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VAERS ID	2583863
성별	남성
나이	96세
주 코드	FR
제약회사	PFIZER\BIONTECH
로트 번호
예방접종 횟수	4
접종일	2022-08-07
발병일	2022-08-07
상태	입원 사망

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Test Date: 20220807; Test Name: body temperature; Result Unstructured Data: Test Result: 38 Centigrade; Comments: pyrexia; Test Date: 20220808; Test Name: body temperature; Result Unstructured Data: Test Result: 39.
1 Centigrade.

증상 상세

developed pyrexia of 38 degrees centigrade/increased up to 39.
1 degrees centigrade on the following day; Pneumonia aspiration; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from License Party.
A 96-year-old male patient received BNT162b2 (COMIRNATY), on 07Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 96 years intramuscular for covid-19 immunisation.
The patient's relevant medical history and concomitant medications were not reported.
Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunisation.
The following information was reported: PNEUMONIA ASPIRATION (death) with onset 2022, outcome "fatal"; PYREXIA (hospitalization) with onset 07Aug2022, outcome "not recovered", described as "developed pyrexia of 38 degrees centigrade/increased up to 39.
1 degrees centigrade on the following day".
The patient was hospitalized for pyrexia (start date: 08Aug2022).
The patient underwent the following laboratory tests and procedures: Body temperature: (07Aug2022) 38 Centigrade, notes: pyrexia; (08Aug2022) 39.
1 Centigrade.
The patient date of death was 30Oct2022.
Reported cause of death: "Pneumonia aspiration".
It was not reported if an autopsy was performed.
The patient was a 96-year and 6-month-old male.
The patient's primary disease/complication was unknown.
The reporter classified the event pneumonia aspiration as serious (death) and assessed that the event was related to BNT162b2.
The course of the event was as follows: on 07Aug2022, the patient received a vaccination.
From the evening, he developed pyrexia of 38 degrees centigrade, which increased up to 39.
1 degrees centigrade on the following day, and he was admitted to the hospital.
Although he had been hospitalized for about 2 months, his condition did not recover.
At the end of Oct2022, he died due to pneumonia aspiration.
Since the patient had no underlying disease, the physician judged as related.
The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
BNT162b2 is under agreement with Private PHARMACEUTICAL.
; Sender's Comments: Based on available information, a possible contributory role of subject product cannot be excluded for the reported event pyrexia, based on temporal relationship and the known safety profile .
Based on the information provided by the reporter, it appears unlikely that the subject product contributed to the other reported event pneumonia aspiration, which likely represent intercurrent medical condition.
There is very limited information provided in this report.
This case will be reassessed upon receipt of follow-up 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: Pneumonia aspiration