"Notes" "VAERS ID" "VAERS ID Code" "Vaccine Type" "Vaccine Type Code" "Age" "Age Code" Adverse Event Description "0928933-1" "0928933-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "0936805-1" "0936805-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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." "0937527-1" "0937527-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "0943397-1" "0943397-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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." "0947891-1" "0947891-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Resident experienced an overall decline in condition on 1/8/21 and continued to decline until he passed away on 1/13/21." "0951688-1" "0951688-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Resident expired 1/17/21" "0952713-1" "0952713-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Weakness, Low O2, death. Positive for COVID on 1/12/21, dies on 1/16/21" "0952799-1" "0952799-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "On 1/17/2021 at 4:35 am resident found apneic and pulseless, at 4:40am death confirmed" "0955425-1" "0955425-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "0956365-1" "0956365-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "0956962-1" "0956962-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "0962318-1" "0962318-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""Called to schedule second vaccine and daughter reports that he died on01/19/2021 with ""COVID"""" "0962714-1" "0962714-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient deceased" "0963269-1" "0963269-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away on 01/18/2021" "0964617-1" "0964617-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death, which I believe is unrelated to vaccination" "0964629-1" "0964629-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "0964671-1" "0964671-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death on 1-5-21" "0964724-1" "0964724-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death 1-15-21" "0965256-1" "0965256-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "Found deceased, presumed while exercising" "0965565-1" "0965565-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "0965910-1" "0965910-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "The employee found dead at her home on 1/21/2021." "0967754-1" "0967754-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death - unknown cause, no reported side effects Narrative: Unknown cause of death" "0971559-1" "0971559-1" "COVID19 VACCINE" "COVID19" "Unknown" "U" "her mother passed away 7-8 days after receiving the vaccine; This is a spontaneous report from a contactable consumer, the daughter of the patient. A female patient of an unspecified age received the first dose of COVID-19 mRNA VACCINE (MANUFACTURER UNKNOWN), via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 19Jan2021 about 7-8 days after receiving the vaccine, the patient passed away. The patient was fine before she received the vaccine and then passed away 7-8 days later. The cause of death was not reported. It was not reported if an autopsy was performed. The reporter thought her mother's death had everything to do with the COVID-19 vaccine. The lot number for the vaccine was not provided and will be requested during follow up.; Reported Cause(s) of Death: Death" "0972890-1" "0972890-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "On the evening of 10JAN2021, patient experienced a low grade fever, decreased oxygen saturation of 38%, heart rate of 124, confusion. Patient received oxygen via face mask, morphine and ativan. By 11JAN2021, patient was no longer verbal, able to eat or communicate and was kept on comfort measure only. On the morning of 17JAN2021, the patient passed away." "0973808-1" "0973808-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""shortness of breath, chest xray with pulmonary edema, periorbital edema Narrative: 73 yo M w/ PMH HTN, HLD, EVAR (2013) for AAA c/b persistent type II endoleak s/p multilple repairs (2015 & 2017) c/b glue embolization down into the R CIA secured with additional stent placement with the R iliac limb, s/p b/l Iliac artery aneurysm stent 08/31/20, and PTSD. Former smoker, quit 12+ yrs ago. 11/1/20-11/6/20: Hospitalized for acute on chronic back pain, found to multiple hypermetabolic lesions in the axial skeleton. Diagnosed with epithelioid angiosarcoma. Patient discharged to facility. 12/17/20: Patient received his 1st COVID-19 vaccine w/o complications at facility. 12/21/20: Underwent cyberknife treatment. 12/31/20: Transferred from facility to ER for new O2 requirement, SOB, cough, chest X ray / pulm edema, tachycardic and new periorbital edema. 12/31/20: Admitted to ICU before transfer to acute care. 1/1/21: Pulmonary consult, ""Labs are notable for progressive left shift with bandemia, markedly elevated inflammatory markers (D-dimer, ESR, CRP, ferritin, LDH), mild elevation in procalcitonin, mild elevation in lactate that has improved, and negative viral panel including COVID-19 x2. CT chest is notable for b/l GGOs along with some interstitial infiltrates with an upper and particularly mid zone and perihilar predominance, septal thickening and crazy paving, and numerous cystic lesions or pneumatoceles. There is a lack of lobar consolidation and pulmonary nodules. Of note, PET/CT about 2 months ago only demonstrated some mild to moderate emphysema mostly in the upper lobes. Therefore, there has been a relatively dramatic change in a few months, suggesting a more subacute process, rather than an acute infectious process such as a viral pneumonia, including COVID-19 infection, in which the GGOs tend to be subpleural and peripheral. Overall, our suspicion for COVID-19 is relatively low, with negative testing x2 yesterday, negative testing a few weeks ago, and lack of sick contacts, but it is possible. Therefore, higher on the differential is a more subacute infection or chemotherapy-induced pneumonitis. Risk factors include malignancy, chemotherapy, and use of steroids (equivalence of about 27 mg of Prednisone in the form of Dexamethasone since 11/6/20 without PJP prophylaxis). These risk factors, along with consistent imaging and elevated LDH, make PJP quite likely. Fungal infection is less likely based on imaging. Chemotherapy-induced pneumonitis is a possibility, especially given the more subacute picture based on imaging. Both Gemcitabine and Docetaxel can cause pneumonitis. However, the patient has been on steroids, which is used to treat drug-induced pneumonitis, although this does not exclude it completely."" 1/2/21: Transferred to ICU for worsening hypoxemia as patient reached 40L/100% FIO2 and remained on COVID isolation/COVID patient under investigation per ID recommendation. 1/4/21: Isolation precautions discontinued due to lower suspicion for active COVID infection to explain current presentation 1/6/21: Went into atrial fibrillation w/o RVR overnight 1/6. Tolerating, with MAPs in low 60s and HR in high 90s/low 100s. Suspect due to being-1L yesterday from diuresis, lasix stopped. S/p amiodarone bolus + drip, albumin 5% bolus 1/5/21: Macrocytic anemia NOS w/ slowly worsening H/H s/p PRBC x 1 unit 1/7/21: Per ICU Life-sustaining treatment note, ""Following discussion w/ patient that his lung dx has been refractory to txt and hasn't improved despite maximal therapy, patient agreed to transition to hospice after he settles affairs. "" 1/7/21 Infectious Disease note: ""This is an immunocompromised host due to cancer on active chemotherapy (albeit ANC>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"""" "0973820-1" "0973820-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Narrative: Symptoms: & DEATH DUE TO COVID 01/13/21 Treatment:" "0974033-1" "0974033-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Resident deceased on 1/26 at 445am. No signs ahead of time." "0974454-1" "0974454-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away 23 days after receiving COVID vaccine" "0974573-1" "0974573-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "0975206-1" "0975206-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "0975689-1" "0975689-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "0976146-1" "0976146-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Resident is asymptomatic" "0976166-1" "0976166-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "ASYMPTOMATIC" "0977319-1" "0977319-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "0978529-1" "0978529-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient developed Covid pneumonia dx 1/15/21, patient expired" "0978567-1" "0978567-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "0979773-1" "0979773-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "0981407-1" "0981407-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Expired in sleep on 1/24/21" "0982354-1" "0982354-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "patient received COVID vaccine on 12/29/2020 and passed away on 1/23/2021" "0982517-1" "0982517-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "patient received COVID vaccine on 1/11/2021 and passed away on 1/25/2021" "0982929-1" "0982929-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "0983173-1" "0983173-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "0983428-1" "0983428-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death Narrative: Patient had Parkinson's and advanced Dementia. He was on a palliative care unit and a DNR." "0983721-1" "0983721-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death Narrative: Patient with Severe Dementia and on Hospice for end of life care." "0985004-1" "0985004-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "0985367-1" "0985367-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "0985451-1" "0985451-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "COVID-19 + 1/11/2021, EXPIRED ON 1-24-2021" "0985527-1" "0985527-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "COVID-19 + ON 1-13-2021, TRANFERRED TO HOSPITAL ON 1-23-2021 DUE TO HYPONATREMIA" "0986200-1" "0986200-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "0986672-1" "0986672-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient tested Covid positive, cough, low oxygen levels, COVID Pneumonia, patient is now deceased" "0986773-1" "0986773-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "0987663-1" "0987663-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Died" "0987877-1" "0987877-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "0988246-1" "0988246-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""Narrative: See ""Other Relevant History"" in Section 6 above Symptoms: ElevatedLiverEnzymes & death, pneumonia, afib Treatment:"" "0988270-1" "0988270-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Narrative: Symptoms: & death Treatment:" "0990034-1" "0990034-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "0992063-1" "0992063-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "0992154-1" "0992154-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "0992238-1" "0992238-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Tested positive for COVID19 on 12-30-2020, Admitted to Hospital on 1/5/2021 with active COVID, Patient died 1/29/2021." "0992734-1" "0992734-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "0993112-1" "0993112-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "0995147-1" "0995147-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "0995520-1" "0995520-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "0996086-1" "0996086-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "0996291-1" "0996291-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "0996959-1" "0996959-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Vaccine was administered Thursday and my father Died early Monday morning unexpectedly" "0997145-1" "0997145-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death on 1/17/21. Death certificate reports: Septic Shock, UTI, Pneumonia, Chronic Renal Failure" "0997642-1" "0997642-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "We were notified 02/02/2021 of patient's death. Unknown cause at this time." "0998421-1" "0998421-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Resident passed away unexpectedly on 1/27/21 from presumed sudden cardiac death." "0998463-1" "0998463-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient had heart attack. Spoke with spouse on 2/3/2021 stated had multiple health issues including heart and lung issues." "1000709-1" "1000709-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1000752-1" "1000752-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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."" "1001488-1" "1001488-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1002229-1" "1002229-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "spontaneous death, found unresponsive in cell after normal morning activities" "1002418-1" "1002418-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Patient death" "1002636-1" "1002636-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "On 1/17/2021 patient woke and began her day as usual, was found down by family member 1 hour later conscious but unable to speak and unable to move her R side. She was admitted to the hospital - Initial NIHSS was 26 and CT imaging showed no acute hemorrhage but mild hypodensity of greater than 1/3 of the MCA territory (TPA not recommended). CTA did show distal L M1/M2 occulsion and she was transferred to larger facility for thrombectomy. Unfortunately the patient had persistent severe neurological deficits after thrombectomy. Was discharged home on hospice care and expired on 1/23/21." "1002808-1" "1002808-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "According to medical report, Pt presented to the ED on 1/14/21 w/ cc of SOB for 1 day. She received her COVID-19 vaccine on 1/9/21. Pt stated that she developed a dry hacking cough 2 days prior to the vaccine on 1/7/21. Over the last few days prior to admission, she developed generalized weakness, SOB, loss of sense of taste and smell w/ associated decreased appetite and nausea ultimately SOB in the24 hours prior to admission. Final Diagnosis- acute hypoxic respiratory failure secondary to COVID-19 pneumonia. Pt died on 2/3/21. See Medical report for more information." "1004811-1" "1004811-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "On 1/23/21 the patient had a single-car accident, slid off icy road into snowbank. She was seen in our ER, diagnosed w/ trauma and L4 compression fracture. She was transported to Hospital for further trauma workup. We believe she was treated and released. On 1/31/21 the patient had a headache but did not seek medical attention. In the morning of 2/1 she became unresponsive and was pronounced dead on the scene when EMS arrived. Autopsy showed a left temporal subdural hematoma." "1004956-1" "1004956-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Wife reported patient expired on 2/3/2021" "1005130-1" "1005130-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Report of patient expired on 2/3/2021" "1006416-1" "1006416-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Patient died of a heart attack on 1/31/21, 2.5 weeks after vaccination" "1006577-1" "1006577-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away within 60 days of receiving a COVID vaccine" "1007033-1" "1007033-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient presented to emergency room on 2/1/2021 with a chief complaint of having a chronic headache and fatigue following receipt of the Moderna vaccine 10 days prior. Following examination by the physician, the patient was diagnosed with an acute subdural hematoma. The patient subsequently underwent decompressive surgery, however demonstrated worsening neurologic status over the next several days and ultimately expired on 2/4/2021." "1007371-1" "1007371-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21" "1009266-1" "1009266-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient with failure to thrive symptoms prior to 2nd dose, not eating, not taking medications." "1009813-1" "1009813-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient became immobile on 1/25/21 (4 days after receiving Moderna COVID-19 vaccine). He died on 1/27/21" "1010025-1" "1010025-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient Expired" "1011130-1" "1011130-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Temp of 100.1 and unproductive cough on 1/17; temp of 100.4 1/28; O2 desaturation 88% on RA 1/28; Diagnosed with Covid-19 on 1/18/2021 Patient passed away on 1/29/2021" "1011149-1" "1011149-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Developed heart arrhythmia and was unable to be revived." "1011222-1" "1011222-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "My mom received the Covid 19 vaccine on Jan 5, 2021 and became very about a week later. I was informed that she tested positive for Covid 19 on January 14th. One January 17th she became very tired and weak and would not eat. Hospice called me and told me that she was in a decline state. I saw her on January 25 and 26 and she was just sleeping and could not open her eyes. Her vitals were good and she seemed to understand when I talked to her - she would squeeze my hand and moan but she could not talk or open her eyes. My mom passed away on January 27, 2021 just 22 days after receiving the Covid 19 vaccine. She was very think to begin with and being to weak and tired to eat resulted in her losing even more weight. Some of the other residents were given fluids to help and they recovered. My mom was not given fluids. I believe there were 20 deaths in her care home for the month of January when they vaccinated. This was an alarming number of deaths for the home. The facility had very few Covid deaths in 2019 and 2020. I asked every week if they had any Covid and or Covid deaths and this amount was shocking to me and the workers there." "1011492-1" "1011492-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "1/18/2021- Tested positive for Covid-19. 1/20 Patient lethargic, unable to swallow. 1/24 Although 90% O2 sat on RA, it has decreased from her baseline ranging at high 90's. 1/27/2021 Patient passed." "1011834-1" "1011834-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "patient passed away within 60 days of receiving COVID vaccine series" "1011894-1" "1011894-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "patient passed away within 60 days of receiving COVID vaccine" "1011905-1" "1011905-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Ongoing decline overall. Remained on Hospice with increased lethargy documented on 1/20/21 and progressively worsening thereafter." "1011983-1" "1011983-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""Narrative: See ""Other Relevant History"" in Section 6 above Other Relevant Hx: 76yo man with a history of for C5 tetraplegia 2/2 cervical stenosis leading to neurogenic bowel/bladder (chronic suprapubic catheter) and chronic respiratory failure with tracheostomy, severe dysphagia s/p G tube placement and multiple aspiration pneumonias, COPD GOLD III, hx MRSA bacteremia (7/2018) and E coli bacteremia (12/2019). Patient transferred from Spinal Cord Injury until to ICU on 1/11/2021 due to worsneing dyspnea, hypoxia (80s) and tachycardia and was found to have acute hypoxic respiratory failure likely 2/2 multifocal pneumonia. CXR findings of ""There is interval increase in patchy airspace infiltrates and consolidation in bilateral lungs concerning for pneumonia"" Patient was started on vancomycin and pip/tazo on 1/11 and tracheal aspirate cultures were obtained for VAP diagnosis which ultimately grew Serratia liquifaciens and Proteus mirabilis. Infectious Diseases was consulted who recommended a switch to ertapenem therapy for a total 10 day course for VAP. UCx/BCx remained negative. On 1/20, a therapeutic bronchoscopy was completed with cultures growing Stenotrophomonas maltophilia and pan-S Klebsiella pneumoniae. The following day a chest tube was inserted and the course of ertapenem completed but vancomycin was continued. By 1/22, patient developed shock liver with ALT/AST 2135/1579 from normal range the day prior and SCr increased to 1.3 from baseline 0.7/cystatin C of 2.46 up from 1.15. Levofloxacin was added for Stenotrophomonas coverage. By 1/25, patient's clinical status continued to decline and Cardiology was consulted for new onset Afib with RVR. Discussion was documented with patient's family who requested DNR. Patient passed away in the early AM on 1/26. Demise does not appear to be related to COVID-19 vaccination but occurred in recent timeframe. Symptoms: ElevatedLiverEnzymes & death, pneumonia, afib"" "1012021-1" "1012021-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Resident on Hospice. 1/18 Hand Shaky. 1/19- Covid +19. 1/20 Desat 85% on RA, provided 2L O2 supplement= 97% 1/20 congestive cough, 1/28- RR-28;1/29- Hypoglycemia 1/30-NPO. 1/30-resident passed away." "1012604-1" "1012604-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1012894-1" "1012894-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "1-2 days after vaccine, pt developed weakness, fatigue, body aches, nausea, headache and poor appetite. Pt was admitted to the hospital on 2/5/21 and death occured on 2/6/21" "1012926-1" "1012926-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Early in the shift on January 31 resident was noticed to be more tired than usual and was not eating well. Lung sounds were crackly and resident was found to be hypotensive. He was evaluated in emergency department. He was diagnosed with pneumonia. Received a loading dose of antibiotic and returned to facility." "1013041-1" "1013041-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Vaccine was administered on 1/15/2021 and death occurred on 1/31/2021." "1013051-1" "1013051-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "On 2/6/21 at 6:00PM, resident experienced sudden left facial droop, left arm and left leg weakness. She was sent to hospital and they confirmed she had an acute ischemic stroke." "1014865-1" "1014865-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "He had not been feeling well after his second Covid vaccination (on 01/23/2021) and was found unresponsive in his room at the nursing home (late evening on 02/02/2021). He was taken to a hospital where they did tests and he had pneumonia and kidney failure, but he was being transferred to a larger hospital when he arrested and died (02/03/2021)" "1015465-1" "1015465-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "DISCOVERED UNRESPONSIVE WITHOUT PULSE, RESPIRATIONS, HEART BEAT ON 2/7/21 AT 0435 A.M. RESIDENT WAS DNR STATUS." "1016097-1" "1016097-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient died 02/08/21" "1016111-1" "1016111-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "her arm was sore but no other adverse reactions until Saturday, Feburary 6th 2021 she had stroke between 4 and 6pm. She died within 6 to 7 hours later." "1017129-1" "1017129-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Sudden cardiac death. Autopsy report: right coronary artery thrombosis." "1017960-1" "1017960-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pt was deceased when we came for second dose. COD unknown to pharmacy." "1017971-1" "1017971-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pt was deceased when we came for second dose. COD unknown to pharmacy" "1017974-1" "1017974-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pt was deceased when we came for second dose. COD unknown to pharmacy" "1017978-1" "1017978-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Pt was deceased when we came for second dose. COD unknown to pharmacy" "1018278-1" "1018278-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death- unexplained cause" "1019850-1" "1019850-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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)." "1020002-1" "1020002-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1020079-1" "1020079-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1020135-1" "1020135-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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."" "1020702-1" "1020702-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Passed away the morning of 2/9/21." "1020724-1" "1020724-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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."" "1021040-1" "1021040-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient had passed since the first dose was given." "1021052-1" "1021052-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient had passed since the first dose was given." "1021058-1" "1021058-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient had passed since the first dose was given." "1021919-1" "1021919-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1022397-1" "1022397-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death 2/9/21" "1022529-1" "1022529-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1022902-1" "1022902-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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."" "1024067-1" "1024067-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1024539-1" "1024539-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "patient tested positive for covid on 1/29/21. was hospitalized on 2/8/21 for shortness of breath, generalized weakness, nausea." "1024788-1" "1024788-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pt had passed away before second dose given." "1024790-1" "1024790-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pt had passed away before second dose given." "1024795-1" "1024795-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pt had passed away before second dose given." "1026095-1" "1026095-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "DEATH 2/12/21" "1026141-1" "1026141-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death 2/12/21" "1026233-1" "1026233-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "patient developed autoimmune thrombocytopenia" "1026362-1" "1026362-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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." "1026581-1" "1026581-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1029514-1" "1029514-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "patient deceased" "1029554-1" "1029554-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient died suddenly on 2/1/21 from unknown causes according to his son." "1030729-1" "1030729-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "deceased, 2/1/21" "1031176-1" "1031176-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1031595-1" "1031595-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Unresponsive, Increase BP and H. Hospital Dx Renal Failure" "1031909-1" "1031909-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1032163-1" "1032163-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1032252-1" "1032252-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Resident tested COVID-19 confirmed positive a few days after covid vaccination." "1032265-1" "1032265-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Resident has shortness of breath on 1/19/2021 and was transferred to Hospital 1/20/2021" "1032662-1" "1032662-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1032880-1" "1032880-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1033263-1" "1033263-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "patient passed away within 60 days of receiving COVID vaccine" "1033323-1" "1033323-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "patient passed away within 60 days of receiving a COVID vaccine" "1033873-1" "1033873-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "PATIENT PASSED AWAY ON 2-1-2021" "1034116-1" "1034116-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Presented from clinic with 3-4 days of extensive rash. There were multiple areas of skin sloughing on bilateral upper extremities and abdominal wall." "1035546-1" "1035546-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1035597-1" "1035597-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Death on 1/17/2021. Found at home deceased." "1035641-1" "1035641-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Healthcare was advised that this patient expired approximately two weeks after receiving her initial COVID vaccination" "1035950-1" "1035950-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient found deceased at home on 2/15/2021. There was no known cause of death with no significant medical history." "1036437-1" "1036437-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient died at home in hospice care from complications of stage 4 bladder cancer" "1036655-1" "1036655-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death on 1/31/2021 multiple comorbidities" "1036731-1" "1036731-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "SOB, DOE, oxygen desaturation, nausea. Ems transport to ER for eval" "1036770-1" "1036770-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Feb 10th died in her sleep. No apparent reason." "1036935-1" "1036935-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "unkown" "1037124-1" "1037124-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1037865-1" "1037865-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1038225-1" "1038225-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death, 2-17-21 at 1802 hours" "1038517-1" "1038517-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Pt. received vaccine on 2/3/2021. Coded at home on 2/17/2021." "1039250-1" "1039250-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1039597-1" "1039597-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" ""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"""" "1041185-1" "1041185-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death within 30 days" "1041740-1" "1041740-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient died on 2-13-21" "1041990-1" "1041990-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Patient died suddenly 2/14/2021" "1044420-1" "1044420-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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." "1045150-1" "1045150-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Patient found in home deceased." "1045894-1" "1045894-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "COVID infection, death" "1045972-1" "1045972-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "patient passed away within 60 days of receiving a COVID vaccine" "1046230-1" "1046230-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death. My father-in-law was found unexpectedly deceased in his home Saturday morning. He worked the previous day." "1046397-1" "1046397-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1046542-1" "1046542-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "patient passed away with in 60 days of receiving a COVID vaccine" "1046613-1" "1046613-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "patient passed away within 60 days of receiving a COVID vaccine" "1046698-1" "1046698-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "patient passed away within 60 days of receiving a COVID vaccine" "1047351-1" "1047351-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1047634-1" "1047634-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1048882-1" "1048882-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1049389-1" "1049389-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1049963-1" "1049963-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1050158-1" "1050158-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1051699-1" "1051699-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death on 02.15.2021." "1051923-1" "1051923-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away within 60 days of receiving a COVID vaccine" "1051975-1" "1051975-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away within 60 days of receiving a COVID vaccine" "1052045-1" "1052045-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away with in 60 days of receiving the COVID vaccine series" "1052108-1" "1052108-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away within 60 days of receiving the COVID vaccine series" "1052179-1" "1052179-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away within 60 days of receiving a COVID vaccine" "1053322-1" "1053322-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Pt had passed away before second dose" "1053788-1" "1053788-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Received call that patient is now deceased" "1053879-1" "1053879-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Shortness of breath - related to chronic comorbidities" "1054114-1" "1054114-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1054434-1" "1054434-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1054551-1" "1054551-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Resident expired on 2/29/21." "1054592-1" "1054592-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Resident expired on 2/24/21, under hospice care." "1054694-1" "1054694-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1054813-1" "1054813-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Chest clear - Hospitalized for a UTI" "1055027-1" "1055027-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "patient deceased no show to 2nd appointment notified by family" "1055107-1" "1055107-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "No documented vaccine reaction Hospitalized due to co-morbities" "1055298-1" "1055298-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1055563-1" "1055563-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1055618-1" "1055618-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pt tested positive for COVID-19 on 2/10/2021, and was deceased on 2/16/2021 at." "1056518-1" "1056518-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1057281-1" "1057281-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "patient's husband reported her death that happened after first COVID-19 vaccine" "1057750-1" "1057750-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1058160-1" "1058160-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Resident expired on 2-25-21" "1058171-1" "1058171-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1058464-1" "1058464-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Pt tested Covid positive 2/8/2021." "1058963-1" "1058963-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "2/182021: Witnessed cardiorespiratory arrest with PEA arrest upon EMS arrival" "1059001-1" "1059001-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1059344-1" "1059344-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death 2/25/21" "1059360-1" "1059360-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Cardiac arrhythmia, EMS on site within minutes, outcome of death." "1060520-1" "1060520-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1060523-1" "1060523-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1061184-1" "1061184-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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."""" "1061303-1" "1061303-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death. Patient was found unresponsive in the morning hours after her shot." "1062895-1" "1062895-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "patient passed away within 60 days of receiving a COVID vaccine" "1063000-1" "1063000-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away within 60 days of receiving a COVID vaccine" "1063561-1" "1063561-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "EMS responded to a call at his home; he was found unresponsive by family slumped over in a chair" "1063727-1" "1063727-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Called pt for Dose 2 appt. Pt had passed away." "1063846-1" "1063846-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "NO SPECIFIC ADVERSE EVENT DUE TO THE VACCINE BUT THE PATIENT PASSED AWAY 02/10/2021 DUE TO COVID" "1065543-1" "1065543-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1066093-1" "1066093-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1066199-1" "1066199-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "[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." "1066289-1" "1066289-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1066715-1" "1066715-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "epistaxis." "1066770-1" "1066770-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "died" "1066906-1" "1066906-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1068308-1" "1068308-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1068761-1" "1068761-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "DEATH Narrative: patient was placed on hospice care following vaccine, unclear cause of death, not documented" "1068762-1" "1068762-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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."""" "1068882-1" "1068882-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "DEATH Narrative: PATIENT PASSED AWAY WHILE ON HOSPICE CARE" "1068884-1" "1068884-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1068887-1" "1068887-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "DEATH Narrative: UNSURE DETAILS OF EVENT, NO DOCUMENTATION IN PROGRESS NOTES" "1068889-1" "1068889-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death Narrative: no other details available, as nothing documented in record" "1068890-1" "1068890-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death Narrative: unclear of details, s/p spine surgery on 2/2/21 and discharged on 2/6/21" "1068901-1" "1068901-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1068993-1" "1068993-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Spontaneous intracerebral hemorrhage and death on 2/20/2021" "1069026-1" "1069026-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1069235-1" "1069235-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1069560-1" "1069560-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1069830-1" "1069830-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1069938-1" "1069938-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "expired at Hospital" "1070040-1" "1070040-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Admitted to hospital 2/22/21" "1070937-1" "1070937-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Unwitnessed Cardiac arrest. ACLS protocols were performed. Cessation of resuscitation was called in the field by Dr." "1071134-1" "1071134-1" "COVID19 VACCINE" "COVID19" "Unknown" "U" "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" "1072166-1" "1072166-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1073092-1" "1073092-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "The decedent reported a continuous headache since receiving the vaccination. On March 3rd he suffered a cardiac arrest and was pronounced deceased." "1073167-1" "1073167-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "She passed away 2/24/2021" "1073225-1" "1073225-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death within 30 days of vaccine" "1073283-1" "1073283-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death within 30 days of vaccination" "1073344-1" "1073344-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "patient died." "1073361-1" "1073361-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "passed away" "1073435-1" "1073435-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1073812-1" "1073812-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "DEATH Narrative: PT WAS PLACED ON HOSPICE ON 1/21/2021" "1073813-1" "1073813-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "DEATH Narrative: UNCLEAR WHY PATIENT WAS HOSPITALIZED AS LIMITED INFORMATION IN RECORD" "1073814-1" "1073814-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "DEATH Narrative: NO ADDITIONAL DETAIL PROVIDED OTHER THAN PATIENT DIED AT HOME" "1073815-1" "1073815-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "DEATH Narrative: NO DETAILS PROVIDED, NO NOTE REGARDING DEATH" "1073816-1" "1073816-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "RESPIRATORY FAILURE Narrative: PT PASSED AWAY WHILE IN THE HOSPITAL" "1073895-1" "1073895-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away after getting the 1st dose of COVID vaccine. He seemed otherwise very healthy." "1073902-1" "1073902-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient seemed otherwise healthy before the vaccination. Patient was hospitalized then shortly passed after getting the 1st dose." "1074873-1" "1074873-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1075017-1" "1075017-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1075024-1" "1075024-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1075042-1" "1075042-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away within 60 days of receiving a COVID vaccine" "1075057-1" "1075057-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1075090-1" "1075090-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1075211-1" "1075211-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1075298-1" "1075298-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1075354-1" "1075354-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away within 60 days of receiving a COVID vaccine" "1075407-1" "1075407-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient passed away within 60 days of receiving the COVID vaccine series" "1075412-1" "1075412-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1075620-1" "1075620-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1076949-1" "1076949-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "Patient admitted on 2/21/21 and died in hospital on 2/22/2021. Patient had a significant, lifelong underlying medical condition." "1080430-1" "1080430-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1080433-1" "1080433-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "unknown cardiovascular event" "1080538-1" "1080538-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Unexpected Death. No details known at this time." "1080932-1" "1080932-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1081132-1" "1081132-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Severe thrombocytopenia approx. 10 days after vaccine administration." "1081155-1" "1081155-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pt died on 3/6/2021. Received Vaccine on 2/12/2021. Unknown cause of death." "1082172-1" "1082172-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient hospitalized 2/18/21, second dose was scheduled for 2/23/21. Patient expired in hospital 2/27/21." "1082345-1" "1082345-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Pt passed away on 3/6/21." "1082787-1" "1082787-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death on 3/7/21" "1082804-1" "1082804-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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." "1084145-1" "1084145-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "At home Care Hospice Patient" "1084187-1" "1084187-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "At Home Care Hospice Patient" "1084203-1" "1084203-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1084390-1" "1084390-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1085375-1" "1085375-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1085478-1" "1085478-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1086868-1" "1086868-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1087735-1" "1087735-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1087949-1" "1087949-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1088175-1" "1088175-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death within 30 days of vaccination" "1088216-1" "1088216-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death within 30 days of vaccination" "1088287-1" "1088287-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1088338-1" "1088338-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1088367-1" "1088367-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "He was found unresponsive, cold and with rigor mortis present after family requested welfare check. He had not been seen for 36 hours." "1088956-1" "1088956-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Tested positive and had symptoms for Covid-19 . Admitted to hospital on 2/14/21 in the icu and died in 2/28/21" "1089441-1" "1089441-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1089759-1" "1089759-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1091158-1" "1091158-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "patient passed away with in 60 days of receiving the COVID vaccine series" "1091337-1" "1091337-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1091799-1" "1091799-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Became COVID-positive, pneumonia, ARDS, hospitalized for hypoxia 2/21/2021, death 2/25/2021" "1091928-1" "1091928-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1092047-1" "1092047-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "patient passed away within 60 days of receiving a COVID vaccine" "1092110-1" "1092110-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away within 60 days of receiving a COVID vaccine series" "1092168-1" "1092168-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away within 60 days of receiving a COVID vaccine" "1092477-1" "1092477-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pericardial effusion; multiple blood clots in portal vein." "1092737-1" "1092737-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Sudden death. Alone at home, found on floor 4 hours after last phone contact" "1093418-1" "1093418-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1093762-1" "1093762-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "3/12/2021-EXPIRED AT FACILITY ON HOSPICE SERVICES" "1093791-1" "1093791-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Unknown" "1094110-1" "1094110-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "unknown. Patient is deceased" "1094146-1" "1094146-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "2nd dose administered on 2/20/21, on 2/23/21 the patient fell and sustained a facial injury" "1094164-1" "1094164-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "deceased" "1094187-1" "1094187-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "ABDOMINAL PAIN BACK PAIN death" "1094197-1" "1094197-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "ALTERED MENTAL STATUS Death" "1094290-1" "1094290-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "death" "1094322-1" "1094322-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "2nd dose given on 2/24/2021, deceased on 3/2/2021" "1094343-1" "1094343-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "ABDOMINAL PAIN death" "1094402-1" "1094402-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1094421-1" "1094421-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "cardiac arrest death" "1094441-1" "1094441-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1094468-1" "1094468-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Hospitalization after a fall resulting in femoral neck fracture. Patient deceased 3/4/21." "1094490-1" "1094490-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1094868-1" "1094868-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death within 60 days of COVID vaccine administration. Dose 1 on 12/23/2020 Dose 2 on 01/13/2021" "1094990-1" "1094990-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death within 60 days of COVID vaccine administration" "1094993-1" "1094993-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death within 60 days of receiving COVID vaccine" "1095025-1" "1095025-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1095053-1" "1095053-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death" "1095070-1" "1095070-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "SHORTNESS OF BREATH Respiratory distress Hypoxia Pneumonia due to COVID-19 virus Death" "1095081-1" "1095081-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1095111-1" "1095111-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Admitted on 2/17/2021 2nd dose injected on 2/20/2021 Shortness of breath died on 03/04/2021" "1095140-1" "1095140-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death" "1095160-1" "1095160-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1095174-1" "1095174-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Cardiac arrest Acute respiratory failure with hypoxia Death" "1095183-1" "1095183-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1095236-1" "1095236-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1095254-1" "1095254-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Shortness of breath Death" "1095360-1" "1095360-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "SHORTNESS OF BREATH Bradycardia Hypothermia Cardiomyopathy Elevated troponin Acute renal failure (ARF) Death" "1095424-1" "1095424-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1095435-1" "1095435-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Headache, nausea on 1/25 progressed to SOB 1/26 and death 1/27" "1095437-1" "1095437-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "2nd dose injected on 02/19/2021 death on 2/24/2021" "1095456-1" "1095456-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "date of injection 01/30/2021 CARDIAC ARREST 1/30/2021 Death 1/30/2021" "1095536-1" "1095536-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1095562-1" "1095562-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death" "1095571-1" "1095571-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1095596-1" "1095596-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "cardiac arrest death" "1095605-1" "1095605-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1095636-1" "1095636-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1095642-1" "1095642-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1095659-1" "1095659-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1095695-1" "1095695-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1095725-1" "1095725-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death" "1095737-1" "1095737-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Shortness of breath Acute on chronic renal failure Abnormal LFTs Death" "1095765-1" "1095765-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1095771-1" "1095771-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1095779-1" "1095779-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1095798-1" "1095798-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1096913-1" "1096913-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patients cancer progressed quicker than expected. Resulting in his passing" "1098119-1" "1098119-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1098680-1" "1098680-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1098902-1" "1098902-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Death" "1099216-1" "1099216-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "PATIENT'S SISTER REPORTED PATIENT PASSED AWAY 03/07/2021" "1100951-1" "1100951-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was found unresponsive by family members in the early morning on 2/23/2021. Patient passed away." "1102443-1" "1102443-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1102722-1" "1102722-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1103186-1" "1103186-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient was vaccinated with the Pfizer vaccine in early February. On February 19th, she was diagnosed with Acute Myeloid Leukemia" "1103821-1" "1103821-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Weakness Death" "1103826-1" "1103826-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "chest pain, acute heart failue death" "1103831-1" "1103831-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1103876-1" "1103876-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "shortness of breath, cough, nausea, diarrhea death" "1103885-1" "1103885-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1103943-1" "1103943-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "unexplained death" "1104031-1" "1104031-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Patient died of cardiac arrest at hospital 3/12/2021" "1104080-1" "1104080-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death" "1104177-1" "1104177-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1104428-1" "1104428-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1104666-1" "1104666-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient presented with dyspnea and found to have COVID 19 infection. Treated with steroids and oxygen but clinically deteriorated and died" "1104698-1" "1104698-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "RESPIRATORY DISTRESS Death" "1104720-1" "1104720-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death" "1105261-1" "1105261-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1105408-1" "1105408-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1105600-1" "1105600-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death on Feb 14, 2021" "1105749-1" "1105749-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient died on 2/28/2021" "1106603-1" "1106603-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1107648-1" "1107648-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Developed leukemia and kidney failure. Died in 6 days." "1107656-1" "1107656-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient was found dead on 3/15/2021" "1107735-1" "1107735-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death on March 8 due to a large blood clot at the base of his brain. This was 16 days after innoculation." "1108262-1" "1108262-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1108264-1" "1108264-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1108279-1" "1108279-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1108469-1" "1108469-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1108475-1" "1108475-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1108477-1" "1108477-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1108762-1" "1108762-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1109535-1" "1109535-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "My Father had a hemorrhagic stroke. He passed away 13 days after receiving the second Modern?s vaccine." "1109578-1" "1109578-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient died at nursing home." "1110160-1" "1110160-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1110311-1" "1110311-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "patient passed away within 60 days of receiving a COVID vaccine" "1110329-1" "1110329-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient passed away within 60 days of receiving the COVID vaccine series" "1110437-1" "1110437-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1110641-1" "1110641-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away within 60 days of receiving a COVID vaccine" "1110654-1" "1110654-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Constipation Shortness of Breath Death" "1110673-1" "1110673-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "shoulder injury death" "1110693-1" "1110693-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death" "1110696-1" "1110696-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away within 60 days of receiving a COVID vaccine" "1110712-1" "1110712-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1110732-1" "1110732-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death" "1110878-1" "1110878-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "patient passed away within 60 days of receiving a COVID vaccine" "1111300-1" "1111300-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1111624-1" "1111624-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "expired on 02/09/2021" "1111645-1" "1111645-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1111699-1" "1111699-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was reported by adult care home to have passed away 3/12/21" "1112104-1" "1112104-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away within 60 days of receiving a COVID vaccine" "1112185-1" "1112185-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away within 60 days of receiving the COVID vaccine series" "1112223-1" "1112223-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away within 60 days of receiving a COVID vaccine" "1112420-1" "1112420-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1112585-1" "1112585-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "patient diagnosed with covid on 2.18.2021 and died of covid 3.6.2021" "1113647-1" "1113647-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient died 3 days after vaccination" "1114257-1" "1114257-1" "COVID19 VACCINE" "COVID19" "Unknown" "U" "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" "1114448-1" "1114448-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1114511-1" "1114511-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Acute mesenteric ischemia; shock secondary to necrotic bowel." "1114752-1" "1114752-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "12/31/2020: vaccine given 1/17/2021: symptom onset and subsequent hospital course: dyspnea, hypoxic, tachypnea, afib w/RVR, septic, NSTEMI" "1115126-1" "1115126-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "NA Patient hx COPD,CAD," "1115838-1" "1115838-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "NA History - CAD,CKD-Stage 3 DMII HTN" "1116006-1" "1116006-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away within 60 days of receiving a COVID vaccine" "1116073-1" "1116073-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away within 60 days of receiving a COVID vaccine" "1116096-1" "1116096-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Narrative:" "1116097-1" "1116097-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Narrative:" "1116098-1" "1116098-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Death Narrative:" "1116100-1" "1116100-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Narrative:" "1116102-1" "1116102-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Narrative:" "1116103-1" "1116103-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Narrative:" "1116104-1" "1116104-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Narrative:" "1116105-1" "1116105-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Narrative:" "1116107-1" "1116107-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Narrative:" "1116108-1" "1116108-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Hospice patient passed away within 60 days of receiving a COVID vaccine" "1116353-1" "1116353-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away within 60 days of receiving the COVID vaccine series" "1116400-1" "1116400-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away within 60 days of receiving the COVID vaccine series" "1116436-1" "1116436-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away within 60 days of receiving the COVID vaccine series" "1117213-1" "1117213-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1118229-1" "1118229-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Sudden Death" "1118954-1" "1118954-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Narrative:" "1118959-1" "1118959-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Narrative:" "1118960-1" "1118960-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Narrative:" "1118961-1" "1118961-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death Narrative:" "1118962-1" "1118962-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Narrative:" "1118963-1" "1118963-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Death Narrative:" "1118965-1" "1118965-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1120315-1" "1120315-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1120523-1" "1120523-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Hemorrhage/Bleeding" "1122392-1" "1122392-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1122969-1" "1122969-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Resident Expired at facility on Hospice services on 3/21/21" "1123065-1" "1123065-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "CHF death" "1123066-1" "1123066-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1123078-1" "1123078-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "mass on right lung fall, arm fracture arm pain leg pain death" "1123229-1" "1123229-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1123405-1" "1123405-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "None stated." "1123737-1" "1123737-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "PATIENT PASSED AWAY ON 3.20.2021" "1123768-1" "1123768-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "PATIENT DIED AT HOME ON 03/19/2021" "1123927-1" "1123927-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "NA CAD, Chronic Abd pain with Opioid treatment - Chronic Pancreatitis" "1124100-1" "1124100-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "NA - Reaction Age 103.dementia" "1124281-1" "1124281-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1124363-1" "1124363-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1125070-1" "1125070-1" "COVID19 VACCINE" "COVID19" "Unknown" "U" "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" "COVID19 VACCINE" "COVID19" "Unknown" "U" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death unknown. Patient caregiver reported that it may be related to broken heart syndrome due her family member's passing." "1125283-1" "1125283-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Systemic: Patient passed away-Severe, Additional Details: Patient passed away on 3/9/2021" "1125300-1" "1125300-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1125469-1" "1125469-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "PER FAMILY PATIENT PASSED AWAY 2/28/2021" "1125507-1" "1125507-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death within 60 days of vaccination" "1126004-1" "1126004-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "When attempting to schedule dose #2, was advised by the family that the patient passed away on 3/13/2021." "1126012-1" "1126012-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Death within 60 days of vaccination" "1126293-1" "1126293-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1126643-1" "1126643-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death within 30 days of vaccination" "1126681-1" "1126681-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Family notified facility of death when we contacted to confirm second dose appointment" "1126683-1" "1126683-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1126724-1" "1126724-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death within 30 days of vaccination." "1127148-1" "1127148-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1127157-1" "1127157-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1127175-1" "1127175-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Death" "1127653-1" "1127653-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death by Hemorrhagic Stroke" "1129069-1" "1129069-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1129413-1" "1129413-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1129706-1" "1129706-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "RECEIVED REPORT THAT TWO WEEKS AFTER HIS SECOND DOSE, HE DIED OF A MYOCARDIAL INFARCTION." "1129951-1" "1129951-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Family stated she felt fine after shot. Had upset stomach night before her death. Took tums. Died in sleep." "1130105-1" "1130105-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Kidney failure and death. Patient heart labs were good." "1130110-1" "1130110-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1130113-1" "1130113-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1130340-1" "1130340-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "1130955-1" "1130955-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Atrial fibrillation, respiratory distress, acute renal failure" "1131280-1" "1131280-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1131556-1" "1131556-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Diagnosis?s with TTP on March 12. Passes away on March 19 2021" "1131557-1" "1131557-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "COVID-19 disease, symptoms started 3/5/21, deceased of COVID-19 on 3/14/21" "1131585-1" "1131585-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1132299-1" "1132299-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Unstable vitals" "1132327-1" "1132327-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1132458-1" "1132458-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "He was in Hospice. He died as a veteran. He had a constant lack of appetite. Has no additional information" "1132667-1" "1132667-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1133552-1" "1133552-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Unknown - Documentation not available" "1133564-1" "1133564-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "It was sent for low pressure on 02/12/2021 to the Hospital Medical Center. He died of respiratory arrest." "1133750-1" "1133750-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1134021-1" "1134021-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient death within 60 days of receiving the COVID vaccine series" "1134070-1" "1134070-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient death within 60 days of receiving the COVID vaccine series" "1134376-1" "1134376-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away from cardiogenic shock after a CABG" "1134616-1" "1134616-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient death within 60 days of receiving the COVID vaccine series" "1135351-1" "1135351-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "2/03/2021 Death. No treatment. Deceased." "1136004-1" "1136004-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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)." "1136547-1" "1136547-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "92 y/o - Severe dementia. Hospice" "1136624-1" "1136624-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "N/A 98 y/o with dementia and heart disease" "1136657-1" "1136657-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "NA 74 y/o several comorbidities. Stroke" "1136716-1" "1136716-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1137449-1" "1137449-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1138309-1" "1138309-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Death - unattended" "1139677-1" "1139677-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1139999-1" "1139999-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Daughter-in-law called earlier this week to report that has passed away on March 10, 2021." "1141569-1" "1141569-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1142078-1" "1142078-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1142950-1" "1142950-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "ALTERED MENTAL STATUS Bradycardia Elevated troponin Non-traumatic rhabdomyolysis Death" "1142953-1" "1142953-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1142957-1" "1142957-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "SHORTNESS OF BREATH Pleural effusion Acute renal failure superimposed on chronic kidney disease, unspecified CKD stage, unspecified acute renal failure type (CMS/HCC) DEATH" "1142969-1" "1142969-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Thrombocytopenia (CMS/HCC) Prostate cancer (CMS/HCC) Pain VOMITING DEATH" "1142975-1" "1142975-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1143063-1" "1143063-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "CHEST PAIN WEAKNESS - GENERALIZED Hyperkalemia Lactic acidosis Hyponatremia SEPSIS EKG abnormalities Acute kidney injury (CMS/HCC) Neutropenia (CMS/HCC) DEATH" "1143239-1" "1143239-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "He was taken to hospital 2/27/2021 for respiratory problems, diagnosed with pneumonia and died in hospital." "1143240-1" "1143240-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Acute renal failure (ARF) (CMS/HCC) Septic shock (CMS/HCC)" "1143266-1" "1143266-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1143356-1" "1143356-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Breathing difficulties, not taken to hospital, managed at home. Certifies respiratory arrest." "1143393-1" "1143393-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1144220-1" "1144220-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Bacteremia - strep epidermidis, developed respiratory distress required intubation for hypercapnic respiratory failure. Developed PEA on 3/28 died." "1144356-1" "1144356-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1144499-1" "1144499-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1144818-1" "1144818-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient death within 60 days of receiving a COVID vaccine" "1144826-1" "1144826-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1145423-1" "1145423-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1145488-1" "1145488-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1145508-1" "1145508-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1145531-1" "1145531-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1146282-1" "1146282-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1146461-1" "1146461-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Shortness of Breath A-fib COPD exacerbation Pneumonia" "1146467-1" "1146467-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1146761-1" "1146761-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" """"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"" "1146787-1" "1146787-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1146789-1" "1146789-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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)" "1147303-1" "1147303-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient death within 60 days of receiving a COVID vaccine" "1147354-1" "1147354-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient death within 60 days of receiving a COVID vaccine" "1147393-1" "1147393-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Died 20 days after first vaccine." "1147433-1" "1147433-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1147518-1" "1147518-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient death within 60 days of receiving a COVID vaccine" "1147527-1" "1147527-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Pt. died due to natural causes at home" "1147625-1" "1147625-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient death within 60 days of receiving a COVID vaccine" "1148091-1" "1148091-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Hospice Care. End of Life. Expired." "1148204-1" "1148204-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1148285-1" "1148285-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1148527-1" "1148527-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Overall decline, Hospice, Crisis Care, Expired" "1148585-1" "1148585-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Overall Decline, Hospice Care, Crisis Care, Expired." "1148826-1" "1148826-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Overall Decline w/congestion and ABT tx, Hospice Care, Crisis Care, Expired" "1149202-1" "1149202-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1149448-1" "1149448-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient death within 60 days of receiving the COVID vaccine series" "1149497-1" "1149497-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient death within 60 days of receiving the COVID vaccine series" "1149826-1" "1149826-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1150107-1" "1150107-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1151270-1" "1151270-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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"""" "1151679-1" "1151679-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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."" "1151915-1" "1151915-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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"""" "1152267-1" "1152267-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "The patient was a Hospice patient that passed away." "1152421-1" "1152421-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "hospice patietn passed away" "1152686-1" "1152686-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Respiratory distress, Atrial fibrillation, Acute Kidney Injury, COVID 19 positive High flow nasal cannula, BiPAP machine, antibiotics" "1152693-1" "1152693-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient received dose #1 of Moderna COVID-19 vaccine 2/13/2021. Family member reported patient death 3/12/2021" "1153162-1" "1153162-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1154140-1" "1154140-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1154145-1" "1154145-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1154152-1" "1154152-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1154465-1" "1154465-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "NA MS End Stage Vascular disease COPD" "1154501-1" "1154501-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Within days symptoms of likely CVA. Within one week diagnosis of shingles." "1155311-1" "1155311-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "NA Lymphoma - Hospice Care" "1155594-1" "1155594-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient death within 60 days of receiving a COVID vaccine" "1155752-1" "1155752-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient death within 60 days of receiving a COVID vaccine" "1155785-1" "1155785-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "NA Advanced age PVD, Heart failure ,respiratory failure" "1156029-1" "1156029-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient death within 60 days of receiving the COVID vaccine series" "1156266-1" "1156266-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Cerebral stroke on 3/23/21" "1156328-1" "1156328-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death on 03/29/2021" "1156392-1" "1156392-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ".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." "1156579-1" "1156579-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1158952-1" "1158952-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Death of patient reported to have happened on 3/30/2021" "1159900-1" "1159900-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1160180-1" "1160180-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Long term care patient death within 60 days of receiving a COVID vaccine" "1160235-1" "1160235-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Hospice Patient death within 60 days of receiving the COVID vaccine series" "1160361-1" "1160361-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Respiratory distress, led to heart failure, and ultimately death of patient" "1160722-1" "1160722-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient diagnosed with COVID on 2/21/2021 and subsequently expired" "1160839-1" "1160839-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Hospice patient death within 60 days of receiving the COVID vaccine series" "1160874-1" "1160874-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1161015-1" "1161015-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" ""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"""" "1163369-1" "1163369-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Blood clots" "1163428-1" "1163428-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "It was reported that patient died on 3/14/2021. This may have had nothing to do with the vaccine." "1165154-1" "1165154-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "My husband died 18 days after the shot" "1167886-1" "1167886-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient death within 60 days of receiving the COVID vaccine series" "1167930-1" "1167930-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient death within 60 days of receiving the COVID vaccine series" "1168104-1" "1168104-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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." "1168198-1" "1168198-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was hospitalized x 3 and died within 60 days of receiving a COVID vaccine series" "1168221-1" "1168221-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1168503-1" "1168503-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "reports death due to age and dementia" "1168645-1" "1168645-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient death within 60 days of receiving the COVID vaccine series" "1168691-1" "1168691-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient death within 60 days of receiving the COVID vaccine series" "1168794-1" "1168794-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1168799-1" "1168799-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1169796-1" "1169796-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1169913-1" "1169913-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "none noted or reported after the injection" "1170822-1" "1170822-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "1172620-1" "1172620-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1173826-1" "1173826-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1175454-1" "1175454-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1175952-1" "1175952-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Patient death within 60 days of receiving the COVID vaccine series" "1176003-1" "1176003-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient death within 60 days of receiving a COVID vaccine" "1176064-1" "1176064-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient death within 60 days of receiving a COVID vaccine" "1176121-1" "1176121-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient death within 60 days of receiving a COVID vaccine" "1176215-1" "1176215-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient death within 60 days of receiving the COVID vaccine series" "1176274-1" "1176274-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Patient became SOB 911 called patient arrested in ambulance and died" "1176278-1" "1176278-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient within 60 days of receiving a COVID vaccine death" "1176372-1" "1176372-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1176896-1" "1176896-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient died of an apparent Cardiac Arrest." "1177616-1" "1177616-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient death within 60 days of receiving the COVID vaccine series" "1178571-1" "1178571-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Pt was found deceased at home, 4/2/2021." "1179434-1" "1179434-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1179974-1" "1179974-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1180107-1" "1180107-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death within 30 days of vaccination" "1180145-1" "1180145-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Hospitalization within 30 days of vaccination. Death within 60 days of vaccination" "1180245-1" "1180245-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death within 30 days of vaccination" "1180291-1" "1180291-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Hospitalization x 2 within 30 days of vaccination; Death within 60 days of vaccination" "1180374-1" "1180374-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death within 60 days of vaccination. Unwitnessed cardiac arrest, CPR attempted and unsuccessful." "1180533-1" "1180533-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1180587-1" "1180587-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Acute Hemorrhagic CVA resulting in eventual death." "1180895-1" "1180895-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "1182258-1" "1182258-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "UKNOWN - SAW ON SOCIAL MEDIA THAT PATIENT PASSED AWAY ON 4/1/2021" "1183418-1" "1183418-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1188040-1" "1188040-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "nontraumatic subcortical hemorrhage of left cerebral hemisphere resulting in death" "1188126-1" "1188126-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1188345-1" "1188345-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1196346-1" "1196346-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Unknown" "1196478-1" "1196478-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "MASSIVE HEART INFARCTION" "1196846-1" "1196846-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient within 60 days of receiving a COVID vaccine death" "1197095-1" "1197095-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1197393-1" "1197393-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1197395-1" "1197395-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1197398-1" "1197398-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Narrative: already reported VAER for hospitalization on 3/3; the patient subsequently died once transferred to SNF" "1197611-1" "1197611-1" "COVID19 VACCINE" "COVID19" "Unknown" "U" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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)"" "1197795-1" "1197795-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient expired at some point after infection; not in the immediate time period of injection" "1198102-1" "1198102-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "Hospice patient death within 60 days of receiving the COVID vaccine series" "1198400-1" "1198400-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Sudden Death" "1198405-1" "1198405-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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." "1199402-1" "1199402-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "She was found deceased after likely sudden cardiac death" "1199415-1" "1199415-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away from blood clot, did not feel well after 2nd shot" "1199446-1" "1199446-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "admitted to the hospital with recurrent hypoxemic and hypercarbic respiratory failure. discharged home. passed away at home after discharge." "1199642-1" "1199642-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was not present for 2nd dose clinic today. Manager of facility reported that patient died in his sleep on 4/6/21" "1200541-1" "1200541-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1200658-1" "1200658-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Bell's palsy Altered Mental status Death" "1200724-1" "1200724-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1200805-1" "1200805-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "FEVER VOMITING ISOLATION-INFECTIOUS DISEASE Death" "1200851-1" "1200851-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Acute hypoxemic respiratory failure (CMS/HCC) Chest pain sepsis Death" "1200923-1" "1200923-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient died of a heart attack" "1200939-1" "1200939-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1201130-1" "1201130-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death on 03/25/2021 ruled as cardiac arrest." "1201182-1" "1201182-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Sudden death - found by paramedics" "1201247-1" "1201247-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Paralysis (CMS/HCC) death" "1201277-1" "1201277-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1201283-1" "1201283-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Had a fatal heart attack" "1201361-1" "1201361-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away between 3/30/21 and 4/1/21 at home." "1201682-1" "1201682-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "PATIENT HAD DIZZINESS, WENT TO DR, THEN NEXT DAY ER AND ENDED UP DYING 4-2-2021" "1201993-1" "1201993-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1202257-1" "1202257-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1202386-1" "1202386-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Multiple comorbidities - Cardiogenic/septic shock, Acute Respiratory failure, AKD stage 3" "1202463-1" "1202463-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was hospitalized x 2 within 60 days of receiving a COVID vaccine series" "1202478-1" "1202478-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1202561-1" "1202561-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "CVA with residual hemiparesis - C-Diff, diarrhea, weakness. AKI" "1202616-1" "1202616-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient death within 60 days of receiving the COVID vaccine series" "1202649-1" "1202649-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Blood clots then death" "1202683-1" "1202683-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine" "1202725-1" "1202725-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Advanced age, Hospice" "1203159-1" "1203159-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Metastatic Lung cancer" "1203475-1" "1203475-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Advanced Age, Likely Sudden Acute MI" "1203534-1" "1203534-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "NA Hospice Care" "1203542-1" "1203542-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1203711-1" "1203711-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1203902-1" "1203902-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Blood Clot which led to Pulmonary Embolism, Pneumonia, and death." "1203939-1" "1203939-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "NA Septic shock Aspiration pneumonia Acute encephalopathy Pancytopenia Seizure" "1203976-1" "1203976-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient death within 60 days of receiving the COVID vaccine series" "1204227-1" "1204227-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1204272-1" "1204272-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1204479-1" "1204479-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1204726-1" "1204726-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "1205036-1" "1205036-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1205282-1" "1205282-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient had a stroke 11 days later(on 4/6/21) and expired" "1205684-1" "1205684-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Blood Clot blocked oxygen to the brain. Suffered a severe stroke Was hospitalized Suffered brain swelling Lost brain function Died." "1205863-1" "1205863-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1207001-1" "1207001-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Intracerebral hemorrhage" "1207106-1" "1207106-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "CARDIAC ARREST DEATH" "1207139-1" "1207139-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death Cardiac arrest Hyperkalemia NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) ESRD needing dialysis (CMS/HCC)" "1207198-1" "1207198-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Anemia GI bleed Lactate blood increased CKD (chronic kidney disease) Jefferson fracture" "1207228-1" "1207228-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1207237-1" "1207237-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1207395-1" "1207395-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "SUDDEN DEATH - PULMONARY EMBOLUS DUE TO DEEP VEIN THROMBOSIS RIGHT POPLITEAL VEIN" "1207600-1" "1207600-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1207773-1" "1207773-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1207863-1" "1207863-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient death within 60 days of receiving the COVID vaccine series" "1207869-1" "1207869-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Shortness of breath" "1208082-1" "1208082-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1208419-1" "1208419-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Patient described throwing up, pale in skin, sweating prior to passing away." "1208477-1" "1208477-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1208505-1" "1208505-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away due to metastatic cancer in esophagus and liver." "1208670-1" "1208670-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death" "1208709-1" "1208709-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1208724-1" "1208724-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death" "1208762-1" "1208762-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1208779-1" "1208779-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1208807-1" "1208807-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Anasarca Hyperammonemia Altered mental status Pulmonary edema Hypermagnesemia ARF (acute renal failure) Anemia" "1209096-1" "1209096-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Death" "1209119-1" "1209119-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death Dehydration Community acquired pneumonia Closed head injury, initial encounter Fall at home, initial encounter Acute hypoxemic respiratory failure" "1209139-1" "1209139-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Shortness of breath Sepsis" "1209441-1" "1209441-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1209498-1" "1209498-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Pt received the vaccine on 3/24/21. On 4/12/21 pt died of cardiac arrest" "1209825-1" "1209825-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Hospitalized 03-13-2021, Diagnosed with Thrombotic Thrombocytopenic Purpura, Died 03-16-2021" "1209873-1" "1209873-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1209906-1" "1209906-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1210673-1" "1210673-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1211052-1" "1211052-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1212176-1" "1212176-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death Metastatic adenocarcinoma Intertrochanteric fracture of left femur" "1212182-1" "1212182-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1212194-1" "1212194-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death R06.02 - Shortness of breath J18.9 - Pneumonia" "1212227-1" "1212227-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1212418-1" "1212418-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1212489-1" "1212489-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "CARDIAC ARREST Death" "1212869-1" "1212869-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient expired on 4/3/2021 after refusing dialysis x 2 weeks" "1212969-1" "1212969-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient Expired" "1213032-1" "1213032-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1213085-1" "1213085-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "End Stage dementia, overall decline, hospice care, expired" "1213131-1" "1213131-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "PATIENT DIED FROM BLOOD CLOT 3/29/2021 - AUTOPSY PERFORMED AND CONFIRMED" "1213217-1" "1213217-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death - no symptoms, signs or treatment provided" "1213285-1" "1213285-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1213302-1" "1213302-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" ""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."" "1213364-1" "1213364-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Patient admitted with massive portal vein thrombosis and low plt in setting of infection. Symptoms started one week prior" "1213551-1" "1213551-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "My brother is now dead, less than one month after his second shot" "1213993-1" "1213993-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Abdominal pain, transferred to ER 2/24/21, admitted to hospital, Expired at hospital 3/21/21" "1214500-1" "1214500-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1214544-1" "1214544-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1214882-1" "1214882-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "unknown" "1214997-1" "1214997-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was terminal when he received the vaccine" "1215373-1" "1215373-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "no symptoms" "1215435-1" "1215435-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "fatal pulmonary embolism from RLE DVT" "1216091-1" "1216091-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Cardiac arrest...death" "1216240-1" "1216240-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Massive stroke Death 4 Days later" "1218454-1" "1218454-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1218602-1" "1218602-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1219000-1" "1219000-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1219229-1" "1219229-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1219404-1" "1219404-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pt was admitted with COVID-19 pneumonia on 4/15 that has progressed to COVID ARDS, DKA, AKI on CKD, NSTEMI" "1219772-1" "1219772-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient died 1 month after vaccination, cause of death is failure to thrive" "1219816-1" "1219816-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Resident passed on 3/23/2021. Resident continues to decline medically. 2/22 He was admitted to nursing home with worsening pressure injury." "1220223-1" "1220223-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "None stated." "1220264-1" "1220264-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "On 4/16/2021 I received a phone call from public health informing us that the patient died on 3/31/2021." "1221106-1" "1221106-1" "COVID19 VACCINE" "COVID19" "Unknown" "U" "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" "1221145-1" "1221145-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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"" "1221329-1" "1221329-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1221916-1" "1221916-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1222324-1" "1222324-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Died a natural death" "1222399-1" "1222399-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1222837-1" "1222837-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1222852-1" "1222852-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "The manager says the patient lost her appetite, presented a cough with difficulty swallowing" "1223056-1" "1223056-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1223683-1" "1223683-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1223971-1" "1223971-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1224177-1" "1224177-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1225854-1" "1225854-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Death, 04/16/2021" "1226364-1" "1226364-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1228009-1" "1228009-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1228011-1" "1228011-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1228014-1" "1228014-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1228019-1" "1228019-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Narrative: 2/8/2021 UTI, sepsis, hyperglycemia, staphylococcus, MRSA infection-discharged to hospice care from Medical Center 2/9, passed 2/11." "1228481-1" "1228481-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1228974-1" "1228974-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "PATIENT GOT FIRST DOSE OF MODERNA ON 03/11/21 AND PASSED AWAY ON 03/28/2021" "1228976-1" "1228976-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death SHORTNESS OF BREATH" "1229005-1" "1229005-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1229079-1" "1229079-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1229092-1" "1229092-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "PATIENT GOT FIRST MODERNA DOSE 03/11/2021 AND SECOND DOSE 04/08/2021 AND PASSED AWAY ON 04/14/2021" "1229211-1" "1229211-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "hemorrhage in the brain" "1229390-1" "1229390-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1229734-1" "1229734-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1229805-1" "1229805-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1229878-1" "1229878-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Dissection of the right ICA with occlusion of tthe right ICA, right MCA and portions of A1 segmenet of the ACA" "1230008-1" "1230008-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Shortness of breath, hypoxia, Pulmonary Embolism, intubation death." "1230079-1" "1230079-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "My husband passed away two weeks and one day after getting his last vaccine" "1230493-1" "1230493-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1231384-1" "1231384-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Sharp Chest Pain resulting in Death 2 hours later, 03/13/2021 @ 12:08" "1232096-1" "1232096-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "On 2/28/2021 while having lunch at noon he suffered an apparent heart attack." "1232115-1" "1232115-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1232416-1" "1232416-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Dies at long term care facility doe to a stroke." "1232456-1" "1232456-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1232936-1" "1232936-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Taken to the Hospital due to a fracture, severe UTI and sepsis. Dies at the Hospital." "1232938-1" "1232938-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1232970-1" "1232970-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away." "1232988-1" "1232988-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient death within 60 days of receiving the COVID vaccine series" "1233229-1" "1233229-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1233385-1" "1233385-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Pt presented with abd pain, dark stool, altered mental status, febrile, hypotensive, septic, cardiogenic shock, progressed to multi organ dysfunction." "1233510-1" "1233510-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Death. Multiple pulmonary thrombi." "1233587-1" "1233587-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was in ED x 2 and died within 60 days of receiving a COVID vaccine series" "1233672-1" "1233672-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1233769-1" "1233769-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" ""According to death certificate patient died of ""blunt force injuries from a motorcycle accident"""" "1235191-1" "1235191-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "my sister had a ruptured brain aneurysm on 3/25/2021" "1235811-1" "1235811-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" ""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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "1236405-1" "1236405-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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"""" "1236407-1" "1236407-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1236412-1" "1236412-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1236416-1" "1236416-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1237069-1" "1237069-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1237704-1" "1237704-1" "COVID19 VACCINE" "COVID19" "Unknown" "U" "Death, blood clots in liver" "1237837-1" "1237837-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1237890-1" "1237890-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Found dead at home 10 days post vaccine administration. Unclear correlation." "1238188-1" "1238188-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "The decedent suffered fever and malaise after the second dose on 04/13/2021." "1238254-1" "1238254-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "The decedent was visiting family. There are no reported adverse effects known." "1238302-1" "1238302-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Suffered a fall, stopped eating, on February 28, 2021 was found without vital signs." "1238326-1" "1238326-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1238440-1" "1238440-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1238623-1" "1238623-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1238843-1" "1238843-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1240207-1" "1240207-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1241384-1" "1241384-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Narrative: Patient was 96 yr old, prostate cancer, peg tube placed, Died on Hospice service, No vaccine complication reported." "1241386-1" "1241386-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1241388-1" "1241388-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1241393-1" "1241393-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1241399-1" "1241399-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Narrative: 95 yr old Renal failure, renal anemia, Died on Hospice service. No vaccine complications reported." "1241400-1" "1241400-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1241402-1" "1241402-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1241404-1" "1241404-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1241676-1" "1241676-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "The patient was with respiratory difficulties, low pressure and low pulse." "1241936-1" "1241936-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "acute respiratory failure 12 days post vaccination, emergency room visit, death of patient." "1242118-1" "1242118-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1242520-1" "1242520-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1242654-1" "1242654-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1243206-1" "1243206-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1243301-1" "1243301-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1243358-1" "1243358-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine" "1243574-1" "1243574-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1243715-1" "1243715-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1244814-1" "1244814-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1245000-1" "1245000-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Blood clots in the lungs, pulmonary embolism" "1245985-1" "1245985-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1246210-1" "1246210-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "NA Hospitalization for Acute Resp Failure with Hypoxia secondary to acute and chronic CAD" "1246223-1" "1246223-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Hospitalization - comfort measures -acute on chronic combined CHF caused by ischemic cardiomyopathy with Cardiorenal syndrome + acute hypoxic respiratory failure, major decline, failed CABG" "1246604-1" "1246604-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" ""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."" "1247180-1" "1247180-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1247588-1" "1247588-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "One week and 6 days after second vaccine fatal heart attack" "1248086-1" "1248086-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "PATIENT RECEIVED THE VACCINE ON 3/15, HE PASSED AWAY ON 3/29" "1248748-1" "1248748-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1249366-1" "1249366-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Died in sleep. Not sick when he went to bed. Not breathing when found. No sign of puke, blood, urine or BM." "1249681-1" "1249681-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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"" "1251507-1" "1251507-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" ""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."" "1255719-1" "1255719-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1256806-1" "1256806-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Unknown if any immediate reaction. The patient passed away on 3/28/21 approximately 2 weeks from the first dose of the vaccine." "1257204-1" "1257204-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1257832-1" "1257832-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Hospitalized +Covid post vaccination with decreased mental status" "1258483-1" "1258483-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death on 4/4/2021 from subdural hematoma" "1258524-1" "1258524-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away in between dose 1 and 2. Cause unknown." "1258614-1" "1258614-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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." "1258858-1" "1258858-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1259340-1" "1259340-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1260071-1" "1260071-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "FOUND DECEASED, COLD IN VEHICLE" "1261821-1" "1261821-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1261865-1" "1261865-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death after experiencing blood clot to the lung" "1262349-1" "1262349-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Pt came in with positive D-dimer, coded and passed" "1262580-1" "1262580-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1263560-1" "1263560-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1264171-1" "1264171-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pt Deceased prior to dose 2. Reported by home health agency as unrelated to vaccination." "1264707-1" "1264707-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1266384-1" "1266384-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1266554-1" "1266554-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1266615-1" "1266615-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1266624-1" "1266624-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Acute respiratory failure with hypoxia Death" "1266936-1" "1266936-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1267143-1" "1267143-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Veteran died on 4/21/2021" "1267444-1" "1267444-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1267721-1" "1267721-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1267794-1" "1267794-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1267822-1" "1267822-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Admitted to hospital on 9/30/2020 and discharged on 10/28/2020." "1267950-1" "1267950-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1268019-1" "1268019-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1268049-1" "1268049-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Fall Death" "1268064-1" "1268064-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1268351-1" "1268351-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Died of heart attack" "1268440-1" "1268440-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Death due to cardiac arrest on 4/26/2021" "1269178-1" "1269178-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1269770-1" "1269770-1" "COVID19 VACCINE" "COVID19" "Unknown" "U" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "nose bleeds, black and blue marks weeks later," "1269850-1" "1269850-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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"" "1269854-1" "1269854-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1270114-1" "1270114-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient presented to the ED on 3/1/2021 and was subsequently hospitalized. She died on 3/25/2021." "1270844-1" "1270844-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1271190-1" "1271190-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Contracted COVID-19 on 4/4/2021, Pt. demise 4/15/2021" "1271305-1" "1271305-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death within 60 days of vaccine" "1271382-1" "1271382-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient was admitted to facility 2/25 and passed away 3/4." "1271726-1" "1271726-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death within 60 days of vaccination" "1271737-1" "1271737-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death within 60 days of vaccination" "1271827-1" "1271827-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "lungs shut down from 95 to 0 in a blink of an eye" "1272201-1" "1272201-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1273174-1" "1273174-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1273409-1" "1273409-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Resident CTB" "1273511-1" "1273511-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1273691-1" "1273691-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "GI Hemorrhage Covid + Respiratory Failure" "1273868-1" "1273868-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Sudden death (Patient's son should have access to COVID-19 vaccination card with lot numbers and location where vaccine was administered.)" "1273988-1" "1273988-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Patient had vaccination 4/7/2021 and started having symptoms 04/25/2021 arrived at the ER today with hypoxia" "1274103-1" "1274103-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1274247-1" "1274247-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1274462-1" "1274462-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1275726-1" "1275726-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "massive Pulmonary embolism causing cardiac arrest" "1275915-1" "1275915-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1277679-1" "1277679-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Death on 04/30/2021" "1278019-1" "1278019-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1279431-1" "1279431-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Death. Autopsy was done. Awaiting results" "1280064-1" "1280064-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1280657-1" "1280657-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient tested positive for COVID back in December 2020. She passed away at the nursing home facility on April 1, 2021." "1281242-1" "1281242-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Weakness loss of appetite 1wk after trouble breathing body hicups heart attack death (almost 2 wks after)" "1281798-1" "1281798-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1282523-1" "1282523-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "March 22 had a stroke, admitted, respiratory entire time, then rec'd death certificated Death Certificate" "1282830-1" "1282830-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1283733-1" "1283733-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1284937-1" "1284937-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1285193-1" "1285193-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Multiple Blood Clots in Right Lung, clots passed through his heart and caused his death" "1285303-1" "1285303-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1285561-1" "1285561-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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"" "1286108-1" "1286108-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1286158-1" "1286158-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1286341-1" "1286341-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1287685-1" "1287685-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "WEEKNESS IN THE RIGHT SIDE OF BODY" "1289201-1" "1289201-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1289390-1" "1289390-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient hospitalized and died of pneumonia caused by COVID-19 after being fully vaccinated." "1289756-1" "1289756-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away before receiving second dose, husband states not COVID related death." "1290096-1" "1290096-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "1290282-1" "1290282-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1290733-1" "1290733-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Found unresponsive but still breathing at assisted living. Sent by ambulance to the hospital" "1290874-1" "1290874-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "My sister died on 4-28-2021" "1293194-1" "1293194-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "I63.9 - Acute CVA (cerebrovascular accident) (CMS/HCC) I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC)" "1293211-1" "1293211-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "J96.01 - Acute respiratory failure with hypoxia (CMS/HCC) R57.9 - Shock (CMS/HCC) A41.9 - Sepsis, unspecified organism" "1293272-1" "1293272-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1293530-1" "1293530-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "death" "1294370-1" "1294370-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1295712-1" "1295712-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "cough, body aches, fever--COVID +, afib, tachycardia, acute coronary syndrome" "1296067-1" "1296067-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Stroke lead to death" "1296253-1" "1296253-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "ACUTE HYPOXIC RESPIRATORY FAILURE, ATYPICAL PNEUMONIA, MULTIPLE MYELOMA" "1296384-1" "1296384-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1296415-1" "1296415-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "The nurse was called by the family letting us know that the patient had passed away at home. No further details were provided," "1296636-1" "1296636-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1298020-1" "1298020-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1300070-1" "1300070-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1302239-1" "1302239-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1302490-1" "1302490-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" ""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."" "1302677-1" "1302677-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "This 70 year old female received the Covid shot on 3/17/21 and died on 5/1/21." "1302705-1" "1302705-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1302958-1" "1302958-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Hospitalization and Death" "1303031-1" "1303031-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "This 68 year old black male received the Covid shot on 3/17/21 and died 5/21." "1303069-1" "1303069-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "This 75 year old female hospice patient received the Covid shot on 3/24/21 died on 5/6/21." "1303190-1" "1303190-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1303474-1" "1303474-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death. Date of death unknown" "1304689-1" "1304689-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Blood clot" "1306869-1" "1306869-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Hospitalized and died due to COVID-19 after being fully vaccinated." "1307636-1" "1307636-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "diabetic ketoacidosis on 5/8/21" "1307637-1" "1307637-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1308207-1" "1308207-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "#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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Patient died from methamphetamine/opiate overdose" "1310163-1" "1310163-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient died at nursing home facility. Patient had COVID back in 09/2020." "1310557-1" "1310557-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Cardio respiratory arrest. During rounds, patient was found without vital signs" "1310651-1" "1310651-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Cardiac arrest." "1310855-1" "1310855-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pneumonia." "1311196-1" "1311196-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "FEVER COUGH FATIGUE HEADACHES" "1311665-1" "1311665-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1312036-1" "1312036-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1313560-1" "1313560-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "I21.3 - STEMI (ST elevation myocardial infarction) (CMS/HCC)" "1313860-1" "1313860-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Health Department was notified of patient death. Health Department was not informed of cause of death. VAERS report completed." "1313931-1" "1313931-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1314186-1" "1314186-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "? Sore Throat ? Cough ? Abdominal Pain Diarrhea Sinus congestion" "1314214-1" "1314214-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1314308-1" "1314308-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Fever and respiratory problems." "1314511-1" "1314511-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Low arterial pressure, low saturation pressure." "1314994-1" "1314994-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Heart Attack May 7, 2021, Death May 8, 2021" "1316583-1" "1316583-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Couldn't Breath, Died due to Blood Clots on Lungs, Bilateral Pulmonary Embolism, Bleeding on the Brain." "1316645-1" "1316645-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1317043-1" "1317043-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Spontaneous Cortical Non aneurysmal subarachnoid hemorrhage with diagnostic suspicion but not confirmation of cortical venous thrombosis, and spontaneous ventricular tachycardia." "1317164-1" "1317164-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Upon reviewing patient's need for 2nd dose, we learned that patient died on 4/25/21." "1317367-1" "1317367-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "This 99 year old female received the Covid shot on 4/9/21 and died on 5/8/21." "1317389-1" "1317389-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1318046-1" "1318046-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1320726-1" "1320726-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "One week after receiving the injection, patient went into complete kidney failure. Patient died on May 14, 2021" "1322807-1" "1322807-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1323098-1" "1323098-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "This 83 year old black woman received the 2nd dose of vaccine on 3/24/21 and died early May 2021" "1323109-1" "1323109-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "This 73 year old female patient received the Covid shot on 3/26/21 died on 5/4/21." "1323208-1" "1323208-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "SYNCOPE FATIGUE" "1323260-1" "1323260-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death within 30 days of vaccination." "1323599-1" "1323599-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1323719-1" "1323719-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1324012-1" "1324012-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1324268-1" "1324268-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Lethargy, Exhaustion, Inability to Walk, Heart Attack and Death from Acute Cardiac Arrest" "1326063-1" "1326063-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Died February 12, 2021" "1326587-1" "1326587-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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."" "1326764-1" "1326764-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1327444-1" "1327444-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "seizure, encephalopathy, death" "1327598-1" "1327598-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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," "1327755-1" "1327755-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Hospitalized for COVID-19 pneumonia on 4/23, ICU on 5/3, passed on 5/17 of 2021" "1328720-1" "1328720-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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" "1329905-1" "1329905-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Died due to respiratory cardiac arrest." "1329933-1" "1329933-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Deterioration of condition." "1330030-1" "1330030-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Loss of apatite." "1330155-1" "1330155-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Died of missive hart attack." "1330231-1" "1330231-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Decay, irregular pulse, cardiorespiratory failure are observed." "1330240-1" "1330240-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1330552-1" "1330552-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Blood clot in brain causing stroke then death" "1330767-1" "1330767-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1331122-1" "1331122-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1332849-1" "1332849-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "No event description for this event." "1333650-1" "1333650-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1334038-1" "1334038-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1334174-1" "1334174-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1334600-1" "1334600-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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."" "1334884-1" "1334884-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1336534-1" "1336534-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "NA Acute Systolic AFIB Pancreatic cancer Heart Failure" "1336582-1" "1336582-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "NA PAD, Coronary Artery Disease" "1336695-1" "1336695-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "unknown" "1337198-1" "1337198-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1337439-1" "1337439-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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." "1337556-1" "1337556-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Stage IV Pancreatic Cancer" "1337675-1" "1337675-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "NA Left Upper Lobe Lung CA COPD" "1337689-1" "1337689-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1337780-1" "1337780-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Person died on 5/7/2021 with death note stating acute respiratory failure with hypoxia, thrombocytopenia." "1337918-1" "1337918-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Unaware of any adverse events between administration and death. Reporting agency became aware of patient's expiration on 05/14/2021." "1338394-1" "1338394-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "Death N17.9 - Acute kidney failure, unspecified FATIGUE CHEST PAIN NAUSEA" "1338572-1" "1338572-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death Thrombocytopenia Subdural bleeding HEADACHE DIZZINESS" "1338610-1" "1338610-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death J18.9 - Pneumonia, unspecified organism" "1338618-1" "1338618-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death N17.9 - Acute kidney failure, unspecified" "1339062-1" "1339062-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Massive stroke from huge clot right of brain. Never regained con.." "1340758-1" "1340758-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1340821-1" "1340821-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Please check with her doctors. I know she mentioned Myocarditis. She was vaccinated I am correct, on March 8 and April 6, 2021" "1343241-1" "1343241-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "left MCA infarct" "1343387-1" "1343387-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient died of a myocardial infarction." "1343514-1" "1343514-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death within 90 Days" "1343527-1" "1343527-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death within 90 days" "1343543-1" "1343543-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death within 90 Days" "1343571-1" "1343571-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1343926-1" "1343926-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1346714-1" "1346714-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death J18.9 - Pneumonia, unspecified organism shortness of breath chest pain" "1346731-1" "1346731-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) N17.9 - Acute kidney failure, unspecified SHORTNESS OF BREATH LEG SWELLING ASCITES" "1347105-1" "1347105-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "Found dead on May 3, 2021. Question day of death 05/01/2021. Medical examiners case. Cause pending, possible SUDEP." "1347172-1" "1347172-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Unexpected Death" "1347211-1" "1347211-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Dies at the Hospital do to a respiratory arrest." "1347843-1" "1347843-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1348474-1" "1348474-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient Died of Heart Failure unexpectedly." "1349127-1" "1349127-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Symptoms: & cardiopulmonary arrest Treatment: EPINEPHRINE 8 MG Unknown during code" "1349979-1" "1349979-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "unknown" "1350521-1" "1350521-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1350875-1" "1350875-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "During vital sign inspection, patient presented low saturation, and was taken to the Hospital." "1350978-1" "1350978-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1351084-1" "1351084-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Death on 2/18/21. Pulmonary embolism found on autopsy." "1351207-1" "1351207-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1351466-1" "1351466-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1351511-1" "1351511-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1351564-1" "1351564-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Pulmonary embolism that resulted in death" "1351581-1" "1351581-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "1351907-1" "1351907-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" ""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."" "1353752-1" "1353752-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1354152-1" "1354152-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Hospice patient death within 60 days of receiving a COVID vaccine" "1354359-1" "1354359-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1354548-1" "1354548-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "No adverse symptoms reported. Death following a fall while at home alone." "1354601-1" "1354601-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "cardiomegaly, with significant bilateral lung abnormality. in addition, pulmonary edema with extensive bilateral multifocal pneumonia" "1354616-1" "1354616-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Difficulty breathing, coughing, congestion, dies of cardiac arrest." "1354811-1" "1354811-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1354848-1" "1354848-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1354872-1" "1354872-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient was hospitalized multiple times and died within 60 days of receiving a COVID vaccine series" "1354899-1" "1354899-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1354978-1" "1354978-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "He received the vaccine and had a heart attack on May 3, 2021 and passed away on May 4th. They did an full autopsy" "1355032-1" "1355032-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine" "1355126-1" "1355126-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Difficulty breathing and pain in the chest." "1355174-1" "1355174-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" ""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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient found dead" "1355384-1" "1355384-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1355806-1" "1355806-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1357112-1" "1357112-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1357990-1" "1357990-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1358130-1" "1358130-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1359313-1" "1359313-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1360403-1" "1360403-1" "COVID19 VACCINE" "COVID19" "Unknown" "U" "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" "1361131-1" "1361131-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1361447-1" "1361447-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1361818-1" "1361818-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Death" "1362130-1" "1362130-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Upset stomach and vomiting. Shortness of breath. Pressure in chest. Heart attack and DEATH." "1362402-1" "1362402-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia" "1362539-1" "1362539-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "1363989-1" "1363989-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1364724-1" "1364724-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1364886-1" "1364886-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death after fall and hospitalization." "1365222-1" "1365222-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death Pneumonia, unspecified organism Cerebral infarction, unspecified" "1365328-1" "1365328-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death Non-ST elevation (NSTEMI) myocardial infarction Acute kidney failure, unspecified" "1365410-1" "1365410-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "1365932-1" "1365932-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Patient passed away on April 27, 2021, which was two weeks after receiving second dose of Moderna Covid-19 vaccine." "1366333-1" "1366333-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "Death" "1366598-1" "1366598-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1367840-1" "1367840-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death vision loss Acute cerebrovascular accident acute hyponatremia" "1367844-1" "1367844-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death weakness E87.1 - Hyponatremia" "1367997-1" "1367997-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Massive Heart Attack resulting in death." "1368008-1" "1368008-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1368648-1" "1368648-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Died on 1/31/2021." "1368670-1" "1368670-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1371338-1" "1371338-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1371740-1" "1371740-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Resident was found in his bed to be passed away. He had been on Hospice." "1371745-1" "1371745-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1371859-1" "1371859-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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"" "1371933-1" "1371933-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "PASSED AWAY 06/01/21" "1372112-1" "1372112-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "Pt died of massive pontine hemorrhage and then cardiac arrest two weeks after vaccination." "1372120-1" "1372120-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was hospitalized Feb 18th to the 21st and passed away on Feb 28, 2021." "1372151-1" "1372151-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1374110-1" "1374110-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "death N17.9 - Acute renal failure, unspecified acute renal failure type" "1374138-1" "1374138-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "death - Non-ST elevation (NSTEMI) myocardial infarction" "1374461-1" "1374461-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Hospitalization and death within 30 days of vaccination. Obituary stated that he died at Hospital." "1374481-1" "1374481-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1375050-1" "1375050-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Cardiac Arrest, DVT, AKA, Stroke" "1375797-1" "1375797-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Sepsis/Bacterial Meningitis" "1375972-1" "1375972-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1376795-1" "1376795-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1377674-1" "1377674-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Sudden Cardiac Arrest . Resuscitated and transferred to the hospital. Never regained consciousness and died on 5/11/21." "1378451-1" "1378451-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1380716-1" "1380716-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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" "1381705-1" "1381705-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "First shot Lot# ER 8732 administered 04/03/2021 Death" "1381998-1" "1381998-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "death J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia" "1382410-1" "1382410-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient was hospitalized and passed away" "1382612-1" "1382612-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "case was hospitalized and passed away." "1382641-1" "1382641-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1382906-1" "1382906-1" "COVID19 VACCINE" "COVID19" "6-17 years" "6-17" "Unexplained death within 48 hours" "1383413-1" "1383413-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Sudden death in sleep" "1384860-1" "1384860-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" ""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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1385230-1" "1385230-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1385337-1" "1385337-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1385652-1" "1385652-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "-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" "1385984-1" "1385984-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "DEATH FROM BLOOD CLOT" "1386215-1" "1386215-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death within 60 days of vaccination" "1386631-1" "1386631-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1387032-1" "1387032-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Dizziness, loss of memory, fatigue, and death 10 days later" "1387202-1" "1387202-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Inital Fever followed by severe fatigue for 2-3 weeks followed by death" "1387512-1" "1387512-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "1387996-1" "1387996-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Non-ST elevation (NSTEMI) myocardial infarction RESPIRATORY DISTRESS" "1388005-1" "1388005-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "J18.9 - Pneumonia, unspecified organism" "1388182-1" "1388182-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1388528-1" "1388528-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1388920-1" "1388920-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1389554-1" "1389554-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1390921-1" "1390921-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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" "1391671-1" "1391671-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "brain bleed/aneurysm" "1391864-1" "1391864-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Died of unknown cause 2 weeks after receiving vaccine." "1392054-1" "1392054-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1394685-1" "1394685-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1394899-1" "1394899-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1395203-1" "1395203-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death J18.9 - Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung" "1395420-1" "1395420-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "1395663-1" "1395663-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Massive heart attack and death" "1395873-1" "1395873-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Approx 16 days following vaccine patient's Sp02 saturation dropped to 70-80% despite being on 6liters O2" "1396378-1" "1396378-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1396396-1" "1396396-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away on 5/12/2021 at assisted living facility" "1396420-1" "1396420-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Client passed away on 5/12/2021, she had been residing at assisted living facility." "1396485-1" "1396485-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Per obituary, patient died at the Hospital on 5/13/2021. SARS CoV2 PCR on 5/12/2021 was negative." "1397246-1" "1397246-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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." "1398476-1" "1398476-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1399375-1" "1399375-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "began with a fever, and slowly starting having nausea and diarrhea. we could not bring down fever with antibiotics" "1399516-1" "1399516-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Sweating, soreness, vomiting" "1400020-1" "1400020-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Death" "1400093-1" "1400093-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Died suddenly, autopsy pending" "1400218-1" "1400218-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient CTB" "1400337-1" "1400337-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1401732-1" "1401732-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "1402809-1" "1402809-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Deceased 6/7/21 (Unsure if related)" "1403424-1" "1403424-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "dyspnea, pneumonia, difficulty breathing. positive for COVID-19 3/25/2021, hospitalized and later died of COVID-19" "1403521-1" "1403521-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "weak, loss of appetite, pneumonia, ARDS" "1403750-1" "1403750-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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"" "1405284-1" "1405284-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1407166-1" "1407166-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "DYSPNEA 3/7/2021, CONFIRMED BREAKTHROUGH WITHA POSITIVE COVID-19 RESULTING IN DEATH" "1407647-1" "1407647-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient received the COVID 19 vaccine on 3/30/21 at home. Per the obituary, he died at home on 5/10/2021." "1408205-1" "1408205-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" ""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."" "1410139-1" "1410139-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1410366-1" "1410366-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Cough and fever as symptoms of COVID infection Cause of death: Congestive heart failure" "1410894-1" "1410894-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "presented to the ED with generalized weakness progressing to fever, cough, dyspnea, myalgia, pneumonia. admitted to Hospital" "1411020-1" "1411020-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Shaking, almost spasm type shaking. Weakness in her legs. progressing to abd. pain, cough, headache, nausea" "1411290-1" "1411290-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death due to PEs in bilateral lungs caused by DVTs in bilateral legs." "1413086-1" "1413086-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1413807-1" "1413807-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "1414207-1" "1414207-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1414259-1" "1414259-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Low heart activity and low oxygenation." "1414703-1" "1414703-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "High blood pressure, low oxidation, urine infection. cardiac arrest." "1414988-1" "1414988-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" ""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."" "1415021-1" "1415021-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Cardiac arrest, death" "1415200-1" "1415200-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1415237-1" "1415237-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1415368-1" "1415368-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1416476-1" "1416476-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient died at home 3 weeks after receiving first dose of vaccine." "1416721-1" "1416721-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1417063-1" "1417063-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away on 6/20/2021. Cause of death unknown." "1417175-1" "1417175-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Massive Heart Attack" "1417204-1" "1417204-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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)" "1417278-1" "1417278-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1417642-1" "1417642-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1417870-1" "1417870-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Profuse rectal hemorrhaging and blood clots" "1418084-1" "1418084-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Patient was found dead in his bed on June 11, 2021." "1420192-1" "1420192-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Died do to unknown reasons, did not present symptomology." "1420208-1" "1420208-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Died, unknown reasons, no symptomology reported." "1420630-1" "1420630-1" "COVID19 VACCINE" "COVID19" "6-17 years" "6-17" "~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." "1420750-1" "1420750-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Severe Sepsis with Acute Hypoxic Resp failure Chronic liver disease" "1420765-1" "1420765-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Renal cell carcinoma of right kidney metastatic to other site ? Bone metastasis ? Perforated bowel" "1421063-1" "1421063-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "PAF Seizure , ETOH dependency , Dyspnea" "1421500-1" "1421500-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Covid 19, Blood Clot in Lung, Myocardia" "1421819-1" "1421819-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1423055-1" "1423055-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "1423365-1" "1423365-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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)." "1423516-1" "1423516-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "My husband died of ?heart Attack? on April 17, 2021 Had an enlarge hearth and rupture in the Aortic Artery" "1423631-1" "1423631-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death 3/8/2021" "1423807-1" "1423807-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death 4/8/2021 1) Acute respiratory failure secondary to COVID 19 pneumonia" "1423845-1" "1423845-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death 3/31/2021 Causes of death listed on death certificate: 1) Cardiac arrest 2) covid 19 pneumonia" "1424081-1" "1424081-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death 3/23/2021 Cause of death listed on death certificate: Myocardial Infarction" "1424098-1" "1424098-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death 04/23/2021 Causes of death listed on death certificate: 1. hypoxic respiratory failure 2. covid 19 3. diabetes mellitus 4. hypertension" "1424154-1" "1424154-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1425844-1" "1425844-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death 4/21/2021 Causes of death listed on death certificate: 1) respiratory failure 2) covid 19 pneumonia" "1425847-1" "1425847-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death 4/26/2021 Causes of death listed on death certificate: 1) Pneumonia 2) Coronary Artery Disease Other: Covid 19" "1425907-1" "1425907-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death: 04/20/2021 Causes of death listed on death certificate: 1) Covid" "1425926-1" "1425926-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death 4/30/2021 Causes of death listed on death certificate: 1) Covid Pneumonia 2) Chronic obstructive pulmonary disease, unspecified Other: none" "1426149-1" "1426149-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "1426155-1" "1426155-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death: 5/2/2021 Causes of death listed on death certificate: Covid 19" "1426471-1" "1426471-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death 5/2/2021 Causes of death listed on death certificate: 1) Small-bowel obstruction 2) Carcinoma of small-bowel" "1426477-1" "1426477-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1426836-1" "1426836-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Died of COVID-19" "1427073-1" "1427073-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death on 3/12/2021. Primary cause of death was COPD, with COVID-19 listed as an underlying cause." "1427108-1" "1427108-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "COVID symptoms began 3/16, positive test 3/19, hospital admission 3/22, death 4/1" "1427367-1" "1427367-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1427448-1" "1427448-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1427664-1" "1427664-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Died 3/6/2021" "1427666-1" "1427666-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Tested positive for COVID-19 on 3/7, likely an incidental finding. Died of liver cancer 3/17." "1427845-1" "1427845-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Hospice patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1427848-1" "1427848-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1427858-1" "1427858-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1428052-1" "1428052-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "cough, difficulty breathing, productive cough, 02 requirement, weakness resulting in hospitalization and death. received treatment : Azithromycin and Decadron 02/09/2021-02/19/2020" "1428887-1" "1428887-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "1429643-1" "1429643-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Lethal stroke" "1430563-1" "1430563-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "on 06/18/2021 my husband suffered a central brain aneurysm and passed away om 06/19/2021" "1430652-1" "1430652-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient noted with decline in condition starting from his first vaccine and expired shortly after 2nd vaccine." "1430661-1" "1430661-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Fatigue, chills, fever, exhaustion. The following Sunday, 9 days after his second dose he went to bed and never woke up." "1430883-1" "1430883-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient expired following cardiac arrest. COVID test indeterminate for infection." "1431067-1" "1431067-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "Pt died during child birth on 06/24/2021" "1431100-1" "1431100-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death I21.4 - Non-ST elevation (NSTEMI) myocardial infarction J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified" "1431146-1" "1431146-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death E87.1 - Hypo-osmolality and hyponatremia" "1431162-1" "1431162-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death N17.9 - Acute kidney injury (CMS/HCC)" "1431198-1" "1431198-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death E87.1 - Hypo-osmolality and hyponatremia N17.9 - Acute kidney failure, unspecified" "1431234-1" "1431234-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death J18.9 - Pneumonia, unspecified organism" "1431289-1" "1431289-1" "COVID19 VACCINE" "COVID19" "6-17 years" "6-17" ""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"" "1431351-1" "1431351-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "3/7/2021: dysregulated taste, dyspnea, Myalgia, pneumonia, hospitalized, treated but died" "1432196-1" "1432196-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1433305-1" "1433305-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "patient collapse with subsequent EMS transport to ED, multi organ system failure, coagulation issues, required mechanical ventilation" "1433463-1" "1433463-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away on 02/17/2021." "1433479-1" "1433479-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away on 02/25/2021." "1433483-1" "1433483-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away on 03/09/2021." "1433491-1" "1433491-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away on 03/12/2021" "1433503-1" "1433503-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away on 03/14/2021" "1433516-1" "1433516-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away on 03/16/2021" "1433542-1" "1433542-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away on 04/05/2021" "1433561-1" "1433561-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away on 03/07/2021" "1433671-1" "1433671-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away on 04/15/2021." "1433714-1" "1433714-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away on 04/28/2021" "1433744-1" "1433744-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away on 05/02/2021." "1433753-1" "1433753-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "dry cough, difficulty breathing, SOB, fatigue, pneumonia" "1433778-1" "1433778-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away on 05/01/2021" "1433796-1" "1433796-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away on 04/28/2021" "1433809-1" "1433809-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death 5/19/2021 Causes of death listed on death certificate: 1) COVID 19" "1433819-1" "1433819-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death 6/6/2021 Causes of death listed on death certificate: 1) covid pneumonia" "1433899-1" "1433899-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Died of COVID-19 illness on 02/26/2021" "1437053-1" "1437053-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "N17.9 - Acute kidney failure, unspecified" "1437238-1" "1437238-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "death N17.9 - AKI (acute kidney injury)" "1437339-1" "1437339-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death 5/27/2021 No cause of death provided." "1437342-1" "1437342-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Death 5/21/2021 Causes of death listed on death certificate 1) COVID-19 2) ARDS Other: Lung Transplant for cystic fibrosis" "1437360-1" "1437360-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death 3/2/2021" "1437378-1" "1437378-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Died of COVID-19 illness on 05/05/2021" "1437381-1" "1437381-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Death 06/04/2021" "1437419-1" "1437419-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Died of COVID-19 illness on 03/16/2021" "1437580-1" "1437580-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1438057-1" "1438057-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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." "1440669-1" "1440669-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient presented to the ED and was subsequently hospitalized for DVT within 6 weeks of receiving COVID vaccination. Patient died on 6/23/2021." "1440746-1" "1440746-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pneumonia, SOB, and Fatigue" "1440769-1" "1440769-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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." "1441060-1" "1441060-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient died on March 13 2021." "1443294-1" "1443294-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1443544-1" "1443544-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient was hospitalized and died within 60 days of receiving a COVID vaccine series" "1446338-1" "1446338-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1446466-1" "1446466-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1446954-1" "1446954-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "person was found dead 3 and a half weeks after last shot" "1449786-1" "1449786-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1450056-1" "1450056-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death J18.9 - Pneumonia, unspecified organism" "1450098-1" "1450098-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1450341-1" "1450341-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death I61.9 - Nontraumatic intracerebral hemorrhage, unspecified R29.810 - Facial weakness I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC)" "1450387-1" "1450387-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Stroke" "1450558-1" "1450558-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death J18.9 - Pneumonia, unspecified organism" "1450577-1" "1450577-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death N17.9 - Acute kidney failure, unspecified" "1450632-1" "1450632-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death - Hypo-osmolality and hyponatremia" "1454305-1" "1454305-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Breakthrough resulted in COVID death" "1454420-1" "1454420-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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. ." "1454753-1" "1454753-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1455101-1" "1455101-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1457004-1" "1457004-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1457253-1" "1457253-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away on 02/18/2021." "1459756-1" "1459756-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Pericarditis, large vessel vasculitis, death" "1459796-1" "1459796-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1459938-1" "1459938-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1460257-1" "1460257-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1461866-1" "1461866-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1462011-1" "1462011-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "My mother had chest and abdominal pain and the passed out and died" "1462975-1" "1462975-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1464255-1" "1464255-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Acute onset of dementia, intubated est 1 mo after vaccination Deceased 7/3/21 at Hospital" "1464276-1" "1464276-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1464628-1" "1464628-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "? June 20 ? struggling to breathe; morphine administered ? June 21 ? passed away" "1466009-1" "1466009-1" "COVID19 VACCINE" "COVID19" "6-17 years" "6-17" "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." "1466862-1" "1466862-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Progressively worse muscle and body aches, shortness of breath upon exertion, aggressive behavior, insomnia, confusion," "1466883-1" "1466883-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" """"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."" "1467970-1" "1467970-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death due to brain bleed, per wife's message left with agency. Obituary located at:" "1469672-1" "1469672-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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"" "1474062-1" "1474062-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Hospitalization within 6 weeks of receiving COVID vaccination. Patient deceased." "1474311-1" "1474311-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Patient died 04/06/2021 Covid vaccine #1 Pfizer 03/16/2021 Lot #EN6207 Covid Vaccine #2 Pfizer 03/19/2021 Lot # N/A" "1474379-1" "1474379-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1474430-1" "1474430-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) Pulmonary emboli (CMS/HCC) Acute kidney failure, unspecified Thrombocytopenia, unspecified" "1475006-1" "1475006-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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." "1475654-1" "1475654-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1478327-1" "1478327-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "PE diagnosed 6/11/21 death 7/4/21" "1478374-1" "1478374-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1478618-1" "1478618-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1479422-1" "1479422-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1481780-1" "1481780-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1484023-1" "1484023-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1484098-1" "1484098-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1484524-1" "1484524-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "death 18 days after vaccine" "1484651-1" "1484651-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Daughter, came to clinic and informed participant, passed away on 6/2/21 from COVID complications at Hospital." "1484677-1" "1484677-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Death, found dead at home" "1484908-1" "1484908-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death J18.9 - Pneumonia N17.9 - Acute renal injury" "1484966-1" "1484966-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "death N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia" "1485039-1" "1485039-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient died of a heart attack on 07/17/2020 while sleeping." "1485157-1" "1485157-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1485987-1" "1485987-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1486583-1" "1486583-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1486814-1" "1486814-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine." "1486815-1" "1486815-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1486859-1" "1486859-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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."" "1487409-1" "1487409-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1489603-1" "1489603-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1490419-1" "1490419-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Pain in upper abdomen, sudden cardiac arrest on 5/3/21" "1490511-1" "1490511-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1490927-1" "1490927-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1491638-1" "1491638-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Stroke. Death." "1493615-1" "1493615-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" ""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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine." "1496326-1" "1496326-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Pt died 15 days post vaccine admin without prior medical history." "1498209-1" "1498209-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1498879-1" "1498879-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Bilateral retinal branch vein occlusions 1 month after. Died 5/7/21" "1501721-1" "1501721-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death after 2 1/2 weeks. Received 2nd shot on 6/21/21 and died on July 9, 2021." "1501814-1" "1501814-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1502013-1" "1502013-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1502047-1" "1502047-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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." "1502062-1" "1502062-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "death E87.1 - Hyponatremia J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia D69.6 - Thrombocytopenia, unspecified" "1502104-1" "1502104-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death Thrombocytopenia ORAL SWELLING FEVER" "1502205-1" "1502205-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death. Last known May 19, 2021. Found May 25, 2021" "1502285-1" "1502285-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death - Gastrointestinal hemorrhage, unspecified - Acute kidney failure, unspecified" "1503509-1" "1503509-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1505250-1" "1505250-1" "COVID19 VACCINE" "COVID19" "6-17 years" "6-17" "patient arrived in ventricular tachycardia via EMS, but responsive. deteoriarated to pulseless ventricular tachycardia, PEA and ultimately death." "1505461-1" "1505461-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1505509-1" "1505509-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Patient is deceased." "1505528-1" "1505528-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Discovered patient passed away within 30 days from vaccine" "1505530-1" "1505530-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "patient passed away" "1505591-1" "1505591-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1506767-1" "1506767-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Death" "1507895-1" "1507895-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1509547-1" "1509547-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine." "1509847-1" "1509847-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1511092-1" "1511092-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1512372-1" "1512372-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1512430-1" "1512430-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient past away." "1512442-1" "1512442-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "She collapsed in her bathroom and her boyfriend immediately began CPR. Paramedics were unable to revive her. Cardiac event." "1512863-1" "1512863-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient hospitalized and died of COVID after being vaccinated." "1515049-1" "1515049-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1515492-1" "1515492-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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"" "1518664-1" "1518664-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1519067-1" "1519067-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1519902-1" "1519902-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1522680-1" "1522680-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1523152-1" "1523152-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" ""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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "pt admitted for low BP" "1523226-1" "1523226-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1523422-1" "1523422-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "1525780-1" "1525780-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "death Other pulmonary embolism without acute cor pulmonale Unspecified convulsions" "1525795-1" "1525795-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death I26.99 - Other pulmonary embolism without acute cor pulmonale J18.9 - Pneumonia, unspecified organism" "1526026-1" "1526026-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Came to ER 7.15.2021 for leg wound" "1526275-1" "1526275-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1526529-1" "1526529-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Became lethargic and had malaise, called 911 and could only be heard breathing on the line. When EMS arrived, she was deceased." "1528593-1" "1528593-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Vaccinated patient, tested positive and was admitted with COVID on 5/21/2021. Patient passed away on 6/7/2021." "1528618-1" "1528618-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1528901-1" "1528901-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death shortness of breath N17.9 - AKI (acute kidney injury) K92.2 - Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type" "1528988-1" "1528988-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Gangrene of right foot with refused treatment No symptoms of COVID Date of death 4/14/2021" "1529585-1" "1529585-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "SUDDEN CARDIAC DEATH" "1529596-1" "1529596-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "SUDDEN CARDIAC DEATH" "1529599-1" "1529599-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "SUDDEN CARDIAC DEATH" "1529871-1" "1529871-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "SUDDEN CARDIAC DEATH" "1530068-1" "1530068-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Stroke on March 24, 2021. Widespread blood clots discovered on April 3rd, 2021. Death on April 5th, 2021." "1531545-1" "1531545-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient was found dead in his home on 07/27/2021." "1531963-1" "1531963-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Began on February 11, 2021: thrombocytopenia, anemia, pneumonia, multiple pulmonary embolisms, pulmonary aspergillosis pneumonia" "1532004-1" "1532004-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1532040-1" "1532040-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1532154-1" "1532154-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "The patient died of a hemorrhaging cerebral hemangioma 3 weeks after getting the vaccine." "1534829-1" "1534829-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death from blood clot" "1535531-1" "1535531-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "CARDIAC ARREST" "1535895-1" "1535895-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Brain Bleed, Hemorrhage (Intracranial Hemorrhage). Death" "1536023-1" "1536023-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient died at home of an apparent heart attack, was not rescesitated and did not make it to hospital" "1536241-1" "1536241-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "COVID PNEUMONIA DEATH 8/6/2021" "1536432-1" "1536432-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1537187-1" "1537187-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Pt died on April 15, 2021 of cardiac arrest." "1541088-1" "1541088-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "The patient died on 08/09/2021" "1541629-1" "1541629-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1542098-1" "1542098-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "DROWNING" "1542100-1" "1542100-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "PRESSUMED CARDIAC DEATH" "1542102-1" "1542102-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "SUDDEN CARDIAC DEATH" "1542103-1" "1542103-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "EPILEPSY" "1542104-1" "1542104-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "SUDDEN CARDIAC DEATH" "1542107-1" "1542107-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "CARDIOPULMONARY ARREST" "1542109-1" "1542109-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "SUDDEN CARDIAC ARREST" "1542844-1" "1542844-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "CARDIAC ARREST" "1544982-1" "1544982-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "CARDIOPULMONARY ARREST" "1545923-1" "1545923-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1549402-1" "1549402-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient death within 60 days of receiving a COVID vaccine" "1549500-1" "1549500-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Patient was hospitalized multiple times and died within 60 days of receiving a COVID vaccine series" "1549639-1" "1549639-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "developed fever, cough and diarrhea." "1549649-1" "1549649-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Resident tested positive for COVID-19, on 8/9/2021. He declined quickly and passed away on 8/10/2021." "1553967-1" "1553967-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "experienced dyspnea, diarrhea, nausea, vomiting Associated with a long term care facility" "1554013-1" "1554013-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient died on August 9, 2021." "1554249-1" "1554249-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1554444-1" "1554444-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Cough, dyspnea, fatigue, headache, pneumonia, chest pain and wheezing" "1558329-1" "1558329-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1558466-1" "1558466-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Felt fatigued the day before adverse event, died in his sleep of arterial occlusion" "1570787-1" "1570787-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1573992-1" "1573992-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Death" "1574074-1" "1574074-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1577895-1" "1577895-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away on 05/11/2021." "1577924-1" "1577924-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death on 3/21/2021 of respiratory illness" "1577966-1" "1577966-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1578274-1" "1578274-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient expired 4/10/2021 as reported by husband" "1578377-1" "1578377-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Admit 6/27. Vaccine 4/19, 5/18 PRIMARY CAUSE OF DEATH:Cardio respiratory Arrest secondary to Covid 19 pneumonia" "1578504-1" "1578504-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1578963-1" "1578963-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1582313-1" "1582313-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "presented to the hospital with weakness, fatigue, decreased appetite. diagnosed with pneumonia which progressed to ARDS" "1582987-1" "1582987-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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?" "1586730-1" "1586730-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "couch, SOB, chest pain resulting in hospitalization" "1587163-1" "1587163-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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!"" "1587255-1" "1587255-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away on 08/05/2021" "1591198-1" "1591198-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1591271-1" "1591271-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1592139-1" "1592139-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1597699-1" "1597699-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Increasingly weak after receiving vaccine. Tremors started 5 days after vaccine" "1604558-1" "1604558-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Brought on water retention and heart failure symptoms 3 weeks after second dose. Death on August 5 2021" "1617434-1" "1617434-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1617531-1" "1617531-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Severe septic shock, followed by death. Stomach pain, followed by hospitalization, gradual organ failure, septic shock and death." "1617585-1" "1617585-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Dilated cardiomyopathy- right ventricle. CAUSED DEATH!!!! Complained of a headache and tired two hours prior." "1623476-1" "1623476-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "DEATH" "1624122-1" "1624122-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "Expired" "1624134-1" "1624134-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "shortness of breath and weakness" "1624319-1" "1624319-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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" "1624537-1" "1624537-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Sudden death" "1625032-1" "1625032-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Loss of appetite after vaccine, fatigue, died of organ (liver) failure." "1628577-1" "1628577-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1628604-1" "1628604-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1636499-1" "1636499-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1636675-1" "1636675-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1636967-1" "1636967-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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." "1640942-1" "1640942-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Confusion" "1641180-1" "1641180-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Pt came to ER with difficulty breathing, came by EMS. Pt admitted to ICU." "1641249-1" "1641249-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Pt came to ER with difficulty breathing and cough onset 1 week ago. Patient admitted to ICU." "1641358-1" "1641358-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Difficulty breathing, on 6L oxygen from PCP office, cough, weakness." "1641444-1" "1641444-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Pt came to ER with SOB that began morning of. Found to be hypoxic by EMS." "1641484-1" "1641484-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1641586-1" "1641586-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "COVID infection. Specimen collected 8/8/21. Patient died on 8/11/21." "1642678-1" "1642678-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Veteran Died on 8/23/2021" "1644342-1" "1644342-1" "COVID19 VACCINE" "COVID19" "Unknown" "U" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "1645034-1" "1645034-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "1645204-1" "1645204-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1646186-1" "1646186-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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" "1654195-1" "1654195-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Blood clots resulting in many strokes, brain bleeding due to strokes resulting in crushing the Brain Stem, heart attacks and death" "1655115-1" "1655115-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1655701-1" "1655701-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1656401-1" "1656401-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Pt died on July 11, 2021" "1656560-1" "1656560-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1657576-1" "1657576-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient was very ill after her second dose and died two weeks later. Symptoms-fever, muscle aches, fatigue" "1658459-1" "1658459-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1658553-1" "1658553-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Janssen on 8/17. Positive 8/29. death at end hospital stay" "1658919-1" "1658919-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Death- 7-24-2021 Myocarditis" "1659476-1" "1659476-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1659951-1" "1659951-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death" "1660313-1" "1660313-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Swollen legs, could no longer walk, low platlet levels, needed a blood transfusion, cognitive decline, kidney failure, death" "1662858-1" "1662858-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "PATIENT BELIEVED TO HAVE HAD A STROKE PER DAUGHTER AND PASSED AWAY" "1662918-1" "1662918-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "cough, SOB, nausea x 7 days prior to hospital admission" "1666642-1" "1666642-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1670084-1" "1670084-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Died within 36 hours after first inoculation" "1670157-1" "1670157-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1670460-1" "1670460-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1673117-1" "1673117-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1675107-1" "1675107-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "He died , found dead after 24 hours, Closed casket, no foul play. I am unable to get an autopsy." "1678330-1" "1678330-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "See Attachments" "1679272-1" "1679272-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Wife claims that patient was coughing up blood after they received the shot and passed away, not much else was described" "1684789-1" "1684789-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1685315-1" "1685315-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1685563-1" "1685563-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Decedent on hospice for acute respiratory failure due to chronic obstructive pulmonary disease." "1685567-1" "1685567-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1685648-1" "1685648-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1688944-1" "1688944-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Pt came to ER c/o URI and nasal drainage onset 3 weeks prior." "1689072-1" "1689072-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Suffered a major heart attack on 09/06/2021 and expired on 09/07/2021 on hospice." "1689182-1" "1689182-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1689318-1" "1689318-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1689372-1" "1689372-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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"" "1689447-1" "1689447-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Pt came to ER c/o cough, difficulty breathing." "1689485-1" "1689485-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1689610-1" "1689610-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1689932-1" "1689932-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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)." "1693704-1" "1693704-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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." "1694308-1" "1694308-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1694567-1" "1694567-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1694645-1" "1694645-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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."" "1696195-1" "1696195-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "PT EXPIRED ON 09/09/2021" "1696273-1" "1696273-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Pt sent to ER via EMS for AMS and hypotension, cool to touch." "1696293-1" "1696293-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pt came to ER for jaundice on 2/23. Seen in ED again on 2/27 for weakness and fatigue." "1696571-1" "1696571-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Pt came to ER with confusion, nausea, fever one week prior, loss of appetite, on/off pressure to chest." "1696875-1" "1696875-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1697220-1" "1697220-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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."" "1700218-1" "1700218-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Pt came to ER c/o fever, hypoxia." "1700284-1" "1700284-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pt came to ER c/o difficulty breathing and cough. Onset 2 days prior." "1700329-1" "1700329-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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" "1700415-1" "1700415-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1700698-1" "1700698-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Pt came to ER c/o difficulty breathing and cough." "1700902-1" "1700902-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" ""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."" "1703893-1" "1703893-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "Death occurred 7 days after the second dose" "1703960-1" "1703960-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "Bilateral leg pain, history of venous thrombosis." "1704016-1" "1704016-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "presented with pneumonia due to COVID, respiratory failure, acute kidney injury, discharged to hospice where he died" "1704289-1" "1704289-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "sudden death" "1704505-1" "1704505-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient died 8/27/2021 at the Hospital with diagnosis of Pnuemonia caused by SARS-CoV-2" "1704749-1" "1704749-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1708627-1" "1708627-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "within a month started having shortness of breath, fatigue, and chest discomfort" "1713423-1" "1713423-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Back of heart collapsed." "1713660-1" "1713660-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1714418-1" "1714418-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Diffuse large B cell lymphoma" "1714965-1" "1714965-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1715299-1" "1715299-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "Short of breath, weak, lost consciousness, eventually lead to cardiac arrest, death" "1715538-1" "1715538-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1718168-1" "1718168-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "1718958-1" "1718958-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" ""Patient passed away on May 29th due to ""Sudden Cardiac Death due to Cardiomegaly."" "1718996-1" "1718996-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient received a 3rd dose of Moderna vaccine on 09/01/2021. Patient passed away on 09/11/2021 from cardiac arrest." "1719415-1" "1719415-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "extreme fatigue, sudden weight loss and distended belly" "1719457-1" "1719457-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "patient expired 9/18/2021" "1719477-1" "1719477-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1719557-1" "1719557-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1719650-1" "1719650-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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!!" "1722274-1" "1722274-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient never recovered after the shot and had difficulty breathing or holding conversations. She died 08/12/2021" "1722888-1" "1722888-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient presented with Edema and developed CHF and Cardiomyopathy progressing to death on 08/15/2021" "1722922-1" "1722922-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Pt with complaints of headache, painful legs, fatigue and died within 48 hrs of taking 2nd dose. Found in her bed." "1723432-1" "1723432-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death SHORTNESS OF BREATH U07.1, J12.82 - Pneumonia due to COVID-19 virus" "1723439-1" "1723439-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death COVID-19 Pneumonia due to coronavirus disease 2019 Acute respiratory failure with hypoxia" "1723566-1" "1723566-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "death N17.9 - Acute kidney failure, unspecified WEAKNESS - GENERALIZED RAPID HEART RATE" "1725384-1" "1725384-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1726211-1" "1726211-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Patient died on 9/13/2021. Verbally to be reported from a Pulmonary Embolism." "1726435-1" "1726435-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1729444-1" "1729444-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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!" "1731203-1" "1731203-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pt received Pfizer vaccination series at local pharmacy. Was hospitalized with COVID-19 diagnosis 9-20-21. Passed away 9-24-21." "1731354-1" "1731354-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1731372-1" "1731372-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1731745-1" "1731745-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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.)" "1732172-1" "1732172-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1734462-1" "1734462-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1735298-1" "1735298-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Death for no apparent reason" "1735402-1" "1735402-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient vaccinated 4/19/2021. Patient became immobile 4/30/2021. Patient died 5/9/2021." "1736821-1" "1736821-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1736918-1" "1736918-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Shortness of breath" "1737079-1" "1737079-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "1737526-1" "1737526-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1738037-1" "1738037-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Death on 9/24/21. Pfizer administered on 9/10/21. Jand J on 3/12/2021" "1740088-1" "1740088-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1740836-1" "1740836-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1741118-1" "1741118-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1741267-1" "1741267-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "Patient died and preliminary autopsy revealed Massive pulmonary embolism" "1741776-1" "1741776-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Fatal myocardial infarction" "1742182-1" "1742182-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "High fever. Died 3 weeks later from spontaneous brain bleed" "1749730-1" "1749730-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Patient found passed away in his sleep on 9/16/2021" "1753479-1" "1753479-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient fully vaccinated and hospitalized then later died due to Covid related causes." "1753893-1" "1753893-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1756001-1" "1756001-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1757610-1" "1757610-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1759308-1" "1759308-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1759458-1" "1759458-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1759504-1" "1759504-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1760635-1" "1760635-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "Death. My daughter passed away in her sleep ." "1761370-1" "1761370-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" ""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."" "1762006-1" "1762006-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "Died of COVID illness." "1762722-1" "1762722-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "Shortness of breath, dizziness and lightheaded" "1764846-1" "1764846-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1764920-1" "1764920-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient died after contracting COVID-19 in September 2021." "1765070-1" "1765070-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Onset of severe shortness of breath and death within several minutes." "1765535-1" "1765535-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1765690-1" "1765690-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1766159-1" "1766159-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death by heart attack" "1767952-1" "1767952-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1768151-1" "1768151-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1768225-1" "1768225-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Fever, Aches, Shortness of breath/difficulty breathing, Cough Cause of death: ACUTE HYPOXIC RESPIRATORY FAILURE, COVID PNEUMONIA" "1768495-1" "1768495-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death - Acute intracranial hemorrhage" "1770624-1" "1770624-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1771570-1" "1771570-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Patient expired with COVID-19 after COVID-19 vaccination" "1771747-1" "1771747-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "NA" "1775791-1" "1775791-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Found unresponsive in bed without pulse or respiration?s" "1776636-1" "1776636-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Died of heart attack 10 days after vaccine with no family history or prior indication of heart problems" "1776938-1" "1776938-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "COVID PCR +9/23/21. Admitted for shortness of breath on Bi-pap." "1779214-1" "1779214-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Notified by medical examiner that patient was found deceased at home 10/08/2021, no report of symptoms in interim" "1782484-1" "1782484-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "Patient Passed Away" "1782569-1" "1782569-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "On September 2nd of 2021 patient died." "1784945-1" "1784945-1" "COVID19 VACCINE" "COVID19" "6-17 years" "6-17" "Blood in airway, Death" "1785001-1" "1785001-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Atherosclerotic Cardiovascular Disease, Hypertension and Diabetes Mellitus" "1785118-1" "1785118-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Had Pfizer COVID on 12-18-20, 1-7-21. Have Pfizer COVID Booster on 9-29-21" "1785145-1" "1785145-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "1785234-1" "1785234-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "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." "1785447-1" "1785447-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "BREAKTHROUGH HOSPITALIZATION AND DEATH" "1785676-1" "1785676-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1787777-1" "1787777-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Sudden death on 9/3/2021" "1790377-1" "1790377-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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"" "1794355-1" "1794355-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "1794960-1" "1794960-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "1796350-1" "1796350-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Eye bulging out of socket Swelling on right side of face Next day DEATH 08/19/2021" "1797898-1" "1797898-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1797997-1" "1797997-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1798224-1" "1798224-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1798477-1" "1798477-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Death Less than Two weeks after vaccine Pfizer booster. Autopsy report stated cardiomyopathy with CHF . Died suddenly was previously healthy." "1799489-1" "1799489-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "1802763-1" "1802763-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1804051-1" "1804051-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "death Acute renal failure, unspecified acute renal failure type (CMS/HCC)" "1804117-1" "1804117-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Sudden Death" "1804256-1" "1804256-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1804274-1" "1804274-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient developed PEA arrest from massive PE 6/19/21. Patient died 6/21/21" "1804354-1" "1804354-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Died in her sleep 3 weeks after second vaccine..heart attack" "1804391-1" "1804391-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1804559-1" "1804559-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1804633-1" "1804633-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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." "1804641-1" "1804641-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Had breakthrough infection and passed away." "1804672-1" "1804672-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death E87.1 - Hypo-osmolality and hyponatremia" "1804809-1" "1804809-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1807590-1" "1807590-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1807886-1" "1807886-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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." "1808007-1" "1808007-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1810654-1" "1810654-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "1813852-1" "1813852-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Cardiopulmonary Arrest/ Cardiac Death/Myocardial Rupture" "1813898-1" "1813898-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1814787-1" "1814787-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1815096-1" "1815096-1" "COVID19 VACCINE" "COVID19" "6-17 years" "6-17" ""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."" "1815295-1" "1815295-1" "COVID19 VACCINE" "COVID19" "6-17 years" "6-17" "Acute Hyperglycemic Crisis" "1818171-1" "1818171-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1818204-1" "1818204-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Symptomatic on 09/18/2021: headache and myalgia" "1821065-1" "1821065-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Pt died on 05/04/2021. COVID Negative at time of death." "1821139-1" "1821139-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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)." "1821164-1" "1821164-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1821256-1" "1821256-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1821601-1" "1821601-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "death ABDOMINAL PAIN JAUNDICE N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia" "1821692-1" "1821692-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "death U07.1, J12.82 - Pneumonia due to COVID-19 virus" "1821773-1" "1821773-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1825439-1" "1825439-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1825612-1" "1825612-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1825631-1" "1825631-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Death" "1826661-1" "1826661-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1828685-1" "1828685-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1828699-1" "1828699-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1828802-1" "1828802-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death on 10/27/2021" "1828901-1" "1828901-1" "COVID19 VACCINE" "COVID19" "6-17 years" "6-17" "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." "1828975-1" "1828975-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1831721-1" "1831721-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "Blood clot induced death." "1832044-1" "1832044-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1833119-1" "1833119-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1833657-1" "1833657-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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'." "1839201-1" "1839201-1" "COVID19 VACCINE" "COVID19" "18-29 years" "18-29" "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" "1840440-1" "1840440-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1842829-1" "1842829-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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."" "1843222-1" "1843222-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1843289-1" "1843289-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Patient received the vaccination one week prior to death" "1843328-1" "1843328-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "One week later, decedent experienced shortness of breath, diarrhea, pneumonia, hypoxia, elevated troponin" "1843805-1" "1843805-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1847400-1" "1847400-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Swollen throat" "1848307-1" "1848307-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1849480-1" "1849480-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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" "1849728-1" "1849728-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1849876-1" "1849876-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1850380-1" "1850380-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "1850726-1" "1850726-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Headache, body aches, complained about not being able to get out of bed, couldn't talk, suffered heart attack." "1850811-1" "1850811-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1850904-1" "1850904-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "unknown pt possibly passed from covid complications." "1850989-1" "1850989-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "My father got very sick and weak- his heart started shutting down and he died" "1854176-1" "1854176-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1854317-1" "1854317-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1854890-1" "1854890-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "Suicide on 11/8/21" "1857596-1" "1857596-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "DIAGNOSIS 1. Acute chest pain 2. Elevated troponin level 3. SOB (shortness of breath) 4. Elevated d-dimer DECEASED" "1857677-1" "1857677-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1858297-1" "1858297-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "[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" "1860168-1" "1860168-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "1864738-1" "1864738-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1865333-1" "1865333-1" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1865474-1" "1865474-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Event: Low Platelet count. Treatment: Received radiation therapy and blood infusions Outcome: Death" "1865581-1" "1865581-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away on 08/26/2021." "1865615-1" "1865615-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Patient passed away on 10/21/2021" "1867933-1" "1867933-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" ""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."" "1868024-1" "1868024-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "1869598-1" "1869598-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1869633-1" "1869633-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death- unexplained" "1869644-1" "1869644-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1869664-1" "1869664-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" ""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."" "1869927-1" "1869927-1" "COVID19 VACCINE" "COVID19" "30-39 years" "30-39" "General malaise, fatigue." "1872660-1" "1872660-1" "COVID19 VACCINE" "COVID19" "Unknown" "U" "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" "1873273-1" "1873273-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1873551-1" "1873551-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "40-49 years" "40-49" "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." "1873689-1" "1873689-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1873779-1" "1873779-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1874394-1" "1874394-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death (Found dead in bed on 03-09-2021 by staff)." "1876748-1" "1876748-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Pt death. Unsure of cause of death" "1876807-1" "1876807-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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." "1877266-1" "1877266-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1877338-1" "1877338-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1877549-1" "1877549-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" ""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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Ataxia, encephalitis." "1879616-1" "1879616-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "1880619-1" "1880619-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "Increased fatigue and SOB 1 week after receiving vaccine, Acute MI 4 weeks after vaccine administration" "1881273-1" "1881273-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Death - Symptoms unknown" "1881390-1" "1881390-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1884298-1" "1884298-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "1885034-1" "1885034-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "DEATH" "1885300-1" "1885300-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death Non-ST elevation (NSTEMI) myocardial infarction Acute kidney failure, unspecified Thrombocytopenia, unspecified" "1885309-1" "1885309-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death - TIA (transient ischemic attack) - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC)" "1885324-1" "1885324-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "death- Acute kidney failure, unspecified" "1885417-1" "1885417-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1885574-1" "1885574-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Not listed." "1887894-1" "1887894-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Rapid declining health and death 14 days after covid booster shot" "1888979-1" "1888979-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "My brother died from a heart attack just 21 days after receiving his Moderna vaccine." "1889162-1" "1889162-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Had booster. Don't have her card with me. Very sick, totally weak." "1889278-1" "1889278-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Blood clots in the lungs cardiac arrest sever headache" "1889986-1" "1889986-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1890222-1" "1890222-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Death" "1890266-1" "1890266-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Blood clot" "1893761-1" "1893761-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1894487-1" "1894487-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "1895092-1" "1895092-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "the vaccine recepient died 9/9/2021, 2 weeks after receiving the J&J covid vaccine" "1897295-1" "1897295-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient passed away 2/2/2021" "1897811-1" "1897811-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "1897886-1" "1897886-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "cause of death-complications of covid 19. fully vaccinated" "1898729-1" "1898729-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1899642-1" "1899642-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient had hematoma form on arm then 3 days later died suddenly" "1902165-1" "1902165-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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." "1905900-1" "1905900-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient had severe hypoxia and hypotension, arrived to the hospital on 11/25/21, was intubated, and died 8hrs later." "1906913-1" "1906913-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "3 weeks after 3 shot Patient started to experience more breathing issues, ended up with phenomena x2 and passed away" "1909167-1" "1909167-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1909307-1" "1909307-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1909574-1" "1909574-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "Patient had brain hemorrhage 11 days following 0.25ml Moderna booster vaccination and died" "1909882-1" "1909882-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Died of heart attack on May 3." "1909908-1" "1909908-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" ""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. """" "1910053-1" "1910053-1" "COVID19 VACCINE" "COVID19" "50-59 years" "50-59" "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" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1912324-1" "1912324-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "DRIZZY, UNABLE TO WALK, UNABLE TO EAT, DARK CIRCLES UNDER EYES, PAIN THROUGH OUT BODY." "1912626-1" "1912626-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "Passed away. Swollen body, blue lips, oxygen deprived, clotting" "1912847-1" "1912847-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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." "1913135-1" "1913135-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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)." "1913198-1" "1913198-1" "COVID19 VACCINE" "COVID19" "6-17 years" "6-17" "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." "1915672-1" "1915672-1" "COVID19 VACCINE" "COVID19" "60-64 years" "60-64" "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" "1916675-1" "1916675-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "Patient passed away 45 days after receiving covid dose #3" "1916804-1" "1916804-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "11/23/2021 Resident noted to have garbled speech, slight weakness to R arm, pupils fixed, R side weaker than L" "1917294-1" "1917294-1" "COVID19 VACCINE" "COVID19" "65-79 years" "65-79" "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" "1917345-1" "1917345-1" "COVID19 VACCINE" "COVID19" "80+ years" "80+" "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." "---" "Dataset: The Vaccine Adverse Event Reporting System (VAERS)" "Query Parameters:" "Date Died: 2020; 2021" "Date of Onset: 2020; 2021" "Date Report Completed: 2020; 2021" "Date Report Received: 2020; 2021" "Date Vaccinated: 2020; 2021" "Event Category: Death; Life Threatening; Permanent Disability; Congenital Anomaly / Birth Defect *" "Onset Interval: 10-14 days; 15-30 days; 31-60 days" "Serious: Yes" "State / Territory: The United States/Territories/Unknown" "Vaccine Products: COVID19 VACCINE (COVID19)" "VAERS ID: All" "Group By: VAERS ID; Vaccine Type; Age" "Show Totals: False" "Show Zero Values: Disabled" "---" "Help: See http://wonder.cdc.gov/wonder/help/vaers.html for more information." "---" "Query Date: Dec 11, 2021 7:13:39 PM" "---" "Suggested Citation: Accessed at http://wonder.cdc.gov/vaers.html on Dec 11, 2021 7:13:39 PM" "---" Messages: "1. The full results are too long to be displayed, only non-zero rows are available." "2. VAERS data in CDC WONDER are updated every Friday. Hence, results for the same query can change from week to week." "3. These results are for 2,166 total events." "4. 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." "5. 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. Under Title 21, Code of Federal Regulations Section 600.80: http://wonder.cdc.gov/wonder/help/vaers/21CFR600-80.htm., a" "serious event is defined with any of the following outcomes: Death, a life-threatening adverse experience, inpatient" "hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital" "anomaly/birth defect." "6. Values of Event Category field vary in their availability over time due to changes in the reporting form. The ""Emergency" "Room/Office Visit"" value was avaliable only for events reported using the VAERS-1 form, active 07/01/1990 to 06/29/2017. The" """Congenital Anomaly/Birth Defect"", ""Emergency Room"", and ""Office Visit"" values are available only for events reported" "using the VAERS 2.0 form, active 06/30/2017 to present. These changes must be considered when evaluating count of events for" "these categories." "7. About COVID19 vaccines: "