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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: suddenly passed away; This is a spontaneous report from a contactable healthcare professional reporting on behalf of friend''s husband. A 43-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Apr20201, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient suddenly passed away on 11Apr2021. It was unknown if an autopsy was performed or not. The patient passed away at home and he was otherwise healthy. The reporter stated there was not a way to know if it was related to the vaccine as of right now. Information on lot number/batch number has been requested.; Sender''s Comments: Limited information precludes a medically meaningful assessment of the case. A possible contributory role of the suspect product BNT162B2 to the development of event Sudden death cannot be totally excluded. The case will be reassessed if additional information becomes available. 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: suddenly passed away
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