이상반응 보고

VAERS ID	1533660
성별	남성
나이	78세
주 코드	FR
제약회사	PFIZER\BIONTECH
로트 번호	EY0573
예방접종 횟수	1
접종일	2021-07-05
발병일	2021-07-01
상태	사망

증상

• 죽음(Death)

이환 중 질병

지병

Medical History/Concurrent Conditions: Gastrointestinal stromal tumor; Lung cancer recurrent (postoperative recurrent).

기타 의료

BAYASPIRIN; NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]

이전 예방접종

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임상 검사

증상 상세

died at home; This is a spontaneous report from a contactable physician received via the Regulatory Authority.
A 78-year-old male patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) intramuscular in the left arm on 05Jul2021 at 11:15 at age of 78 years old as single dose for COVID-19 immunization.
Medical history included postoperative recurrent lung cancer and gastrointestinal stromal tumor (GIST) of stomach.
The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
The patient received acetylsalicylic acid (BAYASPIRIN), esomeprazole magnesium hydrate (NEXIUM) and other unspecified medications within 2 weeks of vaccination.
Prior to vaccination, the patient was not diagnosed with COVID-19.
On an unspecified date in July2021 at unspecified time (unknown days after the vaccination), the patient died at home, and local police telephoned the reporter.
The event resulted in death.
It was unknown if the patient received any treatment for the event.
The reporting physician assessed the event as serious (death).
The cause of death was reported as unknown (the causal relationship could not be denied) lung cancer, the patient had GIST of stomach.
It was unknown if autopsy was performed.
Since the vaccination, the patient has not been tested for COVID-19.
; Sender's Comments: Based on current convention, the reported death is assessed as related to BNT162b2 until sufficient information is available to confirm an unrelated cause of death.
The patient's underlying risk factors/predisposing condition postoperative recurrent lung cancer and gastrointestinal stromal tumor (GIST) of stomach have been assessed to provide an alternative explanation.
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 RAs, Ethics Committees, and investigators, as appropriate.
; Reported Cause(s) of Death: Unknown cause of death