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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: patient passed away after receiving the Covid vaccine; This is a spontaneous report from a contactable nurse. An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular into the right arm on 07Jan2021 at 0.3 mL, single for covid-19 immunization. There was no medical history and no concomitant medications. On 08Jan2021, the patient passed away after receiving the COVID vaccine. The patient died on 08Jan2021. An autopsy was not performed. Investigations indicate that unspecified labs were done, but nothing two weeks prior; no further details were provided. The patient received the first dose the day prior. The reporting nurse discussed it with the medical director, and he thought that he potentially passed away from the COVID vaccine. The relatedness of the event to the suspect vaccine was reported as related by the reporting nurse per The Agency. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender''s Comments: Based on the limited information available, it is medically not possible to make meaningful causality assessment, it is unlikely the vaccine could have contributed to the death of the patient based on the known safety profile. However case will be reevaluated when additional information is received during the follow-up 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: Stated that the patient passed away after receiving the Covid vaccine
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