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Life Threatening? No
Write-up: was found dead in her home; This is a spontaneous report received from a contactable other HCP via regulatory authority. A 77-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK4238) via an unspecified route of administration on an unspecified date (at the age of 77-year-old), at single dose for COVID-19 immunisation. Relevant medical history included ischemic heart disease, rheumatoid factor (as reported), hypertension and diabetes. Concomitant medications were not reported. The patient was found dead in her home on the day of the vaccine. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The reported event is likely due to underlying disease, however, unless further information regarding specific cause of death is provided, at present, the reported event death, cause unknown, is assessed as possibly related to BNT162B2, as a cautionary measure and for reporting purposes. 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: was found dead in her home
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