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Life Threatening? No
Write-up: suddenly died; This is a spontaneous report from a contactable physician received from the Regulatory Authority. A 76-year-old male patient received the second dose of BNT162B2 (PFIZER concentrate for dispersion for injection, tozinameran; MAH: BioNTech Manufacturing GmbH, batch number: not reported, expiry date: unknown), administration route and site not reported, at 0.3 ml single dose on 20Apr2021 for COVID-19 immunisation. In the patient medical history, there was myocardial infarction, severe lower limb vasoconstriction and lung neoplasm malignant. The patient''s concomitant medications were not reported. On 20Apr2021, the patient suddenly died. It was unknown if an autopsy was performed. According to the patient wife, he experienced stabbing chest pain in the morning, before the vaccination. According to the reporter, there was no causal relationship between sudden death and vaccination. Sender Comment: Sudden death is not expected after the use of Comirnaty concentrate for injection. TTO is less than a day. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the events is considered not assessable per lack of information. The case is considered serious due to fatal outcome. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Sender''s Comments: Based on the available information and known product profile, the causal relationship between the reported fatality and the use of the vaccine is unrelated, in agreement with the reporting physician. This is considering that the patient was reported to have had already experienced stabbing chest pain in the morning, before the vaccination which may indicate an ongoing event prior to vaccination. The possibility that the noted stabbing chest pain is a manifestation of an unknown fatal event is supported a history of myocardial infarction, severe lower limb vasoconstriction and lung neoplasm malignant. The case will be assessed further upon receipt of additional information.; Reported Cause(s) of Death: suddenly died
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