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Life Threatening? No
Write-up: death; shortness of breath; This is a spontaneous report from a contactable physician. This is a report based on information received by Pfizer from a regulatory authority. An 80-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 08Apr2021 as single dose for covid-19 immunisation. Medical history included heart insufficiency from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient was vaccinated on 08Apr2021 with the 1st dose of BioNtech corona vaccine. The patient has been doing well so far. Shortness of breath began around 24 hours late (09Apr2021). Then patient died on 10Apr2021 due to an unknown cause of death. It was not reported if an autopsy was performed. Outcome of shortness of breath was unknown. Follow-up (12Apr2021): New information received by Pfizer from a contactable physician via BioNTech (license number: 36038), license party for COMIRNATY. Batch/lot number: EW8904.; Sender''s Comments: Lacking any details on the circumstances and cause of patient''s demise, the reported death is considered as related to BNT162B2 as a cautionary measure only. 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: unknown cause of death
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