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Life Threatening? No
Write-up: deaths; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. The regulatory authority report number is not provided. An elderly patient of unspecified gender received BNT162B2 (COMIRNATY) at single dose on an unspecified date for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient experienced deaths. The reporter was reporting the deaths of elderly individual this week. The death was considered by the Agency, the Regulatory Authority and medical staff involved to be unrelated to the administration of BNT162B2 but were reported through an abundance of caution. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Death with unknown cause is considered related to BNT162B2 for reporting purpose. Case will be reassessed once receiving additional information, including cause of death and clinical course. 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: deaths
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