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Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: Death (Geromarasmus); This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A female patient in her 90''s received BNT162B2 (COMIRNATY, Lot unknown, first dose) solution for injection intramuscular on 19Apr2021 at 16:00 (at the age of 90''s) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 20Apr2021 at 05:30 (13 hours and 30 minutes after the vaccination), the patient died (geromarasmus). The outcome of the event was fatal. It was not reported if an autopsy was performed. The pharmacist stated/reported that the primary physician considered that the event was unrelated to BNT162b2 and stated that the cause of death was geromarasmus. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the available information the event geromarasmus is attributed to an underlying medical condition and assessed Unrelated to BNT162B2 (COMIRNATY) 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: geromarasmus
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