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Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: Patient died; This is a spontaneous report from a contactable physician. A 91-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EN1185), intramuscular at single dose on 17Feb2021 for covid-19 immunisation. Medical history included Alzheimer''s disease. Concomitant medications were not reported. The patient died on 19Feb2021 14:45. No treatment required. An autopsy was not performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, 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: patient died
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