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Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: death; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The medical history was not reported. The concomitant medications were not reported. It was unknown if the patient was pregnant at the time of report. The patient died 8 days after receiving bnt162b2. Death cause was not provided; it was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: The information provided is too limited for a reasonable medical assessment. There was no information provided regarding the specific cause of death, detailed medical history and counteractive treatment measures. As per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified and re-assessed based on additional data. Queries are in place for the missing information. This case will be updated once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study 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: Unknown cause of death
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