. The test for strep was negative, the oxygen was low at 86 percent when he got to the hospital on Monday and they just had to keep increasing his oxygen, stated a culture, no further details provided about the culture. A CTA done on the chest on Monday which was bad and stated the patient was symptomatic and they did not treat him for COVID but had a clinical suspicion for COVID. Adenovirus was not detected, metapneumonia virus was not detected, respiratory syncytial virus was not detected, parainfluenza was not detected, his platelets kept dropping and he had two tests for valley fever which is Cocci IGG and IGM and those were negative, the sodium level on 02Mar2021 was 126, all of these things were low: chloride 92, CO2 18, calcium 7.8, glucose was high at 222, bun was high at 21, creatinine was high at 1.4, EGFR was low at 52, WBC was high at 18.6, RBC was high at 7.39, HGB was 22.6, HCT was 66.4, RDW was high at 15, RDWFD was 45.5, and platelets were low at 61. The patient came into the emergency room those labs were when he was failing completely and on 01Mar2021 was when he arrived in the ER; at that time his WBC were normal, RBC was high at 6.16, HGB was high at 18.5, HCT was high at 54.9, platelets were low at 73, monocytes absolute were high at 0.96, sodium was low at 129, chloride was low at 95, calcium was low at 8.3, glucose was high at 150 and this was 7 days past the Pfizer COVID Vaccine. The patient was negative for strep pneumonia antigen and negative for Legionnaires Urinary antigen. The chest X-ray was done on 26Feb2021 and the patient was in misery and feeling horrible and they sent him home with albuterol and possible antibiotic to start that Monday and he had severe chills, headache, shortness of breath, fever, fatigue, diarrhea, muscle aches, skin sensitivity and rash, sore throat. Chest X-ray says normal; states the albuterol was PROAIR HFA 90mcg and he tested negative for influenza AB and he never got to the antibiotic because they said to wait til Monday and by that time this was an emergency. The patient outcome of sepsis and shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar damage was fatal and unknown for the other events. The patient died on 02Mar2021. An autopsy was performed that revealed the cause of death was sepsis and complications from sepsis and shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar damage.; Reported Cause(s) of Death: Sepsis; Autopsy-determined Cause(s) of Death: Shock due to bilateral pulmonary acute disease syndrome; Diffuse alveolar damage" "1394314-1" "1394314-1" ""73 y.o. female with a past medical history of non-insulin-requiring diabetes type 2 and recent admission at Hospital (5/31-6/6/2021) who was transferred on 6/9 for chest pain with worsening EF with concerns for ischemic cardiomyopathy. Hospital course by dates 5/31?6/6/2021: Admitted for abdominal pain, nausea and vomiting thought to be secondary to ischemic colitis and severe constipation. Patient was found to be anemic during that hospitalization, but did not require blood transfusion. Patient's hospital course was complicated by aspiration pneumonia requiring PICC placement and norepinephrine. She is no longer requiring supplemental oxygen was discharged home. 6/9: Return to hospital with increasing shortness of breath, confusion and generalized malaise. Repeat TTE with anterior wall motion abnormalities and decreased EF. Patient was transferred to bed for cardiology evaluation 6/10: Cardiac catheterization with moderate three-vessel coronary disease, wall motion abnormality does not correspond to coronary disease. Cardiology thinks findings are related to stress-induced cardiomyopathy. 6/11: Patient continues have downtrending hemoglobin, started to prep for colonoscopy on 6/12. 6/12: Rapid response was called at at approximately 4:40 AM, patient ultimately expired at 7:35 AM Patient was transferred from Hospital given new wall motion abnormalities and severe hypokinesis seen on repeat TTE. Fortunately, cardiac catheterization on 6/10 without coronary artery disease that corresponded to these wall motion abnormalities. Ultimately, it was thought to be stress induced cardiomyopathy. Patient was improving, but still complained of epigastric discomfort. Given her recent diagnosis of ischemic colitis and ongoing abdominal pain, GI was consulted for EGD/colonoscopy on 6/12 Rapid response was called at at approximately 4:40 AM. They were mottled appearing, hypotensive and cool to touch. Patient was found to be severely hypoglycemic and had wide-complex tachycardia. Multiple amps of D50 were given but remained hypoglycemic. Patient was also found to be hypoxemic and did not tolerate BiPAP. Eventually patient was transition to comfort measures only. After discussion with patient's daughter, patient's last 10 minutes of life consisted of ""fluid pouring out of her mouth"". Work-up also was positive for elevated lactic acid and elevated D-dimer. Given the abrupt change in patient's clinical status, concern for embolic thrombosis is the most likely cause. Unclear if had pulmonary embolism or ischemia to gut. Interestingly, patient was visiting her from Indiana for her brother's funeral. After discussion with family, patient's brother had a similar unexplained death just a few weeks prior. The Family going back to the fact that she had her second Maderna vaccine 3 days prior to presenting to select hospital. Patient's brother also had a Maderna vaccine before his recent demise. Given the unknown cause of death, an autopsy was discussed with family. They were agreeable to this. Highly concern for thrombotic event, but unable to confirm at this time without autopsy. Unknown if recent vaccine was related to her death, but could explain thrombosis leading to ischemic colitis prompting her last admission. Patient was noted to have a ""severe"" reaction to her first vaccine."" "1394685-1" "1394685-1" "He died suddenly on May 13th. Had just had thorough physical prior to vaccines. Perfect health, weight perfect. No prior health concerns. Heart attack or stroke in his yard. After his first dose on March 16, 2021 he ceased his several mile walk each day stating he was tired and lethargic. He was a military man that rose each day of his life to that walk. His second dose was 04/16/21 he still did not continue the walks and on May 13, 2021 died suddenly of heart attack or stroke." "1394730-1" "1394730-1" "Pt had a spontaneous brain hemorrhage, leading to his death. Pt was found by his wife at approximately 0800, slumped over in the corner of the room, pt was brought into the ER unresponsive. Pt died 4 hours later." "1394806-1" "1394806-1" "My father passed 2 days after vaccine" "1394845-1" "1394845-1" "Patient received 2nd Moderna shot on 6/11/21 at 10:32am. Went home after the shot and didn't feel well, so he laid down to rest. His wife checked on him and he was unconscious, so she called 911. Patient was taken to local hospital and died of Cardiac Arrest sometime between his vaccine and 7pm on 6/11/21." "1394899-1" "1394899-1" "Stroke at approx 1:10 p.m. on 5/4/21. Taken to emergency room. CT scan and given clot-buster mediation shortly after arrival at emergency room. Transport to hospital on 5/4/21 at 5:45 p.m. and subsequent CT scan revealed intracerebral hemorrhage. Administer medication to reverse clot buster medication and airlifted at approx 7:30 p.m. on 5/4/21. At medial center CT scans and EKG testing. Continued brain bleeding. Brain surgery to relieve swelling. Death on 05/08/2021." "1395042-1" "1395042-1" "Cardiac arrest leading to death" "1395203-1" "1395203-1" "Was feeling sick and in bed all day on 6/6, could barely walk or talk on 6/7. Collapsed and stopped breathing/ passed away in the middle of the night late 6/7 or early 6/8." "1395416-1" "1395416-1" "death J18.9 - Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung" "1395420-1" "1395420-1" "Patient presented to emergency department for increasing trouble breathing on 4/23/2021. She was previously diagnosed with COVID-19 infection on 3/3/2021. She was admitted to a different facility from 4/8/2021 to 4/20/2021 for management of COVID-19 infection where she also tested positive for COVID-19. She was admitted for further management of COVID-19 infection. Her symptoms did not improve and she was placed on comfort measures on 5/4/2021. Patient expired on 5/5/2021 due to complications from COVID-19 infection." "1395442-1" "1395442-1" "stroke and MI came in with symptoms of stroke but symptoms for 24 hours so did not receive tPa. MRI showed brainstem infarct. Statin was increased and started on plavix 75 mg daily for 3 weeks due to small stroke with low NIH. Patient came back in 3 days later due to STEMI and went into cardiac arrest. patient died after 1 hour of resuscitation" "1395443-1" "1395443-1" "Four days post-vaccination, she had a serious spell with a hiatal hernia which resulted in a possible gastric volvulus. Over the course of the episode, she ended up aspirating while vomiting. Within 24 hours she couldn't hold her O2 sats at an acceptable level and was put on a ventilator in ICU. She recovered enough to extubate and go to a regular room but then ended up back on the vent and in ICU a second time. She was extubated again, but still could not maintain her O2 levels without medical intervention. She passed away on April 3, 2021. She did have covid-19 in late November 2020, with a mild case of pneumonia. She had been under the care of her primary doctor, as well as home health care and physical therapy, as part of her recovery. Her death may have been unrelated to the vaccine, but I have been told I should report anyway, as a precaution." "1395556-1" "1395556-1" "Death. Ischemic and Hypertensive Heart Disease. No signs. Active and athletic middle age man. Was riding bicycle on a trail, stopped pedaling and dropped dead. Died instantly. CPR was performed. No vitals upon arrival." "1395663-1" "1395663-1" "Massive heart attack and death" "1395843-1" "1395843-1" "Dad woke up on January 29, 2021 with severe stomach pains and vomiting. He was very uncomfortable and ended up going back to bed. He was miserable all day. I called his physician and we decided to keep him comfortable at home and give him the BRAT diet which seemed to be helping with the pain and vomiting. Dad never got out of bed again. On February 4th, Dad was placed on Hospice and died on February 7, 2021." "1395844-1" "1395844-1" "pt had 2nd Moderna vaccine on 2/10/2021 lot # 013M20A. Pt became Ill on 5/10/2021, test covid-19 positive on 5/17/2021 and treated with BAM, Intubated on vent 6/1/2021 deceased 6/13/2021" "1395873-1" "1395873-1" "Pt went to the hospital with covid 05/30. She was on bipap at 100%. Pt ended up passing away 06/11 at 5:32 pm." "1395978-1" "1395978-1" "Approx 16 days following vaccine patient's Sp02 saturation dropped to 70-80% despite being on 6liters O2" "1396032-1" "1396032-1" "Patient had no reaction at time of vaccination; was monitored for 15 minutes prior to leaving clinic. This nurse was notified today by ER Physician that the patient came into the ER around 8pm (on the night of the same day that he received his vaccine in the early morning hours) with c/o shortness of breath. It was reported that the patient had taken nebulizer treatments at home with no relief. Symptoms began around 5:30pm. Patient ambulated into ER at time of visit but during the visit became unresponsive. Patient was intubated and coded with time of death called at 9:52pm. Patient has history of asthma." "1396353-1" "1396353-1" "Worsening abdominal pain and distention on 3/2/21 which progressed to include shortness of breath for which he did not seek medical care. He was found unresponsive on the couch on 3/11/21 and resuscitation was unsuccessful." "1396378-1" "1396378-1" "Patient received the COVID 19 vaccine on 3/30/21. He died at home on 5/10/2021. Per his daughter, he began to decline approximately 2 weeks prior to his death (poor po intake, weight loss, increased sleep) and had not been dx or treated for an acute illness prior to his death." "1396391-1" "1396391-1" "No adverse event reported during home visit provided by RN on 5/26/2021 from 11:15am to 11:45am. VIS information given to patient prior to vaccination. Patient went to ER on 5/27/2021-5/28/2021 and reported that not feeling well. Patient discharged home from ER. Family found him dead in his apartment on 6/3/2021." "1396396-1" "1396396-1" "Patient passed away on 5/12/2021 at assisted living facility" "1396420-1" "1396420-1" "Client passed away on 5/12/2021, she had been residing at assisted living facility." "1396485-1" "1396485-1" "Per obituary, patient died at the Hospital on 5/13/2021. SARS CoV2 PCR on 5/12/2021 was negative." "1396672-1" "1396672-1" "4/27/2021 nausea, on 4/28/2021 nausea, vomiting, diarrhea, 4/30/2021 chest pain, 5/1/2021 cardiac arrest" "1396725-1" "1396725-1" "Per daughter, patient died the next day after receiving the shot. Patient didn't have any issues with 1st shot and she went to check on her and she was dead." "1397041-1" "1397041-1" "Day after shot patient was tired, he was not feeling well, & he never fully recovered. He went to work on Monday, May 10th & worked until 6:00pm. Returned home eat a little & went to bed. Tuesday, May 11th he worked at home, Wednesday, May 12th we had coffee, laughed & joked around & he went back to work at home. I went to check on him about five minutes later & he was sitting up sleeping. He would usually wake up & say I took a power nap but he was not breathing. I started mouth 2 mouth but he did not respond. My sister told my nephew to call 911 & they told us to lay him on the floor & start CPR until the paramedics arrived. Once they arrived & took over they tried to get him to breathe & restart his heart. The paramedics worked on him for a long time giving us updates on what they were trying to do. Patient never regained consciousness. They indicated probably a heart attack." "1397246-1" "1397246-1" "HISTORY OF PRESENT ILLNESS: This is a 20-year-old male with past medical history of asthma, who was brought to ED by ambulance for nausea, vomiting, generalized weakness, and fever. The patient received his second dose of Moderna vaccine 10 days ago. The patient is experiencing symptoms of nausea, vomiting, fatigue, poor p.o. intake for the last few days. He was at ED 4 days ago and had a negative workup. The patient had a fever with T-max of 103 at home. He also had 2 episodes of emesis in the last few days. He denies any diarrhea, chest pain, abdominal pain. He complains of headache. He denies any blurred vision or neck stiffness. At hospital, the patient was given 4 L of fluid and had multiple blood tests. Even echocardiograms were unremarkable. The patient is unable to ambulate because of generalized weakness and dizziness." "1397724-1" "1397724-1" "Thrombosis of LAD, death" "1398476-1" "1398476-1" "Death; Felt like he was dying; Can't move; Hurting pain over the whole body; Weak; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), FEELING ABNORMAL (Felt like he was dying), MOVEMENT DISORDER (Can't move), PAIN (Hurting pain over the whole body) and ASTHENIA (Weak) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 028L20A) for COVID-19 vaccination. The patient's past medical history included Coronary artery disease in 2000 and Stroke (recovered) in 1992. Concurrent medical conditions included Diabetes since 2000, Blood pressure high (stable) since 1964, Atherosclerosis since 2016 and Heart attack (recovered) since 2019. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), METOPROLOL for Blood pressure, DULOXETINE for Depression, METFORMIN HYDROCHLORIDE for Diabetes, FERROUS SULFATE HEPTAHYDRATE (FERROUS SULFATE [FERROUS SULFATE HEPTAHYDRATE]) for Iron deficiency, LAMOTRIGINE for Seizure, ACETYLSALICYLIC ACID (ASPIRIN 81) from 18-Jul-2017 to an unknown date, CALCITRIOL, CLOPIDOGREL, FUROSEMIDE, ISOSORBIDE, VITAMIN B12 NOS, COLECALCIFEROL (VITAMIN D3 1000), INSULIN GLARGINE (LANTUS), ACITRETIN, ATORVASTATIN, LOSARTAN POTASSIUM (COZAAR), DULAGLUTIDE (TRULICITY), METFORMIN HYDROCHLORIDE (METFORMINE HCL) and LAMOTRIGINE for an unknown indication. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL (Felt like he was dying) (seriousness criteria death and hospitalization), MOVEMENT DISORDER (Can't move) (seriousness criteria death and hospitalization), PAIN (Hurting pain over the whole body) (seriousness criteria death and hospitalization) and ASTHENIA (Weak) (seriousness criteria death and hospitalization). The patient was treated with TRAMADOL for Pain, at a dose of 50 mg; LORAZEPAM for Anxiety, at a dose of 0.5 mg and MECLIZINE [MECLOZINE] for Dizziness, at a dose of 25 mg. The patient died on 05-Mar-2021. The reported cause of death was heart and kidney failure and Kidney failure. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: unknown (Inconclusive) Inconclusive. This is a case of sudden death in a 74-year-old male patient with a history of Coronary artery disease and Stroke, who died of heart and kidney failure 19 days after receiving last dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received, includes patient's gender. On 07-Jun-2021: Follow up received, includes Patient information, historical conditions, batch number, cause of death, concomitant drugs.; Sender's Comments: This is a case of sudden death in a 74-year-old male patient with a history of Coronary artery disease and Stroke, who died of heart and kidney failure 19 days after receiving last dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Heart and kidney failure; kidney failure" "1398802-1" "1398802-1" "Patient went into cardiac arrest about 14 hours after receiving vaccine and passed" "1399352-1" "1399352-1" "Patient had cataract surgery in mid May, developed shortness of breath after, was seen in ER and admitted. Found to have stage 4 small cell lung cancer (not a smoker to my knowledge). Stayed in hospital until June 3rd when he was transferred home to medical center for end of life care. Died June 7th." "1399358-1" "1399358-1" "Patient deceased 6/9/2021 from COVID pneumonia" "1399375-1" "1399375-1" "Coroner stated that 3 weeks after patient received 2nd dose of COVID-19 Moderna vaccine, patient collapsed from cardiac arrest, which lead to death." "1399413-1" "1399413-1" "began with a fever, and slowly starting having nausea and diarrhea. we could not bring down fever with antibiotics" "1399516-1" "1399516-1" "Sweating, soreness, vomiting" "1399868-1" "1399868-1" "Family reported that the patient died 6 hours after being vaccinated." "1399891-1" "1399891-1" ""Please see ER physician note below. Patient later expired at 1337 on June 12th. One day after receiving the COVID vaccine. ER physician note: Patient presents completely unresponsive, CPR in progress Patient's wife reports that this afternoon, they were lying in bed and he leaned over to her and said ""help me"". He then became unresponsive. She reports that she believed he may have aspirated because he has an issue with his esophagus where he is unable to adequately swallow food sometimes. The family began CPR at home, and reports that EMS arrived approximately 10 minutes later. Patient arrived here at the ED around 1250. CPR continued. Patient given multiple rounds of epi and bicarb. Patient intubated with an 8 at 21 cm with some cold liquid around the tube. He was intubated at arrival."" "1400009-1" "1400009-1" "Patient received COVID 19 vaccination on 3/30/2021 as part of vaccination program. Per obituary, he died at home on 5/13/2021" "1400020-1" "1400020-1" "Death" "1400093-1" "1400093-1" "Died suddenly, autopsy pending" "1400218-1" "1400218-1" "Patient CTB" "1400337-1" "1400337-1" "On May 18, 2021, Patient said he was experiencing severe back pain and that both of his arms had gone numb and he had vomited. Patient called his mother to come help him with the baby because he wasn't feeling well. When she got there 30 minutes later he was not breathing. They were not able to revive him. He died of a blood clot in the front of his heart." "1400869-1" "1400869-1" "Reported to me by patients niece, who developed similar symptoms around the same time: Patient developed cough aches, fartigue and shortness of breath about 8 days after receiving COVID vaccine. After another 10 days of illness was taken to hospital by ambulance as too weak to stand., and died in hospital about 5 days later, on or about 5/22/21" "1401286-1" "1401286-1" "rhabdomyolysis leading to death" "1401722-1" "1401722-1" "Died on the night of 05Jun2021 or Morning 06Jun2021 not Sure; Gastritis; The reaction came back with a vengeance; was doubling over; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Died on the night of 05Jun2021 or Morning 06Jun2021 not Sure) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart disease, unspecified. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced DISEASE RECURRENCE (The reaction came back with a vengeance) and CONDITION AGGRAVATED (was doubling over). On 01-Jun-2021, the patient experienced GASTRITIS (Gastritis). The patient died on 05-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, GASTRITIS (Gastritis), DISEASE RECURRENCE (The reaction came back with a vengeance) and CONDITION AGGRAVATED (was doubling over) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Ultrasound scan: abnormal (abnormal) confirmed gastritis.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Labs included electrocardiogram (EKG) whose results were not provided. It was reported that on 01-jun-2021 at Emergency room, gastritis was diagnosed and patient was sent home. Treatment information was not provided. Company comment: This is a case of sudden death in a 53-year-old male patient with a history of Heart disease, who died 1 month 14 days after receiving last dose of vaccine. Very limited information has been provided at this time. This case was linked to MOD-2021-211580 (Patient Link).; Sender's Comments: This is a case of sudden death in a 53-year-old male patient with a history of Heart disease, who died 1 month 14 days after receiving last dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death" "1401732-1" "1401732-1" "Seizures; Bood clots; Stuggling to breathe; Struggling to walk; ARDS; Acute hypoxic respiratory failure; Acute exacerbation of heart failure and sepsis; Acute exacerbation of heart failure and sepsis; Cardiac arrest; Blood infection; Fever; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS), ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure), SEPSIS (Acute exacerbation of heart failure and sepsis), CARDIAC FAILURE ACUTE (Acute exacerbation of heart failure and sepsis), CARDIAC ARREST (Cardiac arrest), SEIZURE (Seizures), THROMBOSIS (Bood clots), DYSPNOEA (Stuggling to breathe) and GAIT DISTURBANCE (Struggling to walk) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Obesity. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) (seriousness criteria death and medically significant), ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure) (seriousness criteria death and medically significant), DYSPNOEA (Stuggling to breathe) (seriousness criterion hospitalization prolonged) and GAIT DISTURBANCE (Struggling to walk) (seriousness criterion hospitalization prolonged). In May 2021, the patient experienced SEPSIS (Acute exacerbation of heart failure and sepsis) (seriousness criteria death and medically significant), CARDIAC FAILURE ACUTE (Acute exacerbation of heart failure and sepsis) (seriousness criteria death and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant), INFECTION (Blood infection) and PYREXIA (Fever). On 17-May-2021, the patient experienced SEIZURE (Seizures) (seriousness criteria hospitalization prolonged and medically significant) and THROMBOSIS (Bood clots) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized from 15-May-2021 to 25-May-2021 due to DYSPNOEA, GAIT DISTURBANCE, SEIZURE and THROMBOSIS. The patient died on 25-May-2021. The reported cause of death was Cardiac arrest, Acute hypoxic respiratory failure, ards and acute exacerbation of heart failure and sepsis. It is unknown if an autopsy was performed. At the time of death, SEIZURE (Seizures), THROMBOSIS (Bood clots), DYSPNOEA (Stuggling to breathe), GAIT DISTURBANCE (Struggling to walk), INFECTION (Blood infection) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, Blood pressure measurement: elevated (High) Twice normal. On 15-May-2021, Glycosylated haemoglobin: elevated (High) High. On 15-May-2021, Oxygen saturation: low (Low) Required intubation and was placed on ventilator.. On 15-May-2021, SARS-CoV-2 antibody test: negative (Negative) 1 negative COVID antibody test. On 15-May-2021, SARS-CoV-2 test: negatie (Negative) 3 negative COVID antigen tests. No concomitant medications were provided. It was reported that within few hours after second dose of vaccine patient was struggling to walk and to breathe. The reporter and her husband went to see the patient and took him to an emergency room (ER). In the ER his blood pressure was markedly elevated (twice normal) and his oxygen level was low and by midnight he required intubation and was placed on a ventilator. His HbgA1c was noted to be elevated. Two days after admission (17-May-2021), he developed seizures which the medical team believed to be due to blood clots and he was anti-coagulated. It was determined that he did not have blood clots on his heart valves as the source of the clots. The source of the blood clots was never identified. He later developed fever and was diagnosed with a blood infection and treated with antibiotics. At one point his oxygen requirement on the ventilator went down to 65% but later returned and remained at 100%. He ultimately died on 25-May-2021 and as per copy of his death certificate he had 4 causes of death as cardiac arrest, acute hypoxic respiratory failure, acute respiratory distress syndrome (ARDS) and acute exacerbation of heart failure and sepsis. Treatment included, anticoagulants, antibiotics, intubation and ventilator. Very limited information regarding these events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-219410 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Cardiac arrest; Acute hypoxic respiratory failure; ARDS; Acute exacerbation of heart failure and sepsis" "1401971-1" "1401971-1" "Few days after receiving the vaccine around 4/25, my mother complained to me that she was feeling very weak and tired, she was unable to hold anything down. She also had a rash. She became weaker and weaker so suddenly and unable to even drink protein drinks. She finally went to the ER on 5/4 because she could barely walk, unable to eat anything and was short of breath. They diagnosed her with pneumonia and a possible lung mass. She was diagnosed simultaneously 10 days later with small cell lung cancer however she had no symptoms prior. She received first dose chemo on 5/20/21 and had a reaction to the chemo that the doctor stated was very rare. They then had to try a different type of chemo for second dose 2 days later. She progressively got worse suddenly after chemo dose #3 and was in renal failure the day following chemo completion. She died on 5/27/2021. Her primary death diagnosis was sepsis, pneumonia and small cell lung cancer. I am reporting this for my mother because the vaccine has not been tested on cancer or chemo patients. It can and should not be regarded as coincidental. It needs to be tracked in case there are future reports regarding cancer patients." "1402213-1" "1402213-1" "Pt had severe itching started shortly after 2nd shot. MD stated pt having histamine response and Atarax started 3x/day to control itching symptoms. After several weeks pt stated atarax making her drowsy and requested to decrease to 2x/day. Pt started itching severely again after frequency decreased and pt requested to be put back to 3x/day. Shortly after pt had massive stroke which led to her death a couple of days later on 4/23/2021" "1402355-1" "1402355-1" "day after vax she became weak, couldn't walk, couldn't move arms/legs" "1402395-1" "1402395-1" ""2 days after vaccine developed diarrhea & body aches, then loss of smell and appetite. ED visit 4/8/2021, lymphopenia noted, COVID PCR positive. Returned to ED 4/11/2021 with SOB, oximetry low 70s, cyanotic, respiratory distress, elevated D dimer, CXR: COVID pneumonitis. ""Deteriorated quickly despite maximal medical management"" per Discharge Summary. Died 4/24/2021 from hypoxic respiratory failure and multiorgan failure, shock. Had also developed heparin induced thrombocytopenia during treatment for DVT Right lower and upper extremities."" "1402435-1" "1402435-1" "Pt died on 5/29/2021" "1402785-1" "1402785-1" "Patient experienced malaise and shortness of breath within 2-3 hours of getting the shot. Progressed over the next 48 hours and then presented to ER where she was diagnosed with acute hypoxic respiratory failure due to a myocardial infarction. Transferred to care center on 05/15/2021. Patient nor her family desired any heroic measures due to her age and comfort measures were instituted. She expired on 05/19/2021. Prior to the vaccination, patient had been active, going to the YMCA to exercise 4 times weekly. She had no previous history of previous cardiac or respiratory problems." "1402809-1" "1402809-1" "Deceased 6/7/21 (Unsure if related)" "1402834-1" "1402834-1" "Strokes, very weak, vomiting, suffered mild heart attack." "1403394-1" "1403394-1" "Approximately 01:56 the following morning, patient expired" "1403396-1" "1403396-1" "On Friday night, April 16,2021, after working all day for his job, Pt told his roomates that he wasn't feeling well, was throwing up, had the chills and was going to lay down. When the roomates didn't see him Monday morning, April 19, 2021, they went into his room and found him unresponsive. The medical examiner ruled death due to cancer which appears incorrect considering the evidence." "1403424-1" "1403424-1" "Hospital Course: Complicated. Patient was brought in for ostomy reversal, had a colonoscopy performed through his colostomy which revealed the patient to have a right colonic mass, mass was an adenocarcinoma. Had a right colectomy performed , had a massive myocardial infarction and died. Complicated 1 year, started with COVID 19 - patient was admitted prolonged amount of time due to complications of COVID 19 , developed a large decubitus ulcer which was not healing. Was being followed by Dr wound care center. Multiple debridements. Failure to heal. Referred to me for a diverting colostomy to facilitate healing of the large decubitus ulcer. Diverting colostomy was performed September 2nd 2020. Patient had plastic surgery, flap surgeries, in December 2020 and January 2021. finally healed. Brought for a ostomy reversal, found large mass in the cecum attempted endoscopic removal, with micro perforation, taken to the operating room immediately from endoscopy suite had a right colectomy. Colostomy started functioning, patient was recovering, suddenly started having chest pain and had a massive myocardial infarction." "1403441-1" "1403441-1" "dyspnea, pneumonia, difficulty breathing. positive for COVID-19 3/25/2021, hospitalized and later died of COVID-19" "1403521-1" "1403521-1" "weak, loss of appetite, pneumonia, ARDS" "1403750-1" "1403750-1" ""Patient complained of feeling unwell and having headaches after his second dose of Moderna vaccine on 2/2/2021. He became increasingly confused, paranoid and started occasionally refusing medications. On early March 2021, he started refusing all medications. Around 3/17/21, his increasing confusion and paranoia prompted suspicion for UTI which was confirmed with a urinalsis. Unfortunately, he refused antibiotic treatment. On 3/20/2021, nursing staff noted that patients right lower extremity was purple from toes to mid-calf, cold to touch and pedal pulse were not present. He complained of right leg pain. He was evaluated and diagnosed with probable thromboembolic event, since patient refused his oral anticoagulant for weeks prior to these event. Patient was sent to the local Emergency Department (ED) and diagnosed with acute critical right limb ischemia. At the local ED, he had a CTA which showed as per radiology: ""Occlusion of the right superficial femoral artery beginning just beyond the origin. Occluded right popliteal, anterior tibial, tibioperoneal, peroneal, and posterior tibial arteries without reconstitution on arterial and delayed phases. Patent right deep femoral artery with minimal luminal stenosis in the proximal segment. Patent mid and distal right external iliac artery with up to mild luminal stenosis."" Per discharge summary, ""vascular surgery evaluated patient in the ED and did not feel operative revascularization with fasciotomy would provide any benefit; recommended continued anticoagulation with amputation/palliative management."" He was admitted to the general medicine service which consulted orthopedic, infectious diseases and palliative care. Medicine Service also contacted patient's daughter who is his next of kin who opted for comfort care. He was discharged to facility on 3/25/2021 and started in the Comfort Care Program. He was pronounced dead on March 27, 2021 at 0807 hours. His autopsy showed that he also had thrombi on: 1. Pulmonary embolism, Left pulmonary artery 2. Left renal infarct"" "1403766-1" "1403766-1" "Individual passed away within 48 hours of receiving vaccine." "1404023-1" "1404023-1" "patient died. right side of patients face (eye, nose, mouth) were drooped, right hand was drawled up." "1404274-1" "1404274-1" "Death, sudden heart attack or blood clot" "1405284-1" "1405284-1" "loss sense of taste; Lost sense of smell; pain in body; chills; Patient died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Patient died) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss sense of taste), ANOSMIA (Lost sense of smell), PAIN (pain in body) and CHILLS (chills). The patient died on 06-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, AGEUSIA (loss sense of taste), ANOSMIA (Lost sense of smell), PAIN (pain in body) and CHILLS (chills) was resolving. Concomitant medications were not reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-201255 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown casue of death" "1406845-1" "1406845-1" ""Evaluated in Health Services for complaints of SOB on 4/13/21, states he felt 'winded and weak after the 2nd moderna vaccine."""" "1406851-1" "1406851-1" "5/10/2021 Patient died. 5/3/2021 Patient is a 91 y.o. female with a history of afib, PE/DVT, hypothyroidism, GERD, htn, colon resection 206 and HTN who presented to the ED with AMS and difficulty breathing. Patient unresponsive in the ED and was intubated for airway protection. CTA chest with extensive acute pulmonary embolism with findings of right heart strain. Patient intubated and sedated, information is obtained from her son, medical staff and medical records. Patient was hospitalized with Covid 2 weeks ago, following discharge she seemed to slowly be improving until Saturday prior to admission Per son was more tired but she had worked with physical therapy and HH on Friday. Sunday she was having difficulty breathing and was brought to the hospital. 4/17/2021 Altered mental status, unspecified altered mental status type; Pneumonia of left lower lobe due to infectious organism; Atrial fibrillation with rapid ventricular response (HCC); Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type (HCC); Acute hypoxemic respiratory failure (HCC); Chronic respiratory failure with hypoxia (HCC); Pressure injury of sacral region, stage 3 (HCC); SOB (shortness of breath); Palliative care encounter; Shock (HCC); Chronic atrial fibrillation (HCC); Acute respiratory failure with hypoxia and hypercapnia (HCC)" "1407048-1" "1407048-1" "Pt. did not die from COVID vaccine. He was diagnosed with COVID19 on 06/04/2021. He had an extensive past medical history with several preexisting conditions which COVID exacerbated." "1407151-1" "1407151-1" "DIARRHEA, COUGH , PNEUMONIA STARTING 4/27/2021" "1407166-1" "1407166-1" "84 y/o M PMHx of non-hodgkin's lymphoma, adenocarcinoma of the colon (1996) and type 2 DM, presented ED 4/17 with complaints of weakness x 1 week. He reported some Memory loss but denied fever/chills, coughing, dyspnea or fever. Admitted for UTI. On 4/19 patient developed fever, tested positive COVID, started on decadron and remdesivir, pulmonology consulted. 5/1 increasing O2 requirements, prompting transfer to ICU. Mental status improved. 5/3: Fluctuant FiO2 requirements. Transferred to the floor and back to the ICU for hypoxemia. Intubated 5/7. Pt with worsening AKI, metabolic acidosis and shock in the evening of 5/8. Daughter on 5/9 and pt made a DNR. Worsening shock, metabolic acidosis and MODS. Decision to dc to hospice" "1407184-1" "1407184-1" "DYSPNEA 3/7/2021, CONFIRMED BREAKTHROUGH WITHA POSITIVE COVID-19 RESULTING IN DEATH" "1407632-1" "1407632-1" "Patient received the COVID 19 vaccine on 3/30/21 as part of the homebound program. Per the obituary, he died at home on 6/12/2021." "1407647-1" "1407647-1" "Patient received the COVID 19 vaccine on 3/30/21 at home. Per the obituary, he died at home on 5/10/2021." "1407804-1" "1407804-1" "As per wife's account, patient died approximately 9 days after receiving vaccine on 4/21 of massive, unknown (suspected cardiac) event. Wife explained that patient was diagnosed with Wolff-Parkinson-White (WPW) syndrome prior to being vaccinated. PCP unaware of diagnosis, and patient did not disclose that on vaccine consent form. Patient reported to his wife that he was feeling unwell after receiving vaccine including unable to move legs well. Patient later diagnosed with thrush and supposedly treated by physician. Patient did not discuss concerns regarding vaccine or WPW with physician. Patient called his wife the day of death and asked her to bring him to the doctor the following day. Wife reported that patient experienced seizures but not concerned as it was similar to childhood seizure. Wife was done at work and drove home after phone call, arriving at house approximately 10-15 minutes after call. Patient supposedly dead when wife arrived. Wife performed CPR for ~15 minutes until EMS arrived, and EMS attempted for another 40 minutes for any electrical activity. Wife declined full autopsy from ME, suspecting that it was massive MI or clot. Wife and patient unaware that WCW could place patient at risk of clots and wondering if the vaccine was partially responsible." "1407818-1" "1407818-1" "Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine." "1407833-1" "1407833-1" "Patient was found dead next day at home during sleep." "1407929-1" "1407929-1" "Decedent passed away from causes not yet determined" "1407938-1" "1407938-1" "Intense diarrhea, stomach cramps and bloating. nausea, fatigue, memory loss, incoherent, skin peeling over entire body including face, immobile and labored breathing (over and above her COPD)." "1408193-1" "1408193-1" "Stroke possibly from intermittent atrial fibrillation" "1408205-1" "1408205-1" "2/22/2021 - Tested positive for Covid 3/9/2021 - found down at her SNF, taken to ER. complains of lower back pain, left hip pain, bilateral knee pain, low O2 sat Dx: Aspiration pneumonia of both lower lobes (HCC), *Left lower lobe pneumonia, History of COVID-19, Urinary retention, Diarrhea C diff negative. 3/22: placed on palliative care after speaking with family 3/23: Expired" "1408206-1" "1408206-1" "Patient received both COVID vaccines. On 5/21/21 she presented to the ED with COVID symptoms. She was tested on 5/21/2021 and was positive for COVID-19. She died on 6/7/2021 in hospital from complications of COVID-19" "1409932-1" "1409932-1" ""The evening of his second shot, he collapsed. He said he became light headed, but I believe he may have lost consciousness briefly. He rand a low fever for 12 hours. Afterwards, he complained that he had ""not felt right"" since the second shot. He died of a heart attack on May 27, roughly one month after his second shot."" "1410110-1" "1410110-1" "death" "1410139-1" "1410139-1" "The patient received the first dose of vaccine on March the 1st and the 2nd dose of the vaccine on March 28th. Patient had difficulty breathing with swelling feet and ankles that did not begin until April 12th. Patient had no history of breathing problems. Cardiovascular history is unknown at the pharmacy as we had only ever performed vaccinations on the patient. Patient was discovered in his house deceased. Exact date is unknown. The pharmacy was contacted by the patient's prescriber which requested we file this report. I apologize for the lack of precise information." "1410180-1" "1410180-1" "Patient expired 06/18/2021" "1410203-1" "1410203-1" "pt developed pulmonary embolism and passed away 6/14/2021" "1410234-1" "1410234-1" "Blood clot?> loss of consciousness-> artificial coma ?> death 10 days after vaccination" "1410366-1" "1410366-1" "Cough and fever as symptoms of COVID infection Cause of death: Congestive heart failure" "1410369-1" "1410369-1" "Patient received 2nd dose of the COVID-19 vaccine on 2/10/21 and was considered fully vaccinated two weeks later on 2/24/21. On 6/10/21 patient was hospitalized with a possible upper GI bleed. Overnight the patient began to have increased oxygen needs and crackles on auscultation. She was transferred to the ICU, had an abnormal chest x-ray, and tested PCR positive for COVID-19. The patient had acute kidney failure and respiratory failure with a DNR and DNI. She expired on 6/11/21." "1410414-1" "1410414-1" "Janssen Covid-19 EUA 3/22 started feeling ill. 4/4 went for nasal swab Covid test 4/9 results negative. 4/12 went to doctor with extreme abdominal pain, shortness of breath, blurred vision. Ran bloodwork. Sent to ER for cat-scan. Results were colitis. Back to ER x3. Finally admitted and put on antibiotics, and fluids. Released home to hospice after 4 days. Died on 4/30 with cause of death, colitis." "1410464-1" "1410464-1" "Patient was diagnosed with COVID-19 on 6/13/2021 and subsequently died on 6/17/2021. Patient was considered to be fully vaccinated as of 3/24/2021 having received both doses of Pfizer." "1410676-1" "1410676-1" "ACHE, RUNNY NOSE, COUGH, LETHARGIC" "1410797-1" "1410797-1" "Initially had fatigue, diarrhea, and loss of appetite. Tested positive for COVID 19 on 5/28/21 , during surveillance testing related to a facility COVID Outbreak. He went to ED 5/28/21 for decrease level of consciousness, high blood pressure, low blood sugar, anorexia. Once stabilized, transferred back to facility. On 6/7/21, transferred to ED for COVID pneumonia and hypoglycemia, treated with Dexamethasone and oxygen. Discharged back to facility 6/10/2021. On 6/12/2021, went to ED for ischemic stroke. Died 6/13/2021." "1410799-1" "1410799-1" "After first dose of vaccine on 4/23 complained of fatigue and tiredness. After second dose on 5/26 complained of fatigue, dizziness, nausea and body aches. Expired on 5/28." "1410894-1" "1410894-1" "Patient was hospitalized due to COVID-19 from May 19, 2021 to May 22, 2021. Patient was then placed on hospice on 6/5/2021 and expired on 6/7/2021." "1410974-1" "1410974-1" "presented to the ED with generalized weakness progressing to fever, cough, dyspnea, myalgia, pneumonia. admitted to Hospital" "1411020-1" "1411020-1" "Shaking, almost spasm type shaking. Weakness in her legs. progressing to abd. pain, cough, headache, nausea" "1411025-1" "1411025-1" "The hospital gave my mom the Johnson shot on May 18,21.( I was not informed about it until my my told me on May 20th ) she said she had a headache and stomach, My mom was scheduled for an angiogram that day but they couldn't do it then because the doctor had an emergency. So they schedule it for Saturday but they couldn't do it because my mom had an upset stomach. They then schedule it for the 24th but they couldn't do it because her vitamin k and plasma level's were off. So they gave her vitamin k and plasma in the morning of the 25th and said they could do the angiogram. When she came back to the room her blood pressure was extremely low and she was very bloated. I was told they couldn't do the procedure because she had blood clots in her leg. And the bloating was due to fluids they gave her to flush out the heparin they gave her. Later that evening she passed away" "1411290-1" "1411290-1" "Death due to PEs in bilateral lungs caused by DVTs in bilateral legs." "1411734-1" "1411734-1" "Symptoms started with tightness of muscles and body aches, tightness of chest, increased blood pressure, herpes simplex A mouth sores - saw PMD received muscle relaxer, and antibiotic cream... in the 30 days prior to last event she had been having dizzy spells, chills, hot flashes, shortness of breqth, tightness of chest, darkened urine, muscle cramping and knotting, pitting edema, halo discoloration lower right extremity (she wasnt one to complain and thought her symptoms were from use of muscle relaxer) - woke AM 6/11/2021 with severe shortness of breath and was taken to ER - diagnosed with obesity, cardiomegaly, renal failure, severe anemia, hypoxia, and hypokalemia, she went into respiratory distress AM 6/12/2021 and then went into cardiac arrest. She died as a result." "1412293-1" "1412293-1" "not well after the vaccination; Died of a massive heart attack; substantial swelling on her lymph node on the left side on the neck/jaw area; Chills; Nausea; Felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died of a massive heart attack) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in January 2021. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Felt very tired). On 02-Mar-2021, the patient experienced LYMPHADENOPATHY (substantial swelling on her lymph node on the left side on the neck/jaw area). On 30-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died of a massive heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced MALAISE (not well after the vaccination). The patient was treated with NAPROXEN SODIUM (ALEVE) for Lymph nodes enlarged, at a dose of 1 dosage form. The patient died on 30-Mar-2021. The reported cause of death was massive heart attack. It is unknown if an autopsy was performed. At the time of death, MALAISE (not well after the vaccination), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Felt very tired) outcome was unknown and LYMPHADENOPATHY (substantial swelling on her lymph node on the left side on the neck/jaw area) had not resolved. Concomitant medications were not reported. Company Comment ; Very limited information regarding this events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up telephone contact report (TCR) upgraded case to serious, new event added, action taken updated; new reporter added.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Massive heart attack" "1412755-1" "1412755-1" "Patient found in respiratory arrest at 4:20am on 6/19/21. CPR initiated and continued by EMS, along with IV fluids and intubation, remained in asystole throughout course of CPR. CPR terminated by EMS." "1412820-1" "1412820-1" "within 24 hours after second dose of vaccine my mother complained of chest pains and shortness of breath. She saw her Primary Care Dr on 5/10/2021 after experiencing dizziness, fatigue, confusion. She had lost a considerable amount of weight during this time and I was concerned and accompanied her to the doctor visit. Dr prescribed cyanocobalamin B-12 as she had been defficient in her latest blood analysis on 3/15/2021. She also added Donepezil 5mg tablet daily and trazodone 50 mg nightly to help with sleep. She gave referral to get Neuroligical evaluation. My mother had a driving episode on 4/30/2021 where she was taken to Medical Center and some Scans were taken of her brain that were apparently normal they contacted me to pick her up around 2:30 AM 5/01/2021. The number on her release folder to obtain medical Records. My mother was residing with me my home until her appointment for evaluation . She passed away on 6/02/2021 in my home.. Dr was contacted to sign off on her Death Certificate . I have not received Death Certificate as of today but I believe the cause she was putting was Natural Causes due to age." "1413046-1" "1413046-1" "Sudden cardiac arrest 3 days after second vaccine" "1413073-1" "1413073-1" "On April 27, after my husband took a 2 mile run. He returned and collapse outside of our home. My son and I immediately perform CPR on him. Three week later my husband did from respiratory heart failure - cardiac arrest. He had no complaints about any chest pain ever. We had just visited his doctor that afternoon and gave no report of heart problems or any immediate health issues." "1413086-1" "1413086-1" "Coughing started about May 5, 2021, confusion started on about May 8, 2021, put on oxygen in Emergency room on May 9, 2021. Admitted to hospital where he stayed until his death on June 18, 2021." "1413141-1" "1413141-1" "Patient had bad headache within the hour, difficulty breathing soon after, became delirious, couldn't make sense, couldn't walk and had to call EMS." "1413325-1" "1413325-1" "He said he felt bad and fell over and died." "1413354-1" "1413354-1" "Active COVID infection diagnosed 06/14/21" "1413571-1" "1413571-1" "Stroke on the 23rd, hospilized for 10 days. Second stroke on the 12th. Died on the 18th." "1413807-1" "1413807-1" "Systemic: Death-Severe, Additional Details: Patient's wife called and told us that on the day that he passed (6/13/21), he did yard work all morning, then came in for a meal and to watch the soccer game. He then went to their bedroom to lay down and about 15 mins later she heard a strage noise and went check on him. Upon entering the room is when she found that he had passed. Cause of death is unknown" "1413849-1" "1413849-1" "COPD She was a resident at the Senior Living facility. My mother received the vaccine on Tuesday, May 18, 2021 at approximately 11:00 a.m. She was left by herself and called around at 11:32 to say she got the vaccine and she was having a hard time breathing. Around 1:40, the nursing home called to let me know CPR was being performed. My sister rushed to the site and she was pronounced dead around 2:10. p.m." "1414035-1" "1414035-1" "2 months after last dose, a routine bloodwork revealed high kidney numbers. Voice became hoarse and difficulty in swallowing ease was noted. Repeat blood work confirmed kidney numbers still high after hydration, IV fluids given at home. Fatigue increased and I took my mother to the ER. She was admitted and she spent 3 weeks in the hospital, 1 week in ICU. She was eventually diagnosed with the autoimmune disease ANCA Vasculitis. Biopsy confirmed. No previous kidney disease or abnormal blood work. She was treated with high dose steroids and chemotherapy. There was no positive response to treatment. Condition worsened and she was moved to Hospice care. My mother died on 05/16/2021" "1414045-1" "1414045-1" "Unstable vital signs." "1414207-1" "1414207-1" "Pt w/hx significant for COPD (on 1L O2 a baseline) p/w cough, exertional dyspnea, and generalized weakness since 6/7/21). COVID test positive on 6/10 despite receiving Pfizer vaccines on 4/5 & 4/27. Pt was admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. During admission received dexamethasone, convalescent plasma, remdesivir. Culture indicated pseudomonas PNA, but likely colonization given hx, however, due to illness and underlying bronchiectasis, was given cefepime. Hospital stay complicated by significant resistant hypercarbia and respiratory failure, pt placed on comfort measures given that death is imminent. Unfortunately, pt passed on 6/13/21." "1414219-1" "1414219-1" "The patient was vaccinated on 5/26/21 for dose one and 6/16/21 for dose two with Pfizer COVID-19 vaccine. Patient passed away the day following her second dose on 6/17/21." "1414259-1" "1414259-1" "Low heart activity and low oxygenation." "1414492-1" "1414492-1" "Nursing Home Visit 6/2/2021 Geriatric Medicine COVID-19 virus infection +4 more Dx Progress Notes SUBJECTIVE: Patient with history of multiple myeloma, osteonecrosis of jaw on IV antibiotic, CAD with history of stent, seizure disorder and hypertension was seen today. She has been complaining of sinus congestion for past 3 to 4 days. Apparently there has been other resident who tested positive for COVID-19 so rapid antigen test was performed on her. Unfortunately she also tested positive for COVID-19. She has received full dose of COVID-19 vaccine earlier in February. She denies any fever or chills. She denies any shortness of breath. She does complain of cough and sinus congestion going on for a week or so. Chief complaint: Acute hypoxic respiratory failure due to COVID-19 SUBJECTIVE: Patient with history of multiple myeloma, osteonecrosis of jaw on IV antibiotic, hypertension, CAD and seizure disorder was tested positive for COVID-19 yesterday. She has been complaining of sinus congestion for the past for 5 days. However this has been at her baseline. She has multiple allergies and taking antihistamine chronically. There has been Covid outbreak in the facility and multiple other residents are positive for COVID-19. She also tested positive for COVID-19 yesterday. Unfortunately this morning she declined and needed oxygen support. Her oxygen saturation dropped to mid 70s to upper 80s on 5 L O2. She was not using any accessory muscle. She did complain of mild cough but denied any chest pain. Her appetite is poor. She does not look toxic. Date: 6/3/2021 Admission Date: 6/3/2021 Assessments Patient is a 74 y.o. female on hospital day number 0 Medical Problems Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Yes Plan Chief Complaint Patient presents with ? Shortness of Breath #. COVID-19 pneumonia with hypoxia. -Patient was offered plasma and she wants to get plasma therapy. Patient has signed a consent form for blood product transfusion. -Patient states she cannot take steroids due to her medical history. She is refusing steroid therapy. -IV remdesivir ordered for the patient. -Patient is consulted with the ID due to her complicated history. -Patient is on oxygen support via nasal cannula. #. Mandible osteomyelitis diagnosed recently. -Patient has been seen by infectious disease during the prior admission and has PICC line for long-term IV antibiotic. -Patient is reordered IV antibiotic in the form of imipenem and oral doxycycline as well as azithromycin. #. Essential hypertension -Patient continues on various antihypertensive medication. #. Diabetes mellitus type 2 -Patient is on insulin therapy while in the hospital. Patient is on polypharmacy and was advised to discuss with her family doctor to cut down on her unnecessary or unimportant medications if possible. History of Present Illness Patient is an 74 y.o. female. Patient is 74-year-old Caucasian female, who presented from a facility chief complaint of acute hypoxic respiratory failure due to COVID-19 pneumonia. Patient has been at this facility since 5/12/2021 after being diagnosed with bisphosphonate related out for necrosis of the jaw with cellulitis and possible osteomyelitis. Patient had been transferred from a Hospital on 5/12/2021. Patient had been getting IV antibiotics for the osteomyelitis of the mandible and was apparently doing well until today when she was noted to be hypoxic. Patient has been complaining of sinus congestion over the past 5 to 7 days. According to the medical director, there has been Covid outbreak in the facility and multiple other residents are noted to be positive for COVID-19. Patient had a Covid test done yesterday and she was COVID-19 positive. Patient respiratory status declined. Patient required oxygen support. Her oxygen saturation had dropped into the mid 70s to upper 80s and patient was on 5 L/min of oxygen via nasal cannula. Patient had not been using accessory muscles. Patient also reports occasional cough and has yellowish phlegm production. Patient was referred to Hospital emergency department for further evaluation and treatment. ED to Hosp-Admission Discharged 6/3/2021 - 6/14/2021 (11 days) Last attending ? Treatment team Sepsis due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Principal problem DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Hypoxia COVID-19 virus infection Pneumonia due to COVID-19 virus Acute respiratory failure Hospital Course Patient is a 74 y.o. female with a history of multiple myeloma on fifth line treatment. Patient with recent diagnosis of osteomyelitis and on antibiotics per ID. She was admitted to the hospital 6/3 with acute shortness of breath and following 2 days on the general medical floor she required increasing oxygen supplementation and was transferred to the ICU. In the ICU patient had a seizure and required acute intubation for protection of her airway. Patient had further decline of her respiratory status. She did pass SBT's and was extubated. Shortly after she experienced likely an episode of aspiration. She continued to have increased work of breathing following this event. Patient transitioned to comfort care per family request. She received morphine and Ativan as needed and experienced asystole at 0834 this morning." "1414536-1" "1414536-1" "This patient was homeless. Partner was with patient on the night of 6/12 when patient complained of not feeling well and attributed it to side effects of his COVID vaccine, which he received two days prior. Patient declined to go to the hospital. When partner woke up the morning of 6/13, the patient was found dead. A coroner's report is expected sometime within the next 4-6 weeks." "1414703-1" "1414703-1" "High blood pressure, low oxidation, urine infection. cardiac arrest." "1414727-1" "1414727-1" "Admitted to ER with complaints of generalized weakness and report of insomnia for 4 days to getting his second covid shot. He reports having one episode diarrhea and emesis pta. He reports there was no blood in his stool , no black stool, no blood in emesis tonight pta. He reports he saw blood in emesis one day prior" "1414947-1" "1414947-1" "Pt showed up to the ER via EMS on 6/5/2021 with low back pain and weakness, bilateral leg swelling, shortness of breath. On 6/6/2021-developed bilateral upper and lower weakness that progressed to dysphagia and dysphonia. Transferred to ER on 6/8/2021 for Gillian Barre Syndrome On 6/11 had bilateral DVTS He was placed on palliative care and passed away on 6/19/2021" "1414988-1" "1414988-1" ""After receiving the 2nd vaccine on 5/15/21, on 5/16 patient had a ""stomach ache"", on 5/17 he went to work. At 9:30am, the camera's show him going into the women's restroom to service it, a lady tried to go into the restroom and could not go in, she called the supervisor, when the supervisor arrived there was no pulse. Report source believes he goes into work around 7:00AM. Report sources states she was told "" his blood sugar was not elevated"". Report source states that the death certificate states he had a cardiac arrest."" "1414999-1" "1414999-1" "Dies due to Alzheimer complications." "1415021-1" "1415021-1" "Cardiac arrest, death" "1415083-1" "1415083-1" "My husband fell ill within hours of getting the first dose of the vaccine, he started running fever, chills, body aches-within 7 days he was admitted to the hospital and 12 hours after admission to the hospital he was diagnosed with Covid Pneumonia. or they thought- his lungs were showing signs of being attacked. He had no illness, no fever, no underlying health concerns, no allergies, he was not over weight, he was not diabetic, he was still young and within 6 weeks of getting the vaccine he was dead. Doctors could do nothing to save his life. The Moderna vaccine killed my husband and it is killing other perfectly healthy people." "1415200-1" "1415200-1" "Patient presented to the ED and was subsequently hospitalized for atrial fibrillation within 6 weeks of receiving COVID vaccination. She died on 5/26/2021." "1415209-1" "1415209-1" "Fever, discomfort, restlessness. Administered Tylenol at Dr's instruction; He collapsed and died. He first reported nausea occurring around 4 am on 2/25/21 and was uncomfortable all day. He felt worse that evening and was showing a fever. He was given Tylenol around 10 pm on 2/25/21. He fell asleep around 2:00 am on 2/26/21 and woke up around 3:00 or 3:15. He had a drink of water then collapsed. I performed chest compressions until the EMTs arrived but he was likely dead by the time they arrived." "1415237-1" "1415237-1" "My dad died after he had symptoms of sweating without doing anything to increase his heart rate. He had stated his heart had been racing recently. He died suddenly and unexpectedly." "1415239-1" "1415239-1" "Myocarditis in 2 days - diuretics, Respiratory Failure in 2 days Bipap and Airvo, Clotted off leg in a few weeks Angiogram and Fascitomy, Ischemic gut weeks - comfort care orders, DVT in arm in weeks could have been due to PICC also - Elquis" "1415252-1" "1415252-1" "Patient died 06/20/2021." "1415288-1" "1415288-1" "client died. Client had other underlining health conditions." "1415311-1" "1415311-1" ""Patient received her 1st dose of the Pfizer-BioNTech vaccine on March 08, 2021. About a week later she started complaining of feeling fatigued, confused, and disoriented some days. These symptoms progressively got worse over the next 3 months. She received her 2nd dose of the Pfizer-BioNTech vaccine on April 05, 2021. A week later she mentioned waking up more disoriented in the mornings and would look at her hands and think to herself, ""Who's hands are these?"" She said she felt like she wasn't in her right mind. Soon after this she felt she couldn't go to the grocery store alone or drive because she might get lost. She never had symptoms of Dementia prior to March 2021. On May 10, 2021 I noticed she was moving slower and using walls to guide her through her home as she walked. She mentioned she felt more fatigued at this time. On the weekend of May 21, 2021 we took a trip for her birthday and she was mentioning how it was a struggle for her to pack for the trip because she couldn't think clearly and had made a mess in her room trying to find her clothes. She was a very tidy & organized person, so this was very unusual. A week after the trip she mentioned losing some strength in her left leg and needing to lean on walls as she walked through her home. On June 4, 2021 the weakness got worse and she mentioned she felt more ""off"" and wanted to shower before heading to the hospital to be evaluated - when she got out of the shower she completely lost strength in her left leg and fell to the ground, but was conscious. She was taken to Hospital where a CT scan was done that showed brain swelling and a mass. She was then transported to Medical Center where an MRI was done, confirming the swelling and 4cm mass - doctors there believed it could be a Glioblastoma and mentioned it is very aggressive. When asked if the vaccine may have caused this, we were quickly dismissed and told there could be no connection at all. After further research we found that GBM (Glioblastoma) could grow as quickly as .5mm per day and when calculating the time between her 1st dose and her hospitalization (approx. 90 days) it equated to 4.5cm, her mass was 4cm. Even if there was a mass there before her vaccine, there is reason to believe it may have been aggravated by the vaccine. Surgery was suggested, but after 4 days she expressed that she wanted to opt out of the surgery and pursue a second opinion or natural treatments. She was discharged on June 9, 2021 and taken home with medication. She was more alert and lively at home - able to converse and move around with assistance, but did not have strength in her left leg and was losing more strength in her left arm. On June 13, 2021 she suffered a heart attack and was rushed to the emergency room by ambulance. CPR was performed in the ambulance and she was taken to Hospital where they stabilized her but she never regained consciousness. She was taken home for Hospice on June 16, 2021 and passed away on June 19, 2021."" "1415368-1" "1415368-1" "Patient died of a sudden heart attack at age 70, just 2 months after receiving his 2nd dose of the vaccine. His parents lived well into their mid-eighties and patient spent the last 17 years of his working years as a door to door, getting lots of cardio exercise every day. At the time of his death he was a very low stress person and taking good care of himself." "1415733-1" "1415733-1" "The pt received his 2nd Moderna covid vaccine on 6/13/21 at 10:45 am (approximately). Starting at 5pm he c/o pain, redness and tenderness in the injection site, chills, and lethargy . The next day he did not go to work b/o he felt tired and he stayed home with his 7 y/o daughter while his wife went to work. His wife spoke with him in the am and he reports he was making breakfast for their daughter and he was going to lie down and sleep afterward. He made lunch for daughter about 1 pm and he went to lie down in his chair. His brother called his wife at about 4:30 pm stating he was blue. 911 was called and they were unable to revive him." "1415978-1" "1415978-1" "Brain bleed, broken leg, death" "1416338-1" "1416338-1" ""My dad died on February 19th after having been visibly sick immediately after being vaccinated until the day he died, according to his friends. Was told by a friend that he dropped something he was holding while hanging out with friends and they called an ambulance but he refused the ambulance. I do not know that exact date of that incident only that it was following vaccination. Was also told by numerous others that he seemed ""sick"". No other details are known."" "1416476-1" "1416476-1" "Patient died at home 3 weeks after receiving first dose of vaccine." "1416721-1" "1416721-1" "Dehydrated; Collapsed; Cardiac death/the patient woke up and then grab it's chest and collapsed; Started having heart issues; Chest pain; Lose it's appetite; Thirsty; Short of breath/got very winded; Fatigue/ very tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC DEATH (Cardiac death/the patient woke up and then grab it's chest and collapsed), DEHYDRATION (Dehydrated) and CIRCULATORY COLLAPSE (Collapsed) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CHLORTHALIDONE, LOSARTAN POTASSIUM, MELOXICAM, METOPROLOL SUCCINATE, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE SODIUM), TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HCL), RIVAROXABAN (XARELTO), AMLODIPINE BESILATE (AMLODIPINE BESYLATE) and TADALAFIL for an unknown indication. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced DEHYDRATION (Dehydrated) (seriousness criterion hospitalization), CARDIAC DISORDER (Started having heart issues), CHEST PAIN (Chest pain), DECREASED APPETITE (Lose it's appetite), THIRST (Thirsty), DYSPNOEA (Short of breath/got very winded) and FATIGUE (Fatigue/ very tired). On an unknown date, the patient experienced CIRCULATORY COLLAPSE (Collapsed) (seriousness criterion medically significant). The patient died on 10-Apr-2021. The reported cause of death was Cardiac death. An autopsy was not performed. At the time of death, DEHYDRATION (Dehydrated), CIRCULATORY COLLAPSE (Collapsed), CARDIAC DISORDER (Started having heart issues), CHEST PAIN (Chest pain), DECREASED APPETITE (Lose it's appetite), THIRST (Thirsty), DYSPNOEA (Short of breath/got very winded) and FATIGUE (Fatigue/ very tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: inconclusive (Inconclusive) Inconclusive and inconclusive (Inconclusive) Inconclusive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with the mRNA-1273 vaccine due to the events was not applicable. The reporter informed that the patient had received both doses of mRNA-1273 vaccine. He first lost his appetite and started feeling thirsty on the following day after vaccination, which worsened progressively for the next five days. The patient then started having chest pain, was short of breath and experienced fatigue. He got very winded when he went to the bathroom and felt very tired for the next two days, When he went to the hospital, the doctor said that he would need to be admitted if he doesn't feel well. On a Wednesday, the patient went to the hospital and an ECG was done. The reporter informed that when the doctor compared it with an ECG from few days before, he could not believe it was of the same patient's. The patient was taken to the ER (emergency room) and was them transferred to ICU (intensive care unit) as he was dehydrated. Dehydration was treated and at the time the patient started having heart issues. By Friday, the patient started doing better and the doctor discussed discharging him. On Saturday, when the patient woke up he grabbed his chest and collapsed. The reporter informed that they were not able to get an autopsy but the death was assumed to be cardiac death. It was reported that the patient passed away approximately nine days after receiving the second dose of the vaccine. The reporter further informed that the patient was in good health and had a full 'cardiac work' prior to his vaccination. Company comment: Very limited information regarding this event has been provided at this time. Details regarding medical history and course in the hospital is required for further evaluation.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details regarding medical history and course in the hospital is required for further evaluation.; Reported Cause(s) of Death: Cardiac death" "1416816-1" "1416816-1" "Woke that morning very lethargic and hard to arouse. Mom states had been doing very well, exercising and losing weight. States he felt good up until that day. DEATH" "1416951-1" "1416951-1" "The first vaccine was administered on December 30, 2020 from a local pharmacy. She was diagnosed with COVID on January 3. She was in and out of ER for 3 days, when we finally took her home and got hospice care. On January 19, 2021 Dr's office told us that she could get the 2nd vaccine the next day. She received the 2nd vaccine on January 20, 2021 from a local pharmacy. On January 21 she became disoriented and was sleeping most of the time, by Friday, January 22, she could not walk and was incoherent most of the time. The evening of January 22, we presume she had a stroke, but was not officially diagnosed. Her oxygen level dropped to 42 and her blood pressure was 287/182 with seizures that lasted about 1 minute. She died on January 29, 2021." "1416982-1" "1416982-1" "Burning sensation in the stomach, died of respiratory problems." "1416990-1" "1416990-1" "Patient's wife stated Husband 2021/03/12 muscle pain in legs, fever 2021/03/14 (100.4), chills (Treated temp down 99.8), stomach/muscle pains. Contact with Dr. 2021/03/17 (Fever 100.7) phoned. No treatments for nausea, headache, muscle pains. Hospital visit ER with confusion/hallucinations. Temp 100.4 BP 136/110, *8:30am 2021/03/19. Home incident of falling, EMS called (vitals normal) admitted in Hospital. Transferred to another Hospital (Covid Neg.), stated bad infections. Death 2021/03/21" "1417056-1" "1417056-1" "Patient's wife reported that patient died a couple of days after second Moderna vaccine. About 2 days after vaccine, patient presented with lumps all around body and doctor's could not figure out what was wrong. His digestive tract started to deteriorate and he passed away at home. Autopsy was performed but could not confirm cause of death." "1417063-1" "1417063-1" "Patient passed away on 6/20/2021. Cause of death unknown." "1417109-1" "1417109-1" "Patient received first dose of Moderna on May 18, 2021. Spouse came to the pharmacy and informed us that the patient passed away in the hospital on June 15, 2021. She was diagnosed with COVID-19 during her stay at the hospital." "1417119-1" "1417119-1" "lightheadedness, weakness, Pain Narrative: A 63yo male with history of tobacco use, Cocaine dependence in remission, PTSD, Depression, Cirrhosis of Liver due to Chronic Hepatitis, Alcohol Dependence, Spinal Stenosis of Lumbar Region, Obesity, HTN, OA, COPD and OSA. It's documented he received Covid-19 vaccine on January 11, 2021, per protocol, without complications and was advised to stay on site for 15 minutes. Instructions about side effects and ADR reporting were also provided. He called hospital advice line on January 12, 2021 to report ADR symptoms of having LT arm pain that radiates to his back and chest which started on his way home after he received the vaccine. Also reported he felt weak, had diarrhea, nausea, chills and lightheadedness. He was advised by the call documenting nurse, to go the hospital ED, for evaluation. Per telephone note - Physician A/P documentation included that symptoms were discussed with the patient on January 12, 2021 @13:01 PM, patient was assured what he experienced was an expected reaction from the vaccine and it'd be safe to get his second scheduled shot On January 14 the patient called back to report feeling a little light headed, having muscle/ body ache and feeling weaker after the Covid-19 vaccine. Recommendation was made to go to the ER by the call taker Patient called on January 15, 2021 with a fever of 101.5 and asking if it maybe due to the vaccine March 17, 2021 the patient presented to the ED with chief complaint of Chest pain, was hypoxic and with a temp of 101.8, was started on O2 nasal cannula, saturation improved from 83% to 87% and with 5L to 90% He was diagnosed with Covid-19 and admitted to Critical Care. Psox remained above 92% on 6L HFNC The patient remained in MICU and passed away on February 4, 2021" "1417142-1" "1417142-1" "19-year-old male presenting for evaluation due to ongoing nausea and vomiting. Patient says he has had vomiting for approximately 4 days. Admits to daily marijuana use secondary to IBS. He states that he was in the emergency department yesterday and told that he has a acute viral infection. States that he struggled to keep food or liquid down even after discharge home. Patient denies other illicit substance abuse. Patient discharged with ondansetron. Of note, patient Qtc >600ms before discharge." "1417175-1" "1417175-1" "Massive Heart Attack" "1417182-1" "1417182-1" "I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 5/15/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/8 and Dose 2 on 3/1). The patient later died on 5/28/21. Cause of Death is listed as ?Acute hypoxemic respiratory failure Pneumonia COVID-19?. Pre-existing conditions listed as: CARDIOVASCULAR DISEASE, DIABETES MELLITUS, CHRONIC LUNG DISEASE (ASTHMA/EMPHYSEMA/COPD)" "1417184-1" "1417184-1" "The patient died of COVID-19" "1417204-1" "1417204-1" "I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 5/30/21 after the completion of a full Janssen vaccine series (Dose 1 on 5/5/21). The patient later died on 6/03/21. Cause of Death is listed as ?Upper gastrointestinal hemorrhage?. Comments:=======================nnJune 01, 2021 at 3:07 PM by HD nn6/1 3:06 Supervisor Review completed by HD): ICP needednPT resides at ..nPT admitted to hospital- as asymptomatic. No dates were provided. shows specimen collected via hospital on 5/30 and no notes regarding admittance.nClosed as medical barriers.nnn=======================nnJune 01, 2021 at 2:34 PM by CNA, case is hospitalized since 5/30. Head of Nursing sent her to hospital for vomiting and is not currently in the ICU or being treated for any respiratory issues related to COVID," "1417223-1" "1417223-1" "I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 5/14/21 after the completion of a full Moderna vaccine series (Dose 1 on 4/1 and Dose 2 on 4/29). The patient later died on 6/5/21 . Cause of Death is listed as cardiac arrest; hypoxic RF; Extensive PAD and ischemic leg/foot ulcers s/p bypass surgery. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, DIABETES MELLITUS, CHRONIC LUNG DISEASE (ASTHMA/EMPHYSEMA/COPD)" "1417262-1" "1417262-1" "Died of COVID-19" "1417263-1" "1417263-1" "I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/29/21 after the completion of a full Pfizer vaccine series (Dose 1 on 1/24 and Dose 2 on 2/14). The patient later died on 5/04/21. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, IMMUNOCOMPROMISED CONDITION. Comments:05/04/21:Patient was admitted to the hospital on 4/28/2021 for COVID-19 infection, pneumonia, and acute on chronic renal failure. He was transferred to the ICU on 4/29/2021 due to acute hypoxic respiratory failure requiring intubation. Despite maximum therapies, the patient's respiratory status did not improve. He remained mechanically ventilated from 4/29 through 5/4. On 5/4, the patient became hypotensive and bradycardic. The patient died at 10:45." "1417278-1" "1417278-1" "I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/22/21 after the completion of a full Moderna vaccine series (Dose 1 on 2/11 and Dose 2 on 3/11). The patient later died on 5/13/21 . Cause of Death is listed as ?Intestinal Obstruction?." "1417294-1" "1417294-1" "I am the epidemiologist for reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14 was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she could be admitted to hospital for cardiac catheterization. Case reports having a mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX was mild case of COVID with elevated enzymes that indicated a cardiac event. Case is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines. Case lives alone but has 2 adult sons who live nearby that will provide food drop-offs at door. Emailing vaccination breakthrough info to Epidemiologist & supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM." "1417329-1" "1417329-1" "I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/5/21 after the completion of a full Pfizer vaccine series (Dose 1 on 12/28/20 and Dose 2 on 1/18/21). The patient later died on 4/9/21. Cause of Death is listed as ?Metastatic Rectal cancer?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION, DIABETES MELLITUS Comments: Spoke to the case adult daughter. She informed that the case resides at a rehabilitation center. The case's daughter stated that her mother is not having any symptoms and was fully vaccinated. The daughter did not have all the information on dates of vaccine. called center spoke to the administrator who provided the information. The case was at the hospital from 3/27-4/1. Rehab requires a (-) test result to return and a (-) test four days after returning. The case test (+) on her 4th day 4/5.nnn" "1417642-1" "1417642-1" "Patient father reported he passed away in his sleep the night of 06-07-21 and was pronounced diseased on 6-8-21" "1417680-1" "1417680-1" "presented with a cough, difficulty breathing, sinus congestions and headache on 2/7. tested positive for COVID-19. admitted to the hosp. completed 5 days of remdesivir 2/16 and 10 days of dexamethasone 2/21" "1417729-1" "1417729-1" "This was very unfortunate 51 years old male with past medical history of hypertension, hyperlipidemia, obesity. Patient presented with chief complaint of shortness of breath and chest pain. EMS reported that the patient has been complaining of some shortness of breath and chest pain intermittent for couple of weeks. 12 leads EKG showed evidence of anterior ST elevation myocardial infarction. Code heart was called. Patient developed PEA arrest in the Cath Lab. CPR ACLS was initiated. ROSC was achieved initially after 30 minutes of CPR. Intra-aortic balloon pump was placed. Coronary arteries were essentially clean. Due to high suspicion for massive PE-TPA was given 100 mg without meaningful clinical improvement. CPR was continued for more than an hour. Despite all aggressive measures patient continued to deteriorate. At 3:26 PM patient has no spontaneous breathing, no peripheral pulses, no heartbeats by auscultation or by monitor. Pupils were fixed and dilated. No cough no gag reflexes . patient was pronounced dead." "1417790-1" "1417790-1" "37 yo woman with a history of epilepsy and medical noncompliance found dead in her bed less than two days after receiving 2nd COVID vaccine (believed to be Pfizer). Reportedly experienced a seizure following the 1st dose approximately 3 weeks prior." "1417870-1" "1417870-1" "Profuse rectal hemorrhaging and blood clots" "1417871-1" "1417871-1" "Nausea, vomiting, diarrhea, muscle pain with fatigue with the first and second dose. Was reported to not be able to hold anything down with second dose and sudden death while sleeping (nap for fatigue). Found dead in bed 3/21/2021. No allergic reactions were reported. No unusual electrolyte findings suggested the cause." "1417918-1" "1417918-1" "Death" "1418055-1" "1418055-1" "Pulmonary Embolism" "1418084-1" "1418084-1" "Developed s/s of COVID on 4/27/2021, hospitalized, then transferred to another HCF was inpatient ICU 5/8-6/21 expired 6/21/21" "1418095-1" "1418095-1" "Patient was found dead in his bed on June 11, 2021." "1419805-1" "1419805-1" "Died due to heart attack; Lot of blood was on the floor; He fell on bathroom tiles; Feeling weakness/Could not coming out of bed; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died due to heart attack) and HAEMORRHAGE (Lot of blood was on the floor) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes (was on anti-diabetic medicine.). On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills). On 23-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died due to heart attack) (seriousness criteria death and medically significant), HAEMORRHAGE (Lot of blood was on the floor) (seriousness criterion medically significant) and FALL (He fell on bathroom tiles). The patient died on 23-Mar-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGE (Lot of blood was on the floor), FALL (He fell on bathroom tiles), ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Concomitant medication included was anti-diabetic medicine. The treatment information was not provided. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: heart attack" "1419839-1" "1419839-1" "Stated going downhill; He died; Got a little sick,he stated going downhill; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (He died) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery (Bladder surgery on 25 Feb.). On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ILLNESS (Got a little sick,he stated going downhill). On an unknown date, the patient experienced FEELING ABNORMAL (Stated going downhill). The patient died on 26-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ILLNESS (Got a little sick,he stated going downhill) and FEELING ABNORMAL (Stated going downhill) outcome was unknown. Treatment and concomitant information was not provided by the reporter. Patient had the modera shot on 16-Apr-2021 and he was recovering from a bladder surgery. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1420121-1" "1420121-1" "passed away; received second vaccine 44 days after receiving the first dose; Pain the injection site from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain the injection site from the first dose). On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second vaccine 44 days after receiving the first dose). On 05-Apr-2021, VACCINATION SITE PAIN (Pain the injection site from the first dose) had resolved. On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second vaccine 44 days after receiving the first dose) had resolved. The patient died on 09-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was reported. Company comment: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, with associated Adverse Events of Vaccination site pain and Death in a 91-year-old female subject who died 25 days after receiving second dose of vaccine. Very limited information regarding these events has been provided at this time. Further information has been requested. This case was linked to US-MODERNATX, INC.-MOD-2021-132760 (Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Case upgraded to Serious due to death.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, with associated Adverse Events of Vaccination site pain and Death in a 91-year-old female subject who died 25 days after receiving second dose of vaccine. Very limited information regarding these events has been provided at this time. Further information has been requested. US-MODERNATX, INC.-MOD-2021-132760:Son; Reported Cause(s) of Death: Unknown cause of death" "1420192-1" "1420192-1" "Died do to unknown reasons, did not present symptomology." "1420194-1" "1420194-1" "Mild stroke on morning of day following administration of the vaccine (first in series). Stroke resulted in weakness and limited mobility on left side and slurred speech. Patient was bedridden following the stroke. Patient had terminal cancer but the stroke following the vaccine seemed to trigger a swift decline and patient died one week later." "1420208-1" "1420208-1" "Died, unknown reasons, no symptomology reported." "1420257-1" "1420257-1" "hospitalized with respiratory distress and death" "1420492-1" "1420492-1" "Patient hospitalized after testing positive for COVID-19. Patient died. Patient was fully vaccinated." "1420514-1" "1420514-1" "Symptom onset was 12/26/2020, with nausea, fever, chills, rigors, fatigue, cough, & myalgia." "1420517-1" "1420517-1" "1 week history of shortness of breath and nonproductive cough beginning shortly after receipt of second dose. Patient became hypoxic and had diffuse consolidation through left lung with wedge-shapes consolidation involving the right upper and midlateral lungs. Leukocytosis and bandemia noted and acute renal failure. Developed atrial fibrillation and rapid ventricular response. Multilobal pneumonia, septic shock, non-q-wave myocardial infarction, acute renal failure. Patient expired." "1420630-1" "1420630-1" "~4 weeks after the 2nd dose of Pfizer, patient presented to the hospital with chest pain; had pericardial effusion. Initially improved but then had decompensation, prolonged hospitalization. Diagnosed with hemophagocytic lymphohistocytosis (HLH) and ultimately died." "1420707-1" "1420707-1" "Patient presented to ER on 01/18/2021 and stated respiratory symptoms began on 01/14/2021. Positive Covid test that day. Patient was released from ER and admitted as inpatient to the hospital on 01/23/2021 and expired of Covid related symptoms on 02/02/2021." "1420722-1" "1420722-1" "Low blood sugar, fluid retention, congestive heart failure." "1420750-1" "1420750-1" "Severe Sepsis with Acute Hypoxic Resp failure Chronic liver disease" "1420762-1" "1420762-1" "Cardiac arrest without resuscitation. Unknown cause of cardiac arrest. Awaiting autopsy report." "1420765-1" "1420765-1" "Renal cell carcinoma of right kidney metastatic to other site ? Bone metastasis ? Perforated bowel" "1421063-1" "1421063-1" "PAF Seizure , ETOH dependency , Dyspnea" "1421090-1" "1421090-1" "Advanced coronary artery disease, Arteriovascular risk factors, Chronic obstructive lung disease.COVID-19 2/10/2021, Recurrent GI bleed with iron deficiency" "1421273-1" "1421273-1" "DEATH WITHIN 24 HOURS" "1421316-1" "1421316-1" "5/4-5/7 Progressive overall decline and continued to decline Dialysis. 5/7-passed away at 1420" "1421500-1" "1421500-1" "Covid 19, Blood Clot in Lung, Myocardia" "1421533-1" "1421533-1" ""Per report from patient's husband, the patient developed a fever to 103 on the evening of 6/21/21. She awoke in the morning and was ""not herself"". He describes her as having difficulty breathing and not being lucid. He took her to the hospital where she was hospitalized and then he got a call from the hospital in the evening reporting that she had walked to the restroom and then collapsed. Per his report, she had CPR performed for 30 minutes prior to being declared deceased. His phone number is the one included in this report."" "1421767-1" "1421767-1" "Patient died" "1421796-1" "1421796-1" "Case was hospitalized and passed away. 2nd vaccine given 2/27/2021" "1421819-1" "1421819-1" "Pt was vaccinated on 3/31/2021. His long time partner reported that he started feeling a little off 2 days post vaccination, he thought he had indigestion. Over the next few weeks he began feeling worse especially with exertion. While at work on 4/19/2021 he told his friend that he hadn't been feeling well for 3 weeks. Shortly after reporting this he went into Cardiac arrest. He was transported to Medical Center, where he was pronounced dead. His partner reports he was healthy with the exception of hypertension. She reports he was thin, never smoked, didn't drink alcohol and rarely used marijuana. She reports only a visual autopsy was performed and pt was cremated." "1422836-1" "1422836-1" "Slight cold on day of vaccine. The doctor said give him the vaccine anyway. Patient woke up the next morning with a cold that did not go away. He started gaining a lot of weight (10pounds in 2 weeks), he couldn?t sleep laying on his back, he was fatigued, coughing, short of breath. He passed away May 27th, 2021." "1423055-1" "1423055-1" "suffered a massive heart attack; Feeling of faintness; Palpitations; Shortness of Breath; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (suffered a massive heart attack), SYNCOPE (Feeling of faintness), PALPITATIONS (Palpitations) and DYSPNOEA (Shortness of Breath) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced SYNCOPE (Feeling of faintness) (seriousness criterion medically significant), PALPITATIONS (Palpitations) (seriousness criterion medically significant) and DYSPNOEA (Shortness of Breath) (seriousness criterion medically significant). On 09-Jun-2021, the patient experienced MYOCARDIAL INFARCTION (suffered a massive heart attack) (seriousness criteria death and medically significant). The patient died on 09-Jun-2021. The reported cause of death was suffered a massive heart attack. It is unknown if an autopsy was performed. At the time of death, SYNCOPE (Feeling of faintness), PALPITATIONS (Palpitations) and DYSPNOEA (Shortness of Breath) outcome was unknown. No concomitant information was reported. No treatment information was reported. Action taken with mRNA-1273 was not applicable. A Patient called to report that two weeks after the first dose of the Moderna Covid-19 vaccine on 27-May-2021, his boyfriend began to experience palpitations, shortness of breath and feeling of faintness. The caller stated that her boyfriend did not want to go to the emergency room and only set an appointment with his Health Care Provider, but on the 09-Jun-2021, the day that he was going to the appointment, he suffered a massive heart attack and passed away. This is a case of sudden death in a 59-year-old male subject, who died 23 days after receiving first dose of vaccine. Very limited information has been provided at this time. Patient medical history was not provided.; Sender's Comments: This is a case of sudden death in a 59-year-old male subject, who died 23 days after receiving first dose of vaccine. Very limited information has been provided at this time. Patient medical history was not provided.; Reported Cause(s) of Death: suffered a massive heart attack" "1423092-1" "1423092-1" "ischemic stroke; infection; progressive weakness; poor appetite; hardly being able to walk; dehydrated; mild elevated liver enzymes and WBC count; mild elevated liver enzymes and WBC count; SOB; possible lung infection; some lesions on her liver; a small mass in her lung,which they said were suspicious for cancer; a small mass in her lung,which they said were suspicious for cancer; This is a spontaneous report from a contactable nurse. A non-pregnant 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 13Apr2021 (at the age of 84-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension (HTN), hyperlipidaemia (HLD), type II diabetes mellitus (DM2). Concomitant medications included regular prescribed medications for HTN, HLD, DM2 (drugs unspecified). No other vaccines prior to four weeks. Known allergies were unknown. No COVID prior to vaccination. Covid test post vaccination in May2021 was negative. The patient had no acute issues prior to her 1st COVID vaccine. In Apr2021, the started experiencing progressive weakness and poor appetite to the point of hardly being able to walk. The patient saw her primary doctor who ran some blood work and noticed she was dehydrated with mild elevated liver enzymes and WBC count. The patient was admitted to the hospital (for 21 days) for IV fluids and was on oral antibiotics. The patient started having some SOB and scans done indicated possible lung infection. The patient was switched to IV meropenem which did not help. The doctors also noted some lesions on her liver and a small mass in her lung (no biopsy was done cause she declined) which they said were suspicious for cancer. The patient then suffered a large ischemic stroke and she passed about a week later. The patient was feeling well before her vaccine and everything started to go downhill after her vaccine. AEs result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent covid test: negative in May2021. The outcome of events weakness, decreased appetite, unable to walk, dehydration, elevated liver enzymes, white blood cell count increased, short of breath, lung infection, hepatic lesion, lung mass, and lung cancer was unknown. The patient died on 27May2021 due to ischemic stroke and infection. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported suspicion on malignancy and BNT162B2 use is unrelated while the causal relationship between the remaining events and the use of BNT162B2 cannot be fully excluded. There is limited information available which precludes a more meaningful assessment. However, the underlying conditions and the age of the patient maybe risk factors. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: ischemic stroke; infection" "1423126-1" "1423126-1" "Stroke; sitting on the floor totally disoriented; Cardiac arrest; This is a spontaneous report from a contactable consumer (patient's Daughter). A 101-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 101-year-old on 03Mar2021 at single dose for covid-19 immunisation. Medical history included glaucoma, blood pressure high, Mini stroke, her blindness was an infarct to her optic nerve, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, and obesity. Family history included Patient's sister got the vaccination and either 3 or 5 days later she passed away. There was none history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medication included metoprolol taken for high blood pressure; levothyroxine; amlodipine taken for high blood pressure; sertraline to keep her spirits up because she is old and blind; latanoprost (XALATAN); dorzolamide hydrochloride, timolol maleate (COSOPT); acetylsalicylic acid (BABY ASPIRIN); calcium (CALCIUM); vitamin C [ASCORBIC ACID]; tocopherol (VITAMIN E). Prior Vaccinations (within 4 weeks), there was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The patient received the Flu shot every year and patient also received the shingles shot and the pneumonia shot. Reporter stated patient had lunch and was sitting in the chair so it was probably somewhere between 12 and 3pm on 09Mar2021 when she had her stroke. Reporter states when she got back home patient was on the floor totally disoriented. Above events results in Emergency Room and patient was hospitalized from 10Mar2021 to 12 Mar2021. Reporter stated that patient died in her sleep so early in the morning probably between 3am and 6am on 06Jun2021. Reported cause of death was cardiac arrest. Reporter was calling about the Pfizer COVID vaccination. Reporter was calling on behalf of her mother. Reporter believed that her mother had a reaction to the first shot. Reporter stated that her mother had a stroke 6 days after receiving the first Pfizer COVID vaccination and has since passed away. Reporter thought this was a contributing factor. Reporter states that her mother was 101 years old but was an incredibly lucid and healthy individual. Reporter states that her mother used to be 5 foot 1 inch but she was probably 4 foot 11 inches at the time of this event (09Mar2021). Reporter states at the time of this event her mother probably weighed about 133 pounds. Reporter states that she came home on 09Mar2021 and found her mother on the floor. She took her mom to the hospital on 10Mar2021 and she was diagnosed with a stroke. Her mother was hospitalized 10Mar2021 through 12Mar2021. Reporter stated that her mother went to rehab after being discharged from the hospital. Stated that her mother never came back home. Reporter states that her mother lived with her. Reporter states she looked at her labs on 01Jun2021, her labs were always good. She stated that her mother also had a cat scan with contrast in 2021, no further details provided. Reporter states that she was not saying that this product caused her death but the timing was very suspicious. The patient underwent lab tests included Fasting blood glucose: 99 on 01Jun2021, cat scan with contrast with unknown results in 2021. The outcome of events was fatal. The patient died on 06Jun2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Stroke; sitting on the floor totally disoriented; Cardiac arrest" "1423127-1" "1423127-1" "His dad took the shot and died 3 days later, mucked up his arteries, his heart; This is a spontaneous report from a contactable consumer (patient son). A 64-year-old male patient received second dose of BNT162B2 on 15May2021 (at age of 64-year-old) at single dose for COVID-19 immunization. Medical history included Heart Condition (around 1997-1999), High Blood Pressure (all about the same time), Aneurysm (about 2017, 2015-2017 area. He wants to say 2015, because he was there when he found out about them) and open heart surgery (about 1997, 1995, somewhere around there). Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 05Apr2021 (at age of 64-year-old) for COVID-19 immunization. Family Medical History Relevant to AE(s): Caller states not that he knows of. All he knows from the emergency technician is that it looked like he went back to his car and his dog was in the car and he dropped dead. According to you guy's thing, it says muscle cramps, muscle pains and chest pains are all side effects of this and he does believe that the vaccine contributed to the chest pain which contributed to the heart attack that exploded his heart. He states his dad took the shot and died 3 days later (18May2021, also reported as died on Memorial day weekend. He died on Sunday). Caller stated the coroner's has already stated that he died by the coronavirus shot and mucked up his arteries, his heart. It is pretty sad. He was doing something he enjoyed, watching the races, gets up takes two steps, falls dead in his tracks. Vaccination Facility Type was hospital. He does not know Additional Vaccines Administered on Same Date of the Pfizer Suspect, but he highly doubts it. Events not require a visit to Emergency Room or Physician Office. Information about lot/batch number is requested.; Reported Cause(s) of Death: His dad took the shot and died 3 days later, mucked up his arteries, his heart: Death" "1423211-1" "1423211-1" "Sudden unexpected death the day after the vaccine" "1423241-1" "1423241-1" "Within 24 hours, my mom's arms swelled up from shoulder to fingertips and she had never had swelling in her arms prior. She also was hanging her head as if she had fallen asleep, but actually was unable to lift her head. 4 days following the vaccine she started having breathing issues and was intubated, we had the ventilator removed (she was actually a DNR and was not supposed to be intubated). On January 19, 2021 she died. She went into this facility for rehab regarding an infection she had in her leg." "1423287-1" "1423287-1" "Patient received his second Moderna vaccine on 02-24-21. He began to experience chest pains on mild exertion on 02-26-21. He then suffered a heart attack on 03-08-21 and passed away." "1423305-1" "1423305-1" "Patient started to become progressively weaker within 3-4 days after getting vaccine. Family members became concerned and started taking him to doctor -- primary and oncologist and cardiologist -- they ordered multiple tests and could find nothing. No sign of cancer which had been in remission for months. Patient became progressively weaker over the next 2 weeks, was hospitalized, became unable to get out of bed; hospice was called, and he died May 13. No explanation could be offered by his doctors." "1423308-1" "1423308-1" "patient complained of intermittent fevers since the first administration of the Moderna vaccine on 4/7/21. fevers continued intermittently until second moderna dose on 5/5/21. Patient developed lymphadenopathy and eventually was hospitalized on 6/6/21 for sepsis symptoms. Patient was intubated and found to have an acute lymphoproliferative disorder that caused cardiac arrest and the patient expired on 6/8/21. She has no lab abnormalities suggesting a lymphoproliferative disorder prior to these events." "1423365-1" "1423365-1" "Died in the hospital. Was admitted due to respiratory problems, had urinary tract infection, had complications with medications administered at the hospital ( did not specified which ones)." "1423394-1" "1423394-1" "Resident passed away on 6/1/2021 with family at bedside." "1423438-1" "1423438-1" ""PMH Afib, BiV PPM, HTN, pHTN, hypothyroidism, hemorrhoids, hearing loss, macular degeneration, squamous cell carcinoma, Parkinsons brought to ED after her caregiver found her in bed in AM w/a ""dark substance in her bed"" and minimally responsive. On admission vomiting x1, no cough, no SOB, abnormal CXR, covid+ Admission originally planned by IMS, but CCM asked to take over due to rapid decline.Pt w/ shallow breathing, guarded prognosis.In the morning on May 1, 2021 around 830 in the morning patient found to be without any pulse or breathing. DNR DNI with pupils fixed and dilated without any spontaneous breathing. No pulse palpated.pronounced dead at 8:30 a.m."" "1423516-1" "1423516-1" "Resident continued to progressively decline and was receiving Hospice services. Family and MD declined 2nd Covid vaccine on 5/3. Resident passed away peacefully on 5/11/2021." "1423619-1" "1423619-1" "My husband died of ?heart Attack? on April 17, 2021 Had an enlarge hearth and rupture in the Aortic Artery" "1423625-1" "1423625-1" "Two hours after receiving her 2nd dose of the Pfizer Covid Vaccine, patient had a Stroke (large brain bleed). She never recovered and passed away May 18th, 2021" "1423631-1" "1423631-1" "FAMILY PRACTICE was notified by a County coroner that the patient died on 12 June 2021. It is unknown to us if this is related to the Moderna vaccine received 19 May 2021. Dr. had seen this patient one time as a new patient of FAMILY PRACTICE to establish a primary care provider 25 May 2021 FAMILY PRACTICE provided the 1st dose Moderna vaccination 19 May 2021" "1423777-1" "1423777-1" "Death 3/8/2021" "1423807-1" "1423807-1" "Death 4/8/2021 1) Acute respiratory failure secondary to COVID 19 pneumonia" "1423845-1" "1423845-1" "Death 3/25/2021 Causes of death listed on patient's death certificate: 1) COVID-19 Infection, 2) Acute Hypoxic Respiratory Failure, 3) Acute on Chronic Deconditioning" "1423868-1" "1423868-1" "Death 3/18/2021 Causes of death listed on patient's death certificate: 1) Acute cessation of cardiac function Other: Severe symptomatic aortic stenosis, coronary artery disease status post percutaneous coronary intervention" "1423882-1" "1423882-1" "Death 4/1/2021 Causes of death listed on patient's death certificate: 1) Acute on chronic respiratory failure 2) Metastatic spindle cell malignancy Other: COVID-19, pneumonia" "1424014-1" "1424014-1" "Death 4/18/2021 Causes of death listed on patient's death certificate: 1) Sequelae of SARS-Coronavirus 2019 Other: Rheumatoid Arthritis, Insulin Dependent Diabetes, Chronic Hypoxic Respiratory Failure, Morbid Obesity" "1424021-1" "1424021-1" "Patient had an acute MI died after within 8 weeks of last vaccine patient had been complaining of dizziness and feeling different since second vaccine" "1424049-1" "1424049-1" "Death 3/30/2021 Causes of death listed on death certificate: 1) Respiratory distress 2) ITP 3) COVID 19 4) Dementia Other: acute cardiopulmonary failure" "1424069-1" "1424069-1" "Death 3/31/2021 Causes of death listed on death certificate: 1) Cardiac arrest 2) covid 19 pneumonia" "1424081-1" "1424081-1" "Death 4/7/2021 Causes of death listed on death certificate: 1) Acute respiratory failure 2) Chronic kidney disease 3) Diabetes mellitus 4) Atrial fibrillation Other: COVID 19" "1424095-1" "1424095-1" "Death 3/23/2021 Cause of death listed on death certificate: Myocardial Infarction" "1424098-1" "1424098-1" "Death 4/27/2021 Causes of death listed on death certificate: 1) ADULT RESPIRATORY DISTRESS SYNDROME WITH HYPOXIA 2) RAPID ATRIAL FIBRILLATION WITH DIASTOLIC HEART FAILURE 3) COVID-19 Other: COVID-10 ENCEPHALOPATHY, COVID-19 PNEUMONITIS, MULTIPLE MYELOMA, STAGE 3 CHRONIC KIDNEY DISEASE, TYPE 2 DIABETES MELLITUS" "1424120-1" "1424120-1" "Death 04/23/2021 Causes of death listed on death certificate: 1. hypoxic respiratory failure 2. covid 19 3. diabetes mellitus 4. hypertension" "1424124-1" "1424124-1" "The pharmacist was contacted by patients daughter on 6/23/2021. She said that patient was found deceased on the morning of 6/20/2021. They believe he passed away sometime on 6/19/2021." "1424154-1" "1424154-1" "death 4/24/2021 causes of death listed on death certificate: 1) Pneumonia Due to COVID 19 2) Acute Respiratory Failure with Hypoxia 3) COVID 19 4) Acute Exacerbation of Chronic Obstructive Pulmonary Disease" "1424166-1" "1424166-1" "Death 4/30/2021 Causes of death listed on death certificate: 1) Acute hypoxemic respiratory failure due to COVID-19 pneumonia 2) COVID-19 pneumonia 3) Acute on chronic left ventricular systolic congestive heart failure 4) Septic shock, liver shock due to COVID-19 Other: Exacerbation of chronic obstructive pulmonary disease, chronic blood loss anemia, diabetes mellitus type II" "1425204-1" "1425204-1" "Experienced shortness of breathe resulting in death cardiac arrest." "1425840-1" "1425840-1" "Died 5/11/2021 Causes of death listed on death certificate: 1) covid 2) chronic lymphocytic leukemia" "1425844-1" "1425844-1" "Death 4/21/2021 Causes of death listed on death certificate: 1) respiratory failure 2) covid 19 pneumonia" "1425847-1" "1425847-1" "Death 04/23/2021 Causes of death listed on death certificate: 1) End Stage Renal Disease 2) Diabetes Type 2 with nephropathy 3) Hypertension 4) Coronary Artery Disease" "1425897-1" "1425897-1" "Death 4/26/2021 Causes of death listed on death certificate: 1) Pneumonia 2) Coronary Artery Disease Other: Covid 19" "1425907-1" "1425907-1" "Death 5/5/2021 Causes of death listed on death certificate: 1) cardiac arrest 2) unknown cause Other: COVID 19, CAD, AKI needing HD" "1425911-1" "1425911-1" "Death: 04/20/2021 Causes of death listed on death certificate: 1) Covid" "1425918-1" "1425918-1" "Death 5/31/2021 Causes of death listed on death certificate: 1) atherosclerotic heart disease Other: recent Cove at 19, pneumonia, peripheral vascular disease, hypertension, dementia, extensive squamous cell carcinoma of skin of scalp, protein calorie malnutrition" "1425926-1" "1425926-1" "Death: 5/7/2021 Causes of death listed on death certificate: 1) COVID-19 2) Sepsis 3) Sarcoidosis 4) End stage renal disease Other: Hypertension, Congestive heart failure" "1426105-1" "1426105-1" "Death 4/21/2021 Causes of death listed on death certificate: 1) Acute respiratory failure (onset interval 1 week) 2) COVID Pneumonia (onset interval 1 week) Other: acute on chronic congestive heart failure" "1426130-1" "1426130-1" "Death 4/30/2021 Causes of death listed on death certificate: 1) Covid Pneumonia 2) Chronic obstructive pulmonary disease, unspecified Other: none" "1426131-1" "1426131-1" "mild fever, asthma flare-ups" "1426140-1" "1426140-1" "On Saturday, 2/27/21, a little over 24 hours after receiving vaccine, sudden death occurred." "1426143-1" "1426143-1" "Death: 4/22/2021 Causes of death listed on death certificate: 1) Respiratory failure 2) Emphysema Other: Covid-19 pneumonia, diabetes" "1426149-1" "1426149-1" "Death 4/29/2021 Causes of death listed on death certificate: 1) COVID 19 Pneumonia 2) Acute hypoxic respiratory failure 3) advanced amyotrophic lateral sclerosis" "1426151-1" "1426151-1" "On May 6, 2021, patients were relatively normal. On June 4th he started complaining of right sided abdominal pain along with increasing generalized weakness/fatigue. On June 10th CT Abdomen/Pelvis ordered by PCP, it was completed on 6/16/21. On 6/17/21 patient started c/o of right flank pain as well as ongoing right abdominal pain, U/A collected, normal results. On 6/22/21 patient contact PCP office c/o acute shortness of breath, chest pain and increased weakness. He was advised to call 9-1-1 and go to the ER. He was transported to local Medical Center and found to have extremely elevated platelet count as well as elevated liver enzymes. He was admitted to the ICU he ultimately succumbed to this acute illness on 6/25/21" "1426155-1" "1426155-1" "Death: 5/2/2021 Causes of death listed on death certificate: Covid 19" "1426460-1" "1426460-1" "Death: 5/3/2021 Causes of death listed on death certificate: -1) Acute hypoxic respiratory failure 2) Acute on chronic diastolic heart failure 3) Atrial fibrillation 4) Covid 19 pneumonia Other: Hypertension. Acute toxic encephalopathy. Type 2 diabetes. Esophageal dysphagia. Debility. Depression. Moderate malnutrition." "1426471-1" "1426471-1" "Death 5/2/2021 Causes of death listed on death certificate: 1) Small-bowel obstruction 2) Carcinoma of small-bowel" "1426477-1" "1426477-1" "Death 5/15/2021 Causes of death listed on death certificate: 1) COVID 19 pneumonia 2) Acute respiratory failure with hypoxia 3) Pulmonary embolism 4) Paroxysmal atrial fibrillation Other: obesity, hypertension" "1426483-1" "1426483-1" "Death 5/26/2021 Causes of death listed on death certificate: 1. COVID 19 pneumonia 2. acute respiratory distress syndrome due to COVID 19 3. Acute heart failure with reduced ejection fraction 4. aspergillus pneumonia 5. history of prostate cancer, history hypertension" "1426770-1" "1426770-1" "COVID-19 PNEUMONIA, ACUTE RESPIRATORY FAILURE WITH HYPOXIC" "1426836-1" "1426836-1" "The patient received his first dose of Pfizer COVID vaccine 6/9/21 at pharmacy. He was then admitted 6/20/21 at hospital with abdominal pain, sepsis and a suspected aspiration event and expired on 6/23/21. This was felt by the treating physicians to be most likely not related to or associated with the vaccine, but given the close proximity it was asked that this be reported." "1427004-1" "1427004-1" "Died of COVID-19" "1427073-1" "1427073-1" "Death on 3/12/2021. Primary cause of death was COPD, with COVID-19 listed as an underlying cause." "1427108-1" "1427108-1" "COVID symptoms began 3/16, positive test 3/19, hospital admission 3/22, death 4/1" "1427367-1" "1427367-1" "A friend of the patient called us today to inform us that the patient had recently passed away from a brain aneurysm. The friend asked it it were possible that this occurrence was somehow related to patient receiving his covid vaccination. The friend did not have a lot of information about the occurrence; he only stated that the patient's brain aneurysm was about 6 weeks after his 2nd dose of the covid vaccine. Patient was not a regular patient of ours so we have no additional medical history for him. We administered his first Moderna vaccine on 4-2-2021, and he returned for his second dose on 4-30-2021. I assured the friend I would report this to VAERS and thanked him for reaching out to us on behalf of patient." "1427402-1" "1427402-1" "6/23/2021 - pain at injection site, shortness of breath 6/24 /2021 - found dead in bed at 7AM" "1427448-1" "1427448-1" "Notified on 6/16 /2021 patient died. Death by PE 1 month after prime dose of Moderna-since unexpected- reported to VAERS" "1427462-1" "1427462-1" "Client did not have immediate adverse event following vaccine administration. Client died on 6/11/2021, approximately 8 weeks after receiving COVID19 Janssen vaccine. Cause of death is unknown by this reporter." "1427475-1" "1427475-1" "Patient was hospitalized within 60 days of receiving a COVID vaccine series and later died" "1427664-1" "1427664-1" "Died 3/6/2021" "1427666-1" "1427666-1" "Client did not experience any immediate adverse events following vaccination. Client died on 6/8/2021, approximately 8 weeks after vaccination with Janssen product. Cause of death is unknown to this reporter." "1427697-1" "1427697-1" "Tested positive for COVID-19 on 3/7, likely an incidental finding. Died of liver cancer 3/17." "1427795-1" "1427795-1" "Died 4/24. Immediate cause of death acute hypoxic respiratory failure, underlying cause COVID-19 associated respiratory distress syndrome and COVID-19 viral pneumonia" "1427845-1" "1427845-1" "Hospice patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1427848-1" "1427848-1" "Symptom onset 4/12, hospital admission date 4/19, died 4/25. Primary cause of death COVID-19, underlying causes sepsis secondary to COVID-19, hepatic encephalopathy, liver cirrhosis" "1427855-1" "1427855-1" "PATIENT'S MOTHER REPORTED TO PHARMACY THAT PATIENT DIED 6 DAYS AFTER RECEIVING THE JANSSEN COVID 19 VACCINE." "1427858-1" "1427858-1" "COVID-19 symptom onset 4/23, hospital admission date 4/30, died 5/14. Primary cause of death COVID-19 viral pneumonia" "1427870-1" "1427870-1" "COVID-19 symptom onset 5/3, hospital admission 5/11, and death on 5/18/2021. Primary cause of death acute hypoxic respiratory failure, underlying cause COVID-19 viral pneumonia" "1427880-1" "1427880-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1427893-1" "1427893-1" "Hospitalized 5/30-6/10 for altered mental status following recent bacterial sepsis and atrial flutter, discharged to hospice, died 6/16. Primary cause of death acute respiratory failure, underlying cause COVID-19 pneumonia" "1427998-1" "1427998-1" "Patients appointment was either 2:15 or 2:30. His Apple watch recorded it's last heart beat reading at 3:15 pm, 05/21/2021, within an hour after receiving his second Moderna Covid-19. His heart rate increased rapidly from 3:00 to 3:15, reading 104 - 106 - 108 - 116 bpm. I can provide a photo of these last four readings if you need them. I don't know other symptoms. His body was found by police who were called for a well-check three days later, 05/24/2021. Patient died unattended, at home, alone. I only know for sure the vaccine was administered at a Target store near his home. Patient texted me at 2:48pm saying that Target gave him a $5 coupon for getting his vaccine, and he was going to use it to buy Tylenol." "1428001-1" "1428001-1" "Patient received their vaccine on 6/17 and had no complaints of adverse effects. The patient was found unconscious at some point between 6/17-6/18. They appeared jaundice and had low BP. They were airlifted to the hospital and died on 6/18/21." "1428029-1" "1428029-1" "N/A -- patient was perfectly fine during wait time" "1428052-1" "1428052-1" "cough, difficulty breathing, productive cough, 02 requirement, weakness resulting in hospitalization and death. received treatment : Azithromycin and Decadron 02/09/2021-02/19/2020" "1428447-1" "1428447-1" ""My dad suffered what I believe to be a blood clot in his lung on April 6th, directly related to the second pfizer covid vaccination. Though chronically ill, he was not sick at the time, which was 4 days after the vaccine. He walked up the stairs, collapsed at the top, walked again to the chair, collapsed and then made his way into the chair where he told me ""I can't breathe."" and then slumped over. My mom and I lifted his limp body up and noticed he was not breathing. We moved him to the floor and started life support measures. About 5 minutes later the paramedics arrived. They were eventually able to get his heart and breathing going again about 14 minutes later. He was moved to critical care. After it became apparent he suffered irreparable brain damage, I stopped the life support measures (ventilator) and he passed away shortly after on Friday the 9th. They were continuously removing blood from his lungs while he was there. There was no indication he would die prior to this incident. Though we attempted to tell the critical care doctors about his recent vaccination, they were not receptive to the suggestion that this may have caused the incident that proceeded his passing. My mom did try the heimlich and there were indications that he had breathed in vomit, but he had stopped breathing before this and therefore his cause of death WAS NOT aspiration. He also had fallen the day after the vaccination (Saturday) and the notes indicated his broken ribs were from the CPR measures but this is in error as well as he had broken his ribs in the fall. It is my opinion the broken ribs caused a bruise in the lungs, the vaccination caused excessive clotting, and when he was coughing shortly before the incident it loosened the clots that then caused a pulmonary embolism."" "1428887-1" "1428887-1" "Sudden Brain Aneurysm on May 11, 2021, Revived and kept alive on machines until taken off life support and subsequently died on May 21, 2021" "1428895-1" "1428895-1" "Feb 8th 2nd vaccination. Next day lost consciousness, fell no injuries. Following day Feb 10th weak and could not stand, BP low, Dr sent him via ambulance. EMS identified him having a heart attack that started Feb 9th. He had no cardiac history He was hospitalized for a sudden blockage, had a vtach episode, did not lose consciousness, one stent placement, had a 2nd vtach episode and did lose consciousness. Placed on blood thinner, within a few days had uncontrolled urinary bleeding, catheter to irrigate, changed blood thinners and did not stop. Continued weakness and decline. Then developed pneumonia the following week. Placed on antibiotics, oxygen 2-7 L/nc. Went to rehab, back and forth to hospital. Came home twice, once Feb 14th for 24 hours, then 2nd time March 9 (his birthday) for his final 2 weeks t home where I cared for him until he passed March 21st. On 4L/NC, did not have catheter, bleeding had stopped." "1429240-1" "1429240-1" "Death; Dysarthria; Lethargy; This case was received via FDA VAERS (Reference number: 1358542) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), DYSARTHRIA (Dysarthria) and LETHARGY (Lethargy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The patient's past medical history included Back surgery (History of multiple back surgeries including a rod placement.). On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), DYSARTHRIA (Dysarthria) (seriousness criterion death) and LETHARGY (Lethargy) (seriousness criterion death). The patient died on 27-May-2021. The cause of death was not reported. An autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not reported. On 27 May 2021, autopsy was performed. As per the spouse, the autopsy results were pending. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.Very limited information regarding the events have been provided at this time.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.Very limited information regarding the events have been provided at this time.; Reported Cause(s) of Death: Unknown cause of death" "1429581-1" "1429581-1" "Found deceased collapsed over edge of overflowing bath tub with head and upper torso submerged. Autopsy revealed signs of drowning and severe heart disease (hypertensive and coronary heart disease and cardiac amyloidosis). There was no evidence of anaphylaxis or myocarditis. Cause of death = Drowning Contributory causes = Hypertensive and coronary heart disease; Cardiac amyloidosis" "1429643-1" "1429643-1" "Lethal stroke" "1429713-1" "1429713-1" "My son had been complaining of racing heart and became a week after the first dose of Moderna then started vomiting once or twice a week thereafter I tried to get him to go the doctor but he kept saying he was ok. He said he feels like something was wrong but didn?t know what. He received his second dose of moderna 6/13/2021, 5 days later on 6/18/2021 he didn?t feel well laid down around 9 pm was checked on at 9:21 he was unresponsive no heart beat no breathing 911 was called. They resuscitated him after 45 minutes then he was transported to hospital then to medical center. he was in ICU on a ventilator unresponsive brain swollen , totally unresponsive and organs shutting down. He passed away 9:45 pm June 19" "1429777-1" "1429777-1" "Found dead 9 days after vaccine" "1429848-1" "1429848-1" "Chest pain which started 6/17, improved 6/19 and 6/20. Chest pain worsened 6/21 and persisted through the week. Became acutely short of breath and passed away 6/25 at hospital" "1430291-1" "1430291-1" "Started with body aches, joint pain and weakness, followed by SOB that was aggravated over time- especially after the 2nd dose- Then, she started having increase heart palpitations and chest pressure. Eventually noted ischemic changes with purplish discoloration face, hands and feet. At this time it became great effort to walk due to lack of air- SOB was severe. She was taken to ER at hospital where she was admitted with possible PE, MI or heart failure. After few days no improvement was achieved and patient trans ported to another Hospital to receive more advance care but she was pronounced death in the morning of 5-11-21. The death certificate heart failure as immediate cause of death, preceded by PE and pulmonary hypertension." "1430452-1" "1430452-1" "Fever, pain in thigh, vomiting, diarrhea, sepsis, eventually died two weeks later. Time of death 6-11-21 1am" "1430563-1" "1430563-1" "On April 2, 2021, person went to the ED at 10:15 AM, where she complained of shortness of breath, fatigue, mild headache and nausea. Patient symptoms were going on for about 3 days. She also reported feeling a bit achy and decreased appetite. She was treated and discharged home the same day. It was later reported by a family member that this person was found unconscious on floor of her bedroom by family members and taken to hospital where she passed away. It was reported hat Doctors were thinking that this was caused by a rare blood disorder (Thrombotic thrombocytopenic purpura, a disease which causes small blood clots and interrupts the blood's ability to deliver oxygen properly)." "1430566-1" "1430566-1" "on 06/18/2021 my husband suffered a central brain aneurysm and passed away om 06/19/2021" "1430652-1" "1430652-1" "Patient noted with decline in condition starting from his first vaccine and expired shortly after 2nd vaccine." "1430661-1" "1430661-1" "Fatigue, chills, fever, exhaustion. The following Sunday, 9 days after his second dose he went to bed and never woke up." "1430874-1" "1430874-1" "Death" "1430883-1" "1430883-1" "Patient presented to the ED on 5/2/2021 for acute back pain, unable to ambulate, unstable angina, NSTEMI and was subsequently hospitalized. Patient received second dose of vaccine on 5/24/2021. On 6/24/2021 he presented to the ED in cardiac arrest and did expire. These visits were within 6 weeks of receiving COVID vaccinations." "1430959-1" "1430959-1" "Patient expired following cardiac arrest. COVID test indeterminate for infection." "1430978-1" "1430978-1" "03/31/2021 received 1st dose of Moderna COVID-19 vaccine 04/01/2021 104 F fever, dizziness, nausea 04/03/2021 symptoms subsided 04/04/2021 case expired as a result of undetermined natural causes per medical examiner final report" "1430991-1" "1430991-1" "Patient was a 77 year old, resident, past medical history of dementia, hypertension, schizophrenia, hyperlipidemia, Parkinson's disease. Patient presented to the ED with altered mental status and a potential seizure. In the morning of 3/24, patient reportedly had an episode of seizure that lasted 30 seconds, generalized tonic/clonic. It is unknown if she fell or hit her head. Per manager, patient is following Neurology, recent work up for possible syncopal month ago. Patient received her 2nd dose of Moderna Vaccine recently on 3/19. At baseline patient is independent, ambulates by her self. Patient has been ill after receiving a COVID vaccine last week. Patient has progressive weakness of the bilateral lower extremities and progressive difficulties with talking , had had multiple falls." "1431067-1" "1431067-1" "Pt died during child birth on 06/24/2021" "1431080-1" "1431080-1" "Death LEG SWELLING N17.9 - Acute kidney failure, unspecified J18.9 - Pneumonia, unspecified organism K92.2 - GI bleed K92.2 - Upper GI bleed" "1431095-1" "1431095-1" "Death N17.9 - Acute kidney failure, unspecified D69.6 - Thrombocytopenia, unspecified" "1431100-1" "1431100-1" "Death I21.4 - Non-ST elevation (NSTEMI) myocardial infarction J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified" "1431110-1" "1431110-1" "Death Gastrointestinal hemorrhage, unspecified Pneumonia" "1431133-1" "1431133-1" "death J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia N17.9 - Acute kidney failure, unspecified" "1431146-1" "1431146-1" "death E87.1 - Hypo-osmolality and hyponatremia" "1431162-1" "1431162-1" "Death N17.9 - Acute kidney injury (CMS/HCC)" "1431167-1" "1431167-1" "Death J18.9 - Pneumonia of both lower lobes due to infectious organism" "1431178-1" "1431178-1" "Death SAH (subarachnoid hemorrhage) Observed seizure-like activity Hypo-osmolality and hyponatremia Acute kidney failure, unspecified Thrombocytopenia, unspecified" "1431193-1" "1431193-1" "Death J18.9 - Pneumonia, unspecified organism" "1431198-1" "1431198-1" "death E87.1 - Hypo-osmolality and hyponatremia N17.9 - Acute kidney failure, unspecified" "1431206-1" "1431206-1" "Death J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified" "1431211-1" "1431211-1" "Sudden Death" "1431215-1" "1431215-1" "Death N17.9 - AKI (acute kidney injury)" "1431227-1" "1431227-1" "Death N17.9 - Acute kidney injury (CMS/HCC) J18.9 - Bilateral pneumonia" "1431234-1" "1431234-1" "Death J18.9 - Pneumonia, unspecified organism" "1431244-1" "1431244-1" "started with runny nose, fever, cough. ended in death due to Upper GI Bleed and inflammatory markers very elevated and no explanation why." "1431289-1" "1431289-1" ""Date of Admission: 6/19/2021 Date of Death: 6/20/2021 Primary Care Physician: No primary care provider on file. REASON FOR ADMISSION: Patient is a 13-year-old previously healthy male who was admitted after out-of-hospital cardiac arrest with ROSC after CPR for 15 minutes in the field, found to be in the context of large cerebellar hemorrhage secondary to brain lesion (AVM vs tumor). BRIEF SUMMARY OF HOSPITALIZATION: Patient was intubated prior to arrival to the ED. Upon arrival he was started on epinephrine and norepinephrine drips to maintain perfusion and was administered bicarbonate x2. Head CTA was obtained and was notable for midbrain hemorrhage and tonsillar herniation, and no contrast enhanced blood flow in the brain. Brain death exams were completed at 09:59 and 14:20. APNEA test was performed at 13:30, which is the official time of brain death. Official cause of death was brainstem herniation from intracranial hemorrhage. Mechanical ventilation was continued to allow family time to grieve and perform last rites. Time of cardiac death after mechanical ventilation withdrawal was 18:36. HOSPITAL COURSE BY PROBLEM: FEN/Renal/Endo: #Central DI He received 1.5 L of normal saline bolus in the ED and an additional 3 L of ringers lactate bolus overnight in the ICU to maintain perfusion and decrease heart rate. His sodium was 141 upon presentation but reached a maximum of 160 due to central diabetes insipidus. He was started on 0.45% normal saline at 100 mL/hr to improve hypernatremia, which was monitored Q1h until normonatremic. He additionally required vasopressin drip to be started due to central DI, which was increased to a maximum of 20 mU/kg/hr. CV: At time of admission, epinephrine was running at 0.1 mcg/kg/min and norepinephrine was 0.1 mcg/kg/hr. Norepinephrine was increased shortly thereafter to 0.12 mcg/kg/min. In the morning after admission, he had tachycardia to the 190s, which appeared to be narrow complex. Epinephrine and norepinephrine were discontinued. Two doses of adenosine were administered (6 mg first dose, 12 mg second dose) due to suspected SVT. The rate decreased for ~4 seconds after the second dose however returned to ~180. EKG arrived which showed sinus tachycardia so no further medications or cardiac interventions were done. Fluid rates were increased to 2x MIVF rate and additional 500 mL bolus of LR was administered. Norepinephrine and epinephrine were restarted and escalated due to low blood pressures in the early afternoon.to allow family time with patient. Both titrated to effect. Pulm: Patient was mechanically ventilated to achieve normal pH, normocarbia, and high arterial oxygen tension per brain death protocol. He had no primary pulmonary disease during this admission. Neuro: #Intraparenchymal hemorrhage #Tonsillar herniation Neurosurgery was consulted. Mannitol x1 and hypertonic saline 23% x1 were administered to decrease intracranial pressures. Keppra 2g was administered for seizure prophylaxis. No sedation was needed during patient's hospitalization. PERTINENT STUDIES & CONSULTS: Pediatric neurology Neurosurgery PENDING TESTS RESULTS: None RECOMMENDATIONS AND FOLLOWUP: None No future appointments. PHYSICAL EXAMINATION: BP 108/78 | Pulse (!) 144 | Temp 36.5 ¦C (97.7 ¦F) | Resp (!) 15 | Ht 1.65 m (5' 4.96"") | Wt 46.5 kg (102 lb 8.2 oz) | SpO2 99% | BMI 17.08 kg/m¦ Estimated body mass index is 17.08 kg/m¦ as calculated from the following: Height as of this encounter: 1.65 m (5' 4.96""). Weight as of this encounter: 46.5 kg (102 lb 8.2 oz). ALLERGIES No Known Drug Allergies"" "1431322-1" "1431322-1" "Patient began experiencing Shortness of Breath, which increased until he had to be transported to the ER on 3/26/2021. He was diagnosed with severe Congestive Heart Failure, with an injection fraction of 15% and kidney function below 30%. He was released to hospice care 4/5/2021 with Pleur-Ex drains to both lung areas. He continued to get worse, including TIAs, until he died on 5/31/2021." "1431331-1" "1431331-1" "Patient received second COVID vaccine on 2/3/2021. Was admitted to Medical Center on 6/15/21 for generalized weakness and tested positive for COVID 19 on 6/15/2021. Patient was also positive for COVID 19 in November 2020. Patient expired on 6/26/2021 while hospitalized." "1431351-1" "1431351-1" "3/7/2021: dysregulated taste, dyspnea, Myalgia, pneumonia, hospitalized, treated but died" "1431372-1" "1431372-1" "13 hours after the patient had had her 2nd covid-19 shot, she was found dead. She had indicated that she had no side effects after her shot." "1431502-1" "1431502-1" "Patient died of complications due to COIVD-19 illness, which was 4 months after receiving his second dose of vaccine. He was a breakthrough case that died with full vaccination status for COIVD-19. No one is indicating that the vaccine had anything to do with this persons' death." "1431522-1" "1431522-1" "Pt's cause of death was due to COIVD -19 illness. No one believes that the vaccine was part of the death. The patient was fully vaccinated with 2 doses of Pfizer vaccine." "1431530-1" "1431530-1" "Pt. got shot on 5/25 but started feeling real bad arm pain on day 2. The pain got worse in arm and patient reached out to pharmacy questioning arm pain to which he was told it was an expected side effect of the shot but because he was still in pain he made an appointment with his doctor on the coming Monday, but unfortunately, he passed away on Sunday 5/30/21 and was found by neighbors. Brother wants to report death because he took the vaccine" "1431548-1" "1431548-1" "Patient died due to COVID-19 illness after being fully vaccinated. no one believes the death to be related to the vaccine." "1431730-1" "1431730-1" "Patient died due to COVID-19 illness after being fully vaccinated. no one believes the death to be related to the vaccine." "1431733-1" "1431733-1" "I am filing this on behalf of my sister, who feels it needs to be reported but she is too grief-stricken to do this herself. The morning after the second shot, my sister texted that her husband was up at least 10 times during the night, and five times the next night. He was agitated and hallucinating (swatting at bugs that weren't there.) For the next four weeks he had progressively more difficult breathing, and on 4/28 a liter of fluid was drained from his chest. He continued to have difficulty breathing and was taken by ambulance to Hospital on May 2 where they again drained his chest and diagnosed him with pneumonia. A nurse told him they were seeing a number of cases of fluid around the lungs (his fluid was around the lungs, not in them) after COVID vaccines. He was sent home May 4 and commented that it was strange his cardiologist hadn't visited. Almost immediately he was experiencing liver and gall bladder pain, even though tests for those showed the two organs were healthy. On May 8 my sister said patient woke up hyperventilating, which also became more frequent. On the 9th his daughter told me the labs were not trending well, and on May 10 he saw his cardiologist. He diagnosed him with congestive heart failure and got him an appointment at the Heart Hospital on May 17 - he explained congestive heart failure is scary but can be managed through programs at the heart hospital. He began sleeping outside because it made it easier to breathe. On May 15 he was advised to go to the ER/Hospital for tests the heart hospital would need and, once there, they discovered his kidneys weren't functioning and he was admitted immediately. He spent 17 days at Hospital- if the kidneys improved, the heart got worse. If the heart improved, the kidneys failed. He was released on June 2. On June 7 my brother took him to get blood work done - Patient was too weak to get in and out of the car by himself. The blood work came back bad, and on June 8 he was admitted to the Heart Hospital. On June 10 he was transferred to the Regional Community Hospital to be closer to his cardiologist. From there he continued to decline, and the doctors wanted to do surgery for a LVAD but couldn't. To help him get stronger, he had an impeller put in by catheter on June 19 and died that night. His own cardiologist said congestive heart failure is manageable. The symptoms started the night of the second vaccine and his illness wasn't gradual - he went off a cliff. With all the heart problems appearing in males, we don't think this was coincidence." "1431770-1" "1431770-1" "Shortness of breath, low blood oxygen which gotten increasingly worse the days following first vaccine. Went to ER two days after vaccine as symptoms continued to get worse and was placed on oxygen full time. Had a portable oxygen machine. Was also placed on hospice care March 18, 2021; 3 days after 1st vaccine. He had a stable bill of health on Feb 4,2021. Dizziness, fainting and falling down days after second vaccine on March 8 2021. Was in and out of urgent care, ER and assisted care as symptoms and health rapidly deteriorated. He died May 1, 2021" "1432196-1" "1432196-1" "The day she received the second dose she started with flu like symptoms. She also had tingling hands and feet her condition did not get better and was rushed to the ER. She was there for 4 days and sent to a long term facility where her condition worsen. She started having breathing issues went back to the ER with chronic breathing complications. At the hospital she had low oxygen level, lung complications, kidney failure and went into cardiac arrest. She was resuscitate and put on a ventilator for 3 days. She started breathing on her own and was taken off the machines. She was sent home a few days later and nine days later went into cardiac arrest again and this time did not make it." "1432207-1" "1432207-1" "Trouble speaking, cold chills, hot flashes. Death on 5/21" "1432736-1" "1432736-1" "Death; Cardiac arrest; Fatigue; This case was received on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), CARDIAC ARREST (Cardiac arrest) and FATIGUE (Fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Hemodialysis. Concurrent medical conditions included Chronic kidney disease (On HD). On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant) and FATIGUE (Fatigue) (seriousness criterion death). The patient died on 02-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment/concomitant medications were reported. Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Unknown cause of death" "1432862-1" "1432862-1" "Small cell carcinoma; cancer of pancreas / metastasized; Metastases to lungs; Metastates to bone; Metastases to brain; Wheezing; This spontaneous case was reported by a consumer and describes the occurrence of SMALL CELL CARCINOMA (Small cell carcinoma), METASTASES TO PANCREAS (cancer of pancreas / metastasized), METASTASES TO LUNG (Metastases to lungs), METASTASES TO BONE (Metastates to bone), METASTASES TO CENTRAL NERVOUS SYSTEM (Metastases to brain) and WHEEZING (Wheezing) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced WHEEZING (Wheezing) (seriousness criterion hospitalization). On an unknown date, the patient experienced SMALL CELL CARCINOMA (Small cell carcinoma) (seriousness criteria death, hospitalization and medically significant), METASTASES TO PANCREAS (cancer of pancreas / metastasized) (seriousness criteria death, hospitalization and medically significant), METASTASES TO LUNG (Metastases to lungs) (seriousness criteria death, hospitalization and medically significant), METASTASES TO BONE (Metastates to bone) (seriousness criteria death, hospitalization and medically significant) and METASTASES TO CENTRAL NERVOUS SYSTEM (Metastases to brain) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 25-Apr-2021 to 10-May-2021 due to METASTASES TO BONE, METASTASES TO CENTRAL NERVOUS SYSTEM, METASTASES TO LUNG, METASTASES TO PANCREAS, SMALL CELL CARCINOMA and WHEEZING. The patient died on 10-May-2021. The reported cause of death was Cancer of lung, Bone cancer, Metastases to brain, Pancreas cancer and Small cell carcinoma. It is unknown if an autopsy was performed. At the time of death, WHEEZING (Wheezing) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant Product use was not provided. LABORATORY / DIAGNOSTIC TEST: Ultrasound, computerized tomography (CAT) scan and numerous other tests; result was not provided. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: cancer of lung; bone cancer; metastases to brain; pancreas cancer; small cell carcinoma" "1433128-1" "1433128-1" "Patient developed dyspnea, diarrhea, chills and cough. Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes" "1433147-1" "1433147-1" "My husband died suddenly, with no warning, in his sleep" "1433164-1" "1433164-1" "Patient diagnosed with COVID on 6/6/21. Patient was fully vaccinated. Patient admitted to our hospital with respiratory failure and COVID-19 pneumonia on 6/9/21. Patient was treated with oxygen, remdesivir, dexamethasone, and antibiotics. His pneumonia progressed, oxygen requirements increased, and chest xray showed worsening airspace opacities and decreased aeration. Patient's code status was updated to DNR/DNI per family request. Patient's condition continued to deteriorate and patient expired on 6/13/21." "1433305-1" "1433305-1" "patient collapse with subsequent EMS transport to ED, multi organ system failure, coagulation issues, required mechanical ventilation" "1433312-1" "1433312-1" "Died of COVID-19 illness 05/14/2021" "1433345-1" "1433345-1" "Died of COVID-19 Illness on 05/13/2021" "1433374-1" "1433374-1" "Died of COVID-19 illness on 05/17/2021" "1433430-1" "1433430-1" "Died of COVID-19 illness on 05/03/2021" "1433452-1" "1433452-1" "Died of COVID-19 illness on 05/08/2021" "1433463-1" "1433463-1" "Patient passed away on 02/17/2021." "1433471-1" "1433471-1" "Died of COVID-19 illness on 05/08/2021" "1433479-1" "1433479-1" "Patient passed away on 02/25/2021." "1433483-1" "1433483-1" "Patient passed away on 03/09/2021." "1433491-1" "1433491-1" "Patient passed away on 03/12/2021" "1433503-1" "1433503-1" "Patient passed away on 03/14/2021" "1433516-1" "1433516-1" "Patient passed away on 03/16/2021" "1433542-1" "1433542-1" "Patient passed away on 04/05/2021" "1433561-1" "1433561-1" "Patient passed away on 03/07/2021" "1433591-1" "1433591-1" "Patient passed away on 04/09/2021" "1433663-1" "1433663-1" "Vaccinated person reported pain in his hands, nausea and chest pain approximately 48 hours post second Pfizer vaccine. was diagnosed with a STEMI heart attack and then coded on April 26, 2021." "1433671-1" "1433671-1" "Patient passed away on 04/15/2021." "1433683-1" "1433683-1" "Patient passed away on 04/18/2021" "1433695-1" "1433695-1" "Patient passed away on 04/21/2021" "1433714-1" "1433714-1" "Patient passed away on 04/28/2021" "1433722-1" "1433722-1" "Patient passed away on 04/30/2021" "1433724-1" "1433724-1" "On March 8 we went and got the 2nd vaccine and he came home with a fever and confusion and I guess dementia just seeming crazy. He was eating dinner on March 9 sitting at the bar with my Mom and for whatever reason when she got back to him (with 5minutes) he was on the floor balled up in a ball, all his muscles were tight- it was hard for us to get him to stretch or even move, unable to move or control his bowels. I went and got him and put him in bed, in the middle of the night he woke up and was going crazy. My Mom called the ambulance and they took him to the hospital and he stayed for 3 days. They got him some Occupation therapy and they were able to snap him out a little bit. They helped him walk a little it was hard because he has only one arm. We ended up taking him to a nursing home for physical rehab for him to snap out of it but after 2 weeks in the home his brain and cognition and physical abilities deteriorated everyday. To the point we had to send him to a behavioral health hospital who tried to get him on medication to keep him from getting violent- he was there for 31 days and sent back to nursing home and lasted 3 weeks and then he passed away. It was just rapid exponential deteriorated from day to day and was unbelievable to watch. Every Dr. that saw him said that the vaccine was a contributor to his rapid decline." "1433741-1" "1433741-1" "Patient found unresponsive at home, CPR administered by EMS/ER, patient deceased." "1433744-1" "1433744-1" "Patient passed away on 05/02/2021." "1433753-1" "1433753-1" "dry cough, difficulty breathing, SOB, fatigue, pneumonia" "1433776-1" "1433776-1" "Death 5/5/2021 Causes of death listed on death certificate: 1) acute bleeding 2) rupture of internal iliac aneurysm" "1433778-1" "1433778-1" "Patient passed away on 05/01/2021" "1433783-1" "1433783-1" "Death 5/7/2021 Causes of death listed on death certificate: 1) Ventricular fibrillation 2) Covid19 pneumonia Other: Diabetes" "1433788-1" "1433788-1" "Death 5/29/2021 Causes of death listed on death certificate: 1. pneumonia 2. COVID 19 3. coronary artery disease, hypertensin, Non insulin dependant diabetes" "1433789-1" "1433789-1" "Patient went into cardiac arrest on 05/04/2021 when she was getting into a vehicle. CPR was initiated from EMS in the ambulance to the hospital. CPR was done for approx. 30 minutes when family asked them to stop. Patient passed away on 05/04/2021." "1433796-1" "1433796-1" "Patient passed away on 04/28/2021" "1433797-1" "1433797-1" "Death 5/13/2021 Causes of death listed on death certificate: 1) COVID-19 Pneumonia" "1433809-1" "1433809-1" "Death 5/19/2021 Causes of death listed on death certificate: 1) COVID 19" "1433813-1" "1433813-1" "Death 5/12/2021 Causes of death listed on death certificate: 1) Acute Myocardial Infarction 2) Acute Coronary Artery Thrombosis 3) COVID-19 Other: Acute Respiratory Failure" "1433815-1" "1433815-1" "Patient passed away on 04/18/2021." "1433819-1" "1433819-1" "Death 6/6/2021 Causes of death listed on death certificate: 1) covid pneumonia" "1433830-1" "1433830-1" "Patient passed away on 05/11/2021" "1433851-1" "1433851-1" "patient passed away on 05/03/2021." "1433859-1" "1433859-1" "Patient signed off of dialysis on 05/31/2021. Patient passed away on 06/07/2021" "1433867-1" "1433867-1" "Patient passed away on 06/20/2021." "1433878-1" "1433878-1" "Patient passed away on 06/21/2021" "1433898-1" "1433898-1" "Patient passed away on 06/28/2021" "1433899-1" "1433899-1" "Died of COVID-19 illness on 02/26/2021" "1433939-1" "1433939-1" "Patient received Moderna #1 on 4/20/21 and Moderna #2 on 6/15/21. Our office was notified on 6/19/21 that this patient was found deceased and appeared to have passed away several days prior due to level of decomposition. The cause of death is unknown at this time and is being evaluated by Medical Examiner due to recent Covid vaccination and recent drug overdose on 6/2/21. No foul play suspected." "1434034-1" "1434034-1" "Died of COVID-19 illness on 05/27/2021" "1434041-1" "1434041-1" "Died of COVID-19 illness on 05/25/2021" "1434056-1" "1434056-1" "Died of COVID-19 illness on 05/23/2021" "1434080-1" "1434080-1" "2nd vaccine given 2/19/2021" "1434271-1" "1434271-1" "Died of COVID-19 illness on 06/02/2021" "1435934-1" "1435934-1" "She had a non traumatic intracerebral hemorrhage; Never regained consciousness after the stroke/unresponsiveness; Stroke; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBRAL HAEMORRHAGE (She had a non traumatic intracerebral hemorrhage), LOSS OF CONSCIOUSNESS (Never regained consciousness after the stroke/unresponsiveness) and CEREBROVASCULAR ACCIDENT (Stroke) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Type 2 diabetes mellitus on 21-Jan-2021. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CEREBRAL HAEMORRHAGE (She had a non traumatic intracerebral hemorrhage) (seriousness criteria death, hospitalization and medically significant), LOSS OF CONSCIOUSNESS (Never regained consciousness after the stroke/unresponsiveness) (seriousness criteria death, hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria death, hospitalization and medically significant). The patient died on 21-Jan-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The concomitant medications include unspecified medications for diabetes and low pressure. Reporter further explained the event as non traumatic intracerebral hemorrhage. Patient was hospitalized for some days and died one or two days after coming back to home. The treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1437053-1" "1437053-1" "Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: severe flu-like symptoms-Severe, Systemic: Headache-Severe, Systemic: Weakness-Severe, Additional Details: husband reported patient had severe flu-like sypmtoms" "1437233-1" "1437233-1" "N17.9 - Acute kidney failure, unspecified" "1437238-1" "1437238-1" "death N17.9 - AKI (acute kidney injury)" "1437339-1" "1437339-1" "Death 5/27/2021 No cause of death provided." "1437342-1" "1437342-1" "Death 5/21/2021 Causes of death listed on death certificate 1) COVID-19 2) ARDS Other: Lung Transplant for cystic fibrosis" "1437355-1" "1437355-1" "Death 5/30/2021 Causes of death listed on death certificate 1. respiratory failure 2. covid pneumonia" "1437360-1" "1437360-1" "Death 3/2/2021" "1437364-1" "1437364-1" "Death 5/1/2021 Causes of death listed on death certificate: 1) Cardiac arrest 2) Failure to thrive 3) Parkinson's Disease 4) COVID-19 infection 4/2021 Other: Coronary artery disease" "1437373-1" "1437373-1" "Death 05/24/2021 Causes of death listed on death certificate: 1) COVID 2) ATRIAL FIB 3) CKD 3 4) Hypertension" "1437378-1" "1437378-1" "Died of COVID-19 illness on 05/05/2021" "1437381-1" "1437381-1" "Death 06/04/2021" "1437393-1" "1437393-1" "Died of COVID-19 illness on 05/12/2021" "1437399-1" "1437399-1" "Death 5/30/2021 Causes of death listed on death certificate: 1) Covid 19 Pneumonia 2) colo-vesical fistular 3) Heart failure 4) chronic uti" "1437419-1" "1437419-1" "Died of COVID-19 illness on 03/16/2021" "1437439-1" "1437439-1" "Death 5/25/2021 Causes of death listed on death certififcate: 1. Acute Hypoxic Respiratory Failure due to Bilateral COVID-19 pneumonia 2. Bilateral Covid-19 Pneumonia 3. Covid-19 disease 4. Acute Renal failure, Metabolic Acidosis, Hyperkalemia, Acute Congestive cardiac failure" "1437443-1" "1437443-1" "Death 5/31/2021 Causes of death listed on death certificate: 1. Autoimmune cold-agglutinin hemolytic anemia 2. COVID 19 3. rheumatoid arthritis, chronic immunosuppression" "1437449-1" "1437449-1" "Death 5/30/2021 Causes of death listed on death certificate: 1) Hypertensive Heart disease with Heart Failure Diastolic Other: Covid-19" "1437456-1" "1437456-1" "Death 6/2/2021 Causes of death listed on death certificate: 1) aspiration pneumonia 2) dysphagia 3) esophageal stenosis Other: congestive heart failure, hypertension, chronic kidney disease stage 3" "1437464-1" "1437464-1" "found unresponsive CT of head show large frontotemporal intra-axial hemorrhage" "1437490-1" "1437490-1" "Patient was feeling in good health prior to receipt of vaccination- Patient reported not feeling well right after receiving the dose; fainted the following day- sought medical care that same day- no issues detected; patient continued to say he did not feel like something was right. Patient died on June 4, 2021- brain bleed - transferred to different hospital-intraparenchymal bleed ---please note- there are NO LOT NUMBERS WRITTEN ON PT VACCINE RECORD!" "1437505-1" "1437505-1" "Death 6-28-2021" "1437580-1" "1437580-1" "Was found on the floor, snoring with foam forming out of his mouth. Was sent to the emergency room suffered a heart attack, passed away June 21, 2021." "1437654-1" "1437654-1" "03/19/2021 wife had severe stomach pain, went to urgent care, referred to hospital for cat-scan, admitted to hospital for observation and tests, tests inconclusive, Monday, 03/22/2021 @ 02:42 wife declared dead." "1437814-1" "1437814-1" "mild fever, congestion, headaches" "1437852-1" "1437852-1" "Arm pain following vaccination. Was found deceased the following morning (less than 24 hours after the vaccine). Death was not attributed to the vaccination; cause of death was hypertensive and atherosclerotic heart disease." "1437933-1" "1437933-1" "Patients daughter called on 6/29/21 to inform pharmacy that patient had passed away. It is unclear what patient passed away from as patients family did not leave that information with the floater pharmacist who was working." "1437946-1" "1437946-1" "COVID-19 infection resulting in severe ARDS requiring intubation and ultimately death from COVID-19 infection." "1438057-1" "1438057-1" "Patient died on March 27, 2021. Coroner ruled it Acute Asthma Exacerbation. Because it was only a short time after his shot, his family wants to rule that out as a possible cause of death." "1440399-1" "1440399-1" "death" "1440448-1" "1440448-1" "Severe thrombocytopenia, transaminitis, followed by worsening AKI and death." "1440449-1" "1440449-1" "death I61.9 - Intraparenchymal hemorrhage of brain (CMS/HCC)" "1440493-1" "1440493-1" "Pt became severely sick with flu-like symptoms and could not work on April 20-22. He worked on April 23. He told people he was sick again on April 24. He was very anxious and committed suicide some time between April 27-28." "1440669-1" "1440669-1" "Patient was admitted to the hospital on 04/29/2021. And was discharged with Care on 5/5/21 and expired on 5/26/21." "1440726-1" "1440726-1" "Patient was admitted to Hospital on 7/14 after after two weeks of weakness and found to have AKI and cholestatic liver injury of unknown origin. His clinical course was complicated by progressive liver failure (bili to 20s, LFts >6K), hypoxemic respiratory failure, renal failure requiring dialysis), and a CK >120K. He had an extensive workup including MRCP, Pan CT, liver and muscle biopsy which did not reveal definitive dx. Leading diagnosis is statin -induced immune mediated necrotizing myositis, though biopsy not quite consistent and his labs are beyond what has been reported in the literature. He passed away on 7/28 despite treatment with IVIG, pulse dose steroids, broad spectrum abx. Cause of acute decompensation still unknown, autopsy pending. But wife noted he received covid vaccine doses x2 a few weeks prior to hospitalization, which warranted reporting due to unexplained etiology." "1440737-1" "1440737-1" "Patient presented to the ED and was subsequently hospitalized for DVT within 6 weeks of receiving COVID vaccination. Patient died on 6/23/2021." "1440742-1" "1440742-1" "No symptoms or signs" "1440746-1" "1440746-1" "Pneumonia, SOB, and Fatigue" "1440769-1" "1440769-1" "Patient was gone out for a run on 28th May. While running, he collapsed suddenly. Onlookers called 911 and they tried to revive him but he died on the spot. his autopsy result is still pending. He had no history of any illness and had been a healthy individual. He used to exercise regularly. He had received his second dose of vaccine that month on 13th May and had faced expected symptoms like fever and chills that only lasted for 2 days." "1440830-1" "1440830-1" "Patient presented to the ED for closed fraction dislocation of left ankle on 5/30/2021. Patient was hospitalized on 6/8/2021 for hospice/palliative care. Patient hospitalized on 6/9/2021 for open reduction internal fixation left trimalleolar ankle fracture, medial and lateral malleoli with fixation of the syndesmosis. He died on 6/24/2021. These visits are within 6 weeks of receiving COVID vaccination." "1440841-1" "1440841-1" "secretions and vomitting at 11pm...suctioned. 2:25 am 6/30 vent alarm. pt pale, bp 72/38 pulse 46 , cyanotic lips, limp, resps 11. pt passed at 2:30" "1440865-1" "1440865-1" ""Family stated patient had been weaker since ""last covid shot"". Patient death 5-5-2021 - 1 week after vaccination"" "1440922-1" "1440922-1" "ADMITTED TO HOSP AFTER BYSTANDER CPR. COVID TEST AT ADMIT POSITIVE" "1441060-1" "1441060-1" "Blood clots in heart with extremely low blood pressure and shortness of breath. Symptoms suddenly appeared on 04/02/21. Hospitalization and rehabilitation Until discharge of 05/03/2021. Extremely low blood pressure, weakness and shortness of breath continued until he was hospitalized again 06/02/2021 He passed away 06/09/2021. He was labeled as Covid 19" "1441115-1" "1441115-1" "Patient found down at home unresponsive on the floor. EMS was summoned the patient was found to be in asystole. EMS was able to get a heartbeat. Pt intubated and transferred to hospital. Shortly admission to ICU patient began having severe myoclonic jerking and seizures. Patient was extubated and made no respiratory attempts. Patient expired" "1441553-1" "1441553-1" "Severe anemia, low hemoglobin, low body temp, weakness, confusion, shakiness, all blood levels abnormal. Meningitis due to varicella zoster virus. Died on June 13 2021" "1441825-1" "1441825-1" "Patient died on March 13 2021." "1443104-1" "1443104-1" "States had mild stroke and passed away on 6/15/21 in his sleep" "1443143-1" "1443143-1" "48 y/o female with pmh of HTN, HLD, DM2 and bipolar disorder, transferred to ICU from the psychiatric until after cardiac arrest. The patient was originally admitted on 5/22 for evaluation of bizarre behavior. She was noted to have flight of ideas, emotional instability and multiple attempts to leave the room naked. She was admitted to the floor there with behavioral health consulted for evaluation. She was then transferred to another unit on 5/27/21 for additional management, with a plan for a 90 day inpatient hold. While in the unit she was managed with a medication regimen including Thorazine, Lithium and Abilify. Medicine was consulted for management of hypertension, and Ob-Gyn was following for abnormal vaginal bleeding with work-up unable to be completed due to her mental status. ECT treatments were also started this week on 6/23, with the patient receiving her second ECT treatment this afternoon. From review of the pre-procedure note, the planned induction was with etomidate, succinylcholine, glycopyrrolate, and Brevitol (methohexital, barbiturate class); the actual MAR is not up to date with her procedural medications at the time of admission. Post treatment, the patient was noted to be conversive and in her normal state of health. This evening, nursing staff heard a loud noise from the patient's room around 1630. Upon arrival, they found her down, unresponsive and without a pulse. An ACT was called and CPR was initiated for a duration of approximately 30 minutes. Reportedly the AED display showed asystole, followed by PEA. She received a reported five rounds of epinephrine, one dose of bicarbonate, and one dose of calcium during the event. The patient was intubated during the code with a large amount of gastric contents present, concerning for aspiration. A right ankle IO was placed due to significant difficulty securing access elsewhere. ROSC was obtained with a junctional rhythm, and the patient was transferred for further management. On arrival the patient is non-responsive without any sedation running. She became hypotensive by arrival to the ICU requiring norepinephrine. On later inspection of her IO, there was suspicion for infiltration of fluids and medications around her right ankle. She has had significant secretions into her ETT since transfer. HPI as noted above. ICU course notable for hypoxic respiratory failure with ARDS likely from lung injury from cardiac arrest. She subsequently developed shock and required vasopressors. Initially the patient was noted to have brainstem reflexes, however on 6/25 the patient had an exam change with no spontaneous breaths and pupils fixed and dilated. The initial head CT following arrest was performed which showed diffuse cerebral edema with effacement of the sulci and gray and white matter differentiation consistent with severe anoxic brain injury. There was diminished ventricular size with complete effacement of the fourth ventricle and tonsillar herniation from mass effect. Neurology was consulted. The patient remained on vasopressor and mechanical ventilator support. A NM scan was performed to evaluate cerebral blood flow showed absence of effective cerebral perfusion. Neurology performed an exam and the patient was pronounced deceased at 1802 on 6/27/21 a doctor. The family was informed of the results. After discussion with family, the patient was removed from mechanical ventilator support and vasoactive medications discontinued with the family at beside." "1443187-1" "1443187-1" "Unexpected death. Coroner reported enlarged heart, enlarged liver." "1443226-1" "1443226-1" "myocardial infarction leading to death. Impossible to know causality, but completing this out of an abundance of caution." "1443294-1" "1443294-1" "Unusual swelling. Pr referred by PCP to rheumatology and nephrology for elevated ESR and ANA w/ concern for poss vasculitis or nephritis.. While work-up in process, pt experienced cardiopulmonary arrest. Hospitalized and ventilator supported. Remained encephalopathic, presumed anoxic, w/ seizure disorder and shock liver that precluded proceeding w/ planned coronary/cardiac catheterization. CT chest showed no pulm emb, CT brain showed multiple punctate infarcts suggestive of embolic etiology. Neurology felt infarcts could not explain his encephalopathy. Echocardiogram neg. Family declined trach and PEG and pt was compassionately weaned to comfort from ventilator support, extubated and transitioned to hospice care. Pt passed 6/22/21. Autopsy declined." "1443497-1" "1443497-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1443528-1" "1443528-1" "My brother died 8 days after the vaccine due to a blood clot in his heart. Death Certificate indicates blood clot in heart." "1443544-1" "1443544-1" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1444158-1" "1444158-1" "Death... left ventricle rupture of the heart 4 days after the vaccine" "1444577-1" "1444577-1" "My father became ill after the 2nd does and did not recover. His legs began to hurt. He found it hard to walk. He didn?t want to go to the doctor from fear of COVID. But his legs began to swell and he couldn?t walk, so he went to ER on 4/18/2021 and released on 04/20/2021. He then went to his PCP on 04/28/2021. He went to see a cardiologist who said his heart was good on 04/30/2021. He passed away on 05/06/2021 in his sleep. Please help." "1445672-1" "1445672-1" "Sudden cardiac death; Acute kidney injury; Atrial fibrillation; Cardiac arrest; Cardio-respiratory arrest; Cardiomegaly; Chest pain; Chronic left ventricular failure; Condition aggravated; Decreased appetite; Dehydration; Diastolic dysfunction; Dyspnoea; Fall; Fatigue; Feeding disorder; Fluid intake reduced; Hypokalaemia; Hypotension; Hypovolaemia; Malaise; Palpitations; Renal impairment; Renal tubular necrosis; Sleep apnoea syndrome; Tachycardia; This case was received via DA VAERS (Reference number: 1391483) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SUDDEN CARDIAC DEATH (Sudden cardiac death), ACUTE KIDNEY INJURY (Acute kidney injury), ATRIAL FIBRILLATION (Atrial fibrillation), CARDIAC ARREST (Cardiac arrest), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), CARDIOMEGALY (Cardiomegaly), CHEST PAIN (Chest pain), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure), CONDITION AGGRAVATED (Condition aggravated), DECREASED APPETITE (Decreased appetite), DEHYDRATION (Dehydration), DIASTOLIC DYSFUNCTION (Diastolic dysfunction), DYSPNOEA (Dyspnoea), FALL (Fall), FATIGUE (Fatigue), FEEDING DISORDER (Feeding disorder), FLUID INTAKE REDUCED (Fluid intake reduced), HYPOKALAEMIA (Hypokalaemia), HYPOTENSION (Hypotension), HYPOVOLAEMIA (Hypovolaemia), MALAISE (Malaise), PALPITATIONS (Palpitations), RENAL IMPAIRMENT (Renal impairment), RENAL TUBULAR NECROSIS (Renal tubular necrosis), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) and TACHYCARDIA (Tachycardia) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included Coronary artery disease, Congestive heart failure, Hypertension, Atrial fibrillation (Chronic Afib), Pulmonary hypertension, Cholecystectomy, Hernia repair, Tonsillectomy and Anticoagulant therapy on 02-Apr-2021. Concomitant products included CHLORTHALIDONE, LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ACCORD), MELOXICAM and METOPROLOL SUCCINATE for an unknown indication. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria hospitalization, medically significant and life threatening), ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization, medically significant and life threatening), CARDIAC ARREST (Cardiac arrest) (seriousness criteria hospitalization, medically significant and life threatening), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria hospitalization, medically significant and life threatening), CARDIOMEGALY (Cardiomegaly) (seriousness criteria hospitalization and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure) (seriousness criteria hospitalization and life threatening), CONDITION AGGRAVATED (Condition aggravated) (seriousness criteria hospitalization and life threatening), DECREASED APPETITE (Decreased appetite) (seriousness criteria hospitalization and life threatening), DEHYDRATION (Dehydration) (seriousness criteria hospitalization and life threatening), DIASTOLIC DYSFUNCTION (Diastolic dysfunction) (seriousness criteria hospitalization and life threatening), DYSPNOEA (Dyspnoea) (seriousness criteria hospitalization and life threatening), FALL (Fall) (seriousness criteria hospitalization and life threatening), FATIGUE (Fatigue) (seriousness criteria hospitalization and life threatening), FEEDING DISORDER (Feeding disorder) (seriousness criteria hospitalization and life threatening), FLUID INTAKE REDUCED (Fluid intake reduced) (seriousness criteria hospitalization and life threatening), HYPOKALAEMIA (Hypokalaemia) (seriousness criteria hospitalization, medically significant and life threatening), HYPOTENSION (Hypotension) (seriousness criteria hospitalization and life threatening), HYPOVOLAEMIA (Hypovolaemia) (seriousness criteria hospitalization and life threatening), MALAISE (Malaise) (seriousness criteria hospitalization and life threatening), PALPITATIONS (Palpitations) (seriousness criteria hospitalization and life threatening), RENAL IMPAIRMENT (Renal impairment) (seriousness criteria hospitalization, medically significant and life threatening), RENAL TUBULAR NECROSIS (Renal tubular necrosis) (seriousness criteria hospitalization, medically significant and life threatening), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) (seriousness criteria hospitalization and life threatening) and TACHYCARDIA (Tachycardia) (seriousness criteria hospitalization and life threatening). The patient died on 10-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ACUTE KIDNEY INJURY (Acute kidney injury), ATRIAL FIBRILLATION (Atrial fibrillation), CARDIAC ARREST (Cardiac arrest), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), CARDIOMEGALY (Cardiomegaly), CHEST PAIN (Chest pain), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure), CONDITION AGGRAVATED (Condition aggravated), DECREASED APPETITE (Decreased appetite), DEHYDRATION (Dehydration), DIASTOLIC DYSFUNCTION (Diastolic dysfunction), DYSPNOEA (Dyspnoea), FALL (Fall), FATIGUE (Fatigue), FEEDING DISORDER (Feeding disorder), FLUID INTAKE REDUCED (Fluid intake reduced), HYPOKALAEMIA (Hypokalaemia), HYPOTENSION (Hypotension), HYPOVOLAEMIA (Hypovolaemia), MALAISE (Malaise), PALPITATIONS (Palpitations), RENAL IMPAIRMENT (Renal impairment), RENAL TUBULAR NECROSIS (Renal tubular necrosis), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) and TACHYCARDIA (Tachycardia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood creatinine: increased (Inconclusive) increased. On 02-Apr-2021, Chest X-ray: abnormal (abnormal) CXR showed enlarged cardiac silhouette.. On 02-Apr-2021, Echocardiogram: normal (normal) normal. On 02-Apr-2021, Ejection fraction: normal (normal) 55-60% with Grade 1 diastolic dysfunction. On 02-Apr-2021, Electrocardiogram: abnormal (abnormal) atrial fibrillation. On 02-Apr-2021, Myocardial necrosis marker: normal (Negative) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Advanced Cardiovascular Life Support (ACLS) was performed and despite maximal effort, the patient subsequently expired at 0737. Company Comment : This is a case of death in a 66-year-old male patient with medical history of Coronary artery disease, Congestive heart failure, Hypertension, Chronic Atrial fibrillation and Pulmonary hypertension, that occurred 10 days after receiving second dose of vaccine (Lot number unknown). The patient experienced sudden cardiac death during hospitalization for worsening dyspnea in the past weeks prior to hospitalization. No further information is expected.; Sender's Comments: This is a case of death in a 66-year-old male patient with medical history of Coronary artery disease, Congestive heart failure, Hypertension, Chronic Atrial fibrillation and Pulmonary hypertension, that occurred 10 days after receiving second dose of vaccine (Lot number unknown). The patient experienced sudden cardiac death during hospitalization for worsening dyspnea in the past weeks prior to hospitalization. No further information is expected.; Reported Cause(s) of Death: unknown cause of death" "1445735-1" "1445735-1" "Possible Kidney Infection; Possible Pneumonia; Passed away; Low Iron Levels; Lack of appetite continued after first shot; Nauseous; Felt Cold (Chills); This spontaneous case was reported by an other caregiver and describes the occurrence of KIDNEY INFECTION (Possible Kidney Infection), PNEUMONIA (Possible Pneumonia) and DEATH (Passed away) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Aspiration pneumonia (Had Aspiration Pneumonia prior to vaccination and was hospitalized.), Stent placement (Received a heart stent 7 years ago.), Heart valve replacement on 12-Jan-2021 and Intubation. Concomitant products included AMIODARONE and HYDROCHLOROTHIAZIDE (DIURETIC [HYDROCHLOROTHIAZIDE]) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Felt Cold (Chills)). On 14-Mar-2021, the patient experienced KIDNEY INFECTION (Possible Kidney Infection) (seriousness criteria death, hospitalization, medically significant and life threatening), PNEUMONIA (Possible Pneumonia) (seriousness criteria death, hospitalization, medically significant and life threatening), DECREASED APPETITE (Lack of appetite continued after first shot), NAUSEA (Nauseous) and BLOOD IRON DECREASED (Low Iron Levels). On 23-Mar-2021, DECREASED APPETITE (Lack of appetite continued after first shot) and BLOOD IRON DECREASED (Low Iron Levels) outcome was unknown and CHILLS (Felt Cold (Chills)) and NAUSEA (Nauseous) had resolved. The patient died on 23-Mar-2021. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Blood iron: (Low) Had very low Iron levels.. On an unknown date, Polymerase chain reaction: (Negative) Had several Negative PCR tests every time he was hospitalized. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter states that her Husband passed away on 23MAR2021 but his death was not vaccine related. Had damaged his esophagus while intubating him. He was not doing great but he was functional prior to vaccination. On 14MAR2021 he was hospitalized. Doctors did not know what was wrong with him. His doctor stated that he had Kidney infection or pneumonia but all tests were normal. Reporter stated that the Doctors do not know what was happening to him but it was not vaccine related. Concomitant medications included Defibrillator along with above mentioned medications.; Sender's Comments: This fatal case concerns a 90-year-old male hospitalized with serious unexpected events of kidney infection, pneumonia, death and nonserious decreased appetite, blood iron decreased, chills and nausea. Event latency 11 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Possible Kidney Infection; Possible Pneumonia; Passed away" "1445766-1" "1445766-1" "she died from a blood clot that ran into her heart; felt very very tired; nauseas for the first couple of days; nauseas for the first couple of daysdidn't eat well for the first couple of days; This spontaneous case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (she died from a blood clot that ran into her heart), FATIGUE (felt very very tired), NAUSEA (nauseas for the first couple of days) and DECREASED APPETITE (nauseas for the first couple of daysdidn't eat well for the first couple of days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced NAUSEA (nauseas for the first couple of days) (seriousness criterion death) and DECREASED APPETITE (nauseas for the first couple of daysdidn't eat well for the first couple of days) (seriousness criterion death). On 04-Apr-2021, the patient experienced FATIGUE (felt very very tired) (seriousness criterion death). On 08-Apr-2021, the patient experienced INTRACARDIAC THROMBUS (she died from a blood clot that ran into her heart) (seriousness criteria death and medically significant). The patient died on 08-Apr-2021. The reported cause of death was she died from a blood clot that ran into her heart. It is unknown if an autopsy was performed. As per source document the patient received the 2nd dose on 4 or 5 April 2021 and she died from a blood clot that ran into her heart on 8Apr2021. Treatment medication was not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Relevant concomitant medications were not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: she died from a blood clot that ran into her heart" "1446042-1" "1446042-1" ""coughing; Pulmonary embolism/ respiratory impairment; Sinus infection; Was cold and so cold to the touch/ couldn't get warm; tired; Didn't feel good; just wanted to stay down and didn't want to get up/ just couldn't wake up; eat very little and he didn't like to eat; color was off, looked grey; Pressure in lower stomach; Lost weight; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient of unspecified age and gender received the first/second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via intramuscular at left arm on 02Feb2021 10:00 (80-year-old at time of vaccination), at single dose, for COVID-19 immunisation. The patient's medical history included Stents from 2005 (a stent placed in 2005; a heart attack in 2017 and additional 5 stents were placed in 2017; a stent placed in his neck in Nov2019); Heart attack from 2017; Reaction to contrast dye from 2005 (has a reaction to the dye that they use for stents; had a stent placed in 2005 and had a reaction to the dye then; a mild heart attack in 2017 and did stents; once again had a reaction to the contrast dye); Sensitivity to bug bites (When the patient got big bites, you would think someone had beat him he had so many knots; the last few years the patient's reaction to bug bites got much worse); High blood pressure. Additional information for other conditions: The patient was very highly allergic or has a reaction to the dye that they use for stents. The patient had some heart stents and he had bad reactions to the contrast used. The patient was allergic to different things. The patient couldn't take codeine. When the patient got big bites, you would think someone had beat him he had so many knots. Reaction to contrast dye: the patient's physicians then wanted to do imaging with contrast dye on the patient's neck. Physician put the patient on a cocktail for 24-48 hours before the stent was placed and the patient still had a reaction. The patient was given a cocktail of Benadryl and 2 other medications that she cannot remember. The patient's reaction to the dye was not as bad as the first 2 but he still had one. The patient had the stent placed in his neck in Nov2019. The patient still had a reaction to the contrast dye, a mild reaction, even with the cocktail. The reaction was enough the patient was told to continue taking the medication afterward. The patient always carried a nitro bottle in his pocked but he never took any of them. They asked how the nitro tablets were and they were powder. They were blessed as far as the patient's heart. Concomitant medications included cetirizine taken for allergy problems; amlodipine taken for high blood pressure for years; acetylsalicylic acid (ASPIRIN) (for the arteries, just to keep the blood thin, the patient began taking aspirin after experiencing side effects from Effient). The patient previously received codeine and experienced sensitivity (Couldn't take codeine, goes way back, 40-50 years). The patient previously received prasugrel hydrochloride (EFFIENT) from 2017 and experienced shortness of breath (The patient was put on Effient after his stent placement in 2017. Doctor took the patient off of Effient and instructed him to just take aspirin because the patient was showing side effects of shortness of breath and different things. Doctor informed the patient that he would rather the patient just take Aspirin than have the side effects from Effient). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) at left arm on 12Jan2021 (80-year-old at time of vaccination) for COVID-19 immunisation and experienced ""so excited"" (the patient was so excited after the first shot of the COVID-19 vaccine). The patient previously received tetanus vaccine toxoid (TETANUS) shot for immunisation (20 years ago at least) and experienced ""Couldn't move arm, arm swelled and turned red and was messed up for a while"". Prior vaccinations within 4 weeks was none. Patient's wife reported that she and her husband (the patient) took the COVID-19 vaccines on 12Jan2021 and 02Feb2021. After his second dose, the patient kept telling her that he didn't feel good and that he was tired (from 03Feb2021). The patient just did not feel good. The patient was cold and so cold to the touch (from 03Feb2021). On 03Feb2021, he was dragging. The patient just wanted to stay down and didn't want to get up. She asked the patient if this was going to keep him in the room all day. The patient replied that he just couldn't wake up. The patient was tired and cold and couldn't get warm. The patient lost 30 pounds (in Feb2021) after he got the second dose of the COVID-19 vaccine. The patient walked around holding his pants up. The patient would eat very little and he didn't like to eat. When he was weighed at the doctor on Friday 02Apr2021, he weighed 136 pounds fully clothed. The patient normally weighed 150-160 pounds. The patient had lost a lot of weight. The patient's color was off, stating that one of her friends said the patient looked grey. The patient experienced pressure in lower stomach (in Feb2021). The patient told her that in his lower stomach, he described it as pressure, and the patient thought he was just kind of sore from coughing from the sinus infection. The patient couldn't stand clothes to touch him and would cut holes in his underwear elastic so that it wouldn't press into him. The patient went to the doctor twice from the time he took the second shot of the COVID-19 vaccine to his death (on 04Apr2021). The patient went to the clinic. The clinic thought the patient had a sinus infection (from 27Mar2021) and gave him a shot that would make him feel good. The patient got a shot on 27Mar2021. She wasn't sure what the shot was and she didn't get a print out. They treated the sinus infection with amoxicillin-clavulanate (875mg-125mg, manufacturer is Teun). The amoxicillin hadn't worked well and the patient went back to the clinic a second time on Friday, 02Apr2021. When the patient went to the doctor on 02Apr2021, they were unable to get a register on the finger pulse-ox monitor. The patient's physician did an X-ray (on 02Apr2021) and the X-ray was perfectly fine (normal). Nothing showed up on the X-ray at all. The patient passed away easter Sunday morning (04Apr2021). The cause of death listed on the patient's death certificate is due to consequence or problem of pulmonary embolism (from 04Apr2021), respiratory impairment. The patient did not receive an autopsy. The family didn't feel the need and the staff didn't even ask if the family wanted an autopsy. ""When you live to be 80 years old, you're blessed."" HCP: The patient's heart doctor did not see the patient on 04Apr2021 before he died. The last time the patient saw the doctor was Dec2020. The wife reported that she is not complaining, the patient made the decision to take the shot, she is just concerned that the patient had something that could help someone else. The wife stated she was not trying to complain at all, she took the COVID-19 vaccine right beside him and had no consequences. She didn't even have a sore arm. The family is just concerned that there is an ingredient in the COVID-19 vaccine or something that could trigger that in them. Yesterday, 23Jun2021, they were showing a lady on TV that was so sick (unable to provide details). ""The patient"" (unknown to which patient this is referring) got the shot and ended up in the hospital with side effects. The wife reported that's why she wanted to let Pfizer know about her husband. She was just reporting the patient's symptoms and was not wanting to hurt anyone's feelings in the world. She is not blaming the COVID-19 vaccine for the patient's death, and stated that it could have been his heart or more anything. She just felt like she needed to let pfizer know some of the side effects the patient was having that didn't start until after the second COVID-19 shot. The wife unable to provide the NDC number, lot number, or expiry date of the patient's COVID-19 vaccines. She does not have the information but her son does have that if Pfizer wanted to call and talk to him. The adverse events did not require a visit to emergency room; the adverse events requiref a visit to physician office (The patient went to the clinic 27Mar2021 and went back 02Apr2021 for Sinus infection). Therapeutic measures were taken as a result of the event sinus infection and included a shot and amoxicillin-clavulanate. The outcome of the event pulmonary embolism/ respiratory impairment was fatal; outcome of other events was unknown. The patient died on 04Apr2021. No autopsy was done. The cause of death was pulmonary embolism/ respiratory impairment. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Pulmonary embolism/ respiratory impairment"" "1446338-1" "1446338-1" "Pt received initial dose of vaccine on March 16, 2021. Pt received the second dose on April 15, 2021. Pt had CVA on April 16, 2021 affecting right hand and lower arm with generalized weakness. Pt was fully cognizant at this time. Pt developed pneumonia and was hospitalized in ICU on April 29,2021, requiring ventilation support. Pt died May 6, 2021." "1446344-1" "1446344-1" "Lungs filled up - CT scan looked like glass - similar to COVID19 patients Had multiple COVID 19 tests all negative o2 levels very low in hospital for 12 nights to stablezize" "1446385-1" "1446385-1" "She started to feel very sick almost immediately after taking it. She wasn't herself (according to her husband, aka my girlfriend's dad) and she died on March 20th, 2021. Yet somehow the EMT had the nerve to try and pretend it wasn't because of the experimental mRNA thing you guys call a Vaccine." "1446466-1" "1446466-1" "Died of cardiac complications, heart attack, stroke or blood clot were all mentioned. Collapsed at work, grabbing his chest. Was revived 5 times before dying. Doctors mentioned his chest was oddly discolored so they thought blood clot but ekg was abnormal as well so heart attack was also mentioned." "1446611-1" "1446611-1" "Sob, death" "1446639-1" "1446639-1" ""My husband passed away June 3, 2021 resulting from complications which began a few hours after receiving his 2nd Moderna shot on April 29, 2021. He never tested positive for Covid19, however his first symptoms were the typical fever, muscle aches, rash. He declined daily from a host of mysterious symptoms including full body rash, blood clots, muscle spasms, atrial fibrillation, ulcers lining his esophagus and colon, and exorbitant WBC (157K) with extremely high eosinophils (90%). He was treated with a host of drugs including antibiotics, steroids, blood thinners, ivermectin and finally chemotherpay (Campath). His ICU team included hematology, pulmonology, ... oncology and infectious disease. After an incredible amount of diagnostic testing ( daily routine blood work, EKGs, chest x-rays, CT scans, MRI, bone marrow biopsy, endoscopy, colonoscopy, skin biopsy, genetic testing) no definitive diagnosis could be made, however, he was given the possible diagnosis of chronic eosinophilia leukemia in late May. The big question among the medical staff was, ""Did the shot trigger something?"" He was eventually treated with the chemotherapy drug Campath, which reduced the WBC and EOs some, but his organs, especially, lungs had been very compromised by the high WBC and eosinophils. Several days after being placed on a ventilator and given a feeding tube at the end of May, a CT scan and MRI confirmed patient had suffered multiple strokes. He passed away a half hour after being taken off the ventilator the morning of June 3, 2021. His death certificate read: A. cardiopulmonary arrest B. acute hypoxic respiratory failure C. hypereosinophila"" "1446668-1" "1446668-1" "Patient died 5 days after receiving the covid vaccine of a heart attack or a blood clot that stop the heart" "1446746-1" "1446746-1" "She died" "1446849-1" "1446849-1" "death" "1446875-1" "1446875-1" "Patient is an 83 year old male admitted with COVID respiratory failure who has end stage COPD. His condition declined throughout hospitalization and expired 7/2/2021." "1446954-1" "1446954-1" "person was found dead 3 and a half weeks after last shot" "1446993-1" "1446993-1" "Unable to recover- date of death 5-29-2021" "1447016-1" "1447016-1" "Death - less than 24 hours after 2nd dose of Covid19 - Pfizer vaccination" "1449786-1" "1449786-1" "chest hurt; pulmonary issues; heart failure; kidney failure; Cardiac arrest; flu like symptoms; tingling in arms and feet; rashes in the body; itchy; weakness to the point that she could not walk; passed away; cardiac arrest; hurting arm; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away), CARDIAC ARREST (cardiac arrest), CARDIAC FAILURE (heart failure), RENAL FAILURE (kidney failure), CARDIAC ARREST (Cardiac arrest), INFLUENZA LIKE ILLNESS (flu like symptoms), PARAESTHESIA (tingling in arms and feet), RASH (rashes in the body), PRURITUS (itchy), ASTHENIA (weakness to the point that she could not walk), LUNG DISORDER (pulmonary issues) and CHEST PAIN (chest hurt) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion hospitalization), PARAESTHESIA (tingling in arms and feet) (seriousness criterion hospitalization), RASH (rashes in the body) (seriousness criterion hospitalization), PRURITUS (itchy) (seriousness criterion hospitalization) and ASTHENIA (weakness to the point that she could not walk) (seriousness criterion hospitalization). 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (hurting arm). On 27-May-2021, the patient experienced CARDIAC FAILURE (heart failure) (seriousness criteria hospitalization and medically significant), RENAL FAILURE (kidney failure) (seriousness criteria hospitalization and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria hospitalization prolonged and medically significant) and LUNG DISORDER (pulmonary issues) (seriousness criterion hospitalization). On 05-Jun-2021, the patient experienced CHEST PAIN (chest hurt) (seriousness criterion hospitalization). On 14-Jun-2021, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criteria death and medically significant). On 27-May-2021, CARDIAC ARREST (Cardiac arrest) had resolved. The patient died on 14-Jun-2021. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. At the time of death, CARDIAC FAILURE (heart failure), RENAL FAILURE (kidney failure), INFLUENZA LIKE ILLNESS (flu like symptoms), PARAESTHESIA (tingling in arms and feet), RASH (rashes in the body), PRURITUS (itchy), ASTHENIA (weakness to the point that she could not walk), LUNG DISORDER (pulmonary issues) and CHEST PAIN (chest hurt) outcome was unknown and PAIN IN EXTREMITY (hurting arm) had resolved. No relevant medical history was reported. No concomitant medication provided. The patient was having respiratory problem few days after the 2nd dose along with other issues. She was administered with asthma medicines. The name was not specified. Action taken with mRNA-1273 in response to the events was not Applicable. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: cardiac arrest" "1449792-1" "1449792-1" "passed away; short of breath; unwell & very unwell; extremely thirsty; dry mouth; This spontaneous case was reported by a pharmacist and describes the occurrence of DEATH (passed away) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Oxygen therapy (Required Oxygen Assistance in the office). Concurrent medical conditions included Diabetes and Brain tumor. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced DYSPNOEA (short of breath), MALAISE (unwell & very unwell), THIRST (extremely thirsty) and DRY MOUTH (dry mouth). The patient died on 16-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (short of breath), MALAISE (unwell & very unwell), THIRST (extremely thirsty) and DRY MOUTH (dry mouth) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information is not provided. Concomitant medication is not provided. Reporter states that the friend stated that the patient had other underlining conditions, patient needed oxygen assistance in the office,friend advised patient to go to the ER and Patient refused Action taken with mRNA-1273 in response to the events was not Applicable. Company Comment: Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death" "1450055-1" "1450055-1" "Passed away from a heart attack after receiving the COVID 19 JOHNSON AND JOHNSON vaccination." "1450056-1" "1450056-1" "death J18.9 - Pneumonia, unspecified organism" "1450098-1" "1450098-1" "Patient experienced onset of COVID symptoms 05/26. Tested positive for SARS-COV-2 by PCR on 06/09. Presented to ER on 06/12/21 c/o cough, SOB, and hypoxia. O2 sat was 72%. Patient was hospitalized and passed away on 06/18/2021." "1450112-1" "1450112-1" "J18.9 - Pneumonia of right middle lobe due to infectious organism E87.1 - Hyponatremia" "1450176-1" "1450176-1" ""Pt received vaccine 07/01/2021 in the afternoon and patient felt fine with no complaints that day. The following day the patient complained of SOB and the nursing staff found her O2 sat in the 50 so she was brought to the hospital. She was evaluated at the Hospital and discharged back to nursing facility the same day. Patients daughter brought patient back to facility from hospital. On 07/03 patient complained of congestion but ""breathing better"". On 07/04, patient stayed in bed all day. RN at facility administered tylenol and a soda and right after administration found the patient unresponsive. Nurse started CPR and 911 was called. EMS used defibrillator until the staff alerted EMS that patient was DNR. Patient passed away in room between 3-4pm."" "1450231-1" "1450231-1" "Pt. went to pharmacy on 6/22/21 to receive the second dose of Pfizer-BioNTech vaccine, lot number EW0177. The day after the vaccine was administered, her lower arm was swollen, red and her elbow felt hot to the touch. It was too painful to fully extend her arm. There was a white streak across the reddish purple elbow area where it appeared as though there was an infection growing. She went to her normal doctors office, she saw his nurse practitioner who took an x-ray and gave her two intravenous injections of antibiotic (unknown type). One in each buttock and prescribed an oral antibiotic: Cephalexin 500 mg., and Ibuprofen 800 mg. From that day forward she was unable to move the arm at all and the medication did not bring the swelling or the infection down. She was very tired and her arm did not lessen in pain as the days passed. On June 29, 2021 she was in her bedroom and her older daughter was in her room and believed her mother was resting. At approximately 7:20 p.m., pts. husband returned from work and came into the master bedroom turning on the television. As he did so he made joke expecting pt. to laugh or comment, when she made no response he looked over at her and saw that she was laying on the love seat at an awkward angle. He moved to her side and saw her eyes were open but unseeing and saw that her dental prosthetic was partially pushed out of place. He removed and called EMS immediately, not detecting any obvious signs of life. Her daughter came into the room and immediately started CPR. Paramedics arrived in under 2 minutes and moved pt. to the living room where they could intubate a breathing pathway and carried on with attempts to revive her heart muscle for approximately 25 minutes before Paramedic called time of death at 8:02 p.m. Paramedics departed and the Police arrived staying until the Mortuary attendants came to the home at about midnight to accept pt. body for transport to its facility. The Family is seeking an autopsy and the coroner is claiming one is not necessary. The family believes it is absolutely necessary to ascertain whether or not the second dose caused her death as it seems is likely and whether she should have been advised of her heighten risk level. Regardless of COVID 19 Emergency measures, an autopsy is necessary and the family is determined to ensure that it is conducted. Pt. has had a history of the following: Adult onset Asthma, allergic reactions in skin rashes that were significant. Hypothrodism (Graves Disease) which proved to be difficult to find the right meds to bring it under control; prone to incidents of Atrial fibrillation which have escalated as she has aged; she has been treated for emergency visits for Tachycardia; she frequently has developed respiratory issues as a result of the asthma which often landed her in the emergency and days in the hospital on oxygen. She often experienced shortness of breath and chest pain and last year underwent emergency appendicitis. Her last episode of atrial fibrillation which landed in the hospital was 12/29/16. She has been on anticoagulants for many years. Since COVID 19 she may not have been able to afford her Eliquis prescription however which she did not disclose to any of her family members that she was struggling in this wasy. She is likely not to have been taking her Hypothyrodism (Graves) medication either since these medications have not been recovered since her death." "1450252-1" "1450252-1" "my wife died of a hart attack 4 days after her shot she was only 30 years old,. with no previous symtoms. please explain to me how this could happen." "1450256-1" "1450256-1" "Wife stated that Husband passed after receiving dose of Pfizer vaccine, he developed a Guillain-Barre Syndrome after receiving vaccine. Wife stated that he lost ability to walk, ability to speak was severely impacted, had difficulty eating and drinking bc his throat muscles were effected from the syndrome. Then, he couldn't sit up in bed. Then, after was diagnosed that's when his kidneys started to fail and then his heart stopped. DOD: 04/06/2021" "1450281-1" "1450281-1" "Daughter stated that patient got very weak about a week after the 2nd dose of pfizer vaccine. Daughter also stated that patient was taken to ER bc she was unresponsive and her blood pressure was dropping, patient passed at ER on 05/19/2021" "1450294-1" "1450294-1" "Found dead. Evidence of diffuse alveolar pulmonary damage (ARDS, DAD)." "1450298-1" "1450298-1" "Pfizer Dose #1 - Jan 22, 2021 - Symptom: arm pain, fatigue Pfizer Dose #2 - Feb 16, 2021 (11:57am) - Death approximately 12 hours later before 1am 02/17/2021." "1450341-1" "1450341-1" "death I61.9 - Nontraumatic intracerebral hemorrhage, unspecified R29.810 - Facial weakness I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC)" "1450387-1" "1450387-1" "Stroke" "1450510-1" "1450510-1" "death J18.9 - Pneumonia, unspecified organism abdominal pain" "1450558-1" "1450558-1" "death J18.9 - Pneumonia, unspecified organism" "1450563-1" "1450563-1" "death I63.9 - CVA (cerebral vascular accident) E87.1 - Hyponatremia" "1450577-1" "1450577-1" "death N17.9 - Acute kidney failure, unspecified" "1450601-1" "1450601-1" "death I61.9 - Nontraumatic intracerebral hemorrhage, unspecified" "1450612-1" "1450612-1" "death AKI (acute kidney injury) Pneumonia, unspecified organism" "1450632-1" "1450632-1" "death - Hypo-osmolality and hyponatremia" "1450643-1" "1450643-1" "death N17.9 - Acute kidney failure, unspecified" "1450647-1" "1450647-1" "death J18.9 - Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung" "1450691-1" "1450691-1" "death R56.9 - Unspecified convulsions R56.9 - Focal seizures" "1450702-1" "1450702-1" "Within a few minutes of his 2nd dose, he said his throat felt tight like it was closing. I alerted staff. They checked his blood pressure. 155/50. Made us wait another 20 minutes and my dad said he felt better after drinking water. Once we got home he said he felt brain fog and a bit dizzy. He passed away on May 4th, 2021. 3 days after his 2nd dose of Pfizer. It was ruled a heart attack." "1450703-1" "1450703-1" "Patient sparked a high fever shortly after receiving vaccine, was treated with Tylenol suppositories and Morphine. Patient was on 1.5 liters of Oxygen. Hospice refused any additional treatment including IV fluids or doctor visit requested. Patient stopped eating and drinking and lapsed into unconsciousness. He died on June 29. 2021 after Hospice nurse recommended removing Oxygen. At home nurse insisted on maintaining oxygen until his death a few hours later." "1450706-1" "1450706-1" "Sudden death" "1450712-1" "1450712-1" "death N17.9 - Acute kidney injury" "1450909-1" "1450909-1" ""Was informed by local Medical Examiner that on 04/10/2021, 4 days after receiving second Covid-19 vaccine, that the pt slipped on a rug and hit her chin very hard and that she died. The family informed Medical Examiner that she was not feeling very well after receiving her vaccine and felt more fatigued than usual. Family raised concerned that the cause of her fall was due to vaccination. Medical Examiner ruled cause of death as a closed-head injury or cardiac arrhythmia, with significant other conditions at time of death being ""mild symptoms following covid-19 vaccination"""" "1453698-1" "1453698-1" ""Tinnitus; Committed suicide; Fatigue; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: ER8730), on 05Mar2021 11:15 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: ER8730), on 26Mar2021 10:30; both via an intramuscular route of administration, administered in Arm left (left shoulder), as single dose, for covid-19 immunization. Medical history included multiple sclerosis (MS) from 07Jul2002 and ongoing. Patient's prior vaccination was none. The patient's concomitant medications were not reported. Caller reported the side effects after the administration of the Covid-19 vaccine. On unknown date in Mar2021, after the first shot his tinnitus started and he was also fatigued; and he committed suicide eventually. The caller went to a specialist and was told that he had heard about that symptom before from 6 patients who reported the same thing. Later the reporter mentioned he didn't know the guy other than he was a founder of one organization (name no provided) and he committed suicide. Had spoken with one of his friends who knew of a friend who also had tinnitus shortly after getting Covid and it was serious because the guy committed suicide. The guy was about his age and he ended up committing suicide and he had similar symptoms. This all happened around the same time in March when he had his vaccine and it's kind of eerie. It stated on the guy's obituary he had covid and tinnitus, but caller unable to clarify if guy had covid virus or vaccine. He didn't know the guy, but his other friend who have friends that were doctors said that you could go crazy. No further details provided for this person or other persons. This was the report two of three. Upon receipt of the follow up, it was stated that approximately 1-2 days after just vaccine, the patient started with hissing second on both ears which stated was diagnosed as tinnitus. As of today, 12Jun2021, the ""hissins"" was consistent or worse than the start and it fall day and night. On an unspecified date in Mar2021, the patient died, and the autopsy was not performed. The outcome of the events committed suicide and tinnitus was fatal while the outcome of the event fatigue was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Tinnitus; committed suicide"" "1454063-1" "1454063-1" "I am the epidemiologist reporting on behalf of patient. Patient received two doses of Pfizer on 01/09/21 and 02/02/21. Case was admitted to hospital on 6/26 due to slurred speech, low heartrate, and low oxygen (75%) and tested positive for COVID-19 via a PCR test. The patient passed away on 07/01/21. Cause of death is listed as sepsis. Death cert # 20210042573." "1454101-1" "1454101-1" ""Several days following 2nd Covid vaccine, patient began experiencing visual changes including seeing ""sparkles"", black spots, loss of color and blurriness. 8 days following the vaccine, patient lost vision in left eye and was taken to the ER and diagnosed with vasculitis. Large doses of Prednisone were administered as a means of protecting the other eye from loss of vision. A biopsy determined that the diagnosis was small cell vasculitis. Patient was in hospital for one week and returned home. Patient was under the care of specialists but becoming weaker. Approximately 6 weeks later, patient could no longer bear her own weight and was re-admitted to the hospital where additional tests were run. Medical staff were unclear what was causing the decline and patient passed away while still under their care."" "1454152-1" "1454152-1" "73 year old male, vaccinated with the Janssen Covid-19 vaccine at the time of hospital admission (5/31/21) for a type 3 odontoid fracture; C2 vertebral body fracture extending into bilateral transverse foramina and nasal bone fracture from a fall from standing. Admitted to the trauma service for pain control. Noted to be somnolent throughout admission. On 6/2, developed AKI, likely related to dehydration vs. contrast nephropathy. On the early morning of 6/3, found unresponsive. Given naloxone 0.02 mg x 3 with no documented response. Transferred to the ICU, intubated and had PEA arrest on induction for intubation. CPR was initiated and he received epi x 1 with ROSC within 3 minutes. Remained intubated and sedated in the ICU with labile pressures on 2 pressors throughout the day on 6/3. The patient expired following compassionate extubation 6/3 2211." "1454169-1" "1454169-1" "Death" "1454205-1" "1454205-1" "Unable to swallow food and liquids beginning Saturday 7pm 08 May 2021." "1454242-1" "1454242-1" "Cause of death: sub drawn hematoma with a normal platelet count" "1454267-1" "1454267-1" "Breakthrough; resulted in death from COVID related symptoms." "1454278-1" "1454278-1" "Breakthrough death resulted from COVID." "1454305-1" "1454305-1" "Breakthrough resulted in COVID death" "1454319-1" "1454319-1" "Breakthrough COVID related death" "1454364-1" "1454364-1" "~5 months following vaccination, COVID-19 infection: Abnormal CXR, fatigue, cough, shortness of breath, confusion, COVID RNA positive; Patient died as result of illness 4 days after admittance to hospital from nursing home." "1454388-1" "1454388-1" "Singles virus broke out within one week of receiving the 2nd COVID-19 vaccination shot. The patient reported to Dr who was then given 400 mg of anti-virals medication. Patient did not improve and was taken to Hospital on 5/17/2021. The Patient was transferred to Hospital on 5/26/2021 and then died on 6/4/2021." "1454420-1" "1454420-1" "When pt's wife came to the clinic for her second dose on 3/11/21 she informed staff that her husband had passed away on 3/7/21 of a brain tumor. Death does not appear to be related to the vaccine - reporting only because death occurred within 30 days of first dose of vaccine. ." "1454552-1" "1454552-1" "Patient vaccinated with pfizer COVID vaccines 02/26/21 and 03/18/21 Patient presented to ER due to nonhealing lesion of right heel as well as erythema and was admitted on 06/15/21 Patient tested negative for COVID-19 on 06/15/21 Patient deteriorated and tested again for COVID-19 and positive on 06/28/21 Patient expired on 07/01/21" "1454630-1" "1454630-1" "Sudden death 5 days after second vaccination." "1454651-1" "1454651-1" "Pt was admitted to the hospital on 7/4 and tested positive for covid. Pt died 7/6" "1454681-1" "1454681-1" "6/18/21: Guest experienced episode of hypoxia. Was able to be corrected with use of )2. Chest X-ray and bloodwork completed. 6/28/21: Seen by NP for weight loss. Ongoing issue prior to vaccine r/t poor appetite 7/1/21: Incident of hypoxia that required increase in 02, SOB, and lethargy. Sent to the hospital. Guest did end up passing at this hospital" "1454753-1" "1454753-1" "Pt had long complicated course spanning almost a month. He was initially admitted for right intertrochanteric hip fracture (following a fall at home) for which he required surgery. Also had bacterial pneumonia and received Zosyn. He was close to discharge at 1 point but then had Covid testing done which came back positive. He gradually worsened from there with acute hypoxic respiratory failure and very poor oral intake. He had multiple episode of hypoglycemia and required D5. He was made care only but improved on his own and was back on medical Mx. It did not last long and he again became very tachypnic in 60s and hypoglycemic. He was made care again. Pt passed away peacefully with his daughter at the bedside on 3/11/21 at 11 AM Causes of Death: 1. Cardiopulmonary arrest due to reason #2 2. Failure to thrive due to reason #3 3. Old age and COVID-19 No autopsy performed." "1454790-1" "1454790-1" "Patient tested positive for COVID-19 on 03/29/2021 via both antigen and PCR despite being fully vaccinated. She was subsequently hospitalized and then died on 03/30/2021. Symptom onset for COVID-19 was 03/23/2021, with symptoms of fever (101.8) and respiratory distress which required an increase in oxygen. Per the death certificate, causes of death are as follows: Part 1: Cause of Death: A. Multi organ failure B. COVID-19 infection Part 2: Other Significant Conditions: Congestive Heart Failure, Diastolic Heart Failure with Preserved Ejection, history of cerebrovascular accident, diabetes mellitus type 2, and morbid obesity" "1454812-1" "1454812-1" "Patient admitted to the hospital with shortness of breath and cough after being diagnosed with pneumonia in the clinic. He was found to have Covid pneumonia and was treated with maximal support but unfortunately became profoundly delirious and developed worsening hypoxia associated with Covid pneumonia. Family was called to the bedside due to progression in his illness and concerns for cardiac dysrhythmias occurring in the setting of worsening hypoxia on maximal support. Decision was made to transition to comfort care and aggressive life-prolonging interventions were discontinued for primary focus on comfort. Patient subsequently expired at 1810 on 04/18/2021. Patient was vaccinated against COVID 19. Death Certificate Information: Part 1: Cause of Death: A. COVID B. SARS COVID 19 Part 2: Other Significant Conditions: Diabetes Mellitus Type 2, Coronary Artery Disease, Hypertension, Hyperlipidemia" "1454827-1" "1454827-1" "Patient fell down the stairs on 04/18/2021; EMT services found no pulse upon their arrival to the scene. Patient was transported to hospital and found to have several broken bones in neck and ultimately died on 04/18/2021 at the hospital. Patient tested positive for COVID-19 upon admission to hospital, despite being fully vaccinated. Patient did not have any known symptoms of COVID-19; the death is not thought to be related to COVID-19." "1454844-1" "1454844-1" "Patient admitted to hospital on 04/20/2021 for significant shortness of breath; patent tested positive for COVID-19 despite being fully vaccinated against it. Patient died on 04/24/2021. Death Certificate Information: Part I: Cause of Death: A. Repiratory Arrest B. COVID-19 Part II Other Significant Conditions COPD; Multiple Myeloma" "1454861-1" "1454861-1" "Patient admitted to hospital on 03/24/2021 for high fever and shortness of breath; these symptoms began in 3/17. Patient tested positive for COVID-19 on 03/21/2021 and again on 03/24/2021 despite being fully vaccinated against COVID-19. Patient died on 04/19/2021. COVID-19 is listed on the death certificate. Death Certificate Information: Part I Cause of Death: A. Acute Hypoxic Respiratory Failure B. Suspected pulmonary embolism Part II: Significant Other Conditions: COVID 19 subacutely" "1454878-1" "1454878-1" "65-year-old with history of TBI and end-stage renal disease subsequently initially admitted to the floor secondary to fever and chills. Found to have COVID-19 pneumonia. On June 13 a rapid response was called for worsening respiratory failure. Subsequently transferred to ICU. Initially on CPAP at 100% FiO2. CTA negative for PE but did show diffuse ground glass infiltrates. Completed 10 days of dexamethasone. Not a candidate for remdesivir given end-stage renal disease. Additionally on cefepime and Rocephin for 10 days subsequently restarted on meropenem. Fortunately patient continued to have hypoxemia unresponsive to noninvasive ventilation. He was intubated on June 19. At the time of intubation he expresses desire not to be intubated for an extended period of time. Unfortunately they are unable to wean from ventilator. Remains on 100% FiO2 with PEEP of 18 and was on nitric oxide. In addition was on paralytics. Remained on prednisone taper off of dexamethasone. In addition to above patient had complications A. fib with RVR further complicated by hypotension. Was on 3 pressors. Suspect multifactorial to sedation and patient with severe Covid who also has end-stage renal disease. SLED initiated while in-house. On the afternoon of June 23 palliative team did meet with patient's siblings. That time determined to transition to comfort care. Compassionate extubation performed. Patient passed away shortly after extubation. Patient died of COVID-19 despite being fully vaccinated against it. Death Certificate Information: Part I: Cause of Death A. Respiratory Failure B. Pneumonia C. COVID-19 Part II Other Significant Conditions: Hypertension, Diabetes Mellitus Type 2, End Stage Renal Disease" "1454883-1" "1454883-1" "Heavy breathing, sick, can?t walk, loss of memory, incoherent, couldn?t sleep, no appetite" "1455101-1" "1455101-1" "Father received vaccine on May 13, 2021. Complained of migraine headaches, feeling tired, and generally unwell. Migraines became more persistent. Father died on June 16, 2021 at home. Coughed up blood and vomited around time of death." "1455120-1" "1455120-1" "All events took place: Following first dose, minor rash on left arm; following second dose, first developed severe rash on arm and belly, extreme fatigue, severe hiccups and inability to swallow without choking; ultimately developed liver and kidney failure, was diagnosed with DRESS syndrome resulting from reaction to vaccine, was administered high-dose corticosteroids and antibiotics but continued to decline, developed hemorrhage in lungs and died due to multi-organ failure. PDF Continuation field did not permit entering text, see attached Continuation Page." "1457004-1" "1457004-1" "Received dose 2 of Moderna vaccine on 3/11/21. Symptoms worse after 2nd dose, and on March 31, 2021 get worse. On April 4 at church, became very hot and weaker and weaker. Came home and put him to bed and slept some. At lunch time, ate a bite of jello and sipped 7 up and said he did not feel very good. Took an Alka Seltzer for heart burn, but it did not help. Went to sleep. Wife unable to waken him later that day. Died 4/4/21." "1457198-1" "1457198-1" "Death. Found resident expired in bed, hands gripped on his gown over his sternum at 6:15am on 6/14/21. He had no complaints of discomfort before going to bed or overnight." "1457205-1" "1457205-1" ""Reportedly ""didn't feel well"" after vaccine but didnt want to seek medical treatment."" "1457207-1" "1457207-1" "Patient was fully vaccinated. Doses on 1/14/21 and 2/4/21. Diagnosed with COVID-19 on 6/21/2021 and passed away on 7/3/2021." "1457210-1" "1457210-1" "Caller stated that she was contacted by Sherriff department that father called 911. When ambulance arrived they did CPR. When they took him to the hospital they perform CPR again. Father was pronounced dead at 1am." "1457215-1" "1457215-1" "Patient passed away on 06/28/2021" "1457253-1" "1457253-1" "Patient passed away on 02/18/2021." "1457452-1" "1457452-1" "Completed suicide on 04/29/2021. Family reported an increase in suicidal ideations after the vaccination." "1457522-1" "1457522-1" "I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)" "1457593-1" "1457593-1" "While receiving Hospice care, tested positive for COVID illness, prior fully vaccinated status noted. Remained at baseline w/overall status during covid illness, asymptomatic for covid illness. Following completion of covid illness recovery, continued to decline as observed during extended hospice care. End of life progressed with overall decline and she expired 6/8/21 at facility." "1457614-1" "1457614-1" "Patient's wife states that he was not the same the evening after receiving the vaccine. She stated that he was unable to hold objects and his eyes were bulging from his head. He was going to a nursing facility after vaccination and later died on 7/4/21." "1457622-1" "1457622-1" "Vaccine received 4/28/30. During 4/30/21 resident overall status changed to altered mental status, which included unresponsive and inability to take in food or drink. Breathing became shallow. Skin pale. Lungs congested w/Chest xray ordered. Moved to Covid PUI unit. Hospice notified w/comfort care initiated and preparations made for end of life w/family notification. COVID testing negative. Bedside observations continued w/NP noting possibility of adverse effect to vaccine r/t multiple sclerosis dx. Hx of others w/multiple sclerosis observed by NP included returning to baseline within 24-48 hours. IV gently hydration initiated during time of little to no response. Within 12 hours, resident was observed to exhibit returning to her baseline status which included responsiveness, ability to drink, swallow, eat, interact w/communication. She returned to baseline, was seen by MD and cleared to return to her previous living area. After several weeks of baseline, she did decline gradually overall with end of life under hospice care with exacerbation of multiple sclerosis symptoms and expired at facility." "1457640-1" "1457640-1" "Was currently w/hospice care. 5/25/2021 exhibited symptoms nausea/emesis. Seen by MD. Treated for symptoms. continued to decline consistent w/ dx. End of life care with nitro prn, oxygen continued and emotional support followed and he expired 5/27/2021 at facility." "1457646-1" "1457646-1" "Confirmed that pt passed away 3/13/21, 5 days after 1st covid vaccine. Per relative who rec'd the autopsy report, pt had no obvious health problems prior to death, was a smoker, but otherwise very fit and active, healthy eater. On day of death, pt had gone hiking for a few hours on a camping trip, they were sitting around eating dinner and pt said he had to go to the bathroom and never came out. Pt's family feel sure something was triggered by vaccine. Relative I spoke to retrieved the autopsy results during the call and read them on the phone as they were reported on paper. Final dx on autopsy was: I. atherosclerosis, generalized, severe. A. Atherosclerotic coronary artery disease i. atherosclerosis, coronary arteries w/ 75% occlusion of LAD, 90% occlusion of L obtuse marginal and 80% occlusion circumflex coronary artery. a. Ruptured acute myocardial infarction, transmural, posterior left ventricle i. cardiac tamponade ii. hemopericardium 350cc COD listed as: ruptured, acute MI d/t atherosclerotic coronary artery disease, tox report was clear." "1458126-1" "1458126-1" "Father of patient came to store pharmacy to inform us of his son's passing. He stated patient died 5 days after receiving his Moderna vaccine on 6/13/2021 due to blood in the lungs. He stated the autopsy has not been done yet to confirm his death, however he was curious of the possibility. I contacted Moderna on July 8th at 4:30pm and spoke to a pharmaceutical representative of Moderna regarding possible side effects of the vaccine." "1458145-1" "1458145-1" "Fever, coughing, body ache, head ache, congestion, chest pain, death" "1458628-1" "1458628-1" ""My previously healthy brother received the Pfizer vaccine (1st dose) and 4 days after he was hospitalized with shortness of breath, heart failure, blood clots in his arm, lungs and leg along with a stroke and many medical conditions kept arising as he was hospitalized. He was in the CICU for a week and a half. Unfortunately, my brother passed away from the Pfizer vaccine. Until his last day the doctors still ""didn't know"" what was wrong with him. A lot happened during his hospital stay, but this is just a brief statement. They have been keeping his medical records from me. They tested him repeatedly there from covid and he wa salways negative. They had no other explanation to what was happening and all along they wanted it to be COVID-19 and were so quick to say it was not the vaccine."" "1458791-1" "1458791-1" "didn't know anyone around her; very weak; not feeling well; failure to survive complications from COVID-19; Hospice care; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (failure to survive complications from COVID-19), MALAISE (not feeling well), CONFUSIONAL STATE (didn't know anyone around her) and ASTHENIA (very weak) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure abnormal. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MALAISE (not feeling well) (seriousness criteria death and hospitalization). On 06-Mar-2021, the patient experienced CONFUSIONAL STATE (didn't know anyone around her) (seriousness criteria death and hospitalization) and ASTHENIA (very weak) (seriousness criteria death and hospitalization). On 26-Mar-2021, the patient experienced HOSPICE CARE (Hospice care). On 29-Mar-2021, the patient experienced VACCINATION COMPLICATION (failure to survive complications from COVID-19) (seriousness criterion death). The patient died on 29-Mar-2021. The reported cause of death was failure to survive complications from covid-19 vaccine. It is unknown if an autopsy was performed. At the time of death, HOSPICE CARE (Hospice care) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. Patient was concomitantly taking blood pressure medications. Patient received IV fluids as corrective treatment. Company Comment : Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: failure to survive complications from COVID-19 vaccine" "1459398-1" "1459398-1" "Died of COVID-19 illness on 05/05/2021" "1459403-1" "1459403-1" "Died of COVID-19 illness on 04/11/2021" "1459409-1" "1459409-1" "Died of COVID-19 on 05/26/2021 Symptoms: Dyspnea (shortness of breath), Fatigue" "1459439-1" "1459439-1" "Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family" "1459444-1" "1459444-1" "Died of COVID-19 illness on 06/02/2021 Symptoms: low oxygen levels" "1459461-1" "1459461-1" "From EMR: Immediate cause of death: acute hypoxemic respiratory failure (2 days from onset to death) Secondary conditions leading to death: pneumonia (2 days from onset to death) COVID-19 (2 weeks) Other conditions present at time of death: coronary artery disease, Parkinson dementia, pulmonary embolism Was smoking a factor: no COD listed as COD listed as CARDIAC ARREST, COVID-19 PNEUMONIA, HYPOXIC ISCHEMIC ENCEPHALOPATHY, ASPIRATION PNEUMONIA Died of COVID-19 illness on 06/13/2021" "1459478-1" "1459478-1" "Died of COVID-19 illness on 06/14/2021 Immediate Cause of Death: Acute respiratory distress syndrome with respiratory failure Due To or as a Consequence Of: COVID-19 infection Interval between Onset & Death: 4 days COD listed as ACUTE RESPIRATORY DISTRESS SYNDROME WITH RESPIRATORY FAILURE INTERVAL BETWEEN ONSET & DEATH and COVID-19 INFECTION INTERVAL BETWEEN ONSET & DEATH" "1459756-1" "1459756-1" "Pericarditis, large vessel vasculitis, death" "1459791-1" "1459791-1" "A few days after taken the vaccine are became swollen with a big knot under it and turning red" "1459796-1" "1459796-1" "three days before the patent died he started having sloop apnea and for several days before the event he started having memory problems and the day before the event he started having a issue with his heart where he just said his heart felt irregular." "1459912-1" "1459912-1" "temp on 101.7 6/25/2021" "1459938-1" "1459938-1" "Participated in skilled therapy, continued visits w/oncologist, vaccine requested and administered, continued skilled therapy w/decrease in strength as what brought resident to SNF w/RLE cellulits w/MRSA, Vaccine series completed, continued skilled therapy, WBCs chronically elevated per oncologist as expected may occur w/cancer tx med for active leukemia. Continued decline overall w/decline in intake of food and fluids, hospice care initiated. Over the course of months, resident declined to bedrest w/expiration 5/24/21." "1459979-1" "1459979-1" "Resident was given Moderna COVID vaccine dose #1 on 7/7/2021 around 10:40 am and was found deceased on 7/8/2021 at 4:10 pm. Member had no acute illnesses/adverse reactions identified prior to death." "1460019-1" "1460019-1" "Decline noted w/increased hospitalizations over months, including during time of vaccination. CHF and pulmonary edema. Hospice care initiated, end of life care, expired at facility." "1460035-1" "1460035-1" "According to family and certificate of death, patient suffered from an acute mid-brain cerebrovascular accident and died on 6/24/2021." "1460241-1" "1460241-1" "Sudden death 17 hours after vaccine shot. Ambulance to Hospital. Unable to resuscitate." "1460255-1" "1460255-1" "Patient received COVID vaccine on 6/30/21. She had been experiencing chronic dyspnea, lower extremity edema. On 7/7 had some nausea, vomiting at home. Found unconscious by her spouse a few hours later and subsequently died." "1460257-1" "1460257-1" "Admitted 6/10/21 w/current covid illness. Partial vaccination noted. 6/17/21 urine culture w/no growth. Progressed to release from Covid unit to general population in recovery status on 6/22/21. Seen/Assessed by NP/MD /IDNP during stay. 6/26/21 urine culture w/no growth. 6/27/21 seen by MD d/t increased falls and confusion. Fall on 6/29/21 w/increased confusion and immediate transport to ER for increased confusion, decreased oxygen saturation and fall w/possible head injury r/t unwitnessed fall and increased confusion. She expired at the hospital 7/3/21 w/respiratory failure." "1460326-1" "1460326-1" "Medical Examiner at time of autopsy ordered Covid testing 06/30/2021 08:30 Nasal swab- reported SARS-CoV-2 RNA detected and confirmed at lab. Cause of death: Complication of Covid-19 Other significant conditions: Chronic A-Fib, HTN, Chronic systolic heart failure, COPD" "1461692-1" "1461692-1" "Fine in Am. Started complaining of stomach pain in afternoon. Had dinner around 6 pm & threw up part of it along with clear mucus and all the water she drank. After that it was all clear mucus off & on through the night. Has had this episode before but only lasting a few minutes never this long! Tried to give water but kept coming back up. Meanwhile pain in stomach (pelvic area) was getting worse. Called 911 at 2 AM (see line 19). Sometime after 911 left, the clear mucus started coming at a faster rate. Had bowel movement around 6 AM but said no relief in stomach pain. Called at 8Am. Could not come til between 12-1 PM. Seemed weak and very tired so let sleep. Around 10-10:30 AM could not wake her up. Called 911 again. This time it was cardiac arrest and they could not revive her." "1461721-1" "1461721-1" "Onset occured 5-7 days post 2nd dose of vaccine. Developed intracranial hemorrhage / hemorrhagic brain bleed causing death." "1461745-1" "1461745-1" "Developed pneumonia 5 days was hospitalized 2 days later and tested positive for covid pneumonia" "1461758-1" "1461758-1" ""Severe diarrhea and destruction of part of her intestine and subsequent sepsis. ER doctors ""could not rule out the vaccine as a contributing factor."" It was suggested she have a portion of her intestines removed. She refused and went on a high dose of antibiotics. She was hospitalized in the ICU and eventually released to a nursing home when stabilized. She never regained control of her bowels or had a solid bowel movement. Her antibiotics were reduced and she again suffered severe abdominal pain and a distended abdomen and return of sepsis. She went back to ER and was told this would keep happening if she did not have the damaged portion of her intestine removed. She elected to go home on hospice, where she died. Her kidney doctor also relayed to her family that this reaction was a direct result of the vaccine. When the family questioned reporting this event, every healthcare provider backed off from admitting it was a result of the vaccine or stated they were not the primary physician and thus was not for them to report."" "1461829-1" "1461829-1" "Dead" "1461866-1" "1461866-1" "She wasn't sick. She just said that she was tired and needed to go home to get some rest and she died that afternoon." "1461898-1" "1461898-1" "Had 2nd vaccine a few days earlier and died of cardiac arrest. Was healthy and active prior to vaccine with no known health problems." "1462011-1" "1462011-1" "Death; my question is, why wouldn't the CDC want to investigate/autopsy any individual who has an adverse event??? The body was sent to mortuary without autopsy, as the family wouldn't want one done at their expense. However, it would seem feasible that the CDC would see this as an opportunity to add to the available statistics on vaccine recipients. Its unknown whether the vaccine contributed to the adverse outcome, but given that this person had the vaccine recently, it should have been investigated. It seems there should be a protocol for Drs and medical examiners to note ALL conditions in the patient not just cause of death, if vaccinated within a few months to a year. It just seems like good research opportunities to me, and I have to wonder why it isn't being done." "1462036-1" "1462036-1" "My mother had chest and abdominal pain and the passed out and died" "1462975-1" "1462975-1" "Death; Adenocarcinoma of colon; Chest pain; Myocardial infarction; This case was received via Regulatory Authority on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), ADENOCARCINOMA OF COLON (Adenocarcinoma of colon), CHEST PAIN (Chest pain) and MYOCARDIAL INFARCTION (Myocardial infarction) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 045B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19, Plastic surgery in December 2020, Surgery in January 2021 and Stoma closure (surgery). On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced DEATH (Death) (seriousness criteria death and hospitalization), ADENOCARCINOMA OF COLON (Adenocarcinoma of colon) (seriousness criteria death and hospitalization), CHEST PAIN (Chest pain) (seriousness criteria death and hospitalization) and MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criteria death and hospitalization). The patient was treated with Surgery (Colectomy) for Death and Surgery (Colectomy) for Adenocarcinoma of colon. The patient died on 05-Jun-2021. The reported cause of death was Myocardial infarction. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2021, Colonoscopy: abnormal (abnormal) Abnormal had a colonoscopy performed through his colostomy which revealed the patient to have a right colonic mass, mass was an adenocarcinoma.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not reported Treatment medication were not reported. Action taken with mRNA-1273 in response to the drug was not applicable. Additional information included the patient had decubitus ulcer which failed to heal multiple times and also had plastic and flap surgeries and finally healed . Patient had underwent Stoma closure surgery .Colostomy started functioning, patient was recovering, suddenly started having chest pain and had a massive myocardial infarction. Endoscopy large bowel was performed. Complicated 1 year, started with COVID 19 - patient was admitted prolonged amount of time due to complications of COVID 19 , developed a large decubitus ulcer which was not healing. Was being followed by Dr wound care center. Multiple debridements.Failure to heal. Referred to me for a diverting colostomy to facilitate healing of the large decubitus ulcer. Diverting colostomy was performed September 2nd 2020. Patient had plastic surgery, flap surgeries, in December 2020 and January 2021. finally healed. Brought for a ostomy reversal, found large mass in the cecum attempted endoscopic removal, with micro perforation, taken to the operating room immediately from endoscopy suite had a right colectomy. Colostomy started functioning, patient was recovering, suddenly started having chest pain and had a massive myocardial infarction. Company Comment : This case concerns a 77-year-old male patient who experienced adenocarcinoma of colon, myocardial infarction and chest pain and died 51 day following the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 77-year-old male patient who experienced adenocarcinoma of colon, myocardial infarction and chest pain and died 51 day following the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: myocardial infarction" "1463403-1" "1463403-1" "Caused extreme dehydration. 3 days after shot her Kinsey?s went into failure and she never recovered despite all the efforts of the doctors / staff. She was never advised not to get shot if she had kidney issues. She diesels eight days after getting shot" "1463406-1" "1463406-1" "Death. My mother died 4 days after receiving the first round of Moderna vaccine." "1463962-1" "1463962-1" "Found unresponsive on the floor of her residence; DOA in the ER" "1464151-1" "1464151-1" "Pfizer COVID19 Vaccine EUA Hospitalized after presenting with dark brown emesis and abdominal pain-> small bowel obstruction." "1464157-1" "1464157-1" "Cardiac arrest, followed by seizure and death. Pt was hospitalized, undetermined cause of death, case send to a medical examiner. Case was noted upon chart review by reporter." "1464197-1" "1464197-1" "Patient Expired" "1464255-1" "1464255-1" "Acute onset of dementia, intubated est 1 mo after vaccination Deceased 7/3/21 at Hospital" "1464271-1" "1464271-1" "death N17.9 - Acute kidney failure, unspecified" "1464276-1" "1464276-1" "Death caused by probable cardiac arrhythmia on May 10, 2021. No previous heart symptoms. Had the normal reaction to the second dose (body aches, chills, low grade fever), but was recovering as of April 19. First dose was administered 3/21/21. Second dose was administered 4/18/2021." "1464398-1" "1464398-1" "death Acute renal failure (ARF)" "1464403-1" "1464403-1" "As per patients family, approx 2 days after receiving Moderna Dose #2 Immunization( was received 5/13/21) patient developed soreness of Rt Arm, body ache, shortness of breath. Was sleeping upright in wheelchair.in order to breath easier. Family stated due to pt having polio as a child, he was fearful of hospitals and refused to have family call 911 These symptoms continued until 6/1/2021 when pt was found dead in wheelchair.by family." "1464404-1" "1464404-1" "She had a brain aneurysm. We question if this was related to the covid 19 vaccine" "1464424-1" "1464424-1" "Death N17.9 - Acute kidney failure, unspecified" "1464551-1" "1464551-1" "Discovered dead in residence three days after vaccination. Last seen alive on day of vaccination" "1464628-1" "1464628-1" "? June 20 ? struggling to breathe; morphine administered ? June 21 ? passed away" "1464651-1" "1464651-1" "This was a J&J vaccine but I didn't see that as a choice in the drop down. My son passed away on June 5 2021. He had severe nausea" "1464745-1" "1464745-1" "Reporter stated that patient got real ill and new symptoms arrived everyday from the day she reviewed the vaccine.. loose stool, fatigue nausea and pain in her spine and headaches. . A few days after the vaccine patient went to the hospital and tested positive for COVID. Patient went to the Hospital on June3rd around 5pm. Test was perform and said she was filled with inflammation of the spine. Patient was release from hospital on June 4th with pain killers and steroids. Patient was pronounced dead on June 6th." "1464775-1" "1464775-1" "Death. It's not known if pt. died on March 31 or soon thereafter. His body was found on April 7, but he was incommunicado before that when I tried to contact him over the Easter weekend. He was found on the floor of his bedroom as if he were getting ready for bed and keeled over." "1465112-1" "1465112-1" "Patient died we think on March 27th although he wasn't found until March 28th. We are waiting for the histology report on his cardiac tissue samples. We are suspecting myocarditis." "1465600-1" "1465600-1" "Tried all the time, not eating, anemia, stopped making blood, hospitalized from may 21, 2021 to dying on June 29, 2021with ANCA vasculitis renal failure. My mother was never sick with this until She got the vaccine moderna" "1465684-1" "1465684-1" "Elevated blood pressure since receiving first dose.; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated blood pressure since receiving first dose.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. Concurrent medical conditions included Bone cancer. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Elevated blood pressure since receiving first dose.) (seriousness criterion death). The patient died on 13-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: high (High) Elevated blood pressure. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided. Company Comment: Very limited information regarding the event has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received on 07 Jul 2021 included relevant history detail (bone cancer), seriousness (death) and outcome of the event (fatal).; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death" "1465762-1" "1465762-1" "Fever, chills, malaise, progressive shortness of breath and sudden collapse" "1466009-1" "1466009-1" "My son died, while taking his math class on Zoom. We are waiting for the autopsy because the doctors did not find anything. He was a healthy boy, he had a good academic index, he wanted to be a civil engineer. He was the best thing in my life." "1466254-1" "1466254-1" "Patient receive vaccine, was very sick the first 3 days after getting it started to feel better for two more days and then died suddenly around 3 p.m." "1466464-1" "1466464-1" "7/3/2021 7:23:41 AM > phone call from Officer pt deceased. discussed with wife. she heard him make a loud breathing noise at 3am and then could not wake him. had been feeling well with no complaints. planned to run a road race this Sunday. offered support. pls mark chart and then FYI to Dr." "1466685-1" "1466685-1" "ARM PAIN, COUGHING, LETHARGIC, CHEST PAIN, CLAMMY," "1466773-1" "1466773-1" "Convulsions, loss of brain function, then death." "1466862-1" "1466862-1" "Progressively worse muscle and body aches, shortness of breath upon exertion, aggressive behavior, insomnia, confusion," "1466883-1" "1466883-1" """"Chills and aches"" the day and evening of the shot. After a couple of weeks, Pt began to experience various pains at different points of his body. He developed severe indigestion resulting in him visiting his physician on April 19th where he was put on a 7-day steroid regimen. One week later, early on Monday morning, April 26, 2021, Pt collapsed in his bathroom at home, was unresponsive, and pronounced dead by the paramedics who responded."" "1466971-1" "1466971-1" "shortness of breath, endotracheal intubation, ventilator, death" "1467970-1" "1467970-1" "Death due to brain bleed, per wife's message left with agency. Obituary located at:" "1469661-1" "1469661-1" "Crticial illness; He couldn't dress himself; The elbow on his left arm was killing him; he had a lot of pain in his left arm; Warmth of hands; swelling, pain, and the heat in his hands; Couldn't move his right arm; Both of his hands and fingers swelled; Pain in elbow; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Crticial illness), MOBILITY DECREASED (Couldn't move his right arm), PERIPHERAL SWELLING (Both of his hands and fingers swelled), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He couldn't dress himself), PAIN IN EXTREMITY (The elbow on his left arm was killing him; he had a lot of pain in his left arm), ERYTHEMA (swelling, pain, and the heat in his hands), FEELING HOT (Warmth of hands) and ARTHRALGIA (Pain in elbow) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K0A) for COVID-19 vaccination. The patient's past medical history included Lyme's disease (4 years ago) and Paralysis (Both legs and one arm). On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MOBILITY DECREASED (Couldn't move his right arm) (seriousness criterion medically significant), PERIPHERAL SWELLING (Both of his hands and fingers swelled) (seriousness criterion medically significant) and ARTHRALGIA (Pain in elbow) (seriousness criterion medically significant). On 17-Jan-2021, the patient experienced ERYTHEMA (swelling, pain, and the heat in his hands) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced ILLNESS (Crticial illness) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He couldn't dress himself) (seriousness criterion medically significant), PAIN IN EXTREMITY (The elbow on his left arm was killing him; he had a lot of pain in his left arm) (seriousness criterion medically significant) and FEELING HOT (Warmth of hands) (seriousness criterion medically significant). The patient was hospitalized on sometime in 2021 due to ILLNESS. The patient died on 04-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MOBILITY DECREASED (Couldn't move his right arm), PERIPHERAL SWELLING (Both of his hands and fingers swelled), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He couldn't dress himself), PAIN IN EXTREMITY (The elbow on his left arm was killing him; he had a lot of pain in his left arm), ERYTHEMA (swelling, pain, and the heat in his hands), FEELING HOT (Warmth of hands) and ARTHRALGIA (Pain in elbow) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. on 17-Jan-2021. There the patient underwent bloodwork, ultrasound, and x-rays to rule out blood clots or anything else. Treatment included a steroid shot, antibiotic shot, and medication, steroids and antibiotics and 4 pain pills on 17Jan2021. No concomitant medications was provided by the reporter. Company Comment: Very limited information regarding this events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Added reporter's email address. On 06-Jul-2021: F/U-1 : Case upgraded to serious: Patient has died on 04-Jun-2021.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1469672-1" "1469672-1" ""Congestive heart failure, he had 32% of his heart; Patient asked caller to ""help him with suicide""; escape from house, Confused; Super sick; medication having opposite effect on him; his kidney levels were also not where they needed to be; died after receiving the Moderna vaccine; Nails were blue; Very cold; Fidgety; Vomiting; Wasn't breathing right/abdomen breathing; Continued to deteriorate; Went outside and could barely make it up the steps; Neck veins distended; Had not slept the night before; Didn't feel good; right arm was swelling; Pale in the face; Right arm red; Chills; Nausea; This spontaneous case was reported by an other caregiver and describes the occurrence of DEATH (died after receiving the Moderna vaccine), CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) and SUICIDAL IDEATION (Patient asked caller to ""help him with suicide"") in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced PALLOR (Pale in the face), ERYTHEMA (Right arm red), PERIPHERAL SWELLING (right arm was swelling), CHILLS (Chills) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced INSOMNIA (Had not slept the night before) and FEELING ABNORMAL (Didn't feel good). On 13-Apr-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps) and VASODILATATION (Neck veins distended). On 25-May-2021, the patient experienced VOMITING (Vomiting). On 26-May-2021, the patient experienced DEATH (died after receiving the Moderna vaccine) (seriousness criteria death and medically significant), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold) and RESTLESSNESS (Fidgety). On an unknown date, the patient experienced SUICIDAL IDEATION (Patient asked caller to ""help him with suicide"") (seriousness criterion medically significant), CONFUSIONAL STATE (escape from house, Confused), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him) and RENAL IMPAIRMENT (his kidney levels were also not where they needed to be). The patient was treated with HALOPERIDOL (HALDOL [HALOPERIDOL]) at a dose of 1 dosage form and DIAZEPAM at a dose of 1 dosage form. The patient died on 26-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart), SUICIDAL IDEATION (Patient asked caller to ""help him with suicide""), PALLOR (Pale in the face), ERYTHEMA (Right arm red), INSOMNIA (Had not slept the night before), FEELING ABNORMAL (Didn't feel good), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps), VASODILATATION (Neck veins distended), CONFUSIONAL STATE (escape from house, Confused), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold), RESTLESSNESS (Fidgety), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him), PERIPHERAL SWELLING (right arm was swelling), RENAL IMPAIRMENT (his kidney levels were also not where they needed to be), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Renal function test: abnormal (abnormal) Kidney levels were also not where they needed to be. No concomitant product information was provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request. This case was linked to MOD-2021-248336 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information added in laboratory data, treatment drug and events.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.; Reported Cause(s) of Death: unknown cause of death"" "1470106-1" "1470106-1" "PATIENT ADMITTED TO HOSPITAL ON 6/25/21 DUE TO RESP DISTRESS. COVID TESTING POSITIVE. DIAGNOSED WITH COVID PNEUMONIA. ON 6/25/21 NAD 6/26/21. PATIENT DIED ON 7/8/2021." "1470120-1" "1470120-1" ""Patient had 1st dose of Moderna COVID-19 vaccine on 5/10/2021. Several days after he complained of ""not feeling well"" and fatigue, but did not give more specific symptomatology. On 5/17/2021 he had a sudden collapse at home and was transported to local hospital, where he was pronounced dead. Case accepted as medical examiner jurisdiction due to no apparent medical history and sudden death after vaccine administration. Full autopsy completed on 5/19/21 revealed obstructive pulmonary thromboemboli as cause of death, with lower extremity DVT. Both portions of the pulmonary thromboembolus and the DVT show organization, thus raising question of whether this process started before or after the vaccination. No known history of thrombophilic disorder, recent injury, or prolonged stasis/immobility. Not known to be current smoker. See below for additional autopsy information."" "1470235-1" "1470235-1" "catastrophic stroke on 7/9/21, death on 7/10/21" "1470249-1" "1470249-1" "The first dose of vaccine (lot number EW0176) was taken on 05/06/2021, and the second dose of vaccine (lot number EW0186) was taken on 05/27/2021. within 12 hours of second does she had gotten severe headache, she couldn't eat for severe vomiting, she said she felt like she was hit by a truck, and had the chills. she would go from really cold to really hot. She couldn't keep anything down even water. On the third day after the vaccine she was very sick and we ( the family) thought she was sleeping but when we went to try and wake her up we discovered her dead." "1470347-1" "1470347-1" "PATIENT DEVELOPED ACUTE RESPIRATORY AND RENAL FAILURE AND EXPIRED 7/11/2021" "1470463-1" "1470463-1" "Patient suffered complete kidney failure despite no history of kidney disease. Acute tubular necrosis." "1470499-1" "1470499-1" "The patient received her COVID vaccine on March 17, 2021 at a local clinic. She developed bruises within days after the shot. She pursued care and diagnosis and reporting with the vaccine administrator, but finally had to see PCP. After multiple visits, the patient was sent to Hospital. She was diagnosed with AML (hospitalized 5 days: April 6-10) and started chemotherapy (outpatient on April 19). She returned to hospital on April 25 in distress and diagnosed with COVID. The patient was put on a ventilator with pressor support on May 1 and passed away on May 10, 2021." "1470622-1" "1470622-1" "Acute heart attack on 4/5/2021 that lead to death on 4/5/2021 at 9:58am." "1470647-1" "1470647-1" "PER SPOUSE, HE HAD A CUT ON HIS LEG THAT DID NOT STOP BLEEDING. THEY WENT TO CLINIC TO GET IT CAUTERIZED. DAY LATER HIS BODY HAD MULTIPLE BRUISES, THEN HE WAS EVEN BLEEDING FROM HIS PENIS. AT HOSPITAL THEY TOLD HIM HE HAD LOW PLATELETS AND WAS BLEEDING OUT. HE WENT INTO HOSPICE AND PASSED AWAY ON 5/8/2021" "1471305-1" "1471305-1" "2 days after the vaccine pt developed a stomach ache radiating to the back ,after several tests and seven weeks later pt. was diagnosis with multiple myeloma went blind and passed away," "1474054-1" "1474054-1" "None stated." "1474062-1" "1474062-1" "Hospitalization within 6 weeks of receiving COVID vaccination. Patient deceased." "1474154-1" "1474154-1" "ED/Hospitalization within 6 weeks of receiving COVID vaccination. Patient Deceased." "1474305-1" "1474305-1" "Pt died 05/27/2021- not a covid related death Vaccine #2 Moderna 03/05/2021 Lot # 032M20A" "1474311-1" "1474311-1" "Patient died 04/06/2021 Covid vaccine #1 Pfizer 03/16/2021 Lot #EN6207 Covid Vaccine #2 Pfizer 03/19/2021 Lot # N/A" "1474326-1" "1474326-1" "Disseminated Intravascular Coagulation" "1474379-1" "1474379-1" "No immediate adverse reaction, however, began developing nightly fevers/profuse sweating on June 11. This continued for two weeks with increasing symptoms of loss of appetite, nausea, abdominal pain, tingling sensation on scalp before going to ER. Visited urgent care on June 16 and bloodwork results indicated elevated white blood cell count and eosinophil count. There was a question as to whether patient had been subjected to a tick bite, so doxycycline was prescribed. After several days, patient returned to urgent care for follow-up bloodwork (June 20th). Results showed WBC and eosinophil count continued to escalate. He went to ER on June 25th and was admitted to the hospital for 5 days. During his visit at Hospital, he was seen by a team of specialists: cardiologist, pulmonologist, hematologist, infectious disease doctor. Multiple tests were run, as the doctors started broad to eliminate certain diagnoses - i.e., bone marrow biopsy, heart cath, CT scans, x-rays, thoracentesis, etc. Patient had fluid around his heart and lungs and was diagnosed with myocarditis. He had no previous heart issues nor family history of heart issues. Test results indicated no abnormal blockage or other issues, other than inflammation and his heart strength was at 27%. I am unable to access his account, as it was disabled after his death. An autopsy is being performed and results are pending; however, the question(s) at large: what was the condition of his heart at the time of his death and was this vaccine-related? Did his myocarditis get worse? Did his heart muscle weaken further and rupture? Please let me know if the autopsy results are needed and where to send them." "1474425-1" "1474425-1" "RESP. DISTRESS AND DEATH" "1474430-1" "1474430-1" "death NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) Pulmonary emboli (CMS/HCC) Acute kidney failure, unspecified Thrombocytopenia, unspecified" "1474596-1" "1474596-1" "Pt.'s daughter states after receiving the 2nd Phizer dose 06/09/2021, shortly after 06/11/2021 started experiencing chest pain, went into Cardiac Arrest and Passed away 06/19/2021." "1474730-1" "1474730-1" "Within two hours of the vaccine, my father was unable to walk, suffered severe weakness, and had severe shortness of breath. The weakness, inability to walk, and shortness of breath lasted in a severe state for 48 hours. After that, he continued to be unable to walk, suffered weakness and had shortness of breath until he died. He never recovered the strength and vitality he had prior to the 2nd vaccine. That 2nd shot shortened his life and killed him." "1475006-1" "1475006-1" "Pt. started coughing Tuesday, June 22, 2021, in the afternoon and it worsened through the rest of day. She also was beginning to be drowsy. Wednesday, June 23, 2021, coughing continued, she became drowsier, she felt warm to the touch (forehead, face, arms, back) and was not acting like herself. Thursday, June 24, 2021, 9am she was at the clinic. The doctor ordered an x-ray and blood work. After results arrived, we were advised to go to the emergency room. There the doctor ordered CT scan. The results showed an abscess and fluid in her left lung and pneumonia. Her lung was drained, was not able to get all of it out. They discussed surgery but needed to send pt. to ER. The discussion for surgery was a daily thing but never happened. They tried multiple procedures, CT scans, etc. On Tuesday, June 29, 2021 there was a meeting called with her doctor to discuss palliative care. The risk of surgery and all the complications following were high risk. Pt. did not understand that she needed to leave the IV and drainage tube in as well as leaving the oxygen on. Based on the complications and pts. quality of life after surgery and the fact that the fluid and pneumonia spread quickly throughout her body - the doctors were leaning towards end-of-life comfort. It all happened so fast! The evening of the 29th, pt. was transported home to end her life on hospice. On Wednesday, June 30, 2021 pt. passed away in the afternoon. Pt. was rarely ever sick. Once in a great while she would get a runny nose or little cough. Everyone around her would catch a virus and she simply would not. We had a member of our family test positive for COVID-19 in November 2020, and pt. never showed any symptoms of being ill. This was all before she received the COVID-19 Vaccine. About a week or two after she received the second vaccine, on May 27,2021. she had increased behaviors with eating and daily ADLs. But the behaviors were her ?normal? behaviors that would occasionally come and go. Nothing was ever persistent. Then on Tuesday June 22, 2021 when sick like symptoms started to appear it was less then four weeks after the second vaccine." "1475167-1" "1475167-1" "Early in the morning Saturday, the day after the injection, patient became very nauseaus with a bad headache. She was sick all day on Saturday with nausea and headache. She could not sleep. On Sunday, she felt worse and called ambulance. They came and checked her out. Said Oxygen level was normal and all her symptoms were normal side effects. They did not take her to the hospital. All day Sunday, she continued to be agitated and not able to get comfortable. She was hot and cold, back and forth. Her headache was very bad and she felt like she would throw up, but only threw up a little that day. By Monday, she started not making sense and slurred her words. We thought this was due to lack of sleep (exhaustion). Her sugar was high, so we gave her an insulin shot. She continued to make less and less sense so we called 911 approximately 7 PM on Monday night. She was hallucinating. At the hospital, they looked for infection, but could not find any source of infection. They intubated her and soon after this, her heart stopped breathing. They performed CPR 3 times, but not successful. She died at 5 AM Tuesday morning." "1475432-1" "1475432-1" "No details on hospitalization aside from palliative care are noted." "1475434-1" "1475434-1" "The patient died 6 days after receiving dose #2" "1475654-1" "1475654-1" "headache, some what tiered and slightly lost of appetite from what I recall my mom telling me after her first shot and then same symptoms on her second shot a month later." "1478018-1" "1478018-1" "Wife reports that patient went to see his cardiologist on 6/7/21 for a follow up to the aortic valve replacement on 10/1/20. He received a good report from the cardiologist and was going to be taken off Warfarin the following week. On the way home he complained of a headache and felt like it was sinus headache. When he got home he went to bed as the headache had worsened. His wife assisted him up to the bathroom and back to bed and he went to sleep. She could hear him breathing from the other room. Later in the evening she became aware that she could not hear him breathing and upon checking on him she found him unresponsive, not breathing and he was blue in the face. She call 911 and they attempted to resuscitate him without success. Wife also reported that after the aortic valve replacement in 10/20, her husband went to the hospital with a fever and was diagnosed with covid and sepsis on 12/14/20. He was admitted and started on IV antibiotics and was hospitalized for 5 days. He had home health care coming into his home for 6 weeks of IV antibiotic therapy. He made a good recovery and was followed by an infectious disease doctor who put him on Amoxicillin po tid until the end of May. She states that he was doing very well physically and was playing golf, walking and felt better than he had in a long time." "1478056-1" "1478056-1" "Presented to ED with shortness of breath. Tested + for COVID-19 at nursing home 1 day prior to presentation. Reports complaints of increasing fatigue, body aches, and respiratory difficulties. Was hypoxic on arrival to ER and required high flow nasal cannula at 45L 60% FiO2 initially. Admitted to floor for oxygen/dexamethasone treatment. Patient's oxygen was titrated as needed. The day following admission patient developed apnea/cyanosis with large amounts of thick sputum. Patients respiratory status declined rapidly and patient expired." "1478259-1" "1478259-1" "no known cardiovascular disease. He has been feeling less well recently . About 1 month ago, he received the 2nd dose of the Moderna COVID-19 vaccine, and he developed an erythematous, non-raised rash involving the upper and lower extremities. This has subsided, but still persists on his thighs. He presented to the emergency department on 7/3 with worsening dyspnea. and diagnosed with pulmonary emboli. After a week in the hospital deteriorating with the following the patient expired. Pulmonary embolism Active Problems: Cardiogenic shock NSTEMI (non-ST elevated myocardial infarction) Cardiomyopathy Acute liver failure without hepatic coma Rheumatoid arthritis Renal failure Aortic stenosis Lactic acidosis Cardiac arrest Cerebral anoxia" "1478327-1" "1478327-1" "PE diagnosed 6/11/21 death 7/4/21" "1478374-1" "1478374-1" "Patient contacted the office 3/31/21 with complaints of arm/shoulder/axillary pains since receiving the vaccines, treated in office 4/5/21 for lump at injection site and continued axillary pain, treated 5/25/21 for shingles outbreak on chest, contacted office again 5/28/21 with elevated bp, heart rate and confusion- possible med reaction, contacted office 6/9/2021 with low blood pressure, dizziness, confusion, increased edema, treated 6/15/21 for urinary tract infection. Treated with oncology - notes from 4/13/21 notes patient is doing well, but with 'knot' on arm and axillary tenderness following COVID vaccine, then notes from oncology 6/24/21 notes patient found to have new retroperitoneal and pelvic lyphadenopathy, along with new splenic lesions with sudden rapid change in mental status and new diagnosed pulmonary hypertension. Patient placed on hospice and deceased as of 7/7/2021" "1478375-1" "1478375-1" "Patient passed away 18 days after vaccine receipt. Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient had end-stage Parkinson's dementia which was the cause of death. Not attributed to vaccination." "1478387-1" "1478387-1" "death 13 days following receipt of vaccination. Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Cause of death not documented. Significant comorbidities include dementia with neuropsychiatric behaviors including anxiety." "1478393-1" "1478393-1" "PT was found on floor in dining room expired by wife on 6/20/21 at approximately 7:30. Body was hard and cold. Called EMS immediately , EMS provided treatment. Declared dead. Body taken to coroner for autopsy." "1478430-1" "1478430-1" "The lot number for the first dose of vaccine was taken on 04/06/2021is: EW0153, and the lot number for the second dose of vaccine that was taken on 04/25/2021 is: EW0162. He started swelling really bad, and the mortician said all of his organs were very swollen. He was in terrible mental condition, he couldn't think. He had so much swelling that his feet were blue. He was so swollen in his brain he couldn't make basic cognitive decisions. His chest was so swollen his chest was up to almost double his normal size. He was under severe mental strain to the point that it took him 14 hours to make a 10 hour drive. He was dealing with maratil strain and shot himself on 05/20/2021." "1478607-1" "1478607-1" "Received Vaccine on 03/21/2021 accoring to niece and had shortness of breath after. Found dead on 03/24/2021. No pneumonia, pulmonary thrombus or meningitis at autopsy but posmortem COVID test positive." "1478618-1" "1478618-1" "Patient reported deceased to public health today. Date of death: 7/15/2021. Sister of patient reports that case reported chest pain while at home walking on his treadmill, he then had to lie down and sister asked him if he was having pain and wanted ambulance called. Reports that patient declined 911 call. Sister then reports that patient had what looked like a seizure, but then went completely unresponsive, so she initiated CPR and called 911. Reports that CPR and 911 response was not successful and patient passed away." "1478647-1" "1478647-1" "patient began running a fever day 1 after vaccination, this exacerbated a seizure, he was admitted to the hospital on 3/13/21 and stayed in a coma until his death" "1478698-1" "1478698-1" ""ILLNESS, LOWER ABDOMINAL PAIN, LOWER BACK AND UP SIDES - IN AND OUT OF DR.'S APPT. AND MEDS. FINALLY DIAGNOSED WITH NON-HODGKINS LYMPHOMA AROUND 6/6/2021 AND BEGAN CHEMO 6/28/2021. DECEASED FROM ""NEUTROPENIC FEVER"" (NOT OFFICAL AS THEY HAVE YET TO PRODUCE A DEATH CERTIFICATE.)."" "1478896-1" "1478896-1" "Cardiogenic shock, Respiratory failure, Ventricular fibrillation, thrombocytopenia, Acute Stroke, seizure, acute deep venous thrombosis" "1479422-1" "1479422-1" "after her first shot on FEB 24 she began looking white as ghost. She was very weak, unstable, in pain, and felt like her life force was getting drained out of her. Then her 2nd shot on MAR 24 and she continued to not feel good. On May 9th she lost consciousness on the bathroom floor, rushed to the ER. She was admitted and told she had pneumonia. By that evening she could not breathe. Her lungs filled with blood and she was dead within 6 days." "1481360-1" "1481360-1" "PATIENT DEATH" "1481541-1" "1481541-1" "Sudden cardiac arrest 5/30/21 (4 days after vaccination)" "1481694-1" "1481694-1" "Had given him vitamin K to stop the bleeding; kidneys started shouting down; Died; Raised C-reactive protein; Shoulder pain; Loss of appetite; Stomach discomfort; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021. The most recent information was received on 08-Jul-2021 and was forwarded to Moderna on 08-Jul-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (Died) and HAEMORRHAGE (Had given him vitamin K to stop the bleeding) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cardiac disorder NOS. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach discomfort) and ARTHRALGIA (Shoulder pain). On 03-Feb-2021, the patient experienced C-REACTIVE PROTEIN INCREASED (Raised C-reactive protein). On an unknown date, the patient experienced HAEMORRHAGE (Had given him vitamin K to stop the bleeding) (seriousness criterion medically significant) and RENAL DISORDER (kidneys started shouting down). The patient was treated with VITAMIN K NOS for Bleeding, at an unspecified dose and frequency. The patient died on 23-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGE (Had given him vitamin K to stop the bleeding), RENAL DISORDER (kidneys started shouting down), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach discomfort), C-REACTIVE PROTEIN INCREASED (Raised C-reactive protein) and ARTHRALGIA (Shoulder pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, C-reactive protein: 128 (High) 128 it gradually increased to 246 and 259. Concomitant medications were not provided. The patient was given a steroid shot for raised c-reactive protein. On 01-Mar-2021 the patient's kidneys started to shut down. On an unreported date, the patient was given Vitamin -K to stop unspecified bleeding. On 23-Mar-2021 the patient died, specific cause of death was not reported. Treatment included Vitamin K. Very limited information regarding these events has been provided at this time. Further information has been requested. Further information is not expected This case was linked to MOD-2021-252597 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Additional events reported: Patient died; kidneys started to shut down and bleeding. Current conditions updated to include 'heart patient'. Date of vaccine confirmed as first dose.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. Further information is not expected; Reported Cause(s) of Death: Unknown cause of death" "1481758-1" "1481758-1" "passed away; blood in lungs; This spontaneous case was reported by a pharmacist and describes the occurrence of DEATH (passed away) and PULMONARY HAEMORRHAGE (blood in lungs) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced DEATH (passed away) (seriousness criteria death and medically significant) and PULMONARY HAEMORRHAGE (blood in lungs) (seriousness criteria death and medically significant). The patient died on 18-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Company Comment: Very limited information regarding the events has been provided at this time. Further information is expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is expected.; Reported Cause(s) of Death: unknown cause of death" "1481780-1" "1481780-1" "lungs filled up with fluids; terrible pain in his back; couldn't lay had to sleep sat down; swelling of his ankles; swelling of his hands; shortness of breath; chills; died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (died) and PULMONARY OEDEMA (lungs filled up with fluids) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure and Diabetes. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY OEDEMA (lungs filled up with fluids) (seriousness criterion medically significant), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PULMONARY OEDEMA (lungs filled up with fluids), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills) outcome was unknown. No treatment medication was provided. Patient took concomitant medication for Blood pressure and Diabetes.; Sender's Comments: This is case of death in a 72-year-old male patient with medical history of blood pressure and diabetes who died more than a month after receiving the mRNA-1273 vaccine. Cause of death was not reported. Very limited information regarding the event has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death" "1481803-1" "1481803-1" "Stroke; itching/pruritus; redness/erythema; Hypersensitivity reaction; Shingles; Rash; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), PRURITUS (itching/pruritus), ERYTHEMA (redness/erythema), HYPERSENSITIVITY (Hypersensitivity reaction), HERPES ZOSTER (Shingles) and RASH (Rash) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010MZ0A and 0111Z0A) for COVID-19 vaccination. Concurrent medical conditions included Alzheimer's disease (Alzheimer's Disease worsened after taking vaccination.), Thyroid disorder (Thyroid Disorder), Incontinence (Incontinence), Glaucoma (Glaucoma) and Chronic kidney disease stage 3 (Chronic Kidney Disease (CKD) Stage 3 or 4 worsened after taking vaccination). Concomitant products included DONEPEZIL from an unknown date to 01-Mar-2021 for Alzheimer's disease, HYDROXYZINE from an unknown date to 01-Mar-2021 for Anxiety, LISINOPRIL from an unknown date to 01-Mar-2021 for Blood pressure fluctuation, TIMOLOL from an unknown date to 01-Mar-2021 and LATANOPROST, TIMOLOL MALEATE (LATANAPROST/TIMOLOL) from an unknown date to 01-Mar-2021 for Glaucoma, MIRABEGRON (MYRBETRIQ) from an unknown date to 01-Mar-2021 for Incontinence, LEVOTHYROXINE from an unknown date to 01-Mar-2021 for Thyroid disorder, VITAMIN D3 from an unknown date to 01-Mar-2021 for an unknown indication. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PRURITUS (itching/pruritus) (seriousness criterion death), ERYTHEMA (redness/erythema) (seriousness criterion death), HYPERSENSITIVITY (Hypersensitivity reaction) (seriousness criterion death), HERPES ZOSTER (Shingles) (seriousness criterion death) and RASH (Rash) (seriousness criterion death). On 01-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria death and medically significant). The patient died on 01-Mar-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: normal mmHg (normal) All within normal ranges. In 2021, Body temperature: normal DF (normal) All within normal ranges. In 2021, Heart rate: normal (normal) All within normal ranges. Additional information was provided by the reporter that 7 days after taking vaccination patient got bumps, on left leg that spreaded to her groin region and all over her thighs, which were painless but itchy. Patient's Home Health Nurse took pictures and sent to the physician on which the physician prescribed medications. Treatment information were not reported. This is a case of death in a 88-year-old female subject with a medical history of Alzheimer's disease, Thyroid disorder, Incontinence, Glaucoma and Chronic kidney disease stage 3, who died 28 days after receiving the second dose of vaccine. Very limited information has been provided at this time. Further information has been requested. Additional information provided was that 7 days after taking vaccination patient got bumps, on left leg that spreaded to her groin region and all over her thighs, which were painless but itchy. Patient's Home Health Nurse took pictures and sent to the physician on which the physician prescribed medications. This case was linked to MOD-2021-006200 (Patient Link). Reporter did not allow further contact; Reporter's Comments: Event Outcomes were given as Recovered in SD but the patient has passed away so captured as Fatal.; Sender's Comments: This is a case of death in a 88-year-old female subject with a medical history of Alzheimer's disease, Thyroid disorder, Incontinence, Glaucoma and Chronic kidney disease stage 3, who died 28 days after receiving the second dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Stroke" "1481806-1" "1481806-1" "Thick blood; Missed a whole week of work; second shot:-heart attack; second shot: tired; second shot- started running a temperature; second dose- throwing up; Sinus infection; second dose-coughing; second dose- blood clots; left arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (second shot:-heart attack) and THROMBOSIS (second dose- blood clots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Renal failure. Concurrent medical conditions included Dialysis and Blood disorder. In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PAIN (left arm was hurting). On 14-Feb-2021, the patient experienced SINUSITIS (Sinus infection), COUGH (second dose-coughing) and VOMITING (second dose- throwing up). On 15-Feb-2021, the patient experienced FATIGUE (second shot: tired) and PYREXIA (second shot- started running a temperature). In February 2021, the patient experienced THROMBOSIS (second dose- blood clots) (seriousness criteria death and medically significant). On 21-Feb-2021, the patient experienced MYOCARDIAL INFARCTION (second shot:-heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced BLOOD DISORDER (Thick blood) and IMPAIRED WORK ABILITY (Missed a whole week of work). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN MELT) for Stomach pain, at an unspecified dose and frequency. On 21-Feb-2021, SINUSITIS (Sinus infection), COUGH (second dose-coughing), VOMITING (second dose- throwing up) and FATIGUE (second shot: tired) outcome was unknown and PYREXIA (second shot- started running a temperature) had resolved with sequelae. The patient died on 21-Feb-2021. The reported cause of death was blood clots leading to heart attack. An autopsy was not performed. At the time of death, BLOOD DISORDER (Thick blood), IMPAIRED WORK ABILITY (Missed a whole week of work) and VACCINATION SITE PAIN (left arm was hurting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: abnormal (abnormal) started running a temperature. On an unknown date, Blood test: normal (normal) normal. Patient took first dose of moderna vaccine in JAN 2021 and second dose in FEB 2021. Patients body temperature was 98-104 after taking ibuprofen for few days. Patient's blood was thick as pancake syrup. Patient was on dialysis for 5 years before the shot. On 16 FEB 2021 Dialysis and blood work was done. Patient went to doctor on 19 FEB 2021. Patient missed her work a week from 15 FEB 2021 to 21 FEB 2021. Very limited information regarding this event/s has been provided at this time. Further information has been requested. This case was linked to MOD-2021-256627 (Patient Link).; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Blood clots leading to heart attack" "1483122-1" "1483122-1" "Received first dose on 27May2021/ received second dose on 10Jun2021; he had a massive heart attack; This is a spontaneous report from a contactable consumer (patient parent). A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0176, on 10Jun2021 at single dose (at the age of 36-year-old) for COVID-19 immunization. Medical history and concomitant medication were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number : EW0176, on 27May2021 and experienced chest pain. Reporter stated Pfizer drug kill the patient yesterday (28Jun2021). He had a massive heart attack in Jun2021. The outcome of massive heart attack was fatal. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: he had a massive heart attack" "1483478-1" "1483478-1" "Heart attack; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Feb2021 as a Dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that, came to know a man who walked outside of the center and died right after the Covid vaccine from a heart attack. The reporter was unsure if it was Pfizer. People were there to help the patient right away and he still died. The reporter can't find much information about this event on the internet because of censorship. On 08Feb2021, the patient collapsed and later died after leaving the vaccination site. The patient died 25 mins after receiving the vaccine. First responders got to the man in seconds, and he passed away in the hospital. It was not reported if an autopsy was performed or not. Information on the lot/batch number had been requested.; Reported Cause(s) of Death: Heart attack" "1483525-1" "1483525-1" "Patient went into unexpected and sudden cardiac arrest and died on 18Jun2021, prior to cardiac arrest patient was short of breath and was using increased oxygen (5L to maintain at 92%); Patient went into unexpected and sudden cardiac arrest and died on 18Jun2021, prior to cardiac arrest patient was short of breath and was using increased oxygen (5L to maintain at 92%); Patient went into unexpected and sudden cardiac arrest and died on 18Jun2021, prior to cardiac arrest patient was short of breath and was using increased oxygen (5L to maintain at 92%); Patient went into unexpected and sudden cardiac arrest and died on 18Jun2021, prior to cardiac arrest patient was short of breath and was using increased oxygen (5L to maintain at 92%); This is a spontaneous report from a contactable nurse. A 65-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via intramuscular route, administered in right arm on 17Jun2021 16:00 (age at vaccination: 65 years) as DOSE 1, SINGLE for covid-19 immunisation. The medical history included muscular sclerosis, myasthenia gravis, diabetes mellitus, multiple sclerosis and covid-19. The patient had covid prior vaccination. There were no known allergies. On 18Jun2021, the patient went into unexpected and sudden cardiac arrest and died, on 18Jun2021 22:00, prior to cardiac arrest patient was short of breath and was using increased oxygen (5l to maintain at 92%). The patient was attempted for resuscitation via CPR and EMS. On an unknown date, the patient underwent sars-cov-2 test which was positive. The patient received other medications received within 2 weeks of vaccination. The patient has not been tested for covid-19 since the vaccination. The patient died on 18Jun2021 due to cardiac arrest. An autopsy was not performed. The device timestamp was 04Jul2021. Information on Lot/Batch information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, cardiac arrest, Dyspnea, Death cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest" "1483546-1" "1483546-1" ""Passed away/Hemorrhagic shock acute blood loss ruptured abdominal aortic aneurysm; Passed away/Hemorrhagic shock acute blood loss ruptured abdominal aortic aneurysm; Shingles; This is a spontaneous report received from a contactable consumer or other non hcp (patient's child). A 67-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: ER8731) via an unspecified route of administration in arm (arm shoulder) on 18Apr2021 (age at vaccination 67years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had the test (before vaccination) where they put dye in the bloodstream and where they check for any ""insularism"" (presented as reported until clarified) or anything he had that process done, may be in March (result: not reported). There was no other prior vaccination. On 20Apr2021, the patient had shingles. He broke out to shingles 2 days after receiving the Pfizer Covid-19 vaccine, reported the shingles broke out. The patient went to the Doctor and they gave him some medicine (unspecified medication) for his pain (onset date: 2021). Therapeutic measures were taken as a result of shingles. In May2021 (one month to the date he got his vaccine exactly), the patient went into the hospital (as per death record but the patient told reporter that 2 days after getting the vaccine, he broke out shingles and when he called, they gave him a confirmation). The patient had hemorrhagic shock acute blood loss ruptured abdominal aortic aneurysm on an unspecified date and patient passed away (as per death record). The reporter stated that patient had passed away and reporter believed it was due to the Pfizer BioNTech Covid-19 Vaccine. The clinical outcome of the events shingles was unknown. The patient died on 20May2021. Autopsy was performed with results not reported. Follow-Up 07Jul2021: Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: hemorrhagic shock acute blood loss; Acute blood loss ruptured abdominal aortic aneurysm"" "1483859-1" "1483859-1" "Mom was feeling fine before she had the Moderna vaccines. A few weeks later, she became extremely ill. She died on May 14, 2021." "1483888-1" "1483888-1" "Tingling/numbness in feet on 3/27/2021. By 3/29/2021 woke up and could not stand. Went to local ER. Transferred to other hospital that evening. Put on ventilator 3/30/2021 for 2 weeks. Diagnose Guillian Barre Syndrome. Adverse reaction to GBS treatment caused kidney failure and many complications. In ICU 2 months then dies on 05/29/2021." "1483917-1" "1483917-1" "admitted with STEMI and acute hypoxic respiratory failure and severe cardiogenic shock requiring ICU vasopressor support." "1483928-1" "1483928-1" "Left brachial plexus neuritis with paralysis 3 days after second covid shot. hospitalized again for seizure episode on 4/21/21 , hospitalized again for sepsis on 6/10/2021" "1484023-1" "1484023-1" "Patient was in decline in the last month due to increase weakness and increase edema. Daughter visited, found patient unresponsive, taken to hospital - found to be Covid Positive. Patient had had a 15lbs weight loss, had become bed bound, SOB on minimum exertion, incontinent of bowel & bladder. Patient had a pacemaker placed 3 weeks ago. Patient taken to hospice" "1484030-1" "1484030-1" "4/6/21: unwell , tested for Covid 4/15/21: Patient condition continues to decline - family informed 4/15/2021, 8:56am Patient expired" "1484098-1" "1484098-1" "This patient developed COVID-19 about 3 weeks after being vaccinated. The patient had the Janssen adenovirus COVID-19 vaccine at a local pharmacy. She developed COVID-19 on 6/19/2021 and was diagnosed at the urgent care, placed on Zithromax, medrol dosepak, and albuterol MDI. Also was placed on hydroxychloroquine. She developed hypoxia on the 25th of June, and acute on chronic renal failure, was transferred for higher level of care to medical Center. Discharged eventually and re-presented on 7/1/2021. Was sent home with continued oxygen. Patient was confused and kept taking oxygen off at home and was direct admitted by myself on7/1/2021. I was treating her daughter for the same infection (COVID-19). The patient rebounded, had normal mental status, but continued to have signs and symptoms of a severe COVID-19 pneumonia. On 7/4/2021, the patient had a sudden escalation in oxygen requirement, sudden drop in blood pressure, and she became febrile and hypotension and septic. She did not recover. Eventually family elected to withdraw care and the patient expired. Was on remdesivir,dexamethasone, had a dose of actemra, had vitamin C, Vitamin D, zinc" "1484107-1" "1484107-1" "arrhythmia, presumed MI, death" "1484118-1" "1484118-1" "Death" "1484524-1" "1484524-1" "death 18 days after vaccine" "1484573-1" "1484573-1" "74 year old male with a past medical history of CHF, CKD stage III, paroxysmal atrial fibrillation treated on Xarelto, hypertension, hyperlipidemia, history of alcohol abuse who presented to hospital postacute care with hypoxemia and worsening shortness of breath over the previous week. He noticed a progression of the shortness of breath and subsequently developed cough without productive sputum. Due to his worsening shortness of breath and cough he underwent PCR testing for COVID-19 was found to be positive. He reports that he received 2 doses of the Pfizer Covid vaccine the last of which was 6 weeks ago. The patient had an extensive hospital stay that included acute decompensated heart failure, ARDS with COVID, intubation, cardiogenic shock, and AKI on CKD requiring CRRT. His family ultimately made the decision to transition to hospice care and the patient passed away 7/12/21." "1484587-1" "1484587-1" "Daughter called on 07/19/21 and stated patient had a CVA on 01/17/2021. Patient was transported to Hospital and patient died on 01/23/2021." "1484651-1" "1484651-1" "Daughter, came to clinic and informed participant, passed away on 6/2/21 from COVID complications at Hospital." "1484665-1" "1484665-1" "COVID 19 Death - 7/17/2021 - Admitted to ICU from ED with symptoms of shortness of breath, productive cough, diarrhea, and chills. Started 1 week ago. COVID19 PCR positive while in ED. Diagnosed with COVID19 Pneumonia. Expired later on same day 7/17/2021." "1484677-1" "1484677-1" "Daughter stated that patient passed on 07/06, a few weeks after getting her 1st vaccine. Daughter stated that she noticed that her mother had stomach pains the day before and the day of passing. Daughter stated tat Mother had EKG test and heart inflammation was found. Patient passed due to heart inflammation." "1484736-1" "1484736-1" "Pt.'s mother states that after receiving the 2nd dose of Phizer vaccine the Pt. collapsed 05/26/2021 and passed away. Currently waiting for Autopsy results." "1484890-1" "1484890-1" "Death, found dead at home" "1484899-1" "1484899-1" "Brain aneurysm with no prior symptoms and no medical history or family history of aneurysms. Grade three hemorrhage at brain stem. Resulting in death" "1484908-1" "1484908-1" "death J18.9 - Pneumonia N17.9 - Acute renal injury" "1484918-1" "1484918-1" "death R56.9 - Seizure-like activity (CMS/HCC) Cardiac arrest" "1484925-1" "1484925-1" "death - Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung - Acute kidney failure, unspecified" "1484930-1" "1484930-1" "death E87.1 - Hypo-osmolality and hyponatremia N17.9 - AKI (acute kidney injury) (CMS/HCC)" "1484940-1" "1484940-1" "death (non-ST elevated myocardial infarction) (acute kidney injury)" "1484959-1" "1484959-1" "death Acute CVA (cerebrovascular accident) Facial weakness" "1484966-1" "1484966-1" "death N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia" "1484972-1" "1484972-1" "death I61.9 - Intracerebral hemorrhage (CMS/HCC)" "1485039-1" "1485039-1" "Patient died of a heart attack on 07/17/2020 while sleeping." "1485145-1" "1485145-1" "Woke up at 5am and transported to hospital . never regain conciousmess" "1485157-1" "1485157-1" "Death - coroner's report received on 7/15/2021. Coroner Dr performed an autopsy and determined the cause of death as brochopneumonia. Heart disease and drug use also contributed to his death. The manner of death is natural." "1485234-1" "1485234-1" "DEATH THE FOLLOWING DAY" "1485423-1" "1485423-1" ""After his office visit with me on Tuesday 7/13, the patient went to get the Moderna COVID vaccine. He received the vaccine on Tuesday evening. On Wednesday, he developed new fevers as high as 104F (measured at home). Fevers improved with Tylenol. He did not report his symptoms, as per his wife, he assumed this was related to the COVID vaccine. By the following morning, his fevers had resolved. He took a nap midday, and shortly after waking, he reported to his wife that he was feeling short of breath. According to his wife, he appeared in respiratory distress and she heard wheezing. He asked to be helped to the ground, and she immediately called EMS. Unfortunately, before they could get him to a hospital, he died. At the hospital, his wife was told that because his death was outside the hospital, it was presumed to be due to ""natural causes"". She was told an autopsy would cost $5000, which she could not afford."" "1485987-1" "1485987-1" "Within 4-6 weeks of the second vaccine, patient started showing signs of shortness of breathe, swollen feet, cough, weak muscles, tired and no energy. patient had been walking with walker up to that point 5 times a week for 15-20 minutes. Since these symptoms began, he was not been able to walk more than a few feet without resting and being out of breath. He had been put on a diuretic and inhaler which didn't seem to be doing much. He saw his primary and heart Dr since the beginning of June. On June 24th he was admitted into the Hospital with Congestive Heart Failure. After blood tests, he was also diagnosed with Leukemia. A week later, on July 1, 2021, patient passed away." "1485991-1" "1485991-1" "White blood cell count almost doubled one month after the second vaccine and nearly tripled 6 weeks after the second vaccine. Patient was placed on hospice on April 23rd and passed away on May 8th." "1486022-1" "1486022-1" "Myasthenia Gravis; Death; Hallucinations; confusion; shortness of breath; dizziness; stroke like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), MYASTHENIA GRAVIS (Myasthenia Gravis) and HALLUCINATION (Hallucinations) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart attack (20 years ago). On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (Myasthenia Gravis) (seriousness criteria death, hospitalization prolonged and medically significant), HALLUCINATION (Hallucinations) (seriousness criterion medically significant), CONFUSIONAL STATE (confusion), DYSPNOEA (shortness of breath), DIZZINESS (dizziness) and CHEST DISCOMFORT (stroke like symptoms). The patient died on 12-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HALLUCINATION (Hallucinations), CONFUSIONAL STATE (confusion), DYSPNOEA (shortness of breath), DIZZINESS (dizziness) and CHEST DISCOMFORT (stroke like symptoms) outcome was unknown. Patient started experiencing side effects 2 weeks after taking the vaccine. He was taken to the hospital for stroke like symptoms but it was ruled out by X-ray. He went to the hospital as symptoms persisted & got admitted on 13March2021. He died 24 hour later after being diagnosed with Myasthenia Gravis and thymus removal refusal. Concomitant medications were not provided by the reporter. Treatment medications were not provided by the reporter. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death" "1486071-1" "1486071-1" "daily fever of 103.3, cough, diarrhea, chest pain, SOB, sore throat" "1486583-1" "1486583-1" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486590-1" "1486590-1" "Systemic: Patient was found at home passed away. no autopsy was performed to determine cause of death-Severe, Additional Details: Patient received his vaccine from our pharmacy. He waited for 15 minutes after vaccine and no adverse effects were reported. Niece states he went home and was found passed away in his room two hours later" "1486784-1" "1486784-1" "Lower extremity deep vein thromboses, pulmonary thromboses, cerebral thromboses and hemorrhage, death" "1486808-1" "1486808-1" "death N17.9 - Acute renal failure, unspecified acute renal failure" "1486814-1" "1486814-1" "Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine." "1486815-1" "1486815-1" "Death. Body was found and pronounced dead on 6/14/2021. It is assumed he died on 6/4/2021 as body was badly decomposed at time he was pronounced dead." "1486852-1" "1486852-1" "4/14/21 became confused and had cardiac arrest with seizure EMS called 1757 was taken to 2 hospitals with multiple resuscitation efforts and defibrillations declared deceased 0042 4/15/2021" "1486859-1" "1486859-1" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486881-1" "1486881-1" "Moderna COVID-19 Vaccine EUA Patient received two doses of Moderna Vaccine at a Facility on the reported dates of 3/16/21 and 4/14/21. On 7/5/21 patient presented to ED with complaints of breathing difficulties and was diagnosed with multifocal pneumonia and COVID Positive with symptom onset of 7/1/21. Patient subsequently developed acute renal failure.Patient expired on 7/19/21 from complications of acute hypoxic respiratory failure due to COVID-19." "1486995-1" "1486995-1" "Shortness of breath, fatigue, body aches, cough, diarrhea, nausea. Supplemental nasal cannula O2, labs, VBG, D-Dimer, chest imaging, COVID-19 test. Low probability of pulmonary embolism; CXR- bilateral hazy opacities on wet read; dexamethasone" "1487226-1" "1487226-1" "Patient passed away on 07/02/2021" "1487263-1" "1487263-1" "Patient passed away on 06/03/2021" "1487270-1" "1487270-1" "Patient passed away on 07/09/2021" "1487285-1" "1487285-1" "Patient passed away on 07/12/2021" "1487290-1" "1487290-1" "Patient passed away on 06/25/2021" "1487364-1" "1487364-1" "patient went on hospice 7/16/21 and expired 7/17/21 developed sudden neuro degenerative disease unspecified with paralysis of lower extremities first then arms, neck and complained of shortness of breath, swelling left and then progressive swelling" "1487409-1" "1487409-1" "Pt admitted to inpatient rehab hospital following a stroke with PMH significant for hypertension and hyperlipidemia. She had multiple cardiac arrests secondary to massive pulmonary embolism and right ventricular failure. Patient expired on 5/20/2021 upon chart review it was identified patient had received J&J vaccine on 4/7/2021." "1487416-1" "1487416-1" "The patient expired 7/15/2021 under Hospice care." "1487432-1" "1487432-1" "Patient passed away on 07/09/2021" "1487451-1" "1487451-1" "Patient passed away on 06/10/2021." "1488518-1" "1488518-1" ""Patient received first Moderna vaccine on April 28th. Did not complain of any adverse effects. Patient received second Moderna vaccine on May 26th at approximately 11am. Spoke to son at 11pm that night and reported that she felt fine, her arm felt fine, the only complaint was ""mouth feels funky"" and she felt dehydrated. Was in typical spirits. She passed on May 27th. Time of death cannot be confirmed as an autopsy was not completed but the assumption is between 6-9am. This would have been less than 24 hours after she received the second vaccine."" "1489603-1" "1489603-1" "Fluid in lungs; Lethargic after second vaccine; disoriented/confusion; Dehydration; Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), DEHYDRATION (Dehydration), PULMONARY OEDEMA (Fluid in lungs), LETHARGY (Lethargic after second vaccine) and DISORIENTATION (disoriented/confusion) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 024M20A) for COVID-19 vaccination. Concurrent medical conditions included COPD since 06-Jan-2021. Concomitant products included PREDNISONE from 10-May-2020 to an unknown date for Bullous pemphigoid, ROSUVASTATIN CALCIUM (CRESTOR) and ACETYLSALICYLIC ACID, DIPYRIDAMOLE (AGGRENOX) for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced DEHYDRATION (Dehydration) (seriousness criterion hospitalization), LETHARGY (Lethargic after second vaccine) (seriousness criterion hospitalization) and DISORIENTATION (disoriented/confusion) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY OEDEMA (Fluid in lungs) (seriousness criteria hospitalization and medically significant). The patient died on 26-Jun-2021. The cause of death was not reported. An autopsy was not performed. At the time of death, DEHYDRATION (Dehydration), LETHARGY (Lethargic after second vaccine) and DISORIENTATION (disoriented/confusion) had resolved and PULMONARY OEDEMA (Fluid in lungs) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. After 2nd vaccine 09-apr-2021, 36 hrs later (name) Lethargic, Disorientated ems to hospital. Some dehydration, fluids, than he has fluid in lungs. 8 days hospital. Never the some after discharged 4/19/21. (name) declined until his DEATH on 26-Jun-2021. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-042828 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death" "1490255-1" "1490255-1" "Family reported patient had increased seizures after receiving vaccines. No documented hx of seizures prior to vaccines." "1490310-1" "1490310-1" "2 mini heart attacks the night of 4/3/2021, major heart attack morning of 4/4/2021 which lead to her death." "1490373-1" "1490373-1" "Within 24 hours of taking the vaccine my mom was very sick. She could not get out of bed and didn't leave her room for two days. She was shaking hard as if she was cold and could barely talk." "1490419-1" "1490419-1" "Pain in upper abdomen, sudden cardiac arrest on 5/3/21" "1490478-1" "1490478-1" "She received her first COVID vaccine on 1-13-21 and her second on on 2-3-21. She was hospitalized for shortness of breath and multiple subsegmental pulomnary emboli without acute cor pulmonnale. Other active hospital problems were: acute hypoxemic respiratory failure due to CVOID-19, acute kidney injury, lower limb ischemia. Patient was admitted to the hospital on 6-22-21 and tested positive for COVID-19 on 6-30-21. Patient was put on comfort measures on 7-9-21 and died at the facility on 7-12-21." "1490511-1" "1490511-1" "Family notes patient started to have issues controlling blood glucose levels, prior to day of event patient had syncope episodes. 7/21/2021 patient had sudden cardiac arrest." "1490520-1" "1490520-1" "Patient presented with fatigue and SOB starting about a week after vaccination. Was admitted to hospital SOB. No evidence of TTS. Progressive ARDS and death in 2 weeks after admission. Microbiology negative. No aetiology identified." "1490551-1" "1490551-1" "UNKNOWN COVID-19 vaccine was administered within the community on the same day patient expired. Family might have this information. Was not shared with us." "1490566-1" "1490566-1" "Non stop hiccups, fatigue, coughing, raspy voice" "1490599-1" "1490599-1" "30 days after receiving the vaccination, patient passed away due to blood clots and being sepsis." "1490662-1" "1490662-1" ""Office of the Regulatory Authority reported to the Dept. of Health that this patient had a ""sudden collapse witnessed by a friend"" approximately one hour after receiving vaccine. Notified in March. At that time no VAERS reports found or noted by CDC. As of today, no VAERS received from CDC for this patient so submitting the limited information available. Final findings were released on 7/18/21 (decided on 7/16/21) were: ""CAUSE A: Anaphylaxis CAUSE B: Status post COVID vaccination Should you have any questions about this case please contact Dr. Please note he is leaving state service at the end of this month."""" "1490902-1" "1490902-1" ""Pfizer COVID vaccine dose #2 administered 15 Jul 2021 @ 07:59. ED physician documentation on 19 Jul 2021: ""37-year-old female came the emergency department after found down by her husband. Has a history of attempted overdose in the past,, she was found down by her husband at 545, and unresponsive on scene. Medic was on scene and patient was noted to be in V. fib and therefore CPR was started, compressions were in progress upon arrival, however the patient remained in cardiac arrest. Other history was able to be gathered from the patient or family, however EMS stated that they had found that her glucose was 99 on scene, and she been given full dose Narcan as well on scene. And was shocked 3 times a 200 J, she was given 2 doses of epinephrine, as well as 300 of amiodarone. They attempted to intubate the patient however the patient was clamped down, and therefore they could not pass any sort of apparatus to control the airway, therefore they placed a nasal trumpet. Pertinent physical exam findings: Jaw clamped shut, pupils fixed, and was obviously cyanotic, no palpable pulses. No chest rise. EKG as interpreted by me (ED attending): Monitor showed that the patient was in asystole the entire time. Medical Decision making and plan of care: Patient was immediately moved from gurney onto bed, and chest compressions were continued without interruption. Given that the patient was in V. fib in the field, we did decide to place dual pads for dual sequential defibrillation, is on the plats however, the patient was noted to be in asystole, therefore chest compressions were continued, epinephrine, as well as calcium, as well as bicarb. See code chart for further details. IO was also placed in the patient's left proximal tibia. Regarding the patient's airway, several attempts were made to pass an ET tube, as well as paralyzed the patient with rocuronium, however tube passing was unsuccessful, and therefore I performed a cricothyrotomy. Followed by bilateral finger thoracostomies. See procedure notes below for further details. Despite 5 rounds of ACLS, with multiple doses of epinephrine, as well as bicarb and calcium carbonate administered, the patient remained in cardiac arrest, death was declared at 1851."""" "1490927-1" "1490927-1" "Patient presented to hospital with acute hypoxemic resp failure. Pt had history of COVID19 infection in Nov 2020. Pt has chronic medical conditional including but not limited to marginal zone lymphoma on chemo, h/o aspergillus, MAC on atovoqone and voriconazole. Pt received moderna vaccine in May (1st shot), and June (2nd shot). Pt admitted on 7/16 found to have positive covid infection second time. Pt resp status steadily worsen from NC to reservoir, and then HFNC. Despite on remdesivir, prednisone, antibiotics, and antifungal. Pt had code blue due to resp arrest, intubated, then coded again in ICU for over 1 hour. Family elevated make patient DNR, and she died soon after on 7/20." "1490965-1" "1490965-1" "Resident was vaccinated. Pt was admitted on 6/28 with dx of pneumonia, cdiff and sepsis. On admission pt noted to have dry cough and lethargy. Pt had signs of aspiration and dyspnea and was sent to ED for evaluation within five hours of admission to Beecher Manor. She was treated for aspiration pneumonia w/diagnosis of pneumonitis r/t food and vomit. She was re-admitted to Beecher Manor on 7/3 with orders for Augmentin PO 7/4 - 7/9. She continued to decline w/plans by family to begin Hospice care. She expired during process of initiating hospice care." "1490980-1" "1490980-1" "Steady decline under hospice care which began 1/4/2021 r/t CVA hx. Mild improvment at times with consistent decline throughout until expiration 7/15/21 at facility." "1491016-1" "1491016-1" "Admitted 4/1/2021 and discharged to Sunrise assisted living 5/14/21. Return admission to Hospital from hospital 7/17/21 w/dx R femur fracture under Hospice Comfort Care for end of life. Expired at facility 7/18/21 at hospital." "1491031-1" "1491031-1" "Stable at time of vaccine 1/15/21 and 2/5/21, Transferred to ER for pocketing food, Left facial drooping and left sided weakness on 7/4/21. Returned from hospital 7/14/21 w/gastrostomy nutritional status and hospice care. She expired w/end of life hospice care in place on 7/15/21." "1491638-1" "1491638-1" "Stroke. Death." "1491659-1" "1491659-1" "Blood clots, strokes, death I believe that there were subtle unrecognized signs starting in March - off balance, slurred speech, confusion- thought to be diabetes related. I would have her check her sugar and it would be fine, but I dismissed it as a good thing that her sugar was ok. It didn?t cross my mind until the major strokes that it could be related to the vaccine. She had major strokes in May as a result of blood clots in heart and head. I strongly believe that her death is related to the vaccine. She was well, and had her diabetes under control, and three months after getting the vaccine, she was dead." "1491868-1" "1491868-1" "alphasia , ..March 4 March 18....MRI, CT SCAN, EKG.... brain tumors March 23....Crainiotomy Brain Cancer" "1493251-1" "1493251-1" "states her husband died 5 months ago with the second shot, after he had his second shot in 5 days; This is a spontaneous report from a contactable consumer (patient wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 02Feb2021 as dose 2, single for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The reporter stated that on 05Feb2021, her husband died 5 months ago with the second shot, after he had his second shot in 5 days and reporter confirmed that her husband had the Pfizer Covid-19 vaccine. She stated that her husband was in the hospice before that, he died a little bit over 5 months. Reporter stated she was a nursing student and said no to completing a report, by saying that her husband was gone, he died but because she looked at the medical statement that the Medicare paid for him the first time $35 and the second time $35 but she sees he took the second shot on 02Feb2021 and he died on 05Feb2021. He was in the emergency right after the shot, she thought, on the same day he had the shot on 02Feb2021 and he died in the hospital, but he was in the nursing home facility paid for seven months and hospice for seven months. She stated they wouldn't let her visit him and she was not able to visit him for a while before he died. The patient died on 05Feb2021. Cause of death was not provided. The outcome of event was fatal. Information on Lot/Batch information has been requested.; Reported Cause(s) of Death: states her husband died 5 months ago with the second shot, after he had his second shot in 5 days" "1493419-1" "1493419-1" "Pt. Passed away in her sleep at night following receiving her 2nd Covid vaccination earlier in the day." "1493615-1" "1493615-1" ""He had Covid 19 on Thanksgiving 2020 and recovered fully. Even though he now had natural antibodies, his Doctor convinced him that he needed the so called Covid 19 vaccine ""mRNA gene therapy"". On 04/29/2021, he was injected with the so called vaccine and that was the beginning of the end. On 05/10/2021, he was admitted to the Hospital with irregular heartbeat and trouble breathing. The Hospital could not get him stabilized so they transported him to another Hospital. He was there a couple of weeks or so and was now having issues with his kidneys and liver. It appeared the spike proteins had started to battle the rest of his viable organs. The hospital had to transport him to a nursing home facility because his number of days in the hospital per insurance had run out. Then on the evening of 06/13 or 14/ 2021, he became violently ill. He was taken to hospital again and was subsequently transferred back to another Hospital. The Spike proteins had now gone into overdrive attacking all his major organs. His liver, kidneys, lungs and heart were being attacked by the spike proteins created by this deadly vaccine. He was put on 24 hour dialysis and then had to be put on a ventilator. He died 06/24/2021."" "1493712-1" "1493712-1" "90 y.o. Nursing home resident with comorbidities including oxygen dependent CHF with gradual declining course prior to 1st dose of COVID 19 Moderna vaccine died 12 days after receiving 2nd dose. Resident experienced increased dyspnea and hypoxia 5 days after receiving 2nd dose." "1493717-1" "1493717-1" "Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine." "1493805-1" "1493805-1" "Patient began vomiting and medications could not control it" "1494078-1" "1494078-1" "PRESENTED TO THE HOSPITAL EMERGENCY DEPT. WITH HYPOTENSION AND RAPID HEART RATE" "1494091-1" "1494091-1" "Patient was admitted to medical facility on 7-12-21. She had fever, chills, nausea/vomiting, fatigue, shortness of breath, diarrhea, and light headed" "1494168-1" "1494168-1" "Fatigue, body aches, initially, June 29, 30th. Then fever and respiratory difficulty July 6 and 7th. Cough on July 8th, then labored breathing on July 10th, went to the ED." "1494294-1" "1494294-1" "Approximately 24 hours after receiving the first dose of the COVID vaccine, patient fell ill with extreme tiredness, profuse vomiting and loss of consciousness. Patient never regained consciousness, pronounced brain dead after AVM rupture and died on 3/8/21." "1494343-1" "1494343-1" "Started with suspected seizure onset after 3/10/21 covid vaccine and subsequently deceased of unclear etiology on 7/12/21. Family is concerned it is covid vaccine related." "1496326-1" "1496326-1" "Pt died 15 days post vaccine admin without prior medical history." "1497990-1" "1497990-1" "Death" "1498061-1" "1498061-1" "The patient expired 07/17/2021." "1498078-1" "1498078-1" "He passed away in the bathroom very suddenly. Never had any medical issues." "1498080-1" "1498080-1" "7/22/2021 Child collapsed on soccer field while playing soccer at a local camp. CPR was initiated immediately. EMS arrived and found patient in vtac. Shock x 5. ACLS, intubation attempted. Transported to Medical Center. Patient had covid in April 2021. Dx in May 2021 hypertrophic cardiomyopathy. Started on lopressor 25mg BID. Patient had reported to parents that he had not recently taken his medications. Patient had his second covid vaccine on Sunday 7/18/2021." "1498083-1" "1498083-1" "The patient expired on 07/22/2021." "1498124-1" "1498124-1" "Patient died due to COVID-19. Patient was fully vaccinated." "1498141-1" "1498141-1" "Patient died due to COVID-19. Patient was fully vaccinated." "1498209-1" "1498209-1" "Per family had progressive decline post vaccination with agitation. Significantly worse than prior baseline. He was hospitalized and transitioned to inpatient hospice. Time/Date of death 7/22/21 at 23:03pm" "1498269-1" "1498269-1" "Patient hospitalized and died due to COVID after being vaccinated." "1498450-1" "1498450-1" "Atrial Fibrillation resulting in death July 8, 2021" "1498879-1" "1498879-1" "Bilateral retinal branch vein occlusions 1 month after. Died 5/7/21" "1499484-1" "1499484-1" "Completed 2nd COVID-19 vaccine March 16, 2021 - On May 13, 2021, he had massive pulmonary embolism resulting in cardiac arrest. Pulmonary embolism occluded pulmonary arteries to both lungs." "1500185-1" "1500185-1" "My mother passed away 3 days after jab on July 4, 2021" "1500607-1" "1500607-1" "Heart Failure; troubled breathing; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Heart Failure) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COPD since an unknown date and Arteriosclerosis since an unknown date. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DYSPNOEA (troubled breathing). On an unknown date, the patient experienced CARDIAC FAILURE (Heart Failure) (seriousness criteria death and medically significant). The patient died on 29-May-2021. The reported cause of death was Chronic obstructive pulmonary disease, Heart failure and Atherosclerosis. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (troubled breathing) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No concomitant product information was provided. No treatment information was provided. This is a 66-year-old male patient who experienced CARDIAC FAILURE and died 30 days after receiving mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unknown). Patient had a concurrent CHRONIC OBSTRUCTIVE PULMONARY DISEASE, and ARTERIOSCLEROSIS. It is unlikely, that the events are related to the vaccine based on long standing illness of COPD and Arteriosclerosis. Very limited information has been reported at this time. Further information is expected.; Sender's Comments: This is a 66-year-old male patient who experienced CARDIAC FAILURE and died 30 days after receiving mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unknown). Patient had a concurrent CHRONIC OBSTRUCTIVE PULMONARY DISEASE, and ARTERIOSCLEROSIS. It is unlikely, that the events are related to the vaccine based on long standing illness of COPD and Arteriosclerosis. Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: Chronic Obstructive Pulmonary Disease; Heart Failure; Atherosclerosis" "1500614-1" "1500614-1" "myocardial infarction; Fluid; Shortness of breath; Chest pain; This is a spontaneous report from a contactable nurse (patient's wife). A 64-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0180), via an unspecified route of administration, administered in left arm on 11Jun2021 10:00 (64-year-old at time of vaccination) as single dose for COVID-19 immunization. The patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. There was no family medical history relevant to adverse event. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0186), via an unspecified route of administration, administered in left arm on 21May2021 (64-year-old at time of vaccination) for COVID-19 immunization. There were no vaccines administered on same date with the Pfizer vaccine considered as suspect. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced chest pain on 17Jun2021, fluid and shortness of breath on 25Jun2021, and myocardial infarction on an unspecified date. Patient's wife (a registered nurse, recently retired) just wanted to report this. She can't say that it is the vaccine or anything. Her husband received the second COVID-19 Vaccine on 11Jun2021 and he died at the emergency room 2 weeks later of a cardiac event. She couldn't do the report online because it was making her the one she was reporting on. Chest pain: She took him to the emergency room on 25Jun2021. He had been having chest pain that he reported to her that Monday before. He told her that it actually started the Thursday before on 17Jun2021. He had some chest pain that felt a little better over the weekend, then Monday it was worse. He wasn't a complainer, but he was obviously having chest pain. He was very stubborn and so he just kind of let it progress and it got worse during the week. He wouldn't go to the doctor. She kept telling him she read about myocarditis mostly with adolescent males. She thought what if it is something like that. Time of Onset of Chest pain: He reported it on Monday that he had chest pain on Thursday. She became aware when he woke up at 06:30 on 21Jun2021 and she knew something was wrong when he went for the Ibuprofen. Fluid and shortness of breath: The day she took him to the emergency room the chest pain had worsened and he had fluid and shortness of breath. The fluid and shortness of breath started on 25Jun2021. Death: He died on 25Jun2021. The cause of death was a myocardial infarction. They didn't do an autopsy. The reason they gave for not being able to do an autopsy was they were overwhelmed with drug overdoses and homicides. Indication for COVID-19 Vaccine: He didn't want it, but he needed to go back to the office and didn't want to wear a mask. Adverse events required a visit to emergency room. Investigations: She doesn't have his medical records yet. Essentially they were recording him. She can't believe she got him in in a wheelchair. Immediately they were doing resuscitation efforts. Relevant Tests was reported as none. The outcome of myocardial infarction was fatal; outcome of other events was unknown. The patient died on 25Jun2021. No autopsy was performed. The cause of death was a myocardial infarction. Causality: the reporting nurse has no opinion. She just thinks that the patient didn't randomly die any of his other 64 years. It may be a coincidence.; Sender's Comments: The event myocardial infarction with fatal outcome is considered unrelated to suspect product (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0180). The compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity may explain as alternative cause.; Reported Cause(s) of Death: Myocardial infarction" "1500649-1" "1500649-1" "Hernia; Shortness of breath; Lightheaded; losing weight; appetite had decreased; itching; Heart attack; He had a bad case of shingles and needed something for nerve pain, the nerve pain was bad.; Shingles; They put tegaderm on his stomach and he developed blisters.; Rash on his arms and legs; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, administered in Arm Left on 16Feb2021 at age of 67 years old (Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cholesterol and Hernia. Concomitant product included ongoing ASPIRIN [ACETYLSALICYLIC ACID] at 81mg tablet once a day by mouth given his age to help from getting blood clots. None additional vaccines administered on same date of the Pfizer suspect. None prior Vaccinations within 4 weeks. He did not have high blood pressure and was not a diabetic. The only thing he took was an aspirin and cholesterol pill and his cholesterol was better than hers, she does not know the name of the cholesterol pill he took, states it begins with r, unknown dose, and he took half a pill once a day by mouth, every night. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at age of 67 years old at as DOSE 1, SINGLE (Lot: EL8982) for covid-19 immunisation and experienced Shingles. After he got the second dose, he developed a rash on 20Feb2021 on his arms and legs. He went to the doctor and they gave him a steroid and something for itching. He did not think anything about the shot. On 25Mar2021 he had hernia surgery done and they put tegaderm on his stomach and he developed blisters. He had about 12 blisters on his stomach. He has had tegaderm dressings in the past and never broke out. He developed shingles on 22Apr2021. He had a heart attack and died 15May2021. No autopsy done. She had to do CPR on him at home. She is looking for answers. Her husband complained of shortness of breath and being lightheaded. She met a younger man that also developed shingles after the Pfizer covid vaccine. Her husband had a lot more shingles compared to the young man. Her husband had shingles that looked like clusters. Her husbands shingles was terrible and she has pictures of that. Her husband was doing fine before he took the shot. She knows the shot has caused people to get shingles, have heart attacks and all other stuff. She is not going to ask if it can happen, because she knows it can. She mentions something about a family member that put it in and something in regards to things happening after the shot but she did not provide further clarification. He started losing weight after the shot. He was normally 168 lbs and died at about 158 lbs. His appetite had decreased. She had to get him off the bed and put him on the floor to do cpr. Reports his shingles had cleared up on 6May2021 and they were scabbed up but he was left with severe pain. He called the doctor the Monday before he died and told him that he had a bad case of shingles and needed something for nerve pain, the nerve pain was bad. The doctor sent him medicine and the medication came in the day he died, and never took the medication. He died that Saturday and she has his death certificate that states the cause of death . The paramedics tried cpr as well. AEs require a visit Emergency Room. No physician office. Outcome of the event Heart attack was fatal. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest" "1500722-1" "1500722-1" "Death" "1500766-1" "1500766-1" "Loss of balance, loss of memory, blood clots, hospitalization, brain surgery, death" "1500781-1" "1500781-1" "Heart trouble. Death" "1500834-1" "1500834-1" "She got very sick, was already not feeling well before vaccine. She died may 15, 2021." "1500862-1" "1500862-1" "On first day, patient was feeling tired, dizzy and foggy and 18 hours later was found dead on the floor." "1501086-1" "1501086-1" "Day 8 following 2nd Moderna vaccine shot, patient began experiencing heaviness, dull pain in chest. She layed down which seemed to help alleviate the chest issues. Day 10 after receiving the second Moderna shot, patient died suddenly while sitting in her recliner of cardiac arrest. There were no symptom s leading up to the event." "1501182-1" "1501182-1" "Suicide" "1501721-1" "1501721-1" "Death after 2 1/2 weeks. Received 2nd shot on 6/21/21 and died on July 9, 2021." "1501811-1" "1501811-1" "Day of injection patient was experiencing fever and chills, also had sore arm. 2 days after the injection the patient was found dead" "1501814-1" "1501814-1" "After 2nd vaccination - patient was having trouble breathing whenever she worked out in the yard doing minor task such as raking leaves/gumballs. She had 3 or more episodes of feeling light-headed and stopping activity and walking into living room and sitting. Was able to catch breath and didn't want to go to hospital in any of these cases. However on March 8 at 3pm, she felt light-headed but on her way back to her living room, her breathing was disrupted. Her breaths were cut short and she was not receiving much air into her lungs. The breaths were shorter and shorter until she wasn't receiving hardly any air into her lungs. Her face turned blue. She passed out. She had CPR administered about 30 seconds after passing out. Ambulance arrived about 1 minute after passing out. EMT crew worked on her for 18 minutes and was ready to contact coroner when they got a heartbeat. She was taken to hospital on March 8. She was transferred to another hospital later than night. She was sent home for hospice (still unconscious) on March 16 or 17. She passed morning of March 19. Death certificate states cause of death was lack of oxygen to the brain, but no determination was made to what caused her breathing problems, which caused the lack of oxygen to her brain. EMT crew said her symptoms were very similar to blood clot in lungs. Hospital ruled out a blood clot. They also downloaded data from the pacemaker and ruled out A-Fib as the cause. Pacemaker data had indicated a mild event around 3pm on March 8 and sent a shock to her heart but nothing unusual. I believe the hospital also ruled out another cause or two, but never did determine the cause." "1501826-1" "1501826-1" "7/4/2021: Patient transferred from Hosptial after presenting with generalized weakness, cough, shortness of breath and blood in the urine. Patient tested positive for COVID on 7/3/2021. Diagnosed with acute bilateral pneumonia secondary to COVID-19, acute hypoxic resp failure, severe ARDS, acute metabolic encephalopathy, AKI. intubated in the ICU. Note: patient fully vaccinated with Moderna COVID-19 vaccine. 7.25.21: patient died." "1501871-1" "1501871-1" "COVID-19 Breakthrough disease which possibly resulted in death. Patient was fully vaccinated and was COVID-19 positive at time of death. Patient had symptom of cough that began 7/17/2021; the patient died on 07/20/2021. Patient tested positive for COVID-19 on 7/20/2021 at the long-term care facility at which they were a resident. I do not have death certificate details available at this time." "1501996-1" "1501996-1" "Pt Recieved firts Pfizer covid shot on May 7 , ( Shot was given at Pharmacy ) over the next week, not feeling well, body aches, headache, ect. by the started felling better on the 15th of May , then took a turn for the worse. On the 18th, hypodermic Temp 95, severe dyspnea on May 19th. Pt was checked into Medical Center, on the 19th May. A Lymphnode on his Clavicle was found and was found to have lymphoma. Also, his Sister, believes that he had his second Pfizer Covid shot on May 20. and that he tested pos for Covid. He was sent home on the 4th of June. He came back to my emergency room on the 10th of June for respiratory failue., was intubated and sent to the ICU where he expired on June 24." "1502013-1" "1502013-1" "developed COVID after vaccine, sx onset 4/21/21, hospitalized 4/24-4/27, treated with remdesivir and steroids, improved, then readmitted 5/2/21 with respiratory failure, required ICU admission 5/21/21, intubated, PEA arrest, passed away 5/24/21." "1502028-1" "1502028-1" "ADMITTED TO HOSPITAL AND SUBSEQUESTLY DIED" "1502042-1" "1502042-1" "Death 7/25/21 N17.9 - AKI (acute kidney injury) K92.2 - Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type" "1502047-1" "1502047-1" "Patient found deceased in her bed on june 12, 2021, reported to Strongsville Police Department at 10:15am., taken to Cuyahoga Medical Examiner's Office the same day. Autopsy done. Results still pending for 4-5 months." "1502051-1" "1502051-1" "Death R65.10 - SIRS (systemic inflammatory response syndrome)" "1502062-1" "1502062-1" "death E87.1 - Hyponatremia J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia D69.6 - Thrombocytopenia, unspecified" "1502067-1" "1502067-1" "death J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified" "1502072-1" "1502072-1" "death J18.9 - Pneumonia, unspecified organism K92.2 - Gastrointestinal hemorrhage, unspecified N17.9 - Acute kidney failure, unspecified" "1502098-1" "1502098-1" "death D69.6 - Thrombocytopenia, unspecified N93.9 - Vaginal bleeding JAUNDICE BLOATED SHORTNESS OF BREATH" "1502104-1" "1502104-1" "death Thrombocytopenia ORAL SWELLING FEVER" "1502131-1" "1502131-1" "death N17.9 - Acute kidney failure, unspecified D69.6 - Thrombocytopenia, unspecified chest pain" "1502145-1" "1502145-1" "death N17.9 - Acute renal injury J18.9 - Multifocal pneumonia" "1502153-1" "1502153-1" "death Focal seizure Subdural bleeding Acute kidney failure, unspecified Unspecified convulsions" "1502205-1" "1502205-1" "Death. Last known May 19, 2021. Found May 25, 2021" "1502233-1" "1502233-1" "Received Pfizer vaccines on 2/19/21, 3/16/21. Tested positive for COVID-19 on 7/10/21. Symptoms began on 7/6/21 w/ cough, dysgeusia, fatigue. Hospitalized on 7/13/21; transferred to ICU on 7/22/21. Patient expired on 7/25/21 due to pneumonia d/t COVID-19. Patient was intubated; given dexamethasone 6 mg x9 d, 5 day course of remdesivir, one dose of tocilizumab for COVID pneumonia. PMH significant for past medical history significant for pulmonary sarcoidosis, on prednisone 5 mg daily; immune thrombocytopenic purpura, on rituximab." "1502277-1" "1502277-1" "positive for COVID-19 4 months after receiving vaccine and died" "1502285-1" "1502285-1" "death - Gastrointestinal hemorrhage, unspecified - Acute kidney failure, unspecified" "1502302-1" "1502302-1" "tested positive and died after being fully vaccinated" "1503303-1" "1503303-1" "4 days after her second shot, she was sitting at the lunch table and she became unresponsive. She went into a coma and died 4 days later. Doctor said she had a stroke." "1503509-1" "1503509-1" "after first vaccine was given 4/08, patient became very weak, tired and slept almost the entire 3 weeks, when it was time to take the second dose, on 4/29 she drove herself to the hospital, got the shot and went home, that evening she becan to feel very weak and fell down, calling an ambulance for help, the following day, she fell down once again, called 911 and got help getting to her feet, she began to realize her body was too weak to carry herself and when she fell the 3rd time called 911 and asked to go to the hospital. arriving she was immediately give blood transfusions, being told her kidneys had somehow gotten much much worse out of no where and they were no longer producing red blood cells properly, within the first week she was in the hospital, she was given 4 total blood transfusions and was told her heart was not functioning properly, There were elevated enzymes. She was beginning to bloat as her kidneys were not working at all anymore, she was no longer urinating. she was scheduled to have a dialysis port put in and she started dialysis. she was given medication and was sent to a rehab facility for a few weeks where she made no progress at all, she was still weak and unable to walk. due to her inability to walk she was sent home from the rehab, our family had to rally around her to help keep her clean, no bed was sent to us, no commode, we had to find money for all of these things, she quickly got bed sores and we tried all we could do to care for her with little help there was home health coming to see her twice a week, and we repeatedly asked if someone could look into the vaccine doing this to her no one cared to hear our suspicions of the vaccine doing this to our mother, she went to the dialysis clinic 3 times a week all the while paying for her own 800 dollar a week gurney transportation due to her inability to walk, on july 15th she finally got to see her dr, upon taking her vital signs they found no pulse, no blood pressure and no pulse ox but the dr did not seem to think this was a good reason to go to the hospital. we asked if the vaccine did this to her, the dr laughed it off, she went back home and was very tired, she went to sleep and the next morning when my father tried to wake her up for dialysis, she would not wake, 911 was called and she was once again rushed to the hospital, where her heart stopped within minutes of arriving.we asked the people in the ER if there was anyway we could talk to someone about the vaccine doing this to her. our mother is dead!! we were advised to call the health department, they told us to call the cdc, and i was directed to the compensation fund" "1505241-1" "1505241-1" "Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Likely comorbidities that were related to death were adenocarcinoma and possible stroke symptoms." "1505244-1" "1505244-1" "Death 7-23-21" "1505250-1" "1505250-1" "patient arrived in ventricular tachycardia via EMS, but responsive. deteoriarated to pulseless ventricular tachycardia, PEA and ultimately death." "1505279-1" "1505279-1" "Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Likely comorbidities that were related to death was End Stage Renal Disease" "1505319-1" "1505319-1" "Cause of death not documented. Significant comorbidities include dementia with neuropsychiatric behaviors including anxiety." "1505323-1" "1505323-1" "positive covid infection after vaccination" "1505461-1" "1505461-1" "Patient presented to the ED and was subsequently hospitalized for hepatic encephalopathy within 6 weeks of receiving COVID vaccination. She died on 7/9/2021." "1505466-1" "1505466-1" "Death within a few days of second dose of Pfizer COVID-19 vaccine" "1505509-1" "1505509-1" "Patient is deceased." "1505518-1" "1505518-1" "Patient was fully vaccinated in February, admitted to acute care hospital, positive for COVID19 in July. Patient diagnosed with COVID pneumonia, completed treatment, was considered recovered from COVID. Patient while still in acute care expired on 7/26/2021" "1505528-1" "1505528-1" "Discovered patient passed away within 30 days from vaccine" "1505530-1" "1505530-1" "Patient presented to the ED and was subsequently hospitalized with closed displaced fracture of shaft of left femur. He died on 06/27/2021" "1505544-1" "1505544-1" "patient passed away" "1505591-1" "1505591-1" "Soreness in the arm at sight. Tumors started coming back daily in his stomach, sides and back outside the rib cage. Looked like big hard masses. Cancer was in remission for about 6 months and aggressively came back after taking the 2cnd vaccine." "1505764-1" "1505764-1" "Patient hospitalized due to COVID-19. Patient died. Patient was fully vaccinated." "1505902-1" "1505902-1" "Resident was fully vaccinated. Tested positive for covid on 7/2/2021. Had two subsequent covid tests which were negative. Did pass away on 7/24/2021 but not from covid." "1505922-1" "1505922-1" "Pt passed away on 07/26/2021." "1505970-1" "1505970-1" "Patient hospitalized and died due to COVID-19 after being fully vaccinated." "1506767-1" "1506767-1" "Death" "1507866-1" "1507866-1" "Aortic Dissection hemostatic shock; Anaphylactic shock; Paralyze in the lower half of her body; Clotting; Excessive bleeding; Burning sensation going down to her spine; Difficulty breathing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock), PARALYSIS (Paralyze in the lower half of her body), THROMBOSIS (Clotting), HAEMORRHAGE (Excessive bleeding), BURNING SENSATION (Burning sensation going down to her spine), DYSPNOEA (Difficulty breathing) and AORTIC DISSECTION (Aortic Dissection hemostatic shock) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054c21a and 009c21a) for COVID-19 vaccination. The patient's past medical history included Open heart surgery on 18-May-2021. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria death, hospitalization and medically significant), PARALYSIS (Paralyze in the lower half of her body) (seriousness criteria death, hospitalization and medically significant), THROMBOSIS (Clotting) (seriousness criteria death, hospitalization and medically significant), HAEMORRHAGE (Excessive bleeding) (seriousness criteria death, hospitalization and medically significant), BURNING SENSATION (Burning sensation going down to her spine) (seriousness criteria death and hospitalization) and DYSPNOEA (Difficulty breathing) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced AORTIC DISSECTION (Aortic Dissection hemostatic shock) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 22-Jun-2021 to 04-Jul-2021 due to ANAPHYLACTIC SHOCK, BURNING SENSATION, DYSPNOEA, HAEMORRHAGE, PARALYSIS and THROMBOSIS. The patient died on 04-Jul-2021. The reported cause of death was aortic dissection hemostatic shock. An autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Blood pressure measurement: decreased (abnormal) Systolic blood pressure <90 mmHg. On 22-Jun-2021, Heart rate: increased (abnormal) Heart rate >100 beats per min. No relevant concomitant medications were reported. Oxygen was given as treatment. She had the second dose on 22JUN2021. 5 hours after the vaccine, she had a burning sensation going down to her spine. Then she was paralyzed in the lower half of her body. She was rush to the local hospital. She was medevac to another hospital. She had clotting and excessive bleeding. She was in the hospital for 13 days. She passed on 04JUL2021 Company comment: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received- Patient demographics, cause of death, lab data, causality and vaccination details updated.; Sender's Comments: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence.; Reported Cause(s) of Death: Aortic Dissection hemostatic shock" "1507895-1" "1507895-1" "Blood clots; strokes; This is a spontaneous report from a contactable consumer. A 81-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FT8886), via an unspecified route of administration, administered in left arm on an unknown date in Feb2021 (at the age of 81-year-old) as dose 2, single dose for COVID-19 immunisation. Medical history included type II diabetes, arthritis and fibromyalgia. Prior to the vaccination, the patient was not diagnosed with COVID. The patient taken other medications in two weeks: insulin shots, prescription pain medications, urine medications and anxiety medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), administered in left arm on an unknown date in Feb2021 (at the age of 81-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. On an unknown date in Apr2021, the patient had blood clots and strokes. The events resulted in emergency room/department or urgent care, hospitalized for 7 days. The patient did not receive any treatment in response to the events. The patient died on 31May2021. An autopsy was not performed. Cause of death was reported as blood clots and strokes. Outcome of the events was fatal. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Blood clots; strokes" "1508935-1" "1508935-1" "Stated that the coroner wrote the cause of death as a blood clot that caused a heart attack.; tired; coughing; sinus infection; throwing up; fever/started running a temperature; Stated that the coroner wrote the cause of death as a blood clot that caused a heart attack.; Stated that she went from her blood being thin to as thick as pancake syrup after the second shot; Patient previously received first dose of Moderna shot; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received BNT162B2 [COVID-19 Vaccine-Manufacturer Unknown; Solution for injection; Lot number: unknown] via an unspecified route in left arm on an unspecified date in Feb2021 as single dose for COVID-19 immunization. Medical history of the patient included renal failure [she had been on dialysis for 5 years before the shot. Stated that she had renal failure before the shot. dialysis blood work done on 16Feb2021] and dialysis. Concomitant medications were not reported. Patient previously received first dose of Moderna shot via an unspecified route on an unspecified date in Jan2021 as single dose for COVID-19 immunization and experienced first shot left arm hurt. On an unspecified date in Feb2021, after receiving second dose of vaccination, patient started running a temperature which lasted for five days. On 14Feb2021, patient experienced coughing, throwing, sinus infection and on 15Feb2021 experienced being tired. Reportedly, four days after receiving second dose of vaccination patient started running temperature. The doctor asked patient to rotate with ibuprofen for a few days and during that time it was 98-104. Patient was given medicine for coughing and Zofran to settle her stomach because she was throwing up, all of this was after the second shot. On Friday, patient went to the doctor and they never drew blood work, but patient had blood work from where she does dialysis. The doctor said it was fine, patient worked 40 hours per week and with dialysis and was told that she was healthy despite renal failure. Patient was told that she would be okay in 3-4 days. Two days later on Sunday night at 20:05 patient passed away. The coroner wrote the cause of death as a blood clot that caused a heart attack. Patient did not have an autopsy done. Patient blood was as thick as pancake syrup. Reporter mentioned that sometimes they would pull the needle on dialysis and it would take 30 minutes to stop the bleeding because her blood was so thin. Patient went from her blood being thin to as thick as pancake syrup after the second shot on an unspecified date in 2021. Reporter said it was odd all of the coughing, throwing up, fever and blood thickening that happened after the second shot was given. Patient had been on dialysis for 5 years before the shot and had renal failure before the shot. Dialysis blood work was done on 16Feb2021. Reporter (patient husband) was very observant of wife and takes care of her. After the second shot patient missed whole a week of work [from 15Feb through 21Feb] and had never missed work. Patient was tired, fever, coughing and throwing up. Reporter believes that the medication caused all of these issues. Patient received treatment in response to the events fever, coughing, sinus infection and throwing up. Outcome of the event blood clot that caused a heart attack was fatal, for fever was recovered/resolved with sequel and for other events were unknown. Information on Lot/Batch information has been requested.; Reported Cause(s) of Death: blood clots leading to heart attack; blood clots leading to heart attack" "1509224-1" "1509224-1" "death I63.9 - Cerebral infarction, unspecified" "1509547-1" "1509547-1" "Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine." "1509613-1" "1509613-1" "Dose #1 Moderna 01/20/2021 Lot # 041L20A Pt died while in the hospital" "1509620-1" "1509620-1" "Dose #1 Moderna 01/21/2021 Lot # 041L20A Pt died while hospitalized" "1509660-1" "1509660-1" "pt developed fever later the day after getting his covid vax so he took ibuprofen and went to bed. Next day he went back to work. Pt showed no symptoms until the month of June when he started complaining about pain in both arms. He was using a heating pad on his shoulders to help with the pain. He was taking Aleve for the pain but it was not helping so he no longer wanted to take it. He had a vomiting episode on the afternoon of June 16th stating he thought he has eaten a bad lemon. He wasn't feeling well the morning of June 18th, 2021 but continued working. He only wanted something light to eat since he didn't feel well and was headed to bed. When his wife went to go to bed she found him collapsed on the bedroom floor with face forward in the bed. She turned him around and found him unresponsive. She contacted 911 and he was taken to Medical Center ER. They were not able to revive him. County conducted an autopsy where they found a blood clot in left artery." "1509756-1" "1509756-1" "Patient was hospitalized and passed away. 2nd vaccine given 4/6/2021" "1509847-1" "1509847-1" "Patient is 88yo old male, received 2nd dose of Pfizer on 4/20/21. Started feeling sick on 5/21/2021, tested positive for covid on 5/21/2021. Potentially exposed at Dialysis Clinic. Admitted to Hospice on 6/3/2021" "1509983-1" "1509983-1" "The patient received the Janssen vaccine on 5-29-21 and had previously well controlled asthma. The patient presented to ED on 6-1-21, 6-13-21, 6-28-21, and 7-19-21 with acute asthma exacerbation. On 7-21-21 the patient was admitted into the ED and later ICU with cardiac arrest related to asthma acerbation and pronounced deceased on 7-25-21. Symptoms: - Wheezing -Shortness of breath - Onset following the day after vaccine administration Treatments: - Albuterol/ipratropium nebulizers - Prednisone -Albuterol inhaler" "1510133-1" "1510133-1" "Patient is a 97 year old female, received first dose on 12/29/21 and second dose on 02/09/2021. Patient had previously tested positive for COVID on 12/07/2020. Patient was living in a long term care facility, when she was sent to ER for abnormal labs, where she again tested positive for COVID on 03/09/21. She did not have any symptoms of COVID. Patient was discharged back to the care facility for hospice care and died on 03/13/21." "1510268-1" "1510268-1" "Patient died." "1510691-1" "1510691-1" "Death; paralyzed before, couldn't breath, tired, weak" "1511092-1" "1511092-1" "Patient began feeling like she was having panic attacks. She was nauseous and went to the ER. ER ran tests including Ct scan, ekg and blood work. All tests came back normal. A couple of hours later patient became delirious and oxygen started to drop. Then patient was intubated at which point she had a major heart attack and died." "1511267-1" "1511267-1" "Within 2 days of second shot, Patient exhibited extreme fatigue. This continued for the next several weeks culminating with the inability to move which resulted in admission to Hospital the week of 2/22/21. After weeks to stabilize vital systems, a diagnosis of multiple myeloma was obtained. Patient continued to decline until multiple organ failure occurred within 30 days of admission. Death occurred on 3/25/21. It is not clear whether the vaccine potentially caused and/or exacerbated a previously undiagnosed condition (multiple myeloma). However, the proximity of an immune cell related cancer which resulted in rapid decline and death within 60 days of vaccination should be noted in case there are any other previously undiagnosed blood cancers being found in newly vaccinated individuals." "1511612-1" "1511612-1" "He passed in his sleep that night.; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (He passed in his sleep that night.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 22-Jul-2021 The patient died on 22-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was given. No treatment information was given. Patient received the 1st dose of the Moderna Covid-19 vaccine. He died in his sleep that night. This a report of dead one day after the first dose of the product in an 52-year-old patient with no comorbidities. Very limited information regarding the event has been provided for inferring causality. Further information is not expected.; Sender's Comments: This a report of dead one day after the first dose of the product in an 52-year-old patient with no comorbidities. Very limited information regarding the event has been provided for inferring causality. Further information is not expected.; Reported Cause(s) of Death: unknown" "1512372-1" "1512372-1" "79 Male received both doses of Pfizer. Developed symptoms - SOA, decreased activity, generalized weakness, decreased P. O. intake. Tested PCR positive 4/26/2021 & serology 4/29/2021. Hospitalized 4/27/2021. Diagnosis at time of death: Hypoxic ARF requiring MV, COVID-19 PNA, rule out superimposed bacterial PNA, renal failure, oliguric, metabolic acidosis. CWP/COPD exacerbation, CAD, DM present on admission" "1512389-1" "1512389-1" "Patient received both doses of the Pfizer COVID vaccine on 01/29/2021 and 02/22/2021. Patient tested positive for COVID on 03/12/2021. She was admitted on 03/14/2021 where she was diagnosed with Covid pneumonia with acute hypoxic respiratory failure. Discharged on 03/18/2021 Nursing & Rehab, where she died on 03/21/2021." "1512405-1" "1512405-1" "74 Male hospital admission for SOA with COVID-19 PNA. PCR positive 2/20/2021 & 3/23/2021. Started on convalescent plasma, remdesivir, Zyvox, meropren. Developed hypoxia with worsening respiratory problems 2/24/2021 & placed on BiPAP. Transferred to ICU - required mechanical ventilation, intubation. 3/19/2021 had tracheostomy & PEG tube. Placed on Rocephin & vancomycin until 4/4/2021 for bactermia developed 3/17/2021. Required CRRT & hemodialysis for worsening renal function. Developed thrombocytopenia. Patient became encephalopathic. 4/4/2021 several rounds of epinephrine given and patient coded." "1512407-1" "1512407-1" "Patient awakened me with 2 deep snoring sounds and then stopped breathing. I began CPR. Fire Dept, Paramedics and Hospital used paddles to get a heart beat but it was unstainable. He was pronounced deceased at the hospital due to a heart attack. He had no previous heart disease diagnosis." "1512416-1" "1512416-1" "Patient tested positive for COVID on 12/16/2020. Patient received both doses of the Pfizer COVID vaccine on 01/14/2021 and 02/04/2021, and again tested positive for COVID on 03/26/2021. She was transferred from outside medical facility to Medical Center on 03/28/2021 due to concerns over new COVID infection and cellulitis. Patient was found unresponsive and not breathing the morning of 03/30/2021 and died at 5:34AM from cardiac arrest." "1512430-1" "1512430-1" "Patient past away." "1512442-1" "1512442-1" "Patient received both doses of the Moderna COVID vaccine on 02/02/2021 and 02/26/2021. Patient tested positive for COVID on 03/25/2021 and was admitted to hospital 03/25/2021 - 04/23/2021. Patient was readmitted on 04/27/2021 for UTI. Patient died on 05/07/2021, suspected cause of death was multi organ failure." "1512493-1" "1512493-1" "She collapsed in her bathroom and her boyfriend immediately began CPR. Paramedics were unable to revive her. Cardiac event." "1512524-1" "1512524-1" "97 Male PCR positive 4/28/2021. Vaccinated with Pfizer 1/6/2021 & 1/28/2021. Hospitalized 4/28/2021- 5/6/2021 for COVID PNA & fatigue, SOA, diarrhea. Placed on Rocephin for UTI. Required more than 4L of oxygen, decreased appetite. Developed hematuria due to Pseudomonas. Transferred. Passed away 5/13/2021." "1512561-1" "1512561-1" "Patient received both doses of the Pfizer vaccine on 2/24/21 and 3/17/21. Patient came to the ER on 5/8/21 with chest pain, where she tested positive for COVID. While patient was receiving a precordial drain she went into V. tach but was successfully resuscitated. She went to ICU but went into cardiopulmonary arrest and died on 5/9/21." "1512612-1" "1512612-1" "92 year female admitted to hospital for fall on 5/24/2021. Unknown exposures in 14 days prior. Pfizer vaccine 2/25/2021 & 3/19/2021. PCR positive 5/24/2021. Transferred to hospice on 29th. Passed on 5/30/2021. Diagnosis at time of death: ARF on chronic with hypoxia, hematoma anterior chest wall left hip and upper thigh, suspected mild heart failure preserved ejection fraction, mechanical fall, delirium, bilateral PNA, pulmonary HTN, acute encephalopathy." "1512619-1" "1512619-1" "COVID-19 positive 7/20/2021. Pt expired at the hospital on 7/24/2021." "1512650-1" "1512650-1" "Patient told family members he received second dose of Pfizer-BioNTech COVID19 vaccine on April 18, 2021. Sheriff's Department contacted next of kin on morning of April 20, 2021 stating that patient had died suddenly on April 19, 2021." "1512688-1" "1512688-1" "4/22/2021 Tested positive for Covid-19 discovered during Universal Swabbing on Specific Unit. Resident was asymptomatic. COVID-19 screening were completed every 4 hours. 5/3/2021 COVID-19 screening revealed runny nose, declining meds and combative. Urine tea colored and foul smelling, Poor PO Intake. 5/4/2021 resident appeared uncomfortable and distressed with increased respiratory rate. Morphine and Ativan given for comfort measures. 5/5/2021 Deceased." "1512695-1" "1512695-1" "death I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)" "1512705-1" "1512705-1" "93 Male vaccinated Pfizer 1/06/2021 & 1/28/2021. Symptom onset 4/30/2021 - SOA, fatigue. Taken to ER 5/10/2021 for blurry vision. Diagnosed with COVID 4/30/2021. Started dexamethasone. Patient claims left eye problems secondary to dexamethasone. Discharged and final diagnosis at time of death 5/24/2021 - COVID-19 with PNA" "1512749-1" "1512749-1" "39 Male tested positive 6/4/2021. Vaccinated with Pfizer 12/22/2021 & 1/12/2021. 6/4/2021 hospital admission for tracheo-esophageal fistula (TEF) transfer from hospital. Diminished breathing sounds, minimally conscious. Removed from ventilator support 6/17/2021. Problems at time of death 6/19/2021 - chronic respiratory failure, COVID-19, history of severe TBI, TEF, trach vent/PEG dependent." "1512824-1" "1512824-1" "Patient hospitalized and died of COVID-19 after being vaccinated." "1512861-1" "1512861-1" "4/22/2021 Tested positive for COVID-19 discovered during Universal Testing on specific Unit. Resident was asymptomatic. COVID-19 screening completed every 4 hours. 4/26/2021 Received therapeutic treatment Etesev-Bam 1400mg IV. 5/2/2021 Developed increased temperature and foul smelling urine. Rocephin 1 Gram given daily on 5/2/2021 and 5/3/2021. 5/4/2021 declining clinical presentation with fatigue. Morphine and ativan started for End Of Line/Comfort Care. 5/10/2021 Continued declining vital signs, fatigue, pain. Deceased on 5/10/2021" "1512863-1" "1512863-1" "Patient hospitalized and died of COVID after being vaccinated." "1512933-1" "1512933-1" "Hospitalized and died due to COVID1-19 after being vaccinated." "1512969-1" "1512969-1" "After the vaccine the pt said she felt like she had the flu. She was tired and sore and achy. And a week later she went to bed and woke her husband up to help her to go the the bathroom, she collapsed on the way and the husband called 911 and was taken to the hospital and the doctor said she had a massive brain bleed, she was put on life support, she passed away five minutes after being taken off of life support." "1513095-1" "1513095-1" "Death. Died on 7-9-21 (approximately 24 hours after vaccine)." "1514458-1" "1514458-1" "heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unk) for COVID-19 vaccination. No Medical History information was reported. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria death and medically significant). The patient died on 22-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medications were reported. No laboratory data was provided. No treatment information was provided. Very limited information regarding this event has been provided at this time. No further information is expected at this time. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: unknown cause of death" "1515049-1" "1515049-1" "My mother developed a neck swollen lymph nodes after the first vaccine. It resolved on its own. After the second vaccine she was diagnosed as having widespread lymphedema. Her doctor reviewed her past medical records that did not show swollen wide spread lymphedema in November of 2020. My mother passed on 7.13.21. While I will never be able to get a medical professional to say the vaccine may have caused the lymphedema . I feel sure I will read of this reverse reaction in the medical journals in the next few years." "1515162-1" "1515162-1" "Patient admitted to hospital on 13/07/21, and to Intensive Care on 14/07/21 for nasal high flow oxygen. He received dexamethasone IV. He was intubated on 24/07/21 following deterioration that day, and was proned. On 26/07/21 he had a chest drain inserted for a pneumothorax, and his endotracheal tube was changed due to a kinked tube. He was also started on antibiotics and antifungals to cover for superimposed infection. He passed away on 27/07/21 following further deterioration and ST elevation on ECG." "1515179-1" "1515179-1" "Patient's death was reported to our facility by a file. Any other information is unknown at this time." "1515338-1" "1515338-1" "7/16/21: patient presented to ED with altered mental status. found to be PCR COVID-19 positive. Patient received J&J COVID-19 vaccine on 4/5/21. Diagnosed with septic shock secondary to bacteremia and UTI, acute hypoxic and hypercapnic resp failure requiring mechanical ventilation, resp metabolic acidosis, COVID-19 infection. 7/20/2021: Patient expired" "1515405-1" "1515405-1" "Pt found unresponsive at home and confused. Enroute to hospital by EMS, pt respiratory arrested. ROSC was achieved. Pt cardiac arrested 2nd time, with ROSC. Pt critical upon admission." "1515487-1" "1515487-1" "Admitted to hospital 7/23/21 with covid pneumonia requiring high flow nasal cannula. Respiratory status never improved and patient transitioned to hospice care. Expired 7/30/31" "1515492-1" "1515492-1" ""Staff at SNF stated, ""feeling well yesterday."" On 4/5 at staff initiated a call for resp. distress at 2235, he was pulseless, and CPR was started. Fire Dept. there at 2245 to assume CPR. EMS arrived at 2252 and found pt. in PEA with vomit in airway. He received 2 rounds of epi with return of circulation. He was intubated in the field. His post-arrest rhythm appeared to be ST. He was transferred to local ER at 2256 where a right SC line and FC placed. He received Zosyn while in local ER. His GCS was 3. FiO2 = 80%, COVID-19 PCR positive. He was transferred to another facility r/t lack of beds. He was placed in COVID ICU on with ventilator. He remains unresponsive during stay 4/6 - 4/7. Pt. expired on 4/7/21"" "1515497-1" "1515497-1" "ON 7/30/21 @ 0329 AM, RESIDENT BEGAN RUNNING FEVER 104.2 DEGREES WITH A RESPIRATORY RATE OF 60 BPM. B/P 54/30. PULSE RATE OF 74 BPM. O2 SAT OF 88% ON O2 @ 4LPM PER TRACHE COLLAR. RESIDENTS BASLINE COGNITIVE STATUS UNCHANGED FROM PERSISTENT VEGETATIVE STATE. DR. WAS CALLED BY NURSE AND ORDERS WERE GIVEN TO SEND TO ER. UPON ARRIVAL, EMS HAD TO START CPR AS RESIDENT CODED DURING PICKUP. RESIDENT WAS PRONOUNCED DEAD AT 0520." "1515732-1" "1515732-1" "Moderna COVID-19 Vaccine EUA Patient received dose #1 of Moderna Vaccine on 1/20/2021, and dose #2 of Moderna Vaccine on 2/26/2021 from another Facility. The patient was admitted in 7/19/2021 with a diagnosis of Pneumonia due to COVID-19 virus. Patient expired on 7/23/2021 despite treatment with supplemental oxygen, steroids, and remdesivir." "1515743-1" "1515743-1" "Moderna COVID-19 Vaccine EUA Patient received dose #1 of Moderna Vaccine on 1/20/2021, and dose #2 of Moderna Vaccine on 2/26/2021 from a Facility. The patient was admitted in 7/9/2021 with a diagnosis of Acute respiratory failure due to COVID-19. Patient expired on 7/28/2021 despite treatment with supplemental oxygen, steroids, and remdesivir, and tocilizumab." "1516529-1" "1516529-1" "Death on 5-10-2021" "1516531-1" "1516531-1" "Weakness, declining health, admitted to hospice 6 days later, followed by death on 4/21/21 (9 days following vaccine)." "1516750-1" "1516750-1" "Hospitalization from COVID-19 reported per vaccine" "1518468-1" "1518468-1" "Death. He died within 24 hours of receiving the 1st dose" "1518627-1" "1518627-1" "Covid-19 Pneumonia, Hypertension, Black lung" "1518664-1" "1518664-1" "Patient was a 71-year-old Male, fully vaccinated with Moderna on 03/05/2021. Admitted to hospital on 03/21/2021 as he is tested positive for COVID-19 and passed away on 04/09/2021." "1518997-1" "1518997-1" "After receiving vaccine he was with me (mom), visiting my grandkids, shopping and eating, for approximately 3 hours at which time I dropped him off at my ex husbands house where he lived. Within 30 minutes he walked to his dad and grabbed his chest and slumped to the ground. Emergency Ambulance was called and attempted unsuccessfully to revive him but transfer to hospital where they worked for an hour. He was placed on life support and transferred to one of their larger facilities. On 2-14-21 they did the brain activity test ad he was pronounced dead. Remain on live support until Core could harvest usable organs" "1519067-1" "1519067-1" "Patient received the 2nd Pfizer Covid-19 Injection on 4/27/2021. She began having severe stomach pain the following day that did not resolve. She went to the hospital and was admitted on 4/30/2019. She underwent CTs, Ultrasounds. Found that she had 1 blood clot in a mesenteric artery. A second CT performed 2 days later showed that she had a 2nd blood clot that formed in a mesenteric vein. She has a condition ITP where she does not clot very well, however, it was stable at this time. She was started on heparin drips which made no improvement to the clots. Lysis catheter inserted with a TPA drip. This resulted in hemorrhagic stroke. She was placed on palliative care and passed away on 05/11/2021." "1519700-1" "1519700-1" "Client fully vaccinated for COVID-19 tested positive for COVID-19 on 7/10/2021. Vaccine Dose #1 given 2/27/2021. Vaccine Dose #2 given 3/20/2021. Client hospitalized on 7/14/2021 for shortness of breath, cough, confusion, and severe generalized weakness. Client died on 7/17/2021." "1519738-1" "1519738-1" "Admit 7/17 due to weakness, fall at home and SOB" "1519779-1" "1519779-1" "Admit to Medical Center 7/9/2021. Intubated 7/18-7/24 & 7/26-7/30" "1519797-1" "1519797-1" "Admit 7/1-7/4. Re-Admission 7/11. Expired 7/14." "1519803-1" "1519803-1" "Patient was a 92-year-old Female, fully vaccinated with Pfizer on 01/12/2021. Admitted to hospital as she is tested positive for COVID-19 and passed away on 05/14/2021." "1519840-1" "1519840-1" "Patient developed CP SOB Chest Congestion, tested positive for COVID 19 on 7/8/2021" "1519871-1" "1519871-1" "Patient was a 100-year-old Female, fully vaccinated with Pfizer on 01/12/2021. Admitted to hospital as she is tested positive for COVID-19 and passed away on 04/26/2021." "1519899-1" "1519899-1" "Patient was hospitalized due to breakthrough covid-19 infection on 7/23/21 after worsening shortness of breath for the past 5 days. Patient tested positive for covid-19 5 days prior to admission. Patient was pronounced deceased on 8/1/2021 @22:53. Patient completed Pfizer vaccination series in February. Information below is copied from progress note (8/1/21): PLAN: NEURO: h/o peripheral neuropathy, HOH o Lyrica o PRN: Tylenol o PRN: Trazadone Cardio: h/o HTN o Hydralazine prn o Statin daily o ASA RESP: Acute Hypoxic Respiratory Failure Secondary to Covid - 19 o HFNC, goal O2 sat 88%, wean as able o Bipap QHS o CPT, flutter valve, IS o Solumedrol BID o Guaifenesin prn o Albuterol prn o ABG/CXR PRN RENAL/FEN: h/o CKD 3 o Regular diet o Monitor electrolytes and replete as needed o Monitor renal indices ENDO: o Blood glucose checks AC & HS with insulin sliding scale coverage PRN HEME: h/o non hodgkins lymphoma with bone, liver and pulm involvment o Monitor CBC o Stopped chemo in June- resume when feasible ID: Covid - 19 o Completed Remdesivir o No ABX at this time o Trend inflammatory markers o Supportive care PPX: o DVT ppx: SCDs, Lovenox o GI ppx: Protonix" "1519902-1" "1519902-1" "Patient presented to ED for evaluation of headache, body aches, agitation. Increased O2 needs once admitted, requiring high flow O2. Greater than 14 days post J&J vaccination. Patient passed away 8/2/2021" "1519928-1" "1519928-1" "None" "1519940-1" "1519940-1" "Patient hospitalized due to breakthrough covid-19 infection on 7/24/21 with complaints of cough, SOB, generalized weakness, myalgias, fevers, chills and lightheadedness x 1 week. Patient was pronounced deceased on 7/25/2021 @ 8:52am. Patient completed the Moderna vaccination series in March/April. Information below is copied from the discharge summary: Summary of stay below: PNA present on admission- COVID 19 - cap - CXR bl infiltrates - high risk - o2 supplement, bipap at max settings, DNR - therapeutic ac renally adjusted -statin -recommended voluntary prone positioning 8hrs per day - solumedrol bid -procalcitonin elevated given abx for pna -borderline benefit for remdesivir, given Acute respiratory failure w hypoxia - setting of PNA - o2 supplement - as above Sepsis- sec to above - cultures were negative - lactic acid 6-2 - ivf for hydration given HTN- fairly controlled - home meds Hypothyroidism -synthroid BPH - flomax" "1519955-1" "1519955-1" "Back Pain & Stomach discomfort/Pain" "1520136-1" "1520136-1" "Client fully vaccinated for COVID-19 developed breakthrough infection and tested positive via PCR on 7/2/21. Vaccine dose #1 administered on 2/5/2021 and dose #2 administered on 3/5/2021. Client was hospitalized on 7/2 for COVID-19 pneumonia and subsequently died on 7/24/2021." "1521946-1" "1521946-1" "Strokes; Blood clots; Died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died), CEREBROVASCULAR ACCIDENT (Strokes) and THROMBOSIS (Blood clots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Aneurysm. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Strokes) (seriousness criteria death and medically significant) and THROMBOSIS (Blood clots) (seriousness criteria death and medically significant). The patient died on 13-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter Patient had multiple medical issues , got vaccine after and aneurysm. Very limited information regarding this events has been provided at this time. Further information can't be requested. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information can't be requested.; Reported Cause(s) of Death: Unknown cause of death" "1522680-1" "1522680-1" "I am the epidemiologist reporting on behalf of patient. The patient is fully vaccinated and the second dose of Pfizer. Date of second vaccine was listed as 05/08. Case began new medication, began vommiting 6/25. Got tested for COVID-19, tested +,. The patient was is in end stage liver disease awaiting a transplant and was tested as part of routine testing for weekly paracentesis. The patient's wife reports that he began three new medications on 6/24 and began vomiting that evening. Patient was admitted after testing positive because the test caused him to miss his paracentesis procedure and has no other symptoms. Patient is listed as having died from COVID-19, end stage liver failure, and liver cirrhosis." "1522766-1" "1522766-1" "a 80 y.o. female with a past medical history of CLL, chronic obstructive pulmonary disease on 3 L oxygen at baseline, chemotherapy-induced pancytopenia, transfusion dependent anemia, iron overload, and type 2 diabetes who presented to Hospital on 0724/2021 with increased shortness of breath and productive cough and was admitted for COVID pneumonia." "1522879-1" "1522879-1" "Cough, Fever, Muscle Aches" "1522892-1" "1522892-1" "7/26/2021 TESTED FOR COVID AT CLINIC RESULTS = DETECTED. 7/28/2021 PATIENT ADMITTED TO HOSPITAL FOR COVID PNA 8/1/2021 PATIENT DIED." "1522949-1" "1522949-1" "Case fully Covid-19 vaccinated at the end of February. On 07/16/2021 patient tested positive with Covid-19. Patient admitted on 07/27/2021 ICU with shortness of breath, productive cough and O2 % on 86%. CXR on 07/27/2021 shows bilateral infiltrate's. patient was hypoxic and tachypneic. 07/31/2021 patient become more shortness of breath and was put on CPAP high flow and CT of the chest was done showing PE. Patient was put on Heparin drip. Patient decompensated on 08/02/2021, was connected to MV and went to cardiac arrest, patient pass at 09:57 on 08/02/2021." "1522982-1" "1522982-1" "Patient passed away on 07/25/2021." "1523005-1" "1523005-1" "Patient passed away on 07/28/2021." "1523021-1" "1523021-1" "Patient passed away on 07/29/2021." "1523029-1" "1523029-1" "Patient passed away on 07/29/2021 from a intracerebral stroke." "1523152-1" "1523152-1" ""Girlfriend came in for her 2nd dose and reported that her boyfriend ""died in my arms from a blood clot after his first covid vaccine."" Patient, died suddenly at home on 7/21/2021 in the presence of Girlfriend. She called 911 and the fire department responded. He was dead when they arrived. They did not transport him to the hospital but directly to the morgue. No autopsy was performed. The coroner did not speak with Girlfriend. She got the information about the blood clot from the EMTs who said ""I could tell by looking at his neck that he had a clot"". Not sure why she attributed it to the Moderna vaccine? He was vaccinated in our pharmacy on 7/6/2021. I told Girlfriend I would report this to the Pharmacy system and to VAERS. She said no one else had reported it to her knowledge."" "1523184-1" "1523184-1" "pt admitted for low BP" "1523226-1" "1523226-1" "Drenching night sweat on April 4 and then happening every few nights and sometimes every night throughout April and May. Also, starting early April, just feeling ill, aching all over, several nights of extreme anxiety which was not normal, extreme tiredness to the point (mid April) of almost going off the road driving." "1523231-1" "1523231-1" "Unrelated to vaccine: He had community acquired pneumonia; sepsis and septic shock. Went by ambulance to ER and that evening they got him to ICU room. I think they were administering strong antibiotic. He was in the hospital three days. Came home on Jan 27th. We started hospice on Jan 29 and he passed on February 23rd." "1523234-1" "1523234-1" "presented ED on 5/14/21 - O2 in 60's., SOB, cough lower body edema, dx with covid pneumonia" "1523257-1" "1523257-1" "PATIENT DID NOT COMPLAIN ABOUT ANY SIDE EFFECT. HOWEVER, DAUGHTER REPORTED THAT PATIENT WAS FOUND DEAD AT HER HOUSE LAST NIGHT 08/02/21" "1523317-1" "1523317-1" "Pt. passed while inpt. at Hospital on 7/28/21 from COVID19 disease." "1523422-1" "1523422-1" "7/20/2021 Client received Janssen COVID 19 vaccine in a long term care facility. 8/2/2021 Client died at long term care facility 8/3/2021 Coordinator received email notification of client's death" "1525590-1" "1525590-1" "No sx. Tested due to being a resident of a long term care facility where there was a current outbreak due to a staff member testing positive during routine testing." "1525599-1" "1525599-1" "No sx. Tested due to being a resident of a long term care facility where there was a current outbreak due to a staff member testing positive during routine testing." "1525661-1" "1525661-1" "Brain nauseum." "1525685-1" "1525685-1" "Friday night I woke up he was foaming in the mouth, I sat him up and elevated him and cleaned him up I called 24 hour doctor line. The doctor recommended going to er. We stayed home, He was coughing and seemed irritated. Breakfast he seemed fine very lathargic, no fever, lost conciousness and I called paramedics . The paramedics could not get his body tempature 80. I waited when I got to the hospital 4 hours later and went to his room thay had a heat machine and thermal blanket on him, he was concious but looked like he was going to sleep, his blood pressure started going up and down and up and down. He was very cold to touch. He had a cough and they were given him 2 types of antibiotics to help clear up pnemonunia which then damaged his kidney and he got septisis . They had to use an ultrasound to get ivy and foley in because of fluid. Physical therapy had to get him in and out of bed. Doctors said they had done everything they could do and sent him rehab before sending him to hospice. He was Hypothermic, kidney failure and sepsis." "1525780-1" "1525780-1" "death Other pulmonary embolism without acute cor pulmonale Unspecified convulsions" "1525789-1" "1525789-1" "death N17.9 - Acute renal failure, unspecified acute renal failure type" "1525795-1" "1525795-1" "death I26.99 - Other pulmonary embolism without acute cor pulmonale J18.9 - Pneumonia, unspecified organism" "1525804-1" "1525804-1" "death rash following vaccination sepsis N17.9 - Acute kidney failure, unspecified multiple mylenoma" "1525940-1" "1525940-1" "TO ER ON 7/21/21 WITH SHORTNESS OF BREATH AND DYSPHAGIA. POSITIVE PCR TEST FOR COVID-19. HAD MONOCLONAL INFUSION IN THE ER AND WAS HOSPITALIZED INTO THE ICU. DIED ON 8/1/21. WAS FULLY VACCINATED WITH THE MODERNA VACCINE. DOSE 1-2/22/21 AND DOSE 2-3/23/21." "1525967-1" "1525967-1" "Admission due to covid and death was due to covid+19. ER visit on 7/8 and complained of weakness. Diagnosed with covid on 7/7 by her physician. Death summary from medical records indicates COVI-19 viral pneumonia and acute hypoxemic respiratory failure" "1525971-1" "1525971-1" "Patient received vaccine on 2/12/2021 and 3/12/2021. He was admitted to the hospital on 6/23/2021 and passed away on 6/29/2021." "1525977-1" "1525977-1" "Pt experienced a syncopal episode which prompted a hospital visit on 7/12/21. Pt tested negative by PCR for COVID-19 on 7/18/21 and positive by PCR for COVID-19 on 7/24/21. Pt passed away on 7/28/21." "1525985-1" "1525985-1" "Patient received vaccines on 2/12/2021 and 3/12/2021. He was admitted to the hospital on 7/4/2021 and passed away 7/20/2021." "1526026-1" "1526026-1" "Pulmonary Embolism 7/20 presented to ED with right sided pain which he had for about 2 weeks. Denies any hx of trauma. Did admit to moving furniture but did not recall an injury. D/C'd with chest wall pain and given Ultram 50mg 1 tab q 4hrs qty= 7. on 7/26 he presented to ED with symptoms of PE and was dx'd with acute PE He was declared deceased on 7/29/21" "1526049-1" "1526049-1" "My dad had a cardiac arrest one month after his second vaccine. He had complained of severe indigestion for 6-8 hours within 2 days of his second dose and refused medical attention for it. The day he passed he did not verbalize any complaints." "1526134-1" "1526134-1" "Came to ER 7.15.2021 for leg wound" "1526275-1" "1526275-1" "My Mom received her 2 shots at the same facility.The 1st shot no reaction the second shot she was in bed sick for 3 days.She did recover but seemed to feel very weak after that second shot.She kept saying she did not feel right.On April 21 her legs buckled she could not stand or walk.We put her back to bed and at 7 her legs buckled again.She was taken by ambulance to hospital where she stayed for 7 days .She was then transferred to another hospital for PT for 21 days.She never was able to stand or walk again.Neither of these facilities could say why it was a mystery.She was transferred to a nursing home because she could not stand or walk on May 24.She continued to go downhill and on July 4th she passed away.I cannot help but wonder if it was not this second shot." "1526316-1" "1526316-1" "death of unknown reason" "1526319-1" "1526319-1" "Victim went to bed immediately upon returning from the facility. He did not eat dinner because he was not feeling well. The next day he did not wake up until after noon and found he could no longer walk. He reported his legs burning as if they were on fire. He began to break out in a painful rash over two thirds of his body. He had pain in his back that would come and go. The burning pain in his body was intermittent and he was able to use a walker after a few days but he never recovered his strength like he was before he was vaccinated and he deteriorated further everyday and then began to exhibit memory and thinking problems. 29 days after the shot he became so weak he could not catch his breath and was taken to the emergency room and died within minutes after being put on the examination table. Cause of death was listed as heart failure. Prior to receiving the vaccine he was energetic and put in a full day everyday of home maintenance, gym workouts and exercise classes. He regular drove to social events and breakfast events and had not been sick with the flu for several years." "1526341-1" "1526341-1" "Patient expired 19 days after receiving her first shot of Moderna. Patients family is convinced the shot killed her and wants it reported. patient has a history of vasculitis. Primary provider believes the vaccine could have contributed to her death. Patient was on the transplant list and was told it was a requirement to receive this shot." "1526529-1" "1526529-1" "Became lethargic and had malaise, called 911 and could only be heard breathing on the line. When EMS arrived, she was deceased." "1528238-1" "1528238-1" "Heart attack and lungs filled with water; Heart attack and lungs filled with water; Stopped breating; This is a spontaneous report from a contactable consumer. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 23Jun2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included stroke occurred 20 years ago, kidney problems, heart attack eight years ago, patient had 7 stents around her heart, her capillaries were small, The veins to her heart were small, asthma, schizophrenia, stated lungs were bad, had a stroke 20 years ago and it affected her emotions. She could only laugh or be mad. Concomitant drug were unspecified. Patient was on a lot of them. The patient had first shot of BNT162B2 on 31May2021 in left arm for COVID-19 Immunization and she started crying. The patient experienced heart attack and lungs filled with water (death, hospitalization) on Jul2021 with fatal outcome, stopped breating (hospitalization) on 28Jun2021 with outcome of unknown. The patient was hospitalized for 3 days. The patient died in Jul2021. It was unknown whether autopsy done. The clinical course was reported as follows: Caller on the line who mentioned he was a PCA, clarified as a patient care attendant for his wife. He is calling about the Pfizer Shot, the vaccination, clarified as to prevent COVID, the COVID Shot. He stated his wife died due to the shot. He mentioned he has no avenue to go down. No direction. He stated he is upset no research has been done form people who died from the shot, or information from it causing one to have a heart attack, lungs filling with water, or weakening the immune system. He later clarified this is what happened to his wife. Caller stated he feels that his wife died from the COVID shot, but he is not a scientist and has no way of proving that. He wants someone to call him and tell him. Caller clarified the patient's cause of death. He stated the death certificate has she passed away due to heart attack due to lungs filling with water and she could not be resuscitated. They tried for two hours. Caller stated he does not know the exact date patient passed away, it is all packed up. It was either 02Jul 2021 or 03Jul2021. He confirmed the heart attack and lungs filling with water occurred on the date she passed away. Caller explained, he wanted to explain what he saw. After she first got the shot she started crying. He mentioned his wife had a stroke 20 years ago and it affected her emotions. She could only laugh or be mad. Patient's mother and father had passed away within three months of each other and she could not even cry then. Caller stated after patient got the shot she started crying and did not know what was going on. He mentioned she was close to menopause and he thought it was just menopause going on. It was all day, every day, she was crying. Then after the second shot a few days later patient stopped breathing. The paramedics were called who provided a breathing treatment. Patient was taken to the hospital and was there for three days. They could not figure out what was wrong. They did work-ups. Patient was in ICU. Then she crashed. They started CPR. Patient's lungs filled up with water, patient had a heart attack, and she stopped breathing. Caller clarified patient had the issues with breathing and stopped breathing initially like on 28Jun2021. Then patient was taken to the hospital. Stated patient's health was never like us. However, he kept her not sick. He was good at his job. However, when patient was sick he would take patient to the hospital or the doctor's to find out what is going on. When sick she was in the hospital, when she was fine she was home. No vaccines administered on same date of the pfizer suspect. Confirmed none were given on the same date. The paramedics were called, patient was taken to hospital and was admitted to ICU due to patient stopped breathing. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Heart attack; Lungs filled with water" "1528254-1" "1528254-1" "Post-vaccine auto-immune reaction, organ failure (DRESS syndrome); This is a spontaneous report from a contactable consumer. An 81-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not provide) on 23Mar2021 12:00 at age of 81 years old as single dose on left arm via an unspecified route of administration for COVID-19 immunization. Relevant medical history included hypertension, temporomandibular joint syndrome, tinnitus and joint discomfort. On 02Mar2021 at 12:00 PM at 81 years old, on Left arm the patient received first dose of BNT162B2 for COVID-19 immunization. Concomitant medications included hydrochlorothiazide, valsartan (CO-DIOVAN), vitamin D3, ginkgo biloba, collagen and melatonin. It was informed that on 29Apr2021 the patient died after developing a severe allergic auto-immune reaction, diagnosed as DRESS Syndrome, started on 24Mar2021 09:00. The adverse event result in emergency room visit and physician office visit. It was mentioned that patient was hospitalized 13 days due to the event and was treated with high-dose of cortico-steorids, antibiotics. It was also informed that It took a lot of effort by several doctors, and ultimately the intervention of a premiere infectious disease expert in another location, on 18Apr2021, to make a definitive diagnosis and to confirm it was a reaction to the Pfizer COVID vaccine. (as reported). The doctors tried but failed to save him, and he died on 29Apr2021 (as reported). The patient underwent a SARS-CoV-2 test (Blood test) on 28Apr2021 which resulted negative. An autopsy was not performed. Serious criteria was fatal, life-threatening and hospitalization. The event [Post-vaccine auto-immune reaction, organ failure (DRESS syndrome)] occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. Information on the lot/batch number has been requested. Follow-up (20May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: updated the reporter's country.; Reported Cause(s) of Death: Post-vaccine auto-immune reaction, organ failure (DRESS syndrome)" "1528593-1" "1528593-1" "Vaccinated patient, tested positive and was admitted with COVID on 5/21/2021. Patient passed away on 6/7/2021." "1528612-1" "1528612-1" "Moderna Vaccine given 3/15/21 and 4/12/21. Developed spontaneous renal infarct 6/12/21., placed on apixaban. Had acute CVA 6/24/21, unknown cause with no arrhythmia, negative hyper coagulable work up, and no evidence of recurrence of malignancy. 7/13/21 with new DVT was started on aspirin in addition to apixaban and 7/18/21 another CVA occurred. Was started on warfarin. 7/29/21 develop cerebral hemorrhage and passed." "1528618-1" "1528618-1" "This case was hospitalized 4/6 due to bowel issues. Exposed and developed symptoms in hospital. Eventual transfer to hospice d/t decline in part d/t pneumonia symptoms. COVID Positive PCR - 5/3/2021" "1528695-1" "1528695-1" "The patient became unresponsive on the day after the vaccine, was unable to communicate or eat and died 6 days later." "1528841-1" "1528841-1" "COVID-19 BREAKTHROUGH CASE THAT EXPIRED APPROXIMATELY THREE MONTHS AFTER COMPLETING VACCINATION SERIES." "1528852-1" "1528852-1" "COVID -19 BREAKTHROUGH CASE THAT EXPIRED FOUR MONTHS AFTER COMPLETING COVID VACCINATION SERIES." "1528864-1" "1528864-1" "Came to EC for CHF was put on hospice during admission" "1528874-1" "1528874-1" "Patient went to the medical center for appointment with primary care for blood work and to receive the COVID-19 vaccine. When he returned home with his wife, he started feeling bad. He took a nap and woke up with sweat and chills. Patient's wife attempted to call his PCP and the Medical Center with no success and transported patient to the local Emergency Department. There it was discovered he had a fever and he was admitted for possible urinary tract infection. Overnight, while in his room he became agitated and had a sense of impending doom. Per his wife, he grabbed his chest and turned blue, falling to the bed. A code blue was called and CPR was performed. He was intubated and put on some sedation. He was transferred to the ICU. After a couple days of a poor prognosis he was put on comfort care or hospice. He passed away on January 24, 2021" "1528880-1" "1528880-1" "death I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) J18.9 - Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung" "1528889-1" "1528889-1" "death - Multifocal pneumonia" "1528901-1" "1528901-1" "death shortness of breath N17.9 - AKI (acute kidney injury) K92.2 - Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type" "1528939-1" "1528939-1" "Patient passed away on 06/03/2021" "1528947-1" "1528947-1" "Patient passed away on 05/31/2021." "1528952-1" "1528952-1" "Client fully vaccinated for COVID-19 - received dose #1 of Moderna on 2/2/2021 and dose #2 of Moderna on 3/2/2021 tested positive via NAAT on 6/18/2021. Client was hospitalized for COVID-19 and died on 7/6/2021" "1528988-1" "1528988-1" "Gangrene of right foot with refused treatment No symptoms of COVID Date of death 4/14/2021" "1529110-1" "1529110-1" "Death on 8/2/2021" "1529227-1" "1529227-1" "rec'd vaccination 8/3/21, was tested for covid as part of building wide sweep 8/4/21, facility was notified at approx 1500 on 8/5/21 that PCR test was positive code blue was in progress when facility rec'd notification of positive test result- code called at approx 1430 on 8/5/21" "1529248-1" "1529248-1" "Patient presented to the emergency room one day following being vaccinated in cardiac arrest. Patient is deceased." "1529585-1" "1529585-1" "SUDDEN CARDIAC DEATH" "1529596-1" "1529596-1" "SUDDEN CARDIAC DEATH" "1529599-1" "1529599-1" "SUDDEN CARDIAC DEATH" "1529868-1" "1529868-1" "SUDDEN CARDIAC DEATH" "1529871-1" "1529871-1" "SUDDEN CARDIAC DEATH" "1530068-1" "1530068-1" "Stroke on March 24, 2021. Widespread blood clots discovered on April 3rd, 2021. Death on April 5th, 2021." "1531540-1" "1531540-1" "Pfizer-BioNTECH COVID-19 Vaccine EUA Patient received Pfizer COVID Vaccines on 1/29/2021 and 2/22/2021. Patient presented to ED on 7/16/2021 with worsening shortness of breath for the last few days. Admit diagnosis of Pneumonia due to COVID-19. Patient was treated with remdesivir daily (7/16 - 7/20), IV steroids, and Tocilizumab 800 mg x2 doses (7/20&21). Patient expired on 7/29/2021." "1531545-1" "1531545-1" "Patient was found dead in his home on 07/27/2021." "1531639-1" "1531639-1" "07/24/2021 Patient was admitted to Hospital, with microplasma pneumonia and breathing difficulties." "1531784-1" "1531784-1" "Pfizer-BioNTECH COVID-19 Vaccine EUA Patient received Pfizer COVID Vaccines on 3/09/2021 and 4/06/2021. Patient presented to ED on 7/17/2021 with 2 week history of increasing shortness of breath and cough with associated chills, weakness and unsteadiness on her feet.Admit diagnosis acute hypoxic respiratory failure due to COVID-19. Upon admission, CTA showed a nonocclusive segmental PE and ground-glass opacities. Patient was treated with IVF, Rocephin, Zithromax, Decadron 6mg (10 days), a heparin drip, and remdesvir (5 days). Patient expired on 7/28/2021." "1531963-1" "1531963-1" "Began on February 11, 2021: thrombocytopenia, anemia, pneumonia, multiple pulmonary embolisms, pulmonary aspergillosis pneumonia" "1532004-1" "1532004-1" "11 days following COVID vaccine #2, patient died within 15 hours on February 16, 2021, of sudden, new onset atrial fibrillation leading to bradycardia unresponsive to atropine and oxygen. Patient had been seen by primary care doctor in December 2020 for Medicare annual wellness exam and had a normal EKG and heart exam; moderate hypertension well controlled. No other history of cardiac disease or arrhythmias, no angina, no dyspnea, no cyanosis. All renal dialysis parameters had been stable since starting on thrice-weekly dialysis in 2017. No history of preceding illness or vaccine reactions. No fever, no rash, no GI symptoms, no change in consciousness (clear mental status), no asymmetry of face/arms/legs. All medications administered by caregiver who is daughter and MD." "1532021-1" "1532021-1" "Janssen COVID-19 Vaccine EUA Patient received Janssen Vaccine on 4/30/2021. Presented to ED on 7/9/2021 with Altered Mental Status and Shortness of Breath. Admitted with Respiratory failure. Patient admitted 7/9/21 for COVID-19 pneumonia. Intubated 7/10 and completed treatment with decadron and remdesivir daily (7/9 - 7/13). Treated with ceftriaxone and azithromycin. Patient expired on 7/26/2021." "1532026-1" "1532026-1" "it made her arthritis flare up. She was having issues breathing and catching her breath. She had swelling and a rash, weakness, pain and the worse is she passed away on Sunday July 25, 2021." "1532040-1" "1532040-1" "Vaccinated at a location on 5/17/2021, staff mentioned her obituary June 24th, 2021 and was concerned of her death so close to her vaccination date." "1532064-1" "1532064-1" "Case had COVID vaccines x 2. Last vaccine given at HCF on 2/12/21. Case presented to ED on 7/24/2021 with covid like symptoms. Postitive test for COVID 19 and was admitted to another HCF on 7/24/2021. He expired at that facility on 8/4/21." "1532154-1" "1532154-1" "On July 17, my baby passed away. I had been breastfeeding my 6 week old baby at the time that I received the first Pfizer vaccine on June 4, 2021. He became very sick with a high fever about 2 weeks after I got the first Pfizer vaccine on June 21. He was treated for 2 weeks with IV antibiotics for a supposed bacterial infection. However, they never found any specific bacteria, and called his diagnosis culture-negative sepsis. At the end of his hospital stay he tested positive for rhinovirus. After the 14 day course of antibiotics, he was home for one week, but exhibited strange symptoms (e.g. swollen eyelid, strange rashes, vomiting). I took him back to the hospital on July 15, where he presented with what they called an atypical Kawasaki disease. He passed away shortly thereafter from clots in his severely inflamed arteries. I am curious if the spike protein could have gone through the breast milk and caused an inflammatory response in my child. They say Kawasaki disease presents very similarly to the Multi-System Inflammatory Syndrome in children that they are seeing in post Covid infections. (My baby also had unusual birth circumstances, as he was born at 37 weeks, triggered by a maternal appendicitis.) However, if they know that antibodies go through the breastmilk as a good thing, then why wouldn't the spike protein also go through the breastmilk and potentially cause problems." "1532167-1" "1532167-1" "The patient died of a hemorrhaging cerebral hemangioma 3 weeks after getting the vaccine." "1532192-1" "1532192-1" "Vomiting, Heat Attack & Death" "1532890-1" "1532890-1" "Patient received vaccine on 7/28/21 at clinic. Presented to ER on 7/31/21 after vomiting large amount of bright red blood 1 hour PTA. She was admitted to ICU, required 8 units PRBSx, 3 units FFP, and 1 unit platelets with poor response in Hgb and Hct. Required pressors up to maintain BP. EGD revealed bleeding varices which were banded. On ICU day 2 patient became increasingly acidotic and began to desaturate. Oxygenation improved with increased sedation and 2 additional units PRBC. On ICU day 3 patient became hypertensive, pressors were stopped. There was acute change in LOC with decreased responsiveness to painful stimuli and nonreactive pupils. Head CT showed severe diffuse cerebral edema c/w hypoxic brain injury. Patient continued to deteriorate and decision made for compassionate extubation. Pateint expired at 2110." "1534654-1" "1534654-1" "Patient started feeling bad the day following the injection. Tired, diarrhea, nausea. Death - Died on 4/12/21 at approximately 5:00 AM" "1534807-1" "1534807-1" "My uncle received the vaccine on 26 july. He immediately became unwell and by 1 august, he had lost over 15 lbs. He was admitted to ICU when conditions did not improve. He was put on a breathing machine because he was unable to breathe. His covid test was negative and doctors said it was nothing transmittable. He died early next next morning." "1534829-1" "1534829-1" "Death from blood clot" "1534934-1" "1534934-1" "Bullous Pemphigoid, eye redness (serious), swollen stomach, death" "1535013-1" "1535013-1" ""On 5/22/21 he was taken emergently to the operating room and underwent repair of Type A aortic dissection with replacement of ascending aorta with re-suspension of his aortic valve. Post op he developed new onset right arm and right sided facial twitching along with right arm weakness. Neurology was consulted for focal motor status epilepticus and he was loaded on Keppra and started on Vimpat. EEG and MRI brain ordered. MRI revealed small foci of acute infarcts in the left occipital and right temporal lobes which may be embolic in etiology. He was initially very slow to wake up and follow commands appropriately. This improved over a number of weeks. By day of discharge on 6/21 to acute rehab, his right arm and facial twitching had completely resolved. He was alert, oriented X 3. His right arm continued to have slow return of function with fine motor skills. 6/22, patient reportedly had a 1 hour episode of AMS, witnessed by wife and daughter, in which his eyes rolled back into his head. He was arousable and answered simple questions. He had no associated tremors, shaking, rigidity. This resolved with an episode of emesis and patient was back to baseline within minutes of vomiting. 6/23, patient had another episode described as ""generalized seizure"" involving upper and lower extremities last several seconds followed by multiple focal seizures including only UEs. Was readmitted on 6/24 and was discharged on 7/16/21. He subsequently passed away on 7/19/21"" "1535017-1" "1535017-1" "C/O feeling short of breath & flushed at times. Unsure if he went to his primary doctor for a follow up. He was found deceased at home by his daughter" "1535066-1" "1535066-1" "Perforated bowel that was sudden and caused sepsis." "1535195-1" "1535195-1" "Patient experienced flu-like symptoms and an upset stomach and died 60-72 hours later. Immediate cause of death is still pending further study." "1535278-1" "1535278-1" """"brain fog,"" blurred vision, extreme mucous, body aches, fatigue, bowel incontinence"" "1535282-1" "1535282-1" "Increased SOB" "1535284-1" "1535284-1" "Cough, congestion" "1535351-1" "1535351-1" "Patient was vaccinated with 2 doses Pfizer Covid-19 vaccine in January and February of 2021, and was hospitalized for Covid (8/1/21) and subsequently died of Covid pneumonia on 8/4/21." "1535468-1" "1535468-1" "Patient developed cerebral venous sinus thrombosis (superior sagittal vein) and a large right occipito-parietal intracerebral hemorrhage. He developed epilepsy ~ a month prior to his presentation and there was a possible meningioma seen on a prior MRI - he was started on levetiracetam and had a follow-up appt but had his hemorrhage first. The patient had a seizure upon arrival and was intubated. Ultimately, we have pursued palliative care this afternoon." "1535508-1" "1535508-1" "RESPIRATORY FAILURE" "1535518-1" "1535518-1" "DROWNING" "1535520-1" "1535520-1" "SUDDEN CARDIAC ARREST" "1535531-1" "1535531-1" "CARDIAC ARREST" "1535548-1" "1535548-1" "sudden death" "1535603-1" "1535603-1" "SUDDEN CARDIAC ARREST" "1535608-1" "1535608-1" "GUNSHOT WOUND, HEMORRHAGE" "1535895-1" "1535895-1" "Brain Bleed, Hemorrhage (Intracranial Hemorrhage). Death" "1535913-1" "1535913-1" "Patient was hospitalized on 6/7/2021 for severe protein-calorie malnutrition and received the first dose of covid vaccine while hospitalized. Patient received second dose on 6/30/2021. Patient presented to the ED and was subsequently hospitalized on 7/4/2021 for squamous cell carcinoma of right lung. She died on 7/20/2021." "1535996-1" "1535996-1" "Covid 19 Pfizer, Lot # EL3247 #2 obtained 02/08/2021. Client died August 2, 2021." "1536019-1" "1536019-1" "Contracted Covid-19. Died after 12 days in hospital" "1536023-1" "1536023-1" "Patient died at home of an apparent heart attack, was not rescesitated and did not make it to hospital" "1536025-1" "1536025-1" "Six days after her first vaccine patient became lightheaded. She presented to Hospital where she was found to have bilateral pneumonia with ground glass opacities, AKI and severe hypertension-systolic BP 200. She was admitted and began a steady downhill course intubated 5/5/21. Transferred to another hospital and seen by multiple specialists. On ventilator with kidney support. Repeated cultures negative for bacterial infection although pressors needed to maintain BP. Kidney biopsy showed vasculitis. Patient died with catastrophic multiorgan failure 5/26/21. Autopsy lists cause of death as pneumonia complicated by antiphospholipid Syndrome." "1536043-1" "1536043-1" "Death from Covid-19" "1536077-1" "1536077-1" "death" "1536142-1" "1536142-1" "Admitted to hospital on 7/20/21 with respiratory congestion, dry cough and rhinorrhea after positive COVID test on 7/15. Resulted in acute hypoxic respiratory failure with death 8/6/21." "1536189-1" "1536189-1" "Pt founds unresponsive and transferred to the hospital. Pt was intubated after being given Narcan with no response. Pt was GCS 3 at the scene. Medical History of alcoholism, frequent falls and CAD, Hep C, etc. Pt Neurosurgery was consulted due to SAH and admitted to the trauma service. DX: Acute alcohol intoxication; Coma; TBI with loss of consciousness; Traumatic subarachnoid hemorrhage. COVID + on admission. Pt expired on 8/8/2021." "1536208-1" "1536208-1" "Admited to hospital on 8/7. Expired 8/8" "1536214-1" "1536214-1" "Stroke, Sepsis, and Death" "1536241-1" "1536241-1" "COVID PNEUMONIA DEATH 8/6/2021" "1536271-1" "1536271-1" "Pt. passed from COVID19 Pneumonia on 8/6/2021" "1536432-1" "1536432-1" "March 18 2021 my mom received her first Pfizer vaccine followed by her second on 4/03/2021. After she received it she started having an overall feeling of not well. Tired, fatigue, headache, and complained to her doctor on multiple occasions. Since 12/09/2020 she had only went to the doctor one time on 02/08/2021. After the first dose until her death she had gone to her doctor many times, on 03/30, 04/01, 04/21, 04/28, 05/25. That may not be a complete list of every visit." "1536441-1" "1536441-1" "The only chemical change to my father in 2021 were the 2 injections. He had had seizures of unknown origin 4 times in the prior 18 months. A little over 2 weeks later he had a seizure. It was thought to be dehydration or lack of food. He was given a water bottle and we started watching his food intake. He had 4 seizures in 2 weeks. He had another 4 the week after, then they came everyday. More often, longer durations, and more powerful. He passed away on June 8, 2021 cause of death ruled to be parkinsons." "1536481-1" "1536481-1" "Patient's caretaker, called today on 08/09/21 to request us to submit a report that patient passed away on June 17th due to major stroke, which is believed to be linked to the Janssen Covid Vaccine." "1536521-1" "1536521-1" "Extremely sick & Died on 06/14/2021" "1536899-1" "1536899-1" "1 -2 days after the first dose he started getting confused . 3rd day we admitted him to the hospital . At one point they thought or were testing about his brain bleeding . Roughly after 4 days in the hopsital his body crashed he was in a coma and then died roughly 14 days after the injection on March 24, 2021. He died of an acute intracerebral hemorrhage which we were told he had a blood clot then stroke" "1536906-1" "1536906-1" "Death" "1537187-1" "1537187-1" "Pt died on April 15, 2021 of cardiac arrest." "1540347-1" "1540347-1" "I am the epidemiologist reporting on behalf of patient. Case was admitted after daughter found Dad on the floor was previously being treated for a UTI -- Transported to the ED as he had Difficulty breathing -- during hospital start was treated for COVID Pneumonia -- was treatment at hospital and discharged 8/6 -- 8/7 Returned to ED w/Acute Respiratory Distress -- Daughter was by bedside declined Mechanical Inc -- pt. expired 3 hrs later. Patient was fully vaccinated with Pfizer on 2/17 and 3/10." "1540381-1" "1540381-1" "Patient Death" "1540391-1" "1540391-1" "Patient presented to the ED and was subsequently hospitalized for cellulitis of foot within 6 weeks of receiving COVID vaccination. She died on 7/12/2021." "1540494-1" "1540494-1" "Patient test positive for COVID at the nursing home where she lives on 8/4/21. Received casirivimab and imdevimab monocolonal antibodies on the same day. Pt arrived unresponsive at the ER 8/8/21 and expired." "1540547-1" "1540547-1" "Patient Died" "1540687-1" "1540687-1" "Found in cardiac arrest at his residence. Brought into the emergency department by ems in cardiac arrest. No return of spontaneous circulation. Pronounced dead at 0746." "1540952-1" "1540952-1" "Cardiac arrest resulting in death" "1540970-1" "1540970-1" "Tested positive for COVID-19 on 7/28/21, admitted to the hospital on 8/3/21 with a date of death of 8/8/2021 via cardiac arrest." "1541088-1" "1541088-1" "The patient died on 08/09/2021" "1541117-1" "1541117-1" "Pfizer BioNTech COVID-19 Vaccine EUA Patient received Pfizer Vaccines on 3/5/2021 and 3/23/2021. Presented to urgent care on 7/24 and had a positive COVID test, started on azithromycin and benzonatate. Patient presented to ED on 7/30 with fever, dyspnea, myalgia, loss of taste, muscle weakness. Patient was initially admitted to the medical floor, on 4 L nasal cannula, but quickly escalated to high-flow nasal cannula and was then transferred to the ICU. The patient required high levels of oxygen and also developed delirium, as well as had acute kidney injury. Patient was treated with dexamethasone, terbutaline, remdesivir. In discussion with the patient's primary medical decision makers, including the patient's husband and son, the patient/s status was made a do not attempt resuscitation, but may continue the treatments. The patient was transferred to the medical wards on high levels of oxygen 60 L and 90% FiO2. Unfortunately, the patient continued to decompensate and passed away the evening of 8/3/2021. Additional information for Item 9: Atorvastatin 10 mg QD, Azithromycin 250 mg QD, Benzonatate 100 mg TID prn, Cholecalciferol 1000 units QD, Furosemide 40 mg QD, MagOx QD, Metoprolol 25 mg QD, Mycolog cream BID." "1541119-1" "1541119-1" "Janssen COVID-19 Vaccine EUA Patient received Janssen Vaccine on 3/10/2021. Presented to ED on 7/10/2021 with hip pain of two weeks in duration. CT Angiogram showed a right inguinal hematoma and active extravasation and was medically managed. Patient subsequently developed shortness of breath and pneumonia and treated with 7 days of cefepime. Patient tested positive for COVID-19 using the Cepheid GeneXpert platform on 7/30/2021, which was the anticipated day of transfer to skilled nursing facility. On 8/4 she developed abd pain prompting KUB whihc showed SBO but patient deferred NG tube.Later she had CT chest neck and abd which showed worsening PNA with aspiration of bowel content and SBO and poss oropharyngeal perforation. Patient did agree after detailed discussion with family about CT findings and IR able to place NG tube but shortly after she began throwing up bile and needing high flow oxygen. She was not able to maintain oxygen saturation and family changed her status to AND, and she expired on 8/6 at 0415 AM." "1541629-1" "1541629-1" ""DEATH. My wife was in excellent health with no heart issues when she awoke five weeks after her second Pfizer shot feeling ""like a load of bricks was on her chest"". She was transported by ambulance to the Hospital Emergency Room around 11 am on March 16, 2021. She was monitored closely and after a couple of hours, the attending folks said they didn't think it was a heart issue per fine blood work and full time EKG hook up. They were looking at GI possibilities and wanted to keep her overnight, do a couple more tests in the morning and then send her home. She stayed in an ER bay because there were no regular beds available. We made plans for the next morning and I left her around 8 pm and drove home. Around 2:50 am on the 17th, I received a phone call that she had a massive coronary event. The were able to bring her back one time momentarily, but then she passed away within a few minutes. I'm submitting this report because of the general belief that older women have heart attacks all the time. However, though she felt a heavy chest pressure, twelve plus hours in an ER bay couldn't find any issues. She may have had some coronary inflammation that may have been exacerbated by the vaccine but I and we will never know. Nevertheless, this was sudden and unexpected and five weeks after her second vaccine dose and it seemed appropriate to toss it in your data pile. Thanks."" "1542057-1" "1542057-1" "Extremely painful recurrence of bulbous phemphigoid covered most of body. 3.5 weeks after initial vaccine. Required hospitalization 3 times and admission to rehab twice. Unable to walk, difficulty breathing, swollen legs, 2nd hospital. Unable to speak or walk 3rd hosp, ended in death/ bacteremia." "1542093-1" "1542093-1" "CARDIAC ARREST" "1542094-1" "1542094-1" "RESPIRATORY ARREST" "1542096-1" "1542096-1" "CVA WITH SEVERE CEREBRAL EDEMA" "1542098-1" "1542098-1" "DROWNING" "1542100-1" "1542100-1" "PRESSUMED CARDIAC DEATH" "1542102-1" "1542102-1" "SUDDEN CARDIAC DEATH" "1542103-1" "1542103-1" "EPILEPSY" "1542104-1" "1542104-1" "SUDDEN CARDIAC DEATH" "1542106-1" "1542106-1" "CARDIAC ARREST" "1542107-1" "1542107-1" "CARDIOPULMONARY ARREST" "1542108-1" "1542108-1" "Myocardial Infarction" "1542109-1" "1542109-1" "SUDDEN CARDIAC ARREST" "1542837-1" "1542837-1" "SEVERE HYPOTENSION WITH CARDIAC ARREST" "1542839-1" "1542839-1" "ACUTE CORONARY SYNDROM" "1542842-1" "1542842-1" "CARDIAC ARREST" "1542843-1" "1542843-1" "SUDDEN CARDIAC DEATH" "1542844-1" "1542844-1" "CARDIAC ARREST" "1544928-1" "1544928-1" "AMI" "1544932-1" "1544932-1" "UROSEPSIS" "1544937-1" "1544937-1" "CARDIAC ARREST" "1544941-1" "1544941-1" "DEHYDRATION" "1544943-1" "1544943-1" "REFRACTORY RESPIRATORY FAILURE" "1544945-1" "1544945-1" "None stated." "1544951-1" "1544951-1" "ALTERED MENTAL STATUS" "1544952-1" "1544952-1" "RESPIRATORY FAILURE" "1544953-1" "1544953-1" "SUDDEN CARDIAC ARREST" "1544962-1" "1544962-1" "PULSELESS VENTRICULAR FIBRILLATION" "1544965-1" "1544965-1" "CARDIOPULMONARY FAILURE" "1544970-1" "1544970-1" "AMI" "1544973-1" "1544973-1" "SEPSIS" "1544977-1" "1544977-1" "CARDIOPULMONARY ARREST" "1544982-1" "1544982-1" "CARDIOPULMONARY ARREST" "1544986-1" "1544986-1" "SUDDEN CARDIAC ARREST" "1544990-1" "1544990-1" "MYOCARDIAL INFRACTION" "1544991-1" "1544991-1" "SEPSIS" "1545011-1" "1545011-1" "Death less than 24 hr after receipt of Pfizer #1 covid vaccine: 43 yo reportedly received her first Pfizer covid vaccine on 7/2302021. Her agent received a call from Staff to inform her of this sudden death. She was reportedly found on her couch deceased on Friday evening, 30 JUL 2021 and law enforcement had her transferred to a Funeral Home pending determination on Autopsy and Family wishes. Presumed cause of death is Heart Failure with Autopsy pending for etiology of Dilated Cardiomyopathy and death. Patient had 1.5 yr hx of dyspnea on exertion, intermittent chest pain at rest, and palpitations. She was evaluated here for a LBBB and long QT in 2018. Echo at the time was normal and she was cleared. BP: 118/72; HR: 71; RR: 16; T: 98.6 ¦F (37 ¦C); HT: 66 in (167.64 cm); WT: 155 lbs (70.31 kg); SpO2: 98%; BMI: 25.02; BSA: 1.795 square meters; Tobacco Use: Yes; What type of tobacco product?: menthol; Amount of tobacco product used per day: 2 per day;" "1545170-1" "1545170-1" "Vaccine #1 Moderna 02/04/2021 lot # 029K20A Pt died of cardiac arrest on 08/06/2021" "1545175-1" "1545175-1" "PT IS A COVID-19 BREAKTHROUGH CASE THAT EXPIRED ON 8/10/2021. NEARLY 5 MONTHS AFTER COMPLETING SERIES. HEALTH DEPARTMENT WAS NOT THE VACCINATING FACILITY BUT WE ARE THE REPORTING FACILITY." "1545180-1" "1545180-1" "Dose #1 Moderna 01/25/2021 lot # 029K20A Pt died in hospice care on 8/9/2021" "1545276-1" "1545276-1" "Resident noted with loss of appetite on 8/8/21 and resident expired on 8/10/21" "1545319-1" "1545319-1" "Dose #1 03/07/2021 Moderna lot # 032M20A Pt died of cardiac arrest 8/2/2021" "1545487-1" "1545487-1" "Patient was hospitalized due to breakthrough covid-19 infection on 7/27/21 with complaints of shortness of breath, nonproductive cough, daily fevers, decrease taste, chest pain when coughing, and fatigued. Patient completed the Pfizer vaccine series in February. Patients condition worsened over hospital course and he was pronounced deceased on 8/09/21 @21:55. Below information is copied from progress note on 8/08/21: 7/30/21: Patient has had no new issues overnight. He remains on HFNC + NRB 80L/100% maximum support, refusing bipap. Educated on importance of utilizing bipap, still refusing. Sats remain mid 80s. 8/1: No acute events overnight. Tol slow wean of HFNC. Bipap overnight. Hemodynamically stable. 8/2: No acute events overnight. On FFB overnight 85% 12/8. Was reportedly in chair most of the day yesterday on HFNC 70%/70l with stable sats. Hemodynamically stable. No fevers. 8/3:Patient sitting up in chair , on HFNC, nostrils bloody and with dry mucus. Requesting to be placed on regular diet with no restrictions. Uneventful night. 8/4: Sats upon intial exam this AM by this provider were 77%. Pt had just transferred bed to chair with HFNC and NRB. Sats slow to recover but with NRB, slowly improved to 89%. Pt states that he slept poorly last night and this AM upon getting up had trouble with severe left thigh cramp. Was given Robaxin, pain med, warm pack to thigh and is better now. Added Melatonin to HS meds prn to help with sleep. Additional aspart given for hyperglycemia. 8/5: no events overnight. Patient remained on BIPAP with no issues. 8/6: Pt required BIPAP d/t decreasing O2 sats to low 80s on HFNC. 8/7: Intubated last night for hypoxemia refractory to FFB 100%. Currently stable sats on APRN 100%, PH 30. Sub cut emphysema to neck. AM CXR, ABG, and labs pending. TF ordered. Wife notified of intubation- she was diagnosed with covid at same time as husband. She will contact her son who has been fully immunized and no current covid s/s. 8/8: patient remained intubated and sedated on ventilator overnight. APRV PH 24, 95% fiO2" "1545589-1" "1545589-1" "Pt admitted to hospital on 7/25/21 with shortness of breath, which turned out to be positive for Covid-19. Pulmonology was consulted and patient was started on dexamethasone, remdesivir, baricitinib, as well as Tocilizumab. Started on vapotherm O2 with Fi02 of 100 %. Despite aggressive measures patient condition deteriorated. Family made patient a do not resuscitate, and patient expired on 7/28/21." "1545621-1" "1545621-1" "The day after the vaccination, 02/18/2021, He was having headaches and confusion and it got worse over the weekend. On 02/21/2021 he went to the ER and was told he had bleeding in his brain. They stopped Coumadin and the bleeding stopped. He was in the hospital in town for less than a week and was transferred to Nursing and Rehab . On 03/12/2021- he had a major stroke and he went back to the hospital and came home for hospice, and died on 03/20/2021." "1545923-1" "1545923-1" "Patient presented 3 weeks after vaccination with massive bilateral femoral and portal visceral thrombosis. Taken to surgery and resected dead bowel. Thrombosis progressed and patient died after 2 days." "1546116-1" "1546116-1" "Continuous Weakness until death" "1548970-1" "1548970-1" "She was not feeling well - vomiting, chest and upper back pain for a few hours prior to visit. Died suddenly while workup in progress" "1548975-1" "1548975-1" "fully vaccinated, covid-19 death" "1548984-1" "1548984-1" "Patient was hospitalized with due to COVID-19 after being fulling vaccinated. Patient expired on 8/10/2021" "1549018-1" "1549018-1" "Admit 8/1/2021 From facility. tested positive for COVID 7/28/2021 at facility. Day of admit 02 sat 81% and facility called daughter to notify pt. was going to be taken to the ER. For EMS patient's oxygen dropped as low as 57% and patient was lethargic, and patient arrives to the ER non-rebreather. On my examination patient is oriented x1 and further history is limited due to altered mental status. The onset was 4 days ago. The course/duration of symptoms is worsening. The character of symptoms is COVID 19, hypoxia. Transferred to hospice 8/2/2021 and expired 8/4/2021." "1549046-1" "1549046-1" "Admitted 07/24/07/27 for weakness in legs, found to have O2 sat of 50% on room air. COVID test positive on 7/24 and pt diagnosed with acute hypoxemic respiratory failure due to COVID-19 . She was also found to be in acute renal failure. Pt was intubated, placed on vent and started on CRRT. She received Moderna vaccine, 2nd dose on May 15, 2021. On admission, pt denied any shortness of breath, body aches, headache, fever or chills. Patient condition deteriorated. was made comfort care on 7/27 and expired 7/27/21." "1549114-1" "1549114-1" "After the shot, sick, tired, aches and pains for two - three days. Day 3 - 5 Dizziness, blurred vision. Day 5 went to the hospital, ER found sign of stroke. Day 7 saw a neurologist, was told that a stroke occurred, but was not sure if it was new or old. Day 12, massive Ischemic Stroke followed by multiple hemorrhages. The Clot left a 10mm hole in the left side of the brain." "1549143-1" "1549143-1" "PASSES AWAY ON 7/25/21 OF UNKNOWN CAUSE BUT HAD PERICARDITIS" "1549226-1" "1549226-1" "Death - Symptom onset date 04/24/21 to include chills, loss of taste/smell, headache, fatigue, cough, SOB, nausea, vomiting and diarrhea." "1549276-1" "1549276-1" "She was extreme tire from the moment that she got home after the vaccine. no appetite to eat. I have to help her get up from bed. We call the doctor twice. We thought the doctor know the answer. The doctor said it is normal. As the days pass by, the condition got worse. She ate less and less. One the fourth day evening, she kept on calling my name. That was unusual. She probably not feeling well. One the fifth day morning, She seems very confused. That same morning. We call ambulance to take her to hospital. Two day later, she passed away. Doctors said it is blood inflection." "1549402-1" "1549402-1" "Patient was seen in the ED and hospitalized multiple times after second dose of vaccine, tested positive for COVID on 2/22/2021. Patient passed away on 8/11/2021" "1549423-1" "1549423-1" "Patient death within 60 days of receiving a COVID vaccine" "1549424-1" "1549424-1" "Blood clot to heart death" "1549429-1" "1549429-1" "Hospitalization and death COVID-19 PNEUMONIA, ACUTE KIDNEY INJURY, HYPOXIC RESPIRATORY" "1549456-1" "1549456-1" "Patient was hospitalized multiple times and died within 60 days of receiving a COVID vaccine series" "1549498-1" "1549498-1" "Admitted to acute inpatient hospital from Rehab for new diagnosis COVID-19 with lethargy without hypoxia on 8/6/21. Patient had a sudden event with bradycardia hypotension suspected MI. Patient was DNR DNI. Patient expired 8/9/21" "1549500-1" "1549500-1" "Patient was hospitalized multiple times and died within 60 days of receiving a COVID vaccine series" "1549543-1" "1549543-1" "Breakthrough Covid." "1549564-1" "1549564-1" "Week, wheezing, cough. low O2 saturations admitted to the hospital where he later died" "1549612-1" "1549612-1" "Dealth" "1549639-1" "1549639-1" "developed fever, cough and diarrhea." "1549649-1" "1549649-1" "Resident tested positive for COVID-19, on 8/9/2021. He declined quickly and passed away on 8/10/2021." "1553645-1" "1553645-1" "The patient is a 36 y.o. female with a past medical history notable for Hemolytic anemia on Rituxin monthly, Follows with Dr., chronic pain, depression, hypertension, migraines, sickle cell disorder, and thyroid disease who presents as a transfer from ER due to sickle cell crisis. Patient presented to ER with AMS, family reported finding patient unresponsive at home this am. Per record GCS was 5-7 when EMS arrived. Her sats were in the 60s. Patient was found to have a fentanyl patch which she is prescribed. She did not appear to be improving. She was subsequently intubated. She was somewhat difficult to oxygenate. Bronchoscopy showed copious edema bilaterally. Chest x-ray showed diffuse pulmonary edema. Her hemoglobin was found to be 4.9. She was noted to have some vaginal bleeding. Occult blood testing was positive. Per report patient's pulse bradied down into the 30s. It was unclear if she had a pulse so CPR was started. She quickly regained ROSC. Her heart rate improved to the 90s. She was given 1 unit of blood, started on propofol and epinephrine. Creatinine was 1.2. Potassium was 3.2, and it was replaced. WBC 10,Initial head CT scan was nondiagnostic due to limited patient cooperation. Repeat CT head was negative for acute abnormality. Patient was started on cefepime. She was transferred here for higher level of care. She is subsequently being transferred to another facility for further evaluation. On arrival here patient is intubated, sedated on propofol, in no distress. Vital signs stable. Patient tested positive for COVID-19. Started on Decadron and remdesivir. Critical care consulted. Has developed hypertriglyceridemia. Additionally, sputum culture growing MSSA consistent with superimposed MSSA pneumonia. Patient on cefepime. Patient had general worsening of her condition with worsening respiratory issues. On the night of 810, patient coded multiple times. Family visually made the decision to make patient DNR. Hemoglobin dropped consistent with acute chest syndrome. Lactic acid was greater than 18. Patient coded 1 more time and expired early this morning." "1553728-1" "1553728-1" "There were no signs or symptoms. Patient received his last Covid19 vaccine on 5/13/21. He passed away on 06/15/2021. The diagnosis on the autopsy report shows that he died from Dilated Cardiomyopathy. There was no evidence of trauma and a clean toxicity report. He has no previous diagnosed health problems." "1553784-1" "1553784-1" "possible breakthrough case on 8/2 if patient indeed was fully vaccinated last April" "1553959-1" "1553959-1" "Admitted to hospital on 7/23/2021. Intubated on 8/1. Expired 8/12" "1553967-1" "1553967-1" "experienced dyspnea, diarrhea, nausea, vomiting Associated with a long term care facility" "1554013-1" "1554013-1" "Patient died on August 9, 2021." "1554115-1" "1554115-1" "Nurse entered room patient was in PEA CODE BLUE called and patient expired on 8/13/2021" "1554249-1" "1554249-1" "Clot resulted in a stroke; was leaving a checkup with the doctor when she collapsed. August 3rd 4:30pm; passed away 7 hours later at 11:30pm." "1554322-1" "1554322-1" "Case was vaccinated with covid vaccine on 5/6/21 & 5/27/21. Was admitted to Medical Center on 8/2/2021 with chest pain and shortness of breath. Tested positive for COVID 19. Case expired at Medical Center on 8/10/21." "1554378-1" "1554378-1" "Death" "1554434-1" "1554434-1" "Patient required hospitalization due to breakthrough infection. He received the Pfizer vaccine (2nd dose in series) on 03/25/2021. Hospitalized from 07/24/21 - 08/13/21 (death). Below is copied from his discharge (death) summary: Cause of Death Cardiac arrest Acute respiratory failure Discharge Condition: Expired Hospital Course: 87 y.o. male admitted on 7/24/2021 for evaluation of generalized weakness for the past day, loss of appetite, increased dyspnea. In the ED with diffuse rhonchi. Sats 88% on room air. Started on 5 L NC. Work up with COVID. Also AKI. Started on abx and steroid AMS and confusion Acute hypoxic respiratory failure on nasal cannula. COVID pneumonia, present on admission. Asthma exacerbation improved. Sepsis, now resolved, secondary to COVID. Acute kidney injury likely prerenal dehydration, resolved. Hypertension well controlled. Benign prostatic hypertrophy. Bipolar/schizophrenia. Delirium ? Psychosis vs dementia, improved. SI s/p mental health act 08/04. Patient had a very long hospitalization on the floor and in the ICU Treated with IV abx, IVF and all COVID treatment He was on HF but improved at some point and placed on RA then got worse again so abx restarted and speech reevaluated During the admission his mental status didn't improve and he was on restraints to avoid self-harm Psych, neuro and pulm followed during the admission CTH no acute findings as well as MRI . Druing my round today around 11.15-11.20a found the patient to be unresponsive when I stepped in his room. Pulse ox wasn't on his finger tried to place it but didn't work so called RN but we couldn't appreciate any pulse that time so we called code blue . Patient still unresponsive and very faint heart sounds on exam with no significant pulse . Code staff/ICU team responded. Compressions , respiratory support , epi given as well trial of intubation since the pateint still listed as FULL code, but unfortunately didn't tolerate it and expired around 1138am Discussed in details with the staff Also called and discussed with his Care giver and empathy provided Patient has no family around and his care giver knows him and takes care of him for 20 years" "1554435-1" "1554435-1" "Patient received dose 1 and 2 of COVID vaccine on 2/6/21 and 2/27/21, respectively. On 8/4/21 the patient presented from home after progressive upper respiratory symptoms that began on 7/28/21. She states that about a week prior to admission she started having some generalized fatigue with progressively worsening shortness of breath to the point where it is difficult for her to ambulate. She checked her oxygen levels at home and they were low hence she presented to the ED today for further evaluation. On arrival she was found to be 82% on room air oxygen saturation. She had no recent nausea, vomiting or diarrhea. She stated that she has been occasionally seeing blood in her stools. She had an EGD April 2021 which showed some gastritis and Schatzki's ring. She also stated that she had a colonoscopy 2 weeks prior to admission which according to the patient showed some hemorrhoids. Patient was started on remdesivir, Lovenox for prophylaxis of DVT, continued home blood pressure medications, as well as vitamins. Her inflammatory markers were trended. Since oxygen saturation deteriorated rapidly, patient was upgraded and was placed on Vapotherm 40 L 100% with as needed BiPAP. Patient was continued on IV steroids and remdesivir. Patient continued to decompensate while on Vapotherm, patient was requiring continuous BiPAP for several days and was unable to be weaned off of it. Patient's mental status deteriorated as well. All attempts were made to reach family but had difficulty, supportive care medicine was involved as well. Her mentation began to further deteriorate and patient began to desaturate on BiPAP, necessitating intubation as per family's wishes. Further goals of care discussion guarded family patient was made DNR. Patient's family members came to hospital to see her, noted her again deconditioning discussed poor prognosis. Patient is then made comfort care as per family. Patient expired on 8/13/2021 at 4:18 AM." "1554444-1" "1554444-1" "Cough, dyspnea, fatigue, headache, pneumonia, chest pain and wheezing" "1554791-1" "1554791-1" "Pneumonia or Pneumonitis Weakness Severe hypoxia Cough Atrial fibrillation Dyspnea Death Progressed from ambulatory to death in 8 days" "1558329-1" "1558329-1" "Patient was found dead in the yard of his residence. He laid in the yard for a couple of days before he was discovered. No further information was provided by the family. His wife lives with him in the home; however, she is disabled and unable to provide any information." "1558346-1" "1558346-1" "Was very tired and wanted to stay in bed from short time after receiving the vaccine. Experienced some chest pain. Was found deceased in house at night 14 days later." "1558466-1" "1558466-1" "Felt fatigued the day before adverse event, died in his sleep of arterial occlusion" "1559265-1" "1559265-1" "Patient c/o sudden onset of headache to family and suddenly passed away immediately following statement made that she had a headache" "1569053-1" "1569053-1" ""Patient required hospitalization due to breakthrough infection. He received the Pfizer vaccine (2nd dose in series) on 03/03/21. Hospitalized from 08/10/21 - 08/14/21 (death). Below is copied from patients discharge (death) summary: Hospital Course: Patient is an 84 year old man with a past medical history of Afib (on eliquis, metoprolol), HTN, HLD, MI admitted to the ICU for acute hypoxemic respiratory failure secondary to Covid-19 pneumonia. He presented to the ED after EMS was called for fall out of bed with generalized weakness, he denies hitting his head or LOC. He was satting 78% on EMS arrival and tachypneic, he had minimal improvement with NRB. In the ED he was found to be in Afib RVR to the 160s with hypotension, levophed was begun, he was cardioverted, and was begun on amiodarone infusion. The patient reports a 1 week history of generalized fatigue and shortness of breath without leg swelling or orthopnea. He was vaccinated in March with the Pfizer vaccine. He reports his cardiologist is at another facility and doesn't remember his medications offhand but knows he takes Eliquis BID. 8/11: TTE ordered, not yet performed. K+, Mg, phos low and repleted. On HFNC + NRB 60L/92% satting high 80s/low 90s. Currently on amio drip. No other acute events. 8/12 Patient elected to be DNR/DNI yesterday. Urine culture growing >100K Staph, started on Vanc/Cefepime while waiting sensitivity. Amio gtt changed to metoprolol. Patient endorsing soreness/back pain and states he uses Percocet and fentanyl patch outpatient. On HFNC + NRB 60L/95%, satting high 80s/low 90s past 24 hours. Echo performed shows EF 50-55%, impaired relaxation, moderately enlarged RV, moderately dilated LA, PASP 45 mm Hg. 8/13: Patient elected to rescind DNR/DNI 1 day ago. Became acutely agitated throughout the night and was removing HFNC stating that he ""did not want to do this anymore"". Started on precedex gtt and haldol prn for agitation. Pt w/ improved compliance w/ HFNC and able to maintain O2 saturation between 87-89%. 8/14: Patient now DNR/DNI, daughter at bedside while patient's wife was again admitted to the hospital. Decision made to pursue compassionate wean. Started on Morphine infusion for comfort and to prevent air hunger. O2 saturation continually downtrending. Asystole at 1803, confirmed in 2 leads. No signs of life. Pronounced expired at 1803. Dr notified at 1806."" "1570787-1" "1570787-1" "Very healthy 70yr old man who sees his doctor regularly became tired, confused, depressed and lost weight suddenly. March and April tried to shake it off and thought he was just feeling his age. In May he went to his doctor who treated him for depression. He took an overdose of his anti depressant medication and was hospitalized (5/29/2021) Went to medical Center for treatment. They said he was on wrong anti depressant and changed his medication to Lexapro 5mg. On 7/6/2021 he committed suicide. He was being treated for a chemical imbalance. He did not have a chemical imbalance before the vaccine. He has had the same doctor for 10yrs. and has been on the same medications. No reason for depression. Best time of his life. I can not rule out or prove the vaccine played a major part in his death." "1573848-1" "1573848-1" "Internal bleeding, purplish fluid began to ooze from her mouth on." "1573968-1" "1573968-1" "My mother experienced fatigue, headache, arm pain, nausea, loss of appetite and passed away two days after second dose of Covid-19 Pfizer vaccine. *Please note: Hospital has patient listed with a 7/4/1945 birth date which was incorrect and never corrected. Birth certificate shows 7/5/1945 as correct date of birth." "1573981-1" "1573981-1" "Patient has 1st dose of Pfizer vaccine documented on 8/4/2021. Per hospital notes, pateint recevied dose and has been short of breath since." "1573992-1" "1573992-1" "Death" "1574001-1" "1574001-1" "On 8/12/21 at 8:30 p.m. resident noted in bed alert and responsive. Resident noted talking to nurse. At 9:10 p.m., resident noted to be unresponsive by staff. CPR initiated. 911 arrived at 9:27 p.m. and was unsuccessful. Pronouncement of death at 9:30 p.m. Medical examiner deemed resident death as natural causes" "1574026-1" "1574026-1" "Pt developed acute TTP ~3 weeks post dose and subsequently passed away." "1574074-1" "1574074-1" "69 year old male who presented with abdominal pain due to mesenteric venous thrombosis of the portal vein / superior mesenteric vein confluence. He was managed medically with therapeutic heparin anticoagulation, however he rapidly progressed in less than 24 hours despite medical therapy to having extensive superior mesenteric vein thrombosis and portal vein thrombosis causing bowel and liver ischemia with septic shock. He went to Interventional Radiology and underwent extensive thrombectomy, however he was too unstable to undergo surgery for resection of dead bowel and died secondary to septic shock and multi organ failure." "1574126-1" "1574126-1" "-pt was found to have acute hypoxic respiratory failure secondary to COVID19 and severe hyponatremia - 8/6/21 pt received monoclonal antibodies but not a candidate for remdesivir d/t duration of symptoms -d/t minimal improvement symptoms, Palliative care was consulted. per family wishes pt was transitioned to inpatient hospice on 8/12/21 pt pronounced deceased at 1148 on 8/13/21" "1574223-1" "1574223-1" "The patient was admitted to Hospital on 5/19/2021. Patient was having shortness of breath. Patient was diagnosed with acute respiratory failure with hypoxia. Patient was admitted to the CCU. Patient died on 5/23/2021" "1574282-1" "1574282-1" "Admitted to hospital with shortess of breath, cough, diarrhea, nausea, vomiting. While admitted increase in oxygen demands" "1574401-1" "1574401-1" "Several pain in her legs, hands, and arms. developed Several Vasculitis. Hospitalized for 4 months in pain. Acquired COVID in the hospital and died 5 days later." "1574415-1" "1574415-1" ""Called from Medical Examiner's office that record of vaccination was needed on a deceased person. Upon talking to local Fire Chief states, ""patient received Moderna COVID 19 vaccination on 8/10/21 complained of chest pain on 8/11/21 and deceased on 8/12/21. Fire Chief reports that patient was overweight and had hypertension."" "1574423-1" "1574423-1" "Client tested positive for COVID-19 via PCR on 7/26/2021 after being fully vaccinated. Pfizer vaccine dose #1 administered on 1/22/2021 lot#EL9262 and Pfizer vaccine dose #2 administered on 2/12/2021 lot# EN9581. Client died on 7/29/2021 cause of death as COVID-19 per Coroner's office." "1574553-1" "1574553-1" "Patient has extensive history of autoimmune disorders. Received Moderna vaccine #1 on 3/13/21. Developed sore throat 3/15, progressing to oral lesions - went to urgent care on 3/22/21 and ED on 3/25/21 (diagnosed with stomatitis). Evaluated by ENT specialist 4/2/21 and diagnosed with oropharyngeal lichen planus. Was prescribed steroids. Hospitalized 4/2/21, 4/17/21, and 7/23/21 due to dehydration, malnutrition, and weakness. Patient opted for hospice care and died 8/10/21." "1574576-1" "1574576-1" "5/20/2021 experiencing symptoms: dyspnea 5/24/2021 Admitted to hosp. and treated for COVID-19/ pneumonia 5/30/2021: died" "1574592-1" "1574592-1" "Covid vaccine received 1/29/21 and 3/4/21, Pfizer mRNA Covid-19 vaccine. Client died of Covid related death on 7/25/2021" "1574608-1" "1574608-1" ""On 8/2/21, client had a reported sudden death in the morning after complaining of ""being unable to hear"" and dizziness. EMS was called to the site and CPR was attempted by employees until EMS arrived. Resuscitation attempts were unsuccessful. Pt had tested positive for Covid 19 approximately one week after the first vaccine was given. She had not been hospitalized. An autopsy was conducted with reported preliminary report of citing cardiac arrhythmia. PCP name is Dr. was notified. Medical Director Dr. and she was notified. Both the Covid 19 and autopsy reports should be available through Hospital."" "1574621-1" "1574621-1" "She was complaining about feeling nausea and sick. She got extremely weak. She was having difficulties shallowing. Over the next 2-3 weeks she lost 20 pounds." "1574642-1" "1574642-1" "Nausea after 4-5 hours; coughing, fever for 8-10 hours" "1577653-1" "1577653-1" "Hospitalization for COVID19 7/24/21 and death 08/02/2021" "1577657-1" "1577657-1" "Overall, critical condition with poor outcome. Discussed with patient's daughters 8/13. I explained that the patient is deteriorating gradually and I agrees with comfort measures. On 8/14, discussed with the patient's son at bedside, all questions answered. I also called the POA updated on the patient current condition. Family will meet today and update us on their plan of care. Addendum 3 PM on 8/14: Family had a meeting about goals of care, all questions answered. Family decided to proceed with comfort measures. Will add Ativan and Morphine. Will continue high flow oxygen as per family request. Will continue to monitor. Discussed with the RN. Expired peacefully 8/15/2021" "1577863-1" "1577863-1" "8/7/21 Came to ED with shortness of breath and fall from standing. Was exposed to COVID on 7/31/21 and started having symptoms on 8/2/21. Had been vaccinated but test was positive for COVID on admission. On and off ventilator. Started on dexamethasone and remdesivir on 8/9. Oxygen requirements continued to increase. Patient/family elected for comfort measures only and patient died on 8/14/2021." "1577882-1" "1577882-1" "Massive right MCA stroke 31 hours after receiving vaccine, resulting in death 5 1/2 days later." "1577895-1" "1577895-1" "Patient passed away on 05/11/2021." "1577924-1" "1577924-1" "Death on 3/21/2021 of respiratory illness" "1577926-1" "1577926-1" "Sxs onset 7/26. -Death Disease Report says that the patient was admitted to ICU. Admitted to hospital on 8/6 and died on 8/10. *Death DIsease Report said he was NOT admitted to hospital due to COVID. *Death Disease Report said his death was NOT related to COVID." "1577966-1" "1577966-1" "Patient admitted to ICU on 8/13/21 on noninvasive ventilation. Patient repeatedly verbalized she did not want to be intubated. Overnight, increasing oxygen needs and AVAPS increased to fio2 100% and epap 14. She had increased work of breathing and tachypnea with respirations up to 50s and oxygen saturations 79-85%. This morning, monitor alarmed asystole and RN called code blue and initiated CPR with bag valve mask. Monitor tech advised patient was normal sinus rhythm and then ventricular standstill just prior to arrest. Multiple rounds of CPR with epinephrine administered, unfortunately we were not able to regain pulse. Patient was not intubated in honor of her wishes. Resuscitation attempts stopped, and time of death called at 09:18; may she rest in peace." "1577967-1" "1577967-1" "Hospitalization for COVID19 8/01/21 and death 8/09/21" "1577972-1" "1577972-1" "Hospitalization 8/6/21 for Covid19 and death 8/10/21" "1577987-1" "1577987-1" "Hospitalization 7/28/21 for Covid19 and death 8/07/21. Received dexamethasone 6 mg IV daily and Remdesivir for 8 doses" "1578038-1" "1578038-1" "Sxs onset 7/17. Moderna-1/21 and 2/18. Admitted to hospital 7/18 to 8/09. Died on 08/09 due to COVID related death per Disease report. Never admitted to ICU. Was in Step Down unit when he passed away" "1578066-1" "1578066-1" "7/29/2021 admitted to hospital; Pfizer on 4/10 and 5/3. Positive on 7/30" "1578245-1" "1578245-1" "Pfizer on 3/9 and 3/30. Positive on 8/6 8/5-8/13 admitted" "1578254-1" "1578254-1" "Pfizer on 1/4 and 1/26. Positive on 8/7 8-6/8-16 admitted" "1578274-1" "1578274-1" "Patient expired 4/10/2021 as reported by husband" "1578362-1" "1578362-1" "Admit 6/24, vaccine 3/16, 4/6. H/O HTN, CAD, emphysema. Per wife patient had asymptomatic COVID in Dec 2020.Admit for fever, SOB. Admit for spetic shock, lactic acidosis. Patient progressively hypoxic, BiPap then emergent intubation. Tfer to ICU, sepsis tx started. Shortly after pt required vasopressors. Coded, cardiac arrest and expired." "1578377-1" "1578377-1" "Admit 6/27. Vaccine 4/19, 5/18 PRIMARY CAUSE OF DEATH:Cardio respiratory Arrest secondary to Covid 19 pneumonia" "1578487-1" "1578487-1" "short of breath, chest pain resulting in death" "1578498-1" "1578498-1" "DEATH" "1578504-1" "1578504-1" "weakness, SOB, Abdominal cramps, nausea and vomiting starting 5/28/2021. admitted to the hospital required breathing assistance. tested positive for COVID-19 06/03/2021, died 7/18/2021" "1578507-1" "1578507-1" "SHORT OF BREATH, EXPOSURE TO WIFE WITH covid, FEVER, ADMITTED TO ICU AND THEN HOSPICE" "1578516-1" "1578516-1" "ALTERED MENTAL STATUS, SHORT OF BREATH" "1578593-1" "1578593-1" "Died June 25th after cardiac arrest on June 23rd, 8 days after his vaccine." "1578659-1" "1578659-1" "tested as pre-operative procedure/surveillance. No symptoms. Patient was diagnosed with encephalopathy and was transferred to comfort care on 7/11 and died peacefully with family at bedside. He tested positive for COVID w/no symptoms on 06/04/2021 during admission surveillance; LTCF where patient lived had 3 other residents tests positive" "1578678-1" "1578678-1" "Patient was found to be hypoxic and he required high-flow oxygen. Patient was also found to be COVID-19 positive. According to the patient he was diagnosed with COVID-19 last year. He also to the vaccine this year. He took the 2nd dose back in March of 2021. When I interviewed the patient. Patient had a hard time recalling events and answering the questions directly. He said something about having some fluids buildup for which he had water pills. Patient appeared to be very poor historian about his current condition. He just said that it started 2 days ago to get really worse. He reports generalized weakness and generalized fatigue with generalized pain. He also reported low-grade fever. Nothing made symptoms worsen nothing made his symptoms better. Patient died on 8/14/2021, cause of death under review." "1578963-1" "1578963-1" "Unexplained death. Patient was found dead near his front door with car keys still in his hand. Pacemaker had recently been checked and was working fine, so it was not a heart attack." "1582152-1" "1582152-1" "I21.4 - Non-ST elevation (NSTEMI) myocardial infarction J18.9 - Pneumonia, unspecified organism" "1582161-1" "1582161-1" "death N17.9 - Acute kidney failure, unspecified" "1582313-1" "1582313-1" "presented to the hospital with weakness, fatigue, decreased appetite. diagnosed with pneumonia which progressed to ARDS" "1582335-1" "1582335-1" "Chest and back pain, Shortness of breath, Feelings of having a fast-beating, fluttering, or pounding heart, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell, diarrhea, vomiting and eventually signs of pancreatitis, jaundice and death within 4 months of 2nd shot. This is 5 in family and friend group taking Pfizer." "1582506-1" "1582506-1" "vaccine given 7/9/21 patient admitted to local Hospital then transferred to another Hospital and finally transferred to a final Medical Center ICU 7/15/21 with liver failure" "1582568-1" "1582568-1" "death Acute kidney failure, unspecified" "1582618-1" "1582618-1" "Patient admitted to hospital on 8/10 with acute respiratory failure. Symptoms started 8/4. Respiratory status worsened and transferred to ICU on 8/15. Patient passed away on 8/17/21." "1582680-1" "1582680-1" "Pt.'s Wife states that after receiving the 1st dose of Moderna 02/14/2021, started experiencing symptoms 02/17/2021 of head swelling, swelling in the Lymphoids lasting 3 weeks, shortness of breath, coughing up mucus, passed away from from Blood Clots in the lungs 06/15/2021. Primary visit (no tests) treated with Antibiotics for 2 months, noted as Congestive Heart Failure. Primary recommendation to not receive the 2nd dose of Moderna." "1582847-1" "1582847-1" "Patient was a 58 year old patient. He had ESRD on HD MWF. He had previously been hospitalized 8/4/21 - 8/5/21 - diagnosed with Covid 19 during this stay - stabilized and was able to be discharged home. He deteriorated at home and was brought back to the ED via EMS 8/6/21 with ARDS secondary to Covid - 19. He was intubated and remained for the duration of his stay in the ICU. He had two code incidents 8/16/21 and 8/17/21. Upon the 3rd Code, they were unable to revive him and upon discussion with family - decision made to stop CPR and patient expired." "1582850-1" "1582850-1" "8/12/21 @ 03:37 AM - PT NOTED TO HAVE EMESIS ON SHEETS AND GOWN. RESPONSIVE, VITALS STABLE, MD AND FAMILY NOTIFIED, ZOFRAN ORDERED AND GIVEN. NO DISTRESS NOTED. 8/12/21 @ 09:55 AM - PT NOTED TO BE EATING BREAKFAST. NO DISTRESS NOTED. 8/12/21 @ 8:50 PM - VOMITING, NON-RESPONSIVE, RESPIRATORY DISTRESS. 02 SATS 48-50%. AMBULANCE CALLED, PT TAKEN TO ER. 8/12/21 @ 8:58 PM - FACILITY NOTIFIED THAT RESIDENT EXPIRED." "1582941-1" "1582941-1" "Four days after the shot, patient started having blood clots in the urine. After a few weeks, was able to get back to normal but seemed to stimulate previously stable cancers into growth. Four days after the 2nd (3/19/21) covid shot blood clots started again." "1582950-1" "1582950-1" "The patient presented to the ED on 8/4 with 2-3 day history of progressive SOB that had gotten worse in the past 24 hours. She tested positive for SARS-CoV-2 on 8/4 with an antigen positive test. On 8/12/21, the patient took a turn with desaturation and difficulty breathing on high flow oxygen at 15L. The family opted to make her comfort care and she expired at 1715 on 8/12/21" "1582987-1" "1582987-1" "Young, healthy 25 year old male. Very physically active, no health issues. Suddenly had horrible headache at 2am. Threw up, went to take a shower, girlfriend found him 10-20 min later purple in the shower. Called EMS. Heart & lungs brought back with defibrillator & ventilator. CT scan showed massive brain hemorrhage. No brain activity. Pronounced dead Tuesday Aug 3rd. Doctors concluded ruptured AVM due to amount of blood in brain. Does vaccine cause inflammation that could have caused early rupture?" "1583011-1" "1583011-1" "Associated with a LTC facility. experienced dyspnea, cough, wheezing and fever Hospitalized" "1583081-1" "1583081-1" "COVID19 death" "1583177-1" "1583177-1" "08/11/2021 19:08 The patient presents with 77 year old male with a PMHx of HTN, MI, distant lung cancer, CAD, and high cholesterol presents with shortness of breath x 2 days. Pt got COVID a week ago and states he was feeling better but reports he started to have shortness of breath 2 days ago. He denies taking any medication for COVID. He denies fever, n/v, diarrhea or any other symptoms. Pt reports he had a headache, chills, myalgia but denies those symptoms now. Pt states he is here to get BAM done. Pt reports he got his COVID vaccine earlier this year but is unsure which one. No chest pain, abdominal pain, urinary symptoms. No leg swelling. No other complaints. The onset was 1 weeks ago." "1583179-1" "1583179-1" "Patient passed away suddenly and unexpectedly on 5/7/21. Cause of death on death certificate states ventricular fibrillation" "1583196-1" "1583196-1" "Pt was hospitalized with covid and died" "1584021-1" "1584021-1" "My father threw up and had a fever after the first vaccine. After the 2nd vaccine he couldn't breath. He could no longer walk well, and started having me push him in a wheel chair. We got him a machine and for one week it seemed to help. He passed away on March 26 2021. Just a month and a half after his vaccine. He was swelling up and having difficulty breathing. I found him dead the day we were going to see Dr. for a follow up. I didn't want to believe it was the vaccine so I didn't rush him to the doctor saying it was the vaccine. This is important and you all need to know that some people are dying from it." "1586331-1" "1586331-1" "Patient expired due to Large Bowel Obstruction. (found to be COVID positive) Attestation signed by MD at 8/7/2021 11:02 PM (Updated) General Surgery Pt seen and examined on 8/6/2021 with the surgery team, all labs, vitals, imaging and objective data reviewed. Agree with the below note with the following addendum: The patient is a 75-year-old female with multiple chronic medical comorbidities presenting to the emergency department with a complaint of abdominal pain. She states that her pain just started this morning and really worsened around noon. Has been rapidly worsening since that time. She also notes significant nausea and abdominal distention. She reportedly underwent colonoscopy several years ago which was incomplete due to inability to pass the colonoscope. She reports that for the last several months the caliber of her stools has been very small. AAOx3. Writhing in pain. No focal Neuro-deficits Non-labored respirations. Very distended, severely ttp throughout Moving all extremities A/P: 75 year old female with large bowel obstruction -large bowel obstruction: The patient's CT scan and history are consistent with a diagnosis of large bowel obstruction. She has evidence of severe dilation of all proximal colon. The etiology of her obstruction is unclear. It could be related to malignancy or, based on her history, it is more likely related to chronic diverticular inflammation. Regardless of its etiology the patient is in distress and I am concerned that she is at high risk for colon ischemia or perforation. She will need emergent operative exploration. I discussed this case with the Dr with the colorectal surgery service. Following our discussion the decision is made that the general surgery service should take the patient to the operating room. I discussed the plan for operative intervention with the patient as well as her daughter. I will plan for an exploratory laparotomy with sigmoid colectomy. Risks of the surgery are significant. We discussed the risks which include bleeding, infection, need for reoperation, need for multiple operations, cardiopulmonary complications from anesthesia, ostomy creation which may be temporary or permanent, hernia, and need for postoperative ventilator support. The patient voices understanding of these and is eager to proceed with surgery. -COVID positive: The patient has already had COVID and has since been vaccinated. She is PCR positive for COVID today. I will take respiratory precautions. Is unclear whether this is an active COVID infection or not. -Coagulopathy: The patient takes eliquis. Reverse with PCC at this time for emergent operative intervention. -hypoxia: The patient is hypoxic and requiring supplemental oxygen at this time. This is unclear whether this is related to her COVID diagnosis for her severe abdominal distention. -sepsis: The patient has evidence of sepsis with the source of ischemic colon. Administer broad-spectrum antibiotics at this time. Procedure the operating room for source control. Continue with hemodynamic support." "1586540-1" "1586540-1" "I am the epidemiologist reporting on behalf of patient. The patient received two doses of the Pfizer vaccine on 2/17 and 3/10. On 8/10/21, the patient tested positive via a PCR test for COVID-19 (vaccine breakthrough). The patient died on 8/10 and the cause of death is listed as ?Respiratory Arrest.? I do not have any further detail regarding pre-existing conditions or provider information." "1586554-1" "1586554-1" "I am the epidemiologist reporting on behalf of patient. The patient received two doses of the Pfizer vaccine on 03/09 and 03/30. The patient was initially hospitalized on 07/19 with an initial diagnosis of pneumonia. The patient tested COVID + on 07/20 and again on 07/28 via a PCR test (vaccination breakthrough). The patient was reported as having died on 08/15. Cause of death is listed as acute, hypoxic, respiratory failure; pneumonia/ARDS; COVID 19; Acute on Chronic Renal Failure. Underlying health conditions include chronic lung disease (asthma/emphysema/copd), chronic renal disease." "1586730-1" "1586730-1" "couch, SOB, chest pain resulting in hospitalization" "1586737-1" "1586737-1" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586787-1" "1586787-1" "SOB hospitalized" "1586812-1" "1586812-1" "Dose 1 Moderna 02/09/2021 no lot # Patient died of pneumonia, ARDS on 8/18/2021-not a covid infection, not vaccine related" "1586819-1" "1586819-1" "Dose 1 01/25/2021 moderna lot # 029K201 Pt died from CVA complications on 8/18/2021- NOT a covid or vaccine related death" "1586824-1" "1586824-1" "Admitted 08/05/2021. Deceased 08/18/2021. Diagnosis was Covid-19." "1586852-1" "1586852-1" "Recent N/V/D Presented Viral Gastroenteritis COVID vaccine related" "1586877-1" "1586877-1" "Resident had no issues after receiving vaccination. The next morning he was found in his room laying face down on the floor and unresponsive. CPR was started, 911 called. Unfortunately resident was pronounced dead at 7:55am." "1586886-1" "1586886-1" "hospitalization resulting in death" "1586936-1" "1586936-1" ""RESIDENT REC'D FIRST DOSE MODERNA VACCINE LEFT DELTOID AT 1334. PROGRESS NOTE FROM FACILITY READS: 8/18/21 @ 15:11- ""RESIDENT IS ALERT AND WATCHES TV IN HIS (?) FOR ENTERTAINMENT. RESIDENT RECEIVES ROOM VISITS AND MONITORING NEEDS AND INTEREST."" 8/18/21 @ 20:50- ""RESIDENT WAS UNRESPONSIVE WITH SHALLOW BREATHING, EYES OPEN BUT VERBALLY NO SOUND, PLACED RESIDENT ON 02 @ 3 LITERS PER NASAL CANNULA, NOTIFIED NP OF RESIDENTS STATUS RECEIVED ORDERS TO SEND RESIDENT TO HOSPITAL VIA 911, NOTIFIED 911, 911 UNABLE TO GET A BP ON RESIDENT, RESIDENT SAFELY TRANSFERRED TO STRETCHER FOR TRANSPORT TO ER, RESIDENT FAMILY NOTIFIED, RN NOTIFIED."" RN STATES THEY REC'D WORD THAT PT HAD EXPIRED BETWEEN 8:50 AND 10:14PM."" "1587119-1" "1587119-1" "Patient was hospitalized on August 14th and Passed on August 15th,2021" "1587125-1" "1587125-1" "Patient tested positive for COVID-19. He was hospitalized due to falling frequency, fatigue, and worsening gait. Patient died." "1587137-1" "1587137-1" "signs and symptoms of covid- hospitalization and death" "1587163-1" "1587163-1" ""About 2 wks post vaccine my husband started to develop dyspnea which appeared at that time on exertion (walking & exercise). Probably took another week to get into the doctor but I do not remember for sure. Dr. Diagnosed him with exertional asthma. He was put on inhalers and a medication. I do not know what medication. He seemed to be getting worse and was put on a more potent inhaler with cortisone and took an OTC supplement called NAC which he bought at a healthfood store. Then on May 19 at 7;45am we were sitting on the sofa having morning coffee. I noticed he was having what looked like a worse breathing episode. I asked if I should call 911. He said, ""No, this will pass."" So I said I was going to take a Pulse/Oximeter reading because I brought that and an AED from our surgery center which we had just closed and retired in 2019. His O2 was 100% w 62 pulse. That looked good to me. I layed down the Pulse/Oximeter and about a minute or two he had a cardia arrest! I called 911, pulled him on the floor and started CPR while talking with the EMS all the while. I stopped for a minute to put on the AED. I told EMS I am going to defibrillate , he has not pulse! The AED did not go off. I continued CPR, then the EMS came and started CPR and tried defibrillation but theirs did not go off. The EMS told me he was in a PEA (pulseless electrical activity) where he had not heartbeat but still had electrical activity in his body so the the debribrillators read it as a rythymn that was not amenable to defibrillation.. Now I found out the threat of blod clots and feel that is what he had!"" "1587223-1" "1587223-1" "Patient passed away on 08/03/2021." "1587255-1" "1587255-1" "Patient passed away on 08/05/2021" "1587300-1" "1587300-1" "Fully immunized at time of death from COVID-19" "1587309-1" "1587309-1" "8/1/2021 Client admitted to Hospital with c/o fever, weakness, cough. No persistent hypoxia noted at the time. 8/9/2021 Client transferred to Hospital for Hospice and comfort due to declining condition. Notes on transfer indicating he had been admitted to ICU and intubated and had a CXR indicating pneumonia. Client died 8/10/2021. Death report: PNEUMONIA SECONDARY TO COVID-19. ACUTE HYPOXIC RESPIRATORY FAILURE. Submitter does not have access to any further medical records for this client. Please contact hospitals for any further information required:" "1591198-1" "1591198-1" "I have minimal information but wanted to report as patient's wife is unsure if patient's death is related to his vaccine. Patients wife, called me and was very hard to understand but was able to tell me that her seemingly healthy 42 year old husband died out of nowhere on Wednesday August 18th, 13 days after receiving his second dose of the Pfizer vaccine. They are not sure what the patient died from, the wife states everything happened so fast and she said she wasn't sure if he was having a seizure or a heart attack. According to the wife an autopsy is being performed to discover cause of death. Patient had no complaints after his first dose, and only had normal possible side effects after his first dose." "1591215-1" "1591215-1" "Cause of death not documented. No ADRs reported between the observation period and date of death. Significant comorbidities include multiple myeloma, HTN, BPH, PTSD. History of hospitalization prior to death not available. Death updated on the system on JuL 28, 2021." "1591241-1" "1591241-1" "Cause of death not documented. Not information about previously COVID-19 positive, predisposing factors, hospitalization history, and co-morbidities on the electronic health record. No adverse events during the observation period after administration of the vaccine. No primary care provider listed. Death documented on our EHR on 08/02/2021." "1591249-1" "1591249-1" "Patient passed away on 08/08/2021." "1591253-1" "1591253-1" "Patient passed away on 08/07/2021." "1591258-1" "1591258-1" "Patient passed away on 07/30/2021." "1591262-1" "1591262-1" "Death" "1591265-1" "1591265-1" "Patient passed away on 08/01/2021." "1591271-1" "1591271-1" "Cause of death not documented. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Significant comorbidities include HTN, hyperlipidemia, COPD, GERD, prolonged QT interval, and history of polypectomy." "1591410-1" "1591410-1" "WEAKNESS" "1591428-1" "1591428-1" "POSITIVE COVID TEST" "1591433-1" "1591433-1" "COUGH, RUNNY NOSE, FOR TWO WEEKS, GENERAL MALSIE, BODY ACHE" "1591528-1" "1591528-1" "covid symptoms beginning on 7/25/21" "1591538-1" "1591538-1" "Pt was admitted on 7/30/21 for SARS-CoV-2 and remained hospitalized until 8/16/2021 when he expired." "1591539-1" "1591539-1" "PMHx of Alzehimer ds, CVA and dysphagia , HTN presented w/ AMS per Ag Rhods, Per EMS tachypnic & placed oxygen for comfort, on arrival to ED, alert but tachypnic and diaphoretic, 3 L NC oxygen. Patient is admitted with Sepsis 2/2 urosepsis vs osteomyelitis of the left forefoot + AKI + Abbot positive COVID PNA patient's son decided his mother should not get surgical intervention and he relayed she wouldn't want aggressive treatment and placed patient on hospice through SNF Death: CARDIAC ARREST, END STAGE ALZHEIMER'S DISEASE, DEMENTIA, SEPSIS" "1591545-1" "1591545-1" "Pt was hospitalized with covid 8/15 and died 8/20" "1591552-1" "1591552-1" "Patient passed away on 08/19/2021" "1591564-1" "1591564-1" "Case received second covid vaccine on 03/04/2021. Hospital on 8/7/21 with respiratory distress . Positive COVID lab on 8/7/21. Case expired at hospital on 8/18/2021." "1591608-1" "1591608-1" ""This is the case of a 76 year old with a history of DM, high cholesterol, and a recent humeral bone infection. The decedent had his PORT removed today after his bone infection appeared to be healed. The decedent did not smoke cigarettes, did not drink alcohol, did not use illicit drugs, did not have depression, and did not have any COVID symptoms. Today the decedent appeared in high spirits after he received his booster/third shot of Moderna. He received it on 8/19/21 at the Pharmacy at 1300 hours. This evening the decedent was with his wife when he told her all of a sudden he felt sick. He started toward the bathroom when she reported hearing a noise from him that ""she has never heard before"". She heard the decedent collapse and called 911. EMS started ALS and EMS took over. They continued for minutes but he could not be resuscitated and was pronounced on scene. EMS confirmed all of the medications were in order, no concerns of foul play, or any other unnatural death. Jurisdiction is assumed due to vaccination shot within 48 hours. Previous vaccinations received included Moderna on 2/14/21, lot #015M20A, Second shot 3/14/21 lot #044A21A"" "1591620-1" "1591620-1" "Patient had covid vaccine x 2. Last dose on 2/8/21. Admitted to Hospital on 08/15/2021 with covid symptoms. Positive COVID specimen on 8/15/2021. Patient expired at hospital on 8/18/2021." "1591660-1" "1591660-1" "Patient received covid vaccine x 2. Last dose on 1/27/21. Admitted to Hospital on 8/9/2021 with covid symptom and tested positive for COVID 19 upon admission. Case expired at hospital on 8/17/2021." "1591682-1" "1591682-1" "2ND COVID19 VACCINE ADMINISTERED 4/13/2021. ADMITTED TO MEDICAL CENTER ON 08/06/2021 WITH COVID PNEUMONIA AND ACUTE HYPOXIC RESPIRATORY FAILURE. WAS TREATED WITH REMDESEVIR IV, DEXAMETHASONE, AND PLACED ON HIGH FLOW O2. PATIENT DECOMPENSATED, WAS PLACED ON BIPAP, AND THEN TRANSFERRED TO ICU AND INTUBATED. CONTINUED TO HAVE INCREASING VENTILATORY SUPPORT. FAMILY EVENTUALLY REQUESTED COMFORT-FOCUSED CARE. EXTUBATED AND EXPIRED ON 8/18/2021." "1591702-1" "1591702-1" "6/30/2021 symptoms: cough, 7/6/2021 Positive COVID-19 7/19/2021 died" "1591731-1" "1591731-1" "weak, short of breath, failure to thrive, hypoxia leading to hospitalization" "1591750-1" "1591750-1" "PATIENT RECEIVED SINGLE DOSE OF JANSSEN COVID19 VACCINE ON 5/04/2021. ADMITTED TO MEDICAL CENTER ON 08/15/2021 WITH WORSENING SHORTNESS OF BREATH. TESTED POSITIVE FOR COVID19 ON 08/10/2021 AFTER STARTING CHEMOTHERAPY FOR SMALL CELL LUNG CANCER THE WEEK PRIOR. REQUIRED HI FLOW O2 IN ED, STARTED ON DECADRON, REMDESIVIR, CEFTRIAXONE, AND LASIX. PATIENT HAD PROGRESSIVE RESPIRATORY DECLINE. FAMILY ELECTED TO PURSUE COMFORT MEASURES. PATIENT EXPIRED ON 08/18/2021." "1591754-1" "1591754-1" "weakness, cough, loose stools" "1591831-1" "1591831-1" "SOB, fever" "1591854-1" "1591854-1" "Hospitalization 8/5/21 on dexamethasone 6 gm IV daily for 10 days and Remdesivir for 5 days; expired 8/17/21" "1591913-1" "1591913-1" "8/7/2021: Patient is a pleasant 82-year-old male c significant past medical history of CVA c left-sided deficits, P 80, hypertension, hyperlipidemia, diabetes, heart failure, carotid artery disease history of endarterectomy. Patient presents to Hospital from nursing home for slight cough. He did test positive for COVID on 8/7/2021 but is been satting well on room air. Chest x-ray is still in progress. Laboratory significant for a dramatic increase in creatinine. Creatinine of 3.42 on 08/07 which has increased from 1.84 2 days prior. 8/12/2021: patient to hospice 8/19/2021: patient expired" "1591931-1" "1591931-1" "Pfizer BioNTech COVID-19 Vaccine EUA: Fully Vaccinated Expired Patient received Pfizer Vaccines on 3/5/2021 and 3/26/2021. Patient had a history of ESRD secondary to diabetes and hypertension, renal transplant on 7/13/2021, and was admitted on 7/26/2021 through ED for worsening shortness of breath, weakness and dyspnea. Patient found to be positive for COVID-19 and pneumonia. Patient was treated with remdesivir, dexamethasone, and piperacillin+Tazobactam. Patient continued to decline and expired on 8/11/2021" "1591935-1" "1591935-1" ""presented to ED for triage with ""flu-like symptoms 7/9/21, was tested for COVID. Returned on 7/12, admitted, with increased weakness."" "1592011-1" "1592011-1" "Pfizer BioNTech COVID-19 Vaccine EUA: Fully Vaccinated - Expired from COVID Patient received Pfizer Vaccines on 1/13/2021 and 2/2/2021. Patient has a previous admission from 6/20-7/2 for stroke and RSV and COVID tests were negative at that time. On 7/29/2021 Patient presented to ED with SOB and found to have COVID Pneumonia. Patient was admitted to ICU and treated with Remdesivir, dexamethasone, ceftriaxone, and azithromyicn. Patient continued to decline an on 8/2/2021 family elected for comfort care. Patient expired on 8/5/2021" "1592025-1" "1592025-1" "Death" "1592078-1" "1592078-1" "HX: Prior to event pt reported weakness for 5 days post vaccine. On 06/17 c/o chest pain throughout the day. Pt experienced syncopal episode on EMS arrival at home. Afib- Asystole- Cardiac Arrest. Shocked and cowated, transport - ed. Tarry black stool on arrival to ED. Cardiac arrest in ED, CPR initiated- ACLS algorithm followed. Lab h/h 2.8/10.4, APTT 5635, PT 17.5, INR 1.4, BNP POCT 308, LACTIC ACID 20.00 /Patient died at 8:00 pm 06/21/21. ME accepted the case." "1592110-1" "1592110-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID19 resulting in Hospitalization/ Death Patient received Pfizer Vaccines on 4/14/2021 and 5/5/2021. Patient presented to ED on 8/8/2021 with symptom onset 8/6/2021 of SOB, Cough, Fever, Body Aches, diagnosed with COVID-19 and pneumonia. Patient expired on 8/14/2021." "1592139-1" "1592139-1" "Died of aspiration pneumonia due to Diaphragmatic inflammatory myopathy/myositis Systemic inflammatory response Found and pronounced days after the actual death, which probably occurred approximately 5 days after the first shot." "1592763-1" "1592763-1" "Patient suffered a heart attack 18 hours later, and died less than 50 hours after 2nd vaccine injection." "1592769-1" "1592769-1" "Patient's family report that patient developed new onset migraines after first vaccine and then after 2nd vaccination developed seizure disorder with grand mal seizures, acute diastolic heart failure, respiratory failure." "1597699-1" "1597699-1" "Pneumonia; Stroke/couldn't talk and was blind; Couldn't talk and was blind; Couldn't talk; Nausea; Arm was sore at the injection site; He was sweating a lot; Body aches; Temperature was 99.4¦F; Had chills; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia), CEREBROVASCULAR ACCIDENT (Stroke/couldn't talk and was blind) and BLINDNESS (Couldn't talk and was blind) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cancer (He has cancer, & got an infusion of Keytruda that day( date not specified)). On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced HYPERHIDROSIS (He was sweating a lot), MYALGIA (Body aches), PYREXIA (Temperature was 99.4¦F), CHILLS (Had chills) and VACCINATION SITE PAIN (Arm was sore at the injection site). On 15-Mar-2021, the patient experienced NAUSEA (Nausea). In April 2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria death, hospitalization, medically significant and life threatening), CEREBROVASCULAR ACCIDENT (Stroke/couldn't talk and was blind) (seriousness criteria death, hospitalization prolonged, medically significant and life threatening), BLINDNESS (Couldn't talk and was blind) (seriousness criteria disability and medically significant) and APHASIA (Couldn't talk). The patient was treated with Surgery for Cerebrovascular accident. The patient died on 17-Apr-2021. The reported cause of death was Pneumonia and stroke/couldn't talk and was blind. It is unknown if an autopsy was performed. At the time of death, BLINDNESS (Couldn't talk and was blind), APHASIA (Couldn't talk), HYPERHIDROSIS (He was sweating a lot), MYALGIA (Body aches), PYREXIA (Temperature was 99.4¦F), CHILLS (Had chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (Arm was sore at the injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 99.4 f (High) High. No Concomitant product use was reported. No treatment information was provided. The reporter was calling on behalf of their husband who received their 2nd dose of Moderna vaccine and on that night, their arm was sore at the injection site. The patient's body temperature was 99.4¦F and had chills and developed body aches. Reportedly, the patient was sweating a lot and on 15-Mar-2021 morning, the patient experienced nausea. It was also reported that the patient had cancer and got an infusion of Keytruda that day (Date unspecified). On 05-Aug-2021, the reporter informed that the patient contracted pneumonia in the beginning of Apr-2021 after the patient's second vaccine. The patient had a stroke on the 5th evening of hospitalization and was transferred to a second hospital where they did surgery. Reportedly, the patient was not able to talk and was blind post-surgery. The reporter also informed that the patient died from getting the COVID vaccine and died on 17-Apr-2021. Company Comment: Very limited information regarding these events has been provided at this time. Patient's advanced age along with the history of cancer may have been contributory for the occurrence of the events.. This case was linked to MOD-2021-046338 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up was received. The case has been upgraded to serious from non-serious. Added the first dose details including the dose start date and batch number. Added new events including Death, pneumonia, stroke, blindness and speech loss and the event outcomes. Added the date of death and the cause of death. Updated the description of event.; Sender's Comments: Very limited information regarding these events has been provided at this time. Patient's advanced age along with the history of cancer may have been contributory for the occurrence of the events..; Reported Cause(s) of Death: Pneumonia; Stroke/couldn't talk and was blind" "1602687-1" "1602687-1" "Increasingly weak after receiving vaccine. Tremors started 5 days after vaccine" "1602904-1" "1602904-1" "Patient developed high D-dimer and blood clots immediately after vaccination. Kidney failure followed shortly thereafter. Went into hypertensive cardiac arrest approximately 3 weeks later. All started with vaccination." "1604558-1" "1604558-1" "Brought on water retention and heart failure symptoms 3 weeks after second dose. Death on August 5 2021" "1617434-1" "1617434-1" "Patient required hospitalization due to breakthrough infection. She received J&J vaccine on 05/25/21. Hospitalized from 07/23/21 - 08/21/21 (death). Below is copied from discharge (death) summary: Patient 47 y.o. female with PMH of asthma, MAC PNA, and MRSA PNA (treatment course above) admitted to Hospital on 07/24/2021 for evaluation of progressive fatigue of 2 weeks, generalized weakness limiting activities of daily living. Found to be COVID positive. She recived J&J COVID-19 vaccination 5/25/21. Pt also noted to have a fever of 101, chills, and sore throat. Patient has been followed by pulmonary service for pulmonary cavitary lesions, MRSA, and MAC. Pt went to PCP and told her to go to ED. Patient admitted to Hospital North campus. Pulm and ID consulted this admission. CT chest with mycetomas noted. IV abx given per ID recs. BAL done 07/27 cx growing MRSA put on Bactrim, which was transitioned to Vanc, Zosyn, and minocycline given worsening thrombocytopenia. MICU consulted for worsening respiratory status and increasing oxygen requirements. 8/10/2021 ED Intubated in the setting of respiratory failure and transferred to MICU for further management. On 8/12 CT Head showed 3.4mm thickness subdural hematoma in the R frontal with occipital infarcts. S/p BAL with MRSA, started on linezold. 8/15 Transitioned from Zyvox to Bactrim due to rash, for treatment of superimposed pneumonia with MRSA on BAL. Pt transitioned to PS 8/16 and tolerated well. After discussion w family, they would like to proceed with tracheostomy. Pt has increasing WBC this AM. Respiratory cultures. Tracheostomy placed 8/20 with minimal blood loss 8/20, 95/39 MAP 59 200mcg phenylephrine given plus 100 more Pt was found to be bleeding through her tracheostomy tube, surgery consulted and placed sutures, bleeding slightly decrease Hbg 6.8 1U blood trans 8/21/2021: Patient's family visited at bedside, and then proceeded to the family counseling room. After an extensive discussion regarding the patients status and prognosis, the family (Pt's mother, father, and daughter) decided to compassionately wean the patient. A morphine drip was started, pressors, and O2 were weaned. The patient expired shortly after." "1617479-1" "1617479-1" "Patient required hospitalization due to breakthrough infection. She received the Moderna vaccine (2nd dose in series) on 07/10/21. Hospitalized from 08/01/21 - 08/12/21 (discharged and then admitted 2 hours later, result was death in ED). Below is copied from discharge summary: Patient is a 50 y/o morbidly obese female admitted on 8/2/2021 due to acute respiratory failure due to COVID 19 pneumonia. Severe Sepsis with acute organ dysfunction/ Acute respiratory failure with hypoxia 2/2 COVID 19: - Now on 4L , oxygen delivered at bedside - Chest Xray showed bilateral atypical findings - CRP 63, sed rate 22. - DVT ppx given while inpatient - dexamethasone completed x10 days on 8/10/2021 - atorvastatin given during admission - Completed Remdesevir 8/5/2021 - Isolation Chronic lymphocytic leukemia - Leukocytosis due to CLL Flow cytometry with CD+5 mature B cell lymphoma CT abdomen showing lymphadenopathy Out patient hematology follow up, no need for acute intervention AKI: resolved -Cr back to baseline Hyperkalemia: -Resolved Arterial hypertension -Controlled - continue amlodipine + HCTz Morbid Obesity, BMI of> 40s: -would benefit from lifestyles modifications regarding low fat diet, weight loss and daily excercise -F/U with PCP Patient is discharged in stable condition with stable vital signs. All questions rearding hospital course and plan of care after discharge have been answered to satisfaction. Prescriptions for medications needed to be taken after discharge have been given to patient. Patient has been instructed to follow up with PCP within the next 7 days after discharge. Patient verbalizes understanding all given instructions and has no further doubts regarding discharge. ED admission 2 hours later: 50 y.o. female presents c/o SOB. Pt was discharged from hospital today and was known covid positive. She was discharged with home O2. At home, patient's mother noticed that she was having more difficulty breathing than usual, prompting her to call 911. Pt arrived via EMS, which states she became unresponsive on arrival with a faint pulse. She quickly lost her pulse after her arrival here. Hx limited by events/condition of patient. The history is provided by the EMS personnel, a parent and medical records. The history is limited by the condition of the patient." "1617486-1" "1617486-1" "NEXT DAY AFTER RECIEVING THE VACCINE, MY FATHER EXPERIENCED CHEST PAIN, SHORTNESS OF BREATH, AND WEAKNESS. DUE TO MY FATHER BEING BLIND, HE WAS NOT PROPERLY INFORMED OF ALL THE POTENTIAL RISK, AND SIDE EFFECTS BY THE CLINIC. THE CLINIC GAVE HIM LITERATURE ON THIS, BUT HE COULDNT SEE TO READ ALL THE SIDE EFFECTS THAT MAY BE CAUSED BY TAKING THIS VACCINE, NOT KNOWING HOW CRITICAL IT WAS TO BE SEEN BY A PHYSICIAN, HE STAYED HOME. CONTINUED TO HAVE SHORTNESS OF BREATH, AND WEAKNESS SYMPTOMS UNTIL HE PASSED. MY FATHER DIED ON 8/9/2021." "1617531-1" "1617531-1" "Severe septic shock, followed by death. Stomach pain, followed by hospitalization, gradual organ failure, septic shock and death." "1617585-1" "1617585-1" "Dilated cardiomyopathy- right ventricle. CAUSED DEATH!!!! Complained of a headache and tired two hours prior." "1617843-1" "1617843-1" "Burning in chest, vomiting. Death" "1622381-1" "1622381-1" "Feeling sick after the Modena vaccine; Stomachache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (Stomachache) and MALAISE (Feeling sick after the Modena vaccine) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. Concurrent medical conditions included Heart disorder. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL PAIN UPPER (Stomachache). On an unknown date, the patient experienced MALAISE (Feeling sick after the Modena vaccine). At the time of the report, ABDOMINAL PAIN UPPER (Stomachache) and MALAISE (Feeling sick after the Modena vaccine) outcome was unknown. Concomitant product use was not provided by the reporter. After 2-3 weeks of vaccination patient experienced stomachache, patient thought this was indigestion or pancreatitis. Patient contacted doctor online. Patient's condition aggravated after second dose and died on 05-Jun-2021. No treatment was provided. Action taken with mRNA-1273 in response to the events was not Applicable. This case was linked to MOD-2021-211616 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up information received on 07-May-2021 had a new event feeling sick after the Modena vaccine was added to the case." "1622738-1" "1622738-1" "Sudden death" "1623388-1" "1623388-1" "Pt.'s daughter states that after her Mother received the 2nd dose of Moderna 03/04/2021, started experiencing symptoms 03/05/2021 with nausea, vomiting, and severe headache. ER visit 03/07/2021 noted internal bleeding (treated with coils) 03/15/2021 discharged. Blood clot located *heparin treated. No resolve, made comfortable and passed away 03/18/2021 03:00pm. Blood Clot blocking blood flow to bowels. No noted Autopsy, Cause of Death listed (Organ Failure)" "1623471-1" "1623471-1" "Acute respiratory failure secondary to COVID-19 infection" "1623476-1" "1623476-1" "DEATH" "1623489-1" "1623489-1" "Patient became sick aroun 8/5. Not tested for COVID, but quarantined. Came into ED extreme weakness, productive cough, dry heaves. Oxygen was 89% room air" "1623505-1" "1623505-1" "8/10/21: He developed SOB, cough, and muscle aches, starting 3 days ago. He was referred to ER, where he was admitted on 8/10/21. Tested positive for COVID-19 on 8/10/21. 8/18/21: waxing and waning mentation, requires non-rebreather mask and desaturates quickly. In the afternoon of 8/18/21, he was found in cardiac arrest, PEA and code was called. Family requested to stop resuscitation given his age and poor prognosis. Time of death was called at 1628. Note: He received Pfizer vaccines on 2/3/21 and 2/25/21." "1623508-1" "1623508-1" "Resident was diagnosed with COVID-19 on 8/19/2021. Code status DNR with comfort measures. Began taking Recephin due to cough and crackles in lung bases on 8/20/2021. On 8/21/2021, resident began purse lip breathing and O2 sat dropped to low 80s. Continued to decline and passed away morning of 8/22/2021." "1623587-1" "1623587-1" ""Client received Pfizer Dose 1 on 2/16/21 and Dose 2 on 3/10/21. On 7/29/21 she had chest pain and confusion. She was taken to the ER - diagnosed w/ ""little pneumonia."" While still in the hospital, she wasn't tested for COVID until 8/2 when she tested positive. Client passed away on 8/8 with ""Acute Hypoxemic Respiratory Failure due to COVID-19."""" "1623625-1" "1623625-1" "Patient deceased on 5/4/21 - learned of this on 8/23/21 and filed report. Unknown cause of death." "1623756-1" "1623756-1" "12 hours, back pain." "1623771-1" "1623771-1" "Covid 19 pneumonia" "1623782-1" "1623782-1" "Discharge diagnosis: Acute hypoxic respiratory failure secondary to viral pneumonia in the setting of COVID-19 Acute kidney injury Septic shock Right popliteal DVT Hyponatremia" "1623874-1" "1623874-1" "Died the day after receiving the vaccine" "1624009-1" "1624009-1" ""Case is hospitalized at Hospital. Per EMR, case was admitted for weakness and altered mental status; also complaining of abdominal pain. ""CT of the abd was done in the ED which shows distended bladder with emphysematous cystitis."" It was later documented in EMR that case had ""asymptomatic COVID""."" "1624122-1" "1624122-1" "Expired" "1624134-1" "1624134-1" "shortness of breath and weakness" "1624176-1" "1624176-1" "Respiratory failure due to Covid pneumonia; Hospitalized 7 days; deceased" "1624181-1" "1624181-1" "Patient Passed on august ." "1624286-1" "1624286-1" "Blood clots in both lungs." "1624304-1" "1624304-1" "Vomiting and Diarrhea 08/03-08/09. Found dead at residence on 08/09." "1624319-1" "1624319-1" "er records indicate pt noted to pass out with seizure like activity, taken to er and found in status epilepticus, stabilized and transferred to tertiary care facility. tertiary center records not yet available but report from family indicates ongoing seizures as well as recalcitrant cardiac arrhythmias. Pt was intubated and never recovered despite 3 days care and resuscitation. Autopsy report available to me indicates lymphocytic myocarditis as primary cause of death" "1624351-1" "1624351-1" "Blood clot in heart" "1624537-1" "1624537-1" "Sudden death" "1624538-1" "1624538-1" "Pfizer-BioNTech COVID-19 Vaccine EUA: Patient received Pfizer Vaccines on 1/26/2021 and 2/22/2021. Patient presented to ED on 07/12/2021 with SOB (starting 3 days ago), cough, and fever. Patient received remdesivir x 5 days and was dosed with actemra on 7/20. Patient also completed azithromycin x 5 days and cefepime x 7days. 7/22/21: Patient was intubated on 7/22/21, proned on 7/23/21, started on CRRT on 7/25/21. Pt declined and was found to have worsening hypercapnia and hypoxia despite full support. Patient expired 7/27/21." "1624591-1" "1624591-1" "Mom started with pain in her left ankle less than 24 hours after receiving the vaccine. The pain made its way up her leg and after 3 phone calls to 911over the course of 6 days she finally agreed to go to the hospital. These severe leg spasms would last for 3 hours and she had them about 4 times a day. She would state her pain level was a 20. She was admitted to the hospital and the Drs said due to the severe pain her BP was highly elevated and she was in congestive heart failure. She spent 2 weeks in the hospital. Went into A-fib. The spasms stopped exactly 2 weeks after they started but at that point she was so weak from being in bed that they wanted to discharge her to a rehab facility but she would have needed her second vaccine and it wasnt time yet( plus she refused because all her issues seemed to stem from the first vaccine). Or she would have to be in complete quarantine for 14 days and she was hard od hearing and that would not have been good either. So we brought her home for myseld and my sister to care for her. She was independent before this vaccine and needed complete care when she got home. She was home for 6 days and progressivly got worse each day and we had to put her on hospice on the 6 day and she passed that night." "1625032-1" "1625032-1" "Loss of appetite after vaccine, fatigue, died of organ (liver) failure." "1625270-1" "1625270-1" "4 month after completing immunization series patient noted with SMA, SMV, and cerebral venous thrombus. Report from outside hospital show that the SMA had collateralization in August suggestive of a chronic occlusion s/p thrombectomy with TPA infusion the patient develped ALF and died on 8/23" "1627712-1" "1627712-1" "Suicidal ideations began immediately. Suicide by gunshot completed July 27, 2021" "1627981-1" "1627981-1" "Moderna COVID-19 Vaccine EUA Patient received Moderna Vaccines on 1/27/2021 and 3/01/2021. Patient transferred from another ED on 7/17/2021 with complaint of body aches, cough, fever, chills, sore throat, and difficulty breathing. Patient was Intubated on 7/22/21. Completed 5 days of Remdesivir on 7/21. Completed vanc/cefepime 10 days on 7/27. Received 14 doses of Decadron. Pt continued to decline and comfort care initiated. Patient expired 7/30/21" "1627989-1" "1627989-1" "Pfizer BioNTech COVID-19 Vaccine EUA Patient received Pfizer Vaccines on 1/29/2021 and 3/2/2021. Presented to emergency department on 7/20/2021 with c/o fever and dyspnea x24 hours. Patient had a chest xray and positive COVID-19 test at another facility prior to presentation. Patient was hypoxic at 85% and started on Nasal cannula O2. Patient was treated with Remdesivir and dexamethasone. Patient expired on 7/31/2021." "1627995-1" "1627995-1" "Pfizer-BioNTech COVID-19 Vaccine EUA Patient received Pfizer-BioNTech COVID Vaccines on 2/4/2021 and 2/25/2021. Patient diagnosed with COVID-19 on 8/6/21 presented to ED complaining of worsening repsiratory status over a couple of days. 1 day prior to ED visit pt was given Decadron and discharged from unknown location per provider note. Associated symptoms include headache, cough, fever (T-max 104¦), chills, decreased appetite/thirst, abdominal cramping with cough, and fatigue. X-ray shows moderate bilateral airspace opacities left greater than right, most consistent with multilevel low-grade pneumonia in this clinical setting. Pt treated with ceftriaxone, azithromycin x 3days 8/10, solumedrol #4 cont." "1628006-1" "1628006-1" "Hospitalization 8/14-8/22/2021 for acute respiratory failure/pneumonia due to COVID. Treated with dexamethasone 6 mg IV daily; Remdesivir for 5 days. Expired 8/22/2021" "1628018-1" "1628018-1" "PT succumbed to COVID-19 after diagnosis on 8/10/21 during nursing home outbreak. Pt was hospitalized on 8/13/21" "1628050-1" "1628050-1" "Pfizer-BioNTech COVID-19 Vaccine EUA Patient received Pfizer-BioNTech COVID Vaccines on 2/12/2021 and 3/5/2021. Patient presented to ED on 7/25/21 and diagnosed with COVID-19 pneumonia. Associated symptoms included fever and abdominal pain. X-ray showed development of patchy bilateral alveolar airspace. While in the hospital, patient was treated with remdesivir, ceftriaxone, and azithromycin. On 7/27/21, patient received 1 unit of convalescent plasma transfusion. He was discharged on 7/28/2021. Patient expired on 8/5/21." "1628054-1" "1628054-1" "3-4 days after receiving the vaccine, patient developed shortness of breath, loss of appetite, and fatigue. Patient believed that symptoms were a result of seasonal allergies and contacted PCP for treatment. PCP prescribed prednisone and albuterol. Patient took medication for 4 days without change in symptoms. Follow-up appointment with PCP found patient with low blood oxygen levels and low blood pressure, possible mild fever. patient was sent to ER on 5/21. Patient was admitted with pneumonia of unknown origin. Patient spent 1 week on general care floor with worsening conditions, possible ARDS. Patient was admitted to ICU and put on a ventilator on 5/28. Patient continued to worsen until MRI lead to a diagnosis of Myositis with ILD. Patient was transferred on 6/4 and put on ECMO. Patient health continued to decline (kidney failure) and was pronounced brain dead on morning of 6/7 and family decided to remove patient from life support." "1628055-1" "1628055-1" "Pfizer-BioNTech COVID-19 Vaccine EUA Patient received Pfizer-BioNTech COVID Vaccines on 1/25/2021 and 3/2/2021. Patient was admitted to the hospital from 7/20/2021 through 7/24/2021 with COVID. She had some cough and an episode of fever. She was not hypoxic. Her chest x-ray did not show any pneumonia at that time. She was readmitted 07/24/2021 through 7/28/2021 and again 8/4/2021 through 8/8/2021. Chest x-ray on 8/4/2021 showed worsening diffuse bilateral infiltrates most suggestive of multifocal infection and/or edema. While in the hospital, patient was treated with convalescent plasma, ceftriaxone, and doxycycline. Patient expired on 8/8/21." "1628061-1" "1628061-1" "Moderna COVID-19 Vaccine EUA Patient received Moderna COVID Vaccines on 1/30/2021 and 2/27/2021. Patient presented to the ED and was admitted on 8/02/2021 for lab abnormalities (high uric acid and glucose). Patient had a previous admission due to AKI and hyponatremia. Patient tested positive for COVID-19 on 8/3/2021. Patient's symptoms for COVID-19 were mild/asymptomatic with reports of runny nose, sore throat and mild cough. While in the hospital, patient was treated with remdesivir. Patient expired on 8/14/21." "1628068-1" "1628068-1" "Pfizer BioNTech COVID-19 Vaccine EUA Patient received Pfizer Vaccines on 1/29/2021 and 2/23/2021. Patient presented to ED on 7/16/2021 with symptom onset 7/10/2021 of cough, diagnosed with COVID-19 and acute hypoxic respiratory failure secondary to COVID-19 pneumonia. While in the hospital, patient was treated with remdesivir, steroids, antibiotics and tocilizumab. Patient expired on 8/5/21." "1628076-1" "1628076-1" "Vaccinated hospitalized patient expired 8/14/2021" "1628079-1" "1628079-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID19 resulting in Hospitalization/ Death Patient presented to ED on 7/20/2021 complaining of SOB for about two days prior, worsening with increasing cough, abdominal pain and fever. COVID-19 test administered in ED and returned positive, admitted for acute COVID-19 pneumonia and acute respiratory failure with hypoxia. CT Angiogram showed no evidence of PE and had patchy ground glass opacities. Treatment included Decadron, antibiotics, Remdesivir. Patient continued to decline and ultimately expired on 8/2/2021 secondary to Pneumonia due to COVID-19. Vaccines administered on 1/29/2021 & 2/25/2021" "1628098-1" "1628098-1" "Hospitalization for COVID pneumonia/hypoxemia 8/15-8/21/2021. Treated with dexamethasone 6 mg IV daily; Remdesivir for 5 days; Expired 08/21/2021." "1628140-1" "1628140-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/29/2021 and 2/25/2021. Presented to ED on 7/19/2021 after a fall. For the past several days prior patient developed a dry cough and fever, pneumonia due to COVID-19 present on admission. Patient treated with remdesivir, dexamethasone, convalescent plasma, ceftriaxone, and azithromycin. Patient continued declining in mental status, renal function, and oxygenation. Patient expired on 7/29/2021." "1628171-1" "1628171-1" "Pt mortality from COVID 19 post COVID vaccination." "1628279-1" "1628279-1" "Death 4-12 hours after 1st dose administered on 7/26/21. Body discovered on 7/28/21 at approximately 9:30 am" "1628338-1" "1628338-1" "7/13/2021: headache, sore throat, cough, shortness of breath,. admitted to the hospital 7/21/2021 dies" "1628365-1" "1628365-1" "Vaccinated patient deceased from COVID." "1628493-1" "1628493-1" "Pt is currently hospitalized and was admitted on 07/06/2021 due to COVID-19. Updated pt symptoms and pre-existing medical conditions. Pt has a PMH of arthritis, DM, GERD, HLD, and HTN. Pt complained of chills, aches, and pains, constipation, shortness of breath, and dry cough. Per medical records, patient developed rapid worsening hypoxia despite BiPAP support and was intubated on 07/13/2021 and proned. Patient died." "1628577-1" "1628577-1" "Death on 4/16/2021?. Hemorrhaged (mouth), and choked on blood. Family was present at the time of occurrence but nothing could be done to help her. This was 16 days after receiving the J and J shot and would not perform autopsy due to age even when her primary wouldn?t sign off on the death cert." "1628578-1" "1628578-1" "Patient was hospitalized on 8/22/21 stating that she could not breath and passed away. Her second COVID vaccine was received on 8/19/2021." "1628604-1" "1628604-1" "A 91-year-old gentleman with significant known history for coronary artery disease/CVA/history of B-cell lymphoma/hypertension and significant other medical history, presented to hospital due to shortness of breath; it is noted the patient was saturating at 76% on non-rebreather. The patient was desatting despite being on non-rebreather and therefore it was requested that the patient be transported to the ER. He was evaluated , was on AVAP 80%, alert, however, unable to fully follow any commands. He was placed on AVAP and his oxygenation/pulse ox increased to 90%. Lab workup showed hypernatremia/acute renal failure/lactic acidosis with a D-dimer of more than 10,000. Transitioned to hospice care." "1628631-1" "1628631-1" "Pt was hospitalized on 8/13/2021 and passed away on 8/21/2021." "1628645-1" "1628645-1" "7/14/2021: symptoms onset. temp 110.4F,abdominal cramps, cough, diarrhea 7/17/2021 hospitalized 7/28/2021 died" "1628647-1" "1628647-1" "Death" "1628702-1" "1628702-1" ""Patient went into cardiac arrest on 08/21/2021. Patient seen by wife ""going down"" and CPR was started within minutes. CPR performed prior to arrival to emergency room and after, patient also intubated. Patient non-responsive on arrival to hospital. Patient ultimately died."" "1628747-1" "1628747-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/20/2021 and 2/10/2021. On 7/27/2021, patient presents to the ED with weakness and fatigue after being diagnosed with COVID-19 1 day prior. On arrival to the ED, patient O2 saturation 88%, 2LNC initiated. Patient admitted to the hospital for COVID-19, hypoxemia, and elevated troponin. Patient received remdesivir x 5 days, convalescent plasma 1 unit, tocilizumab 800 mg x 1 dose, dexamethasone, azithromycin, ceftriaxone. Patient developed new onset atrial fibrillation on 8/7/2021. Throughout hospitalization patient continued to decompensate and eventually expired on 8/8/2021." "1628749-1" "1628749-1" "Patient with multiple underlying conditions presented to hospital with severe LE pain on 6/15/2021. Recently treated for cellulitis (6/15/2021). SOB and poor po intake were baseline x 1 year 2/2 cancer and PE. 1L o2 at baseline. Difficult to distinguish any possible COVID sx from other causes, unknown onset of sx. Tested negative upon admission and positive on Hospital Day 3. Hospital course complicated by hypoxemia 2/2 COVID PNA and HF exacerbation, hallucination. Transferred to ICU 6/27-6/30 recieved dexamethasone, remdesivir, piperacillin/tazobactam and then again 7/6. 7/6 asystole/PEA arrest with ROSC achieved after 20 min of CPR and 4 x epinephrine. Intubated 7/6. Increasing pressor requirements, transitioned to comfort care." "1628789-1" "1628789-1" "Pfizer-BioNTech COVID-19 Vaccine EUA Patient received Pfizer-BioNTech COVID Vaccines on 1/20/2021 and 2/12/2021. Presented to ED on 8/9/21 from acute rehab with complaints of unresponsiveness at Rehab. PMH of CVA (2019). 2 weeks prior to admission patient with admitted to hospital and diagnosed with pontine stroke. Patient was scheduled for TEE and underwent routine COVID test and tested positive. Pt caregivers reported patient showed no respiratory symptoms prior to this admission. During this stay patient was treated with empiric antibiotics, Decadron for 10 days and Lovenox for treatment of a DVT and discharged to acute rehab. Upon arrival to ED pt was hypotensive, intubated and found to have a large retroperitoneal hematoma. Pt was also started on Cefepime, Vancomycin, and Doxycycline. Patient diagnosed with acute hemorrhagic shock and, acute blood loss anemia. Patient continued to decline and family decided to withdraw care and initiate comfort care. Patient expired on 8/10/2021." "1628824-1" "1628824-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/6/2021 and 4/1/2021. Patient was diagnosed with COVID-19 infection on 07/16 and has been having intermittent fevers, fatigue, cough and was evaluated at Hospital on 7/16, 7/18, and 7/22. Patient was discharged from the emergency room as he was nontoxic appearing, he was readmitted on 7/22 with hypoxia saturating 83% on 6 L, evidence of COVID pneumonia on CT. Patient quickly escalated from nasal cannula to requiring high-flow oxygen and on 07/24 was also intubated. Required norepinephrine for hemodynamic support. Completed remdesivir course and 9 days of Dexamethasone. Had worsening oxygenation and family decided to withdraw support and provide comfort care. He expired on 8/10/2021." "1628876-1" "1628876-1" "On the 4th day following the vaccine, patient suddenly became extremely weak, unable to do smallest of activities which were easy to perform before. Could not get up from toilet, chair, etc. Unable to get into vehicle without assistance. Unable to walk without walker and assistance. Prior to day 4 after vaccine, completely able to live independently, preparing meals, doing minor housework, get into and out of chair, on and off of toilet, etc. Patient was moved to daughter's home, and homecare was set up. After visit to cardiologist and various tests, she was diagnosed with afib and congestive heart failure; was taken off of all blood pressure meds as now blood pressure was suddenly low. Condition continued to deteriorate, and placed on hospice care. Died five weeks later." "1629075-1" "1629075-1" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629325-1" "1629325-1" "Died!" "1629537-1" "1629537-1" "PT WAS VACCINATED SEVERAL MONTHS AGO, PRESENTED TO ER WITH C/O CP AND SOB 8/22, NEG ANGIOGRAM COMPLETED 8/23, DC HOME 8/23 RETURNED TO ER 8/24 WITH LARGE SADDLE PE, PT EXPIRED. ONLY REPORTING BECAUSE PT HAD NO PRIOR HISTORY OF MI OR THROMBOSIS, ONLY HTN AND TYPE 2 DM." "1629717-1" "1629717-1" "Developed asthmatic like symptoms about two weeks after the 2nd shot. This manifested itself by coughing, shortness of breath, wheezing and fatigue. These symptoms waxed and waned until on the day of her death, she passed out and fell. Shortly after getting to the ER (within 20 minutes), she went into cardiac arrest, was resuscitated but never regained consciousness." "1632015-1" "1632015-1" "Within 3-4 days of first shot on 3/11/2021 increased pain throughout body, increased agitation and greater confusion and ability to follow simple commands. With 24 hours of second shot on 4/1/2021 unbearable pain throughout body, pain for someone to touch, balance issues. By 4/15/2021 tremors in arms and legs, loss of balance, hallucinations\ Patient died on 4/19/2021" "1632201-1" "1632201-1" "Patient s/p vaccination in spring 2021. Admitted to the hospital on 8/9/2021 with generalized weakness. Pt reported chronic dry cough, malaise and runny nose; denied chest pain, SOA, V/N/D. No known exposures to COVID. Patient found to be COVID+; started on oxygen, dexamethasone and remdesivir. O2 requirements continued to worsen; imaging showed worsening PNA - concern for secondary aspiration PNA. Started on IV zosyn. After 10 days with worsening confusion, agitation patient family decided to transition to comfort measures. Pt agreed to Hospice on 8/19 and passed on 8/20" "1632245-1" "1632245-1" "periodic uncontrollable shaking renal failure death" "1632254-1" "1632254-1" "patient given the Pfizer vaccine on 8/24 and went into cardiac arrest and died at 0650 8/25/21" "1632537-1" "1632537-1" ""Patient tested positive for COVID-19. Patient was fully vaccinated. He started feeling ""different"" about the middle of July. He was more fatigued, disoriented, and unstable. The following week, he developed cold symptoms which everyone assumed was just the common cold. Pt. daughter was sick the previous week with a common cold (took her 3yo to the doctor to confirm, but wasn't tested for Covid). After 7/26, his condition started to deteriorate more with fever and vomiting. By the evening of 07/30, he was having great difficulty breathing and so he was taken to the hospital. He was admitted for very low blood oxygen levels as well as Covid pneumonia. He has several underlying health conditions to include heart disease and obesity. Patient died due to COVID."" "1632595-1" "1632595-1" "Patient was initially admitted to the medical COVID floor. He was initiated on remdesivir and dexamethasone. He was transferred to the ICU on 8/17/2021 due to worsening respiratory status and need for noninvasive ventilatory support. Due to his worsening renal function, remdesivir was discontinued as it is known to potentially contribute to worsening renal function. He was initiated on CRRT on 8/18/2021. Patient's respiratory status continued to worsen and he was intubated on 8/21/2021. Unfortunately, over the next several days, patient's condition worsened overall. He was unable to be weaned from high ventilatory support needs. CRRT was optimized to insure diuresis to try to optimize ventilator conditions. Unfortunately, on the morning of 8/25/2021, the patient did suffer a sudden cardiac arrest. CPR and ACLS interventions were initiated without success. Nursing staff was in contact with the patient's family via telephone during the cardiac arrest and resuscitation. They did advise that they did not want to continue ongoing resuscitative efforts and further efforts were terminated. Unfortunately, patient did pass on the morning of 8/25/2021 at 0150 hr" "1632600-1" "1632600-1" "throwing up, high white blood cell count, raspatory arrest, cardiac arrest, un able to destabilize, death do to organ failure" "1632629-1" "1632629-1" "74-year-old female presents emergency room complaining of shortness of breath. EMS reported that initial sats were 50% she was placed on a non-rebreather mask. She subsequently was placed on BiPAP in the emergency room and her saturations actually decreased therefore she was placed back on a non-rebreather mask. The patient continued to decline and ultimately required intubation after her initial blood gas revealed her to be extremely acidotic with a pH is 7.19 and pCO2 of 83. Little is known about the patient's history otherwise I do not know if she has had any fever. I have been told that the patient has been fully vaccinated for COVID. She has had a COVID swab returned as positive tonight. I am unaware of exposures at this time. She has other remarkable findings in the emergency room specifically a leukocytosis of 34,000 with left shift. ProBNP is 11000. Procalcitonin is elevated at 1.18. The patient has a history of incarcerated diaphragmatic hernia in 2014. On chest x-ray tonight it appears that she has stomach in her chest. On the CT it also appears that she has hiatal hernia with part of the stomach in the chest also part of the colon in the chest through her diaphragmatic hernia. Question of bowel obstruction is raised but no definitive answer is given on CT. Patient also has a consolidation of the right upper lobe with possible mass. CT also reveals bilateral findings consistent with COVID. No PE. The patient I believe has a cardiac history and has a history of heart failure with reduced ejection fraction. DISCHARGE: Patient was a 74-year-old patient, who was admitted after arriving via EMS with respiratory distress. Apparently, she had been sick for 2 weeks for shortness of breath. She came to the ER, was emergently intubated with acute hypoxic hypercapnic respiratory failure. The patient has multiple CTs done, one of the chest revealed a central mass with significant narrowing of the right upper lobe and right middle lobe pulmonary arteries, stenosis of the right upper lobe bronchus. I thought she probably had a postobstructive pneumonia. Also, of note, she has some patchy airspace disease, consistent with COVID-19 pneumonia. The patient did test positive for COVID-19. The patient was intubated, placed in ICU. Palliative Care was consulted and after discussion with family, it was decided to remove her from the ventilator given her diagnoses. The patient was extubated and pronounced by Dr. at 05:39 p.m." "1632684-1" "1632684-1" "Patient received second vaccination on 07/06/2021. The next day the patient was having problem breathing with shortness of breath." "1632692-1" "1632692-1" "Patient is a resident of a SNF - found to be COVID 19 + 6 days prior to admission on 7/19. Pt reported to have minimal symptoms - on O2, but unknown if this is baseline. Patient admitted with GI Bleed; underwent colonoscopy and removal of a oozing polyp. Patient tolerated procedure well, but continued to decline in terms of mentation during hospitalization including the use of sedative medications and restraints. On 7/25 patient and family decided to proceed with comfort/palliative care. Patient passed on 7/26. Although patient was COVID positive, there is no indication that his death was directly due to COVID." "1632700-1" "1632700-1" "Received vaccine at 10:00 am on 8/18, monitored for 15 post-vaccine, noted unresponsive at 12:30:Pt was noted to be unresponsive to verbal and tactile stimuli. VSS: BP 72/48, Pulse 116, Placed on nonrebreather at 15LPM. O2 sat 98%. NP in the building called and responded. 911 called and responded. HCP niece declined for the resident to be transferred to the hospital. 8/19/2021 09:07 am Resident expired, Code Status: DNR. Dr. was notified. Pronounced at the facility by the RN" "1632705-1" "1632705-1" "Case completed Covid vaccine series 4/2/21, and was admitted to hospital 8/15/21 for Covid, and died of Covid on 8/18/21." "1632726-1" "1632726-1" "Patient found in early morning hours by family member. Unfortunately he had already expired with rigor." "1632786-1" "1632786-1" "After receiving vaccination pt felt weak and had trouble breathing. She was rushed to the ER where she was diagnosed with pneumonia and a mass was found on her ovary. She stayed about 2 days and was then released under Hospice care." "1632795-1" "1632795-1" "DIAGNOSIS OF COVID-19 WITH HOSPITALIZATION/DEATH AFTER BEING FULLY VACCINATED" "1632912-1" "1632912-1" "Patient started having SOB in June 2021; in July found to have a large Pulmonary embolism; Was readmitting for SOB 2 more times and ultimately died 08/24/2021;" "1633600-1" "1633600-1" "patient had cardiac arrest x2 and died." "1634215-1" "1634215-1" "Death. Heart attack" "1636469-1" "1636469-1" "Patient had heart attack and died at 10:15 PM following dose at 3:00 PM" "1636482-1" "1636482-1" "Admitted on 8/18/21 for hypoxia, COVID +, and was found to have heart failure exacerbation, UTI, COVID pneumonia. Worsening compensation transferred to ICU for hypoxia and max Vapotherm. pt. taking dexamethasone and remdesivir. Patient DNR/DNI . Not a candidate for monoclonal antibody due to strep pneumonia positive infection. Given supportive care with death on 8/25/21." "1636496-1" "1636496-1" "8/11/201 PRESENTED TO ER REPORTED NAUEA, VOMITING AND DIARRHEA DX COVID POSITIVE. DISHCARGED HOME. 8/13/21 PRESENTED TO ER ADMITTED TO HOSPITAL IN PATIENT. BEGAN FEELING SHORT OF BREATH PROGRESSIVELY GETTING WORSE. DX COVID PNEUMONIA. ALSO REPORTED COUGH, DIFFUSE BODY ACHES, CHILLS. PLEURATIC CHEST PAIN, TIRED. REQUIREING O2. 15L. BY 8/17/21 NEW ONSET OF ATRIL FIB. NOTED. 8/18/21 REQUIRING 100% NON RE BREATHER. 8/23/21 100% /40L VIA VAPOTHERM. ICU LEVEL OF CARE. PATIENT INTUBATED ON 8/25/21. AFTER INTUBATION PATIENT WENT IN TO CARDIAC ARREST. 8/25/21 PATIENT DIED." "1636499-1" "1636499-1" "Present on 8/11 following 4-5 days of myalgias, fevers and fatigue. Received only 1 dose of cvocid vaccine. Admitted and started on antibiotics. COVID +. Given decadron and 5 day course of remdesivir. His stay was complicated by AKI and CKD. Respiratory status continued to decline and antibiotics broadened but continued to worsen." "1636579-1" "1636579-1" "Cough, SOB" "1636612-1" "1636612-1" "Patient: Deceased BRIEF OVERVIEW: Admission Date: 8/21/2021 Discharge Date: 8/22/2021 Active Hospital Problems Diagnosis Date Noted POA ? Pneumonia due to COVID-19 virus 08/21/2021 Unknown ? Bacterial pneumonia 08/21/2021 Unknown ? Acute respiratory failure with hypoxia and hypercapnia 10/21/2018 Unknown DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia and hypercapnia Pneumonia of both lungs due to infectious organism, unspecified part of lung Acute hypoxemic respiratory failure due to COVID-19 HOSPITAL COURSE: 87-year-old female with history of heart failure, atrial fibrillation, SIADH, coronary artery disease, metastatic adenocarcinoma (recently diagnosed), and previous lung cancer who presented to the emergency department with hypoxia and cough noted at bed. The patient was recently admitted to our service for a hip fracture for which she underwent repair 8-10. She was reportedly doing well at her rehab facility when she developed hypoxia and a cough. Chest x-ray showed changes consistent with pneumonia. EMS was called when the patient was found to be short of breath requiring 2.5 L of oxygen. Her oxygen saturation was in the 70s on their arrival. She was brought to the emergency department and BiPAP was initiated. She was febrile tachycardic. ProBNP was elevated. Procalcitonin was greater than 100. COVID-19 PCR was positive. CTA was negative for PE, but showed consolidative airspace disease and patchy ground-glass opacities. The patient was started on IV antibiotics and admitted to the hospitalist service. She refused steroid therapy. IV diuresis was initiated. On the morning following admission she refused to be placed back on BiPAP. Goals of care were addressed with the patient at bedside and she elected for comfort care. She had been planning to sign on to hospice services as an outpatient with her recent diagnosis of metastatic adenocarcinoma and requested their services while inpatient. Hospice was consulted and she was transitioned to inpatient hospice. The patient's family was aware of her wishes and were supportive. A morphine drip was initiated per hospice recommendations. The patient passed away at 16 30 on 08/22/2021. The medical examiner was contacted as her death occurred within 24 hours of admission, but declined the case." "1636632-1" "1636632-1" "death Acute kidney injury (nontraumatic) (CMS/HCC)" "1636675-1" "1636675-1" "Patient was admitted to Medical Center on 8/11/21 in respiratory distress. Patient expired on 8/24/21 vaccine dates were 1st dose Pfizer vaccine on 7/14/21 2nd dose 8/4/21." "1636693-1" "1636693-1" "double PE" "1636955-1" "1636955-1" "Hospitalization, On supplemental O2, Remdesivir, Decadron, Death" "1636956-1" "1636956-1" "Pt. given dose. NO lot number in our vaccination system, pt. passed from COVID19 on 8/22/2021." "1636961-1" "1636961-1" "Patient main reason for hospitalization was for hypoxic respiratory stress secondary to covid pneumonia. Pt had two separate hospitalizations, but the hospitalization at time of positive test was admit on 8/8 and discharged to hospice on 8/12. Death: ACUTE RESPIRATORY FAILURE WITH HYPOXIA, PNEUMONIA DUE TO COVID-19" "1636967-1" "1636967-1" "Patient woke up 8/23 morning c/o dizziness, slurred speech and with ringing in his left ear. Shortly afterwards pt exhibited seizure-like activity. Family called 911. EMS witnessed seizure at home and was actively seizing on arrival of EMS. Pt was administered 5mg Versed w/o relief then was given Ketamine and intubated. After airway was secured pt was transported to the ED. Pt was admitted for treatment for status epilepticus. Pt sedated on Propofol gtt, Keppra and placed on cEEG. Initial CT Head w/o contrast negative for any acute findings. cEEG was negative for seizures. Pt treated prophylactically with Rocephin and Vancomycin for suspected aspiration. MRI brain w/o contrast obtained early today at the outside hospital and showed Bilateral cerebellar and thalamic AIS with possible basilar occlusion. Dr was contacted and accepted for transfer for acute stroke evaluation and treatment. Prior to transfer obtained CTA head/neck. Pt transported via helicopter. Upon arrival pt was met in ED CT for stat CT cerebral perfusion and CT Head w/o contrast. Pt arrived 8/24/2021 16:08. NIH 36 and GCS 3T. Pt arrived on Propofol and was stopped. Scans showed a large infarction and no intervention recommended. Of note: pt had just received this Johnson and Johnson COVID vaccination 2 weeks ago." "1637006-1" "1637006-1" "65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea. Patient died 18 Aug 2021, COD COVID-19 pneumonia." "1637039-1" "1637039-1" "ACUTE RESPIRATORY FAILURE WITH HYPOXIA, COVID-19 Hospitalization and Death" "1637081-1" "1637081-1" "Case received Moderna vaccine x 2. Last dose received on 3/9/2021. Patient developed signs and symptoms of COVID 19 Infection on 8/24/2021. Case was tested positive for COVID 19 on 8/24/2021 and was admitted to Medical Center ED on 8/24/2021 and Case expired while still in the hospital on 8/24/2021." "1637159-1" "1637159-1" "Case received Moderna vaccine x 2 with last dose on 6/18/2021. Was admitted to Medical Center on 8/20/2021. Case expired at hospital 8/21/2021." "1637169-1" "1637169-1" "Patient was fully vaccinated with Pfizer with last dose given on 02/01/2021. Case developed covid symptoms on and tested positive for COVID 8/14/2021. He was admitted to Hospital on 8/16/2021. Case expired on 8/21/2021." "1637303-1" "1637303-1" "Suddenly more weak , exhausted, all around much worse then she had been feeling as she was in her last days of lung cancer. Within hours of the vaccine she was worse and in two days unresponsive and in a hospice. 4 days after vaccine she died." "1637338-1" "1637338-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/27/2021 and 3/20/2021. Presented to ED on 8/17 with complaints of shortness of breath x1 week, diarrhea, light-headedness, headache, and right lower extremity swelling. Patient was placed on supplemental oxygen and admitted. On 8/18 patient exhibited facial droop and left arm/leg weakness. CTA revealed right ICA occlusion and underwent thrombectomy and stenting. ICU, patient had persistent L-sided deficits with concern for devastating neurologic injury. On 08/19, patient was found to have new R pupillary dilation and repeat CTA & CTH revealed re-occlusion of R ICA & R M1 occlusion and petechial hemorrhage. Per Neuro IR, patient not a candidate for repeat MT. Patient was managed with 3% saline and blood pressure control with Cardene gtt with permissive parameters. On 08/21, the patient became hypoxic with increased work of breathing. CXR revealed stable chest and she was placed on HFNC. She was also found to have oliguric AKI in the setting of contrast nephropathy and loss of renal autoregulation in the setting of acute stroke. Nephrology was consulted and discussed with family. Patient's family decided to transition to comfort care measures and withdraw life-sustaining treatment. On 8/22/2021, the patient was pronounced deceased. For COVID, Patient was treated with Remdesivir, Acyclovir, Dexamethasone." "1637391-1" "1637391-1" "Patient died of COVID-19 illness on 07/01/2021" "1637396-1" "1637396-1" "Family states patient never recovered after 2nd Moderna dose. Entered hospital with extreme shortness of breath. Ventilated after several days. Passed away while in hospital." "1637398-1" "1637398-1" "date of first dose 01/27/2021 date of second dose 02/18/2021 patient was transferred to hospital on 08/09/2021 and was tested just prior to transfer was found Covid positive. admitted with encephalopathy (mutifactorial)" "1637847-1" "1637847-1" "Death. Unknown" "1640748-1" "1640748-1" "Death" "1640942-1" "1640942-1" "Confusion" "1641014-1" "1641014-1" "Case had covid vaccines x 2 with last dose administered on 2/17/2021. Developed symptoms of Covid 19 on 8/17/2021. Case had a positive COVID 19 lab test on 8/18/2021 was admitted to Medical Center. Case Expired while still hospitalized on 8/21/2021." "1641054-1" "1641054-1" "Came to ER with SOBx1 month worse around midnight, cough x 1 month." "1641059-1" "1641059-1" "1 st dose Moderna 01/28/2021- no lot # Pt dies from heart failure complications in the hospital Did not die from Covid 19" "1641066-1" "1641066-1" "strong healthy active mom went into Afib passed 9 wks later....of the 50-60 ppl there 5 have passed since May. (2 others currently in Hospital)" "1641127-1" "1641127-1" "Patient was hospitalized due to COVID-19 and died. Patient is fully vaccinated." "1641163-1" "1641163-1" "Patient developed COVID-19 after being fully vaccinated. Patient visited the ER. Patient died." "1641168-1" "1641168-1" "positive covid test" "1641180-1" "1641180-1" "Pt came to ER with difficulty breathing, came by EMS. Pt admitted to ICU." "1641198-1" "1641198-1" "no adverse effect noted after administration of 3rd dose. resident expired on 8/24/21 after long battle with Alzheimer's disease. death does not appear to vaccine related" "1641233-1" "1641233-1" "Weak and fell Exposed from caregiver who had recently tested positive" "1641249-1" "1641249-1" "Pt came to ER with difficulty breathing and cough onset 1 week ago. Patient admitted to ICU." "1641295-1" "1641295-1" "Patient received COvid vaccine x2 with last dose administered on 2/5/2021. Patient developed symptoms of Covid 19 Case tested positive for COvid 19 on 7/30/2021 and was admitted to Medical Center on 8/11/2021. Patient expired while still hospitalized on 8/19/2021." "1641319-1" "1641319-1" "Pt. passed of COVID19 in August after being fully vaccinated in January" "1641348-1" "1641348-1" "Body aches, headaches, fevers, chills." "1641358-1" "1641358-1" "Difficulty breathing, on 6L oxygen from PCP office, cough, weakness." "1641364-1" "1641364-1" "Patient brought to ER with cardiac arrest. At home woke up to go to bathroom was wheezing and collapsed (family report)." "1641372-1" "1641372-1" "PT IS A BREAKTHROUGH CASE OF COVID-19. PT EXPIRED ON 8/24/2021." "1641389-1" "1641389-1" "Admitted 7/29/21. Received both doses of Pfizer vaccine, the last on 3/29/21. Presents with diarrhea x5 days, weakness and SOB. Tested positive for COVID on 7/27/21. Patient treated with COVID protocol, antibiotics, remdesivir, BiPAP. Patient responded poorly to treatment and condition declined. On 8/9/21 pt discharged." "1641422-1" "1641422-1" "Pt came to ER c/o SOB that started earlier that morning. Pt became very winded and could not catch his breath, EMS called and pt sats in the 60-70's with tachypnea." "1641444-1" "1641444-1" "Pt came to ER with SOB that began morning of. Found to be hypoxic by EMS." "1641484-1" "1641484-1" "Became symptomatic on 8/8/21 feverish, chills, runny nose, headache, fatigue, cough, vomiting, and tested positive for COVID-19 on 8/10/21. Died on 8/17/21 due to upper respiratory infection d/t COVID-19, HTN, hyperlipidemia, T2D, obesity, per death certificate." "1641497-1" "1641497-1" "Pt came to ER with SOB, cough, difficulty breathing onset 1 day ago." "1641503-1" "1641503-1" "death NSTEMI (non-ST elevated myocardial infarction)" "1641544-1" "1641544-1" "Patient required hospitalization due to breakthrough infection. She received Pfizer vaccine (2nd dose in series) on 05/07/21. Hospitalized from 08/07/21 - 08/23/21. Below is copied from discharge (death ) summary:" "1641551-1" "1641551-1" "7/30/21: admitted for multiple falls 8/5/21: Transitioned to Inpatient Rehab. 8/13/21: He became altered and hypoxic, prompting testing for COVID-19. Resulted positive COVID PCR on 8/13/21; breathing comfortably on 2L nasal cannula 8/17/21: completed remdesivir course, worsening confusion and altered mentation; using heated-high flow at 35L, non-rebreather 8/19/21: patient discharged to hospice. 8/22/21: patient passed. Time of death 0508." "1641573-1" "1641573-1" "COVID infection. Specimen collected on 7/21/2021. Patient died on 8/21/2021." "1641586-1" "1641586-1" "COVID infection. Specimen collected 8/8/21. Patient died on 8/11/21." "1641607-1" "1641607-1" "Pt mortality from COVID 19 post vaccination." "1641622-1" "1641622-1" "Patient admitted 7/21/2021 for presents as transfer for acute hypoxic respiratory failure and covid pneumonia. Vaccinated for COVID 3/31/2021, tested positive 7/21/2021 Patient discharged, DEATH, 7/26/2021 Date of Vaccination:3/31/2021 & 3/10/2021 Dose: 2 doses total Vaccine Manufacturer: Pfizer Lot #: EN6202/EN6207 Clinic Administering Vaccine: unknown Injection site: R deltoid both times Description of event/reaction: patient died from severe ARDS from COVID-19 Patient initially presented on 06/29 with dyspnea, productive cough and wheezing. She reported having difficulty breathing for the last month, however, her symptoms progressively worsened after 6/26/21. Patient was found to be hypoxic on her home oxygen requirement of 3L to SpO2 52% upon arrival to ER. Of note, patient was discharged from a hospitalization on 6/22/21 (unknown reason for hospitalization, duration, and location). Patient is reportedly fully vaccinated for COVID prior to her current admission and received her last vaccine in February 2021. She tested positive for COVID on 6/29 upon admission, and stated that her daughter had been sick recently and tested negative for COVID. Patient was started on Remdesivir, Decadron, Albuterol, Thiamine, Zinc, Quercetin complex, and Vitamin D. Patient was also started on Vapotherm for supplemental oxygen which was alternated with BiPAP, as well as empiric Vancomycin (6/29-7/10 and 7/15-7/21) and Zosyn (6/29-7/8). Patient was ultimately intubated on 07/15 and her antibiotics were escalated to Vanc and Meropenem (7/13-7/21) for presumed pneumonia. She continued to require high ventilator settings (100%, PEEP 16). Her hospitalization was complicated by shock requiring vasopressors. On 7/17, patient was increasingly acidotic with pH 6.99 and PCO2 78 and was subsequently proned and paralyzed. Her infectious work-up was positive for VRE bacteremia on 7/17 and candida in urine culture. On 7/21 she was transferred to MICU for hypoxic respiratory failure and COVID pneumonia. On arrival, she is sedated on mechanical ventilation...Acute Hypoxic Hypercapneic Respiratory Failure requiring Mechanical Ventilation (POA) COVID PNA (POA) History of COPD (POA) - Etiology: COVID PNA - COVID positive 6/29 - Fully vaccinated with Moderna vaccine prior to admission - s/p Remdesivir, convalescent plasma, dexamethasone - 7/15 Intubated at outside hospital - 7/17 Paralyzed and proned - CXR: bilateral diffuse patchy airspace disease - ABG on arrival: 7.43/53/65/35 on 80%, PEEP 10, PF 81 PLAN: - PAL, comp resp panel, Strep and Legionella urine Ag pending - Continue mechanical ventilation to optimize ventilation and oxygenation, maintain SpO2 >/= 92% - DuoNebs q4hr - Empiric broad spectrum antibiotics as outlined below: Linezolid and cefepime - Propofol and Dilaudid drips to facilitate tolerance of mechanical ventilation - Start DEXARDS protocol - Repeat ABG at 2000; prone if PF ratio not improved - Consider CT chest when clinically stable VRE Bacteremia (POA) Sepsis (POA) Leukocytosis (POA) - Has received dexamethasone - Received the following courses abx: Vanc 6/29-7/10, 7/15- 7/21 Zosyn 6/29 - 7/8 Merrem 7/13-7/21 - BCx from 7/17 resulted for +VRE; transitioned to Linezolid prior to transfer - On vasopressors on 7/18 - WBC 26k, lactate here 1.2 - CXR: bilateral diffuse patchy airspace disease Plan: - PAN cultures: Bcx, UA, PAL, strep/legionella urinary Ag pending - Follow cultures; determine insertion date of PICC line - Empiric antibiotics with : Linezolid (start 7/21) and cefepime - ECHO pending AKI (POA) - Scr on admission 0.96, up to 1.96 on 7/17 - Multifactorial AKI is likely related to sepsis PLAN: - BMP here pending - Renal lytes pending - Renally dose medications, avoid contrast medications - Consult the renal team when appropriate T2DM (POA) - HgbA1C pending - FSBG with correction SSI q6hr per ICU protocol" "1641634-1" "1641634-1" "Breakthrough COVID infection resulting in hospitalization and death" "1641642-1" "1641642-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/18/2021 and 4/15/2021. Presented to ED on 8/15/2021 with past medical history of CHF with EF less than 20%, pulmonary hypertension on continuous Milrinone infusion, AFib, CKD arrives via EMS in respiratory distress. When EMS arrived, O2 sats 56% on room air, improved to 86% with 15L NRB. Patient reports 1 week of progressively worsening shortness of breath and cough. Denies any chest pain. Has not been tested for COVID, but lives with household members that have been ill. Patient was intubated in ED. Patient was initially full code but was changed to DNR after discussions with family." "1641668-1" "1641668-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 3/18/2021 and 4/14/2021. Patient presented on 8/14/21 via EMS with shortness of breath and AMS. Per EMS, patient was found unresponsive and short of breath by family member for an unknown duration. EMS was called, with SpO2 of approximately 50%. EMS reports administering 20L O2 by NC and nonrebreather which improved SpO2 to 94% with improved mental status. Per chart review patient symptoms began around 8/5/21 and she tested positive 8/11/21. On admission, patient knew name, responded to pain, and followed commands- otherwise, was unable to communicate. MRI revealed Bilateral globus pallidi infarcts probably related to hypoxic ischemic injury, possibly due to hypoxia from COVID pneumonia. Based on irreversible state of mental status, patient was recommended to hospice team. Patient was transferred to inpatient hospice care on 8/19/21. Patient expired on 8/20/21." "1641714-1" "1641714-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 2/5/2021 and 3/5/2021. Presented to ED on 8/13/21 via EMS from home due to shortness of breath. Patient was 93% on RA en route to ED and stable upon arrival. After arriving to ED, patient has SpO2 88% and was placed on supplemental O2. It was noticed patient may have had short run of ventricular tachycardia and patient went unresponsive with a pulse but agonal respirations. Patient was intubated in the ED on 8/13/21 and eventually extubated on 8/15/21. Patient received Rocephin, Decadron, remdesivir. During this time patient was in AKI. On 8/16/21, pt found to have HR in 20-30s and on 8/17 was severely bradycardic. Remdesivir was stopped. Pt was transitioned to comfort care and hospice Patient expired on 8/18/21." "1642678-1" "1642678-1" "Veteran Died on 8/23/2021" "1644342-1" "1644342-1" "Suicidal ideation; Mouth blisters; Anxiety; Depression; Insomnia; Major changes in mood, demeanor and thought; Irrational behavior; Took his own life Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of COMPLETED SUICIDE (Took his own life Apr2021) and SUICIDAL IDEATION (Suicidal ideation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced COMPLETED SUICIDE (Took his own life Apr2021) (seriousness criteria death and medically significant). On an unknown date, the patient experienced SUICIDAL IDEATION (Suicidal ideation) (seriousness criterion medically significant), ORAL MUCOSAL BLISTERING (Mouth blisters), ANXIETY (Anxiety), DEPRESSION (Depression), INSOMNIA (Insomnia), MOOD ALTERED (Major changes in mood, demeanor and thought) and BEHAVIOUR DISORDER (Irrational behavior). The patient was treated with HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) at an unspecified dose and frequency. The patient died in April 2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, SUICIDAL IDEATION (Suicidal ideation), ORAL MUCOSAL BLISTERING (Mouth blisters), ANXIETY (Anxiety), DEPRESSION (Depression), INSOMNIA (Insomnia), MOOD ALTERED (Major changes in mood, demeanor and thought) and BEHAVIOUR DISORDER (Irrational behavior) outcome was unknown. No concomitant medications were given by the reporter. Patient went to the hospital to have these side effects checked for about 5 times. He was diagnosed to have Depression, Anxiety, Insomnia, and Suicidal Ideation and was prescribed with Vistaril. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death" "1644357-1" "1644357-1" "Chest pain/Heart attack symptoms; Patient did not seem himself; Fatal heart attack; Shortness of breath; Pressure in his jaw; Stabbing pain in his back; Headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (Fatal heart attack), CHEST PAIN (Chest pain/Heart attack symptoms), DYSPNOEA (Shortness of breath), JOINT STIFFNESS (Pressure in his jaw), BACK PAIN (Stabbing pain in his back) and HEADACHE (Headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], AMLODIPINE and LOSARTAN for an unknown indication. On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced CHEST PAIN (Chest pain/Heart attack symptoms) (seriousness criterion hospitalization). On 24-May-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization), JOINT STIFFNESS (Pressure in his jaw) (seriousness criterion hospitalization), BACK PAIN (Stabbing pain in his back) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). On 29-May-2021, the patient experienced MYOCARDIAL INFARCTION (Fatal heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (Patient did not seem himself). The patient was hospitalized from 24-May-2021 to 26-May-2021 due to CHEST PAIN. The patient died on 29-May-2021. The reported cause of death was fatal heart attack. It is unknown if an autopsy was performed. At the time of death, CHEST PAIN (Chest pain/Heart attack symptoms), DYSPNOEA (Shortness of breath), JOINT STIFFNESS (Pressure in his jaw), BACK PAIN (Stabbing pain in his back), HEADACHE (Headache) and FEELING ABNORMAL (Patient did not seem himself) outcome was unknown. Treatment information was not provided. This is a case of a 64 yo Male who died of a Myocardial Infarction 7 days after receiving the second dose. Very limited information regarding these events have been provided at this time. Patient's symptoms of jaw pain, pressure I his head and chest pain prior to vaccination may be a confounding factor to the events. No further information is expected. This case was linked to MOD-2021-287620 (Patient Link).; Sender's Comments: This is a case of a 64 yo Male who died of a Myocardial Infarction 7 days after receiving the second dose. Very limited information regarding these events have been provided at this time. Patient's symptoms of jaw pain, pressure I his head and chest pain prior to vaccination may be a confounding factor to the events. No further information is expected.; Reported Cause(s) of Death: Fatal Heart attack" "1644406-1" "1644406-1" "Bowel blockage; Fever; Severe stomach cramp pain; Headache; Nauseous; Shaky with chills; Could not walk; Chills; Turned pale white like a ghost after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INTESTINAL OBSTRUCTION (Bowel blockage), PYREXIA (Fever), ABDOMINAL PAIN UPPER (Severe stomach cramp pain), HEADACHE (Headache), NAUSEA (Nauseous), NERVOUSNESS (Shaky with chills), GAIT DISTURBANCE (Could not walk) and CHILLS (Chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Dialysis (15 years in dialysis with multiple medical conditions). On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization), ABDOMINAL PAIN UPPER (Severe stomach cramp pain) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), NAUSEA (Nauseous) (seriousness criterion hospitalization), NERVOUSNESS (Shaky with chills) (seriousness criterion hospitalization), GAIT DISTURBANCE (Could not walk) (seriousness criterion hospitalization) and CHILLS (Chills) (seriousness criterion hospitalization). On 26-Apr-2021, the patient experienced INTESTINAL OBSTRUCTION (Bowel blockage) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced PALLOR (Turned pale white like a ghost after vaccination). The patient was hospitalized for 6 days due to ABDOMINAL PAIN UPPER, CHILLS, GAIT DISTURBANCE, HEADACHE, INTESTINAL OBSTRUCTION, NAUSEA, NERVOUSNESS and PYREXIA. On 26-Apr-2021, PYREXIA (Fever), ABDOMINAL PAIN UPPER (Severe stomach cramp pain), HEADACHE (Headache), NAUSEA (Nauseous), NERVOUSNESS (Shaky with chills), GAIT DISTURBANCE (Could not walk) and CHILLS (Chills) outcome was unknown. The patient died on 26-Apr-2021. The reported cause of death was Intestinal obstruction. It is unknown if an autopsy was performed. Concomitant medications was not reported. No treatment information was provided. Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Intestinal obstruction" "1645034-1" "1645034-1" "Very very sick; In bed for several days; flu-like symptoms; Headache; Fatigue; Died in their sleep; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (Died in their sleep) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Very very sick), MOBILITY DECREASED (In bed for several days), INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (Headache) and FATIGUE (Fatigue). The patient died on 30-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ILLNESS (Very very sick), MOBILITY DECREASED (In bed for several days), INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Concomitant medication information not provided. Treatment information not provided. The caller was calling on behalf of their son who died on 30Jul2021. The patient received first dose of Moderna COVID-19 vaccine on 22Jun2021 and second on 16Jul2021. The caller stated the patient received the second dose early. The caller did not know which arm the vaccine was given in. The caller stated after receiving the second dose the patient became very very sick, the patient was in bed for several days, they had flu-like symptoms, a headache, and fatigue. The caller confirmed patient seemed to get better however then the patient died in their sleep on 30Jul2021. The caller did not know if the patient took anything to help with the symptoms experienced and confirmed the patient was not taking any daily medications. Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-286489 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death" "1645045-1" "1645045-1" ""feeling sick; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and MALAISE (feeling sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced MALAISE (feeling sick) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced COVID-19 (COVID-19) (seriousness criterion death). The patient died on 05-Aug-2021. The reported cause of death was Covid-19. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Patient started feeling sick on 13 Jul 2021 and was hospitalized a few days later. Patient was passed away on 05 Aug 2021 with a cause of Death of COVID-19. Very limited information regarding this event/s has been provided at this time. Further information has been requested. The causality for the event Covid-19 will be considered as ""Not Applicable"".; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. The causality for the event Covid-19 will be considered as ""Not Applicable""; Reported Cause(s) of Death: COVID-19"" "1645204-1" "1645204-1" "This spontaneous case was reported by a consumer and describes the occurrence of COMA (went into a coma), CARDIAC ARREST (2 days after she was diagnosed with COVID, she fell into cardiac arrest), HYPOKINESIA (couldn't get out of bed/couldn't move), ARTERIAL OCCLUSIVE DISEASE (clogged arteries in her legs), PERONEAL NERVE PALSY (foot drop), COVID-19 (acquired COVID/2 days after she was diagnosed with COVID, she fell into cardiac arrest), RALES (a little bit of crackling in her lungs), ORAL CANDIDIASIS (thrush in her mouth), ASTHENIA (completely weak/extreme weakness), PAIN (extreme pain/continued with the pain), HOSPITALISATION (she was in the hospital for a total of 131 days) and PYREXIA (fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN (extreme pain/continued with the pain) (seriousness criteria death, hospitalization and disability). In July 2021, the patient experienced COMA (went into a coma) (seriousness criteria death, hospitalization, disability, medically significant and life threatening), CARDIAC ARREST (2 days after she was diagnosed with COVID, she fell into cardiac arrest) (seriousness criteria death, hospitalization, disability and medically significant) and COVID-19 (acquired COVID/2 days after she was diagnosed with COVID, she fell into cardiac arrest) (seriousness criteria death, hospitalization prolonged and disability). On an unknown date, the patient experienced HYPOKINESIA (couldn't get out of bed/couldn't move) (seriousness criteria death, hospitalization and disability), ARTERIAL OCCLUSIVE DISEASE (clogged arteries in her legs) (seriousness criteria death, hospitalization and disability), PERONEAL NERVE PALSY (foot drop) (seriousness criteria death, hospitalization and disability), RALES (a little bit of crackling in her lungs) (seriousness criteria death, hospitalization and disability), ORAL CANDIDIASIS (thrush in her mouth) (seriousness criteria death, hospitalization and disability), ASTHENIA (completely weak/extreme weakness) (seriousness criteria death, hospitalization and disability), HOSPITALISATION (she was in the hospital for a total of 131 days) (seriousness criteria death and hospitalization prolonged) and PYREXIA (fever) (seriousness criteria death, hospitalization and disability). The patient died on 23-Jul-2021. The reported cause of death was Coma, Cardiac arrest, Movements reduced, Arterial occlusion, Foot drop, covid-19, Crackles lung, Oral thrush, Weakness, Pain and Fever. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: abnormal (abnormal) extreme vasculitis after a nerve biopsy. In 2021, Biopsy muscle: abnormal (abnormal) muscles were debilitating. In 2021, COVID-19: positive (Positive) positive. No concomitant and treatment information was provided. Patient was removed from the hospital and taken to a rehabilitation facility. Patient had a fever at that facility and a little bit of crackling in her lungs. Then patient was admitted back in the hospital for four months. They did a biopsy in the throat due to thrush in patients mouth, which the patient never had before. patient was completely weak, and couldn't find out what patient had.. After 3 months in the hospital, they found that patient had extreme vasculitis after a nerve biopsy. They gave patient a treatment to lower her vascular system; the name is unknown. patient was doing well, but then patient acquired COVID in July 2021. Two days after patient was diagnosed with COVID, and fell into cardiac arrest. patient went into a coma, then passed 3 days later on 23Jul2021. patient was in the hospital for a total of 131 days. Company Comment: This is a case of death in a 74-year-old female patient, after receiving on February, date unknown an unspecified dose of vaccine (Lot number unknown). Cause of death was coma, cardiac arrest, movements reduced, arterial occlusion, foot drop, covid-19, crackles lung, oral thrush, weakness, pain and fever. Very limited information regarding underlying medical history, concomitant medications and autopsy report was provided at this time. Further information is expected.; Sender's Comments: This is a case of death in a 74-year-old female patient, after receiving on February, date unknown an unspecified dose of vaccine (Lot number unknown). Cause of death was coma, cardiac arrest, movements reduced, arterial occlusion, foot drop, covid-19, crackles lung, oral thrush, weakness, pain and fever. Very limited information regarding underlying medical history, concomitant medications and autopsy report was provided at this time. Further information is expected.; Reported Cause(s) of Death: cardiac arrest; coma; Pain; Movements reduced; arterial occlusion; foot drop; fever; crackles lung; Oral thrush; weakness; COVID-19" "1645285-1" "1645285-1" "He was placed in the ICU and passed on 16Aug2021; COVID-19; High grade fever; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (He was placed in the ICU and passed on 16Aug2021), COVID-19 (COVID-19) and PYREXIA (High grade fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (COVID-19) (seriousness criteria death and life threatening), PYREXIA (High grade fever) (seriousness criterion life threatening) and DRUG INEFFECTIVE (Lack of drug effect). On 16-Aug-2021, PYREXIA (High grade fever) outcome was unknown. The patient died on 16-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DRUG INEFFECTIVE (Lack of drug effect) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: very low (Low) very low. On an unknown date, Oxygen saturation: low (Low) oxygen was not going to the blood. On an unknown date, SARS-CoV-2 test: positive (Positive) positive. Concomitant information was not provided by reporter. No treatment information was provided. Patient had 1st dose of Moderna COVID-19 vaccine in last week of Jan2021 and 2nd dose was administered 28 days after. Two weeks ago patient was diagnosed to have COVID-19 and initially had high grade fever for a few days but had to be taken to a hospital where patient was intubated because oxygen was not going to the blood and was also noted to have very low blood pressure. Patient was placed in the ICU and passed on 16-Aug-2021. Company comment: This is a case of COVID-19 infection with fatal outcome in a 67-year-old male who died about six months after receiving the second dose of vaccine. This report refers to a case of Drug ineffective for mRNA-1273, lot #unspecified (for the two doses). Based on the current available information and temporal association between the use of the product and the Drug ineffective event, a causal relationship cannot be excluded. For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the prolonged time since the last dose of vaccine was administered and compatibility of the event of Pyrexia with a severe COVID-19 infection, this event is assessed as unlikely related to mRNA-1273. Further information was requested.; Sender's Comments: This is a case of COVID-19 infection with fatal outcome in a 67-year-old male who died about six months after receiving the second dose of vaccine. This report refers to a case of Drug ineffective for mRNA-1273, lot #unspecified (for the two doses). Based on the current available information and temporal association between the use of the product and the Drug ineffective event, a causal relationship cannot be excluded. For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the prolonged time since the last dose of vaccine was administered and compatibility of the event of Pyrexia with a severe COVID-19 infection, this event is assessed as unlikely related to mRNA-1273. Further information was requested.; Reported Cause(s) of Death: Unknown cause of death" "1646186-1" "1646186-1" "passed away 19Jun2021; This is a spontaneous report from a contactable consumer (patient's mother). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23May2021 (Lot Number: EW0172) (at age of 25-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included diagnosed with an enlarged vessel sized heart. The patient's concomitant medications were not reported. The patient experienced passed away on 19Jun2021.An autopsy was performed and results were not provided. Two days after the first vaccine was when the information came out about males 20-30 getting inflammation of the heart. The patient's mother told him not to take the second shot. Then, this happened. She doesn't have the results of the autopsy yet. She believed the Pfizer vaccine escalated his death. He did get diagnosed with an enlarged vessel sized heart. He got it because he thought he was doing the right thing. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: passed away 19Jun2021" "1646411-1" "1646411-1" "he passed away within 48 hours; This is a spontaneous report from a contactable consumer. A 64-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 15:30 (Batch/Lot Number: em9809) as dose 1, single for covid-19 immunisation. The patient has no medical history. Concomitant medication included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Feb2021, 12:00, the patient passed away within 48 hours. The patient received defibrillation as treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient died on 11Feb2021 due to cardiac disorder. An autopsy was not performed.; Reported Cause(s) of Death: Cardiac" "1646822-1" "1646822-1" "Subdural hem; Tiredness; Loss of appetite; Loss of smell; This is a spontaneous report from two contactable consumers (one of was patient's wife). A 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in Deltoid Left on 26Feb2021 16:00 (Lot Number: EN6205) as dose 2, single (at age of 76-year-old) for covid-19 immunisation. Prior Vaccinations was none. Medical history included blood pressure abnormal, chronic obstructive pulmonary disease (COPD), cholesterol abnormal. Concomitant medications included lisinopril taken for blood pressure abnormal from an unspecified date to 22May2021; salbutamol sulfate (PROAIR HFA) via Inhalation route taken for COPD from an unspecified date to 22May2021; pravastatin taken for cholesterol abnormal from 2019 to 21May2021. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9265) Intramuscular administered in Right deltoid on 02Feb2021 08:45 AM for COVID-19 immunisation (at age of 76-year-old) and experienced flu like, sweats, chills, fever, vomiting, extreme tiredness, ill. The patient experienced subdural hem (death, medically significant) on 23May2021, week long tiredness on 2021, loss of appetite on 2021, loss of smell on 2021. The second dose resulted in week long tiredness, loss of appetite, loss of smell. The event subdural hem required visit to Emergency room and had no treatment. The patient died on 24May2021. An autopsy was not performed. Outcome of the event subdural hem was fatal, of the events tiredness, loss of appetite, loss of smell was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Subdural hem" "1647170-1" "1647170-1" "tumor grow to the size of a soft ball/ grow a tumor that size that fast (history of ongoing multiple myloma); She steadily declined every day after getting the shot and died May 3rd./ she could not get out of bed without help; This is a spontaneous report from a contactable consumer (patient's son). A non-pregnant 83-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as a single dose in her left arm, on 03Mar2021 10:00, at the age of 83-year-old of vaccination, for Covid-19 immunization. The patient had a history of ongoing multiple myloma. Concomitant medications included lenalidomide (REVLIMID), gabapentin, and acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had multiple myeloma and was informed in late February that her blood work numbers indicated her cancer had come out of remission. She received the Covid shot on 03Mar2021. Within 3 weeks she had a tumor grow to the size of a soft ball. She steadily declined every day after getting the shot and died 03May2021. Before the shot she was walking 2 mi per day by the end of March she could not get out of bed without help. The reporter considered that the events started on 04Mar2021. Unspecified chemotherapy was received for her condition. Her condition resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. It was unknown if an autopsy was performed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was the reporter's belief that no one grew a tumor that size that fast without help. The reporter believed that the combination of the timing of the cancer coming out of remission and getting the Covid shot was the cause of her fast decline. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: tumor grow to the size of a soft ball/ grow a tumor that size that fast; She steadily declined every day after getting the shot and died May 3rd./ she could not get out of bed without help" "1647389-1" "1647389-1" "not feeling well; not feeling well; This is a spontaneous report from a contactable consumer. A 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 09Apr2021 as DOSE 2, SINGLE (at the age of 83-years-old) for covid-19 immunisation. The patient's medical history included hypertension, drug hypersensitivity (allergic to Penicillin). The patient's concomitant medications included lisinopril (LISINOPRIL) taken for blood pressure measurement. The patient had hip surgery 11 years earlier and was now an inch shorter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The reporter's brother died after getting the second shot. It was reported that, the patient was not feeling well and the reporter talked to him on the 07Apr2021 and then on 11Apr2021. The patient didn't complain and didn't sound well and didn't feel well when the reporter spoke to him. By 15Apr2021 the patient died. It appears the patient had some kind of reaction to the vaccine. The patient was well before he took any vaccines. The patient had his blood pressure under control, low cholesterol, and walked every day. The reporter tried to get an autopsy but was unable because of the condition of the body. The reporter had a welfare check done on the patient on 06May2021 and that's when they found his body in his home. The patient was alive until the 15Apr2021. The reporter knew this because the patient wrote on his calendar daily but it abruptly stopped on 15Apr2021. They did not have the official cause of death for the patient, the reporter will have to look at the patient's death certificate. Everything about the patient was healthy and had his blood pressure under control for a while. The patient died on 15Apr2021. An autopsy was not performed. The outcome of the patient was reported as fatal. Information about Lot/Batch number has been requested.; Reported Cause(s) of Death: not feeling well" "1647424-1" "1647424-1" "He couldn't breathe/ husband passed away after receiving the 2nd dose; This is a spontaneous report from a contactable consumer (wife). A 73-year-old patient (husband) received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Batch/Lot number: was not reported, Expiration date: was not reported, Age at vaccination: 73-year-old) via an unspecified route of administration on 19Apr2021 11:00 AM as dose 2, single for COVID-19 immunization. Medical history included kidney failure. Concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date for covid-19 immunization. It was reported that her husband had passed away, 21Apr2021 around 8:00AM, because he couldn't breathe even with the ventilator. She stated they both received the 2nd dose of the covid vaccine on 19Apr2021 around 11:00 am. On tuesday, the following day, around 1:00 pm, he couldn't breathe, so he went to the hospital at about 1:30 pm. They said he had to go to the big hospital downtown as they did not have dialysis and her husband had had kidney failure. In the morning, she was told that her husband had passed away, 21Apr2021 around 8:00AM, because he couldn't breathe even with the ventilator.; Reported Cause(s) of Death: He couldn't breathe/ husband passed away after receiving the 2nd dose" "1651218-1" "1651218-1" "Patient with history of diabetes and CHF came in for non-ST elevated myocardial infarction on 8/3/21 for Left Heart Cath. Another admission on 8/8/21 for stroke-like symptoms, CT scan of head revealed acute-subacute infarction. Patient had extended stay in hospital, suffering a second stroke. Then underwent vascular surgery on either 8/25/21 or 8/26/21 to remove thrombus (blood clot) in one leg. After surgery went to ICU for recovery, and was transferred to floor bed after one day. He expired (passed away) on 8/27/21." "1651302-1" "1651302-1" "Patient received second dose of covid 19 moderna vaccine March 30 2021 and he died exactly 2 months after that second dose. He died in the shower chair during his shower." "1651415-1" "1651415-1" ""Patient felt unwell - dizzy and tired on the evening of April 5, 2021. She went to bed and died in her sleep, likely early in the morning April 6, 2021. Medical Examiner recorded her cause of death ""Sudden Cardiac Death associated with Mitral Valve Prolapse"" "1651434-1" "1651434-1" ""Patient died 2 weeks following the 2nd dose of Moderna vaccine, Pt died of upper G.I bleed and multi system organ failure in ER at Hospital on feb 19. . Ist day following vaccine, pt experienced fever of 101, shaking chills, feeling like the ""flu"". Over the next several days, pt c/o lethargy, ""No energy"", GI distress, esophageal and stomach "" burning"". He had decreased appetite, and took tums daily. He complained that his 60yr old smallpox and polio site in arm was ""itching."" He had an outbreak of a cold sore on mouth. ( not experience for over 15 years). Pt on Feb 19 was not feeling well, felt dizzy, became cold, clammy before calling ambulance. He was not able to walk to bathroom, he fell and had dark colored stools when medics arrived. He was awake and oriented."" "1654025-1" "1654025-1" "Injection was given with no immediate outward sign of an adverse affect. I, as her sister, noticed an affect when I tried to talk to her on the phone calling from California. She hardly talked which was unusual since we talked or texted everyday. She said she did not feel like texting. From that Sunday (1/10/21) through Thursday (1/14/21), she only texted one time. On Thursday, she said it hurt to text, that her mind could not figure out how to text. From that time on, she had many, many times when she could or would not text. She could not figure out how to operate her phone. She got more and more UTI infections and was hospitalized in acute facilities from then on, numerous times. She even said people were trying to kill her. She went downhill cognitively as well as physically until she passed on 8/07/21." "1654078-1" "1654078-1" "My mother who was completely healthy, alert and active on the morning on May 16 was found by me at approximately 12:30pm deceased on the floor in her bathroom. There were no signs or symptoms prior. Coroners autopsy concluded: hypertension type cardiovascular disease with myrocardial fibrosis, mitral valve prolapse and severe cardiomegaly (in which she was never diagnosed prior)" "1654195-1" "1654195-1" "Blood clots resulting in many strokes, brain bleeding due to strokes resulting in crushing the Brain Stem, heart attacks and death" "1655084-1" "1655084-1" "a very rare cancer; couldn't walk after 2 weeks; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown) on 06Jun2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient received other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: unknown) on an unspecified date at single dose for COVID-19 immunisation. After the second shot on 06Jun2021, the patient couldn't walk after 2 weeks, and was diagnosed with a very rare cancer in Jul2021. The event rare cancer resulted in doctor or other healthcare professional office/clinic visit, death, life-threatening and caused hospitalization. It was unknown whether the patient had been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of rare cancer and couldn't walk. The patient died on 19Aug2021. It was not reported if an autopsy was performed. Reported cause of patient death was cancer. The outcome of event rare cancer was fatal. The outcome of event couldn't walk was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: a very rare cancer" "1655103-1" "1655103-1" "Died; Felt bad all day Saturday and Sunday/wasn't feeling good; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on 09Apr2021(at the age of 63- year-old) as dose 2, single for covid-19 immunization. Medical history included Smoker user from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect and Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. AE(s) following prior vaccinations were none. Family Medical History Relevant to AE(s) and Relevant Tests were reported as none. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on 11Mar2021 as dose 1, single for covid-19 immunization. Reporter stated his wife received the first dose on 10Mar and the second on 09Apr2021, which was a Friday evening. He stated she felt bad all-day Saturday(10Apr2021) and Sunday, and she was going to go to the doctor on Monday. The patient went to sleep that night and the last time she spoke to anyone was 11:00 or 11:30 that evening, 11Apr2021. Then no one could get a hold of the patient and was found dead on 12Apr2021. The reporter believed that the patient died that night of 11Apr2021. The patient did not visit to emergency room or physician office. The patient died on 12Apr2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Died" "1655115-1" "1655115-1" "Pulmonary embolism; This is a spontaneous report from a contactable consumer (patient's cousin). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 27Jan2021 (at the age of 83-year-old) as dose 1, single for covid-19 immunisation. Medical history included controlled hypotension. The patient's concomitant medications were not reported. The patient experienced pulmonary embolism on 12Feb2021. The consumer is calling about the Covid 19 vaccine, on behalf of her cousin (the patient) that used to live with her when they were children. The patient received the Covid 19 vaccine in Jan2021 and he died afterward of a pulmonary embolism. This has been a touchy subject talking to the patient's wife. The patient did not have any other health issues. He was getting ready for work and he died. The only reason he got the Covid 19 vaccine was so he could visit the caller's 97 year old mother. An autopsy was performed by the funeral home and it states cause of death, pulmonary embolism. She reports the coroner with Rolling Hills has the autopsy information. The patient only received one dose of the Pfizer Covid 19 vaccine. The caller reports that the patient was very good at going to his doctor's appointments. She reports the patient did have controlled hypertension on medications, no big deal. He wasn't overweight or diabetic or even prediabetic. His death just seems very random. She reports the date of death as 12Feb2021 early in the morning. The patient was in the bathroom getting dressed for work. The caller is glad the patient's children wanted an autopsy because the patient did not have any preexisting conditions. The evet did not require a visit to Emergency Room or Physician Office. There is no relevant tests. The patient died on 12Feb2021. An autopsy was performed, autopsy-determined cause of death was pulmonary embolism. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolism" "1655136-1" "1655136-1" "He was found dead in his home by friends who went looking for him after he didn't show up for work... possible suicide?" "1655677-1" "1655677-1" ""patient vaccinated 7/23/2021, admitted 7/29/2021, tested positive for covid 7/29/2021. discharged 8/14/2021, patient expired Patient received Pfizer vaccine L deltoid lot numberFA6780 on 7/23/2021. Tested positive on 7/29/2021 after exposure. Writing report since patient received vaccine and now critically ill and intubated to follow procedure. Patient intubated 8/7/2021 History Of Present Illness Patient is a 53-year-old patient with a PMH of CKD4 and HTN who presented to ED on 7/29 with complaints of fatigue, diarrhea, weakness, and loss of taste and smell. Patient stated he was exposed to COVID on 7/20 and received his 1st COVID-19 vaccine on 7/23. On presentation to the ED the Pt stated on 07/24 he began to have subjective fevers, weakness and fatigue, and the following day began having diarrhea and ""passed out"" 4 times since symptoms developed. While on the floor the patient had been treated with dexamethasone 6 mg daily, remdesivir, and tocilizumab, and had been improving, weaned from HFNC to 4L NC on 8/5. On 8/6 the patient had worsening shortness of breath and was transition back to high-flow nasal cannula. Today, 8/7, the patient had worsening respiratory distress and increasing oxygen requirements 100% & 70L HFNC as well as 100% non-rebreather with persistent hypoxia. MICU was called and the patient was emergently intubated for acute hypoxic respiratory failure. Past Medical History He has a past medical history of CKD (chronic kidney disease), stage IV (CMS/HCC), Gout, and Hypertension. Assessment and Plan: The patient is a 53 yo M with CKD4,HTN that presents to UKMC on 7/29 and was diagnosed with COVID at this time. Progressive hypoxic RF that required HFNC, and on 8/7/21 required intubation with mechanical ventilation. Hospital course complicated by pneumomediastinum, transaminitis, and AKI secondary to COVID. ARDS COVID-19 PNA (POA) Pneumomediastinum, worsening -XR chest with B/L peripheral and bibasilar opacities -Inflammatory markers were up trending, will continue to monitor -CXR 8/6: showed air around heart borders and into mediastinum suggestive of pneumomediastinum -8/6: CT chest: significant pneumomediastinum, multifocal pulmonary infiltrates likely 2/2 COVID-19 pneumonia, official read pending -Thoracic surgery consulted: no interventions at this time unless the patient was to clinically decline. -S/p 5-day course of remdesivir finished on 8/6 -ID consulted, tocilizumab 800 mg one dose given 8/2/21 - PF ratio at time of transfer to the unit: 124 PLAN: - Evaluate to repeat CT chest with patient clinical decline. - Low PEEP ventilation with CT imaging indicating likely BPF at the area of the lingula. - Minimize coughing and desynchrony while on mechanical ventilation: Propofol and Dilaudid gtts. - ABG -Continue dexamethasone 6 mg daily (D6/10) -Albuterol inhaler Q 4 hrs. -Heparin 7500 U q8hrs for DVT ppx AKI on CKD stage V not on Dialysis (POA) Hyperkalemia (POA) Mixed AGMA and NAGMA (POA) -Unknown baseline Cr, close to 6.8 upon admission with peak at 7.5, now stable/improving - Multifactorial acidosis: BUN, diarrheal illness, and -K stable with lokelma as recommended per renal -Follows up with his nephrologist OP and was supposed to be referred for kidney transplant PLAN: -Nephrology following on floor, will notify of transfer to the ICU - Place Udall-- > IHD to start 8/7. -Continue sodium bicarb 1300 TID, calcitriol and vitamin D2 at same doses -Strict I&O, Daily weights - Foley Seizure-like activity - Patient with right-sided upper extremity and lower-extremity tonic activity following intubation. - Prior to intubation, patient had EMV 15, appropriate and no focal deficits. - Likely metabolic in nature, patient with BUN >100, sepsis, COVID - No past history of seizures. PLAN: - TSH, B12, ammonia - EEG Newly diagnosed HFrEF (POA) -TTE with 40-50% EF and global LV hypokinesis PLAN: -STOP coreg , HOLD home amlodipine -OP follow up with cardiology for further workup given COVID positive status Transaminitis (POA) - Possibly multifactorial 2/2 volume depletion but also possible drug effect from remdesivir PLAN: - CMP today and as needed. Suspected orthostatic syncope related to COVID-19 infection -Started prior to admission in the setting of ongoing diarrhea, nausea and poor PO intake -No episodes since, symptoms improved with adequate fluid resuscitation -EKG on admission with sinus tachycardia with no significant ST-T changes -PT/OT, recs home with assistance Obesity (POA) - BMI 35.8, complicates all aspects of care. Hospitalization Admit Date/Time: 7/29/2021 3:55 PM Admitting Attending: Discharge Date: 08/14/21 Discharge Attending Physician: 8/9/2021 Assessment and Plan The patient is a 53 yo M with CKD4, HTN that presents to UKMC on 7/29 and was diagnosed with COVID at this time. Progressive hypoxic RF that required HFNC, and on 8/7/21 required intubation with mechanical ventilation. Hospital course complicated by pneumomediastinum, transaminitis, and AKI secondary to COVID. Acute Respiratory Failure Requiring Mechanical Ventilation Moderate ARDS COVID-19 PNA (POA) Pneumomediastinum, stable Pneumopericardium, stable HAP -XR chest with B/L peripheral and bibasilar opacities -CXR 8/6: showed air around heart borders and into mediastinum suggestive of pneumomediastinum -8/6: CT chest: significant pneumomediastinum, multifocal pulmonary infiltrates likely 2/2 COVID-19 pneumonia -Thoracic surgery consulted: no interventions at this time unless the patient was to clinically decline. -S/p 5-day course of remdesivir finished on 8/6 -ID consulted, tocilizumab 800 mg one dose given 8/2/21 - PF ratio at time of transfer to the unit: 127 - Started NMB on 8/8 PLAN: - Low PEEP ventilation with CT imaging indicating likely BPF at the area of the lingula. - Minimize coughing and desynchrony while on mechanical ventilation: Propofol and Dilaudid gtts. - DC nimbex today, PF ratio increased to 164 after paralytic -Continue dexamethasone 6 mg daily (stop date 8/11) -Albuterol inhaler Q 4 hrs. -Heparin 7500 U q8hrs for DVT ppx -Empiric Cefepime for HAP--Follow up cultures from 8/7 - DC vanc AKI on CKD stage V(POA) Hyperkalemia (POA)--resolving Mixed AGMA and NAGMA (POA) -Unknown baseline Cr, close to 6.8 upon admission with peak at 7.5, now stable/improving - Multifactorial acidosis: BUN, diarrheal illness, and -K stable with lokelma as recommended per renal -Follows up with his nephrologist OP and was supposed to be referred for kidney transplant -8/7: udall, failed IHD and converted to CRRT. PLAN: - Nephrology following, appreciate recs - Continue CRRT with goal net even - Dose meds for CRRT -Strict I&O, Daily weights Shock, multifactorial - Medication and sepsis related, stress induced CM - Received approx. 2 L IVF - Cortisol 9.7 on 8/7 PLAN: - Levophed for MAP >65 - Treatment of infections - Defer stress steroids while on Dex, can evaluate to start stress HC Once steroids complete for Dex-ARDS. Newly diagnosed HFrEF (POA) -TTE with 40-50% EF and global LV hypokinesis PLAN: -OP follow up with cardiology for further workup given COVID positive status Transaminitis (POA) - Possibly multifactorial 2/2 volume depletion but also possible drug effect from remdesivir PLAN: - CMP improving, weekly checks. DM type 2 (POA) - Diet controlled at home. PLAN: - Start insulin gtt today, monitoring per protocol. Hypertension - Hold Home meds until clinically appropriate. Obesity (POA)- BMI 35.8, complicates all aspects of care discharge note Chief Concern, Brief History of Present Illness, and Hospital Course Patient is a 53-year-old patient with a PMH of CKD4 and HTN who presented to UK ED on 7/29 with complaints of fatigue, diarrhea, weakness, and loss of taste and smell. Patient stated he was exposed to COVID on 7/20 and received his 1st COVID-19 vaccine on 7/23. On presentation to the ED the Pt stated on 07/24 he began to have subjective fevers, weakness and fatigue, and with reported syncopal events. Patient was treated with dexamethasone 6 mg daily, remdesivir, and tocilizumab. On 8/6 the patient had worsening shortness of breath with increasing oxygen requirements. On 8/7, the patient had worsening respiratory distress and increasing oxygen requirements 100% & 70L HFNC as well as 100% non-rebreather with persistent hypoxia ultimately requiring intubation. Furthermore, a dialysis catheter was placed and CRRT was initiated. Broad spectrum ABX were continued. On 8/8, he required addition of NMB for continued ventilator dys-synchrony. He completed the dex-ARDS protocol on 8/10. The patient had a decline on 8/11 with a fever, worsening shock. He was started back on broad spectrum antibiotics, vasopressin in addition to levophed, and stress dose steroids. Unfortunately, Pt remained with persistent and profound hemodynamic instability. His response to aggressive live saving measures was minimal. WBC up to 80 with no infectious source able to be identified, escalation of ABX still continued. CT scans unable to be obtained secondary to risk of fatal event occurring if moved and/or transported to scanner. On 8/13, Pt going into arrythmias which further exacerbated further instability, required cardioversions X 3 and antiarrhythmic medications. Goals of care discussions completed with wife. Despite attempting to give Pt more time to possibly respond to treatments, his status remained critical. Wife came to see her husband at bedside to be with him briefly before he passed away. Pt passed away on 8/14 at 8:11."" "1655701-1" "1655701-1" "Was in hospital initially on 8/6-10 with covid pneumonia. Treated with antibiotics and steroids with improvement. Discharged with antibiotics, steroids, and home oxygen. Readmitted on 8/14 with worsening shortness of breath. Elevated inflammatory markers (fibrinogen,, D-dimer and CRP). Developed pneumomediastinum with peribronchial preponderance. CT surgery evaluated and did not recommend surgical intervention. Treated with broad spectrum antibiotics and steroids." "1655721-1" "1655721-1" "Covid + August 2 nad had been hospitalized elsewhere for 2 days and discharged on rooma ir and decadron. Presented to Medical Center on 8/16/21 with )2 sat of 50% on room air. Admitted and completed course of decadron and 5 day course of remdesivir. Aslo given broad spectrum antibioitcs and anifungal. Complications of renal failure with hemodialysis started on 8/23/21 and ileus. Unable to wean from ventilator. Decision for comfort care. Expired from COVID pneumonia with severe sepsis with shock." "1655728-1" "1655728-1" "Pt.'s Brother states that after receiving the 2nd dose of Phizer (May Unknown), started experiencing symptoms of chest pains shortly after. EKG 06/28/2021 preformed. Cardiac Event, Heart Enlargement 3x ( Passed Away 08/22/2021 ). Undetermined cause of Death." "1655796-1" "1655796-1" "8/15/21: Patient arrived at the ER due to nausea, vomiting and generalized weakness for the past 5 days. Patient tested positive for COVID on 8/15/21. Diagnosed with: COVID-19 pneumonia, acute hypoxic resp failure, SIRS Note: patient previously vaccinated with Pfizer COVID-19 vaccine in March 2021. Please note: Patient received first dose Pfizer vaccine on 3/11/2021 Lot # EN6199 and the second dose on 3/31/2021 Lot # ER8737 8/18/21: Patient discharged to hospice care 8/19/21: Patient expired. Time of Death 1710" "1655806-1" "1655806-1" "Pt had a breakthrough case of COVID 19 in August 2021 required hospitalization, mechanical ventilation and then he expired on 8/29/21" "1655831-1" "1655831-1" "The patient died from COVID 19 symptoms. His body was being taken to be autopsied on 08/27/2021. I was notified after he had passed." "1655833-1" "1655833-1" "8/15/21: Patient arrived at the ER due to sudden collapse. EMS was called at 1349 and on arrival the patient was in asystole and apneic. Patient underwent emergent right frontal ventriculostomy. COVID-19 PCR came back positive on 8/15/21. Serum creatinine on admission was 1.39 which has gotten worse at 2.67. Patient intubated/mechanically ventilated, sedated; on 3 vasopressors. Stage 5 [Hunt and Hess] SAH associated with diffuse brain edema/herniation. 8/17/21: patient expired. Note: Spouse did not report symptoms of COVID-19 prior to cardiac event. Unknown if COVID-19 was symptomatic or asymptomatic due to patients unresponsive at admission. Please note: Spouse reports 2 doses of Pfizer vaccine in March 2021. Patient received first dose Pfizer vaccine on 3/31/2021 Lot # EN6198 and the second dose on 4/21/2021 Lot # ER8732" "1655858-1" "1655858-1" "PT IS A BREAKTHROUGH CASE OF COVID; EXPIRED 8/28/2021." "1655864-1" "1655864-1" "8/13/21: Admit Hospital. COVID breakthrough. Patient arrived at the ER due to shortness of breath and syncope. EMS were called by the patient's family after they found her unconscious on the floor. Her initial O2 saturation was in the 60's. Patient was brought to ICU and intubated. 8/26/21 remains in hospital intubated on vent. CRRT started. Diagnosed with: Severe ARDS, multifocal Pneumonia due to COVID-19, acute toxic metabolic encephalopathy, acute COPD exacerbation (likely 2/2 multi-focal pneumonia). Note: patient previously vaccinated with Pfizer COVID-19 vaccine in Jan/Feb 2021. 8/27/2021: patient died. Please note: Patient received first dose Pfizer vaccine on 1/23/2021 Lot # EL1283 and the second dose on 2/15/2021 Lot # EL9265" "1655865-1" "1655865-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 4/21/2021 and 5/18/2021. Patient admitted on 7/31/2021 for cardiogenic shock complicated by acute renal failure, coagulopathy and acute respiratory failure. To assist in management of the cardiogenic shock pt was placed on axillary IABP and dobutamine for inotropic support. Pt was decongested with combination of aquadex and diuretics with improvement in filling conditions. Unfortunately, patient developed persistent fever on 8/11 and was placed on broad spectrum antibiotics, ID was consulted and underwent extensive infectious evaluation.She did have MRSA in pneumonia PCR and candida albicans has grown in urine culture. On 8/16/21 morning pt decompensated hemodynamicallly requiring levophed and vasopressin and continued evaluation revealed that pt had positive IgM COVID antibodies and it was suspected that pt developed a new COVID infection. She continued to decline over the next 48 hours with worsening hemodynamics and renal function and therefore a dialsysis catheter was placed and pt was started on renal replacement therapy. Family was kept uptodate about the patients clinical status and at this point decided to transition focus of care to comfort. Pt then expired the morning of 8/18/21." "1655888-1" "1655888-1" "Patient was admitted to Medical Center 8-29-21. Previously diagnosed with right upper lobe pneumonia and was started on Levaquin. Was tested for COVID with admission, test result is positive. 8-30 patient compensated quickly and did pass away. Pt was vaccinated with the Moderna Vaccine 02-03-2021 and 03-03-2021." "1655908-1" "1655908-1" "Patient came to the ED in cardiac arrest day after vaccine, patient expired." "1655925-1" "1655925-1" "patient came to the ED in cardiac arrest, patient expired" "1655956-1" "1655956-1" "8/13/21: Patient arrived at the ER due to shortness of breath since 1 week ago. Associated symptoms include dry cough and dizziness. Intubated in the ER. Diagnosed with: acute hypoxic resp failure, COVID-19 pneumonia, septic shock, oliguric AKI requiring CRRT, partial proximal IVC thrombosis, emboli in the lingula Note: patient previously vaccinated with J&J COVID-19 vaccine on 4/27/21. 8/30/21: patient died this morning." "1655959-1" "1655959-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/24/2021 and 2/19/2021. Presented to ED on 8/4/2021 with 4 day history of feeling ill, and diagnosis of COVID on 8/3/2021. Presented with worsening shortness of breath and cough, also weakness, and vomiting. Initially admitted to telemetry unit requiring 15 L O2, and within 24 hours of presentation was requiring Airvo 60L/90%. Patient quickly decompensated further and was transferred to the ICU on 08/06 on BiPAP. He required intubation overnight on 08/06. Patient treated with convalescent plasma, remdesivir x5 days, dexamethasone, ascorbic acid, and zinc. Family requested comfort care on 8/21/2021, patient was extubated and expired 8/21/2021." "1656005-1" "1656005-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/13/2021 and 2/2/2021. Presented to ED on 8/6/2021 with complaints of acute worsening of weakness of bilateral extremities s/p fall. Of note patient reports he has had a cough since the last week of July. In the emergency room vital signs was slightly elevated blood pressure and temperature up to 101.1¦ F, saturating well on room air. EKG reviewed with slightly worsened ST depressions in inferior lateral leads with a known right bundle branch block. Patient underwent an EGD on 8/7 which revealed erosive gastritis. Patient oxygen requirement increased on 8/12/2021. Dexamethasone started on 8/12/2021. LLL early consolidation seen on CXR on 8/12/2021 that was not present on admission. Remdesivir started on 8/13/2021. On 8/21/2021 patient's family requested to transition to comfort care. Patient expired on 8/21/21." "1656016-1" "1656016-1" "Dose 1 Moderna 02/05/2021 lot # 016M20A Pt died 8/27/2021 from hemorrhagic stroke" "1656025-1" "1656025-1" "Dose 1 Moderna 01/05/2021 Lot # 037K20A Pt died of hemorrhagic stroke 8/28/2021 Non Covid realted death" "1656073-1" "1656073-1" "This is an 86 year old male with O2-dependent COPD (on 2 L NC), CHF, atrial fibrillation, obesity, CKD. We are consulted for COVID-19 infection. SNF resident. This is his third hospitalization in the past few weeks. He was recently admitted to hospital from 8/1-8/7 & also admitted then discharged from hospital 7/23 after prior admission for pneumonia & Coumadin toxicity. He presented to this ER on 8/10 with upper abdominal pain, as well as cough and possibly mild shortness of breath. His daughter called EMS, who noted that the patient was hypoxic on patient's baseline 2 L nasal cannula. No reported vomiting, diarrhea, fever, chills." "1656114-1" "1656114-1" "DEATH" "1656124-1" "1656124-1" "Breakthrough infection 8/10/2021; patient died 8/15/2021 - hypoxia" "1656127-1" "1656127-1" "Result Type: History and Physical Date: August 14, 2021 2:17 Result Status: Auth (Verified) Result Title: Admission H & P Performed By: MD on August 14, 2021 2:21 Verified By: MD on August 14, 2021 2:21 Encounter info: Inpatient, 08/14/2021 - 08/25/2021 * Final Report * Date of Admission 08/14/2021 Chief Complaint for resp distress, COVID+, intubated by EMS and given 4mg versed, 20mg etomidate, 100mg ketamine, 125mg solumedrol History of Present Illness 75-year-old female sent from secondary to respiratory distress. Patient is intubated in the ER therefore history is taken from ER records and chart. Patient had recent admission at hospital rib patient had been initially admitted with symptomatic anemia and abnormal vaginal bleeding. At that time patient was found to have brainstem mass likely metastatic cancer secondary endometrial cancer. Patient required blood transfusion. Patient presents today with acute worsening of shortness of breath at 11:30 a.m. this evening. patient has known covid-19. Per EMS patient's initial O2 sats were in the 70s. Patient started on CPAP with no improvement. Patient intubated in the field. Course of symptoms constant degree at onset severe degree of present severe. No known exacerbating alleviating factors. No known other associated symptoms. Patient by emergency department patient started IV pressors given IV antibiotics. Pneumonia due to COVID-19 virus U07.1 Acute hypoxemic respiratory failure Respiratory failure J96.90 Severe sepsis R65.20 Recent diagnosis metastatic CA likely endometrial History of Abnormal vaginal bleeding CM Ongoing Assessment AH NEW Patient: Age: 75 years Sex: Female DOB: Associated Diagnoses: None Author: Professional Services CM Contact Information: Discharge Planner . Discharge Planner Phone . Assessment Ongoing Assessment Situation: was advised that pt expired this morning 8/25/21. contacted (ex-spouse) to inform him of this information. Pt was not under hospice services as ex-spouse only returned part of the paperwork.." "1656237-1" "1656237-1" "Patient is a 81 y.o. female with history of COPD/emphysema on oxygen at home who presents with shortness of breath, chest pain, and nausea. She states her symptoms started this past Thursday. They progressively worsened with time. She normally wears 2 L of oxygen at home at night at baseline. However, her oxygen needs have had to increased since this past Thursday and she was up to 10 L oxygen at home today prior to coming to the emergency department. She came to the emergency department on Saturday 08/21/2021 and was positive for COVID-19. She did not require any more oxygen to be admitted at that time. She did have her COVID-19 vaccine and was fully vaccinated well over a month ago. She denies any other complaints today. Of note, she states only 1 of her lungs is working at 100% as the other 1 is being collapse by an uneven diaphragm. She had a car accident recently and had a ruptured sternum with diaphragmatic rupture. Hospital Course: Patient was treated for COVID-19 protocol. Unfortunately, her respiratory status continued to decompensate. She began telling staff that she was ?done ?and ?ready to go to the lord.? After difficult discussion, patient elected to make herself comfort measures only. Aggressive measures were discontinued and her family was allowed to visit say goodbye. She passed away 08/29/2021 at 1007. May she rest in peace." "1656270-1" "1656270-1" "Case was fully vaccinated with COVID 19 vaccine. Last dose administered on 2/5/21. Case tested positive for COVID 19 on 8/4/2021. and was admitted to Medical Center with covid signs and symptoms on 8/11/2021. Case expired while still hospitalized on 8/26/2021." "1656294-1" "1656294-1" "Presented to ED with difficulty breathing, O2 saturation 60% on room air. continued to have increased work of breathing and intubated and placed on mechanical ventilation. + Covid-19 test. Required vasopressor support with levophed. Found to have pseudomonas pneumonia. Multisystem organ failure and family requested transition to comfort care and passed on 8/29/21." "1656401-1" "1656401-1" "Pt died on July 11, 2021" "1656402-1" "1656402-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/6/2021 and 1/27/2021. Presented to ED on 8/7/2021 after developing dry cough for about 2 days associated with dyspnea, started using his home oxygen 2-3L continuously though previously was using very infrequently. He endorses mild fevers, headache, and generalized malaise.In the ED, COVID PCR was positive. CXR shows stable cardiomegaly; stable blunting of constophrenic angles either trace effusion vs scarring; no focal consolidation. He received Decadron x 1 dose, reports some improvement after. Patient was DNR/DNI during this hospitalization and progressed with worsening combination. respiratory failure which was not amenable to NIPPV x3 days, and dexamethasone. Discussion was held with patient's wife and decision was made to withdraw artificial support and focus on comfort. Patient expired at 1630 8/17/2021." "1656482-1" "1656482-1" "Death occurred; I performed an autopsy (I'm a Medical Examiner/forensic pathologist) and ultimately certified the death as follows: Cause of death: Congestive Heart Failure due to Atherosclerotic and Hypertensive Cardiovascular Disease. Other significant conditions: Class 1 Obesity. Manner of death: Natural. There is NO evidence to indicate that the vaccination is related to her death." "1656531-1" "1656531-1" "breakthrough Covid infection, acute resp failure, patient died" "1656552-1" "1656552-1" "Pfizer BionCOVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer BionNTech Vaccine on 03/05/2021 and 04/02/2021. Patient presented to ED on 8/4/21 for shortness of breath. Patient reported progressive worsening of shortness of breath which started 3 days prior. EMS found pt to have O2 sats at 70% RA and temp of 104F. Patient tested positive for COVID-19 infection in the emergency room. Patient had a chest x-ray done in the emergency room which revealed bilateral infiltrates consistent with COVID pneumonia versus pulmonary edema. Patient's requirement for oxygen started to increase. He was on high-flow oxygen. He also has thrombocytopenia. Required pressor support. Treated with Rocephin for UTI for Klebsiella. Pt also recieved decadron and remdesivir during stay. Patient had severe bradycardia and had a external pacemaker placed on 8/11/2021. Patient was then intubated for airway support. He also developed some acute kidney injury with the history of CKD. Patient condition slowly worsened requiring pressors. His leukocytosis increased. Patient went on to need dialysis and additional measures and family opted for comfort care. Patient expired on 8/21/21" "1656560-1" "1656560-1" "Janssen (J&J) COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 07/10/2021. Patient started having symptoms on 7/31/2021 and presented to ED on 8/2/2021. Patient received dexamethasone and enoxaparin at outside hospital. Patient rapidly declined eventually requiring mechanical ventilation and was then transfered to ED on 8/5/2021. Patient was diagnosed with bilateral pulmonary embolisms. Patient received dexamethasone, enoxaparin, remdesivir, & ceftriaxone. Hospital course progressed without meaningful recovery of lung function ad patient expired on 8/18/2021." "1656565-1" "1656565-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 01/14/2021 and 02/09/2021. Pt presented to ED on 8/16/21 with c/o rectal bleeding, hematochezia, onset of the previous night. States she had 5-6 episodes last night of bright red rectal bleeding which has continued into today, including diarrhea. She had an episode of BRBPR in the ED. Patient was diagnosed with Covid on 8/13 but is largely asymptomatic. Patient was on 2L NC in the ED which is the same amount of O2 at home. Diagnostic colonoscopy was attempted twice, however, due to tortuous colon with acute angulations in the sigmoid, scope could not traverse area. IR was consulted, however cont., both CTA abdomen and angiogram were negative for any active bleeds. Surgery was consulted but determined that patient was too high risk for surgery. It was discussed with both IR and GI that if pt has significant bleed again, will consider potential repeat angiogram. Patient's cough worsened throughout the course of hospitalization and CXR showed worsening opacities and dexamethasone and remdesivir were started. Patient also received vancomycin. Patient also began to display worsening mental status, became minimally responsive with agonal breathing, and difficulty swallowing. Pt status was changed to DNAR/COT and eventually patient's son decided to make patient comfort care. Patient expired on 8/24/21." "1657248-1" "1657248-1" "Received second dose of Moderna on 2/19/21. On 2/20/20 my father said he felt fatigue and nauseated but thought that was normal side effects. On 2/21/21 @ 0100, my father suffered a massive stroke. He passed away on 3/27/21." "1657576-1" "1657576-1" "Patient was very ill after her second dose and died two weeks later. Symptoms-fever, muscle aches, fatigue" "1657896-1" "1657896-1" "treated for suspected UTI (though urinalysis was normal) with antibiotic; kidney failure; He passed away on 24Mar2021 due to heart failure; diagnosed with pericarditis; Developing fever; weakness; This is a spontaneous report from a contactable consumer. A 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Feb2021 12:00 (Batch/Lot number was not reported) (at age of 81-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation, stroke, kidney disease, hyperlipidemia and Known allergies: NKDA. There was no other vaccine in four weeks. Concomitant medications included rivaroxaban (XARELTO); allopurinol; and acetylsalicylic acid (ASPIRIN 81). On 20Feb2021, The patient started developing fever, weakness. Saw family Dr on 26Feb2021, treated for suspected UTI (though urinalysis was normal) with antibiotic. On 01Mar2021 high fever returned with extreme weakness. Admitted to hospital from 01Mar2021 to 18Mar2021 and diagnosed with pericarditis. He was sent home on Hospice. He passed away on 24Mar2021 due to heart failure. Prior to the vaccination, he was having no symptoms of infection, he was active and healthy, and he was seeing a cardiologist regularly.AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Patient died on 24Mar2021. Death cause: heart failure, kidney failure. AE treatment: numerous medications given during hospitalization. No covid prior vaccination.Covid tested post vaccination: was Yes. Covid test type post vaccination: Nasal Swab, Covid test result: Negative. No autopsy performed. The outcome of the events heart failure and kidney failure was fatal, of the rest of events was unknown. The lot number for BNT162b2, was not provided and will be requested during follow up; Reported Cause(s) of Death: kidney failure; heart failure" "1658364-1" "1658364-1" "Death from Covid Pneumonia" "1658385-1" "1658385-1" "Hospitalization with COVID-19 Reported per vaccine" "1658443-1" "1658443-1" "Hospitalization with COVID-19 Reported per vaccine EUA" "1658459-1" "1658459-1" "Specifically unknown, but patient (he's now deceased) was concerned about throwing up so much that he'd lose his stomach lining." "1658487-1" "1658487-1" "I am the epidemiologist reporting on behalf of 60 year old male patient. The patient received two doses of the Moderna vaccine on 5/17 and 6/14. On 8/9/21, the patient tested positive via a PCR test for COVID-19 (vaccine breakthrough). The patient died on 8/26 and the cause of death is listed as ?Cardiac arrest, myocardial infarction, gangrene LLE, Covid pneumonia.? Pre-existing conditions are listed as DIABETES MELLITUS, CARDIOVASCULAR DISEASE." "1658499-1" "1658499-1" "I am the epidemiologist reporting on behalf of 79-year-old female patient. The patient received two doses of the Pfizer vaccine on 3/04 and 3/25. On 8/12/21 and again on 8/13/21, the patient tested positive via a PCR test for COVID-19 (vaccine breakthrough). The patient died on 8/25 and the cause of death is listed as ?Pneumonia; COVID 19.? Pre-existing conditions are unknown." "1658515-1" "1658515-1" "I am the epidemiologist reporting on behalf of 88-year-old male patient. The patient received two doses of the Moderna vaccine on 3/21 and 4/18. The patient later took three antigen tests. The first two were on 8/16 (one was negative and one was positive) and the third was on 8/17 (positive). The patient died on 8/27 and the cause of death is not listed although it is considered a probable COVID-19 death according to state guidance. Pre-existing conditions are listed as ?CHRONIC LUNG DISEASE (ASTHMA/EMPHYSEMA/COPD), CARDIOVASCULAR DISEASE, CHRONIC RENAL DISEASE.?" "1658553-1" "1658553-1" "Janssen on 8/17. Positive 8/29. death at end hospital stay" "1658556-1" "1658556-1" "Moderna on 2/12 and 3/12. Positive on 8/27 hospital stay ended with death" "1658663-1" "1658663-1" "fully vaccinated 75-year-old male with past medical history significant for HTN, HLD, obesity, tobacco use, and prior DVTs admitted to Hospital on 07/27/2021 for shortness of breath. Patient was seen at urgent care on 07/25/2021 and found to be COVID-19 positive. CT angiogram performed to assess for pulmonary embolism. Imaging was equivocal but demonstrated bilateral patchy ground-glass opacities suggestive of bilateral pneumonia. Patient was administered and completed azithromycin, ceftriaxone, dexamethasone. Initially on 6L of oxygen by nasal cannula on admission. During his admission, patient's respiratory status worsened and he was placed on humidified high-flow nasal cannula at 60 L and 100% O2. Despite being on high-flow nasal cannula patient desaturated to the 70s and a rapid response was called. Patient was placed on BiPAP with some improvement in his respiratory status and was admitted to the hospital on 08/01/2021. On 8/7, his respiratory status progressively worsened and he was sedated and intubated. On 8/8, code status was changed to DNR. He developed progressively worsening renal failure and increased vasopressor requirements to maintain his blood pressure. 08/01 Rapid response called for patient desaturating in the 70s while on 60L. Transferred to Hospital. 8/07 Intubated and sedated due to worsening respiratory failure. 08/08 Worsening hypoxemia, renal failure, Code status changed to DNR. 08/10 Family elects palliative extubation, withdrawal of care with comfort measures. On 8/10/21 following adequate time to say their goodbyes. Palliative extubation performed by RT at 1823 with Nurse and family at bedside. Loss of palpable pulses appreciated by Nurse." "1658828-1" "1658828-1" "Hospitalization with COVID-19 Reported per vaccine EUA" "1658837-1" "1658837-1" "Hospitalization with COVID-19 Reported per vaccine EUA" "1658848-1" "1658848-1" "Patient died of COVID-19 on 07/21/2021" "1658891-1" "1658891-1" "Patient passed away on 08/21/2021." "1658899-1" "1658899-1" "Patient passed away on 08/20/2021" "1658903-1" "1658903-1" "Pt came to ER 7/27 with CP and 7/28 with difficulty breathing." "1658911-1" "1658911-1" "Patient passed away on 07/25/2021." "1658919-1" "1658919-1" "Death- 7-24-2021 Myocarditis" "1658929-1" "1658929-1" "Patient passed away on 07/25/2021." "1659129-1" "1659129-1" "Patient died of COVID-19 illness on 07/29/2021" "1659134-1" "1659134-1" "Janssen (J&J) COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 04/01/2021. Patient presented to ED with complaints of shortness of breath x 3 days. On arrival he was placed on high flow nasal cannula. Patient was mechanically ventilated on 8/5/2021 due to worsening hypoxia. Patient received dexamethasone & remdesivir. Patient was transferred to hospital on 8/5/2021. Patient received methylprednisolone, cefepime, meropenem, metronidazole, & vancomycin IV and PO. Hospital course progressed without meaningful recovery of lung function. On 8/24/2021, family decided to move to comfort care. Patient expired on 8/24/2021." "1659148-1" "1659148-1" "Patient died of COVID-19 illness on 08/01/2021" "1659238-1" "1659238-1" "Patient completed Covid vaccination series on 2/19/2021, then was hospitalized for Covid on 8/21/2021 and died of Covid 8/30/2021." "1659269-1" "1659269-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer BionNTech Vaccine on 06/18/2021 and 07/24/2021. Patient presented to ED on 8/1/21 for shortness of breath. Pt tested positive for COVID-19 on 7/30/21 and was positive for cough x 3 days. Pt was in respiratory distress in ED with worsening hypoxia requiring higher HFNC O2.Upon admission to the hospital she rapidly declined and required intubation and mechanical ventilation. Patient recieved lovenox for dvt ppx, decadron, remdesivir, and vancomycin. Her course was complicated by MSSA pneumonia and bacteremia. She had persistent bacteremia and her lines were exchanged.She decompensated on the cont. ventilator and required continued paralytics and proning. Patient did not recover. Family decided to withdraw care and patient was extubated. Patient expired on 8/20/21." "1659294-1" "1659294-1" "Patient tested positive for Covid-19 on July 10, 2021. Patient was complaining of being confused, had a fever, muscle aches, and headache. Patient also complained about nausea and abdominal pain. Patient was admitted to Medical Center on 07/24/2021 for confusion, SOB, nausea, and abdominal pain. Patient expired before they could be moved from ED to ICU." "1659313-1" "1659313-1" "She had a heart attack and died. Vaccine received on 5/7/2021, per notes chest pain began 5/8/2021, presented to the ED on 5/11/2021, diagnosed with anterior STEMI, directly to cath lab where she had a PEA and then V fib arrest. She passed away on 5/12/2021." "1659476-1" "1659476-1" "she became very tired after the shot and never regained her energy and ended up in the ER for a UTI but there was a lot of blood in her urine. After running blood work and multiple tests she was diagnosed with AML just shy of 4 weeks from the time the shot was administered." "1659718-1" "1659718-1" "Pulmonary Embolism, Acute Respiratory Failure, and Death" "1659931-1" "1659931-1" "Day after shot she began to feel, nausea, hurting, lying in bed a lot, refused to go to doctor thought she would get better. Husband left home about 15 minutes to find her dead sitting on chair, right lower leg hard and cold to touch, purple in color, blood in bilateral nares and upper body white." "1659940-1" "1659940-1" "After the 1st 24 hours from his shot, he was having trouble breathing, by the third day his skin color was looking grayish, but he thought this was all from him being recently diagnosed with COPD. He did not show up for work on Friday and when his coworker went to his home to check on him and found him unresponsive, she called 911. They tried to revive him, but was unable to. I sadly have to report he passed away." "1659951-1" "1659951-1" "Death" "1660313-1" "1660313-1" "Swollen legs, could no longer walk, low platlet levels, needed a blood transfusion, cognitive decline, kidney failure, death" "1660318-1" "1660318-1" "Difficulty breathing began approx 8 days post Vx, progressed to pneumonia after 10 days, deceased at 12 days" "1660763-1" "1660763-1" "Wrong diagnosis Dr told us hiv barely detectable then said gallbladder then walked in ov stating well good news its not cancer . he told patient he had no choice but to get the covid vaccine even tho he didn't want or understand it at all he offered no info no time and threatened patient he would not prescribe his hiv pills unless he was vaccinated fully . patient had too much trust . Dr gave him two different types and he was scheduling athird patient side affects were ignored and told it was normal due to injection he soon after was hospitallzed having lymph nodes cancer and all the tests ran by Dr were not found abbott said well I never looked at imaging and we we re sure it is acid reflex . another doctor a specialist said he shpuld not have given him that type of vaccine with his medical jistory and allergies. Dr told us at hospital dont try goodbye because patient had only 6 months if that to live he walked put two weeks later we went to specialost who said he was wrong and didnt know why Dr said that but to cover his butt because of the wrong dying of covid vaccines. Patient died and the hospital staff said either vaccine caused this or overdose when shift change happened because he was given too many pain meds and three kinds . no one even knew je was in the room he was peed even tho they said he couldnt he had food on him all over and he was on liquod diet he was dirty no water no machines hooled up not even an IV help we need justice story gets more detailed I have pics and med rec this doctor wwas wrong abiut it all even vaccine ." "1661247-1" "1661247-1" "foggy brain; atrial fibrillation; facial paralysis; This is a spontaneous report from a contactable Nurse. This contactable 36-year-old female Nurse (patient) reported for herself that: A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 (at the age of 36-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included nervous system disorder from an unknown date, hay fever, environmental allergies, known allergies hay fever, environmental allergies. Patient had no concomitant medications. Patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Patient had not received any other vaccines within 2 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, the patient was tested for COVID-19On Mar2021 at 15:45, the patient experienced facial paralysis, foggy brain, atrial fibrillation. The patient underwent lab tests and procedures which included Nasal Swab: negative on Mar2021. The patient died on Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Facial paralysis, Feeling abnormal, Atrial fibrillation cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.; Reported Cause(s) of Death: side effect of Covid-19 inoculation" "1661263-1" "1661263-1" "Died; Her sister in law received a booster dose the day before yesterday; Her sister in law received a booster dose the day before yesterday; This is a spontaneous report from a contactable consumer (patient's caregiver) via medical information team. A 70-year-old female patient received third dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 24Aug2021 (Batch/Lot number and expiry date was not reported, age at vaccination: 70-year-old) as dose 3, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously, the patient received first and second dose of BNT162B2 (Batch/Lot number and expiry date was not reported) on an unknown date as dose 1, single and dose 2, single for covid-19 immunization. On 24Aug2021, the patient received a booster dose and went home first. No one lives with her and she lives alone. The reporter's brother went to see her, and she was almost at her death. He called 911 and they took her to the hospital, and she died on 25Aug2021. An autopsy was not performed. The reporter wanted to know why did this happen to her and what caused her death and what happened to her. She was just trying to help the public after this happened. Doctors should be informed and the public needs to be informed on when to take the shot and when not to take the shot. She doesn't have all that information on when the patient received the first and second dose and just know that patient took it at the doctor's office, she went home, and she died after getting the vaccine. The caller asked if adverse reaction/experience may be related to the product or not and response was provided that Pfizer cannot assess causality and doctor/healthcare provider is in the best position to assess and advise as your doctor/healthcare provider was most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case. And also informed that Pfizer was unable to make recommendations or diagnoses on a case-by-case basis for individual patients. It was the healthcare professional's discretion with their use of clinical judgment to determine the safety of their patients. The caller was offered to provide CICP information and offered to provide Pfizer legal teams address and fax number. The reported that it was her sister in law so she doesn't have all the information, she doesn't have the doctors name or what was going on with her. She doesn't know a lot of information to give at this time. She said there was type of website to get some compensation. Do they reimbursement right after or when? She talked to someone in VAERS. She really doesn't know what to report, or why or what happened. She doesn't know if it was a blood clot or what. The doctor just gave her the shot. Maybe the patient needed the booster because her immune system was not up to par. She would like to know more information from the doctor. The caller asked who is capable of getting the booster shot? Is it just people that are immunocompromised or is it specific ages like people above 65 years old? The caller asked if people taking certain medications that don't allow the vaccine to work properly would be included in this group or not. The caller stated the way they have it on TV and everywhere she was thinking that everyone is able to get a booster. She stated the understanding is that certain ages over 65 can get it. (documenting as potential Pfizer complaint because she was commenting on how the guidance is not clear). The caller asked how long it will take to get the email from, agent (she just spoke with her prior to getting transferred. She stated everything is important in regard to timing, this needs to be handled quickly. She was not sure if Pfizer would want an autopsy, but they cannot afford it. She had spoken with (withheld) about wanting compensation and (withheld) was going to send an email because she asked for this in writing and not verbally. She stated she could take this information verbally now. The caller stated she has another family member that takes medication that is on the list of meds that keeps the covid vaccine from working and wanted to know if they could get a booster dose. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: unknown" "1661273-1" "1661273-1" "She took her second dose and she died five days after; This is a spontaneous report from a contactable consumer. This female patient of unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as single dose for COVID-19 immunization. It was reported that the patient took her second dose and she died five days after on 24Aug2021. No prior health issues (further not clarified). The reporting consumer had coffee with patient that morning and she died hour and a half later. In moment reporting consumer find her on ground because of the vaccine. The reporting consumer asked how you guys can give a vaccine that kills people. Like it killed patient two days back (further not clarified) when she took it. Covid was not even that serious. The reporting consumer was going to file a huge lawsuit against you guys, a huge law site. But patient didn't have to die if you guys didn't fear among her and taking your stupid vaccine. She only died because she took up the vaccine. You know that right! because she took Pfizer. There's more than 11 thousand deaths (not clarified) because of that shit. The very system was wrong, they are probably knowing that people are dying because of your stupid vaccine. There's no way that could be approved if it is killing over 11 thousand people. The outcome of the event was fatal. It was not reported if an autopsy was performed. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: She took her second dose and she died five days after" "1662120-1" "1662120-1" "DEATH" "1662149-1" "1662149-1" "I am the epidemiologist reporting on behalf of 89-year-old female patient. The patient received two doses of the Pfizer vaccine on 1/20/21 and 2/10/21. The patient tested COVID + via rapid antigen test on 7/24/21 and again on 8/27/21 via both PCR and antigen test (vaccination breakthrough). The patient was reported as having died on 8/30/21. Cause of death is listed as acute hypoxic respiratory failure; COVID 19 pneumonia. Underlying health conditions are not provided in system." "1662188-1" "1662188-1" "PT IS A BREAKTHROUGH CASE OF COVID-19 THAT EXPIRED ON 9/1/2021." "1662207-1" "1662207-1" "ED to Hosp-Admission Discharged 8/29/2021 (20 hours) Hospital Acute respiratory distress Presenting Problem/History of Present Illness/Reason for Admission Acute respiratory distress [R06.03] Respiratory distress [R06.03] Acute cystitis without hematuria [N30.00] Congestive heart failure, unspecified HF chronicity, unspecified heart failure type [I50.9] Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present [A41.9] COVID-19 [U07.1] Pneumonia due to COVID-19 virus [U07.1, J12.82] Hospital Course Patient admitted to monitored floor. She was started on non-invasive ventilation, found to have renal failure, and signs of severe sepsis. Upon admission goals of care meeting was held and family opted to withdraw active treatment and transition the patient comfort care. Active Issues Requiring Follow-up Not applicable patient expired" "1662253-1" "1662253-1" "Hospitalization/death due to COVID-19 Reported per Pfizer COVID-19 Vaccine EUA" "1662348-1" "1662348-1" "32 hours after patient obtained the 2nd vaccine, he began to seriously decline and died the next day. He was on hospice and his death was eventually inevitable due to his lung cancer, but I am reporting this event as his death occurred so close to administration of the vaccine." "1662371-1" "1662371-1" "Hospitalization/Death due to COVID-19 Reported per Pfizer COIVID-19 Vaccine EUA" "1662372-1" "1662372-1" "patient received 2nd covid vaccine and passed away 24 hours later. He was on hospice because he chose not to treat his pneumonia. We are reporting this event as the death was so close to the administration of the vaccine" "1662411-1" "1662411-1" "Patient admitted to hospital on 8/9/2021 with shortness of breath. He was diagnosed with acute hypoxic respiratory failure with COVID-19 pneumonia. His symptoms started on 8/8/2021. He was on 40% on room air and then required BiPAP to follow over 630% FiO2 with baseline home oxygen of 4 L at rest and 5 L with activity. He was started on dexamethasone, IV antibiotics, and fluids. He had further worsening of respiratory status on the morning of 8/10/2021 and was transferred to ICU and was intubated. He was placed on Levophed for hypotension and was continued on full ventilator support. He also had infectious disease consultation with continued fever and cultures and was switched antibiotics along with addition of antifungal. He continued to stay encephalopathic with CT head showed diffuse mild to moderate atrophic changes and prominent periventricular small vessel disease change. With not further waking up on lightening of sedation patient had a neurology consultation had a EEG x2 and suggested concern for anoxic brain injury. Patient's family including wife and son were discussed about overall prognosis and worsening neurologic status and they did not want him to continue full aggressive measures and switched him to comfort measures and had a vent withdrawal. He passed away in the afternoon of 8/15/2021" "1662426-1" "1662426-1" "Patient hospitalized; positive for COVID-19 (after vaccinated); patient expired / died in hospital. DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Cellulitis of left leg [L03.116] Cellulitis [L03.90] Cellulitis of left lower extremity [L03.116] HOSPITAL COURSE: Patient is a 66-year-old female with past medical history significant for multiple medical comorbidities including severe peripheral arterial disease, chronic obstructive pulmonary disease, pulmonary hypertension, history of TAVR, history of TIA, morbid obesity, OSA/CPAP, diabetes on insulin, CKD 3B, chronic diastolic heart failure, peripheral edema, chronic pain, ongoing tobacco abuse recent fall resulting in a right fibular fracture presents to hospital on 08/23 from subacute rehab facility due to worsening lower extremity pain, lethargy, chills, decreased oral intake for about 5 days prior to presentation and was incidentally noted to be COVID positive. Patient also recently had a hospital stay from 07/28 to 8/3 due to a right fibular fracture and was fitted with a cam boot with instructions to weight bear as tolerated. Patient was admitted with working diagnosis of acute encephalopathy and lower extremity cellulitis on the left and asymptomatic COVID-19 infection. Encephalopathy: Felt to be related to polypharmacy including sedating medications namely gabapentin, Norco and possibly also related to infection. VBG with CO2 of only 44. With supportive treatment alone, her encephalopathy improved over the next 24-48 hours and resolved completely. Only Norco was restarted. Gabapentin was planned to be discontinued due to ineffectiveness. Cellulitis: Patient was noted to have left leg cellulitis associated with changes consistent with venous stasis and edema. Patient was started on Ancef initially but surface cultures obtained at the time of admit showed MRSA and hence vancomycin was added on top. Ancef was discontinued on 08/24 with plans to continue vancomycin and eventually switch over to doxycycline to completed 10 day course. Cellulitis gradually was improving; COVID-19 infection: Incidentally noted at rehab on 08/22, patient without much respiratory symptoms and continued on 3 L baseline oxygen and hence no particular treatment was initiated. Right fibular fracture: due to previous fall/recent hospital stay at which time orthopedics recommended non operative management with a Cam boot and weight-bearing as tolerated. Patient had not had a chance to follow-up with orthopedics and hence consult was obtained here. Repeat x-ray showed improvement and possible healing, Orthopedics recommended continuation of Cam boot with weight-bearing as tolerated in outpatient follow-up. Peripheral arterial disease: With extensive nature of peripheral arterial disease noted on previous imaging studies with plans for following up with vascular surgery at Metro Hospital with upcoming plans for angiography/angioplasty. There was no concern for acute ischemia on exam. Anasarca, acute on chronic diastolic congestive heart failure with significant weight gain compared to previous hospital stay. Daughter did mention that subacute rehab did not really pay close attention to her salt intake and weight gain and she had gained significant amount await (close to 20 kilos) and hence aggressive IV Lasix/diureses were started. Her renal function mostly was holding in spite of aggressive diureses and slow weight loss. This was also noted in the lower extremities with improvement in the edema. On 08/28, during my interview patient had a unremarkable night, used her BiPAP in the night, noticed that she was slightly more short of breath ( while she had taken off her CPAP mask, had not put her oxygen on yet), a short while later when she was helped to the bedside commode for urination, patient became acutely short of breath, appeared unwell and lost her pulse is. All code was called and resuscitation efforts were continued for 29 minutes and and unsuccessful in obtaining ROSC, pronounced at 11:35 a.m.. Suspicion was that she may have had a PE or seizure (she did have seizures during resuscitation). Daughter was notified, discussed with a little bit later when she arrived at bedside. Not a ME case, daughter did not want autopsy; Death certificate signed." "1662469-1" "1662469-1" "Patinet presented to the emergency department for evaluation after being found unresponsive at home prior to arrival. Unable to obtain history from patient due to intubated status. She was found down on the floor by a neighbor. It is unknown how she got on the floor or for how long she was down. She had an episode of emesis upon arrival of EMS, and was found to be bradycardic. She was given 3 mg Atropine en route. She denied any falls or injuries, chest pain, or SOB prior to intubation. She also denied any drug or alcohol use in the ED. She had received her second COVID vaccine on 4/8/2021, admitted to hospital on 4/10/2021. She was intubated and had placement of temporary pacemaker on 4/10/2021. Patient had a tracheostomy placed on 04/22/2021, a permanent pacemaker placed on 04/28/2021, & a PEG tube placed on 04/29/2021. She had episodes of ventricular tachycardia and underwent a cardiac cath on 5/11/21. With deconditioning and multiple comorbidities-family decided to switch her to comfort measures and patient expired on 5/19/2021." "1662503-1" "1662503-1" "Dose 1 Moderna 2/24/2021 Lot # 002A21A Pt dies 8/30/2021 of pneumonia, NOT a Covid relate death" "1662542-1" "1662542-1" "Patient recieved her 2nd moderna dose here on 8/31/21 at about 5:20pm. I recieved a call from my HCP asking us to fill out the Vaers report, she informed me that the patient had reported to hospital last night and had passed away." "1662602-1" "1662602-1" "positive for COVID 8/8/21 ED on 8/9 feeling could not get warm, dx sepsis most likely d/t COVID -19 moved to ICU pt expired 8/12/21" "1662698-1" "1662698-1" "Admission Date: 8/22/2021 Date of Death: 8/31/2021 actual Time of Death: 9:35 am Autopsy Scheduled/Performed: No Manner of Death: Natural Cause of Death: COVID-19 pneumonia 9 days - interval between onset and death Acute hypoxic respiratory failure Obstructive sleep apnea on respiratory support patient has not been compliant with weight prior to this hospital stay Chronic osteomyelitis Quadriplegia Hospital Course: Patient presented with increased weakness hypoxia and hypotension. Patient has history of chronic osteomyelitis and also he has quadriplegia. Patient was admitted started on broad spectrum antibiotics and shortly after admission he required pressors so he was transferred to the intensivist service. Patient also required significant amount of oxygen and that was providing using BiPAP. Once the patient was off of pressors he was transitioned to hospitalist service. Patient developed A. fib with rapid ventricular response cardiology service was consulted and also he was treated with amiodarone. Patient developed worsening infiltrates with increased opacification of the left lung. Initial testing in the emergency room turned back positive for coronavirus. Patient did have the 2 doses of vaccine given approximately 6 months ago. Pulmonology service was consulted due to opacification of the left lung but patient refused bronchoscopy. To note even prior to this hospital stay patient has been declining regarding ability to function. Minimal activity was causing significant shortness of breath. Patient continued to deteriorate and he became hypoxic despite using BiPAP on a maximum settings with FiO2 of 100%. In view of her rapid deterioration patient was intubated but after discussing with family it became clear that patient does not want to be on prolonged mechanical ventilation and that would have been the best outcome in view of his previous deterioration in pulmonary function on top of his pneumonia and COVID-19 disease. Patient was extubated the same day and he died shortly after being extubated. Discharge Diagnoses: Acute hypoxic respiratory failure secondary to COVID-19 pneumonia and bacterial pneumonia worsened by patient quadriplegia and decreased cough reflex Septic shock likely source multilobar pneumonia other possibilities UTI with chronic enduring catheter and chronic osteomyelitis COVID-19/SARS-CoV-2 viral infection patient treated with remdesivir and dexamethasone Partial quadriplegia from an old accident with neurogenic bladder and also with colostomy Anemia acute on chronic acute component likely related to present illness ICU delirium" "1662832-1" "1662832-1" "Fever of unknown origin and encephalopathy. Rapid neurological and respiratory decline of unknown origin." "1662858-1" "1662858-1" "PATIENT BELIEVED TO HAVE HAD A STROKE PER DAUGHTER AND PASSED AWAY" "1662882-1" "1662882-1" "PT was found unresponsive in the back of his vehicle. Last know alive when he spoke to mother regarding receiving the vaccination in the morning/early afternoon. ACLS resuscitative efforts performed. Not successful. NO recent health complaints known" "1662915-1" "1662915-1" "Within 12 hours of my father's second Pfizer covid vaccine, he lost complete use of his legs. OVERNIGHT. He also began to hallucinate, which we suspected was due to a UTI but even after the UTI cleared, his hallucinations got worse. These two adverse events put him on a steady, relatively fast downward path and he died on 03/26/2021." "1662918-1" "1662918-1" "cough, SOB, nausea x 7 days prior to hospital admission" "1662980-1" "1662980-1" "coughing, wheezing, O2 sat of 80%" "1663091-1" "1663091-1" "ACUTE RESPIRATORY FAILURE HYPOXIC, PLEURAL EFFUSION, COVID-19 PNEUMONIA, DEATH" "1663119-1" "1663119-1" "This was my mom. She began to feel extreme fatigue and not herself the day after the vaccination. Almost immediately she was unable to walk. She went into an immediate and extreme physical decline. Bed ridden. Hospice was called in on 1/30/2021, She passed away on 2/15/2021" "1663204-1" "1663204-1" "Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 03/13/2021. On 8/6/2021, pt presented to ED with increasing diffuse abdominal pain that started 3 days prior. Pt reports he was diagnosed with COVID-19 on 8/5/21 and had increasing shortness of breath with cough and headache which began 8/1/21. CT showed acute uncomplicated appendicitis and confirmed patchy ground-glass opacities within the bilateral lung bases consistent with COVID pneumonia. He was given 1 g of Tylenol, 1 g of IV Rocephin, 6 mg of Decadron, 500 mg of IV Flagyl, 2 doses of 4 mg of morphine, 4 mg of Zofran and 40 mg of IV Protonix in the ED. Pt also received remdesivir. He developled hypoxia on HFNC 50/50 sating 84-87%. pO2 49. Patient was able to maintain sats in the lower 90's CXR showed worsening pulmonary edema and he was given 20mg IV lasix. Patient transferred to MICU service for worsening respiratory status on 8/13. Patient was intubated and started on proning protocol. He continued to require pressors and sedation with propofol, versed, and dilaudid. Palliative was consulted and discussed with family comfort care. Patient expired on 8/24/21." "1663206-1" "1663206-1" "Janssen (J&J) COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 03/12/2021 and 04/7/2021. Patient presented to another facility on 8/1/2021 for shortness of breath and cough. Patient received dexamethasone, remdesivir, levofloxacin with continuous BiPAP. Patient was then transfered to hospital on 8/5/2021 for higher level of care. Patient received remdesivir, dexamethasone, methylprednisolone, baricitinib, zinc, vitamin c, and ivermectin. Patient continued to decompensate and expired on 8/19/2021." "1663589-1" "1663589-1" ""Hospitalized; COVID-19 positive (fully vaccinated); Expired in hospital (likely due to COVID-19) BRIEF OVERVIEW: Admission Date: 8/22/2021 Discharge Date: 08/28/2021 Discharge Disposition: Deceased DISCHARGE DIAGNOSIS: 1. Deceased 2. Perforated Gastric Ulcer 3. Acute Blood loss anemia 4. COVID19 5. AKI with CKD stage III 6. Acute Metabolic Encephalopathy DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Respiratory distress HOSPITAL COURSE: Patient was a 94-year-old male who was initially hospitalized with signs of septic shock believed to be secondary to COVID-19 and possible bacterial pneumonia; as well as new onset AFib with RVR. Patient was admitted to the intensive care unit, he did have improvement initially with fluid resuscitation and Levophed as well as amiodarone infusion. Further workup did reveal a pneumoperitoneum patient desired aggressive treatment and went forward knowing high risk of death with exploratory laparotomy. This was done on 08/22/2021 and patient was found to have a pre pyloric perforation and peritonitis. Patient was returned back to the intensive care unit and remained intubated along with central line placements. Aggressive treatment continued, patient was extubated on 8/25 but not responding; further findings on repeat CT scans on 08/25 showed continued leaking from stomach as well as findings of a potential cancerous brain mass. On 08/26/21 family, along with son, mutually agreed on comfort care initiation. Today at 0300 patient passed away, attempted son x3 calls, but then did get through to other son who was to notify the family. HISTORY OF PRESENT ILLNESS: Patient is a 94-year-old man with a past medical history significant for CVA and mild dementia, CKD stage 3, hypertension and hypothyroidism who was admitted to intensive care unit on August 22, 2021 for COVID-19 infection and septic shock. The patient was recently hospitalized from April 11th through April 15th for physical deconditioning. During that time he was diagnosed with dementia with a MoCAa score of 6/30. He discharged to Rehab where he has been continued undergo rehabilitation. Today he presented to the emergency department in extremis. He was in profound respiratory distress and shock. He tested positive for COVID at his care facility a couple days prior. This unclear if he had been undergoing any kind of treatment for this. He had significant episodes of nonresponsiveness an apnea while in the ED. Additionally, he was profoundly hypotensive and tachycardia with new onset rapid atrial fibrillation and rapid ventricular response. He was hypothermic and placed on a Bair Hugger. Initial blood work revealed mild electrolyte abnormalities, lactic acid greater than 7, a creatinine of 1.9. Chest x-ray revealed mild scattered interstitial thickening and lung opacities. Patient was started on IV fluid and placed on phenylephrine infusion. Conversation with the patient's son, as well as his other son reveal that the patient would not want CPR or to be placed on a ventilator but they would want to pursue all other aggressive measures. He was then transitioned up to the emergency department to the intensive care unit for further management. Intensive care unit course: After arrival to the intensive care unit the patient was aggressively fluid resuscitated. His blood pressures responded relatively well. Due to pharmacy shortage of the phenylephrine the patient was transitioned to norepinephrine. His cognitive status drastically improved from when I evaluated him in the emergency department. He is alert and oriented x3. Suspicious for ongoing COVID infection and possible pneumonia the patient's antibiotics were transitioned to cefepime plus azithromycin plus vancomycin. He is started on remdesivir for COVID 19 treatment. ABG revealed compensated metabolic acidosis. The patient's lactic acid has improved to 6.5 from 7. Initial troponins are elevated as expected from demand ischemia from septic shock. EKG does not reveal any ST segment changes in the patient does not complain of any chest pain. He is, however complaining of abdominal pain. He has a soft right inguinal hernia which is difficult to reduce and has no overlying skin changes. The patient has had increasing oxygen needs initially requiring 6 L of oxygen in the emergency department now on 100% oxygen via non-rebreather. At approximately 1630 while I was re-evaluating the patient and discussing his care to son the patient entered into a what appeared to be wide complex ventricular tachycardia with an initial heart rate of approximately 240. Nurse was in the room with me. The patient was not feeling well. His Levophed was shut off and fluids were started. A stat amiodarone infusion of 150 mg was begun. Patient was connected to defibrillator pads. Asked the patient and family if he required cardiac defibrillation if he would want that, and he very explicitly said ""yes!"". His heart rate responded to the amiodarone infusion, however, and he subsequently entered into what appeared to be a narrow complex supraventricular tachycardia with a heart rate of approximately 180. His blood pressure remained stable during this time. As we continued to monitor in supportive care and continued his amiodarone infusion the patient's heart rate then entered into a normal sinus rhythm with a systolic rate of approximately 90. Unfortunately, strips of these rhythms were unable to be captured. EKG afterwards revealed normal sinus rhythm with a first-degree heart block and previously seen right bundle-branch block. After his amiodarone infusion I did not bolus further or start continued infusion for the patient but plan to continue monitoring. Stat CT of chest abdomen and pelvis was obtained. This revealed many things but specifically a pneumoperitoneum. The case was discussed with the on-call general surgeon who evaluated the patient with me in the intensive care unit. Along with the patient's son and other son, it was decided the patient would want to pursue aggressive measures including exploratory laparotomy. Risks of surgery including death were shared with the patient. Furthermore was explicitly stated that he would likely return to the intensive care unit ventilator dependent with multiple drains and need for central line and continued resuscitation the ultimate outcome of which being still high likelihood of death. Understanding this the patient and his son still wanted to proceed. Alternatives, including comfort care were offered and declined. Of note additional findings on CT scan include nodular pulmonary opacities right with recommended CT follow-up in 3-6 months, left pleural effusion, and small abdominal aortic aneurysm and mild pulmonary fibrosis."" "1663606-1" "1663606-1" "Hospitalized; COVID-19 positive (fully vaccinated); patient expired during hospitalization. Active Hospital Problems Diagnosis Date Noted POA ? Acute respiratory failure with hypoxia 08/30/2021 Unknown ? Intertrochanteric fracture of right femur, closed, initial encounter 08/25/2021 Unknown ? COPD (chronic obstructive pulmonary disease) 06/08/2021 Yes Date of Death: 8/30/21 Time of Death: 10:43 PM Preliminary Cause of Death: COVID-19 Discharge Disposition: expired HOSPITAL COURSE: The patient is an 87 year old male history of emphysema, MCA CVA, vascular dementia, hypertension admitted 8/25 to the orthopedic service for right comminuted hip fracture that occurred after a fall at his living facility. He tested positive for covid 19 on 8/20 after an exposure at his nursing facility. He received his J&J vaccine in June 2021. At the time of admission, he was fairly asymptomatic from covid 19 infection. Patient was initially stable with no significant chest x-ray findings. Patient was scheduled for OR on August 26th. Overnight on 8/25, patient had rapid escalation in his oxygen needs, going from room air to requiring 5-6 liters NC and later to HFNC. Unable to obtain CTA thorax due to kidney function, so CT thorax without contrast performed, only showed severe emphysema. VQ scan obtained which was not suspcious for PE. Patient was started on a heparin gtt due to concern for PE vs. Fat emboli. As V/Q scan came back negative for PE, heparin drip was discontinued. Orthopedic team transferred service to hospitalist team and were waiting for improvement in respiratory status before proceeding with surgery. Patient was started on decadron. As patient's oxygen requirements increased, patient was placed on BiPAP to help with workup breathing. Code status confirmed with patient's son wants patient to remain as do not resuscitate. He also reported that guardianship is being pursued patient was made incapacitated at nursing facility. Due to worsening oxygen requirements, Pulmonology was also consulted. Patient was continued on BiPAP with worsening respiratory status and eventually died." "1666080-1" "1666080-1" "PT IS A BREAKTHROUGH CASE OF COVID-19 AND EXPIRED ON 9/1/2021." "1666125-1" "1666125-1" "cough, SOB, hypoxia, confusion" "1666166-1" "1666166-1" "DEATH" "1666193-1" "1666193-1" ""Patient was fully vaccinated. Hospitalized and died due to COVID-19. She presented to the ER ""acute onset shortness of breath with apparent hypoxia at home 45% on room air."" The reason for admission was ""Respiratory failure with hypoxia."" Both of these statements were due respiratory distress from Covid-19."" "1666200-1" "1666200-1" "cough, brown sputum, positive covid test on 7/16/21; 1 yr post kidney transplant" "1666226-1" "1666226-1" "fever, cough, SOB, positive covid test" "1666245-1" "1666245-1" "cough, dyspnea, small cell lung CA with metastasis" "1666264-1" "1666264-1" "Altered mental state, cough, weakness, and headache." "1666292-1" "1666292-1" "cough, dyspnea, severe Alzheimer's disease" "1666326-1" "1666326-1" "Hx of CHF, CAD; falling asleep, excessive weight gain, fluid in lungs" "1666350-1" "1666350-1" "cough and chest congestion x 1 week" "1666378-1" "1666378-1" "Patient admitted to Hospital with acute hypoxic respiratory failure secondary to viral pneumonia from COVID-19 and exacerbation of COPD. Worsening of symptoms prompted Average Volume-Assured Pressure Support. Ventilation did not seem an option d/t HX of severe inflammatory interstitial lung disease." "1666404-1" "1666404-1" "POSITIVE COVID TEST, SOB, O2 SAT 88%, ON O2 @ 3L/M." "1666413-1" "1666413-1" "Right leg showed signs of blood flow stoppage away from groin. Heavyset cough, wet, began as well (both on Monday 2 days after vaccination). Fully in CHF (congested heart failure AND blackening of right foot) and told by STAT home health nurse on her visit Wednesday at 8:00am to get him IMMEDIATELY to the Emergency Room! Was at Hospital from May 19-June 2, 2021. Was given transfusions for White Blood count abnormalities, was clearly showing serious and repeated (as many as 3x daily/night for up to 2 hours each) cognitive ?sundowners? signs to nurses. Began to choke often, twice my use of back pats to clear when nurses unavailable. Not normal! Began talking of God and his beliefs for the first time, with me after a week In treatment. So many brand new issues there is no way this was not vaccine related!" "1666421-1" "1666421-1" "Pt was sent to the hospital from care facility on 08/04/2021 d/t weakness. Pt expired on 08/04/2021 @ hospital." "1666430-1" "1666430-1" "Patient fully vaccinated with two COVID 19 vaccines. Admitted to Hospital on 08/20/2021 with COVID 19. Case expired on 08/31/2021 while still hospitalized." "1666453-1" "1666453-1" "cough x 2 days, pneumonia, low oxygen saturation" "1666464-1" "1666464-1" "Admitted 8/25/2021 SOB, cough" "1666568-1" "1666568-1" "UTI, positive covid test, bacterial shock" "1666578-1" "1666578-1" "patient got progressively worse at home with shortness of breath PCP had tested her Wed day before and returned today positive patient was going to get an infusion today but got worse and arrived at the ED patient was admitted with COVID patient is a known diabetic BNP was 13,822 and first troponin was 0.340 Patient expired on 8/10/2021 at 07:09" "1666579-1" "1666579-1" "positive covid test, asthma, COPD, fever, cough" "1666592-1" "1666592-1" "SOB, fatigue, chills, loose stools." "1666640-1" "1666640-1" ""Diagnosed with COVID-19 on 8/25/2021 emergency room., s/sx of cold/flu symptoms, fever, chills, fatigue, decreased appetite, chest pain and shortness of breath. Patient ended up intubated after acute MI in ER, admitted to hospital. Intubated until 8/28/2021 when family decided to admit to hospice as ""this was not her wishes"". Patient expired on 8/29/2021 at 0415"" "1666642-1" "1666642-1" "Patient had several hospital visits after her second Pfizer dose, for symptoms including pneumonia. Her primary caretaker said that her rapid health decline happened immediately after this second dose. Finally she succumbed to death on April 7th, six weeks after her shot. It was reported that she died of sepsis." "1666664-1" "1666664-1" "Patient received 2nd dose of COVID vaccine on 3/20/21, then tested positive for COVID on 8/12/21 & 8/19/21 Hospitalization Admit Date/Time: 8/19/2021 9:06 AM Discharge Date: 8/30/2021 Referring provider name and address: No referring provider defined for this encounter. Chief Concern, Brief History of Present Illness, and Hospital Course Patient is a 64 yo M with thalassemia and mechanical AV on warfarin who is presenting due to fatigue, cough, fever, and low oxygen saturation. On 8/10, pt started with mild symptoms of cough and fatigue that was generally manageable at home. He tested + for COVID on 8/12. On 8/14, started having fever (Tmax 102-103F) managed supportively. On 8/19, the pt was noted to be in the 80s in his pulse oximeter. He denied having shortness of breath but with a worsened cough. Hypoxia prompted presentation to the ED. Of note, pt is a generally healthy man except for a history of congenital AV disease warranting Ross procedure in 1998 and a mechanical AV replacement in 2018. He exercises regularly. Vaccinated with Pfizer 2/2021. The patient had been managed on the medicine team with progressively worsening chest x-rays and hypoxia requiring HFNC at settings high enough to require ICU care. Our service was consulted to evaluate the patient for ICU admission. On exam, he is calm, conversant and ATO x 3. ABG demonstrates profound hypoxia with a pO2 of 51 with a recheck of 53. He is hemodynamically stable. The remainder of his labs are relatively normal. We discussed these findings and his wishes to proceed with intubation, be FULL CODE and consents to tracheostomy if this is required. His wife was called with the above discussion as well and the patient conversed with her at length before intubation. AHRF/ARDS d/t COVID-19 requiring MV c/b Air Leak - pt was vaccinated man with Pfizer vaccine 2/21 - Treated with Dexamethasone 08/19- 08/29 for total of 10 days, with PPI prophylaxis Completed remdisavir (08/19 - 23) - admitted to MICU on day 11 of hospitalization, pO2 53 prior to intubation, PF ration prior to intubation 51 with severe ARDS - received Vanc/Cef for HAP coverage started 8/28 - Dex ARDS for 3d - Diuresed for pulmonary toilet Transaminitis - improving at time of death - likely d/t severe acute viral illness vs remdesivir CHD w/ Mech AVR on AC (warfarin at home) - received heparin gtt while in MICU Chronic Microcytic Anemia d/t Thalassemia - monitored Hb At approximately 5:30 p.m. on 08/30/2021 code blue was called on patient, high-quality compressions were initiated, nursing had reported that prior to cardiac arrest the patient developed tachyarrhythmia followed by precipitous drop in blood pressure followed by hypoxia, rhythm was consistently asystole, patient patient received approximately 17-18 rounds of compressions, doses of epinephrine every 3-5 minutes, bilateral chest tubes were placed due to concern for tension pneumothorax as patient had pre-existing pneumomediastinum with diffuse subcutaneous emphysema, hypoxia improved mildly after chest tubes were placed but return of spontaneous circulation was not achieved, patient also received multiple rounds bicarbonate, calcium, insulin and dextrose during the code, resuscitation was attempted for a total of 35 minutes when out of medical futility with overall poor neurologic prognosis the code was stopped, family had just arrived at the time of stopping resuscitation, patient's family was informed and they voiced understanding of what had happened and the patient had expired, family thank team for excellent care despite outcome, time of death 1805" "1666824-1" "1666824-1" "Unknown" "1666949-1" "1666949-1" "Within hours was short of breath climbing stairs he climbed daily and it never happened before. Doctor diagnosed that his heart was out of rhythm at next appointment. He was treated with a few different drugs but it couldn't be controlled and he never felt well again. On 4/19/21 he was transported to Hospital by ambulance with AFib. The next morning he was found unresponsive and moved to ICU. His oxygen level was low and carbon dioxide level was high. For 2 weeks he suffered greatly. Doctors tried to balance his high heart rate with his low blood pressure. He was intubated twice. He died on May 2, 2021. His cause of death was acute respiratory failure with hypercapnia and hypoxemia. He had never had heart or lung problems before that." "1666952-1" "1666952-1" "Vaccinated individual expired on 08/21/2021" "1666966-1" "1666966-1" "Patient expired on 08/20/2021. 1st dose 02/09/2021 2nd dose 03/06/2021" "1667100-1" "1667100-1" "Patient expired on 09/01/2021" "1667385-1" "1667385-1" "My dad had received the Johnson and Johnson shot end of April. He was sick for a few days with the normal side effects. In July he died from myocarditis the autopsy came back as. Research has been showing that it is linked to the vaccine and to report it to help research just in case." "1667416-1" "1667416-1" "Swollen limbs, swollen tongue, swollen throat leading to paralysis and inability to speak or swallow. Brain inflammation leading to vegetation. All leading to DEATH!" "1669555-1" "1669555-1" "pneumonia; couldn't catch her breath; She had fluid around her lungs; passed away; healthcare facility; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away), PNEUMONIA (pneumonia), DYSPNOEA (couldn't catch her breath) and PLEURAL EFFUSION (She had fluid around her lungs) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (couldn't catch her breath) (seriousness criterion hospitalization). On 27-Jul-2021, the patient experienced healthcare facility (healthcare facility). On an unknown date, the patient experienced PLEURAL EFFUSION (She had fluid around her lungs) (seriousness criterion medically significant). On 29-Jul-2021, PNEUMONIA (pneumonia), DYSPNOEA (couldn't catch her breath), PLEURAL EFFUSION (She had fluid around her lungs) and healthcare facility (healthcare facility) outcome was unknown. The patient died on 29-Jul-2021. The reported cause of death was Pneumonia, couldn't catch her breath, she had fluid around her lungs, she was on the floor and healthcare facility. It is unknown if an autopsy was performed. Concomitant products were not provided. Treatment medication were not reported. The patient had pneumonia and couldn't catch her breath. She was on the floor, and then the emergency took her to the hospital on 25 Jul 2021. She had fluid around her lungs. The following day on 27 Jul 2021, the patient was sent to healthcare facility and then she died early morning on 29 Jul 2021. Company comment: This is a case of death in a 82-year-old female patient who died 7 days after receiving first dose of vaccine. The patient experienced pneumonia, pleural effusion and dyspnoea due to which she was hospitalized but discharged to healthcare facility two days later where she passed away. Very limited information has been provided at this time. Further information will be requested.; Sender's Comments: This is a case of death in a 82-year-old female patient who died 7 days after receiving first dose of vaccine. The patient experienced pneumonia, pleural effusion and dyspnoea due to which she was hospitalized but discharged to healthcare facility two days later where she passed away. Very limited information has been provided at this time. Further information will be requested.; Reported Cause(s) of Death: pneumonia; couldn't catch her breath; She had fluid around her lungs; She was on the floor; healthcare facility" "1669875-1" "1669875-1" "Pregnancy history: G2P1001. Patient had the Pfizer COVID vaccine on 8/6/21 at 33 3/7 weeks gestation (EDD 9/21/21). Presented 8/15/21 at 34 5/7 weeks gestation with preterm labor. CBC with differential found to have significant abnormalities. Twins were delivered via C-section. Twin A birth weight 5lb 2.5oz and twin B birth weight 6lb 1.4oz. Oncology consulted and bone marrow biopsy diagnosed patient with AML. Induction chemotherapy with 7+3 given 8/17-8/23/21 with resulting pancytopenia necessitating daily blood/platelet transfusions. On 9/1/21, had a catastrophic intracranial hemorrhage and patient died on 9/2/21." "1670084-1" "1670084-1" "Died within 36 hours after first inoculation" "1670089-1" "1670089-1" "Client's symptom onset for COVID-19 was on 8/9/21 and included cough, nausea, fatigue, ABD pain, pneumonia, fever, weakness, and dehydration. He tested positive for COVID-19 on 8/11/21. Client was hospitalized on 8/12/21. Client passed away on 8/25/21." "1670157-1" "1670157-1" "Client's husband reported client received a flu shot on 7/27/21 when symptoms began. ( does not indicate client received the influenza vaccine and last documented shot was given on 8/23/16.) Symptoms included fatigue, aches mostly in hip, dehydration, and breathing difficulties, which continued to get worse throughout the week. On 8/6/21 husband found client on floor in the bathroom. When paramedics arrived, client refused to go to the hospital. On 8/7/21, husband physically brought client to Hospital where she was admitted with COVID pneumonia. She was in the ICU, ventilated and passed away on 8/30/21." "1670372-1" "1670372-1" "Hospice patient, COPD, positive COVID test, diabetic, BPH" "1670444-1" "1670444-1" "Date of Admission 08/03/2021. Chief Complaint COVID + on 7/29/21, increased shortness of breath; placed on 4L NC in triage This is a 72-year-old Caucasian gentleman who presented to the hospital on August 3rd with complaints of shortness of breath after being diagnosed with COVID-19 4 days earlier. The patient has a known history of COPD and states that he uses a trilogy machine at home but is not on oxygen on an around the clock basis. The patient did ultimately require intubation but was extubated on August 8th. He had some difficulties yesterday with oxygenation and was on BiPAP at 100% there was some concern that he was going to need re-intubation. However, the patient status has improved somewhat today he is on Precedex to help control some of his agitation and restlessness and he is now been weaned to high-flow nasal cannula. The patient is in the intensive care unit and is awake and alert to self and place but otherwise pleasantly confused. He does not know the year nor the name of the president. Result Title: Patient Death Performed By: RN on August 28, 2021 19:38 EDT Verified By: RN on August 28, 2021 19:38 EDT Encounter info: 3791927, DEL, Inpatient, 08/28/2021 - 08/29/2021 Examined patient. No spontaneous audible heart sounds, no spontaneous audible breath sounds, no corneal reflex, no pupil response. Patient expired at 1705 with family at bedside." "1670460-1" "1670460-1" "August 29, 2021 patient with NO HISTORY OF SEIZURES had a seizure in the Emergency Room of Hospital. Patient was treated with Keppra for seizure. On August 31, 2021 patient had another seizure and died." "1670560-1" "1670560-1" "Patient deceased 08/25/2021" "1670621-1" "1670621-1" "patient died" "1670639-1" "1670639-1" "admitted 8/08/2021 to hospital and died 08/09/2021" "1670713-1" "1670713-1" "After her first dose she has a metalic taste in her mouth but was ok but after her 2nd dose, the metallic taste was worse and her muscles and limbs were weak and it changed her life. she was in a nursing home and was neglected. She was vomiting. Not sure if she had covid but she could not do anything and became sick . before she died, the back of her month had like nest. she died on 05/14/2021" "1670758-1" "1670758-1" ""Patient got his modern shot on August 6th, 2021 between the time of 11:00-11:15 at Pharmacy. Less than 22 hours later he was violently ill, and started vomiting. He also had joint pain in his right hip and was unable to walk. For one week he stayed at home and was weak and was unable to walk. On August 15th, Patient was brought to Hospital with c/o right hip pain. At ER, he was diagnosed with fluid collection on right hip. It was a rule out septic joint. The next day he went to IR where he had 150 ml of fluid drained off his hip. At this time they placed a drain and it was draining fluid. The next day he was brought to OR with Orthopedic surgeon and he had more fluid drained off his right thigh. They said the procedure was a incision and drainage. They pulled the old drain and placed a new drain. He stayed in hospital 2 more days with the drain and received Rocephin and Vancomycin via IV catheter. While he was in hospital they were treating him with lovenox SQ injection because patient kept telling everyone he was not sick or had not fallen prior to receiving his vaccination. On Thursday he was discharged to home after the drain was pulled on just Cephalexin, and no lovenox. On Monday August 23rd 17 days after his moderna vaccination patient died at home by what was said by the coroner as ""Natural Causes"" . patient had not been to the Dr since 2016."" "1670809-1" "1670809-1" "Positive COVID test, dementia, CVA, CKD3, seizure disorder" "1670812-1" "1670812-1" ""ACCORDING TO DAUGHTER & SISTER: THE DECEASED HAD NO RECENT COMPLAINTS. THEY HAD A HISTORY OF HTN FOR, WHICH THEY WERE TAKING MEDICATION, BUT NO KNOWN CARDIAC ISSUES. THEY WERE AT WORK WHEN THEY HAD ""SEIZURE-LIKE"" ACTIVITY & COLLAPSED TO THE GROUND. EMS WAS CALLED. SHE WAS NOTED BY EMS TO BE IN ASYSTOLE AND ACLS BEGAN. EMS ADMINISTERED 3MG OF EPINEPHRINE AND CONTINUED COMPRESSIONS UNTIL THEIR ARRIVAL TO ED AT 11:38AM ON 8/22/21. WHILE IN THE ED, SHE RECEIVED MAGNESIUM SULFATE, AMIODARONE, CALCIUM CHLORIDE, SODIUM BICARBONATE, AND ADDITIONAL DOSES OF EPINEPHRINE. BEDSIDE CARDIAC US REVEALED NO CARDIAC WALL MOTION. A CENTRAL VENOUS CATHETER WAS PLACED AND tPA WAS ADMINISTERED. CPR WAS CONTINUED. DESPITE ALL EFFORTS, SHE REMAINED IN ASYSTOLE. REPEAT BEDSIDE CARDIAC US AGAIN REVEALED NO CARDIAC WALL MOTION. SHE WAS PRONOUNCED AT 12:11PM."" "1670826-1" "1670826-1" "Death." "1670831-1" "1670831-1" "SOB, POSITIVE COVID TEST" "1672600-1" "1672600-1" "Heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). The patient died on 14-Mar-2021. The reported cause of death was Heart attack. An autopsy was not performed. Treatment information was not provided. Company comment Very limited information regarding this event/s has been provided at this time. Further information has been requested Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Follow-up received and contains reporter contact information.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested; Reported Cause(s) of Death: Heart attack" "1673117-1" "1673117-1" "stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Urinary tract infection, Blood pressure high and High cholesterol. Concomitant products included BENZOIC ACID, METHENAMINE, SALICYLATE SODIUM (CYSTEX [BENZOIC ACID;METHENAMINE;SALICYLATE SODIUM]) for Urinary tract infection, VITAMIN D [VITAMIN D NOS] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria death and medically significant). The patient died on 14-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant medication of the patient also included medication to treat her blood pressure and cholesterol. The had been taking her concomitant medications since a long time ago. No treatment information was provided by the reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's age and med HX of HTN and high cholesterol are possible confounding factors.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's age and med hx of HTN and high cholesterol are possible confounding factors.; Reported Cause(s) of Death: unknown cause of death" "1674474-1" "1674474-1" "My father received the shot on Sunday May 23rd in the late afternoon, on Tuesday May 25th he had an artery embolism and passed away that morning." "1674723-1" "1674723-1" "Went to urgent care 4 days after first vaccination for back pain. Thought to be a kidney stone or pulled muscle and sent home. Died at home two days later on 8/24/21." "1674908-1" "1674908-1" "Patient with no prior heparin exposure. Started on prophylactic heparin (5000U TID SQ) following lobectomy. Developed severe HIT with optic density 2.8. Placed on argatroban after diagnosis, which was prompted by PE. Please note, patient immediately on heparin ppx following surgery and ambulatory. No history of coagulopathy in family or personally. Platelets never rose despite a week of therapeutic argatroban without any pauses in drip or sub therapeutic ranges. At 7 days after initiation of drip, the patient had a second PE and expired. I know it's a long time out from his vaccine but wondering if prior vaccination and subsequent heparin may be a trigger for HIT." "1675012-1" "1675012-1" "Patient required hospitalization due to breakthrough infection. He received J&J vaccine on 03/12/21. Hospitalized from 08/18/21 - 08/30/21. Below is copied from discharge (death) summary: Hospital Course: HPI: Patient is a 70 year old male with a PMHx of COPD / Emphysema with home O2 dependence recently increased to 3L/NC, HFrEF, recent Dx of PE one month ago on Eliquis and depression who presented to the ED for worsening shortness of breath and hemoptysis. He is Covid positive and did receive the J&J vaccine. He was admitted to the Hospitalist's Service. He has worsening shortness of breath and increased oxygen demand and work of breathing. He is transferred to the ICU for increased level of care. 8/22: CTA Chest negative for PE but showed severe centrilobular emphysema, left lung apex cavitary lesion (infxn vs. Malignancy). Echo pending. Patient on BiPAP 10/5, 70% FiO2. No other concerns. 8/23: Holding off Baricitinib given concern for CAP. Given Lasix 40 IV x 1 and will resume home Lasix BID in AM for HFrEF. Currently on BiPAP 10/6, 80%. Weaning to HFNC +/- NRB as tolerated. 8/24: Pt with high level of anxiety prn yesterday for which Buspar was effective. He has been anxious overnight. Remains on HFNC. 8/25: Over day time transitioned to bipap with improvement in oxygenation. Reports no change in respiratory status. 8/26: Patient had several episodes of removing HFNC or BiPAP. Placed in restraints w/mittens on HFNC + NRB. Patient with more confusion recently as well. Started on Seroquel. Currently on HFNC + NRB 60L/100%. 8/27: Patient with confusion/agitation yesterday. CT head ordered but patient unable to cooperate even w/Ativan. Patient maxed out on Precedex gtt and still agitated. Added ketamine gtt w/improvement in sedation and patient able to tolerate BiPAP. NG placed. 8/28: Patient with increasing O2 demands last night, patient subsequently intubated and placed on PRVC. Today, patient changed from PRVC to PS with improvements in oxygenation. Patient on 14/10 75% PS satting mid 90's. 8/29: Overnight patients blood pressure dropping despite being on Levo and Vaso infusions. Neosynephrine infusion added. Bedside ultrasound performed showing ~50% collapse of IVC on inspiration - patient bolused 1L IVF with minimal improvement of blood pressure. Patient with increasing O2 requirements. ABG performed showing Hgb 6.5. Patient type & screened, crossmatched, transfused 1u PRBC's. Vancomycin added for broad spectrum antibiotic coverage. Spoke with patients significant other who came in to the hospital to see patient - she confirms status of DNR with being ok for intubation. 1957: Maxed on 4 vasopressors. GCS 3T. HR trended down to asystole. No heart tones auscultated. Time of death 1957. Significant other notified. Discharged Condition: deceased" "1675019-1" "1675019-1" "Patient required hospitalization due to breakthrough infection. He received the Pfizer vaccine (2nd dose in series) on 04/14/21. Patient was hospitalized from 07/31/21 - 08/31/21. Below is copied from discharge summary: Discharged Condition: deceased Hospital Course: Patient is a 82 y.o. male with a PMH of recurrent UTIs, BPH, COPD, bicytopenia (leukopenia and erythropenia), DDM2, HTN, and HLD who presented to the ED on 7/31 for AMS. He was found down by family and EMS was called. SpO2 was 68% and pt was placed on NRB. He was brought to the ED and was COVID + (despite previous Pfizer vaccination on 3/24 & 4/14). CT C/A/P showed bilateral opacities. He also had a brief episode of afib RVR treated w/ metoprolol w/ subsequent hypotension requiring levophed gtt. He later was intubated d/t hypercapnic respiratory failure and admitted to the MICU. His course was complicated by hypernatremia elevated CK, AKI, PSAR UTI and enterococcus bacteremia. Abx were de-escalated to levoflaxacin and ampicillin.Of note he did not receive Remdesivir or Toclilizumab d/t bacteremia. He completed a 7 day course of solumedrol. He was extubated to HFNC on 8/6 and was transferred to the floor on 8/8 and only requiring 5L NC at the time. While on the floor pt had increased lethargy. On the evening of 8/11 pt was noted to have tachypnea and use of accessory muscles. Pt was placed on a VM and on the morning of 8/12 placed on BIPAP.CTH was obtained and showed new bilateral SDH/hygromas. IM team spoke with team and they recommended MRI brain stroke protocol. Patient continued to have respiratory decline remain on ventilator his symptoms continue to escalate was shortness of breath desaturation to patient was ventrally placed on 100 percent was on flow land saturation still remains low family meeting with palliative Care patient was made DNR with no escalation." "1675027-1" "1675027-1" "Patient required hospitalization due to breakthrough infection. He received J&J vaccine on 03/15/21. Hospitalized from 08/21/21 - 08/27/21. Below is copied from patients discharge (death) summary: Patient lost pulse soon after family visit. 4 rounds of ACLS performed. Asystole on monitor Time of death pronounced at 1719. Alerted by RN that patient regained a weak pulse at 1722. Pressors restarted. Patient again lost pulse soon after and 1 round of ACLS was performed. No ROSC obtained. Asystole on monitor. No cardiac activity noted. Time of death 1734. 75 y.o. male with a PMH of HTN, HLD, COVId diagnosed 1 week ago presents to the ED c/o worsening SOB. Over the past week he has been noticing exertional SOB, fatigue and dyspnea. He had been able to recover with rest , today he was not able to get back to baseline so he decided to come in. At triage he was satting in the 70s on RA. He was placed on a nonrebreather at that time." "1675092-1" "1675092-1" "Patient required hospitalization due to breakthrough infection. Patient received Pfizer vaccine (2nd dose in series) on 02/19/21. Patient was hospitalized from 08/13/21 - 08/31/21. Below is copied from patients discharge (death) summary: Hospital Course: Patient is a vaccinated 75 y.o. male with a pmhx of HTN, DM, CAD s/p PCI (10 yrs ago), CKD3 and breast cancer s/p lumpectomy and CT who presented to ED on 8/13/21 c/o SOB in setting of known COVID-19 infection. Patient recieved both doses of his vaccine (2nd dose 2/2021). Patient was admitted to hospitalist service for acute hypoxic respiratory failure in setting of COVID-19. Throughout course of stay, had increasing oxygenation requirements (requiring FFCPAP after found to have removed mask from face) with pulse ox O2 sats reportedly in 20's, lethargy, and new onset tremor. On pulmonology's evaluation at bedside, patient was A&Ox2 (person/place, thinks year is 2001). Not hypoglycemic on accucheck. Difficult to obtain hx as patient with AMS however shakes head yes when asked if he feels SOB. Admitted to ICU on 18Aug, now intubated and sedated. Bronchoscopy performed at bedside, which was unrevealing. Did not show any mucous plugging. Received solumedrol and lipitor. Toci not given due to depleted supplies. Episodes of hypoglycemia, NPH 35u TID d/c. S/p D5W drip. Continue with SSI. Oligouric AKI on CKD, requiring CRRT. Nephrology on board. New onset A-fib with RVR, now rate controlled. S/p amiodarone drip & metoprolol. Increasing leukocytosis. Continue Vanc/Aztreonam/Flagyl and empiric Caspo, follow cultures. Episodes of coffee ground emesis. Hgb downtrended. Recevied 1 unit of pRBC. Hgb stable. On Levophed. Continue proning protocol. CRRT better when placed in left position. Keep net even. Wean off Levo as tolerated, start midodrine 10mg tid. DC empiric Abx given negative cultures. Palliative care for goals of care. Shock state of unclear etiology at this time. EV1000 hemodynamics to help guide management. Currently on 40 of levophed and vasopressin. Poor oxygenation. Prone ventilation discontinued. DC'd empiric Abx given negative cultures. Spoke to patient's wife and she wants patient to be DNR with no escalation of care given his overall poor prognosis. Plan to compassionately wean. Confirmed DNR. No further escalation of care. Death Note I was called to the room of patient to pronounce that patient had died. Patient was laying motionless and unresponsive to verbal/tactile stimuli. Pupils where fixed and dilated. There were no spontaneous breath sounds. Peripheral pulses were absent. No heartbeat was heard during auscultation. Family was made aware. Condolences offered. Chaplain and postmortem services offered. Pt was DNR code. Time of death was 1724, confirmed and witnessed by Nurse" "1675107-1" "1675107-1" "He died , found dead after 24 hours, Closed casket, no foul play. I am unable to get an autopsy." "1675587-1" "1675587-1" "Immune response, COVID-19 pneumonia. Patient told the pharmacist giving vaccine he was not feeling well. They did not test him for COVID and gave vaccine anyway. It is unknown if he officially had COVID-19, but he became sick almost immediately after getting the vaccine. Taken to hospital by ambulance on 08/06/2021, put on a ventilator on 08/13/2021 and died on 08/31/2021." "1675849-1" "1675849-1" "Day after vaccination fell backwards in parking lot trying to get into car. Hit head. Taken to ER. CT/MRI of brain showing evidence of 3rd ventricle and left lateral ventricle intracranial hemorrhage." "1676783-1" "1676783-1" "MRI brain showed large ischemic stroke involving brainstem, bilateral cerebellum, occipital and thalamic region due to basilar artery occlusion." "1677294-1" "1677294-1" "arm was sore; felt really sick; dizziness; once he got the shot he just went downhill; nauseous; extremely fatigued; died on 28JUL2021, 4 days after receiving the vaccine, passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died on 28JUL2021, 4 days after receiving the vaccine, passed away) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cirrhosis liver, Acute kidney failure, Hypertension, Immune system disorder (weak immune system) and Hospitalization from 03-May-2021 to 11-May-2021. On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore), ILLNESS (felt really sick), DIZZINESS (dizziness), MALAISE (once he got the shot he just went downhill), NAUSEA (nauseous) and FATIGUE (extremely fatigued). The patient died on 28-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PAIN IN EXTREMITY (arm was sore), ILLNESS (felt really sick), DIZZINESS (dizziness), MALAISE (once he got the shot he just went downhill), NAUSEA (nauseous) and FATIGUE (extremely fatigued) outcome was unknown. He had medications for his chronic illnesses. The patient had recent hospitalization from 03-May-2021 to 11-May-2021. No treatment information was reported. Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested. Patient¦s underlying Cirrhosis , Acute kidney failure, Hypertension and Immune system disorder could be confounding factors for the case.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Patient¦s underlying Cirrhosis , Acute kidney failure, Hypertension and Immune system disorder could be confounding factors for the case.; Reported Cause(s) of Death: Unknown cause of death" "1678327-1" "1678327-1" "Patient received second dose of COVID vaccine on 3/31/2021, tested positive for COVID on 8/14/21. 8/14/21: History Of Present Illness Patient is a 61 y.o. male with a PMH of depression, insomnia, GERD, hypothyroidism, COPD, OSA on BiPAP at bedtime, DMII, HTN, HLD, CAD s/p PCI with stents x 6 (last 8/2021), and metastatic colon cancer on chemotherapy presents to ED with dyspnea. Pt reports having a cough and congestion that started last Thursday (8/5). Pt reports feeling more fatigue as well which he thought was related to cycle 2 of FOLFIRI that he just completed. Pt was evaluated by his PCP on 8/5 and started on cough medicine with Cefdinir. Pt was not tested for COVID19 at that time. Pt reports his symptoms became progressively worse with dyspnea even at rest over the last 3 days. Pt reports he has been checking his SpO2 at home with saturations as low as 81% on room air yesterday. Pt reports fever at night as high as 102. Pt denies nausea, vomiting, diarrhea, abdominal pain, dysuria, sore throat, chest pain, heart palpitations, travel, or known sick contacts. Pt received the COVID19 vaccine a few months ago. On presentation to the ED, pt with SpO2 in the low 80's. Pt was placed on 6L nasal cannula with slight improvement with SpO2 88-90%. Pt then placed on his home BiPAP that he wear at night with improvement of his SpO2. Pt then weaned back down to 4L nasal cannula with SpO2 90% on admission. CXR shows patchy opacities in both lungs that could be edema pneumonia and atypical infection. COVID19 was positive. IM consulted for admission. Assessment and plan: 61 y.o. male with a PMH of depression, insomnia, GERD, hypothyroidism, COPD, OSA on BiPAP at bedtime, DMII, HTN, HLD, CAD s/p PCI with stents x 6 (last 8/2021), and metastatic colon cancer on chemotherapy presents to ED with dyspnea. Pt reports having a cough and congestion that started last Thursday (8/5). Pt reports feeling more fatigue as well which he thought was related to cycle 2 of FOLFIRI that he just completed. Pt was evaluated by his PCP on 8/5 and started on cough medicine with Cefdinir. Pt was not tested for COVID19 at that time. Pt reports his symptoms became progressively worse with dyspnea even at rest over the last 3 days. Pt reports he has been checking his SpO2 at home with saturations as low as 81% on room air yesterday. Pt reports fever at night as high as 102. Pt denies nausea, vomiting, diarrhea, abdominal pain, dysuria, sore throat, chest pain, heart palpitations, travel, or known sick contacts. Pt received the COVID19 vaccine a few months ago. Acute Hypoxic Respiratory Failure likely 2/2 COVID19 in Immunocompromised with Neutropenia Obstructive Sleep Apnea ?COPD -On presentation to the ED, pt with SpO2 in the low 80's. Pt was placed on 6L nasal cannula with slight improvement with SpO2 88-90%. Pt then placed on his home BiPAP that he wear at night with improvement of his SpO2. Pt then weaned back down to 4L nasal cannula with SpO2 90% on admission. Wife placing pt back on BiPAP with home setting for the night -pH 7.4, PCO2 36, PO2 50, and HCO3 22 -WBC 2118 with ANC 1590 -Troponin 18--- >19 -EKG without acute ST changes -COVID 19 positive on 8/13/21 -BNP, procal, LDH, CRP, d dimer, and ferritin pending -CBC with diff, ferritin, LDH, d dimer, and CRP daily with AM labs -Pt given Vanc and Cefepime in the ED, will hold further antibiotics for now. Strep pneumo, legionella, and blood cx pending -Pt started on Decadron 6mg daily and Remdesivir per protocol -Titrate O2 to maintain SpO2 > 95% -MDI with spacer given COVID PRN -Airborne, contact and eye protection precautions Metastatic Colon Cancer on Chemotherapy -Follows with Oncology -s/p colectomy then end ileostomy -s/p 6 cycles FOLFOX -PET in June with liver and poss mediastinal node -Started on FOLFIRI with bevacizumab added Cycle #2 on 8/3/21 (with plans for ECHO Q3 months) -Consult Oncology as needed Pancytopenia -Hgb 11.0, Platelets 153K, and WBC 2118 with ANC 1590 -Etiology likely 2/2 chemotherapy -Continue to trend, transfuse Hgb < 7 and platelets < 10,000 Acute Kidney Injury -sCr 1.37, baseline ~1.0 to 1.1 -UA pending -Avoid NSAID/Nephrotoxin -Renal dose medications -Strict I&O -Repeat BMP in the AM Type II Diabetes with Hyperglycemia -Glucose was 123 on admission -Pt on Metformin and Victoza at home -FSBS AC/HS with correctional insulin -Consistent carb diet CAD -s/p cardiac stents x 6, last 2 placed in 2020 -ECHO 8/2021 with EF 50-60% -Resume home ASA, Plavix, and statin -Will hold home Losartan in setting of AKI, resume as appropriate -Will resume home Bisoprolol for now -Resume home Spironolactone Hypertension -SBP 100's on admission -Will hold home Losartan in setting of AKI, resume as appropriate -Will resume home Bisoprolol for now Obesity -BMI 36.96 -Complicates all aspects of care 9/3/21: Discharge Summary Hospitalization Admit Date/Time: 8/13/2021 9:57 PM Admitting Attending: Discharge Date: 9/3/21 Discharge Attending Physician: Md Referring provider name and address: No referring provider defined for this encounter. Chief Concern, Brief History of Present Illness, and Hospital Course Patient is a 61 y.o. male with a PMH of depression, insomnia, GERD, hypothyroidism, COPD, OSA on BiPAP at bedtime, DMII, HTN, HLD, CAD s/p PCI with stents x 6 (last 8/2021) at CB, Familial Hydrocalcicuric Hypercalcemia and metastatic colon cancer on chemotherapy presents to UK ED with dyspnea on 8/13, found to be COVID + 8/14. Per chart review, patient called his medical oncologist with worsening respiratory symptoms and he was advised to come to ER for workup for fever and possible COVID symptoms. Of note, patient did receive Pfizer COVID Vaccine [3/6, 3/31]. Patient thought his increasing fatigue and weakness was related to cycle 2 of FOLFIRI that he just completed. On presentation to the ED on 8/13, pt with SpO2 in the low 80's. Pt was placed on 6L nasal cannula with slight improvement with SpO2 88-90%. Pt then placed on his home BiPAP that he wear at night with improvement of his SpO2. CT PE remarkable for GGO and consolidations most consistent with multifocal infection. During the afternoon of 8/14, MICU was consulted for increasing oxygenation requirements. On examination patient is on HFNC 40L/60% with a nonrebreather. Sats 88-91%. Increased work of breathing appreciated. Admitted to MICU for further management and evaluation. After admission to ICU, he remained on HFNC. He was diuresed and started on broad spectrum antibiotics with Vanc and Cefepime and dexamethasone 6mg. On 8/17, he had a hypoxic event after coughing, and was placed on 100% BiPAP with improvement in hypoxia. However, later in the afternoon on 8/17, he was intubated for hypoxia. He was started on low dose vasopressors after intubation and increased to dexa/ARDS. He completed 7-day course of empiric Cefepime for secondary bacterial PNA on 8/20. He completed dexa/ARDS on 8/26. He has been intermittently diuresed. He was proned on 8/25 due to severe ARDS and decreased PF ratio. He was supined on 8/27. On 8/28, he spiked a fever and had worsened leukocytosis (from 15k to 40k) along with shock. He was re-cultured and started on empiric broad-spectrum Vanc and Zosyn. He had increased ileostomy output at that time, therefore C. Diff sample was obtained, however was negative. Levophed drip was started for septic shock. He has had persistent fever despite Tylenol and worsening leukocytosis and without source, therefore venous duplex and beta glucan and fungal serologies obtained on 8/29. RESOLVED ISSUES: Pancytopenia (POA) (Resolved) - Etiology likely due to chemotherapy - Continue to trend, transfuse Hgb < 7 and platelets < 10,000 Given severity of patient's respiratory failure/ARDS secondary to COVID-19 pneumonia he will be unable to receive any chemotherapy for the foreseeable future. Heme Onc was consulted and without chemotherapy his aggressive metastatic colon cancer will likely cause him to pass away. Extensive discussions with his wife and she wishes to make him comfortable and terminally extubate with our inpatient hospice team. Time of Death: 9/3/21 10:52pm" "1678330-1" "1678330-1" "See Attachments" "1678477-1" "1678477-1" "Death due to COVID-19" "1678487-1" "1678487-1" "Death due to COVID-19" "1678499-1" "1678499-1" "Vaccine breakthrough, symptomatic. Inpatient admit 8/23-9/5. Expired." "1678502-1" "1678502-1" "PT EXPIRED OF COVID-19 ON 9/5/2021; BREAKTHROUGH CASE" "1678562-1" "1678562-1" "PT EXPIRED FROM COVID-19 ON 9/5/2021; BREAKTHROUGH CASE" "1678570-1" "1678570-1" "Acute respiratory distress, SOB, positive COVID test" "1678597-1" "1678597-1" "Admitted on 8/22/2021 with fever, cough, dyspnea and decreased appetite. Had contact with COVID + person 6-7 days prior. COVID + on admission.. Received remdesevir 5 day course, steroids, azythromycin, rocephin. Intubated on 8/25. recovering well and extubated on 8/31. on 9/1 complaint of right hip pain and had episode of decompensation requiring intubation nd pressors. CT showed acute retroperitoneal bleed. Received blood products. Bleeding stabilized but continued acute renal failure and electrolyte abnormalities. Family opted for comfort care measures." "1678683-1" "1678683-1" "Patient passed away on 09/03/2021." "1678809-1" "1678809-1" "HOSPITALIZED WITH COVID PNEUMONIA 8/19/2021, ICU AND INTUBATED 8/24/2021, DEATH 9/3/2021" "1678823-1" "1678823-1" ""Fully vaccinated patient who tested positive for COVID with admission testing to hospital. Patient admitted 05/25/21 after an out of hospital cardiac arrest with return of spontaneous circulation after EMS arrival and administration of epinephrine and shock. Patient intubated upon arrival to ED and provided hypothermia protocol. Patient did not have return of consciousness. Encephalopathy and acute to subacute brain infarct per MRI and ""severe diffuse encephalopathy"" per EEG. Family requesting continuation of ""aggressive care."" PEG tube placed, feedings were not tolerated so patient was sent back to surgery for removal of PEG and placement of J tube for feedings during which time she was found to have necrotic stomach from ischemia. Family meeting including Palliative Care team and family chose to change to comfort care. Patient was removed from ventilator on 06/24/21 and died shortly after."" "1678834-1" "1678834-1" "DEATH 9/3/2021" "1678923-1" "1678923-1" "dyspnea, positive COVID test, HTN, aches, non-small cell CA, taking chemo" "1678934-1" "1678934-1" "Fully vaccinated patient tested positive 8/28/2021 and hospitialized then expired 09/03/2021." "1678944-1" "1678944-1" "hx of renal transplant, hypoxia, positive COVID test" "1678955-1" "1678955-1" "had a couple of fainting episodes after first vaccine, but collapsed and was hospitalized 2 days after second dose" "1678961-1" "1678961-1" "hx cardiopulmonary disease, dyspnea, hypoxia, positive COVID test" "1678982-1" "1678982-1" "positive COVID test, viral pneumonia, hypoxic, sepsis" "1679014-1" "1679014-1" "Fully vaccinated patient admitted for COVID PNA. Treated with Remdesivir and decadron. Discharged to facility on 08/20/21. Returned to ED on 08/22/21 with hypoxia and weakness, discharged back to facility with O2. Returned to ED again on 08/30/21 with hypoxia and started on Bipap. CTA showed extensive infiltrates and was negative for pulmonary emboli. Started on empiric antibiotics with concerns for secondary infection/PNA, diuresis, and steroids. Continued to decline and became comfort care on 09/02/21. Went into cardiac arrest on 09/04/21 and died." "1679065-1" "1679065-1" "Pt. contracted COVID-19." "1679098-1" "1679098-1" "Pt was hospitalized with Covid and died 8/20-9/3" "1679133-1" "1679133-1" "The patient's husband informed the pharmacy that the patient passed away the day following vaccination. He stated he was unaware of the cause of death at this time." "1679141-1" "1679141-1" "Patient was taken with the ER, tested positive for COVID-19 upon admission. He passed away on 9/01/21" "1679166-1" "1679166-1" "4/5/2021 patient received 1st shot on 4/10/2021 noticed that she was lethargic, we thought that is might be her blood sugar but it was in normal range. we continued to check blood sugar daily thinking that was causing her to be lethargic and voice to be slow. 4/23/2021 my son and I spent the day with her noticing and she was getting worse but had also noticed that she was getting winded easily and would need to sit down. 4/26/2021 canceled 2nd covid shot. 4/30/2021 at about 1:30 pm she called me and said something was wrong something just happened she was scared! She called her Dr. and spoke to the the nurse PA. My sister was with her at the time so they checked for stoke signs none were found. Spoke to my mom through out the day on 5/1 & 5/2/2021 and she sounded out of breath and very lethargic. 5/3/2021 the Nurse PA called mom and said that she needed to go to the hospital where she stayed until she passed away on 5/15/2021. She had passed blood clots to her lungs then kidney and liver failure." "1679272-1" "1679272-1" "Patient was transferred to Hospital from different Hospital with acute hypoxic respiratory failure, COVID pneumonia, afib with RVR, and pulmonary vascular congestion. CTA chest was negative for a PE but again demonstrated concern for an atypical pneumonia along with evidence of pulmonary vascular congestion. She was noted to be in afib with RVR and was placed on a cardizem gtt. She received a dose of lovenox as her INR was subtherapeutic at 1.3. Kidney function appeared stable. Received a dose of dexamethasone at the other hospital. BP is on low side while on the cardizem but HR is now in the 80s. She is on 3-4L O2 NC. She was placed on dexamethasone and remdesivir, but remdesivir was stopped due to elevated liver function tests" "1679276-1" "1679276-1" "PHYSICIAN STATES PATIENT RECEIVED JOHNSON AND JOHNSON VACCINE ON 07/23/2021. BECAME ILL 08/06/2021, RESULTING IN COVID PNEUMONIA AND PATIENT'S EXPIRATION ON 09/05/2021" "1679277-1" "1679277-1" "1015 , I found my mother on the floor. She had a contusion on her head from hitting a table edge on the way down. Her right hand was curled up near her face. She was unconscious and breathing with a very loud rasping sound. She was taken to the hospital by ambulance. The Dr told us she had a catastrophic event. One side of her brain was filled with blood. Surgery or comfort care was the only choice. At 1317 they removed everything and began comfort care. Approximately 2000 she was moved to the hospice floor and passed away at approximately 2200.." "1679301-1" "1679301-1" "Wife claims that patient was coughing up blood after they received the shot and passed away, not much else was described" "1679351-1" "1679351-1" "He was noted to have had a change in his mental status as per nursing home staff. Over the night his saturation dropped to 61% on room air because the patient took off his oxygen bed saturation came back to 90s after oxygen was replaced. He does have occasional cough. He has developed worsening swelling in his legs and has gained 20 lb since February 14th. Was placed on dexamethasone, azithromycin, cefepime and vancomycin due to immunocompromised state and chest xray showing pneumonia. Also received remdesivir. Resolved and discharged on 3/26/21. Came back on 4/27/21 for 8 days due to acute hypoxic respiratory failure and found to have CHF exacerbation. Was put on Hospice. Died 6/3/2021" "1679762-1" "1679762-1" "Received the vaccine at approx 8:45 am on 8/27. Spent the day at the house with his son and claimed to be feeling totally fine throughout the day. Was last seen alive by his son at 2:30 pm and advised that he felt fine at that time. He was found deceased at 4:00 pm by his son sitting in his workshop with his tools still in his hands and sitting upright." "1681700-1" "1681700-1" "After the first dose he complained of bloody stool, severe vomiting, high fever and flu-like symptoms. His symptoms occurred within a few hours of receiving his first dose and lasted approximately 21 days. He said he felt ?run down,? and similar feelings of dehydration and exhaustion. He had the above side effects with second dose but complained that the magnitude of symptoms were much worse and bloody stool increased. He complained of feeling as if he was going to ?pass out,? upon instances of brief aerobic activity. Upon the" "1682027-1" "1682027-1" "Found him dead while he was sleeping; Heart attack; This is a spontaneous report from a contactable consumer. This consumer (patients brother) reported for a 66-year-old male patient (reporters brother). A 66-year-old male had received BNT162B2 (Pfizer-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and expiration date: not reported) via an unspecified route of administration on 08jun2021 as DOSE 2, SINGLE for covid-19 immunization (At the age of 66 years).The patient medical history had included High blood pressure, Diabetes, and Continuous positive airway pressure. It was reported that, patients brother son had brain cancer. He was on high blood pressure medication and was diabetic but, does not know what medication he was on. He is not sure of the name and can't say.The patient concomitant medication He was on high blood pressure medication. It was reported that there was no idea that patient took any vaccination within 4 weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: PHURCR8735) on 18May2021 as DOSE 1, SINGLE for COVID-19 Immunization. On 25Aug2021 the patient found while he was sleeping. It was reported that, received Comirnaty second dose and died in his sleep 6 weeks later and was found dead last Wednesday when he was sleeping. He reports he was cremated so an autopsy was unable to be performed so they are unable to determine if there is a connection between the vaccine and his death. He wants to know if deaths after the vaccine have been reported. As cause of death was unknown, Caller figured he just had a heart attack. He still had his CPAP machine on and had copabilities. They figured he would outlast all of them. The patient was on a CPAP machine, had diabetes that wasn't too bad, and was overweight, probably about 250 pounds, and had been taking blood pressure medications for years. The patient had not visited any emergency room and physician office. The clinical outcome of the event Found him dead while he was sleeping and heart attack was fatal. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Found him dead while he was sleeping" "1682403-1" "1682403-1" "Patient tested positive for COVID-19 and is now deceased" "1682432-1" "1682432-1" "ED to Hosp-Admission Discharged 8/31/2021 - 9/2/2021 (2 days) - DECEASED 09/02/2021 Presenting Problem/History of Present Illness/Reason for Admission Thrombocytopenia [D69.6] History of myelodysplastic syndrome [Z86.2] Pneumonia due to COVID-19 virus [U07.1, J12.82] Hospital Course Patient is an 86 yo gentleman with past medical history of MDS, on IV chemotherapy with Vidaza. Most recent chemo was given 8/9/2021 through 8/17/2021. He also has past medical history of GERD, HTN, BPH, asthma, thrombocytopenia, COPD, HLD, CAD, PVD, AAA, TIA, Mobitz type II AV block, LVH. He presented to ED from infusion center on 08/31/2021. He was there for a platelet transfusion. He was found to have a temperature and shaking chills. For approximately 3 days prior to admission he had been having increasing cough productive of yellow sputum. Pt lives at nursing facility where he was possible exposed to COVID. In the ED he was found positive for COVID 19 pneumonia. Initially on admission pt had fever and no hypoxia. He was not initially started on dexamethasone. Overnight he developed fevers which steadily climbed during the day. Blood work in the morning showed a normal ferritin, elevated crp/LDH/trop and procalcitonin, normal LFT's Mid afternoon pt became tachypnic and per nursing pt was more confused. He was oriented to person, place and time when I examined him. His temp increased and did not respond to tylenol. Antibiotics were initiated due to concerns of possible bacterial pneumonia. Repeat lab work was ordered. I was contacted again around 6 pm that pt's temp was 106. The call provider was contacted to see the pt at bedside. She was already aware of the situation. ICU was called and made aware of the pt. They indicated that pt's condition was dire and family was updated on the pt's current status. PT's sister who is POA was contacted and pt was made DNR/DNI. Pt continued to decline overnight. Pt's sister, who is also his POA was contacted that and updated that he was actively dying. Due to COVID she declined to come into the hospital. Patient expired at 0758 09/02/2021" "1682464-1" "1682464-1" "Diagnosed with COVID on 8/27 at outside hospital after cough, shortness of breath and diarrhea x 2 weeks. Treated with steroids and remdesivir. Transferred to Medical Center on 9/2 with COVID pneumonia and intubated. continued to decline with increased respiratory support, septic shock, dual pressors and worsening renal failure. Developed new Afib and EKG showed evidence of acute MI/mycardial injury. Multi organ system failure. 9/7 family chose comfort care." "1682490-1" "1682490-1" "I am the epidemiologist reporting on behalf of 61-year-old female patient. The patient received two doses of the Pfizer vaccine on 1/29/21 and 2/19/21. The patient tested positive for COVID-19 on 8/10/21 via PCR. The patient died 9/1/21 and the cause of death is listed as ?ARDS Covid-19?. I do not have further information regarding immunodeficiency status or underlying health conditions." "1682500-1" "1682500-1" "I am the epidemiologist reporting on behalf of 84-year-old female patient. The patient received two doses of the Moderna vaccine on 3/11/21 and 4/8/21. The patient tested positive for COVID-19 on 8/23/21 via PCR. On 8/26/21, nurse at facility where patient resided reported the patient?s only symptom as ?a bit of weakness.? The patient died 8/30/21 and the cause of death is listed as ?Acute Respiratory Failure; Pneumonia; Covid-19?. I do not have further information regarding immunodeficiency status or underlying health conditions." "1682712-1" "1682712-1" "Approx 14 hours post-vaccination, patient's wife awoke to her husband struggling to breath. EMT was called, and he was transported to the hospital ED and passed away. ED physician believed death was related to CHF and not directly related to the Moderna vaccine." "1682874-1" "1682874-1" "Death one day after vaccine." "1682937-1" "1682937-1" "Resident was end of life care, tested positive for COVID-19 8/26/21 and expired" "1682967-1" "1682967-1" "Patient death." "1683006-1" "1683006-1" "Admitted to hospital 8/24/2021, had fever, cough abdominal cramps, was intubated and pt. expired on 8/27/2021" "1683013-1" "1683013-1" "DECREASE APPETITE, SOB, WEAKNESS, POSITIVE COVID TEST" "1683035-1" "1683035-1" "Patient reported to family that she began feeling tired and weak after the second dose on 9/3. Passed away in her home on the couch sometime during the night of 9/5" "1683041-1" "1683041-1" "Upon the regulatory authority reviewing their weekly notifiable conditions death report, they came across a report of decedent where the death certificate COD literal text is indicated to be: ACUTE MOTOR NEURON DISEASE SERUM REACTION TO VIRAL VACCINE Here is some additional decedent details: DOD: 08/30/2021 We speculate that the COD literal text is in reference to COVID-19 vaccinations since those were the most recent two vaccinations that this person had received based on data. Here are the COVID-19 vaccine dose dates: 3/16/2021 (Pfizer) 4/06/2021 (Pfizer)" "1683045-1" "1683045-1" "positive COVID test; hypoxic; septic shock" "1683049-1" "1683049-1" "Patient death" "1683101-1" "1683101-1" "hypoxic, SOB, positive COVID test" "1683127-1" "1683127-1" "Admitted in the hospital on 08/09/2021. Date of death 09/02/2021" "1683133-1" "1683133-1" "SOB; HYPOXIC; PNEUMONIA, POSTIVE COVID TEST" "1683142-1" "1683142-1" "Patient died within 12 hours after vaccination. Sudden death without prodrome. Only complaints after administration were soreness at the vaccine site. Autopsy performed and no obvious evidence vaccine played a role. Dilated cardiomyopathy at examination. No evidence of anaphylaxis, or pulmonary emboli." "1683150-1" "1683150-1" "PNEUMONIA, POSITIVE COVID TEST" "1683226-1" "1683226-1" "6 months later died of suddenly when heart stopped" "1683287-1" "1683287-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 2/26/2021 and 3/26/2021. Presented to ED on 9/1/2021 from Medical Lodge with complaints of shortness of breath requiring oxygen. Patient was placed on high flow oxygen and started on Dexamethasone, ceftriaxone, doxycycline, remdesivir, piperacillin + tazobactam, vancomycin, ascorbic acid, zinc, and Vitamin D. Per patient's wishes he was transitioned to comfort care at 08:40 and expired at 09:00 on 9/5/2021." "1683324-1" "1683324-1" "Patient presented to the ED around 10pm on 4/21, ~one week after her J&J COVID vaccine (exact date of initial vaccination not confirmed but was reportedly 1 week prior) with abdominal pain and headache. She was found to have thrombocytopenia (Plt 38) on presentation as well as renal and ovarian vein thrombosis. CT head showed a large right frontal intraparenchymal hemorrhage. She was taken for urgent craniotomy on 9/5 with EVD placement. Brain tissue was noted to have bleeding spots unresponsive to cautery and requiring local hemostatic agents. Repeat imaging showed worsening infarction. She had continued elevated intracranial pressures, so was taken back to the OR on the morning of 9/6 for bilateral EVD placement to help relieve pressure. Given her thrombocytopenia, thrombosis, significantly elevated D-dimer, low fibrinogen, and +HIT Ab test, she was diagnosed with vaccine-induced thrombocytopenia and thrombosis (VITT). She was started on IVIG 1g/kg daily x 2 days, bivalirudin with supportive transfusions to maintain goal plts >50K, fibrinogen > 150. Despite this, her neurologic status deteriorated due to elevated pressures, clotting off of her EVDs, and ultimately was declared brain dead in the afternoon on 9/7. Family withdrew supportive care and patient passed at 3:57PM on 9/7/21." "1683350-1" "1683350-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 2/25/2021 and 3/23/2021. Presented to the ED on 8/11/2021 for asymptomatic testing so he may resume dialysis. On 8/14/2021 patient returns to ED with a two day history of fatigue, nausea, vomiting, diarrhea, chills, body aches, and loss of taste and smell. Denies shortness of breath, headache or chest pain, Has O2 sats of 100%. Patient was discharged from ED with instructions to return if dyspnea occurs. On 8/17/2021 patient returns to ED with shortness of breath and sepsis secondary to infected dialysis catheter (MSSA bacteremia). Treated with dexamethasone, heparin prophylaxis dosing, zosyn, and vancomycin. Antibiotics were later changed to cefazolin once culture and sensitivity resulted. Patient also developed bleeding from catheter site. he eventually succumbed to multiple acute illnesses with multiorgan failure." "1683354-1" "1683354-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 5/1/2021 and 5/29/2021. Presented to ED on 8/11/2021 with complaints of worsening symptoms over the past 10-11 days including generalized fatigue, body aches, weakness, decreased appetite, nausea, vomiting, diarrhea, dyspnea, and cough. Intubated 8/19. His course was complicated by L pneumothorax requiring Left chest tube placement X 2. He was given Decadron 10 d through 8/21. Completed course of Remdesevir 5 days. Course complicated by MSSA pneumonia and concern for fungal pneumonia. Was being treated with Ancef and Micafungin. However he rapidly declined on 9/2. The patient was with significant. hypotension and bradycardia, despite vasopressin and levophed gtts. Atropine x 1 given. Patient with full cardiac arrest at 1255 and CPR was initiated. Epinephrine 1mg given. 1257 pulse check revealed a pulse that progressed into vtach at 1259, shock x 1 at 200J with PEA and subsequent sinus tachycardia. 1303 patient again went into vtach and another shock x 1 at 200J given and amiodarone bolus of 150mg administered. Return of sinus tachycardia. ABG revealed acidosis and 3 amps of bicarb were administered. At that time the patient's family was called and the wife and daughter arrived at bedside. The family decided at that time to make the patient comfort care. He was taken off the ventilator and passed at 1350." "1683357-1" "1683357-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 3/25/2021 and 4/29/2021. Presented to ED on 8/12/2021 with complaints of dyspnea for 1 week requiring oxygen. Patient was placed on oxygen and eventually required mechanical ventilation. Patient had septic shock and acute kidney injury. Medications administered: dexamethasone, ascorbic acid, ceftriaxone, azithromycin, micafungin, remdesivir, piperacillin/tazobactam, tocilizumab, prednisone, and vancomycin. Patient continued to decompensate and expired at 14:44 on 8/29/2021." "1683449-1" "1683449-1" "Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Jannsen Vaccine on 4/01/2021 and 3/23/2021. Presented to facility of 8/28/2021 with a chief complaint of cough without SOB, with room sats of 85%, fever, and COVID positive. Patient required intubation on 8/30/2021 during a cardiac arrest. On 8/31/2021 patient transferred to facility. On arrival with air transport, patient is hemodynamically stable, sedated on propofol. Patient is connected to MV with settings CMV 20/450/.70 +10. On 9/2/2021, spontaneous movement but not following commands. Remains in prone position. HD yesterday." "1683451-1" "1683451-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/25/2021 and 3/17/2021. Presented to another organizations ED on 8/7/2021 with complaints of hematuria in Foley bag, and pain in lower part of abdomen. Patient was subsequently found to have COVID infection that was asymptomatic (on room air throughout admission) and discharged on 8/12/2021. Patient subsequently presented to ED on 8/26/2021 with generalized weakness and altered mental status. Patient's mentation briefly improved with supplemental oxygen. Chest X-ray Atelectasis/infiltrate especially left mid and lower lung zones, clinical correlation recommended for developing acute pneumonia/pneumonitis. CT Chest shows occlusive and non occlusive PE LUL, small bilat eff, bilat lower lobe consolidation. In ER patient was noted to be in atrial fibrillation with RVR and was initiated on cardizem. Patient was diagnosed with severe sepsis, bilateral pneumonia, and UTI from indwelling foley (Candida albicans), Pulmonary embolism, hypernatremia, as well as continued COVID positive originally diagnosed 8/7/2021 and confirmed with repeat testing on 8/26/2021. Patient was transitioned to inpatient hospice on 8/30/2021, and expired on 9/5/2021." "1683454-1" "1683454-1" "Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/29/2021 and 2/21/2021. Presented to ED on 8/17/2021 with complaints of fever and shortness of breath for 2 days with increased oxygen requirements. Medications administered: dexamethasone, methylprednisolone, ceftriaxone, cefepime, azithromycin, remdesivir, epoprostenol, and vancomycin. Patient continued to decompensate requiring more oxygen. On 8/29/2021 patient's mental status declined while on BiPAP. Patient expired at 13:44 on 8/29/2021." "1683459-1" "1683459-1" "Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/2/2021 and 2/23/2021. Presented to ED on 8/16/2021 with complaints of shortness of breath and productive cough for two weeks. Supplemental oxygen initiated in ED. Medications administered: dexamethasone, ceftriaxone, azithromycin, vancomycin. Patient's chronic renal dysfunction continued to worsen while hospitalized. Patient refused dialysis. After discussion with family discharged home with hospice on 8/25/2021. Per patient's son, patient expired on 8/30/2021 at home." "1683491-1" "1683491-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/15/2021 and 2/12/2021. Presented to ED after referral from primary care provider on 8/4/2021 for hypoxia. Patient was hospitalized, placed on oxygen supplementation and received dexamethasone, remdesivir, and tocilizumab. Oxygen demand continued to increase so patient was transferred to hospital on 8/8/2021 after chest tube placement. On 8/14/2021, patient required mechanical ventilation for respiratory distress. Patient received multiple rounds of antibiotics. Head CT confirmed an ischemic stroke. Patient continued to decompensate requiring vasopressor support and developed an ileus. After discussion with family, comfort care measures were pursued and patient expired at 1420 on 9/6/2021." "1683492-1" "1683492-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/28/2021 and 2/23/2021. Presented to physician office on 8/9/2021 for evaluation of dry non-productive cough, clear runny nose x3 days. Was prescribed levofloxacin for acute sinusitis, benzonatate, albuterol nebs, and prednisone taper. Patient called provider back on 8/11/2021 stating symptoms are still persistent and a COVID test was ordered w positive result. on 8/12 the prednisone taper was discontinued and patient was prescribed dexamethasone 4 mg QD. on 8/17/2021 patient presented to ED with shortness of breath and hypoxia. Pulse ox on presentation was 70% on room air. Patient was treated with dexamethasone, Remdesivir, ascorbic acid, zinc sulfate, and convalescent plasma. Patient status deteriorated and was switched to comfort care on 9/4/2021, expired at 1335." "1683498-1" "1683498-1" "Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/11/2021 and 4/8/2021. Presented to ED on 8/11/2021 with complaints of shortness of breath for last 7 days. Supplemental oxygen was initiated in the ED. Admitted with COVID 19 pneumonia with ARDS and ongoing respiratory failure. On 8/22/2021 patient had cardiorespiratory arrest and required mechanical ventilation. Medications administered during hospitalization include: dexamethasone, cefepime, levofloxacin, micafungin, and remdesivir. Support withdrawn after discussion with family about poor prognosis. Patient expired at on 9/1/2021." "1683500-1" "1683500-1" "Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/3/2021 and 2/24/2021. Presented to ED on 8/5/2021 with shortness of breath. Medications administered: acetylcysteine, baricitinib, dexamethasone, methylprednisolone, prednisone, ceftriaxone, azithromycin, remdesivir, piperacillin/tazobactan, zinc, and vancomycin. During hospitalization, patient aspirated and had small bowel ileus subsequently requiring vasopressor support. Patient eventually went to cardiac arrest and expired on 9/01/2021." "1683905-1" "1683905-1" "client fully vaccinated, patient died 09/05/2021-Cause: Complications of COVID-19" "1684121-1" "1684121-1" "Death" "1684500-1" "1684500-1" "Patient received Pfizer on 2/8/2021 and 3/1/2021. Patient was admitted to the hospital on 8/29/2021 for COVID pneumonia, and acute on chronic respiratory failure. Patient died on 9/8/2021." "1684691-1" "1684691-1" "Patient presented to emergency department on 8/19/2021 with shortness of breath. He was found to be COVID-19 positive and admitted for further management. He was transferred to the ICU on 8/23/2021 due to worsening hypoxia. He was intubated on 8/28/2021. Patient's condition further deteriorated into multisystem organ failure. He was placed on comfort measures on and expired on 9/8/2021." "1684695-1" "1684695-1" ""Became unable to take care of her daily activities, unable to remember anything and when she passed away we found that none of her bills had been paid since before she took her 2nd shot. She was disoriented, confused, didn't know where she was or remember speaking with anyone on the phone and just felt overall worse. Since she had the chronic health issues she/we were not aware she had gotten worse as she pulled away from everyone and kept telling us ""this episode was just lasting longer"". When she passed and I started going through her things I realized it all started after the shot. Nothing had been taken care of after that date. She also had been driving up until March, she herself stopped driving stating she didn't feel comfortable in driving any longer."" "1684789-1" "1684789-1" "Patient brought to the ED on 4/15/2021 at 0330 with increased weakness. Patient takes Sinemet every 3 hours and last Sinemet dose was sometime late on 4/14/2021. Patient stated the medication wore off sooner than it should have. Patient was discharged to home on 4/15 at 0551. Patient was seen again in the ED on 7/17/2021 at 2100 for weakness. Again, brought in by EMS. No medications were given in the ED. Patient discharged to home on 4/17/2021 at 2345." "1684819-1" "1684819-1" "8/14/2021 Admit Hospital. Patient presented to emergency room with shortness of breath for the last 4 days with weakness and decline in status and diarrhea. Her oxygen saturation was low in the low 90s. home oxygen dependent. Tested positive for COVID-19 from PCR on 8/15/21. Diagnosed with: COVID-19 pneumonia, acute on chronic hypoxic respiratory failure. Transferred to Hospice 8/20/21. patient died on 8/25/21. Note: COVID-19 Moderna vaccine previously given: First dose: 03/08/21 Lot Number 025A21A; Second dose: 04/14/21 Lot Number 030B21A" "1684866-1" "1684866-1" "It was noted that he had weakness in his legs and some weakness in his arms and a diagnosis of Guillain-Barre." "1684882-1" "1684882-1" "POSITIVE COVID TEST IN JULY 2021, SOB WORSENED, SENT BACK TO HOSPITAL DUE TO HYPOXIA,, THEN DISCHARGED TO HOSPICE WHERE HE PASSED AWAY." "1684903-1" "1684903-1" "COUGH, SOB, HX OF MOTHER BEING POSITIVE FOR COVID, PT TESTED POSITIVE FOR COVID" "1684960-1" "1684960-1" "CONFUSION, POSITIVE COVID TEST, BILATERAL PULMONARY INFILTRATE, PULMONARY EDEMA" "1684977-1" "1684977-1" "1st vaccine given on 1/20/21, 2nd dose given on 2/9/21; tested positive for COVID-19 via PCR on 8/16/2021; admitted to hospital on 8/31/21 with acute respiratory failure secondary to COVID, also had superimposed bacterial pneumonia, severe fever, and died on 9/5/21." "1684982-1" "1684982-1" "POSITIVE COVID TEST, MYALGIAS, FEVER, BLOOD CULTURE POSITIVE FOR MSSA" "1685005-1" "1685005-1" "8/1/2021: patient admitted. Apparently, he has been ill for a few days. He was given antibiotic as outpatient basis - including oral ivermectin. He was diagnosed with COVID at outside facility. He failed outpatient treatment. His oxygen has been going down. He presented to the emergency department with shortness of breath as well as chest pain. Diagnosed with Covid pneumonitis, hypoxic resp failure Note: patient previously vaccinated with Covid-19 vaccine: First dose: 01/02/21 Lot Number E110140;Second dose: 01/23/21 Lot Number EL3248 8/7/2021: patent Died" "1685011-1" "1685011-1" "SOB, FEVER, WEAKNESS, POSITIVE COVID TEST, RESPIRATORY FAILURE, CARDIAC ARREST" "1685045-1" "1685045-1" "DIARRHEA, POSITIVE COVID TEST, HX OF DIABETES AND HTN; SEIZURE DISORDER" "1685068-1" "1685068-1" "PNEUMONIA, POSITIVE COVID TEST, RSV POSITIVE, ALTERED MENTAL STATE" "1685087-1" "1685087-1" "Patient diagnosed, hospitalized and expired with COVID 19 while fully vaccinated" "1685092-1" "1685092-1" "Patient is fully vaccinated and died in hospice care. Case was previously living in a Long term care facility and recently relocated to hospice as in-patient in hospital. Case tested Covid positive at hospital and didn't show any signs and symptoms. Case was told his heart and kidney medical conditions were declining. Case had chronic conditions listed previously. Case died about a week later after being admitted to hospice." "1685095-1" "1685095-1" "Patient started with symptoms on Friday 8/6/21. They decided to test him on Tues 8/10/21 and he came back positive on Wed 8/11/21. Patient has a history of COPD, CHF, Diabetes, Prostate Cancer, CVA. He started with SOB, cough, loss of taste and smell and now is very fatigued, has a loss of appetite and has low O2 saturation. DON of PHH denied that he has any stomach concerns (no vomiting or diarrhea). His O2 sat has been in the high 70's and they are concerned about him. They may look into if he has pneumonia, as he has not had a chest xray, however they have already prescribed antibiotics, steroids, ivermectin, and vitamins C, D, and Zinc" "1685099-1" "1685099-1" "PRESENTED IN RESPIRATORY DISTRESS, COVID POSITIVE, PNEUMONIA DUE TO COVID" "1685126-1" "1685126-1" "Nursing notes have been submitted into system, death summary is not available yet." "1685155-1" "1685155-1" "Patient diagnosed and hospitalized with COVID 19. Patient expired." "1685163-1" "1685163-1" "RECENT CVA; HX OF COPD, HTN, ASTHMA; PNEUMONIA DUE TO POSITIVE FOR COVID" "1685183-1" "1685183-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 03/11/2021 and 04/08/2021. On 8/20/2021, pt presented to ED with increasing shortness of breath. Pt was admitted to a hospital on 8/17/2021 and diagnosed with COVID-19 pneumonia. She was discharged on 8/20/2021 with 4 L NC oxygen. Once discharged patient began to desaturate to 80% and called EMS. Patient was transported to ED and placed on HFNC 50/40 then titrated up to 60/60 and then later 70/60. Her lab work demonstrated elevated procalcitonin and her x-ray demonstrated a multifocal pneumonia. She was given dexamethasone, Rocephin and remdesivir. On morning of 8/25/21 she was noted to be significantly tachypneic with RR to 40s and slightly altered. Despite ongoing treatment, she declined. Patient expired on 8/25/21." "1685188-1" "1685188-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 03/11/2021 and 04/02/2021. On 7/12 he began developing symptoms of fatigue, chills, low-grade fevers, body aches, intermittent nausea, poor p.o. intake, poor appetite, some dry cough. He tested COVID positive on 7/16 and continued symptomatic treatment at home. Patient was then admitted 7/24 and discharged on 7/30 with oxygen. Received decadron during this stay. Returned to ER on 8/12 due to worsening shortness of breath. Received vancomycin and cefepime. Started on BiPAP then eventually intubated on 8/17. Patient's respiratory status continued to worsen. Multifocular infarcts noticed on 8/22. Patient treated for PJP on 8/23. Family planned withdrawal of care on 8/24 after discussion of patient's poor prognosis. Patient expired on 8/25/21." "1685194-1" "1685194-1" "fever, fatigue, cough, positive for COVID" "1685242-1" "1685242-1" "54-year-old female who was diagnosed with Covid several weeks prior presented to outside hospital due to facial numbness/tingling. She was found to have evidence of MCA stroke and was given TPA, she was transferred here for further management. Upon arrival here she was found to have evidence of bilateral MCA strokes, given that the patient was intubated and there is no likelihood of meaningful recovery goals of care discussions were had with neurology and the recommendation was to proceed with comfort care measures. The patient was extubated and transitioned to comfort care measures. Patient expired on 8/31/2021, cause of death was bilateral MCA strokes." "1685297-1" "1685297-1" "Fever, cough, recent pneumonia diagnosed by chest xray." "1685315-1" "1685315-1" "Patient admitted to COVID floor on 8/25/21 for acute hypoxic respiratory failure secondary to bilateral pneumonia COVID-19. She was initiated on dexamethasone and remdesivir. Pulmonology consulted 8/31 for worsening hypoxemia, on heated high-flow nasal cannula and alternating with noninvasive positive pressure ventilation. On 09/02 patient was transferred to the COVID19 ICU for worsening respiratory status. Patient requested multiple times to delay intubation and maintain on AVAPS. She did have a feeding tube placed and was receiving tube feeds. She essentially became dependent on noninvasive ventilation unable to wean. She did attempt self proning with some improvement in her oxygenation. This morning, patient's oxygen saturations dropped to 60s with increased work of breathing despite noninvasive ventilation and self proning. Discussed with patient again and she was agreeable to being intubated and family agreed. Patient sedated and intubated, unfortunately shortly after intubation patient had a PEA arrest and Code Blue called. See previous note for details. Ultimately, after multiple rounds of CPR, epinephrine, defibrillations without persistent return of spontaneous circulation and approx 35 minutes resuscitation efforts, all resuscitation efforts stopped and time of death called at 08:07am." "1685326-1" "1685326-1" "Patient of Hospice who requested to have Covid Vaccine. Our Community Paramedic, took the vaccine to the Hospice on 9/2/2021. He administered the vaccine and waited 15 minutes to observe for reactions. No adverse reactions were noted. The following morning we received a call from the nurse at the Hospice House that pt was pronounced deceased on 9/3/2021 in early am." "1685347-1" "1685347-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/6/2021 and 3/27/2021. Patient started having cough and sneezing around 8/11 after going out of town. She then developed nausea, vomiting, and diarrhea on 8/12. Patient presented to ED on 8/17, o2 sat was 75% on room air. She was placed on a non-rebreather but was saturating at 100%. Imaging showed multifocal pneumonia. Patient was treated with dexamethasone, remdesivir, and baricitinib . Patient continued to experience respiratory failure. Patient developed AKI and acute delirium and was unable to safely swallow. Dobhoff tube was placed, and she received enteral nutrition. She developed worsening hypoxia on 8/25/21. Patient continued to have acute worsening of breathing, became apneic, and expired on 8/25/21." "1685352-1" "1685352-1" "Had COVID 19 in November 2020 and again in May 2021. Came to hospital with complaint of worsening shortness of breath associated with cough and sputum expectoration. Recently discharged for recurrent pneumonia. WBC 20. Started on ceftriaxone, azithromycin and dexamethasone. Placed on 2L NC. Diagnosed with community acquired bacterial pneumonia. Had VRE bacteremia. Switched to daptomycin and discharged on linezolid x 10 days. Readmitted on 5/29/21 with SOB, cough, and new left-sided pneumonia. Discharged 6/9/21. Admitted again on 6/10/21 for aspiration pneumonia and CHF exacerbation. Placed on unasyn and discharged on augmentin. Admitted again on 6/28/21 for sepsis secondary to pneumonia. Went comfort measures at this time and discharged with hospice. Died 7/15/21" "1685364-1" "1685364-1" "Fever, cough" "1685422-1" "1685422-1" "Fever, cough, runny nose" "1685430-1" "1685430-1" "unknown" "1685498-1" "1685498-1" "Fever, sore thoat, cough." "1685546-1" "1685546-1" "8/14/21: patient brought to ED as she was found unresponsive by family last time was seen was 8:00 p.m. on arrival to ED patient has to be intubated for low GCS round 3 stroke alert team was activated head CT is negative chest x-ray significant for right upper lobe mass patient required norepinephrine as she was hypotensive. COVID test PCR came back positive. admitted to COVID unit Note: patient previously vaccinated with Pfizer Covid-19 vaccine on 4/26/21 & 5/17/21. Diagnosed with hypoxic respiratory failure secondary to covid pneumonia. 8/22/21: patient died." "1685561-1" "1685561-1" "Presented to the ED with chief complain of fever, myalgia and noted low oxygen saturation. He was possibly exposed to the coronavirus at his bar during a hosted festival from 8/6-8/8 where one attendant called to inform him he tested positive to the coronavirus. His symptoms started with fever, myalgia, chills about 1-2 weeks prior to his admit on 8/24/21, In the ED, he was desaturating to the 50s and placed on a HFNC. His code status is DNR/DNI. He has received remdesivir, decadron, 2 doses of barticinib and therapeutic anticoagulation for being at high thrombotic risk from the coronavirus infection. Patient was managed in the ICU from the time of admission. On the night of 9/5/21 patient became hypotensive and not responding adequately to IV fluids. Patient was found to have asystole at 3:06 AM on 9/6/21. Pronounced dead at 3:06 AM." "1685563-1" "1685563-1" "Decedent on hospice for acute respiratory failure due to chronic obstructive pulmonary disease." "1685567-1" "1685567-1" "On 8/29/2021, decedent presented to the ER with a three day duration of worsening shortness of breath. He was admitted to the hospital and discharged home on 9/1/2021 with COVID pneumonia." "1685584-1" "1685584-1" "SOB, positive COVID test, productive cough, current lung CA" "1685607-1" "1685607-1" "chest tightness, shortness of breath after walking short distances, on 23rd collapsed at work and died" "1685619-1" "1685619-1" "8/18/2021: admitted with COVID breakthrough Pt reports fully vaccinated in April 2021. Reports since Sunday having fatigue, diarrhea, mild cough, loss of taste/appetite, and exertional dyspnea. reported testing positive for COVID-19 on 8/16/21. 1st vaccine 3/8/2021 second 4/15/2021. Diagnosed with: COVID-19 pneumonia, acute hypoxic respiratory failure, viral enteritis 9/9/21: patient died." "1685644-1" "1685644-1" "He received the vaccine on 2/13/21 by 2/15/21 he was not feeling himself didn?t really eat by 2/17/21 he couldn?t walk by 2/19/21 he was admitted to hospice and by 2/22/21 he passed away" "1685648-1" "1685648-1" "Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 5/24/2021 and 7/1/2021. Patient previously hospitalized for COVID-19 8/11/2021 to 8/15/2021 where he received remdesivir an. Presented to ED on 8/23/2021 with complaints of difficulty breathing. BiPAP was initiated in ED. Patient oxygenation continued to decompensate and eventually required mechanical ventilation. Patient developed seizures, shock, GI bleeding, DIC, and acute kidney failure requiring dialysis. Patient had enterobacter bacteremia. Patient received dexamethasone, ceftriaxone, cefepime, methylprednisolone, azithromycin, and vancomycin. After discussion with family, care was withdrawn on 9/1/2021 and patient expired at 1442." "1685668-1" "1685668-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/14/2021 and 2/2/2021. Patient contacted physician office on 8/9/2021 stating had a positive COVID HOME test on 8/8/2021 with a three day history of sore throat, headache, congestion, coughing also noted to have oxygen level of 81 and fever of 101.9. Patient was retested on 8/10/2021 and was positive. Patient presented to ED on 8/10/2021 with complaints of shortness of breath. On presentation SpO2 100% on room air without significant tachypnea, but with mild bilateral wheezes. Patient received Imdevimab+casirivimab and was discharged home @ 1645. Patient presented back to ED at 2011 in respiratory distress with increased work of breathing, accessory muscle use, and transient hypoxia. Noted O2 sats of 74% on room air, and placed on high-flow nasal cannula. Patient improved rapidly overnight coming down to just 2 L NC by the following morning. Patient stated she felt better as well denying SOB, fevers or chills but reporting some cough. Patient O2 needs had decreased to 4 L on ambulation by 8/13. She was discharged on home with home O2 on 8/13. She was prescribed dexamethasone to complete a total of 10 days of therapy for COVID and cefdinir to complete 5 days of therapy for suspected overlying bacterial PNA. Patient presented to ED on 8/14/2021 due to shortness of breath. She was transferred to ICU 8/15 due to acute hypoxic respiratory failure due to COVID-19 pneumonia and found to have secondary bacterial pna. Patient returned to the floor in hosptial but subsequently bounced back to the ICU 8/25 and intubated 8/26. Patient continued to deteriorate and palliative care was consulted. 8/31 decision was made by family to pursue DNR/AND. Patient passed away peacefully at 8:54PM on 8/31/2021." "1685685-1" "1685685-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/14/2021 and 2/12/2021. Presented to ED on 8/16/2021 with complaints of worsening hypoxia after a positive COVID test the previous week from an outside facility. Symptom onset was 8/11/2021. Patient has been on 5L NC at baseline for pulmonary fibrosis. Patient treated with dexamethasone, remdesivir, and highflow oxygen. Patient initially improved after 5 days of remdesivir and 10 days of dexamethasone, but hypoxia worsened starting on 8/30/2021. On 9/3/2021 patient rapidly deteriorated, and expired at 1545 on 9/3/2021." "1685687-1" "1685687-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 4/7/2021 and 4/30/2021. Presented to ED on 8/17/2021 with cough, nausea, vomiting, diarrhea fever of 102, loss of appetite, and decreased UOP. Treated initially for DKA, and placed on HFNC. DKA resolved, and transitioned off insulin gtt 8/21. Due to increasing oxygen requirements, patient intubated on 8/23, and subsequently required proning. Developed septic shock, requiring norepinephrine and vasopressin gtt. Worsening renal function prompted Vascath placement and initiation of dialysis 8/29. Patient continued to deteriorate clinically, requiring the addition of epinephrine for blood pressure support, and worsening respiratory acidosis and hypoxemia. He developed wide complex tachycardia requiring 1 shock, after which family was called for goals of care discussion. Transitioned patient to comfort care, and he expired shortly thereafter." "1685693-1" "1685693-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/18/2021 and 4/15/2021. Presented to ED on 8/16/2021 with complaints of weakness and fever over the past day. Patient's nephrostomy tube was changed two weeks prior for an infected kidney stone and patient just started noticing blood in his foley bag the morning of presenting to the ED. Admitted for UTI. On 8/17/2021 patient expressed concern for COVID status since family at home is COVID positive. Patient has mild cough but feels it is chronic at baseline. Patient tested positive for COVID on 8/18/2021 and spiked a fever that afternoon. On 8/19/2021 patient reported feeling cold and having chills overnight as well as dry cough, but denies shortness of breath. On 8/20/2021 patients SPO2 dropped (86-88%) on 6L O2. Patient was placed on NRB with 96% sats. On 8/21 patient on HFNC with escalating oxygen requirements, patient started on dexamethasone. On 8/25 patient experienced destauration to 87% while on 6L NC. On 8/30/2021 patient wished to discuss comfort care. On 8/31/2021 patient was transitioned to inpatient hospice, and patient expired on 9/1/2021." "1685705-1" "1685705-1" "Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 3/11/2021. Presented to ED on 8/25/2021 with a 9-10 day history of coughing, fevers, diarrhea, fatigue, hypoxia, myalgiam and chills. She was started on Dexamethasone on 8/26 and continued this through her hospital course. Eventually her oxygen requirements escalated and she required intubation on 8/27/21 due to persistent significant hypoxia despite maximum non-invasive interventions. A trialysis catheter was also placed for her and nephrology was consulted due to urgent need for dialysis as her kidney function continued to deteriorate since admission. Renal ultrasound did not show any hydronephrosis or obstructive processes. On 8/27 she had 3L removed via HD. She required paralytics, sedation, and pain control while on the ventilator. On 8/27/21, her code status was changed to DNAR/COT. Eventually, she developed septic shock and was found later to be bacteremic (GPC in clusters) with a positive MRSA PCR nares. The culture did not have a final result by the time of her passing. She was started on broad spectrum antibiotics on 8/30 at the time of her becoming more septic. On 8/31, the patient's MAPs and oxygen saturations continued to decrease despite maximal therapy (including four vasopressors). The patient passed away at 0630 on 8/31/21." "1686251-1" "1686251-1" "patients daughter reported to us that the patient died on 9/4 or 9/5. the patient was otherwise healthy. the patient told her daughter that her arm itched some at the injection site. the family is not doing an autopsy" "1688944-1" "1688944-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 05/20/2021 and 06/17/2021. Presented to ED on 8/14 with complaints of shortness of breath and coughing. Noticed symptoms of chills, nausea, and abdominal pain on 8/11. In ED pt was febrile, tachycardic, and tachypneic. CXR showed bilateral infiltrates. Patient required HFNC at 75-90% and Non-rebreather. Patient was proned. During stay, patient received zosyn, vacomycin,prednisone, ceftriaxone, and decadron. Renal disease precluded use of remdesivir. Patient continued to decline and expired on 8/28/21." "1688947-1" "1688947-1" "Pt came to ER c/o URI and nasal drainage onset 3 weeks prior." "1688950-1" "1688950-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 01/28/2021 and 02/20/2021. Presented to ED on 8/18 with complaints of fever and vomiting. On 8/22, Patient was placed on high flow oxygen and required vasopressors. Patient was intubated on 8/23. Patient continued to decline and also developed renal failure. Patient was transitioned to comfort care on 8/26. During stay patient received cefepime, vacomycin, doxycycline, remdesivir, baricitinib, and decadron. Patient expired on 8/26/21." "1688955-1" "1688955-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 05/06/2021 and 06/03/2021. Patient presents to ER on 8/6/2021 referred directly from outpatient clinic with chief complaint of fever, chills, chest pain and dyspnea times 3 days. He was admitted to medical floor 08/06/2021 for acute hypoxemic respiratory failure secondary to COVID pneumonia requiring 2 L supplemental oxygen via nasal cannula. Patient received remdesivir, ceftriaxone, Bactrim and Baricitinib. On 08/10, oxygen demand increased from 7 L nasal cannula to high-flow nasal cannula 40 L 40% FiO2. Oxygen demand slowly increased requiring 60 L 100% FiO2. Patient was transferred to ICU for worsening hypoxia. 8/14-8/15 patient remained on HFNC and desaturated in the 50s. 8/15 patient left the hospital against medical advice. Patient expired on 8/26/21." "1689025-1" "1689025-1" "FOUND UNRESPONSIVE ON 8/2/2021, TAKEN TO ED IN CARDIC ARREST, FOUND COVID POSITIVE, NEVER RESPONDED TO TREATMENT, DIED ON 8/2/2021" "1689045-1" "1689045-1" "Hospitalization (8/9/2021-8/18/2021) and death (8/18/2021) due to COVID-19" "1689053-1" "1689053-1" "COVID DIAGNOSIS 8/18/2021; HOSPITALIZED 8/24/2021 WITH COVID PNEUMONIA; ACUTE RESPIRATORY FAILURE." "1689072-1" "1689072-1" "Suffered a major heart attack on 09/06/2021 and expired on 09/07/2021 on hospice." "1689102-1" "1689102-1" "Breakthrough COVID-19 case, death. Vital records cause of death: CARDIOPULMONARY FAILURE, FAILURE TO THRIVE, END STAGE DEMENTIA. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: COVID-19" "1689182-1" "1689182-1" "Patient was sleeping, rolled over siezed up body postured with arms drawn. Called 911.Patient was unconscious and appeared to take his last breath as medics arrived. Medics and sheriffs arrived. I verified patient did not hit his head, fall or have any injury. They worked on the patient and transferred him to the hospital. Patient was pronounced Dead at the hospital." "1689193-1" "1689193-1" "lethargy; decrease appetite, positive for COVID and flu B; hx of HTN, pacemaker, A Fib" "1689211-1" "1689211-1" "LETHARGY; DECREASE APPETITE, POOR SLEEP X WKS, POSITIVE COVID TEST; ACUTE HYPOXEMIC RESPIRATORY FAILURE" "1689212-1" "1689212-1" "SARS COV2 POSITIVE ON 7/20; EXPIRED 8/29/2021" "1689261-1" "1689261-1" "Patient had her 1st dose of the vaccine on Friday 8/20. Over the next day the patient developed nausea, vomiting and abdominal pain. The pain continued until the patient presented to the emergency department on 08/22. Patient was found to have emphysematous gastritis. She was started on antibiotics and admitted to the intensive care unit. The patient also had significant elevation in liver enzymes. She developed altered mental status and eventually respiratory failure and was unable to protect her airway. Further radiologic examinations showed perforated viscus and diffuse pneumoperitoneum. Patient died on 08/24." "1689284-1" "1689284-1" "weakness; pneumonia due to COVID-19" "1689315-1" "1689315-1" "positive for COVID-19, fever, confusion" "1689318-1" "1689318-1" "8/17/2021 Client received Pfizer #1 in a homebound mission. 9/7/2021 Homebound team contacted husband for Pfizer #2 and he informed the team that she was in the hospital after a stroke. 9/92021 Team notified that client had died." "1689320-1" "1689320-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer BioNTech Vaccine on 1/23/2021 and 2/13/2021. Presented to ED on 8/16 with complaints of syncope and right shoulder pain. Patient had been diagnosed with COVID on 8/13, with his main symptoms being fatigue/tiredness, cough, nausea. On 8/27, patient was agonal breathing (after he removed his bipap); patient was intubated and placed on mechanical ventilation and moved to ICU. On 8/29, patient became more hypoxic in respiratory distress with dyssynchronous hypotensive Afib with RVR. Patient received decadron x 6 days, baricitnib x 8 days, doxycycline x 7 days, Micafungin started on 8/26, started vancomycin and meropenem on 8/28. Patient expired on 8/29/21." "1689321-1" "1689321-1" "Hospital states pt was admitted 8/16 -8/24 for treatment of Covid and Flu B+, patient was discharged to Nursing Home. Pt was readmitted 8/30 ? 9/4 for encephalopathy and hyperglycemia. Patient expired 9/4/21. No ventilators either hospitalization. Patient was fully vaccinated." "1689323-1" "1689323-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer BioNTech Vaccine on 1/18/2021 and 2/06/2021. Presented to ED on 8/20/21 with worsening shortness of breath. Patient was diagnosed with COVID-19 on 8/18/2021. Patient was tachypneic upon arrival and did not improve with BiPAP and was subsequently intubated and transferred to ICU. Before admission patient developed poor appetite and mild cough and PCP ordered monoclonal antibody for patient. Bedside echo showed an underfilled, hyperdynamic RV. Patient developed ST elevations in inf leads. She underwent LHC on 8/22 which showed myocarditis and lvef of 10%. She had an IABP placed and started on multiple pressors for cardiogenic shock. Patient also developed AKI, afib (started on amiodarone). Received vancomycin, cefepime, and azithromycin. Patient was transitioned to inpatient hospice on 8/28/21. Patient expired on 8/29/21." "1689325-1" "1689325-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 1/14/2021 and 2/12/2021. Presented to ED on 8/18/21. Family was concerned about patient's increasing confusion and generalized weakness, urinary frequency, incontinence, and fever. In the ED, the patient was found to have WBC count 16.9, Cr 1.38, urine is hazy with amorphous crystals, blood pos 1+, trace protein, CRP 11.3, Cr 1.38 which was up from 0.8 from July 2021, CT chest shows ground glass opacities in bilateral lungs. Patient was experiencing respiratory failure and was placed on Airvo at 80%. He experienced low saturations in low 80s and was tachypneic in 40s. Patient voiced he did not want to be intubated. Patient received Solumedrol, Ceftriaxone, Doxycycline, Remdesivir. Pt removed his oxygen and restated he did not want it. The patient expired on 8/28/21." "1689346-1" "1689346-1" "Patient presented to our ED on 9/2/21 complaining of progressive shortness of breath. She tested positive for COVID-19 PCR on admission. She expired 9/9/21 following cardiopulmonary arrest." "1689354-1" "1689354-1" "Patient fully vaccinated with Pfizer vaccine x doses. Tested positive for COVID 19 on 8/6/2021 and died at home on 8/20/2021." "1689360-1" "1689360-1" "Patient tested positive for COVID-19 on 8/23/2021 and was hospitalized. The patient had been having a cough for over a week. He states that he feels tired and fatigue and is worse when he ambulates. The patient was hospitalized for about 8 days until he expired on 9/1/2021 due to cardiac disturbances." "1689372-1" "1689372-1" ""Blood counts prior to that date: always perfect March 31, 2021 1st dose Pfizer COMIRNATY vaccine 01 April 2021 I start vomiting: over 3 mouthfuls of food everything is vomited April 21, 2021 2nd dose Pfizer COMIRNATY vaccine April 21-23, 2021 fever 39.5 ¦ C-40 ¦ C and uninterrupted epistaxis April 29, 2021 personal malleolus fracture May 02, 2021 hospital for foot plaster and start of heparin May 05, 2021 CBC: thrombocytopenia, Hb 11.4 g / dL, CRP 3 mg / dL May 11, 2021 orthopedic discontinue heparin and start fondaparinux 2.5 mg 1 fl. He said ""surely it's all due to the vaccine."" May 12, 2021 CBC: thrombocytopenia, Hb 11.1 g / dL, RBC 3.89x106 mcL. request for ""heparin dependent PF4 antibodies"" test May 14, 2021 CBC: thrombocytopenia May 17, 2021 CBC: thrombocytopenia, Hb 10.9 g / dL, RBC 3.77x106 mcL, HCT 32.7%. ""heparin-dependent PF4 antibodies"" test has been suspended throughout: perhaps because it is the only test that would have admitted the correlation between the covid19 vaccine and thrombocytopenia and splenomegaly? May 26, 2021 CBC: thrombocytopenia, Hb 10.9 g / dL, reactive lymphocytes present May 28, 2021 haematologist ""it is possible (but not demonstrable) that the induction of thrombocytopenia is linked to the 2nd dose of the anti SarsCoV2 (Pfizer) vaccine ... Important epistaxis and bruising on the whole body are reported from the 2nd / 3rd day post vaccination, which suggests thrombocytopenia prior to trauma and LMWH therapy. "" May 31, 2021 CBC: thrombocytopenia, Hb 10.9 g / dL, HCT 33.5%, RBC 3.85x106 mcL, ferritinaemia 197 ng / mL, calcium 12.9 mg / dL, uricaemia 12.2 mg / dL, creatinine 1.51 mg / dL, VFG according to CKD-EPI 32 ml / min / 1.73 m2, LDH 934 U / L, IgG 627 mg / dL, IgA 44 mg / dL, IgM 281 mg / dL, beta2microglobulin 7 mg / L, CRP 4.8 mg / dL 01 June 2021 orthopedic check: tredimin 50,000 I.U. every 15 days for 6 months 01 June 2021 echo abdomen: ""Liver slightly larger than normal (DL lobe DX 17cm). In the right lobe 1 hyperechoic nodule 22mm and 1 hypoechoic nodule 30mm of doubtful attribution ... Very large spleen (DL 21cm) with widespread structural alteration due to the presence of hypoechoic areas up to 4cm. Without color signal ... "" 01 June 2021 hematologist: ""clinical picture with anemia and thrombocytopenia due to hypersplenism in recent fractures, IR, hypercalcemia, hyperuricemia, high LDH values, inflammation and reduction of peripheral IgG and IgA ..."" 07 June 2021 CT scan of the abdomen without MDC: ""Slightly enlarged liver. à Marked splenomegaly (160% x 105 mm), presence of small middle III parenchymal calcification. à Some lymphosdenopathies appear to be in the lumbo-aortic area. Lymphadenopathy 30 mm right iliac-femoral region. Oval lymph node short diameter 13 mm ipsilateral inguinal region. ... "" 08 June 2021 hospitalization for further investigations. Enter with the help of a walker. June 10, 2021 hematology: posterior iliac crest marrow biopsy June 16, 2021 hematology: inguinal lymph node biopsy: they spoke of ""disease neither good nor evil that is treated with chemotherapy"" June 22, 2021 hematology: checkup after bone marrow biopsy: they talked about ""a rare disease that is treated with chemotherapy"" June 25, 2021 hospital discharge: until now no doctor has ever clearly stated what the patient is suffering from: they said to read the discharge letter at home. ""à Diagnosis of discharge:"" Non-Hodgkin B-lymphoid malignant lymphoma, follicular, grade 3 ¦ sec WHO "". ... Hematology ... 847% of B lymphocytes have large lesions (FSC +++) ... Conclusions: flow cytometric pattern compatible with localization of large cell B lymphoma. à Medullary biopsy: cytological picture free from infiltration, compatible, with medullary hypoplasia with prevalent aspects affecting the erythroid seriesà Lymph node biopsy: morpho-phenotype picture compatible with localization of non-Hodgkin B-lymphoid, follicular malignant lymphoma, grade 3 ¦ sec. WHO (immunophenotypic profile: CD3-, CD20 +, CD10 +, CD21-, CD23-, Bcl2-, Bcl6-, cMyc - / + (15%), MUM1-, CD5-, EBV-; Ki67 proliferation antigen 80%). à Microscopic description. Iliac crest bone marrow: biopsy needle frustule of hypercellulated osteomedullary tissue with the presence of interstitial infiltration and, predominantly. Diffuse (70%) of small and medium-sized B-lymphoid elementsà with medullary localization of the lymphoproliferative neoplasm known in the anamnesis (follicular NHL grade 3, leukemized). June 26, 2021 begins to walk safer, always with the help of the walker 05 July 2021 PET 07 July 2021 she can no longer walk, even with the help of a walker: bedridden July 14, 2021 hematology: check after lymph node biopsy: they insist on chemotherapy without saying what the patient has. In the letter to the attending physician: ""Conclusions: Non-Hodgkin B-lymphoid, follicular malignant lymphoma, grade 3 ¦, st IV (marrow), IPI High."" July 15, 2021 PET outcome 19-22 July 2021 discussions on chemotherapy July 21, 2021 should have entered the PICC to do chemotherapy. July 30, 2021 request for home palliative care: never had: the doctor is on vacation and no one replaces him. 03 August 2021 CBC: thrombocytopenia 07 August 2021 last full meal: from now on only a few bites in free fall 11 August 2021 at 11:00 (after heated discussions with the doctor for not being admitted to the Hospice) they give her morphine 40 mg / 24h 12 August 2021 at 15:00 dead"" "1689377-1" "1689377-1" "Case fully vaccinated with Pfizer. Last dose on 3/4/21. Tested positive for COVID on 8/11/2021. Admitted to Community Hospital East on 8/16/2021. Expired on 8/27/2021 while still hospitalized." "1689378-1" "1689378-1" "Patient admitted on 8/10/2021 with acute respiratory failure secondary to COVID pneumonia. She was COVID positive on 7/22/2021 following a family gathering. She had been hospitalized for 3 days previously (8/4 - 8/7/2021) and seen in the ED on 8/8/2021. This current admission, she was intubated and required high dose dexamethasone. After 20 days, she was converted to comfort care and compassionate extubation was performed. She passed away comfortably soon after this." "1689405-1" "1689405-1" "Case fully vaccinated with Pfizer. Last dose on 2/24/2021. Tested positive for COVID 19 on 08/31/2021. Admitted to Hospital on 8/31/2021. Expired on 9/7/2021 while still hospitalized." "1689428-1" "1689428-1" "This patient presented to the emergency department with shortness of breath, cough, fevers, and generalized weakness. Patient tested positive for COVID-19 on 8/28/2021 and was hospitalized for 4 days until she ultimately expired after experiencing a NSTEMI during admission." "1689447-1" "1689447-1" "Pt came to ER c/o cough, difficulty breathing." "1689485-1" "1689485-1" "Breakthrough COVID-19 case with Muscle or body aches, and Cough (new onset or worsening of chronic cough). Hospitalization 7/30/2021. Death due to COVID-19 8/3/2021" "1689508-1" "1689508-1" "Patient hospitalized and died due to COVID-19. Patient was fully vaccinated. Primary cause of death: Acute hypoxic respiratory failure from COVID-19 pneumonia." "1689524-1" "1689524-1" "Pt. contracted COVID 19 and passed away." "1689538-1" "1689538-1" "developed symptoms on 08/04/2021 and was admitted to the ICU on 08/09/2021 Patient expired on 8/24/2021" "1689555-1" "1689555-1" "Presented to MC on 8/12 with progressive SOB, weakness and fatigue. Previously diagnosed with COVID. Evidence of sepsis and pneumonia with increased O2 support. Given remdesivir, dexamethasone and broad spectrum antibiotics. Due to long stay her isolation was discontinued and got first vaccination for COVID on 8/31. On 9/2 experience recurrent respiratory decompensation. Again treated with steroids and antibiotics for pneumonia as well as dialysis. Respiratory status continued to decline and patient requested DNR/DNI with family agreeing to comfort care." "1689572-1" "1689572-1" "Patient was admitted from ED due to 1 day history of shortness of breath and altered mental status. Pt was intubated upon arrival to ED and later admitted to ICU. Pt had a hx of COPD, CKD3, hypertension, obesity, and was a former smoker. Pt was admitted to Hospital on 08/06/2021 and expired on 08/19/2021. Patient was fully vaccinated." "1689574-1" "1689574-1" "Patient is fully vaccinated for Covid and later was hospitalized and died. Case son suspects case may have gotten it during a hospital visit July 30th after collapsing and hitting his head. Only close contact was case's son and wife, but he did not want to be contacted by contact tracers, almost through with quarantine." "1689598-1" "1689598-1" "Patient passed away on 09/03/2021" "1689608-1" "1689608-1" "COVID-19 Breakthrough case. 8/20/21: Patient states he has had COVID like symptoms for almost 2 weeks now and had an outpatient positive COVID test 9 days ago on 8/11/2021. He states he has had symptoms of a productive cough, worsening shortness of breath, chest congestion, some diarrhea, subjective fevers and chills that have now resolved. He states at baseline he has some shortness of breath but since testing positive for COVID, SOB has been worse than his baseline. He states he had a Regeneron treatment 2 days ago but does not believe his symptoms are any better. Admitted 8/20/21. Note: previously received Moderna COVID-19 vaccines on 12/29/21 & 1/26/21. Diagnosed with ARDS, acute hypoxic respiratory failure, Covid-19 viral pneumonia and sepsis. Condition deteriorated and patient died on 8/29/21." "1689610-1" "1689610-1" "Patient received 2nd dose of Pfizer vaccine on 07/22/2021. Patient participated in weekly testing at hospital and tested positive for COVID-19 on 08/26/2021. Symptom onset of a low grade fever also started on 08/26/2021. Patient received Regeneron treatment and then passed away on 09/08/2021." "1689846-1" "1689846-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/27/2021, 2/21/2021, and 8/25/2021. Presented to ED on 8/31/2021 with malaise, low-grade fever, and feeling lightheaded. His daughter was recently diagnosed with COVID and had been quarantining. Patient admitted for acute hypoxic respiratory failure secondary to COVID PNA. Initially required BiPAP, but able to be weaned off. Patient transferred to ICU 9/4 due to increased work of breathing and increased oxygen requirements. Hospital course complicated by worsening hypoxic respiratory failure requiring emergent intubation 9/8 overnight. Pt with a total of 2 cardiac arrests overnight. PEA Arrest on 9/9/2021 @ 0658. Patient converted to DNAR/COT per family wishes and patient expired at 0750 on 9/9/2021. Patient treated with dexamethasone, remdesivir," "1689932-1" "1689932-1" "Transferred from another hospital. Presented there on 7/14/2021 with shortness of breath. While at outside hospital (OSH), pt with BP of 103/54, HR of 65, RR 20. Upon presentation there, pt with oxygen saturation of 77%. He was started on Optiflow with 25 L at 85%; pt now with spO2 of 91%. Pt had elevated D-dimer, so CT angio chest done. It showed multifocal pneumonia; no PE. He had nl trop and EKG. Pt was given Azithromycin and Decadron while there. Request for transfer made given pt's need for Optiflow. When received at our hospital, patient was resumed on dexamethasone, started remdesivir, ceftriaxone and doxycycline. He continued to have acute hypoxemic respiratory distress requiring mechanical ventilation. Developed septic shock was requiring pressors had low blood pressure and was found to have septic shock from COVID pneumonia, with superimposed likely Gram-negative bacterial infection. received Steroids, Rocephin, doxycycline, remdesivir. Received 1 dose of Actemra. Course complicated by rhabdomyolysis, new onset atrial fibrillation. Passed away on 8/16/2021" "1690161-1" "1690161-1" "Patient passed away on 05/06/2021, 16 days after the first Pfizer injection. He was a healthy 34 year old. Autopsy report showed no organ or other physical abnormalities. The autopsy report stated his cause of death was an hemopericardium (acute dissection of proximal thoracic aorta / fatal cardiac tamponade / rupture into pericardial sac)." "1690543-1" "1690543-1" "Female was well, alert, on no medications, active with family. Then just fell to the floor , was sweaty and drooling, taken to the ER. Tests revealed massive stroke and heart attack. Due to clot. No chance of recovery, no ability to gain speech or function was incubated and on a sedative. She was taken off life support 2 days later and passed away on 8/5/21" "1692895-1" "1692895-1" "Breakthrough case on 9/8. Unfortunately passed from cardiac arrest on 9/11/21" "1692936-1" "1692936-1" ""complained of ""inflamed bowels"" on May 14,2021 then shortly expired that day."" "1693148-1" "1693148-1" "Death Patient was being prepared for discharge. Found pulseless in room around 1845 which was roughly 3 hours post vaccination. Additional therapies given during ED stay were IV fluids and IV acetaminophen. ACLS initiated and continued for ~45 minutes. Time of death called at 1928" "1693272-1" "1693272-1" ""Patient verbally reported to me (spouse) that since receiving the vaccine he would have on and off ""weird"" feelings in his chest at times. He never sought medical attention for this particular issue despite his medical history. He received his first dose of the Pfizer - BioNTech vaccine on 03/25/2021 Lots number EP6955. Second dose was as noted on 04/15/2021 Lot number EP0153"" "1693366-1" "1693366-1" "Death" "1693704-1" "1693704-1" "The decedent was found deceased at home on 05/23/2021. The decedent's cause of death is acute fentanyl toxicity. The pathologist found blood clots in her lungs during autopsy, and she was concerned the blood clots may be related to the vaccine she received on 05/08/2021." "1693771-1" "1693771-1" "weakness, SOB, takotsubo cardiomyopathy , acute systolic heart failure, acute hypoxemic respiratory failure pt expired" "1694105-1" "1694105-1" "PATIENT EXPIRED ON 09/02/2021" "1694121-1" "1694121-1" "PATIENT EXPIRED ON 09/05/2021" "1694228-1" "1694228-1" "Tested positive for COVID-19 on 8/14/21 via PCR; Admitted to hospital on 8/16/21;" "1694248-1" "1694248-1" "Tested positive for COVID-19 on 9/5/21 via PCR; Admitted to hospital on 9/5/21; Died on 9/10/21." "1694281-1" "1694281-1" "death" "1694308-1" "1694308-1" "Surgery was done at on 5/19/21 to replace her aortic valve. While other complications came up, all of the fixes worked. Everything was repaired. My Mother?s blood would not clot. They were unable to close her following surgery. They tried again over night to stop the bleeding but her blood would still not clot. She had stopped all of her blood thinning medications days earlier than suggested prior to surgery. She died the next morning. Had her blood clotted I believe she would be here today. I believe her blood did not clot because of her two doses of this vaccine." "1694393-1" "1694393-1" "hypoxic respiratory failure, CVA, MI, UTI, Death" "1694414-1" "1694414-1" "Pt succumbed to COVID-19 virus on 9/12/2021 after being diagnosed on 8/28/21." "1694456-1" "1694456-1" "Within 3-4 hours was having mild side effects such as fatigue, soreness. The next 2 days his symptoms became more severe with nausea, chills, diarrhea. The 2nd day he developed a blood clot in his stomach and died as a result." "1694459-1" "1694459-1" "Hospitalization and death. From vital records: CARDIORESPIRATORY FAILURE, HYPOXIA, COVID-19 PNEUMONIA, Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: None listed" "1694567-1" "1694567-1" "Pt.'s sister states that after receiving the 2nd dose of Phizer 06/24/2021, Pt. passed away suddenly 08/21/2021. Unknown Autopsy preformed." "1694568-1" "1694568-1" "pulmonary embolism" "1694602-1" "1694602-1" "Dose 1 Pfizer 2/26/2021 lot # EN6205 Pt had a cardiac arrest at home 9/7/2021, died in the Emergency Room on 9/7/2021. Not a Covid related death." "1694624-1" "1694624-1" "Lot numbers not available for vaccines. Pt died on 9/12/2021 of aspiration pneumonia and respiratory failure. This is not a covid related death" "1694644-1" "1694644-1" "Breakthrough COVID-19 case with symptom onset 7/19/2021: Fever >100.4, Chills, Muscle or body aches, Runny nose/Congestion, Sore throat, Cough (new onset or worsening of chronic cough), Shortness of breath or difficulty breathing, Fatigue or tiredness, Headache. Death 7/31/2021, from vital records: CARDIAC ARREST, COVID 19 POSITIVE, Per vital records, Other Significant Conditions include: HYPERTENSION. place of death: HOSPITAL-EMERGENCY ROOM/OUTPATIENT." "1694645-1" "1694645-1" ""HOSPITAL COURSE: This is a 66-year-old male with history of hep C cirrhosis, BPH with chronic retention, methamphetamine/tobacco/PTSD/homelessness, mesothelioma and non-small cell carcinoma of the lung s/p chemo/XRT, and middle lobectomy/thoracotomy at medical facility in 2013. He had a hospitalization in July 2020 where he was noted to have recurrent pulmonary malignancy, but was not a surgical candidate. He was counseled to discharge to Transitional Care but he instead requested discharge to the street. He repeated has declined appropriate care when in the hospital, and he has repeatedly left the hospital against medical advice and without appropriate follow-up plan in place. He was interviewed by Dr. on 7/2 who documented fixed delusions but capacity to make his own medical decisions, feeling patient's interpretation of facts ""did not appear to be unduly influenced by delusion"". I discussed the patient's care with admitting physician, and we agreed that in the combination of social and medical chaos, and noting a prior decision by another Dr. not to proceed with surgical intervention of a pulmonary mass, that heroic resuscitative efforts would be futile, and patient should be limited code - no compressions or intubation. Dr., palliative care, reviewed chart and also agrees that No Code is appropriate. On the last day of hospitalization, September 8, 2021, this patient was seen and examined at the bedside and he was comatose and did not respond to voice, touch, or a sternal rub. For maintenance of an adequate blood pressure this patient was on a maximal dose of vasopressin at 20 mL/h. This patient was noted with severe acute kidney injury on admission and on the day of discharge his sodium was 139, potassium 5.6, BUN 144, and creatinine 5.22. This patient was seen in consultation by the nephrology service but his blood pressure was too low to allow hemodialysis. If the patient's white blood count was 16.7 on the day of discharge. Total bilirubin was elevated at 3.7, AST 49, ALT 74, and serum albumin was low at 1.4. Blood cultures on admission September 4, 2021 were positive for Streptococcus pneumonia a and Staphylococcus hominis. This patient was receiving appropriate IV antibiotic therapy during this hospitalization. The patient again was comatose and given the constellation of the severe end organ damage in the setting of severe sepsis the patient was subsequently transitioned to comfort care and end-of-life care. I discussed this case with Dr. with the nephrology service and Dr. with the palliative care service and we all agreed that a transition to comfort care was the best treatment plan for this patient. In the morning on September 8, 2021 I did not renew the patient's treatment with IV vasopressin and I discontinued all IV antibiotic therapy. Telemetry was also discontinued. IV morphine and IV Ativan were ordered for treatment of pain and anxiety respectively. This patient subsequently expired at 12:45 PM on September 8, 2021. I was unable to make contact with any family members or any possible DURABLE POWER OF ATTORNEY for this patient. The mortuary on duty was contacted this afternoon. This patient was pronounced expired on September 8, 2021 at 12:45 PM."" "1694688-1" "1694688-1" "This case meets vaccine breakthrough criteria . PT ADMITTED FOR EVALUATION OF MELENA, CONFUSION, COUGH, BACK PAIN. PT PASSED AWAY 9/13/21" "1694705-1" "1694705-1" "Breakthrough COVID-19 case. Symptoms started 8/3/2021: Fever >100.4, Muscle or body aches, Cough (new onset or worsening of chronic cough), Chest pain, Hospitalized for unknown duration. Death. From vital records: COVID-19, PNEUMONIA, ACUTE RESPIRATORY FAILURE, Per vital records, COD ICD Codes include: Not yet coded; Other Significant Conditions include: N/A, place of death: HOSPITAL-INPATIENT, MEDICAL CENTER; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: MACHINE ADJUSTER, MANUFACTURING" "1694712-1" "1694712-1" "cough, hx of diabetes, long term immunosuppression; positive COVID test, pneumonia" "1694755-1" "1694755-1" "Admitted to medical center 8/25/2021 on the COVID unit. Moved to ICU on 9/4 and intubated. Extubated on 9/12 and expired" "1694787-1" "1694787-1" "patient tested postive for covid and hospitalizied on 09/07/2021 . Patient expired 9/11/2021. unable to complete section 21 for patient died will not allow me to enter date." "1694810-1" "1694810-1" "Patient initially developed symptoms of COVID on 8/10 with + test on 8/15. Patient was previously admitted from 8/17- 8/23 at hospital for COVID pneumonia and acute hypoxic respiratory failure. Was treated with steroids, remdesivir and antibiotics. Discharged home on oxygen , steroids and antibiotic. Returned to hospital on 8/25 due to hypoxia despite home oxygen. O2 sats on arrival at 80% and placed on Vapotherm with improved oxygenation. Chest xray showed worsening bilateral multifocal pneumonia. Required intubation and mechanical ventilation on 8/28. Found to have pulmonary embolism throughout lungs and evidence of right heart strain on CTA on 8/30. Started anticoagulation with heparin. Acute worsening of chronic kidney disease and started on CRRT and levophed. Due to continued deterioration family decided on comfort care on 9/11." "1694811-1" "1694811-1" ""Patient reported being vaccinated with Moderna. However I was unable to find record of this vaccination. Admitted on 08/20/21 with COVID, acute respiratory failure, CKD stage 5, and possible UTI. Discharged on 08/23 but readmitted on 08/25 for worsening symptoms. Patient placed on high flow without improvement. Patient experienced 2 ""code"" events on 09/03 and expired."" "1694851-1" "1694851-1" "Patient presented to the hospital on 9/1/21 with weakness and dizziness. The patient developed a cough around 9/5/2021, although the patient stated that is a chronic cough. The patient had a fever on 9/6/2021 of 100.2. On 9/10/21 she tested positive for COVID. Her maximum Oxygen requirement was 5L on 9/10/21. On 9/12 the patient expired." "1694955-1" "1694955-1" "HOSPITALIZATION AND DEATH RELATED TO COVID-19 AFTER BEING FULLY VACCINATED" "1695504-1" "1695504-1" "Brief Hospital Course: # Acute Hypoxic Respiratory Failure 2/2 COVID-19 Pneumonia - vaccination status: Janssen - COVID-19 + on 9/4, out of isolation on 9/19 - continue dexamethasone 6mg x 10 days, final day 9/12 - completed remdesivir x5 days - albuterol HFA 2p q4-6hr prn cough, wheeze, SOA - Wean O2 as tolerated, titrate to goal saturations >88-90% - guaifenesin, benzonatate, APAP prn - Therapeutic Anticoagulation (PMID: 34351721) with heparin gtt, though lost IV access overnight and renal function precludes use of other agents - pulmonology following - being treated for CAP with azithro + ceftriaxone - on 9/11, discussions with family lead to decision to transition to comfort measures only. Patient died at 2020 PM on 9/11/2021" "1695753-1" "1695753-1" "Admitted with severe COVID19 on 9/10/2021 and subsequently declined and deceased on 9/11/2021" "1696049-1" "1696049-1" "symptomatic as of 07/30/2021 with cough and diarrhea - reports COPD, chronic anemia, ischemic cardiomyopathy, and hypertension - admitted to hospital on 07/24/2021, discharged 07/30/2021 - returned to nursing home and placed on COVID unit to isolate - fully vaccinated, Pfizer, 01/12/2021, 02/02/2021 - other positive residents and staff at facility - expired under hospice care on 08/05/2021" "1696066-1" "1696066-1" "Patient hospitalized and died due to COVID-19. Patient was fully vaccinated." "1696115-1" "1696115-1" "Patient hospitalized and died due to COVID-19. Patient was fully vaccinated." "1696131-1" "1696131-1" "Patient presented to ED from local nursing facility with shortness of breath, fever and cough. Patient had CK D stage III, anemia, hyperlipidemia, hypothyroidism, hypertension, hypercalcemia, and hypernatremia. Patient is fully vaccinated. Patient died." "1696195-1" "1696195-1" "PT EXPIRED ON 09/09/2021" "1696219-1" "1696219-1" "Daughter called on 9/13/2021. Reports patient began having palpitations the day after the vaccine. She thought the palpitations was due to anxiety and did not wish to go to the ED. She had a friend who was passing away and she was slightly upset. She continued to have some symptoms. On 3/28/2021, she passed away." "1696271-1" "1696271-1" "Pt had vaccine on 9/9. Four days later he presented at local emergency room with blood clots in both legs. He died at the hospital the same day." "1696273-1" "1696273-1" "Pt sent to ER via EMS for AMS and hypotension, cool to touch." "1696293-1" "1696293-1" "Pt came to ER for jaundice on 2/23. Seen in ED again on 2/27 for weakness and fatigue." "1696347-1" "1696347-1" "Patient is fully vaccinated and died due to COVID related causes. According to patient's wife, he presented to hospital with sinus problem runny nose and congestion headache two days before the 8/21 and on 08/21/21 he became Lethargic and had a unsteady Gait prior to testing. Believe contracted Covid from church. Patient died nine days later." "1696376-1" "1696376-1" "Patient fully vaccinated and died of Covid related causes. The patient had shortness of breath, cough, and pneumonia. She was admitted to hospital where she passed away." "1696378-1" "1696378-1" "COVID pneumonia, progressed to ARDS, severe encephalopathy" "1696394-1" "1696394-1" "SOB WITH HOSPITALIZATION AND DEATH" "1696431-1" "1696431-1" "COVID INFECTION WITH HOSPITALIZATION AND DEATH WHILE FULLY VACCINATED" "1696480-1" "1696480-1" "Covid positive week prior to admission, SOB, central line placement, intubation, vasopressors, patient expired" "1696501-1" "1696501-1" "Received the the 1st Pfizer COVID vaccine on 08/12/2021 and the 2nd Pfizer COVID vaccine on 09/02/2021. The Decedent's wife had told Police that the Decedent was complaining about not feeling well ever since he got the 2nd vaccine. 09/12/2021 -- Decedent had an Asthma attack at 0400 hours. Per the Decedent's wife, the Decedent did at least 10 Albuterol and Nebulizer treatments before calling for an ambulance at 1857 hours. While in the ambulance, the Decedent went unresponsive and then into Cardiac Arrest. EMS started CPR & ACLS procedures, and worked the Decedent for 1 hour before calling Time of Death at 2015 hours." "1696534-1" "1696534-1" "Moderna vaccines given on 1/5/21 and 2/1/21 at long term care facility. Patient tested positive for COVID on 8/22/2021. Patient died on 9/6/21 with cause of death documented as sudden respiratory arrest and COVID 19." "1696550-1" "1696550-1" "Breakthrough COVID-19 case. Asymptomatic. Hospitalization 7/23/2021-7/26/2021. Death on 7/26/2021. From Vital Records: COD = COVID 19 PNEUMONIA. was in hospice then transported to hospital where he died. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: DEMENTIA HEART DISEASE. Place of death: HOSPITAL-INPATIENT, ; certified by: PHYSICIAN; occ/ind." "1696554-1" "1696554-1" "Patient was recently hospitalized for left BKA from 7/19-8/27 and transferred to rehab. Patient coded and passed away on 9/01. Death doesn't not seemed attributed to vaccine based on patient's PMH." "1696571-1" "1696571-1" "Pt came to ER with confusion, nausea, fever one week prior, loss of appetite, on/off pressure to chest." "1696588-1" "1696588-1" "Admit date: 9/11/2021 Date of Death and Time: 09/13/21 at 12:05 Admitting Physician: Physician: Admission Diagnoses: Hyperkalemia [E87.5] Lactic acidosis [E87.2] Hypotension [I95.9] SIRS (systemic inflammatory response syndrome) (CMS/HCC) [R65.10] AKI (acute kidney injury) (CMS/HCC) [N17.9] Septic shock (CMS/HCC) [A41.9, R65.21] Left lower quadrant abdominal pain [R10.32] Diagnoses at Time of Death: Septic shock Acute kidney injury on CKD SARS-CoV-2 infection Acute hypoxemic respiratory failure History of atrial fibrillation History of hypertension Morbid obesity Diabetes mellitus History of hypothyroidism Admission Condition: critical Indication for Admission: Hospital Course: Patient was admitted with abdominal and back pain, cough and hypoxia. Documented to be hypotensive at the emergency department with evidence of worsening creatinine and hyperkalemia. CT imaging demonstrated peripancreatic, duodenal stranding with mild rectal wall thickening and vascular calcifications. Patient required vasopressors through central venous catheter as well as broad-spectrum antibiotics. She was known to have chronic kidney disease with new acute kidney injury, was treated with bicarbonate, calcium gluconate. Patient had worsening of her respiratory status and required bilevel positive airway pressure. She changed her CODE STATUS to DO NOT RESUSCITATE after admission. Was seen by nephrology with a recommendation for continued dialysis, started after placement of temporary dialysis catheter. Patient had worsening mental status becoming minimally responsive. Had progressive deterioration with increasing requirements for hemodynamic support, at some point on maximal dose of norepinephrine and phenylephrine. Testing was positive for SARS-CoV-2 for which she was treated with dexamethasone She continued to have deterioration of her overall status, hypothermic, acidemic, with severely elevated creatinine, anuria, dependent on noninvasive ventilatory support. This was discussed with her POA who mentioned that patient would not want to depend on artificial life-sustaining measures. A decision was made to change focus of care to comfort and aggressive management was discontinued Patient was pronounced deceased on September 13, 2021 at 12:05 PM Consults: Critical Care Nephrology Pulmonary and Critical Care Medicine" "1696621-1" "1696621-1" "Patient fully vaccinated and died of Covid related causes. According to patient's daughter, her father was taken about 1 month ago with symptoms, waited 12 hours in the waiting room, was diagnosed with pneumonia, negative for Covid and returned. Symptoms worsened 1 to 2 weeks later on 08/24/2021. Was taken to ER and finally admitted to a room. Tested positive for Covid and isolated. Patient died about five days later." "1696626-1" "1696626-1" "Admitted to hospital 8/30 c/o Can't breath. Started on Nasal cannula at 4 L/min. 9/2 60 L/MIN heated high flow. 9/3 BIPAP. Expired 9/12" "1696633-1" "1696633-1" "Received his first COVID vaccine on Saturday September 4th. He complained to family about feeling ill afterwards. He was found deceased on 9/8/2021." "1696698-1" "1696698-1" "Patient passed away on 7/28. Previous to this, he was COVID positive on 7/21 which he believes he got from his wife. Patient did have symptoms." "1696718-1" "1696718-1" "Breakthrough COVID-19 case with symptom onset 8/17/2021: Cough (new onset or worsening of chronic cough) and Shortness of breath or difficulty breathing. Hospitalized from 8/24/2021-8/25/2021. Died 8/25/2021." "1696737-1" "1696737-1" "PATIENT DEVELOPED ACUTE RESP FAILURE WITH HYPOXIA 2ND TO COVID PNEUMONIA, AKI," "1696749-1" "1696749-1" "Breakthrough COVID-19 case with symptom onset 7/20/2021: Muscle or body aches, Fatigue or tiredness, Nausea or vomiting. Living in a nursing home at time of positive COVID test. Death 08/12/2021" "1696783-1" "1696783-1" "09/04/2021 The patient presents with 1 week hx of of worsening shortness of breath. Per EMS, pt was evaluated at his PCP at onset due to viral symptoms. Pt was diagnosed with an URI and prescribed with antibiotics, ceased administration of at home medication. Pt was evaluated today by nurse at Assisted Living and was noticed to be experiencing increased shortness of breath. At arrival, EMS found pt on 82% room air. At ED bedside, pt has been experiencing shortness of breath with cough, nausea, and abdominal pain. Pt denies vomiting, fevers, chills, chest pain, diarrhea, and all other symptoms. Pt has recieved the COVID vax" "1696788-1" "1696788-1" "pt presented to the Medical Center on 9/2 in respirator Distress pt placed on bipap, later intubated pt expired on 9/10/21 @ 1432" "1696796-1" "1696796-1" "08/31/2021 The patient presents with SOB, worsening 3 days ago. Pt tested positive 3 days ago for COVID 19 and note symptoms beginning 1 week ago. He arrived to ED in severe respiratory distress respiratory distress.. The onset was just prior to arrival. Patient is an 83 y/o male admitted to hospital on 8/31 after presenting to ED for evaluation of shortness of breath. He was found to have acute hypoxic respiratory failure secondary to COVID-19 pneumonia, quickly failed BiPAP and was intubated and proned in ED. He had SVT x2 episodes in ED requiring electrical cardioversion each time 100J. Started on levophed gtt after CVC placed in ED. Received bicarb IVP x3 + gtt." "1696812-1" "1696812-1" "The patient presents with 8 day hx of viral symptoms. Pt reports to have been experiencing fevers, chills, cough, shortness of breath, myalgia, headache, nasal congestion, rhinorrhea, and headache. Recent sick contacts and COVID-19 exposure. Has administered with over the counter cold medicine. Denies all other acute systemic symptoms. The onset was 8 days ago. Associated symptoms: fevers, chills, cough, shortness of breath, myalgia, headache, nasal congestion, rhinorrhea, and headache, denies chest pain, denies abdominal pain, denies nausea, denies vomiting, denies dizziness and denies back pain." "1696820-1" "1696820-1" "Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/6/2021 and 3/27/2021. Patient was recently hospitalized for COVID-19 from 8/23/2021 to 8/26/2021. Patient presented to ED on 8/27/2021 due to repeated hypoxia. Dexamethasone and cefuroxime was administered. Throughout hospitalization, patient had significant change in mental status and continued weakness. Palliative care was consulted on 9/4/2021 and patient expired at 06:37 on 9/8/2021." "1696821-1" "1696821-1" "My husband and I both tested positive for Covid-19 after receiving the vaccine. He started to have symptoms like a cold, and it was like sinus symptoms. I also had sinus symptoms. He was prescribed Azithromycin and when it was gone a fever broke out. My husband throat was sore. He was admitted to the hospital and waited for a room for 24 hours. He was admitted directly to the Covid-19 ICU. He was tested again after being admitted on 07/10/2021 and he died on 08/06/2021. He had improved and he was supposed to come home and then I got a call that he had been intubated. He got Pneumonia after being on a ventilator. He lived for two more weeks but then he passed away." "1696822-1" "1696822-1" "Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/27/2021 and 2/24/2021. Patient presented to ED on 8/14/2021 with complaints of shortness of breath. Medications administered: ascorbic acid, azithromycin, baricitinib, ceftriaxone, dexamethasone, epoprostenol, fluconazole, remdesivir, zosyn, vancomycin, and zinc. Throughout hospitalization patient continued to decompensate eventually requiring mechanical ventilation. Patient had brief episode of cardiac arrest. After family discussion, patient was taken off life support and expired on 9/9/2021." "1696824-1" "1696824-1" "Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/19/2021 and 2/2/2021. Patient was recently hospitalized for COVID 8/11/2021 to 8/17/2021. Patient presented to ED on 9/9/2021 with complaints of shortness of breath with increased oxygen requirements. Medications administered: levofloxacin and aspirin. Patient became unresponsive with no palpable pulse. Patient expired at 01:55 on 9/9/2021." "1696875-1" "1696875-1" "Patient developed ALS shortly after his vaccine. He passed away within 4 months. It is unclear whether or not there is any relation to his development of ALS and his taking the vaccine - other than the association of timing. His wife felt strongly that this should be reported." "1696895-1" "1696895-1" "Patient fully vaccinated and died of covid related causes. According to patient's wife, patient was in critical care at the hospital and also had cancer. Patient's wife says they haven't went anywhere except for their oncology visit on 8/2. Patient died 13 days later after admitted to hospital." "1696901-1" "1696901-1" "Hemorrhagic Stroke on 07/30/2021 died 08/03/2021" "1696910-1" "1696910-1" "Came to ER for confusion and possible low blood sugar on 7/29/21. Blood sugar 124 on arrival. Patient was lethargic and tested positive for COVID. Stable vitals temperature 99.7¦ 0 blood pressure 137/64 below pulse of 93 and 98% on room air. Also found to have acute metabolic encephaloprathy likely secondary to UTI and COVID19. Placed on ceftriaxone for UTI . During her stay she developed acute hypoxic respiratory failure, requiring opti-flow 90% and 60L. Likely from COVID pneumonia. Placed on dexamethasone and remdesivir. Required precedex for BP. Patient went comfort and passed away on 8/25/2021" "1696937-1" "1696937-1" "Patient hospitalized due to COVID-19. Patient is fully vaccinated. Placed on BiPAP in hospital and moved to ICU. Patient died due to COVID-19." "1697220-1" "1697220-1" ""She heard media urge all at-risk to get the booster (before they changed their stance later). She immediately went out and got it, her 3rd Moderna. It was a big reaction for her. I became aware after she called me to tell me how bad she felt. Several days of feeling very beaten down, fatigued and ill. She kept hydrated, though, and was able to start eating, and seemed to be getting better. Day 9 I talked with her, she was tired by up and about, and thought she was getting better. Morning of day 10, my wife got the alert call, rushed over, confirmed to them that it was a 911 for real. I rushed over and held her upright while ambulance was enroute. She was having trouble breathing, couldn't get enough (couldn't get enough) air in her lungs. She said to me: ""This could be it. I've had a good life."" But she was on the road to being a centenarian, riding her exercise bike regularly, an iron-clad diet to keep her diabetes in check, etc. She had multiple cardiac arrests enroute and in the emergency room. While stabilized with extreme blood thinners, (suspected Pulmonary embolism confirmed by ultrasound), they took her for a scan, where they found MULTIPLE pulmonary embolisms in BOTH lungs. She died less than an hour later, even on the breathing machine with a team of attendants. She wanted to not be a burden on the medical resources and I checked with them during this event and they said they had the capacity and that she was the sickest person in the hospital by far, 'we have the resources now'. I signed the DNR after the (I think) 4th cardiac arrest to stop them from shattering more bones in her torso, about an hour before she died. She was intubated the whole time in the hospital."" "1697353-1" "1697353-1" "Complained of feeling very fatigued in the weeks following following the vaccination, but was heathy prior to the injection. Died of a massive heart attack exactly 3 months after the date of vaccination. Death certificate notes Atherosclerotic Cardiovascular Disease as the immediate cause of death." "1697379-1" "1697379-1" "On 5/19, there were two lumps grew on his left neck. He visited his family doctor on 6/2, and some exams were done. He got the exam report on 6/3. It showed that his hemoglobin dropped to around 12, and he is severely dehydrated. Second Covid shot on 6/6/2021, 2 weeks later, he couldn't walk any more due to weakness and pain, around 6/21/2021. He went to the family doctor on 7/7, and did more test. His hemoglobin dropped to around 11 as the result showed on 7/8. He was sent to the emergency room at Hospital on 7/14. He found 1 lump in his brain and he was admitted to the hospital immediately. He was diagnosed lymphoma. There was no treatment. He was transferred on 7/15. They found 3 lumps in his brain. There was no treatment. He was then diagnosed Goblet Cell Adenocarcinoma. He was then transferred on 7/15 at 3am. He had open skull surgery on 7/28, and there 7 tumors in his brain, 1 in his right eye, and numerous in his body. No treatment. He passed away on 8/19." "1697946-1" "1697946-1" "Day 2 after injection complaining of chest pain...day 3 went to urgent care was sent home, told she just needed rest. Day 5 heart attack rushed to hospital. Day 6 testing, Day seven heart surgury for blockage...doctors refused to discuss what blockage was...no prior heart, blood pressure issues or cholesterol issues. Day 7 in recovery up and walking due to be released in 48 hours...Day 8 recovering then at 9pm suddenly full cardiac arrest unable to revive and died at 10:38 pm" "1700082-1" "1700082-1" "COVID ASSOCIATED DEATH; PT FULLY VACCINATED." "1700088-1" "1700088-1" "Case had covid vaccine x 2. Last dose on 1/15/2021. Tested positive for COVId 19 on 8/13/2021. Was admitted to medical center on 8/30/2021 with COVID Pneumonia. Case expired while still hospitalized on 9/9/2021." "1700089-1" "1700089-1" "COVID RELATED DEATH; PT FULLY VACCINATED" "1700097-1" "1700097-1" "COVID RELATED DEATH; PT FULLY VACCINATED" "1700103-1" "1700103-1" "Case fully vaccinated with COVID 19 vaccine. Dose #2 given on 2/5/2021. Tested positive for COVID 19 on 9/5/2021. Was admitted to Medical Center on 9/6/2021 and expired while still hospitalized on 9/14/2021." "1700162-1" "1700162-1" "Per medical records, patient has an underlying history of hypothyroidism, oropharyngeal cancer post chemotherapy who presented to the ER on 08/22/2021 with altered mental status and shortness of breath. Pt is also a former smoker. Pt was intubated in the ED on 08/22. Pt expired on 09/05/2021." "1700191-1" "1700191-1" "Minimal nursing notes were provided. Patient lived at Healthcare facility and died at their sister facility - Nursing and Rehabilitation." "1700218-1" "1700218-1" "Pt came to ER c/o fever, hypoxia." "1700221-1" "1700221-1" "Patient presented with symptoms of of URI, shortness of breath, dyspnea on exertion, diaphoresis, chills, and worsening cough. On arrival to ED, O2 sat noted to be 88%, rapid COVID test was positive, and patient was admitted for COVID-19 infection. Patient became fully vaccinated on 03/01/2021 (Moderna). On 08/14/2021, patient passed away due to COVID 19, Cellulitis, Septic Shock, and UTI" "1700248-1" "1700248-1" "COVID RELATED DEATH; FULLY VACCINATED PT." "1700284-1" "1700284-1" "Pt came to ER c/o difficulty breathing and cough. Onset 2 days prior." "1700296-1" "1700296-1" "COVID RELATED DEATH; FULLY VACCINATED PT." "1700305-1" "1700305-1" "acute on chronic respiratory failure secondary to COVID, hypoxic, SOB, weakness, in hospital from 08/01/2021 to 08/12/2012 then discharged to long term care facility where he passed away" "1700310-1" "1700310-1" "Patient was admitted to the hospital on 08/22/2021 with nausea, vomiting, and shortness of breath. Died on 08/23/2021" "1700329-1" "1700329-1" "Patient is a 18 y.o. male patient with a past medical history significant for lupus who presents with Pulmonary hemorrhage. About 2 days ago, pt developed fevers and worsening shortness of breath. T max 102 F at home. He did not note anything that relieved or exacerbated his difficulty breathing. He also reported fatigue, abdominal pain and several episodes of NBNB emesis the week prior to admission. No recently chest pain, diarrhea, hematuria, dysuria, headache or neck stiffness. Pt presented to ED yesterday and was treated with antibiotics and discharged, he came back today due to worsening shortness of breath. Of note, pt was had 2 hospital admissions in the last 2 months, most recently for febrile neutropenia. Completed 2 doses of COVID vaccine. At ED, pt arrived with temp of 39.1, HR 143, RR 28, BP 117/67, SpO2 98% EKG with sinus tachycardia, no ST elevations/depressions or other acute ischemic changes. CXR revealed diffuse bilateral airspace opacities without pneumothorax. CBC 10.6>8.1/27.4<203, CMP 137/3.9/110/22/18/0.58<99, Ca 7, Alb 1.5, AST 15, ALT 86. UA negative for infection, no protein. CXR with progressive diffuse bilateral airspace opacity with air bronchograms, no pneumothorax. Cultures obtained. Pt was treated with vancomycin, cefepime and levofloxacin for sepsis and concern for pneumonia and given IV fluids per ED sepsis protocol. He was also given Solumedrol 1g. Less likely COVID given vaccination status and negative COVID swab. Due to worsening tachycardia and hypoxia on oxygen, pt was intubated and bleeding in airway was noted. Pt was admitted to the ICU, and pulm crit care performed a bronchoscopy that revealed diffuse alveolar hemorrhage. Repeat CXR in ICU revealed almost complete white out of both lungs. Pt was bagged for almost an hour due to persistent hypoxia. Pt was subsequently transferred to CW due to concern for requiring VV ECMO. On arrival to CW CICU, pt satting low 70s, vent settings titrated and sats improved to 90s. He was continued on Epi, Norepi, Dexmed and Fentanyl. Rheum history: Lupus diagnosed on renal biopsy 7/21/21, on bactrim prophylaxis recently, recent treatment with rituximab, on daily prednisone 30 mg BID Parents spanish speaking. Patient is a 18 y.o. male patient with a past medical history significant for lupus who presents with acute hypoxic respiratory failure requiring mechanical ventilation, septic shock and pulmonary hemorrhage. It is unclear at this time if his pulmonary hemorrhage is related to lupus vs idiopathic process. COVID negative and fully vaccinated, making COVID pneumonia less likely. He is maintaining his MAPs on epinephrine and arterial sats in the 90s on SIMV PC PS. He is candidate for VV ECMO but does not require it at this time due to decreasing vent settings. Rheumatology consulted and large lab workup is underway. Plan to continue broad spectrum antibiotics, close monitoring of hemodynamics and to continue to watch for signs of recurrent pulmonary hemorrhage. Pt requires CICU due to risk of acute cardiopulmonary decompensation. Patient was an 18 yo man with Dx of lupus who presented to hospital (transferred from outside hospital) in respiratory failure due to pulmonary hemorrhage. Due to worsening hypoxemia in spite of mechanical ventilation he was started on VV ECMO. While on VV ECMO, he had a cardiac arrest due to right ventricular failure and was converted to VA ECMO. He also developed acute renal failure and was on CRRT. On 9/14, while on VA ECMO, he developed a massive MI due to occlusion of his LAD and circumflex coronaries. This heart injury was assessed as non recoverable and all further care was considered futile. After given time to the family to say their goodbyes, patient was removed from VA ECMO support and pronounced dead with his family at the bedside on 9/15/2021 at 7:30 am" "1700395-1" "1700395-1" "Hospitalization and death due to COVID-19" "1700415-1" "1700415-1" "DEVELOPED RESTLESS LEG SYNDROME, INSOMNIA, DOUBLE VISION, DIZZINESS WITHIN 3 WEEKS OF LAST SHOT. DIAGNOSED WITH A STROKE ON 05/24/21. WITHIN 24 HOURS OF DISCHARGE, SHE COULD NOT WALK PROPERLY AND HAD TO USE A CANE. RE ENTERED THE HOSPITAL ON 06/7/21 TO REHAB CONTINUED TO DECLINE WITH ADVANCED SYMPTOMS OF GAIT DIFFICULTY, MEMORY AND SPEECH PROBLEMS AND STILL INSOMNIA, ULTIMATELY BEGAN TO HAVE SEIZURES AND WAS INTUBATED AND SEDATED ON 06/21/21. TRANSFERRED TO HOSPITAL 9TH FLOOR NEUROLOGICAL ICU ON 06/25/21 AND BEGAN PROCESS OF DIAGNOSIS WITH A LUMBAR PUNCTURE. RECEIVED THE CJD DIAGNOSIS ON 07/14/21 AND SHE PASSED AWAY ON 07/17/21. MY MOTHER WAS COMPLETELY HEALTHY, WENT TO THE DOCTOR EVERY 6 MONTHS WITH GREAT CHECK UPS , WORKED OUT EVERY DAY, AND LOVED LIFE." "1700421-1" "1700421-1" "Patient presented to the ED on 08/10/2021 with reports of confusion and weakness. Patient was fully vaccinated. He died on 8/18/2021." "1700460-1" "1700460-1" "Patient was brought to ED due to shortness of breath, cough, and worsening confusion. He was hospitalized and died. Patient was fully vaccinated." "1700518-1" "1700518-1" "Patient here with acute hypoxic respiratory failure, improved with respiratory support via BiPAP. He is hemodynamically stable, awake and alert. He patient has voiced clearly to myself and to multiple nursing staff, Members at the bedside that patient would not wish to be intubated and placed on mechanical ventilation should his respiratory status further deteriorate. Patient had very little oxygen reserve with desaturations very quickly into the high 70s on room air when transitioned from stretcher into bed. He has no prior history of cardiac or pulmonary disease. Presentation highly suspicious for COVID-19, which was confirmed with diagnostic testing here today. Bilateral pneumonia noted on chest XR. Likely viral in nature. Patient presented to the emergency room at this facility by ambulance which had been summoned to his house by his sister whom happens to be a nurse practitioner. Apparently the patient had developed upper respiratory symptoms for the last 5 days or so and at his sister had called in the prescription for Zithromax and a Medrol Pak about 3 days ago. Apparently she went to check on him today and found him cyanotic. When EMS arrived to assess the patient they found his oxygen saturations to be 55% on room air. The patient was placed on a non-rebreather and improved to mid 80s and he was then placed on CPAP with improvement to the low 90s. Upon arrival to the emergency room he was placed on a BiPAP and he has remained stable in terms of oxygenation. Patient reports receiving 2 doses of Pfizer vaccine. He reported not being aware of sick contacts. I had received a call from reading radiologist the reported and small burden of blood clot in the right upper lobe of the lung besides findings compatible with pneumonia. Patient had also been found to be in atrial fibrillation with moderate ventricular response." "1700531-1" "1700531-1" "SOB, Sudden onset Atrial Flutter March 10 2021" "1700543-1" "1700543-1" "Patient Death" "1700557-1" "1700557-1" "Patient Died" "1700698-1" "1700698-1" "Pt came to ER c/o difficulty breathing and cough." "1700712-1" "1700712-1" "Patient presented to hospital in full trauma alert after motorcycle crash on 9/8. Intubated with subarachnoid hemorrhage with base skull fracture and multiple other fractures. Covid test +. No improvement with multiple trauma appropriate treatments. Family agreed with comfort care on 9/13." "1700738-1" "1700738-1" "Death" "1700765-1" "1700765-1" "Pt diagnosed with COVID-19 on 7/24/2021, succumbed to POST COVID INTERSTITIAL LUNG DISEASE" "1700768-1" "1700768-1" "Patient admitted on 08/26 diagnosed with COVID on 08/23. Presented to the hospital with sob, syncope and weakness. DX with COVID PNA, hypoxia, syncope and Afib RVR. also with a PMHx of MS and on fingolimod. Patient continued to decompensate and expired on 09/10/12" "1700774-1" "1700774-1" "Death. Presented to the emergency department with diffuse ST elevations concerning for myocarditis. His troponin was elevated at 113. His lactate was 14. He was in renal failure with a creatinine of 2.97, GFR 26. D-dimer was elevated at 1.25 without any obvious pulmonary embolism according to the CT. Upon presentation he was hyperventilating, not complaining of chest pain. Labs demonstrate a significant metabolic acidosis with a pH of 7.124, PCO2 of 15.4. O2 sat 96.8% on room air. Patient unfortunately went into cardiac arrest and was unable to be revived. Cause of death suspected to be myocarditis and cardiogenic shock In the setting of active COVID-19 infection." "1700799-1" "1700799-1" ""Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 4/7/2021. Patient had a preoperative COVID-19 screening test performed on 9/6/2021 that resulted positive. On 9/8/2021 patient requested telemedicine visit due to relentless cough interfering with sleep and hemoptysis. Also noted that wife and son are also COVID positive with symptoms. Patient was prescribed Casirivimab+Imdevimab which was administered on 9/10/2021, with a noted SpO2 of 98% on room air. On 9/13/2021 patient was transported to ED for evaluation of cardiac arrest. Patient had a witnessed arrest with CPR initiated while awaiting EMS. The treatment prior to presentation was 6mg Epinephrine, 450mg Amiodarone, 600 ml fluid, and 100 Fentanyl per EMS. The patient was shocked x2 before cardioverting. The patient was intubated by EMS. EMS states that the patient was taking a shower and started to feel ""crummy"" when he became unresponsive. This is when his wife started CPR and called EMS. Total CPR time per EMS was 30 minutes. Patient was initiated on therapeutic hypothermia and was unresponsive after his event. Unfortunately he experienced a recurrent cardiac arrest in the ER with Ventricular Fibrillation that was refractory to again prolonged CPR and resuscitative efforts. After prolonged efforts he was pronounced deceased in the ER by the ER physician on duty at 0354 on 9/14/2021."" "1700856-1" "1700856-1" "Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 5/22/2021. Patient was diagnosed with COVID-19 on 8/25/2021 with symptoms of nausea, vomiting, diarrhea starting on 8/24/2021. Per patient reoprt, she was admitted to a different facility for COVID-19 Pneumonia for two days. Patient did not require oxygen at that time. On 9/4/2021 patient presented to ED via EMS with complaints of shortness of breath. When EMS arrived patient was 55-70% on room air, was placed on a non-rebreather and came up to 88%, and was then placed on CPAP en route. Patient was admitted and started on dexamethasone and empiric ceftriaxone. On 9/10/2021, respiratory status" "1700861-1" "1700861-1" "Hospitalized and died. COVID-19 pneumonia. IV Remdesivir and Decadron; IV antibiotics, CCU, BiPap with setting of 16 over 10 with rate 12 and FiO2=80%; Severe sepsis; Acute kidney injury, cardiac arrest." "1700902-1" "1700902-1" ""Patient had no outstanding medical history but anxiety. Per her husband, patient rapidly declined since receiving the first dose of Moderna COVID19 vaccine on 9/2/21. Patient was seen falling to the ground and having a ""seizure"" and then becoming unresponsive on 9/14/21. EMS found the patient to be in ventricular fibrillation cardiac arrest. Patient was brought to ED with CPR in progress. At ED, 45 minutes of resuscitative effort was done without ROSC. Time of death called at 1504."" "1700908-1" "1700908-1" "Sudden inability to walk, Hospice was called in, they determined probably only had months to live. Stopped speaking and eating April 25, 2021, and passed away on May 1, 2021." "1703893-1" "1703893-1" "Death occurred 7 days after the second dose" "1703894-1" "1703894-1" "CASE DEVELOPED COVID19 AND DIED" "1703904-1" "1703904-1" "COVID RELATED DEATH; FULLY VACCINATED" "1703909-1" "1703909-1" "Patient received vaccine about 130pm on 9/16/21. After the vaccine, the patient waited in the pharmacy for 15 minutes to make sure she did not have a reaction. After that time, she went next door to the restaurant for lunch. About 7pm, the fire marshall came into the pharmacy requesting information about the patient. He was aware that she had just received the vaccine at our pharmacy and was inquiring because she went into cardiac arrest while at restaurant. After life-saving measures by EMT, patient was brought in to Medical Center and shortly after, passed away" "1703921-1" "1703921-1" "COVID RELATED DEATH; FULLY VACCINATED" "1703929-1" "1703929-1" "This is a 76-year-old Laotian male with reported cirrhosis of the liver, whom we are consulted on for septic shock. All history was obtained from the ICU RN & from the chart, given the patient is intubated. Was driving down to another State. He presented to the ER on 9/3 with generalized weakness and abdominal pain. In the ER, he was hypotensive & confused. CT C/A/P demonstrated cirrhosis of the liver & suspected gastric bleeding. GI was consulted for an EGD, however, the patient was too unstable to undergo endoscopy, hence this procedure had to be canceled. Initial Hgb was 9.7. Unknown baseline. He was transfused. Placed on pressors. He was intubated for respiratory distress." "1703941-1" "1703941-1" "DEVELOPED COVID19 (ONSET AND DETAILS UNKNOWN, LOST TO FOLLOWUP) AND DIED" "1703960-1" "1703960-1" "Bilateral leg pain, history of venous thrombosis." "1704016-1" "1704016-1" "presented with pneumonia due to COVID, respiratory failure, acute kidney injury, discharged to hospice where he died" "1704039-1" "1704039-1" "COVID RELATED DEATH; FULLY VACCINATED" "1704056-1" "1704056-1" "diagnosed with COVID on 8/11/21; went to hospital on 8/16/21 with SOB, weakness, fever, confusion; hx of chronic kidney disease, type 2 diabetes" "1704077-1" "1704077-1" "PALPITATIONS (HS OF A FIB), POSITIVE COVID TEST, ACUTE RESPIRATORY FAILURE" "1704104-1" "1704104-1" "presented to ED with weakness and hyperkalemia; admitted to hospital; positive COVID test on 8/24; bilat air space disease, condition declined" "1704111-1" "1704111-1" "Patient had known recent covid infection on 8/20/21. Admitted to hospital on 9/7/21 with SOB, abdominal distension and nausea, vomiting and diarrhea. Paracentesis was performed on 9/8 and 9/13 for continued abdominal swelling. Increasing need for 02 supplement due to swelling/volume overload. Chest xray worsening. Was being treated with combivent nebs and symibcort for COPD exacerbation and zosyn. Continued to decline with multiorgan compromise. Elected transition to comfort care and passed on 9/15." "1704209-1" "1704209-1" "presented to ED with hx of positive COVID test earlier in the week; mild SOB, cough, diarrhea; pneumonia COVID related; end-stage renal disease (hemodialysis 3xwk); fld overload" "1704228-1" "1704228-1" "positive COVID test on 8/19/21; presented to ED with generalized malaise, rhinorrhea, fever; acute hypoxic respiratory failure; acute renal failure superimposed on CKD stage 4" "1704256-1" "1704256-1" "positive COVID test 8/14/21; presented to ED from infusion center where she had been receiving antibody infusions since 8//18/21; complains of increasing chills, fever, cough, SOB, diarrhea; hx of diabetes mellitus type 2; acute hypoxemic respiratory failure due to COVID" "1704279-1" "1704279-1" "Covid vaccine dose #1 2/10/2021 Moderna Lot # 024m20A dose #2 3/1/2021, Moderna, lot # n/a pt died on 9/16/2021 in the hospital from cardiac arrest, aspiration, prolonged hospitalizations for chronic illnesses, not a covid related death." "1704289-1" "1704289-1" "sudden death" "1704317-1" "1704317-1" "positive COVID test on 8/14/21; presented to ED from infusion center where she's been receiving antibody infusions since 8/18/21; presented with increasing fever, chills, cough, SOB, and diarrhea; hx of diabetes mellitus type 2; acute hypoxemic respiratory failure due to COVID" "1704342-1" "1704342-1" "Just sick as per family." "1704443-1" "1704443-1" "presented with worsening SOB; pneumonia due to COVID; acute hypoxemic respiratory failure" "1704452-1" "1704452-1" "my daughter was complaining of loss of movement in both arms and legs, along with pain, approximately 1 hour after administration of the second dose of Moderna. she took tylenol, and went to sleep at approxiamately 5 pm, and never woke back up." "1704464-1" "1704464-1" "presented with increasing SOB, sore throat; husband diagnosed with COVID earlier in week; patient positive for COVID; HX of A Fib; pneumonia due to COVID; acute hypoxemia respiratory failure" "1704467-1" "1704467-1" "Not feeling well and headaches" "1704478-1" "1704478-1" "presented with weakness; COVID positive; acute hypoxemia respiratory failure" "1704505-1" "1704505-1" "Patient died 8/27/2021 at the Hospital with diagnosis of Pnuemonia caused by SARS-CoV-2" "1704514-1" "1704514-1" "Had heart attack 7 weeks post 2nd dose of COVID vaccine on May 11. Had STENT placed the next morning on May 12. Died the morning of May 15 which was to be her discharge home morning. Death certificate says STENT thrombosis. Never had any Hx of CAD." "1704515-1" "1704515-1" "Hospitalization due to COVID19. Reported per Moderna COVID vaccine EUA." "1704518-1" "1704518-1" "presented to ED with seizure due to hypoglycemic coma; hx of type 2 diabetes, CVA; experienced fever, positive COVID test; pneumonia due to COVID, with hypoglycemic coma and secondary acute hypoxemia respiratory failure" "1704534-1" "1704534-1" "Admitted to hospital after exposure to household cooking gas (gas leak) on 9/10/21 Tested positive for COVID-19 on 9/11/21 Noted to have COPD and chronic respiratory failure which required 3 Liters of Oxygen per minute at home. Patient expired on 9/15/21" "1704542-1" "1704542-1" "positive for COVID on 8/17/21; presented to ED with increasing dyspnea; hypoxic, chest with severe bilateral infiltrates; pneumonia due to COVID" "1704564-1" "1704564-1" "presented with acute respiratory failure, COVID positive; hx of type 2 diabetes, CHF, COPD; developed acute lower extremity DVT and A Fib with RVR while in hospital; pt's condition declined; was admitted to long term care facility where he died" "1704600-1" "1704600-1" "Patient fully vaccinated and died of covid related causes." "1704688-1" "1704688-1" "presented with cough and increasing dyspnea; positive for COVID; hx of granulomatous polyangiitis and airway strictures; ARDS with intubation, mechanical assistance" "1704749-1" "1704749-1" "I am the coordinator for the facility. She started to have problems after the first dose of the vaccine. There was also a lot of fatigue and feeling poorly. Her condition got worse after the second dose of the vaccine and she saw her doctor. It was discovered that she was in the final stage of Lung cancer. She had two treatments of radiation and then it was advised that she receive Hospice Care. She passed away shortly after that." "1705032-1" "1705032-1" "Wayde Olmsted is a 62 y.o. male was admitted on 8/31/2021 for abdominal pain. On imaging he was found to have The superior mesenteric artery origin is chronically occluded with dense calcifications. There is a very high-grade stenosis of the proximal celiac artery. General surgery was consulted. Vascular surgery was consulted. IR was consulted. Initially on clinical monitoring it was suspected that his symptoms are from chronic atherosclerosis of the arteries of gut supply. An attempt was made to stent with no success patient tolerated the procedure and plan was to try the next with different approach to stent. Next morning patient found to be unresponsive, hypotensive, hypoglycemic, RRT was called, upon evaluation patient was only minimally responsive to verbal commands, reponded to painful stimuli with grimacing, pupils were uneven and dilated, breathing was even, abdomen was tender, blood sugar 20-30, bp 70/30, Hb 6.8, Ph 7.2 Patient received if fluid bolus, dextrose, attempts to resuscitate made. Patient transferred to ICU. Intubated in ICU. Discuss with General surgery for possible worsening and Acute abdomen, Discuss with Vascular surgery for revascularization option. Patient went to OR open EX Lap done, Ischemic bowel deemed not salvageable. Patient returned to ICU. Called brother and Sister. Shared thought on treatment at this point would be medically futile and discussed Goals of care. They are on the way to hospital to see him and would express choices for goals of care. Patient coded before family could reach to the hospital. Code went on for more than 10 minutes. Patient was positive for covid. Family reached to the hospital and decided for comfort care measures only. Patient passed away on 9/2/2021." "1707311-1" "1707311-1" "Had a massive stoke; Convulsions; Gasping for breath; Lost function of left side of bod; Couldn't take tongue out of mouth; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had a massive stoke), SEIZURE (Convulsions), DYSPNOEA (Gasping for breath), HEMIPARESIS (Lost function of left side of bod) and TONGUE MOVEMENT DISTURBANCE (Couldn't take tongue out of mouth) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00C21A) for COVID-19 vaccination. The patient's past medical history included Stroke (Consumer previously had a stoke in his 30's.) and Cardiopulmonary resuscitation. Concurrent medical conditions included Emphysema (little) and Smoker. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had a massive stoke) (seriousness criteria death and medically significant), SEIZURE (Convulsions) (seriousness criteria death and medically significant), DYSPNOEA (Gasping for breath) (seriousness criterion death), HEMIPARESIS (Lost function of left side of bod) (seriousness criteria death and medically significant) and TONGUE MOVEMENT DISTURBANCE (Couldn't take tongue out of mouth) (seriousness criterion death). The patient died on 13-May-2021. The cause of death was not reported. An autopsy was not performed. No Concomitant medication was reported. No treatment medications were reported. Patient had a massive stoke, convulsions, gasping for breath, lost function of left side of body, and couldn't take tongue out of mouth on 13May2021. Wife noticed the symptoms of stoke and called 911 immediately. While on the phone with dispatcher, wife performed CPR and used mouth to mouth technique on her husband for up to 20 minutes. Wife stated they shocked the patient to bring back but it was unsuccessful and patient passed away on 13May2021 in wife's arms. Patient was on heavy blood thinners. Company Comment: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information required.; Sender's Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information required.; Reported Cause(s) of Death: Unknown cause of death" "1708239-1" "1708239-1" "Patient was admitted to Hospital for acute hypoxic respiratory failure secondary to COVID-19 infection and acute kidney injury on 09/05/2021. Patient was started on dexamethasone he was also anticoagulated with heparin given AKI. Acute kidney injury suspected to be prerenal secondary to poor oral intake in the setting of COVID-19 infection patient was also taking several medications at home such as Lasix and lisinopril. Patient required of supplemental oxygenation and fell heated high-flow nasal cannula to refractory hypoxemia then required noninvasive positive pressure ventilation. He continued to become more hypoxic and MRT was called 9/7/21 for hypoxia with oxygen saturation in the 70s and change in mental status. Decision was made to intubate the patient. At this time patient was transferred out of the ICU on mechanical ventilation. He continued to have worsening acute kidney injury and hyperkalemia which point nephrology was consulted and decision was made to start CRRT. Concern for superimposed bacterial infection and patient's antibiotics were escalated to cefepime and vancomycin, no growth on cultures. Patient also required norepinephrine intermittently throughout the admission for hypotension. Patient continued to remain hypoxic despite mechanical ventilation requiring paralytics, proning and was also on nitric oxide. Nitric oxide was stopped and protein was also stop later of the admission due to skin breakdown. Fluid removal per CRRT given concerns for volume overload. Family decided to withdraw care transition to comfort measures only. Patient passed shortly after with family at bedside. Time of death 1435 September 15, 2020" "1708241-1" "1708241-1" "PUI is at Ave. PUI was fully vaccinated however wife indicated why she was out of town he was exposed by someone and upon her return he was found non-responsive. He currently is in critical condition on a ventilator and currently experiencing kidney failure. Prognosis is not good. Patient died." "1708245-1" "1708245-1" "Patient is a 82-year-old white male who presents to the emergency room via emergency traffic with CPR in progress. Patient was a witnessed arrest at home. Patient just finished his 10 day isolation for COVID-19 yesterday but was still very ill apparently according to the wife. CPR was started within approximately 5 minutes of patient's witnessed arrest. Initial rhythm on scene per EMS was asystole. Patient was intubated at the field with a 8 0 ET tube and IO in the right leg was placed. And route patient received 3 rounds of epinephrine and CPR. Upon arrival here at the emergency room a total length of time over 15-20 minutes has been performed on the patient and the patient is still in asystole as he is wheeled into room." "1708279-1" "1708279-1" "DEATH! FINDING: Posterior right scalp hematoma. Additional right frontal/periorbital scalp hematoma. Mild scattered mucosal thickening in the paranasal sinuses. Air-fluid level in the right maxillary sinus. Mastoids aerated. Motion artifact limits evaluation of the globes and orbits, within this limitation the appear unremarkable. Calvarium intact. Low-density change involving nearly the entire left frontal lobe, left basal ganglia, left insula, anterior left parietal lobe, and superior left temporal lobe. There is associated loss of gray-white differentiation and is consistent with an acute to subacute subacute infarct. Measurements are approximately 4.7 x 11.0 cm. Foci of hyperdensity noted centrally within the tissue measuring up to 1.4 x 1.5 cm likely represents small amount of hemorrhage/hemorrhagic conversion. This involves both the left ACA and left MCA territories. Question hyperdensity within the left MCA. There is mass effect with sulcal effacement, compression of the left frontal horn/left lateral ventricle, and 2.5 mm rightward midline shift. IMPRESSION: 1. Large acute to subacute infarct measuring up to 4.7 x 11.0 cm involving nearly the entire left frontal lobe, left basal ganglia, left insula, superior left temporal lobe, and anterior left parietal lobe. This involves both the left anterior cerebral artery and left middle cerebral artery territories. 2. Foci of hyperdensity centrally within the infarcted tissue is consistent with hemorrhage/hemorrhagic conversion. Largest focus of hemorrhage measures up to 1.5 cm. 3. Together these findings contribute to mass effect with sulcal effacement, compression left lateral ventricle, and 2.5 mm rightward midline shift. 4. Question hyperdense left MCA, presents potentially representing vascular occlusion or intravascular thrombus. CTA or MRA could provide further characterization. 5. Posterior right and right frontal/periorbital scalp hematomas." "1708406-1" "1708406-1" "Patient was fully vaccinated. he PUI says that the only symptom that he has had was a cough. The PUI is currently in the hospital but it is not covid related. Patient died due to COVID-19 on 8/30/2021." "1708500-1" "1708500-1" "pt presented with excessive sleepiness and SOB; positive COVID test; pneumonia due to COVID; hx of emphysema/COPD, CKD, HTN; pt's condition deteriorated and died in the hospital" "1708627-1" "1708627-1" "within a month started having shortness of breath, fatigue, and chest discomfort" "1708656-1" "1708656-1" "Shortness of breath or difficulty breathing Chest pain Fatigue or tiredness Hospitalization and death" "1708661-1" "1708661-1" "Pt came to ER c/o difficulty breathing." "1708822-1" "1708822-1" "Hospitalization (9.10.21) --- > patient deceased (9.15.21) due to COVID-19 pneumonia; COVID-19 positive 9.10.21; fully vaccinated Date of Death: 9/15/21 Time of Death: 1:29 PM Preliminary Cause of Death: Pneumonia due to COVID-19 virus Discharge Disposition: expired DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus COVID-19 HOSPITAL COURSE: 74 yo male presented with the complaint of fever and weakness. He had been admitted on 9/6/21 with fever and weakness and had tested negative for covid. He had a UTI and was discharged home on the 8th. He returned 2 days later and was positive for covid and had hypoxia with CXR findings. He was admitted for the treatment of covid pneumonia dn started on dexamethasone. Over the course of his stay his baseline dementia was worse with note sun downing and associated agitation. He did not like having oxygen on or pulse ox monitoring. Family stayed with him which did not help. They decided to change his goals of care and talked to hospice. He was changed to comfort care and passed away with his family at bedside. (at admission: HISTORY OF PRESENT ILLNESS: Patient is a 74 y.o. male who presents today with fever and weakness . Recently discharged 9/8/2021 with febrile illness meeting sepsis criteria with elevated lactic, wbc, fever . Started with empiric abx With zosyn. Infectious work up neg for covid, film array , cxr, blood and urine cultures neg . Op urine culture growing serratia. He improved clinically and was dc to complete x2 more days cipro. Per wife still having low grade fever on dc . He progressively became more generally weak . continued with higher fever and chills taking tylenol for relief. With fever and weakness brought back in to ed where tested pos for covid 19 . In ed lactic elevated initially then trended down . Per wife he has become more and more wean . Still able to stand and walk to bathroom . Notes increasing urine incontinence now utilizing depends. No co chest pain and really has not been sob significantly . Minimally cough. No dysuria other wise . No diarrhea . No co ha vision changes. Notes progressive decline in cognitive function over last several months. occasionally wit hand tremors . No other sz like movements .)" "1708831-1" "1708831-1" "Diagnosed, hospitalized and expired with COVID 19- fully vaccinated" "1708865-1" "1708865-1" "Patient death." "1709442-1" "1709442-1" "Resident was noted to have a low blood pressure on 9/4/21 89/47 and oxygen was less than 90% with usual supplemental oxygen at 2L. On 9/5/21 oxygen need was increased to 5-6LPM for saturations in the low 80s and redness and petechia was noted to his left leg. (Was already being treated for venous insufficiency in right leg). On 9/6/21 the resident was started on antibiotics (Levofloxacin) for pneumonia with pleural effusion. Daily INRs were initiated due to use of antibiotics and chronic Coumadin use. Coumadin was given on alternate days of the antibiotic. On 9/9 the INR was 5.4 and on 9/10 the INR was 5.8. He received a one time dose of Vitamin K. On 9/11/21 he was started on Doxycycline for cellulitis. He continued to decline and had decreased lung sounds. The resident was noted to have increase in pain and was started on morphine on 9/13/21. The resident passed away on 9/17/21." "1709467-1" "1709467-1" "Patient came in after an ER visit for a reported intentional opioid overdose. She was doing ok at the visit, some minor wheezes on exam. She had requested refills on meds and reported having worsening asthma after her first shot but no ER visits. We decided to give her the second moderna shot due to her high risk should she contract covid 19 and sent her home with a course of prednisone in case of exacerbation. RN administered injection and had her wait in the room after the visit per protocol, patient was doing fine and was sent home. We found out several days later she passed away at home according to a coroners report of reported possible asthma exacerbation versus drug overdose, still being investigated. coroner reported finding drug paraphernalia at the scene and case is pending tox screen results." "1709844-1" "1709844-1" "My father went to thr hospital for knee pain and was admitted to the ER same day saying he had COVID. He spent 4 days in ER and was then transferred to local ICU. After a couple days he was released from ICU into a room in the hospital. At somepoint here, he was sedated by hospital staff because they said he was taking tubes out of his body and stuff. He never came too after be sedated, and was moved back to the ICU. Another few days passed with no one havimg a clue what was going on and finally MRI was conducted MRIs by the doctor revealed 'numerous strokes in his brain.' He died on August 26, 2021" "1709850-1" "1709850-1" "No symptoms" "1711923-1" "1711923-1" "flu like symptoms; This is a spontaneous report from a contactable consumer (patient's brother). A 49-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 28Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient started experiencing flu like symptoms on Aug2021, which only got worse for the next few days. He passed away Monday, 30Aug2021. His death was extremely unexpected since he was feeling great before the Pfizer vaccine. The patient died on 30Aug2021. It was not reported if an autopsy was performed. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: flu like symptoms" "1712070-1" "1712070-1" "Hx malignant Carinoid tumor of the Bronchus; Lung-Hx of Respiratory Failure; This is a spontaneous report from a contactable nurse. An 89-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 89-years-old intramuscular, administered in Arm Left on 09Sep2021 11:00 (Lot Number: 301358A) as single dose for covid-19 immunisation. Medical history included failure to thrive. No known allergies. No COVID prior vaccination. No COVID tested post vaccination. No other vaccine in four weeks. Concomitant medication(s) included alprazolam; ondansetron; clarithromycin (CLARITIN); clopidogrel; sennoside a+b (SENNA); albuterol sulfate. It was reported resident expired 24 hours after COVID vaccination, death causes were hx malignant carinoid tumor of the bronchus, lung-hx of respiratory failure. The adverse event start date and time was reported as 10Sep2021 14:45. No treatment was received. The patient died on 10Sep2021. An autopsy was not performed.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Carcinoid tumor pulmonary (fatal) Respiratory failure (Fatal) and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: Lung-Hx Of Respiratory Failure; Hx malignant Carinoid tumor of the Bronchus" "1712704-1" "1712704-1" "Patient required hospitalization due to breakthrough infection. Patient received J&J vaccine on 08/11/21. Patient was hospitalized from 08/19/21 - 09/12/21. Below is copied from discharge (death) summary: Patient is a 62 y.o. male with PMH significant for HLD, morbid obesity, DMII, schizophrenia, and anxiety/depression who presents for shortness of breath 2/2 to COVID. Initially admitted on 8/19/21. Patient had increasing O2 requirements with multiples desaturations on HFNC, and subsequently admitted on 8/31 for acute hypoxic respiratory failure/worsening O2 requirements 2/2 COVID PNA. Pt intubated on 8/31. Episodes of Paroxysmal A-fib, lopressor started and amiodarone started on 9/1. HDS during episodes. Bedside echo demonstrated reduced EF. Formal echo on 9/1 was normal LVEF 65%. Fever spiked 8/31 empiric abx (Vanc and Cefepime and flagyl) started. Blood, urine, and respiratory cultures ordered. Initiated prone ventilation with improving oxygenation. Continue solumedrol, floloan, and statin. DVT ppx. No Toci given duration of illness. Afib with RVR but his cardiac function is wnl so this likely driven by his sepsis and hypoxia. Continue Amio. Strep/Staph bacteremia, however, may be contamination and unable to speciate staph so given his clinical picture, will treat and continue Cefepime. D/c Vanc. D/c Cefepime. Switched to Ancef given MSSA pneumonia. Repeat blood cultures negative. Strep viridans 1/2 blood cultures. Weaning Solumdrol. Tolerating prone ventilation. Procal remains negative but up trending WBC so will send fungal cultures. US lower extremity negative for DVT. US UE negative. Diuresing with Lasix 60 mg IV x2. Robitussin-codeine started for cough. Fevers persistent and WBC slowly downtrending. D/c Diamox given mild worsening of acidosis. NPH 25 bid with SSI. CXR concerning for progression to fibrotic covid. S/p Ancef for MSSA pneumonia. Progressive Hemodynamic instability 9/11 requiring pressors with levophed and vasopressin. Repeat blood cultures 9/10, 1/2 with gram positive rods. Started on vanc/zosyn/caspofungin for broad coverage on 9/11. Called at 10:00PM for lost pulses. Pulse check without pulse. ACLS inititated as patient was full code at the time. Patient received 2x Epi/Bicarb, IVF bolus, and 3 rounds of CPR with PEA. At 3rd pulse check, patient with ROSC. Epi gtt initiated alongside Levo/Vaso/IVF. Pulse Ox with persisent desaturation depsite max FiO2/PEEP. Bedside US without signs of PNX or RV enlargement/strain. ECG without RV strain. CXR without signs of PNX; persistent b/l infiltrates consistent with active COVID. Called significant other, pt made DNR. Bicarb and epi gtt added. Pt's pulse lost again. Time of death 10:17." "1713220-1" "1713220-1" "Found dead in restroom about four hours after administration of vaccine. Patient has been rapidly declining w/ Metastatic lung CA." "1713242-1" "1713242-1" "two days breathing problems, then boom - dead" "1713249-1" "1713249-1" "Feeling very sick then had trouble walking. Died of a deep vein thrombosis and pulmonary embolism." "1713331-1" "1713331-1" "Patient death" "1713423-1" "1713423-1" "Back of heart collapsed." "1713447-1" "1713447-1" ""Patients boyfriend came into the pharmacy on 09/18/21 asking when she received her 2nd dose of the vaccine. I asked if it was because she lost her card and he said ""No, she died a few days after and I'm trying to figure out if it was from the vaccine"". Date of death/causes/symptoms of death unknown."" "1713499-1" "1713499-1" "Severe and continue headaches for months, followed by two heart attacks on Sept 7, resulting in damaged heart artery leading to death on September 17, 2021 at 3AM." "1713660-1" "1713660-1" "After receiving his second vaccine, he complained that he was having a headache, a stomach ache, and ?not feeling good?. Went to the hospital on 03/20/2021 complaining of worsening pain and the hospital only treated him for a UTI with antibiotic, altough his platelet count was low (was unaddressed). After being released two days later, he became delirious and then starting throwing up blood, having a nose bleed, and throwing up his feces. They put him on the vent, tested him for Covid 3-6 times (all negative), and then diagnosed him with a brain hemorrhage that later led to a massive stroke. They diagnosed him (tentatively) with TTP due to low platelet count, however upon informing the doctor of him recently being vaccinated, she stated it could have been ITP, however she did not report this adverse effect. This doctor was in the ICU at hospital." "1713892-1" "1713892-1" "Developed severe headache the morning of 1/15/21 called for help found unconscious in bed room floor regained consciousness taken to Hospital became unresponsive shortly there after. Result of hemorrhaging on the brain. Died 1/17/21." "1714152-1" "1714152-1" "Arrived to ER on 9/13/2021. Patient is an 81-year-old female with advanced dementia, diabetes, hypertension, tested positive for COVID on 09/08/2021. Was vaccinated approximately 7 months ago with Pfizer. Has not been eating. Has episodes of desaturation below 90% on room air. Patient unable to provide any history whatsoever. Admitted to hospital on 9/13/21. She started on decadron, keep oxygen above 90%. I covered her with abx due to possible superimposed bacterial GNR PNA. She was tested positive for COVID on 09/08/2021. She was vaccinated approximately 7 months ago with Pfizer. Was started her on remdesivir 9/14; started on doxycycline and ceftriaxone. CTA confirmed Covid-19 PNA and possible superimposed RLL PNA GNR; no signs of PNA. Pt developed acute hypoxic respiratory failure with increasing oxygen requirement on 9/15. She is now on HFNC 60 liters. Niece is aware of deterioration. Ct with supportive measures. Due to worsening of respiratory status. Talked with POA the niece and patient placed on comfort on 9/18. She was on IV prn morphine and IV ativan prn. She passed away on 9/19/21 01:02AM" "1714282-1" "1714282-1" "Received Pfizer 2/24, 24 hours later buttocks cheeks hurt, flank pain started and within 7 days, urinating blood, general feeling unwell, clots became so large they ultimately blocked urine flow completely. Went to ER 3/8, creatine was elevated, did a cat scan which showed enlarged lymph nodes attributed to vaccine hospital said and otherwise unremarkable. Hospital, through a catheter did and aggressive bladder flush and was put on morphine, flushed for 48 hours then had drops in oxygen and labored breathing, x ray showed fluid in lungs, diagnosed with hospital acquired pneumonia from the flush, once on antibiotics and creatine/ bun stabilized, was released. Clots returned in 3-4 days, went to urologist for scope, unremarkable, no invasion of bladder cancer through the wall, recommends another cat scan (3.5 weeks after previous scan ) scan showed enlarged lymph nodes and some liver lesions, recommend biopsy of liver and lymph nodes and kidney scan, both are scheduled. Blot clots get worse, end up in ER 4/18, elevated creatine and bun, urologist tried to do ureter stents, ureters blocked so bilateral nephrostomy tubes were put in. Liver biopsy done 4/20. Dad was stabilized and released with no biopsy results until 4/27, metastatic bladder cancer diagnosis. Oncologist put dad on Keytruda once every 3 weeks. Dad has been feeling unwell since his 1st vaccine, never got the 2nd due to all of these complications. Dad ends up back in hospital on 6/21 with general unwell feeling, fatigue, cat scan shows further progression and because of an error a resident did a cat scan with dye which then added contrast induced nephropathy to the issues. Dad passed away on Wednesday, July 21st at 6:45pm." "1714343-1" "1714343-1" "Increase in White blood count and kidney failure, resulting in death. Increase of white blood cell count went from completely normal to over 100,000 over a couple month time frame. At time of death, he had physically observable lymph nodes swelling all over his body and were nearly bursting from his skin on his belly. He died a horrible in hospice at home." "1714418-1" "1714418-1" "Diffuse large B cell lymphoma" "1714727-1" "1714727-1" "Death following severe breathing difficulties starting shortly after vaccination. Patient had a second vaccination but this was not reported on her vaccine card." "1714925-1" "1714925-1" "Hospitalized for COVID and died as a result of COVID pneumonia" "1714934-1" "1714934-1" "Reportedly experienced shortness of breath beginning after vaccination between 8/4-8/6. Traveled by car to drop daughter off at college and on the return trip began to feel unwell and stopped in a Truck stop, where he became unresponsive. He was transported by EMS to the hospital where he was pronounced deceased at 23:07 on 8/9/2021." "1714965-1" "1714965-1" "A few days after the first covid vaccine patient started to experience left ear fullness and slight tinnitus. This lasted for approximatley 2-3 weeks. He was told he may have fluid in his ears and was treated with OTC medications for allergies, reported by patient to myself. After his second vaccine he developed tinnitus in the left ear. He went see his physician and they were unsure what the corelation was but he was then treated for stress and placed on Wellburtrin. After this trail and the tinnitus not getting anybetter, he stopped taking his Wellburtrin and began seeing a serious of ENT/ Audiologist - all could not determine the cause of tinnitus (they rule out MRI/neck/HL etc.). After a month of seeing ENTs/ PT he reported to me for severe tinnitus. He was wearing a HA at this time and we used sound enrichment and counseling to help cope with the onset of tinnitus. However, even after working with him for 7 months, referring to specialist along the way, attending counseling, PT, TMJ, etc. He ended his life by suicide due to the tinnitus on 8/16/21." "1714994-1" "1714994-1" "Fever, cough, shortness of breath, difficulty breathing, Chest pain, fatigue. Death: 8/14/2021" "1715223-1" "1715223-1" "Patient was hospitalized with COVID-19 symptoms on 8/26/2021 with respiratory failure. Patient was subsequently intubated and mechanically ventilated for a total of 17 days before being make compassionate care by family on 9/14/2021." "1715261-1" "1715261-1" ""Breakthrough COVID-19 case, hospitalization 9/4/2021-9/5/2021; death 9/5/2021. COD from vital records: LYMPHOMA, IMMUNE THROMBOCYTOPENIC PURPURA, COVID 19. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: None listed. place of death: HOSPITAL-INPATIENT, MEDICAL CENTER; certified by: CERTIFYING PHYSICIAN; occ/ind: SETTER OPERATOR, INDUSTRIAL MANUFACTURING .""Did the patient die?"" marked YES; ""Is this a COVID-related death?"" marked YES."" "1715267-1" "1715267-1" "Shortness of breath." "1715299-1" "1715299-1" "Short of breath, weak, lost consciousness, eventually lead to cardiac arrest, death" "1715352-1" "1715352-1" ""Patient was on hospice for senile degeneration of the brain. She had been having abnormal vaginal bleeding in the months leading up to her death, and in mid July, she had increased facial drooping. The vaccine was administered on 9/16 and on 9/18 at 0540, her sister/ primary caregiver called to report that she was breathing ""differently"" and her ""eyes were glassy"". She died at 2239 on 9/18. It is unclear if the vaccine is related to her death; however, we are reporting to VAERS per CDC guidance. She is also being reported to the Office of the Medical Examiner."" "1715421-1" "1715421-1" "Last three days of nursing notes and discharge summary submitted into system. Patient had not tested positive for COVID since 12/2020." "1715467-1" "1715467-1" "Nursing notes and discharge summary submitted. Patient had not tested positive to COVID since 12/2020." "1715501-1" "1715501-1" "This is a 76yo male with a PMHx significant for chronic diastolic heart failure, CKDIII, cirrhosis of the liver, hepatocellular carcinoma, and HTN admitted on 9/4/2021 with increasing shortness of breath. He was tested positive for COVID and received the monoclonal antibodies on 9/2. His shortness of breath continued to worsen. He was admitted to Hospital and was originally requiring 10L nasal cannula. His troponin was mildly elevated with a maximum of 0.21. He received ceftriaxone and azithromcyin. His d-dimer was elevated and he was started on enoxaparin BID because CTA could not be obtained to rule out PE because of his renal function. He was transferred here to the medical unit. Cardiology, Vascular surgery and Nephrology were consulted. ECHO was obtained and showed no right heart strain, normal EF and increased right systolic pressure. Vascular surgery advised no thrombolysis therapy and to continue treatment dose enoxaparin. Cardiology felt his troponin elevation was due to supply demand mismatch and not ischemia. He was kept on dexamethasone but increased to BID dosing, ceftriaxone and azithromycin. Due to a CRP >4, he was started on baricitinib, renally dosed. In the early morning of 9/6 his Optiflow cannula came out while he was sleeping. The nurse found him saturating in the 50s and pulse was thready. Rapid response was called and then he went into PEA and vfib. ACLS protocol was followed and patient received 2 rounds of epinephrine. He was not defibrillated because he came out Vfib prior to shocking. ROSC was achieved in 9 minutes. He was intubated and moved to the ICU. He was following commands and opening his eyes after the incident. Pulmonary/CCM was consulted. His hemoglobin dropped to 6.3 so was transfused 1 unit. Heme + stool, so PPI BID ordered. Baricitinib discontinued due to worsening renal function. He was extubated on 9/8 to high-flow nasal cannula. Unfortunately, he did not do well overnight with tachypnea and was re-intubated. His kidney function continued to worsen due to ATN from his cardiac arrest. Trialysis catheter was placed, and dialysis was initiated 9/10. Patient with hemoptysis 9/13. He underwent bronchoscopy, which revealed proximal clot but no active bleeding, and no active bleeding or endobronchial lesions in either lung. Patient started on high-dose steroids for alveolar hemorrhage. Pathology shows atypical cells suggestive of malignancy. CT chest performed shows extensive bilateral infiltration verses edema with consolidative airspace disease in bilateral lung bases, large bilateral pleural effusions, large subcarinal lymph nodes, left 1-7 rib fractures with right 4-6th rib fractures. Repeat bronchoscopy performed 9/17, showing some evidence of nodularity. No biopsies done due to risk of bleeding, washings were performed. CRRT started 9/17. Patient was not showing sign of improvement. Family presented to bedside to discuss goals of care. They ultimately chose to proceed with withdrawal of care and transition to comfort measures." "1715534-1" "1715534-1" "Breakthrough COVID-19 case with symptom onset 8/3/2021: Diarrhea (>/=3 loose/looser stools in 24 hr period). died on 8/11/2021" "1715538-1" "1715538-1" "Patient had diabetes, breast cancer and hypertension. Presented to the ED with a fever of 104, productive cough, shortness of breath, loss of taste, fatigue, and low oxygen saturations. She was diagnosed with COVID one week ago. Patient was admitted with COVID PNA and was placed on a ventilator on 8/22/2021. Patient developed significant bradycardia due to COVID myocarditis. She had only received her first dose of Moderna 8/3/2021. She continued to deteriorate and family chose to terminally extubate her and she expired on 9/4/2021." "1715552-1" "1715552-1" "Breakthrough COVID-19 case with symptom onset 8/6/2021: Cough (new onset or worsening of chronic cough). Death 8/19/2021. From vital records: CONGESTIVE HEART FAILURE-UNSPECIFIED. Per vital records, Codes include: Not yet coded ; Other Significant Conditions include: HYPERTENSION DEMENTIA. Place of death: NURSING HOME-LONG TERM CARE FACILITY ASSISTED LIVING; PRONOUNCING AND CERTIFYING PHYSICIAN." "1715568-1" "1715568-1" "death" "1715570-1" "1715570-1" "9/16/21 - patient sent to ED due to worsening confusion and hypoxemia. Recently tested positive for COVID-19 at his SNF. Determined to be in septic shock. Patient was palliatively extubated and expired shortly after." "1715571-1" "1715571-1" "Breakthrough COVID-19 case with symptom onset 8/10/2021: Cough (new onset or worsening of chronic cough). Death 8/18/2021. From vital record cause of death: CARDIOPULMONARY ARREST, SENILE DEGENERATION OF THE BRAIN. Per vital records, Codes include: Not yet coded ; Other Significant Conditions include: None listed. Place of death: NURSING HOME-LONG TERM CARE FACILITY, ASSISTED LIVING; PRONOUNCING AND CERTIFYING PHYSICIAN" "1715587-1" "1715587-1" "Pt came to ER with SOB, no endurane, nausea. Recieved first dose of covid vaccine 2/10 unsure of manufacturer." "1715588-1" "1715588-1" ""Patient is a 78 y.o. female with a history of HTN, DMII, anxiety and depression presenting with worsening shortness of breath over the past 1 week. Pt went to PCP on 9/13 and was ordered curb-side rapid COVID test, and was notified the following day that it was positive. Pt underwent Regeneron infusion on 9/15. When symptoms worsened pt came to ED for further evaluation and treatment. Patient was admitted to the COVID-19 cool floor. Patient was placed on AV APS for acute hypoxic respiratory failure. It appears her mask was dislodged, oxygen saturations to dropped patient went into PEA cardiac arrest. ROSC obtained patient was transferred to the ICU where she was coded again. Once again, ROSC regained. Patient was placed on an epinephrine followed by norepinephrine and vasopressin. hydrocortisone followed by hydrocortisone every 8 hr. Family was at bedside they were notified of patient's poor prognosis. They asked patient remains a full code. Once again patient coded, asystole. ACLS protocols were started, family was updated in a asked patient""s status to DNR patient expired soon after. time of death240hr"" "1715608-1" "1715608-1" "HOSPITALIZATION AND DEATH RELATED TO COVID-19 WHEN FULLY VACCINATED" "1715630-1" "1715630-1" "Fully vaccinated patient positive COVID test on 09/04/21 in ED, 24 hour stay and discharged with dexamethasone no O2 needs. Patient fell on 09/06/21 and was admitted inpatient. Some hypoxia (87%), cough, shortness of breath. Dyspnea continued to worsen, starting having runs of SVT. Required Bipap for increased respiratory needs. Patient requested to move to hospice care and agressive therapy was discontinued per his request. Patient died on 09/14/21." "1715718-1" "1715718-1" "The patient reported that she experienced a: Fever, Sore Throat, Headache, Muscle Aches, Chills, Runny nose, Shortness of Breath Abdominal Pains, Cough, Nausea, Vomiting, Diarrhea, and Fatigue. Symptoms started on 7/30. The patient stated that she lives with her husband who tested positive. Reported Chronic Kidney Disease, Hypertension, PROBABLE MYOCARDIAL INFARCTION> DEATH ON 8/28/2021" "1715739-1" "1715739-1" "Fully COVID vaccinated patient admitted through ED for breakthrough COVID PNA. Positive COVID test on 09/09/21. Febrile, cough, shortness of breath, O2 68% on room air. Patients respirtory status continued to decline and required BiPap. On 09/16/2021 patient requested to elect comfort care only and agressive cares were discontinued. He died on 09/16/2021." "1715779-1" "1715779-1" "diagnosed positive for COVID on 8/10/21; changes in mental state on 8/21/21 with hypoxia and hypoglycemia, was seen in ED and admitted to hospital where condition worsened; Acute hypoxemia respiratory failure due to COVID pneumonia" "1715804-1" "1715804-1" "presented to ED with decrease in appetite, nausea, vomiting x approximately 1 wk; tested positive for COVID; fever and fatigue, decreased oxygen saturation; intubated on 8/7/21; condition worsened where she passed away at the hospital" "1715811-1" "1715811-1" "Fully vaccinated patient passed away due to COVID-19 pneumonia. Received second Pfizer vaccine on 3.1.2021." "1715844-1" "1715844-1" "worsening dyspnea, required high flow oxygen, declined intubation, passed away" "1718168-1" "1718168-1" "Patient passed away February 9, 2021 at 2:12am.; At around 11:30pm-11:45pm difficulty of breathing was noted.; fever,Fever progressed to 103F; Very tired/feeling of very tired; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient passed away February 9, 2021 at 2:12am.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L-20A and 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced DYSPNOEA (At around 11:30pm-11:45pm difficulty of breathing was noted.), PYREXIA (fever,Fever progressed to 103F) and FATIGUE (Very tired/feeling of very tired). The patient was treated with PARACETAMOL (TYLENOL) on 08-Feb-2021 for Fever, at a dose of 1 dosage form. On 09-Feb-2021, DYSPNOEA (At around 11:30pm-11:45pm difficulty of breathing was noted.), PYREXIA (fever,Fever progressed to 103F) and FATIGUE (Very tired/feeling of very tired) outcome was unknown. The patient died on 09-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 103 (Inconclusive) Fever progressed to 103F. On 08-Feb-2021, Oxygen saturation: decreased (Inconclusive) At 10pm his oxygen level dropped. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication also included medication for blood pressure. On 08 Feb 2021 patient had the 2nd dose of Moderna Covid19 vaccine in the morning. Patient was fine until 5pm when patient complained of fever and feeling of very tired. Fever progressed to 103F. Patient took Tylenol. At 10pm his oxygen level dropped; patient laid down in bed. At around 11:30pm-11:45pm difficulty of breathing was noted. They immediately called 911. 911 came at around 12:50am but the patient arrested in the driveway. At the Emergency Room, they tried to revive the patient but unsuccessful. Patient passed away on 09 Feb 2021 at 2:12am. This case concerns a 62 year old male experienced serious adverse event of death one day after receiving the second dose of the vaccine and in addition with non-serious adverse events of dyspnea, fever and fatigue. Dechallenge was unknown and rechallenge was not applicable. Limited information provided. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns a 62 year old male experienced serious adverse event of death one day after receiving the second dose of the vaccine and in addition with non-serious adverse events of dyspnea, fever and fatigue. Dechallenge was unknown and rechallenge was not applicable. Limited information provided. The benefit-risk relationship is not affected by this report.; Reported Cause(s) of Death: Unknown Cause of death" "1718715-1" "1718715-1" "Pt. had a sever hemmoragic stroke the week after her 2nd vaccine dose. We did not know it at the time but she was later diagnosed with Cerebral Amyloid Angiopathy." "1718725-1" "1718725-1" "Sudden death by cardiac arrest" "1718792-1" "1718792-1" "Patient died within hospice care. He tested positive for COVID on 8/22/2021. Hospice notes submitted into data base." "1718832-1" "1718832-1" "She had reportedly received a Johnson and Johnson (Janssen) COVID-19 vaccine on 05/14/2021 and had essentially never been well since. The following week, she was diagnosed with pneumonia (thought to possibly be COVID-related due to ?ground-glass? appearance of lungs on radiologic exam); however, a follow-up COVID-19 test was negative. She was treated with short-term steroids and antibiotics." "1718833-1" "1718833-1" "At work, got short of breath, found down. CPR in progress. Unknown how long down. EMS paged at 0555. Bystander CPR started. 0637 ROSC received. Monitor sinus tach. 0638 no pulse. CPR resumed. 0640 - ROSC received. 0641 - No pulse. CPR started. DEATH" "1718910-1" "1718910-1" "SOB/RESP DISTRESS, ACUTE RESP FAILURE, ACUTE RENAL FAILURE, DEATH" "1718927-1" "1718927-1" "Pt came to ER c/o SOB, chest pain, and feeling of knots all through his back. EKG done STEMI alert activated." "1718935-1" "1718935-1" "91 year old lady with hx dementia, HTN, HLP, PAFib, was brought INTO the hospital for worsening mental status, fatigue and body aches. In the ED she was found to be in atrial fibrillation RVR rate 120s, . She is afebrile but was hypoxic on room air 88%. Patient tested positive for covid. CTA positive for bilateral infiltrates r>L with bilat effusions and noted to have a small non occlusive embolus of subsegmental branch of right lower lobe with no right heart strain, and ascending aortic dilatation, no dissection, and CT head shows remote lacunar infarcts and age related small vessel changes. ." "1718958-1" "1718958-1" ""Patient passed away on May 29th due to ""Sudden Cardiac Death due to Cardiomegaly."" "1718980-1" "1718980-1" "Renal transplant recipient Jan 2019, on immunosuppressives, became SOB, cough" "1718996-1" "1718996-1" "Patient received a 3rd dose of Moderna vaccine on 09/01/2021. Patient passed away on 09/11/2021 from cardiac arrest." "1719006-1" "1719006-1" "Patient passed away on 09/12/2021" "1719028-1" "1719028-1" "Patient passed away on 09/14/2021" "1719035-1" "1719035-1" "Patient passed away on 09/14/2021" "1719155-1" "1719155-1" "My Father received his second COVID19 shot on May 19th, 2021. He felt fine the day of his vaccine and the day after. He experienced minor side effects. On May 22nd, 2021 my Father suddenly died while driving to work." "1719230-1" "1719230-1" "On September 5 the patient started showing signs of a heavy chest cold. She was sick for the next week with heavy cough, on and off fever, extreme fatigue, shortness of breath. She kept insisting she just had a strong chest cold. On September 12 I found her barely conscious, foaming at the mouth, with extreme labored breathing. Emergency medical services took her to the ER. She was in ICU intubated for one week, then died on September 19." "1719262-1" "1719262-1" "Patient fully vaccinated with pfizer COVID vaccine on 2/5/2021 and 3/5/2021. Pt has h/o advanced COPD and is chronically oxygen dependent, on 5L of O2 at home, multiple sclerosis, Afib, GERD, CHF. Required admission to hospital for COVID pneumonia on 8/29/2021, requiring mechanical ventilation, and ultimately patient expired on 9/18/2021." "1719347-1" "1719347-1" "severe shortness of breath" "1719349-1" "1719349-1" "Patient experienced severe elevated blood pressure and a hemorrhagic stroke a few days post receiving 2nd dose of Moderna Covid vaccine. Patient was hospitalized and then moved to care facility. In care facility, patient experienced UTI and sepsis, which led to re-hospitalization. Due to issues swallowing, patient suffered aspiration pneumonia. Patient could not swallow properly post stroke, and directive was no feeding tubes. Thus, patient moved to hospice and subsequently passed away on 9/10/21." "1719415-1" "1719415-1" "extreme fatigue, sudden weight loss and distended belly" "1719423-1" "1719423-1" "presented to ED confused, O2 saturation decreased, hx of COVID positive for approximately 1 week; hx of COPD; dyspnea; intubated, acute hypoxemic respiratory failure, COVID pneumonia; pt's condition deteriorated where he died in the hospital" "1719456-1" "1719456-1" "nausea, vomiting" "1719457-1" "1719457-1" "patient expired 9/18/2021" "1719460-1" "1719460-1" "presented to hospital with complaints of increased weakness, dyspnea, and weight loss; immunosuppressed due to heart transplant; intubated, condition worsened and patient passed away in the hospital; COVID pneumonia ARDS" "1719477-1" "1719477-1" "admitted to hospital with positive test for COVID, COVID pneumonia; hx of COPD, type 2 diabetes, cirrhosis, and known liver mass; stayed in ICU, then admitted to in-house hospice where she later died" "1719493-1" "1719493-1" "Sudden death" "1719557-1" "1719557-1" "Resident received 3rd dose of COVID-19 vaccination d/t immunocompromising condition - ESRD with dialysis. Following the vaccination he had not adverse reactions or side effects. The family met with the MD and reviewed resident status. The resident was told his dialysis treatments were not working. Resident's wounds were worsening and he was not a surgical candidate. Family and resident decided to utilize hospice and palliative care approaches and dialysis treatment was stopped on 9/8/21. Reported to VAERS d/t death after COVID vaccination. In this case the decline in condition seems to be stopping dialysis treatment but reported d/t unclear information on reporting requirements." "1719592-1" "1719592-1" "PATIENT EXPIRED ON 09/11/2021" "1719634-1" "1719634-1" "PATIENT EXPIRED ON 09/06/2021" "1719650-1" "1719650-1" "My brother was admitted to the hospital 2 weeks after his last vaccine. There was NOTHING wrong with him prior to the shot. He went in for respiratory problems. He's was having a hard time breathing. He recovered from that, and then died from organ failure, again, never having other problems before. I know from visiting that other spinal cord patients were in the hospital at the same time with the same issues. I knew that two of them not including my brother also died. These vaccines are NOT safe for everyone!!" "1719659-1" "1719659-1" "PATIENT EXPIRED ON 09/19/2021" "1719757-1" "1719757-1" "Contracted COVID 2 months after second shot (second dose administered on 05/17/21) and passed away after hospitalization." "1719772-1" "1719772-1" "PATIENT EXPIRED ON 09/20/2021" "1719793-1" "1719793-1" "Patient found in bathroom at 1 pm unconscious; When put back to bed no pulse or respirations and CPR started; Unsuccessful; Unclear if at all related to the vaccine" "1720055-1" "1720055-1" "1st Moderna Covid imm given 3/15 or 3/19, within weeks afterward reported heartburn, early satiety, bloating. 2nd Moderna Covid imm given 4/16, within few wks afterward c/o gurgling stomach, decreased appetite, losing weight, nausea, back pain, loss of energy. Episode in May where he became lightheaded after working around home which was new. Easily fatigued. Had sudden cardiac arrest while sitting at home June 7 witnessed by wife, unresponsive, CPR initiated, taken to hospital, deceased June 10th cause of death myocardial infarction, coronary artery disease per wife" "1720323-1" "1720323-1" ""After 1st dosage: Complaints of breathing problems, lite chest pains, tiredness, dizzy and headaches. (Vitals ok) After 2nd dosage: Worsen, breathing problems worsen, vitals change dramatical, Oxy levels, blood Pressure, heart went into AFIB. 3 ER ""Chest Compression"" to stabilize. Body swollen, feet, hands and legs In March, Same challenges, -- A chest scan was done, Lung cancer came back, Heart still acting up. diabetes fluctuated, swollen lymph nodes, etc. loose stools, tired, dizzy, - Still suffering for oxygen. March/April û In Intensive care: stabilized introduced chemo to shrink the cancer. Blood transfusions, monitoring afib, vitals, he needed constant respiratory therapy to continue to breathe. | Note: Dec 2020 he was in remission of the lung cancer. All his medications were the same. The only new toxin that was introduced to his system was the Moderna Vaccines. One on January 19th, 2021 and 2nd Feb 19,th 2021. If you need all his medical records - Please let me know. My father was a strong man, even with his alignments he was strong a fighter. If he didn't take the vaccines, we could have had more time with my dad. The vaccine is dangerous and should be noted. Please confirm receipt of my submission. 3 EMT Emergencies - 3 Heart Compression Shocks."" "1720339-1" "1720339-1" "myocarditis ... died April 24th 2021 - one month after 2nd dose." "1722274-1" "1722274-1" "Patient never recovered after the shot and had difficulty breathing or holding conversations. She died 08/12/2021" "1722510-1" "1722510-1" "The decedent received his initial Pfizer vaccine on 07/29/2021; and the second Pfizer vaccine on 09/14/2021. On 09/18/2021, the decedent reported to his mother that he was vomiting blood. On 09/19/2021, the decedent was found deceased in his residence." "1722573-1" "1722573-1" "Patient?s health was declining gradually . The day following second vaccine dose she stopped eating and taking meds , went to bed and died on Monday, 2/15/2021. I believe that the vaccine effect on her health caused her to die sooner than she would have from CHF on its own path." "1722668-1" "1722668-1" "Patient was in the Hospital from 8-23-21 to 9-8-21. Patient expired on 9-8-21. symptoms: shortness of breath, muscle aches, hypoxia, runny nose, cough, and acute hypoxemic respiratory failure." "1722670-1" "1722670-1" "hx of peripheral artery disease, multiple sclerosis, CHF; presented with SOB, decrease O2 saturation, positive for COVID; pt requested do not intubate, pt's condition worsened where he died in the hospital; Acute hypoxemic respiratory failure secondary to COVID pneumonia" "1722691-1" "1722691-1" "hx of thyroid disease, HTN, arthritis; presented to ED with productive cough, SOB, fever; diagnosed COVID positive 6 days before at a clinic, condition worsening; admitted to hospital where hypoxia worsened with increased work of breathing, patient died in the hospital" "1722700-1" "1722700-1" "Symptoms: runny nose, fatigue, shortness of breath, wheezing, n/v diarrhea. Developed pneumonia. Hospitalized and died" "1722728-1" "1722728-1" "Symptoms started on 8-22-21. 101 fever, runny nose, fatigue, cough, and shortness of breath. Was hospitalized on 8-28-21 with pneumonia due to COVID 19 virus and acute respiratory failure with hypoxia. Expired on 9-2-21." "1722748-1" "1722748-1" "Patient died on 09/20/2021" "1722775-1" "1722775-1" "Hospitalized on 9-13-21 for COVID" "1722820-1" "1722820-1" "Patient was fully vaccinated. Patient died due to COVID." "1722846-1" "1722846-1" "Breakthrough COVID-19 case with symptom onset 8/26/2021. Hospitalized 8/26/2021 for unknown duration. Death 9/9/2021" "1722851-1" "1722851-1" "EMS CALLED TO NH FOR SYNCOPAL EPISODE ON 7/7/2021. PT IS DNR. ON ARRIVAL TO ER, NO CHEST WALL MOVEMENT NOTED NOR BREATH SOUNDS HEARD. WEAK CAROTOID PULSE; BP UNABLE TO BE DETECTD. PT PRONOUNCED AT 8:00:00 EXPIRED." "1722860-1" "1722860-1" "8/7/2021 tested for COVID-19 and was positive, was admitted to medical center with lethargy, minimally responsive, no oral intake. She expired 8/22/2021 with pneumonia due to COVID-19, Acute hypoxemic respiratory failure, systolic heart failure, difficulty in walking, pleural effusion, bilateral, muscle weakness, atrial fibrillation, diabetes mellitus, and dementia" "1722888-1" "1722888-1" "Patient presented with Edema and developed CHF and Cardiomyopathy progressing to death on 08/15/2021" "1722922-1" "1722922-1" "Pt with complaints of headache, painful legs, fatigue and died within 48 hrs of taking 2nd dose. Found in her bed." "1722958-1" "1722958-1" "Began 8/5/2021 non-productive cough, nausea, vomiting, 8 lbs. weight loss in last 2 months, dyspnea, deconditioning, lower extremity weakness COVID Quad collected 8/9/2021 that was positive for COVID-19. She expired 8/17/2021" "1723053-1" "1723053-1" "This individual is now deceased due to a myocardial infarction secondary to a thrombus. He was alone at the time of the event, therefore no immediate details are known. His family reported that the 2 days prior, they were all hiking and he had no problems. He is suspected to have actually died on 03/20/2021; however, it took some time to find him, therefore the autopsy indicates date of death to be 03/21/2021 due to that's when he was located, already deceased." "1723056-1" "1723056-1" "Patient was fully vaccinated. Patient died due to COVID-19." "1723096-1" "1723096-1" "Dyspnea c/o. Pt is on 2 liters at home. COVID positive recently. Hypoxia concerns with exertion. Pt is currently on 6 liters via NC, but plan to place on Bipap. patient was a transfer to our facility. one dose of the vaccine was administered on 2/1/2021 but no record of lot number" "1723124-1" "1723124-1" "Death" "1723131-1" "1723131-1" "Patient fully vaccinated with Pfizer vaccine. Tested positive for COVID 19 on 9/17/2021. Brought to ED at Medical Center on 9/18/2021 with shortness of breath and expired while in the ED." "1723155-1" "1723155-1" "Case fully vaccinated with Pfizer vaccine. Tested positive for COVID on 9/15/2021. Admitted to hospital on 8/24/2021. Tested positive for COVID while hospitalized and expired on 9/21/2021." "1723190-1" "1723190-1" "Case fully vaccinated with Moderna vaccine. Tested positive for COVID on 9/8/2021. Admitted to Medical Center on 8/29/2021 and expired while still hospitalized on 9/19/2021." "1723384-1" "1723384-1" "77 years old male with past medical history of A. fib on anticoagulation, glaucoma, prostate cancer on Lupron, arthritis, brought to the emergency room today for confusion and weakness. The patient reported that his weakness started around 6 AM when he woke up trying to go to pee. He reported that he was having trouble trying to keep his head up and he was confused as he does not know how to use his phone. However, he has no focal deficit. I believes he may have taken too much of his norco10mg as well. He cannot recall how often he took the med. He also claims to add tylenol 500mg To the norco 10 to help with his pain. I believe he call his neighbor and the neighbor called the ambulance and he was brought to the emergency room. On presentation, his heart rate was 107 but his systolic blood pressure was 93. Due to history of A. fib and on anticoagulation, the patient had a rectal exam and guaiac stool was strongly positive. He got Kcentra infusion to reverse the Eliquis. The work-up in the ER showed her the patient has INR 2.12, hemoglobin 11.8, platelet of 70, sodium 131, potassium 4.7, chloride 97, BUN 30 and creatinine 1.3. There is no chest x-ray, UA or CT scan of the head done. However, the patient denies any recent head injury. On the medical floor, the patient continued to be confused but no focal deficit or facial droop. He is quite confused and his answer is quite tangential. I spent around 30 minutes trying to get the history and it looks like he has been on new medication for his prostate cancer. It also sounds like he has been treated with a new medication for his A. fib. However, it sounds like the patient stopped these medications. However, he cannot provide me the exact name of the medication nor when he stopped taking them. It seems like the patient has leg swelling and he has been going on for about 6-week, after he started on the new medication to treat his A. fib. However, he reported that the medication was not helping his A. fib and he went back to his old medication. Other than that, his history is quite confusing as he is Talking mostly about his wife, who is being admitted to another hospital for possible CVA workup... ROS: Limited but (-) HA, visual changes, f,c,n/v, diarrhea, sob, chestpain, neckpain, lnew focal weakness, dysuria, dysphagia, dyspnea." "1723432-1" "1723432-1" "death SHORTNESS OF BREATH U07.1, J12.82 - Pneumonia due to COVID-19 virus" "1723439-1" "1723439-1" "death COVID-19 Pneumonia due to coronavirus disease 2019 Acute respiratory failure with hypoxia" "1723558-1" "1723558-1" "death SHORTNESS OF BREATH Non-ST elevation (NSTEMI) myocardial infarction Acute respiratory failure with hypoxia" "1723566-1" "1723566-1" "death AKI (acute kidney injury) Cerebrovascular accident (CVA), unspecified mechanism Acute respiratory failure with hypoxia Acute kidney failure, unspecified Thrombocytopenia, unspecified" "1723574-1" "1723574-1" "death N17.9 - Acute kidney failure, unspecified WEAKNESS - GENERALIZED RAPID HEART RATE" "1723575-1" "1723575-1" "death Acute kidney failure, unspecified COVID-19 Acute respiratory failure with hypoxia Pneumonia due to coronavirus disease 2019" "1723579-1" "1723579-1" "death J12.82 - Pneumonia due to coronavirus disease 2019 U07.1 - COVID-19 N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia D69.6 - Thrombocytopenia, unspecified" "1723582-1" "1723582-1" "death I63.9 - CVA (cerebral vascular accident) (CMS/HCC)" "1723828-1" "1723828-1" "patient died on 9/13/21. He was healthy prior to sudden cardiac arrest at approx. 8:00 am on 9/9/21. His CT scan showed multiple clots in his right lung. Patient had no history of clots. He had no heart disease or lung disease. Origin of clots is unknown. Patient was 9 months post 2nd Covid vaccine. COULD THE VACCINE CAUSED THE CLOTS AT 9 months post vaccine?" "1723877-1" "1723877-1" "Death-emts tried to ressusitate" "1725384-1" "1725384-1" "very agitated; couldn't breathe/ lungs were low; stroke; weak/ very bad; yellow; was sweating a lot; I am not feeling well; blood pressure was very low; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke), AGITATION (very agitated), DYSPNOEA (couldn't breathe/ lungs were low), ASTHENIA (weak/ very bad), YELLOW SKIN (yellow), HYPERHIDROSIS (was sweating a lot), MALAISE (I am not feeling well) and HYPOTENSION (blood pressure was very low) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stomach ulcer. Concurrent medical conditions included Bone cancer (In treatment for past 5 years), Hypercholesteremia and Hypertension. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 11-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (weak/ very bad) (seriousness criterion hospitalization), YELLOW SKIN (yellow) (seriousness criterion hospitalization), HYPERHIDROSIS (was sweating a lot) (seriousness criterion hospitalization), MALAISE (I am not feeling well) (seriousness criterion hospitalization) and HYPOTENSION (blood pressure was very low) (seriousness criterion hospitalization). On 12-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced AGITATION (very agitated) (seriousness criterion hospitalization) and DYSPNOEA (couldn't breathe/ lungs were low) (seriousness criterion hospitalization). The patient was hospitalized from 11-Apr-2021 to 12-Apr-2021 due to AGITATION, ASTHENIA, CEREBROVASCULAR ACCIDENT, DYSPNOEA, HYPERHIDROSIS, HYPOTENSION, MALAISE and YELLOW SKIN. On 21-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 12-Apr-2021, HYPOTENSION (blood pressure was very low) outcome was unknown. The patient died on 12-Apr-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed. At the time of death, AGITATION (very agitated), DYSPNOEA (couldn't breathe/ lungs were low), ASTHENIA (weak/ very bad), YELLOW SKIN (yellow), HYPERHIDROSIS (was sweating a lot) and MALAISE (I am not feeling well) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Blood pressure measurement: low (Low) Low. Relevant concomitant medications included, cancer medications, cholesterol medications, blood pressure medications and some other unspecified medications were reported. Treatment information was not provided. The reporter was not sure if the patient has got Moderna vaccine itself. Patient was in treatment for cancer for past 5 years. His doctor has changed the pills a few years ago and he was not able to tolerate this change of pills as they were too strong. In an appointment with the doctor, patient was very agitated and could not breathe. Patient's lungs were mentioned as too low. So the patient was with a machine that helped him to breathe properly. On 11-April-2021, patient was sent to the hospital. On 12-April-2021 past midnight, the patient died of a stroke. Company comment: This is a case of inappropriate schedule of vaccine administered for this 77-year-old male patient with medical history of stomach ulcer, hypercholesteremia and hypertension, who experienced the unexpected events of cerebrovascular accident, agitation, dyspnoea, asthenia, yellow skin, hyperhidrosis, malaise and hypotension. The events of asthenia yellow skin, hyperhidrosis, occurred 22 days after the second dose of mRNA-1273, and the remaining events occurred a day later. The rechallenge was not applicable as the events occurred after the second dose and no information about the first dose was disclosed. Causality for the events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Cerebrovascular accident is confounder by the history of bonecancer, hypercholesteremia, hypertension and advanced age. Reporter did not allow further contact; Sender's Comments: This is a case of inappropriate schedule of vaccine administered for this 77-year-old male patient with medical history of stomach ulcer, hypercholesteremia and hypertension, who experienced the unexpected events of cerebrovascular accident, agitation, dyspnoea, asthenia, yellow skin, hyperhidrosis, malaise and hypotension. The events of asthenia yellow skin, hyperhidrosis, occurred 22 days after the second dose of mRNA-1273, and the remaining events occurred a day later. The rechallenge was not applicable as the events occurred after the second dose and no information about the first dose was disclosed. Causality for the events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Cerebrovascular accident is confounder by the history of bonecancer, hypercholesteremia, hypertension and advanced age.; Reported Cause(s) of Death: Stroke" "1726206-1" "1726206-1" "Rapid hearth rate after 1st and 2nd vaccine. He died ." "1726211-1" "1726211-1" "Patient died on 9/13/2021. Verbally to be reported from a Pulmonary Embolism." "1726306-1" "1726306-1" "Hospitalized (9.2.21); Deceased (9.17.21); COVID-19 positive; Fully Vaccinated Discharge Provider Primary Care Physician at Discharge Admission Date: 9/2/2021 Date of Death: 9/17/21 Time of Death: 3:30 PM Preliminary Cause of Death: Bacteremia Discharge Disposition: death DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hyponatremia Loss of vision AKI (acute kidney injury) HOSPITAL COURSE: Patient is a 70 y.o. male with a pertinent past medical history for chronic diastolic heart failure, cirrhosis, non-insulin-dependent type 2 diabetes, who presented to the ED primarily with generalized weakness and left vision sided loss. The patient's wife is at bedside and provides aspects of history. 8/19 he started having some confusion and generalized weakness and went to the ED due to wife concern for hepatic encephalopathy, however ammonia normal. He went back to the ED 8/25 and was found to be COVID positive but did not have any symptoms, he received monoclonal antibodies the next day. He presented to the ED again 8/31 for right knee pain and swelling and thought that he may have twisted his knee, he has had a prior arthroplasty there. Radiograph was negative for fracture or other acute abnormality at that time. He then returned with left eye vision loss that started 5-6 days prior to admission that he had never mentioned until day of admission. He was noted to have hyponatremia and mild AKI both of which corrected while hospitalized. CT orbits negative for globe issue. Ophthalmology evaluated him and stated this was Iritis and started patient on prednisolone and atropine drops (the atropine caused left eye pupillary dilation). He was evaluated by ortho and had his right knee tapped which returned septic and grew MSSA. On Ancef with plan to continue 6 weeks course. His hospitalization was complicated by his lethargy and confusion likely related to pain medications and liver function. He had a stroke rap called which did not show concern for a stroke. He was found to have MSSA bacteremia as well and was seen by ID. TTE negative for vegetations. Unfortunately patient developed worsening LFTs and bilirubin. Gastroenterology was consulted. It is noted that patient had cirrhosis have baseline etiology unclear. Hepatitis-C and hepatitis-B workup were negative. Imaging did not show thrombus. Acute liver failure was initially attributed to recent anesthesia exposure and Ancef use as well as Tylenol. These medications were discontinued but LFTs continue to trend up. There was also concern for Bilateral endogenous endophthalmitis. IV Ancef was discontinued and patient was started on IV vancomycin and linezolid. Unfortunately this led to acute kidney injury with high vancomycin trough level. Given that his LFTs have continued to worsen despite stopping ancef, id felt the Ancef is less likely to be the cause of Abnormal LFTs, hence; he was placed back on Ancef and Vanco was discontinued. Unfortunately patient continued to decline and have further elevation in bilirubin levels. Ultimately after consultation with various consultants it was felt that the liver failure was more attributable to sepsis. Renal function also continued to decline with subsequent noted hyperkalemia. Given patient's overall decline and lack of options for possible medical intervention to reverse liver failure (patient deemed not to be a transplant candidate per Gastroenterology in setting of bacteremia) patient and family ultimately decided to pursue comfort care and patient was transitioned to inpatient comfort care on 09/16. Palliative Care was consulted and assisted with medication. Patient was placed on a fentanyl drip. Physician was called that patient passed away at 3:30 p.m. 09/17/2021. Patient officially pronounced on 15:50 on 09/17/2021. Family present in room." "1726435-1" "1726435-1" "Initially diagnosed with COVID-19 pneumonia. He required intubation shortly after arrival to the ED. He required significantly elevated ventilatory support since the beginning. He has required high ventilatory settings since the beginning of his ventilation course. Throughout his course he was treated aggressively with COVID-19 treatments, his baracitinib was stopped due to concern for concomitant bacterial infection. He remained on steroids and was increased to higher doses of steroids due to continued lack of improvement. He was started on therapeutic anticoagulation due to high concern for PE. He was never stable enough for CT scan unfortunately. He had difficult to control blood sugars during his course and was at one point in time on an insulin infusion. On the morning of 9/22/21 he had worsening of his oxygenation into the low 80s with a po2 of 51. Despite no changes to his ventilator and attempts to diurese he continued to decline. His sats dropped to the 70s and his po2 dropped to 41. He continued to decline throughout the morning with persistent hypoxemia and worsening hypotension despite pressor support and early afternoon and became bradycardic and subsequently asystole." "1726482-1" "1726482-1" "Patient fully vaccinated and hospitalized and eventually died due to Covid related causes." "1726490-1" "1726490-1" "COVID positive, admitted 9/9 for worsening hypoxia, deceased 9/10 while admitted. Fully vaccinated March 2021." "1726638-1" "1726638-1" "pt admitted to hospital for COVID-19 from 8/5/21 - 8/19/2021; discharged to nursing home where he began to have weakness and abnormal lab work with an increase in his heart rate; he was again transported to the hospital on 8/28/2021; hx of elevated liver enzymes and a known lung mass; COVID-19 pneumonia with acute hypoxemic respiratory failure" "1726639-1" "1726639-1" "Hospitalization due to shortness of breath and death" "1726726-1" "1726726-1" "presented to ED with productive cough, increasing SOB, fever, tested positive for COVID; HX of COPD, CHF, HTN,DM2, CKD II; intubated on 8/13, condition worsened where patient died in the hospital" "1726730-1" "1726730-1" "Patient fully vaccinated and died due to Covid related causes. Patient was a resident at a Nursing and Rehabilitation facility" "1726783-1" "1726783-1" "seen in ED after a dr's appointment for complaint of pain in L buttock area, COVID test done - positive; confusion, decreased appetite and drinking x 2days; mildly hypoxic; pt wanted to go home; dc'd to home with O2; pt died at home 5 days later" "1726785-1" "1726785-1" "Moderna COVID-19 vaccine on 2/13/21 & 3/11/21 Deceased- Positive COVID related death, 9/13/21" "1726842-1" "1726842-1" "Resident found unresponsive without a pulse at approx. 0730am on 9/22/21, CPR initiated, spouse chose to discontinue CPR, resident expired." "1726857-1" "1726857-1" "pt was hospitalized earlier with COVID-19, discharged to a nursing home where condition worsened and was brought back to hospital; presented with COVID-19 pneumonia; condition deteriorated and patient passed away in the hospital; hx of CHF, AFib, HTN" "1726966-1" "1726966-1" "HX of multiple myeloma, BMH, CKD 3; presented to ED after a fall at home with SOB and weakness, positive for COVID; acute hypoxemic respiratory failure due to COVID pneumonia" "1727109-1" "1727109-1" "obese 35yoM who presents with acute SOB which was found in the ED due to acute COVID 19. He is diaphoretic, and speaks in only short sentences, frequently expressing varying preference for BPAP or facemask. He received the Moderna vaccine series several months prior, and had been in his usual state of good health prior to the abrupt onset of symptoms. He takes medication for hypertension. DISCHARGE DIAGNOSIS: 1. Acute hypoxic respiratory failure secondary to COVID- 19 pneumonia 2. COVID- 19 pneumonia with super-imposed bacterial pneumonia 3. Sepsis secondary to above on pressor support 4. Obesity with body mass index 57 5. Elevated D-dimer He was started on NRB and BPAP, as well as all COVID therapies of steroids, anticoagulation, Colchicine, and Ivermectin. He was also started on broad spectrum antibiotics for possible super-imposed bacterial pneumonia. His oxygenation worsened and he was intubated on 8/8. His O2 levels remained difficult to control and the AM of 8/9 he was proned with increasing PEEP. His oxygenation improved and he appeared to be overall stabilizing by 8/10. The afternoon of 8/10, he was getting suctioned by RT and was noted to become bradycardic, however, this quickly resolved with Atropine and was attributed to increased vasovagal tone secondary to prone positioning and increased PEEP. He remained HD stable and his O2 remained 90s (Last recorded VS HR 61, RR 24, BP 111/67, and O2 99%). Unfortunately, at approximately 2117 the patient developed an irregular heart rate before going into ventricular tachycardia and then asystole. He was started on medical management as per guidelines and CPR was initiated as soon as possible under the direction of Dr. was never obtained and Dr called at 2150. The patient's family was informed of his passing and all questions were answered. Cause of death appears to be cardiac arrest secondary to ventricular tachycardia secondary to hypoxic respiratory failure secondary to COVID- 19 pneumonia." "1727167-1" "1727167-1" "Acute hypoxic respiratory failure secondary to COVID-19 pneumonia Left pneumothorax 2/2 COVID-19, s/p chest tube insertion Covid-19 pneumonia with superimposed Hospital acquired bacterial pneumonia Sepsis with septic shock and multiorgan failure requiring pressors 2/2 above Acute kidney injury with anuria secondary to above Hypertension Hyperlipidemia Coronary artery disease Aortic valve replacement Congestive heart failure with diastolic dysfunction Chronic back pain Rheumatoid arthritis Anemia Hypothyroidism Diabetes mellitus II 71 yo Male with a history of hypertension, hyperlipidemia, coronary artery disease, aortic valve replacement, congestive heart failure with diastolic dysfunction, prostate enlargement, rheumatoid arthritis, and anemia presenting for cough, mild shortness of breath, and back pain. He reports that he is vaccinated and got both Moderna vaccines several months ago. He reports about 2 days of worsening fatigue, back pain, cough, and mild shortness of breath. He came to the ED for the cough and was found to have borderline low O2. He reports mild chest pain with cough only. No fever, chills, nausea, vomiting, bowel changes. His son also has COVID as is currently admitted. Patient was vaccinated and inflammatory markers were elevated Overnight 8/11, his O2 worsened to 15L NC, however, he was able to be weaned back to 3L NC. He again worsened 8/14 with concerns for HAP vs aspiration PNA. He was started on empiric coverage but he continued to decompensate and it was decided to undergo RSI on 8/16. He was moved to the ICU and began to improve being able to tolerate wean down to 50% fiO2 but then on 8/19 he began to desaturate again. Stat XR noted L sided pneumothroax requiring chest tube insertion. Despite aggressive therapy he continued to decline going into renal and eventually multiorgan failure. Spouse was updated regularly during his admission of his progress and prognosis. On 8/23/21 family notified us to discontinue aggressive care, discontinue life support, and focus on comfort measures. Emergency services was called to the bedside as patient was found unresponsive. The patient was found to be in asystole. At 1223 the patient was pronounced deceased. Family was notified." "1727193-1" "1727193-1" "pt was seen in the doctor's office earlier in the week and diagnosed with pneumonia (COVID test was negative)before being seen in the ED on 8/27; presented to ED after falling 3x in past 24hrs; c/o weakness x 1 wk and cough, pt admitted; condition worsened; COPD exacerbation with sepsis due to COVID; pt passed away in the hospital" "1727253-1" "1727253-1" "Patient's grandmother found him dead in the bathroom 4 to 4:30 hours after his vaccine. She was not aware of him having complaints. He had vomited in the commode -that was the only comment that she had." "1727443-1" "1727443-1" "Patient died on July 7, 2021 of a pulmonary embolism. The clots were in his lungs." "1727523-1" "1727523-1" "Hospitalized (9.13.21); COVID-19 positive (9.13.21); Deceased (9.22.21); Fully Vaccinated Admission Date: 9/13/2021 Discharge Date: 09/22/2021 Discharge Diagnoses: Severe COPD COVID-19 positive GAD CKD3 DISCHARGE INSTRUCTIONS Discharge Disposition: Deceased DETAILS OF HOSPITAL STAY Hospital Course: Patient is a 81 y.o. male with PMH of O2 dependent COPD, GAD, CKD3 who presented 9/13 with chest pain/pressure and SOB. He was discharged 8/23 after hospitalization for COPD exacerbation and had loose stools, SOB, and cough. He tested positive for COVID-19 and was on baseline O2. He was having trouble sleeping due to anxiety and SOB. He was treated with Decadron for COVID-19 which was transitioned to methylprednisolone when COPD seemed to be more of his underlying problem. Initial chest x-rays and CTA were unremarkable for underlying pneumonia or blood clot. Patient's symptoms were difficult to assess as underlying anxiety, respiratory status, or both. Patient remained on home O2. He was treated with frequent nebulizer treatments, and PRN Ativan and hydroxyzine added for underlying anxiety. He was started on antibiotics for possible underlying bacterial pneumonia on 9/17 although clinical suspicion was low. The patient did not improve symptomatically and discussed goals of care with Dr. At that point, he transitioned to comfort care on 9/19. Comfort measures were initiated and patient passed overnight 9/21-9/22." "1728780-1" "1728780-1" "Death due to COVID-19 pneumonia and acute hypoxic respiratory failure" "1729444-1" "1729444-1" "Patient began having severe headaches within 24 hours of second dose of Moderna vaccine. The following day patient became light headed and dizzy, unable to stand up straight with blinding headaches. Called the clinic where she received the vaccine and told to relax as these were temporary side effects and that is how she knows it's working. Headaches did not subside, patient died 2 and a half months after second dose of Moderna vaccine that was administered at the Hospital/clinic" "1730309-1" "1730309-1" "cause of death of unknown aetiology (her spelling) coronary artery disease; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CORONARY ARTERY DISEASE (cause of death of unknown aetiology (her spelling) coronary artery disease) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced CORONARY ARTERY DISEASE (cause of death of unknown aetiology (her spelling) coronary artery disease) (seriousness criterion death). The patient died on 30-Jan-2021. The reported cause of death was unknown aetiology (her spelling) coronary artery disease. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant and treatment medications were reported. Company comment- This case concerns a 77-year-old, male patient with no known medical history, who experienced the unexpected event of CORONARY ARTERY DISEASE. The event occurred approximately 11 days after the first dose of Spikevax and had a fatal outcome, with death occurring in this day. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 77-year-old, male patient with no known medical history, who experienced the unexpected event of CORONARY ARTERY DISEASE. The event occurred approximately 11 days after the first dose of Spikevax and had a fatal outcome, with death occurring in this day. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: unknown aetiology (her spelling) coronary artery disease" "1730336-1" "1730336-1" "Clot in his Heart due to the Vaccine; A small Bubble in the Injection site; This spontaneous case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (Clot in his Heart due to the Vaccine) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 092D21A and 059E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced APPLICATION SITE VESICLES (A small Bubble in the Injection site). On 06-Sep-2021, the patient experienced INTRACARDIAC THROMBUS (Clot in his Heart due to the Vaccine) (seriousness criteria death and medically significant). The patient died on 06-Sep-2021. The reported cause of death was clot in his heart due to the vaccine. It is unknown if an autopsy was performed. At the time of death, APPLICATION SITE VESICLES (A small Bubble in the Injection site) outcome was unknown. Concomitant product use was not provided by the reporter. The patient died in his sleep after 24 hours of getting his second dose of the Moderna Covid-19 vaccine. The patient did not have any existing medical condition and the cause of death indicated on death certificate was a clot in his heart due to the vaccine. Patient only had a small bubble in the injection site. No treatment information was provided. Company comment: This fatal case concerns a 74-year-old male patient with no medical history reported, who experienced the serious unexpected event Intracardiac thrombosis .The event occurred approximately 28 days after the first dose and one day after the second and most recent dose of mRNA-1273 Moderna vaccine. The reported cause of death was clot in his heart due to the vaccine. It is unknown if an autopsy was performed. Further information has been requested. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This fatal case concerns a 74-year-old male patient with no medical history reported, who experienced the serious unexpected event Intracardiac thrombosis .The event occurred approximately 28 days after the first dose and one day after the second and most recent dose of mRNA-1273 Moderna vaccine. The reported cause of death was clot in his heart due to the vaccine. It is unknown if an autopsy was performed. Further information has been requested. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Reported Cause(s) of Death: Clot in his Heart due to the Vaccine" "1730909-1" "1730909-1" "My friend was fully vaccinated got covid on ventilator 14 days then died - how can you say it is safe and effective if you can still get it and die? Stop this madness of this vaccine NOW!" "1731177-1" "1731177-1" "9/23/2021 2:30pm- Resident noted having agitation this shift taking his right arm and banging on the wall with his right arm noted 3 new discolorations to his right forearm and hand. Resident continued to bang on wall hospice notified visited resident to assess status change. Resident noted having agitation this shift taking his right arm and banging on the wall with his right arm noted 3 new discolorations to his right forearm and hand. Resident continued to bang on wall hospice notified visited resident to assess status change. New order for Seroquel 25mg in the am and 2 25mg tabs at bedtime with prn dose 25mg as needed for agitation q6h will evaluate need for prn medication on 10-7-21. Resident is resting comfortably in his bed at this time. 9/23/2021 9:30pm- Resident noted to be non responsive with no audible or visible signs of life. Unable to obtain BP. Unable to auscultate apical pulse or palpate any peripheral pulses. Respirations are nonexistent. Pupils non reactive to light, fixed and dilated. Hospice notified of findings. Family notified, son stated he did not set up funeral home arrangements and will be calling right away and would contact facility. Pronouncement of death made by Dr." "1731202-1" "1731202-1" "pt presented to hospital after a fall earlier today, c/o abdominal pain, confusion, fatigue and decreased appetite x 1 wk; tested positive for COVID; condition deteriorated where pt passed away in the hospital." "1731203-1" "1731203-1" "Pt received Pfizer vaccination series at local pharmacy. Was hospitalized with COVID-19 diagnosis 9-20-21. Passed away 9-24-21." "1731205-1" "1731205-1" "Admitted to hospital with covid pneumonia on 9/10/21. Patient was fully vaccinated with doses of Pfizer covid vaccine with first dose on 2/1/2021 and second dose on 2/23/21. Patient eventually required intubation and ultimately expired on 9/23/21." "1731226-1" "1731226-1" "pt's husband positive for COVID, pt presents to ED with c/o progressive weakness, N/V/D x 2 wks; fever, non-productive cough, SOB; positive COVID test; pt's condition worsened where she died in the hospital" "1731246-1" "1731246-1" "Breakthrough COVID-19 case with Symptom onset 7/19/21; c/o cough, congestion, malaise. Death 8/3/2021. From vital records: HEART FAILURE UNSPECIFIED, ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS, COVID-19. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: None listed. place of death: NURSING HOME-LONG TERM CARE FACILITY,, PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: HOMEMAKER, OWN HOME" "1731261-1" "1731261-1" "PRESENTED TO ED WITH DYSPNEA, TESTED COVID19 POSITIVE. DEVELOPED ACUTE RESP FAILURE AND DIED 9/11/21" "1731266-1" "1731266-1" "Deceased. Heart attack. 24-48 hours after 2nd injection." "1731299-1" "1731299-1" "Fully vaccinated individual, hospitalized on 9-20-21 for COVID. Passed away 9-24-21." "1731305-1" "1731305-1" "Breakthrough COVID-19 case with unknown symptom status. Hospitalized 9/9/2021-9/12/2021. Death 9/12/2021. Death certificate not yet available" "1731338-1" "1731338-1" "PT PRESENTED WITH ALTERED MENTAL STATUS, DELERIUM WHICH RESULTED IN LETHARGY; POSITIVE FOR COVID-19, HX OF CLL AND A FIB; PT'S CONDITION WORSENED WHERE SHE DIED IN THE HOSPITAL" "1731354-1" "1731354-1" "Breakthrough COVID-19 case with symptom onset 3/8/2021: abdominal pain. Hospitalized 3/5/2021 for unknown duration. Death 6/1/2021. From Vital Records COD = CHRONIC DIASTOLIC CONGESTIVE HEART FAILURE, HYPERTENSION. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: CHRONIC KIDNEY DISEASE PERIPHERAL VASCULAR DISEASE ADULT FAILURE TO THRIVE. place of death: NURSING HOME-LONG TERM CARE FACILITY, PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: OWNER OPERATOR, RETAIL" "1731362-1" "1731362-1" "presented to ED with hypoxia, cough, SOB, chills, loss of taste and smell, loose stools; hx of HTN; tested positive for COVID-19; acute chronic kidney disease; pt deteriorated during the hospital stay and eventually passed away in the hospital; COVID-19 pneumonia" "1731372-1" "1731372-1" "Breakthrough COVID-19 case with unknown symptom status. Death 6/30/2021. From Vital Records COD = ACUTE CARDIOPULMONARY ARREST, ALZHEIMER'S WITH DEMENTIA DISEASE, DIABETES MELLITUS TYPE 2. Per vital records; Other Significant Conditions include: None listed. place of death: DECEDENT'S HOME; certified by: CERTIFYING PHYSICIAN; occ/ind: HOME ECONOMICS TEACHER, EDUCATION" "1731400-1" "1731400-1" "positive for COVID on 8/23; took monoclonal antibodies on 8/25 and dc'd to home; presented to ED 8/27 with SOB, chills, fever, poor appetite, diarrhea x5days, generalized weakness; acute respiratory failure" "1731423-1" "1731423-1" "presented to ED with c/o dyspnea, confusion, known bronchitis (on a Z pack), hypoxic; positive COVID -19 test; severe acute hypoxic respiratory failure; pt intubated; condition worsened where patient died in the hospital; hx of HTN, HL, NIDDM" "1731435-1" "1731435-1" "Case fully vaccinated with Pfizer. Tested positive for COVID 19 @ 9/15/2021. Admitted on 9/15/2021 and expired on 9/20/2021 while still hospitalized." "1731451-1" "1731451-1" "pt tested positive for COVID on 8/18; presented to ED on 8/24 hypoxic with confusion, SOB, coughing; placed on BIPAP; pneumothorax occurred; condition worsened where patient died in hospital" "1731465-1" "1731465-1" "Patient was hospitalized for unknown reasons. Patient was fully vaccinated. Died due to COVID." "1731525-1" "1731525-1" "hx of pituitary adenoma - post surgical resection back in April 2021; presented to ED with weakness and SOB, positive for COVID - 19; pt's condition worsened where he passed away in the hospital; Acute hypoxemic respiratory failure secondary to COVID pneumonia" "1731557-1" "1731557-1" "Hx of recent hospitalization for cellulitis, dc'd home with IV antibiotic therapy; tested positive for COVID while in the hospital; presented to ED with severe hypoxia; respiratory failure with intubation; AFib; COVID pneumonia; pt passed away in the hospital" "1731564-1" "1731564-1" "Breakthrough COVID-19 case with unknown symptom onset: sob/difficulty breathing, nausea or vomiting, generalized weakness. Hospitalized 8/9/2021 to 8/16/2021. Death 8/16/2021. COD respiratory arrest, COVID-19. Place of death: HOSPITAL. CERTIFIED BY PRONOUNCING AND CERTIFYING PHYSICIAN" "1731598-1" "1731598-1" "pt presented to ED with SOB x 1wk, worsening; morbidly obese; cough, hypoxic; hx of CHF, chronic A Fib, DM2; positive for COVID; intubated on mechanical ventilation; condition worsened, pt died in the hospital" "1731635-1" "1731635-1" "Breakthrough COVID-19 case with symptom onset 7/24/2021: weakness, cough, body aches, nausea, cough, congestion, anorexia, shortness of breath. Hospitalized 7/31/2021 for unknown duration. Death 8/27/2021. COD reported by ICP Acute respiratory failure with hypoxia, COVID-19 pneumonia, pulmonary edema, Acute kidney failure" "1731647-1" "1731647-1" "Client was discharged from hospital on 09/20/2021 and was found deceased on 09/21/2021" "1731676-1" "1731676-1" "Breakthrough COVID-19 case with unknown symptom status. Hospitalization, unknown date and duration. Death 8/11/2021. COD from vital records: hypoxemic respiratory failure, COVID-19 pneumonia. Place of death: HOSPITAL INPATIENT, PRONOUNCING AND CERTIFYING PHYSICIAN, occ/ind: UPHOLSTERER, UPHOLSTERY" "1731745-1" "1731745-1" "Was taken to pharmacy for Janssen Covid-19 shot, she passed away after hospitalization for bilateral blood clots in lungs and blood clout in leg. Date of death July 31, 2021. (Cause of death per death certificate: pulmonary thromboembolism and deep venous thrombosis.)" "1732122-1" "1732122-1" "Death sometime the next A.M." "1732172-1" "1732172-1" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732186-1" "1732186-1" "Patient began complaining about not feeling well. He was nauseated and began throwing up and going to the bathroom. That continued off and on all night. Around 6:30 - 6am the next morning he said he was feeling somewhat better but was very weak. H e went back to bed. We checked on him around lunch time lying on his bed with his phone in his hand. He appeared to be trying to text. I checked on him a few minutes later and he had not moved. I checked and saw he wasn't breathing. At that time he had a heart beat. We called 911 and I started CPR and continued for approx 25 until paramedics arrived. They bagged him and used defibrillator but could not bring him back." "1732348-1" "1732348-1" "unknown" "1732399-1" "1732399-1" "No adverse effect during the 15 minutes after administration of vaccine patient expired on 9/23/21 reported by facility" "1732415-1" "1732415-1" "increased feeling of unwellness and weakness, gasping like chest or stomach spasms" "1732810-1" "1732810-1" "breathing, chest pain, and severe pain within joints." "1733185-1" "1733185-1" "Death" "1734141-1" "1734141-1" "killed this young man/he died of an enlarged heart (500+ grams); The initial case was missing the following minimum criteria: unidentified reporter. Upon receipt of follow-up information on 20Sep2021, this case now contains all required information to be valid. This is a spontaneous report from Pfizer sponsored Program, via contactable consumers. A 16-year-old male patient received BNT162B2 via an unspecified route of administration on 19Apr2021 (Lot Number: ER8731; Expiration Date: Jul2021) (at 16-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient died in 24Apr2021. His father claimed he took the Pfizer vaccine five days before (24Apr2021) he died and that he died of an enlarged heart (500+grams) from Apr2021. It's not reported if autopsy performed. Follow-up attempts are completed. No further information is expected. ; Reported Cause(s) of Death: died of an enlarged heart" "1734462-1" "1734462-1" "on Day 8 post vaccination, who presents to ED complaining of worsening shortness of breath for the past 4 days associated with cough and fever. Tested positive for COVID 8/29/21. Pneumonia, ARF, Septic Shock, AKF, Received CRRT from effects of Baricitinib, . Coded resulting in Death 9/25/21." "1734587-1" "1734587-1" "Heart attack, death" "1734641-1" "1734641-1" "Patient required hospitalization due to breakthrough infection. Patient received Pfizer vaccine (2nd dose in series) on 03/28/2021. Patient was hospitalized from 08/31/21 - 09/24/21. Below is copied from patients discharge (death) summary: Patient is a 73 y.o. female with PMH of RA/PMR and hypothyroidism who was initially admitted to the hospital on 8/31 for stroke like symptoms (left sided weakness, right facial droop and aphasia) for which she recieved TNK and had neuro ICU admission. MRI and stroke workup was unrevealing how patient remained enephalopathic with development of hypoxic respiratory failure requiring intubation from 9/5-9/14. Following extubation, patient was downgraded to hospitalist serevice for further management on 9/16. On 9/24, patient was admitted to MICU following cardiac arrest with asystole noted on telemetry. Patient recieved 6 rounds of CPR, epix3, bicarbx2, and calcium. She was intubated at that time and ROSC was achieved with post-resuscitation BP 100/50. Epi gtt was started and patient was admitted to MICU service. Immediately upon arrival to patient coded again at 4:21 AM with PEA arrest. She recieved Epix5, bicarbx3 with ROSC at 4:36. Upon achieving ROSC, patient again became pulseless with PEA arrest at which time an additional 3 rounds of CPR were performed however patient did not achieve ROSC and began to have copious blood return from ETT. Given patients anemia and active bleed, TNK was not administered as risks overweighed benefits. No further rounds of CPR performed. No Subsequent spontaneous movements were present. There was no response to verbal or tactile stimuli. Pupils were dilated and fixed. No breath sounds were appreciated over either lung field. No carotid pulses or peripheral pulses were palpable. No heart sounds were auscultated over entire precordium. Patient pronounced dead at 5:16 AM. Family was notified and condolensces were offered." "1734644-1" "1734644-1" "Vaccine Breakthrough Case - led to hospitalization and death Vaccinated Moderna: 2/12/2021 & 3/12/2021 The individual tested positive for COVID-19 on several respiratory tests beginning on 9/10/21. Her symptoms began on 9/8/21, and she was admitted to the hospital on 9/10. She was found to have double pneumonia. The patient also had acute respiratory distress syndrome. The patient unfortunately passed away on 9/24/21. The case has a positive test from 6/18/21, because she was supposed to go in for a procedure, but was asymptomatic at the time and tested negative on 6/23/21." "1734652-1" "1734652-1" "Pt. is a 65 y.o. female with past medical history of asthma, diabetes, morbid obesity with BMI of 55, hypertension, who presents to the Emergency Department with chief complaint of as mentioned above. The patient has been sick for the last 1 week with fever, cough, shortness of breath. She went to ER a couple times and was diagnosed with COVID-19 and viral pneumonia. The patient was sent home with Decadron. Despite the treatment, the patient progressively became more hypoxic with oxygen saturation of 70 to 80% at her baseline of 4 L of home O2. The patient also continues to have fever 101 F. Onset of her condition was gradual with moderate symptom. Exertion aggravates her condition and oxygen helps In the ER today, the patient has fever 101.5 Fahrenheit. Blood pressure was mildly low between 90-110. The patient had a chest x-ray today that showed stable diffuse patchy multi lobar lung infiltrate. The patient at this point is being admitted for COVID-19, multi lobar pneumonia, acute on chronic hypoxic respiratory failure, failure of outpatient treatment." "1735004-1" "1735004-1" "Presented from home for N/V/D. CXR showed opacities, COVID PNA. Tx w/ supplemental O2, abx, steroids, remdesivir. Hx HTN, Type II DM. At time of DC stable on 2.5L. DCd to SNF." "1735014-1" "1735014-1" "Admit for COVID pna, dx with COVID 8 days PTA. Placed on O2, steroids remdesivir, lovenox, Tocilizumab, rocephin/azithro, vit-C. Progressed to HFNC." "1735298-1" "1735298-1" "Death for no apparent reason" "1735402-1" "1735402-1" "Patient vaccinated 4/19/2021. Patient became immobile 4/30/2021. Patient died 5/9/2021." "1735547-1" "1735547-1" "My husband developed sclerosis of the live followed by a heart attach and then kidney failure. My husband was complaining about feeling exhausted and ache all over. He fell the following day and was transported to the emergency room on 8/5/2021 and admitted later that day. My husband never left the hospital and passed away on 8/11/2021." "1735797-1" "1735797-1" "Pt received Pfizer x2. Pt tested COVID + on 8/9/21 and admitted to hospital for COVID on 8/10/2021. Pt received remdesivir and dexamethasone. Deceased on 9/4/2021" "1735866-1" "1735866-1" ""Patient fell off edge of bed face forward; ambulance was called. They helped her up off the floor, then assisted her into a chair in the living room. Later that same evening, patient got up and walked into the bathroom to use the toilet. While sitting on the toilet, she fell forward and to the left hitting her head on the side of the bathtub that was positioned to the left of the toilet. Her husband asked if she was okay. She responded, ""I hit my head"", then she stopped talking and he went for help. Emergency workers attempted CPR, but were unable to recussitate."" "1736146-1" "1736146-1" "Death" "1736473-1" "1736473-1" "Weakness, achy, increased signs of dementia, fatigue, confusion, stomach pain, headaches (which he had never had his whole life). About 6 months later, developed pneumonia, tested positive for COVID-19. Death on 9/21/2021." "1736654-1" "1736654-1" "Pt s/p fall on 9/6 and seen in ED. Pt is resident of assisted living facility. Returned on 9/14 with general body weakness, wheezing and dry cough x 5 days. Testing for RVP in the ED is positive for COVID 19 and RSV coinfection" "1736661-1" "1736661-1" "Patient brought in by EMS admitted from the ED with difficulty breathing, altered mental status and severe hypoxemia. Pt intubated in ED and found to have bilateral basilar infiltrates - testing + for COVID 19 on PCR. Pt treated for COVID 19 from 9/6-9/13 when his medical team and family agreed that comfort care was the best option. Patient pass on 9/22." "1736676-1" "1736676-1" "Breakthrough COVID-19 case with symptom onset 8/16/2021: Fever, Shortness of breath/difficulty breathing, Nausea/Vomiting, Cough. Hospitalized 8/16/2021 to 9/2/2021. Death 9/2/2021. From Vital Records = SEPTIC SHOCK, COVID-19 PNEUMONIA, Per vital records, Codes include: Not yet coded ; Other Significant Conditions include: None listed. Place of death: HOSPITAL-INPATIENT, MEDICAL CENTER; certified by: HCP, PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: ." "1736717-1" "1736717-1" "MODERNA COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/2/2021 and 1/30/2021. Patient previously hospitalized for for COVID pneumonia 8/26/2021 to 8/31/2021. Patient presented to ED on 9/9/2021 for shortness of breath. Patient was placed on BiPAP for worsening hypoxia. Patient received: methylprednisolone, zosyn, and vancomycin. Respiratory condition worsened and family decided to place patient on comfort care. Patient expired shortly after at 0953 on 9/16/2021." "1736722-1" "1736722-1" "Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/13/2021 and 2/3/2021. Patient presented to ED on 9/16/2021 for hypoxia. Patient was hospitalized, became delirious, and aspirated. Patient received dexamethasone, remdesivir, ceftriaxone, and zosyn. Patient continued to decline throughout hospitalization. Family decided to transition to comfort care and patient expired at 1212 on 9/21/2021." "1736724-1" "1736724-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/10/2021 and 4/7/2021. Presented to ED on 9/4/2021 with new onset of altered mental status, and right sided facial asymmetry. Patient admitted, and diagnosed as COVID-19 positive, treated with remdesivir, dexamethasone, baricitinib. Patient began requiring oxygen (3L NC) on 9/6, escalating to 5 L NC on 9/7, to 9L on 9/9, 11 L Oximizer on 9/10. Patient transitioned to comfort measures on 9/11/2021. Patient expired on 9/15/2021" "1736735-1" "1736735-1" "Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/12/2021 and 4/9/2021. Patient presented to emergency department on 8/26/21 with shortness of breath, cough, fatigue, and diarrhea, all starting 11 days prior to admission. She was diagnosed with covid on 8/25. She was admitted with acute respiratory failure with hypoxia due to covid 19 pneumonia.She was initially placed on airvo. Inflammatory markers were elevated. Her procalcitonin was elevated and she received and completed a course of Rocephin. She completed a 10-day course of Decadron and was changed to solumedrol. She completed a course of remdesivir and baricitinib. She was subsequently started on cefepime with dense consolidation on her Xray. She was on Lovenox that was decreased to DVT prophylaxis dose. Her echo showed normal LVEF of 55-60% with Grade II diastolic dysfunction. Her oxygen requirements increased, and she was intubated on 9/16. She was switched from solumedrol to a prednisone taper. Her Lovenox dose was changed to bariatric dose. She was continued on insulin. Her Lovenox was switched to heparin. She had worsening pulmonary fibrosis and developed hypoxia refractory to ventilatory support (saturations in the 60% range). She was not deemed a candidate for CRRT. ICU team met with family and her code status was changed to DNR/AND. Patient's ventilation was deescalated. Patient expired at 1444 on 9/22/21." "1736739-1" "1736739-1" "Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/6/2021 and 2/27/2021. Patient stated he received a third COVID vaccine around the 1st of September 2021 but unable to verify with documentation. Patient presented to ED on 9/9/2021 for hypoxia. Hospitalized for COVID pneumonia. Dexamethasone, levofloxacin, zosyn, vancomycin, and remdesivir were administered. Patient continued to decompensate throughout hospitalization. Patient was transitioned to comfort care on 9/20/2021 and expired at 1734 on 9/20/2021." "1736741-1" "1736741-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/1/2021 and 3/5/2021. Patient presented to ED on 8/26/2021 with shortness of breath, after a diagnosis of COVID-19 the day prior. Patient also has had nausea, diarhhea, diffuse muscle aches and fever as high as 101. UTI noted and patient was discharged from ED with Bactrim. Patient returned to ED on 8/31/2021 with complaints of fever, back pain, and O2 sats of 88% subsequently admitted with diagnosis of COVID-19, E. coli UTI, Severe sepsis with organ dysfunction. Patient started on ceftriaxone, remdesivir, and steroids. Blood cultures positive for staph epi 2/2 sets and started on vancomycin. Cultures cleared with patient placed on Vancomycin. Patient ultimately required high O2 requirement on HFNC. She showed some improvements but declined and 9/10 repeat CT chest showed: persistent infiltrates, worsened fibrotic changes and traction bronchiectasis compared to 1.5 weeks ago. She also was noted to have a positive fungitell. She eventually progressed to BiPAP. Pallitiave care was consulted and patient's MPOA, transitioned to DNR/AND on 9/15. Comfort care initiated with the assistance of palliative care physician." "1736745-1" "1736745-1" "Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/6/2021 and 2/27/2021. Patient presented to ED with generalized weakness for several days prior to admission. Patient noticed difficulty walking and progressed to being unable to stand/get out of chair. In the ED, temp 99.9, vitals stable. Labs with normal WBC, procalcitonin 0.51, lactate wnl, Cr 2.06, BNP 604 and trop 0.1. UA with rare bact, 3+LE, 20-50 WBCs. Patient was admitted for acute hypoxic respiratory failure, due to covid 19. He was treated with steroids for 10 days and cefepime. He had acute CHF, renal failure. He eventually developed spontaneous PTX and had chest tube placed by pulmonary. Goals of care addressed with family who eventually elected comfort measures and hospice. Patient expired at 1600 on 9/17/21." "1736748-1" "1736748-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 4/28/2021 and 5/19/2021. Presentes to ED on 9/2/2021 with complaints of illness for 5 days with symptoms of nausea, vomiting, diarrhea, chills and subjective fever. Also reports COVID-19 exposure. Patient admitted. At time of admission no respiratory symptoms, SpO2 of 98%. Patient reports dyspnea on 9/6, with need for O2 via nasal cannula. Patient experiences desturation on 9/11 requiring 7 L/min (SpO2 = 93%). On 9/12 requiring 60L FiO2 70%. On 9/13 60L FiO2 86% with an SpO2 of 100%. On 9/14, while receiving HFNC at 50L 80% patient desats to 80%. Patient transitioned to comfort care. Patient expired on 9/16/2021." "1736750-1" "1736750-1" "Patient is a 71-year-old male with a past medical history of COPD, bronchiectasis, asthma, dilated cardiomyopathy, last ejection fraction 20% who presents to our facility with concerns of dyspnea, malaise, fatigue. Symptoms present for the last 3 days. Of note, patient recently admitted to her SOB for similar complaints. At this time he did not have COVID. He presents to our facility hypotensive with heart rate near 150s. He currently denies chest pain but admits to mild increased work of breathing and shortness of breath. No nausea, vomiting, or abdominal pain. He follows up with his cardiologist. He is currently on torsemide daily which was switched by his cardiologist on the 23rd. He is compliant with his other medications. He was recently started on entresto." "1736780-1" "1736780-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/12/2021 and 3/5/2021. Presented to ED on 9/5/2021 with complaints of generalized weakness, cough, body aches, diarrhea, as well as subjective fever and chills. Weakness has been progressing over 1 week. Patient treated with dexamethasone, remdesivir, ceftriaxone, azithromycin. Increasing O2 needs on 9/8. On 9/15 patients condition deteriorated, and using high flow O2 80% 50 L. Patient expired on 9/16/2021." "1736783-1" "1736783-1" "Breakthrough COVID-19 case with unknown symptom status. Hospitalized 8/9/2021-8/15/2021. Death 8/15/2021. From Vital Records COD = CARDIOPULMONARY ARREST, ACUTE RESPIRATORY FAILURE, ACUTE CARDIAC FAILURE. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: None listed. place of death: HOSPITAL-INPATIENT, MEDICAL CENTER; certified by PRONOUNCING AND CERTIFYING PHYSICIAN, occ/ind: RETAIL SALES, SALES" "1736784-1" "1736784-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/13/2021 and 2/10/2021. Presented to ED on 8/31/2021 for weakness secondary to hyponatremia which is acute on chronic. She was incidentally found to have COVID-19 infection.She was treated with stress dose Solu-Cortef. During her 1st 24 hour, she started to show some desaturation. She was started on dexamethasone 6 mg daily. Patient continue showing no respiratory symptoms. Her hypoxia did worsen slightly during her hospital stay and the maximum need of oxygen was 3-4 L. Her examination showed no wheezes or rales. And she has no respiratory symptoms. Patient was discharged on 9/4/2021. On 9/7/2021 presented to the ED with mild hypoxemia and shortness of breath. She was started on dexamethasone therapy and broad-spectrum empiric antibiotics with cefepime. She received baricitinib from 9/8-12 but discontinued for suspected thrombosis. She continued to require increasing oxygen and ultimately on 09/17 intubated. Blood culture and sputum culture have been negative respiratory pneumonia panel was negative, MRSA nasal swab negative. She has been receiving Unasyn for possible aspiration pneumonia. Unfortunately, she continued to progressively worsen developing renal failure with multi-system organ failure, acidosis, hyperkalemia, and refractory shock on multiple pressors. On 9/21 patient's family elected for comfort care. Patient expired 9/21/2021." "1736790-1" "1736790-1" "Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/13/2021 and 2/2/2021. Patient presented to ED on 9/9/2021 for shortness of breath, diagnosed with COVID-19 on 9/5/21 which was onset of his symptoms, including fever to 101, productive cough with white sputum, no hemoptysis. Hospitalized for COVID pneumonia and diabetic ketoacidosis. Azithromycin, ceftriaxone, dexamethasone, fludrocortisone, hydrocortisone, meropenem, micafungin, zosyn, vancomycin were administered. Patient required mechanical ventilation upon admission. Patient continued to decompensate throughout hospitalization and expired at 12:18pm on 9/18/2021." "1736795-1" "1736795-1" "Breakthrough COVID-19 case with symptom onset 8/6/2021: Cough. Hospitalized 8/6/2021-8/7/2021. Death 8/7/2021. Vital records data not available yet." "1736811-1" "1736811-1" "PT EXPIRED; BREAKTHROUGH CASE OF COVID-19" "1736816-1" "1736816-1" "PT EXPIRED; BREAKTHROUGH CASE OF COVID-19" "1736821-1" "1736821-1" "42-year-old lady with a history of obesity who was recently admitted to outside hospital with COVID-19 pneumonia and associated complications including acute hypoxemic respiratory failure, ARDS, and AKI. During the course of her hospitalization, she was treated with dexamethasone, remdesivir, tofacitinib, Plaquenil, and ivermectin. She required intubation on 9/10 and developed cardiac arrest after a prolonged period of hypoxia on 9/12. She was transferred for higher level care and treatment with CRRT. She had a vascular catheter placed on 9/15 initiated dialysis that same night. She had an echocardiogram on 9/15 that most notably showed RV was mildly dilated with moderately reduced function therefore she was started on therapeutic heparin given the concern for possible PE in the setting of Covid. Patient underwent dialysis again on 9/17. Lower extremity Dopplers were negative for DVTs on 9/16. From a respiratory standpoint, she is being treated with flolan and has been continued on zosyn and zyvox since admission. She was started on voriconazole on 9/17 and fungal labs (fungitel, galactomannan, blaso/histo Ag) were ordered for concern of possible underlying fungal infection. CT PE studay showed two RV thrombus. Therapeutic heparin was changed to argatroban to reduce fluid intake. Unfortunately, despite our best efforts including maximizing ventilator settings and multiple rounds of hemodialysis patient continued to decline without improvement. After discussion with family on 9/22 decision was made to transition patient to comfort care but to keep her on the ventilator. On the morning of 9/23 at 0655 patient lost pulse and was pronounced dead." "1736876-1" "1736876-1" "ONSET 09/13/2021 WITH SOB, MYALGIA, RHINORRHEA, OLFACTORY/TASTE DISORDER, FATIGUE, COUGH, FEVER 102.6, NAUSEA RESULTING IN ICU HOSPITALIZATION AND DEATH" "1736905-1" "1736905-1" "Breakthrough COVID infection admitted with acute hypoxic respiratory failure secondary to SARS-CoV-2" "1736918-1" "1736918-1" "Shortness of breath" "1737002-1" "1737002-1" "Patient is fully vaccinated, then later hospitalized and died four days later due to Covid related causes. Patient was resident of long-term care facility" "1737051-1" "1737051-1" "Acute exacerbation of end stage CHF and Endstage COPD" "1737079-1" "1737079-1" "Severe headache within 4 hours of shot and after 4 days of feeling very unwell Pt stood up and fell over instantly of and aneurysm and died .I lost my partner of 23 years due to vaccination" "1737140-1" "1737140-1" "Diagnosed, hospitalized and expired from COVID-19" "1737143-1" "1737143-1" "unknown" "1737160-1" "1737160-1" "Diagnosed, hospitalized and expired from COVID" "1737167-1" "1737167-1" "Breakthrough COVID-19 case with symptom onset 8/19/2021: Cough. Hospitalized 8/19/2021 for unknown duration. Death 8/26/2021. Vital records COD = ACUTE HYPOXIC RESPIRATORY FAILURE, COVID-19. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: BRONCHIECHIECTASIS PULMONARY EMBOLUS; Place of death: HOSPITAL;" "1737223-1" "1737223-1" "Breakthrough COVID-19 with symptom onset 8/24/2021: Shortness of breath/difficulty breathing. Hospitalization 8/24/2021. Death 8/24/2021. From Vital Records COD = OBSTRUCTIVE SHOCK, SADDLE PULMONARY EMBOLUS, HYPERCOAGULABLE STATE, COVID 19. Per vital records, Codes include: Not yet coded ; Other Significant Conditions include: MORBID OBESITY PROTEIN DEFICIENCY. Place of death: HOSPITAL-INPATIENT, MEDICAL CENTER; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: PEER COUNSELOR, SERVICE. Dizziness. Pt c/o dizziness while at work. Pt COVID+ 8/9/21 and fully vaccinated. Pt VSS, GCS 15. Ambulatory on arrival. Denies N/V/fever" "1737230-1" "1737230-1" "On 06/02/2021 my father started having extreme abdominal pain. He visited er and was sent home with a surgeon follow up in one week. They said he had a hernia However no hernia was noted on autopsy report. He died suddenly on the morning of 6/9/2021 just before surgeon appointment" "1737285-1" "1737285-1" "PATIENT DEVELOPED COVID19 INFECTION FOLLOWED BY SUBSEQUENT HOSPITALIZATION AND DEATH" "1737314-1" "1737314-1" "On Jan. 30, 2021, my mom's blood pressure dropped, she was placed on oxygen support, and a blood panel indicated elevated risk of blood clotting. This was shortly after receiving a dose of Moderna COVID vaccine on or about Jan. 27. These symptoms seemed very similar to what she had experienced in December when she contracted COVID." "1737322-1" "1737322-1" "Pt. developed COVID-19 virus and passed away on 9/26/21" "1737341-1" "1737341-1" "Fully vaccinated on 3/16/21 and 4/14/21 with moderna covid vaccines. Admitted to hospital with COVID pneumonia requiring nasal cannula oxygen initially. Oxygen requirements increased and patient later required high flow oxygen. Patient was admitted on 9/10/21 and expired on 9/26/21" "1737367-1" "1737367-1" "On 8/28/21 after patient had been fully vaccinated, Patient became COVID positive. On 8/30/21, her respiratory status declined and she was admitted to Hospital. On 9/18/21 while still admitted as inpatient, she declined and required mechanical ventilation and ICU care. On 9/22/21 case died." "1737481-1" "1737481-1" "presented to ED with c/o worsening SOB x 3days, respiratory distress, collapse of left lower lobe secondary to consolidation versus atelectasis; earlier was diagnosed with bilateral pneumonia; has taken her antibiotics; was diagnosed with COVID a few days after pneumonia diagnosis; pt's condition deteriorated and patient died in the hospital" "1737526-1" "1737526-1" "Resident was administered 3rd dose d/t immunocompromising condition. He was on hospice at the time of vaccination living in a nursing home. He was observed to have a blood pressure lower than normal on 9/21/21 and hypoxia and tachycardia. The resident received morphine. He continued to decline and was provided comfort/end of life care." "1737583-1" "1737583-1" "Vomiting, diarrhea, fatigue, DEATH" "1737614-1" "1737614-1" "First dose January 10, 2021. Second dose January 31,2021. Awakened early February 1 and admitted to ICU where she remained until death March 5, 2021" "1738037-1" "1738037-1" "Death on 9/24/21. Pfizer administered on 9/10/21. Jand J on 3/12/2021" "1738061-1" "1738061-1" "Developed COVID Symptoms within <24 hours of receiving vaccine (Sore throat, mild fever, headache the morning after the vaccine). Patient had minimal to no contact with any other people prior to vaccination, and had not been around any individuals exposed to COVID in the past 2 weeks. Symptoms included fever, headache, nausea, joint & muscle pain, difficulty breathing, low oxygen stats, and vomiting. Patient was taken to medical facility on September 6th, was admitted to the hospital, and later transferred to the MICU. Patient pronounced dead September 18, 2021." "1738259-1" "1738259-1" "Patient came in to receive his 3rd dose of Pfizer Covid-19 vaccine. He said he qualified as immunocompromised. The pharmacist on duty stated that he appeared to be in good health as far as she could tell. Team member claimed he was disoriented upon checking out for his purchase, they helped him to his car. He crumpled to the ground and team members helped him sit up in his car and waited with him for EMS. After a few minutes we were told that he became incoherent and this continued when EMS arrived. EMS medic came to the pharmacy around 12:30pm to let the pharmacist know the patient was despondent. Upon later information from the family, the patient had passed away at the hospital due to a brain bleed." "1738486-1" "1738486-1" "Patient experienced breakthrough COVID infection despite getting vaccine. She passed away on 9/14/21." "1738603-1" "1738603-1" "Vaccine administration was uneventful. Patient and son confirmed that patient was cleared for vaccine and that she was well during and after the observation period. No signs of distress and no abnormality of breathing." "1739176-1" "1739176-1" "Death" "1740088-1" "1740088-1" "stroke; UTI; sepsis; aspiration pneumonia; first dose on 17Jun2021 (048A21A) Second dose was administered on 27Jul2021; Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), CEREBROVASCULAR ACCIDENT (stroke), URINARY TRACT INFECTION (UTI), SEPSIS (sepsis), PNEUMONIA ASPIRATION (aspiration pneumonia) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 17Jun2021 (048A21A) Second dose was administered on 27Jul2021) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 048A21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI) (seriousness criteria hospitalization and medically significant), SEPSIS (sepsis) (seriousness criteria hospitalization and medically significant), PNEUMONIA ASPIRATION (aspiration pneumonia) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 17Jun2021 (048A21A) Second dose was administered on 27Jul2021) (seriousness criterion medically significant). The patient died on 10-Sep-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed. At the time of death, URINARY TRACT INFECTION (UTI), SEPSIS (sepsis), PNEUMONIA ASPIRATION (aspiration pneumonia) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 17Jun2021 (048A21A) Second dose was administered on 27Jul2021) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased: elevated blood pressure (High) elevated blood pressure. No concomitant medications information was reported. No treatment medications were provided. This is a case of Inappropriate schedule of vaccine administered concerning an 88-year-old female patient with no reported medical history who experienced the fatal unexpected events of cerebrovascular accident, urinary tract infection, sepsis and aspiration pneumonia. The events of urinary tract infection, sepsis and aspiration pneumonia occurred on an unspecified date after CVA occurred 3 day after the second dose and the subject expired 1 month 4 days after the second dose of mRNA-1273 The rechallenge was not applicable as events occurred after second dose with a fatal outcome. Causality assessment for the event was not provided by the reporter. However, the subject is of an advanced age and UTI is of an infective origin which can lead to sepsis and thus assessment with product used is determined as unlikely. The benefit-risk relationship of mRNA-1273is not affected by this report; Sender's Comments: This is a case of Inappropriate schedule of vaccine administered concerning an 88-year-old female patient with no reported medical history who experienced the fatal unexpected events of cerebrovascular accident, urinary tract infection, sepsis and aspiration pneumonia. The events of urinary tract infection, sepsis and aspiration pneumonia occurred on an unspecified date after CVA occurred 3 day after the second dose and the subject expired 1 month 4 days after the second dose of mRNA-1273 The rechallenge was not applicable as events occurred after second dose with a fatal outcome. Causality assessment for the event was not provided by the reporter. However, the subject is of an advanced age and UTI is of an infective origin which can lead to sepsis and thus assessment with product used is determined as unlikely. The benefit-risk relationship of mRNA-1273is not affected by this report; Reported Cause(s) of Death: stroke" "1740833-1" "1740833-1" "Covid-19 after complete vaccination. Patient expired on 9/26/2021" "1740836-1" "1740836-1" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1740865-1" "1740865-1" "felt sick tired and no appetite, and headache the day after the vaccine the next day felt ok no complaints still no real appetite the third day had coffee got up to do dishes and apparently just dropped where she stood and died." "1741038-1" "1741038-1" "PT EXPIRED; BREAKTHROUGH CASE OF COVID-19" "1741067-1" "1741067-1" "Pt died after contracting COVID-19 in Sep 2021. Pt developed COVID pneumonia" "1741085-1" "1741085-1" "Developed Acute Respiratory Failure leading to intubation and death." "1741118-1" "1741118-1" "Admitted on 9/7/2021 with COVID-19 and sever hypoxia. Known COVID contact several days prior. Treated with remdesivir, dexamethasone, ceftriaxone, and azithromycin. Also started on barictnib on 9/9 but stopped due to ARF. Echocardiogram showed EF of 25-50% with moderately severe LV function. Started on heparin and continued throughout hospital stay. DVT in right lower leg. Seen by infectious disease and continued on cefepime and levofloxacin for 14 days. Underwent cryo-amputation of right ischemic lower extremity and then BKA by vascular surgery. Prognosis poor and not improving. Family elected comfort care." "1741146-1" "1741146-1" "Parents reported to Death Investigator that patient complained of body aches, severe headache, and pain in his lower extremities on the evening of 9/22/21 (thee date he received the vaccine). He was taking Tylenol for his symptoms per his parents. On Thursday, 09/23/21, he continued with the above symptoms and felt worse per parents. Mother asked him if he needed to go to the doctor and he said no. On Friday, 09/24/21, he felt better than the day before but still had symptoms. Parents last talked with him around 2230 Friday night. They went to wake him up at 1100 on Saturday, 09/25/21 and found him deceased in the bed. EMS was called and he was transported to Hospital Emergency Department DOA." "1741248-1" "1741248-1" "Dhiarrea" "1741267-1" "1741267-1" "Patient died and preliminary autopsy revealed Massive pulmonary embolism" "1741301-1" "1741301-1" "Patient received first dose of COVID-19 vaccine on 8/30/2021. Patient was then hospitalized on 9/7/2021 with COVID-19 symptoms. Patient was a no code/no intubation at admission. Patient ultimately progressed to high flow oxygen and was made compassionate care and passed away on 9/19/2021." "1741327-1" "1741327-1" "90-year-old male history of AFib, on anticoagulation with Eliquis, HTN, dementia, DM type 2, BPH presents with increasing shortness of breath. Previously lived in an assisted living facility, was admitted on 08/23 with confusion and generalized weakness, decreased heart rate. He was treated with IVF hydration, empiric antibiotics with ceftriaxone azithromycin, 2D echocardiogram was performed that demonstrated a preserved EF, he was transferred to a local SNF. He fell upon arrival to the sniff within 24 hours, with a subsequent left proximal humerus fracture, and is pending outpatient orthopedic evaluation. Unfortunately patient tested positive for COVID-19 on 08/31. He is fully vaccinated since January '21. Felt in ED profoundly hypoxic, proBNP elevated >39k, troponin T 262, CXR with bilateral multifocal infiltrates. Initiated on treatment with dexamethasone, Remdesivir, IV diuresis, and supplemental O2. Patient was seen by Cardiology and Pulmonary during hospitalization. They recommended continuing present management as above and reiterated patient has very poor overall prognosis given his multiple comorbidities and frail state. Unfortunately, despite aggressive treatment, at 3:55 a.m. On 09/12/2021, patient passed away. His family was notified of death by nursing staff." "1741335-1" "1741335-1" "Patient suffered from cardiac arrest and past away due to underlying medical conditions on 9-28-2021." "1741359-1" "1741359-1" "Patient is a 57 y.o. male with a history of testing testing diabetes, bronchitis, hypertension and recent COVID-19 infection presenting with worsening shortness of breath and fever at 102. Initially treated outpatient with antibiotics steroids without improvement. Patient presented today with decreased oxygen saturations at 84% on 4L. Reports dyspnea. Reports fatigue. Reports fever. Denies nausea vomiting diarrhea. Reports recently tested positive COVID-19 on August 31st. Patient admitted to hospitalist service. History was obtained from patient who seemed an accurate and reliable historian. Significant other was present. From Pulmonary/Critical Care Consult: Patient is a 57 y.o. male who initially presented to the emergency department on 9/13/2021 with worsening respiratory status. Pt provides some information, majority of info provided by significant other that is at the bedside. Pt was diagnosed with 8/31 with COVID 19 in the emergency department. He was sent home with home oxygen and managed by his fiance. His status waxed and waned. He presented back to the ED on 9/13 with increased dyspnea, increased fatigue, decreased oxygen saturation, and fever. Pt was then admitted to the pulmonary floor to the hospitalist services. He remained on the pulmonary floor. He did require more supplemental oxygen and was eventually receiving maximum amounts of oxygen via heated high flow NC with a nonrebreather on top. He was also started on IV dexamethasone on admission. Decision was made to transfer the patient to the ICU for AVAPS. Pt arrived to the ICU. He was placed on NIV. He did become anxious with application, so he was started on precedex. Pt is alert and oriented. His fiance is at bedside. Hospital Course: Patient was transferred to the ICU on 9/19/2021 due to worsening respiratory status and was transition to noninvasive ventilatory support. He required a dexmedetomidine infusion for anxiety. He further decompensated on 9/23/2021 and required intubation. He suffered a spontaneous left pneumothorax and a chest tube was placed. He required paralytic infusion as well. He was initiated on broad-spectrum antibiotics while in the ICU for a possible secondary bacterial infection. Unfortunately, the patient continued to decompensate despite maximal mechanical support. On the evening of 9/26/2021, the patient's family mid determination to transition to comfort measures and terminal extubation. Patient did succumb to his critical illness on the evening of 9/26/2021 at 1910 hr, may he rest in peace. Disposition: Deceased; time of death 1910 hr, 9/26/2021" "1741384-1" "1741384-1" ""Patient is a 84 y.o. female with dementia who resides in an assisted living facility. She usually ambulates with a walker per her son. She fell OOB almost 2 weeks ago and hit her right cheek - has a bruise there but seemed fine afterwards. Her son reports she had some slurred speech on Sunday but by Monday it had resolved. Caretaker had reported she seemed to be dragging one leg when she walked earlier this weak. Today she was sent to ER for some confusion - her NIH stroke scale was 11 but some of the score was felt to be due to confusion with understanding directions. An MRI shows acute stroke to the Left Posterior Parietal area and also small Left Lacunar infact adjacent to the left lateral ventricle. She does not appear to be on any antiplatelet drugs or statins per her med list. Her son reports she had trouble moving her left leg in the ER and trouble with speech. she is able to follow simple commands for me. There is no facial droop. She does have expressive aphasia but pulls the covers up over herself and says ""cold"". She easily lifts both legs off the bed for me on command and has good hand grips. Hospital Course: Patient was admitted with expressive aphasia - Neurology was consulted - family requested hospice care as patient had little hope of improvement. She tested + for Covid but was not requiring any oxygen. She was made hospice care only on the Covid unit and died on 9/27/2021 at 10:01 AM"" "1741405-1" "1741405-1" "Brief History: Patient is an 84-year-old male. He is a resident of assisted living. He was diagnosed with COVID at least 3 or 4 days prior to admission.. He fell at assisted living. He was brought to the emergency department and subsequently admitted. He does have advanced COPD. Hospital Course: Patient was admitted and even though he was diagnosed with COVID his CT chest and CXR did not show any signs of this. So he was not treated with remdesivir - However, he was started on steroids, antibiotics, nebulizer treatments - typical COPD treatment. He continued to have high oxygen requirements, using significant accessory muscles to breath and agitation.He did require both morphine and ativan for this. Mutliple converstaions with family lead to family coming and determining comfort care. On 9/28/21 we withdrawaled care. Her son and daughter were both at bedside. He passed peacefully the early morning of 9/28/21 with family at his bedisde." "1741622-1" "1741622-1" "Patient received Pfizer Covid vaccine on 1/8/2021 and 1/29/2021 and was admitted to the hospital for 12 days for COVID symptoms." "1741639-1" "1741639-1" "Case fully vaccinated with Pfizer vaccine. Last dose on 3/2/2021. Case tested positive for COVID on 9/7/21. Was admitted to hospital on 9/21/2021 and expired on 9/24/2021 while still hospitalized." "1741669-1" "1741669-1" "On the 16th of Aug., went to ER for fever, chills, and jaw pain. Was given antibiotics but was back on 17th by request because blood test reveled a blood infection. Early on the 18 Afib, Metoprolol given for it. By midday discharged and was upset at care that was given. On the 19th Admitted to Hospital, because racked with pain and felt like he couldn't breathe. Drew blood for new tests. Couldn't drink or eat, issues with taking blood(iv lines infiltrated and kept popping out). On the 20th, contrast media given, one was a drink and one was injected for CT scan. Rapid fluids given, and had a bad response with it, Rapid afib(tried convert to sinus rhythm twice and failed), kidney issues. PCU on 21th Kidney started to fail, BiPap, elevated creatinine, BUN elevated. On 8/22 blood test showed kidney failure imminent was then advised a kidney transplant would be needed, patient declined, discharged about 12:30PM MT and patient died under Hospice care by 6:00PM MT" "1741688-1" "1741688-1" "Case fully vaccinated with Pfizer Vaccine. Last dose given on 1/22/2021. Tested positive for COVID on 9/21/2021. Case expired at Hospital East while in the ED on 9/26/2021." "1741705-1" "1741705-1" "Case fully vaccinated with one dose of Janseen vaccine on 3/10/2021. Tested positive for COVID on 8/18/2021. Case was admitted to hospital on 8/22/2021 and expired on 9/24/2021 while still hospitalized." "1741776-1" "1741776-1" "Fatal myocardial infarction" "1741874-1" "1741874-1" ""[Directed to enter VAERS report due to close proximity of vaccine administration] Member received first dose of Pfizer COVID-19 vaccine on 23 September 2021. On 24 September 2021, member complained to co-workers of abdominal pain with nausea/vomiting, treating symptomatically over the weekend. On 26 September 2021, member's co-worker contacted him and member was coherent and alert, On 27 September 2021, after member did not respond to co-workers' attempts to contact him, co-workers and first responders went to member's residence, where member was found somewhat disoriented. Member was subsequently transferred to local Hospital ED (arrived at approximately 09:15), where member was found to have confusion and hyperglycemia (GCS of 14 and blood sugar reading, measuring as 'high"".). During treatment and monitoring process, member was found to have labored breathing (at approximately 11:00) and a CODE was called at 11:05. Member subsequently expired at 11:30."" "1742182-1" "1742182-1" "High fever. Died 3 weeks later from spontaneous brain bleed" "1742990-1" "1742990-1" "Illness, Blood clots, Strokes, Cancer Diagnosis, Death" "1744331-1" "1744331-1" "Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell (lasted about a week, then disappeared) Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell, trouble breathing, headaches, loss of appetite(05/09/2021, went to hospital twice, was discharged too early the first time; 11 May 2021; returned to the hospital 21 May 2021 due to shortness of breath, fatigue, dizzy, nausea, loss of appetite, which the trouble breathing and shortness of breath was due to fluid build-up around the heart and his lungs). Admitted approximately late afternoon 21 May 2021 and did not get discharged, died on 9 June 2021 in the Hospice house." "1744381-1" "1744381-1" "Hospitalization and death on 9/9/2021 cause of death is under review" "1744398-1" "1744398-1" "The patient is deceased six days after Pfizer vaccination (first dose)" "1744606-1" "1744606-1" "Pt died after contracting COVID in September 2021" "1744645-1" "1744645-1" "unknown" "1744676-1" "1744676-1" ""See continuation page o Jan 2018 Mom was diagnosed with stage 4 lung/brain/lymph node cancer o Feb 25th: Mom was brought to ER for a respiratory issue. Full set of tests were done, nothing was found and she was sent home. ER was happy she was going to see her primary the next day for follow up. o Feb 27th: Mom woke up feeling ok, by afternoon she was too weak to walk and brought back to the ER. Lungs shown with pneumonia and inflammation. Mom was admitted to ICU that evening. o Feb 28th: Mom seemed ok in ICU, but oxygen demands increased. o Mar 1st: Mom was placed on bi-pap o Mar 2nd: Mom was placed on vent o March 8th: Mom fought back and was able to come off vent o March 12th: Due to lack of rooms in ICU (from my understanding), Mom was moved to medical o March 13th: Mom expressed pain behind knee (maybe referred pain due to bleeding noted on the 14th) o March 14th: Mom had severe side pain, blood work indicated potential internal bleed. Hours later a CT scan was done and confirmed bleeding. Plan was to give her plasma and maybe other drugs to hopefully stop the bleed (that doesn't make complete sense to me, but I'm not a doctor). Mom said she ""Felt like she was dying"". The nurse said that given Mom's condition, it would be best that someone spend the night with her. I relieved my sister around 8:30 that night. Mom was receiving plasma and whole blood. I asked the nurse if her blood pressure and pulse were monitored at the nurses station, she said no but she would come in every hour to check (note additional checks were done every 15 minutes when a blood transfusion was started). Mom's door was closed due to 4 other psych patients on the floor making a lot of noise, so I was the only one to hear alarms. Mom was too weak and couldn't press the nurse button when her side pain increased after 10 pm. I pushed the button for her, a couple minutes later a nurse came on the intercom wondering what Mom needed, and what felt like 10 minutes later a nurse arrived. Around 11:15 pain meds were administered but didn't have any impact initially. I questioned whether Mom should be in the ICU given the internal bleed, pain, and number of units of blood/plasma she was receiving (in my mind she was critical enough not to be on a medical floor where there is a high patient to nurse count and no continuous monitoring of vitals). o March 15th The on call doctor came in around 12:30 am, I think, after pain meds started to settle Mom. His first words, which I felt were said in a stern way, were ""I hear you want your Mom moved to ICU"". I expressed my concerns and that I was just trying to do what was best for Mom. His voice softened and he said there is nothing more that ICU can do. My impression was that he stated they would give more blood and if vitals drop, then move her to ICU. Nurse came back in after the doctor left (note I felt the nurse did a great job that night) and said the doctor wanted her to discuss with me re-evaluating whether Mom should be a full code... It is very confusing since I felt the doctor was saying she was stable enough to stay on the medical floor, but then have the full code reconsidered at 1:00 in the morning by family... I was in full tears after she left, didn't sleep, and said a few rosaries. At 3:30 am Mom was moved to ICU. By 6 or 7 am Mom had received 5 units of blood and 5 units of plasmas, which I believe is as much as the body can hold... Around 7:15 am there was a clear indication on the monitor that Mom's blood pressure was dropping linearly over last hour. Her breathing over night was 18 and normal, but increased to over 20 was very labored. Her heart rate went from 90s to 114. I walked over to ICU nurse with tears and there is a scary trend happening, do I need to call family in. She stated that ""Mom is in the right place and no need to call family"". But took no action to correct decline. Her only action was to get zophrane (or similar drug) since Mom was nauseous. It wasn't until after the doctor came in after 8:15 am that the decision was made to transport. At that point family was allowed to come in 1 by 1. It was also the same time that the snow storm started and Mom had to go by ambulance, which by time coordinating wass complete didn't happen until 11 am. Mom was given blood pressure medication which helped initially, but by time Mom reached it we were told her blood pressure was 37/19. It feels if action was taken over night, Mom could have been flown and the blood pressure might not have dropped that far. Mom's procedure was successful to stop bleeding. o March 16th: We were told that given the amount of fluid Mom's lungs were starting to fill with fluid again and given low blood pressure on arrival, her kidneys were shutting down. o March 17th: Mom was placed on hospice o March 18th: Mom was brought home o March 26th: Mom went peacefully to heaven"" "1744956-1" "1744956-1" "fully vaccinated-covid death" "1745080-1" "1745080-1" "Patient hospitalized 9/13/21, diagnosed with COVID19 9/14/21, deceased 9/25/21" "1745088-1" "1745088-1" "08/03/2021 pt had at-home COVID-19 test, results positive; presented to ED on 8/12/2021 with SOB, cough, nausea, malaise, weakness; condition worsened; pt was a DNR; admitted to hospice on 08/18/2021 where he passed away" "1745114-1" "1745114-1" "Patient admitted to hospital and tested for COVID 8/24/21. Discharged 8/28/21. Deceased 9/7/21" "1745116-1" "1745116-1" "tested positive for COVID-19 at dr's office approximately 1 week before being seen in the ED; presents to ED with SOB and is hypoxic, with runny nose, sore throat, headache, and cough; hx of COPD, placed on a ventilator; condition worsened; pt passed away in hospital" "1745141-1" "1745141-1" "presented to ED with SOB; c/o cough, flu like sx, SOB, weakness, head congestion and runny nose x 2-3 wks; started using wife's O2 at home due to SOB; chest xray showed bilateral infiltrates; positive COVID test; acute respiratory failure due to COVID; pt passed away in the hospital" "1745214-1" "1745214-1" "Patient admitted to hospital via ED 9/7/21. COVID test positive 9/7/21. Deceased 9/15/21" "1745215-1" "1745215-1" "presented to ED with SOB, c/o fever, SOB, nausea, decreased appetite x 1 wk; hx of DMT2; tested positive for COVID-19; acute respiratory failure and pneumonia due to COVID; refuses to be intubated; will use BIPAP; pt's condition worsened where he passed away in the hospital" "1745226-1" "1745226-1" "Patient died at home under hospice care. Hospice notes submitted into database." "1745253-1" "1745253-1" "Hospice patient. Died due to COVID-19. Was fully vaccinated." "1745270-1" "1745270-1" "Patient admitted to hospital 9/17/21, tested positive for COVID same day. Deceased 9/21/21." "1745271-1" "1745271-1" "hx of prostate and pancreatic cancer; 3 days ago had chemotherapy treatment; within 24 hrs after chemo, pt began to experience fever, fatigue, cough and SOB; presented to ED with SOB; chest x-ray showed severe diffuse bilateral asymmetric infiltrates; positive for COVID-19; pt was a DNR/DNI; placed on BIPAP; condition worsened and pt died in the hospital; Acute Respiratory Failure with Hypoxemia; pneumonia due to COVID-19" "1745292-1" "1745292-1" "Pt. contracted COVID several months after receiving vaccine." "1745293-1" "1745293-1" "Patient admitted to hospital 9/20/21 for sepsis due to COVID pneumonia. Tested positive for COVID 9/20/21. Discharged and readmitted 9/24/21. Deceased 9/27/21." "1745330-1" "1745330-1" "Patient admitted to hospital 9/12/21, COVID positive test 9/13/21, deceased 9/16/21." "1745353-1" "1745353-1" "Patient admitted to hospital 8/10/21. COVID test positive 8/12/21. Deceased 9/13/21" "1745362-1" "1745362-1" "Patient tested positive for COVID 8/18/21. Patient admitted to hospital 8/21/21 with atrial fibrillation with rapid ventricular rate. Patient deceased 9/18/21" "1745371-1" "1745371-1" "SARS COV 2 listed as cause of death on death certificate." "1745378-1" "1745378-1" "Patient tested positive 9/15/21. ED visit at Hospital 9/16/21, discharged. Patient returned to ED 9/19/21 and admitted. 9/20/21 COVID test positive. Deceased 9/24/21" "1745412-1" "1745412-1" "Admission to critical care hospital with COVID-19 diagnosis on admission" "1745427-1" "1745427-1" "Bradycardia and needed a pacemaker implanted around 8/16/2021. She died suddenly on 9/2/2021 in the afternoon." "1745477-1" "1745477-1" "Patient died suddenly 5 days after taking her second pfizer covid vaccine." "1745544-1" "1745544-1" "Death SEPTIC SHOCK, HYPOTENSION, DIABETES MELLITUS TYPE 2, RHEUMATOID NODULAR FIBROSIS" "1745554-1" "1745554-1" ""Admission Diagnoses: CAP (community acquired pneumonia) [J18.9] Community acquired pneumonia, unspecified laterality [J18.9] Discharge Diagnoses: Deceased Acute Hypoxic Respiratory Failure due to COVID 19 PNA Hospital Course: Patient is a 97-year-old female with a history of chronic atrial fibrillation, subdural hematoma, CAD status post CABG, CHF, hypertension, Waldenstr÷m's macroglobulinemia who presented for fever and cough. The patient had a fever of 101 degrees for 2 days along with significant weakness and deconditioning. She was fully vaccinated for COVID-19. Upon arrival to the ER she was hemodynamically stable, T-max of 99.1 ¦F. She had an admission evaluation which revealed WBC 8.8, elevated lactic acid 2.4. She underwent a CT of the chest which showed no signs of pneumonia. CT of the abdomen pelvis showed no evidence of obstruction and no acute abdominal abnormalities. The patient was admitted under observation status due to generalized weakness. Prior to transfer to the medical floor her viral PCR results were positive for COVID-19. She was admitted under isolation status. During the first few days of her hospitalization she did not have any respiratory symptoms and had significant deconditioning. She did not meet criteria for remdesivir therapy. Subsequently the patient had decompensation with hypoxia and respiratory failure requiring transfer to the ICU. She was treated with steroids and remdesivir. The patient had quick decompensation requiring BiPAP placement. She had significant respiratory distress while on BiPAP and her family was consulted in regards to goals of care. Due to her significant respiratory distress while on BiPAP the decision was made to make the patient comfort care. The patient had comfort care medications administered along with removal of the BiPAP. The patient passed away on September 28, 2021 at 7:34 AM. Family was at the bedside. Consults: IP CONSULT IP CONSULT TO SPIRITUAL CARE Significant Diagnostic Studies: N/A Discharge Exam: Blood pressure 96/56, pulse (!) 0, temperature 97.6 ¦F (36.4 ¦C), temperature source Temporal, resp. rate (!) 1, height 5' 1"" (1.549 m), weight 49.4 kg (108 lb 14.4 oz), SpO2 93 %. Absent Pulses Absent Respirations Pupils fixed and Dilated Disposition: Deceased Code status: DNR Time Spent on Discharge more than 30 minutes Signed: MD 9/28/2021 10:33 AM"" "1745669-1" "1745669-1" "Client diagnosed with Covid-19 on 8/7/2021, hospitalized with intermittent dyspnea on exertion, cough, LE edema. He was discharged on 8/13/2021 after being treated with IV Decadron and a 5 day course of Remdesivir. He was readmitted on 8/16/2021 with SOB, fevers, cough and weakness. During this admission, he was given high-dose IV steroids. He died on 8/20/2021 due to Acute hypoxemic respiratory failure due to severe bilateral COVID pneumonia and suspected superimposed bacterial pneumonia. Submitter does not have access to full medical record. If further information is required, please contact the admitting hospital." "1745703-1" "1745703-1" "Patient was a breakthrough case diagnosed on 8/14/2021 and died of COVID-related conditions on 8/21/2021." "1745749-1" "1745749-1" "After first dose patient hospitalized for RDS/ pneumonia, complicated hospitalization due to sudden CVA. Then to nursing home for rehab. Second dose done months later and next day, hospitalized- heart failure, RDS. complicated rehabilitation. Two hospitalizations both ocurred within 24 hours of vaccine. Died in her sleep suddenly at SNF. Initial and Second Acute care Stay both began within 24 hr after vaccine doses. Sudden unexpected death in September at SNF. Likely related to patients with Factor V Leiden defect should not receive these vaccines." "1745752-1" "1745752-1" "fever and weakness day after vaccine with increasing weakness at home /admitted to hospital 4 days later with weakness /progressive decline with weakness and paralysis of left arm / stroke suspected but could not be confirmed on 2 magnetic resonance scans /inability to speak and then swallow / treated for possible aspiration pneumonia /progressed to being obtunded and respiratory distress / died 9/25/21" "1745753-1" "1745753-1" "Patient was a breakthrough COVID case and died due to COVID-related causes on 8/18/2021." "1749522-1" "1749522-1" "PT EXPIRED; BREAKTHROUGH CASE OF COVID-19" "1749557-1" "1749557-1" "Arrival to ED: 9/23/21 @ 1:45pm Patient arrived to ED via EMS with chief complaint of altered mental status and emesis. His nephew was at his side. Patient's nephew and EMS stated patient received COVID-19 vaccine the day before and became progressively more weak and lethargic. Patient's baseline is AA0x4 and he takes care of himself. Pt is non verbal and vomited x1 prior to arrival. Upon presentation in the ED, the patient was obtunded and unresponsive. Patient was seen immediately on arrival. The patient's history was provided by the EMS personnel and a relative (nephew). Medical staff were unable to obtain history from patient due to his condition. Physical Exam findings: Constitutional: Obtunded Eyes: Pinpoint pupils bilaterally, minimally reactive Neck: JVD Pulmonary: Breath sounds with rhonchi present bilaterally (R>L); spontaneous respirations Musculoskeletal: Edema to Right Lower Leg and Left Lower Leg; bilateral edema pitting to mid tibia Neurological: Unresponsive to painful stimuli; No posturing noted Vitals on presentation to ED: BP 145/86; HR 88; Resp 21; SpO2 83% Patient seen by critical are provider at 2:15pm Patient placed on nonrebreather oxygen mask with improvement to oxygen saturation (to low 90s). Discussed plan of care with nephew (living will states patient wanted to be DNR/DNI) Stat Imaging ordered and results interpreted Infectious workup initiated & IV antibiotics ordered Discussed case with inpatient admitted MD ED diagnosis: Pneumonia of both lungs due to infectious organism Medication Administration Zosyn 4.5gram IV @ 3:05pm Vancomycin 1,000 mg IV @ 3:05pm Patient expired while in the ED. Time of death, 7:13pm." "1749656-1" "1749656-1" "Dose 1 04/22/2021 Lot # EW0172 Pfizer Pt died on 9/30/2021 in the ED from complications with her end stage adenocarcinoma. This was not a Covid illness related death" "1749730-1" "1749730-1" "Patient found passed away in his sleep on 9/16/2021" "1749855-1" "1749855-1" ""83-year-old male with history of multiple myeloma presented to the emergency department with respiratory distress. Per EMS and wife, patient was discharged from the hospital a few days prior, following an 8 day hospital admission. He was hospitalized due to difficulty breathing and was found to have ""fluid in his lungs"". Patient was discharged to a nursing home, where he has been for the last 3-4 days. Nursing home staff found him to be in respiratory distress and satting in the 60s on room air. EMS was called and placed him on 15L NRB with O2 sats in the 80s. They then placed him on CPAP which increased his O2 to 94. Patient was on BIPAP on arrival. Additionally, per family patient's right shoulder and arm have been swollen over the last 2 days. Patient was found to be COVID-19 positive. Patient was in acute hypoxic respiratory failure. Code status was changed and patient expired in hospice care."" "1749992-1" "1749992-1" "pt tested positive for COVID-19 on 8/4/21, sx of cough and SOB; presented to ED with hypoxia due to COVID pneumonia; experienced A Fib; worsening ARDS; placed on BiPap; transported to in-patient hospice; DNR; respiratory condition worsened and pt passed away in the hospital" "1750025-1" "1750025-1" "pt presented to ED with hx of positive COVID test earlier in the week from a dr's office, cough, weakness, fatigue x 1 wk; hypoxic, placed on nonrebreather; in respiratory failure due to COVID pneumonia; pt's condition worsened and she died in the hospital" "1750163-1" "1750163-1" """"Fully vaccinated patient who admitted to the hospital on 09/25/21 with positive COVID test. Patient had recently discharged from facility on 09/23/21 after a repeat pneumothorax and returned on 09/25/21 due to weakness and inability to care for self and upon admission testing was positive for COVID. Discharge summary from provider below: ""42/F with long-standing history of COPD and recurrent pneumothorax for which she L partial lobectomy in 2015 and VATS/pleurodesis recently 9/2021. Pt had just been in our ICU August 2021 for respiratory failure due to COPD Exacerbation and was on the vent for 12 days. Unfortunately, she contracted COVID-19 PNA despite being fully vaccinated and was admitted to the hospital for that reason. We believe she had an anaphylactic shock and acute respiratory failure/bronchospasm due to Regeneron that caused her cardiac arrest with prolonged resuscitation 9/26/21. She developed multi-organ failure -- shock liver and aneuric renal failure thereafter. She was profoundly hypotensive, acidotic and hyperkalemic despite HD/CRRT and bicarb infusion. She had limited ventilatory compensation /difficult to ventilate because of underlying COPD with possible bronchospasm from anaphylaxis. She had coded multiple times in the ICU this am and family decided to stop CPR during the last code"" Pharmacy has submitted a report to the FDA."" "1750453-1" "1750453-1" "She died from large bilateral pulmonary embolism and had inflammation to her heart" "1753250-1" "1753250-1" "Deceased (9.26.21); Hospitalized due to COVID-19 (9.2.21); COVID-19 positive (8.31.21); Fully vaccinated Admission Date: 9/2/2021 Died 9/26/21 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] Pneumonia due to COVID-19 virus [U07.1, J12.82] Acute hypoxemic respiratory failure (HCC) [J96.01] COVID-19 [U07.1] HOSPITAL COURSE: Patient is a 65 y.o. female with a PMHx of COPD not on home oxygen, HTN, Hypothyroid, RA on immunomodulator therapy who was admitted for AHRF secondary to Covid pneumonia. Completed 4 days of dexamethasone, 3 days of remdesivir so far. Bcx, other infectious work-up have been negative. Going intermittently between HFNC and BiPAP, stays relatively comfortable without additional work of breathing. She has been responding well to once/day diuresis. Multiple conversations at that time were held with the patient, who has elected to be DNR/DNI - okay with vasopressor medications if needed. After transfer out of the ICU she completed dexamethasone, remdesivir, diuresis as needed- she developed an AkI that resolved. She was able to alternate between HFNC and BiPAP but developed hypoxia despite continuous BiPAP at 100%. She was readmitted to the ICU on 9/11 and was unsure of her code status to be DNR or FULL. Overnight she remained on continuous BiPAP with O2 sats in the high 80s. A CTA to rule out PE was unable to be performed given her respiratory status, U/S showed no signsof DVT. On 9/12 Patient had increased work of breathing and anxiety, especially with repositioning and requested to be FULL CODE and was electively intubated for hypoxic respiratory failure 2/2 COVID-19 PNA. Following intubation, the patient did develop worsening urine output and AKI. She ultimately was started on CRRT for volume overload. With volume overload, her O2 requirement did improve somewhat, but she still had significant ventilatory needs due to her COVID-19 pneumonia. Patient also had persistent tachycardia during her hospital stay. Her serotonergic medications were held to rule out serotonin syndrome, repeat cultures were obtained without any growth, and extremity ultrasounds were performed which did show equivocal left coronal DVT. Patient was started on heparin drip for this possible DVT. Due to the persistent high ventilatory needs, goals of care were discussed with the family. It was agreed that tracheostomy tube placement was not in line with the patient's goals of care, and due to her persistent refractory hypoxemia requiring high ventilatory needs, plan was made to transition patient to comfort care on Monday, 09/27/2021. On Sunday 9/26 patient had acute worsening in clinical status with decreasing oxygen levels. Based on patient's families wishes for the patient to be with her husband upon passing the patient was made comfort care and passed away at 1108 AM. Date of Death: 9/26/21 Time of Death: 11:08 AM Preliminary Cause of Death: COVID-19" "1753262-1" "1753262-1" "COVID infection. Specimen collected on 8/16/21. Patient died on 9/4/21." "1753280-1" "1753280-1" "COVID infection. Specimen collected on 8/19/21. Patient died on 8/24/21." "1753284-1" "1753284-1" "COVID infection. Specimen collected on 8/11/21. Patient died on 8/13/21." "1753291-1" "1753291-1" "COVID infection. Specimen collected on 8/27/21. Patient died on 9/9/21." "1753307-1" "1753307-1" "COVID infection. Specimen collected on 8/24/21 (per ED notes). Patient died on 09/13/21." "1753324-1" "1753324-1" "Patient has expired / died (9.28.21); Hospitalized (9.15.21); COVID positive (9.9.21); fully vaccinated Discharge Provider: Admission Date: 9/15/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 virus infection [U07.1] COVID-19 [U07.1] Acute respiratory failure with hypoxia [J96.01] Acute respiratory failure due to COVID-19 [U07.1, J96.00] HOSPITAL COURSE: Patient is a 57 year old with asthma, MS (ocrelizumab q 6 months), tobacco abuse (30pkyr), and congenitally absent left kidney. He was COVID (+) 9/9 (was vaccinated in the spring). He presented 9/15 with 10 days cough/SOB/fevers. In the ED, he was hypoxemic and would desaturate with activity. CXR showed patchy bilateral opacities. He was admitted and treated with Decadron, remdesivir, and empiric antibiotics. On 9/18, he was transferred requiring HFNC/NRB. On 9/19, he required intubation, NMB (until 9/22), and proning (until 9/21). Doppler US 9/20 showed acute right IJ and right SC DVTs. He was extubated 9/26 and initially tolerated low-flow NC oxygen but was profoundly weak. He decompensated requiring BiPAP. He had been made DNR by family then comfort measures. He passed away on 9/28 while this attending was off service and at home Date of Death: 9/28/21 Time of Death: 8:07 PM Preliminary Cause of Death: Acute respiratory failure due to COVID-19" "1753438-1" "1753438-1" "Patient fully vaccinated and died of Covid related causes" "1753479-1" "1753479-1" "Patient fully vaccinated and hospitalized then later died due to Covid related causes." "1753480-1" "1753480-1" "9/29/21- to ER for treatment." "1753482-1" "1753482-1" "Death due to COVID-19. Details unknown" "1753483-1" "1753483-1" "Admitted on 9/21 with syncope spell and sense of weakness with 2 day history of nausea and diarrhea. Revealed COVID-19 pneumonia requiring 8L O2 with severe stenosis with regurgitation (not candidate for TAVR). Underwent dialysis with several episodes of hypotension. Initiated CRRT but continued to decline. Patient and family agreed to palliative care but continued to deteriorate and passing on 9/30." "1753621-1" "1753621-1" "Hospitalization and death. Symptoms unknown" "1753662-1" "1753662-1" "RESIDENT CONTRACTED COVID-19 VIRUS AFTER BEING FULLY VACCINATED ON 9/24/21. RESIDENT PASSED FROM COVID-19 ON 9/28/21." "1753844-1" "1753844-1" "Death" "1753893-1" "1753893-1" "10 days after receiving the first dose of Moderna, patient presented at the ER with difficulty breathing. CT revealed bi-lateral pulmonary embolisms. A few days on anti-coagulants and was released. She returned a couple days later with worsening breathing. Patient received bi-pap oxygen then underwent procedure to place filter to prevent blood clots from traveling. Patient was intubated and placed on mechanical ventilation and diagnosed with multiple system organ failure. Patient succumbed to the vaccine injury September 29, 2021." "1754078-1" "1754078-1" "Death due to COVID-19 PNEUMONIA" "1754103-1" "1754103-1" "Received call this morning 10/1/2021 from medical examiner that wife found patient deacesed - medical examiner states that he determinded natural causes." "1754149-1" "1754149-1" "Death due to COVID-19 , CARDIORESPIRATORY FAILURE, DEMENTIA" "1754209-1" "1754209-1" "Admitted to Memorial Hospital on 8/19/2021 with cough, SOB, weakness, hypoxia. Admitted to Hospital and Clinics on 8/27/2021 with dx: COVID-19 Pneumonia-ARDS with severe hypoxemic/hypercarbic respiratory failure. She died on 9/4/2021 of ACUTE HYPOXIC RESPIRATORY FAILURE 16 DAYS BACTERIAL PNEUMONIA SUPERINFECTION 16 DAYS COVID PNEUMONIA Submitter does not have access to full hospitalization records. If further follow up information on hospital course or treatment is needed, please contact: HOSPITAL AND CLINICS MEMORIAL HOSPITAL" "1754274-1" "1754274-1" "death, 0 signs/ symptoms noted," "1754275-1" "1754275-1" "None stated." "1754283-1" "1754283-1" "Death" "1756001-1" "1756001-1" "Heart attack; Arthrosclerosis; COPD; Other terms on autopsy report caller does not understand after the second dose; Not feeling well after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack), JOINT STIFFNESS (Arthrosclerosis), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and ADVERSE EVENT (Other terms on autopsy report caller does not understand after the second dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced MALAISE (Not feeling well after the second dose). On 20-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death, medically significant and life threatening), JOINT STIFFNESS (Arthrosclerosis) (seriousness criteria death, medically significant and life threatening), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criteria death, medically significant and life threatening) and ADVERSE EVENT (Other terms on autopsy report caller does not understand after the second dose) (seriousness criteria death, medically significant and life threatening). The patient died on 20-Sep-2021. The reported cause of death was Heart attack, Arthrosclerosis and copd. An autopsy was performed, but no results were provided. At the time of death, MALAISE (Not feeling well after the second dose) outcome was unknown. No concomitant medical information were reported. No treatment information was reported. Company comment: This case concerns a 74-year-old, male patient with no relevant medical history, who experienced the unexpected events of Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and other Adverse event (Nos). Patient initially experienced malaise (not feeling well) approximately 3 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The patient reportedly passed away approximately 7 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine); and autopsy revealed cause of death as Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and Other unspecified terms on autopsy (Adverse event Nos). The rechallenge was not applicable as events occurred after second dose with fatal outcome. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 74-year-old, male patient with no relevant medical history, who experienced the unexpected events of Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and other Adverse event (Nos). Patient initially experienced malaise (not feeling well) approximately 3 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The patient reportedly passed away approximately 7 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine); and autopsy revealed cause of death as Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and Other unspecified terms on autopsy (Adverse event Nos). The rechallenge was not applicable as events occurred after second dose with fatal outcome. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: Heart attack; arthrosclerosis; COPD" "1756099-1" "1756099-1" "They said it was cardiac arrest; but the caller thinks it was a pulmonary embolism; collapsed in the bathroom at 10pm; He was having trouble breathing. He collapsed in the bathroom at 10pm; he wasn't feeling well; This is a spontaneous report from a contactable consumer (patient's son). A 57-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 14Sep2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation at the age of 57-year-old. Medical history included alcoholism, seizures. There were no concomitant medications. The patient experienced cardiac arrest on 23Sep2021, pulmonary embolism on 23Sep2021, trouble breathing and collapsed in the bathroom at 10pm in Sep2021, wasn't feeling well in Sep2021. The patient died on 23Sep2021. An autopsy was not performed. The outcome of wasn't feeling well was unknown, outcome of other events was fatal. The clinical course was reported as: his father died yesterday, and the only difference recently in his health was that he got the COVID vaccine. His father died 9 days later on 23Sep2021. The coroner denied an autopsy. The hospital denied an autopsy. His father was not obese or diabetic, and he was only 57 as healthy as a horse. His father had gotten the vaccine, and said he wasn't feeling well to his girlfriend. He was having trouble breathing. He collapsed in the bathroom at 10pm. They called an ambulance who did everything they could do to bring him back. They pronounced his dad dead 23 minutes after midnight on 23Sep2021. They said it was cardiac arrest, but the reporter thinks it was a pulmonary embolism. His dad was not COVID positive. His father did have a history of alcoholism. Any time he would try to quit drinking, he would drink too much water out of compulsion since he couldn't drink beer. He would flush his system so much that he would deplete his sodium. His dad would get seizures every time he quit drinking. He tried to tell his dad that he needed to drink the normal amount of water. He can't just sit there and drink that much water to replace all the beer he drank. It would flush his system of all that sodium. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Reported Cause(s) of Death: They said it was cardiac arrest; but the caller thinks it was a pulmonary embolism; He was having trouble breathing. He collapsed in the bathroom at 10pm" "1756641-1" "1756641-1" "PT EXPIRED ON 09/22/2021" "1756674-1" "1756674-1" "PATIENT EXPIRED ON 09/26/2021" "1756876-1" "1756876-1" "Received covid vaccine at another (unknown) location prior to admission to facility. experienced multiple falls with significant fractures (prior to facility admission), which put her in the hospital, then needing rehab. transferred to this facility, facility sent to the hospital r/t medical concerns on 09/05/2021, returned to the facility on 09/10/2021, tested positive for covid 19 on 09/17/2021. was treated per facility APRN and MD, however, despite efforts, expired on 09/23/2021. Death is under investigation with health department for cause." "1756951-1" "1756951-1" "During hospital stay patient was started on Rocephin and azithromycin along with remdesivir and dexamethasone. She had been on 3 L of oxygen since admission which was normal for her. Had her finish her 3 doses of remdesivir. She was discharged on cefdinir and was to have an outpatient follow-up with her PCP. Patient returned on 9/14 and was admitted to the ICU where she unfortunately passed from COVID-19 Pneumonia." "1757402-1" "1757402-1" "Patient required hospitalization due to breakthrough infection. Patient received J&J vaccine on 03/11/21. Patient was hospitalized from 08/01/2021 - 08/17/2021. Below is copied from patients discharge (death) summary: Hospital Course: a 67 y.o. male with a PMH of Type II DM and HFpEF who initially presented to the ED complaining of shortness of breath with a recent COVID positive result. Patient stated this started around 7/26/2021 along with a nonproductive cough, subjective fevers, loss of appetite and nausea, with minimal diarrhea. He described the cough as being nonproductive. On the morning of 8/01/2021 the cough worsened which prompted him to call EMS. On arrival to the ED his SpO2 was at 81%-86% on room air. He was then placed on HFNC at 60L and FiO2 on 60% which brought his SpO2 at 94%. Pt stated he was vaccinated on March with J&J. He finished coverage. MICU consulted for increasing oxygen requirements. At the time of consult, he was sating 90% of max settings on HFNC, however pt was intubated on 8/9 due to respiratory failure. Upon discussion patient confirmed he is full code. On 8/10 pt desatted with development of SubQ emphysema. Stat CXR revealed large pneumomediastinum and pneumothorax. Emergent right sided Pigtail catheter was placed with increase in O2 sats. Patient self-extubated on 8/14 followed by desaturation to the 50s, he was subsequently re-intubated. I was called to patient?s bedside to pronounce that patient has expired. No spontaneous movements were present. There was not response to verbal or tactile stimuli. Pupils were dilated and fixed. No breath sounds were appreciated over either lung field. No carotid pulses or peripheral pulses were palpable. No heart sounds were auscultated over entire precordium. Patient pronounced dead at 1903. Dr. notified. Family were notified. Condolences offered. Chaplain and postmortem services offered. Pt was Full code. Time of death was 1903, confirmed and witnessed by Nurse." "1757610-1" "1757610-1" "Deceased; Toe infection; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Deceased) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ENZALUTAMIDE (ENZALUTAMIDE ASTELLAS) capsule for Prostate cancer. Concurrent medical conditions included Prostate cancer (Received enzalutamide). On 24-Sep-2020, the patient started ENZALUTAMIDE (ENZALUTAMIDE ASTELLAS) (Oral) 160 mg once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2020, the patient experienced LOCALISED INFECTION (Toe infection). The patient died on 22-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, LOCALISED INFECTION (Toe infection) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. This case concerns a 90 year-old male patient with history of prostate cancer, who experienced the unexpected serious event of Death (unknown cause) and the unexpected non-serious event of Localised infection. The events occurred an unknown number of days after the first and second doses of mRNA-1273 vaccine. The history of prostate cancer with unknown onset may have contributed to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The seriousness of criteria of Medically significant was overridden for the event of Localised infection based on medical judgement and review of source document that does not include information supporting seriousness criteria.; Sender's Comments: This case concerns a 90 year-old male patient with history of prostate cancer, who experienced the unexpected serious event of Death (unknown cause) and the unexpected non-serious event of Localised infection. The events occurred an unknown number of days after the first and second doses of mRNA-1273 vaccine. The history of prostate cancer with unknown onset may have contributed to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The seriousness of criteria of Medically significant was overridden for the event of Localised infection based on medical judgement and review of source document that does not include information supporting seriousness criteria.; Reported Cause(s) of Death: Deceased" "1757635-1" "1757635-1" "fatigue then death" "1757766-1" "1757766-1" "Pt is a 68 yoM vaccinated for COVID and hx of HTN, HLD, gout who presents with worsening shortness of breath found to have acute hypoxic respiratory failure 2/2 COVID pneumonia, given rapid worsening started on dexamethasone, remdesevir and barcitinib. He was also found to have a LLE DVT and given worsening oxygenation, possible PE. Pulm, Nephrology were consulted. He eventually needed to be intubated and then developed a pneumothorax requiring a chest tube. He then developed septic shock from superimposed HAP, completed therapy for it and meanwhile went into ARF, initially stable on diuretics, but eventually required HD. Had initial decline in neurologic status with nonresponsive R. Pupil, but unable to perform head imaging d/t clinical instability. Following another clinical decline on 9/26 where he was found to have another pneumothorax along with worsening s/s of infection. His family decided to make him comfort care at this point and plan to transition with terminal extubation and transfer to hospice scatterbed. He was terminally extubated and TOD was 9/28/21 0202." "1758643-1" "1758643-1" "Patient died." "1758695-1" "1758695-1" "PATIENT TESTED POSITIVE FOR COVID-19 ON 10/1/2021 (BREAKTHROUGH CASE); PATIENT EXPIRED ON 10/3/2021" "1758805-1" "1758805-1" "shortness of breath patient Deceased" "1758808-1" "1758808-1" "Patient didn?t feel well the day after his COVID vaccine. He was extremely tired and he had body aches. This continued until his 1st visit to the hospital on July 1st. He was jaundice and weak. They diagnosed cirrhosis, high blood pressure and low blood platelets. He stayed in the hospital for 3-4 days and was released. 4-5 days later we went to the hospital again with the same symptoms. This time they told him he had hepatitis B along with the other things already diagnosed, again he was released from the hospital after a few days. 5-6 days later he had a doctors appointment, she told him he needed to go back to the hospital. This stay was for 16 days. He needed platelets and was then diagnosed with an aggressive form of lymphoma, received treatment and was released on July 30. That evening he started with a cough and felt progressively worse. August 3rd he was scheduled for more blood platelets, arrived to the hospital and was again admitted. They then diagnosed him with an ecoli infection which was to much for his weakened state and he passed away on August 10" "1758810-1" "1758810-1" "PATIENT TESTED POSITIVE FOR COVID-19 ON 8/27/2021; EXPIRED ON 10/3/2021" "1758997-1" "1758997-1" "Death." "1759157-1" "1759157-1" "Cessation of talking and eating followed by death." "1759168-1" "1759168-1" "Pt.'s Sister states that after her brother received the 2nd dose of Phizer 09/22/2021, Pt. started experiencing shortness of breath and pain in the chest, Urgent Care visit 09/27/2021. Ultrasound preformed, treated with Updraft. Died 09/27/2021 2 Blood Clots located." "1759181-1" "1759181-1" ""Fully vaccinated patient admitted for COVID. Provider discharge summary below: ""Presented with 8/30 with worsening shortness of breath and chest discomfort following testing positive for COVID-19 on 8/25. He was vaccinated against COVID-19 with the Pfizer series on 5/3 and 5/28. He was admitted and started on oxygen and completed 5 days of remdesivir and a steroid course. Bilateral PE were found on CTA pulm on 9/5/21 and heparin was started. He continued to worsen despite HiFlo and NIPPV. He required intubation and transfer to CCU on 9/13, and started on pressors for support. CCU course was complicated by ARDS, shock, AKI and anuria requiring CRRT (managed by nephology), metabolic acidosis, liver failure, as well as acute blood loss anemia from a rectus sheath bleed causing an abdominal wall hematoma that required 1U pRBC and an abdominal binder. He was found with Serratia odorifera, Enterobacter cloacae on respiratory cultures suggesting aspiration pneumonia. HSV was detected on skin culture. Staph simulans that grew on one blood culture was deemed a contaminant. He received vancomycin, Zosyn, meropenem, metronidazole, acyclovir with antibiotic management guided by Infectious disease. ENT performed a biopsy of an ulcer of his left nare on 9/25, but pathology was pending at time of discharge. Patient did not improve despite treatment and had persistent respiratory acidosis and required maximum vasopressin and norephinephrine support. Palliative care was consulted and the grim prognosis of the patient communicated to family given his multiple organ failure. Patient was switched to comfort care status per family on 10/3/21. Patient died at 3:45 PM on October, 3, 2021."""" "1759243-1" "1759243-1" "ED to Hosp-Admission Discharged 8/27/2021 - 9/15/2021 (19 days) Last attending ? Treatment team Acute on chronic diastolic (congestive) heart failure Final Summary for Deceased Patient BRIEF OVERVIEW Admitting Provider: MD Discharge Provider: MD Primary Care Physician at Discharge: MD Admission Date: 8/27/2021 Discharge Date: 9/15/2021 Final Diagnosis Principal Problem: Acute on chronic diastolic (congestive) heart failure Active Problems: Paroxysmal A-fib Pulmonary hypertension, moderate to severe Chronic obstructive pulmonary disease with acute exacerbation Pleural effusion on right End stage COPD Congestive heart failure, unspecified HF chronicity, unspecified heart failure type Endocarditis Lactic acidosis DETAILS OF HOSPITAL STAY Date and time of death: September 15, 2021, 12:11 PM Cause of death: Septic shock from COVID-19 pneumonia Acute respiratory failure from COVID-19 and systolic heart failure Secondary diagnoses: Severe aortic insufficiency Superimposed bacterial pneumonia Acute renal failure Lactic acidosis Possible endocarditis Atrial fibrillation with rapid ventricular response End-stage COPD Elevated LFTs Coagulopathy from malnutrition and acute illness Hospital Course Patient is a 72-year-old female with history of COPD, atrial fibrillation on Coumadin, systolic heart failure, recent TMVR presented to the hospital with systolic heart failure. She is admitted to medical service and seen by the heart failure team. Echocardiogram showed severe aortic insufficiency and was being considered for valve intervention. She was treated with IV diuretics however her respiratory status did not improve. Hospital course was prolonged and she was hospitalized for 18 days. There is consideration of endocarditis given possible vegetations noted on aortic valve. CT surgery recommended aggressive antibiotic regimen and stated she was high risk for surgery. Initially was plan for IV antibiotics through October 4. She was treated with Lasix infusion, however urine output became marginal. Patient's x-ray developed progressive infiltrates and on September 14 she was found to have COVID-19 infection. She was started on steroids and received plasma as well. Antibiotics were also broadened to cover potential superimposed bacterial pneumonia. Despite this, her clinical condition deteriorated. She developed progressive renal failure as well as elevated LFTs and coagulopathy. She became more somnolent and oxygen requirement escalated. She became progressively critically ill and was requiring vasopressors, and was maxed on norepinephrine. Unfortunately, she continued to deteriorate and passed away on September 15. I passed along my condolences to the patient's son." "1759308-1" "1759308-1" "Asymptomatic breakthrough COVID-19 case. Death 5/22/2021. From Records cod = ALZHEIMER'S DEMENTIA, COVID 19, HYPERLIPIDEMIA, PULMONARY HYPERTENSION. Other patient details: pt has dementia, adult failure to thrive . glaucoma, and sepsis. place of death: HOSPITAL-EMERGENCY ROOM/OUTPATIENT; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occupation: PLAYGROUND DIRECTOR-BOARD OF ELECTIONS" "1759327-1" "1759327-1" ""ED to Hosp-Admission Discharged 9/13/2021 - 9/18/2021 (5 days) Hospital Problems * (Principal) COVID-19 Yes Rheumatoid arthritis Yes RHEUMATOID ARTHRITIS; Current use of long term anticoagulation Not Applicable Supratherapeutic INR Yes Acute hypoxemic respiratory failure Yes Encephalopathy Yes Poor prognosis Yes Immunosuppressed status Yes Presenting Problem/History of Present Illness/Reason for Admission Acute hypoxemic respiratory failure Hospital Course 1. Acute hypoxic respiratory failure secondary to COVID-19 pneumonia: Patient has been continued on remdesivir IV, Decadron 6 mg IV, infectious disease consultation appreciated patient is not a candidate for baricitinib as she has immunosuppression. 2. Supratherapeutic INR: Patient got a dose of vitamin K 3. Known rheumatoid arthritis on multiple immunosuppressive medications including prednisone methotrexate and rinvoq , hold on medications until she recovers from COVID-19 pneumonia. 4. Hypothermia likely related to severe infection with COVID: resolved Because of the comorbidities, patient was extremely sick and was requiring very high oxygen she decided to change her CODE STATUS to comfort care, patient will be changed to hospice. Operative Procedures Performed Treatments: treated for Covid, changed to comfort care Procedures: none Consults: none Pertinent Test Results:none Physical Exam at Discharge Heart Rate: (!) 104 Resp: (!) 24 BP: 119/84 Temperature: 36.6 ¦C (97.8 ¦F) Weight: 71.9 kg (158 lb 8.2 oz) General: Patient seems very sick, seems anxious HEENT: Atraumatic normocephalic Neck supple CVs: S1-S2 regular rate and rhythm Respiratory: Patient has bilateral coarse breath sounds, requiring supplemental oxygen with nasal cannula Abdomen: Soft nontender bowel sounds present Neurologically: seems restless Patient has right BKA Discharge Instructions Condition at Discharge Discharge Condition: very sick Chief Complaint Patient presents with ? Shortness of Breath 1. Acute hypoxemic respiratory failure 2. COVID-19 3. Current use of long-term anticoagulation 4. Supratherapeutic INR 5. Poor prognosis 6. Encephalopathy Plan: Pulse oximetry continuously - high flow nasal cannula. Consult pulmonology. Decadron 6mg IV daily Remdesevir IV full course guidelines advise AGAINST routine plasma use in hospitalized patients. I do not believe benefits > risks. Spoke to ED physician personally Given vitamin K to reverse INR > 9.8 Critical care time spent 60 minutes o Nutrition: heart healthy if passes dysphagia screen o VTE prophylaxis: heparin o Full Code History of Present Illness a 69 y.o. female. I personally interviewed patient, reviewed chart, and reviewed emergency room resident history and agree with it in its following entirety unless otherwise noted below. "" a 69 y.o. female w h/o DVT on coumadin, vaccinated against covid. presenting to the ED with weakness and fatigue for the past 2 weeks. Patient is not able to provide much history. Per her sister she has been ill for the past 2 weeks symptoms including weakness, fatigue, shortness of breath. She is normally alert and oriented x3, no history of dementia. She was seen in urgent care and prescribed antibiotics and steroids but she did not receive a Covid test. She continued to worsen on the next couple days and her neighbors who checked on her, and she was not very responsive so they called EMS. Per EMS patient was satting approximately 50% on room air and she was put on nonrebreather at 15 L and had improvement in saturation."" Patient is on high flow nasal cannula saturating in the upper 90s. She has a very poor historian. Not coughing just short of breath. No edema No rashes Principal problem Acute hypoxic respiratory failure Covid pneumonia Rheumatoid arthritis-immunocompromised state Patient was admitted to Hospital on 9/13 with Covid pneumonia and acute hypoxic respiratory failure. She was requiring high flow nasal cannula at the time of admission. She was started on Decadron and IV remdesivir. Due to the requirement of high flow nasal cannula pulmonology was consulted and also infectious disease was also consulted. Per infectious disease immunomodulators are contraindicated in this immunosuppressed patient. Due to patient worsening respiratory state patient opted for comfort care and hospice. Patient was changed to comfort care and was consulted on 9/17. Patient is continued on comfort care medications with the help of the hospice Patient died on 9/21 at 2320"" "1759405-1" "1759405-1" "Admitted to COVID unit on 9/23. Was transferred to ICU and intubated on 10/2. Expired on 10/4" "1759418-1" "1759418-1" "Fully COVID vaccinated patient who admitted through emergency department with COVID positive test on 09/19/21. Patients respiratory status continued to decline, he required CCU admission high flow oxygen, and subsquently BiPAP. Medical team reviewed ongoing respiratory decline and grave status with patient and family who declined intubation. Patient moved to comfort care and died on 10/02/21." "1759420-1" "1759420-1" "Pt had a history of right lower lobe small cell lung cancer and emphysema. He reports a feeling of fatigue and loss of appetite. He is still receiving chemotherapy. He was found to be COVID positive." "1759433-1" "1759433-1" "Admitted to COVID unit 9/28 with 2 liters. Oxygen requirements continued to increase. On date of death 70 L/min Heated High-flow." "1759458-1" "1759458-1" "Breakthrough COVID-19 case. Hospitalized on unknown date for unknown duration. Death 5/7/2021. From Records COD = SEPTIC SHOCK, MULTISYSTEM ORGAN FAILURE, BOWEL PERFORATION. place of death: HOSPITAL-INPATIENT; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occupation: MAINTENANCE, HEAT AND AIR CONDITION" "1759487-1" "1759487-1" ""ED to Hosp-Admission Discharged 9/15/2021 - 9/18/2021 (3 days). Last attending ? Treatment team Anemia requiring transfusions Principal problem Details of Hospital Stay Presenting Problem/History of Present Illness/Reason for Admission Chills [R68.83] Weakness [R53.1] Anemia requiring transfusions [D64.9] Acute kidney injury superimposed on CKD (HCC) [N17.9, N18.9] Hospital Course 1. Severe sepsis secondary to Covid pneumonia in a immunocompromise patient, patient also has endorgan damage which includes acute renal failure and transaminitis. Patient has been started on cefepime and doxycycline, Decadron. Time of discharge I have changed him to cefpodoxime and doxycycline for 2 more days, he will be on dexamethasone 6 mg oral for 5 more days Was not a candidate for convalescent plasma and remdesivir due to transaminits 2. Elevated D-dimer: VQ scan negative for pulmonary embolism, ultrasound lower extremity negative for DVT 3. Acute blood loss anemia related to MDS: Status post blood transfusion, outpatient follow-up with oncology as outpatient. 4.Acute Renal failure superimposed on CKD stage III: Nephrology has been consulted, holding on Entresto. At the time of discharge his renal function has improved, needs follow-up as outpatient with his family doctor 5. Systolic heart failure ejection fraction 30%: Holding on entresto, he could have as needed Lasix 20 mg for shortness of breath, follow-up with heart failure clinic as outpatient 6. Atrial fibrillation: Continued on home medication 7 coronary artery disease with CABG 2009, peripheral arterial disease with carotid stenting, AAA with endovascular repair: Not on aspirin due to MDS 8. Diabetes mellitus 2: On glipizide 9. Hypothyroidism: Continue Synthyroid Physical Exam at Discharge Heart Rate: (!) 55 Resp: 18 BP: 123/57 Temperature: 36.5 ¦C (97.7 ¦F) Weight: 96.8 kg (213 lb 6.5 oz) Physical Exam General : Patient is no acute distress, sitting comfortably HEENT: Atraumatic normocephalic Neck supple CVS: S1-S2 regular rate and rhythm Respiratory: Bilateral equal entry, no wheezing sounds heard Abdomen: Soft nontender bowel sounds present Neurologically: Alert and oriented x3, moving all extremities Extremities no edema ED to Hosp-Admission Discharged 9/20/2021 - 9/27/2021 (7 days) Last attending ? Treatment team COVID-19 Principal problem Presenting Problem/History of Present Illness/Reason for Admission Acute on chronic systolic (congestive) heart failure (HCC) [I50.23] Congestive heart failure, unspecified HF chronicity, unspecified heart failure type (HCC) [I50.9] 2019 novel coronavirus disease (COVID-19) [U07.1] Atrial fibrillation with rapid ventricular response (HCC) [I48.91] Diabetes type 2 Severe sepsis due to COVID-19 Cardiogenic versus septic shock Acute renal failure with ATN Hospital Course Patient was recently hospitalized for Covid infection. He tested positive on 9/15/2021. He was discharged on 9/18. He returned to the emergency department on 9/20/2021 with increased shortness of breath and weakness. He does have underlying immunocompromised state in the setting of myelodysplastic syndrome, receiving weekly infusions. He was receiving aggressive care on the medical floor for Covid with steroids and antibiotics, when he decompensated on 9/24/2021. He was transferred to the ICU. He was in atrial fibrillation with RVR with a heart rate of 140, blood pressure was 60 over 30s. He was presumed to be in cardiogenic versus septic shock. He has multisystem organ failure including heart failure, respiratory failure, kidney failure, and transaminitis. Initially he was full team. After discussion with patient and his wife, he is now DNR with short-term intubation only. He cannot receive remdesivir because of transaminitis. He cannot receive interleukin-6 because of immunocompromised state. His ICU course consisted of milrinone drip, Lasix infusion, amiodarone infusion, and brief requirement of norepinephrine. He has acute renal failure, likely ATN. He also has transaminitis, acute on chronic congestive heart failure, and worsening Covid pneumonia. He continues to have hypoxic respiratory failure requiring high flow nasal cannula +100% nonrebreather. He is essentially requiring a cumulative amount of 75 L of oxygen. Today he was initially agitated when discussing hospice and states ""I will not talk to the death squad"". He is insistent on going home, but cannot navigate the decision making process. He does not understand why he can't go home (even though there is no one physically able to care for him at home). In discussion with his wife, the decision was made to transition him to hospice. He is uremic and hypoxemic, and likely cannot make high-level decisions. The patient does agree to go on hospice service. He was initially adamant about not receiving morphine. Therefore, we will use hydromorphone infusion as well as scheduled lorazepam and PRN dosing given his significant anxiety. He will be discharged, and readmitted under inpatient hospice. It is not feasible at this time for him to go home unfortunately. Operative Procedures Performed Physical Exam at Discharge Heart Rate: 60 Resp: (!) 10 BP: (!) 148/59 Temperature: 36.5 ¦C (97.7 ¦F) Weight: 96.5 kg (212 lb 11.9 oz) General: Elderly ill-appearing gentleman sitting upright, appears in mild distress Neck: neck veins are distended Cardiovascular: s1/2, rrr. Warm extremities with positive pulses Respiratory: Lungs are coarse throughout GI/GU: Abdomen is soft and nontender with positive bowel sounds Musculoskeletal: Trace lower extremity edema Integumentary: Skin is pale warm and dry Neurologic: Patient is alert. He is oriented to self, place and situation. He moves all extremities equally. Sensation intact Psychiatric: agitated, blunted affect Condition at Discharge Discharge Condition: poor"" "1759504-1" "1759504-1" "Hospitalized 09/23/2021; COVID-19 positive 09/17/2021; fully vaccinated DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute hypoxemic respiratory failure (HCC) [J96.01] Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01] COVID-19 [U07.1] HOSPITAL COURSE: 73-year-old female with history of chronic respiratory failure on 3-4 L of oxygen at baseline, chronic obstructive pulmonary disease, previous colorectal cancer, OSA, and aortic stenosis who presented with worsening dyspnea, hypoxia, hemoptysis, abdominal pain, and diarrhea after being diagnosed with COVID-19 9-17. She had symptoms for 2 weeks prior to admission. The patient required non-rebreather while in the emergency department. CTA was negative for PE, but showed diffuse bilateral peripheral airspace disease. CT of the abdomen and pelvis showed an atrophic pancreas, but no acute process. Steroids were started in the emergency department and the patient was admitted to the hospitalist service for further continuation of care. The patient's oxygen requirement worsened to the point where she was on 100% via high-flow nasal cannula. Her diarrhea and abdominal pain improved without intervention. IV vancomycin was started as her sputum culture grew Staph aureus. IV Lasix was administered. The patient was discussed with pulmonology who reported that prognosis was poor in the setting of her pre-existing lung disease. Goals of care were discussed with the patient by this provider. The patient was clear that she would not want intubation and mechanical ventilation in the case of worsening respiratory failure. The patient desaturated overnight 9-25 the and was hypoxic despite high-flow nasal cannula and non-rebreather. Comfort measures were initiated after discussion with the patient and her son. The patient passed away 09/26/2021 at 11:40 with family at bedside." "1759518-1" "1759518-1" "ED to Hosp-Admission Discharged 9/15/2021 - 9/19/2021 (4 days) Last attending ? Treatment team Septic shock Principal problem Final Summary for Deceased Patient BRIEF OVERVIEW Admission Date: 9/15/2021 Discharge Date: 9/20/2021 Final Diagnosis Principal Problem: Septic shock Active Problems: Chronic lymphocytic leukemia Pneumonia of right lower lobe due to infectious organism Infected laceration COVID-19 virus infection Suspected urinary tract infection Elevated troponin Acute respiratory failure with hypoxia Immunocompromised state Cellulitis DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Acute pulmonary edema [J81.0] SIRS (systemic inflammatory response syndrome) [R65.10] Septic shock [A41.9, R65.21] Urinary tract infection without hematuria, site unspecified [N39.0] Congestive heart failure, unspecified HF chronicity, unspecified heart failure type [I50.9] COVID-19 [U07.1] Sepsis [A41.9] Pneumonia due to COVID-19 virus [U07.1, J12.82] Hospital Course: Please send details from H&P intensive care critical care note cardiology was done for neurologist as well as palliative care note In briefly 85-year-old male history of multiple comorbid condition including CLL with history colon cancer with hemicolectomy admitted with fever chills confusion found to have a right lower lobe pneumonia UTI sepsis septic shock left arm cellulitis. Complicated with septic shock secondary from pneumonia UTI with immunosuppressive state COVID-19 pneumonia patient progressively going downhill even with dopamine drip and continue having persistent hypotension including respiratory failure. Patient also found to have a right lower extremity DVT patient was initially started Lovenox changed to therapeutic since patient was continued required dopamine unable to discontinue dopamine because of persistent low blood pressure Case discussed with patient family palliative care was consulted and in spite of of all the antibiotic Maxipime and Zithromax and dexamethasone for COVID-19 patient progressively getting downhill palliative care was consulted patient family was involved with the case and since patient prognosis going downhill initially there may DO NOT RESUSCITATE and do not intubation and finally his 2 sons who is the power of attorney decided to comfort care only. Patient was discontinued dopamine as per policy and was only on oxygen comfort medication was started patient expired approximately September 19 approximately 1830. Because of that respiratory failure secondary from septic shock secondary from multifactorial including pneumonia UTI cellulitis COVID-19 and persistent hypotension in the setting of immunosuppressive patient with CLL colon cancer and lung mass. Operative Procedures Performed Treatments: As per hospital policy Procedures: ICU care including dopamine infusion Consults: Intensivist palliative care Pertinent Test Results: CT right lower lobe pneumonia right middle and lower lobe pneumonia POA * (Principal) Septic shock Yes Chronic lymphocytic leukemia Yes Acute nontraumatic kidney injury Yes Pneumonia of right lower lobe due to infectious organism Yes Infected laceration Yes Overview Signed 9/16/2021 7:31 AM Infected laceration left wrist with surrounding cellulitis COVID-19 virus infection Yes Suspected urinary tract infection Yes Elevated troponin Yes Overview Signed 9/16/2021 1:19 AM Probably due to demand Acute respiratory failure with hypoxia Yes Immunocompromised state Yes Overview Signed 9/16/2021 1:23 AM Due to Medical Problems Plan: 1. Sepsis with shock probably due to multifactorial, including right lower lobe pneumonia, infected laceration left wrist with cellulitis, suspected UTI. The patient will be started on vancomycin, cefepime, and Zithromax. Patient will be continued on Levophed which has been started in the emergency room. Respiratory treatment. Oxygen support. Continue with BiPAP. 2. Elevated troponin probably due to demand. Serial cardiac enzymes. If the troponi increase, we will get get an echocardiogram as well as start the patient on IV heparin drip. 3. Acute respiratory failure with hypoxia. The family does not want the patient to be intubated. The agreeable to using BiPAP. And they also agreeable to admitting the patient to the ICU and use ICU level medications to maintain the blood pressure. We will continue aggressive management with BiPAP. Respiratory treatment. 4. Acute kidney injury. Gentle IV hydration. If kidney function continues to discharge in the morning, consider nephrology consultation. VTE Prophylaxis: SCD Lovenox 40mg subcu daily DNR (Do Not Resuscitate) History of Present Illness Chief Complaint Patient presents with ? Fever ? Altered Mental Status Patient is an 85 y.o. male. Patient was brought to the emergency room and altered mental status and unable to give any history. According to the emergency room doctor, the patient was found in respiratory distress with O2 sat of 90% on room air but the patient was very tachypneic. Patient was also noted to be hypotensive with a blood pressure of 78/68. Temperature was 101.5. Patient has history of CLL. The white count in the emergency room was 94.6. Hemoglobin was 7.8. BUN was 41 with a serum creatinine of 2.53. Chest x-ray revealed bibasilar interstitial prominence. However, CT scan of the chest shows right lower lobe pneumonia. Assessment Review of Systems Unable to perform ROS: Mental status change" "1759576-1" "1759576-1" "Breakthrough COVID-19 case with unknown symptom status. Death 7/26/2021. From Vital Records COD = ACUTE HYPOXIC RESPIRATORY FAILURE, COVID 19 INFECTION. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: OBESITY UNKNOWN BUT SIGNIFICANT CARDIAC HISTORY. place of death: HOSPITAL-INPATIENT, HEALTH SYSTEM; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: CERTIFIED NURSE ASSISTANT, NURSE ASSISTANT" "1759593-1" "1759593-1" "Hospitalized for COVID-19 on 9/6/21. Passed away on 9/18/21." "1759634-1" "1759634-1" "Guest passed/expired within 10 days of dose #2 of COVID-19 vaccine series. Began transitioning on 9/27/21-- 5 days s/p Dose #2. Guest was a hospice resident prior to COVID-19 vaccine and overall was having general decline prior to vaccination. Signed on to hospice on 8/6/21. Had active diagnosis of adult failure to thrive and hx of gastric CA--declined PEG tube. Only acute side effect 2 days s/p dose 2 noted was fatigue. No side side effects were reported with dose #1." "1759662-1" "1759662-1" "Breakthrough COVID-19 case with unknown symptom status. Death 8/19/21. From Vital Records COD = CARDIOPULMONARY ARREST, COVID 19, END STAGE RENAL FAILURE. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: None listed. place of death: HOSPITAL-INPATIENT, HOSPITAL; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: COMANPY" "1759710-1" "1759710-1" "Breakthrough COVID-19 case with unknown symptom status. Hospitalized 8/10/2021. Death 8/20/2021. From Vital Records COD = SEVERE HYPERKALEMIA, ACUTE RENAL FAILURE, ACUTE HYPOXIC RESPIRATORY FAILURE, COVID 19 PNEUMONIA. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: None listed. place of death: HOSPITAL-INPATIENT, HOSPITAL; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN." "1759771-1" "1759771-1" "Breakthrough COVID-19 case with symptom onset 8/9/2021: shortness of breath. Hospitalized 8/10/2021-8/11/2021. Death 8/11/2021. Case-pt was diagnosed with hypoxia, pneumonia, difficulty breathing, shortness of breath, respiratory problems." "1759807-1" "1759807-1" "Patient died suddenly at approximately 6AM on the following morning of 9/28/2021 after receiving the vaccine on 9/27/2021. Pt became acutely SOB and family called 911 for an ambulance but patient died before help could arrive. Pt's wife unable to give much further history." "1760262-1" "1760262-1" "9/18/2021 tested positive for COVID-19 via PCR; developed pneumonia, fever, chills, myalgia, sore throat, headache, cough, dyspnea, abdominal pain, congestion, bloody stool, weakness;" "1760282-1" "1760282-1" "83-year-old Caucasian female, initially seen in the emergency department with symptoms of cough, palpitations, body aches and fever. Patient had multiple family members positive COVID-19 in which she was in close contact. In the emergency department, patient required supplemental oxygen to keep O2 saturations above 88%. Patient also discovered to be atrial fibrillation with RVR. Patient was admitted to the hospitalist service, patient was started on COVID-19 protocol and isolation airborne precautions. Given dexamethasone 6 mg daily for 10 days and remdesivir for 5 days. Patient was started on therapeutic Lovenox. Cardiology was consulted for atrial fibrillation RVR, patient was to continue home amiodarone and started on a Cardizem drip. 21 September pulmonology is consulted with recommendations to keep potassium greater than 4 and magnesium greater than 2 in regards to atrial fibrillation. Treat hypoxia increasing O2 requirement to heated high-flow starting at 60 L at 100% FiO2. Patient's oxygen requirements continue to become problematic patient eventually was transferred to the ICU and placed on noninvasive ventilation. Atrial fibrillation and heart rate remained to be problematic with rate into the 130 to 140s at times. 29 September patient expressed to family members that she was tired and was ready to die, code status changed to DNR patient was transition to comfort measures and expired 1917Hr" "1760463-1" "1760463-1" "Backache/side ache most of the day on Sept 25th. My mother thought it might be a kidney stone so she took Ibuprofen every 4 hours. She also had nausea most of the morning of the 25th. She woke up around 2am on the 26th gasping for air and could barely breathe. She went into cardiac arrest." "1760635-1" "1760635-1" "Death. My daughter passed away in her sleep ." "1760669-1" "1760669-1" "Per niece a couple hours after getting the vaccine started to have issues with arm and his wife took him to the hospital to get checked out. It was took late by the time getting to the hospital and patient passed away around 1 pm. Per the coroner the preliminary cause of death is a blood clot. This information was provided to the pharmacy by the patients niece around 3 pm." "1761370-1" "1761370-1" ""Wife called to report a COVID-19 vaccine reaction. Patient received the J&J vaccine on 9/16 at Pharmacy. He did not feel well that night- achy joints, ""fever skin"", states skin felt as if he had the flu. He felt well after 3 days. On 9/27, Patient developed achy joints and stated he did not feel well. He died on their driveway. He was transported to Hospital and pronounced dead. Wife states she was informed he had an enlarged heart. Reports autopsy pending. States he was overweight, but had no medical history."" "1761422-1" "1761422-1" "Breakthrough Covid + 35 year old female with a Past Medical History of Evans Syndrome, Immune Deficiency Disorder, Lymph Node Abscess, B-cell Lymphoma, Cytomegalovirus, Pneumonia, Pneumothorax, Bone Marrow Biopsy, Port, and Lymph Node Biopsy. Admitted to Medical PCU for Low Grade Fever, COVID19, B-Cell Lymphoma, Evans Syndrome, Pneumonia, Splenomegaly, Elevated LFT's, Elevated Bilirubin, Dehydration, Hypoxemia, Tachycardia, Leukopenia, Anemia, Pancytopenia, Elevated Blood Glucose, Hyponatremia, Hypokalemia, and Questionable Small Lesions within the Liver. Patient was admitted to the hospital for shortness of breath cough and fever. Symptoms have been progressively getting worse over last 1-2 days." "1761478-1" "1761478-1" "Patient came in with respiratory failure" "1761528-1" "1761528-1" ""Fully vaccinated patient admitted for COVID pneumonia. Provider discharge note: ""Admitted to the hospital on September 20, 2021 for hypoxia. She was fully vaccinated against COVID-19. At that time she is requiring high-flow nasal cannula oxygenation. On 09/20 for a CT scan was done which showed a possible nonocclusive emboli in the left lower lung. She was started on heparin. She was transferred to the intensive care unit on the morning of 09/30/2021. She developed bilateral pneumothoracies that time. She was intubated and chest tubes were placed. Over the next 5 days she developed worsening ARDS with multiorgan system failure. This presented initially with AFib with RVR and progressed to kidney failure. On the morning of 10/04/2021 the patient's family decided that they did not want to pursue additional care. Her respiratory cardiac function decreased until 9:45AM on 10/5/2021 when she passed away."""" "1761541-1" "1761541-1" "unknown patient representative contacted pharmacy to report the patient had died hours after getting the moderna vaccination" "1761576-1" "1761576-1" "Patient fully vaccinated and later hospitalized then died due to Covid related causes." "1761633-1" "1761633-1" ""Breakthrough COVID-19 case with unknown symptom status. Death 9/21/2021. From Records COD= RESPIRATORY FAILURE, RENAL FAILURE, ATRIAL FIBRILLATION. Per records, Other Significant Conditions include: N/A. place of death: HOSPITAL-INPATIENT, MEDICAL CENTER; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occupation: MACHINIST, MACHINERY .""Did the patient die?""marked YES; ""Is this a COVID-related death?"" marked YES."" "1761641-1" "1761641-1" "pt was admitted on 9/17/21 with increased shortness of breath, pt was a DNR/DNI at time of hospitaliztion, pt was made hospice on 9/29/21 pt expired 9/29/21" "1761668-1" "1761668-1" "9/27/21 PATIENT REPORTED GENERALIZED WEAKNESS, COUGH , CHEST CONGESTION, SOB AND CHEST PAIN. 9/29/21 SEEN IN THE ER AT TURKEY CREEK MEDICAL CENTER WITH COMPLAINTS OF SOB AND WEAKNESS.SpO2= 95 DX WITH COVID-19 BILAT PNEUMONIA , HYPOXIA ADMITTED TO INPATIENT HOSPITAL STATUS. 4 L OF OXYGEN. ALSO NOTED TO HAVE CHRONIC KIDNEY DISEAE WITH UNKNOWN STAGE. dIED ON 10/4/21 WITH THE FOLLOWING DX: NSTEMI LIKLEY TYPE 1, ACUTE HYPOXIC RESP FAILURE, SEPSIS SECONDRAY TO COVID 19 PNEUMONIA AND POSSIBLE BACTERIAL PNEUMONIA, ACUTE CHF, ACUTE RENAL FAILURE,. CAUSE OF DEATH: V.FIB DUE TO NSTEMI." "1761752-1" "1761752-1" "Patient passed away on 09/24/2021." "1761787-1" "1761787-1" "Patient passed away on 09/25/2021." "1761801-1" "1761801-1" "Patient passed away on 09/29/2021" "1761807-1" "1761807-1" "pt admitted 9/20 with sob found to be hypoxic pt made comfort care and expired on 9/24 pt had of GI cancer," "1761825-1" "1761825-1" "Patient passed away on 09/05/2021." "1761843-1" "1761843-1" "Patient passed away on 09/01/2021." "1761852-1" "1761852-1" "Patient passed away on 09/20/2021." "1761858-1" "1761858-1" "Patient fully vaccinated and died due to Covid related causes." "1761864-1" "1761864-1" "ADMITTED TO FACILITY 9/29/21 AFTER FALLS AT HOME. RECEIVED J&J VACCINE FROM PHARMACY ON 10/1/21. ON 10/4, STAFF PRESENT IN ROOM, RESIDENT BECAME DIAPHORETIC, PALE, AND UNRESPONSIVE. 911 CALLED, RESIDENT EXPIRED MOMENTS LATER." "1761871-1" "1761871-1" "pt admitted on 9/2 syncopy and sob, pt placed on cpap in er condition continued to worse, pt intubated pt went into septic shock and expired on 9/12/21" "1761895-1" "1761895-1" "Patient passed away on 08/25/2021." "1761916-1" "1761916-1" "Recieved Booster Pfizer Vaccine on 9/29/21, on 9/30/21 had temp of 106.0, then 103.0, 102.0. CXR showed bilat infiltrates, started on rocephin., temp down to 97.9 on 10/1/21. Multiple long standing chronic health conditions, active with Hospice Services. DNR/DNI. On Aspiration Precautions." "1761982-1" "1761982-1" "Deceased (10.1.21); Hospitalized (9.17.21 - Acute massive, bilateral PE; cardiac arrest); Fully Vaccinated (8.18 & 9.8.21) Discharge Provider: Doctor Primary Care Physician at Discharge: Doctor Admission Date: 9/17/2021 Date of Death: 10/1/21 Time of Death: 7:10 AM Preliminary Cause of Death: Acidosis Discharge Disposition: Deceased PRESENTING PROBLEM: Cardiac arrest Shock Acute pulmonary embolism with acute cor pulmonale, unspecified pulmonary embolism type HOSPITAL COURSE: Patient is a 61-year-old male with past medical history significant for glaucoma, hypertension, hyperlipidemia who presented to the emergency department with syncope on 9/17. Had PEA cardiac arrest x4 secondary to bilateral massive PE with right heart strain. Received systemic thrombolysis 9/17. Initially in shock, likely obstcutive, and requiring pressors, though this did improve after a few days and patient came off pressors. Also initially with metabolic/lactic acidosis, likely secondary to PEA arrest hypoperfusion. Labs monitored with resolution. Post arrest echo with mildly reduced EF and dilated RV. No DVT on lower extremity Dopplers. PE possibly provoked secondary to recent COVID-19 vaccination, though hematology felt to be unprovoked. There was initially some concern for vaccine induced immune thrombotic thrombocytopenia secondary to patient's recent receipt of the COVID vaccine as well as thrombocytopenia. Pf4 antibodies and serotonin release assay sent per hematology recommendation, and patient was started on argatroban for anticoagulation. Pf4 and SRA negative with improved platelet count, so patient was transitioned to heparin infusion and remained on this throughout the course of his hospitalization. Patient also initially with DIC, received cryoprecipitate, and labs were monitored with resolution. He was not cooled given concerns for increased risk of bleeding secondary to DIC, thrombocytopenia, receipt of tPA. The patient continued to require intubation and mechanical ventilation. Initially secondary to massive PE/PEA arrest. Continued predominantly secondary poor mental status secondary to anoxic brain injury and extremely high doses of sedating medication to control seizures. The patient developed severely refractory seizures secondary to anoxic brain injury. Initial EEG demonstrated status epilepticus. He eventually required multiple antiepileptic medications as well as very deep sedation to achieve suppression. Critical Care were consulted and followed patient's course, providing recommendation. Patient was also kept continuous EEG. Patient was taken for MRI on 09/20 after he was sufficiently stabilized, notable for anoxic brain injury. CT head obtained 9/27 stable, no acute abnormalities. Ammonia level mildly elevated, not enough to explain cognitive deficit. Per neuro recommendation, LP was not felt to be necessary given the predominantly etiology of anoxic brain injury. Patient also developed primary lung findings of hemopneumothorax, bilateral lower lobe consolidations and pleural effusions. Bronchoscopy performed 9/22 with removal of large amount of thick mucus, cultures negative. Bronchoscopy again performed 9/26 with thin secretions, cultures negative. Patient covered with Zosyn. Chest tube placed 9/24 for hemothorax, with decrease in the amount of hemothorax confirmed on imaging. Chest tube remained in place throughout remainder of admission. The patient was additionally found to have bilateral renal infarctions on CT as well as AKI. Initial AKI most likely secondary to ATN in the setting of cardiac arrest. He did not require dialysis. Creatinine plateaued, then improved, though eventually did again worsen, unclear etiology. Continued to make urine, though was very challenging to fully diurese, particularly given large intake from IV drips as well as hypernatremia. Patient eventually did again develope a metabolic acidosis, likely secondary to worsened renal function. Fluid overload caused a large amount of anasarca, particularly abdominal distension/abdominal wall edema. Abdominal distension was initially thought to be secondary to obstruction, though imaging demonstrated no signs of obstruction and patient had bowel movements. Patient additionally with a normocytic anemia, predominantly secondary to hemothorax. Down trended slowly during admission. Did require transfusion with one unit with appropriate response. Further issues addressed during patient's hospitalization include hemoperitoneum and lower abdominal mesentery hemorrhage demonstrated on CT 9/17, improved on repeat imaging. Chest wall fractures additionally noted on CT 9/17, though these did not require management. The patient also had shock liver with transaminitis, though LFTs trended downward appropriately. Family was kept appraised of patient's condition and poor prognosis, particularly given severe brain injury. Caregiving assisted, and patient's family made the decision to refrain from escalating care on 9/30. Planned to withdraw care likely the following day once further family had had time to come and see the patient. Patient had a worsening acidosis as well as FiO2 requirement overnight 9/30 to 10/1. Bicarb drip was held as decision had been made for no escalation of care. Patient expired on 10/1 at 0700." "1761992-1" "1761992-1" "COVID breakthrough and death related to illness." "1761994-1" "1761994-1" "09/16/2021-09/19/2021 Patient remained in bed coughing, feeling ill, drinking fluids and eating but slept mostly. 09/20/2021-Patient complained about being congested so she took mucus relief and cough drops 09/21/2021-09/23/2021-Patient began moving around the house feeling short of breath and a little foggy but symptoms felt to be slowly disipating and she was glad to be out of bed. Took a shower and sat outside to get fresh air and discussed how 09/16-09/19 she had never felt the burning in her chest and tightness like anything before and was glad it was over with. She was given water and left to her own accord at 10:30 pm. 09/24/21- At approximately 9:30 patient was discovered in her bed having died sometime throughout the night." "1762006-1" "1762006-1" "Died of COVID illness." "1762030-1" "1762030-1" "Illness and death related to COVID." "1762046-1" "1762046-1" "COVID illness and death." "1762101-1" "1762101-1" ""Patient vaccinated for COVID on 2/17/2021, admitted on 8/3/2021, tested positive for COVID 8/3/2021. discharged 8/8/2021 patient admitted again on 8/23/2021, tested positive for COVID 8/23/2021. Patient passed away on 9/4/2021 History Of Present Illness a 80 y.o. male with a PMH of A-fib (on Eliquis), severe MVR, HTN, HLD, CAD s/p 2xDES (2005), Saddle PE (2017), reduced LVEF, Waldenstrom macroglobulinemia (on imbruvica) who presents with worsening weakness, dizziness, SOA, chills and decreased appetite over the past 1.5 wks. Associated with mild abdominal pain. Symptoms started back in June, but acutely worsened. He was evaluated for these issues. His cardiologist performed a LHC showing 50% LAD stenosis, severe MR, LVEF 30-35%, LVEDP of 40. Given these findings, he was referred to another doctor for evaluation for potential MV replacement. However, given his worsening symptoms, he presented to the ED. Patient denies recent sick contacts. No fevers, N/V/D. He is vaccinated against COVID. He was given lasix to take for 2 wks if he had significant weight gain- states he only took it 3 times and had not since. Compliant with all meds. Review of Systems Constitutional: Positive for activity change, appetite change and chills. Negative for fever. HENT: Negative for trouble swallowing. Respiratory: Positive for shortness of breath. Negative for cough, chest tightness and wheezing. Cardiovascular: Positive for palpitations and leg swelling. Negative for chest pain. Gastrointestinal: Positive for abdominal pain. Negative for constipation, diarrhea, nausea and vomiting. Assessment and Plan He is an 80 y/o male with PMH of A-fib (on Eliquis), severe MVR, HTN, HLD, CAD s/p 2xDES (2005), Saddle PE (2017), reduced LVEF, Waldenstrom macroglobulinemia (on imbruvica) who presents with worsening weakness, dizziness, SOA, chills and decreased appetite over the past 1.5 wks noted to have Covid Infection. #COVID Infection -Now needing 3 l of O2 -CXR- Peribronchial thickening and interstitial opacification may be associated with viral infection -Patient states he was previously vaccinated. -Given patient's hypoxia, will start dexamethasone 6 for 10 days and also Remdesivir -Encourage Pul toilet, BD and Proning -Monitor AKI on CKD -baseline Cr 1.6 -Likely due to prerenal in the context of IV lasix on admission with N BNP -Monitor in the background of Remdesivir -Hold further diuresis -avoid nephrotoxic agents -Repeat CMP in AM #Severe Mitral Regurgitation #Mitral Valve Prolapse #HFrEF #CAD s/p DES - Baptist LHC 6/22/2001 - 50% LAD stenosis, severe MR, LVEF 30-35%, LVEDP of 40 - ECHO 12/2015 - bileaflet prolapse with posterior mitral cleft with severe MR. - ECHO 8/2018- shows MV prolapse with severe MR. - ECHO 6/30/2021- severe MR. No sig mitral valve stenosis is present. LVEF 45-50%. - BNP- 864, Na 135, Cr 1.6 (baseline). - CXR- Peribronchial thickening and interstitial opacification may be associated with viral infection A/ Overall believe patient's symptoms are 2/2 to Covid infection and his worsening, severe MR. He was diuresed well with 40 of IV lasix. Will have evaluation from CT surgery. If they believe valve is the root cause of his issues and do not feel surgical intervention is warranted, will consider interventional cardiology consultation. Plan: - CT Surgery Consulted - Hold further diuresis given severe MR and improvement in symptoms #A-fib - Patient on eliquis and atenolol -C/w eliquis and atenolol #Waldenstrom macroglobulinemia - Started on imbruvica for treatment. Patient states he does not take venclexta Plan: - Consult oncology in AM for approval of imbruvica Chronic Conditions -Benzodiazepine dependence- Tranxene 15 mg nightly; recommended weaning and discontinuing as outpt -Skin Lesions- multiple lesions on abdomen and UEs- continue doxycycline. -HLD- pravastatin 40 -HTN- on atenolol only -GERD- PPI F: po E: po N: Cardiac, low salt; DVT Ppx: Hold eliquis, heparin 5000 q8hrs Code:code status: do not resuscitate, okay to intubate. POA- Son. Has living will. Hospitalization Admit Date/Time: 8/3/2021 9:47 AM Discharge Date: 08/08/21 Chief Concern, Brief History of Present Illness, and Hospital Course He is an 80 y.o. male with a history of A-fib (on Eliquis), severe MVR, HTN, HLD, CAD s/p 2xDES (2005), Saddle PE (2017), reduced LVEF, Waldenstrom macroglobulinemia (on imbruvica) who presents with worsening weakness, dizziness, SOA, chills, mild abdominal pain and decreased appetite over the past 1.5 wks and noted to have Covid Infection. He was here for the mitral valve surgery and found to have COVID. He transiently required oxygen and was off oxygen at the time of discharge. He was treated with dexamethasone and remdesivir. Hematology advised to hold ibrutinib in the setting of COVID infection and upcoming surgery and follow up with patients OSH hematologist to decide about ibrutinib. CTS will follow up with the patient regarding surgery which is likely to be in a month as per my discussion with CTS. The details of A&P while in the hospital is listed below. #COVID Infection # Acute Hypoxic Respiratory failure (resolved) -discharged on room air. -CXR- Peribronchial thickening and interstitial opacification may be associated with viral infection -Patient states he was previously vaccinated. -Given patient's hypoxia, c/w dexamethasone 6mg for 10 days and Remdesivir AKI on CKD-Resolved. Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable) second admission 8/23/2021 Patient admitted for altered mental status Chief Complaint Chief Complaint Patient presents with ? Trauma Alert ? Fall ? Epidemic Concern ? Altered Mental Status History Of Present Illness He is an 80 yo male with PMH waldenstrom macroglobulinemia (on imbruvica), Afib (on Eliquis), severe MVR, HTN, HLD, CAD s/p 2xDES (2005), Saddle PE (2017), reduced LVEF. Who presented to the Emergency Department after a fall at home. History is obtained from son who is at bedside and prior records as patient is currently altered and minimally responsive to exam. Per the son the patient had become increasingly confused over the past 2 days where he was ""talking off the wall"". After falling to his left side, son brought him to emergency department for further evaluation. On arrival the patient was saturating in the low 80s on room air and tachycardic to 120s with normotension. He was administered 2 L of fluid and placed on high-flow nasal cannula. His oxygenation improved, however he developed A-fib RVR with HR up to 180s. His blood pressure dropped with this to maps in the low 70s. At this time MICU was consulted for further evaluation. On exam the patient is altered, alert to person only. He also has notable swelling and erythema to his left forearm which is hot to touch. Noteworthy labs include WBC 20.67, Creatinine 2.15, and Lactate 4.5. Patient will be admitted to ICU with plan for Amio gtt for A-fib RVR and management of Sepsis. Pulmonary: Breath sounds: No stridor. Decreased breath sounds present. No wheezing or rhonchi. An 80 y/o male with PMH of Afib on Eliquis, severe MVR, HTN, HLD, CAD s/p DES. PE (in 2007), HFrEF (50% EF), CKD, Waldenstrom macroglobulinemia, recent COVID infection who is being admitted for sepsis likely 2/2 SSTI of L arm. #Sepsis and Septic Shock - Patient presented with F 101.2F, Tachycardia, tachypnea, hypotension and had elevated WBC at 20.67 - L arm swollen, erythematous, warm to touch and weeping. L arm cellulitis appears to be the likely source. - Blood cultures pending. Check urine cultures, sputum cultures, S pneumo and legionella. - S/p Vanc and Zosyn. Continue broad spectrum antibiotics and tailor them pending culture results. - 2L fluid given in boluses. Due to HFrEF will hold off on any more IV boluses. Can give gentle maintenance fluids. - Lactic acid elevated at 4.5. Follow post resuscitation levels. Dispo - Admit to ICU - DNR/I a 80 y.o. male with past medical history significant for atrial fibrillation on Eliquis, severe mitral valve regurgitation, hypertension, hyperlipidemia, chronic systolic heart failure, CAD, previous saddle PE, Waldenstrom macroglobinemia, and critical aortic stenosis, who presented to ED with after a fall at home. Per report, the patient was diagnosed with COVID-19 on the 3rd of this month and has been living with his son while he has been recovering. Of note, the patient was due to undergo evaluation for surgical repair of his symptomatic valvular heart disease, however this was postponed due to his COVID-19 infection. His son states that for the past 2 days, he has become increasingly confused with worsening mentation from his baseline. His son noticed that his father became acutely tachypneic today and suffered a mechanical fall from standing, landing on his left side. He was brought to the ED as a trauma alert with subsequent workup significant for oxygen saturation of 84% on room air, tachycardia with HR between 150-180, and breathing at 30-35 breaths per minute. He was given 2L of fluid, IV antibiotics per sepsis protocol, and Tylenol for symptomatic relied. He continues to be tachycardic in the 170's on average at this time with high flow nasal cannula required for adequate oxygen saturations above 90%. Hospital medicine was consulted for admission given concern for this patient's clinical presentation and unstable vital signs. He was eventually endotracheally and transferred to the ICU for further care. He was treated for assumed pneumonia and on workup was found to have severe mitral regurgitation. With diuresis and antibiotics, the patient's mechanical ventilation was eventually weaned and the patient was extubated. CTS was consulted for his severe MR and potential surgical options, however given the patient's age and level of illness and debilitation, this was not possible. The family was consulted at every stage of the decision making process and they elected to make him DNR/DNI and palliative care was consulted. On 9/3 comfort care measures were instituted and the patient passed away peacefully with his family at bedside. Hospitalization Admit Date/Time: 8/23/2021 11:42 AM Discharge Date: 9/3/2021 1. Severe mitral regurgitation with respiratory failure- patient and his son understand that there are longer medical or surgical options for his valve disease. Their goal is to focus on comfort care duing his last days of life. It is important to them that he lives for the next several days in order for his son to complete the sell of patients home on Tuesday. This will allow them to avoid escrow and gift the house to a family that is important to him. Should he decline to dying before then we will not attempt to prolong his life. However in the interrim we will continue hi flo oxygen as any attempt at weaning will shorten life now. Will also continue tube feeds but allow to eat and drink for pleasurer and not replace tube if becomes removed. Comfort Care Only Goals of care- comfort care plan, allow natural death with no escalation of care -can dc lab draws -do not increase oxygen supplementation past current hi flo setting -can stop telemetry, rapid response -dc scd -allow food and drink for pleasure Patient Expired during this admission and was discharged to morgue."" "1762271-1" "1762271-1" "The patient was found dead on 28th September. The deceased seemed to have struggled to stand up and fell onto the floor. There was a great deal of blood. The medical investigator immediately declared this death to be natural causes and refused to file a Vaers report stating that it had been too long (6 months and 2 weeks) and she would only file one up to 6 months; or carry out an autopsy which was requested by the various next of kin who were contacted, stating the body wasn't 'fresh enough'. Communications suggest the death occurred on 20th of September on the evening that the deceased had attended (and lead) a Meeting." "1762703-1" "1762703-1" ""Pt received vaccines at our pharmacy the morning of 10/4/21. She was monitored for 15 minutes after vaccination and no reactions were noted or observed in the patient waiting time. She left without any known complications. On 10/5/21, the Coroner came to the pharmacy with documents to retrieve medical records for the patient as she had ""went into cardiac arrest yesterday and needed these records for the autopsy investigation."" After contacting my direct supervisor and he contacted necessary persons to confirm the release of the PHI, we called him back to inform him he could come to pick up records. There was no communication in between the time the patient left the pharmacy without complications from the vaccines and the time the coroner came to pharmacy to retrieve patient records for her death."" "1762722-1" "1762722-1" "Shortness of breath, dizziness and lightheaded" "1762881-1" "1762881-1" "Death within 7 days of receiving vaccine." "1762892-1" "1762892-1" "None stated." "1763088-1" "1763088-1" "Patient is fully vaccinated and later hospitalized and died a day later" "1763094-1" "1763094-1" "Death within 48 hours of vaccine" "1763098-1" "1763098-1" "Death within 7 days of vaccine" "1763101-1" "1763101-1" "Patient fully vaccinated and died of Covid related causes." "1763115-1" "1763115-1" "Death within 7 days of receiving vaccine" "1763118-1" "1763118-1" "Patient fully vaccinated and died due to Covid related causes." "1763122-1" "1763122-1" "Death within 7 days of vaccination" "1763701-1" "1763701-1" "Patient fully vaccinated and died due to Covid related causes. Patient believes was exposed from husband" "1763702-1" "1763702-1" "Patient fully vaccinated and died due to Covid related causes" "1764194-1" "1764194-1" "Swelling and bumps; Double stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Double stroke) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Double stroke) (seriousness criteria death and medically significant). On an unknown date, the patient experienced SWELLING (Swelling and bumps). The patient died on 20-Jul-2021. The reported cause of death was double stroke. It is unknown if an autopsy was performed. At the time of death, SWELLING (Swelling and bumps) outcome was unknown. Patient passed away after getting Moderna COVID-19 Vaccine. No relevant concomitant medications were reported. No treatment information was reported.; Sender's Comments: This case concerns a 75 year old male with no relevant medical history who experienced serious unexpected fatal event of CVA approximately 2 months after the first dose of the vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.; Reported Cause(s) of Death: Double Stroke" "1764619-1" "1764619-1" "Hospitalized 3/24/2021 to 4/7/2021. Death 4/7/2021. From Records COD = SEPTIC SHOCK, COVID - 19. place of death: HOSPITAL-INPATIENT; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occupation: HOMEMAKER, NONE" "1764717-1" "1764717-1" "Breakthrough COVID-19 case with symptom onset 8/18/2021: worsening confusion and loss of appetite. Hospitalized 8/26/2021-9/3/2021. Death 9/3/2021. Vital Records data not available yet" "1764754-1" "1764754-1" "Breakthrough COVID-19 case with unknown symptom onset date: Fatigue or tiredness and weakness. Patient presented to ED on 08/19/2021 after a fall with weakness and feeling tired. Patient death reported by hospital. Patient was admitted on 08/20/2021 and died on 08/24/2021." "1764836-1" "1764836-1" "BECAME SYMPTOMATIC AND TESTED COVID POSITIVE 8/13/21. DIED 9/7/21" "1764846-1" "1764846-1" "Fever, Runny Nose/Congestion, Sore Throat, Cough recent diagnosis of lung cancer on the left side. He had a left lung biopsy yesterday. Last night he developed shortness of breath. He is very dyspneic. He normally is on oxygen from 2-4 L. On 4 L he was in the mid 70s on EMS arrival. They placed him on oxygen but his oxygen status was still low and he was tachypneic. He was placed on CPAP with improvement. He also received steroid, Solu-Medrol as well as breathing treatments. No chest pain. No abdominal pain. No nausea vomiting. No fever. patient reports having his 2nd dose of COVID vaccine 2 weeks ago In ER, patient was noted to be in AFib with RVR. The per patient and wife was at bedside, he does not have any history of atrial fibrillation. Death on 3/31/2021" "1764856-1" "1764856-1" "Pt died after contracting COVID-19 in early August 2021." "1764880-1" "1764880-1" "Patient died after contracting COVID-19 in Aug 2021." "1764890-1" "1764890-1" "Started w/ shortness of breath mid to late June 2021. This was intermittent x 6-8 weeks. Started with upper calf pain end of July 2021. This was also intermittent. Started with cough and had increased shortness of breath first week in August. Went to his PCP. She thought it was asthma. Started on albuterol. This did not help. I found him 8/9/21 on our bed when I came home from work and he had passed away. Verbal autopsy report from Coroners office told me DVT in R calf and 2 pulmonary emboli. My husband was a non-smoker and worked out 7 days a week including long distance running, gym twice a week, playing basketball and hiking 14,000 ft mountains. No one can explain to me why he developed clots. No history or family history of any clotting disorders." "1764920-1" "1764920-1" "Patient died about a month later. Unknown whether she had a second vaccination for COVID. She was resident at Rehab Facility." "1764923-1" "1764923-1" "Patient died after contracting COVID-19 in September 2021." "1764974-1" "1764974-1" ""He was in his usual state of good health. 5 days after receiving the vaccine, he complained of brief unilateral shoulder pain (unclear to family which shoulder), which the family attributed to a musculoskeletal source. No chest pains, shortness of breath, or palpitations. He was playing with 2 friends at a community pond, swinging from a rope swing, flipping in the air, and landing in the water feet first. He surfaced, laughed, told his friends ""Wow, that hurt!"", then swam toward shore, underwater as was his usual routine. The friends became worried when he did not re-emerge. His body was retrieved by local authorities more than an hour later."" "1764984-1" "1764984-1" "81 y.o. female with PAD s/p aortobifem bypass, Atrial fibrillation on xarelto who presents to Medical Center with COVID19. Spoke with patient and daughter briefly at bedside prior to emergent intubation. Patient and daughter report that patient tested positive for COVID19 about 10 days ago. Patient has been at home on nasal cannula. Patient reports that today she felt as though she could not breathe. Daughter reports that saturations had dropped at home. Patient reports that otherwise she has felt ok in the last ten days, has had diarrhea that has been bothering her more in the last few days prior to presentation. Of note patient is vaccinated with Pfizer. In the emergency room, patient was requiring HFNC. CTPE showed no pulmonary embolism and moderate bilateral airspace disease consistent with COVID19. Patient also has advanced emphysema. She has a past medical history of CHF (congestive heart failure), Chronic renal failure, Compression fracture of fourth lumbar vertebra with routine healing (11/2020), COPD (chronic obstructive pulmonary disease), Hyperlipidemia, unspecified, Hypertensive heart disease without congestive heart failure, PAD (peripheral artery disease), and Personal history of other diseases of the digestive system. #Acute Hypoxic Respiratory failure secondary to COVID19 infection - Patient's CTPE negative of PE, did show bilateral GGO c/w COVID and some concern for underlying lung disease. No concern for concurrent bacterial pneumonia. PLAN - DEXA ARDS started 8/23 - a.m. gas was borderline requiring proning- will reevaluate this afternoon - Ongoing ICU level care given hypoxic respiratory failure #Acute Hypoxic Respiratory failure secondary to COVID19 infection- worsened - Required increased PEEP for recruitment, paralytic, and increasing to FiO2 100% overnight. This a.m. remains hypoxic despite being on 100% FiO2. Differential includes PE, pneumonia, progression of COVID19 infection. Initially started antibiotics, however as goals are now to keep the patient alive until family arrives, are minimizing treatment to only what is sustaining her life for the next 24 hours. PLAN - Continue steroids - Not proning due to multiple comorbidity and poor prognosis - Cont vent settings. - Heparin drip for possible PE, will not pursue imaging to confirm Patient was unable to be weaned down on her ventilator settings despite dexamethasone and attempts to optimize patient's fluid status. Patient's family elected to have no escalation of care on 8/28, and ultimately decided on comfort care with terminal extubation on 8/30." "1765070-1" "1765070-1" "Onset of severe shortness of breath and death within several minutes." "1765077-1" "1765077-1" "an 18-year-old gentleman with a past medical history significant for perimembranous ventricular septal defect and severe aortic valve insufficiency, status post ASD and VSD and aortic valvuloplasty back in 2004. He had repeated surgical aortic valvuloplasty with moderate residual aortic valve insufficiency. He is followed closely by the pediatric cardiology service. On his last office visit on 1/7/2020, there were concerns regarding increased BMI, elevated systolic blood pressure, and wide pulse pressure. Need for repeat aortic valve surgery was addressed during the visit. The cardiac MRI was done in March of 2021 which revealed worsening to severe aortic insufficiency with an increasing left ventricular dilation with a reduced EF of approximately 60% and reduced right ventricular ejection fraction of 66% from previous studies. The patient was COVID positive in February 2021. He received the second COVID vaccine back on 6/10/2021. The patient presented to Emergency Department on 6/12 at approximately 12:30 in the afternoon complaining of shortness of breath, cough as well as nausea and vomiting for approximately 1 week. He had chest pain and fatigue that had been worsening over the last 48 hours. No fevers. No sick contacts. A CT angiogram of the chest was obtained which was negative for PE. After return from that study, a nurse found the patient in severe respiratory distress. The patient became bradycardic and profoundly hypotensive and then subsequently went into a PEA cardiac arrest at approximately 4:30 p.m. on the 12th. CPR was initiated. He was intubated and subsequently placed on venoarterial ECMO at 1719 that day by the cardiac surgery service. Post ECMO, the patient's mental status was questionable after the arrest. He was noted to have rightward gaze by the emergency department physician. A transthoracic echo was performed at 1815 which demonstrated wide open aortic insufficiency with flail segment. He was transferred to us as a tertiary care center and escalation of care. The patient was admitted to the Heart and Vascular ICU team in the adult cardiothoracic surgery service. Upon arrival to the ICU, the ECMO circuit was changed from a Novalung to the CentriMag ECMO circuit." "1765256-1" "1765256-1" "Patient was hospitalized and died due to COVID-19. Patient was fully hospitalized." "1765317-1" "1765317-1" "My dad had a physical 9/30/2021 and received a clean bill of health complete with lab work. He then received his second covid vaccine. sunday 10/3/2021 my dad got up went to the store..called my mother around noon had lunch and went back to work. two hours later he had an event and DIED. he was In perfect tip top health. he was taken from us way to soon" "1765357-1" "1765357-1" "Patient is a 64 y.o. female with a past medical history of hyperlipidemia, IDDM2, OSA, anxiety/depression, and chronic back pain who presented from Clinic on 9/4/2021 with acute respiratory failure due to COVID-19 infection. Required intubation secondary to refractory hypoxemia with worsening mental status and increased work of breathing on 9/6. Was initially on paralytics and intermittently in prone position following intubation. Hospital course complicated by persistent fevers up to 103.9, multiple infectious workups negative. On 9/16/2021, Patient had acute decompensation with hypotension, hypoxia and ventricular tachycardia requiring defibrillation. CTPA revealed pulmonary embolism. EKG with anterior leads concerning for ischemia, on-call cardiologist notified, stat echo ordered. See code documentation from 9/16 for further information. She continued to decompensate despite maximal support from vasopressors and mechanical ventilation. Family present at beside, pt husband expressed wishes to transition to Home Care. Code status changed to DNRCC, pt compassionately extubated with time of death at 2051 on 9/16/2021." "1765443-1" "1765443-1" "employee of facility. she came to work and was sitting in locker room and noted by another employee to be hyperventilating/shaking. Coworker got nursing staff who went in to assess her. Employee stated she had been having chest pain on and off for the past few days and that her PCP suggested getting tested for covid. She was again complaining of chest pain, stating she can't breath, and became very anxious. BP was high, HR was in 170's, oxygen was 87. Applied O2 via nonrebreather, contacted EMS. At time of EMS arrival employee fainted x 2 and went into asystole. CPR performed for almost an hour before time of death was called. medical examination performed post death and determined she had a pulmonary embolism." "1765464-1" "1765464-1" "Immediate rash and swelling in groin and upper extremities . Swollen lymph nodes within two weeks. Lymphoma diagnosis July" "1765475-1" "1765475-1" "Deceased (10.4.21); Hospitalized (9.14.21); COVID-19 positive (9.29.21); fully vaccinated Admission Date: 9/14/2021 Date of Death: 10/4/21 Time of Death: 6:56 AM Preliminary Cause of Death: Hypoxia DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Perforated abdominal viscus Bowel perforation a 68 y.o. female with past medical history significant for Crohn's disease on immunosuppressive therapy, history of stroke, and PAD who presented to the emergency department with severe abdominal pain. CT concerning for bowel perforation and Colorectal took patient for urgent laparotomy and was treated with broad spectrum antibiotics and antifungals. CT also with concern for liver metastasis and biopsy done in the OR showing metastatic neuroendocrine tumor. Workup further showed a cardiac mass which was biopsied via RHC showing metastatic SCC indicating patient having two primary metastatic diseases. Patient continued to decline and developed dyspnea; unfortunately she tested positive for COVID19. Patient ultimately wished to be made comfort care and so hospice was consulted and comfort care orders initiated. Medicine service took over care to facilitate this on 10/2. Patient expired on 10/4/2021 at 6:56am." "1765490-1" "1765490-1" "Patient contracted COVID, was hospitalized, and died" "1765535-1" "1765535-1" "Breakthrough COVID-19 infection. Admitted for painful swallowing. Progressed to shortness of breath and difficulty breathing. History of esophageal cancer with recent start of chemo and radiation. Required intubation and ventilator support. Developed acute kidney injury, and goal changed to comfort measures." "1765598-1" "1765598-1" "Nearly immediately patient didn't feel well with general malaise. He took that afternoon off work and the following Tuesday off as well (May 10 and 11). He went back to work Wednesday (May 12) and complained of being tired and having a hard time breathing. He took Thursday off and only worked a couple of hours on Friday (May 13 and 14 respectively). He described a heaviness on his chest. On Saturday, May 15 he experienced chest pains while mowing the lawn. He told people he was in a lot of pain and thought he was having a heart attack especially at night when he would lie down to sleep. He was drinking lots of water and was checked by a men's health clinic with a handheld ECG on Monday, May 17. They reported his heart was healthy but he continued to experience shortness of breath and tightness in his chest. He worked a few hours each day Monday through Thursday, May 17-21, but continued to indicate he didn't feel well." "1765690-1" "1765690-1" "suspect patient death based on timing Patient was seen on 3/31 for lumbar back pain with leg pain. had follow up visit scheduled with regular PCP within a few days. had covid shot the next day. Then we noted he missed his appointment follow up with pcp and were told he had passed. noted his covid shot was the next day. sounds like he may have been found at home expired." "1766155-1" "1766155-1" "Found dead in her bathroom floor 8 days after vaccine. Was fine the night before." "1766159-1" "1766159-1" "Death by heart attack" "1766330-1" "1766330-1" "9/9/21 pos for covid 9/15/21: admitted to hospital and put on steroids and had 1 dose of tocilizumab pt intubated and put on ventilator pt expired on 9/20/21 of COVID" "1767137-1" "1767137-1" "Patient fully vaccinated and died due to Covid related causes" "1767140-1" "1767140-1" "Patient fully vaccinated and hospitalized. Died about 20 days later due to Covid related causes" "1767952-1" "1767952-1" "Pt is a 55 y.o. male who presents with Acute respiratory distress syndrome (ARDS) due to 2019 novel coronavirus (CMS/HCC) Pulmonary: Effort: He is intubated. Breath sounds: Decreased breath sounds and rhonchi present. Comments: On mechanical ventilation and ecmo (Principal) Pneumonia due to 2019 novel coronavirus Initially tested positive for Covid on 8/3 Intubated and cannulated for VV ECMO on 8/20 Bivent w/ 50% FiO2; ECMO 100%, sweep 4 On Veletri: ECHO EF 60-80%, RV mildly dilated, fxn normal Wean settings as able Continue q4hr and PRN ABG's CXR as needed Continue diuresis with lasix drip Patient presented as a transfer for management of Covid pneumonitis with ECMO. He was supported for a short time, But 6 days later a CT of the Brain revealed multiple intracranial hemorrhages with midline shift. With these findings, comfort measures were undertaken, and he expired shortly after that." "1767953-1" "1767953-1" ""Breakthrough COVID-19 case with symptom onset 8/20/2021: Fever, Aches, Shortness of breath/difficulty breathing, Cough. Hospitalized 8/20/2021-8/27/2021. From HCW: Respiratory Distress. Per pt, he got ""stuck in bed, couldn't sit up for 3 hours"". Pt found semi-responsive by EMS, initially satting 40s RA, mid-80s NRB, heard wet lung sounds. No known Covid exposure, recently vaccinated. Hx sleep apnea, lymphedema. No other aggravating or alleviating factors. Symptoms are described as mild to moderate in intensity, severity, quality, and character. Nurse's notes have been requested, obtained, and reviewed. I agree with their assessment. The patient presents with shortness of breath with hypoxia. The patient is a very morbidly obese male with a history of sleep apnea and significant lymphedema to the left lower extremity. The patient denies using Lasix. The patient does seem to have a dry oral mucosa and feels thirsty. Patient denies any history of congestive heart failure. The patient was found semi responsive by EMS with an O2 saturation in the 40s but increased to the upper 80s on 100% non-rebreather mask. Death 8/27/2021. From Vital Records: place of death: HOSPITAL-INPATIENT, MEMORIAL MEDICAL CENTER; certified, PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: DIRECTOR, SCHOOL BOARD DIRECTOR . Per vital records, COD ICD Codes include: U071, A419, J80, J969, N288 ; Other Significant Conditions include: None listed"" "1767972-1" "1767972-1" "Breakthrough COVID-19 case with symptom onset 8/23/2021: Runny Nose/Congestion, Cough. Hospitalized on unknown date for unknown duration. Death 8/29/2021. From Vital Records COD = ACUTE RESPIRATORY ARREST, COVID 19 PNEUMONITIS. per vital records (09/08/2021) other significant conditions: (none listed). place of death: HOSPITAL-INPATIENT PRONOUNCING AND CERTIFYING PHYSICIAN;" "1767987-1" "1767987-1" "Breakthrough COVID-19 case with symptom onset 8/22/2021: Shortness of breath/difficulty breathing. Hospitalized 8/25/2021-9/7/2021. Death 9/7/2021. Acute respiratory failure due to Covid-19" "1768064-1" "1768064-1" "Breakthrough COVID-19 case with unknown symptom status. Hospitalized 8/23/2021. Death 8/26/2021." "1768110-1" "1768110-1" "Developed COVID and had to be put on a ventilator. Symptoms were: runny nose, headache, shortness of breath, nausea, vomiting, diarrhea, and congestion." "1768151-1" "1768151-1" "Diagnosed with COVID on 9/22 and treated OP with antibiotics and monoclonal antibody infusion. Admitted to hospital on 10/5 with increasing chest pain and shortness of breath. Abnormal EKG. Cardiology and Nephrology followed patient. COVID + on admission. Had cardiac arrest with 5 rounds of chest compressions and multiple meds. Family contacted and requested DNR so ACLS was terminated." "1768160-1" "1768160-1" "Aches, Runny Nose/Congestion, Cough Death due to COVID-19 complications" "1768179-1" "1768179-1" "Breakthrough COVID-19 case with symptom onset 8/24/2021: Shortness of breath/difficulty breathing. Hospitalized 8/27/2021 for unknown duration. Death 9/19/2021. From Vital Records = COVID-19. Per vital records, Not yet coded ; Other Significant Conditions include: None listed. lace of death: HOSPITAL-INPATIENT, certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: MECHANIC, SALES" "1768207-1" "1768207-1" "Transfer from clinic where patient was attempting to receive monoclonal antibody infusion when found to be hypoxic with SPO2 in low 80s. Upon arrival to our hospital vomited and underwent seizure like activity and lost pulse. CPR initiated with v tach. Defibrillated, intubated, started on amiodarone drip. Developed shock and started on levophed and propofol drips. STAT EKG showed ST elevation, code STEMI was called. Ejection fraction 15%. Started on remdesevir for covid pneumonia but stopped due to liver failure. Given dexamethasone. Developed right sided pneumothorax and developed renal failure requiring CRRT. Increasing respiratory failure with max vent settings and flolan. Family decided to transition to comfort care." "1768218-1" "1768218-1" "Breakthrough COVID-19 case with unknown symptom status. Hospitalized unknown date and duration. Death 8/31/2021. From Vital Records COD = COVID 19 PNEUMONITIS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DILATED CARDIOMYOPATHY. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: None listed. place of death: HOSPITAL-INPATIENT, HOSPITAL; certified, PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: CASHIER, CIVIL SERVICE" "1768219-1" "1768219-1" ""Dose #2 on Sunday 8/1/2021, decedent expressed no medical complaints at that time. However, on 8/2/2021, decedent told his wife that he ""wasn't feeling good"" but went to work as a landscaper anyway. On 8/2/2021 at the end of the work day, the decedent had a witnessed collapse and CPR was initiated by bystanders. Paramedics found decedent to be in vfib and defibrillated and subsequently intubated. Epi given every four minutes, Amiodarone between epi. Decedent was found to be in asystole and back to vfib and shocked again. Second dose of Amiodarone was given and Narcan and decedent went into PEA. When bicarbonate was given, decedent back into vfib, shocked and back into PEA until pronounced at 1805 hours."" "1768225-1" "1768225-1" "Fever, Aches, Shortness of breath/difficulty breathing, Cough Cause of death: ACUTE HYPOXIC RESPIRATORY FAILURE, COVID PNEUMONIA" "1768227-1" "1768227-1" "presented to ED with SOB (increasing over last 3 days), diarrhea x 5 days, fever, chills, and fatigue; COVID test positive; PMH: sickle cell disease; diagnosed with pneumonia due to COVID, sepsis, hypoxia; started on oxygen, steroids and antibiotics; pt's condition worsened and he passed away in the hospital" "1768241-1" "1768241-1" "Patient's caregiver called us on 10/7/2021 to inform us that patient passed away at 1 am on 10/03/2021 from a heart attack. He had mild redness at the site of injection. No flu like symptoms or fever after receiving the shot." "1768253-1" "1768253-1" "Had tested covid + on 8/-22-25 at another facility. Admitted on 9/14 with large right cerebellar stroke, edema, compression and hydrocephalus. Has required multiple admissions to ICU for neuro status changes. Covid + on admission by PCR. Family requested no aggressive treatment. Ventriculostomy stopped draining and removed. Family requested comfort care only." "1768259-1" "1768259-1" "Breakthrough COVID-19 case with unknown symptom onset date: altered mental status. Hospitalized 8/24/2021-8/25/2021. Death 8/25/2021. Per medical records, patient presented to ER with altered mental status. Patient was emergently intubated and was admitted to ICU. Patient's previous medical history and symptoms were unable to be obtained due to patient's clinical condition. Per patient's husband, she was recently released from hospital and had recently had COVID-19. Patient expired on 08/25/2021. Vital records data not available yet." "1768273-1" "1768273-1" "Shortness of breath/difficulty breathing, Nausea/Vomiting, Loss of smell or taste, Cough" "1768324-1" "1768324-1" "ACUTE HYPOXIC RESPIRATORY FAILURE IN SETTING OF COVID-19 PNEUMONIA" "1768337-1" "1768337-1" "My mom received her first dose feb 11, 2021 and second dose of the pfizer covid vaccine on Mar 4, 2021. She experienced two brain bleeds, one after the first shot and the second brain bleed after the second dose. Both brain bleeds were detected by hospital's CAT scan. The emergency room neurosurgeon indicated that he saw evidence of the old brain bleed that happened several months back and this new one that brought her into the emergency room on july 17, 2021. My mom died of this brain bleed on july 22, 2021" "1768407-1" "1768407-1" "63 y.o. female patient with PMHx of COPD s/p bilateral lung transplant (CMV D+/R+, EBV D+/R+, Toxo D-/R-) from an increased risk donor on 6/14/18 who was HCV NAT+/Ab+ as well as HBcAb+ and history of acute transplant rejection who presented to ED for dyspnea on exertion for two days. She was found to have had exposure to close contact with Covid 19 infection. She was previously vaccinated for COVID; admitted 8/1/2021 with confirmed COVID-19. Respiratory status has been worsening, requiring higher oxygen suppor, thus she was transferred to the MICU. At a local hospital, she was started on HFNC and then intubated for increasing/worsening hypoxia. ICU course complicated by need for ECMO cannulation with ARDS, sepsis from E.faecalis UTI and strep pneumoniae PNA ISO aspergillus colonization, and acute bilateral lung transplant rejection. Overall burden of lung injury felt to be not survivable, so her family made the decision for CMO on 9/12/21. VV ECMO support discontinued at 12:35 PM on 9/12/2021 and time of death was 1:05 PM on 9/12/2021." "1768415-1" "1768415-1" "He had due to chemo hospital stay had 9 months of extremely low white blood cell count that didn't move at all. 1/07/21 on a Thursday he had his first COVID vaccine, his has labs drawn done every Friday and when he went to the Doc. On 1/8 the white blood cell count had moved up just a little. And it was still moving up just a little and had his 2nd dose on Friday 2/4/21. And from then on every week when he went in for bloodwork it would go up just a little more. It continued to go up slowly and when he had his 3rd vaccine Aug 7th after the shot while in the hospital his white blood cell count went up 40k (he hit 340K) in a 12 hour period. We got to the emergency room they took lab work and by 8pm the next day it went up by 40K. They were pulling white blood cells out and he was making more that they could pull out. On 9/10 we lost him, the white blood cells attached his organs and made them all start shutting down. On Aug 12th before his vaccine his white blood cell count was 104K. By 9/6 he was over 300K. So his wbc tripled from his 2nd shot to his 3rd shot." "1768471-1" "1768471-1" "after shot on thursday, on friday his white blood cell count moved up just a little when he did his routine weekly blood work on fridays. the wbc count went up dispite the fact that he had been doing weekly xarixo shots (white blood cell boosting shots) from may 2020 - jan 2021 and the wbc did not move even after this time. and for the first time it went up after his 1st covid shot. WBC count slowly started going up and never stopped and continued to go up and when he got his 3rd shot in august it went up an accelerated rate in the 3 weeks and then he died. I noticed before his aug shot, he was at 700 at his wbc count and was at 100k on his august shot and 3 wks later at nearly 400K after that shot." "1768495-1" "1768495-1" "death - Acute intracranial hemorrhage" "1768504-1" "1768504-1" "death I61.9 - Cerebral parenchymal hemorrhage (CMS/HCC)" "1768512-1" "1768512-1" "death J18.9 - Pneumonia I26.99 - Pulmonary embolism U07.1 - COVID-19" "1768518-1" "1768518-1" "death U07.1 - COVID-19 J96.01 - Acute respiratory failure with hypoxia J12.82 - Pneumonia due to coronavirus disease 2019 N17.9 - Acute kidney failure, unspecified" "1768522-1" "1768522-1" "HYPOXIC RESPIRATORY FAILURE COVID-19, SEPSIS COVID-19, PNEUMONIA COVID-19" "1768531-1" "1768531-1" "death Acute respiratory failure with hypoxia Pneumonia due to COVID-19 virus" "1768541-1" "1768541-1" "death - COVID-19 - Pneumonia due to coronavirus disease 2019 - Acute kidney failure, unspecified" "1768546-1" "1768546-1" "death U07.1 - COVID-19 J96.01 - Acute respiratory failure with hypoxia J12.82 - Pneumonia due to coronavirus disease 2019 N17.9 - Acute kidney failure, unspecified" "1768554-1" "1768554-1" "death E87.1 - Hyponatremia" "1768564-1" "1768564-1" "death J96.90 - Respiratory failure J96.01 - Acute respiratory failure with hypoxia" "1768570-1" "1768570-1" "death I63.9 - Acute CVA (cerebrovascular accident)" "1768576-1" "1768576-1" "death E87.1 - Hyponatremia" "1768580-1" "1768580-1" "death N17.9 - AKI (acute kidney injury)" "1768588-1" "1768588-1" "death N17.9 - AKI (acute kidney injury) (CMS/HCC) J96.01 - Acute respiratory failure with hypoxia (CMS/HCC)" "1768591-1" "1768591-1" "death G45.9 - TIA (transient ischemic attack)" "1768599-1" "1768599-1" "death J18.9 - Pneumonia, unspecified organism J96.01 - Acute respiratory failure with hypoxia" "1768610-1" "1768610-1" "Coughing and fatigue" "1768611-1" "1768611-1" "death J96.01 - Acute respiratory failure with hypoxia" "1768620-1" "1768620-1" "death Acute kidney injury" "1768627-1" "1768627-1" "death - Pneumonia, unspecified organism - Acute kidney failure, unspecified - Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type" "1768639-1" "1768639-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 4/14/2021 and 5/5/2021. Presented to ED on 10/1/2021 with reports of loss of taste, dyspnea on exertion, and diarrhea consists of watery stools 3 times a days for the past 2-3 days. Patient reports drinking 5 of 8oz water bottles every day but is having very minimal urine production. He reports associated lightheadedness, chills, non-productive cough, and decreased appetite. He was treated with Remdesivir, Tocilizumab, Decadron and supportive care. On 10/3/21 patient had a syncopal episode and became bradycardic. He went into cardiac arrest. CPR was initiated. Patient eventually expired." "1768718-1" "1768718-1" "Hospitalization and Death" "1768827-1" "1768827-1" "He had a heart attack two months after receiving the shot. They had to put a stent in. He had blood clots they didn't know where they were coming from. One month later, July 12, he had another heart attack that killed him. They put him on a ventilator and after they removed that he was doing fine. Then they put him on rendezevere. It filled his lungs with fluid and he was gone in 12 hours. They murdered him." "1768835-1" "1768835-1" "MULTI SYSTEMS FAILURE, TRAUMATIC SUBDURAL HEMATOMA Death on 9/6/2021" "1768856-1" "1768856-1" "PATIENT DIED FROM COVID 19 AFTER BEING FULLY VACCINATED" "1768909-1" "1768909-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/23/2021 and 2/23/2021. Patient presented to physician office on 9/3/2021 after developing COVID symptoms of cough, sore throat, congestion, loss of taste and smell 4-5 days prior, as well as reports that daughter had recently tested COVID positive. Patient received Casirivimab and Imdevimab on 9/6/2021. On 9/28/2021 patient presented to the ED for altered mental status. She was found to have a subarachnoid hemorrhage and was admitted with consultation to the Stroke team. She was intubated on 9/30/2021. BCx2, Pneumonia Panel, Sputum culture without any organism found. She underwent diagnostic cerebral angiogram and subsequent coiling of the anterior communicating artery aneurysm on 9/30/20201. On 10/01/2021 she was awake and following commands. After completing a spontaneous breathing trial she was successfully extubated. She was initially communicating, following commands, and A&O x 3. Over the night of 10/02/2021 she had increasing O2 demands and was placed on HFNC. She was tachycardic on 10/03/2021, she was more lethargic and would not swallow sips of water. A sepsis work up was initiated along with DVT studies do to history of Essential Thrombocytosis. She was found to have DVTs in BL upper extremities and R lower extremity. She required BIPAP to maintain ventilation. She was sent for CT/CTA of head which noted slightly increased intravenricular hemorrhage and vasospasm of the right ACA, left ACA, and left MCA. CT Chest was consistent with multifocal pneumonia. She was increased to subcutaneous heparin TID with ASA 81 mg. On 10/4/2021 she continued to regress. The morning of 10/05/2021 she would respond only to pain stimulus. She was evaluated again with CT with worsening vasospasm. Patient was intubated, after which her BP dropped Two attempts were made with push dose Phenylephrine to increase BP with out success. Her pulse was lost and compressions were started. Code Blue was called. Family was informed of the changes to her status and they decided to stop chest compressions and let her pass peacefully." "1768915-1" "1768915-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/23/2021 and 2/13/2021. Patient presented to the emergency department with complaints of shortness of breath and admitted for COVID pneumonia. Patient progressed to respiratory failure requiring intubation on 9/16/2021. Despite lung protective mechanical ventilation, paralysis, proning, inhaled pulmonary vasodilators, steroids, broad spectrum antibiotics, and remdesivir, her respiratory failure progressively worsened. On 9/25/2021 patient developed acute renal failure with worsening shock. Family elected to pursue comfort care at that time. Patient was extubated on 9/25/2021, and expired at 2107 on 9/25/2021." "1768972-1" "1768972-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 3/31/2021 and 4/27/2021. Presented to ED on 9/10/2021 with complaint of confusion, as per family this happens when patient has urinary tract infection. Patient stated that she took a home urinary tract infection test kit which resulted positive. She was evaluated for urinary tract infection, but urinalysis was unremarkable. Chest x-ray was normal, but she underwent CT of the abdomen and pelvis which did show findings in the lung bases consistent with pneumonia versus pneumonitis. She was prescribed doxycycline, but stopped taking it after 2 days due to nausea. Subsequently changed to levofloxacin on 9/14/2021 during follow-up clinic visit. On 9/16/2021 patient presented to ED with shortness of breath, labored breathing, fever and chills. Placed on 6L O2 NC. Despite aggressive treatment, she has deteriorated and is no longer alert but is obtunded. Family has decided to transition to comfort care. Patient expired 9/25/2021." "1768982-1" "1768982-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/5/2021 and 3/23/2021. Presented to ED on 9/18/2021 with reports decreased appetite over the last 3 days, diarrhea and abdominal pain 2 days duration, shortness of breath, and fatigue. She was found to have pneumonia secondary to COVID-19. She was hypoxic and admitted to the hospital. She was started on dexamethasone and determined to not be a candidate for remdesivir. She rapidly decompensated and required high-flow nasal cannula. By September 24th she had become relatively obtunded and stop taking all oral medications. On maximum high-flow she was only maintaining O2 saturations in the 86-89% range. Palliative Care evaluated the patient on that evening and on the morning of the 26th she was transitioned to comfort care. On September 26 at 3:16 a.m. the patient passed away." "1769000-1" "1769000-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/27/2021 and 2/26/2021. He tested positive for COVID on 9/20/21 after cough, fever, sob developed on 9/17. He was brought to the ED by spouse on 9/22 for a mechanical fall and worsening altered mentation with hallucinations. In the ED imaging shows worsening fluid overload, COVID PNA and left femoral neck fracture. COVID treatment was initiated (Remdesivir and Dexamethasone) and it was the plan for him to go to the OR. However, he continued to decompensate and O2 demand continued to increase - he was transitioned to high flow nasal cannula. He remained encephalopathic, agitated, and in respiratory distress. Family requested comfort care in the hospital. He was admitted for EOL cares on GIP service and ultimately expired on 10/3/2021." "1769002-1" "1769002-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/9/2021 and 4/6/2021. Presented to the ED on 9/24/2021 reports that over the past 2 weeks, he has had a productive cough, nausea, loss of appetite, and progressivley worsening SOB leading to EMS call. Pt tested positive for COVID, on arrival. He was satting 92% on 10L NRB; hypoxia progressed and pt was transition to HFNC 50/50. He was admitted and ended up requiring max HF settings, developing respiratory failure. Decision made to transfer to comfort care, patient expired on 10/3/2021" "1769006-1" "1769006-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/14/2021 and 2/22/2021. Presented to the emergency department on 9/18/2021 for worsening hypoxia and fever. Recently diagnosed with COVID pneumonia and treated at a different facility. Upon arrival to ED, on 9/18/2021, patient was placed on oxygen 5L nasal cannula (increased from home requirements of 2L). Throughout hospitalization, respiratory status continued to decline and patient received: remdesivir, dexamethasone, baricitinib, and antibiotics. Patient expired on 9/29/2021 at 1412." "1769008-1" "1769008-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/27/2021 and 3/27/2021. Presented to ED on 9/11/2021 after patients son found him shallow breathing this morning and appears cyanotic and pushed on his chest which prompt patient to take a deep breath subsequently his color returned. EMS upon arrival noted he was hypoxic, placed him on 15 L of non-rebreather. Patient states that he has symptom onset about 10 days ago. He felt very fatigued, no appetite, generalized body ache, fever, cough and shortness of breath. He also have nausea vomiting couple days ago this has improved. He has some diarrhea a few days ago this is resolved. He continued to require high-flow oxygen and subsequently requiring mechanical ventilation on 9/20/21. He completed the 5 day course of remdesivir. Patient also treated with IV antibiotic therapy. Patient required vasopressor support. Determination made to initiate comfort care. The patient expired on 9/30/2021." "1769012-1" "1769012-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/5/2021 and 3/26/2021. Patient presented to emergency department with hypoxia and hypotension. Patient required supplemental oxygen upon arrival. Patient was transferred to a Med Cntr for admission. Patient's respiratory status continued to decline throughout hospitalization. Patient received: azithromycin, ascorbic acid, cefepime, ceftriaxone, dexamethasone, remdesivir, vancomycin, and zinc. Patient was transitioned to comfort care and expired 9/26/2021 at 2043." "1769037-1" "1769037-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 12/31/2021 and 1/31/2021. Patient recently diagnosed with COVID on 9/20/2021 and hospitalized at a different facility from 9/20/2021 to 9/22/2021. Patient presented to emergency department for shortness of breath and required oxygen supplementation 4-5L nasal cannula. Patient received cholecalciferol, ceftriaxone, and dexamethasone. Patients respiratory status continued to deteriorate and patient declined intubation. Patient expired 10/3/2021 at 0917." "1769681-1" "1769681-1" "Deceased (10.4.21); Hospitalized (9.30.21); COVID-19 positive (9.30.21); fully vaccinated Discharge Provider: MD Primary Care Physician at Discharge: None Physician, MD None Admission Date: 9/30/2021 Date of Death: 10/4/21 Time of Death: 12:50 PM Preliminary Cause of Death: Acute respiratory failure due to COVID-19 PRESENTING PROBLEM: Hyponatremia [E87.1] Type 2 diabetes mellitus with hyperglycemia, without long-term current use of insulin [E11.65] COVID-19 [U07.1] Acute respiratory failure due to COVID-19 [U07.1, J96.00] Acute hypoxemic respiratory failure [J96.01] HOSPITAL COURSE: Patient admitted for acute hypoxic respiratory failure due to COVID-19 pneumonia. Patient was fully vaccinated, however she did not respond well to maximum medical therapy including iV decadron, IV remdesivir, and broad spectrum antibiotics to cover superimposed bacterial pneumonia. She was transferred to the ICU on maximum HFNC. She continued to have low oxygen levels. Patient decompensated and after long discussion with the family, resulted in transition to comfort care. She expired comfortably surrounded by family at 1250 on 10/4/21." "1770624-1" "1770624-1" "Death; This is a spontaneous report from a contactable other healthcare professional (HCP). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in right arm on 27May2021 at 09:00 as single dose for COVID-19 immunisation. The relevant medical history included atherosclerosis from unspecified date. Concomitant medications included rosuvastatin calcium (CRESTOR). No other vaccine in four weeks. The patient experienced death on 07Jun2021 at 04:45. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The patient died on 07Jun2021. It was unknown if an autopsy was performed. The outcome of the event was fatal. The Lot number for the vaccine [BNT162B2] was not provided and will be requested during Follow-up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death" "1771449-1" "1771449-1" "Became unresponsive during non emergency transport to dialysis. Rerouted to nearest hospital. Transport company failed to supply hospital with patient info. Was admitted as generic patient around 5pm on Sept 3, 2021. Transport company failed to contact me with patient unresponsive, and emergency location. I couldn't locate my son until after midnight." "1771519-1" "1771519-1" "Patient expired due to COVID-19 after having been vaccinated." "1771542-1" "1771542-1" "Patient expired due to COVID-19" "1771570-1" "1771570-1" "Patient expired with COVID-19 after COVID-19 vaccination" "1771573-1" "1771573-1" "Patient expired due to COVID-19 after being vaccinated" "1771581-1" "1771581-1" "Patient expired on 09/07/21" "1771603-1" "1771603-1" "Hospitalization, acute liver failure & death on 10/8/2021" "1771613-1" "1771613-1" "Patient fully vaccinated and died due to Covid related causes" "1771639-1" "1771639-1" "Patient fully vaccinated and died due to covid related causes" "1771697-1" "1771697-1" "Stomachache pain, vomiting, diarrhea, chest pain, headache, confusion and death" "1771747-1" "1771747-1" "NA" "1771748-1" "1771748-1" "Breakthrough COVID-19 case with unknown symptom status. Hospitalized 8/25/2021-8/29/2021. Death 8/29/2021. From Vital Records COD = RESPIRATORY FAILURE, COVID-19. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: None listed. place of death: HOSPITAL-INPATIENT; certified, PRONOUNCING AND CERTIFYING PHYSICIAN." "1771763-1" "1771763-1" "Breakthrough COVID-19 case with symptom onset 8/24/2021: Fever, Cough. Hospitalized 8/20/2021. Death 8/27/2021. From Records COD = CARDIORESPIRATORY ARREST, COVID-19 VIRAL PNEUMONIA. Per records, Other Significant Conditions include: None listed. lace of death: HOSPITAL-INPATIENT; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN, occ/ind: COOK, FOOD" "1771765-1" "1771765-1" "Patient tested positive for C19 on 09/12/2021. Pt was admitted to the hospital on 09/12/2021 and required intubation and immediate dialysis. Patient had an admitting diagnosis of acute hypoxemic respiratory failure: secondary to volume overload and C19 infection; C19 infection with Hypoxia, suspected pneumonia, acute on chronic kidney disease stage IV; pulmonary edema/volume overload due to congestive heart failure vs. worsening renal failure; acute on chronic congestive heart failure; cardiomegaly; hypertension; hyperlipidemia; diabetes type 2; atrial fibrillation in a controlled rate. Patient was intubated for 13 days before passing away." "1771777-1" "1771777-1" "Presented with SOB, normally on NC at night, hypoxic on RA. Required O2. Dx with COVID PNA, received Remdesivir and steroids. Patient does not remember receiving vaccine. Discharged to inpatient hospice and later expired." "1771861-1" "1771861-1" "Chart review showed he received 2 Moderna COVID-19 mRNA vaccines on 7/20/21 and 8/17/21. Wife called PCP on 8/19/21 to report that he had developed loss of appetite and fatigue and appeared ill. PCP recommended ED eval, but pt did not go until 9/29. At that time he was found to have profound thrombocytopenia with platelets of 18000 and wbc 2700. Previous CBC on 7/21/21 showed wbc 6200 and platelets 150,000. INR initially 1.7 (9/29) then increased to 2.8 (10/3). PT 18 -- >27, PTT 45-- >62, Fibrinogen 110 then decreased to <80 mg/dl. Blood and urine cultures did not show any growth. CT C/A/P showed airspace opacities LLL/RUL/RLL and moderate right pleural effusion, hepatic cirrhosis, large ascites, NORMAL spleen. He was started on broad spectrum abx. ALso started on high dose dexamethasone per hem/onc for possible ITP. He received multiple platelet transfusions. He had chronic hep C, mRNA load 1209 mIU/mL. He developed hypotension refractory to IVF and had to be transferred to the ICU on 10/3/21 and subsequently passed on 10/4/21." "1771931-1" "1771931-1" "Breakthrough COVID-19 case with unknown symptom status. Hospitalized 8/26/2021-8/31/2021. Death 8/31/2021. Vital Records data not available yet." "1772014-1" "1772014-1" "Patient came to the emergency room on 09/17/2021 with complaints of shortness of breath after testing positive for COVID-19 on 09/11/2021. Patient was transferred to the ICU on 09/17/2021 later in the day due to acute hypoxemic respiratory failure. The patient was in the ICU for a total of 9 days before passing away due to acute hypoxic respiratory failure secondary to COVID-19 pneumonia. Patient was hypoxic and eventually went to asystole and died at 5:30 PM on 9/26/2021." "1772016-1" "1772016-1" "Breakthrough COVID-19 case with unknown symptom onset: Fever, Aches, Shortness of breath/difficulty breathing, Fatigue or tiredness, Cough. Hospitalized 9/2/2021-9/17/2021. Death 9/17/2021. Vital Records data not available yet. Patient was hospitalized for UTI and was diagnosed with pneumonia. Patient was retired." "1772023-1" "1772023-1" "Breakthrough COVID-19 case with unknown symptom onset: low grade temp and diarrhea. Death 8/28/2021. From Vital Records COD = CHRONIC COMBINED SYSTOLIC CONGESTIVE AND DIASTOLIC CONGESTIVE HEART FAILURE, UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE. HTN, anxiety CHF Afib . Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: UNSPECIFIED ATRIAL FIBRILLATION. place of death: NURSING HOME-LONG TERM CARE FACILITY; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN, occ/ind: EDUCATOR, EDUCATION" "1772039-1" "1772039-1" "Case vaccinated with Janssen on 5/28/2021. Tested positive for COVID on 9/16/2021. Admitted to Hospital on 9/21/2021 and expired on 10/02/2021 while still hospitalized." "1772066-1" "1772066-1" "Case fully vaccinated with Pfizer. Second dose received on 3/22/2021. Tested positive for COVID on 9/14/2021. Admitted to Medical Center on 9/20/2021. Expired on 9/27/2021 while still hospitalized." "1772083-1" "1772083-1" "Case fully vaccinated with Moderna. Last dose on 2/26/2021. Tested positive for covid on 9/21/2021. Admitted to Medical Center on 9/27/2021. Expired on 10/01/2021 while still hospitalized." "1772110-1" "1772110-1" "Case fully vaccinated with Pfizer. Last dose on 2/26/2021. Tested positive for COVID on 9/16/2021. Admitted to Hospital on 9/11/2021. Expired while still hospitalized on 9/27/2021." "1772156-1" "1772156-1" "Case fully vaccinated with Moderna . Last dose on 4/1/2021. Tested positive for COVID on 9/21/2021. Admitted Medical Center on 09/21/2021. Expired on 9/30/2021 while still hospitalized." "1772180-1" "1772180-1" "Breakthrough COVID-19 case with unknown symptom status. Hospitalized 8/25/2021-9/16/2021. Death 9/16/2021. Vital records data not available yet." "1772188-1" "1772188-1" "Fully vaccinated COVID-19 death" "1772326-1" "1772326-1" "Breakthrough COVID-19 case with unknown symptom onset date: Shortness of breath/difficulty breathing, Cough. Hospitalized 8/28/2021-9/10/2021, SOB and low O2 stats (86%) reported, developed pneumonia. Death 9/20/2021. From Records COD= CARDIAC ARREST, COVID-19 PNEUMONIA. Per records, Other Significant Conditions include: None listed. Place of death: HOSPITAL-INPATIENT; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: MIDDLE MANAGEMENT, TELECOMMUNICATIONS ." "1773639-1" "1773639-1" "Two days later, he passed away.; felt fatigued; fever; achy; got the booster shot; got the booster shot; This is a spontaneous report from a non-contactable pharmacist. An elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscularly on 28Sep2021 (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunization (administered in a Pharmacy or Drug store); and influenza vaccine via an unspecified route of administration on 28Sep2021 (Batch/Lot number was not reported) for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient got the booster shot on 28Sep2021. On 29Sep2021, the patient felt fatigued, fever, and achy. The patient took paracetamol (TYLENOL) and felt a little bit better. Two days later, he passed away. The outcome of felt fatigued, fever, and achy was unknown. It was not reported if an autopsy was performed. The cause of death was not reported. The patient died on 30Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the event death and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Two days later, he passed away." "1774920-1" "1774920-1" "Patient was admitted to the hospital under a medical service to the COVID-19 unit due to hypoxic respiratory failure secondary to COVID-19 pneumonia. He was started on remdesivir Decadron 6 mg b.i.d. Along with therapeutic dose Lovenox. He was admitted to another unit on BiPAP and pulmonology was consulted. Given his leukocytosis and elevated procalcitonin he was started on cefepime and azithromycin. The patient developed a nose bleed PTT and INR was extremely elevated thus he was given Kcentra and vitamin K. Fibrinogen was high not suggestive of DIC. Overnight the patient cardiac arrested code was called at despite ACLS measures the team was unable to obtain ROSC and resuscitation efforts were discontinued. The patient was pronounced deceased at 0249." "1774923-1" "1774923-1" "Patient was admitted due to acute hypoxic respiratory failure secondary to COVID-19 pneumonia. Additionally was found to have bacterial pneumonia started on cefepime and Zithromax. He was started on remsedivir along with Decadron. CTA was negative for pulmonary embolism. A few days into hospitalization the patient developed acute kidney injury nephrology was consulted felt it was likely secondary to thrombus. The patient also developed bilateral foot ischemia surgery is consulted and recommended continuation of anticoagulation. Surgery is consulted for line placement as the patient's renal failure progressed to needing dialysis with electrolyte abnormality and the patient's warfarin was reversed. The following day the patient developed severe thrombocytopenia with platelet count and in the 30s thus further anticoagulation was held and hematology was consulted. The patient's lower extremity ischemia progressed and his extremities were cold mottled from the knee down. Multiple conversations were had with the patient and family and yesterday they decided given his overall poor prognosis and worsening condition the patient his family decided to cease aggressive care efforts and requested comfort measures. The patient passed away today with family at bedside." "1774925-1" "1774925-1" "Patient was admitted and being treated for covid. She was receiving maximal therapy (see my progress note from today), but unfortunately underwent a cardiopulmonary arrest. Patient started to be resuscitated, but discussions with family revealed that she did not want to be put on a machine. She was made a DNR and comfort medications (morphine) were administered given pain of CPR. Patient passed shortly after stopping CPR." "1775009-1" "1775009-1" "Major stoke three days after injection. He was unable to recover and subsequently passed away after one month." "1775146-1" "1775146-1" "My mother died suddenly on 9/25/2021 around noon while swimming in a pool. Pathologist cause of death was aortic dissection." "1775170-1" "1775170-1" "Chest pain, shortness of breath, Acute Myocardial Infarction" "1775206-1" "1775206-1" "myocardial infarction resulting in death" "1775309-1" "1775309-1" "Respiratory arrest Death" "1775475-1" "1775475-1" "Signee called to resident''s room. Upon entering room resident noted lying on his left side. Skin noted to be warm to touch. Eyes open and fixed. Absent movement of chest noted. Heart and lungs sounds auscultated and noted to be absent. Absent vital signs. Resident assessed by signee. Time of death- 1:52pm. Call placed to Dr. New order received to release body to funeral home of choice. Call placed to on-call guardianship office. Call placed to resident''s son. No answer and signee un-able to leave message due to mailbox being full. Number for resident''s daughter-in-law listed but not a working number. No funeral home is listed with facility or guardianship office. Will continue to keep calling resident''s son. Awaiting returned call." "1775575-1" "1775575-1" "Day 1: lethery and weak Day 2: Flulike symtoms and no appetite Day 3: Vomiting, weaker, by evening could not stand up, lost ability to move left arm or leg up. Was taken to emergency room admitted to Hospital Day 4: Able to talk cat scan and MRI show no Neurological issue Legs is spastic and eyes open and close rapidly Day 3: Can mot sit upright ,Growing weaker Start antibiotics Day 4: Still cannot eat, Speaks last words, Low blood pressure and fever Day 5: High blood pressure and low blood pressure @nd Cat scan and MRI show nothing Start antibiotics Day 6 :start steriods, blood work normal Day 7: Eyes still track fighting for life Day 8: Dies" "1775763-1" "1775763-1" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775791-1" "1775791-1" "Found unresponsive in bed without pulse or respiration?s" "1775807-1" "1775807-1" "on 10/08/2021 we received a call from a nurse that the patient was found dead in her bed. she was not having any ailment prior to that." "1775828-1" "1775828-1" "SWEATING, CHILLS, ACHES, SHORTNESS OF BREATH, TIGHTNESS IN CHEST FOLLOWED BY DEATH ON 06/06/2021" "1776306-1" "1776306-1" "On 09/10/21: Patient is a 57 y.o. male with recent COVID infection, HFpEF, NASH cirrhosis, CKD IIIb, and IDDM2 who presented to ED via EMS post-code after PEA arrest. According to patient's wife, he developed acutely worsening shortness of breath early this morning. Wife called EMS after his shortness of breath did not improve upon resuming his home oxygen 3L NC which he had discontinued two days prior due to subjective improvement. Family estimates he stopped breathing less than 5 minutes prior to EMS arrival. EMS reports patient was apneic and in wide-complex PEA on arrival. He was coded for 20 minutes before ROSC. He arrived intubated and on levophed. Cardiogenic etiology considered due to transient hypoxia; however troponins without significant delta, EKG did not show ST abnormalities concerning for ischemia, or MI. Bedside echo without concerning findings. Infectious workup negative. Aggressively diuresed patient with minimal renal recovery. On exam patient was lacking gag reflex and pupils unreactive. Due to concern for severe anoxic encephalopathy and PVS, all sedation was stopped. Patient remained without any purposeful movement, without gag reflex, and without reactive pupils after >48 hours of complete cessation of sedating agents. Poor prognosis discussed with wife (NOK) and daughter. They both stated he has previously said he would not want to continue with current measures in this type of situation. Wife (NOK) ultimately decided to withdrawal care and pursue comfort care. Patient was terminally extubated and discharged to inpatient hospice" "1776366-1" "1776366-1" "80 y.o. male with a PMH of COPD, CHF, HTN, DM II, hx of DVT, afib, pacemaker, depression, PAD, HLD, depression, and recent viral pneumonia who presented to ED with shortness of air, worsening productive cough, generalized weakness, loss of appetite, body aches, subjective fevers, and chills. Patient presented to ED and was found to be hypoxic with spo2 of 80% requiring supplemental oxygenation and eventually had oxygen increase to 40L 70%. Patient had one episode of hypotension that resolved with 500ml fluid bolus. MICU was consulted due to increased high flow settings and deferred patient to progressive care. On assessment, patient's o2 saturation of 87% with RR of 35 on 35% 30 liters high flow nasal cannula. Increased the patient to 50% 35 liters with o2 saturation of 92%. Constitutional: Positive for appetite change, chills, diaphoresis, fatigue and fever. Negative for unexpected weight change. HENT: Negative for congestion, hearing loss, sore throat, tinnitus and trouble swallowing. Loss of taste/smell Eyes: Negative for pain, redness and visual disturbance. Respiratory: Positive for cough and shortness of breath. Negative for wheezing. Cardiovascular: Positive for palpitations. Negative for chest pain and leg swelling. Chronic palpitations. #Acute on chronic hypoxic respiratory failure 2/2 COVID 19-PNA c/b CAP in setting of severe COPD and HFrEF - reports of severe COPD on home O2 (unsure of settings) and HFrEF 20-25% - COVID-19 positive on 9/6/21; s/p J&J vaccine earlier this year - CT PE 9/6: negative for PE, b/l GGO and consolidation, L>R. emphysematous changes w/ peripheral blebs and airtrapping. Some peripheral honeycombing concerning for fibrotic changes with traction bronchiectasis - elevated d-dimer, LDH, CRP, and procal - 9/6: started on remdesivir + dexamethasone 6 mg daily, CAP coverage with ceftriaxone and azithromycin - not currently a candidate for barcitinib per ID due AKI - on transfer to MICU, was on HFNC 60L @ 100%, but this is likely 2/2 agitation and patient intermittently removing cannula. Precedex started and able to wean HFNC to 50L @70%. Plan: - Continue ceftriaxone for 5 days (thru 9/10) and azithromycin for 3 days (thru 9/8) for CAP coverage Patient continued to decline after admission as expected ultimately to his death on 09/16/2021 at 1134AM . Patient was pronounced dead by hospital bedside RN." "1776387-1" "1776387-1" "Found unresponsive after coworker heard a thud. Code Blue called. CPR initiated, AED applied and no shockable rhythm x3. Code continued for 45 minutes with paramedics on scene and drugs administered. Time of death called by ER physician on phone." "1776391-1" "1776391-1" "DEVELOPED SYMPTOMS AND TESTING POSITVE FOR COVID19 10/4/21" "1776412-1" "1776412-1" "Blood in corner of patients eye, severe diarrhea, lethargy, loss of appetite." "1776504-1" "1776504-1" "Loss of consciousness; fall; injury - over about 1 hour" "1776569-1" "1776569-1" "fully vaccinated-covid 19 death" "1776605-1" "1776605-1" "death approximately 18 hours following vaccination. Asymptomatic. Died in sleep." "1776628-1" "1776628-1" "PT EXPIRED; COVID BREAKTHROUGH CASE" "1776636-1" "1776636-1" "Died of heart attack 10 days after vaccine with no family history or prior indication of heart problems" "1776673-1" "1776673-1" "Patient was alert, ambulating in hallway. Patient a sudden, unexpected death in her sleep. Most likely suspect pulmonary embolis. However, patient has no pre-exisiting condition to explain this sudden death" "1776894-1" "1776894-1" "I received a call from patient's daughter who was upset he received the COVID booster on Monday October 4, 2021 and died of a MI on October 6, 2021. I am not sure where he received the booster or where he received it." "1776925-1" "1776925-1" "Patient has hx of hypertension and Stage 3 kidney disease, obstructive sleep apnea with c/o palpitations, productive cough, congestion, fatigue, and weakness. Patient's HR was up and EKG revealed atrial fib with RVR. He was given antibiotics and steroids He was discharged on 8/22 and was readmitted on 8/25 with worsening of symptoms patient developed sepsis and returned with afib with RVR again. Patient's oxygen demand increased and worsening resp. failure patient was intubated and placed on a ventilator. Patient also had a NSTEMI Patient was terminally extubated and expired on 8/28." "1776938-1" "1776938-1" "COVID PCR +9/23/21. Admitted for shortness of breath on Bi-pap." "1777314-1" "1777314-1" "Patient did well with the first two doses, received the booster and two hours after he passed away. According to the wife, he was alright in the two hour time frame post vaccination. He went shopping and showed no signs of anaphylaxis or intolerance." "1777335-1" "1777335-1" "My husband died of a massive pulmonary embolism four moths after receiving the vaccine on 06/24/2021 ( never had any symptoms or injuries prior to receiving the vaccine). I found my husband dead in our home upon arriving from work. An autopsy was performed and that's how I learned that he died of a massive pulmonary embolism.." "1778769-1" "1778769-1" "Patient Contracted COVID-19 Patient Died from COVID-19 on 10/09/2021" "1778825-1" "1778825-1" "Pt received COVID booster shot (3rd dose) on 10/7/21. On 10/10/21 pt was found unresponsive/ no pulse/no resp. Hospice nurse pronounced death at 0820 on 10/10/21" "1778854-1" "1778854-1" "COVID RELATED DEATH; BREAKTHROUGH CASE" "1778866-1" "1778866-1" "COVID RELATED DEATH; BREAKTHROUGH CASE. VACCINE PROVIDED BY PHARMACY" "1778922-1" "1778922-1" "9/24 PMHx of COPD, pneumonia, pulm HTN, Anxiety who presents for SOB w/ wheezing x 3 days. Diag. w/ Pneumonia upon assessment. 9/25 CT suspicious for small pulmonary emboli. Examination of the lungs reveals numerous groundglass airspace opacities throughout the upper lobes and lower lobes bilaterally. 9/28 Lungs reduced to auscultation bilaterally. Right lower lobe crackles. On CT There is interval worsening in aeration with development of bilateral infiltrates diffusely throughout both lungs. The pleural spaces remain clear. 10/4 patient currently requiring warmed high flow oxygen at 45L. Overnihgt desaturations into 10/5 10/6 pt desat to 62%, pt pale, tachypenic, tachycardic. Rapid response called to aid 10/6 Again RRT was called due to hypoxia Osat was in mid 80s%, pt was on high flow 10/6 She has been transferred to the ICU due to worsening respiratory status. Discussed plan for EGD tomorrow with patient and her daughter at the bedside. 10/6 Called to ICU patient showing signs of respiratory fatigue, requested to intubate patient. Patient oxygenated with ambu bag and mask with FiO2 100%. Intubation followed. 10/7 Central Line Placement - Right Internal Jugular 10/7 COIVD+ Result 10/7 Discussed with family poor prognosis, and clinical deterioration, will remain full code 10/8 CRITICAL CARE PROCEDURE NOTE - ARTERIAL CATHETER INSERTION 10/8 Septic shock with multiple organ failure, suspect ischemic bowel 10/8 Code blue called at 05:31 pm. On arrival to room, patient had achieved ROSC. Per nursing staff patient has been severely acidotic throughout the day with pH<7. Patient is on multiple pressors. Renal failure with hyperkalemia. There was suspicion for possible ischemic bowel however CT of abdomen could not be obtained as patient is too unstable. Patient had coded again while I was at rapid response. Per nurse staff ED doctor present for the code and pronounced patient" "1779140-1" "1779140-1" "COVID RELATED DEATH; BREAKTHROUGH CASE" "1779181-1" "1779181-1" "COVID RELATED DEATH; BREAKTHROUGH CASE" "1779214-1" "1779214-1" "Notified by medical examiner that patient was found deceased at home 10/08/2021, no report of symptoms in interim" "1779236-1" "1779236-1" "Patient was fully-vaccinated and admitted to the hospital with COVID. Patient had multiple comorbidities and passed away while in the hospital secondary to severe respiratory failure and ARDS." "1779241-1" "1779241-1" "Initial visit. Patient is sitting up in bed drinking some juice. She is somewhat drowsy, drifting off to sleep when not directly engaged. PPS 30%; bedbound. Patient denies pain when asked; states she feels much better than last night. Son reports that she had a good deal of pain and anxiety last night, but it is much better this AM after she received some Roxanol and Ativan before bed. When she does have pain, it is in the perineum. Having copious amounts of thin, malodorous brown drainage/stool coming from the vaginal fistula. She often groans and grimaces when peri-care is performed. from Skin is intact and pale/cool to touch. Fingers and legs very cool to touch. Unable to obtain sats as fingers were cold to touch and unable to warm them up. Respirations unlabored at rest; labored if repositioned and with pain. LS diminished throughout. Edema 2+ BLE. BS active; having constant stool leaking. Discussed timeline, prognosis, and reviewed patient?s routine medications and CCK. Written instructions provided. Discussed POC with son. No refills needed. Instructed to call hospice with any changes or concerns. Visit made to pronounce death. Patient had no pulse or respirations at time of visit" "1779294-1" "1779294-1" "BREAKTHROUGH INFECTION" "1779444-1" "1779444-1" "Myocarditis resulting in death." "1779504-1" "1779504-1" "Admission to critical care hospital with COVID-19 diagnosis on admission. Passed on 9/22/21" "1779515-1" "1779515-1" "Patient fully vaccinated against Covid-19, died on 10/07/2021 from complications of Covid-19 pneumonia respiratory failure, sepsis, and uncontrolled diabetes. Second Moderna dose administered on 03/31/2021. Second Moderna dose Lot # 025B21A. Patient" "1779581-1" "1779581-1" "Woke up with a fever of 99.4. When I checked on her in the evening she was dead." "1779892-1" "1779892-1" "DEATH" "1779903-1" "1779903-1" "Coughing then turned to pneumonia" "1780142-1" "1780142-1" ""Patient received Pfizer COVID vaccine on 3/17/21 and 4/22/21 at another facility. On 9/27/21, patient admitted to our facility for acute blood loss anemia from ostomy. COVID status was negative on 9/27/21 and 9/29/21. However, COVID status changed to positive on 10/4/21 and 10/6/21. Patient expired on 10/9/21 likely related to abdominal pathology. Here's the discharge summary from hospitalist: ""Patient with recurrent bleeding episodes from her stoma requiring total of 8 U PRBC. CT for GIB was negative for active bleeding on admission. She was seen by GI service who felt there is no role for GI controlling bleed. Colorectal surgery was contacted after an other episode of large quantity bleed. Unfortunately she developed progressive hypoxic respiratory failure with abdominal distention, lactic acidosis, progressive hypotension requiring HFNC, vasopressor support, transfusion. CXR was surprisingly clear and felt that severe hypoxia likely related to abdominal pathology."""" "1780477-1" "1780477-1" "cough, phlegm, shortness of breath, fatigue, for 12 days an then death." "1780517-1" "1780517-1" "Had a heart attack and was gasping for air" "1782222-1" "1782222-1" "Patient was hospitalized. Patient died due to COVID-19. Patient was fully vaccinated." "1782231-1" "1782231-1" "Patient was hospitalized. Patient died due to COVID-19. Patient was fully vaccinated." "1782247-1" "1782247-1" "Patient was hospitalized for heart problems. Patient died due to COVID-19. Patient was fully vaccinated." "1782301-1" "1782301-1" "COVID RELATED DEATH; BREAKTHROUGH CASE" "1782307-1" "1782307-1" "transferred to hospital on 10/10/2021, Passed away on 10/12/2021 REASON FOR ADMISSION Stroke HOSPITAL COURSE Patient is a 79-year-old male admitted to the hospital on 10/10/2021 after he was found to have multiple focal ischemic strokes, mainly a left cerebellar stroke due to left vertebral artery and PICA occlusion. Past medical history if significant for atrial fibrillation on Xarelto, OSA on CPAP, and diabetes (on metformin). On 10/4/2021 he developed COVID-19 infection and presented to the ED for evaluation of shortness of breath and weakness. He was admitted to the medical floor and given supplemental oxygen, remdesivir, and dexamethasone. Around midnight on 10/10/2021 he became unresponsive and bradycardic with heart rates in the 30s with oxygen desaturation. He was initially placed on BiPAP but required intubation shortly thereafter. CT/CTA chest was obtained after intubation, negative for acute PE but did show findings consistent with Covid-19 pneumonia. Around 0200 a head CT was obtained which showed an acute left cerebellar infarct with effacement of the 4th ventricle and hydrocephalus with dilated 3rd ventricle and lateral ventricles. He was transferred to another hospital on 10/10/2021. Recommended starting barcitinib (JAK inhibitor) for COVID pneumonia. He was started on Lovenox 30 mg subcutaneous b.i.d. for D-dimer greater than 3000. Lower extremity ultrasound was negative for DVT. Neurology was consulted who recommended a repeat head CT with CTA 12 hours from the initial. CT/CTA at 1500 showed bilateral inferior cerebellar infarcts with an occluded left vertebral artery and left PICA. There is progressive edema with worse effacement of the 4th ventricle and the prepontine cistern. Given worsening mass effect and brain compression he was transferred to another hospital for management. His initial neurological exam was poor, although confounded by sedative medications. He was started on mannitol with improvement early in the day on 10/11/2021. Neurosurgery was consulted and evaluated. They discussed neurosurgical options with his family, who conveyed that surgical options would not reverse injury already sustained and therefore not be consistent with his wishes. His neurological exam worsened overnight on 10/11/2021 where he was not following commands in the left hemibody. Despite hydration and careful monitoring he developed acute kidney injury. Family including wife and three sons were updated via telephone regarding the severity of his strokes. After discussion they agreed that he would not want to live with neurological disability and losing any part of his independence would not be consistent with his wishes. He also had a living will stating that he would not want artifical means prolonging his life if recovery consistent with his wishes was not able to be achieved. Therefore, he was transitioned to comfort care measures after discussion with patients family on 10/12/2021. He passed away peacefully with family at the bedside at 4:44 pm." "1782334-1" "1782334-1" "9/20 noticed increase SOB and went to urgent care on 9/23 for covid swab that was positive. Worsening SOB and EMS took her to Hospital. Stated she received a dose of steroids and antibiotics and discharged home. No improvement so family brought her to Medical Center on 9/24. CXR showed multifocal pneumonia secondary to covid. Transferred tp ICU from 9/28-10/4 due to increase oxygen requirements. Back to regular ward on 10.4-10/10. Being followed by transplant and nephrology and on enoxaparin for DVT. On 10/10 showed symptoms of GI bleed with hypotension, dark stools, anemia and worsening O2 requirements. Transferred back to ICU with O2 desaturation. Intubated for respiratory failure and on vent. Enoxaparin discontinued. Dopplers showed acute right peroneal vein thrombus. Transfused 3 units RBCs and q unit FFP. Cultures obtained and given cefepime, flagyl and zyvox. No further sings of bleeding. Renal function deteriorated rapidly and started on CRRT. CT revealed bilateral pneumothorax and chest tubes placed. Developed progressive shock requiring high doses of vasopressors. Family chose comfort care on 10/12 and patient passed away." "1782370-1" "1782370-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/14/2021 and 2/04/2021. Patient reportedly tested positive for COVID at nursing home on 9/2/2021. Patient admitted for hypoxia and renal failure on 9/10/2021. Patient required mechanical ventilation 9/15/2021 to 9/19/2021. Patient was in shock and required re-intubation on 9/21/2021. Patient also required continuous renal replacement therapy. Patient received baricitinib, dexamethasone, remdesivir, and broad spectrum antibiotics. Patient continued to decompensate and expired 9/25/2021 at 2230." "1782372-1" "1782372-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 2/3/2021 and 3/2/2021. Patient reportedly COVID positive on 9/8/2021. Patient presented to the emergency department for hypoxia on 9/10/2021 and admitted on 9/11/2021. Patient received: ascorbic acid, methylprednisolone, remdesivir, tocilizumab, and zinc. Patient's respiratory status continued to decline throughout hospitalization. After discussion with family, patient was transitioned to comfort care. Patient expired 9/30/2021 at 1700." "1782382-1" "1782382-1" "Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Vaccine on 4/6/2021. Patient admitted for septic arthritis 9/9/2021. Patient began to experience respiratory symptoms on 9/11/2021. Patient received: ascorbic acid, broad spectrum antibiotics, dexamethasone, remdesivir, tocilizumab, and zinc. On 9/272021, patient was emergently intubated, shortly after went into cardiac arrest and CPR initiated. Patient expired 9/27/2021 at 1447." "1782423-1" "1782423-1" "Hospitalized and death; symptoms include fever, rhinorrhea, sore throat, cough, shortness of breath, chest pain, headache, fatigue, diarrhea, congestion, and loss of taste/smell." "1782484-1" "1782484-1" "Patient Passed Away" "1782511-1" "1782511-1" "Patient died 10/12/2021, not a covid related death" "1782569-1" "1782569-1" "On September 2nd of 2021 patient died." "1782614-1" "1782614-1" "Dose 1 1/30/2021 Moderna lot # 029K20A patient dies of pneumonia, not a covid related death" "1782631-1" "1782631-1" "AFTER SECOND DOSE OF COVID -19 VACCINE ON APRIL 9 2021 ,HE GOT 2 TIMES HEAD ACHE AND ON APRIL 19 2021 HE DIED IN SLEEP." "1782634-1" "1782634-1" "Vaccine #1 Moderna 3/1/2021 Lot # 011A21A patient died from cardiac arrest on 10/9/2021, not a covid related death" "1782675-1" "1782675-1" "I had stayed with her Wed night and she seemed fine. Thurs morning I left about 2 in the afternoon. The next morning I found out she didn't feel like eating that night and had been vomiting and the caregiver that came told me that also she was a little unresponsive and didn't feel like eating anything. Caregiver thought to call the EMS and they evaluated her, at that time (9am) she was responsive and doing ok and advised not to take her to ER due to Covid situation. We decided not to take her. About 10 caregiver called back and she had fainted and couldn't get up by herself. And she called EMS again and they came out and she was sitting up at that time and she was responsive again. They again advised that with the 2hr wait in the ambulance and advised that if it was their mother they wouldn't take her. Since she was responsive she said she didn't want to go to the ER. Another night caregiver came to stay with my Mom. The caregiver called and had called EMS and they were taking her to the ER because she became unresponsive again and was seen by Dr. and she was admitted to the hospital. Bunch of tests were run and she was there from Sept 10th until she passed away Sept 22. While there she couldn't eat anything and she had a hernia where her stomach was coming up to her esophagus. And after a endoscopy she took a turn for the worse. They couldn't draw blood because her veins started collapsing. they weren't' able to get her any medications or nutrients through her veins because I guess her body was shutting down. On the 20th she was admitted into hospice." "1782687-1" "1782687-1" "admitted to Hospital 9/13/2021 directly to ICU. No interview was done. At last communication on 9/23/2021, hospital said he was still in the ICU. Passed away on 9/24/2021" "1782711-1" "1782711-1" "Presented to ED with increased shortness of breath x 1 week and associated nausea/vomiting, cough, fevers, headaches, and body aches. Exposure to multiple COVID positive contacts. Was hypoxic on arrival to ER and tachypneic. Placed on HFNC but subsequently required intubation due to continued desaturations. Noted to have severe anemia and severe multi-lobar ground glass opacities consistent with pneumonia. Upon placement of central line, patient went into cardiac arrest and ROSC was unable to be achieved." "1782712-1" "1782712-1" "Patient is a 76 y.o. female patient injured as a result of a fall from standing height on 10/3/2021. Patient reports she slipped on water in her bathroom and hit her head, but denies LOC. Patient denies any difficulty breathing or chest pain at the time. She actually denies any pain from her fall. She was not able to get herself up from the bathroom floor and slept there that night. The following day she crawled into her bed room and was able to call for help. She again denies any pain or difficulty breathing, just general weakness preventing her from being able to get up from the floor. On the day of presentation she had developed pain of her back and right hip and this was her reason for presentation. She also reports that she had shortness of breath for the past 2 weeks especially on exertion. On evaluation in the ED she has been found to be COVID (+) and multiple rib fractures in various stages of healing. She was started on oxygen via nasal cannula on 10/5/2021. She was also started on dexamethasone at that time. She became more hypoxic and oxygen requirements increased, and she was requiring Bipap on 10/8/2021. She was started on remdesivir on 10/8/2021. Patient refused intubation and was made comfort measures on 10/9/2021. The patient expired on 10/10/2021." "1782792-1" "1782792-1" "I am the epidemiologist reporting on behalf of 75-year-old male patient. The patient received two doses of the Moderna vaccine on 3/19/21 and 4/16/21. The patient tested positive for COVID-19 on 4/23/21 (5 days post second dose) via PCR. The patient died 5/1/21 (15 days post second dose) and the cause of death is listed as ?Pneumonia secondary to COVID 19?. Other significant conditions contributing to death but not resulting in underlying cause are listed as ?gastrointestinal hemorrhage, acute cholecystitis, and congestive heart failure.?" "1782821-1" "1782821-1" "Presented to hospital after being unresponsive at home. Patient began having upper respiratory symptoms on the Sunday prior to admission with frontal sinus pressure. Began having diarrhea the day prior to admission. Day of admission patient was found to be nauseous, hot, profusely sweating and short of breath on the toilet. While on the toilet patient went unresponsive, slumped over, lips turned blue and EMS was called. Patient was intubated upon admission to the ER." "1782872-1" "1782872-1" "Respiratory distress, Intubation, death" "1782901-1" "1782901-1" "Cough, pneumonia, COVID" "1782965-1" "1782965-1" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782970-1" "1782970-1" "Patient was hospitalized. Died due to COVID-19. Patient was fully vaccinated." "1782988-1" "1782988-1" "1 hour after vaccination patient felt dizzy and collapsed on kitchen floor. Paramedics were called and patient transported to Medical Center. Patient died several hours later." "1783008-1" "1783008-1" "Patient died due to COVID-19. Patient was fully vaccinated." "1783010-1" "1783010-1" "Immediately after receiving the second doze my mother told family members that something was not right and she didn't feel well. At first is started as flu like symptoms but that is to be expected. On the morning of the July 26th I found her face down, not breathing well and unresponsive. She was taken to Hospital and has a temperature of 107. She was immediately placed on a ventilator and her health declined. She passed away on August 29th." "1783015-1" "1783015-1" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1783020-1" "1783020-1" "He got his vaccination, his arm started swelling up and got hot. Then he started getting nauseated and he called over to where he got the vaccine, and they told him that it would be alright. He kept getting worse and he was tired. He was working on a project at home, and complained of a terrible headache. His mother kept asking him if he needed anything to eat or drink and he said no. He had been throwing up apparently, but did not know when possibly in the middle of the night. This continued for the several days, and he told her to leave him alone. Four days later his mother went to check on him, knocked on his door, there was no answer, and her son and daughter broke the door down and he was dead on the floor." "1783028-1" "1783028-1" "Patient fully vaccinated and died due to Covid related causes" "1783039-1" "1783039-1" "PATIENT DIED OF ACUTE HYPOXEMIC RESPIRATORY FAILURE SECONDARY TO COVID 19 PNEUMONIA AFTER BEING FULLY VACCINATED FOR COVID 19" "1783053-1" "1783053-1" "Entered the ED 9/12/2021 with SOB and AFib (no history of AFib). Placed on bipap, admitted to ICU, intubated. Suffered multiple cardiac arrests, treated for probable PE. Client died 9/12/2021: Acute Hypoxic Respiratory Failure and Covid 19 Pneumonia. Submitter does not have access to further medical records. For further information, please contact." "1783092-1" "1783092-1" "Pt presented to the ED 10/13 with syncope and what appeared to be a pulmonary embolism. Tried to resuscitate patient for 90 minutes but no success." "1783104-1" "1783104-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/7/2021 and 3/28/2021. Presented to the ED on 9/17/2021 with shortness of breath that started yesterday, as well as a 4 day history of nausea and vomiting. Patient was admitted 9/17/21 and initiated on bipap. She was intubated 9/27/21. She was on max mechanical ventilation and epoprostenol and despite proning her saturations were consistently in the 70s-80s. Patient treated with remdesivir, tocilizumab, and methylprednisolone. Her husband elected to make her DNR and then comfort care. Patient passed away on 10/8/2021." "1783124-1" "1783124-1" "Admitted to hospital on 9/14/2021 with SOB, cough, hypoxia. Had been recommended monoclonal antibiotic therapy, but had not been initiated. DX: acute hypoxic respiratory failure, c-19 pneumonia. on 15 L O2, Decadron, declined intubation. 9/16/2021 awaiting transfer to hospice. Died 9/18/2021. Immunized with Moderna 1/22/2021 and 2/19/2021 - only 2/19 dose available. Copy of vaccination card received where client resided showing both doses." "1783607-1" "1783607-1" "On August 27, 2021, was he found deceased in his bed. An autopsy was performed by the medical examiner's office. Patients' sister reported that the night before he went to bed and was behaving normally. On Saturday, August 28th, the medical examiner called and informed us that his heart was enlarged. No previous history of enlarged heart had ever been reported and no heart issues had ever been considered in his past." "1783798-1" "1783798-1" "Patient fully vaccinated and died due to Covid related causes" "1783814-1" "1783814-1" "Patient fully vaccinated and hospitalized. Later died due to Covid related causes" "1783817-1" "1783817-1" "Patient fully vaccinated and died due to covid related causes. Patient has a previous medical history of ESRD, anemia of chronic disease, HTN, osteopenia and sarcoidosis. Patient presented to ER on 09/06/2021 with complaints of increasing SOB with productive cough, headache, and occasional nausea. Patient was found to be hypoxic with O2 in 60s on arrival and had to be placed on Bipap. Patient expired on 09/17/2021." "1783819-1" "1783819-1" "Patient fully vaccinated and died due to Covid related causes" "1783820-1" "1783820-1" "Patient fully vaccinated and died due to Covid related causes." "1784824-1" "1784824-1" "Patient died due to COVID-19. Patient was fully vaccinated." "1784834-1" "1784834-1" "Breakthrough COVID-19 case with unknown symptom status. Hospitalized unknown date for unknown duration. Death 9/24/2021. From Vital Records = ACUTE CARDIOPULMONARY FAILURE, ACUTE RESPIRATORY FAILURE, COVID 19. Per vital records, ICD Codes include: Not yet coded ; Other Significant Conditions include: None listed. place of death: HOSPITAL-INPATIENT, MEDICAL CENTER; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN" "1784918-1" "1784918-1" "Patient fully vaccinated and died of Covid related causes" "1784945-1" "1784945-1" "Blood in airway, Death" "1784958-1" "1784958-1" "Patient fully vaccinated and died due to Covid related causes" "1784983-1" "1784983-1" "Hospitalized twice: 8/23-9/7 and 9/20-9/28. Patient died due to COVID-19. Patient was fully vaccinated." "1784999-1" "1784999-1" "Per medical records, patient was admitted to hospital on 08/25/2021 denying chronic illness or medications who presented with 3 weeks of gait instability, BUE weakness, subjective fever/chills, nausea, cough with phlegm, and SOB. Patient was a former smoker. Per medical records, the patient was emergently intubated and required admission to the ICU. Patient expired on 09/15/2021. Patient was fully vaccinated with J&J" "1785001-1" "1785001-1" "Atherosclerotic Cardiovascular Disease, Hypertension and Diabetes Mellitus" "1785015-1" "1785015-1" "Patient died due to COVID-19. Patient was fully vaccinated." "1785065-1" "1785065-1" ""From H&P: ""Patient is a 72 y.o. male who presented to the emergency department due to shortness of breath. According the patient symptoms started after he was diagnosed with Covid 19 on 9/29. Reports initially was mild shortness of breath but progressed to severe thus presented to the emergency department for evaluation. The patient reports symptoms were associated with mild epigastric pain and nausea. Reports constipation. Denies chest pain, fever, chills, hemoptysis, lower extremity edema, orthopnea. Evaluation emergency department included chest x-ray which was negative. CBC revealed mild leukocytosis with white count 12.7. Sodium is 131. Lipase was normal. BNP was normal in trop was negative. With ambulation the patient required 2 L nasal cannula thus admission was requested. Upon evaluation patient continues report shortness of breath. He continues to deny pertinent negatives outlined above. Does not appear to be in acute distress."" Hospital Course: The patient was admitted to Hospital COVID-19 medical unit for hypoxic respiratory failure secondary to COVID-19 viral pneumonia on 10/04/2021. He reportedly received the Jansen vaccine, single dose March 2021. Upon admission he was started on dexamethasone, Remdesivir and therapeutic Lovenox. Patient was diuresed as needed throughout hospital stay and pulmonary was consulted. Unfortunately the patient continued to have increased oxygen requirements and worsening respiratory distress requiring heated high-flow nasal cannula and was transferred to the ICU on 10/12/2021 and placed on AVAPS. Patient was started on a Precedex drip for agitation also started on broad-spectrum antibiotics as superimposed bacterial infection cannot be ruled out. Morning of 10/13/2021 code blue was called, CPR was started immediately and patient was intubated. Several rounds of ACLS were performed and patient was also given bicarb, calcium and dextrose. Unfortunately patient remained asystole or PEA and the code was eventually called. Time of death 0640 October 13th, 2021. Disposition: Deceased"" "1785118-1" "1785118-1" "Had Pfizer COVID on 12-18-20, 1-7-21. Have Pfizer COVID Booster on 9-29-21" "1785145-1" "1785145-1" "Death diagnosed with covid pneumonia, hypoxia, acute respiratory failure, intubation, Death increased sob reported on 10/8/2021, recommended to go to ER. Patient admitted to Hospital. Death on 10/10/2021" "1785157-1" "1785157-1" "Patient was unexpectedly found deceased at home on 10/12/21" "1785167-1" "1785167-1" "Was admitted 9/28/2021 to 10/1/2021 received 3 doses of Remdesivir. Pt was readmitted 10/6/2021 where he progressively worsened, pt was in ICU. Pt then put into hospice care and passed away 10/12/2021 at 1949" "1785175-1" "1785175-1" "BECAME SYMPTOMATIC AND TESTED COVID POSITIVE ON 8/30/21. DEVELOPED ACUTE HYPOXIC RESPIRATORY FAILURE. DIED 9/30/21" "1785182-1" "1785182-1" "Pt died after testing positive for COVID-19 on 9/2/2021" "1785200-1" "1785200-1" "BECAME SYMPTOMATIC. EXPERIENCED RESPIRATORY FAILURE AND COVID19 PNEUMONIA. DIED 9/17" "1785202-1" "1785202-1" "Patient presented to medical clinic on 30AUG21 for evaluation of vertigo, photophobia, dizziness, vomiting. Patient was evaluated on 31AUG21 via Emergency Department, was later diagnosed with Angiosarcoma and passed away on 07OCT21." "1785212-1" "1785212-1" "Patient was hospitalized. Patient died due to COVID-19. Patient was fully vaccinated." "1785213-1" "1785213-1" "Pt died after being diagnosed with COVID-19 on Sep 29, 2021" "1785229-1" "1785229-1" "Patient received dose one as above. Dose 2 (Pfizer lot#ER2613 given IM in left deltoid on 3/19/21. Patient reported to ED on 10/2/21 and tested positive with PCR for covid. Admitted to hospital. During stay, he was placed on steroids, oxygen and bipap. Patient passed on 10/11/21. Patient was DNR/DNI prior to admission" "1785234-1" "1785234-1" "08/31/2021: Second dose of COVID19 vaccine received. 10/04/2021: EMS respond to 911 call. Patient was found in car with altered mental status, unable to move left side, experiencing vomiting and diarrhea. 10/05/2021: Brought to ER by EMS as a code stroke. Pt admitted after acute IP hemorrhage (confirmed on ED CT and MRI) involving R thalamus with accompanied hypertensive emergency, AKI, and respiratory failure. No surgical treatment indicated for hemorrhage. Patient intubated, nursing staff suctioning and laid on side as vomiting persisted. Given anti hypertensives and vasopressor. 10/06/2021: Patient pronounced brain dead at 0752. 10/06/2021: consulted and performed routine lab work for organ donation. Patient found to be syphillis positive and COVID positive by tracheal aspirate." "1785258-1" "1785258-1" "Symptom onset was 7-13-2021. Symptoms included fever, cough, shortness of breath, congestion, diarrhea, headache, fatigue, myalgia, ear infection, UTI. Patient was hospitalized from 7-28-21 through 8-15-2021. She passed away on 8-15-2021." "1785275-1" "1785275-1" "9/15/21 - tested positive for COVID 9/20/21 present to ED with SOB 9/21/21 re-presents to ED with SOB and admitted. pt given remdesivir, dexamethasone, zinc and barcitinib during stay and expired 9/27/21" "1785281-1" "1785281-1" "Admitted with adult respiratory distress syndrome, septic shock, pneumonia, COPD . Family chose comfort care instead of aggressive treatments and patient died. Vapotherm, BiPap, intubated, pressors" "1785312-1" "1785312-1" "DEVELOPED SYMPTOMS, ACUTE HYPOXIC RESPIRATORY FAILURE, COVID19 PNEUMONIA AND DIED." "1785320-1" "1785320-1" "10/8/21 PATIENT ADMITTED TO MEDICAL CENTER aCUTE ON CHRONIC lv SYSTOLIC HEART FAILURE. PATIENT REPORTING SOB , CARDIAC CATH SHOWED NORMAL, ACUTE RENAL FAILURE NOTED .imPELLA DEVICE PLACED. COVID + ACUTE RESP FAILURE. 10/9/21 PATIENT HAD CARDIOPULMONARY ARREST. PATIENT INTUBATED . PATINET PROGRESSIVELY MORE HYPOTENSION AND BRADYCARDIC. ON 10/9/21 PATIETN DIED." "1785380-1" "1785380-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/11/2021 and 3/11/2021. Presented to ED on 9/19/2021 with a 6 day history of cough and worsening shortness of breath. On admission was hypoxic on room air that improved with 5 L of oxygen via nasal cannula. Patient was treated with dexamethasone, remdesivir, and baricitinib. Ultimately had progressive hypoxemia requiring mask BiPAP making it difficult to eat or drink and on the evening of 9/30 was intubated. Over the next 7 days he continued to deteriorate with worsening hypoxemia requiring prone ventilation strategy. Despite maximization of ventilator efforts he never improved. Moreover, he developed persistent hypotension and renal failure with minimal urine output ultimately with acidosis and hyperkalemia. Palliative care was involved with family discussions. He was transitioned to DNR status and expired on 10/6/2021." "1785447-1" "1785447-1" "BREAKTHROUGH HOSPITALIZATION AND DEATH" "1785490-1" "1785490-1" "Janssen COVID-19 Vaccine EUA: Patient received Janssen Vaccine on 4/11/2021. On 10/1/2021, patient presented to Medical Center with a chief complaint of cerebrovascular accident. Symptom onset was overnight and patient woke with complaints of left sided weakness. He was seen by teleneurology and CTA showed occlusion at the right ICA origin. CT perfusion scan revealed at risk tissue that was felt to be amenable to reperfusion, so pt was transferred to Hospital emergently for cerebral thrombectomy. He was intubated for procedure. Of note he is Covid positive. Patient was extubated after procedure on 10/1. Patient was reintubated on 10/7. He developed acute hemodynamic instability and worsening hypoxemia on 10/11/2021. Etiology was unclear: acute sepsis vs cardiac event vs venous thromboembolic disease. WBC acutely elevated. CXR stable. LE dopplers (-). Troponin 0.14-- >0.15. Hb stable. He progressed to PEA arrest and did not have ROSC despite ACLS. Patient passed away on 10/11/2021." "1785494-1" "1785494-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 4/8/2021 and 4/29/2021. Presented to ED on 10/1/2021 with low blood sugar (25 per EMS arrival and 31 on arrival), generalized weakness, and a decreased appetite. Around 7AM son tried to wake her up but she was unresponsive prompting EMS activation. Patient reports weakness for about two weeks, cough for approximately one week with diarrhea. Patient completed 5 days of Remdesivir, also treated with Dexamethasone. Patient required intubation on 10/8. Patient progressed to shock, A-fib with RVR, COVID, and possible UTI and maxed out on three pressors. Family requested to switch to comfort care. Patient expired on 10/8/2021 with cause of death documented in chart as Septic shock with MOD & acute hypoxic respiratory failure 2/2 Covid PNA." "1785497-1" "1785497-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 3/6/2021 and 4/8/2021. Presented to ED on 10/1/2021 for hypoxia. He was diagnosed with COVID in his PCP's office on 9/21. His symptoms began on 9/19 with lack of energy and worsening of his chronic sinus issues. He received an infusion of monoclonal Abs on 9/30. He reports having decreased appetite (but no dysgeusia or anosmia) with poor PO intake, persistent cough that keeps him from being able to sleep, and fatigue with low energy. Today, he was noted to have saturations of 70's at home. His sats here on RA measured on his ear lobe are 85%. He comes up to 95% on 2L. Patient was admitted and Additional information for Item 18: started on dexamethasone. He completed treatment for a secondary bacterial pneumonia and was started on abx again later for suspected hospital acquired pneumonia shortly before he passed. Patient's O2 needs gradually increased, despite proning his O2 needs continued to worsen and he had to be intubated on 10/8. Patient coded on 10/10 and was pronounced at 15:01." "1785501-1" "1785501-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/19/2021 and 2/26/2021. Patient presented to a different facility on 9/10/2021 with complaints of worsening shortness of breath over the last month associated with cough and sore throat. Patient reported that he was recently exposed to Covid and tested positive on 9/9/2021 on a home test. He was admitted and completed a 5 day course of remdesivir, and completed a 10 day course of Decadron after being discharged on September 15. On September 23," "1785515-1" "1785515-1" "HOSPITALIZED AND DECEASED AFTER BEING FULLY VACCINATED FOR COVID 19" "1785592-1" "1785592-1" "She stated the PUI started to have symptoms on 09/10/2021 with cough, fatigue and brain confusions. She stated as of today the PUI is not doing so well. PUI is hospitalized at Hospital since 09/11/2021. She said she think the only reason why he still in the hospital is due to his brain cancer and since having COVID it has made things worse. Patient is fully vaccinated." "1785593-1" "1785593-1" "Admitted to hospital on 10/2 with covid pneumonia with acute hypoxia respiratory failure. Also stated history of having bright red bleeding per rectum. Treated with covid bundle medications. Intubated on 10/4 due to Upper airway obstruction due to large volume posterior aspect epistaxis. Internal maxillary artery embolization on 10/7 but continued to have anemia and thrombocytopenia with continued melanotic stool and suctioning of bleeding in the setting of severe sepsis. Received 9 units platelets and over 3 units PRBC. Diagnosed with bilateral sub segmental PEs but not candidate for anticoagulation due to bleeding risk. Evidence of rhabdomyolysis with AKI. Treated with cefepime and zyvox due to sepsis and shock. Coagulopathy continued with cyanosis of the upper and lower digits. Decreased pulsations in the dorsal pedis and upper extremities. Ultrasound showed no flow in right dorsalis pedis and dampened flow in right and left ulnar arteries. Given prophylactic anticoagulation due to bleeding risk. Mucosal bleeding increased. A=complicated course with encephalopathy and unable to be weend from vent. Family aware and transitioned to comfort care." "1785676-1" "1785676-1" "Patient was admitted to the hospital on 9/13 for both chest pain and abdominal discomfort. Called paramedics after a sharp pain was felt in her epigastric region and profuse sweating occurred." "1786208-1" "1786208-1" "Patient died suddenly. Because there was no foul play, an autopsy was not done. ER doc guessed massive heart attack. Patient's cardiologist does not believe it was a heart attack because his labs were fine in July. His blood pressure was controlled." "1786357-1" "1786357-1" ""91 year old (deceased) Male. Communication details: Call to PCP office to report patient up all night with a cough, elevated temp this morning. Poor appetite today and fatigue. SOB, +DOE, diarrhea. They will call the patient after speaking to the MD. Office Visit Family Medicine Chronic diastolic congestive heart failure +4 more Dx Cough ? Shortness of Breath ? Insomnia ? Poor Appetite Reason for Visit Patient was seen today for cough, shortness of breath, insomnia and poor appetite. Diagnoses and all orders for this visit: Chronic diastolic congestive heart failure - CBC and differential; Future - B-type natriuretic peptide; Future - Basic metabolic panel; Future - X-ray chest 2 views; Future Stage 3a chronic kidney disease - CBC and differential; Future - B-type natriuretic peptide; Future - Basic metabolic panel; Future Suspected COVID-19 virus infection - COVID-19 PCR; Future - COVID-19 PCR Bradycardia - ECG 12-lead: IN OFFICE Patient Instructions I am not entirely sure what is causing your shortness of breath. I think it is going to turn out to be a combination of things. Your pulse is a little bit low. EKG does not show anything that would make me insist upon a pacemaker but you do have an irregular rhythm with some ""supraventricular"" beats. Chest x-ray Blood work Today when you get home take an extra furosemide 20 mg pill You do not want to go to the emergency department. If you change your mind at any time call 911 Visit time 40 minutes including obtaining history, physical exam, placing orders and, interpreting past test results, communicating to pt/family and dictating. Daughter was a bit frustrated that he did not agree to go to the emergency department. She thought it would be in her dad's best interest but he strongly and consistently refused emergency department evaluation. He did say that he is dying and his time is limited even if they would elect for hospitalization Return for Next scheduled follow up. Patient is here with wife and daughter due to cough, shortness of breath, decreased appetite. He is known to have interstitial lung disease, COPD, diastolic heart failure, pulmonary hypertension. He was hospitalized a little bit over a week ago for similar symptoms. He was felt to be in heart failure due to an elevated BNP at 503. He was given IV Lasix but that adversely affected his kidney function. He was transitioned and discharged to 20 mg of Lasix daily. He is on chronic oxygen. Since being at home he has not been doing well. He has cough productive of clear sputum, shortness of breath and yesterday he had a fever of 100.6. Yesterday and earlier today when we heard of his difficulties we recommended that he go to the emergency department. He and his wife absolutely refused. They are well aware that emergency department is the most rapid and efficient way of getting testing done. In spite of this they wanted to come into the office to see me today. Patient arrives in a wheelchair. He appears to be in moderate respiratory distress. He appears weak and frail. I confirmed with patient and his wife their desire to return to the hospital. They are again very clear that they do not want emergency department evaluation. They would like for me to do what I can in the outpatient setting. ROS: Patient denies headache, vision changes, chest pain, chest pressure, lightheadedness, dizziness, shortness of breath at rest, nausea, vomiting, melena, bright red blood per rectum, abdominal pain, dysuria, hematuria, focal neurologic deficit, fever, unexplained weight loss ED to Hosp-Admission Discharged 10/6/2021 - 10/10/2021 (4 days) Last attending ? Treatment team Severe sepsis Principal problem Hospital Course:Patient is a 91 y.o. male with past medical history of pulmonary fibrosis and ILD with chronic respiratory failure on home oxygen 2 L per nasal cannula, hypothyroidism, BPH, chronic diastolic heart failure was admitted to Hospital with severe sepsis secondary with associated acute on chronic respiratory failure with hypoxia secondary to COVID-19 pneumonia. He has been undergoing treatment with dexamethasone and Remdesevir for COVID-19 pneumonia. He did receive IV Tocilizumab treatment per ID for worsening acute on chronic respiratory failure with hypoxia requiring maxed out high flow nasal cannula oxygen. He also required empiric antibiotics for possible superimposed community-acquired pneumonia. Over the past 24 hours he developed worsening acute on chronic respiratory failure with hypoxia requiring maxed out high flow nasal cannula oxygen and nonrebreather. The patient also developed worsening acute metabolic encephalopathy and end-stage agitation that did not respond to lorazepam, Zyprexa, or haloperidol. The patient's breathing and confusion continued to worsen. After further discussion with the patient's wife, the family has agreed to transition the patient's goals of care to comfort measures only. The patient was seen by hospice and community care and consents were signed to transition the patient to inpatient hospice. Admission Discharged Acute on chronic respiratory failure with hypoxia Principal problem Details of Hospital Stay Presenting Problem/History of Present Illness/Reason for Admission Acute on chronic respiratory failure with hypoxia Severe sepsis secondary to COVID-19 pneumonia Acute metabolic encephalopathy Patient is a 91 y.o. male with past medical history of pulmonary fibrosis and ILD with chronic respiratory failure on home oxygen 2 L per nasal cannula, hypothyroidism, BPH, chronic diastolic heart failure was admitted to Hospital with severe sepsis secondary with associated acute on chronic respiratory failure with hypoxia secondary to COVID-19 pneumonia. He has been undergoing treatment with dexamethasone and Remdesevir for COVID-19 pneumonia. He did receive IV Tocilizumab treatment per ID for worsening acute on chronic respiratory failure with hypoxia requiring maxed out high flow nasal cannula oxygen. He also required empiric antibiotics for possible superimposed community-acquired pneumonia. Over the past 24 hours he developed worsening acute on chronic respiratory failure with hypoxia requiring maxed out high flow nasal cannula oxygen and nonrebreather. The patient also developed worsening acute metabolic encephalopathy and end-stage agitation that did not respond to lorazepam, Zyprexa, or haloperidol. The patient's breathing and confusion continued to worsen. After further discussion with the patient's wife, the family has agreed to transition the patient's goals of care to comfort measures only. The patient was seen by hospice and community care and consents were signed to transition the patient to inpatient hospice. The patient was readmitted under inpatient hospice. He was started on continuous IV morphine infusion at 2 mg/hr. he did rest comfortably on the morphine drip and passed comfortably in the late afternoon. The family was present at the bedside and were very grateful for the excellent care the patient had received. All of our best wishes were offered to the family at this time. Condition at Discharge Discharge Condition: Expired"" "1786697-1" "1786697-1" "Patient fully vaccinated and died due to Covid related causes" "1787045-1" "1787045-1" "Patient fully vaccinated and died due to Covid related causes" "1787777-1" "1787777-1" "Sudden death on 9/3/2021" "1787902-1" "1787902-1" "Notified that individual developed shortness of breath and died on 10/9/21." "1787943-1" "1787943-1" "DIAGNOSED WITH COVID 10/3/2021; CARDIAC ARREST AND DIED 10/6/2021 FROM COVID COMPLICATIONS" "1788052-1" "1788052-1" "Unable to eat, elevated sodium level, less responsive." "1788168-1" "1788168-1" "within days of vaccine pt experienced increased fatigue, weakness and increased number of falls ( 3 reported by family member) , pt had dementia and family noticed worsening of memory after the vaccine , Pt experienced heart attack July 25, 2021" "1788244-1" "1788244-1" ""Fully vaccinated patient admitting through ED for COVID who subsequently died from COVID. Provider discharge note ""65 YO male with AML requiring BMT and subsequent GVHD admitted with hypoxia due to covid pneumonia. Patient developed respiratory failure with hypoxia requiring HFNC and BiPAP support. Eventually transitioned to comfort care with progression of disease despite aggressive treatment. Patient passed today comfortably with family at bedside at 856AM."""" "1788331-1" "1788331-1" "Death" "1788529-1" "1788529-1" "FULLY VACCINATED COMPLETED SERIES ON 3/31/21 DIAGNOSED WITH COVID-19 10-07-21. PATIENT HOSPITALIZED 10-7 THROUGH 10-14" "1788583-1" "1788583-1" "Janssen (J&J) COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen (J&J) Vaccine on 7/3/2021. Patient was diagnosed with COVID on 9/29/2021 and reportedly received Regeneron monoclonal antibody treatment. Patient presented to emergency department with hypoxia on 10/2/2021. Patient immediately required supplemental oxygen. Throughout hospitalization, patient's oxygen requirements increased and patient decompensated. Patient received: dexamethasone and azithromycin. Patient was transitioned to comfort care and expired 10/11/2021 at 0225." "1788585-1" "1788585-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 3/5/2021 and 3/26/2021. Patient reportedly diagnosed with COVID on 9/23/2021 and received Regeneron 9/28/2021. Patient presented to the emergency department on 10/4/2021 for rapidly progressed malaise. Patient admitted to hospital for altered mental status, dehydration, and COVID pneumonia. Patient received: ascorbic acid, azithromycin, ceftriaxone, cholecalciferol, and zinc. Patient was comfort care and expired 10/10/2021 at 1416." "1788586-1" "1788586-1" "Patient found down at home 10/3 due to large brainstem intracerebral hemorrhage. Likely due to cocaine use as she was found with drug paraphernalia- but report being submitted to rule out vaccine contribution" "1788588-1" "1788588-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/12/2021 and 4/09/2021. Patient presented to the emergency department with hypoxia and admitted to hospital. Patient received: dexamethasone, remdesivir, antibiotics, tocilizumab. Patient's respiratory status continued to decline. Patient became obtunded and family elected to initiate comfort care. Patient expired 10/12/2021 at 0340." "1788590-1" "1788590-1" "Janssen (J&J) COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen (J&J) Vaccine on 3/13/2021. Patient presented to emergency department for altered mental status. Patient admitted for delirium and received Regeneron monoclonal antibody and dexamethasone. Patient went into ventricular fibrillation and expired 10/10/2021 at 0021." "1788593-1" "1788593-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/29/2021 and 3/4/2021. Patient presented to emergency department complaining of shortness of breath. Patient was admitted for COVID-19 pneumonia and hypoxia requiring supplemental oxygen therapy. Patient received: ascorbic acid, broad spectrum antibiotics, methylprednisolone, remdesivir, tocilizumab. Patient's respiratory status rapidly declined and patient became encephalpathic, hypernatremic, and bradycardic. Patient was transitioned to comfort care and expired 10/8/2021 at 1935." "1788666-1" "1788666-1" "99-year-old female who presents with acute hypoxemic respiratory failure due to Covid-19, she will be admitted for oxygen supplemental and then further evaluation treatment the hospitalist. She was requiring high flow nasal cannula oxygen, given an IV dose of steroids of Decadron. She does have also paroxysmal atrial fibrillation, formerly on warfarin but her daughter states the son who she lives with has been holding it. She is in atrial fibrillation with rapid ventricular response and started on IV Cardizem at 10 mg/h. She ultimately died on 09/23/2021 from complications of COVID-19 despite being fully vaccinated. This is a breakthrough case of COVID-19 that resulted in death. Death Certificate Details: Part I Cause of Death A: Acute Hypoxemic Respiratory Failure B: COVID 19 Pneumonia Part II Other Significant Conditions: Dementia, Atrial Fibrillation" "1788724-1" "1788724-1" "Vaccine breakthrough disease that resulted in death. The individual died on 09/28/2021; positive COVID-19 test was from nearly about a month prior on 08/27/2021. However, COVID-19 is listed on the death certificate cause of death. The individual was interviewed prior to passing away and had symptoms of fever, loss of taste/smell, shortness of breath, chills, cough, fatigue, and runny nose. The individual was hospitalized 08/27/2021-08/29/2021 for the COVID-19 symptoms, and then had a later hospitalization 09/14/2021 until his death on 09/28/2021. The primary reason for this later hospitalization seems to be joint issues/pain that resulted in a toe amputation. Death certificate details: Part I Cause of Death A: Respiratory Failure B: Acute Respiratory Distress Syndrome C: COVID 19 Part II Other Significant Conditions: None Listed" "1788903-1" "1788903-1" "Before vaccine, was suffering from health problems. Starting 2/18/21 (day after first Moderna vaccine) - defibrillator went off, went to hospital and was sent home. then 2/19 the defibrillator went off again at home, stayed at hospital for a couple days, 4 days after arrived home got another defibrillator shock - back to hospital, was treated for hypoxia. Patient was on hospice 2.5 months and then passed 5/20/21." "1789155-1" "1789155-1" "Pfizer booster dose given Wednesday 10/13/21 on 10/14/21 patient was not feeling well unsteady gait, Nausea, Vomit, poor appetite, shivering. 7pm patient was unresponsive with poor vitals, emergency service transported the patient and CPR initiated. Patient pronounced deceased around 750pm." "1790377-1" "1790377-1" ""she found her mother dead on her bed; More than 36 days after the first dose without receiving the second dose; shortness of breath/ it was the worst ever; the patient had burning in her chest; stayed in bed for a few days; not feeling well/ did not feel great; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (she found her mother dead on her bed) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood sugar increased (took Insulin because she had her blood sugar levels up for 6 months). Concomitant products included INSULIN for Blood sugar increased, GABAPENTIN, CEFIXIME (FLEXERIL [CEFIXIME]) and RISPERIDONE for an unknown indication. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose). In September 2021, the patient experienced DYSPNOEA (shortness of breath/ it was the worst ever), CHEST PAIN (the patient had burning in her chest), BED REST (stayed in bed for a few days) and VACCINATION COMPLICATION (not feeling well/ did not feel great). The patient died on 24-Sep-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (shortness of breath/ it was the worst ever), CHEST PAIN (the patient had burning in her chest), BED REST (stayed in bed for a few days) and VACCINATION COMPLICATION (not feeling well/ did not feel great) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: up (High) Had blood sugar levels up for 6 months. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BED REST (stayed in bed for a few days) to be possibly related. No further causality assessments were provided for DEATH (she found her mother dead on her bed), DYSPNOEA (shortness of breath/ it was the worst ever), CHEST PAIN (the patient had burning in her chest), VACCINATION COMPLICATION (not feeling well/ did not feel great) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose). It was reported that treatment was not taken by the patient. Caller states that she took her mother to take her second vaccination with the Moderna Covid19 vaccine on 15September2021.After the vaccine, she had some side effects: At first she stayed in bed for a few days, not feeling well, she had some side effects and didn't feel great. It took her 3 days to get out of bed, she had shortness of breath but was feeling good. Caller also stated that the patient had burning in her chest: The patient stated she never felt anything like the burning in her chest that she felt those 3 days, and also felt shortness of breath. Stated ""it was the worst ever"". After those 3 days she got up and started moving around for a couple of days. And caller states that 9 days after, on 24September2021, she found her mother dead on her bed. Patient did not see any doctor for months, she was fine, and there was no diagnose made by a doctor on the cause. Patient did not receive any treatment, she had side effects and didn't feel well, but started feeling better and thought everything was better. She did not have a prior diagnose of Covid or Myocarditis or Pericarditis, and did not experience symptoms like this before. Company Comment: This case concerns a 65 year-old female patient with no relevant medical history, who experienced the unexpected fatal event of Death (unknown cause). The event occurred approximately one week after the second dose of mRNA-1273 vaccine. the cause of death is unknown, however the non-serious events of shortness of breath and chest pain may have contributed to the event and fatal outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 65 year-old female patient with no relevant medical history, who experienced the unexpected fatal event of Death (unknown cause). The event occurred approximately one week after the second dose of mRNA-1273 vaccine. the cause of death is unknown, however the non-serious events of shortness of breath and chest pain may have contributed to the event and fatal outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death"" "1790508-1" "1790508-1" "two hours later, she was cyanotic, lips, hands, and feet were blue; She had no heartbeat; was not breathing; She was completely unresponsive; They took her to the hospital and worked on her for a couple hours and then pronounced her dead; feeling very tired; an hour later, and she was snoring heavily; This spontaneous case was reported by a consumer and describes the occurrence of CYANOSIS (two hours later, she was cyanotic, lips, hands, and feet were blue), CARDIAC ARREST (She had no heartbeat), APNOEA (was not breathing), LOSS OF CONSCIOUSNESS (She was completely unresponsive) and DEATH (They took her to the hospital and worked on her for a couple hours and then pronounced her dead ) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Oct-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced CYANOSIS (two hours later, she was cyanotic, lips, hands, and feet were blue) (seriousness criterion death), FATIGUE (feeling very tired) and SNORING (an hour later, and she was snoring heavily). 03-Oct-2021, the patient experienced CARDIAC ARREST (She had no heartbeat) (seriousness criteria death and medically significant), APNOEA (was not breathing) (seriousness criteria death and medically significant), LOSS OF CONSCIOUSNESS (She was completely unresponsive) (seriousness criteria death and medically significant) and DEATH (They took her to the hospital and worked on her for a couple hours and then pronounced her dead) (seriousness criteria death and medically significant). On 03-Oct-2021, FATIGUE (feeling very tired) and SNORING (an hour later, and she was snoring heavily) outcome was unknown. The patient died on 03-Oct-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication information were provided. No treatment information were provided. The patient was taken to hospital and after a couple of hours, she was pronounced to be dead. Company Comment: This case concerns a 57-year-old female with no relevant medical history, who experienced the unexpected event of cyanosis. The event occurred the same day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine) and had a fatal outcome, with death occurring the same day. The cause of death was not reported. It is unknown if an autopsy was performed. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 57-year-old female with no relevant medical history, who experienced the unexpected event of cyanosis. The event occurred the same day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine) and had a fatal outcome, with death occurring the same day. The cause of death was not reported. It is unknown if an autopsy was performed. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death" "1791260-1" "1791260-1" ""death/died; Couldn''t even urinate, collapsed with kicking by Mess, like to trauma unit.; swelling from the waist down; collapsed with kicking by Mess, like to trauma unit; This is a spontaneous report from a non-contactable consumer. A 62-year-old male patient (Uncle) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 23Jun2021 (at the age of 62 years old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history included hospitalization. Patient had had multiple hospitalization. No Other Medical Conditions, not even cold, no diabetes, no cancer. The patient's concomitant medications were not reported. The patient declared death and died on 24Jun2021 from the Pfizer vaccine. He died because he was forced to get the shot to keep his job and died within 24 hour and that was in the report. He died in the trauma unit of the hospital. It was unknown if an autopsy was performed. He experienced swelling from the waist down immediately after his 2nd shot and by that evening, couldn't even urinate, collapsed with kicking by Mess, like to trauma unit and died next morning and doctor declared, It's a vaccine injury. For Height and Weight, Reporter Stated, ""Probably 6 foot may be 175 (not clarify, hence not captured in tab). For Other Medications, Reporter Stated, ""Not that I am aware of. They are not take any medications"". The patient was hospitalized on the 23rd, that evening he admitted, 23rd June (23Jun2021). Seriousness for He died in the trauma unit of the hospital was Hospitalization, Death. The patient underwent lab tests and procedures which included lab test with unknown results on an unspecified date. The outcome of the event death/died was fatal, of the other events was unknown. No follow-up attempts are possible; information about lot/batch cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101335055 same reporter/drug, different patient/event.;US-PFIZER INC-202101335048 same reporter/drug, different patient/event.; Reported Cause(s) of Death: death/died"" "1793706-1" "1793706-1" "On 8/12 patient developed nose bleed and was admitted to hospital Bone marrow bx showed acute myeloid leukemia. Chemo therapy started. Patient became septic on 10/9 with hypotension and was intubated. She coded on 10/10 and expired." "1793710-1" "1793710-1" "On 4/2, patient (22 weeks pregnant) developed numbness and tingling down one leg. Symptoms progressed and she was admitted for BLE paralysis 4/5. MRI showing transverse myelitis. Process continued despite maximal medical therapy. 4/12 intubated. 4/20 tracheostomy. 7/11 C section and then developed post-operative bleeding needing mass transfusion protocol. 8/11 family decided to withdraw care and patient expired." "1793925-1" "1793925-1" "Confused and not able to communicate, never clear thinking again" "1794355-1" "1794355-1" "My mom received the first Pfizer dose and unexpectedly went into sudden cardiac arrest and died one week and a half later. She had no known prior Comorbidities. Her death came as a total shock to us all" "1794807-1" "1794807-1" "Patient received her booster dose from Pharmacy at an unknown time on 10/15/21. Her husband reports she had been well throughout the day. At some point, the patient began to complain of left sided chest pain and then became weak and had to lay down onto the floor. She then became unresponsive and upon arrival of EMS, she was asystole. She presented to our ED and we were able to get ROSC, but then the flight crew took off, the patient went into complete arrest again and was brought back to ED where resuscitation efforts continue, but the patient was pronounced dead at 2359." "1794843-1" "1794843-1" "Pt started with chills and sore throat approximately 12 hours after receiving the vaccines. She presented to urgent care on 10/7/21 and was seen. The urgent care did a rapid strep which was negative and advised to due symptomatic treatment. They felt she was experiencing an immune response the vaccines." "1794855-1" "1794855-1" "PATIENTS DEVELOPED COVID-19 PNEUMONIA ON 09/11/2021 THAT PROGRESSED TO PATIENT'S DEATH ON 10/09/2021 AFTER MANY DAYS IN HOSPITAL." "1794887-1" "1794887-1" "PATIENT EXPIRED ON 10/06/2021" "1794922-1" "1794922-1" "Pt came to ER c/o difficulty breathing onset 3 days prior." "1794958-1" "1794958-1" "Fever, diarrhea, shortness of breath, weak. Went to hospital, tested positive for Covid-19 and died." "1794960-1" "1794960-1" "10/8/2021 - Patient c/o fatigue, inability to walk, decreased appetite, fever, chills, and low back pain. Noted CK is elevated (> 12,000). A CT scan was also done and showed colitis. Patient is admitted with rhabdomyolysis (possibly due to the COVID vaccine of which the second dose was given on 9/20/2021) and colitis. Note that she has a PMH of rhabdomyolysis from April 2021. Patient was admitted to the hospital from 4/30 to 5/19/2021 with rhabdomyolysis and her first COVID vaccine was given on 4/2/2021. Patient was given IV fluids and continued on the levofloxacin which was started on 10/5/2021 for sinusitis. 10/10/2021: Patient became hypotensive, was given fluid boluses, transferred to the ICU and started on pressors. 10/11/2021: C. diff pCR test came back positive and antibiotics were changed to oral vancomycin and IV metronidazole 10/12/2021: Patient was intubated; coffee ground emesis from OGT after intubation and patient was transfused with PRBCs 10/13/2021: Hemodynamics worsened, patient developed acute renal failure. CRRT was ordered, but never started due to instability 10/14/2021: Patient made comfort measure and expired" "1794987-1" "1794987-1" "Patient expired from COVID-19 on 10/8/21 after being vaccinated" "1794994-1" "1794994-1" "Informed of cardia event and dealth 10/17/2021" "1795017-1" "1795017-1" "PATIENT EXPIRED ON 10/11/2021" "1795102-1" "1795102-1" "Glioblastoma. Death on October 4th." "1795156-1" "1795156-1" "History per chart review and husband. The patient is a 55 Years-old Female with a history of rheumatoid arthritis, anxiety/depression, overweight who presented with acute shortness of breath. 2 weeks prior to admission she filled her routine prescription for hydroxychloroquine for her rheumatoid arthritis, however husband reports that she stopped taking this and started taking a supplement from another country called RT King and reported improvement in arthritis symptoms. She also had congestion and sore throat around this time and tested herself for Covid with a home test that was negative. Shortly after this she was performing her job as a provider for patient that passed away from Covid and attended the funeral. On 9/8 she reported difficulty breathing and pain in the chest and back with deep breaths. This spontaneously resolved. Then on 9/9 in the evening she had fever, body aches, however she attributed this to her rheumatoid arthritis and the storm pressure changes. 9/12 she felt great then played at the beach with her grandkids running around. Then 9/12 in the evening she felt ill and took a home Covid test that was positive. Husband took a home Covid test that was negative. She did not initiate any outpatient care other than Mucinex and vitamin C. 9/13 in the morning she had difficulty breathing, hyperventilating, blue lips, diffuse body pain, feeling very weak to stand. She was not drinking or caring for herself. She was able to walk to the truck. Her family brought her to the ER freestanding. At the freestanding ER, she had initiated and tested positive for flu and negative for Covid by antigens. Covid PCR later returned negative. She was transferred to the main ER and desaturated during the transport and stopped breathing. She maintained a pulse. In the ER she was intubated. Pressors Were Started to Maintain MAP. CTA was negative for PE, however ED physician and family practice physician clinically suspected PE and that there could be multiple small thrombi in the lungs rather than a large PE detectable by CTA. She was started on heparin drip. ICU accepted the patient and began management. She tested negative for COVID IgM antibodies and positive for COVID IgG antibodies. She devloped DIC (disseminated intravascular coagulation) and TTP (thrombotic thrombocytopenic purpura). During the hospital course she had sputum and blood cultures positive for streptoccocus pneumonia. She later had pseudomonas VAP and Enterococcus faecalis bacteremia. She had failure of lungs, liver, and kidneys. She was treated with maximal critical care management including broad spectrum antibiotics, ventilation, continuous renal replacement therapy, blood/platelet transfusions, chest tube, OG tube feedings, and anticoagulation initially that was later discontinued. She had minimal responsiveness to pain only after sedation withdrawal and was unable to breath spontaneously. On 10/9 the family agreed to palliative vent withdrawal and she expired. I suspect her severe illness may have occured due to abrupt discontinuation of hydroxychloroquine for rheumatoid arthritis and antibody dependent enhancement of influenza due to COVID vaccine." "1795158-1" "1795158-1" "dose 1 moderna 2/4/2021 lot # 016M20A patient has a cardiac arrest at home and died in the ED" "1795185-1" "1795185-1" "Patient passed away on 09/29/2021" "1795225-1" "1795225-1" "Patient passed away on 10/10/2021." "1795256-1" "1795256-1" "Patietn recived J & J vaccine early August and within 2 weeks became SOB. He presented to Medical center after syncopal episode and had acute thrombosis of RCA on 9/25 /21 . He underwent PCI and thrombectomy . He was noted to have Cardiomyopathy at this time with EF < 20% . Several hours later while in the ICU he had siexzure followed by PEA arrest with ABG Po2 28 ( presumed pulmonary embolus ) and was pronounced dead at that time" "1795403-1" "1795403-1" "PATIENT EXPIRED ON 09/13/2021" "1795422-1" "1795422-1" "Family notified healthcare professional on 10/18/2021 that patient died on 10/18/2021" "1795447-1" "1795447-1" "Patient presented to ED on 9/2/21 from a rehab facility with fever and cough and found to be covid positive. Patient is fully vaccinated. Patient was appropriately treated for his covid 19 infection. On 9/14, patient developed a new fever and acute hyposia requiring high flow nasal cannula and was started on broad spectrum antibiotic due to suspicion for aspiration pneumonia. Chest x ray confirmed development of a new consolidation along with a rising procalcitonin. Despite antibiotics, patient was unable to be weaned from HFNC with high FiO2 and flow requirement. Given worsening work of breathing and inability to tolerate HFNC, patient's family transitioned him and patient passed away peacefully on 9/19." "1795457-1" "1795457-1" "pt presented with SOB; tested positive for COVID; hx of multiple myeloma, currently taking chemotherapy; HSV encephalitis; pt's condition declined, need for oxygen requirement increased and pt died in the hospital" "1795480-1" "1795480-1" "pt presented to ED with SOB, cough, N/V/D x 3 days; PMH: dementia, OSA on CPAP, chronic hypercapnic respiratory failure; intubated on 8/31; developed AKI and shock; transitioned to comfort care; extubation on 9/4; pt died shortly after extubation" "1795494-1" "1795494-1" "pt arrested @ nursing home; presented to ED being positive for COVID, pupils fixed and dilated, asystole, CPR was being done on pt by EMS; CPR done for 20mins; pt in asystole; pronounced dead in the ED" "1795506-1" "1795506-1" "10/16 patient falls from sob and low 02 level. Patient sent to ER and passed away 10/17/21." "1795535-1" "1795535-1" "Pt admitted to Hospital with COVID symptoms. She was placed on the medical covid floor requiring supplemental oxygen. She did receive IV steroids. Remdesivir contraindicated d/t poor renal function. Pt did continue to decline with increasing oxygen requirements. She was eventually transferred to ICU for close monitoring, precedex infusion and BIPAP. Pt did began to tire and did require incubation, Pt continue to Decline. She required vaspressor support and throughout the night required maximum doses of three different medications. Family arrived to discuss goal of care. They did decide to transition to comfort measures. Pt passed with family at bedside TOD 1427 on 10/17/2021" "1795543-1" "1795543-1" "Following her COVID vaccination patient developed GI symptoms and was diagnosed with CMV colitis. Patient failed outpatient therapy and was admitted to hospital on 5/21/2021. Upon admission, she was found to have a vulvar lesion that was biopsied and proven to be CMV positive. Despite maximal medical therapy, patient developed CMV viremia. She was admitted to ICU on 7/23/2021 for sepsis, requiring pressors. She subsequently had episodes of altered mental status and possible seizure, and had a negative head CT and equivocal EEG results. Patient then developed respiratory failure. Family at this time deemed patient DNR/DNI and then patient expired on 7/26/2021." "1795737-1" "1795737-1" "Became unable to walk or maintain activities of daily living within 3 days of vaccination, followed by death within 10 days of vaccination." "1796350-1" "1796350-1" "Eye bulging out of socket Swelling on right side of face Next day DEATH 08/19/2021" "1797314-1" "1797314-1" "Death Cause-Loss of Oxygen; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported) via an unspecified route of administration on 08Oct2021 (at the age of 74 years old) as dose 3 (booster), single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient previously received the first dose and second dose of BNT162B2 (lot numbers were not reported), via an unspecified route of administration on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunisation. The patient did not receive any other vaccines in 4 weeks and it was unknown if the patient had other medications was received in 2 weeks. The patient experienced loss of oxygen as death cause on 11Oct2021. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Event resulted in life threatening illness (immediate risk of death from the event). The patient died on 11Oct2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death Cause-Loss of Oxygen" "1797685-1" "1797685-1" "Moderna on 1/12 and 2/8. Positive on 10/9" "1797778-1" "1797778-1" "This is a 76 year old male, with recently diagnosed cancer (?? gastric), whom we are consulted on for sepsis. He is receiving outpatient Chemotherapy & XRT. Recently diagnosed LLE DVT, for which he was begun on Eliquis as an outpatient by Oncology. He presented to the ER yesterday with worsening LLE edema, along with rib cage pain. He is s/p a prior R AKA. Afebrile. BP was 80's/50's @ 9 am -- > 101/61 at noon. O2 sats 92% on room air. WBC 7.8K. GFR 69. Lactate POC 3.5. Blood cx from 9/14 NGTD. COVID-19 PCR pending. CT chest PE today: no PE, but showed bilateral patchy opacities with pulmonary nodules, suspicious for metastases. LLE venous doppler showed an occlusive LLE DVT. This is a 76 year old male, with recently diagnosed cancer (?? gastric), whom we are consulted on for sepsis. He is receiving outpatient Chemotherapy & XRT. Recently diagnosed LLE DVT, for which he was begun on Eliquis as an outpatient by Oncology. He presented to the ER yesterday with worsening LLE edema, along with rib cage pain. He is s/p a prior R AKA." "1797830-1" "1797830-1" "pt presented to ED one day after being seen at urgent care with a positive COVID test; SOB x1 wk with non-productive cough; HX of Cancer, diabetes - IDDM, HTN; diagnosed with acute respiratory distress, COVID pneumonia, chronic renal failure; pt's condition deteriorated and she died at the hospital" "1797848-1" "1797848-1" "pt presented to ER with positive COVID status from earlier yesterday; EMS called to home due to SOB and pt unresponsive; 02 saturation in 50s, placed on CPAP; SOB continued, pt intubated; kept on ventilator, pt required dialysis during this time; became hypotensive in spite of pressors being used, pt's condition declined and she died in the hospital" "1797897-1" "1797897-1" "pt presented to ED after EMS was called for pt experiencing SOB, low O2 saturation, placed on CPAP; hx of CHF, anasarca to lower limbs; acute respiratory failure, positive COVID test, hypoxic hypercapnic respiratory failure; placed on BIPAP in ED; pt was a DNR; pt's condition worsened and she died in the hospital" "1797898-1" "1797898-1" "death Atrial fibrillation; Acute kidney failure, unspecified; Dehydration; Low back pain; CVA (cerebral vascular accident); History of bladder cancer; Elevated serum creatinine; History of urethral stricture; History of cancer metastatic to bone; Urothelial carcinoma of bladder" "1797919-1" "1797919-1" "Patient death." "1797927-1" "1797927-1" "Patient lived in a nursing home. The following was reported to our on-call MD. Nurse from home called to report Pt is lethargic. BP this morning 139/57, HR60. BP now 86/42. O2 sats RA 85-86%; O2 @ 1.5L applied and sats went up to 95%, temp 99.4. Pt had covid booster on 10/12/2021. At around 1:40pm, nurse found him very lethargy, can't lift his arms but responding and able to talk. He was hypotensive and hypoxia with low grade fever. He is DNR/DNI/DNH. Ambulance was called, while trying to get hold of HCP. At ~2:25pm, Patient passed away." "1797944-1" "1797944-1" "pt tested positive for COVID on 9/1; presented to ED with chills and SOB, placed on BIPAP, had several episodes of ventricular tachycardia; appeared to be stable on BIPAP but had several episodes of ventricular tachycardia which led to ventricular fibrillation; pt became hypotensive; 30mins of ACLS, epinephrine drip, and intubation didn't establish circulation, pt died in the hospital" "1797961-1" "1797961-1" "death K92.2 - GI bleed I95.1 - Orthostasis K92.2 - Gastrointestinal hemorrhage, unspecified" "1797962-1" "1797962-1" "pt presented to Ed with worsening cough, fever and SOB, sx X 4 days; hypoxic, placed on a non-rebreather; mucoid sputum, tested positive for COVID; pt declined intubation; acute respiratory failure with hypoxia; pt's condition declined and he died in the hospital" "1797983-1" "1797983-1" "pt hospitalized with positive COVID test 9/4 - 9/7, received steroid txmt and remdesivir, dc'd to home with O2; returned to hospital (by home health) with low O2 saturation; diagnosed with COVID pneumonia, acute on chronic respiratory failure with hypoxia; pt's condition worsened, placed on comfort measures, pt died in the hospital" "1797997-1" "1797997-1" "Within 2 weeks of initial vaccine dose the patient developed new-onset acute neurologic symptoms resulting in a diagnosis of cerebral thrombosis with ICH and vasogenic edema. He underwent several outpatient, ER and inpatient evaluations (in the system, except for final hospitalization at Hospital); he continued to clinically deterioriate and died on August 8, 2021." "1798150-1" "1798150-1" "10/17/21 BROUGHT TO ER BY FAMILY DUE TO WORSENING SOB, , GENEREALIZED PAN. FOUDN TO HAVE COVID 19 PNEUMONIA PLACED ON BIPAP. WAS ADMITTED TO HOSPITAL AND WAS TRANSITIONED TO COMFORT CARE AD FAMILY REQUEST. PATIENT DIED 10/18/21." "1798168-1" "1798168-1" "Death" "1798190-1" "1798190-1" "pt diagnosed COVID positive in ED on 8/21, cough and no taste, dc'd to home; next day received monoclonal antibodies; on 8/24 pt was confused and had more SOB, O2 saturations low, placed on O2 via nasal cannula; started on full treatment for COVID; pt's condition worsened where he died in the hospital; acute respiratory failure, COVID pneumonia, metabolic encephalopathy" "1798201-1" "1798201-1" "PATIENT EXPIRED ON 10/19/2021." "1798213-1" "1798213-1" "7/26 positive for COVID, placed on Azithromycin and Prednisone; hx of IDDM, chronic lymphocytic leukemia, asthma; presented to ED on 8/4 with weakness, N/V/D, diaphoretic, fever; COVID pneumonia; placed on BIPAP, required reintubation; pt's condition worsened; pt's wishes to not be on life support for long; pt was extubated and passed away in the hospital" "1798224-1" "1798224-1" "Patient seen in the emergency department for shortness of breath beginning that morning. Patient had COVID-19 PCR test and was found to be positive. Patient did not meet criteria for admission and received monoclonal antibodies prior to discharge. Patient died on 10/16/21 which is the same day she was discharged home." "1798229-1" "1798229-1" "PATIENT EXPIRED ON 10/19/2021" "1798258-1" "1798258-1" "pt presented to ED via EMS with dyspnea and low O2 saturation, placed on non-rebreather; positive for COVID; hx of stage III CKD, DMT2, Alzheimers; condition worsened, placed on BiPAP; condition continued to deteriorate, pt died in the hospital" "1798345-1" "1798345-1" "Received both Moderna vaccines at the medical facility (01/16/2021 and 02/12/2021). Fully vaccinated covid death." "1798396-1" "1798396-1" "fully vaccinated, covid related death" "1798477-1" "1798477-1" "Death Less than Two weeks after vaccine Pfizer booster. Autopsy report stated cardiomyopathy with CHF . Died suddenly was previously healthy." "1799489-1" "1799489-1" "She showed signs of shortness of breath and fatigue/ confusion less than 2 weeks after her first dose Was hospitalized and it was determined that she had an infection that was septic She had cardiovascular damage (blood pressure issues) Fluid build up in her body Nausea Joint and muscle pain Fatigue Injection potentially entered her bloodstream or blood vessel as she received it during her chemotherapy session" "1800582-1" "1800582-1" "Presented to hospital on 9/28 with worsening shortness of breath. Diagnosed with COVID-19 pneumonia. Received dexamethasone and remdesivir with Vapotherm support. Saturations continued to decrease and was intubated. Also received PICC line and vascular catheter for renal replacement therapy. Developed candid fungemia and given antifungal therapy. Develope renal failure requiring CRRT. Had cardiac arrest on 10/16 with 3 rounds of CPR and received calcium and epinephrine with continued asystole. After discussion with patient sister the code was called." "1800750-1" "1800750-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/1/2021 and 2/23/2021. Daughter in law tested positive for COVID and was with patient on 9/19/2021. Patient reported to have had persistent dry cough and vomited on 9/23/2021. Patient prescribed medrol dosepack and doxycycline. On 10/10/2021 patient was brought to ED with decreased level of consciousness. In the ED her GCS was 7/15. She was intubated for airway protection. She became hypotensive after intubation requiring norepinephrine drip briefly. Her UA was abnormal and started on cefepime. Patient diagnosed with sepsis, and acute kidney injury. Patient expired on 10/17/2021." "1800765-1" "1800765-1" "Admitted on 9/26 with c/o generalized weakness. Covid + 2 weeks prior and also on admission. Noted hypernatremia without respiratory distress. Treated with hypertonic saline and followed by nephrology. Progressive respiratory distress and admitted to ICU on 10/3. Treated with remdesevir, dexamethasone and baricitinib. Noted bilateral pulmonary embolism treated with enoxaparin. Required intubation on ventilator. Developed unexplained profound episodes of hypotension requiring vasoactive medications. Suffered a PEA arrest during hypotensive episode. 2 rounds of CPR before ROSC achieved. on 10/18 noted atrial fib with rapid ventricular rate. Started on amiodarone and IV magnesium. Vasopressor infusions increased with no help and became pulseless. CPR unsuccessful." "1800781-1" "1800781-1" "patient admitted with COVID on 28 Sept. Was in ICU shortly after admission, consult obtained due to high oxygen requirement. On NiPPV initially. Transferred on 1 Oct on NiPPV 15/10 FiO2 80%- transitioned to high flow" "1800859-1" "1800859-1" "Patient fully vacinated. Admitted to hopital on 09/02/2021. Expired on 09/16/2021" "1800987-1" "1800987-1" "This patient was initially seen in Emergency Department in October with a complaint of shortness of breath, cough malaise fatigue and rhinorrhea. Patient's husband did test positive for COVID-19, this patient did as well test positive during emergency department evaluation. This patient did receive COVID-19 vaccination Jansen single dose. Patient was admitted to the hospital service started on dexamethasone 10 mg q. 12 hours and 5 day course of Remdesivir. Patient also started on therapeutic Lovenox and IV antibiotic directed at acute acquired pneumonia ceftriaxone and azithromycin. 7 October pulmonary was consulted, with recommendations to continue the course of dexamethasone and Remdesivir. 10 October Pt transferred to the ICU started on noninvasive ventilation. 13 October respiratory failure with pending respiratory arrest patient was intubated placed on full mechanical ventilation. Pt then underwent proning protocol with some benefit early on. However, patient continued to be hypoxic while supine. Prone protocol was DC due to skin breakdown with persistent hypoxia as supine. Patient later developed septic shock placed on broad-spectrum antibiotics. Patient requiring pressor support to maintain map pressure above 60. Discussing patient's care with daughter, given its poor diagnosis, decision was to make patient DNR and to redirect care to comfort." "1801095-1" "1801095-1" "pt presented in acute respiratory failure with hypoxia, tested positive for COVID; respiratory status worsened and pt intubated with mechanical ventilation; condition continued to decline; pt was extubated and died in the hospital" "1801178-1" "1801178-1" "PT DECEASED ON 10/06/2021-HAD VACCINE ON 3/10/21. PT DIAGNOSED WITH BILATERAL COVID PNEUMONIA-WAS DEPENDENT ON BIPAP. WAS MADE DNR, AND COMFORT MEASURES" "1801206-1" "1801206-1" "PT DEVELOPED COVID PNEUMONIA WITH RESPIRATORY FAILURE" "1801359-1" "1801359-1" "Patient breakthrough infection and deceased." "1801362-1" "1801362-1" "Vaccine dose 1 3/3/2021 Lot # EN6198 Pt died from anoxic brain injury 10/19/2021" "1801379-1" "1801379-1" "pt admitted to hospital on 8/13/21 with COVID pneumonia, started on Azithromycin & Rocephin, O2 need increased due to low O2 saturations, placed on non-rebreather; transferred Medical Center on 8/19/21 where Rocephin was changed to Cefepime, started on Dexamethasone & remdesivir, on 100% non-rebreather; went into renal failure; condition deteriorated and pt died in the hospital" "1801398-1" "1801398-1" "Patient died 10/07/2021 at SNF after testing positive for COVID19 10/06/2021. Family elected for comfort measures after COVId19 diagnosis due to other ongoing medical issues." "1801421-1" "1801421-1" "Patient had breakthrough infection and expired." "1801461-1" "1801461-1" "pt brought to hospital via EMS due to generalized weakness that has increased over past 3 days; fell this morning at home due to weakness; fever; placed on O2 via NC; positive for COVID; O2 requirements increased; pt taken for a CT Scan and while in the room pt coded; CPR unsuccessful; pt died in the hospital" "1801521-1" "1801521-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/28/2021 and 2/23/2021. He began to feel unwell on 9/12 and tested COVID+ on 9/14. He began to have progressive dyspnea and fevers at home up to 103 F so he presented on 9/19 to ED. SpO2 was in 70s on RA, failed NRB, and was placed on HFNC. CTA chest negative for PE but notable for extensive GGO and alveolar infiltrates. He was also found to have an AKI and elevated LFTs. He was admitted to HCF due to HCF requirements. He was started on Decadron. Dr was consulted who recommended Remdesivir and okay with continuation of his cellcept. He was determined not to be a candidate for Toci or Baricit a. He was started on empiric abx. Unfortunately, he decompensated requiring intubation. Despite supportive measures, he slowly clinically declined with multisystem organ failure including ARF requiring dialysis. He was compassionately extubated and passed at 1225 10/1/21." "1801522-1" "1801522-1" "Patient was a Hospice patient with no change in symptoms" "1801554-1" "1801554-1" "admitted to hospital with acute encephalopathy, COVID positive; placed on a nonrebreather; pt was a DNR/DNI; condition declined with AKI; comfort care received; pt worsened and died in the hospital" "1801581-1" "1801581-1" "pt presented with SOB and hypoxia despite being on 3L O2 via NC; placed on nonrebreather; oxygen requirement increased; hypotension occurred; O2 sats dropped; pt was a DNR/DNI; condition declined and she died in the hospital" "1801585-1" "1801585-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/9/2021 and 4/6/2021. Presented to ED on 9/20/2021 after being found down in barn where he was working. The fall was not witnessed, and family does not believe he hit his head as only abrasions noted are on elbows. Patient found to be COVID positive and treatment with Dexamethasone, remdesivir, and baricitinib, HFNC oxygen started. Patient developed confusion and agitation on 9/25/2021. Patient began to experience SOB on 10/1/2021, and enterococcus bacteremia noted. On 10/5/2021 patient developed tachycardia and worsening hypoxia. Patient condition continued to deteriorate and family decided comfort measures on 10/11/2021. Patient expired on 10/15/2021." "1801596-1" "1801596-1" "Patient died within 72 hours of second dose. Extensive medical history including HTN, ESRD on dialysis and DM. Autopsy revealed cause of death to be Hypertensive and atherosclerotic cardiovascular disease with DM in part two. Vaccine didn't contribute to death." "1801611-1" "1801611-1" "Patient had a breakthrough infection and expired while infected with virus." "1801645-1" "1801645-1" "Patient had breakthrough infection and expired while infected" "1801664-1" "1801664-1" "Patient had breakthrough infection and expired." "1801679-1" "1801679-1" "Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 3/16/2021. Patient presented to ED on 9/25/2021 and found to have pneumonia secondary to COVID-19. He began to develop symptoms around 9/14/21 and was diagnosed on 9/15/21. He was started on ceftriaxone, azithromycin, dexamethasone and baricitinib. He also was managed with LABA and SABA. Despite this, he continued to deteriorate and required increasing oxygen support and was brought to the ICU on 10/5/21 in respiratory distress and he was intubated. Post intubation CXR revealed a large right sided pneumothorax which was managed with chest tube. He required additional pressor support due to deep sedation. Patient developed AKI on 10/7/21 and started on CRRT. On 10/9/21 the patient experienced acute desaturation and epoprostenol was started. Patient continued to deteriorate and expired on 10/15/2021." "1801702-1" "1801702-1" "seen in ED on 9/5 and dx with COVID; c/o cough, dyspnea, confusion, N/V, chest pain; admitted to hosp with COVID pneumonia; pt's condition deteriorated; O2 needs increased despite O2 being given; pt's condition worsened and she died in the hospital" "1801805-1" "1801805-1" "101 Y male with history of hypothyroidism presenting with altered mental status, severe hypotension, hypernatremia, hypothermia, lactic acidosis and positive COVID test. Patient's history of cough, diarrhea and known exposure (daughter) most consistent with COVID pneumonia. Patient met criteria for septic shock due to pulmonary source. CT Chest/abdomen/pelvis with evidence of widespread metastases to lungs, liver and spleen. Patient required 3 pressors, and after discussion with son and daughter 10/13, patient transitioned to comfort care. Patient expired on 10/14/21. Complications: none Diagnoses: Active Hospital Problems Diagnosis ? (Principal) COMFORT CARE ONLY ? CORONAVIRUS COVID-19 PNEUMONIA ? SEPTIC SHOCK" "1801813-1" "1801813-1" "March 13, 2021. 27 hours after receiving the second dose of the Moderna vaccine we had to take my Mother to the hospital because she couldn't breathe. They put her on oxygen for a bit and then switched her to a cpap as the oxygen wasn't doing anything. . Her lungs were full of fluid. They suspected a heart event and did all of the tests to look for a cardiac abnormality and found nothing. Also, she had a defibrillator which showed no abnormalities. They found no reason for the fluid in her lungs and basically did nothing for her except make sure she was stable and breathing normally before they discharged her. The completely ignored the fact that she had the Covid vaccine the day before, in fact. they didn't record the information in her admit file. I have given you the name of her Internist, but he didn't care for her when she was in the hospital and didn't have that much information about what was going on. She had a Hospitalist assigned to her. The people who know the whole story are myself and my brother. She was discharged on March 18th. She had spent about 1 and a half days in ICU, then spent the rest of the time in a regular room until discharge. They took her off of oxygen when her levels seemed fine, they didn't do anything for her other than that. She continued to feel bad for the next two months. She had stomach pain, no appetite, a head ache, was weak, and generally didn't feel well. She didn't complain of having any issues with her breathing. On May 24th we took her back to the hospital because she was having issues breathing again. She passed away on May 29th. During her stay this time, she never recovered her ability to breath well, she was on oxygen, was extremely tired, had a headache and was just exhausted. On May 29th she passed peacefully while trying to eat her lunch." "1802198-1" "1802198-1" "Death occurred within 24 hours of COVID-19 booster vaccine" "1802763-1" "1802763-1" "The patient had tumors growing in her mouth which was diagnosed as squamous cell cancer in May 2021. Patient had surgery May 17, 2021, they removed the tumor, took a graph from her leg and bone from the leg to reconstruct the jaw. By July 6, 2021, the tumor had grown back and was the size of an almond. Patient had chemo on 8/30/2021, became septic and was back in the hospital. Patient went home one week later, by this time the doctors said she was no longer a candidate for surgery and she had 2 tumors that broke out of the skin on her left side of her face. The tumors were 7 inches by 4 inches by 2.5 inches" "1803857-1" "1803857-1" "Hospitalization 10/14-10/17 for COVID pneumonia, respiratory failure. Treated with dexamethasone 6 mg IV daily, Actemra 800 mg x1 . Expired 10/17/21" "1804024-1" "1804024-1" "Gastric Hemorrhage. Asphyxiation of hemorrhage ultimately resulting in death." "1804051-1" "1804051-1" "death Acute renal failure, unspecified acute renal failure type (CMS/HCC)" "1804053-1" "1804053-1" "Patient passed away three days after receiving his third Pfizer COVID vaccine." "1804067-1" "1804067-1" "death sepsis UTI J18.9 - Pneumonia D69.6 - Thrombocytopenia (CMS/HCC)" "1804068-1" "1804068-1" "death R65.10 - SIRS (systemic inflammatory response syndrome) N17.9 - AKI (acute kidney injury)" "1804117-1" "1804117-1" "Sudden Death" "1804144-1" "1804144-1" "EXPIRED; Hospitalized (10.11.21); COVID-19 positive (10.11.21); fully vaccinated Admission Date: 10/11/2021 Date of Death: 10/16/21 Time of Death: 3:41 AM Preliminary Cause of Death: Acute on chronic systolic CHF (congestive heart failure) PRESENTING PROBLEM: Congestive heart failure with left ventricular dysfunction HOSPITAL COURSE: The patient expired on comfort care. For exact date and time of death please refer to nursing staff documentation. a 92 y.o. male who presented with SOB. in the ER and admitted to the hospital for further management of his medical problems noted below The patient has a PMHx significant for CKD stage lV, systolic CHF and hypothyroidism. Below is a list of his medical problems addressed during this hospitalization. Acute CHF exacerbation AKI with CKD stage lV COVID-19 Dysphagia DM ll, diet controlled BPH Hypothyroidism HPI (10.11.21): HISTORY OF PRESENT ILLNESS a 92 y.o. male who presents today with SOB. The patient has a PMHx significant for CKD stage lV, systolic CHF and hypothyroidism. The patient developed SOB and peripheral edema about two week ago. He has been being followed by his outpatient cardiology office who added metolazone to his regimen. Despite this adjustment he continues to have SOB and productive cough. Associated peripheral edema. His kidney function and BNP have also been worsening so the patient was instructed to go to the ED to be hospitalized so his kidney function could be monitored while trying diuresis. The patient notes he is vaccinated for COVID-19 and has no known contacts. Denies fevers, chills, and N/V/D. Upon arrival to the ED Na 140. K 3.4. Cr 3.93. BNP 30,280. HsTnT 208>>197. WBC 6.22. Hgb 10.7. CXR shows improvement of mild CHF. The patient was given IV lasix in the ED. The patient has remained hemodynamically stable. The patient is being admitted to SHMG for further management and evaluation" "1804145-1" "1804145-1" "Developed pneumonia; Symptoms included-fatigue, cough, wheezing, SOB, & leg/calf swelling. Had symptoms for 3 weeks prior to death. Cause of death listed on hospital records as COVID pneumonitis, with contributing factors of CAD, tobacco abuse, HFrER, CKD, and HTN." "1804217-1" "1804217-1" "increase weakness, low oxygen saturation at 85% RA, fever, cough and congestion" "1804252-1" "1804252-1" "Pfizer BioNTech COVID-19 Vaccine: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/6/2021 and 1/27/2021. Patient presented to ED on 9/29/2021 with complaints of diarrhea, fever, chills and diagnosed with COVID-19. CT abd/pelvis showed mild diverticulitis- levaquin/flagyl ordered. Meduri protocol ordered but no bari or toci due to active infection (diverticulitis). Placed on Airvo for hypoxia initially and later on had worsening hypoxia and work of breathing. Admitted to ICU required intubation, line placement, paralysis. Was started on Meduri protocol of steroids. Started flagyl and cefepime for sigmoid diverticulitis and bacteroides bacteremia. Had worsening AKI and Additional information for Item 18: and also had Afib with RVR. Her clinical status continued to deteriorate and patient expired on 10/16/2021." "1804254-1" "1804254-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/29/2021 and 2/24/2021. Presented to ED on 10/6/2021 complaining of shortness of breath x3 days, diffuse body aches, chills, nausea, vomiting, and abdominal pain. On presentation satting 94% on room air. Patient started on dexamethasone. Patient's respiratory sats decompensated on 10/9/21, requiring intubation. Patient continued to decline and expired on 10/16/2021." "1804256-1" "1804256-1" "Death" "1804274-1" "1804274-1" "Patient developed PEA arrest from massive PE 6/19/21. Patient died 6/21/21" "1804276-1" "1804276-1" "Had breakthrough infection and passed away." "1804284-1" "1804284-1" "Patient contracted COVID 19 and subsequently passed away." "1804286-1" "1804286-1" "Had breakthrough infection and passed away." "1804303-1" "1804303-1" "They had a breakthrough infection and passed away." "1804354-1" "1804354-1" "Died in her sleep 3 weeks after second vaccine..heart attack" "1804363-1" "1804363-1" "Patient contracted COVID 19 and subsequently passed away." "1804382-1" "1804382-1" "pt brought to hospital via EMS post cardiopulmonary arrest; CPR and intubation performed; acute respiratory failure with hypoxia, COVID pneumonia; pt's condition worsened; pt was made a DNR and expired in the hospital" "1804391-1" "1804391-1" "10/20/21 1610 patient comes into ED complaining for the past several days has had increasing shortness of breath mild cough back pain. She has had lightheaded episodes. Increasing leg pain after which she describes as possible fall. No head injury. No nausea no vomiting. No cough no hemoptysis. On arrival in the ED her room air pulse ox was between 85 and 88%. Pulse rate was 120s. Respiratory rate was in the 30 range. Lungs were clear soft nontender right extremity has some tenderness in the calf and medial thigh. Mild edema neuro intact. Patient states she had her second Pfizer vaccine on Wednesday. Symptoms started on Monday of gotten worse. Admitted for bilateral PE and right leg DVT. 10/21/21 AM taken to cath lab for pulmonary angiogram with measurement of central venous pressures, mechanical thrombectomy. Cardiac arrest at 0630 10/21/21 in cath lab during procedure. CPR performed for 45 minutes and while being transported to OR for emergent CABG. 10/21/21 1000 patient arrived to ICU with chest still cracked open and physician providing cardiac massage. Time of death called at 1005 10/21/21." "1804413-1" "1804413-1" "pt admitted to hospital one day after discharge from local Medical Center with COVID pneumonia; taking oral antibiotics; labored breathing, agitation/delirium; admitted with O2 via NC; hx of AKI, DMT2, CAD, dementia; beyond the window for remdesivir; palliative care initiated; pt's condition worsened and he expired in the hospital" "1804445-1" "1804445-1" "per pt he was diagnosed COVID positive 3 wks prior to coming to the hospital; saw PCP and was sent to ED for dyspnea and cough not improving ;diagnosed with acute on chronic hypoxic respiratory failure due to pneumonia; hx of COPD; required BiPAP; DNR/DNI; pt's condition worsened and he died in the hospital" "1804476-1" "1804476-1" "pt diagnosed COVID positive on 8/23; hx of MS; admitted to hospital 8/26 for increasing dyspnea, cough, weakness; diagnosed with COVID pneumonia, acute hypoxic respiratory failure; developed pneumothorax; chest tube placed; on BiPAP mask, DNR/DNI; condition worsened and pt died in the hospital" "1804506-1" "1804506-1" "pt to ER via EMS with SOB; diagnosed with AHRF with COVID pneumonia; placed on nonrebreather mask; comfort measures and meds requested as pt's condition worsened; pt expired in the hospital" "1804507-1" "1804507-1" "Patient contracted COVID 19 and subsequently passed away." "1804518-1" "1804518-1" "Prolonged hospitalization with eventual patient death. Acute respiratory failure with hypoxia secondary to COVID pneumonia. BiPAP, hasd previous hospitalization requiring ICU placemtn on Vapotherm and BiPAP, discharged home then hospitalized again with acute hypoxi respiratory failure, IV antibiotic therapy, IV solumendrol, SVT" "1804530-1" "1804530-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/8/2021 and 2/5/2021. On 10/9/2021 presented to ED with complaints of dyspnea, back pain, chest pain and nausea. Patient was noted to require high O2 requirements and ultimately required intubation. Echo with findings of acute drop in EF compounded with significant elevation in biomarker's. Patient given DAPT + Heparin infusion for maximal medical management. Pt pancultured and negative but developed worsening cardiogenic shock. Patient maxed out on vasopressors and later developed worsening leukocytosis and fever. Abx broadened but further progressed into multiple organ failure. Family elected to transition to full comfort measures. Patient passed away on 10/15/2021." "1804539-1" "1804539-1" "COVID-19 death of fully immunized individual" "1804541-1" "1804541-1" "Pt had a GI bleed and increasing respiratory symptoms. Pt tested positive for COVID. Pt ultimately passed." "1804559-1" "1804559-1" "On 9/10/21 this individual died. Beginning on 9/2/21 he began complaining of not feeling well and he informed a friend that he had a positive COVID-19 test. The whereabouts of this test and actual results have not been verified. Shortly prior to his death he informed his friend that his throat and chest felt tight. An autopsy performed at the Medical Examiner's Office on 9/10/21 revealed an infection of his larynx; his lungs shows some focal fibrinous deposits with mononuclear cell infiltrations but not classic hyaline membranes. A postmortem COVID-19 test was not performed; however, paraffin blocks have been submitted to the CDC with the assistance of the DOH Laboratory for COVID-19 testing. The CDC recommended this case be reported to VAERS." "1804572-1" "1804572-1" "78M w progressive met. gastric ca. w. peritoneal carcinomatosis (s/p J-Tube for TF 3/20) on hospice, CKD (s/p kidney tx 2017, on Tac/Pred), initially p/w SBO, ccb worsening ascites (para x2, 9/13, 9/15), COVID, GPC bacteremia/?SBP, transferred for HRF likely 2/2 PNA Patient with new dry cough overnight 9/12-9/13. Vitals stable on room air. COVID +. CT 15. ID consulted. S/p casirivimab/imdevimab on 9/13. Patient started on Remdesevir on 9/13 (completed 5 day course on 9/17). Given new hypoxia necessitating 2L NC, patient started on Decadron on 9/14 with plan for 10 day course. PMHx: DMII and HTN78 y.o.male with metastatic gastric cancer originally admitted with SBO and then prolonged hospitalization complicated respiratory failure, bacteremia, COVID 19 (treated with remsdesivir/decadron), and ESRD. Given multiple co morbidities, metastatic disease, and frailty, family decided to transition to CMO." "1804597-1" "1804597-1" "pt in ED with c/o cough and dyspnea; hx of hypoxia and uses supplemental O2 at home prn; O2 sats in the 70s; placed on BiPAP; diagnosed with COVID pneumonia, acute and chronic HRF; pt's condition declined; placed on comfort care measures; pt expired in the hospital" "1804620-1" "1804620-1" "death U07.1, J12.82 - Pneumonia due to COVID-19 virus J96.01 - Acute respiratory failure with hypoxia" "1804633-1" "1804633-1" "Was not feeling well one month after vaccine. Had chest pains beginning in July of 2021. Did not go to doctor. Died suddenly on July 11th . It will be 6-9 months for autopsy results. Appeared to be sudden heart attack." "1804638-1" "1804638-1" "pt sent to ED by PCP due to low Calcium & multiple electrolyte abnormalities; during hospital stay he complained of body aches and weakness; tested positive for COVID; began running fever; renal function declined; pt's condition worsened; DNR; comfort measures instituted; pt passed away in the hospital" "1804641-1" "1804641-1" "Had breakthrough infection and passed away." "1804644-1" "1804644-1" "Hospital Course: 27 yo M with Bardet-Biedel syndrome manifesting with transitional AV canal defect s/p repair (followed by Hospital), blindness, developmental delay, multicystic dysplastic kidneys s/p DDKT 11/2/11 and living kidney transplant 1996 on azathioprine and prednisone c/b EBV negative CD20 negative PTLD (dx 10/2016 s/p rituximab in remission), hx of BK and CMV viremia, ?COPD on CPAP, CVID on IVIG every 3 weeks, ON of L hip s/p THR 2019, and DM presenting from OSH with COVID ARDS. Patient lives in group home where several patients had COVID. Of note he is s/p 3 doses of Moderna. On 9/18/21, he was brought to the ER for SOB, headaches, myalgias and chills. He was found to be febrile, hypoxic and COVID positive. He was admitted for COVID pneumonia and developed progressively worsening respiratory status and was ultimately intubated 9/22. He was transferred 9/23 to Hospital (could not be transferred to location due to bed availability). While at Hospital, he continued to have poor respiratory status despite max ventilator settings. He had a rapid response for subcutaneous emphysema, no acute surgical intervention was pursued. He was paralyzed and pronated to improve oxygenation. He also developed a lactic acidosis felt to be 2/2 hypoperfusion from hypotension and underlying sepsis. Per report 1/2 BCx with GPCs, not started on vanc due to hx of red man syndrome. S/p toci x1 9/23, 2 doses of dex 6mg (9/23 - ), 1 dose of remdesivir 100 mg 9/23. He was felt to be needed to transfer to a center with ECMO capabilities, thus was transferred to Hospital. On arrival to the ICU, patient was intubated, sedated and paralyzed. He was satting initially on 78% with improvement subsequently to the 80s. He was subsequently proned. HOSPITAL COURSE 9/24 - 9/27 #COVID ARDS The patient had severe COVID-19 infection and significant risk factors including immunosuppression for kidney transplant and CVID. Presented with hypoxemic respiratory failure, bilateral opacities on CXR with clear injury source and P:F ratio most recently of 56 c/f severe ARDS. Has been getting appropriate PCP ppx but potentially also has other overlying superinfection given immunosuppression, though he has no fever, leukocytosis. He arrived intubated. He was paralyzed, proning, and supported with lung protective ventilation. He was given diuretics, antibiotics and steroids. Evaluated for ECMO but determined not to be a candidate given his baseline lung disease. Infectious disease specialists were consulted and agreed with the management. #Bardet-Biedel syndrome Patient with Bardet-Biedel syndrome with cardiac involvement manifesting as transitional AV canal defect with a primum atrial septal defect and cleft mitral valve as well as an LSVC to the coronary sinus. He underwent surgery in 1994 for repair but was found to have residual subaortic stenosis and required a second surgery in 2007 to reassess subaortic membrane and accessory mitral valve attachment. Follows with Doctor from Hospital." "1804653-1" "1804653-1" "Patient is a 66 year-old obese Caucasian male patient, with known medical history as stated below, presenting to the emergency department via air transport as a transfer for evaluation and treatment for progressive symptomatic COVID-19 disease. He was noted to be hypoxic at 86% on RA at the OSH with easy recovery with application of O2 BNC. His primary concern is that of a substantial and irritating cough. Constitutional: Positive for chills and fatigue. Respiratory: Positive for cough and shortness of breath. Negative for chest tightness. Over the course of his admission, he had worsening respiratory status requiring higher levels of O2 in order to maintain goal saturations. He was admitted to the ICU on 9/12/21 because of his worsening respiratory status which required intubation. After he was intubated, he continued to decline and required pressors to maintain his saturations. Family was called at this time to discuss goals of care and asked to come in given his worsening status. He was on maximum vent settings with persistent hypoxia and was unable to maintain MAP goal despite being on 3 pressors. He was made a DNR at this time and after family arrived, it was decided to pursue comfort care only and extubate. Patient deceased" "1804656-1" "1804656-1" "death J96.01 - Acute respiratory failure with hypoxia I26.99 - Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type" "1804666-1" "1804666-1" "death Hyponatremia Carcinoma brain mass" "1804672-1" "1804672-1" "death E87.1 - Hypo-osmolality and hyponatremia" "1804673-1" "1804673-1" "Hospital Course: =========== Admission HPI =========== Patient first presented to the Hospital 8/25 for low blood pressures and lightheadedness for several days. He had exposure to non-vaccinated friends visiting the week prior and reports he and his wife developed a cough afterwards. Of note he received the COVID vaccine x2 in Feb/March. In the ED, he tested positive for COVID 8/25, CXR at the time with patchy R sided infiltrate. He was admitted to medicine floor. COVID treatment initially deferred as he was doing well without asx, initiated 8/26 with remdesivir and dexamethasone. Was not a tocilizumab candidate given that he was too far out. Convalescent plasma considered but not available. He was also treated for potential superimposed CAP given patchy airspace opacity on CXR in RLL with Ctx and azithro (8/26 - 8/29). Patient also had asx pyuria, felt to be adequately covered by CTX. Patient then began to have desats with increasing O2 requirement, eventually requiring ICU transfer 8/29 for HFNC. Patient endorsing pleuritic chest pain thus treated empirically for PE with heparin gtt, unable to transfer safely to CT-PE, though recent 8/28 CT-PE negative. LENIs negative for DVT. On 8/31 decision was made to intubate given worsening respiratory status.In the setting of intubation, patient was hypotensive with systolics down to 60s. He was started on levophed and antibiotics broadened to cefepime due to concern for shock. He was transferred to main campus. On arrival to the ICU, patient was intubated and sedated. ========================= MICU Hospital Course (8/31 - 10/6/2021) ========================= #Acute Hypoxemic Respiratory Failure 2/2 COVID-19 #ARDS Patient presented initially with hypotension and lightheadedness to Hospital, found to be COVID+ (PCR date 8/26) for which he has been initiated on a 5 day course of remdesivir and 10 day course of decadron. Then developed progressive O2 requirement, intubated for acute hypoxemic respiratory failure. Patient with bilateral opacities on CXR, clear injury within 1 week (COVID infection and ARDS). P/F ratio 135 at admission, consistent with moderate risk. He treated empirically for PNA with vanc (9/2 - 9/7) +cefepime (8/29 - 9/4) and broad infectious workup sent. Tracheal aspirate ultimately grew coag negative staff thus continued on vanc empirically and d/ced cefepime, ultimately repeat tracheal aspirate negative for growth thus vanc discontinued 9/7. For treatment of COVID, he ultimately was treated with additional 5 days of remdesivir (8/26-8/30, 9/1-9/5), complete 10 days of dexamethasone (8/26 - 9/4) and baricitinib 4mg (total 14 days). After multiple days of improved P:F ratio and tolerating pressure control then subsequently pressure support the patient was extubated on 9/13. At the time of extubation he was following commands and had positive cuff leak. However, shortly after extubation he was noted to have quite severe stridor that didn't resolve with racemic epinephrine or dexamethasone. He was ultimately re-intubated within the hour by anesthesia who noted edema/swelling of the glottic structures. Upon re-intubation he immediately tolerated SBT again and was ultimately extubated on 9/16 to high flow, which he tolerated with some subjective dyspnea. Unfortunately in the setting of likely aspiration event (rapid increase in O2 requirement, fever, HDUS) patient was re-intubated for a third time on 9/18 and treated with broad spectrum abx, paralysis, and proning with resolution of fevers and improved oxygenation. Given hx of immigration and rising covid cycle threshold (clearing virus effectively) w/ continued lung pathology ID recommended empiric treatment for strongiloides w/ ivermectin x2 doses + TB PCR which was ultimately negative. Unfortunately, despite initially improving, he continued to struggle when sedation or paralysis were weaned down producing vent dyssynchrony. Additionally, despite broad spectrum antibiosis he developed a worsening pressor requirement and third spacing resulting in broad edema with intravascular dryness. Liver and kidney function continued to deteriorate, and after long discussion with the family, the decision was made to transition to comfort care. HE was extubated on 10/6 and passed away peacefully at 2:46 PM." "1804677-1" "1804677-1" "Had breakthrough infection and deceased." "1804695-1" "1804695-1" "Had breakthrough infection and deceased." "1804706-1" "1804706-1" "Fully vaccinated patient admitted through ED for COVID pneumonia. Patient received Zosyn, systemic steroid, oxygen , and heparin anticoagulation. Patient continued to decline with ABG showing severe acidosis and kidneys not producing urine. Collaboration with family who chose comfort care over continued aggressive treatment and intubation. Patient died on 10/15/21." "1804786-1" "1804786-1" "pt admitted to hospital with SOB, fever, and hypoxic; tested positive for COVID; pt's condition worsened and required intubation; comfort measures and extubation occurred; pt expired in the hospital; diagnosed with COVID pneumonia, septic shock, septic PE;" "1804809-1" "1804809-1" "This is a breakthrough case who died, but the causality is not clear. There are unusual circumstances, in that the positive test was done post-mortem since the patient was an organ donor, thus the delay in identifying this as a breakthrough case. The patient was vaccinated on 04/02/2021. On 04/24/2021, he suffered a presumed cardiac arrest while exercising at home, and he subsequently passed away on the same day. Per policy, the organ/tissue donation facility ran a routine COVID-19 test on a sample taken on 04/25/2021 which came back PCR-positive on 04/27/2021. Per follow-up with the surviving spouse, the patient had been experiencing fatigue in the week prior to death, but no other possible COVID-19 symptoms that they were aware of. The case had also previously been COVID-19 positive in October 2020." "1804819-1" "1804819-1" "pt admitted to hospital with c/o abdominal pain; pt has dementia and failure to thrive due to inadequate home care; COVID positive; pt's condition worsened and he was placed on comfort care; pt expired in the hospital" "1804826-1" "1804826-1" "This is an instance of breakthrough disease that resulted in death. Death Certificate details are as follows: Part I Cause of Death A: Acute Respiratory Failure B: Adult Respiratory Distress Syndrome C: COVID 19 Pneumonia Part II Other Significant Conditions: Acute Kidney Failure, Sepsis, Encephalopathy, Atrial Fibrillation, Coronary Artery Disease The patient was admitted to the hospital on 09/08/2021. It is unknown if they were having symptoms, but the patient did receive diagnoses of both pneumonia and ARDS so it seems that respiratory symptoms were likely." "1805973-1" "1805973-1" "Patient died one day after receiving the Pfizer Booster at her skilled nursing home." "1806181-1" "1806181-1" "Deceased; Hospitalized (10.15.21); COVID-19 positive (10.15.21); fully vaccinated Discharge Provider: MD Primary Care Physician at Discharge: DO Admission Date: 10/15/2021 Date of Death: 10/19/21 Time of Death: 4:45 PM Preliminary Cause of Death: Acute hypoxemic respiratory failure due to COVID-19 (HCC) Discharge Disposition: Deceased DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE: The patient is an 81 year old female with HX of DM type 2, hypertension, diastolic heart failure, body dementia, and obesity who presented with complaint of worsening shortness of breath in the setting of known COVID. The patient is vaccinated and symptoms started 10-9-21. In the emergency department she was hypoxic and required oxygen via mask. She was hypokalemic. She was admitted to the hospitalist service and started on Decadron and remdesivir. Her oxygen requirements worsened and she was placed on high-flow nasal cannula. Steroids were transitioned to IV Solu-Medrol. Overnight of 10/19 pt had worsening hypoxia w/ HFNC w/ 100% FiO2 and non-rebreather. Pt was evaluated by provider overnight, pt confirmed that she was DNR/DNI. After discussion with pt and daughter over the phone decision was made to transition to comfort care. Morning of 10/19, pt appeared comfortable noted interest in hospice and consult was placed. She was started on morphine and versed drip, she was terminally weaned from HFNC. In the afternoon, was called to bedside by nursing staff. Patient resting supine in bed with eyes closed and is unresponsive to verbal and painful stimuli. No spontaneous respirations. No palpable pulses. Bilateral pupils fixed and dilated. No heart sounds auscultated over entire precordium. No breath sounds auscultated in either lung field. Patient pronounced dead at 16:45 on 10/19/2021. Next of kin, daughter, present at bedside, verbalize remaining family notified. Family has not yet decided funeral arrangements, are pursuing cremaiton per pt wishes. Pt PCP Dr notified via answering service. Dr was also notified of pt passing. TIME OF DEATH: 16:45 DATE OF DEATH: 10/19/2021" "1807590-1" "1807590-1" "Patient is a 68 y.o. female with PMHX of COPD, afib on eliquis, DM2, HTN, HLD, chronic anemia, HFpEF, OSA presented to ED on 8/5 with complaints of worsening SOA x4 days with associated fever, cough, dizziness. Constitutional: Positive for diaphoresis, fatigue and fever. HENT: Positive for congestion. Respiratory: Positive for cough, chest tightness and shortness of breath. Hospital Course: Upon admission, patient required escalating oxygen requirements and was admitted to the ICU. She was intubated on 9/8 due to worsening hypoxia. She was treated with 10 days of IV dex and an empiric course of antibiotics with 2 days of Vanc and 7 days of Cefepime. CT PE was obtained which showed no PE. Her course was complicated by mucus plugging on 9/10 requiring bronchoscopy. She was found to have aspergillus at that time and started on voriconazole for a 6week course. She was unable to be weaned from the vent and tracheostomy was performed on 9/27 by ENT. She also experienced Afib RVR during her hospitalization which required beta-blockade, diltiazem gtt, and amiodarone. On 10/1, she underwent bronchoscopy for BAL sample as concern for new VAP. That night, her O2 saturations decreased to the mid 80s sustaining. She also became hypotensive, requiring vasopressors. Patient is DNR/DNI and passed away on 10/02" "1807856-1" "1807856-1" "Resident passed away on 10/19/21 he had received the Booster dose of Pfizer on 10/13/21 the primary doses were 1/28/21 and 2/22/21. The Medical Director said to report it" "1807864-1" "1807864-1" "Resident suddenly collapsed to ground unresponsive at 14:46, CPR initiated and continued until 15:32 when paramedic pronounced death." "1807874-1" "1807874-1" "Resident found unresponsive, CPR administered by Nursing Home staff and 911, not able to resuscitate." "1807886-1" "1807886-1" "Patient started with headache, dizziness, blurred vision, nausea and vomiting which she went to an urgent care facility on 10/18. On 10/19 she presented to an outside ER for the same symptoms, had a negative head CT and was sent home with antibiotics for a suspected UTI and meclizine for suspected vertigo. On 10/20 she returned to that same ER with no improvement in symptoms, she experienced a seizure in their ER and Head CTa showed near complete thrombosis of superior sagittal sinus, with acute parasagittal frontal parenchymal and subarachnoid hemorrhage. Patient arrived at our facility." "1807889-1" "1807889-1" "Cardiac Arrest- died 24 hour after vaccination" "1807900-1" "1807900-1" "fully vaccinated, covid death" "1807911-1" "1807911-1" "presented to ED with c/o SOB, cough, fever, chills, abdominal pain; on O2 @ 4LPM @ baseline for COPD; placed on nonrebreather; tested positive for COVID; pt's condition declined; was intubated; condition continued to decline and pt expired in the hospital" "1807936-1" "1807936-1" "pt presented to ED with SOB, cough, edema in LEs, low O2 sats; hx of HTN, CHF; tested positive for COVID; O2 requirements increased during hospital stay; placed on BiPAP but pt didn't tolerate well; DNR; comfort measures instituted; pt's condition declined and she expired in the hospital" "1807967-1" "1807967-1" "Pt died of Respiratory failure- ARDS, sepsis. This was not a Covid related death" "1807978-1" "1807978-1" "Covid vaccine #1 2/5/2021 Lot # N/A Pt had cardiac arrest at home- died in the emergency room-not a covid related death" "1807988-1" "1807988-1" "pt presented with worsening SOB, cough, fever since 8/27; tested positive for COVID on 8/30; supplemental O2 started via NC and proceeded to BiPAP; diagnosed with AKI and COVID pneumonia; pt's condition worsened and he expired in the hospital" "1807989-1" "1807989-1" "Pt was admitte dto the hospital with small bowel obstruction, sepsis, died 3 days later. Not a Covid related death" "1807998-1" "1807998-1" "Covid vaccine #1 2/4/2021 Lot # 016M20A Moderna Patient was admitted to the hospital 10/8/2021 for acute respiratory failure and died 10/20/2021. This was not a Covid related death." "1808007-1" "1808007-1" "pt presented with acute respiratory failure and confusion; DKA; tested positive for COVID; experienced AFib; worsening respiratory failure; comfort measures instituted; pt's condition worsened and he passed away in the hospital" "1808014-1" "1808014-1" "at approximately 910am this writer responded to a code blue paged to room 212B. Upon arrival resident was being assisted to the floor from bed. Resident unresponsive without pulse or respirations. Color pale in appearance. 911 Activated. MD/Family were notified. CPR initiated at 912am. AED applied. 3 cycles of CPR was completed upon arrival of EMS at approximately 919am. EMS assumed care. at 934am EMS called and ordered to terminate code. NP on scene aware. Call placed to family and updated." "1808029-1" "1808029-1" "Resident Received 3rd dose of vaccine on 10/8/2021 , resident expired on 10/15/2021" "1808031-1" "1808031-1" "Death" "1808100-1" "1808100-1" ""Brief Summary/Assessment: 80M with a history of NSVT, type 2 diabetes mellitus, gout, BPH, HLD, HTN, GERD, admitted for COVID-19 pneumonia, s/p intubation on 9/11/21 now s/p remdes, dex, and Baricitinib; paralysis stopped 9/21, reparalyzed 9/22 with new consolidations c/f aspiration PNA. Hospital Course Hospital Course: Updated as of 9/24 ============== HPI ============== Patient is a 80 y.o. male with a history of NSVT, type 2 diabetes mellitus, gout, BPH, HLD, HTN, GERD, who presented as a transfer from MGH with hypoxia in the setting of COVID-19 infection. The patient states that he had attended a party/""feast,"" where he believes is the event at which he contracted COVID-19. On 8/27, he called his ambulatory practice at MGH, where he noted rhinorrhea, rhinitis, post-nasal drip, and cough. He has a history of rhinosinusitus (followed by Dr.), treated with nasal lavage and ipratropium spray TID, though he only uses it once a day or less. He had received 2 doses of Pfizer vaccination earlier this year. Given his history, vaccination status, and otherwise non-concerning symptoms, he was advised to restart the nasal lavage and ipratropium sprays. He was seen on 8/31 and noted to have a cough over the last few months and a tickle in his throat. A CXR was ordered, which showed no evidence of PNA or pulmonary edema. On 9/2, he presented to urgent care for worsening symptoms and was started on doxycycline 100mg BID for 7 days and given medication for cough. A COVID test was obtained. The patient tested positive for COVID and was found to be hypoxic to 70% on RA. EMS placed him on 10L NC with improvement to 80%. He was transferred to ICU on HFNC. CT surgery Course Course was notable for increased O2 requirement, FiO2 increased to 80% on HFNC (60-70L), with SpO2 >85%. Desaturation to the 70%s when coughing. He was tachypneic over the past 3-4 days, with RR in the 50s. He occasionally felt that he was tiring out. FiO2 was weaned from 80% to 70%, with goal O2 of 85-88%. He was continued on remdesivir (planned 5-day course), dexamethasone 6mg daily (planned 10-day course), baricitinib 4mg daily (planned 14-day course). ========== MICU COURSE (09/11 - 9/24 ) ========== (By problem) # COVID-19 c/b PNA+severe ARDS, with possible superinfection/sepsis When PT was admitted to the medical facility, he was on HFNC of 60L/min and FiO2 80%. He was working hard to breathe, with more frequent desaturations and longer recovery times despite being maxed on HFNC. He was started on and completed a 5-day course of cefepime and doxycycline for possible bacterial superinfection. After a lengthy discussion with the patient (and daughter + son on the phone), he was intubated. He was paralyzed, proned, and began Veletri with improvement in his oxygenation. He was diuresed generally with net goal even. He was unparalyzed after 2 days and stopped proning given only mild improvement in oxygenation upon proning. He developed a pressor requirement originally thought to be due to sedation; however, early sepsis also on the differential due to ongoing pressor needs. Despite trying to avoid paralysis, he developed worsening oxygenation with vent dyssynchrony, and so he was re-paralyzed and re-proned on 9/17. Oxygenation and pressor requirements continued to worsen despite AC/VC settings of 420/30/12/90%, with PaO2 in the 50s. The patient was started on cefepime (switched to ceftazidime), vancomycin, and fluconazole (switched to micafungin). Blood cultures were negative. RUQUS showed a contracted gallbladder with stones. He was able to wean down on the RR, FiO2, and pressor requirements, so he was un-paralyzed on 9/21. Restarted paralysis 9/23 after oxygen requirements increased, patient's MAP started to drop to the 50s, and fever spiked on 9/22 c/f septic shock. Patient was broadened to meropenem on 9/22. CXR 9/23 showed worsening lower lobe haziness and consolidation c/f aspiration pneumonia with residual volumes in stomach of up to 1.8 L (likely cause of pneumonia). Patient's condition continued to decline with renal failure likely in setting of septic shock with decreased/minimal urine output. Patient was started on CVVH on 9/23 and continued to worsen on 9/24 with increased acidosis (likely metabolic) in setting of sepsis. He was given a dose of vancomycin on 9/24. Lactate continued to increase rapidly at a peak of 7.1 on 9/24. At that time, the medical team contacted the family to provide further insight into the poor clinical trajectory at which time, the HCP made the decision to change the patient's code status to DNR/OK to intubate and later to comfort measures as nothing more medically could be done. The patient was extubated and passed peacefully with family surrounding him. # Nutrition # Hyperglycemia He was started on tube feeds with insulin to manage hyperglycemia (in the setting of a 10-day course of dexamethasone). Tube feeds were then stopped on 9/22 evening as team was concerned that patient was aspirating. Patient was started on D5 on 9/24 to provide some nutrition. # Goals of Care Several conversations took place with the patient (prior to intubation) and family (once oxygenation status worsened despite near-maximized ventilation/oxygenation with re-paralysis, re-proning). The family ultimately decided to change the person's code status to DNR/OK to intubate and ultimately to comfort care."" "1808117-1" "1808117-1" "Case was hospitalized for pneumonia, SOB, Cough, Fever, and chills and had to be admitted to the ICU" "1808146-1" "1808146-1" "Patient was transferred to ED on 8/7/21 from rehab after cardiac arrest and then transferred to ICU at another facility. Arrest was thought to be most likely due to hypoxia iso respiratory failure from ADCHF and superimposed covid infection. Patient is fully vaccinated. Patient tested positive for covid on 8/5 but imaging not consistent with covid pneumonia. Respiratory failure largely driven by large bilateral pleural effusion and pulmonary edema secondary to decompensated heart failure. Remdesivir was deferred due to renal and hepatic impairment. Patient was pronounced deceased on 8/11 after family elected to decline further intervention and transition to CMO only on 8/10." "1808173-1" "1808173-1" "Patient was transferred to hospital on 8/8 via medical flight from his facility due to persistent intermittent bleeding from his trach and mouth. Subsequently goals of care transitioned to CMO only and patient passed away on 8/17. Regarding covid, patient had mild infection without hypoxemia and was given course of remdesivir. Patient is fully vaccinated." "1808191-1" "1808191-1" "Patient is a 73 y.o. adult with no known past medical history who presents to the Emergency Department via EMS for evaluation of a potential stroke. Per EMS, the patient was found flat on his back at approximately 4 PM by neighbors outside of his apartment in a parking lot. EMS states that they found a receipt in the patients belongings for a purchase at a local pharmacy at 2:30 PM. Patient presents to the ED with unknown last known well time as well as a complete left side neglect. Head CT showed right parietal skull fracture, right parietal ICH with mixed density concerning for ongoing hemorrhage, extravasation, cerebral edema, brain compression and IVH. Repeat head CT with expansion of hemorrhage, worsening IVH with hydrocephalus, cerebral edema and herniation. Clinically with rapid neurologic decline and coma with functional quadraparesis at time of admission. Etiology unclear, potentially underlying vascular malformation, unknown if iatrogenic coagulopathy, or trauma. Possible hemorrhage of underlying mass not excluded. Neurosurgery consulted, discussed overnight. Due to massive expansion and no meaningful improvement in neurologic exam with medical intervention, surgical intervention not offered as would not benefit patient due to extent of injury and poor neurologic prognosis. Patient underwent brain death testing and time of death was called 10/22/21 at 1441." "1808215-1" "1808215-1" "Patient presented to ED on 9/13/21 with progressive cough, SOB and fatigue with a positive covid 19 test as well as yellow tinged sputum concerning for a superimposed bacterial infection. Patient additionally had uptrending troponins prompting question of decreased cardiac function and cardiogenic shock in setting of CAD and increased metabolic demand. Patient's respiratory status and overall condition progressively worsened and the family made the decision to transition to CMO only. Patient passed away on 9/26/21." "1808242-1" "1808242-1" "Hospital Course: 61F with ovarian cancer, metastatic to LN and omentum, most recently Carboplatin (4/2021), pelvic XRT (6/2021), with comorbidities of bipolar affective disorder, chronic BLE lymphedema/anasarca, recurrent cellulitis, pAfib, right THA (2019) c/b PJI (9/2020) and sepsis (5/2021), admitted 8/10 with abdominal pain and symptoms from worsening lymphedema/anasarca. Admit complicated by AMS, ongoing pain, and intermittent hypotension (responsive to IVF). Given clinical decline, transition to CMO. Now COVID positive; plan to remain in-house for EOL. We were unable to transfer to an hospice at end of life because of covid infection. Patient passed peacefully at 7:17 AM on 9/26. She was kept comfortable with a morphine drip and PRN thorazine. Her husband and her outpatient providers were notified. See below for problem based hospital course." "1808247-1" "1808247-1" "Patient presented to ED on 9/13/21 with fever and cough, found to be covid positive with concern for overlying CAP +/- pulmonary pneumonia. Patient was treated appropriately and was recovering from covid 19 pneumonia when she became somnolent, developed acute hypoxemic respiratory failure and then cardiopulmonary arrest. The precipitating cause of her somnolence and respiratory failure are unknown. Patient was deceased on 9/26/21" "1808355-1" "1808355-1" "Case fully vaccinated with Moderna with second dose administered on 2/4/2021. Tested positive for COVID 19 on 10/17/2021. Was admitted to hospital on 10/14/2021. Expired on 10/19/2021 while still hospitalized." "1808386-1" "1808386-1" "Case fully vaccinated with Moderna with second dose administered on 2/12/21. Tested positive for COVID 19 on 9/15/2021. Admitted to Medical Center on 9/14/2021. Case expired on 9/27/2021 while still hospitalized." "1808415-1" "1808415-1" "Case fully vaccinated with Pfizer with second dose administered on 2/18/2021. Tested positive for COVID on 9/24/2021. Admitted to Hospital on 9/24/2021 and expired on 10/16/2021 while still hospitalized." "1808577-1" "1808577-1" "My husband became weak thought he had MS, was not able to ride his bike or go for 3 mile walks starting the end of March. He thought he might have pleurisy so he went to the Cardiologist. Dr ran test said he was retaining fluid and put him on diuretics. He starting to lose his grip strength and could not work. He found it difficult to breath and stumbles and dropped things. He woke up with numbness in his feet and it quickly spread to his hands, then his legs and arms he went to the ER they thought he had Dengi Fever could not help, we drove to ER they diagnosed him with Guillan Barre syndrome intimated him and med evacuated him. While we were I was told they still didn't know what was wrong with him and that he would not die if he had Guillan Barre, they started IV IG therapy. He died in ICU on 16 May 2021. I have some of the same symptoms we had the same vaccine we went together on the same day and times. I have body reactive extreme anxiety. I feel as though I will not make it. My feet are becoming numb my arms are weaker. I notice a twitch in my limbs every now an then. I have heart palpatations and increased blood pressure it used to be consistently low. I have a dryness in the back of my mouth. I have balance issue from time to time. I have trouble thinking while I am at work. I am a dental hygienist. My husband was a prosthetist orthotist." "1808619-1" "1808619-1" ""Pt. came to the clinic stating she was ""just not feeling well"" on 10/5/2021. After further questions, she had a cough for about 5 days. Pt. is on supplemental oxygen for her COPD. Her 02 sats were at 89 which were not unusual for pt. Provider seen pt. and he ordered a Covid-19 test. Test came back positive. Pt. was sent home with family member and given instructions to take pt. to ER if she shows any signs of having a hard time breathing. Family took pt. to the hospital on 10/9 or 10/10. She passed away on 10/12/21"" "1810608-1" "1810608-1" ""cancer throughout her body, including spine and lesions on her brain, radiologist said as far as the lesions go says they were hemorrhagic; hypersensitive reaction; cough; Pain; chest pain; lymph node swelling throughout the chest and upper abdomen; nodules on her lungs; got really sick; death; This is a spontaneous report from a contactable consumer (parent) via Medical information team. A 49-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 17Apr2021 (Batch/Lot Number: ER8735) as DOSE 2, SINGLE for covid-19 immunisation at the age of 49 years old. Medical history included breast cancer from an unknown date diagnosed in Feb2020 and mastectomy from Sep2020. The patient's concomitant medications were not reported. The patient previously took BNT162B2 dose 1, on 27Mar2021 at the age of 49 years old, lot number: ER8734 and expiry: Unknown for COVID-19 immunization and experienced back pain, headaches, dry cough and bilateral pleural effusions. The patient's parent stated, ""Ishe had the first dose on 27Mar2021, the following week she started to complain of back pain, headaches and dry cough, had not had those symptoms before the vaccines, states for the back pain she was saying she guessed she needed a new mattress, so it was there but not serious, states then on the 17Apr2021 is when she got the second dose of the Pfizer Covid vaccine, on a Friday after that and that Sunday afterwards she described the pain as just really worse, states the cough got worse, states in the early part of week she called the doctor and was not able to get in to see them, states her daughter got to point where she used the word excruciating to describe her pain, she made an appointment at a same day clinic, by the time she got to the appointment on 23Apr2021, she was complaining of chest pain as well, the doctor sent her for chest X-ray, the chest X-ray showed pleural effusions in the bases of both lungs. Sent for a CT scan of the chest, they couldn't get her in for a month for this, states by the time she had the CT scan, one of the things on the CT scan is that she had lymph node swelling throughout the chest and upper abdomen, doctor said this was unusual, from there she deteriorated quickly. States they did a thoracentesis and they found cancer cells riddled through the fluid the pulled out, found nodules on her lungs. It is important to note her daughter's history, she has a history of breast cancer, she was diagnosed in Feb 2020, the year before the vaccines, she had a mastectomy in Sep2020 and by all indications afterwards, the doctors said her her margins were negative, the skin in her breast was negative and lymph nodes were negative for cancer, was her oncologist, she had a follow up with the doctor in Feb2021 of this year, about a month before the Covid vaccines and if you read her note, she was basically given a clean bill of health just a month before the vaccines and her symptoms started. Caller states the only thing oof was the patient's blood count was a little low, exact details not provided. She thinks that her daughter had a unique reaction to the mRNA in the vaccine, believes this sprinkling of cancer all of a sudden after just receiving a clean bill of health a month before was triggered by the vaccine, caller understands that with the mRNA there is something to do with copying cells and she believes that the MRNA copied something different, states she ended up with cancer throughout her body, including spine and lesions on her brain, radiologist said as far as the lesions go says they were hemorrhagic, said it was unusual. She thinks the vaccine caused her daughter's death, her daughter was completely healthy, she did have breast cancer and mastectomies, she got the vaccine, got really sick, and the I think the mRNA of the vaccine copied the wrong cell and copied the cancer cell instead of the cell that it was supposed to"". They did no autopsy, the reason she is really questioning the mRNA is the patient's condition rapidly deteriorated after the second vaccine, she complained of back pain, coughing and headaches after the first vaccine but she was still able to work and go about her day but 17Apr2021 was on a Friday, by that Sunday her back pain was severe, the coughing increased and she even started to develop chest pain, what she wanted to say was that this all happened after the second injection is when, she was at #, they did a CT scan of her chest, it showed swollen lymph nodes, they did a biopsy that showed cancer cells, so the reason the caller thinks it was the mRNA, is because in Feb the patient had been healthy by all indication, it appeared something just showered her body with cancer cells, she had cancer in her lungs, spine, brain. Caller states because of how many tumors patient had they didn't do an autopsy. Caller states the patient was put on hospice, they did do brain radiation, but she got to a point where she was deteriorating rapidly and was put on hospice for a week before she died, doctors did ask about an autopsy, but at that point, as a parent, it was all happening so quickly. The patient died on 22Jul2021. An autopsy was not performed. The outcome of the events was unknown.; Reported Cause(s) of Death: Metastatic breast cancer"" "1810629-1" "1810629-1" ""committed suicide/gun shot went to the head; Parkinson; He couldn't turn his head; nausea; never the same; This is a spontaneous report from a contactable consumer. A 38-year-old male patient (reporter's husband) received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration (Batch/Lot number was not reported) Arm Right on 22Sep2021 at age of 38-year-old as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Asthma. Concomitant drugs included Montelukast, fluticasone propionate (FLOVENT) for Asthma, salbutamol (ALBUTEROL HFA) allergies (Not Clarified) his Montelukast. No Prior vaccination within 4 weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. After the first shot he could not see for three days. He received the COVID vaccine his second dose on 22Sep2021 and he was never the same. He started having what look like Parkinson. He couldn't turn his head, took him to the hospital they gave him three shot (Treatment)one to sedate him, a Benadryl shot (Treatment) and one to stop nausea (further not clarified) He was never the same and he just committed suicide. He had a gun shot went to the head and it appears to be some inflicting but they are going to check. Events were in 2021 and Hospitalized and death. No Autopsy performed. Death date: Reporter stated, ""We don't know if it was 8Oct or 9Oct2021,we are still waiting on the coroner."" Outcome of the events was fatal. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Parkinson; He couldn't turn his head; nausea; never the same; He was never the same and he just committed suicide"" "1810654-1" "1810654-1" "blood clot in the lungs; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (BNT162B2), first single dose via an unspecified route of administration, administered in arm right on 10Sep2021 (Batch/Lot Number: FC3182) for covid-19 immunisation at age of 50-year-old. The patient was not pregnant at vaccination. Medical history included covid-19. No other vaccine received in four weeks. There were no concomitant medications. There was no covid tested post vaccination. The patient experienced blood clot in the lungs (death, life threatening) on 21Sep2021. No treatment received for the event. The patient died on 21Sep2021. It was unknown if an autopsy was performed. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: blood clot in the lungs" "1813526-1" "1813526-1" "PATIENT BEGAN FEELING PAIN IN HIS CHEST CAVITY APPROX. JUNE 15, 2021" "1813840-1" "1813840-1" "Increasing weakness, diarrhea, urinary incontinence - tried antidiarrheal, fluid boluses, offered hospitalization (refused)" "1813852-1" "1813852-1" "Cardiopulmonary Arrest/ Cardiac Death/Myocardial Rupture" "1813870-1" "1813870-1" "Unresponsive, CPR started 911 called" "1813898-1" "1813898-1" "Patient stopped any shopping and phone activity as of May 19, 2021. We found him on June 1, 2021 which the coroner was required to list as the day of his death. He had been dead for quite a while. Coroner decided he had cardiovascular disease." "1814233-1" "1814233-1" "No symptoms, passed away 31 hours after vaccine" "1814760-1" "1814760-1" "Approximately 3-5 week after 2nd dose of vaccine patient experience Myocardial Infarction. Angiography revealed diffuse thrombus in coronary arteries and enlarged heart. Pulmonary Embolism is not excluded. Patient expired during angiogram procedure" "1814787-1" "1814787-1" "Breakthrough hospitalization of vaccinated COVID19 patient. Pt was DNR with a history of major neurocognitive disorder. Pt had acute non-ST elevation myocardial infection. Family made patient comfort care and she passed away on 10/19." "1814816-1" "1814816-1" "severe vomiting and exhaustion for two days resulting in diabetic ketoacidosis, and death on 9/28/2021" "1814845-1" "1814845-1" "FEVER, CHILLS, NAUSEA" "1814957-1" "1814957-1" "The patient died of a stroke 5 days after receiving the COVID-19, he was very old and it is unknown what other medical conditions they he had." "1814974-1" "1814974-1" "AMS" "1815001-1" "1815001-1" "COVID RELATED DEATH; BREAKTHROUGH CASE" "1815035-1" "1815035-1" "COVID RELATED DEATH; BREAKTHROUGH" "1815096-1" "1815096-1" ""Patient received first COVID vaccine on 7/11/21. She was well until 7/26/21 when she developed nausea, vomiting, shortness of breath and dizziness. At approximately 04:00 on 7/27/21, she woke up feeling poorly, went into the bathroom and then lost consciousness. EMS was called, she was in a tachycardia at 180 bpm, BP 88/64, unresponsive. EMS report states she was ""in SVT and cardioverted at 30J then 70 J. Still in SVT but becoming more alert. HR 165 bpm, sats 98%."" In ED, she was felt to be in ventricular tachycardia, She received attempted resuscitation with multiple rounds of CPR including chest compressions, defibrillation for reported ventricular fibrillation, and medications. She was unable to be resuscitated and death was pronounced in the ED. Autopsy is pending."" "1815135-1" "1815135-1" "COVID-19 death of a fully vaccinated individual." "1815163-1" "1815163-1" "COVID-19 death of fully vaccinated individual." "1815217-1" "1815217-1" "This is a case of breakthrough COVID-19 disease that resulted in death. The patient became symptomatic while on a trip out of state. Several other people on this trip were also ill with COVID-19. This case was vaccinated with the Pfizer product on 02/19/2021 and 03/13/2021. The case became symptomatic for COVID-19 on 09/21/2021 and experienced symptoms of diarrhea, general weakness, fatigue, and sore throat. The exact timeline here is not clear, but over the course of the following days, the case developed difficulty breathing and was admitted to the hospital on 09/27/2021.. The case subsequently died on 10/01/2021. The death certificate details are as follows: Part I Cause of Death A: Acute Hypoxic Respiratory Failure B: COVID 19 Pneumonia; Adult Respiratory Distress Syndrome Part II Other Significant Conditions: Acute Kidney Failure; Acute Metabolic Encephalopathy" "1815295-1" "1815295-1" "Acute Hyperglycemic Crisis" "1815351-1" "1815351-1" "pt admitted to hospital with c/o SOB, fever, malaise; positive for COVID; pt's O2 saturations decreased eventually requiring intubation; pt's condition worsened on 9/19 with maximum vent support; he continued to experience refractory hypoxemia; attempted to place pt in a prone position and he went into cardiac arrest; expired in the hospital" "1815409-1" "1815409-1" "patient passed away on 10/22/2021 due to COVID. Per doctor's note on ED visit 10/19/2021: Given that her history of present illness, past medical history, physical exam findings and laboratory medic epic results are consistent with an acute COVID-19 pneumonia with hypoxia, I do not believe any further emergent work-up is needed. I had a lengthy discussion with the patient regarding the benefits of hospitalization, and now she is willing to be admitted. I gave her Decadron 6 mg IV and remdesivir 200 mg IV for hypoxia in the setting of a COVID-19 infection. 1145: During her evaluation by Dr, she was noted to have a precipitous decline in her mental status and increasing respiratory drive with tripoding, grunting respirations and supraclavicular retractions. I discovered the patient awake, but not responding in obvious respiratory distress. Her oxygen saturation was in the mid 70s on a nonrebreather mask at 15 L of oxygen per minute. She was also placed on a nasal cannula at 15 L/min with no improvement. I contacted the respiratory technician who placed her on BiPAP and her oxygen saturation improved to 97%, but she remained altered and tachycardic. With the decline in her mental and respiratory status, Dr. requested that she be transferred to a facility for a higher level care. I gave her Zofran 8 mg IV to help prevent nausea and vomiting. 1330: I gave her Toradol 15 mg IV for chronic low back pain. 1255: I had a lengthy discussion with the patient's husband concerning her CODE STATUS via telephone. He would like her to be a full code, including intubation. Patient was transferred to Medical Center on 10/19/2021 at 1740." "1815433-1" "1815433-1" "Contracted COVID 19, was hospitalized and subsequently passed away." "1815471-1" "1815471-1" "First dose was 4/22/2021, general dr visit on 5/12/2021 showed radical heart beat. Second dose on 5/20/2021 became very ill, uncontrolled heartbeat, hospital admission that same day. He passed away the morning of 5/23/2021. I am his daughter, POA/Executor and was his designated health care director and caregiver." "1815689-1" "1815689-1" "Patient complained about being nauseous and then shortness of breathe. Then by the time her aid was able to call 911 for help she died." "1816151-1" "1816151-1" "Cardiac arrest with no symptoms. Patient had no previous symptoms. Cardiac arrest that led to death." "1817829-1" "1817829-1" "My dad was taking a shower getting ready to go to a podiatry appointment. After about 1/2 hour, my mother checked on him and found him on the bathroom floor after his shower unresponsive. Calling 911, the responders came and found a faint heartbeat, but were unable to revive him. He was pronounced dead. medical examiner at the scene." "1817863-1" "1817863-1" "On Wednesday, August 25th, 2021 my mother awoke and assumed her normal daily routine. She had a breakfast of one egg, two slices of bacon and wheat toast. She was perfectly ambulatory and needed no help in walking, dressing, her personal hygiene or assistance in going to the restroom. At 12:30 that afternoon she walked down the stairs of her home and she and I left for her COVID vaccination at the local store. We arrived at store and immediately went to the pharmacy department where she received the Moderna vaccination. We continued shopping for grocery items for an additional 15-20 minutes, paid our bill and exited the store. As we were leaving the store she complained of soreness in her vaccinated arm and a feeling of weakness. I had to help her into our vehicle and upon arriving home had to physically carry her up the steps and into the house. I put her onto the couch where she could relax and watch television. She was alert and mentally clear but extremely weak. I researched reactions to the vaccination on line and attributed her initial weakened condition as normal reaction to the vaccination and that they could last 1-3 days with minor continuing symptoms for as long as two weeks. She continually worsened for the next three days and her mental state continually degenerated to where she seemed unaware of her surroundings and had difficulty responding to verbal stimuli. She could not walk, dress, bathe herself, lost control of her bowels and could not eat without assistance. I contacted my sister and she came over to help me care for her in regards to personal hygiene, feeding, dressing and putting her into and changing of adult diapers. After three days passed with her showing no signs of improvement, I reached out to her primary care physician and left a detailed message of her symptoms with the messaging service of what was happening and asked for advice. I was informed that it was a normal reaction to the vaccine and to monitor her for any worsening signs. On 17 September with her health showing no signs of improving we called 911 for emergency care and had her transported to hospital. A full battery of tests were performed including a CAT scan with no indications of what was causing this digression in her health. The staff stated she was exhibiting signs of dementia which we refute. Her last complete physical dated Feb 05, 2021 indicates her mental and Neurological state at baseline and her Psychiatric state as normal. She was discharged from hospital on Sept 22, 2021 and was transported home where she remained under family care pending assistance from local elderly programs. On Sept, 29th 2021 she was reclining in her armchair when she slumped over to the side and was unresponsive. 911 was called and paramedics arrived, transported her into the emergency vehicle where she went into cardiac arrest. The emergency response team administered CPR until arrival at hospital where she was pronounced dead. My mother went from a person able to care for herself with minimum assistance to a person who seemed to be in the last stages of Alzheimer?s disease in a matter of three weeks. She did not suffer from any of the mental or physical problems until immediately after the receiving the Moderna COVID vaccination. At 83 years of age she did have normal health issues associated with someone of her age. She was a colon cancer survivor and had been diagnosed with COPD and was on oxygen but she suffered no medical condition which would have resulted in her rapid decline and subsequent death such as happened immediately following her vaccination. Based on what I personally witnessed following her vaccination, I fully believe that if she had not taken it, that she would be with us still. There has not been enough time allowed or documentation of adverse reactions to the COVID vaccination, especially with the elderly or persons with pre-existing medical conditions." "1818084-1" "1818084-1" "Symptomatic 8/26/2021 - headache and SOB" "1818134-1" "1818134-1" "Symptomatic:(unknown onset date) subjective fevers" "1818136-1" "1818136-1" "Patient was admitted as inpatient on 10/19 with Covid. complex medical history including dementia, HTN, constipation, and hypothyroidism, admitted with acute hypoxic resp failure d/t COVID-19 infection . Palliative Care was consulted to assist with goals of care and to transition to comfort focused care at the end of life." "1818141-1" "1818141-1" "Diagnosed with COVID-19 on 8/23/2021 and experienced shortness of breath, pneumonia." "1818158-1" "1818158-1" "diagnosed COVID positive 1 wk prior to hosp admission (8/28); End-stage renal failure, dialysis 3xwk; has missed 2 rounds of dialysis due to increased weakness; EMS brought pt to hosp due to confusion and weakness; dx with COVID pneumonia; hypoxic; experienced hypotension and A Fib with RVR during dialysis tx in hospital; required emergent cardioversion; DNR/DNI; pt's condition rapidly worsened on the day of dc from hospital to a nursing facility and pt expired in the hospital" "1818171-1" "1818171-1" "My mother had a minor stroke the week of March15th she went to the ER on March 16th but since an MRI was not performed they missed the stoke. 10 days later on Friday March 26th she had a larger Ischemic stroke and was hospitalized. She was moved to acute rehab when they found a blood clot in her leg on April 12th. By the end of the month she became non verbal and catatonic so she was moved back to Hospital on May 3rd, 2021. She was so agitated they couldn't even give her a MRI to verify if she indeed she had another stroke. On May 28th she was moved to sub acute rehab and failed to thrive or respond to rehabilitation treatment. She died on June 21, 2021 just 4 months after her second Pfizer shot." "1818190-1" "1818190-1" ""Symptomatic on 9/13/2021: cough and ""other"""" "1818204-1" "1818204-1" "Symptomatic on 09/18/2021: headache and myalgia" "1818213-1" "1818213-1" "Patient tested positive for COVID-19 on 9/13/2021. They were asymptomatic at the time, but on hospice for CHF." "1818238-1" "1818238-1" "Symptomatic on 9/13/2021: subjective fever, cough, Pneumonia, difficulty breathing" "1818264-1" "1818264-1" ""pt admitted to hosp with acute on chronic systolic heart failure; CRTD placed; pt c/o weakness, poor appetite, food tasted like ""cardboard""; positive COVID test; DNR; O2 @6L/M via face mask; pt's condition worsened and he passed away in the hospital"" "1818265-1" "1818265-1" "my sister went to the er on July 20th with what seem to be a illergic reaction... she said she was itching all over and was swelling. They sister passed away on July 26th from myocarditis which is stated o. The cdc website a direct side effect of the moderna shot." "1818285-1" "1818285-1" "pt diagnosed positive for COVID 4 dys prior to hosp admission; admitted due to worsening SOB, cough, hypoxic, A Fib with RVR; COVID pneumonia; intubated; O2 requirements increased; family decided to extubate; comfort measures were instituted; pt's condition worsened and he expired in the hosp" "1818312-1" "1818312-1" "Fall down stairs, +EtOH, catastrophic brain injury, death. Though her death seems to be clearly caused by direct head trauma, the cause of her fall may be multifactorial including weakness from recent vaccination in combination with EtOH." "1818365-1" "1818365-1" "Death due to extensive pneumonitis, with onset three weeks after breakthrough COVID-19 infection diagnosed on September 22, 2021; initially presenting as severe fatigue necessitating hospitalization." "1818410-1" "1818410-1" "Hospitalized 10/18/2021; COVID-19 positive 10/17/2021; fully vaccinated BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider at Discharge: DO Admission Date: 10/18/2021 Discharge Date: 10/20/2021 Discharge disposition: Home Condition on discharge: Stable DETAILS OF HOSPITAL STAY: Hypoxia [R09.02] HOSPITAL COURSE: Acute on chronic respiratory failure with hypoxia. Resolved. Back on baseline O2 needs of 6L COVID19 infection. Improving ILD -presents w/ 1 month of progressive dyspnea w/ 2 days of more acute worsening -in ED was saturating well on FIO2 of 50% from BL 6L NC -CT angio thorax shows no acute process -is vaccinated -wife is getting over COVID19 -wean off oxygen as able. Patient nearing his baseline -Remdesivir, steroids, SQ lovenox per COVID19 treatment with improvement. -To finish Decadron course at home. Lovenox at home -pulmonary evaluated Chronic systolic heart failure s/p AICD -EF 35% -appears euvolemic -continue home meds -CHF diet, daily weights, I/Os No ACEi or Spironolactone Rx due to soft BP and currently recovery from COVID 19. To be considered later on by his cardiologist. Also pt considering hospice due to new diagnosis of gastric adenocarcinoma and chronic illness, so may not be indicated Hospice note 10/21/2021: Reason for referral: 10/21/21: I spoke with patient's spouse by phone, she was tearful regarding his declines. He was seen by hospital team yesterday and at that time did not feel that they were ready for hospice care, he wanted time to recover from Covid before making a decision (patient is currently Covid positive). He was discharged from the hospital yesterday with a referral for home care. Wife then called this morning stating that he has been up most of the night with shortness of breath., on 15L NC, Medical equipment store is bringing a second concentrator this morning as he only had one that went to 10L and was then using a supplemental tank which they used up last night. Nurse did info visit in hospital and started the discussion on morphine for SOB symptoms, they were hesitant on this at first but after last night, he states he is willing to try to get some relief. Patient passed away on 10/22/2021 per hospice note" "1818543-1" "1818543-1" "BROUGHT TO HOSPITAL FOR FACIAL DROOP AND DECREASED ALERTNESS" "1818558-1" "1818558-1" "Patient died several hours after receiving first COVID-19 vaccine from Pfizer." "1818591-1" "1818591-1" "swelling and other adverse events, finally hospitlalized and then sent home to die." "1818596-1" "1818596-1" "SOB O2 54% ON RA" "1818604-1" "1818604-1" "Pt found deceased by family 2 days after vaccine administered." "1821065-1" "1821065-1" "Pt died on 05/04/2021. COVID Negative at time of death." "1821085-1" "1821085-1" "Patient diagnosed and hospitalized with COVID-19 while fully vaccinated." "1821109-1" "1821109-1" "After receiving the Moderna COVID-19 booster at 11:15am on 10/24/21, she felt normal until 10pm that evening. The she was chilling slightly, headache and general body aches. On 10/25/21, at around 10am, she became short of breath and experienced pain in her left side. She measured her O2 and was a 94; after using some auxilary oxygen (her husband's machine) at 3 liters, she reached 97. General malaise continued and at approximately 8pm, she suddenly collapsed and died." "1821117-1" "1821117-1" "Patient diagnosed and hospitalized with COVID-19 while fully vaccinated." "1821139-1" "1821139-1" "COVID-19 Vaccine Breakthrough Case: Hospitalization & Death The case tested positive for COVID and went to the emergency room and was admitted on 10/9/21. The case unfortunately passed away on 10/20/21. The individual received a monoclonal antibody infusion on 10/9/21. As part of his COVID-19 symptoms, the individual had difficulty breathing, loss of smell/taste, and a fever. The case also developed pneumonia and acute respiratory distress syndrome (ARDS)." "1821160-1" "1821160-1" "Patient diagnosed and hospitalized with COVID-19 while fully vaccinated." "1821164-1" "1821164-1" "Pt.'s Sister states that after receiving the 1st dose of Phizer 09/10/2021, started experiencing symptoms 10/19/2021 pt. found unconscious on the floor, Emergency Room visit *transported suffered 3 Heart Attacks, Cardiac Arrest resulting in Death 10/20/2021." "1821184-1" "1821184-1" "Pt died after testing positive for COVID-19 on 10/4/2021" "1821214-1" "1821214-1" "This is a breakthrough case of COVID-19 that resulted in death. The individual was vaccinated with the Pfizer product on 02/01/2021 and 02/22/2021. The individual tested positive via PCR for COVID-19 on 09/18/2021 and was admitted to the hospital on that same day. The individual reported COVID-19 symptoms of fatigue, weakness, cough, shortness of breath, fever, chills, nausea, vomiting, diarrhea, and feeling lightheaded. They were hospitalized until their death on 10/04/2021. Death Certificate details are as follows: Part I Cause of Death A: Acute Respiratory Distress Syndrome B: COVID 19 Pneumonia Part II Other Significant Conditions: Viral Sepsis, Shock, Immunosuppression, Acute Kidney Failure ON Chronic Kidney Disease, Hospital Acquired Pneumonia The patient was considered to be immunosuppressed at the time of death, due to medication use; the person was a kidney transplant recipient." "1821230-1" "1821230-1" "pt admitted to hospital in sickle cell crisis after a fall at home; confused; febrile, hypoxic; positive for COVID; increasing O2 requirements (15L NRB); pRBCs given; hx of HTN,COPD, sickle cell; condition worsened and pt experienced cardiac arrest and expired in the hospital" "1821241-1" "1821241-1" "Pt died after being diagnosed with COVID concurrently with a devastating left thalamic IPH with extensive IPH and ventricular blood." "1821256-1" "1821256-1" "Myocarditis with effusion. Hospitalized at hospital and then other hospital and then discharged. Readmitted at hospital with infected gallbladder but myocarditis limited treatment. Now deceased. Happened over 3 weeks." "1821271-1" "1821271-1" "pt admitted to hosp with dehydration, AKI, tested positive for COVID; intubated; suffered an acute CVA in hospital; remained hypotensive despite vasopressors; made a DNR; sepsis with acute organ dysfunction due to COVID - Septic Shock; pt's condition worsened and she expired in the hospital" "1821282-1" "1821282-1" "Patient's daughter states that the patient started having a sore throat on 9/30. She was taken to the hospital on 10/4 (reason not available currently). The patient was then found deceased at her home bent over her empty bath tub on 10/6/21. She had a bloody nose when she was found. Cause of death was determined to be a heart attack or stroke." "1821313-1" "1821313-1" "low 02 sats, with shortness of breath increased pulse rate (120) low BP vomited x 1 she was given a breathing tx and starte 02, she was then sent out to the hospital, paramedics could not get a BP, she was transported to the nearest hospital" "1821320-1" "1821320-1" "Patient diagnosed and hospitalized with COVID-19 while fully vaccinated." "1821321-1" "1821321-1" "pt has hx of dementia; brought to ED with increasing lethargy x 1wk, non-productive cough, rhinorrhea, diarrhea, decreased UOP; started on supplemental oxygen; diagnosed positive for COVID; started on decadron and remdisivir; antibiotics for suspected UTI; DNR/DNI; respiratory status decreased despite being on Vapotherm 40 L 100% and supplemental NRB mask @ 15 LPM; O2 sats in 60 - 70s; full comfort measures instituted; pt expired in the hospital; acute hypoxic respiratory failure due to COVID pneumonia" "1821324-1" "1821324-1" "Moderna Dose 1 2/5/21 (016M20A) Moderna Dose 2 3/5/21 (013A21A) COVID Positive 9/18/21 9/20/21: -Patient is an 89yo male with medical history of tobacco use -History obtained from ER provider and chart review. Daughter unreachable on phone and patient very fatigued -Presenting because of worsening COVID symptoms, anorexia , dehydration -Tested COVID positive on 9/18 -In the ER he was febrile 100.5F, HR 96bpm, BP 111/67 with oxygen saturation of 91-96% on room air -CXR showed interval increased bilateral pulmonary infiltrate. -Labs remarkable for glucose 140, Cr 2.57,ast 57, normal lactate, trop 0.04 , Hb 11.5 -He recieved 1L NS bolus -Patient will be admitted under hospitalist service for dehydration and AKI due to COVID 10/4/21: Patient is on 100 % FIO2 on BIpAP. I discussed with his sons who have agreed about the poor prognosis and change him to DNR status with comfort measures, but they would like to continue supportive measures for the moment. Per family request pt taken off BiPAP for comfort cares, Dr. aware. Patient passed away." "1821341-1" "1821341-1" "pt diagnosed and hospitalized x 2days with positive COVID test prior to this hosp admission; pt presented to ED with fever, chills, fatigue and increasing SOB, placed on Airvo; hx of DM and RA; eventually placed on BiPAP; alternated with BiPAP and Airvo; pt was tiring and requested intubation; placed in prone position most of the time; family requested no CPR; developed Shock, renal failure related to COVID sepsis; pt's condition worsened and he expired in the hospital" "1821342-1" "1821342-1" "Pfizer Dose 1 2/5/21 (lot not listed in system) Pfizer Dose 2 2/26/21 (lot not listed in system) COVID Positive 9/2/21 9/2/21: Patient is a 77 yo male with medical history of CAD , Parkinson disease, Prediabetes, HLD, OSA He presented with SOB, non productive cough and fever . he also endorses abdominal pain and being fatigued He denies sick/ COVID contacts but says wife also has similar complaints 3 days after his illness started He is COVID vaccinated In the ER vitals remarkable for fever and elevated SBP 140- 170 with RR 30s and requiring 2 L supplemental oxygen CXR showed mild bilateral airspace disease in the lower lobes, may represent atelectasis or infectious infiltrates. CT abdomen done showed mesenteric stranding in right lower quadrant and a trace amount of free fluid, suggesting adjacent infection or inflammation. The appendix is not visualized, indeterminate for appendicitis. However patient states his appendix has been removed CBC, CMP were wnl, VBG was wnl, trop negative , UA unremarkable , PT/INR unremarkable . Blood cultures sent in the ER He received tylenol 650, Duoneb, 2g IV Ceftriaxone, 2.7 L LR , 4 mg IV Zofran in the ER 9/17/21: Patient is a 77 yo male with medical history of CAD , Parkinson disease, Prediabetes, HLD, OSA who presented with SOB, non productive cough and fever. He is COVID vaccinated. In the ER vitals remarkable for fever and elevated SBP 140- 170 with RR 30s and requiring 2 L supplemental oxygen. CXR showed mild bilateral airspace disease in the lower lobes, may represent atelectasis or infectious infiltrates. CT abdomen done showed mesenteric stranding in right lower quadrant and a trace amount of free fluid, suggesting adjacent infection or inflammation. CBC, CMP were wnl, VBG was wnl, trop negative , UA unremarkable , PT/INR unremarkable. COVID PCR returned POSITIVE. He received Tylenol 650, Duoneb, 2g IV Ceftriaxone, 2.7 L LR , 4 mg IV Zofran in the ER. Pt was subsequently admitted to the hospitalist service for further evaluation and management. Pt was started on Dexamethasone and Remdesivir. Ceftriaxone was continued. Pt with increasing O2 needs ultimately requiring 100% OptiFlow. Pulmonology was consulted at that time. Pt was started on Actemra. Pt also developed enteritis during admission was was treated with a 7 day course of Flagyl. Pt with fluctuating O2 needs. Pt did not desire intubation. Ultimately pt and family decided on comfort cares and home hospice. 9/20/21: Patient deceased." "1821390-1" "1821390-1" "pt presented with SOB, HA, non-productive cough, anorexia, weakness x 5dys; positive for COVID; dx with COVID pneumonia; started on decadron and remdisivir; given monoclonal antibodies; hx of HTN; went into septic shock, hypotensive despite vasopressor treatments; pt expired in the hospital" "1821423-1" "1821423-1" "pt with hx of DMT2, heart and liver transplant; previous CMV viremia; previously tested positive for COVID, placed on antibiotic for pneumonia; presented to ED due to O2 sats at home in the 70s; Optiflow 50L and 70% FiO2; pt's O2 sats worsened; intubated; transitioned to comfort care measures; pt expired in the hospital" "1821462-1" "1821462-1" "pt tested positive in nursing home for COVID; hx of dementia, HTN; brought to hospital due to worsening respiratory failure; dx with COVID pneumonia, AKI; made a DNR/DNI; comfort care measures; pt's condition declined and she expired in the hospital" "1821590-1" "1821590-1" "death J96.01 - Acute respiratory failure with hypoxia N17.9 - Acute kidney failure, unspecified K92.2 - Acute upper GI bleed K92.2 - Upper GI bleed" "1821601-1" "1821601-1" "death ABDOMINAL PAIN JAUNDICE N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia" "1821612-1" "1821612-1" "death U07.1 - COVID-19" "1821624-1" "1821624-1" "presented to ED with SOB; tested positive for COVID; dx with COVID pneumonia; given monoclonal antibody; continued to require high amounts of O2; given high doses of steroids; respiratory support with NIPPV; DNI; removed NIPPV and pt expired in the hospital" "1821642-1" "1821642-1" "death I63.9 - Cerebrovascular accident (CVA), unspecified mechanism" "1821651-1" "1821651-1" "death R56.9 - Unspecified convulsions E87.1 - Hypo-osmolality and hyponatremia D69.6 - Thrombocytopenia, unspecified R56.9 - Seizure J18.9 - Pneumonia" "1821662-1" "1821662-1" "death N17.9 - AKI (acute kidney injury) (CMS/HCC)" "1821676-1" "1821676-1" "Patient experienced chills & weakness following the vaccine. Patient died the following day. No gross anatomical findings of anaphylaxis at autopsy. Tryptase study pending." "1821677-1" "1821677-1" "death N17.9 - Acute renal failure (ARF)." "1821687-1" "1821687-1" "death COVID" "1821692-1" "1821692-1" "death U07.1, J12.82 - Pneumonia due to COVID-19 virus" "1821773-1" "1821773-1" "She had a hemorrhagic stroke March 8th at 7pm, she was non responsive almost the next 4 weeks . We git some hand responses only. Last week she was in horrible pain, we put her on hospice so they would get rid of her pain?and we let her go. I didn?t consider the vaccine at first, but after reading about it causing hemorrhagic strokes and only 10 days after her 2nd Covid 19 vaccine, I?m convinced, she died because of the vaccine." "1821942-1" "1821942-1" "CARDIOPULMONARY ARREST" "1823674-1" "1823674-1" "she passed away less than 24 hrs; This is a spontaneous report from a contactable consumer (patient parent). A 28-year-old female patient (daughter) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Oct2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer reported that her 28 year old daughter received her 2nd pfizer vaccine dose on 15Oct2021 and she passed away less than 24 hrs. The medical examiner was conducting a thorough review. The patient died on 16Oct2021. An autopsy was performed and results were not available. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away less than 24 hrs" "1825035-1" "1825035-1" "Patient presented to emergency department with shortness of breath on 10/13/2021. He had been diagnosed with COVID-19 on 10/7/2021. He was previously admitted to hospital from 9/8/2021 to 9/13/2021 with neutropenic fever, community acquired pneumonia, and pleural effusion. He was diagnosed with non-hodgkin lymphoma and was undergoing treatment at time of presentation. He was admitted for further management of COVID-19 infection. Patient continued to deteriorate during his admission and was eventually put on comfort measures only. Patient expired on 10/23/2021." "1825093-1" "1825093-1" "partially vaccinated-covid related death" "1825097-1" "1825097-1" "74yr old female who presents to ED with complaints of not feeling well. Patient states she woke up yesterday morning with a headache and body aches. Patient states she has had a fever and an increase in her cough. Patient states she has been coughing up thick, yellow phlegm. States she feels short of breath with exertion. Patient on O2 via NC at 4L, states this is her normal at home. Patient states she has diarrhea but states this is not new for her. Patient states she has had the dry heaves. Patient states they had a family gathering over the weekend. Patient states she has been vaccinated for covid. Pneumonia due to COVID-19 virus AIRBORNE PRECAUTIONS CONTACT PRECAUTIONS INFECTION CONTROL REFERRAL CULTURE, BLOOD FERRITIN LDH TOTAL CK cefTRIAXone (ROCEPHIN) in D-2.22% 50 mL IV piggyback (DUPLEX) (premix) 2,000 mg 2. Cough INFECTION CONTROL REFERRAL SARS-COV-2, INFLUENZA A+B, AND/OR RSV NUCLEIC ACID TESTING PANEL COMPLETE BLOOD COUNT WITH DIFFERENTIAL COMPREHENSIVE METABOLIC PANEL C-REACTIVE PROTEIN (INFLAMMATION) LACTIC ACID ESR BLOOD GASES VENOUS albuterol-ipratropium (DUO-NEB) 2.5-0.5 mg/3 mL inhalation solution 3 mL methylPREDNISolone sod succ (SOLU-medrol) injection 60 mg PROCALCITONIN XRAY CHEST PORTABLE - 3. Nausea ondansetron (ZOFRAN) injection solution 4 mg ondansetron (ZOFRAN) injection solution 4 mg 4. Other headache syndrome INFECTION CONTROL REFERRAL SARS-COV-2, INFLUENZA A+B, AND/OR RSV NUCLEIC ACID TESTING PANEL COMPLETE BLOOD COUNT WITH DIFFERENTIAL ondansetron (ZOFRAN) injection solution 4 mg ketorolac (TORADOL) intravenous injection 15 mg 5. Shortness of breath INFECTION CONTROL REFERRAL SARS-COV-2, INFLUENZA A+B, AND/OR RSV NUCLEIC ACID TESTING PANEL COMPLETE BLOOD COUNT WITH DIFFERENTIAL COMPREHENSIVE METABOLIC PANEL C-REACTIVE PROTEIN (INFLAMMATION) D-DIMER QUANTITATIVE TROPONIN I EKG LACTIC ACID ESR CULTURE, BLOOD BRAIN NATRIURETIC PEPTIDE albuterol-ipratropium (DUO-NEB) 2.5-0.5 mg/3 mL inhalation solution 3 mL methylPREDNISolone sod succ (SOLU-medrol) injection 60 mg PROCALCITONIN XRAY CHEST PORTABLE - CTA CHEST TROPONIN I 6. PAH (pulmonary arterial hypertension) with portal hypertension BLOOD GASES VENOUS 7. Elevated troponin level 8. Positive D dimer CTA CHEST 9. Elevated serum lactate dehydrogenase (LDH) 10. AKI (acute kidney injury) URINE DIP, REFLEX TO MICROSCOPIC, REFLEX TO CULTURE sodium chloride 0.9% (bolus) IV solution 250 mL 11. Liver cirrhosis secondary to NASH PROTIME/INR PTT ASSESSMENT/PLAN/DECISION MAKING: -Transferred to another healthcare facility." "1825226-1" "1825226-1" "Pt presented to Emergency Room at local Medical Center on August 29, 2011 with complaints of not feeling right and fell at home. The patient was diagnosed with COVID-19 infection, he was previously fully vaccinated on 2/19/2021 & 3/12/2021. Patient completed Remdesivir and Decadron, patients oxygen requirements increased during hospitalization, requiring additional course of steroids. Patient required CPAP during the Hospital Course. After using the CPAP, the patient developed a facial abscess. ENT did an incision and drainage. The patient completed antibiotics. Patient was admitted to a Specialty Hospital. to continue care. On 10/27/2021 the patient met with the physician and family members and due to his significant decline, poor prognosis and increased oxygen needs, the patient chose to go comfort cares and expired on 10/27/2021 1835." "1825328-1" "1825328-1" ""I am the epidemiologist reporting on behalf of 92-year-old male patient. The patient received two doses of the Pfizer vaccine on 02/09/21 and 03/02/21. The patient received their third dose of the Pfizer vaccine on 10/01/21. On 10/10/21 (10 days post dose 3), the patient took a PCR test and a rapid test and was positive on both. According to contact tracing team who spoke with daughter of case, case was asymptomatic with the 3rd dose of the Pfizer vaccine. On 10/12, the case was moved to Hospice care as they are not treating the case for COVID, however, as they speaker mentioned a ""heart attack."" The patient died on 10/15/21 (15 days post 3rd dose). The cause of death is listed as ?Acute respiratory failure; Pneumonia due to Covid ;Covid? on the death certificate. Other significant conditions contributing to death but not resulting in underlying causes are listed as ?adult failure to thrive syndrome.? Known pre-existing conditions include cardiovascular disease."" "1825340-1" "1825340-1" "Case of a 65 years old female with past medical history of high blood pressure, HFrEF, COPD, CAD with CABG x 5 and hyperlipidemia presents to the ED due to complaints of shortness of breath, On EMS arrival patient was found in the 70s O2 room air, given breathing treatments during route to the ED, she is vaccinated against covid. She has been exposed to family members at home. Denies any hx of diarrheas, abdominal pain, headache, fever or other associated symptoms. Urine and bowel pattern within normal limits, patient is also aware that she has a mass in her lung and she has been unable to have a CT, since she has been denies twice by her insurance. Patient is independent ADLs and instrumental ADLs. Denies any toxic habits/ former smoker On admission: ProBNP is 29783. Her creatinine is noted to be 5.2. Previous creatinine from September of 2021 was 2.4. EKG shows sinus rhythm at 73 beats per minute with incomplete right bundle-branch block. XR Chest 1V 1. Focal masslike opacity in the left midlung. This may reflect a well-defined focus of consolidation or pneumonia however a mass is not ruled out. Further characterization with CT chest recommended. 2. Left basilar infiltrates and adjacent mild left-sided effusion. 3. Background of COPD and scattered fine reticular opacities suspected chronic. Tested + COVID 10/10/2021 1256" "1825439-1" "1825439-1" "Previously submitted data on this patient, E report #679858 submitting f/u information. Pt expired 10/28/2021 PRINCIPAL DIAGNOSIS COVID-19 Infection SECONDARY DIAGNOSES Principal Problem: COVID-19 Infection Active Problems: Pneumonia Due To COVID-19 Leukemia Lymphocytic Chronic Not Having Achieved Remission (HCC) Acute Respiratory Failure With Hypoxia (HCC) Leukemia Lymphocytic Chronic In Relapse (HCC) Chronic Kidney Disease (CKD), Stage 3b Glomerular Filtration Rate (GFR) 30 To 44 (HCC) Thrombocytopenia (HCC) Depression Major Recurrent Partial Remission (HCC) PreDiabetes Hypertension Essential Primary Hypogammaglobulinemia (HCC) Decline Functional Status Depression Major Recurrent (HCC) Shortness Of Breath" "1825514-1" "1825514-1" "pt diagnosed positive for COVID, received monoclonal antibodies and afterwards became hypoxic, transferred to ED and admitted to hospital; hx of CAD, OSA, COPD; O2 @15 L via NC; pt found in room with O2 off her face; coded a total of 3 x; after the last code, family made her a DNR; pt's condition worsened and she died in the hospital; COVID pneumonia" "1825543-1" "1825543-1" "Covid-19 diagnosis and symptom onset 9/7/2021 including cough, pneumonia" "1825563-1" "1825563-1" "Deceased (10.23.21); Hospitalized (10.20.21); COVID-19 positive (10.20.21); fully vaccinated Primary Care Physician at Discharge Admission Date: 10/20/2021 Date of Death: 10/23/21 Time of Death: 5:47 PM Preliminary Cause of Death: Pneumonia due to COVID-19 virus DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Supratherapeutic INR Acute on chronic anemia Acute respiratory failure due to COVID-19 HOSPITAL COURSE: 86yo Afib on coumadin, trip/fall on 10/20, admitted to IM for INR-7.3, recent GIB (9/13 EGD with coag, 10/1 21 friable polyps resected for oozing and need for anticoagulation), found to be COVID + (full vax with Pfizer and booster), symptoms of weakness, poor appetite since 10/14, 10/22 Azith/Rocephin started for CAP, pt mentation declining, taking off his oxygen, not following commands, early AM 10/23 pt removed oxygen, went into PEA arrest. ROSC obtained after 15min. Intubated, cooled to prevent fever, no target temp. CT head done and NEG, EEG ordered however son came in to see patient, held a family mtng and decided to go comfort care. Therefore pt was extubated this afternoon, sedation off and passed away peacefully." "1825612-1" "1825612-1" "Death" "1825631-1" "1825631-1" "Death" "1825665-1" "1825665-1" "pt admitted to the hosp with increasing SOB over past 2 days; hx COPD; positive test for COVID; placed on BiPAP due to increasing O2 requirements; acute on chronic respiratory failure with hypoxemia; cough continued to worsen and O2 requirements increased requiring intubation; cardiac arrest occurred and pt died in the hospital despite aggressive measures to prolong life" "1825680-1" "1825680-1" "Patient had breakthrough infection and deceased." "1825688-1" "1825688-1" "covid death 10/10/2021" "1825695-1" "1825695-1" "death on 10/8/2021" "1825704-1" "1825704-1" "They had a breakthrough infection and deceased." "1825715-1" "1825715-1" "DECEASED" "1825790-1" "1825790-1" "5 days prior to hosp, pt tested positive for COVID; admitted with increasing SOB; taking Medrol Dosepak and antibiotic; O2 @ 6L via NC initially; progressed to BiPAP and eventually required intubation; experienced hypotension and A Fib; pt was extubated in palliative manner; she died in the hosp" "1826661-1" "1826661-1" "Shortly after receiving vaccine my mother began to suffer dizziness, blackouts, and a headache that would not stop no matter what she did. Tylenol, ibuprofen, fainting spells and brain fog like amnesia. There were recent visits to the emergency room and never before but the er had difficulty stopping bleeding from trying to start an iv then sudden death october 24th body found in apartment at 930 pm pacific time." "1827561-1" "1827561-1" "became worse, she could not speak, the right part of the limbs did not move/diagnosed a stroke; coma; evening of the same day she was gone; low blood pressure; ill; confused in conversation; This is a spontaneous report from a contactable consumer. A 97-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Aug2021 the patient was vaccinated. After 2 hours, when they were returning home, the patient became ill (she began to react unusually to events, confused in conversation, slowed down her speech). After 10 we arrived home, the situation did not change, being scared, the reporter immediately called an ambulance. The doctor said that this was a normal phenomenon after vaccination, and because of low blood pressure, he gave an injection that increases blood pressure, recommended sleeping and resting. The reporter did not calm down on this and called the doctor who did the vaccination, she repeated the same thing that everything would pass in 2-3 days, and that this condition fully complies with the recommendations. The doctor and reporter called several times during 22Aug2021 and 23Aug2021, she assured they that she had called the COVID center, and they said the same thing - a normal reaction of the body. At about 8.30 am on 24Aug2021, the patient became worse, she could not speak, the right part of the limbs did not move, an ambulance was immediately called, the doctor diagnosed a stroke, then took her to the specialized hospital. As a result, she was in a coma (24Aug2021) until 31Aug2021, and in the evening of the same day she was gone. The patient died on 31Aug2021. It was not reported if an autopsy was performed. The outcome of events was not reported. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: evening of the same day she was gone" "1827568-1" "1827568-1" "Passed away in the sleep; This is a spontaneous report received from a non-contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration in the right arm on 02Oct2021 05:00PM (at the age of 66-years-old) as dose 3 (booster), single for COVID-19 immunisation at a pharmacy or drug store. The patient's medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included insulin taken for an unspecified indication, start and stop dates were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date in Feb2021 (at the age of 66-years-old; Batch/lot number and expiration date were not reported) as dose 2, single and on an unspecified date in Jan2021 (at the age of 66-years-old; Batch/lot number and expiration date were not reported) as dose 1, single, both via an unspecified route of administration in the right arm and for COVID-19 immunisation. No other vaccine in was administered in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. On 07Oct2021 09:00AM, 4 days later after the booster shot, the patient passed away in the sleep. It was unknown if treatment was received for the event. The outcome of the event was fatal. The patient died on 07Oct2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Passed away in the sleep" "1828445-1" "1828445-1" "observed resident to be passed away" "1828580-1" "1828580-1" "Patient presented to emergency room on 9/4/2021 with generalized body aches and loss of consciousness. He was found to be COVID-19 positive on 9/3/2021. Patient's symptom were mild at that time and was discharged home with instructions for further management. Patient presented to emergency room again on 9/7/2021 with chest pain and shortness of breath. He was immediately placed on high-flow nasal cannula and admitted for further management. He was treated with dexamethasone and baricitinib and was transferred to the ICU on 9/8/2021. Patient's condition continued to deteriorate and he was intubated on 9/24/2021. Patient's condition was further complicated with bacterial infection, septic shock, acute renal failure requiring CRRT, acute toxic metabolic encephalopathy, and GI bleeding. Patient went into PEA arrest on 10/18/2021 and was unable to be resuscitated. Patient expired on 10/18/2021." "1828586-1" "1828586-1" "Vertigo, Dizziness, Hearing loss progressing to kidney and liver failure and death." "1828596-1" "1828596-1" "COVID RELATED DEATH; BREAKTHROUGH CASE" "1828603-1" "1828603-1" "COVID RELATED DEATH; BREAKTHROUGH CASE" "1828678-1" "1828678-1" "Patient was a 89 y.o female with medical hx including afib, htn, hypothyroidism who presented to OHRH ED with worsening SOB after being diagnosed with COVID19 on 10/20/2021. Symptoms started a few days prior. She was COVID 19 vaccinated. She was requiring some O2 via nc, but not more than a few L. However, she was in afib RVR and minimal pleural effusions seen in CXR. Pt's GFR was only 35 no remdesivir not given. bnp 2800, lactic acid 5.4. ER concerned about suggestive of infectious process. No wbc, procal pending. No purulent sputum production. Cardiology consulted. Patient was resumed on oral medication and weaned from Cardizem drip. Cardiology also felt that her NSTEMI was demand ischemia from her underlying sepsis. Staff were able to control her heart rate. Unfortunately, she did have some issues with AKI, but they could not give any fluids due to shortness of breath and 3rd spacing. Pt was being treated empirically for severe sepsis. She received vancomycin and cefepime. According the the Dr. she was complaining of not feeling well when he visited her. The Doctor stated her morning labs had not yet resulted as they were not collected until 0847 hr. About 15 min after he saw her. MRT was called. He urgently went to the room, unfortunately, Pt. was already unresponsive." "1828681-1" "1828681-1" "Died six months later from CJD." "1828685-1" "1828685-1" "Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 8/26/2021. Patient presented to ED on 10/2/2021 for shortness of breath, coughing and wheezing. Patient has a week of feeling unwell, saying she has had worsening dyspnea on exertion, PND and orthopnea. She also mentions stopping all of her medications for two days when that happened because she was feeling too unwell. 4 days ago, her shortness of breath acutely worsened. She had been dusting and the dust made her wheezing and coughing worse. Shortness of breath became severe enough that she needed to come to the ED. The patient was admitted on 10/3 for COPD exacerbation and COVID pneumonia. She developed worsening hypoxemic respiratory failure with increasing HFNC requirements and was subsequently transferred to the ICU on 10/11. Her renal failure worsened so a femoral quinton was placed but the patient became very hypotensive and hypoxic with every attempt at HD or CRRT. The patient decided that she would not want to pursue intubation in the setting of further respiratory deterioration. Code status was changed to DNAR-COT. Since dialysis made the patient too hypoxic while already on HFNC, the decision was made to not pursue further dialysis and the quinton was removed. Then, the patient's pneumonia panel came back positive for pseudomonas and her respiratory culture indicated the presence of mold. She was started on cefepime and cresemba. Her oxygen requirements decreased and she was transferred back to the floor on 10/19. However, on 10/20 she was brought back to the ICU once again for worsening hypoxia requiring 60L/90% on HFNC. She also developed hemoptysis, anemia, and thrombocytopenia requiring transfusion of platelets and pRBCs. V/Q scan was negative for PE. On 10/23, the patient developed acute word finding difficulty while speaking with family member in the setting of a brief run of afib and ongoing thrombocytopenia. CT brain was ordered to assess for stroke/bleed. However, after discussion with the patient and her daughter, the decision was made to withdraw all support. She was made DNAR-AND and was started on comfort care. On 10/24/2021, patient was pronounced deceased." "1828690-1" "1828690-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 3/31/2021 and 4/29/2021. Patient presented to outside facility ED on 9/30/2021 with chief complaint of feeling ill and fever of 2-3 days duration. Patient also had slight dry cough, diagnosed with COVID, and discharged home. On 10/2/2021 patient presented to ED with c/o SOB, chills, and generalized weakness that had been ongoing for 3 days PTA. Pt had also had hematuria and increased urinary frequency. ED workup revealed BUN 24, sCr 1.4 and thrombocytopenia, While in ED, following the Regen-COV infusion He became hypoxic requiring 15L/min O2 and syncopal episode lasting <30 seconds. He was admitted to med-surg for acute respiratory failure. On 10/10, his clinical course was complicated by worsening respiratory distress and he was transferred to ICU for further management. On 10/14/2021 patient required intubation and mechanical ventilation support. On 10/23 patient required multiple vasopressor support. On 10/24 family decided to transition to comfort care and patient expired on 10/24/2021." "1828696-1" "1828696-1" ""Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/2/2021 and 3/24/2021. Presented to ED on 10/22/2021 for evaluation of weakness that resulted in falls yesterday and today with associated upper back and neck pain. Pt is unable to give a complete ROS. States that he got COVID from his wife but does not know when his symptoms started, endorses a cough with green sputum for ""a long time"", weakness, and upper back and neck pain from fall. He states that he is so weak he is unable to stand up. Denies n/v, diarrhea, CP, SOB, ABD pain, ROS otherwise limited. PT extremely HOH. EMS reported O2 sat 90% on RA at home. Patient started on dexamethasone and remdesivir. Further history from patient indicated his prior diagnosis of bacterial of PNA was done over the phone. His imaging findings were consistent with bacterial PNA, he had no WBC and a relatively unimpressive procal, bacterial PNA was unlikely so abx were stopped. The following day patient became agitated and confused. He was alert only to himself but still attempted to converse and answer questions, he had no focal neurological signs. This was thought to be delirium from COVID-19, his UA was negative and his CXR was negative for aspiration and he did not show signs of sepsis. The following morning patient was obtunded and would not respond to sternal rub, he had nonreactive pupils. A stat CT head was ordered which revealed a massive extra-cranial bleed with 5 cm midline shift and subfalcine as well as uncal herniation. The bleed was most likely epidural or subdural in origin. Family elected to make patient comfort care and patient expired on 10/26/2021."" "1828699-1" "1828699-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/27/2021 and 2/22/2021, and 8/31/2021. Patient presented to ED on 10/15/2021 with complaints of cough & SOB x 2 weeks - diagnosed with covid PNA 2d prior prescribed doxycycline. Pt presents today because he reports he was coughing and had sharp pain at center of chest/ xiphoid process. Pt transferred to the ICU due to increasing oxygen requirements from COVID pneumonia. Pt also found to be anemic at that time and transfused 1 unit w/ improvement in Hgb levels. Pt had a history of aortic stenosis so a TTE was performed which revealed severe aortic stenosis, which significantly increased his chances of a difficult intubation due to poor cardiopulmonary reserve. Pt subsequently began developing worsened respiratory status and required intubation. Pt then developed worsening renal failure requiring CRRT. CRRT caused pt to become extremely hypotensive despite being on 3 pressors and near max. Pt also developed afib w/ RVR and had to be started on amio gtt. CRRT was paused and initially BP recovered without use of pressors, however over the course of a few hours pressors had to be added back. Pt also began having elevation of lactic acid, low temperatures, and elevated WBC so was re-cultured at that time. Family decided at that time they would like to allow patient to have comfort care, and patient expired on 10/26/2021" "1828700-1" "1828700-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 2/2/2021 and 3/2/2021. Presented on 10/13/21 with dyspnea and hypoxia. Diagnosed with acute/chronic CHF, anemia and COVID pneumonia. Aggressively managed but failed to respond. Family opted for comfort care rather than continued aggressive management and she was admitted to hospice for end of life care." "1828735-1" "1828735-1" "My son died of a brain bleed. He was a healthy 39 yr old. It was sudden and unexpected." "1828774-1" "1828774-1" "Patient fully vaccinated with Pfizer. Second dose received 4/29/2021. Tested positive for COVID on 10/14/2021. Admitted to Hospital on 10/15/2021. Expired on 10/20/2021 while still hospitalized." "1828795-1" "1828795-1" "Case fully vaccinated with Moderna. Second dose administered on 4/23/2021. Tested positive for COVID on 10/12/2021. Admitted to Medical Center on 10/21/2021 and expired on 10/27/2021 while still hospitalized." "1828802-1" "1828802-1" "Death on 10/27/2021" "1828858-1" "1828858-1" "Feeling ill, became unresponsive and called 911 Full resuscitation efforts given, patient expired in the field" "1828873-1" "1828873-1" "Feeling ill, weakness - cardiac arrest Full resusitation efforts, transported to Hospital ED" "1828901-1" "1828901-1" "Patient reported symptomatic (non-severe) case of COVID-19 August 2021 and recovered fully. She reported receiving Pfizer COVID vaccine 9/3/21 and second dose 9/15/21. She present to the emergency department of my hospital 10/23/21 with chest pain and dyspnea for 48h. Was feeling completely well prior to onset of chest discomfort. Symptoms were mild. No sick contacts or family members. ED evaluation remarkable for normal exam, no hypoxia, normal blood pressure. EKG with diffuse ST elevation. Troponin elevated at 20. CTA chest negative for PE or pneumonia. SARS-CoV-PCR positive but thought to be persistent positive rather than reinfection because of lack of clinical symptoms, recent COVID-19 and recent vaccination. Cardiologist consulted, thought acute coronary syndrome unlikely based on age and lack of risk factors. STAT Echo resulted depressed EF 40-45%. Simultaneously she had become increasingly tachycardic and EKG appeared more ischemic. Cardiac cath lab was activated and she was about to be transported when she suffered cardiac arrest. Initial rhythm was VT. Received ACLS protocol CPR x 65 minutes including multiple cardioversion, amiodarone, lidocaine, magnesium and other antiarrhythmics. Unfortunately she was not able to be resuscitated and died. Cause of death possible acute myocarditis." "1828960-1" "1828960-1" "Patient presented to ED on 10/13/21 from a long term care facility with covid positive status. Patient is fully vaccinated, on hospice care. Due to failure to thrive, family transitioned the patient to private facility and patient passed on 10/24/21." "1828972-1" "1828972-1" "pt diagnosed COVID positive 2 days before hospital admission; admitted with increasing SOB and malaise; O2 saturations @ home were 85%; placed on O2, 8L via NC; cough, treated with dexamethasone and baricitinib; has AKI therefore didn't treat with remdesirvir; COVID pneumonia and ARF with hypoxia; placed on Vapotherm and eventually BiPAP; pt's condition worsened; palliative care was consulted; pt was taken off BiPAP and she was kept comfortable; pt expired in the hospital" "1828975-1" "1828975-1" "On 10/14/21 the resident had a change of condition and was unresponsive. He was pale and lethargic. He had hypoxia and sats were 58% and supplemental oxygen was increased. Resident was transferred to the ER. The resident was treated at the hospital for pulmonary infiltrates, cellulitis LUE, aspiration pneumonia, hypokalemia, hypomagnesis." "1828986-1" "1828986-1" "Patient had a breakthrough infection and deceased." "1828993-1" "1828993-1" "Resident passed away on 10/17/21" "1828998-1" "1828998-1" "Patient tested positive for COVID" "1829051-1" "1829051-1" "Patient was admitted to the hospital on 09/27/2021. Patient tested COVID positive on 10/08/2021 after cough initiated. He was placed in isolation, On 10/11/2021 CXR was suggestive of infiltrates and became very symptomatic on 10/12/2021 requiring oxygen treatment. Treatment was started on Decadron and remdesevir. On 10/14/2021, baricitinib was added; on 10/16/2021 his pneumonia worsened and theres was small to moderate effusion; Vancomycin and zosyn IV were added as well. It was noted that he had anasarca and treated with lasix which didn't help his respiratory status. On 10/18/2021, CXR showed continued opacities and RT lung atelectasis; 10/19/2021 he was coughing uncontrollably. Palliative care was recommended and patient transferred to hospice on 10/21/2021 and passed away on 10/22/2021." "1829067-1" "1829067-1" "pt tested positive for COVID 10 dys prior to hosp admission; presents to hosp with increase in SOB and chest pain; O2 sats at home were 60% on O2 3 LPM; placed on 100% NRBM; hx of COPD and OSA with CPAP; treated with dexamethasone and redisivir; pt's condition worsened and she requested a DNR/DNI; pt expired in the hosp; COVID pneumonia" "1829098-1" "1829098-1" "Patient passed away on 10/27/2021 from a heart attack." "1829128-1" "1829128-1" "Patient was hospitalized after testing positive for COVID" "1829151-1" "1829151-1" "First shot was February 8, 2021. A day later he started to lose control of his nerves. He was constantly shaking. He couldn't hold a glass with water without it flying out of his hand accidentally. He needed someone behind him to walk anywhere because he would faint. The second shot was March 8, 2021. The symptoms got worse. He was not able to walk without a walker, which quickly led him to a wheelchair. There was one day he felt to confident and tried to sit at the counter barstool. His legs gave out, or he fainted, we're not sure, but he landed on the ground and hit his head so hard he was unconscious and he brought him to the hospital. A week later he was on his way out from discharge and he fell again. He did not leave the hospital again. His kidneys failed, then his liver, and then his heart. He died on May 14, 2021." "1829189-1" "1829189-1" "Patient hospitalized after testing positive for COVID." "1829223-1" "1829223-1" "pt admitted to hosp with hypoxic respiratory failure and sepsis due to positive for COVID 19; treated with antibiotics, steroids, breathing treatments; remdesivir, Baracitinib; overall condition and oxygenation worsened; pt experienced respiratory arrest in the hospital" "1829230-1" "1829230-1" "Patient expired 10/27/2021." "1829244-1" "1829244-1" "Pt came to ER c/o SOB." "1829253-1" "1829253-1" "pt presented to ED with 3 days of increasing SOB; positive for COVID in ED; treated with dexamethasone, remdisivir, tocilizumab; on 15 L O2 via NC; oxygenation worsened requiring ICU and intubation; bronchopleural fistula secondary to heavy hx of vaping and cigarette use; was eventually made a DNR; comfort measures; extubated and patient expired in the hosp" "1829274-1" "1829274-1" "Unknown" "1829276-1" "1829276-1" "pt admitted to hosp after 3 days of fever, cough, SOB; positive for COVID 19; hypoxic respiratory failure; septic shock - treated with Levophed; acute encephalopathy; remained in coma; exacerbated episode of COPD; placed on ventilator 100% FiO2; multiorgan system failure; pt was made a DNR and comfort measures; extubated and pt died at the hospital" "1829320-1" "1829320-1" "NECK PAIN AND DEHYDRATION" "1829361-1" "1829361-1" "EMS brought pt to ED; O2 sats on room air are 50%; placed on CPAP; pt unresponsive; tested positive for COVID; intubated; went into cardiac arrest x 10 mins and a second time for 7 mins; family states they do not want CPR or medication to be used on patient; pt's condition worsened and he expired in the ED" "1829423-1" "1829423-1" "pt was found at home by family unresponsive and with facial cyanosis after an apparent fall; EMS called; no CPR done due to cyanosis and unresponsiveness; family states he had cough and congestion past 5 - 6 days; pronounced dead at home; COVID test was positive." "1830620-1" "1830620-1" "From the date of his vaccine til the date he went to the hospital (August 22, 2021) he felt these symptoms more and more. Soar arm, chills, body aches, fatigue, fever, lost of taste, cough, shortness of breath, excessive sweating, heavy chest, couldn?t walk or use legs, couldn?t urinate after drinking water. He took Advil(red pill). He died August 23, 2021" "1831095-1" "1831095-1" "Cardiac arrest one week later, on 03Mar died 3 months later; Cardiac arrest one week later, on 03Mar died 3 months later; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 24Feb2021 02:00 (at the age of 73-years-old) (Batch/Lot Number: En6302) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. The patient has no known allergies. The patient did not have covid prior vaccination and was not covid tested post vaccination. On 03Mar2021 07:00, the patient experienced cardiac arrest one week later, on 03Mar2021 died 3 months later. Therapeutic measures were taken as a result of the events. The patient died on 03Mar2021. It was not reported if an autopsy was performed. The outcome of the event cardiac arrest was not recovered. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest one week later, on 03Mar died 3 months later" "1831721-1" "1831721-1" "Blood clot induced death." "1832044-1" "1832044-1" "Found unconsious, vomiting in bed following a very normal day CT scan revealed catastrophic cerebral hemhorrage on both sides of the brain Intubated at hospital, withdrew care from ventilator the next day due to unrecoverable diagnosis Booster vaccine given 9 days prior to incident. Died 10/27/2021" "1832228-1" "1832228-1" "04-07-21 reported fluid in L lung, SOB taking stairs, 1st ER visit 04-12-21 difficulty breathing, fluid drained twice bet. April 12 and May 14, tooth pulled at one point in between lung procedures, 06-25-21 reported that fluid drained 3 times total since onset in April, hospitalized July 19 - 26, dr. office to ER by ambulance, reported August 16 more fluid drained, hospitalized prior to Labor Day (Sept 6) O2 was 52 at a dr. office, hospitalized Sept 15 or 16 for five days, 09-27-21 reported O2 of 70 at doctor office, first day out of breath since last hospital stay, pulmonary and cardiac specialists were still conferring, patient was seeking a donation for a portable O2 unit, needing O2 more often throughout the day and night. Tried to drive to hospital again Oct 4, found unconscious on side of road, in a coma on ventilator until October 11 when family removed ventilator and she passed away." "1832259-1" "1832259-1" "Patient's sister, called to inform us that patient received her Pfizer booster vaccine on 10/5/21. Patient did not experience any symptoms/side effects (sister) on 10/5/21; however, patient had a heart on 10/6/21 and later passed away on 10/7/21." "1832300-1" "1832300-1" "weakness, head ache-DEATH" "1832855-1" "1832855-1" "Pt died after testing positive for COVID-19 8/2/2021" "1833007-1" "1833007-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 4/22/2021 and 5/13/2021. On 8/28/2021 patient presented to a outside facility with complaints of worsening shortness of breath and chest tightness with patient report of positive COVID test on August 20th. On 9/1/2021 patient presented to ED with chest pain and shortness of breath. VS stable; minimally tachycardia. Physical exam overall reassuring. The pt is well appearing, nontoxic, in NAD. Lungs CTAB, no respiratory distress. Labs overall reassuring. No leukocytosis to concern for sepsis. Troponin negative. BNP normal. ECG w/o ST elevation;" "1833052-1" "1833052-1" "Patient received her booster vaccine on 10/27/2021. Was found on the floor on 10/28/2021 at the facility at that moment her heart rate was 142. Patient was transferred to the hospital and from there to Larger hospital and went into cardiac arrest and could not get her back. Patient passed away on 10/29/2021 at 11:44am. We discussed with the facility medical director and was advised to let Pharmacy know. As per medical director he doesn't know if the cause of death was due to booster vaccine or patient medical history since cardiac arrest has been reported previously with covid vaccine. Patient had history of some cardiac disease hypertension disease, heart failure acute on combined systolic and diastolic heart failure, and history of MI." "1833084-1" "1833084-1" "8-year-old male presents as a transfer from an outside facility for new onset atrial fibrillation, acute renal failure and COVID-19. VSS, NAD. Saturating well on 3 L nasal cannula. Previously hypoxic on room air. Received Solu-medrol 125 mg IV PTA. Creat 2.9 (prev. 1.2), trop 1.13. COVID positive. Given 5mg Metoprolol IV for HR 113. New onset afib. Rate controlled 90s. On Heparin gtt," "1833098-1" "1833098-1" "According to his mother, Pt received his second dose of the Moderna COVID-19 vaccine on August 2, 2021. Two days later, on August 4, 2021, he complained of not feeling well. He could not provide specific symptoms, but said that it involved his entire body and was not like anything he had ever experienced before. The following day, on August 5, 2021 he was found unresponsive on a train. He was subsequently hospitalized and pronounced deceased on 08/09/2021." "1833104-1" "1833104-1" "pt admitted to hosp and diagnosed with bilateral COVID pneumonia with respiratory failure; treated with remdesivir and Plavix; 15 L O2 on heated high flow; pt coded and was intubated; bradycardic then asystolte; pt pronounced dead in the hospital; acute on chronic hypoxia and respiratory failure due to COVID" "1833119-1" "1833119-1" "He had the shot on 9/1/21 after his dr recommended he get it following his appointment. He complained of arm pain and some lip numbness the same night. He was more tired than usual for the first couple of weeks and complained once of a slight chest discomfort. On 9/20/21, he went to work, got off and went for a walk/ jog and 10 minutes later called me to say he had pressure/pain in his chest. He died a few minutes later." "1833143-1" "1833143-1" "6 days prior to hosp admission, pt diagnosed positive for COVID in the ED; left AMA to home; admitted to hosp with increase in weakness and SOB; O2 sats in the 70s; placed on NRB and NC; treated with remdesivir and dexamethasone; PMH renal transplant, HTN, monoclonal gammopathy; DNI/DNR; optiflow therapy for hypoxia; condition worsened; pt transferred to palliative care; pt's condition continued to decline and she expired in the hosp" "1833171-1" "1833171-1" "pt admitted to hosp with c/o increasing SOB, malaise, N/V, O2 sats in 30s; placed on 60 L high flow NC; O2 sats in 70s, pt was intubated; diagnosed positive for COVID 19 and UTI; pt eventually extubated and placed on 35 L high flow NC with O2 sats @ 97%; began to wean off of O2 but later condition worsened and required intubation; pt's condition worsened and family wished to withdraw care; pt died in the hosp; respiratory failure due to COVID pneumonia as well as PE related to CHF and end-stage renal disease" "1833197-1" "1833197-1" "pt diagnosed positive for COVID on 8/25; received monoclonal antibody infusion on 8/30; presented to ED on 9/2 with increasing SOB, cough, weakness, N/D, poor appetite; found to have A Fib with RVR; hypoxic respiratory failure due to COVID 19; PMH of liver/pancreatic lesions; pt does not want chemotherapy treatment; started on dexamethasone and remdisivir, 2-3 L O2 via NC; AKI on CKD; pt elects to forego liver bx; comfort care measures were instituted and pt died in the hospital" "1833236-1" "1833236-1" "pt comes to ED and states he was diagnosed positive for COVID 2 days ago; presents to ED with increasing SOB, fever, chills, hypoxic, placed on 3 L O2 via NC; COVID test is positive; pt is hyperglycemic; received insulin, steroids, antibiotics, remdisivir, thromboembolic prophylaxis; eventually switched to BiPAP; mental status worsened; MRI of brain shows widespread, extensive acute infarctions; his condition worsened and he eventually passed away in the hospital" "1833377-1" "1833377-1" "pt admitted to hosp after being tested in assisted living for COVID - test was positive; c/o increasing SOB and generalized weakness; placed on O2 therapy, dexamethasone and remdisivir; dc'd remdisivir due to AKI; placed on BiPAP for a period of time, but was able to go back to HFNC; pt not responding well to therapy; palliative care discussed; pt placed on comfort care measures; she passed away in the hospital" "1833444-1" "1833444-1" "pt with metastatic lung CA found after evaluation of a dry cough; pt tool 1 round of chemotherapy and declined any more treatments; asked for hospice care; while in hospice pt expired on 9/21; COVID test performed on 9/21 and reported on 9/23/21, the test was positive for COVID 19" "1833526-1" "1833526-1" "pt arrived to hosp via EMS; EMS called due to increasing SOB; O2 sats 60s; placed on CPAP; cyanotic and no improvement; pt gave consent to be intubated in the field; pt was positive for COVID 1 wk before arriving at the hosp, completed remdesivir and steroids; PMH: chronic respiratory failure, on 10-12 L O2 via NC and astral device at home; in ED pt was severely hypotensive with septic/cardiogenic shock; pt was made a DNR; he arrested in the ED and died" "1833657-1" "1833657-1" "4/27/21 visit to clinic: 74yr old female who has had off balance and leaning way to right and stumbling. This lasted short time. By time sister got to view she was sitting in a chair. Some of these symptoms began 2 days before this visit and have been completely resolved since that time. Patient has tried No medications. 7/9/21 clinic 75yr old female presents for referral to ortho for fracture of elbow and possible wrist. Had fallen 6 days ago. Was seen in ER and pout in posterior cast and told to see ortho when back here. recommends for her to be seen by Specialist. She may need a total elbow replacement. 9/12/21 ED Closed displaced fracture of medial epicondyle of right humerus, unspecified fracture morphology, initial encounter Acute 9/17/21 admit to nursing home H/O: CVA (cerebrovascular accident) Dementia without behavioral disturbance, unspecified dementia type (HCC) Cognitive safety issue Plan: She will be admitted to nursing home on Tuesday, 9/21/2021. We have asked her that the physical therapy would evaluate her for the best cane possible 10/29/21 Patient presents to ED via EMS from nursing home for diaphoresis, altered mental status. She was 'found like this' by nursing just prior to arrival to ED. Patient has prior history of CVA, recovered. Staff believed she may be having 'another stroke'." "1834252-1" "1834252-1" "Patient received Pfizer COVID vaccine on 3/6/21 and 3/26/21. On 10/23/21, patient admitted for acute hypoxemic respiratory failure due to COVID-19 pneumonia with bilateral pleural effusions. During admission, patient also developed MRSA LLE osteomyelitis and sepsis, AKI, pyelonephritis in transplanted kidney. Patient expired on 10/25/21." "1836360-1" "1836360-1" "SHORTNESS OF BREATH with hypoxia, D satting into the 80s when she sleeps at night, now at about the 11th day of illness with COVID-19.Diagnosed with covid on 10/10, presented to outside hospital on 10/12, after having been sick for about 9 days." "1836506-1" "1836506-1" "Tested + for COVID via home kit on 10/17. Scheduled for monoclonal antibody but condition worsened. Present to medical center on 10/21 with worsening dyspnea, cough, and fever. Started on dexamethasone and remdesivir. O2 requirements increased and started on baricitinib. Hx DVT on warfarin with D-dimer 0.42 and low risk for DVT. Bridged to enoxaparin. Increased confusion and mental status changes during hospitalization consistent with delirium. Not tolerating po meds secondary to cough and high aspiration risk. Maxed out on Vapatherm with O2 saturations in the 80's. Family decided to transition to comfort care with DNR." "1836638-1" "1836638-1" "a 63 y.o. male has history of HFrEF due to ICM, mod-severe MR, CKD II-III, DMII, MI X2 with PCI and LV thrombus on warfarin. He is currently listed for heart transplant. Patient complaints of loss of appetite, generalized weakness, mild productive cough, and mild dyspnea since Saturday. He denies fever, chills, sore throat, nausea, vomiting, abdominal pain, diarrhea, loss of taste or smell. Patient denies any recent weight gain or weight loss. He initially went to Emergency Room where he was tested positive for COVID 19. He was given Tylenol then was transferred for higher level care. Unknown contact information for provider who cared for the patient. Review of Systems Constitutional: Positive for appetite change and fatigue. Respiratory: Positive for cough and shortness of breath. Pt remained on warfarin, was started on remdesivir and steriods. Pt was diuresed for fluid overload and developed AKI, lasix were held. Pt had worsening oxygen requirements overnight and was re-started on diuresis. Pt coded and underwent about 1 hour of CPR and was pronounced at 11:28 am." "1836656-1" "1836656-1" "Patient 59 y.o. male who presents the ED today from Hospital for further evaluation of aspiration shortness of breath. Patient has ALS, states that he feels like he is getting worse slowly, is not having difficulty swallowing, states that he wants to focus on his comfort, and go inpatient hospice route. Patient is currently DNR and has a power-of-attorney currently, who is at bedside with him today. Patient denies any symptoms of fever, endorses coughing episodes and severe anxiety, but no other symptoms at this time. Of note, contact information for provider who cared for the patient at the outside facility not available in our electronic health record. On exam, he is ill appearing, cahectic, in mild respiratory distress, on nasal canula, following commands, has good air entry bilaterally with bilateral rhonchi, normal S1S2, soft abdomen, PEG tube in place, has bilateral feet drop and hands contractures and weakness/spasticity. 1- COVID-19 pneumonia in settings of progressive ALS disease: patient was not hypoxic though he is on some oxygen for comfort. No indication for dexamethasone or remdesivir. He was well determined that he would like to pursue comfort care and not undergo any invasive intervention or active treatment of his disease. We will keep im comfortable, morphine PRN, scopolamine patch, Ativan PRN, and Robinul PRN. We will use CPAP at night as may help to make him more comfortable (recommended by pulmonary as outpatient but did not start using it yet) Presented with shortness of breath in the setting of ALS/MND and concern for aspiration. He was found to have COVID-19 pneumonia but opted for comfort measures. He was provided comfort medications. He passed away prior to transitioning to a nursing facility to pursue hospice care." "1836663-1" "1836663-1" "pt told to come to ED due to blood sugars over 500; when got to ED his O2 sats where 59% on RA; increasing SOB; positive for COVID; placed on BiPAP; eventually required intubation and tracheostomy; O2 status continued to worsen and his sats went down; he went into cardiac arrest twice; CPR was done; family decided to stop CPR and pt expired in the hospital; Acute hypoxic respiratory failure secondary to COVID pneumonia; acute renal failure; DMT2; MI." "1836674-1" "1836674-1" "My father went to the emergency room at local HCF early on 28 October after suffering from severe chest pain and difficulty breathing. He was completely awake and lucid. After a few hours in the emergency room, they were unable to resolve the issue and lungs were filling with fluid. My father was intubated and shortly had 2 cardiac events. He was dead by 7AM on 28 october. The reason I am reporting this is because there is no way a completely healthy Human being becomes completely dead in the space of a few hours. It is my opinion that something triggered the mRNA instructions and the hospital was unable to stop the spike protein from taking over my father's system. I am not a doctor, but I have read a lot about Covid and the so called vaccine, and it is my belief that the lack of a 'shut off' valve related to the mRNA instructions caused the process to overload my father's system and a cytokine storm that the emergency room was unable to stop. The doctor did not come out and say this, but he implied that he had not seen anything like this and was unsure why it occurred." "1836681-1" "1836681-1" "pt to ED for increasing SOB over several days; was seen a dr's office for SOB and hypoxemia and told to come to ED; c/o cough; O2 sats in 70s on RA; started on 6 L O2 via NC; eventually transitioned to BiPAP due to worsening oxygenation; COVID test positive; placed on steroids, antibiotics, remdisivir, baricitinib; eventually required intubation and went into septic shock; condition deteriorated and pt expired in the hosp; acute hypoxic respiratory failure with multiorgan failure secondary to COVID" "1836784-1" "1836784-1" "Presents for progressively worsening SOB, fever, cough. Admit for afib RVR, COVID pneumonia, & acute resp failure w/hypoxemia. Tx: decadron, remdesivir, vit c, vit d, zinc. O2. Discharged to rehab." "1836785-1" "1836785-1" "Presents for AMS, cough, fever. +COVID PTA. Admit for acute hypoxic resp failure due to COVID pneumonia. Tx: Actemra, solumedrol, zinc,abx, increased O2 requirements; not a candidate for remdesivir. Made comfort care and expired on 8/7." "1836802-1" "1836802-1" "Presents for L sided chest pain, worsening SOB, weakness, multiple recent falls x1wk PTA; COVID+ PTA . Admit for COVID pneumonia w/hypoxia, closed rib fxs, closed head injury. RRT called on day 3 due to increased lethargy. MRI shows small acute/subacute lacunar infarct L thalamus. Increased O2 demand on day 7, placed on NRB. Tx: dexamethasone, abx, regional nerve block for rib fxs, O2; remdesivir held due to unknown duration of sx." "1836809-1" "1836809-1" "Patient presented to emergency department on 10/27/21 with resp distress. patient was admitted for further management of pneumonia. patient was found to be covid-19 positive on 10/22/2021. patient did requirement treatment for symptoms associated with covid-19 infection. Treatment included aggressive respiratory care, oxygen therapy, breathing treatments and other supportive measures. patient given dexamethasone, remdesivir. patient expired 10/31/2021 due to respiratory distress, acute hypoxemic respiratory failure secondary to covid 19" "1836838-1" "1836838-1" "Patient received 3rd dose of vaccine on 10/25 and experienced cardiac arrest and subsequently passed on 10/28." "1836891-1" "1836891-1" "Tested positive for covid on January 16, 2021. Death 2/9/2021" "1836948-1" "1836948-1" "Death - natural causes - 10/28/2021" "1836965-1" "1836965-1" "90yoF with pmh of hypothyroidism, HTN, RLS, neuropathic pain, HLD, and Parkinsonism who was admitted to the Hospital due to hypoxia. Patient was positive for COVID on 10/07 but was asymptomatic until 10/19 when she began to experience dry cough and had SpO2 in the 70s, requiring HFNC. Work-up on admission included CXR and CT PE, both indicating R enhancing perihilar mass, BL opacities and few nodules c/w pulmonary malignancy. Patient's son was contacted, who knew her wishes, and confidently did not think that she would have wanted further work-up or treatment of lung cancer. Palliative was consulted and involved in patient's care. Pt's hypoxia likely due to COVID pna vs post-obstructive pna secondary to lung cancer. She received dexamethasone. baricitinib, and remdesivir x1 day. She was treated with abx for post-obstructive pna and was weaned from HF to NC, after which she was transferred to the floor. Once on the general floor, patient was hypoxic to upper 80s and required 60% oxygen at 60L/min with concern she would need to be transferred back to the ICU. Patient's son was called and indicated that patient would not want BiPAP intubation or further life-prolonging interventions. At this time, it was decided to wean patient off oxygen, and son understood the gravity of this choice and knew it in alignment with patient's wishes. Patient was placed on comfort care and passed on 10/22 at 0800." "1837087-1" "1837087-1" "Patient was in a skilled facility. The patient presented to Community Hospital on 9/24/2021 with Sepsis likely related to a sacral ulcer. The patient was complaining of a cough and was diagnosed with left lower lobe pneumonia. The patient then developed septic shock requiring vasopressors. The patient was transferred to another Hospital in for a higher level of care. While the patient was at facility they underwent a debridement of a sacral wound. There was a concern for possible diverting colostomy, but Surgery felt with underlying rheumatoid arthritis, multiple abdominal surgeries and overall poor fuctional status the patient was not a candidate for diversion. The patient was admitted to Select Specialty Hospital on 10/07/2021 to continue wound care. The patient had declined while at Select Specialty Hospital. The patient was to be discharged to Hospice on 11/01/2021, the patient expired on 11/01/2021 at Select Specialty Hospital." "1837166-1" "1837166-1" "Patient passed away 20 to 30 minutes after vaccination unsure if related to vaccine or not" "1837210-1" "1837210-1" "PATIENT EXPIRED ON 09/22/2021. TESTED POSITIVE FOR COVID ON 08/31/2021." "1837232-1" "1837232-1" "My father was struggling to breathe as he was trying to get out of bed at 7 am. My mother heard gurgling sounds but he could not speak. Paramedics tried to revive him without success. Dr. claimed it was likely a stroke." "1837240-1" "1837240-1" "Death; prior to death: Extreme lethargy, Global weakness, Difficulty with speech, loss of appetite, difficulty with swallowing" "1837453-1" "1837453-1" "Stroke on 2/12/2021, death on 2/28/2021 Was in 3 hospitals:" "1839197-1" "1839197-1" ""a Acute MI of the LAD; pulmonary embolism that resulted in sudden death; sudden death; symptoms of fatigue; fever; congestion; This is a spontaneous report from a contactable consumer (patient's wife) reported for her husband (the patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Sep2021 10:00 (Lot Number: 301358A) at the age of 62-year-old as single dose for covid-19 immunization at a Pharmacy or Drug Store. Medical history included COVID prior vaccination, Asthma, Atrial fibrillation (A-fib), Hyperlipidemia, bradycardia, Obstructive Sleep Apnea, Mild mitral and tricuspid regurgitation. No known allergies. Concomitant medications included apixaban (ELIQUIS); atorvastatin calcium (LIPITOR); digoxin; flecainide; and tadalafil (CIALIS); all taken for unspecified indications, start and stop dates were not reported. No other vaccine in four weeks. Historical vaccine included bnt162b2, dose 1 on 06Sep2021 11:00 (Lot Number: 301308A) at the age of 62-year-old for covid-19 immunization. The reporter's husband had a Acute MI (myocardial infarction) of the LAD (left anterior descending) on 03Oct2021, six days after second Covid-19 and pulmonary embolism that resulted in sudden death. He experienced symptoms of fatigue, fever, congestion after both vaccines. The above mentioned events were reported as started from On 03Oct2021 17:30, and resulted in patient died. No treatment for the above mentioned events. The patient died on 03Oct2021. Also reported death causes as Acute MI and pulmonary embolism. An autopsy was performed that remarked ""Acute MI to LAD"". No COVID tested post vaccination.; Reported Cause(s) of Death: congestion; fever; sudden death; symptoms of fatigue; pulmonary embolism; a Acute MI of the LAD; Autopsy-determined Cause(s) of Death: Acute MI to LAD"" "1839201-1" "1839201-1" "Cardiac arrest; This is a spontaneous report from a contactable physician. A 28-year-old female patient received the third dose of BNT162B2 at 28-year-old, intramuscularly on 01Oct2021 (Batch/Lot Number: EW0168) at single dose (booster) for COVID-19 immunisation. Medical history was none. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol/ferrous fumarate/norethisterone (NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received the first dose of BNT162B2, intramuscularly on 03Jan2021 (lot number: EL0142) at 27-year-old, and the second dose intramuscularly on 23Jan2021 (lot number: EL9262) at 27-year-old for COVID-19 immunisation. The patient experienced cardiac arrest on 15Oct2021. Unwitnessed at home. When found, patient passed away already without any signs of calling 911 or rescue. No treatment received. Since the vaccination, the patient had not been tested for COVID-19. The patient died on 15Oct2021. An autopsy was performed and results were not provided.; Reported Cause(s) of Death: Cardiac arrest" "1840063-1" "1840063-1" "pt was seen in ED yesterday with Left lower lobe pneumonia and UTI; presented back to ED today after being so weak she fell and EMS was called; pt is confused and has tachycardia; c/o SOB and cough today, appetite decreased; dx with A Fib with RVR; positive for COVID; respiratory failure requiring aggressive O2 therapy; acute metabolic encephalopathy; comfort care measures instituted; pt died in the hospital" "1840091-1" "1840091-1" "Fine the same day and monitored and on the 28th she complained of shortness of breath and chest pain. She also had a 4lb weight gain. She was sent to the ER on the 28th and keep her over night and sent her back the next day. She passed the on 31st of Oct." "1840094-1" "1840094-1" "pt diagnosed positive for COVID in nursing home,11 days prior to hosp admission; admitted to hosp with hypothermia, left sided pneumonia and renal insufficiency; family states she's requiring more O2 and is less interactive; hx of Alzheimer's, DM; COVID test is positive; treated with steroids and antibiotics; DNR/DNI; sent to ICU where she shortly passed away" "1840106-1" "1840106-1" "PT died after testing positive for COVID-19 on 10/3/2021" "1840108-1" "1840108-1" "pt brought to ED with c/o SOB and altered mental status; tested positive for COVID; on 15LO2 via NRB saturating @ 75%; intubated; waiting to transfer to another hospital since there are no isolation bed; severe sepsis secondary to COVID pneumonia; suffered cardiac arrest while waiting to transfer; ACLS started; pt remained in asystole x 20mins where she was declared dead in the ED" "1840132-1" "1840132-1" "pt brought to ED by EMS unresponsive; intubated for acute hypoxic respiratory failure and airway protection; positive for COVID; pt in DKA; given insulin, tocilizimab, and steroids; pt became bradycardic and hypoxic; pt went into cardiac arrest and she died in the ED" "1840173-1" "1840173-1" "pt brought to ED with fever and malaise, BS was in the 50s at home; In ESRD, on hemodialysis; after dialysis pt did not feel well; EMS called; diagnosed with UTI, positive for COVID; acute hypoxic respiratory failure secondary to COVID pneumonia; pt's condition continued to decline; palliative care consulted; family decided to dc dialysis; pt passed away in the hospital" "1840218-1" "1840218-1" "Patient admitted as inpatient on 8/29 due to COVID-19. Patient was tested for COVID-19 and was positive on 8/29. Since Friday (8/27)patient states she has been having low blood pressures while at home. With this she has been having a cough seizing feeling congested having a decreased appetite. She states that she has been stumbling a little bit as well." "1840240-1" "1840240-1" "pt presented to ED with increasing SOB; positive for COVID; on NRB mask; had been dc'd from hosp 2 days before for treatment of COPD exacerbation, was negative for COVID @ that time; placed on BiPAP then Venturi mask; given remdisivir, Baricitinib, antibiotics, steroids; back on BiPAP; DNR/DNI; pt experienced V Tach and condition deteriorated; comfort measures put in place and pt died in the hospital" "1840279-1" "1840279-1" "pt to ED with hx of COPD; presents with increasing SOB x 4-5 days; positive test for COVID; placed on supplemental O2, given remdisivir and steroids; pt's condition worsened and he was admitted to ICU; intubates; developed left intramuscular neck hematoma; condition declined; placed on comfort care and extubated; pt died in the ICU" "1840339-1" "1840339-1" "EMS called due to seizure like activity; altered mental status; hx of DM, A Fib, CHF; positive for COVID on 8/7; started on remdisivir; intubated; EEG shows no seizure activity, moderate encephalopathy; unresponsive; pt's condition worsened and he died in the hospital" "1840440-1" "1840440-1" "pt received COVID vaccine on 8/26/21; presented to ED on 9/11/21 with SOB; diagnosed positive for COVID; placed on 100% BiPAP and eventually required intubation, proning and paralytics; developed a tension pneumothorax and bacterial pneumonia, septic shock; condition worsened; pt placed on comfort measures and she expired in the hospital" "1840473-1" "1840473-1" "Hx of dementia and recent pneumonia; diagnosed positive for COVID 1 wk ago in nursing facility; has been in isolation in the facility; presents to ED with cough; on 4 L O2 via NC, sats in the 90s; increased confusion during the course of hospitalization; condition worsened; encephalopathy; antibiotics and O2 supplementation given; mental status never recovered; comfort care measures in place; pt died in the hosp" "1840511-1" "1840511-1" "8 days before admission to hosp, pt diagnosed positive for COVID; received antibiotic infusion on 9/2; O2 sats @ home were in the 60 -70s; went for x-ray today @ walk-in clinic and O2 sats were in the 80s; EMS transported pt to ED; hx of COPD, DM, HTN, CKD3; given remdisivir; placed on BiPAP; admitted to ICU where he eventually was intubated; condition deteriorated and comfort measures were requested; pt was extubated and passed away in the hosp" "1840544-1" "1840544-1" "Resident was on hospice care, terminal prognosis, end of life prior to vaccination. 11/2/21 residents O2 was decreased and resident declined shortly after." "1840564-1" "1840564-1" "Case completed his Covid vaccine series in March 2021, then was hospitalized and died in October 2021" "1840635-1" "1840635-1" "pt admitted to hosp with c/o cough, congestion, fever, diarrhea worsening over past 10days; positive for COVID; O2 supplementation given; remdisivir; pt is DNR; condition worsened and pt was transitioned to comfort care; she died in the hospital" "1840693-1" "1840693-1" "Case completed Covid vaccine series in March 2021, then was hospitalized for Covid, then died of Covid in September" "1840719-1" "1840719-1" "Case completed covid vaccine series in APril 2021, then was hospitalized for COvid and subsequently died of Covid." "1840752-1" "1840752-1" "PFIZER-BIONTECH COVID-19 VACCINE EUA: PATIENT PASSED AWAY AT MEDICAL CENTER ON SEPT 26,2021 FROM COMPLICATIONS OF COVID-19. SHE WAS FULLY VACCINATED WITH PFIZER COVID-19 VACCINE. 1ST DOSE ON 12/31/20 AND 2ND DOSE ON 1/19/21." "1841222-1" "1841222-1" "Death" "1841372-1" "1841372-1" "Received vaccine 9/1/21 in am. Had shortness of breath later in day. Examined by cardiologist on 9/2/21 and died 9/2/21 later in evening." "1841395-1" "1841395-1" "Hospitalized (10.27.21); COVID-19 positive (10.30.21); fully vaccinated Admission Date: 10/27/2021 Date of Death: 11/2/21 Time of Death: 1:30 PM Preliminary Cause of Death: Pneumonia due to COVID-19 virus DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Closed displaced intertrochanteric fracture of left femur, initial encounter (HCC) [S72.142A] Closed left hip fracture, initial encounter (HCC) [S72.002A] Hypotension [I95.9] HOSPITAL COURSE: The patient was admitted to the hospital on 10/27 after sustaining a fall. He subsequently was found to have a closed left hip fracture and underwent a cephalomedullary nail fixation on 10/28. He subsequently developed anemia and hypotension postop as well as testing positive for COVID-19. Over the next 2-3 days the patient remained on high-flow nasal cannula due to COVID-19 and was unable to be weaned. Discussion with family and the patient today led to them wanting to pursue comfort care due to the patient's continued respiratory decline. The patient was placed in comfort care and started on a morphine infusion. The patient then subsequently passed away peacefully at 1:30 p.m." "1842829-1" "1842829-1" ""83-year-old man comes to an appointment for skin condition - rash. He is currently not on any medications. He does have some swelling in his ankles and a previous years-older history of swelling on his knee. He is diagnosed with scleroderma for the first time and also given his first COVID vaccine, lot #EN6207 on 3/17/21. He comes back for a return appointment and check up on 4/7/21 and receives his second dose of COVID vaccine, lot #EW015D on 4/7/21. As the months go forward his skin rashes increase, his ankles become more swollen and he has increasingly more difficulty upon swallowing food without large amounts of mucus needing to be coughed up soon afterwards, often bringing some or most of his food back up. This mucus accumulation problem continues, worsening through the months which causes and large amount of weight loss. He visited his doctor around July or August 2021 about the problem. They want to check his heart even though it is made clear that he has a swallowing and mucus problem. He completes a stress test and is scheduled for an angiogram. He schedules with a GI doctor to get an endoscopy to help understand the swallowing and mucus issues as this issues is currently the most distressing and he is losing more weight each week. It is cancelled by the heart doctor until the angiogram takes place. He has a lung evaluation that indicates that his lungs have a lot of scar tissue. He smoked for 20 years, 40 years ago and never had any known pulmonary issues to date. He sees a new doctor regarding the heart angiogram and it is completed - 4 areas where stents could be helpful are recommended but the new heart doctor says he needs to be able to swallow a blood thinner for a few months first so schedules the endoscopy. The endoscopy takes place, no cancerous cells noted and they stretch his esophagus in at least one place. Initially the swallowing is improved but soon, more mucus and difficulty swallowing resumes. He is scheduled for heart stents as his doctor suggests. His ankles and feet are increasingly swollen with pitting edema. His cough is productive but getting weaker and more strained, his weight is dangerously low at 155 for a 6'1"" man. He is on a water pill and blood thinners. Just a few days before stent surgery is to be done, he passes away as he wakes in the morning in bed after a night of labored breathing. He was tested 2 times for COVID in the recent months before his passing and both were negative."" "1842856-1" "1842856-1" "Patient passed away hours after receiving vaccination." "1842897-1" "1842897-1" "pt hospitalized at another hosp approx 1 wk ago, tested positive for COVID, dc'd to home on steroids and home O2 @ 3 LPM via NC; called EMS with c/o dyspnea, fever, and chest pain; presented to ED with worsening SOB, hypoxic; COVID test was positive; DNI; on NRB mask; admitted to ICU; pt's condition worsened and she was moved to comfort care measures; BiPAP mask removed and she passed away in the hospital" "1842925-1" "1842925-1" "pt presents to ED with c/o increasing dyspnea and generalized weakness; diagnosed positive for COVID 2 days prior; will receive monoclonal antibodies; hx of pancreatic cancer; pt experienced acute conversion to V Fib with loss of pulse; ACLS performed x approx 45 mins; ROSC eventually achieved; refractory shock with bradycardia requiring meds; family decided to not do any more CPR if became pulseless; pt died in the hospital" "1842972-1" "1842972-1" "pt has been treated in facility for COPD, renal failure, and COVID pneumonia; transferred to MICU with worsening renal failure; DNR/DNI; pt's condition continued to decline; comfort care measures instituted along with in house hospice care; pt passed away in the hosp" "1843015-1" "1843015-1" "pt presents with worsening dyspnea x 2-3 days; hx of COPD, on 5 L O2 via NC @ home; hx of MS, A Fib,CHF; positive for COVID; O2 sats 70s on BiPAP in EMS; c/o fever, diarrhea, myalgias, nausea; pt is septic; required intubation and mechanical ventilation during her hospital stay; extubated and on BiPAP; condition worsened and she died in the hospital" "1843050-1" "1843050-1" "pt seen at ED for dyspnea and hypoxia; positive for COVID; transferred to another hospital for advanced care; on 4 - 8 L O2 via NC; PMH: HTN, OSA; started on decadron, remdisivir, Lovenox, Baricitinib; eventually required Vapotherm then full BiPAP support; transitioned to comfort care due to worsening condition; pt died in the hosp" "1843068-1" "1843068-1" "Individual had a breakthrough infection and expired." "1843093-1" "1843093-1" "resident found unresponsive, last seen alert around 9:15p by NOD" "1843222-1" "1843222-1" "After the two dosis of Moderna, the patient didn't experience any symptoms. On September 3, 2021, the patient got a third complete dose of Moderna. After this third dose, the patient started feeling extreme fatigue, headaches, and fever. A week passed by and he wasn't feeling any better, on the contrary, he developed more symptoms like loss of memory and imbalance. He went to the doctor and had blood tests including a D-dimer test which came high and an MRI which revealed a High-rate Glioblastoma. He later died due to complications of the tumor removal." "1843241-1" "1843241-1" "Patient vaccinated and then tested positive for COVID-19" "1843289-1" "1843289-1" "Patient received the vaccination one week prior to death" "1843324-1" "1843324-1" "headache started 36 hrs post vaccine and continued. Symptoms seemed to get worse daily including general malaise, sinus congestion, body aches and fever started 09/05/2021. Home tested 09/06/2021 positive for covid. Up uintil then she had remained alert and oriented. Husband noticed change in breathing at approx 1000 on 09/06/2021 and attempted to get her up to go to hospital when she went into respiratory arrest. 911 called and CPR initiated. Was eventually helicopter transported to hospital, placed on vent. Vent dc'd 09/08/2021 and she died. Spoke with a person who received the same lot # of vaccine, same date, given just prior to and she also tested positive for covid on 09/05/2021 and was in ER on that date. Neither of them had any common friends or had been in the same location." "1843328-1" "1843328-1" "One week later, decedent experienced shortness of breath, diarrhea, pneumonia, hypoxia, elevated troponin" "1843428-1" "1843428-1" ""The person who received the vaccine, my grandmother, began experiencing side effects the day after the ""COVID-19 booster"" was administered. These side effects include: ""flu-like"" symptoms. Then she began experiencing ""autoimmune"" symptoms that resemble Toxic Epidermal Necrolysis. Her skin developed PAINFUL blisters that popped and her skin was raw, bleeding, oozing, and began to fall off of her own body. She eventually died from this. Her day and time of death was 11-3-2021 at 10:25pm. Her death was one week after the COVID booster was administered."" "1843592-1" "1843592-1" "The resident was found unresponsive in his bed at 11:15AM. CPR was initiated but unsuccessful. The resident was pronounced deceased after attempting CPR for an hour." "1843606-1" "1843606-1" "pt seen in clinic 3 days before hospitalization, was dx'd COVID positive, given monoclonal antibodies the following day; presents to ED with worsening SOB over past week; hypoxic; steroids, antibiotics, remdisivir, baricitinib given; O2 therapy of HFNC with FiO2 of 100%; pt's condition worsened and required BiPAP, O2 sats in 80s; became hypotensive, vasopressors given; intubation; DNR; pt's condition declined and he died in the hosp" "1843708-1" "1843708-1" "Patient had sciatica got better before the 1st shot. Went to hospital on 2/6/21 and confirmed no clots in leg; sciatica. After the 1st shot on 2/19 his leg started hurting; after the 2nd shot could not walk without being in excruciating pain and with a walker and assistance. The doctors and hospital kept saying sciatica and gave him 2 injections in his back. NO relief. His right calf was swollen and tender. But no one questioned the vaccine - not politically correct. After 2 1/2 months of pain which the meds did not help the patient was taken to another state on May 1st. Saw a doctor said either blood clots or bone cancer. At the hospital it was confirmed many, many, many blood clots in his leg. He had no history of blood clots. Patient died in hospital from sepsis (much worse then getting Covid)." "1843805-1" "1843805-1" "increased frequency and severity of asthma attacks with 3 emergency room visits from May 20, 2021 to June 23, 2021. Asthma attacks were different from the past with stomachache and defecation preceding asthma attack. Died in June 23, 2021. Autopsy examination found previously undiagnosed eosinophilic granulomatosis with polyangiitis/Churg-Strauss syndrome, including eosinophilic pneumonia." "1843819-1" "1843819-1" ""Patient initially registered a fever on11/2, patient had low O2 on 11/3 and had to be sent out via 9-11 as O2 could not be efficiently sustained here. Patient passed in the hospital on 11/3 at night due to ""heart attack"""" "1845305-1" "1845305-1" "passed away from Covid-19 Pneumonia 24OCT2021; Caught Covid-19 20OCT2021/Mom developed a cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 PNEUMONIA (passed away from Covid-19 Pneumonia 24OCT2021) and COVID-19 (Caught Covid-19 20OCT2021/Mom developed a cough) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Caught Covid-19 20OCT2021/Mom developed a cough) (seriousness criterion hospitalization). On 24-Oct-2021, the patient experienced COVID-19 PNEUMONIA (passed away from Covid-19 Pneumonia 24OCT2021) (seriousness criteria death, hospitalization and medically significant). The patient died on 24-Oct-2021. The reported cause of death was COVID-19 pneumonia. It is unknown if an autopsy was performed. At the time of death, COVID-19 (Caught Covid-19 20OCT2021/Mom developed a cough) outcome was unknown. No Concomitant medication were provided by the reporter No treatment medications were provided by the reporter This case concerns a 58-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of COVID-19 Pneumonia and COVID-19. The events occurred 6 months and 28 days after the second dose of mRNA-1273 had a fatal outcome, with death occurring the following day. No autopsy report was disclosed. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 in not affected by this report. This case was linked to MOD-2021-365577 (Patient Link).; Sender's Comments: This case concerns a 58-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of COVID-19 Pneumonia and COVID-19. The events occurred 6 months and 28 days after the second dose of mRNA-1273 had a fatal outcome, with death occurring the following day. No autopsy report was disclosed. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 in not affected by this report.; Reported Cause(s) of Death: COVID-19 pneumonia" "1846057-1" "1846057-1" "Patient passed away of a heart attack on 7-15-2021 Unsure if this was related but he had several EKG that were clear. But I thought I should let you know" "1846089-1" "1846089-1" "This case meets criteria for vaccine breakthrough review. Patient brought in unresponsive to ED, no known COVID SxS at the time." "1846093-1" "1846093-1" "pt received covid vaccine. possibly passed from covid after diagnosis." "1846194-1" "1846194-1" "pt diagnosed positive for COVID on 8/24/21; received monoclonal antibody infusion 8/31/21; presented to ED(9/1/21) via EMS for increasing SOB, cough, weakness; O2 sats 75% on RA; Hx of CKD, DM; suffered AKI requiring hemodialysis during his stay; pt's condition worsened; he was made comfort care; died in the hospital" "1846211-1" "1846211-1" "diagnosed positive for COVID on 8/31/21; presents to ED on 9/8/21 with c/o SOB, productive cough, weakness and leg swelling; Hx of CKD III-IV, CAD, lupus, HTN, Gout; states has not taken any polyclonal antibodies; started on dexamethasone and remdisivir; on O2 4-6L and High Flow; DNR/DNI; placed on BiPAP for short period of time but unable to tolerate; pt's condition declined and she was placed on comfort care; she died in the hospital" "1846241-1" "1846241-1" "Individual had breakthrough infection and expired." "1846245-1" "1846245-1" "pt presents with cough, SOB, and poor appetite x 1 wk; hx of dementia, fluid retention, lymphoma, failure to thrive; diagnosed positive for COVID; COVID pneumonia; given dexamethasone, remdisivir, Barcitimib, O2 therapy; initially made a DNR; refused BiPAP; given high flow O2 on Vapotherm and NRB; had an episode of bradycardia hypoxia and had acute respiratory arrest; wife insisted on CPR; despite CPR pt did not regain a pulse or respirations" "1846283-1" "1846283-1" "Individual had a breakthrough infection and expired" "1846286-1" "1846286-1" "pt had recent hospital admission with positive COVID test, was dc'd to home with O2 therapy; presents to ED with acute hypoxic respiratory failure secondary to COVID pneumonia; pt sedated and placed on ventilator; 100% FiO2; no improvement during hospital stay; condition worsened and pt eventually placed on comfort measures; removed ventilator and pt passed away in the hosp" "1846309-1" "1846309-1" "pt died @ home; medical records from doctor who signed death certificate do not mention being positive for COVID, but there is a positive COVID test reported from Lab, test was submitted on 9/11/21; pt died on 9/18/21; COVID -19 is also listed on the death certificate; no other information found on this patient" "1846321-1" "1846321-1" "My father got shot #1 of Moderna, and 10 days later, he collapsed while vomiting and having diarrhea full of blood. He was taken to the ER, and treated with blood clotting agents and stomach medication. A scan showed he also had bleeding in his brain. He also had bad arrhythmia and had a pacemaker implanted. He convalesced in another hospital for a few weeks before returning home. He then got shot #2, and within two weeks, was again vomiting and having diarrhea full of blood. He was taken back to the hospital and was told that he needed to have surgery on his stomach. He was told that he would die without it. He felt so sick and worn out, that he rejected the surgery, went home, and later died on September 2nd. In the last days of his life, he kept the arm that he had gotten the shots in, curled up by his face (like a dead insect). He would scream out in pain if he tried to move his arm. So he didn?t. And that?s how he died. With the injected arm all curled up, like a dead insect." "1846342-1" "1846342-1" "pt diagnosed positive for COVID by PCP; pt presents to ED afterwards c/o myalgias x 4 days; BS was greatly elevated in the ED; DKA; admitted to hospital; AHRF secondary to COVID pneumonia; intubated on mechanical ventilation with prone positioning; pt's condition declined and he passed away in the hospital" "1846354-1" "1846354-1" "DEVELOPED COVID19 OCTOBER 2021, WITH FEVER AND SHORTNESS OF BREATH." "1846368-1" "1846368-1" "pt presented to ED with weakness and non-productive cough; dx with hyponatremia and positive for COVID; admitted to hosp; hx of adenocarcinoma of left lung with metastasis to bone and brain; DNR/DNI; placed on BiPAP; given ATB, remdisivir, dexamethasone, and therapeutic anti-coagulation med; pt's condition worsened; became extremely hypotensive and hypoxic; she passed away in the hosp" "1846534-1" "1846534-1" "Individual had a breakthrough infection and expired." "1846570-1" "1846570-1" "Breakthrough infection and then expired." "1846589-1" "1846589-1" "She had been suffered from dizziness, shortness of breath, fatigue, weight loss, wasy bruising, and then she was diagnoised to Acute Lymphoblastic Leukemia on September 14, 2021. After that, she was treated at Hospital However, my wife passed away on Oct 11, 2021. She was healthy and eated healthy food and worked out regularly. She had never been exposed to any risky environment. Only potential factor is COVID vaccination." "1846613-1" "1846613-1" "They had a breakthrough infection and expired." "1846663-1" "1846663-1" "Hospitalized (10.31.21 - still hospitalized / admitted); COVID-19 positive (10.31.21); fully vaccinated CHIEF COMPLAINT: Acute respiratory failure due to COVID-19 (HCC) HISTORY OF PRESENT ILLNESS: Patient is a 91 y.o. male who presents today with shortness of breath, fatigue, fever and cough for the past few days. PMH of mod-severe COPD (not on O2), venous insufficiency with chronic left ankle ulcer, dysphagia, s/p RLL resection d/t aspirating gold crown, anemia of CKD. He received a Covid booster and flu vaccine 4 days ago, s/s s/s started the next couple days. In the ED, he was initially afebrile, then temp 100F, non tachycardic (on Lopressor), BP normal. CXR without acute airspace disease; however hypoxic to 88% at rest on multiple trials with ED provider. He did test (+) for Covid. He requires admission for treatment of acute respiratory failure in setting of COPD. At time of my exam, he is resting in bed, appears tired with mild increased work of breathing, but alert and oriented. Daughter, who is a nutritionist, is at bedside and assists with hx. He's not having other concerns besides the fatigue and SHOB. At baseline, he is independent at an independent living facility. He does have chronic anemia of CKD, gets somewhat regular Fe infusions as well as Retacrit. He had a stroke in the past, has residual dysphagia and often coughs/chokes while eating. He's had venous insufficiency since he was a teen, and has wraps on his legs all the time; follows with general surgery for OP management of an ulcer on left ankle. He is a beloved member of the volunteer team at this hospital. * Acute respiratory failure due to COVID-19 (HCC) Assessment & Plan -S/P vaccine x2, received booster and influenza vaccine 4 days ago -Fever/cough and fatigue/SHOB for the past 2-3 days, tested (+) today -CXR no acute disease -Needing 2L O2 to maintain sats -Daily inflammatory labs, check viral film array -Remdesivir, decadron, BID lovenox, guaifenesin, duonebs q4 -Treat for CAP, check blood cultures Progress Note from 11.4.21: SUBJECTIVE: Patient is on unresponsive. Family made a decision yesterday they want to convert him to comfort care only. I discontinued all medicines. Discontinue the IVs. Apparently he has not been doing well for the past 6 months or so also and their minds he has been declining dramatically. Progress Note from 11.5.21: SUBJECTIVE: Patient is unresponsive. He is having still lot of agitation discontinue the Haldol switch him over to Ativan. He is a do not resuscitate comfort care" "1846689-1" "1846689-1" "/Patient presented to the emergency room on 10/23/2021 with cough and shortness of breath. He was found to be hypoxic and was admitted for further management. He was treated with remdesivir, dexamethasone, baricitinib, and supplemental oxygen. He condition worsened and he was transferred to the intensive care unit on 10/25/2021. Patient was intubated on 10/29/2021. Patient's condition continued to worsen. Patient had a pulselessness event on 11/5/2021 and code was called. Patient was unable to be resuscitated and he expired on 11/5/2021." "1846699-1" "1846699-1" "pt admitted to hosp on 9/21/21 with positive COVID test; dc'd on 9/22/21; presents back to ED with increasing SOB, productive cough, chills, poor appetite; Respiratory failure probable superimposed bacterial infection; antibiotics given; worsening sepsis and metabolic acidosis; given dexamethasone; worsening delirium; placed on comfort measures only and pt expired in the hosp" "1846776-1" "1846776-1" "brought to ED via EMS; tested positive for COVID; lethargic; responds to painful and repeated verbal stimuli but doesn't answer questions; placed on BiPAP and COVID protocol started; COVID pneumonia; observed with worsening tremors/rigors; in respiratory distress despite BiPAP, BP elevated; DNR/DNI; condition declined; BiPAP removed and pt died in the hospital" "1846810-1" "1846810-1" "Hospitalized on 10/20/21. Released on 10/22/21. Readmitted on 10/26/21. Patient had pneumonia, cough, shortness of breath, and difficulty in breathing." "1846878-1" "1846878-1" "Patient expired 11/4/2021." "1846958-1" "1846958-1" "heart attack, blood clots, stroke" "1846964-1" "1846964-1" "In days after receiving vaccine he reported chest symptoms and changes to chronic breathing. nearly 3 months later he was admitted to hospital with CHF for first time in setting of COPD requiring oxygen and afib at baseline, and an addition 2 months later was admitted with acute on chronic hypoxia in found to have a pneumonia he could not recover from and died from cardiac arrest." "1847178-1" "1847178-1" "Brief Summary/Assessment: Patient is 74 y.o. female w/ PMH of traumatic SDH (c/b seizures on trileptal), HFpEF (EF 70%) DM, HTN, pAfib (low burden on device interrogation, off a/c since 12/2020, considering Watchman procedure) , SSS s/p pacemaker, CVA (2011 c/b residual L hemifield loss and L-sided weakness), R pontine stroke (2021 c/b fecal incontinence), CKD (bl Cr 2.4), GERD, hx of GIB (11/2020 w non-bleeding gastric ulcers, hemorrhoids) who was BIBA for acute SOB, and known COVID exposure, found to be COVID+ s/p intubation for mixed respiratory failure. Hospital Course: #COVID Pneumonia #Mixed Respiratory Failure In the ED, ABG 7.29/56/58, most consistent with a mixed hypercarbic and hypoxic respiratory failure. This is likely the setting of a COVID-19 pneumonia and possible aspiration pneumonia. Chest x-ray on 10 9 with evidence of predominantly right-sided lung disease. There is also likely some contribution of CHF, bedside echo done by cardiology with evidence of diffuse hypokinesis and reduced ejection fraction estimated at 40% and with elevated JVP. Less likely PE, given there are explanations for hypoxia, and LENIs w/o evidence of lower extremity clots. Extubated 10/12/21, now with difficulty with upper airway (swelling and some bleeding), made CMO. #Stress Induced Cardiomyopathy #NSTEMI Type 2 Prior echo with normal ejection fraction in July estimated around 70%. Cardiology consulted in the ED, bedside echo in the ED showing diffuse hypokinesis and reduced ejection fraction estimated at 40% and with elevated JVP on exam and BNP 8,138. Most likely stress-induced cardiomyopathy, EF likely reduced but would not estimate 40% given physical exam findings. Troponins peaked,85 -- > 114, 160, 204, 479 --- > 454, 452, 462, 354, 282. EKG changes inclusion initial TWI w/ resolution of TWI's, but with possible ST segment elevation in V2. STD in V4-V6 as well as 1, avL, V1-V2. Most likely type 2 NSTEMI in the setting of elevated BP's, thus meeting criteria for hypertensive urgency." "1847400-1" "1847400-1" "Swollen throat" "1848170-1" "1848170-1" "Was diagnosed with COVID pneumonia; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (Was diagnosed with COVID pneumonia) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027021A, 028L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD. On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). On 19-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 PNEUMONIA (Was diagnosed with COVID pneumonia) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized on 19-Sep-2021 due to COVID-19 PNEUMONIA. The patient died on 28-Sep-2021. The reported cause of death was covid pneumonia. It is unknown if an autopsy was performed. At the time of death, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. Patient was on some concomitant medications. Treatment information was not provided. Patient mother had all three Moderna vaccination. Patient went to the hospital on 19Sep2021 and was diagnosed with COVID pneumonia and died of COVID pneumonia on 28Sep2021. In the place where patient was staying nobody had COVID so they don't know where picked it up, caller wants to know if it's possible that she got it from the vaccine. Patient was taking other medications but was doing ok. Patient had COPD. Company Comment: This case concerns an 86 year-old, female patient with a history of Chronic obstructive pulmonary disease, who experienced the serious (due to hospitalization and fatal outcome) unexpected AESI of COVID-19 pneumonia. The event occurred approximately 23 days after the booster dose of Moderna COVID-19 vaccine. Drug ineffective was considered as an additional event. The patient died 32 days after receiving the booster dose. It was unknown if an autopsy was performed. The rechallenge was not applicable due to the fatal outcome and nature of the event. The medical history, of Chronic obstructive pulmonary disease and patient¦s advanced age, remain a confounder for the event and fatal outcome. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. This case was linked to MOD-2021-365079 (Patient Link).; Sender's Comments: This case concerns an 86 year-old, female patient with a history of Chronic obstructive pulmonary disease, who experienced the serious (due to hospitalization and fatal outcome) unexpected AESI of COVID-19 pneumonia. The event occurred approximately 23 days after the booster dose of Moderna COVID-19 vaccine. Drug ineffective was considered as an additional event. The patient died 32 days after receiving the booster dose. It was unknown if an autopsy was performed. The rechallenge was not applicable due to the fatal outcome and nature of the event. The medical history, of Chronic obstructive pulmonary disease and patient¦s advanced age, remain a confounder for the event and fatal outcome. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: COVID pneumonia" "1848220-1" "1848220-1" "She was completely fine before the vaccine. The morning after, she started having trouble breathing. It attacked her heart, caused inflammation of the heart, until it forced fluid into the lungs (because of the failing heart), making it impossible for her to breathe. She died. We found our loved one on the ground, where she'd been laying in the hot sun for hours, where she'd tried desperately to get air in. She was blue, foaming at the mouth, from the fluid pushed into her lungs. By 1:00pm, less than 12 hours after getting the vaccine, my sister was dead." "1848307-1" "1848307-1" "Foot wound; passed away about a week after becoming immobile; This spontaneous case was reported by a consumer and describes the occurrence of IMMOBILE (passed away about a week after becoming immobile) and LIMB INJURY (Foot wound) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059B21A and D06B7 or 21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included WARFARIN, METOPROLOL, LEVOTHYROXINE SODIUM, MEMANTINE HYDROCHLORIDE (MEMANTINE HCL) and DONEPEZIL HYDROCHLORIDE (DONEPEZIL HCL) for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IMMOBILE (passed away about a week after becoming immobile) (seriousness criteria death and medically significant). On an unknown date, the patient experienced LIMB INJURY (Foot wound) (seriousness criterion medically significant). The patient died in May 2021. The reported cause of death was Immobile. It is unknown if an autopsy was performed. At the time of death, LIMB INJURY (Foot wound) outcome was unknown. Treatment information was not provided. Concomitant medication include blood thinner medication. This case concerns a 91-year-old female patient with no relevant medical history, who experienced the unexpected events of Immobile and Limb Injury. The events occurred approximately 9 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) and had a fatal outcome, with death occurring in the following week. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 91-year-old female patient with no relevant medical history, who experienced the unexpected events of Immobile and Limb Injury. The events occurred approximately 9 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) and had a fatal outcome, with death occurring in the following week. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Reported Cause(s) of Death: Immobile" "1848575-1" "1848575-1" "3 heart attacks; Cardiac arrest; kidneys started shutting down; brain damage; liver was shutting down; she slipped when she stood up; This is a spontaneous report from a contactable consumer (patient's sister). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 10Sep2021 10:11 (Batch/Lot Number: FE2588) as single dose for covid-19 immunisation (age at vaccination was 64-year-old). Medical history was reported as patient was allergic to penicillin which caused her to have a stroke when she was a baby (2 years old). The penicillin caused her to be paralyzed on her left side. She was slobbered, she could not help it. She could not swallow like the typical person could. She couldn't even close her eyes, she could not blink normally. She had to wait to fall asleep when her eyes could not hold themselves open anymore and would come together on their own. She had a little allergies to things but because they live in the mountains and surrounded by trees, there was all kinds of pollen. She did sneeze, but it was nothing she took any medicine for. The caller confirmed it was something they already had prior to receiving the COVID-19 shot. She had a stroke when she was young and it took her vocal cords so her sister cannot talk. Patient was handicapped. Patient had seizure. Patient had constipation and stomach pain. Concomitant medications included phenobarbital sodium (PHENOBARBITAL [PHENOBARBITAL SODIUM]) taken for seizure, start and stop date were not reported; phenytoin sodium (DILANTIN D.A.) taken for seizure, start and stop date were not reported. The patient previously took macrogol 3350 (MIRALAX) for constipated (prescribed macrogol to get her bowels moving. Patient was constipated for maybe about a week. The caller clarifies the constipation began prior to receiving the COVID-19 shot. When they went and saw the neurologist on 08Sep2021, the doctor wrote patient a prescription for it. Her sister was constipated already. Her sister did go to the bathroom well, but she had not went for about a week. Her stomach was hurting so the doctor thought it was better to start giving her sister the MiraLAX). Patient did not receive other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced slipped when she stood up, 3 heart attacks, cardiac arrest, kidneys started shutting down, brain damage and liver was shutting down, all on 19Sep2021 with outcome of fatal. The patient was hospitalized for the events from 19Sep2021 to 20Sep2021. The patient underwent lab test which included heart rate: no pulse on 19Sep2021. Therapeutic measures were taken as a result the events. The patient died on 20Sep2021. An autopsy was not performed. The events resulted in Emergency Room Visit. Clinical course was reported as on 10Sep2021, patient had their first Pfizer COVID-19 shot. On 19Sep2021, patient was on the floor. The caller clarifies she would walk over to her sister's house to make sure her sister took her medications. The caller stated back in the middle of last year, she discovered her sister was not taking her meds like she was supposed to, she was going off of her schedule. At that point last year, the caller took her sister to the ER to make sure everything was okay. Apparently, they had changed her sister's phenobarbital dose from three times a day to one pill which was causing her sister to hallucinate, her sister was seeing things. They saw her sister in the ER and then the caller began to go over to her sisters three times a day, once at 08:00, then at 13:00, then at 16:00. On 19Sep2021, the caller had gotten her sister breakfast. The caller explains her sister ate and took her medication and was fine. Her sister started getting kind of tired but the caller thought it was due to her sister having a stomach problem. The caller clarified her sister was constipated and her sister said she quit drinking her coffee because it hurt her stomach. So, the caller thought her sister was tired maybe because of that. Later in the evening of 19Sep2021, around 16:00, the caller found her sister on the floor. She clarified her sister wasn't dead. She asked her sister if she had a seizure and her sister waved her hand down and explained she slipped when she stood up. The caller clarifies her sister had a stroke when she was young and it took her vocal cords so her sister cant talk. The stroke also paralyzed her sister on the left side so she is only able to sign language with one hand. The caller explains she was talking to her sister. She asked her sister if she knew who she was and her sister signed her name, Privacy, in her hand (there is a certain way her name is used in sign language for one handed people). The caller was trying to get her sister up but couldn't. The caller had to get her son to help. Her sister could not walk, so they had to carry the patient into the living room. The caller called 911, however, because of the way the trailer was set up, they could not get the gurney through to the bedroom, so her sister had to be carried into the living room where the couch was. When the ambulance showed up, they said her sister had no pulse although the caller had just talked to her. The caller explains it had been 3-4 minutes, at most 5 minutes, and when the ambulance did show up, her sisters eyes were open and everything. They were feeling for a pulse and could not find one. The ambulance used the machine for the heart to try and get her heartbeat to come back. The caller explains it took about 30 minutes to get a pulse, and they ended up going to the hospital. The caller was told they got a slight pulse at the ER doors. Her sister of course could not talk, but because of COVID, the hospital wouldnt allow the caller to go back with her sister. Apparently, there were four positive cases at the hospital. Her sister was put on a ventilator. The caller explains she sat there for a long, long time- it seemed like forever, where they would not let the caller see her sister or nothing. Then, the doctor came out and explained to the caller that because her sister did not have a pulse, her kidneys started shutting down. Her liver was shutting down. The doctor shined the light in her sister's eyes and there was no response. Her eyes were dilated, which could be an indication of brain damage. The caller clarified further she went over to her sister house on 19Sep2021 where she found her on the floor and then she had no heartbeat. But apparently, they got her heartbeat back the next day so they pronounced her dead on 20Sep2021. She received a phone call informing her that her sister passed way at 06:19 on 20Sep2021. Her sister had 3 heart attacks the night of 19Sep2021 in the ER waiting for a room. One was a code blue. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: she slipped when she stood up; kidneys started shutting down; brain damage; liver was shutting down; 3 heart attacks; Cardiac arrest" "1848897-1" "1848897-1" "Became nauseated, dipahoretic; was dead on arrival to ED, presumed MI" "1849135-1" "1849135-1" "Developed pulmonary fluid and difficulty breathing after 2nd Covid vaccine in March 2021. Died from pulmonary edema and heart failure 9 days after 3rd dose." "1849480-1" "1849480-1" "Patient started having multiple CHF exacerbations 10 days post vaccine after having been mostly stable for a while. He was repeatedly readmitted for exacerbations and ultimately was deemed not a candidate for advanced cardiac therapies due to some life choices. He ultimately succumbed to his illness on 09/10/2021" "1849492-1" "1849492-1" "Within 12 hours, could not sleep, had body aches, and loss of strength. Could not stand up from a seated position by herself. Condition continued to worsen. Saw personal physician on Feb. 26 and at that point was very weak and fatigued from continued inability to sleep. Was taken to the ER on March 2 and admitted into the hospital. At that point she could not communicate / talk, she could not sign her name, and could barely walk with a great deal of help. EKG was normal. Found signs of a mild stroke on the left side of her brain and had neurological issues on the left side of her body to the point that she could not use her left arm or leg. Had swelling in her legs that would not dissipate. Was released from the hospital on March 28 and transferred to a rehab facility with continued plans of strengthening and return to home. She still could not stand or walk on her own and barely with two people helping her at maximum assistance. On April 2, she was transferred from the rehab facility to the ER by ambulance due to worsening condition and not responsive but heart was fine. Was transferred back to the rehab facility that night after being treated. On April 6 was transferred to Hospital due to her condition worsening again. Found a large blood clot in her right lung. At this point she could no longer move herself due to weakness and continued neurological issues of her left side. Heart continued to be strong. She passed away on April 16, 2021. Cause of death is unknown." "1849596-1" "1849596-1" "Patient did state he had his 2nd dose of Moderna, but it is not documented where this reporter can find the date (would have been sometime in April). He told this reporter he started to not feel well about 3 weeks after his 2nd dose. He eventually felt so bad he sought treatment in July. He was admitted 8/6/2021 with group B streptococcus agalactiae bacteremia, sepsis resulting in fever, encephalopathy and AKI (likely due to SBP). TTE 8/17 showed severe AR and possible vegetation. TEE 8/18 confirmed infective endocarditis c/b AoV insufficiency. Patient is not an IV drug user. Hospital course also complicated by Afib w RVR and was started on dilt drip, now off as patient's HR improved and he has had low BP in setting of likely worsening AoV insufficiency. Patient also with pulmonary edema periodically requiring 1-2L O2 . Furthermore, 8/22 patient had short run of torsades treated with Mag Over the past several days, patient has developed hepatocardiorenal syndrome with worsening AKI. Transfer to ICU for consideration of CRRT initiation. Structural and CT surgery following due to severe AI. Tentative plan for TAVR. Patient with slowly worsening AMS as well, acute-subacutely worsening today. Thought to be due to hypoperfusion v acute illness. Cosyntropin stim test for hypothermia negative. Patient arrived to ICU somnolent but arousable. HD catheter, PICC and A-line were placed for CRRT initiation, pressor initiation and hemodynamic monitoring respectively. Patient's hemodynamics continued to worsen evening after ICU transfer and temporary pacemaker was inserted and patient was paced with HR 90-110. Despite pressor support and temporary pacemaker, patient continued to worsen and was persistent in stating he no longer wished for current cares to continue. It was felt patient would not tolerate TAVR or liver transplant at this state as patient was not improving with pressor, CRRT, temporary pacemaker and hemodynamic support and as a result decision was made with family to transition patient to comfort cares. He ultimately succumbed into death on 8/26/2021" "1849727-1" "1849727-1" "Pt was 75 y.o female with history of lewy body dementia and CLL who presented at local HCF with cough and shortness of breath. Pt was confused with her dementia at baseline and did not know where she was. Daughter stated she started having a cough with shortness of breath. She states she had a chest x-ray done per her primary provider and was started on Augmentin. This caused some GI upset and was thus stopped. Pt had some worsening shortness of breath and her oxygen saturation dropped down to the 70s. She was therefore transferred to here from the first HCF to be evaluated in the ER. She was fully vaccinated against Covid-19 and had both her shot at the beginning of this year. Pt passed at 1913 on 10/13/2021 with family at side. breathing ceased and no apical pulse noted" "1849728-1" "1849728-1" "Acute and pervasive interstitial lung disease causing hypoxia requiring hospitalization to assist with oxygen needs of 5?10L per min Three month hospital followed by death on 08/07/21" "1849731-1" "1849731-1" "Death approximately 6 hours after administration. Hospice patient." "1849869-1" "1849869-1" "76 y.o female with h/o COPD on 2 L home oxygen, type 2 diabetes, hypertension, having been found unresponsive at HCF. With GCS 3 patient intubated, and mechanically ventilated at a local HCF. Diagnosed with COVID-19 and acinetobacter bacteremia. Right upper extremity with occlusive DVT in right brachial and basilic vein with nonocclusive thrombus in right axillary vein, initiated anticoagulation. Previous CT revealed no PE, However, did show dilated pulmonary arteries. Repeat CT chest with contrast 09/14 revealed small amount of thrombus in left jugular and extensive chronic findings including goiter and marked enlargement of left pulmonary artery prior to previous. Pt was transferred to another HCF for vascular surgery evaluation, advised nonsurgical, continuing anticoagulation. Pt persistently, off sedation, demonstrated no significant improvement with cognition/neurologic status. MRI brain 9/13 revealed no acute intracranial abnormally. EEG resulted abnormal with severe generalized slowing, consistent with severe encephalopathy, concern for possible epileptiform discharge prompted Neurology evaluation, provided Keppra. Pt was provided broad-spectrum antibiotics with cefepime and doxycycline, negative repeat blood cultures prompted discontinuation of antibiotics after 5 days of therapy. HCF provided counsel with family members regarding goals of care, ultimately, decision made to transition to comfort measure on the afternoon on 09/18/2021. Pt succumbed to illness, suffered cardiopulmonary collapse as result of acute respiratory failure with hypoxemia secondary COVID-19 viral pneumonia at 1;45am on 09/29/2021" "1849876-1" "1849876-1" "Pt was initially admitted to the medical COVID floor where he was initiated on Dexamethasone and Remdesivir therapies. His hypoxemia continued to worsen and he required initiation of noninvasive positive pressure ventilation and was eventually transferred to the ICU on 10/28/2021 for ongoing care and management in the setting of refractory hypoxemia. His ICU course was initially complicated by delirium. His condition continued to worsen and was intubated on 10/30/2021 in the setting of impending respiratory/cardiac arrest. He began to experience increasing hypotension as well and required initiation of vasopressors. Given the history of heart failure with reduced ejection fraction, cardiologist was consulted and Pt was additionally placed on Dobutamine. He had worsening acidemia despite optimization of ventilator settings and required initiation on renal replacement therapy on 11/02/2021. Unfortunately, he continued to decompensate and on the evening of 11/04/2021, the patient did suffer of a cardiac arrest. Unfortunately Pt did succumb to his critical illness on the evening of 11/04/2021." "1850145-1" "1850145-1" "Death" "1850162-1" "1850162-1" "Massive Heart attack. Patient is deceased" "1850335-1" "1850335-1" "death Nontraumatic intracranial hemorrhage, unspecified Hemorrhagic cerebrovascular accident (CVA)" "1850339-1" "1850339-1" "death SIRS (systemic inflammatory response syndrome) Acute kidney injury" "1850346-1" "1850346-1" "death I21.4 - Non-ST elevation (NSTEMI) myocardial infarction N17.9 - Acute kidney failure, unspecified" "1850356-1" "1850356-1" "10/27/21 SEEN IN THE ER FOR WITH COMPLAINTS OF 3 DAYS OF DRY COUGH,SOB, FEVER, CHEST PAIN.OXYGEN SAT = 84% ON ROOM AIR. NOTED TO HAVE TACHYCARDIA. DX: WITH PNUEMONIA DUE TO COVID 19, RESP FAILURE.ADMITTED TO ICU. PATIENT CONDITION CONTINUED TO WORSEN, REQUIRED HIGH FLOW BIPAP, INFLAMMATORY MARKERS CONTINUED TO PROGRESS. PATIENT DIED 11/8/2021" "1850358-1" "1850358-1" "Began with sob soon after vaccination. DX pneumonia and put on oxygen." "1850380-1" "1850380-1" "10/24 SEEN IN ER WITH DIFFICULTY BREATHING ONSET 1 WEEK. CHEST PAIN POST FALL DX: PNEUMONIA DUE TO COVID19, RESP FAILURE. HYPOXIC REQUIREING 5-6 L OF OXYGEN SATTING AT 92%. CONDITION CONTINUED TO DECLINE REQUIRING BIPAP THERAPY. PT AND FAMILY ELECTED TO TRANSITION TO COMFORT CARE. PATIENT DIED ON 11/4/21. PATIENT REC'D PFIZER COVID 19 VACCINATIONS: 3/1/21 AT HOSPITAL PFIZER LOT NUMBER : EL9269 DOSE 1 3/22/21 AT HOSPITAL PFIZER LOT NUMBER: EN6200 DOSE 2" "1850452-1" "1850452-1" "Dose 1 2/8/2021 Lot # EN5318 Pfizer. Pt died in the hospital" "1850464-1" "1850464-1" "Pt was found deceased at home on 11/06/2021." "1850465-1" "1850465-1" "Dose 1 1/7/2021 Moderna Lot # 026L20A Pt die d in the hospital" "1850490-1" "1850490-1" "Dose 1 3/22/2021 007B21A Moderna Pt died of end stage breast cancer" "1850510-1" "1850510-1" "Dose 1 1/26/2021 EL1283 Pfizer Patient died of heart failure in the emergency room" "1850525-1" "1850525-1" "Patient tested positive for covid on 9/17and has been symptomatic for 2 weeks with dry cough, myalgias, subjective fevers, fatigue and dyspnea on exertion. Patient was transferred to the ED on 9/24/21 from the infusion center when noted to have O2 sat in the 80s requiring 2-4L NC. Patient was initiated on dexamethasone and remdesivir, however, his oxygen requirements have been escalating from NC to HFNC so he was transferred to the MICU. Patient foudn to have sputum culture positive for aspergillus and was started on posaconazole per ID/ Additional treatment with reeneron was provided. Patient developed renal failure and was started on CVVHD. Acute desaturation event on 10/24 requiring re-paralysis. In the setting of inability to continue with CVVHD and severe refractory respiratory failure, he was made CMO. Patient passed on 11/2/21." "1850695-1" "1850695-1" "Death 11/7/2021 with no related event upon vaccine administration" "1850726-1" "1850726-1" "Headache, body aches, complained about not being able to get out of bed, couldn't talk, suffered heart attack." "1850803-1" "1850803-1" "Reporting to VAERS d/t death less than a week following vaccination. The resident was comfort measures and receiving supportive care in a nursing home. The resident was no longer able to swallow food d/t end-stage dementia and dysphagia. The resident did not exhibit side effects of the vaccination. On 11/6/21 at 2:07PM the patient was ill looking, respirations were non-labored and regular. At 3:30PM the patient was pale, and without respirations or a heart beat." "1850811-1" "1850811-1" "Went to ER with SOB. Was admitted on September 23, 2021, then transferred to another Hospital on October 12, 2021. Pt succumbed to her illness on November 5, 2021." "1850901-1" "1850901-1" "patient vaccinated with janseen vaccine on 6/8/21. tested positive for covid on 10/26/2021. admitted to Hospital on 10/26/2021. Expired on 10/31/2021 while still hospitalized." "1850904-1" "1850904-1" "unknown pt possibly passed from covid complications." "1850927-1" "1850927-1" "case fully vaccinated with moderna. Second dose given on 3/8/2021. Tested positive for covid on 10/15/2021. Admitted to Medical Center on 10/21/2021. Expired on 10/30/2021 while still hospitalized." "1850951-1" "1850951-1" "final diagnosis. Death Summary Date of Admission: 10/17/2021 Date of Death:10/30/2021 Reason for Hospital Admission (Admitting Diagnosis): Acute Hypoxemic Respiratory Failure Hospital Course and Significant Findings: Patient was a 72 Y male with history of renal transplant in 2017, on chronic immunosuppression (cellcept, prograf, pred), CKD who presented with 2 weeks of productive cough, decreased appetite and a positive COVID test on 10/11. Despite being vaccinated on 04/2021 with J&J. In the ED, the patient desatted (87%) with ambulation. He was admitted for hypoxemic respiratory failure. He became gradually more confused, developed worsening kidney injury. The patient also had a CT with evidence of an intramuscular hematoma attributed to coughing with supratherapeutic INR. This was reversed with Kcentra. For his COVID pneumonia treatment, he was given regneron, decadron 6mg, remdesivir for 5 days and tocilizumab once on 10/24. He had multiple rapid responses called on 10/24 and 10/26 for increasing O2 requirements. His confusion and respiratory status worsened and on 10/27 he was admitted to the ICU. He was intubated on 10/29, found to have elevated troponin, worsening renal failure and CT findings of cavitary lesions and severely damaged lungs. This was relayed to the patient's family and he was ultimately transitioned to comfort care. The patient died at 2:40am, on 10/30/21." "1850960-1" "1850960-1" "Admitted to hospital on 11/5/2021 with community acquired pneumonia, COPD exacerbation, benign essential htn, on 11/5/2021. On 11/7 developed acute STEMI, likely RV infarct at ~8am. Code STEMI, transferred to hospital for emergent cardiac cath, possible PCI. Noted to have cardiogenic shock, respiratory failure, Acute mycodardial infarct, lactic acidosis, which was deemed non-survivable. Expired at 1:25 pm on 11/7/2021" "1850965-1" "1850965-1" "case vaccinated on 8/7/21. Tested positive for covid on 11/01/2021. Admitted to Medical Center on 11/01/2021. Expired on 11/4/2021 while still hospitalized." "1850989-1" "1850989-1" "My father got very sick and weak- his heart started shutting down and he died" "1850995-1" "1850995-1" "case fully vaccinated with moderna. last dose on 3/13/2021. Tested positive for covid on 10/8/2021. Admitted to Hospital on 10/29/2021. Expired on 11/04/2021 while still hospitalized." "1851032-1" "1851032-1" "Patient developed altered mental status and 4+ pitting edema on 9/11/21. Her condition deteriorated over the next 2 days, and she was hospitalized on 9/13/21 for 1 day. She returned on comfort care/hospice, and expired on 9/17/21." "1851033-1" "1851033-1" "PT PASSED FROM COMPLICATIONS RELATED TO COVID" "1851055-1" "1851055-1" "case fully vaccinated with moderna. Second dose administered on 2/12/2021. Also had booster dose of moderna on 10/25/2021. Tested positive for COVID on 11/2/2021. Admitted to Hospital 11/02/2021. Expired on 11/08/2021 while still hospitalized." "1851121-1" "1851121-1" "pt in ED with a positive COVID test; dx'd with respiratory failure; pt c/o N/V, SOB, cough; experienced 3 episodes of hematochezia; transferred to ICU; pt became unresponsive and vomited up blood; was intubated; bradycardia and no pulse; CPR started; pt never regained pulse or respirations" "1851149-1" "1851149-1" "Patient was admitted to reporting hospital on 11/2/21 and died on 11/6/21. Patient arrived with approx 5-6 days of chest tightness, dyspnea on exertion, and perhaps some radiation of this feeling to the left side of sternum and back. Patient had fever, cough, shortness of breath, chest pain and leg swelling. Patient was transferred to our hospital as a known COVID positive patient. COVID-19 pneumonia with hypoxic respiratory failure and possible CHF. On the morning of 11/6/21, patient was awake and alert and was talking to the nurse after he had taken his Bipap mask off to transition to Vapotherm, when he suddenly became unresponsive and his eyes rolled back. He subsequently lost his pulse as well. Patient was noted to be DNR and thus aggressive resuscitative measures were not carried out." "1851232-1" "1851232-1" "pt diagnosed positive for COVID on 8/14/21 by PCP; presents to ED with c/o increasing SOB and decreased O2 sats (76% on NRB); hx of COPD, multiple myloma; treated with antibiotics, steroids, anticoagulants, remdisivir; placed on BiPAP; eventually required intubation due to worsening condition; family decided on comfort care measures; pt was extubated and died at the hosp" "1851249-1" "1851249-1" "Patient was having shortness of breath on 11/6/21 and went to emergency room where he passed away." "1851296-1" "1851296-1" "presented to ED with c/o increasing SOB, confusion, cough, orthopnea, DOE and fatigue; on NRb 15 L/M; found to be hypoxic, A Fib with RVR; pt's condition worsened and he required intubation with ventilator; treated with dexamethasone and bronchodilators; living will of do not ventilate, family made pt comfort care and he died in the hospital" "1851393-1" "1851393-1" "Cardiomyopathy resulting a cardiac event that lead to death." "1851630-1" "1851630-1" "On 09/17/2021, exactly 8 days after patient's first injection of Pfizer Covid-19 vaccine, the patient suddenly had numb hands and left side of face was droopy. I called 911. Patient became unresponsive in the ambulance and required intubation. CT results determined that he suffered a wet stroke from a massive brain bleed on the right side of brain. He died the next day on 09/18/2021" "1851808-1" "1851808-1" ""I had received a text message from my father on 9/15/2021 after his first vaccine dose that said ""Yeah that shot was not fun Never had a shot that made me feel so bad so quick ""I felt bad with in a minute 4 hrs ago and breathing is still difficult it sucks"" On 10/23/2021, my father called 9-1-1 and was taken & he passed away 10/24/2021 from what is listed as Massive upper gastrointestinal hemorrhage on his death certificate. I have spoken to people that knew him and said he was feeling sick for the past few weeks, he started taking antacid and Imodium in the days leading up to his death."" "1851846-1" "1851846-1" "PATIENT NOW DECEASED (11.7.21) - presented to ED (altered mental status - coded; expired) ED - DX: acute respiratory failure with hypoxia; COVID-19; respiratory arrest; lactic acidosis Hospitalized (11.1.21 - 11.3.21); COVID-19 positive (11.1.21); Fully vaccinated PLUS booster Date of Admission: 11/1/2021, Hospital Day: 3 Discharge Date: 11/3/2021 PRESENTING PROBLEM: Hypoglycemia [E16.2] Diarrhea, unspecified type [R19.7] Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01] Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE: Patient is a 87 y.o. male who presents today with diarrhea . History obtained from medical record and patient. Patient is extremely hard of hearing and severely limiting obtaining history , does not have hearing aids with him . Niece and nephew now on floor however are not informed as to current medical issues. In ed on arrival found to be hypoxic to 87% placed on 3 lnc , cxr findings consistent with covid infection . Tested positive for covind 19 . Blood glucose on arrival found to be 34 , subsequent testin with rather rapid rise with a meal only . He was given decadron in ed . Hospitalist service consulted for admission further evaluation. Patient was continued on supplemental oxygen and administered dexamethasone and Remdesivir. He was weaned to room air with adequate oxygenation. Patient diarrhea improved likely related to COVID-19. PT/OT evaluated advised home with assist home health PT/OT. Case manager was consulted to arrange for outpatient services. Electrolytes were monitored and repleted throughout the admission. Patient was symptomatic lead treated with antitussives, antiemetics, analgesics p.r.n. patient clinically improved and hemodynamically stable for discharge. Discussed plan of care discharge with patient including outpatient follow-up PCP in 7 days. He will continue 3 additional days of dexamethasone and antitussives. Patient was advised to follow-up outpatient ENT for evaluation of cochlear implant. Patient was advised given difficulties with hearing to stop driving until cochlear implant issues addressed. Patient voiced understanding and was agreeable with the plan of care and discharge. CM arranged for patients niece to pick patient up." "1853287-1" "1853287-1" "diarrhea; nausea; fever; Dyspnoea/shortness of breath; pneumonia; This is a spontaneous report from a contactable other health professional (patient's child). A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 08Mar2021 12:00 (Lot Number: unknown) as single dose for covid-19 immunisation at the age of 74-year-old. Medical history included colitis. There was no other vaccine in four weeks. Patient had no known allergies and no covid prior vaccination. Concomitant medications included azathioprine sodium (IMURAN) from an unspecified date and ongoing taken for colitis ulcerosa and steroid etc. The patient experienced diarrhea, nausea, fever, dyspnoea/shortness of breath and pneumonia on 10Mar2021 at 01:00 AM. The patient was hospitalized for events for 4 days. Events resulted in physician or other hcp office visit, emergency or emergency medicine, hospital treatment and patient died. He had negative COVID test. The patient underwent lab tests and procedures which included nasal swab: negative on 25Mar2021. The patient died on 28Mar2021. An autopsy was not performed. Patient received oxygen and antibiotics therapy for events. Outcome of events was fatal. Events occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumonia; Dyspnoea/shortness of breath; fever; nausea; diarrhea" "1853429-1" "1853429-1" "Death- after vaccine patient was ill with dizziness and lethargia. Patient went to bed at 8pm that night. Patient was found deceased the next day when housemate went to wake him up. Patient had no prior history of underlying health complications. Cause of death ruled to be sudden unexpected heart attack." "1853611-1" "1853611-1" "Hospitalized 10/26/2021; COVID-19 positive 10/27/2021, fully vaccinated BRIEF OVERVIEW: Discharge Provider: DOCTOR Primary Care Physician at Discharge: DOCTOR Admission Date: 10/26/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Septic shock HOSPITAL COURSE: Patient is a 60 year old male with PMH of HTN, HLD, DMII, super morbid obesity who initially presented to outside hospital with a 2-3 day history of right groin rash and found to have necrotizing fascitis. Patient underwent his initial debridement at outside hospital prior to transferring to Butterworth SICU. Of note, patient was hypoxic prior to intubation and found to have COVID-19 pneumonia which was treated with steroids and Remdesivir. Patient was intubated and sedated upon transfer and had pressor requirements due to septic shock from the necrotizing fascitis. Patient underwent IV abx therapy, resuscitation with fluids and pressors, and ventilator support. Patient underwent a second debridement for source control the following day. Patient's ICU course was also complicated by Diabetic ketoacidosis for which he was on endotool with DGMS following, AKI, and SVT with RVR. During his ICU course, source control was obtained from his infection, however patient's respiratory status continued to decline with ARDS. Patient on high ventilator requirements of 90-100% Fi02 with hypercarbia due to large body habitus with chest wall restrction, COVID-19, and volume overload due to resuscitation for septic shock. Patient was paralyzed during his course to assist with ventilation however this did not improve his respiratory status. Pulmonary critical care was consulted however patient not a candidate for ECMO given his BMI. Discussion was held with family (sister) on 10/31/21 given poor prognosis even with aggressive therapy. Comfort care was ultimately decided upon per family. Paralyzation was stopped and patient was subsequently extubated and expired on 10/31/2021 at 1354" "1853632-1" "1853632-1" "Hospitilization, resulting in palliative care and death" "1853728-1" "1853728-1" "COVID-19 pneumonia 93-year-old female who was admitted to Hospital for acute hypoxic respiratory failure. Patient found to be Covid positive and had a positive urine antigen for strep pneumonia. She also had ischemic appearing limbs and was found to have arterial occlusions in bilateral lower extremities on CT angio. On arrival, patient was on BiPAP and stated that she wanted to be DNR/DNI. She was started on broad-spectrum antibiotics and remdesivir. In the morning on 11/5, it was explained to the patient that she would require antibiotics, anticoagulation, and continued respiratory support. She decided that she would prefer to go on comfort care measures of these were initiated. Patient died at 1313 on 11/5." "1853848-1" "1853848-1" "Patient was tested for COVID 19 for preprocedural colonoscopy. Patient was positive and initially had no symptoms. Patient became symptomatic and presented to the hospital where he was hospitalized. Patient passed away from complications on 10/24/2021." "1853967-1" "1853967-1" "PATIENT EXPIRED ON 09/28/2021; PREVIOUSLY COVID POSITIVE 11/30/2020." "1854042-1" "1854042-1" "Had been previously admitted from 8/27-8/31 with +COVID and acute hypoxemia and discharged with good oxygenation on dexamethasone and levoquin for UTI. Admitted again on 9/2 due to worsening dyspnea from covid pneumonia. Treated with zyvox and zosyn on high flow oxygen. Continued to decline and admitted to ICU on 9/3 and intubated. Given remdesevir and continues steroids. Found bilateral IJ and subclavian vein thrombosis. Transitioned from eliquis to lovenox. Unable to be weaned from the ventilator. Family involved in care and transitioned patient to comfort care and patient was extubated and passed on 9/11/21." "1854176-1" "1854176-1" "Admitted 9/27 due to multi-focal pneumonia, +COVID, No supplemental oxygen needed . Treated for bacterial superimposed infection with omnicef and azythromycin. Requested discharge home on 9/28. Returned to hospital ED on 10/1 with worsening Shortness of breath, O2 saturation 75% on room air and altered mental status. O2 given with saturation up to 95%. Respiratory status continued to decline and intubated on 10/3. Treated for candida with eraxis x 7 days. Due to hx of staph epi bacteremia, porta cath and dialysis tunnel catheter removed 10/5. Pt. in septic shock due to pneumonia. on CRRT due to renal failure. Developed pneumothorax and pneumomediastinum with subsequent chest tube placement x 2. Bronchoscopy on 10/9 due to elevated peak airway pressures. Failed ventilator weaning. Required pressors for each dialysis session. Discussion with family for trach and peg tube placement. Family requested comfort care on 10/14." "1854225-1" "1854225-1" "pt diagnosed positive for COVID @ SNF on 9/8/21, treated with dexamethasone, cefuoxime, and azithromycin; brought to ED with confusion, cough, SOB, abdominal pain, vomiting and diarrhea; placed on 4L O2 in ED; found to be dehydrated and with failure to thrive; renal function and respiratory status declined greatly and pt died in the hospital" "1854245-1" "1854245-1" "Shortness of breath, Ascitis, low potassium, cardiac arrest, pneumonia" "1854296-1" "1854296-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/20/2021 and 2/17/2021. Patient presented to ED on 10/14 with c/o general malaise, abdominal pain with a cough and fever that had been ongoing for 4 days. CXR revealed diffuse bilateral lung infiltrates concerning for PNA. Upon arrival to the ED, pt tested positive for COVID-19. Patient started on BiPAP and subsequently intubated on 10/18. CRRT started on 10/20 and requiring vasopressor support. Patient treated with Remdesivir, methylpred, and tocilizumab. Patient family requested palliative care and transitioned to comfort care on 11/3. Patient expired 11/3." "1854316-1" "1854316-1" "pt to ED with worsening SOB, hypoxic, placed on HF O2 with intermittent BiPAP; hx of squamous cell carcinoma of right upper lobe, post chemo radiation, COPD, CKD; pt's condition worsened, he went into respiratory distress requiring intubation and mechanical ventilation; condition continued to deteriorate; was placed on comfort care and extubated; pt died in the hosp" "1854317-1" "1854317-1" "On 11/7/2021 the patient was observed to be in bed with absence of respirations and heartbeat. The patient was a DNR upon admission." "1854367-1" "1854367-1" "pt transferred from hospital for evaluation of elevated troponin; pt found to have a positive COVID test and UTI; while pt was being assessed he went into cardio respiratory arrest; ACLS protocol was performed and a pulse was regained; spoke with pt's wife and she requested no future CPR; pt arrested again and died in the hospital" "1854402-1" "1854402-1" "pt transferred to Hospital from PCP; pt was to receive IV infusion of Regeneron (for positive COVID test) but was dyspneic and O2 sats in the 70s on RA; was transferred from Hospital to another Hospital and found to have COVID pneumonia; placed on NRB mask and eventually BiPAP; given steroids and inhalers; no remdisivir due to renal function; pt's condition deteriorated in spite of treatments; was placed on comfort care measures when pt experienced hypotension and she passed away in the hospital" "1854431-1" "1854431-1" "RESIDENT BECAME TACHYPNEA, SHALLOW BREATHING AND NON-RESPONSIVE PROUNCED DECEASED PER RN AS ORDERED PER MD" "1854443-1" "1854443-1" "pt with positive COVID test x 1 wk; presents to ED with increase in SOB, cough, fever, malaise; treated with corticosteroids, antiviral, bronchodilators; hx of non-Hodgkins lymphoma, treated with immune therapy; O2 supplementation of BiPAP and Vapotherm NRB; suffered left MCA CVA while in hospital; DNI and no PEG tube placement; comfort measures; pt died in the hospital with daughter at her side" "1854452-1" "1854452-1" "Subject became slightly tired the day after her first shot, which increased each day with labored breathing until she died 4 days later. (March 17th, 5:00 a.m.)" "1854473-1" "1854473-1" "fully vaccinated-covid releated death" "1854488-1" "1854488-1" ""Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death.""Patient received ""Patient received Moderna Vaccines on 3/3/2021 and 3/31/2021. Admitted 10/18 as transfer from an outside hospital. Transferred to ICU 10/19 due to worsening hypoxia. Placed on high-flow nasal cannula in ICU and had stable O2 saturations followed by worsening hypoxemia. Per patient and family request transitioned to DNR/DNI. Patient required non-rebreather mask on top of his high-flow nasal cannula in order to maintain O2 saturations. Remained on the settings for several days without significant improvement. On 11/01/2021 Epoprostenol with some improvement for 48 hours, O2 saturations up to 100%. Attempts were made to Additional information for Item 18: wean off of non-rebreather mask, however, patient immediately desaturated to less than 80%. Patient had sudden decrease in oxygenation the morning of 11/03/2021 and was never able to achieve O2 saturations greater than 89%. Patient continue with significant hypoxemia in the afternoon followed by bradycardic episode, expired at 2:15 p.m."" "1854556-1" "1854556-1" "vaccine Dose 1 given 3/30/2021 Moderna Lot # 020B21A Pt died in the ER following a motor vehicle accident" "1854576-1" "1854576-1" "Vaccine dose 1 given 2/2/2021, Lot # N/A Moderna Patient died of Covid 19, heart failure on 11/8/2021" "1854591-1" "1854591-1" "HX OF COVID AFTER VACCINATION; PATIENT EXPIRED ON 11/03/2021" "1854606-1" "1854606-1" "loss of appetite, nausea, diarrhea, within 1st day. passed out on day 6 - cardio Dr said was an effect of low insulin levels. By day 9 she was having difficulty breathing. Was admitted to hospital that day for oxygen. 5 days after entering hospital was placed on ventilator. Died 14 days later." "1854668-1" "1854668-1" "Was very tired and had sore muscles on September 09. Found September 10, 5:25 am dead. There were excessive amounts of blood along with large blood clots that appear to have come vaginally." "1854762-1" "1854762-1" "Immediate blood disorder; low iron, etc., which resulted in hospital critical care, then died 04Jun2021 of Acute Myeloid Leukemia" "1854818-1" "1854818-1" "Death" "1854838-1" "1854838-1" "Death" "1854882-1" "1854882-1" "COVID + on 10/12. Received monoclonal antibody infusion on 10/13. Admitted to hospital on 10/15 with shortness of breath with O2 saturation at 78%. Placed on nonrebreather and Vapotherm. Transitioned to ICU on 10/19 with intubation for ARF with hypoxemia. Treated with remedesivir and dexamethasone. Dependent on mechanical ventilation. Multiple discussion with team and family for trach and dialysis. Family requested comfort care and extubated." "1854890-1" "1854890-1" "Suicide on 11/8/21" "1855554-1" "1855554-1" "Patient was admitted to the Hospital on 08/09/2021 w/ nausea, fatigue and vomiting. She tested positive for COVID-19 on 08/09." "1857174-1" "1857174-1" "death- Hypoxemic Respiratory Failure; STEMI myocardial infarction" "1857371-1" "1857371-1" "Patient developed a cough with increase sputum production that lasted over several days starting approximately 10/22 and patient died on 10/28/2021." "1857441-1" "1857441-1" "DX WITH COVID ON 05/03/2021; PATIENT EXPIRED ON 05/26/2021" "1857465-1" "1857465-1" "DX WITH COVID 07/27/2021; VACCINATED WITH PRIMARY SERIES; PATIENT EXPIRED ON 08/05/2021" "1857473-1" "1857473-1" "Pt initially admitted to the covid medical floor with respiratory failure. She was on nasal cannula which rapidly progressed to high flow cannula. Pt was struggling with anxiety which did contribute to her increasing oxygen requirements and repetitive hypoxic events. Decision was made to transfer her to the ICU on 11/2/2021 given that she was unable to come off NIV. Once on ventilator, Pt required maximum ventilator settings and eventually even nitric oxide. Despite all interventions, Pt rapidly deteriorated on 11/9/2021. Husband and grandson arrived to bedside. Pt went into PEA, CPR was performed. She was able to regain a pulse for a few minutes then again went pulseless. CPR was performed until husband requested all efforts to be terminated. Pt was pronounced deceased @ 1135 on 11/9/2021" "1857540-1" "1857540-1" "Sudden Death" "1857591-1" "1857591-1" "Pt started complaining to family of progressive fatigue, n/v, and tremor that started within days to 1 week after 2nd dose of Moderna. Saw PCP several times for progressive symptoms over the next 2-3 months. Presented to ICU after found down for up to 24 hours. Serum ammonia levels were found to be 436 on presentation. Despite CRRT/HD, ammonia scavengers, low protein diet, pt never woke from coma and expired after being placed on comfort care. Later found to have partial OTC deficiency with no prior episodes of hyperammonemia. Also, no known family hx of any urea cycle disorders." "1857596-1" "1857596-1" "DIAGNOSIS 1. Acute chest pain 2. Elevated troponin level 3. SOB (shortness of breath) 4. Elevated d-dimer DECEASED" "1857612-1" "1857612-1" "DX WITH COVID ON 10/15/2021; FULLY VACCINATED; PATIENT EXPIRED ON 11/06/2021" "1857677-1" "1857677-1" "PT HAD COVID 11/02/2020; FULLY VACCINATED AFTER COVID INFECTION; PATIENT EXPIRED ON 03/23/2021; COVID RELATED DEATH REPORTED ON THE DEATH CERTIFICATE." "1857710-1" "1857710-1" "DX WITH COVID ON 10/26/2020; FULLY VACCINATED, LAST VACCINE RECIEVED ON 02/01/2021; PATIENT EXPIRED ON 03/15/2021; COVID 19 INDICATED ON DEATH CERTIFICATE." "1857715-1" "1857715-1" "Sudden Cardiac Death" "1857749-1" "1857749-1" "Patient's husband stated she became lethargic on 11/01/2021 and was not aware of her surroundings, they called an ambulance and she was hospitalized, the patient passed away on 11/04/2021 with the cause of death stated as a heart attack per her husband." "1857767-1" "1857767-1" "Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 5/11/2021. Patient brought to ED for acute confusion on baseline dementia and resp sx including cough and dyspnea that started yesterday; was covid + yesterday at outside behavioral hospital. Reported to be hypoxic at 88% today at the outside facility as reported by that facility but was 95% on RA when EMS checked on arrival. He was found to have a UTI due to ESBL E coli and initially received merrem and was transitioned to macrobid to complete treatment. He was found to have severe dysphagia. The patient's wife made decision to allow comfort feeds. He did develop aspiration pneumonia and respiratory failure. Wife subsequently decided to focus on comfort care and transition to inpatient hospice. Patient passed on 11/03/2021." "1857772-1" "1857772-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/21/2021 and 2/24/2021. Patient was admitted for hypoxic respiratory failure due to COVID-19, which was complicated by GI Bleed and ultimately superimposed bacterial pneumonia. Patient was transitioned to comfort care on 11/1/2021 and expired on 11/2/2021." "1857805-1" "1857805-1" "10/30/21 0200 SpO2 88% 2at 1L via nasal cannula, rr 32, increased moaning/facial grimacing with HS care. LS dim with occasional congested cough. Repositioned in mid Fowler's position; PRN Oxycodone administrated per order with good relief. RR 20, O2 94% at 2L n/c.. Rapid Covid test negative. 11/1 Continued with decline, desat 80s 2.5 l oxygen via n.c, labored resp, audible congested cough and secretions. res repositioned, large amount of dark yellow/brown mucus from mouth.. skin pale, nail beds dusky, res lethargic. afebrile. o2 placed 3l. Daughter updated, wants comfort care here. Dr. updated. new order Rocephin 1gm IM x7 days. duo nebs tid x7 days as res unable to use scheduled inhalers. cbc, bmp and chest x ray in am. Rocephin 1gm IM administered to l glut. daughter ok with plan. wants f/u palliative. 11/1 MD updated on elevated WBC and Na level and aware of overall condition with hospice referral pending. New orders obtaine to d/c rocephin 1 gram, start zosyn 3.375g Q6hr x7 days and start 1/2 NS @75cc/hr continuous for now, CBC/BMP in AM. Daughter updated and consents to current plan of care at this time. Plan for admit to Hospice Services. Iv started and infusing for additional hydration and comfort. 11/2 Admitted to Hospice. 11/2 Comfort maintained throughout the day with family at bedside.Resident hospice today, 02 stats dropping into 80s today. Family and MD updated, family in for visits throughout the day. N.O morphine started this morning. No s/s of pain or discomfort noted. PRN morphine given this morning for SOB. Resident resting comfortably throughout the shift, family at bedside. Priest called in for visit. Hospice nurse in for eval see n.o., 02 at 93% on oxygen via n.c. Mouth care provided throughout the shift, reposistioned throughout the morning throughout the shift. Currently family sitting bed side. 1500 11/2:increase on overall decline this AM. Oxygen saturation <90% on 4L, tachypnea, increase congestion. Family notified by floor nurse. MD updated on resident status, new order for morphine sulfate 20mg/ml 5mg PO Q4HRS PRN for pan/dyspnea, d/c oxycodone, change PRN Tylenol to suppository for elevated temp, and CMO. Hospice Nurse in shortly after with new recommendations and discontinuation of non essential medications, MD aware, see new orders. Family updated on new orders and consent to POC. Reverend in to provide sacrament of the sick. Resident resting comfortably at this time with family at bedside. 11/2 1410-Passed away with family at bedside." "1857856-1" "1857856-1" "SOB, CYANOTIC," "1857978-1" "1857978-1" "10/1/21 for COVID pneumonia after presenting with hypotension in the setting of increased ostomy output. increasing oxygen requirements and eventually required initiation of HFNC." "1857987-1" "1857987-1" "Systemic: Heart Attack-Severe, Additional Details: 11/1/21 received moderna booster and first flu shot ever 11/2 headache, didn't feel well 11/3 pain in right leg- collapsed at md and couldn't be revived. Mother describes him as healthy and no underlying conditions thought clot earlier this year and pt using asa. We are told md ruled death heart attack as a result of pulmonary embolism." "1858021-1" "1858021-1" "10/9/2021 Hospitalized with cough, hypoxia, weakness, SOB. Initially treated with oxygen, dexamethasone and respiratory treatments. Died. Primary cause: ACUTE ON CHRONIC RESPIRATORY FAILURE WITH HYPOXIA 10/9-10/24/21 Due to or consequence of: COVID-19 PNEUMONIA 10/9-10/24/21, ACUTE CHF EXACERBATION 10/9-10/24/21 COPD EXACERBATION" "1858069-1" "1858069-1" "developed weakness and myalgias 10/17/2021. admitted to Hospital and died on 10/20/2021" "1858071-1" "1858071-1" "Date of Admission: 10/29/2021 Date of Death:11/4/2021 Reason for Hospital Admission (Admitting Diagnosis): Covid-19 pneumonia Hospital Course and Significant Findings: Patient is a 76 Y male with a past medical history of COPD, HTN, HFrEF (last EF 36% on TTE 2019) who presents with 1-week hx of worsening SOB in setting of recently diagnosed COVID-19. Patient reports that he has had shortness of breath in last few years. He has a hx of COPD and was being followed by pulmonologists. However, last week after returning from a trip patient started having increasing SOB and cough productive of sputum. He reports that it has been gradually getting worse. He uses inhalers at home which minimally helped. He also took Robitussin which seemed to have greatly helped his cough. However, the SOB is now to the point that he has difficulty breathing w/movement and sometimes w/talking. These were associated w/loss of taste / smell, headache, and nausea. Patient denies vomiting, abdominal pain, diarrhea, fevers, chills, or night sweats. Patient reports he may have been exposed to COVID + patient while on a trip where he was attending mother's funeral. He and other attendees ended up being positive for COVID a few days after returning from trip. On admission, patient started on Remdesivir (10/29-11/2), Decadron 6 mg x1 (10/29), but due to escalation of oxygen requirements, steroids were changed to Solumedrol 125 mg BID (10/29 PM-11/1 AM), Solumedrol 60 mg BID (11/1 PM-11/2), and patient given dose of Tocilizumab 8 mg/kg x1 after discussion w/pulmonology (Dr.). Pt's O2 requirements continued to increase, 11/1 requiring 10 L. 11/2 was on 7 L, but desaturated to high 80s with any movement or speech. On 11/4 AM, pt complained of significantly increased chest pain which limited his breathing, was placed on max oximizer. Status continued to decline and transitioned to max HFNC with NRB (60 L), and ICU was consulted. On examination, pt was obtunded, unable to clear secretions, appeared dusky, satting in high 80s on HFNC w/ NRB. Anesthesia was called for intubation. Pt was intubated, bagged, transferred to ICU. Upon arrival to ICU, pt went into PEA arrest, code blue was called. Converted to vfib, then shock administered and pt had ROSC. Central line, arterial line chest tube were placed and pressors, sedation, paralytics initiated. Pt continued to be hypotensive with worsening O2 saturations on max pressors. Bronchoscopy revealed significant blood. Pt was severely acidotic, hypotension worsening despite pressors. Discussed w/ family pt's imminent passing and was made DNR/DNI, passed at 1500. Complications: none" "1858245-1" "1858245-1" "Admitted 10/10/2021 with cough, sob, and hypoxia; Patient expired 11/09/2021; past medical history significant for Anemia, Aortic dissection, Diverticulitis, Hemolytic anemia on chronic prednisone pta, HTN, and Hyperlipidemia who was admitted to the hospital on October 10, 2021 with complications from COVID 19 infection. She was started on standard treatment with dexamethasone; remdesivir was held due to elevated LFTs; intubated 10/19 no ecmo no dialysis" "1858297-1" "1858297-1" "[As narrated by wife] patient started to not feel good and felt tired 2 weeks after 1st does. Felt even weaker after the second dose. Had chest x-ray and EKG was told that there was inflammation around the heart and that he had pneumonia. COVID test was negative at hospital. Patient continued to worsen and died on 2/19/2021. Death certificate states cardiogenic shock, respiratory failure, pneumonia" "1858442-1" "1858442-1" "Not feeling well. Decedent found deceased 2 days after vaccine." "1858818-1" "1858818-1" "Do not have exact adverse events -was told by facility that patient passed away in his sleep." "1860168-1" "1860168-1" "Died; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient died on 30-Oct-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. No concomitant medication provided. 1st dose was given on 20Sep2021 with lot number 046C21A. Reporter states that she was fine with no illnesses prior to getting the vaccine. Company Comment: This case concerns a 58-year-old, female patient with no relevant medical history, who experienced the unexpected serious fatal adverse event of death. Inappropriate schedule of product administration was considered an additional event. The event death occurred approximately 1 month and 10 days after the second dose of Moderna COVID-19 vaccine with fatal outcome. Death occurred on 30-Oct-2021 and no autopsy results were available at the time of the report. Cause of death was reported as unknown. The rechallenge was not applicable due to the fatal outcome. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 58-year-old, female patient with no relevant medical history, who experienced the unexpected serious fatal adverse event of death. Inappropriate schedule of product administration was considered an additional event. The event death occurred approximately 1 month and 10 days after the second dose of Moderna COVID-19 vaccine with fatal outcome. Death occurred on 30-Oct-2021 and no autopsy results were available at the time of the report. Cause of death was reported as unknown. The rechallenge was not applicable due to the fatal outcome. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death" "1860741-1" "1860741-1" "patient received covid booster shot, became unresponsive. Bystanders initiated CPR with AED. Shocks administered. EMS paged with paramedic intercept. Patient intubated, I/O placed. arrived to ED. Pronounced at 1754" "1861051-1" "1861051-1" "Patient presented to emergency department on 11/7/2021 for evaluation of hypoxia and fevers. Daughter reported patient has been increasingly lethargic for past week and developed a dry cough. Patient was found to be COVID-19 positive. She was evaluated by critical care for admission due to condition, but decision was made to make patient comfort care measures only due to severity of disease. Patient expired on 11/8/2021 from complications of COVID-19 infection." "1861105-1" "1861105-1" "Patient presented to emergency department on 10/12/2021 with shortness of breath and lightheadedness. He was found to be COVID-19 positive. He was previously admitted to observation unit from 10/2/21 to 10/5/21 following a fall and was given a loop recorder. He was treated with dexamethasone, baricitinib, remdesivir, and supplemental oxygen. His condition did improved during stay, but eventually decompensated. He was placed on comfort care measures only on 10/20/21. Patient expired on 10/23/2021." "1861132-1" "1861132-1" "Patient presented to emergency room on 9/21/2021 with mild confusion, weakness and fatigue. he also had a cough and increased shortness of breath. He was found to be COVID-19 positive and admitted for further management. Patient's condition did not improve and was transferred to the intensive care unit on 10/4/2021 and intubated on 10/4/2021. Patient was placed comfort measure due to worsening of condition on ***. Patient expired on 10/6/2021 from multi-system organ failure." "1861168-1" "1861168-1" "cardiac arrest" "1861248-1" "1861248-1" "Patient was end stage dialysis last dialysis was on Friday Nov 5th she refused to go to dialysis on Monday Nov 8th. Patient received vaccine on 11/09/2021 and on 11/10/2021 was unresponsive at 7am sent to ER and expired." "1861298-1" "1861298-1" "Patient expired 11/3/2021" "1861322-1" "1861322-1" "Patient had a breakthrough infection expired from infection." "1861346-1" "1861346-1" "Patient had a breakthrough infection and expired." "1861403-1" "1861403-1" "Patient had breakthrough infection and expired" "1861455-1" "1861455-1" "Patient had a breakthrough infection and expired." "1861486-1" "1861486-1" "Patient had breakthrough infection and expired" "1862380-1" "1862380-1" "The patient felt dizzy and tired after the moderna booster. Afterwards, she fainted and passed away" "1864738-1" "1864738-1" "Patient presented to the emergency department for complaints of worsening shortness of breath. Patient received the COVID vaccine 3 days into her hospitalization. Patient diagnosed with metastatic breast cancer, and passed away 18 days after presentation to the ED." "1864845-1" "1864845-1" "pt presents to ED with c/o generalized weakness, cough, fever, chills, myalgias x 1 wk; tested positive for COVID in ED; treated with Decadron; developed bilateral pneumothoraces and mediastinal emphyysema; required intubation as condition worsened; developed a PEA arrest with ROSC time of 10 min; required operative repair of a bleeding vessel (right hemothorax); pt's condition deteriorated; was made a DNR and expired shortly afterwards." "1864894-1" "1864894-1" "inflammations occurred frequently, treated with antibiotics, resulted in abnormal white blood cell count and passed away suddenly." "1864913-1" "1864913-1" "Chief Complaint altered mental status History of Present Illness Patient is a 78 years old male with hx of flaccid hemiplegia of R + L side, dysphagia, CAD (s/p CABGx3 in 2018), ESBL infectious endocarditis, OSA, HLD, pAF on Eliquis, hx of hear block s/p pacemaker who is a transfer from Hospital for altered mentation. Patient is confused on exam and somnolent thus most of history is per outside record. He came to the facility from another location due to having fever, slurred speech, change in mentation. Nursing home reported that patient was well 2 days ago, answering questions appropriately, participating in therapy, and following instruction until the acute change. At the facility, patient had CT head which was negative for acute intracranial bleed. EKG showed afib with paced ventricular complexes. He was found to be Covid positive and had soft blood pressure 93/48. He was given 1L IVF and was started on dexamethasone and azithromycin. He was then transferred to ICU for concern of sepsis. Of note, facility record mentioned that patient was supposed to be on 6 weeks IV antibiotics for infective endocarditis, but somehow was only on 5 days of PO antibiotics. Initial vitals at facility were notable for blood pressure 95/64 and sat >92% on 2L. Patient was only oriented to self and intermittently followed command but otherwise remained confuse and somnolent. EKG showed afib with ventricular paced rhythm. Labs were notable for Hgb 7.2, plt 66, Cr 3.05, trop 306 (delta trop negative), procalc 21.4, CRP 22.47, and non-elevated lactic acid 1.6. Nurse after speaking to family stated that his mental status had been like this for the past 6 months. Attempted to reach family by phone but was unsucessful. Of note, he was seen at hospital (admitted 9/22/21-10/21/21) and diagnosed with severe sepsis secondary to endocarditis from ESBL E. Coli (E. Coli sensitive to zosyn) and was treated with ertapenem. He also had UTI with ESBL E. Coli at that time. Document reported persistent delirium secondary to severe illness. Hospital course was complicated by complete heart block suspect from endocarditis with RV PPM placed 9/29/21. He was discharged to SNF on ertapenem to be continued until 11/5/21. Review of Systems Unable to be performed due to patient's altered mentation Physical Exam Vitals & Measurements T: 36.3 ¦C TMIN: 36.3 ¦C TMAX: 36.8 ¦C HR: 87 RR: 22 BP: 95/64 SpO2: 92% WT: 187.4 kg (Dosing) BMI: 57.8 General: Alert Eye: Extraocular movements are intact, conjunctiva pale HENMT: Normocephalic, Normal hearing, Oral mucosa moist. Respiratory: Lungs are clear to auscultation, Respirations are non-labored. On 2L NC Cardiovascular: irregular rate, Normal rhythm, No murmur appreciated. Gastrointestinal: Soft, no tenderness to palpation throughout, BS active Musculoskeletal: No peripheral edema. Integumentary: Skin is warm, dry Neurologic: A&Ox0, following some commands. Somnolent Psychiatric: Somnolent, unable to further assess Assessment/Plan Patient is a 78 years old male with hx of flaccid hemiplegia of R + L side, dysphagia, CAD (s/p CABGx3 in 2018), ESBL infectious endocarditis, OSA, HLD, pAF on Eliquis, hx of hear block s/p pacemaker who is a transfer from Hospital for altered mentation. CT head was negative for acute intracranial bleed. Patient was found to be Covid positive and hypotensive thus was transferred to ICU for further management. Initial vitals at facility were notable for blood pressure 95/64 and sat >92% on 2L. Patient was only oriented to self and intermittently followed command but otherwise remained confuse and somnolent. EKG showed afib with ventricular paced rhythm. Labs were notable for Hgb 7.2, plt 66, Cr 3.05, trop 306 (delta trop negative), procalc 21.4, CRP 22.47, and non-elevated lactic acid 1.6. Encephalopathy is questionable given report from family that patient has been having cognitive impairment/delirium since last admission below. Additionally, ED mentioned that patient was supposed to be on 6 weeks IV antibiotics for infective endocarditis, but somehow was only on 5 days of PO antibiotics. Plan to treat patient empiri Of note, he was seen at hospitalr (admitted 9/22/21-10/21/21) and diagnosed with severe sepsis secondary to endocarditis from ESBL E. Coli (E. Coli sensitive to zosyn) and was treated with ertapenem. He also had UTI with ESBL E. Coli at that time. Document reported persistent delirium secondary to severe illness. Hospital course was complicated by complete heart block suspect from endocarditis with RV PPM placed 9/29/21. He was discharged to facility on ertapenem to be continued until 11/5/21. Neuro: Encephalopathy suspects infectious Hx of persistent delirium - CT Head at facility negative for acute intracranial abnormality - request overread CT head - continue antibiotics - consider MRI head to further evaluate stroke - consider EEG if encephalopathy not improved on antibiotics Cardiovascular: ESBL E. Coli Endocarditis on Imipenem at facility paroxysmal Afib (CHA2DS2-VASC 4) on apixaban Heart block s/p RV Pacemaker (9/29/21) HTN - EKG: afib with ventricular paced rhythm - Troponin elevated but likely chronic (delta troponin 0) - reported only on 5 days of PO abx instead of 6 weeks IV abx - request records from hospital - obtain TEE to assess for vegetation - cont vanc and zosyn - follow blood culture - hold home apixaban in case of procedure - hold home lisinopril and amlodipine due to c/f hypotension Pulm: Hypoxia suspects secondary to Covid pneumonia - CXR: bilateral airspace opacities R>L - cont dexamethasone - hold remdesivir due to impaired renal clearance eGFR < 30 - urine strep, urine legionella - RPP, pneumonia panel - procalcitonin, CRP, ferritin, D-dimer, LDH GI: - NPO for now - bowel regiment Renal: AKI on CKD - UA - urine na, urine urea, urine creatinine - renal ultrasound ID: Covid Pneumonia ESBL E Coli Endocarditis - obtain urine culture - obtain blood culture - obtain sputum culture - urine strep, urine legionella - RPP, pneumonia panel - cont dexamethasone for Covid (11/6-p) Abx: - vancomycin (11/6-p) - zosyn (11/6-p) Endo: - no acute concern Heme-Onc: Thrombocytopenia suspects secondary to infection Macrocytic Anemia - obtain iron panel - obtain B12, folate level Code: Full Dispo: ICU DVT ppx: hold due to elevated INR Diet: NPO Patient staffed with attending Addendum by MD, on November 08, 2021 10:22:55 (Verified) Pt. seen/examined by me 11-6-21, labs/findings reviewed/confirmed by me, images viewed/interpreted by me, and agree with this note by Dr. Patient, although COVID positive, is remarkably ill from gram negative endocarditis, with recurrence of bacteremia now following completion of primary course, which was complicated by heart conduction issues for which a pacer was placed, now possibly also source of infection. He is hypoxemic, potentially due to concurrent COVID for which therapy is underway, and although he is alert and awake is almost completely unresponsive, remarkably confused. Blood cultures are already positive this am, revealing heavy bacteremia almost certainly from endocarditis. Prognosis is very poor without removal of pacer and likely valve replacement, however details of his endocarditis are not yet complete, records from facility have been requested and pt is currently too ill to undergo any surgical management. Have switched zosyn to ertapenem as risk that E. coli is resistant, and have d/c vancomycin. Total time >31mins cc by me. Date of Admission 11/05/2021 Date of Discharge 11/10/2021 Reason for Hospitalization Infective endocarditis Hospital Course 78 y/o male with paroxysmal atrial fibrillation on Eliquis, CAD s/p CABG, ESBL E. coli endocarditis induced heart block s/p R heart pacemaker placement 9/29 (Boston scientific), incomplete treatment duration of endocarditis (~4 weeks out of 6), who was readmitted for septic encephalopathy in setting of ESBL bacteremia. Blood cultures positive for E. coli treated with Ertapenem. Oliguric renal failure appears to chronic given renal US on 11/6 which showed atrophy without obstruction. TEE showed mitral valve vegetation. Patient is not a candidate for definitive surgical management per CT surgery. Son would like DNAR, comfort care. Started treatment for hyperkalemia prior to goals of care discussion. Stopping antibiotics. Family en route. Discharge Diagnoses COVID-19 Vaccinated. Treated, on room air. Infective endocarditis Treat with IV abx, not open heart surgical candidate given comorbidities. Decision was made to pursue comfort care. Encephalopathy 1 month prior to admission, concern for septic emboli or anoxic brain injury prior to arrival. Developed Uremia as well Acute renal failure Declined dialysis as family decided to pursue comfort care. Other Diagnoses Ongoing No qualifying data Historical No qualifying data Consultants Medicine Cardiology Medicine Infectious Disease Supportive/Palliative Care Pending Labs Blood Culture (Preliminary, InProcess, ordered 11/08/2021, 13:10) Discharge Disposition Skilled Nursing Facility Medications New, Changed, or Refilled Medications None Medications to be Continued acetaminophen (acetaminophen 650 mg, 2 Tablet(s), Oral, q4h, PRN: pain/fever albuterol (albuterol HFA 90 2 Puff, Inhalation, q6h, for 30 day(s), PRN: Wheezing, 0 Refill(s) apixaban (apixaban 5 mg) 5 mg, Oral, bid, 0 Refill(s) atorvastatin (atorvastatin 2 20 mg, 1 Tablet(s), Oral, At Bedtime, 0 Refill(s) lisinopril (lisinopril 20 mg 20 mg, 1 Tablet(s), Oral, Daily, 0 Refill(s) modafinil (modafinil 200 mg) 200 mg, 1 Tablet(s), Oral, qAM, 0 Refill(s) Discontinued Medications None Physical Exam at Discharge Vitals & Measurements T: 36.7 ¦C TMIN: 36.7 ¦C TMAX: 36.8 ¦C HR: 83 RR: 36 BP: 138/71 SpO2: 94% General: Resting, non responsive HENMT: Fixed pupils Respiratory: No chest rise Cardiovascular: No peripheral edema. Gastrointestinal: Non-distended Musculoskeletal: Absence of movement Integumentary: Skin is cold Neurologic: Fixed pupils, no response to verbal, tactile stimulation Psychiatric: Unable to assess Time Spent >30 minutes Nursing/Other Orders Regular Diet. Ordered on 11/10/21 12:45:00 Meal Start Time Breakfast 0700 to 0900 Sofcare Static Air Seat Cushion. 11/08/21 10:31:00, when out of bed to chair Fall Precautions. 11/05/21 20:08:27. Order comment: order placed from nursing documentation CLIN_FALL_RISK Code Status. Code Status Description: DNAR (Do Not Attempt Resuscitation) Oxygen Instructions. 11/10/21 12:45:00, Routine, Instructions Titrate to comfort. No O2 Saturation Monitoring. Order comment:" "1864914-1" "1864914-1" "Admitted into hospital on 11/8. Expired 11/11. Admitted with acute flash pulmonary edema, pneumonia and COVID. Experienced multisystem organ failure. Needed increase of oxygen." "1864918-1" "1864918-1" "pt with end stage renal disease, on hemodialysis; presents to ED with SOB; positive for COVID, COVID pneumonia; during the pt's stay, required ventilation support; condition worsened; multi-organ failure; expired in the hospital" "1864948-1" "1864948-1" "pt presents to ED with SOB, dry cough, chills; O2 sats 62% on RA; placed on NRB mask; eventually required BiPAP; treated with COVID vitamins, steroids, remdisivir, tocilizumab; experienced hypertension and started on Cardene drip; had an episode of vomiting on BiPAP with O2 sats in 60 - 80s; intubated; pt coded 4 x with ROSC achieved; experienced decrease in BP, heart rate and O2 sats; coded and expired in the hosp" "1865036-1" "1865036-1" "pt had a short stay in the hosp from 9/27 - 9/28/21 with positive test for COVID; dc'd to home; presents to ED with increasing SOB and altered mental status; O2 sats @ 72% on RA; encephalopathic; positive for COVID pneumonia; intubation required; renal failure on CRRT and transitioned to hemodialysis, didn't tolerate well and required pressors; condition declined and worsened; comfort care measures instituted and pt died in the hosp" "1865279-1" "1865279-1" "Death." "1865333-1" "1865333-1" "I am the epidemiologist reporting on behalf of 42 year-old male patient. Patient received three doses of the Pfizer vaccine, according to immunization records. The first dose was on 02/13/21, the second on 03/06/21, and the third was on 10/16/2021. According to death certificate, patient was found dead on 10/31/21 at home (15 days post dose 3). Immediate cause of death listed is ?complications of pericarditis.? Interval between onset and death is listed as ?unknown.? I do not have any further details on underlying health conditions that may have contributed to this fatality." "1865372-1" "1865372-1" "PMH: CAD (CABG), DM, stage III CKD; in ED tests positive for COVID; dx'd with AHRF and AKI; no remdisivir given due to AKI; treated with IV steroids; intubated requiring up to 70 L O2 supplementation; agitation worsened; developed shock; given vasopressors, antibiotics; worsening O2 needs and increase of pressors; transitioned to comfort care and pt died in the hospital" "1865373-1" "1865373-1" "I am the epidemiologist reporting on behalf of 59 year-old female patient. Patient received two doses of the Pfizer vaccine, according to immunization records. The first dose was on 03/31/21 and the second was on 04/21/2021. The patient died 4/30/21 (nine days post dose 2) in hospital emergency room (outpatient). The death certificate lists ?cardiovascular collapse? as the immediate cause of death. Interval between onset and death is listed as ?5 minutes.? Known underlying health conditions include (but are not limited to) diabetes." "1865402-1" "1865402-1" "I am the epidemiologist reporting on behalf of 69 year-old male patient. Patient received two doses of the Pfizer vaccine, according to immunization records. The first dose was on 1/11/21 and the second was on 02/01/2021. The patient died on 02/02/21 (one day post dose 2) in nursing home. The death certificate lists ?acute myocardial infarction? as the immediate cause of death secondary to ?hypertensive heart disease? (unknown onset). Other significant conditions contributing to death but not resulting in underlying cause include Parkinson?s disease, hypothyroidism, and hyperlipidemia." "1865446-1" "1865446-1" "I am the epidemiologist reporting on behalf of 70 year-old male patient. Patient received two doses of the Moderna vaccine, according to immunization records. The first dose was on 4/23/21 and the second was on 5/26/2021. The patient was found dead at home on 5/28/2021 (2 days post second dose). The death certificate lists ?cardiopulmonary arrest? as the immediate cause of death secondary to ?diabetes, hypertension, and heart disease? (many years). No additional information is available." "1865447-1" "1865447-1" "Patient was brought to ER on 11/6/2021 due to severe weakness and lethargy. She was severly hypotensive with BP that could not be recorded, but she was also in Afib. She was given fluids and started on Zosyn for UTI/sepsis after urinalysis results were obtained. The patient continued to decline and the family decided to pursue comfort measures. The above adverse events may or may not be a result of the booster dose of vaccine, but per EUA provider is responsible to report serious adverse events irrespective of attribution to vaccination." "1865474-1" "1865474-1" "Event: Low Platelet count. Treatment: Received radiation therapy and blood infusions Outcome: Death" "1865504-1" "1865504-1" "I am the epidemiologist reporting on behalf of 75 year-old female patient. Patient received two doses of the Moderna vaccine, according to immunization records. The first dose was on 4/23/21 and the second was on 5/17/2021. The patient was found dead at home on 5/19/2021 (2 days post second dose). The death certificate lists ?cardiopulmonary arrest? as the immediate cause of death secondary to ?CHF, Interstitial Lung Disease, OSA, AFIB (FEW weeks) and RHEUMATOID ARTHRITIS, HTN, DIABETES (MANY years).? No additional information is available." "1865526-1" "1865526-1" "Patient began with bloody nose, unable to stop bleeding, Pressure applied, ice applied, nasal clamp applied. Did also note some bleeding in foley. New foley placed, resident removed clamp and bleeding returned, resident was sitting at 90 degree angle in bed, and was swallowing blood. Suctioning and oxygen attempted. Family alerted and did come and request to have resident have comfort medications only in place of going to hospital. Resident expired 11/11/2021 1240." "1865574-1" "1865574-1" "Patient passed away on 10/16/2021" "1865581-1" "1865581-1" "Patient passed away on 08/26/2021." "1865583-1" "1865583-1" "Patient passed away on 10/19/2021" "1865597-1" "1865597-1" "Patient passed away on 10/22/2021" "1865612-1" "1865612-1" "I am the epidemiologist reporting on behalf of 57 year-old male patient. Patient received one dose of the Pfizer vaccine on 04/06/2021, according to immunization records. The patient passed away on 4/09/2021 (3 days post first dose, hospital emergency room). The death certificate lists ?cardiac arrest? as the immediate cause of death. No additional information regarding underlying conditions that may have contributed to this death is available." "1865615-1" "1865615-1" "Patient passed away on 10/21/2021" "1865638-1" "1865638-1" "Patient had breakthrough infection and expired." "1865657-1" "1865657-1" "Patient had breakthrough infection and expired." "1865658-1" "1865658-1" ""pt presents to ED with productive cough, fever and SOB; states has been on 6 L O2 @ home ""all the time"" for a few days; positive for COVID; treated with steroids, breathing treatments, antibiotics; moved to ICU; COVID pneumonia; required emergent intubation; pt's condition worsened; placed on comfort care and extubated; died in the hospital"" "1865681-1" "1865681-1" "Patient had breakthrough infection and expired." "1865946-1" "1865946-1" "abdominal pain, Gullain-Barre' Syndromw" "1865959-1" "1865959-1" "sudden death" "1867659-1" "1867659-1" "death" "1867933-1" "1867933-1" ""Patient said he ""was not feeling well"", night before and in the morning. Went to work at 8:30 am and collapsed while on the phone at work at 11:10 am. Had heavy breathing and retrieved a pulse while on ambulance but then lost pulse at arrival of hospital."" "1867999-1" "1867999-1" "death Pt died in her sleep less than 48 hours from the time of vaccination. No acute symptoms were occuring before death. No other medical procedures were done close to date of death, other than pfizer vaccine." "1868024-1" "1868024-1" "Starting in mid-October she experienced abdominal pain. Admitted for stroke on 11/5/2021 Superior mesenteric artery occlusion on 11/9/2021 left common femoral artery occlusion on 11/9/2021 death on 11/12/2021" "1868193-1" "1868193-1" ""Adverse event started w/ c/o headache and extreme progressive weakness. Treated at Hospital Center briefly. Diagnosis Low platelets 28k, cerebral hemorrhage, and pneumonia. Transferred Hospital . Received multiple platelet transfusions (5 I believe), and treated w/ IV ABT. Pneumonia ""resolved"" only to return within a week. During hospital stay patient experienced fluid overload, kidney failure, and heart valve failure of replaced heart valve. Lengthy hospital stay ultimately ended with transfer to hospice and death."" "1868233-1" "1868233-1" "Patient died after suffering a heart attack the morning after the first dose was given. Patient had history of diabetes but not heart condition." "1868506-1" "1868506-1" "While on a golf trip with his friends, the victim died shortly after going to bed. Showing no symptoms prior, or complaining of any discomfort." "1868510-1" "1868510-1" ""Hospice Nurse' Note on 9/21/2021: ""This nurse received a phone call from a very close friend of hers reporting that her husband?s uncle Has Covid and took a very bad turn this afternoon. Patient does not want to go to the hospital and does not want to be on any machines. He is a 98 year-old. He is a bachelor and has been living alone since his sister died that he used to live with. He has been alert and oriented and able to live alone with someone just checking in on him. Several months ago his nephew who is his caretaker moved him to a home right down the street from them so it would be closer and making caring for him easier. He was able to walk with a walker. He does not drive anymore since he had an accident a months ago. He has no children and his siblings are dead. He has been able to go to church and he would go on Friday night to play cards with a few other couples in the town down the road. He started having some Covid symptoms on Sunday, 9/12. He was a little congested and said he just did not feel good. Thursday he could not get off the couch and was so weak. He had them call the priest and he did visit and gave pt his last rites. Pt?s Nephew?s daughter did a Home Covid test on pt Thursday, 9/16 and he tested positive for Covid. Patient has been vaccinated. He did go Saturday and have the antibody infusion and he was gradually regaining his strength and almost back to his former activity they said. He took a shower on Saturday and was able to get it out by himself. He also was able to sit up on the couch and watch the ball game on Sunday. Yesterday morning he was doing pretty good and able to sit up and go to the bathroom and then about 3 o?clock this afternoon they went to check on him and could not arouse him. His oxygen level was down to 75% and his heart rate was 35. Before that his oxygen level had only gotten down to 94% at its lowest. Patient told them he did not want to go to the hospital . When they called this nurse they were just beside theirself and did not know what to do. Patient was anxious and moaning and confused. They could not get him settled. ?Hen? is a patient of Dr. It was so late in the day but they were afraid that something might happen to him during the night and they would not know what to do and they would not be able to have any medication and that patient would have to be taken to the hospital and that is not what he wanted. This nurse called RN at the care center and She did get a hold of Dr. He was still in the office and so was Dr. Dr. called back and said that pt could admitted him under the diagnosis of Covid, hypoxia, and hypertension. She wold also cover pt."" Hospice Nurse' Note on 9/22/2021 @ 06:50 CDT: ""Pt?s great niece called and reported that pt?s O2 sat were down to 72% and his HR was 131. At 5:30 this am his O2 sat was in the 80s and was staying up in the 80s all night until now. They have been struggling to keep the O2 nc on pt during the night. He was alert enough to tell them that he did not want the O2 on. The morphine has helped pt but it does not last long. He keeps asking for his nephew. He says hat he wants up to the bathroom and then says no. When he does sleep he makes noises and he is very anxious and jabbering. He is drinking small sips of water. This nurse will visit soon."" Pt expired later on that day. Nurse's note @14:06 CDT: ""Post mortem care provided. Controlled medications disposed of per protocol. Company contacted and patient ruled out due to age. Provisional Report completed and signed by pt?s nephew and great niece. Request put in the system and to contact nephew to set up date and time. Body released to Funeral Home. Emotional support provided throughout visit. Informed family of bereavement services."""" "1868616-1" "1868616-1" "Found deceased on 11/14/2021. Reported to have allergic reaction/rash to 2nd dose on 03/14/2021." "1868972-1" "1868972-1" "Severe Illness" "1869204-1" "1869204-1" "Patient was diagnosed with COVID on October 13. came to the ER with respiratory distress from nursing home on November 4th. Signs and symptoms: shortness of breath Pulse ox on the scene was 70% on oxygen. Treatment: 100% oxygen.(intubation)" "1869327-1" "1869327-1" "On 11/12/21 @ approximately 1:11 pm resident 02 saturation decreased to 84%. rebounded after breathing treatment to 91% but residents overall condition continued to decline. 02 increased to 3 liters with orders to titrate up to 6 liters. This resident was a hospice patient and had been having recent episodes of aspiration. Condition continued to decline and resident expired on 11/15/21 @ approximately 9:44 am" "1869372-1" "1869372-1" "At her home, dyspnea, pulselessness, 1:30 am 10/26/21, treatment 911 per husband, CPR until relieved by medics, EKG indicated pulseless cardiac arrhythmia treated with cardio-conversion X3, intubated, transported to the Emergency Room. Probable rhythm capable of some cardiac output." "1869411-1" "1869411-1" "Headache 8PM on 11/10/21, found dead the next morning unsure of connection." "1869414-1" "1869414-1" "dx'd with COVID 8/29/21, admitted to hospital, dc'd to home on 8/31/21; sent per Home Health nurse to ED on 9/13/21 for chest pain, dyspnea, increased weakness past 2-3 dys; pt found to be hypoxic; placed on O2 OptiFlow 50/70; given diuretics, antibiotics, steroids; DNI/DNR; condition worsened and pt placed on OptiFlow 100%; inpatient hospice; comfort care measures; pt died in the hosp after condition continued to deteriorate" "1869417-1" "1869417-1" "Patient fully vaccinated against Covid-19 and is deceased from covid related pneumonia illness. Patient died on 10/31/2021" "1869456-1" "1869456-1" "VAERS 9 Nov 2021, 11:00 Day Zero: Is in usual state of health 1/2 dose Pfizer Covid vaccine given IM at Pharmacy. 18 hours post vaccine required Ativan to aid sleep. 10 Nov 2021, Day one: hour 24, subject experienced moderate fatigue, pillow and dyspnea due to increasing weakness, treated with acetaminophen hour 32 post vaccine given Ativan (for sleep) hour 42 post vaccine required 0.5 ml morphine via G-Tube for pain and air hunger, 11 Nov 2021, Day two: subject is clinical better hour 57 required Ativan for sleep 12 Nov 2021, Day three: Hour 70 required 0.5 ml Morphine for malaise, pain discomfort resistant to acetaminophen hour 84 required Ativan for sleep 13 Nov 2021, Day four: Subject experienced rapid deterioration in respiratory status hour 92 required Ativan for anxiety, air hunger, dyspnea hour 95 required 0.5 ml Morphine sulfate for anxiety, air hunger, dyspnea hour 96 at patient request non-invasive ventilator tidal volume increased by 15% to 450 ml, hour 98 on advise of Hospice nurse both Morphine and Ativan were both given at 0.5 ml doses Subject expired at 12:40 pm Nov 9th , 2021, 98 hours after Pfizer Booster dose given" "1869473-1" "1869473-1" "Unknown at time of vaccination" "1869491-1" "1869491-1" "Immediately following the first Moderna vaccine, Patient was experiencing headaches and blurred vision. The decedent was admitted to Hospital on 9/12/2021, transported by EMS from home. According to patient, she had just finished cooking lunch when she heard a loud thud. She found patient on the bathroom floor unresponsive. Patient had no known medical conditions. He died at Hospital on 9/15/2021. An autopsy and toxicology testing was completed by the County Coroner's Office." "1869598-1" "1869598-1" "Patient was a 65yr old Male, received 1st dose of Pfizer 01/25/2021. Tested positive for Covid on 03-04-2021. Passed away on 03/21/2021" "1869623-1" "1869623-1" "Breakthrough Case. Tested positive on 04/24/2021, 64 days after vaccination. Hospitalized 04/24/2021, Discharge Date: 05/12/2021. Died 06/10/2021" "1869633-1" "1869633-1" "Death- unexplained" "1869644-1" "1869644-1" "Not LTCF. PCR(+) 05/10/2021. Noted to be asymptomatic for Covid in May 2021. Died at home. Last hospital encounter 5/1/21 notes: dx of malignant neoplasm of esophagus, dehydration, malnutrition, hyperosmolality and hypernatremia. C/M: HTN, current smoker, immunosuppressive condition. Fully Vaccinated (Pfizer): 02/27/2021 & 03/28/2021." "1869650-1" "1869650-1" "pt admitted with AHRF secondary to COVID pneumonia, pt was already intubated; PMH: CHF, CKD, COPD , CAD; refused remdesivir due to kidney disease; pt's condition worsened and he passed away in the hospital" "1869664-1" "1869664-1" ""Had subdural hematoma from fall on 5/23/2021 Death certificate: ""ACUTE RESPIRATORY FAILURE_INTERSTITIAL LUNG DISEASE_COVID-19"" Not LTCF. PCR(+) 5/23/21. On 5/21: Admitted to hospital with subdural hematoma due to fall, diagnosed with Covid PNA. 6/15: Hospitalized again, EMS called for low O2 sats in the 70s, dx of Covid, ARF w/hypoxia, SOA. Fully Vaccinated (Moderna): 3/31/21 and 5/3/21. DC support covid-19."" "1869692-1" "1869692-1" "fully vaccinated covid related death" "1869710-1" "1869710-1" "pt brought to ED with c/o difficulty breathing and congested cough; states was diagnosed positive for COVID 2- 3 wks prior to coming to ED; positive COVID test in ED; pt experiencing A Fib while in ED; admitted to hospital and placed on BiPAP; PMH: chronic AFib, DM2, CAD, diverticulitis; pt unable to progress towards weaning from O2 without desaturation; comfort measures instituted with pt's failing condition; once weaning protocol was initiated, the pt died in the hosp" "1869715-1" "1869715-1" """"IDIOPATHIC PULMONARY FIBROSIS_COVID-19 PNEUMONIA,"" Not LTCF. Ag(+) 6/29/21. S/S: cough, rhinorrhea, difficulty breathing, sore throat, symptoms noted to have resolved on unknown date. Dx: idiopathic pulmonary fibrosis. 8/9/21-8/12/21: Admitted to hospice for IV symptom management of ongoing dyspnea related to pulmonary fibrosis. C/M: chronic lung disease, CAD, DDD, GERD, HTN, OA, thyroid disease, frequent UTIs. No covid-19 on PMH. MRG reviewed as covid-19 related death. Consistent with DC. PROBABLE CASE. Fully Vaccinated 2/18/21 & 3/18/21 (Moderna)."" "1869755-1" "1869755-1" "Admitted 7/26 from ED with COVID, PNA, sepsis. Patient removed BiPAP and dev. hypoxia & bradycardia. Went into PEA when intubating. Symptoms: weakness, CXR noted for PNA, exhausted with minor activity, hypoxic, respiratory distress Non-LTCF. (+) PCR 7/10/2021. Dx: PNA due to COVID, ARF with hypoxia, sepsis without acute organ dysfunction, enlarged thyroid. S/S: cough, wheezing, weakness, develop PNA, SOA, tachycardia. C/M: A. fib with RVR, HTN, HLD. Pfizer: 2/27/2021 & 3/16/2021." "1869769-1" "1869769-1" "Pt received booster shot of Moderna covid vaccine on 11/5/2021. On 11/6/2021 at approx. 0930, pt was found to be unresponsive and asystolic at the nursing home. Last known well was 0600. After pt was found unresponsive and asystolic, CPR was started and pt was then taken to hospital via squad where resuscitative efforts were continued by ambulance staff and hospital staff. Pt was pronounced dead at 1013 on the morning on 11/6/21" "1869816-1" "1869816-1" "Fully vaccinated patient hospitalized with COVID-19" "1869829-1" "1869829-1" ""Pt developed a cough with wheezing and shortness of breath day 3 post vaccine. She saw our medical practice for care on day 4 post vaccine. On Wednesday 11/10/21 (day 9 post vaccine) she had a ""coughing fit"" and lost consciousness. EMS was dispatched and attempted to resuscitate patient but she died shortly there after at the Emergency department."" "1869858-1" "1869858-1" ""Deceased (11.14.21); Hospitalized (11.5.21); COVID-19 positive (11.5.21); fully vaccinated Admission Date: 11/5/2021 Date of Death: 11/14/21 Time of Death: 9:15 AM Preliminary Cause of Death: COVID-19 virus infection HOSPITAL COURSE: Admission H and P : Patient is a 86 y.o. male who presents today with weakness and diarrhea per ER notes. He states ""the COvid is the reason they gave me this room here."" Patient denies falling or having increased confusion today but per Er notes patient had increased confusion. Patient struggles to tell me why he is in the hospital. He denies SOB but is having a cough and it is occasionally productive. Patients denies chest or abdominal pain and denies having diarrhea though does not that he is having some nausea. He notes that he has chills all the time but denies fever. He has some mild congestion and runny nose. He has his sense of taste and smell but does not eat much lately. He denies feeling more weak or fatigued than his baseline and is not having body aches. He thinks that his son had COVID ""I think he is getting tested now."" Patient states ""I had a bad infection in my foot and had my toes amputated last month and had vascular surgery."" he notes that his foot is healing well and he was seen by vascular surgery, he last saw them on 11/2. Per ER notes and report patient had increased confusion today when home health was over doing therapy. They were concerned about him being more weak and not participating like normal. He was also having increased confusion so they recommended that he come into the ER. IN the ER patient was noted to be positive for COVID. CXR showing Patchy opacity in the left mid lung zone may represent infection but imaging follow-up to resolution is recommended. He had head CT that was negative for acute findings. KUB of abdomen was completed showing no acute findings but shows AAA with bilateral iliac stent grafts in place. Patient will be admitted for weakness/confusion and COVID. Following admission was placed on decadron rx , did not qualify for other treatment rx . oxygenation remained stable . On presentation inr was supra tx and was held and dosed by our pharmacy dosing service . Identified sacral pressure ulcer present on admit was evaluated by our wound care team with dressing changes and care directed by them. He remained generally weak Likely 2/2 COVID and recent infection with toe amputation on underlying mild dementia . Through out stay was confusion and delirium waxed and waned and did escalate requiring both physical and chemical restraints . Discussions with family with Plans for signing on with north ottawa Hospice when bed available . Goals of care discussed with over all quality of life declining with underlying Dementia . Hospice care was consulted in the hospital and patient was made GIP Hospice . He was placed on comfort care orders with analgesics , anxiolytics And passed peacefully in the hospital"" "1869927-1" "1869927-1" "General malaise, fatigue." "1869970-1" "1869970-1" "(From interview with Charge Nurse): Patient became very confused on 11/03/2021. On 11.04.2021 She developed wheezing and had diminished lung sounds, and became agitated and more confused. POA agreed to put her on hospice care. No treatment apart from hospice." "1870002-1" "1870002-1" "Dose 1 given 1/29/2021 Moderna lot # 010M20A Patient died of Covid 19, respiratory failure" "1870029-1" "1870029-1" "Dose 1 2/19/2021 Moderna Lot # 024M20A Patient died of complete heart block, not a covid related death" "1870049-1" "1870049-1" "was admitted for acute hypoxemic respiratory failure secondary to COVID 19 pneumonia , intubated 10/25/21 , not on anticoagulation due to alveolar hemorrhage, HD initiated by nephrology due to worsening renal funciton. ID , nephrology and pulmonary medicine evaluating , patient was on Cefepime and vancomycin . In course of hospital stay also received Doxycycline , Vancomycin , Remdesivir, Decadron . Clinically , respiratory status did not improve and patient remained on mechanical ventilator . Family decided for comfort care only , patient was extubated and expired 11/08/21 at 8:56 pm." "1870173-1" "1870173-1" "Plz contact hospital for medical records" "1870176-1" "1870176-1" "Per husband at scene, patient was feeling ill after vaccine, then he called 911 in the evening. Patient was in cardiac arrest." "1870439-1" "1870439-1" "Hospitalized 11/7/2021; COVID-19 positive 11/7/2021; fully vaccinated BRIEF OVERVIEW: Admission Date: 11/7/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute hypoxemic respiratory failure due to COVID-19 HOSPITAL COURSE: 86yo hx COPD, HTN, Fatty liver, tobacco use (quit 1999), presented to ED 11/7 hypoxic in 50's, placed on bipap and nonrebreather but respiratory status worsened and he was intubated in ED. K-6, lactate-7.2. He developed Afib RVR that improved with amio gtt. He required norepi. Pt was transferred to BL and paralyzed. Vanc/Cefepime given for HAP. He has significant AKI, family unclear with desire for dialysis, now full code, aggressive treatment. Nephrology following and discussing with family need for dialysis. Right peroneal DVT noted on US, started on heparin gtt. Hgb 5.7 11/9, transfused 1 u PRBC, no obvious signs bleeding, heparin held but then resumed as Hgb stabilized. Lasix gtt 11/12. Worsening renal failure and persistently high ventilator requirements. Family conference 11/13, family ultimately decided to transition to comfort care measures. Date/time of death 11/13 at 1754." "1872660-1" "1872660-1" "Got covid shot and died; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Got covid shot and died) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 30-Mar-2021 The patient died on 30-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided Concomitant medications were not reported. Treatment medications were not reported. Company Comment - This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected event of Death. The event occurred 22 days after receiving an unknown dose number of mRNA-1273 Vaccine with a fatal outcome. The rechallenge was unknown since only information about an unknown dose number was disclosed. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected event of Death. The event occurred 22 days after receiving an unknown dose number of mRNA-1273 Vaccine with a fatal outcome. The rechallenge was unknown since only information about an unknown dose number was disclosed. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death" "1872793-1" "1872793-1" ""1. Day 3 after shot woke up feeling ill. 2. First week of September, right leg and foot were swelling up. Dr. prescribed lasix. 3. September 10, 2021 û EKG. Indicated ""Sinus tachycardia. Probable left atrial enlargement. 4. September 16, 2021 decided to not walk/run my dog today and went to ER instead. I thought perhaps I was dehydrated from the Lasix and would receive fluids and be sent home. ER doctor indicated that they had seen my same symptoms with Covid-19 and also with the Covid-19 vaccines. ER advise would have to admit me based upon symptoms. 5. Could find no medical reason for my symptoms. Dr. (cardiology) said diagnosis will be through deducing what I DO NOT have. 6. Dr. said she thought I had an infection somewhere in my body that impacted my heart. 7. Was told I had heart function of around 20%. 8. Hospitalized for a week. Given several bags of different multiple antibiotics everyday. 9. September 18, 2021 û Dr. said may start a beta blocker on 09/19/2021. Mentioned Lisinopril. 40 IV 2x per day. IV is double dose of Lisinopril. Significant change after given meds without permission or consent. Given meds to lower blood pressure even though BP was in the 80s and 90s. Meds given and no follow-up to see if I was okay. Began having troubling breathing asking for oxygen and emergency inhaler. Denied oxygen. Emergency inhaler rarely ever came. September 21, 2021 û Cardiology said no reason to keep in hospital any longer. Dr came in, and said that she was internal medicine. She said that my kidneys were being taxed and wanted to keep me overnight, start Jardiance and give me fluids. I advised Dr. that I was going home today and would not be taking Jardiance. The nurse was uncertain what to do since I refused the Jardiance so asked Dr. who said that she would have to ""write an Addendum to speciality hospital"". I realized that Dr. had said something out loud that I had no knowledge of what was going on. I am at this hospital not a patient of this speciality hospital so why and how is this speciality hospital involved or even have knowledge of my situation? I didn't authorize transmission nor sharing of my medical or any other information with this speciality hospital. Heart medications given in hospital without my knowlege and consent were by different doctors: Lasix (diuretic) Entresto (BP medication Metoprolol (Beta Blocker) Aldactone (lowers BP/diuretic) October 11, 2021 - Jaundice. Hospitalized. Never made it home. Here's what happened: I developed multisystem inflammation and multisystem failure that medical professionals could not stop. My muscles disappeared as if to disintegrate. I was in ICU for several weeks and stabbed with needles up to 24 times a day for those several weeks, while also receiving 6 or 7 IVs at the same time (continuously). It was constant torture that I cannot describe. I was no longer treated as a human with feelings and a life. I was nothing more than a covid vaccine human guinea pig and the doctors excited to participate in my fascinating progression unto death. Died November 1, 2021 Death experience described by patient. The nursing staff at hospital, indicated that the doctors are not allowed to submit information about reactions nor deaths to the covid-19 vaccine or they will be fired and blacklisted. We were begged to get the information to you and the public."" "1872901-1" "1872901-1" "N/A" "1872949-1" "1872949-1" "I am the epidemiologist reporting on behalf of 59 year-old male patient. Patient received one dose of the Pfizer vaccine on 4/06/2021, according to immunization records. The patient passed away on 4/08/2021 (2 days post first dose, hospital inpatient). The death certificate lists ?ST Elevation, Myocardial Infarction? as the immediate cause of death due to or as a consequence of acute cholecystitis and diabetic ketoacidosis. No additional information regarding underlying conditions that may have contributed to this death is available." "1872954-1" "1872954-1" "Patient vaccinated against and then tested positive for COVID-19" "1872966-1" "1872966-1" "I am the epidemiologist reporting on behalf of 62 year-old male patient. Patient received one dose of the Pfizer vaccine on 3/15/2021, according to immunization records. The patient passed away on 3/17/2021 (2 days post first dose, hospital inpatient). The death certificate lists ?Cardiac Arrest? as the immediate cause of death due to or as a consequence of esophageal cancer, possible bowel ischemia and colon cancer. No additional information regarding underlying conditions that may have contributed to this death is available." "1872969-1" "1872969-1" "pt admitted to hospital with COVID pneumonia, acute UTI, AHRF; treated with Zosyn, dexamethasone, baricitinib; increasing O2 requirements; Optiflow NRB; DNI/DNR; refused aggressive care or transport; pt's condition declined and she died in the hospital" "1872995-1" "1872995-1" "I am the epidemiologist reporting on behalf of 81 year-old male patient. Patient received one dose of the Pfizer vaccine on 3/25/2021, according to immunization records. The patient was found deceased at home on 3/28/2021 (3 days post first dose). The death certificate lists ?Cardiopulmonary failure? as the immediate cause of death. No additional information regarding underlying conditions that may have contributed to this death is available." "1873014-1" "1873014-1" "I am the epidemiologist reporting on behalf of 83 year-old male patient. Patient received one dose of the Pfizer vaccine on 3/19/2021, according to immunization records. The patient passed away at home on 3/21/2021 (2 days post first dose). The death certificate lists ?Sudden Cardiac Death? as the immediate cause of death secondary to non-ischemic cardiomyopathy (18 months). No additional information regarding underlying conditions that may have contributed to this death is available." "1873056-1" "1873056-1" "pt diagnosed positive for COVID 1 day before presents to ED per PCP request; c/o fever, chills, cough x 4-5 days; hyperglycemic; HX CAD, Kidney transplant 2013, HTN, DM; O2 requirements worsened requiring mechanical ventilation and proning; multiorgan failure; placed on DNR; condition worsened and pt died in the hospital" "1873059-1" "1873059-1" "found unresponsive with no HR or respirations at approximately 3:15am 11/16/21, CPR initiated, declared by 911 emergency personnel" "1873132-1" "1873132-1" "Pt received pfizer booster on 11/3/21 in L deltoid, received seasonal flu vaccine on 11/4/21 in R deltoid with HCP consent. No reactions identified at the time of either administration. Pt current status at time of vaccination was non verbal with late stage dementia, which is his baseline. Initiation of hospice services had been discussed with HCP prior to both vaccines. Pt expired on 11/6/21." "1873163-1" "1873163-1" "I am the epidemiologist reporting on behalf of 80 year-old male patient. Patient received one dose of the Pfizer vaccine on 2/04/2021, according to immunization records. The patient passed away on 2/11/2021 (7 days post first dose, hospital inpatient). The death certificate lists ?Acute Hypoxic Respiratory Failure (3 Days)? as the immediate cause of death secondary to acute heart failure (few days). Other significant conditions contributing to death but not resulting in underlying cause include acute kidney injury requiring hemodialysis, staph bacteremia, chronic systolic heart failure. No additional information regarding underlying conditions that may have contributed to this death is available." "1873186-1" "1873186-1" "pt brought to ED via EMS after going into cardiac arrest @ home; CPR done @ home and en route to hospital; pt intubated; recently recovering from COVID that did require a hospitalization; family made pt a DNR; pt extubated and passed away in the hospital" "1873209-1" "1873209-1" "Presented with SOB/weakness/non-productive cough; fully vaccinated; dx Covid PNA; treated with steroids, antibiotics, remdesivir, zinc, veletri infusion; intubated; initial covid dx 8/8; hospital admit 8/10; intubated 8/22; comfort care 8/24; died 8/24" "1873219-1" "1873219-1" "Presented with weakness/diarrhea/vomiting/fever/SOB; dx with Covid PNA; treated with Vit D/Vit C/Zinc/steroids/antibiotics; discharged home; No oxygen needed. pt died on 8/21/21 during subsequent admission (not covid related)" "1873233-1" "1873233-1" "Presented with SOB, AMS; dx with Covid PNA; treated with steroids, 2 doses of remdesivir, Vit C, Zinc, supplemental O2; developing renal failure; family decided on comfort measures; pt died on 8/17" "1873244-1" "1873244-1" "pt brought to ED with c/o SOB and difficulty breathing; O2 sats 50% upon EMS arrival; intubated; placed on ventilator; HX: COPD, HTN, hypokalemia, hypothyroidism; respiratory failure; pt's condition worsened and he died in the hospital" "1873253-1" "1873253-1" "Presented with AMS; Covid + in ED; asymptomatic at arrival; pt declined 2 status; started on steroids, remdesivir, Vit C, zinc, and supplemental O2 on 8/7; Intubated 8/10, started on veletri; 8/16 worsening infiltrates, 100% FiO2 on vent; 8/26 remains intubated; FiO2 55%; He was started with Solu-Medrol and also treated with remdesivir. He was treated also with supportive care with montelukast, zinc sulfate, and DVT propHe was started with Solu-Medrol and also treated with remdesivir. He was treated also with supportive care with montelukast, zinc sulfate, and DVT prophylaxis with apixaban. Patient was on mechanical ventilation in the ICU. He was also treated with empiric antibiotics with meropenem and IV micafungin. On September 7, patient noted to have atrial fibrillation, and around 9:43 a.m., then he suddenly developed wide-complex tachycardia with possible LBBB with prompt progression to asystole. There was a code blue called. After the round of ACLS, patient noted to have asystole, and he was pronounced dead at 10:07 by ICU team. anaphylaxis with apixaban. Patient was on mechanical ventilation in the ICU. He was also treated with empiric antibiotics with meropenem and IV micafungin. On September 7, patient noted to have atrial fibrillation, and around 9:43 a.m., then he suddenly developed wide-complex tachycardia with possible LBBB with prompt progression to asystole. There was a code blue called. After the round of ACLS, patient noted to have asystole, and he was pronounced dead at 10:07 by ICU team." "1873264-1" "1873264-1" "Presents for AMS & hypotension, known COVID+. Admit for septic shock & COVID pneumonia. New C. diff on day 4, increased O2 demand day 5. Tx: vit c, zinc, abx, O2, levophed, steroids. Remdesivir held due to uknown onset. DC to hospice, expired later same day." "1873265-1" "1873265-1" "Presents for cough/congestions x10 days. Hypoxic on RA. COVID + PTA. Seen & tx by PCP twice during previous 10 days (ivermectin, abx & steroids). Admit for severe resp failure r/t COVID pneumonia. Tx: O2, remdesivir, actomera, convalescent plasma, oral decadron & singulair, oral ivermectin, zinc. Failed inpatient therapies & placed on inpatient hospice. Expired." "1873267-1" "1873267-1" "Arrived with SOB. Admit for COVID pna. Fully vaccinated. Treated with O2, duonebs, doxy, lovenox, steroids, zinc, singulair, Ivermectin, plasma, remdesivir. Initially looked to improve and was back to baseline 3L O2, but then developed hypotension and rapidly declined; septic shock 2/2 HCAP. Transitioned to comfort care and expired." "1873269-1" "1873269-1" ""Admit with COVID infection. Fully vaccinated ""four months ago"". O2, steroids, lovenox, singulair, zinc, vit-c, remdesivir, toci. Continued to decline; palliative care consulted and pt eventually made DNR. Expired."" "1873273-1" "1873273-1" "Sore arm but in May started to feel vertigo like symptoms and was nauseous and couldn?t lay on one side of body. Day she died shortness of breath." "1873283-1" "1873283-1" "Tested + PTA. Presented w/ high fever, worsening cough and SOB. Fully vaccinated 1/2021. Dx w/ COVID pna. Remdesivir, lovenox, steroids, O2 by HFNC. In terms of her COVID infection, she had received 10 days of remdesivir, toci, high-dose steroids, Lovenox. The patient passed away on September 6, 2021, at 1603." "1873288-1" "1873288-1" "Admitted with Rhabdo after being found down at home, dx with COVID pna shortly after admit. Fully vaccinated. O2, remdesivir, singulair, zinc, steroids. 8/25 Discharged to inpatient hospice. Comfort was maintained the several hours he was on hospice He died at 16:20" "1873297-1" "1873297-1" "Patient came to ED with worsening SOB. Patient was admitted for pneumonia due to COVID and hypoxia." "1873327-1" "1873327-1" "pt reports having been positive for COVID x approx 2 weeks @ home; brought to ED with worsening SOB, weakness and cough; HX: CADBG, prostate CA, thyroid disease; hernia repair; on HF NC with O2 sats 89-90%; started on dexamethasone; AHRF; DNI/DNR; condition worsened significantly; pt went into respiratory arrest and died in the hospital" "1873345-1" "1873345-1" "Hospitalized 11/6/2021; COVID-19 positive 11/6/2021; fully vaccinated BRIEF OVERVIEW: Discharge Provider: Primary Care Physician at Discharge: Admission Date: 11/6/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Respiratory failure, acute-on-chronic [J96.20] Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE: Patient is a 87 y.o. female with PMH significant for COPD, HLD, HTN, hypothyroidism, history of ischemic CVA, compression fracture, GERD, depression, and sick sinus syndrome status post pacemaker who presented to the ED on 11/6/21 after exposure to COVID with four day h/o of lightheadedness, cough and weakness. In the ED, she was hypoxic requiring 4L O2 rather than her baseline of 3L. She was started on Remdesivir and Decadron and admitted for hypoxia 2/2 COVID. Patient had progressive hypoxia requiring high flow nasal cannula. She was transitioned to IV salumedrol 40mg q6 hours due to wheezing concerning for COPD exacerbation. She was also given albuterol q4 hours scheduled. O2 requirements continued to increase to % FIO2 on HFNC. Long discussion with patient and family regarding GOC. Ultimately elected to pursue comfort measures. Hospice was consulted an patient made GIP Hospice. Started on Morphine and Versed Gtt. Passed away at 2206 on 11/14/21." "1873358-1" "1873358-1" "pt seen in ED and dx with AHRF, sepsis due to COVID pneumonia, AKI, thrombocytopenia; started on decadron, pepcid, zofran, IV fluids; admitted to hospital; pt has had cough, congestion, confusion, N/V; pt's condition worsened in the hospital requiring intubation with mechanical ventilation; transferred to ICU; pt experienced cardiac arrest and died in the hospital" "1873426-1" "1873426-1" "Deceased due to COVID" "1873502-1" "1873502-1" "On the 3rd day she became a little off. Her walking became to a crawl then she had to use a walker a week later. She started losing control of her bladder. Before the vaccine she was very healthy." "1873551-1" "1873551-1" "He experienced a change of condition on 11/12/21 with frank bleeding in catheter bag, pain in LLQ and worsening tremor. He reported feeling achy all over and pain in left pelvic area. The resident had a telehealth visit in the nursing home with the PA. His blood pressure was 153/99. He pending transfer to ER when his vital signs ceased and he was unable to be resuscitated with CPR." "1873570-1" "1873570-1" "Sudden death due to heart event while at the beach at 7:00 am in the morning. CPR performed for an hour. Heart could not be restarted as my husband had the event in the water." "1873588-1" "1873588-1" "PT ADMITTED ON: 11/03/2021: The patient is admitted to the Palliative care service. HISTORY OF PRESENT ILLNESS: Patient is an 86-year-old man who had a change in level of consciousness and became dyspneic and hypoxic at the nursing home today. He is a resident at Nursing Home. He was sent to the emergency room where he has been found to certainly be hypoxic and has evidence of pneumonia on chest x-ray with a positive COVID test. The patient himself is unable to give the history. REVIEW OF SYSTEMS: The patient is unable to complete review of systems. PAST MEDICAL HISTORY: Patient is unable to cooperate. SOCIAL HISTORY: His sister has arrived today. Additional information for Item 18: (con't): EXPIRED DATE: 11/05/2021: The patient expired on 11/05/2021. ADMISSION DIAGNOSIS: COVID-19 virus infection. FINAL DIAGNOSES: 1. Pneumonia due to COVID-19 virus. 2. Chronic obstructive bronchitis with pulmonary emphysema. 3. Aspiration pneumonia. 4. Encounter for palliative care. HISTORY OF PRESENT ILLNESS: Patient is an 86-year-old man who presented to the hospital from a local nursing home with dyspnea. He was evaluated in the emergency room where he was found to have right-sided pneumonia or right-sided infiltrate on chest x-ray. He had a positive COVID test. He had changes of emphysema on his chest x-ray. His sister arrived in the emergency room and made it clear that she wants the care focused on his comfort. He looked very ill in the emergency room the night that I arrived and I just did not think it was fair to put the sisters through all the hospice procedures to get the patient admitted. I thought his death was imminent. HOSPITAL COURSE: The patient was admitted. He received IV morphine usually about once per shift for shortness of breath. He expired on the morning of 11/05/2021. The first morning after admission he actually was clinically improved and was able to say just a few words and on the morning of 11/05, he said just a few words. He expired that morning. Cause of death was COVID-19 pneumonia. His sister was counseled following this. No autopsy was desired." "1873615-1" "1873615-1" "pt admitted to hosp with severe COVID pneumonia, AHRF; on high flow O2; DNR; placed on comfort care; encephalopathy and her condition continued to worsen; no response to verbal or tactile stimuli for 2 days prior to her death in the hospital" "1873627-1" "1873627-1" "I am the epidemiologist reporting on behalf of 73 year-old female patient. The patient received two doses of the Pfizer Vaccine: First: 2/27/2021 Second: 03/20/2021 The patient was found dead at home on 3/27/2021 (7 days post second dose). The immediate cause of death listed on the death certificate is ?cardiopulmonary arrest? (few minutes) secondary to ?arrhythmia? (few minutes) and ?hypertensive heart disease? (few years). I do not have any additional information about other underlying conditions that may have contributed to this person?s death." "1873689-1" "1873689-1" "I am the epidemiologist reporting on behalf of 65 year-old male patient. The patient received two doses of the Pfizer Vaccine: First: 3/17/2021 Second: 4/07/2021 The patient was found dead at home on 4/19/2021 (12 days post second dose). The immediate cause of death listed on the death certificate is ?coronary artery disease.? Other significant conditions contributing to death but not resulting in underlying cause are listed as ?hypertension COPD?. I do not have any additional information about other underlying conditions that may have contributed to this person?s death." "1873694-1" "1873694-1" "pt to hosp with increasing dyspnea and productive cough x 2 wks; positive for COVID; placed on BiPAP, transitioned to Vapotherm 40 L @ 80%; immunocompromised due to being on Neulasta for prostate CA; started on remdesivir, Decadron; pt's condition worsened; per death certificate, pt expired in the hospital" "1873734-1" "1873734-1" "Client received second dose on 04/15 and was hospitalized on 10/17." "1873747-1" "1873747-1" "Client received her booster on 08/26, and was hospitalized on 10/29 for hypoxia, COVID-19 and sepsis." "1873779-1" "1873779-1" "limited medical records received on this pt; pt admitted to the hospital with coffee-ground emesis and vomiting bright red blood; positive for COVID; PMH: cirrhosis and esophageal varices; per death certificate pt died of GI bleed, COVID, blood loss anemia and cirrhosis" "1873812-1" "1873812-1" "fully vaccinated-covid death" "1873830-1" "1873830-1" "limited medical records received on this pt; pt in ED for cough and SOB; COVID pneumonia; DNR status; per medical records and death certificate, pt died in the hospital of COVID" "1873836-1" "1873836-1" "A 71 y.o. male with a past medical history significant for oxygen dependent COPD, CHF, bronchiectasis, NSCLC, prostate cancer, hypothyroidism, TBI, and seizure disorder who presents to with worsening cough and known Covid infection. Mr. stated that he didn't feel well on 10/31 and was tested for Covid the following day, returning positive. On 11/2, he felt worse with myalgias, fatigue, poor appetite, and weakness. He was started on Dexamethasone for both the Covid infection +/- COPD exacerbation. Unfortunately, his cough has worsened over the last two days. He has appreciated episodes of hemoptysis. No fever, chills, or sweats. He doesn't" "1874377-1" "1874377-1" ""Patient received his COVID ""booster"" shot on 11/09/2021 on the advice of his cardiologist who diagnosed him with new onset CHF. Two days later, on 11/11/2021, patient suffered a stroke caused by a clot in his brain. Patient was taken by ambulance to Hospital. In the Emergency Room, a number of tests- including a CT scan and angiogram were performed. At this point, patient was experiencing complete left side paralysis but was able to speak and to understand speech. One day later- on 11/12/2021 patient's brain began to swell. He was put on comfort care because his family and medical team did not think that patient's heart and body would be able to withstand the surgery. Patient passed away on 11/13/2021- just 4 days after his last COVID shot."" "1874394-1" "1874394-1" "Death (Found dead in bed on 03-09-2021 by staff)." "1876073-1" "1876073-1" "Report made to agency 11/16/2021 @ 17:45: Severe respiratory distress, profuse diaphoresis, hypoxia, tachycardia 11/16/2021 @ 18:06: Respiratory arrest 11/16/2021 @ 18:10: Ventricular fibrillation, cardiac arrest. Unsuccessful resuscitation. Time of death 18:52 on 11/16/2021" "1876559-1" "1876559-1" "pt presented to ED after a fall @ home; c/o generalized weakness, SOB x 1wk; dyspneic; recent metastatic renal cell carcinoma; treated with O2 supplementation, antibiotics, steroids, vitamin supplements; pt's condition declined in spite of therapy; comfort care measures; pt died in the hospital" "1876560-1" "1876560-1" "Fever began 6 days following vaccine and progressed to shortness of breath by day 10. Tested positive for COVID on day 11, admitted to ICU on day 12, intubated and placed on ventilator on day 15, and died on day 57." "1876584-1" "1876584-1" "limited medical records received on this pt; pt presents to hospital being positive for COVID; HX of A Fib, CAD, CKD stage III, HTN; pt actively dying in the hospital; comfort care measures; family agrees to reduce O2 by mask; pt died in the hospital" "1876598-1" "1876598-1" "Death" "1876609-1" "1876609-1" "Brain bleed resulting in death" "1876615-1" "1876615-1" "limited medical information received on patient; pt to ED with a positive COVID test and hypoxic; hx of renal transplant on systemic immunosuppression; COVID pneumonia; required intubation; pt's condition worsened and he died in the hospital" "1876630-1" "1876630-1" "Patient passed r/t perforated viscus" "1876660-1" "1876660-1" "Pt deceased r/t closed head injury" "1876675-1" "1876675-1" "Unsure of reason for death" "1876697-1" "1876697-1" "Covid vaccine #1 given 2/9/2021 Moderna, lot # n/a patient died in the hospital from COPD, failure to thrive, not a covid infection" "1876715-1" "1876715-1" "Vaccine dose #1 given 4/3/2021 Lot # EW0151 Pfizer Patient had a cardiac arrest at home at died in the ED. Not a covid related death." "1876720-1" "1876720-1" "pt admitted to hospital for hypoxia; dx with COVID pneumonia; Vapotherm and BiPAP; in spite of aggressive measures, pt continued to be hypoxic; DNR/DNI; comfort care was instituted and pt died in the hospital" "1876748-1" "1876748-1" "Pt death. Unsure of cause of death" "1876756-1" "1876756-1" "pt in hospice; respiratory failure due to COVID 19; PMH breast CA, HTN, DM, leukemia, dementia; DNR/DNI; on BiPAP; pt continued to decline; family wanted to take pt home; comfort care measures; pt died @ home shortly after arriving" "1876761-1" "1876761-1" "Patient deceased. Unsure of cause of death" "1876764-1" "1876764-1" "Congestive Heart Failure Shortly After Booster 3/20 Seizure 10/20/21 AtrialFlutters 10/26/21 Died 10/28/21" "1876775-1" "1876775-1" "Immediate loss of consciousness/death at 3 pm on 11/16. No symptoms leading up to event. Husband of patient witnessed the event and said it was immediate. Patient was laying down when event occurred. Asystolic when checked by EMTs 10 minutes after. Declared dead." "1876785-1" "1876785-1" "HOSPITAL COURSE: The patient was a 77 yr/o-year-old male with a history of CKD, COPD and OSA who presented to hospital 10/20/21 with cough, fatigue, and overall decline. Labs showed WBC 11.3; Hg 7.1; BUN/Cr 71/5.03, eGFR 11; COVID negative. Chest xray showed cardiomegaly and multifocal airspace disease bilaterally. He was treated for volume overload and was initiated on hemodialysis. His hospital course was further complicated by acute cardiopulmonary arrest requiring ACLS with ROSC after 6 minutes. He was intubated as part of post-arrest care. He was extubated 10/28/21 but failed to improve. His family ultimately opted for comfort-focused care. He was transferred to the Inpatient Care Center for continued care. Upon admission to the Hospital the pt had a PPS of 10% and prognosis judged to be limited to hours to days. Parenteral medications including fentanyl were ordered for comfort. The interdisciplinary team provided ongoing pt and family support. The pt continued to decline and died on 11/1/21 @ 12:33." "1876807-1" "1876807-1" "54M presented with respiratory failure secondary to pleural effusion. The patient was admitted to medsurg and started on diuretics. Plans were made for us guided thoracentesis and likely paracentesis, as well. The patient decompensated, requiring emergent thoracentesis. He was placed on bipap at that time and started on zosyn. When I arrived to hospital day after admission, stat response was called to patient's room and he was rapidly transported to the ICU for intubation and to be started on vasopressors as he had become confused and hypotensive. It was not clear why. In the ICU, he was intubated and started on vasopressors. Central line was placed. He was transfused two units, but lactic started climbing and his hgb did not improve appropriately. Massive transfusion protocol was initiated. Patient's family was contacted by intensivist, and ultimately they decided to withdraw life sustaining treatment. The patient expired on 10/3 @ 1650 due to hemorrhagic shock secondary to upper GI bleeding in the context of chronic decompensated cirrhosis of the liver." "1876808-1" "1876808-1" "pt to ED with chest tightness, SOB, nausea, diaphoresis; scheduled for heart catherization; positive for COVID; placed on BiPAP; transported to ICU; pt's condition worsened and she experienced cardiac arrest and died in the hosp" "1876814-1" "1876814-1" "Hospital Course: Patient with significant past medical history of diabetes 83 spastic paraplegia neuropathy hypertension CAD presented to Hospital with severe worsening pain of the right foot. Patient apparently 3 weeks back due to her neuropathy and spastic paraplegia tripped and fell. She normally uses a walker which got caught in a rug and she fell down. She had some difficulty getting up but otherwise did not feel bad for a few days about a week back she started having some pain in the right foot then she noticed some coldness and discoloration of the right foot last 2 days she has been having unbearable pain in the right foot. She presented to the ER where CT angiogram of the abdomen showed 1. Occlusion of the right external iliac artery just distal to the inferior hypogastric origin with reconstitution at the level of the knee. There is distal occlusion of the right posterior tibial artery as well. 2. High-grade atherosclerotic stenosis of the proximal left femoral artery with segmental distal femoral artery occlusion associated with reconstitution of the distal popliteal artery above-the-knee. There is also diminished three-vessel runoff involving primarily posterior tibial artery. 3. 4.5 cm region of consolidation at the left lung base, potentially pneumonia, rounded atelectasis or a peripheral mass, not fully imaged. When clinically feasible a standard CT scan of the chest would be of benefit. Patient is now admitted to the hospital for further treatment with IV heparin and vascular surgery has already evaluated patient and plans for surgery today. We will start patient on IV Rocephin for possible pneumonia. Patient was started on IV heparin. 2D echo was done which showed left ventricular hypertrophy dilated right ventricle ejection fraction 34%. On 10/12/2021 she underwent right iliofemoral endarterectomy right profunda femoral endarterectomy and patch angioplasty right lower extremity angiogram with runoff right femoral renal to below-knee popliteal arterial bypass with graft. Patient was treated with IV Rocephin and Zithromax for possible pneumonia. Patient had urinary retention and bump in the creatinine nephrology for the patient and a Foley catheter was placed she received bolus of normal saline and renal ultrasound was done. Patient's condition got worse. Patient coded and was transferred over to ICU on 10/14/2021. Patient was made DNR. Patient had multiple codes and expired around 16 00." "1876829-1" "1876829-1" ""Patient is a 68 yr/o male with a history of small cell lung cancer with bone and liver mets, seizure disorder, COPD, who presents to the emergency department complaining of abdominal pain, bloating, acute on chronic back pain, constipation. Wife at bedside supplements most of the history. Patient is a poor historian. He is in palliative care being followed by Dr and on palliative chemo. They deny fever or vomiting. Indicates his last bowel movement was on Saturday, continue treatment for C. difficile. He indicates generalized fatigue and feeling of unwellness. In triage he was noted to ""which she was dead "". He has not here for SI denies SI now. He mearly indicates that he is miserable in his state of health. Symptoms started Saturday and have been constant. Symptoms are worsened by nothing and made better by nothing. Pt denies tobacco, alcohol or drug use."" "1876848-1" "1876848-1" "patient presented to emergency department on 11/4/21 after falling patient tested positive for covid-19 after testing in the emergency room on 11/4/21 patient was admitted to hospital and received treatment for symptoms associated with covid-19 infection. treatment included dexamethasone, oxygen patient required intubation on 11/7/21 and was put on a covid-19 unit patient expired on 11/12/21 due to continuous renal replacement therapy hyperkalemia and bradyarrhythmia" "1876896-1" "1876896-1" "83 yo M with large L thalamic IPH with intraventricular extension; family made it clear they would not want intubation, CSF diversion, or artifical feeding. Patient was transitioned to Hospice scattered bed on 11/1 -he was treated with prn IV morphine, Ativan, and Robinul -continue prn IV Ativan and Robinul - he passed away at 08:39 on 11/5. Cause of death was left thalamic IPH" "1876897-1" "1876897-1" "Pt is a 75 year old female with pmedhx significant for CLL, uncontrolled DM2, HTN, hyperthyroidism, OA, hearing loss, and arthritis. Pt presented to the ER after 3 days of fatigue, non productive cough and runny nose. Pt states she had been cleaning the house and believed she had allergies from dust but then continued to feel fatigued and developed body aches. She admits to hunger as well as nausea, denies vomiting, diarrhea, change in sense of taste or smell. SQ PCR COVID + from 10/25 when she first developed symptoms. Hypoxic in ER on arrival SpO2 of 83%, initially required 5L, able to titrate down to 3L NC. Pt states her sister who is the caretaker to her husband and cooks and cleans for them was contact to sister's son who is COVID + and did not tell pt and her husband until she had been there for a day or two after exposure. Pt believes she contracted COVID from her sister. Pt states her husband is in ER bay next door also with COVID. WBC noted to be 109,000 in ER, appears to be chronic. Discussed with oncology, pt has never required tx, no intervention needed at this time. CTA negative for PE. Pt admitted to RCU with COVID related hypoxia" "1876991-1" "1876991-1" "Patient is a 61 yr/o female who presents today for cardiac evaluation for chest pain, abnormal EKG and prior history of coronary artery disease. Conference for discussion of abnormal PET scan imaging and recommendationsShe has chest pain and shortness of breath on exertion cardiac cath on 6/29/2016 showed the left main 30 to 40% stenosis distally LAD 40 to 60% segmental stenosis and normal LV function at that time. 61 yo woman previously evaluated in office for CAD, who was involved in a MVA. She was seen and cleared by NS to have CABG. She has not been in a neck brace since initial visit. Patient denies any issues or changes since last visit." "1877057-1" "1877057-1" "pt diagnosed positive for COVID 19 on 8/13/21; to ED on 8/15 with increasing SOB; hypoxic with O2 sats 70%; on BiPAP; Hx of lung CA, currently not taking chemotherapy or radiation; treated with dexamethasone, tocilizumab, remdesivir, therapeutic anticoagulation; DNR; TPN; became septic with increasing weakness; made comfort care; inpatient hospice; pt died in hospice" "1877085-1" "1877085-1" "We were completely unaware of an underlying severe health condition: Inoperable, Stage 4 Adenocarcinoma that had metastasized to his liver, lymph nodes, bones, blood. The Moderna Shot triggered the cancer to become aggressive resulting in rapid atrial fibrillation and subsequent pleural effusion progressively getting worse until on August 14, 2021 patient was admitted to Hospital. A drain port was installed and a right lung catheter and later after his first round of chemo a left lung catheter was installed. After two rounds of chemotherapy (the second round included immunotherapy) and a mismanagement of meds, patient died of cardiac arrest during a routine NG tube insertion procedure one Saturday, October 16, 2021." "1877251-1" "1877251-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/28/2021 and 3/21/2021. Presented to ED on 11/4/2021 complaining of passing out at daughters house around 9am today. Patient said it lasted for a few seconds. + previous in rehab 3 weeks ago. Had a fall and did rehab recently where she left on October 1st. Lives with daughter. SOB all the time due to COPD. Uses walker. Bruised on her left knee and right ankle but improving. Patient treated with remdesivir, baricitinib, antibiotics. Patient began to experience more cough on 11/7, patient developed hypoxia on 11/9 started on oxygen NC. Patient expired on 11/13/2021." "1877255-1" "1877255-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 4/14/2021 and 5/5/2021. Covid-19 + in September, 2021. Patient presented to ED on 11/6/2021 for leg pain and diagnosed with severe cellulitis, denies injury to leg, found to be Covid-19 + upon admission. On 11/10/2021 patient began to complain of fatigue and increased dyspnea with increased oxygen requirements. Family elected for palliative care due to declining oxygen saturations despite NIPPV. Patient expired on 11/11/21." "1877258-1" "1877258-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 5/14/2021 and 6/04/2021. Presented to an ED on 11/2/21 with right hand numbness and tingling and transient slurred speech. Admitted and diagnosed with left parietal lobe infarct per MRI and received TPA. In the early am of 11/6 he decompensated and requiring intubation. Taken to cath lab where an Impella CP was placed in the right femoral site. Required extreme high doses of inotropes and pressors with fever spikes. Diagnosed with COVID- PCR + on 11/5/2021. Transferred to another Medical Center for ECMO. Patient noted to have lactic acidosis up to 20 on 11/5/2021, AKI with oliguria requiring CRRT, transaminitis with AST and ALT > 7000, and development of compartment syndrome requiring fasciotomies of RLE. Patient required continued support of ECMO. Code status was changed to DNAR-AND and he expired 11/10 am." "1877261-1" "1877261-1" "Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 5/22/2021 and 6/19/2021. Patient presented to ED on 10/18/2021 with complaints of general malaise, diarrhea, and fever. Hospitalized for sepsis, Covid-19 + upon admission. Received: dexamethasone, remdesivir, baricitinib, broad spectrum antibiotics, paralytics, methylprednisolone, prednisone, and vasopressors. Required mechanical ventilation on 10/24/2021 with continued respiratory decompensation. Patient developed bacterial infection with pseudomonas aerugenosa. Patient's renal function also continued to decline requiring CRRT. On 11/10/2021, CRRT clotted off and patient unstable. Patient receiving norepinephrine and vasopressin with maxed ventilator settings and episodes of V tach. Patient was changed to DNR per husband's wishes and patient expired on 11/11/2021 at 0003." "1877266-1" "1877266-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/8/2021, 3/29/2021, and 9/23/2021. Patient tested for COVID at clinic on 10/19/2021 which resulted positive. Presented to ED on 10/20/2021 with complaints of cough, nausea, vomiting, diarrhea and weakness for 10 days. Admitted for acute kidney injury and requiring oxygen supplementation 3-4 L nasal cannula. Received: dexamethasone, full anticoagulation, remdesivir, broad spectrum antibiotics, paralytics, pressors, and nitric oxide. Transferred to ICU for chest pain and hypoxia. Developed pneumothorax, chest tube placed and intubated." "1877292-1" "1877292-1" "MRG: Report as COVID 19 death as Xray support the COVID 19 death. Not LTCF; PCR positive 3/2/2021, (-) 3/22/21; S/S: shortness of breath, worsening chest X-rays, diffuse ground-glass infiltrates similar to that of Coronovirus, admitted for managing shortness of breath post fall several week priorl; C/M: CVD - A-fib, heart failure, gout, HTN, COPD - black lung; Dx: ARF with hypoxemia, pneumonia, paroxysmal A-fib, HTN, black lung, acute exacerbation of chronic obstructive airways disease, history of COVID-19, heart failure, Moderna vaccines on 1/12 and 2/8" "1877325-1" "1877325-1" "Patient had a breakthrough infection and expired." "1877338-1" "1877338-1" "Hospitalized with shortness of breath, oxygen saturation less than 80%, BP 220/123 on admission. Trialed BiPap but failed and was intubated. Extubated 11/9." "1877357-1" "1877357-1" "Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen (J&J) Vaccine on 5/4/2021. Per patient chart, patient had COVID in Jan. 2021. Presented to ED on 10/25/2021 with complaints of chest pain and shortness of breath for approximately 1 week. Admitted for COVID pneumonia and acute hypoxemic repiratory failure. Throughout hospitalization patient received: dexamethasone, broad spectrum antibiotics, and pressors. On 10/26/2021, patient was transferred to ICU for tachycardia and tachypnea. Overnight patient's respiratory status continued to decompensate.Patient became hypotensive with flash pulmonary edema. Went into cardiac arrest and expired at 0050 on 10/27/2021." "1877360-1" "1877360-1" "Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen (J&J) Vaccine on 3/6/2021. Presented to ED on 10/21/2021 with complaints of chest pain and shortness of breath for approximately 1 week. Per patient she tested positive with a COVID home test on the prior Thursday. Hospitalized for COVID pneumonia and acute respiratory failure. Developed ARDS and required mechanical ventilation. Unable to wean off vent and received trach and PEG. Throughout hospitalization patient received: dexamethasone, baricitinib, broad spectrum antibiotics, paralytics, remdesivir, and pressors. Suffered cardiac arrest on 11/10/2021 with ROSC. Expired on 11/11/2021." "1877361-1" "1877361-1" "Dyspnea c/o. Pt is on 2 liters at home. COVID positive recently. Hypoxia concerns with exertion. Pt is currently on 6 liters via NC, but plan to place on Bipap. patient was a transfer to our facility. one dose of the vaccine was administered on 2/1/2021 but no record of lot number" "1877363-1" "1877363-1" "Patient had breakthrough infection and expired." "1877369-1" "1877369-1" "Pt tested positive for covid and died during hospitalization." "1877391-1" "1877391-1" "Booster dose given. Waited 15 minutes in lobby before leaving. Family came back inside after getting her in the car to leave, for help. She was ash color with tongue protruding from mouth. Opened her eyes upon shaking and breathing noted. 911 called and Oxygen applied via face mask. Ambulance then arrived and transported to Hospital for medical treatment where she expired later the same afternoon." "1877414-1" "1877414-1" "Breakthrough case. Patient tested positive while receiving treatment for multiple falls. Expired 04-14-2021, Traumatic subdural hemorrhage with loss of consciousness of unspecified duration." "1877452-1" "1877452-1" "10/31/2021 ED visit: past medical history significant for Parkinson's disease followed by Dr. and on pramipexole, recent diagnosis of highly advanced hepatocellular carcinoma not amenable to either chemotherapy or XRT followed by oncology here, who presents to the emergency department with acutely altered mental status this evening. She is afebrile and is essentially hemodynamically normal although her blood pressures are little soft. CT scan of the head does not show any acute process. X-ray of the chest revealed lung markings consistent with COVID-19 pneumonia. CT scan of the chest redemonstrates this finding. Abbott rapid coronavirus test is negative and the patient is afebrile and fully vaccinated. I am somewhat skeptical of this finding although I have sent confirmatory Cephied PCR coronavirus test. Although patient's Abbott rapid coronavirus test was negative, her Cephied coronavirus test which I sent is positive. Admitted due to altered mental status likely related to her neoplastic disease." "1877500-1" "1877500-1" "Patient developed COVID-19 on 10/26/2021 and died on 11/4/2021. Patient admitted to long term care facility 5/24/2021. Required VAERS reporting for fully vaccinated patient with COVID death." "1877549-1" "1877549-1" ""From admission H&P dated 9/12/21 by Doctor: ""History per chart and collateral given patient's encephalopathy. The patient was reportedly in USOH when she began experiencing abdominal pain. She reportedly started a short course of penicillin as an outpatient for this abdominal pain. She presented to the Hospital with worsening abdominal pain, worsening of her chronic low back pain, and chest pain. Mild leukocytosis with elevated ALT and bilirubin on admission. Troponin was elevated to 0.44, but down-trended and deemed to be non-cardiac after evaluation by cardiology. CXR, UA not concerning for infection. CT-AP showed diffuse colonic wall thickening, mild pulmonary interstitial opacities, small bilateral pleural effusions, and a horseshoe kidney. V/Q scan without PE, ultrasound of LE showed patents. TTE with normal EF, RUQUS without biliary dilation, only mild fatty infiltration of the liver. Stool-filled colon - had pain relief with aggressive bowel regimen and bowel movement. Due to persistent fevers and back pain with elevated procalcitonin, the patient was started empirically on ceftriaxone and vancomycin. Negative CT-spine for infection. Course complicated by 2x episodes of afib with RVR, the second one requiring amiodarone and beta blocker. She also developed an AKI with Cr rising to peak of 3.56 over the course of days. Intermittent hypotension requiring pressors. Renal consulted, workup concerning for glomerulonephritis, revealed hypocomplementemia, ferritin >80,000, and monoclonal IgG kappa. She refused a bone marrow biopsy. Her urine output dropped to near-anuric, and she became encephalopathic with myoclonus. At this point, she was started on every other day dialysis. No head imaging performed. Other diagnostic studies included utox (positive for morphine and oxycodone), APAP level (undetectible), Hep C, HepB, C.Diff, Due to the elevated ferritin and concern for HLH, he was evaluated by hematology, started on dexamethasone. She had hypoxemic respiratory failure requiring bipap that was ultimately weaned to nasal cannula. Past medical history of major depressive disorder and chronic lower back pain. Notably, she had severe osteomyeletis of the LUE, LLE requiring extensive surgery"" HOSPITAL COURSE: Patient had an unfortunately complicated hospital course. As above, she was transferred from an outside facility with a constellation of clinical and lab abnormalities including fever of unknown origin, abdominal/chest pain, anuric renal failure requiring iHD, respiratory failure, and encephalopathy as well as cryoglobulinemia, hypocomplementemia and hyperferritniemia (>80K) and developing bicytopenia with concern for, though not diagnosis of, HLH from unclear trigger. While pursuing workup for unifying diagnosis she developed progressive multiorgan failure as will be discussed below. In regards to diagnostics for underlying diagnosis, with the assistance of multiple consulting services (infectious diseases, heme/onc, rheumatology, nephrology) she underwent broad workup for diagnosis of and trigger of HLH v. Alternative inflammatory/rheumatologic process including bone marrow biopsy (in progress) , rheumatologic workup (notable for low complement levels and reported cryoglobulinemia at OSH), infectious workup via blood/BAL/LP (negative/in progress). Realization that cryoglobulins + at OSH as well as development of chest/abdomen rash and discolored toes raised question of cryoblobulinemic vasculitis. She was empirically treated with 1g IV methylpred then 40mg IV dex/day while awaiting results and diagnostics which unfortunately were not complete prior to her death and remains a question, hopefully to be answered by pending autopsy. Despite gradual improvement in several body systems (hemodynamics, hypoxemia), she developed DIC and pulmonary hemorrhage on the day of her death which ultimately led to her death as described below. Multiorgan failure will be described below by system: # Hypoxemic respiratory failure: Intubated for airway protection and hypoxemia upon admission to UWMC. Treated for ARDS with LPV possibly secondary to infection, though notably BAL and other infectious workup remained unremarkable throughout her stay. Hypoxemia improved enough with UF for volume removal and empiric ABX to move towards SBT pt was not able to be extubated. On the day of Patient's death, she developed bloody secretions from ETT so underwent repeat bronchoscopy. BAL diagnostic of alveolar hemorrhage with progressively bloody lavage aliquots. She was re-pulsed with IV methylpred and provided platelet replacement with concern for DAH or pulmonary vasculitis on 9/17 though developed severe pulmonary hemorrhage early on 9/18. Despite MTP and DDAVP to try and stabilize coagulopathy/hemorrhage, she ultimately lost >3L blood from ETT and died following this significant pulmonary hemorrhage (see code note and death note from today's date). # Shock: Developed distributive shock requiring 3 vasopressors for support early in her stay. She received empiric antimicrobials, high dose steroids and ID workup with no revealing cause for sepsis. Hemodynamics showed signs of improvement leading up to day of death with vasopressors nearly weaned off. #anuric renal failure- Complicated by anascarca, hyperkalemia and metabolic acidosis. By microscopy related to tubular injury, considered possibly related to cryoglobulinemia v. Vasculitis though unable to pursue renal biopsy due to instability. Required intermittent SLED/SCUF while admitted. # Encephalopathy: Again, unclear etiology of altered mental status. Initially considered related to sedation and metabolic abnormalities and initial CT head WNL and LP without clear infectious cause (though some studies remain in progress), though remained profoundly encephalopathic following wean of sedatives. Other considerations have included CNS involvement of primary underlying diagnosis (cryoglobulinemic vasculitis), undiagnosed infection, NCSE, etc. # DIC # Bicytopenia Likely related to underlying unifying diagnosis. Other considerations included MAHA though no evidence of hemolysis, negative HIT assay, HLH. Progressive throughout stay requiring cryo transfusion and multiple PLT transfusions on day of death."" "1877553-1" "1877553-1" "Ataxia, encephalitis." "1878025-1" "1878025-1" "Resident was observed to be unresponsive at 5 pm. CPR and emergency called, pronounced dead. Resident was not observed with any noted adverse reactions to vaccine prior to being found unresponsive . No definite evidence that death was directly related to administration of vaccine." "1878047-1" "1878047-1" "Wet cough, diarrhea, 88% on RA, encephalopathic, DNR patient- expired, etc." "1879616-1" "1879616-1" "Patient died / Cause of Death Cardiac Arrest; racing heart rate; started having shortness of breath; heaviness in chest; fatigue; This is a spontaneous report from a contactable consumer. This consumer reported for a 50-year-old male patient that, A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735) via an unspecified route of administration on 03May2021 (at the age of 50-years-old), as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included diabetes mellitus and Other medical history: diagnosed with diabetes while in hospital. Patient had no Known allergies.The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150) on 12Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. On 14Jun2021, patient died due to cardiac arrest, shortness of breath, racing heart rate, fatigue, heaviness in chest. Date of death: 09Jul2021. Autopsy was not performed. He was hospitalized for 15 days. Patient received treatment included medication. He did not have covid prior to vaccination. He was not tested for covid post vaccination. He was on other medicines in two weeks which included multivitamins. Patient did not take any other vaccine in four weeks. The patient underwent lab tests and procedures which included angioplasty: no blockage on, cardiac electrophysiologic study: unknown results on, cardiac stress test: unknown results on, echocardiogram: unknown results on.The outcome for the events was fatal. The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardiac arrest" "1879797-1" "1879797-1" "Patient passed away; This spontaneous case was reported by a nurse and describes the occurrence of DEATH (Patient passed away) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 07-Nov-2021 The patient died on 07-Nov-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Reporter reported that patient passed away on 07 Nov 2021 and it could be due to age and comorbidities. Company comment: This case concerns a 83-year-old, female patient with no reported medical history, who experienced the unexpected fatal event of death. Death occurred on 07-NOV-2021, 5 days after receiving the first dose of mRNA-1273. The rechallenge is not applicable considering the outcome of the event. No autopsy results were provided; the cause of death was not reported. Patient¦s age could be a confounding factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 83-year-old, female patient with no reported medical history, who experienced the unexpected fatal event of death. Death occurred on 07-NOV-2021, 5 days after receiving the first dose of mRNA-1273. The rechallenge is not applicable considering the outcome of the event. No autopsy results were provided; the cause of death was not reported. Patient¦s age could be a confounding factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death" "1879843-1" "1879843-1" "Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 14-Mar-2021 The patient died on 14-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No treatment information was provided. Patient did not show symptoms before dying. Reporter did not give precise information on HCP and vaccination site and did not know which concomitant medication patient was taking. Company comment: This fatal spontaneous case concerns a 72-year-old male patient with no relevant medical history who experienced serious unexpected event of death The event occurred 3 days after the second dose of mRNA-1273 vaccine. Rechallenge is not applicable The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report; Sender's Comments: This fatal spontaneous case concerns a 72-year-old male patient with no relevant medical history who experienced serious unexpected event of death The event occurred 3 days after the second dose of mRNA-1273 vaccine. Rechallenge is not applicable The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report; Reported Cause(s) of Death: Unknown cause of death" "1880071-1" "1880071-1" "Patient is Deceased. Date of Death: 11/15/21 Time of Death: 7:40 PM Preliminary Cause of Death: COVID-19 See VAERS #706111 for initial hospitalization reporting. DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute on chronic diastolic congestive heart failure (HCC) [I50.33] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1] Acute respiratory distress [R06.03] HOSPITAL COURSE: This is a 72 y/o male with past medical history significant for AL amyloidosis on active chemo, diastolic CHF, AS s/p bioprosthetic AV replacement 5/2021, diastolic CHF, CKD 3b, CAD, Paroxysmal afib, and OSA. He was admitted on 10/31 with acute hypoxic respiratory failure secondary to COVID PNA and has been under the oncology service. Patient developed symptoms around 10/19 and tested positive on 10/25. He is fully vaccinated and is s/p both booster vaccination. Patient was started on decadron and completed treatment with Remdesivir. He also received monoclonal Ab infusion. He was started on empiric heparin gtt for rising d-dimer. Dopplers were negative for DVT. CTA has been avoided in the setting of his chronic kidney disease. He has been aggressively diuresed and was started on empiric CAP coverage 11/3. Sputum culture 11/4 positive for MSSA. ID was consulted and ordered BDG and aspergillus Ag which are pending. Cardiology was consulted for decompensated diastolic CHF exacerbation. Echo was performed noting EF of 71% and was without critical valve disease. Work up with RHC was not recommended. Nephrology was also following for assistance with diuresis management in the setting of his kidney disease. Lasix was placed on hold 11/6 due to improvement in fluid status/ Pt is also s/p albumin infusions. Despite this, worsening respiratory status continued and pt was transferred to ICU 11/9 and intubated 11/11 after reconfirming code status with him and his wife. There is no desire for prolonged efforts at resuscitation in this regard however. Patient's condition declined. Wife wished to proceed with comfprt care measures on 11/15/2021. Patient passed away peacefully at 1940 on 11/15/2021 with wife and ster daughter at bedside." "1880333-1" "1880333-1" "patient now deceased. Date of Death - 11.12.21 See VAERS #705326 report which covers initial hospitalization DISCHARGE DIAGNOSES 1. ARDS. 2. Severe acute hypoxic respiratory failure secondary to COVID pneumonia. 3. COVID pneumonia. 4. Pneumothorax and pneumomediastinum. 5. Ventilator-associated pneumonia. 6. Permanent atrial fibrillation. 7. Type 2 diabetes mellitus. 8. Hyperkalemia. Resolved. 9. Hypocalcemia. Resolved. HOSPITAL COURSE 70-year-old patient presented to the ER on 10/28 with complaints of shortness of breath. She tested positive for COVID. She was treated with Decadron, then Solu-Medrol, and remdesivir. Unfortunately, the patient's clinical course deteriorated and she required intubation on 10/30. Despite maximal efforts in treating underlying conditions, which included ventilator associated pneumonia and pneumothorax/pneumomediastinum, the patient continued to decompensate. After she developed a pneumomediastinum, she required nearly 100% FiO2 as well as ongoing paralytics and deep sedation for multiple days. It was determined that her lung compliance was so poor that it was a near certainty that she would never get off the ventilator and would require likely weeks of oral intubation before she could have a tracheostomy. Discussions were held with the family at length and they all agreed that she would not want to be kept alive in this state. They agreed that care was futile. They agreed to remove life support on 11/12 and the patient succumbed to her disease process. She passed and was pronounced at 5:46 p.m. on 11/12/2021." "1880450-1" "1880450-1" "PATIENT ADMITTED TO HOSPITAL 9/30/21 WITH PROGRESSIVE SOB, COUGH, POOR APPETITE, BODY ACHES, LOSS OF TASTE. DIAGNOSED WITH CVODI19 DURING ADMISSION. ISSUES WITH MAINTIANING BP AND OXYGENATION DURING HOSPITALIZATION. CODE BLUE CALLED 10/10/2021, ACLS INITITATED, NO ROSC AFTER 18 MINUTES, FAMILY ASKED TO STOP RESUSCITATION EFFORTS. DIED 10/10/2021 AT HOSPITAL." "1880482-1" "1880482-1" "COVID SSX BEGAN 9/22/21 WHILE PATIENT INCARCERATED. TRANSFERRED TO HOSPITAL DUE TO WORSENING SHORTNESS OF BREATH. ADMITTED TO ICU, PUT ON PRESSORS. INTUBATED ON 10/4/21. DEVELOPED WORSENING KIDNEY FAILURE AND BLOOD CULTURES + FOR SALMONELLA. MAXED OUT ON VENT AND PRESSORS. PATIENT MADE DNR BY FAMILY, CODED & DIED 10/12/2021." "1880526-1" "1880526-1" "Unknown at time of vaccine. This person was fully vaccinated against Covid-19 and is deceased." "1880560-1" "1880560-1" "pt to ED with increasing SOB, cough, fever, chills; home sats on RA were in the 70s; placed on O2 supplementation; Acute on chronic HRF secondary to COVID pneumonia; treated with dexamethasone, and remdesivir; condition deteriorated; encephalopathy; DNR; with worsening condition, pt was changed to comfort measures; pt died in the hospital" "1880619-1" "1880619-1" "pt to ED with increasing weakness; positive for COVID; CA pt on chemotherapy; septic shock; AHRF; ARF; started on remdesivir, dexamethasone, barcitinib; unable to tolerate dialysis, became hypotensive and hypoxic; DNR; pt died in the hospital" "1880626-1" "1880626-1" "Increased fatigue and SOB 1 week after receiving vaccine, Acute MI 4 weeks after vaccine administration" "1880706-1" "1880706-1" "PMH: HTN, DM, morbid obesity; pt c/o SOB, fatigue, cough, nausea, anorexia x2wks, worsening past 3 dys; positive for COVID; COVID pneumonia with HRF; placed on BiPAP, remdesivir, dexamethasone, baricitinib; eventually required intubation with mechanical ventilation; pt coded and died in the hosp" "1880715-1" "1880715-1" "Unknown" "1880735-1" "1880735-1" "PMH: HTN, DMT2, prostate CA; to ED with increasing weakness, SOB, cough (x8dys); Positive for COVID; taking antibiotics and steroids from PCP; initially on NRB; AHRF; O2 sats decreased and pt placed on BiPAP; given broad-spectrum antibiotics and baricitinib; DNR/DNI; pt's condition worsened; family declined hospice; pt died in the hosp" "1880771-1" "1880771-1" "pt presents to ED with c/o dyspnea and dry cough; pt with intellectual disability; PMH: HTN, hyperlipidemia, depression; placed on Vapotherm; dexamethasone; remdesivir; O2 sats declined requiring intubation; developed ARF requiring CRRT; experienced cardiac arrest; CPR administered and medications per protocol; pt died in the hospital" "1880780-1" "1880780-1" "74yr old male admitted on 11/3/2021 from Medical Center. The patient had a past medical history of COPD, PE, Hyperlipidemia, Gastroesophageal reflux disease, Hypothyroidism, Cholecystectomy, R knee replacement, PEG on 10/29/2021 and a Percutaneous tracheostomy on 10/27/2021. Pt was vaccinated with Johnson and Johnson vaccine in May 2021. Pt's son passed away from COVID-19 infection. The patient tested positive on 10/5/2021. The patient was transferred to bigger hospital from smaller Hospital with COVID-19 pneumonia and sepsis. When the patient arrived to bigger hospital the patient had a pulseless electrical activity cardiac arrest requiring chest compressions and 1 dose of epinephrine prior to returning to spontaneous circulation. The patients post cardiac echocardiogram showed an ejection fraction decreased to 23%, the pt. also developed acute kidney injury related to acute tubular necrosis. The patient was given tocilizumab, remdesivir and steroids. The patient's hospital course was further complicated by DVT and pulmonary embolism. Pt was noted to also have right upper lobe necrotizing pneumonia due to Pseudomonas. Pt was seen and was on Meropenem. Pt was unable to be weaned off of the ventilator and underwent a tracheostomy on 10/27/2021 and a PEG placement on 10/29/2021. The patient's family met with palliative care and they wanted to continue current care. On admission to Select the patient was on assit-control mode of ventilation with a tidal volume of 380, PEEP of 5, respiratory rate of 14 and FiO2 of 40%. The pt. had also had pneumothoraxes and on admission to Select the pt. had 2 right sided chest tubes and a chest tube on the left. Pt's condition worsened and on 11/12/2021 Pulmonary noted that he had a long discussion with the family, discussed with them the surgical additional chest tube placement needed, but family decided on comfort cares at that time. Pt was placed on comfort cares and expired on 11/12/2021 at 1500." "1880787-1" "1880787-1" "Death less than 24 hours after vaccine." "1880901-1" "1880901-1" """"Deceased (11.17.21); Hospitalized (11.16.21); COVID-19 positive (11.13.21); Fully vaccinated. x2 Discharge Disposition: Deceased DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: CO2 narcosis [R06.89] Acute hypoxemic respiratory failure due to COVID-19 [U07.1, J96.01] COVID-19 [U07.1] Acute respiratory failure with hypoxia and hypercapnia [J96.01, J96.02] HOSPITAL COURSE: 73 yo male who is a resident of facility. Patient presented to the emergency room with several days of worsening dyspnea and decreased responsiveness. He had had a positive COVID-19 test on November 13. In the emergency department he had a blood gas demonstrating a pH of 7.16 with a P CO2 of 104. He was do not resuscitate and do not intubate status. He was treated with BiPAP in the emergency department and had improvement in his blood gas to a pH of 7.26 and pCO2 of 75, with resulting improved alertness. He was admitted to intensive care unit and started on IV remdesivir and IV Decadron and was continued on BiPAP. A repeat blood gas at 1:55 a.m. showed pH 7.04 and a pCO2 of 120, and was associated with decreased responsiveness.. He subsequently had oxygen desaturation and became completely unresponsive. In the morning repeat arterial blood gas showed a pH of 6.83 with a pCO2 greater than 150. I contacted his legal guardian and reported his declining condition with a grave prognosis. He subsequently developed bradycardia followed by ventricular fibrillation and expired at 10:56 a.m.."" "1880917-1" "1880917-1" "Post Vaccine Breakthrough. Was seen in clinic on 10/06/2021 for failing surgical site following surgery for cancer. Surgeon admitted tot the hospital for failing surgical site and was found to be positive for Covid 19 on admission due to routine swab. During hospital stay resident continued to require multiple surgical interventions and did pass away on 10/26/21 at hospital. Does not appear that death was related to Covid but likely due to Cancer diagnosis with poor surgical outcome." "1880937-1" "1880937-1" "PMH: ESRD, CHF, seizure disorder; hypothyroidism; hypercoagulable state, on chronic Coumadin; to ED due to altered mental state; AFR and positive for COVID; placed on BiPAP; condition worsened; to ICU; COVID protocols followed; metabolic encephalopathy; DNR; sepsis and shock; pt died in the hosp" "1881100-1" "1881100-1" "Patient was found down at her assisted living facility. Admitted to hospital with altered mental status, severe sepsis secondary to cholecystitis, atrial fibrillation, new diagnosis of cirrhosis with ascites (unknown etiology), streptococcal bacteremia from infective endocarditis. Hospitalization then complicated by bowel perforation, patient transitioned to comfort care and passed away." "1881203-1" "1881203-1" "The decedent received his Johnson and Johnson COVID 19 vaccine on 11/14/2021. After receiving the vaccine, the decedent started to experience difficulty breathing, chest pain, hot and cold flashes, fevers and lethargy. The decedent did not receive any treatment prior to death." "1881209-1" "1881209-1" "Deceased 11/13/2021; Hospitalized 11/11/2021; COVID-19 positive 11/11/2021; fully vaccinated. BRIEF OVERVIEW: Admission Date: 11/11/2021 Discharge Disposition: Deceased DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Lower GI bleed COVID-19 HOSPITAL COURSE: 88 year old female that presented on 11/11/21 for severe covid-19 infection. Patient was initially intubated in the ED for Acute hypoxic respiratory failure 2¦ COVID. However during the day 11/12/21 family meeting was held and patient's family decided to withdraw care. Patient was initially placed on Venti mask after extubation. However during the night of the 13th to 14th patient developed terminal restlessness. Morphine drip was started and family was contacted. Patient passed away on 11/13/21 at 9:29pm. Daughter was at bedside. Patient had no response pain, no heart/lung sounds over 2 mins, no carotid pulse over 2 minutes, and no pupillary reaction to light. Time of death was called at 9:29 pm." "1881210-1" "1881210-1" "Patient death 9/30/2021" "1881273-1" "1881273-1" "Death - Symptoms unknown" "1881307-1" "1881307-1" "Case suffered massive brain bleed and cardiac arrest while Covid positive 6 months after completing the Covid vaccine. Case died." "1881316-1" "1881316-1" "Patient death 10/30/2021" "1881317-1" "1881317-1" "11/3/21 Altered Mental Status Per EMS, neighbors called for altered mental status, unknown last known well. Per neighbors, pt is usually A&Ox4. Per EMS, pt follows commands, unable to answer any questions. Cardiogenic shock Procedures: 1. CT head: No acute disease 2. CT chest noncontrast: Acute on chronic pulmonary vascular congestion. Marked cardiomegaly. 3. CT abdomen/pelvis: Perihepatic and upper abdominal and pelvic ascites with moderate body wall edema. Advanced atherosclerosis. Mild diverticular disease 4. Renal ultrasound: Normal 5. Blood cultures: No growth 6. COVID-19: Negative 7. Hemoglobin A1c: 8.4 8. TSH: 6.8 10/30/21: This patient was a 49-year-old male with a past medical history significant for chronic systolic CHF with EF 14%, type II poorly controlled diabetes mellitus, LV thrombus on Eliquis, hypertension, chronic kidney disease, history of alcohol abuse, and a history of medical noncompliance who presented to hospital secondary to an altered mental status. She was admitted to the intensive care unit for cardiogenic shock secondary to an acute on chronic systolic CHF and metabolic encephalopathy. The patient was seen and evaluated by the heart failure group at which time it was noted that this patient has remained noncompliant in the outpatient setting as well. Over the course of his hospitalization, multiple discussions took place regarding his status. He eventually agreed to DNR status. He did require multiple continuous drips that included dopamine, Neo-Synephrine, Levophed, vasopressin, milrinone, heparin, amiodarone, Bumex, Precedex, and dopamine drips during the hospitalization. Unfortunately, given his noncompliance, there was little that could be done. Despite multiple continuous drips, the patient eventually expired on November 3, 2021 at 1924." "1881335-1" "1881335-1" "Patient death 10/10/2021" "1881373-1" "1881373-1" "10/25/21-Patient listed as deceased as of this date, no records of where or why" "1881390-1" "1881390-1" "11/8/2021 1. Community-acquired pneumonia 2. Severe sepsis 3. Acute respiratory failure 4. Acute on chronic kidney failure 5. Elevated LFTs and bilirubin" "1882915-1" "1882915-1" "fully vaccincated, complications of covid death" "1884298-1" "1884298-1" "My Mother, at 92, almost 93, was given the Booster shot on Oct. 12. Although she had the start of Dementia, Mom was still Mom. After the booster, Mom went into a spiral downfall. The Dr. diagnosed her with Organic Brain Syndrome. My mother passed away Nov. 6, 2021. She had stopped eating, was in pain, could not speak from approximately Oct 22 - Nov 6. Organic Brain Syndrome is triggered by too many toxins in your body. At 92, her body was not equipped to take such a powerful vaccination and my sisters, nurse and I believe the Booster pushed her into a toxic state that escalated her untimely death." "1884880-1" "1884880-1" "Pt had first Pfizer Covid vaccine on 01/08/2021 Lot: EL140. Pt reported that symptoms of fever and cough began on 08/07/2021. On 08/09/2021, pt went to ER and tested positive for Covid. Called the office on 08/11/2021 to report Covid symptoms; advised to call hospital and arrange for Monoclonal Antibody Therapy. Also, to return to ER if symptoms worsen. Coroner's office was called on 08/12/2021 per friend after well check by PD. Explained to clerk at Coroner's Office what VAERS Reporting entails. Clerk was unsure and asked that clinic submit report. Autopsy Report signed on 11/03/2021 Findings: 1. Complications of Covid-19 infection A. Positive NP swab for covid B. Several day history of fever. 2. Diabetes mellitus and kidney failure" "1884995-1" "1884995-1" "Stroke, death" "1885027-1" "1885027-1" "None stated." "1885029-1" "1885029-1" "Patient expired 11/15/2021. HOSPITAL COURSE: PRESENTING PROBLEM: Shock [R57.9] Colon cancer metastasized to multiple sites [C18.9] Septic shock [A41.9, R65.21] Small bowel cancer [C17.9] Patient is a 62 y.o. male with history of metastatic stage 4 colon cancer who presented to the emergency department with new bowel perforation of a known right colonic mass. He was hypotensive and unstable at the time of presentation. He was taken for an emergent exploratory laparotomy with a right colectomy and small bowel resection. During the case, he had increasing pressor requirements and worsening hypotension. Decision was made to transfer to the SICU and leave the patient in discontinuity with an abthera for temporary closure. Patient was therefore transferred to the SICU. He was started on multiple pressors including norepinephrine, vasopressin, and epinephrine to maintain his blood pressure. Despite these interventions, he continued to be unstable. Family made the decision to make him DNR/DNI, however with continued aggressive care and interventions on 11/14. He continued to be on the ventilator with progressively increasing pressor requirements. On the morning of 11/15, family made the decision to transition to comfort care measures. Propofol was stopped, and pressors were stopped shortly after. Family desired extubation and patient was extubated at 0625. Time of death was 0647 on 11/15/2021 Preliminary Cause of Death: Colon cancer metastasized to multiple sites" "1885034-1" "1885034-1" "DEATH" "1885098-1" "1885098-1" "Patient fully vaccinated. Hospitalized on 11/03/2021. Expired on 11/19/2021" "1885160-1" "1885160-1" "Died 7 days after shot after shot had uncontrolled sugar levels could not get sugar up and felt sick 2 days after and died 7days later" "1885300-1" "1885300-1" "Death Non-ST elevation (NSTEMI) myocardial infarction Acute kidney failure, unspecified Thrombocytopenia, unspecified" "1885309-1" "1885309-1" "death - TIA (transient ischemic attack) - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC)" "1885318-1" "1885318-1" "death - Nontraumatic subarachnoid hemorrhage, unspecified - Nontraumatic subdural hemorrhage, unspecified" "1885324-1" "1885324-1" "death I63.9 - Cerebral infarction, unspecified J96.01 - Acute respiratory failure with hypoxia J12.82 - Pneumonia due to coronavirus disease 2019 N17.9 - Acute kidney failure, unspecified" "1885346-1" "1885346-1" "death- Acute kidney failure, unspecified" "1885359-1" "1885359-1" "death ALTERED MENTAL STATUS FACIAL DROOP G45.9 - Transient cerebral ischemic attack, unspecified" "1885363-1" "1885363-1" "death- Disseminated intravascular coagulation (defibrination syndrome)" "1885417-1" "1885417-1" "what began as memory loss and irritability was followed by loss of motor skills, later diagnosed as Cruetzfeldt-Jakobs disease. Death occurred early morning 10/29/2021." "1885523-1" "1885523-1" "Patient did not want dinner that evening. Found unresponsive in bed around 7pm. Patient had known severe anemia (HgB6.9) with decision to forgo additional transfusion or GI workup." "1885533-1" "1885533-1" "I am the epidemiologist reporting on behalf of 77 year-old female patient. Patient was a resident of a facility for approximately two years prior to death. Patient received three doses of the Pfizer vaccine. The first was on 1/03/2021, the second was on 1/24/21 and the third was on 9/30/2021, according to immunization records. The patient passed away on 9/30/2021 (the same day the third dose was received) in nursing facility. The death certificate lists ?Cerebral Arteriosclerosis (1 year)? as the immediate cause of death. Prior medical information (obtained from facility) includes: 2019-Time of Death: Hypertension, Wernicke?s encephalopathy 2020- Time of Death: Liver cirrhosis, history of TIAs, unspecified chronic kidney disease (stage 3), 2021- Time of Death: Hyperlipidemia The patient was prescribed amlodipine (heart medicine) and Lipitor." "1885536-1" "1885536-1" "Nothing listed" "1885574-1" "1885574-1" "Not listed." "1885595-1" "1885595-1" "Pt began complaining of inability to catch his breath. This was 5 and half hours after receiving 1st dose of vaccine. He became unresponsive. CPR was initiated, 911 arrived and took him to ER. He was given numerous doses of epinephrine, and other advanced cardiac life saving meds, as well as intubated, and all life save measures given over the course of an hour. He was pronounced dead at the emergency room by the ER physician." "1885720-1" "1885720-1" "Patient found deceased in facility. Medical Examiner cause of death: A. Ketoacidosis B. due to COVID-19 vaccination complicating undiagnosed diabetes mellitus. Contributory: Hypertensive cardiovascular disease.; Autopsy report was signed on 11/4/2021" "1885770-1" "1885770-1" "On February 4th, 2021 patient died suddenly while skiing. About 2 PM, there was no accident, he was found laying down in the snow and the first to find him gave him CPR - ski patrol came quickly and shocked him three times. But none of these brought him back. He was already gone." "1885858-1" "1885858-1" "she woke up normal, she went to her room for her prayers, and that's when she fell out of her chair with a stroke. she was brought to the hospital immediately and was confirmed to have had blood clot in her brain. She was hospitalized from 11/09/2021 and passed away on11/19/2021." "1887894-1" "1887894-1" "Rapid declining health and death 14 days after covid booster shot" "1888822-1" "1888822-1" "Patient expired" "1888979-1" "1888979-1" "My brother died from a heart attack just 21 days after receiving his Moderna vaccine." "1889080-1" "1889080-1" ""The patient was in his usual state of health until 48 hours after receiving his 3rd ""booster"" Moderna COVID vaccine. He presented in cardiogenic shock as evidenced by hypotension, elevated lactate, CT imaging showing reversal/reflux of contrast in the IVC and hepatic veins, and echo showing severe LV dysfunction (EF 10%) with a prior echo that was EF 50% in 2020. The patient suffered refractory hypotension despite efforts to maintain blood pressures with multiple pressors and eventually developed PEA arrest. Troponin minimally positive on admission and rose to a high level, suggesting a possible etiology of myocardial infarction (likely LAD territory based on echo) versus myocarditis as a result of the vaccine booster. The patient unfortunately was pronounced deceased on 11/21/21 about 8 hours after presentation to the ED."" "1889084-1" "1889084-1" "CVA on 1/14/21" "1889159-1" "1889159-1" "Patient found on floor, taken to ER via ambulance, placed on ventilator, MRI determined patient suffered a stroke and had zero brain activity or chance of recovery." "1889162-1" "1889162-1" "Had booster. Don't have her card with me. Very sick, totally weak." "1889278-1" "1889278-1" "Blood clots in the lungs cardiac arrest sever headache" "1889448-1" "1889448-1" "Resident had significant decline in condition on 11/21/2021, Resident passed away the morning of 11/22/2021." "1889704-1" "1889704-1" "Patient expired." "1889749-1" "1889749-1" "Patient expired." "1889901-1" "1889901-1" "Patient presented to emergency department on 10/21/2021 following a fall and generalized fatigue. He was found to be COVID-19 positive. His symptoms were relatively mild during admission. He was treated with dexamethasone and albuterol inhaler. He was discharged to home with home health care on 11/2/2021. He was readmitted on 11/4/2021 for increased weakness and rehab placement. He was treated with dexamethasone and supplemental oxygen and discharged on 11/9/2021 to a rehab facility. Patient expired on 11/15/2021." "1889986-1" "1889986-1" "On 5/18/2021 patient admitted in Hospital with SOB Patient died 9/25/21 in hospice care Also significant- Patient had about 5 days of Votrient (half dose) before this episode. He had just started this chemo agent." "1890018-1" "1890018-1" ""NO LOT NUMBER PROVIDED. BOTH DOSES OF VACCINE ENTERED INTO THE STATE SYSTEM AS ""HISTORICAL DOSES"" BY MEDICAL GROUP. BREAKTHROUGH CASE; COVID RELATED DEATH"" "1890024-1" "1890024-1" "Dose 1 Pfizer given 2/19/2021 lot # EN6203 Patient had a cardiac arrest at home and died in the emergency room." "1890159-1" "1890159-1" "Patient is now deceased. Date of Death: 11/4/21 Time of Death: 2:37 PM Preliminary Cause of Death: Acute respiratory failure due to COVID-19 See prior VAERS submission from initial hospitalization: 685006 (patient now deceased) HOSPITAL COURSE: Patient is a 69 y.o. male PMHx notable for history of cardiac sarcoidosis, persistent atrial fibrillation and PVCs (hx of watchman not on AC), CKD, COPD, insulin dependent type 2 diabetes. He was admitted on 10/12 for acute hypoxic respiratory failure secondary to COIVD-19. Symptom onset was 10/8, positive test on 10/10 and intubated and transferred to the ICU on 10/16. S/p 5 day course of ceftriaxone and azithromycin (10/12-10/16). Proning (10/17-10/19). No remdesivir given due to CKD. Patient received 10 day course of decadron for covid-19 infection. Was continued on steroids afterwards, tapering down to daily dose of 10mg. Was placed on endotool for insulin-dependent type 2 diabetes worsened by steroids. Sputum culture on 10/24 grew klebsiella and he was subsequently started on Zosyn and vancomycin. De-escalated to rocephin following susceptibilities for 7 day course. Throughout admission in ICU patient was on volume control, and we attempted to wean FIO2 as tolerated. He was being considered for tracheostomy as he had been intubated for 2 weeks, however this was limited by inability to tolerate lower vent settings. He continued to spike fevers in the days before his death. Chest x-rays demonstrated diffuse airspace disease bilaterally, stable in right lung with progression in left lung. A CT thorax/abdomen/pelvis and CT sinus were ordered to try to locate any foci of infections however were negative. WCC were not elevated, cultures from bronchoscopy grew klebsiella. One peripheral blood culture grew staph haemolyticus, subsequent cultures negative. He was started on vancomycin and zosyn on 11/2. The 72 hours before his death he began experiencing worsening hypoxemia, requiring increased FiO2. He was on lung protective setting and permissive hypercapnia. On the day of his death his respiratory failure worsened further, and he required escalating pressors to maintain MAPs >65. He was on 100% FiO2 and asynchronous. Sedation was increased and paralytic started. Despite adjusting vent settings multiple times his SpO2 remained in the 70s. ABG also demonstrated worsening respiratory acidosis. Goals of care discussion was held with patients wife, two daughters and son. The decision was made to transition to comfort care. He was taken off the paralytic, with goal to make the patient comfortable. He passed peacefully at 14:37 surrounded by family." "1890192-1" "1890192-1" "Patient fully vaccinated with Pfizer vaccine. Last dose on 2/26/2021. Tested positive for COVID 19 on 9/27/2021. Admitted to Medical Center on 11/13/2021 related to COVID and expired on 11/13/2021 while still hospitalized." "1890222-1" "1890222-1" "Death" "1890266-1" "1890266-1" "Blood clot" "1890301-1" "1890301-1" "Patient is a 63 y.o. male admitted on 10/19/21 with Covid-19 (symptom onset around 10/15) and admitted on 10/24 for worsening symptoms. He was treated with decadron and tocilizumab. Remdesivir was contraindicated due to CKD IV. Due to worsening respiratory status and elevated d-dimer he had V/Q scan on 11/1 which was low probability for a PE. He has been transferred out of the Covid unit as he is off precautions. Initially he was being weaned from oxygen, awaiting a level low enough for discharge. He had increased oxygen requirements on 11/14. Pulmonary Medicine was consulted. It was opted to started empiric lovenox for VTE. Patient did not want to have CT for PE done, due to concern for contrast injury. needing dialysis. LE venous US was negative for DVT. V/Q scan was done on 11/16 with high probability for PE. TTE with evidence of severe pulmonary HTN, dilated RA but no evidence of RV Strain and normal LVEF. clinically worsening. Discussed imaging findings which suggest signficant lung damage likely still related to his COVID infection and PE" "1890336-1" "1890336-1" "pt was previously submitted to VAERS on 11/9/2021, VAERS E report # 706662 Updating with pt death 11/21/2021 Principal Problem: Cerebral Hemorrhage Active Problems: Debility Atrial Fibrillation Paroxysmal Transplant Renal Loss Hearing Sensorineural Medication Therapy Long Term Not Anticoagulant Chronic Kidney Disease Stage 4 Glomerular Filtration Rate 15-29 Immunodeficiency Due To Drugs Hypertension And Chronic Kidney Disease Stage 3 Hemiplegia And Hemiparesis Following Cerebral Infarction Affecting Left Nondominant Side COVID-19 Infection Acute Respiratory Failure With Hypoxia" "1890705-1" "1890705-1" "Due to patient's complex PMH, provider asked that patient be monitored overnight after administration of COVID vaccine. Patient was moved from PICU to general peds floor due to improvement in condition on Thursday. Vaccine was administered that evening. Patient did well. Remained on room air. Was discharged home on Saturday. On Monday morning, father checked on patient and she was found pulseless and not breathing. It is unclear whether or not patient was placed on home CPAP during the night. EMS called. Patient arrived to ED as a CPR in progress. Patient presented with a pH of <6. Last known well 9pm the evening prior. Patient expired at 11/22/21 at 11:05 CST." "1890720-1" "1890720-1" "Deceased 11/12/2021; Hospitalized 11/11/2021; COVID-19 positive 11/10/2021; fully vaccinated BRIEF OVERVIEW: Discharge Provider: DO Primary Care Physician at Discharge: MD Admission Date: 11/11/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute UTI Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present COVID-19 HOSPITAL COURSE: Patient is a 88 y.o. female, with a PMH of atrial fibrillation, CHF, CKD stage 3, hypertension, asthma, depression, anxiety, chronic pain, hypothyroidism, mild cognitive impairment, who presented to the emergency department with ongoing nausea/vomiting and diarrhea. In the ED the patient was noted to be hypertensive with an elevated heart rate. EKG confirmed AFib with RVR. She was noted to be hypoxic and placed on 3 L. Laboratory evaluation revealed an elevated white blood cell count and a lactate of 5.6 which trended down to 5.1 following 1 L of normal saline. Chest x-ray showed extensive multifocal pulmonary opacities. CT of the abdomen and pelvis showed evidence of COVID-19 pneumonia with small to moderate pleural effusions and marked cardiomegaly. She did test positive for COVID-19. Urinalysis was suspicious for urinary tract infection. Patient was given a total of 2 L of normal saline, Decadron Rocephin. She was admitted to the hospitalist service for further care. She has an out of hospital DNR on file. Overnight her work of breathing increased as well as oxygen demand. She also became hyopthermic and hypotensive. Due to decline overnight and wishes to be DNR patient's family was contacted and planned to be at bedside by morning however a RAP was called at 715am for hypotension. On evaluation the patient had no chest rise and was not breathing. Tele showed asystole. Pronunciation of death was completed at 0720 and family was informed (daughter and son-2 children. Her other son was not able to be reached) along with patients PCP. Death certification to be completed by admitting physician." "1892837-1" "1892837-1" "shortness of breath, followed by syncope and collapse and subsequently death" "1893326-1" "1893326-1" "Booster; Congestive Heart Failure; Arrhythmia; Heart Attack; This is a spontaneous report from a contactable consumer. An elderly female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 22Oct2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included covid-19. Historical vaccine inlcuded bnt162b2 dose 1 on 06Jan2021 and dose 2 on 26Jan2021 both for COVID-19 Immunization.The patient's concomitant medications were not reported. The patient experienced congestive heart failure (death, hospitalization, life threatening) on 26Oct2021, arrhythmia (death, hospitalization, life threatening) on 26Oct2021, heart attack (death, hospitalization, life threatening) on 26Oct2021. Therapeutic measures were taken Lavix, Nitro paste (nitroglycerin); Transferred back to Long-Term Care Facility. The patient died on 30Oct2021. Autopsy was not performed. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart Attack; Arrhythmia; Congestive Heart Failure" "1893708-1" "1893708-1" "Pt deceased. Unsure of reason for death" "1893761-1" "1893761-1" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893815-1" "1893815-1" "Pain in back and high stomach area for 2 weeks. Ultimately resulted in aorta pulling away from stomach and causing repaired aneurysm to rupture." "1893818-1" "1893818-1" "Received the Booster shot 12pm on 11/5/2021, had chest pain at 9pm 11/5/2021. Was hospitalized at 10pm on 11/5/2021. Heart stopped on 11/10/2021 was revived and placed on a ventilator. Heart stopped again on 11/11/2021 at around 7pm was again revived. Died on 11/13/2021" "1893929-1" "1893929-1" "Deceased 11/19/2021; Hospitalized 11/11/2021; COVID-19 positive 11/13/2021; fully vaccinated BRIEF OVERVIEW: Admission Date: 11/11/2021 Discharge Date: Nov 19, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Generalized weakness AKI (acute kidney injury) Altered mental status, unspecified altered mental status type Venous stasis ulcer of other part of left lower leg with fat layer exposed with varicose veins Venous stasis ulcer of other part of right lower leg with fat layer exposed with varicose veins Pneumonia due to COVID-19 virus COVID-19 AMS (altered mental status) HOSPITAL COURSE: 90 y.o. male who presents today from assisted living with one week of progressive generalized weakness and AMS. PMHx of venous stasis ulcers on legs chronic, unhealable, CAD, HTN, pacemaker, PAF, CKD3, h/o PE and DVT on Eliquis. Patient was actually enrolled in hospice recently to try to achieve better pain control for leg ulcers, despite life expectancy being >6 months. He had been started on neurontin and hydromorphine, then the narcotic was changed to moprhine. Patient has CKD. In the ED he was noted to be COVID+ but on RA. He was admitted for further care. Neurontin and narcotics were held and patient's mental status improved. Palliative care was consulted and began oxycodone for pain control. This was titrated up. Initially patient remained on RA and was symptoms free with the covid19 infection. Repeat CXR was consistent with multifocal PNA and PCR confirmed covid +. Was offered monoclonal AB treatment but declined. On 11/14 patient began declining again with AKI and hypotension and worsening AMS. Lactic acid was normal, WBC 11. CXR 11/14 showed new medial rt lung base opacities concerning for aspiration/PNA. Unchanged lt opacities. Blood cultures sent and zosyn given while ruling out superimposed bacterial infection. Given worsening renal function, despite patient not having had received narcotics in the past 12 hours, narcan was given with good response. Narcotics held. Patient was placed on IVFs and bolused. Starting on 11/14 patient began to have an O2 requirement and was started on Decadron. After initial narcan patient then had recurrent hypotension and sedation. 2nd narcan given with some response. At this point discussion was had with daughter regarding goals of care. As patient was at the beginning of his covid course, which was likely to continue to worsen, having AKI, AMS, and then bleeding and severe pain from his chronic LE venous ulcers, We made the decision to pursue comfort care. All aggressive interventions were discontinued and patient was started on comfort medications. Hospice were consulted. The patient was discharged home with hospice on 11/19/21." "1893982-1" "1893982-1" "Deceased 11/17/2021; Hospitalized 11/10/2021; COVID-19 positive 11/10/2021; fully vaccinated BRIEF OVERVIEW: Admission Date: 11/10/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure [J96.00] COVID [U07.1] COVID-19 [U07.1] HOSPITAL COURSE: Patient is a 57 y.o. female who initially presented on 11/10 for 3-4 days of worsening shortness of breath, diarrhea, and nonproductive cough. She had pitting edema and signs of fluid overload on CXR and was diagnosed with COVID on arrival. She is on 5 L oxygen at baseline and was started on high-flow nasal cannula and initially admitted to hospitalist service. She was diuresed aggressively. She was started on steroids; did not qualify for Remdesivir due to kidney function.Her oxygen requirements continued to increase and she was transitioned to 100% high-flow nasal cannula with non-rebreather mask. Overnight on 11/11, she desated into low 80s and was placed on BIPAP and transferred to ICU service due to concern for impending intubation. Her respiratory status declined and was intubated on 11/13. We had multiple conversations about her likely poor prognosis considering her baseline respiratory status, and patient elected to proceed with intubation at that time. She was sedated and paralyzed, and she subsequent required initiation of norepinephrine. Her respiratory status continued to worsen and we began proning on 11/14. She responded to proning and was continued on a 20:4 proning schedule. Palliative care was consulted on 11/15 after family expressed concern about patient's grim prognosis and likelihood of tracheostomy and long-term care even if she survived this illness. On 11/16, palliative spoke with all first-degree relatives, and they decided to transition to DNR and comfort care. Paralytics turned off and patient pronounced dead on 11/17/21 at 12:45AM. Family at bedside, condolences offered." "1894184-1" "1894184-1" "Within a few days (at least by 9/6/2021) patient began to have fever and a cough. Patient began to progressively decline. Started with inability to ambulate. At baseline patient could ambulate independently in her assisted living room. Within days, she was no longer able to do so, her swelling worsened, and her oral intake declined. This time period was complicated by an elevated potassium that improved with oral hydration and it was rechecked and improved, but her decline continued. She was treated for a UTI from a gathered urine sample starting 9/7/21, but there is uncertainty to the extent it was either responsible or contributing to her declining status. Patient was carried to the office on 9/16/21. She was found to have an oxygen saturation of 79-81% on room air, she was too weak to hold her head up, and her swelling had increased. EMS was recommended for transport to the hospital and with some convincing with her son's assistance, she finally agreed. Patient was transferred from the rural hospital to a tertiary center in city. She became severely oliguric. She was given IV furosemide that was not very effective. Patient was not only volume overloaded but also hypotensive requiring ionotropic treatment. Renal failure worsened and nephrology opinioned that she was a poor candidate for dialysis given her poor clinical condition and recommended hospice care. Patient died three days after admission on 9/19/21. Inpatient team determined that urinary tract infection did not appear to be septic in nature." "1894208-1" "1894208-1" "Pt stated the morning after getting his booster shot he had severe body aches, joint pain, severe fatigue and light headedness. On 11/20/2021 he reported he started coughing up blood. On 11/22/2021 he stated he had a fever and ended up having a Grand Mal Seizure. All symptoms lasted until he was pronounced dead on 11/23/2021." "1894216-1" "1894216-1" "SOB resp failure" "1894487-1" "1894487-1" "Patient was an 88 y.o. female with complex past medical history coronary artery disease, congestive heart failure, CKD, COPD narcolepsy, recent diagnosis of COVID19 on 11/06, who presented to the emergency department in cardiac arrest. Pt arrived in cardiac arrest. Unresponsive with GCS of 3 and different exam as detailed in D/C . She was given another dose of epinephrine at time of arrival and given her shockable rhythm of Vfib pre-hospital, Doctor administered lidocaine. ACLS was continued with continuous chest compressions. Her first initial end-tidal that was obtained in the ED with 9. She was hypoxic at presentation to the 60s with symmetric coarse breath sounds bilaterally. Given the low end-trial and persistent hypoxia she was intubated. Tolerated well with no acute change. Following intubation, her oxygen saturations did temporally improved to the 90s and end-trial did temporally improve to 30; however, she remained pulseless, apneic, unresponsive and asystolic. Sodium bicarbonate was given as she was recently diagnosed with COVID-19 and concern for possible acidosis. ACLS was continued with continuous chest compression and pt. remained asystolic throughout her resuscitation in the ED. Family was available and was able to be with patient and was understandable and agreeable with termination of CPR given no ROSC after 60 minutes of resuscitation efforts. Time of Death was 12.53pm. on 11/17/20" "1894527-1" "1894527-1" "Could not breath, was admitted to Hosp on Aug 2, 2021 around 11a and passed away Aug 16, 2021" "1894536-1" "1894536-1" "# Sudden Cardiac Death - The afternoon/evening of 11/20. patient was found to be without a pulse - ACLS performed with intubation, did obtain ROSC - While prepping to transfer to ICU, patient had recurrent loss pulse and ACLS resume - Event felt likely related to an arrhythmia due to her severely low ejection fraction - Family was contacted, requested that CPR be discontinued Time of Death: 1904" "1894687-1" "1894687-1" "The patient expired (likely as a natural consequence of disease progression) on Hospice about 2 weeks after a C19 vaccine dose on 09/30/2021. Expired on 10/13/2021" "1894700-1" "1894700-1" "The client was diagnosed with COVID-19 and was full-vaccinated. He was hospitalized from what appears to be September 24-25, 2021. He had co-morbid conditions (Myeloma, Kidney Failure, Diabetes, Dialysis) and passed away on September 28, 2021." "1894771-1" "1894771-1" "Death related to COVID illness" "1894933-1" "1894933-1" "Pt. died in the hospital of complications of SARS CoV2 pneumonia. Underlying h/o chronic end-stage renal disease requiring hemodialysis preceding her acute illness." "1895092-1" "1895092-1" "the vaccine recepient died 9/9/2021, 2 weeks after receiving the J&J covid vaccine" "1895355-1" "1895355-1" "Extreme fatigue stared several days after his covid booster. Then 8 days later he had a sudden cardiac arrest that resulted in death." "1896992-1" "1896992-1" "Covid Vaccination Monitoring Documentation: PT admitted 11/9/21 ? 11/12/21. POC SARS COV2 ANTIGEN resulted 11/11/21. Patient had Pfizer covid vaccine 1/30/21 Lot: EL9265, Pfizer covid vaccine 2/20/21 Lot# EL9266. Patient expired 11/12/21. Documented cause of death: Acute respiratory failure 2/2 covid 19, sepsis, tracheobronchomalacia." "1897085-1" "1897085-1" "Deceased 10/16/2021" "1897094-1" "1897094-1" "Deceased 10/23/2021" "1897102-1" "1897102-1" "Deceased 10/26/2021" "1897224-1" "1897224-1" "My brother died 1-2 weeks after receiving his second Moderna vaccine. Outcome was death. The coroner marked an enlarged heart as a significant contribution to his cause of death along with a combination of prescription drugs for back pain and depression. There was no previous awareness of an enlarged heart in his life." "1897280-1" "1897280-1" "patient presented to emergency department on 11/5/21 with shortness of breath, cough and fever. covid-19 specimen taken and came back positive patient was admitted for further management of covid-19 patient did require treatment for symptoms associated with covid-19 infection. treatment with dexamethasone patient was intubated on 11/9/21 and extubated on 11/13/21 patient's condition worsened requiring transfer to the intensive care unit on 11/7/21 patient expired on 11/13/21" "1897283-1" "1897283-1" "patient passed away and was found dead over a day after receiving the vaccine; expiration date of vaccine 11/25/21; patient received this as a booster dose he had first and second dose in the Spring" "1897295-1" "1897295-1" "Patient passed away 2/2/2021" "1897319-1" "1897319-1" "The patient passed away on 11/22/21. There is no clinical evidence to support that the death was caused by the vaccine, but since it meets the definition of reportable we are doing so as required." "1897353-1" "1897353-1" "Death; was hospice and was declining prior to vaccination" "1897657-1" "1897657-1" "On 11/3/21 the patient had emesis, followed by 2 loose bowel movements. Patient was started on Miralax. The patient had decrease food and fluid intake. Was given 2 L of IV fluids on 11/16/21. Due to abnormal lab results the patient was transferred to the hospital on 11/18/21. The patient was transferred back from hospital with orders for hospice." "1897665-1" "1897665-1" "HOSPITAL VISIT, CARDIAC ARREST" "1897686-1" "1897686-1" "Patient tested positive for COVID on 11/8/2021 Developed severe respiratory syndrome 2ndary to COVID pneumonia required up to 50L heated high flow oxygen due to respiratory failure Received remdesivir, dexamethasone Was in the ICU. Patient's wishes were to be DNR. Patient placed on comfort care and subsequently died on 11/22/2021" "1897811-1" "1897811-1" "Nausea and vomitting began after second dose. Patient also started a new medication, Rebylsus, the same time he recieved the injections. Nausea and vomitting progressed despite discontinuing the medication. Eventually diagnosed with esophageal adenocarcinoma" "1897823-1" "1897823-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/13/2021 and 4/3/2021. Patient presented to ED on 11/5/2021 with 1 day worsening of shortness of breath and labored breathing. Patient increased home 0xygen from 2L to 5L, with pulse ox readings in the 60s while on the 5L. Oxygen requirements escalated over following days. Patient's COVID treated with dexamethasone, remdesivir and antibiotics. Intubated on day 9 of admission. Resuscitation efforts limited to intubation only per patient request. Expired on 11/18/2021." "1897825-1" "1897825-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/11/2021 and 4/01/2021. PMHx significant for COPD heart failure and CKD3. Presented to ED on 11/16/2021 with shortness of breath for several days, noted to have severe respiratory distress with oxygen saturation in 50's requiring intubation in ED. CXR in ED confirmed pneumothorax requiring chest tube. Due to chronic lung disease and Covid-19 infx lung status remained poor with persistent air leak. Family decided to withdraw life support on 11/19/2021." "1897826-1" "1897826-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/9/2021 and 3/30/2021. Presented to ED on 11/12/2021 with complaints of difficulty breathing, fever, and chills. Reported previous tx'd at home with decron 6mg POD x7 days, tessalon and azithromycin without relief. Admitted 11/12/2021 for acute respiratory failure with hypoxia, Covid-19 pneumonia and sepsis of undetermined organism. Reports testing positive for COVID on 11/5/2021. Inpatient treated with remdesivir, dexamethasone, and antibiotics. On 11/15/2021 patient's Airvo demand rapidly worsened to 93 FIO2/60L with sats of 92%. Transitioned to comfort care and expired on 11/20/2021." "1897832-1" "1897832-1" "Admitted to the hospital on 10/16/2021 with respiratory symptoms. Passed away 11/7/2021. Cause: RESPIRATORY FAILURE COVID-19 PNEUMONIA PULMONARY EMBOLISM Contributing: IMMUNOCOMP BY PAST LUNG CANCER Submitter does not have access to full medical record. For further details, please contact the admitting hospital" "1897869-1" "1897869-1" "Difficulty breathing starting at approximately 1254, upon EMS arrival she was unresponsive, absent pulse and absent breath sounds. Blood glucose 390. CPR initiated. initially in asystole then 1 episode of a shockable rhythm and was defibrillated at 150 joules, but then returned to asystole. Transferred to hospital. During transport received 5 rounds of epinephrine and supraglottic airway in place with ETCO2 at 25 and chest compression administered via LUCAS device. 1L of NS given during transport and sodium bicarb. Arrived at hospital unresponsive time 45-50 minutes." "1897872-1" "1897872-1" "fully vaccinated-complications of covid-19 death" "1897886-1" "1897886-1" "Presented to ED on 10/28/2021 with hypoxia, SOB, fever, cough, congestion. Entered Hospice on 11/3/2021 with terminal diagnosis of Covid-19 pneumonia, and passed away 11/5/2021 Previously fully vaccinated: Pfizer 1/28/2021 and 2/18/2021 Submitter does not have access to full medial record. If further information is needed, please contact the admitting hospital." "1897897-1" "1897897-1" "cause of death-complications of covid 19. fully vaccinated" "1897981-1" "1897981-1" "The patient had a heart attack and died two days after his second COVID-19 vaccine. He was taken to the hospital. Their phone number is (Privacy)." "1898001-1" "1898001-1" "Case died of Covid 6 months after being vaccinated for it." "1898008-1" "1898008-1" "The patient was feeling relatively normal after vaccine, reporting minimal pain at injection site and no fever at 1900 on 11/14. On 11/16 he was found obtunded on the floor at his home and was transported via ambulance to Medical Center, where he died on 11/18 at 3:20 a.m." "1898729-1" "1898729-1" "Patient is deceased. Hospitalized (11.17.21); COVID-19 positive (11.17.21); Fully vaccinated PLUS booster. Admission Date: 11/17/2021 Date of Death: 11/23/21 Time of Death: 2:13 AM Preliminary Cause of Death: COVID-19 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Lactic acidosis Encephalopathy acute Non-traumatic rhabdomyolysis AMS (altered mental status) COVID-19 HOSPITAL COURSE: Patient is a 64 year old male with past medical history significant for alcohol abuse, cirrhosis, prior hepatitis C infection, diabetes, left BKA. He presented to the ER 11/17 after being found unresponsive at home (reportedly found by program after several uncollected meals left on doorstep). CT head with possible subdural hygroma. CT spine without acute abnormality. CT t/a/p with possible contusion to left upper arm and left anterior chest wall, liver cirrhosis with portal hypertension. He was incidentally found to be COVID positive but was admitted on room air. Patient was orientated x0 but was protecting airway and was admitted to hospitalist service. Overnight, patient became more obtunded and was transferred to ICU 11/18am and emergently intubated. Blood cultures from admission 2:2 positive for staph aureus. Neurology and infectious disease consulted. CT thoracic and lumbar imaging without evidence of abscess (currently unable to obtain MRI due to inability to complete questionnaire). Pt was breath stacking, therefore changed into PSV mode. During turns, pt suddenly desatted requiring full vent support and 100% FIO2. Stat CXR was done and NEG for pneumothorax. CTA chest was ordered and demonstrated pneumotosis of colon, portal venous system and gastric. LP + for Xanthochromia. Family was updated and decided not to pursue ongoing aggressive care. He was pronounced at 02:13 on 11/23/2021. Brother was called and updated." "1899499-1" "1899499-1" "Patient is now deceased. ED 11.20.21; hospitalized 11.21.21; COVID-19 positive (11.20.21); fully vaccinated Admitted for hypotension, septic shock, COVID-19 (with ESRD, cardiomyopathy, bilateral PE) Admission Date: 11/21/2021 Date of Death: 11/23/21 Time of Death: 12:59 PM Preliminary Cause of Death: Hypotension DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Shock (HCC) [R57.9] Hypotension [I95.9] HOSPITAL COURSE: This is a 77 year old male with a PMH significant for HTN, HLD, ESRD on HD, T2DM with retinopathy & neuropathy, gout, hemochromatosis, hyperparathyroidism, cardiomyopathy, OSA on BiPAP, CAD and obesity who was brought to the emergency department on 11/20 by EMS from his care facility with concerns of hypotension. The patient was noted to be hypotensive on initial evaluation and was given Levophed, also found to be positive for COVID-19 and noted to have CT thorax findings of large right effusion unchanged from prior imaging, increasing moderate left effusion, as well as patchy airspace disease in the right upper lobe and right middle lob suggestive of pneumonia representative of changes secondary to COVID-19 with inflammatory changes and early bacterial pneumonia. There was also question about the possibility of a PE on the CT thorax, however it was deemed unlikely as the patient had been anticoagulated with Warfarin for Atrial Fibrillation with therapeutic INR. The patient was started on broad spectrum antibiotics for bacterial pneumonia and was started on Remdesivir and Decadron for treatment of COVID-19 with admission for further evaluation and management. On the first full day after his ER visit that led to admission, the patient had elected not to pursue treatments any further. Hospice was consulted and patient/patient's family ultimately elected for inpatient hospice. Nephrology had been consulted for assistance with the patient's dialysis, although they ultimately signed off the patient's care due to patient choosing not to pursue further treatment and deciding to pursue inpatient hospice care. During the patient's hospitalization, his ICD was turned off given the patient's decision for hospice care. The patient was kept comfortable with the help of hospice during the remainder of his hospitalization and he expired comfortably on 11/23/21 with his wife and son at bedside. The patient was pronounced expired at 12:59PM on 11/23/21." "1899642-1" "1899642-1" "Patient had hematoma form on arm then 3 days later died suddenly" "1899968-1" "1899968-1" "Resident noted to be unresponsive and passed away" "1901641-1" "1901641-1" """"Stabbing"" headaches, progressive memory loss, unexplained uncontrollable swelling below the waist, loss of bowel & bladder control, deaf in right ear, blind spot in left eye, could no longer perform basic movements independently."" "1902018-1" "1902018-1" "[ 89-year-old with past history coronary disease congestive heart failure diabetes pacemaker presents to for altered mental status. Patient was be confused this morning at his nursing blood glucose was checked was 50 so was given dextrose. Also noted be hypoxic. Apparently patient did have a COVID exposure recently had a fever yesterday however is COVID test was pending. At time of evaluation patient is now alert still little confused is A&O x2. No chest pain, abdominal pain vomiting or diarrhea. Of no, EMS found him to be in V-tach at 1 point during transport. This seems to have converted spontaneously.] Patient hospitalized in ICU from 11/12/21 through 11/22/2021 Patient expired on 11/22/2021" "1902165-1" "1902165-1" "patient admitted for stroke 10/20-11/2/2021. received Pfizer vaccine 10/28/2021. discharged to SAR 11/2/2021. date of death = 11/20/2021." "1903479-1" "1903479-1" "red swollen arm with fever to it for 3/4 days after it cleared up leg cramps occured frequently." "1903577-1" "1903577-1" ""Passed away/ Doctors couldn't revive him; passed out; gasping for air/couldn't breathe/tried to breathe for him and do CPR, but it wasn't working; He was sweating/chest was wet; looked a little ashy; his legs went limb and relaxed; ""His eyes were, like, not right""; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away/ Doctors couldn't revive him), LOSS OF CONSCIOUSNESS (passed out), DYSPNOEA (gasping for air/couldn't breathe/tried to breathe for him and do CPR, but it wasn't working), HYPERHIDROSIS (He was sweating/chest was wet), SKIN DISCOLOURATION (looked a little ashy), LIMB DISCOMFORT (his legs went limb and relaxed) and EYE DISORDER (""His eyes were, like, not right"") in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 039*K20A and 038K20A) for COVID-19 vaccination. The patient's past medical history included Heart disease, unspecified and Heart valve replacement (three years ago he had a heart valve replacement surgery, but he had been fine since.) in 2018. Concurrent medical conditions included Diabetes (had diabetes (but under control).), Blood pressure high (had high blood pressure (but under control).) and Overweight. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criteria death and medically significant), DYSPNOEA (gasping for air/couldn't breathe/tried to breathe for him and do CPR, but it wasn't working) (seriousness criterion death), HYPERHIDROSIS (He was sweating/chest was wet) (seriousness criterion death), SKIN DISCOLOURATION (looked a little ashy) (seriousness criterion death), LIMB DISCOMFORT (his legs went limb and relaxed) (seriousness criterion death) and EYE DISORDER (""His eyes were, like, not right"") (seriousness criterion death). The patient died on 15-Nov-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. Patient was sitting on the couch, gasping for air, and told reporter to hurry and call 911 since he couldn't breathe.The ambulance people tried to revive him, they put him on the floor, and they took his pulse. They asked for his medications and took him into the ambulance. When they arrived at the hospital, it took a while for any doctor to come and talk to her, so she thought they could revive him and was expecting some damage, like slow speech or paralysis. But when the doctor came in, he told her that they couldn't revive him, and he had passed. When she got in to see him, he had a tube on his mouth and his body temperature was fine, but he wasn't there anymore. No concomitant medication information were given. No treatment information were given. Company comment: This case concerns a 71-year-old, male patient, with medical history of diabetes, heart disease, and heart valve replacement surgery, who experienced the serious, unexpected events of death, loss of consciousness, dyspnea, hyperhidrosis, skin discoloration, limb discomfort and eye disorder. One day after receiving the booster dose of mRNA 1273 vaccine, patient called out for his wife as he was gasping for air and couldn't breathe, he was sweating and looked a little ashy. Patient passed out before ambulance arrived, CPR was done but patient was not revived. Wife requested for an autopsy by private individual, result not yet provided. The patient's co-morbidities of diabetes, heart disease, and heart valve replacement remains as a confounder to the events. The benefit risk relationship of vaccine is not affected by this report.; Sender's Comments: This case concerns a 71-year-old, male patient, with medical history of diabetes, heart disease, and heart valve replacement surgery, who experienced the serious, unexpected events of death, loss of consciousness, dyspnea, hyperhidrosis, skin discoloration, limb discomfort and eye disorder. One day after receiving the booster dose of mRNA 1273 vaccine, patient called out for his wife as he was gasping for air and couldn't breathe, he was sweating and looked a little ashy. Patient passed out before ambulance arrived, CPR was done but patient was not revived. Wife requested for an autopsy by private individual, result not yet provided. The patient's co-morbidities of diabetes, heart disease, and heart valve replacement remains as a confounder to the events. The benefit risk relationship of vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death"" "1904084-1" "1904084-1" "On November 4th, 2021 he had a catastrophic stroke due to blood clots in his brain. He was declared brain dead on November 6th, 2021 at 12:00 pm. We believe these clots were caused by the covid 19 vaccination. He also had a flu shot in addition weeks prior, which he was advised to get by medical professionals." "1904384-1" "1904384-1" "Death - the patient was hospitalized after receiving the 1st dose, with CF and other issues, upon entry to RRLC she was in recovery - vitals were good. Her health was improving. Three days after the second dose in the morning while the aide waited outside, she died on the toilet - shocking all staff at the facility and the family." "1904387-1" "1904387-1" "Dad was fine until 7:30 11/20/21. Called me to say he had terrible stomach pain, blood pressure through the roof. He vomited 2x. Neighbor had him call for an ambulance and rushed to emergency. when I arrived his BP was still very high and his pain was still bad. He remained in emergency until Sunday when a bed became available." "1904459-1" "1904459-1" "death on 11/28/2021" "1905072-1" "1905072-1" "Case was fully vaccinated against Covid19, and became infected with Covid-19 on 7/12/2021. She died on 7/15/2021 with Covid Pneumonia listed as a secondary diagnosis contributing to her death." "1905343-1" "1905343-1" "Lap Right Colectomy on 11/15/21 11/18/21:10:28 received Covid 19 booster 11/18/21: 8 pm, moaning and discomfort-given tylenol and ultram at 9:45 pm 11/19/21: 2 am, tossing and turning 11/19/21: 7 am, vomited, doctor contacted for ondansetron 11/19/21:7:15 am, patient expired" "1905368-1" "1905368-1" "Fully vaccinated, COVID breakthrough, inpatient hospital stay" "1905379-1" "1905379-1" "Patient presented to emergency room on 11/2/2021 after testing positive for COVID-19 infection on 11/1/2021. She was experiencing shortness of breath, weakness, and cough. Patient was admitted for further management. Patient's respiratory status continued to decline despite steroids and oxygen supplementation. Patient expired on 11/15/2021." "1905402-1" "1905402-1" "Patient passed away 11/28/2021, heart failure, anemia and respiratory failure. Patient was negative for Covid 19. Dose 1 given 1/18/2021, Moderna, Lot # n/a" "1905409-1" "1905409-1" "Dose 1 given 2/5/2021 Moderna lot # 016M20A Patient died of Covid 19 pneumonia, respiratory failure" "1905445-1" "1905445-1" "Dose 1 given 2/25/2021 Pfizer Lot # EN6198 Patient died from Covid 19" "1905460-1" "1905460-1" "Dose 1 Moderna 2/17/2021 Lot # N/A Patient died at a local hospital 11/25/2021 from heart failure, pallitive care initiated. Not a Covid 19 death" "1905479-1" "1905479-1" "diagnosed positive for COVID on 9/18/21; EMS brought pt to ED with altered mental state, increased SOB and hypotension; 70% O2 saturation on RA, glucose greater than 600; PMH: DM, chronic kidney disease; treated with DKA protocol, dexamethasone, remdesivir, Olumiant, Budesonide; to ICU; BiPAP ; intubated on 10/3/21 requiring FiO2 of 100% and proned; septic shock; DNR; transitioned by family to comfort care with worsening condition of pt; pt died in the hosp" "1905482-1" "1905482-1" "Dose 1 Pfizer given 4/1/2021 Lot # ER8737 Patient died of heart failure, multiorgan failure at hospital on 11/24/2021, this is not a covid 19 death." "1905628-1" "1905628-1" "Breakthrough COVID infection in vaccinated patient. Pt expired on 11/23/21" "1905662-1" "1905662-1" "Acute Respiratory Failure, Acute CVA, COVID-19 pneumonia" "1905714-1" "1905714-1" "Patient received COVID booster shot on 11/9/2021. Within 24 hours patient's left arm became erythematous, warm, swollen, painful. Attending M.D. was notified and ordered course of doxycycline. No other reaction noted until the week beginning on 11/15/2021 the patient began having low grade fevers and was more subdued, quieter. The patient became more lethargic by 11/17/2021 and PO intake declined as a result. Attending M.D. ordered CBC, CMP, blood cultures and urine analysis with C+S on 11/17/21. Labs did not have significant findings. The patient continued to be extremely lethargic, very minimal PO intake, having fevers, tachycardia. Patient deceased on 11/20/2021." "1905782-1" "1905782-1" "Patient is now deceased, very likely from Covid-19, based on the positive test of her spouse, and very similar symptoms" "1905809-1" "1905809-1" "Onset of COVID symptoms 11/8, tested positive for COVID 11/10/21. admitted from the floor earlier today for acute hypoxic respiratory failure secondary to Covid PNA. Patient was initially a transfer from a hospital on 11/13. Admitted after he needed NIPPV. Intubated 11/17 and paralyzed and proned 11/17. Deceased 11/28/21." "1905891-1" "1905891-1" "Pt.'s states that after receiving the 1st dose of Phizer 08/18/2021, started experiencing symptoms 08/25/2021 of shortness of breath, fatigue, dry cough, difficulty breathing while sleeping, and heaviness in the chest. 09/02/2021 Primary visit, Prescribed Inhalers for Follow-Up. Emergency Room transported (passed out), Pt. passed 09/08/2021. Cause of Death : Acute Hypoxia Respiratory Failure and Covid Pneumonia." "1905897-1" "1905897-1" ""Deceased (11.21.21); Hospitalized (11.11.21); COVID-19 positive (11.11.21); Fully vaccinated ASSESSMENT / PLAN: * Hypokalemia severe Assessment & Plan Severe hypokalemia Orally and IV potassium replacement Suspect a combination of diarrhea as well as hydrochlorothiazide Hold hydrochlorothiazide consider starting a set discharge instead of hydrochlorothiazide Hypomagnesemia likely contributed as well Intensive care unit on telemetry monitoring until potassium has significantly improved Hypocalcemia Assessment & Plan Suspect related to poor oral intake as well as severe hypomagnesemia IV replacement Replace magnesium Suspect will improve calcium level with magnesium replacement Hypomagnesemia Assessment & Plan Suspect due to hydrochlorothiazide and or diarrhea IV replaced COVID-19 Assessment & Plan Patient vaccinated likely explaining why her oxygenation is so good. No indication for dexamethasone or remdesivir Main symptom is diarrhea Continue respiratory isolation Generalized weakness Assessment & Plan Suspect multiple factors including all of her electrolyte abnormalities on baseline weakness PT OT Essential hypertension with goal blood pressure less than 140/90 Assessment & Plan Blood pressure elevated in the ER will follow. Holding hydrochlorothiazide Consider changing to lisinopril at discharge. Or during hospitalization if antihypertensive needed. Discharge Disposition: Deceased DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypocalcemia [E83.51] Hypokalemia [E87.6] Hypomagnesemia [E83.42] Diarrhea, unspecified type [R19.7] COVID-19 [U07.1] HOSPITAL COURSE: Patient was admitted 11/11/21 with main complaint of weakness, as well as diarrhea, fever, chills, and cough. In the ER she was found to be COVID positive and hypokalemic with a potassium of 2.0. She had been vaccinated for COVID and was not hypoxic at time of admission. She was initially placed in the ICU while potassium was replaced. She was eventually started on IVF for hyponatremia. On 11/13, the patient had a choking episode while taking pills, which resulted in hypoxia and shortness of breath. She had a history of ""tight esophagus"" but did not want to have repeat dilation per daughter. That evening the patient complained of chest pain and nausea. EKG revealed sinus tachycardia with occasional PVCs. BNP was markedly elevated at 32,400 and troponin was 206. CXR showed atelectasis. IVF were discontinued and she was given IV lasix for suspected fluid overload. Heparin drip was started for suspected NSTEMI and nitro paste was placed. She received ASA, statin, and beta blocker. She was started empirically on antibiotics to cover for potential aspiration pneumonia. The patient did not desire cardiac intervention. SLP evaluated the patient and suggested thin liquids with medications crushed in puree or liquidized. Echocardiogram was obtained and notable for diffuse apical akinesis and an EF of 21%. This was discussed with cardiology and felt to likely be takotsubo cardiomyopathy. Her weakness and hypoxia continued to worsen. She continued to be diuresed. The evening of 11/17 the patient expressed thoughts of transitioning to comfort care. 11/18 she stated that she did not want to continue aggressive medical therapies. Family was in support of this decision and Hospice was consulted. The plan was that she would transition to hospice care at discharge. She was given medications as needed for restlessness and pain. The early morning of 11/21, Patient had very shallow respirations. She was pronounced dead at 3:26 on 11/21/21. On exam she was unresponsive, pupils fixed and dilated, no pulse, no breath sounds, and no heart tones. Daughter was notified. Funeral home arrangements pending."" "1905900-1" "1905900-1" "Patient had severe hypoxia and hypotension, arrived to the hospital on 11/25/21, was intubated, and died 8hrs later." "1905948-1" "1905948-1" "Patient received 1st vaccine in series at 11:45 am 11/27/21 during hospitalization. She had been in hospital for 10 days after pancreatitis, fall with hip fracture and fixation of hip fractures. At 11:45pm she was noted to be short of breath. at 6:15 pm on 11/28/21 she was found unresponsive, coded and expired." "1905991-1" "1905991-1" "Case was hospitalized then died of Covid 8 months after being fully vaccinated for Covid. Admitted 11/8/21 for Covid pneumonia, Dexamethasone/remdesivir course completed. Transitioned to Comfort care 11/23/21, died 11/27/21" "1906086-1" "1906086-1" ""96yr old female presents via ambulance for complaints of neurological changes. Patient lives with so., Son reports patient has had ""decrease alertness last couple of hours and"" not feeling good for couple of days"" Patient heard of hearing, does not answer nurses questions, opens eyes to sternum rub. Urinary tract infection with hematuria, site unspecified cefdinir (OMNICEF) 300 mg capsule cefdinir (OMNICEF) 300 mg capsule 2. COVID-19 virus infection 3. Pleural effusion on right 4. Weakness 5. Hypoxemia 6. Hypokalemia Neurological Changes"" "1906128-1" "1906128-1" "Patient fully vaccinated for Covid-19 and deceased." "1906144-1" "1906144-1" "Respiratory distress - Tachycardia, with periods of bradycardia, fever observed at approx 3:09 pm - call to MD who gave order to send to ER for Eval and Treat" "1906148-1" "1906148-1" """"Deceased (11.25.21); Hospitalized (11.11.21); COVID-19 positive (11.18.21); Fully vaccinated with moderna x2 H&P: I have personally interviewed and examined the patient on 11/21/2021. Management was discussed with MD. I agree with the documented findings and plan of care in his/her note. Brief exam: Vitals: 11/21/21 1545 BP: 136/65 Pulse: 114 Resp: 18 Temp: General appearance: Alert, no acute distress HEENT: Oral mucosa moist Respiratory: Normal work of breathing, no wheezes crackles or rhonchi Cardiac: Regular rate and rhythm no murmurs rubs or gallops Abdomen: Nontender, nondistended no hepatosplenomegaly Extremities: No peripheral edema, normal range of motion Integument: No rash Brief history and medical decision making: Patient is an 85-year-old man with history of chronic obstructive pulmonary disease and who was vaccinated against COVID-19 in April 2021. He presented to the hospital with increasing shortness of breath and was tested positive for COVID-19 3 days ago on 11/18. Patient said he was about to get his posterior but became ill before then. When he presented to the emergency department his oxygen saturation was only 25%. Patient was placed on high-flow nasal cannula at 100% and has been saturating in the mid 90s. I had a discussion with him and his wife about code status. Patient would prefer to be do not resuscitate/DNI. If he continues to worsen he would like to be awake and able to visit with his wife as he passes away rather than on a ventilator. Patient is very dehydrated and has not been able to drink water last several days and has had several bouts of diarrhea. Patient was started on normal saline which will continue over the next 15 hours. Will reassess and monitor closely for fluid overload in the setting of COVID-19 pneumonia. History & Physical CHIEF COMPLAINT: Chief Complaint Patient presents with ? COUGH cough, fever, fatigue, weakness x 2 days. Subjective HISTORY OF PRESENT ILLNESS: Patient is a 85 y.o. male who presents with 7 days of symptoms including shortness of breath, productive cough, subjective fever, fatigue, weakness, chills. He states he went to his PCP on Thursday 11/18/2021 and thought he just had a really bad sinus infection. He was diagnosed with pansinusitis acute suppurative otitis media, and an acute upper respiratory tract infection and prescribed Augmentin. He was also tested for COVID-19 and his PCP encouraged him to go to the emergency department for chest x-ray and COVID testing. Patient stated at the time that he would go if he declined. As symptoms worsened over the next few days, his wife drove him to the emergency department today. Upon presentation, his pulse ox in room was 25% with a good waveform. He was escalated to high-flow nasal cannula and was initially able to maintain sats in the low 90s high 80s. Labs were obtained including CMP, BNP, procalcitonin, complete blood count, D-dimer, peripheral blood cultures. CMP showed stable creatinine and GFR from outpatient records, otherwise relatively unremarkable. Complete blood count with no leukocytosis. Procalcitonin was elevated at 0.43, BNP was elevated at 2272, and D-dimer was elevated at 1440. The patient was started on gentle hydration with normal saline infusion per emergency department provider. He was given a dose of dexamethasone and subsequently call was placed to admit the patient to the hospitalist service. Upon my evaluation, spouse is at bedside and patient is lying on his left side with high-flow nasal cannula in place. Despite max FiO2 and high-flow nasal cannula, patient is mildly dyspneic at rest. He is using accessory muscles for respiration and discussion is talking only in 3-5 word sentences, often taking a break to take several breaths through his nose. He endorses same symptoms as described above except for he says his diarrhea is no longer occurring. We have a detailed discussion of code status and patient initially elects to be full code, designating his wife to make decisions if he is incapacitated. Attending provider had further discussion with patient and after he was able to discuss this with his spouse and attending, decision was made to switch patient to DNR/DNI status. He was subsequently admitted to general medicine service in guarded condition. ED Course: IV Dexamethasone 6 mg Review of Systems Constitutional: Positive for activity change, chills, fatigue and fever. Negative for diaphoresis. HENT: Negative for congestion, rhinorrhea and sore throat. Eyes: Negative for visual disturbance. Respiratory: Positive for cough, shortness of breath and sputum production. Negative for wheezing and chest tightness. Cardiovascular: Negative for chest pain and palpitations. Gastrointestinal: Positive for diarrhea. Negative for nausea, vomiting, abdominal pain, constipation and blood in stool. Genitourinary: Negative for dysuria and hematuria. Musculoskeletal: Positive for joint pain (Left hip, chronic). Negative for edema. Neurological: Positive for weakness. Negative for headaches and dizziness. Endo/Heme/Allergy: Negative for easy bleeding or bruising. Skin: Negative for rash. Reviewed 10 systems, pertinent findings included in HPI, all other systems are negative. Objective OBJECTIVE: BP 118/77 | Pulse 103 | Temp 99.5 ¦F (37.5 ¦C) (Rectal) | Resp 17 | SpO2 96% FIO2 (%): 100 % Physical Exam Vitals reviewed. Constitutional: General: He is not in acute distress. Appearance: He is ill-appearing. He is not toxic-appearing or diaphoretic. HENT: Head: Normocephalic and atraumatic. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are dry. Pharynx: No posterior oropharyngeal erythema. Eyes: General: Right eye: No discharge. Left eye: No discharge. Extraocular Movements: Extraocular movements intact. Cardiovascular: Rate and Rhythm: Tachycardia present. Rhythm irregular. Pulses: Normal pulses. Heart sounds: Normal heart sounds. No murmur heard. No friction rub. No gallop. Pulmonary: Effort: Respiratory distress present. Breath sounds: No wheezing or rhonchi. Comments: Tachypneic, coarse crackles bilaterally, using accessory muscles. Only able to talk in short sentences without taking a deep breath through his nose with high-flow nasal cannula. Chest: Chest wall: No tenderness. Abdominal: General: Abdomen is flat. Bowel sounds are normal. There is no distension. Palpations: Abdomen is soft. Tenderness: There is no abdominal tenderness. Musculoskeletal: Right lower leg: No edema. Left lower leg: No edema. Lymphadenopathy: Cervical: No cervical adenopathy. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Coloration: Skin is not pale. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: He is alert. Comments: Tremor noted right upper extremity, lower face and chin Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. ASSESSMENT/PLAN: COVID 19 Pneumonia Acute Hypoxic Respiratory Failure Sepsis Concern for superimposed bacterial PNA Presenting symptoms: Shortness of breath, productive cough, subjective fever, fatigue, weakness, chills. SIRS criteria met, tachycardia, tachypnea COVID 19 detected by PCR: 11/18/2021. Symptomatic day: 7 (symptoms started 11/15) CXR with findings of moderately extensive left greater than right bilateral pulmonary opacities.. Received Decadron 6 mg x1 in ED. Procalcitonin 0.43 Current oxygen saturation 88%, oxygen requirement high-flow nasal cannula 100% FiO2 -Severe Respiratory isolation -Dexamethasone 6 mg oral daily 1/10 days -Remdisivir day 1. Will need daily CMP monitoring for liver and renal toxicities. -Daily labs CBC with differential, CMP, D-dimer -Ins/Outs: Goal even to net negative -recent diarrhea, appears dry on exam -will provide 100 mL/hour x15 hours -Continuous pulse oximetry and telemetry -VTE prophylaxis subQ heparin -CAP abx coverage: start ceftriaxone and azithromycin x5 days Chronic obstructive pulmonary disease No oxygen at baseline, no wheezing on exam Home: Albuterol p.r.n. -Continue albuterol prn Hypertension CAD Nonischemic cardiomyopathy Acute on chronic systolic and diastolic heart failure Frequent PVCs Follows was Cardiology Last echo 09/21/2020: EF 49%, global hypokinesis, mild concentric LVH, grade 2 diastolic dysfunction. Also noted moderate mitral regurg, mild AR, mild tricuspid regurg, mild pulmonary hypertension, severe left atrial enlargement and mild right atrial enlargement. LHC 2018: 30-40% left anterior descending artery, left circumflex artery and right coronary artery diseae BNP on arrival 2272 Home: Amlodipine 10 mg daily -continue home amlodipine -update echo CKD 3 Baseline creatinine 1.1-1.6, GFR 40-55 On arrival, creatinine 1.54, GFR 43 Prediabetes Last A1 c 08/05/2021 was 6.1% No home meds -will start VLD CSI in setting of initiation of steroids for COVID as above Dyslipidemia Noted per chart review, no statin Osteoarthritis Noted per chart review, uses tylenol prn at home Peptic ulcer disease Noted per chart review, no meds at home -Will provide Protonix given initiation of PO steroids S/p left hip replacement Noted Familial benign essential tremor Noted, patient states this is unchanged since symptoms started 7 days ago DVT: subq heparin GI: protonix Diet: general IVF: was placed on NS 125 ml/hr in ED -> will change to 100 mL/hour x15 hours Code status: DNR/DNI Discharge /Deceased Summary: BRIEF OVERVIEW: Discharge Provider: MD Primary Care Physician at Discharge: PA-C Admission Date: 11/21/2021 Active Hospital Problems Diagnosis Date Noted POA ? Acute hypoxemic respiratory failure due to COVID-19 11/21/2021 Unknown Resolved Hospital Problems No resolved problems to display. Pre-Existing Active Problems Diagnosis Date Noted POA ? Coronary artery disease involving native coronary artery of native heart without angina pectoris 06/24/2021 Unknown ? Non-rheumatic mitral regurgitation 06/24/2021 Unknown ? Frequent PVCs 02/12/2019 Unknown ? Non-ischemic cardiomyopathy 02/12/2019 Unknown ? Hypertension, benign Unknown ? Non-sustained ventricular tachycardia 11/29/2018 Unknown ? Primary osteoarthritis involving multiple joints 05/24/2017 Unknown ? Erectile disorder due to medical condition in male patient 11/18/2016 Unknown ? Prediabetes 03/30/2015 Unknown ? Dyslipidemia Unknown ? Statin intolerance Unknown Date of Death: 11/25/21 Time of Death: 11:32 AM Preliminary Cause of Death: Respiratory failure Discharge Disposition: Deceased DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia [J96.01] Acute hypoxemic respiratory failure due to COVID-19 [U07.1, J96.01] Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE: Patient has a history of COPD, vaccinated with COVID in April, and presented to the hospital with acute hypoxic respiratory failure due secondary to COVID-19. He wished to be DNR/DNI. He was on CPAP with 100% FiO2 and unable to maintain his saturations. He was treated with decadron and remdesivir. He was also covered for community acquired pneumonia with azithromycin and ceftriaxone. His oxygenation continued to decline throughout his stay. He had a difficult time eating or drinking due to desaturations without CPAP. Discussed a feeding tube and he declined, but was given IV fluids for hydration. Due to continued decline, family decided to make him comfort measures the morning of 11/25. He passed shortly after. Death Pronouncement Resident Team was called to bedside to pronounce patient death on 11/25/2021 Patient was unresponsive to voice, nail bed pressure No cartoid or peripheral pulses were palpapable No visible chest rise noted Heart sounds were not heard Lung auscultation absent for any breath sounds Pupils were fixed, nonreactive to light Corneal reflexes were negative Time of death was 11:32 on 11/25/2021 Chaplain Services were offered: family declined Family was at bedside"" "1906237-1" "1906237-1" "Case was hospitalized and died from Covid 6 months after completing Covid vaccine series. Was admitted 10/26 with onset of URI symptoms 10/18. Was already on chronic 4 L NC O2 prior to illness. Required high flow nasal cannula oxygen immediately upon admission. Was treated with full course of dexamethasone with some initial improvement in oxygenation. Then began to decompensate again and failed attempts at diuresis with worsening renal function. He wanted to go home on hospice, but was requiring too much supplemental O2 to make this feasible, and probably would have been in florid respiratory distress before leaving the hospital. He further decompensated and his family was called into the hospital. He removed his bipap and placed 15 L mask so could talk with his family. Then he removed the mask and quickly drifted to sleep. Time of death 1620." "1906259-1" "1906259-1" "Death" "1906913-1" "1906913-1" "3 weeks after 3 shot Patient started to experience more breathing issues, ended up with phenomena x2 and passed away" "1908569-1" "1908569-1" "Sudden Death" "1909167-1" "1909167-1" "The patient developed a rapidly progressive lower motor neuron disorder beginning in March 2021 and progressing from her legs to her arms to her bulbar and respiratory muscles, resulting in death in November 2021." "1909176-1" "1909176-1" "Moderna on 2/2 and 3/4. Positive on 11/28" "1909270-1" "1909270-1" "Patient tested positive for COVID on 11/23/2021 and died on 11/29/2021" "1909307-1" "1909307-1" "I am the epidemiologist reporting on behalf of 73-year-old male LTCF patient. The patient received their first dose of the Pfizer vaccine on 1/06/21. The patient tested positive for COVID-19 on 1/26/21 via PCR (20 days post dose 1). The patient received their second dose of the Pfizer vaccine on 5/26/21 and their third dose of the Pfizer vaccine on 10/27/21. The patient tested positive for COVID-19 a second time via PCR on 11/16/21. On 11/27/21 (one-month post dose-3 and 11 days post positive test) the patient expired (listed as COVID-19 death). The cause of death listed on the death certificate is atherosclerosis (3 years). Known patient history includes cardiovascular disease. This is the first instance I have observed within my home county of a person with a repeat infection, fully vaccinated + boosted, passing away with COVID." "1909441-1" "1909441-1" "By the time I came back and saw my mother on Thursday she was short of breath and her lungs were filling with fluid, She was coughing up pink frothy fluid. She called ambulance they gave her shot of oxygen. We took her to hospital because she needed oxygen. They put her on 3 liters of oxygen and 3 days later sent her home on hospice with 3.5 liters of oxygen and round clock care and totally bed bound. She started to get confused, I was requesting for her to get more Lasix, She stopped swallowing. It was a long decline she got weaker and weaker. I think the vaccine was too much for her frail system." "1909487-1" "1909487-1" "Patient developed symptoms the following morning, fever, chills, body aches. He told his neighbor about it and she suggested he lie down and rest. He went to bed and was unable to be reached later in the day. She went to his condo around 7:30 p.m. and found him dead." "1909502-1" "1909502-1" "Client fully vaccinated for COVID-19 and tested positive via PCR on 10/21/21. Client died on 11/14/2021 from COVID-19" "1909512-1" "1909512-1" "Patient was admitted to the hospital on November 13, 2021, and tested positive for COVID-19. Patient was asymptomatic as a patient in a long-term care facility. Patient was discharged back to the nursing home a few days later. Community talk indicated that patient died on November 24, 2021." "1909519-1" "1909519-1" "fully vaccinated, covid related death" "1909565-1" "1909565-1" "fully vaccinated covid related death" "1909570-1" "1909570-1" ""PATIENT AND MOTHER CAME IN WEDNESDAY 11.24.21 AFTERNOON FOR COVID BOOSTER. MOTHER REPORTED TO PHARMACY ON FRIDAY 11.26.21 (DEPARTMENT CLOSED THURSDAY 11.25.21) THAT PATIENT HAD STARTED FEELING ""UNWELL"" (FEVER/TIREDNESS) LATE 11.24.21 / EARLY 11.25.21. MOTHER REPORTED DIDNT THINK MUCH OF IT BUT THAT HER SON (PATIENT) WAS GOING TO REST. MOTHER REPORTED THAT LATER IN THE DAY SON WENT INTO THE BATHROOM AND WAS IN THERE FOR SOME TIME, WHEN SHE WENT TO CHECK ON HIM, SHE COULD NOT GET THE DOOR OPEN. UPON OPENING THE DOOR, SON WAS FOUND UNRESPONSIVE. ATTEMPTS TO REVIVE SON BY MEDICAL PERSONEL WERE UNSUCCESSFUL. PER MOTHER AN AUTOPSY IS SCHEDULED BUT AS OF REPORTING NO CAUSE OF DEATH HAS BEEN LISTED."" "1909574-1" "1909574-1" "Patient had brain hemorrhage 11 days following 0.25ml Moderna booster vaccination and died" "1909575-1" "1909575-1" "This is a 61-year-old female with history of chronic back pain, hypertension, GERD who was recently discharged after being admitted to hospital for acute kidney injury, monomorphic V-tach, paroxysmal atrial fibrillation, hematuria and pancytopenia with UTI. She was at the subacute rehabilitation center Bartley. She was doing okay until last few days when she started having some diarrhea, and urinary frequency, urine analysis and cultures were sent and she was started empirically on ciprofloxacin. Yesterday in the morning patient became acutely short of breath and had severe sore throat with acute hypoxia down to 70s and hypotension with systolic blood pressure in 70s as well hence she was referred to the ER. Her covid test came out positive. In the ER patient was started on empiric antibiotics as per sepsis protocol after cultures were sent, she did not respond to fluid resuscitation hence she was started on Levophed and admitted to ICU." "1909619-1" "1909619-1" "pt had recent hospitalization for being positive for COVID; dc'd to SNF on 10/20/21; to ED with altered LOC on 10/26/2021 with worsening O2 sats; acute encephalopathy and ARF; supplemented with O2; pt's condition worsened; family decided to have pt return to SNF on comfort care; pt was dc'd from hosp on 10/27/21 to SNF; pt's condition never improved and she died in the SNF" "1909675-1" "1909675-1" "Son states: 11/15/21: Both father and mother received Moderna booster. They both started having stomach issues and diarrhea some time later. The wife's symptoms resolved in about 3 days. The husband's symptoms continued. 11/22 or 11/23/21 His father was complaining of intense stomach pain and his abdomen was distended, so his wife took him to the ER. He was admitted to Medical Center and stayed for 5 days They performed exploratory surgery on his father and it was decided they would remove his colon because his small intestine was swollen and twisted on itself. He had the surgery and a colostomy. 11/26/21: The surgery did not resolve his symptoms and his GI system continued to swell until he aspirated on his stomach contents. 11/27/21: Date of death." "1909805-1" "1909805-1" "Brief Summary/Assessment: 68M PMH myopathy (bed bound, most c/w colchicine-induced myopathy, started 8/2021), HFpEF, HTN, CKD, AF (rivarox), DM, bipolar, gout, OSA (CPAP), sacral ulcer with chronic OM, p/w hypercarbic respiratory failure which resolved with BiPAP. Course c/b Cdiff and nosocomial COVID infection. Patient died" "1909882-1" "1909882-1" "Died of heart attack on May 3." "1909908-1" "1909908-1" ""Fully vaccinated patient (2 doses plus booster) admitted for COVID pneumonia and subsequently died. Provider discharge note below: ""67 yo male, with PMH significant for follicular lymphoma s/p chemotherapy, HLD, OSA, and hx of one kidney (born that way), who presented to ED on 10/18/21 after testing positive for COVID. He had received all 3 COVID vaccinations, though is immunocompromised from recent completion of follicular lymphoma and chemotherapy. CTA was done on day of admission and was negative for PE. Respiratory failure with hypoxia from covid pneumonia was initially managed on HFNC but respiratory status worsened and he was transferred to CCU on 10/27/21. BiPAP therapy was started and pt required precedex and fentanyl gtts to tolerate BiPAP. He was treated with decadron and was fully anticoagulated with lovenox. Remdesivir was declined by pt due to having only 1 kidney. Regeneron was given on 11/3/21. No improvement in respiratory status, and oxygenation was marginal despite BiPAP with 100% O2 with pressures of 18/12. Intubation was considered, but pt did not want to be intubated. The pt developed SQ emphysema. Imaging did not show pneumothorax, but pneumomediastinum was seen on CXR 10/28/21. Tube feedings were initiated for nutritional support. Pt intermittently required pressor support for circulatory shock, initially with phenylephrine, then later with norepinephrine. Ongoing discussions regarding goals of care and code status were held with pt and family throughout hospitalization. Pt continued to decline intubation. Code status was changed to DNR/DNI but continue aggressive care. Clinical condition continued to decline. PRN morphine was started for air hunger and comfort. By 11/4/21, the pt was unresponsive, hypotensive and requiring norepi for BP support, oliguric with rising creat. Increased work of breathing on maximum BiPAP support with O2 sats ranging from low 70's to low 90's. Wife was informed that pt actively dying and no escalation of care added to code status. The pt died on 11/5/21 at 1336 with wife at bedside. """" "1909938-1" "1909938-1" "Unforeseen death on 11/25/2021" "1910018-1" "1910018-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient rec'd Pfizer Vaccines on 2/3/2021 and 2/24/2021. PMHx of cirrhosis, COPD, CAD w/stent, osteoarthritis sepsis and repiratory failure requiring tracheostomy in the past. Presented to ED one week ago c/o SOB. COVID negative, s/p bronchoscopy on 11/12, tx'd w/abx, d/c'd home on O2 via NC. Per pt. 2nd Covid test + prior to d/c. Presented to ED on 11/17 w/SPO2 in the 30s on NC. Admitted for ACRF w/hypoxia, Covid pneumonia, A-fib, and lactic acidosis. Intubated on 11/22. Tx'd w/dexamethasone, tocilizumab, inhaled epoprostenol. Remained severely hypoxic and expired 11/26/21." "1910053-1" "1910053-1" "Double pneumonia with blood clots in lungs. Sepsis. Extremely low oxygen levels in blood. Extremely low blood pressure. Rapid breathing - over 60 per minute. 5-day ICU stay at Hospital. Death." "1910821-1" "1910821-1" "patient w/ history of laryngeal cancer; has a total laryngectomy with reconstructive surgery in April 2021; recovered; took the vaccine in june/July. in August 2021, presented with ear pain again, like when first diagnosed; CT revealed recurrence; pt then had a bleed and possible carotid blow out; presented to hospital for embolization; pt coded and died a few days later" "1912249-1" "1912249-1" ""Patient died approximately 20 minutes after receiving booster dose.; booster dose; This is a spontaneous report received from contactable reporter (Pharmacist). The reporter is the patient. A 92-year-old female patient (not pregnant) received bnt162b2 (PFIZER COVID-19 VACCINE), intramuscular, administered in arm left, administration date 29Oct2021 09:10 (Lot number: FD0810) at the age of 92 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: ""Chronic pain""; ""GERD""; ""HTN""; ""DM II""; ""hx DVT""; ""hx. malignant neoplasm of other digestive organs""; ""activated protein C resistance""; ""hx of malignant neoplasm of breast""; ""hx malignant neoplasm of other parts uterus""; all unspecified if ongoing. It was unknown if patient diagnosed with COVID-19 prior vaccination. Patient had not been tested for COVID-19 post vaccination. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included: chlorthalidone; ergocalciferol (VIT D); acetaminophen; omeprazole; metoprolol tartrate (LOPRESSOR); metformin; tramadol; plantago ovata (METAMUCIL); insulin lispro (HUMALOG); warfarin; kcl. Past drug history included: Morphine, reaction: ""Known allegies: Morphine""; Meperidine, reaction: ""Known allegies: Meperidine""; Metoprolol, reaction: ""Known allegies: Metoprolol""; Lisinopril, reaction: ""Known allegies: Lisinopril""; Aleve, reaction: ""Known allegies:Aleve""; Altace, reaction: ""Known allegies:Altace""; Boniva, reaction: ""Known allegies:Boniva""; Doxycycline, reaction: ""Known allegies:Doxycycline""; Oxycodone, reaction: ""Known allegies:Oxycodone"". Vaccination history included: Bnt162b2 (Dose Number: 2, Lot No: EL9269, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 09Feb2021, when the patient was 91 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Lot No: EJ1686, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 19Jan2021, when the patient was 91 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (death) with onset 29Oct2021, outcome ""fatal"", described as ""booster dose""; DEATH (death, medically significant) with onset 29Oct2021 09:30, outcome ""fatal"", described as ""Patient died approximately 20 minutes after receiving booster dose"". Therapeutic measures were not taken as a result of death. The patient date of death was 29Oct2021. The reported cause of death was ""Patient died approximately 20 minutes after receiving booster dose"". No autopsy was performed. Clinical course: Patient died approximately 20 minutes after receiving booster dose.; Sender's Comments: Based on the limited information available and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events immunization and death cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Patient died approximately 20 minutes after receiving booster dose."" "1912324-1" "1912324-1" "DRIZZY, UNABLE TO WALK, UNABLE TO EAT, DARK CIRCLES UNDER EYES, PAIN THROUGH OUT BODY." "1912616-1" "1912616-1" "COUGH, FATIGUE, SORE THROAT, LETHARGY" "1912626-1" "1912626-1" "Passed away. Swollen body, blue lips, oxygen deprived, clotting" "1912733-1" "1912733-1" "Two hours after vax she was vomiting, vomiting stopped next day but pt was complaining of stomach pain. Continued stomach pain and vomiting for a few days until she wasnt able to walk, pt went to ER on 10/15/2021 and she passed in the ER on 10/16/2021" "1912752-1" "1912752-1" "I am the epidemiologist reporting on behalf of 68 year-old female patient. Patient received their first and second doses of the Moderna vaccine on 4/21/21 and 5/18/21 respectively, according to immunization records. Patient received their third dose of the Moderna Vaccine on 11/22/21. The patient was found deceased at home on 11/23/2021 (1 day after third dose). The death certificate lists ?hypertension (5 years)? as the immediate cause of death. Other significant conditions contributing to the death but not resulting in underlying cause include hyperlipidemia. I have no further information regarding the patient?s medical history." "1912773-1" "1912773-1" "pt presented to ED with c/o SOB x 3 days; fever, headache, fatigue, nausea, left sided chest pain; positive for COVID; DNR/DNI; pt went into respiratory arrest in ED, BiPAP attempted but was unsuccessful; pt died in the ED" "1912785-1" "1912785-1" "Dose 1 given 4/21/2021 Pfizer Lot # EW0172 Patient had a cardiac arrest at home and was pronounced dead at Emergency Room. Covid test was negative." "1912821-1" "1912821-1" "Dose 1 given 2/4/2021 Moderna Lot # 016M20A, Patient died in the hospital from Covid 19" "1912847-1" "1912847-1" "After the 2nd vaccine, patient was diagnosed with a rare malanoma in her vagina. Started treatment for cancer. Got booster on 9/18/2021 (Pfizer, Lot # FF2588). Hospitalized with heart problem , eratic heartbeat. Fluxuating suger number. Diagnosed with mayocarditis. and septis." "1912870-1" "1912870-1" "Patient tested positive for COVID 19 on 8/27/2021. Patient hospitalized 11/26/2021 and expired 11/29/2021." "1913091-1" "1913091-1" ""pt found deceased at home on 7/27/2021, ""apparent natural death"" but noted ""prior COVID 19, COPD"" under the ""chain of events that directly caused the death"" on the death certificate from Dr.; PMH: CHF, CVA, COPD, DM, lung CA; Dr. also reports pt had a positive COVID test on 12/16/2020; no other medical information available at this time"" "1913135-1" "1913135-1" "Initial reaction (two weeks) was a reduction in Blood Pressures, followed by Myocarditis/Pericarditis and Pulmonary Edema (8 weeks-diagnosed CHF), followed by Angina & Congestive Heart Failure (Death)." "1913154-1" "1913154-1" "Diagnosed and hospitalized with COVID while fully vaccinated" "1913198-1" "1913198-1" "Patient received Pfizer vaccine in 8/2021. In 9/2021 she began to have some vague complaints of upper back pain. Patient ultimately diagnosed with epitheliod sarcoma. Parents requested that this information be sent to VAERS in case her cancer was related to Vaccine. Physicians caring for the child do not feel her death or her cancer was related to the covid vaccine. Presented to the local Medical Center on 10/30/21 after having received care closer to home. Pt is a 13 y.o. female with no past medical history who presents with fever, chest pain, and diarrhea. About two weeks PTA, she began complaining of sternal chest pain. She had fatigue and sore throat so was taken to an urgent care where she was negative for strep, flu, and COVID. She was prescribed bromfed. She then progressed to a dry mild that started about 10 days PTA. On Tuesday, 10/26, she was seen at an outside ER and was diagnosed with pneumonia. She was started on azithromycin and augmentin. She has continued to have chest pain, SOB, and fatigue. The day of presentation, she stayed home from school. She developed nonbloody diarrhea, tachycardia, and weakness so she was taken back to the ER for evaluation. Found to have a pericardial friction rub. Admitted to hospitalist service." "1913268-1" "1913268-1" ""COVID vaccinated patient admitted for COVID pneumonia who subsequently died. Provider discharge note: ""84-year-old male with a PMH of COPD (on home O2), CKD stage 4, CAD s/p CABG, Hx of HITT, and DM2 who presented to a local healthcare facility with worsening hypoxia, shortness of breath, and generalized weakness after COVID 19 pneumonia diagnosis on 10/24/2021. He was fully immunized against COVID. On admission he was hemodynamically stable. Images were concerning for a superimposed bacterial pneumonia showing infiltrate in the left lung base and labs were positive for elevated procalcitonin. IV antibiotics were started. He had been on a steroid course from his pervious hospitalization for COVID pneumonia and that course was continued on this admission until 10 day completion. Throughout his hospital course Pt's respiratory status continued to decline despite proper interventions. Repeat imaging showed a right pleural effusion. The patient was diuresed. Pulmonology was consulted and recommended against a thoracentesis as there would be low benefits and high risks involved. His DDimer continued to increase despite receiving apixaban. The patient was transferred to PCU for higher level of care. His blood glucose remained elevated since admissions, despite finishing his course of steroids and he required a insulin drip. On 11/8/21 the insulin drip was discontinued due to low blood sugar levels and which improved with some orange juice. Rapid response was called overnight due to lower O2 levels and patient exhibiting altered mental status. Patient had taken his high flow off and became hypoxic and unresponsive. He was placed on bipap and he improved. Today 11/08/2021 the patient expressed desire to be transitioned to comfort care and his wife was contacted and both agreed to this plan. He remained in his full capacity to make decisions. The patient was placed on fentaly and orders were adjusted to reflect comfort care measures. His wife was able to make it to the hospital to be by his side, as bipap was removed and he was kept comfortable until he passed. The patient expired on 1047 on 11/08/2021. Cause of death was COVID pneumonia. The family does not wish to pursue an autopsy."""" "1913275-1" "1913275-1" "Patient presented to emergency department on 11/16/2021 from skilled nursing facility with epistaxis and coughing up blood. He was found to be COVID-19 positive at facility. He was found to have thrombocytopenia and hypernatremia. He was evaluated for monoclonal antibodies, but became hypoxic before administration and required supplemental oxygen. He was admitted for further management. He was treated with dexamethasone. Patient's condition did not improve and the decision was made by family to make comfort measures only. Patient expired on 11/28/2021" "1913317-1" "1913317-1" "Patient was dx with COVID-19, was hospitalized and exipred." "1913322-1" "1913322-1" "Patient presented to the emergency department on 11/12/2021 with shortness of breath and nonproductive cough. He had taken a home test that showed he was positive for COVID-19. He deferred monoclonal antibodies at that time and was discharged home. Patient presented to emergency department again on 11/13/2021 with shortness of breath and hypoxia. He was admitted for further management on his COVID-19 infection. He was treated with dexamethasone, remdesivir, and supplemental oxygen. He was discharged home on 11/19/2021. Patient presented to a different health system on 11/20/2021 with GI bleed and expired on 11/20/2021." "1913376-1" "1913376-1" "Hospitalized, diagnosed and expired from COVID while fully vaccinated" "1913441-1" "1913441-1" "Diagnosed and hospitalized with COVID while fully immunized" "1913456-1" "1913456-1" "A few days after taking the vaccine she was very weak and complaining of a headache. The following day she passed away." "1913465-1" "1913465-1" "immediately became very ill, 9 days later (03/25/21) patient was found nearly dead, rarced to hospital, on the way there he became unresponsive, ambulance carried him the rest of the way 8 days in icu, 4 days on the floor, discharged with acute non- alcoholic liver non-stem heart attack, DOES NOT DRINK, he exibited a typical behavior, therefor they couldnt get his elevated amonia down, never medically responded,was discharged home, 8 days later condition worsened, he was not medically responding as expected, rectal bleeding, discharged on hospice diagnosed with portal vein thrombosis never went back to normal self. died in 8 weeks" "1913670-1" "1913670-1" "fully vaccinated, complications of covid-19 death" "1913788-1" "1913788-1" "This is a case of breakthrough COVID-19 disease that resulted in death. The individual was vaccinated with the Moderna product on 01/28/2021 and 02/25/2021. The individual then developed symptoms including fever, chills, cough, and sore throat on 11/08/2021. The individual had a positive COVID-19 PCR panel from a specimen collected on 11/12/2021. The individual was hospitalized 11/21/2021 until their death on 11/22/2021. I do not have death certificate details or underlying medical conditions immediately available to me at this time." "1913858-1" "1913858-1" "This is an instance of breakthrough case of COVID-19 that resulted in death. The individual was vaccinated with the Moderna product on 12/30/2020 and 01/27/2021. The individual became symptomatic on 04/17/2021 and tested positive for COVID-19 on 04/17/2021. The individual was hospitalized 05/01/2021-05/04/2021 with a chief complaint of altered mental status; they were found to be septic and have a UTI and also to have developed pneumonia. The individual responded well to antibiotics, and was therefore discharged to the long-term care facility at which they were a resident. The individual continued to be monitored for prolonged shortness of breath, and ultimately passed away on 05/10/2021. Death Certificate details are as follows: Part I Cause of Death A: Pneumonia B: COPD Part II Other Significant Conditions COVID 19, Diabetes Mellitus, Schizophrenia" "1915672-1" "1915672-1" "DEATH; APHASIA; THROMBOCYTOPENIA; PACKED RED BLOOD CELL TRANSFUSION; PLATELET TRANSFUSION; ANAEMIA; RESPIRATORY VIRAL PANEL; VENTILATION PERFUSION SCAN NORMAL; WHEEZING; SUSPECTED CLINICAL VACCINATION FAILURE; ATRIAL FIBRILLATION; COVID-19 PNEUMONIA; RESPIRATORY FAILURE; RENAL FAILURE; CHRONIC OBSTRUCTIVE PULMONARY DISEASE; CONDITION AGGRAVATED; COUGH; CULTURE POSITIVE; DYSPNOEA; DYSPNOEA EXERTIONAL; DYSPNOEA PAROXYSMAL NOCTURNAL; HAEMOPTYSIS; HYPOTENSION; INTENSIVE CARE; MALAISE; ORTHOPNOEA; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAER reference number 1828685) concerned a 64 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic obstructive pulmonary disease, chronic kidney disease, hepatitis c, anemia, depression, atrial fibrillation, gastrooesophageal reflux disease, hypothyroidism, hypersensitivity lung disease, and hypertension. The patient experienced anaphylaxis when treated with lisinopril. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, intramuscular, batch number: 205A21A expiry: unknown) dose was not reported, 1 total, administered on 26-AUG-2021 for an unspecified indication. The drug start period was 37 days. Concomitant medications included amlodipine 10 mg once daily, calcitriol 0.25 mcg once daily, fluticasone propionate/salmeterol xinafoate 250/50 once daily, furosemide 40 mg twice daily, metoprolol 50 mg twice daily, mirtazapine 15 mg once daily, ondansetron 4 mg three times a day, salbutamol nebulization PRN, and simvastatin8 10 mg once daily. On 02-OCT-2021, the patient experienced condition aggravated, culture positive, haemoptysis, hypotension, intensive care, malaise, respiratory viral panel, ventilation perfusion scan normal. Laboratory data included: Respiratory viral panel (NR: not provided) Not Reported, and Ventilation/perfusion scan (NR: not provided) Normal. The patient was presented to emergency department for shortness of breath coughing and wheezing. Patient was feeling unwell for a week and had worsening dyspnea on exertion Paroxysmal nocturnal dyspnea (PND) and orthopnea. The patient also mentioned stopped all of medications for two days because of feeling too unwell 4 days ago. The shortness of breath worsened and had been dusting and that dust made her wheezing and coughing worse. Shortness of breath became severe enough that patient needed to come to the emergency department. The patient was admitted on 03-OCT-2021 for Chronic Obstructive Pulmonary Disease (COPD) exacerbation and Covid pneumonia (Suspected clinical vaccination failure). The patient developed worsening hypoxemic respiratory failure with increasing HFNC(High flow nasal cannula)requirements and was subsequently transferred to the intensive care unit (ICU) on 11-OCT-2021. The patients renal failure worsened so a femoral quinton catheter was placed but the patient became very hypotensive and hypoxic with every attempt at hemodialysis or Continuous renal replacement therapy (CRRT). The patient decided that she would not want to pursue intubation in the setting of further respiratory deterioration. Dialysis made the patient too hypoxic while already on HFNC (High flow nasal cannula). The decision was made to not pursue further dialysis and the quinton was removed. Then the patient's pneumonia panel came back positive for pseudomonas and her respiratory culture indicated the presence of mold and was started on cefepime and cresemba. The oxygen requirements decreased and was transferred back to the floor on 19-OCT-2021. However ON 20-OCT-2021 was again brought back to the ICU(Intensive care unit) once again for worsening hypoxia requiring 60L 90% on HFNC. The patient also developed hemoptysis anemia and thrombocytopenia requiring transfusion of platelets and Packet red blood cell ( (PRBC). V/Q (Ventilation/perfusion) scan was negative for pulmonary embolism (PE). On 23-OCT-2021 the patient developed acute word finding difficulty while speaking with family member (aphasia) in the setting of a brief run of atrial fibrillation and ongoing thrombocytopenia CT (Computed tomography) brain was ordered to assess for stroke bleed. However after discussion with the patient and her daughter the decision was made to withdraw all support and was started on comfort care. On 24-OCT-2021 patient was deceased. The cause of death was unknown. It was unknown if an autopsy was performed. Laboratory data (dates unspecified) included: Culture positive (NR: not provided) Presence of mold, Oxygen saturation (NR: not provided) 90 %, Respiratory viral panel (NR: not provided) Positive for pseudomonas, and V/Q (Ventilation/perfusion) scan (NR: not provided) Negative for pulmonary embolism. Treatment medications (dates unspecified) included: cefepime, and isavuconazonium sulfate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death, thrombocytopenia, atrial fibrillation, covid-19 pneumonia, respiratory failure, renal failure, anaemia, aphasia, chronic obstructive pulmonary disease, condition aggravated, cough, culture positive, dyspnoea, dyspnoea exertional, dyspnoea paroxysmal nocturnal, haemoptysis, hypotension, intensive care, malaise, orthopnoea, packed red blood cell transfusion, platelet transfusion, respiratory viral panel, ventilation perfusion scan normal and wheezing on 24-OCT-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000203020. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. a manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed. Additional information received from Central Complaint Vigilance department on 29-NOV-2021. The following information was updated and incorporated into the case narrative: The product quality complaint investigation result was added.; Sender's Comments: V2: This version updates- The product quality complaint investigation result was added. This updated information does not alter the causality of previously reported events 20211129989-COVID-19 VACCINE AD26.COV2.S-death, thrombocytopenia, covid-19 pneumonia, respiratory failure, aphasia, condition aggravated, cough, culture positive, dyspnoea, dyspnoea exertional, dyspnoea paroxysmal nocturnal, haemoptysis, hypotension, intensive care, malaise, orthopnoea, packed red blood cell transfusion, platelet transfusion, respiratory viral panel, ventilation perfusion scan normal and wheezing . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211129989-COVID-19 VACCINE AD26.COV2.S-atrial fibrillation, renal failure, chronic obstructive pulmonary disease, anemia. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY V0; 20211129989-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH" "1916357-1" "1916357-1" "COVID-19 RELATED DEATH; BREAKTHROUGH CASE" "1916426-1" "1916426-1" "Death" "1916505-1" "1916505-1" "Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/28/2021 and 4/25/2021. Previously admitted 10/19 - 11/3 for sepsis w/prosthetic valve endocarditis (E. faecalis). Presented to ED on 11/19/2021 c/o difficulty breathing, per EMS COVID positive w/unknown date of diagnosis. Admitted for hypoxemia requiring 3L NC, progressed to acute hypoxemic respiratory failure requiring noninvasive positive pressure ventilation, c/b pneumothorax requiring chest tube. 11/20 noted to be lethargic w/left facial droop. Tx included anticoagualation, IV steroids, remdesivir and tocilizumab x1. 11/23/21 experienced rapid desaturation and developed PEA and expired." "1916577-1" "1916577-1" "Case completed initial 2 dose Pfizer series in April 2021, and received a booster in September 2021, then was hospitalized for and died of Covid in October 2021. Summary of Important Events: 9/25 - Covid symptom onset 9/27 - Tested covid positive 10/3 - Seen at ER. Creatinine 1.73, Na 129. Started on doxycycline 10/6 - Admitted Hospital with worsening Covid, Sa02 77%. Creatinine 2.18, Na 128. Start decadron, remdesivir 10/7 - Start baricitinib. US negative for DVT. 10/13 - Oxygen requirements increase resulting in ICU transfer 10/20 - BLE DVT noted 10/25 - Cefepime for leukocytosis, possible pneumonia 10/27 - Considering transition to comfort care 10/28 - Deceased" "1916627-1" "1916627-1" "pt had an overnight admission to hospital for diagnosis COVID positive; dc'd to home and back to ED with worsening SOB & weakness, AHRF, AKI; O2 via NC, transitioned to Vapotherm, BiPAP; pt experienced A Fib and was treated; started on dexamethasone; pt's condition worsened and he was intubated; wife asked for extubation on 9/18/21 and pt was transitioned to comfort care; pt died in the hospital" "1916675-1" "1916675-1" "Patient passed away 45 days after receiving covid dose #3" "1916701-1" "1916701-1" "Fatal stroke" "1916799-1" "1916799-1" "PMH: coronary disease, DM, CKD, COPD; presented to ED with SOB; positive for COVID; unable to have hemodialysis due to hypotension; given steroids, IV fluids, Levophed; pt's condition worsened and he was transferred to ICU; condition continued to deteriorate and family decided to not escalate care; pt died in the hosp" "1916804-1" "1916804-1" "11/23/2021 Resident noted to have garbled speech, slight weakness to R arm, pupils fixed, R side weaker than L" "1916912-1" "1916912-1" "fully vaccinated-covid related death" "1917035-1" "1917035-1" "Trembles, Diaforesis, Hepatomegalia, Insomnia and Death by Heart Failure" "1917074-1" "1917074-1" "Mortality of fully vaccinated patient Patient presented on 11/20/2021 with complaints of weakness and dyspnea after being diagnosed with COVID-19 on 11/16. She had been being treated as an outpatient with supplemental oxygen and dexamethasone. She was also being treated for urinary tract infection. supplemental oxygen requirements in the ED were only 4-5 L nasal cannula however upon admission and transfer to the CCU oxygen requirements went up to 15 L high-flow with variable saturations in the mid 80s to mid 90s. Due to this rapid change in O2 requirements the patient was then a candidate for additional COVID-19 treatments under the experimental protocols. After discussing the risks and benefits with the patient she requested to proceed with treatment using baricitinib and remdesivir. Initial hypoxia prior to presentation resulted in a type 2 MI, cardiology was consulted, and echocardiogram was obtained. Repeat echocardiogram performed 3 days later showed significant improvement and resolution of initial injury. Over the next couple days the patient's oxygen requirements continued to increase and she was begun on Airvo and then BiPAP. The patient declined intubation upon presentation should that become necessary. The patient tired of the BiPAP and requested for us to call her children to come in and make a family decision regarding the next steps in her care. Patient and family agreed to go comfort measures, the family gathered around and the patient was taken off of supplemental oxygen, and passed peacefully." "1917109-1" "1917109-1" "Resident received Moderna booster vaccine at a on-site clinic at 3:42pm on 12/1/2021. No sign of adverse reactions after vaccination. Resident was rounded on and living in the 2am hour on 12/2/2021 per chart. Vitals were fine. When rounded on in the 4am hour on 12/2/2021, patient was found deceased. Nursing home staff has yet to identify anything leading to cause of death." "1917185-1" "1917185-1" "Death Note: Date of Admission 11/08/2021 Date of Discharge 11/30/2021 Reason for Hospitalization Severe COVID-19 PNA Hospital Course Patient was a 68 yoM with OSA, ICCM w/ HFrEF 35%, VT s/p AICD on amiodarone, DM2 (newly diagnosed), HTN, and HLD who was initially admitted to the MICU on 11/8 for acute hypoxemic respiratory failure 2/2 COVID infection. In ED, CT C/A/P was performed with his CT Chest showing signs of multifocal PNA c/w Covid. Initial labs were significant for leukocytosis, elevated D. dimer, AKI (Cr 2.89), HAGMA, transaminitis, and elevated bilirubin; admitted to MICU for management. Patient was initially on NIPPV but subsequently intubated on 11/8. S/P on Remdesivir/dexamethasone/tocilizumab x1. Hospital course c/w ongoing hypoxemia requiring bronchoscopy (11/14), RPP growing Serratia and klebsiella, s/p ertapenem. Persistent hypotension requiring initiation of stress dose steroids w/ hyperglycemia requiring initiation of insulin drip. On 11/14, the patient went into shock requiring multiple pressors. Due to shock he had ARF and nephrology was consulted; initiated HD on 11/15-11/18. ST elevation on telemetry 11/16 concerning for inferior MI, likely demand ischemia. Max troponin 55 (on admission 35). Vancomycin and meropenem added 11/16 due to shock and leukocytosis with positive QTL on 11/15 for serratia, but deescalated back to ertapenem. CT abdomen 11/20 with concern for pancreatitis noted findings of acute pancreatitis with small amount of ill-defined peripancreatic fluid, lipase was normal. Palliative care consulted and were following. Goals of care conversation had on 11/22 with patient's brothers and daughter. Decision was made to have daughter as the primary decision-maker. Decision from goals of care conversation was to make patient full code and proceed forward with disease oriented treatment. Plan from family would be to continue ventilator treatment with plan for tracheostomy and PEG tube when appropriate. Septic picture with RUQ US concern for obstructive stone vs infected stone, GI consulted for possible ERCP but not planning intervention at this time. ACS was consulted for concern of cholecystitis, they reviewed and recommended HIDA scan. HIDA scan was completed with no obstruction of the cystic or common bile duct, there was no evidence of cholecystitis, likely passed stone that was noted on ultrasound. Concern with decreasing platelets that patient could have HIT, d/c heparin and placed on argatroban drip for DVT of RIJ. Heparin PF4 lab and unfractionated heparin were negative. Patient did develop some tachypnea on ventilator 11/26, fentanyl drip was restarted. On 11/27 decreased tube feeds to 30 cc/h due to emesis overnight with feeds and free water flushes. Held tube feeds again on 11/28 after emesis. 11/27: Consulted ACS for trach and PEG (consider J-tube based on recent emesis) placement however patient on pressors and still requiring too high level of oxygen. Placed right femoral triple-lumen cath. 11/28: trial of dobutamine drip cause more hypotension so this was held, started on vasopressin overnight due to worsening hypotension 11/29: significantly worsening respiratory status with O2 sats in mid to low 80s on 100% FiO2 on vent; P/F ratio 51; increasing sedation with versed and trial iNO; poor response to PEEP increase; concern patient remains intravascularly depleted; concern for aspiration pneumonitis Daughter, was updated about declining prognosis at bedside on 11/29 during rounds. Questions were answered. Patient significantly worsened on 11/29, was requiring three IV pressors and unable to maintain adequate BP. His oxygenation drop to around 80% with 100% FiO2 on the vent and had minimal imporvement with more sedation and iNO. Family notified again in the evening on 11/29, patient made DNAR. Family elected to continue treatment for ~24 more hours and then would consider comfort care. Patient passed on 11/30/21 at 0937. Discharge Diagnoses COVID-19 Severe Acute Hypoxic Respiratory Failure on mechanical ventilation Severe hypotension and shock, requiring three IV pressures Aspiration pneumonitis" "1917244-1" "1917244-1" "This is an instance of breakthrough COVID-19 disease after which a death occured. The individual was vaccinated with the Janssen product on 06/15/2021. The individual had a symptom onset of 11/05/2021 with main symptoms of loss of appetite (not eating) and being lethargic. The individual tested positive for COVID-19 via an antigen test on 11/05/2021 and was admitted to hospital on 11/05/2021. They remained admitted until their death on 11/17/2021. Death Certificate details are as follows: Part I Cause of Death A: Hypoxic Respiratory Failure B: COVID 19 Part II Other Significant Conditions: Acute Chronic Kidney Insufficiency, Coronary Artery Disease, Anorexia" "1917294-1" "1917294-1" "This is an instance of breakthrough COVID-19 disease after which a death occurred. The individual was vaccinated with the Pfizer product on 02/10/2021 and 03/03/2021. The individual became symptomatic with progressively worsening shortness of breath on 04/19/2021 and sought COVID-19 testing on 04/22/2021, which was positive via PCR. The individual then visited the emergency department on 04/22/2021 and was admitted to hospital same day. They then remained hospitalized until their death on 05/11/2021. Death Certificate details are as follows: Part I Cause of Death A: COVID 19 Part II Other Significant Conditions: History of Liver Failure" "1917303-1" "1917303-1" "Died on 11/14/2021-car accident" "1917345-1" "1917345-1" "On March 19, 2021, a bit more than two weeks after receiving her second COVID-19 vaccine, my mother was suddenly unable to stand up and walk steadily without support. Up to this point she was living 100% independently in a tri-level home with stairs, managing all of her own finances, preparing all of her meals, etc. From that day on her mobility quickly began to fail; she experienced constant edema; she very quickly progressed from mild cognitive impairment to dementia; she was no longer able compose an email or work something as simple as a TV remote. She moved in with me then to assisted living on April 13, 2021. She was in and out of the hospital constantly due to unwitnessed falls and began developing wounds on her feet. (She did not have diabetes.) By mid-August 2021 she entered hospice and died on August 31, 2021. Her cause of death was listed as advanced dementia. She was fine through March 18, 2021." "1917807-1" "1917807-1" ""Patient is deceased (11.26.21); Hospitalized 11.25.21; COVID-19 positive (11.22.21); fully vaccinated Admission Date: 11/25/2021; Discharge Disposition: Deceased (11.26.21) DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus [U07.1, J12.82] Septic shock (HCC) [A41.9, R65.21] HOSPITAL COURSE: Patient is a 64-year-old woman past medical history significant for type 2 diabetes, peptic ulcer disease, paroxysmal atrial fibrillation not on home anticoagulation was admitted for septic shock secondary to COVID-19 pneumonia. Upon arrival to the emergency department, patient was initially hypothermic, tachypneic, hypotensive, hypoxic requiring high-flow nasal cannula and peripheral pressors. Initial labs were notable for pH of 6.78, creatinine 8.36, potassium 6, bicarb to, ALP 112, lactic acid 16.2. CXR demonstrated patchy multifocal opacities. Patient was administered 1 L of normal saline, calcium chloride 3 g, 1 amp of bicarb. While awaiting transfer to the medical intensive care unit, patient underwent a fall in her room. CT head was negative, CT C-spine was notable for severe motion degradation artifact but no evidence of C-spine injury on visualized segments. No injuries noted secondary to fall. Upon arrival to the medical intensive care unit, patient was significantly encephalopathic and agitated. Discussion with her son at bedside confirmed wishes for code status of do not resuscitate/DNI as identified in the emergency department by the social worker. Patient was altered and agitated. She was gasping for air while attempting to get up from bed. She is requiring pressor support, continues to be tachycardic and tachypnic and HFNC @ 50% FiO2. Patient is not producing urine. Fluid status +5.5L since admission. She remained profoundly acidemic with 3 pressors but still had low blood pressures. With her agitation, it will be difficult to place a dialysis catheter without complications or needing to intubate her to place the vascath. Patient's current condition, treatments, and prognosis was shared with the patient , and family. Patient continued at this point have worsening septic shock requiring 3 pressors this morning and worsening renal function for which she would be a candidate for renal replacement therapy. To further pursue renal replacement therapy, patient would likely need to be intubated. At this point, both son and husband wished to pursue and respect patient's wishes she previously expressed ""that she would not want to be on a mechanical ventilator lifelong, or even for short duration if this was only brief while requiring renal replacement therapy."" Patient was deemed DNR/DNI per their wishes. After husband arrived to the hospital, patient was transitioned to comfort care and shortly thereafter Dr. was contacted of patient's passing. Dr's saw the patient at bedside and performed a death examination. Patient was pronounced dead at 5:45 pm likely due to profound shock. I requested for a medical examiner because the patient died within 24 hours of admission and also had a fall while in the emergency department. I spoke with Dr. from the Medical Examiner's office who determined this is not a medical examiner case and does not require autopsy therefore autopsy will not be performed. Ok to release to funeral home."" "1919213-1" "1919213-1" "Death; Angiogram cerebral abnormal; Computerised tomogram head abnormal; Echocardiogram abnormal; Laboratory test; Multiple organ dysfunction syndrome; Acute hepatic failure; Acute left ventricular failure; Brain death; Brain oedema; Brain herniation; Cardiogenic shock; Cardiac failure; Pupil fixed; Distributive shock; Respiratory distress; Lactic acidosis; Intracranial pressure increased; Gastrointestinal haemorrhage; Haematemesis; Hyperammonaemia; Endotracheal intubation; Hyperventilation; Intensive care; Mental status changes; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1582506) and from a medical examiner concerned a 24 year old female. The patient's height, and weight were not reported. The patient's past medical history included: C-section (cesarean section), and post partum (27-FEB-2021). The patient had no allergies to medication, food or other products. The patient had no chronic or long-standing health conditions and was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A and expiry: unknown) dose was not reported, 1 total, administered on 09-JUL-2021 to left arm for prophylactic vaccination. Concomitant medications included ferrous sulfate for unknown indication. On 15-JUL-2021, (as reported after getting vaccinated) the patient was admitted to a local hospital and then transferred to another hospital and was finally transferred to a final medical center intensive care unit (ICU). She was admitted as a transfer from a Health Care Facilities (HCF) with acute liver failure of unknown etiology and without hepatic coma. On arrival, she had altered mental status with respiratory distress and coffee ground emesis (haematemesis). She was promptly intubated (endotracheal intubation) for airway protection. A gastrointestinal (GI) bleed (gastrointestinal haemorrhage) was suspected thus she was started on octreotide and Protonix (pantoprazole sodium) and intravenous (IV) ceftriaxone. An a-line dialysis line and an orogastric tube was placed and there was no acute GI bleeding thereafter. Laboratory tests demonstrated severe lactic acidosis, severe hyperammonemia, and acute renal failure. Thus, Continuous Veno-Venous Hemofiltration (CVVH) was initiated. She was maxed out on triple pressor support for multifactorial vasodilatory (distributive shock) and cardiogenic shock. She had multiple organ dysfunction syndrome. Cardiac echo demonstrated acute systolic and diastolic heart failure (acute left ventricular failure and cardiac failure) with reduced ejection fraction (EF). However, no intervention was recommended by cardiology due to multiorgan failure. Computerized tomography (CT) brain on 15-JUL-2021, demonstrated diffuse brain edema (brain oedema) and mild cerebellar tonsillar herniation (brain herniation). Neurosurgery was consulted and bolt placement was performed. Increased intracranial pressures (ICPs) were consistently elevated greater than 100s. Repeat Computerized tomography (CT) brain demonstrated worsening cerebral edema (brain oedema) and herniation. By the evening of 15-JUL-2021 her pupillary exam became fixed (pupil fixed) and dilated despite being on maximum pentobarbital therapy and propofol. To decrease intracranial pressure (ICP) head of bed was at 45 degrees plus. All times mannitol and mild hyperventilation was given for cerebral edema and elevated intracranial pressure (ICPs). Once CVVH was initiated though mannitol and hypertonic saline were not treatment options as the continuous Veno-Venous Hemofiltration (CVVH) cleared the medication quickly. The patient was listed for orthotopic liver transplantation (OLT) that afternoon, but later determined not to be a candidate due to her worsening neurological status. She had a change in pupil examination, which was suggestive of worsened herniation. Her pupils became fixed dilated and CT confirmed worsening herniation. ICPs remained 120 plus despite triple pressure support in effort to maintain Cerebral perfusion pressure (CPP). A diagnostic cerebral angiogram was performed on 16-JUL-2021, due to limited ability to assess brain death secondary to medication therapy. This revealed no intracranial blood flow. After a discussion with family the patient became do not resuscitate (DNR). The family elected to discontinue supportive measures on 18-JUL-2021, and the patient was pronounced dead at 09:22. It was reported that the patient had not recovered from the adverse events at the time of death. It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to multiple organ dysfunction syndrome, acute hepatic failure, acute left ventricular failure, brain death, brain oedema, brain herniation, cardiogenic shock, cardiac failure, pupil fixed, distributive shock, respiratory distress, lactic acidosis, intracranial pressure increased, gastrointestinal haemorrhage, haematemesis, hyperammonaemia, endotracheal intubation, hyperventilation, intensive care, mental status changes, angiogram cerebral abnormal, computerised tomogram head abnormal, echocardiogram abnormal and laboratory test on 18-JUL-2021. The cause of death on the death certificate was mentioned as cerebellar tonsillar herniation, acute liver failure, multi-organ failure and the manner of death was natural death. This report was serious (Death). Additional information was received from a medical examiner on 29-NOV-2021. The following information was updated and incorporated into the case narrative: The cause of death on the death certificate was mentioned as cerebellar tonsillar herniation, acute liver failure, multi-organ failure and the manner of death was natural death.; Sender's Comments: V4: Additional information received updates the cause of death on the death certificate was mentioned as cerebellar tonsillar herniation, acute liver failure, multi-organ failure and the manner of death was natural death. This updated information does not alter prior causality assessment of reported events. 20210857040-Covid-19 vaccine ad26.cov2.s -Death, Multiple organ dysfunction syndrome, Acute hepatic failure, acute left ventricular failure, Brain death, brain oedema, Brain herniation, cardiogenic shock, Cardiac failure, pupil fixed, Distributive shock, respiratory distress, Lactic acidosis, intracranial pressure increased, gastrointestinal haemorrhage, haematemesis, , hyperammonaemia, endotracheal intubation, hyperventilation, intensive care, mental status changes, angiogram cerebral abnormal, computerised tomogram head abnormal, echocardiogram abnormal, laboratory test. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: CEREBELLAR TONSILLAR HERNIATION; ACUTE LIVER FAILURE; MULTI-ORGAN FAILURE; NATURAL DEATH" "1919643-1" "1919643-1" ""covid pneumonia; diagnosed with COVID-19; diagnosed with COVID-19; kidney failure; It was reported that the chronic kidney disease worsened and he went into kidney failure and was going to need dialysis but they had to choose about that and he never did the dialysis.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. A 92 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 12Feb2021 (Batch/Lot number: unknown) at the age of 91 years as dose 2, single and administered in arm, administration date 22Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: ""TIA"" (unspecified if ongoing); ""problems with one of the disks of his back"" (unspecified if ongoing); ""high cholesterol levels"" (unspecified if ongoing); ""Diabetes"" (not ongoing), notes: The patient did not have diabetes anymore because his tests were fine; ""Hypertension"" (not ongoing), notes: he was not on pills anymore for that and the pills he took were bad for his kidneys; caller states he had not been on those pills for years; hypertension was diagnosed years ago; ""chronic kidney disease Stage III"" (not ongoing), notes: diagnosed many years ago; ""Cancer"" (unspecified if ongoing), notes: the patient had many cancers; ""he lost so much weight"" (unspecified if ongoing); ""left renal cell carcinoma"", start date: 2014 (unspecified if ongoing); ""melanoma stage III in the right ear"", start date: 2013 (unspecified if ongoing); ""lymphoma"" (unspecified if ongoing), notes: does not know if the patient had lymphoma or not but got chemotherapy for the lymphoma; ""chemotherapy"", start date: 2010 (unspecified if ongoing); ""mantle cell lymphoma"" (unspecified if ongoing), notes: they said it was mantle cell lymphoma; ""chronic anemia"", start date: 2010 (unspecified if ongoing); ""Smoked cigars"" (unspecified if ongoing), notes: Smoked cigars a little bit but that was many years ago.; ""triglycerides"" (unspecified if ongoing); ""pain in his back"" (unspecified if ongoing); ""bowels"" (unspecified if ongoing); ""pain"" (unspecified if ongoing). Concomitant medication(s) included: TRAMADOL taken for pain; ASPIRINE; LIPITOR; TYLENOL; COLACE taken for abdominal discomfort; MIRALAX; OMEPRAZOLE; MELATONIN. The patient was on three pills for his cholesterol and triglycerides and cannot think of the names. Past drug history included: Insulin for diabetes, notes: for a while years ago. Vaccination history included: Quadravalent flu shot (lot number: UJ517AA, anatomical location: Arm), administration date: 12Oct2020, when the patient was 91 years old, reaction(s): ""weak"", ""fell"". Prior Vaccinations (within 4 weeks) was none. The following information was reported: VACCINATION FAILURE (death, hospitalization, medically significant), COVID-19 (death, hospitalization, medically significant) all with onset 25Aug2021, outcome ""fatal"" and all described as ""diagnosed with COVID-19""; COVID-19 PNEUMONIA (death, hospitalization) with onset 25Sep2021, outcome ""fatal"", described as ""covid pneumonia""; RENAL FAILURE (hospitalization, medically significant) with onset 2021, outcome ""unknown"", described as ""kidney failure"". The patient was hospitalized for vaccination failure, covid-19, covid-19 pneumonia, renal failure (start date: 26Sep2021). The events ""diagnosed with covid-19"", ""covid pneumonia"" and ""kidney failure"" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: oxygen saturation: (2021) 46 %; sars-cov-2 test: (25Aug2021) positive; (25Sep2021) positive; respiratory rate: (2021) 55. Therapeutic measures were taken as a result of vaccination failure, covid-19, covid-19 pneumonia, renal failure. The patient got dexamethasone and they were going to give him Remdisivir but his kidney started failing so they could not give him that with the kidney failure and they did end up giving him antibiotics. The patient was not there soon enough to get monoclonal antibodies and he has been sick for about 4 days and had not been tested. The patient date of death was 05Oct2021. The reported cause of death was covid-19 pneumonia, vaccination failure, covid-19. No autopsy was performed. Clinical course: The patient was diagnosed with covid and the diagnosis date that led to his death was 25Sep2021 and he was also diagnosed with no symptoms but had a positive test on 25Aug2021 and she thinks that is impossible to have a month apart but was only tested that day as a routine test at another before he went to the 2nd and it was supposedly a rapid test on 25Aug2021 and one covid test they know for sure he had was on 25Sep2021.For the hospitalization the first day he felt awful and it was of course a Sunday so he did not need to go to the hospital until the next day and then it was urgent and he was put on a ventilator and they decided to pull the plug later and he wanted to be a full code but did not know what that all meant at age 92. He was hardly breathing when they got him to the hospital and they knew he had covid and did not bother running anymore tests. The patient was admitted to an Intensive Care Unit. He was awake and everything and was in the ICU and was on the ventilator immediately. Fairly soon after his admission he went into kidney failure. It was reported that the chronic kidney disease worsened and he went into kidney failure and was going to need dialysis but they had to choose about that and he never did the dialysis. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 , COVID-19 pneumonia, and Vaccination Failure, cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information. The events of renal failure, condition worsened, is assessed as possibly related to the suspect drug ""BNT162B2"" based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: diagnosed with COVID-19; covid pneumonia; diagnosed with COVID-19"" "1919665-1" "1919665-1" ""death / Death cause Ventricular Fibrillation; This is a spontaneous report received from contactable reporter consumer via COVID-19 Adverse Event Self-Reporting Solution. A 58 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 17May2021 (Lot number: EW0167) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: ""pain in her knees"" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6206, Location of injection: Arm Right), administration date: 26Apr2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: VENTRICULAR FIBRILLATION (death, hospitalization, disability, life threatening) with onset 15Aug2021,at 16:00, outcome ""fatal"", described as ""death / death cause ventricular fibrillation"". The patient was hospitalized for ventricular fibrillation (hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: blood test: (16Aug2021) negative (elaborated as covid test type post vaccination: blood test). It was unknown if therapeutic measures were taken as a result of ventricular fibrillation. The patient date of death was 17Aug2021. The reported cause of death was ventricular fibrillation. No autopsy was performed.; Reported Cause(s) of Death: Ventricular fibrillation"" "1919878-1" "1919878-1" "PATIENT SUFFERED A STROKE SOMETIME THE NIGHT OF 11/28/21 OR THE MORNING OF 11/29/21 RESULTING IN HOSPITALIZATION AND DEATH. MAY NOT HAVE BEEN RELATED TO VACCINE, BUT HAPPENED VERY CLOSE TO VACCINATION." "1919911-1" "1919911-1" "Excessive dizziness vomiting sleeping in weeks months after receiving vaccine Mental capability reduced to a child Rather distant and lost always exhausted Always sleep" "---" "Dataset: The Vaccine Adverse Event Reporting System (VAERS)" "Query Parameters:" "Title: 211214 CDC covid VAERS report - all reports" "Date Died: 2020; 2021" "Date of Onset: 2020; 2021" "Date Report Completed: 2020; 2021" "Date Report Received: 2020; 2021" "Date Vaccinated: 2020; 2021" "State / Territory: The United States/Territories/Unknown" "Vaccine Products: COVID19 VACCINE (COVID19)" "VAERS ID: All" "Group By: VAERS ID" "Show Totals: False" "Show Zero Values: False" "---" "Help: See http://wonder.cdc.gov/wonder/help/vaers.html for more information." "---" "Query Date: Dec 14, 2021 5:09:29 PM" "---" "Suggested Citation: Accessed at http://wonder.cdc.gov/vaers.html on Dec 14, 2021 5:09:29 PM" "---" Messages: "1. VAERS data in CDC WONDER are updated every Friday. Hence, results for the same query can change from week to week." "2. These results are for 7,779 total events." "3. When grouped by VAERS ID, results initially don't show Events Reported, Percent, or totals. Use Quick or More Options to" "restore them, if you wish." "4. Click on a VAERS ID to see a report containing detailed information for the event." "---" Footnotes: "1. Submitting a report to VAERS does not mean that healthcare personnel or the vaccine caused or contributed to the adverse" "event (possible side effect)." "---" Caveats: "1.

VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine" "manufacturers, and the public can submit reports to VAERS. While very important in monitoring vaccine safety, VAERS reports" "alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain" "information that is incomplete, inaccurate, coincidental, or unverifiable. Most reports to VAERS are voluntary, which means they" "are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports" "should always be interpreted with these limitations in mind.

The strengths of VAERS are that it is national in scope" "and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA's multi-system approach to" "post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events," "also known as ""safety signals."" If a safety signal is found in VAERS, further studies can be done in safety systems such as" "the CDC's Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have" "the same limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine." "

Key considerations and limitations of VAERS data:

" "2." "3. Some items may have more than 1 occurrence in any single event report, such as Symptoms, Vaccine Products, Manufacturers, and" "Event Categories. If data are grouped by any of these items, then the number in the Events Reported column may exceed the total" "number of unique events. If percentages are shown, then the associated percentage of total unique event reports will exceed 100%" "in such cases. For example, the number of Symptoms mentioned is likely to exceed the number of events reported, because many" "reports include more than 1 Symptom. When more than 1 Symptom occurs in a single report, then the percentage of Symptoms to" "unique events is more than 100%. More information: http://wonder.cdc.gov/wonder/help/vaers.html#Suppress." "4. Data contains VAERS reports processed as of 12/03/2021. The VAERS data in WONDER are updated weekly, yet the VAERS system" "receives continuous updates including revisions and new reports for preceding time periods. Duplicate event reports and/or" "reports determined to be false are removed from VAERS. More information: http://wonder.cdc.gov/wonder/help/vaers.html#Reporting." "5. About COVID19 vaccines: "