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Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: was found dead in his home; This is a spontaneous report received from Health Care Professional via Agency Regulatory Authority. A 74-years-old male patient received the second dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EK4238) at single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient was found dead in his home on an unspecified date. the cause of patient''s death was unknown at the reporting time. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow up attempts are possible, no further information is expected.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any 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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