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Life Threatening? No
Write-up: COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-291121 received via regulatory authority. This spontaneous, serious, medically confirmed case was reported on 28Apr2021 by a physician and concerns the occurrence of Covid-19 infection resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. A 70-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot Number: ET1831), intramuscular in right arm on 17Mar2021 at 0.3 ml single for covid-19 immunisation. The patient was hospitalized on 27Mar2021 because of weakness which has been ongoing for 1 week and difficulty in breathing which occurred the day before. Previously a covid antigen was done on 23Mar2021 because the patient''s daughter got infected with covid, who she lives together with. The test result was positive. Bilateral pneumonia was confirmed in the hospital. The patient received antiviral, steroid, anticoagulant, anti-decompensation therapy and ulcus prophylaxis. Despite the therapy, the patients oxygenation continued to worsen and passed away on 30Mar2021 at 18:02. Medical history included atherosclerosis of arteries of the extremities, cardiac insufficiency, cardiomyophathy, COPD, non-insulin-dependent diabetes mellitus, hypertension, measles, myocardial infarct, obesity, respiratory insufficiency, triple vessel disease and ventricular tachycardia. Drug history included Xigduo (metformin; dapagliflozin), clopidogrel and canakinumab. Concomitant drugs were ASA Protect Pharmavit 100 mg (acetylsalicylic acid), Concor 2.5 mg (bisoprolol fumarate), Cordarone 100 mg (amiodarone), Furon 40 mg (furosemide), Kalim-R 1 g (potassium chloride), Nolpaza 40 mg (pantoprazole), Renitec 2.5 mg (enalapril) and Synjardy (empagliflozin; metformin). Further information is not expected. Sender Comment: According to the information of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient got infected with Covid-19 6 days after the first dose, therefore immunity may have not developed yet. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse event as the patient died due to Covid-19. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the available information the event "infected with Covid-19" is attributed to an intercurrent medical condition that was not related to BNT162B2 (COMIRNATY0 vaccine.; Reported Cause(s) of Death: covid-19
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