이상반응 보고
VAERS ID | 2589815 |
---|---|
성별 | 알 수 없음 |
나이 | |
주 코드 | FR |
제약회사 | PFIZER\BIONTECH |
로트 번호 | |
예방접종 횟수 | |
접종일 | |
발병일 | |
상태 | 사망 |
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Death; This is a spontaneous report received from a contactable reporter(s) (Physician) from a sales representative.
A patient (no qualifiers provided) received BNT162b2 (COMIRNATY NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation.
The patient's relevant medical history and concomitant medications were not reported.
The following information was reported: DEATH (death, medically significant), outcome "fatal".
The date and cause of death for the patient were unknown.
It was not reported if an autopsy was performed.
Additional information: On an unspecified date, the patient died.
The reporter classified the event as serious(death).
The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
; Sender's Comments: The Company cannot completely exclude a causal relationship between BNT162b2 vaccine and patient's death of unknown cause, as a cautionary measure and for reporting purposes.
There is minimal information in the case at this time.
Case will be reassessed upon receipt of additional information.
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