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Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: death; This is a spontaneous report from a contactable physician based on information received by Pfizer from Biontech [manufacturer control number: 88130], license party for BNT162B2 (COMIRNATY). A 16-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at 16-year-old) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that parents stated on 16 years old female patient who received a vaccination in the morning and was found dead in her bed in the afternoon. No further details and no cause of death could be obtained by reporting physician. The patient died on an unspecified date. It was not reported if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. 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: death
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