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Life Threatening? No
Write-up: ischemic stroke of the brain with secondary haemorrhage; atrial fibrillation and flutter; atrial fibrillation and flutter; Ischemic stroke of the brain; This is a spontaneous report from a contactable consumer (patient''s granddaughter) downloaded from the regulatory authority [PL-URPL-DML-MLP.4401.2.127.2021]. A 79-year-old male patient received BNT162B2 (COMIRNATY, Lot Number: EJ6136) intramuscular on 04Feb2021 at age of 79-year-old at single dose for COVID-19 immunisation. Medical history included ongoing atherosclerosis, ongoing hypertension, ongoing diabetes, ongoing persistent atrial fibrillation, ongoing cardiac insufficiency (heart failure), ongoing chronic renal failure. The patient''s concomitant medications were not reported. The patient experienced ischemic stroke on 06Feb2021. The patient died on 09Feb2021. An autopsy was not performed. Direct cause of death: ischemic stroke of the brain with secondary haemorrhage; initial cause of death: atrial fibrillation and flutter. The outcome of the events was fatal. The reporting person did not classify the severity of the report. Due to the nature of the side effects and the patient''s death, HA classified the report as serious. Sender Comment: The reported adverse reactions have not yet been included under these terms in the Summary of Product Characteristics of Comirnaty. It cannot be ruled out that the reported cardiovascular diseases of the patient contributed to his death. HA has no information on any additional circumstances (medications used, allergies, etc.) that could have resulted in death. The temporal relationship supports a cause-and-effect relationship. The reporting person did not classify the severity of the report. Due to the nature of the side effects and the patient''s death, regulatory authority classified the report as serious. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: ischemic stroke of the brain with secondary haemorrhage; ischemic stroke of the brain with secondary haemorrhage; Atrial fibrillation and flutter; Atrial fibrillation and flutter
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