이상반응 보고

VAERS ID	2013192
성별	여성
나이
주 코드	FR
제약회사	PFIZER\BIONTECH
로트 번호	EX7389
예방접종 횟수	2
접종일	2021-05-02
발병일	2021-11-07
상태	입원 사망

증상

• SARS-CoV-2 테스트(SARS-CoV-2 test)
• 코로나19 폐렴(COVID-19 pneumonia)
• 예방접종 실패(Vaccination failure)

이환 중 질병

지병

Medical History/Concurrent Conditions: Chronic renal failure; Hypertensive heart disease

기타 의료

이전 예방접종

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임상 검사

Test Date: 20211107; Test Name: COVID-19 PCR test positive; Test Result: Positive ; Comments: SEQUENCING VARIANT AY42

증상 상세

INEFFECTIVE DRUG; COVID 19 PNEUMONIA; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority EudraVigilance-WEB and product quality group.
Regulatory number: IT-MINISAL02-825421.
A 74 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm, administration date 02May2021 13:15 (Lot number: EX7389) as dose 2, 30ug single and intramuscular, administration date 11Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation.
Relevant medical history included: "Chronic renal failure" (unknown if ongoing); "Hypertensive heart disease" (unknown if ongoing).
The patient's concomitant medications were not reported.
The following information was reported: VACCINATION FAILURE (death) with onset 07Nov2021, outcome "fatal", described as "INEFFECTIVE DRUG"; COVID-19 PNEUMONIA (death) with onset 07Nov2021, outcome "fatal", described as "COVID 19 PNEUMONIA".
The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Nov2021) positive, notes: SEQUENCING VARIANT AY42.
It was not reported if an autopsy was performed.
It was reported that the patient was taken to intensive care.
Reporter Comment: SECOND DOSE.
DELTOID INTRAMUSCULAR ADMINISTRATION.
SEQUENCING VARIANT AY42 The lot number for bnt162b2 was not provided and will be requested during follow up.
; Reporter's Comments: SECOND DOSE.
DELTOID INTRAMUSCULAR ADMINISTRATION.
SEQUENCING VARIANT AY42; Reported Cause(s) of Death: Death