이상반응 보고
| VAERS ID | 2265177 |
|---|---|
| 성별 | 여성 |
| 나이 | 87세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | ACB7737 |
| 예방접종 횟수 | 4 |
| 접종일 | 2022-04-21 |
| 발병일 | 2022-04-23 |
| 상태 | 입원 사망 |
증상
- 면제(Immunisation)
- 토혈(Haematemesis)
- 죽음(Death)
- 오프 라벨 사용(Off label use)
이환 중 질병
Cardiac insufficiency; COPD
지병
Medical History/Concurrent Conditions: Anticoagulant therapy (Apixaban)
기타 의료
이전 예방접종
알레르기
임상 검사
증상 상세
resulting in hematinized vomiting under apixaban -; off label use; Immunization; Cause of death unknown; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority.
Regulatory number: DE-PEI-CADR2022293180.
Other Case identifier(s): DE-CADRPEI-2022293180, DE-PEI-202200105680.
An 87-year-old female patient received BNT162b2 (COMIRNATY), on 21Apr2022 as dose 4 (booster),0.
3 ml single (Lot number: ACB7737) at the age of 87 years for covid-19 immunisation.
The patient's relevant medical history included: "COPD" (ongoing); "Cardiac insufficiency" (ongoing); "anticoagulation" (unspecified if ongoing), notes: Apixaban.
The patient's concomitant medications were not reported.
Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown), for Covid-19 vaccination; Covid-19 vaccine (2nd dose, manufacturer unknown), for Covid-19 vaccination; Covid-19 vaccine (3rd dose, manufacturer unknown), for Covid-19 vaccination.
The following information was reported: HAEMATEMESIS (hospitalization, medically significant) with onset 23Apr2022, outcome "not recovered", described as "resulting in hematinized vomiting under apixaban -"; DEATH (death, medically significant) with onset 27Apr2022, outcome "fatal", described as "Cause of death unknown"; OFF LABEL USE (death), outcome "fatal"; IMMUNISATION (death), outcome "fatal", described as "Immunization".
The patient was hospitalized for haematemesis (start date: 26Apr2022).
The patient date of death was 27Apr2022.
The reported cause of death was unknown.
It was not reported if an autopsy was performed.
Sender Comment: Information on risk factors or previous illnesses Complex history / COPD / heart failure / anticoagulation.
Close temporal relationship between vaccination and symptoms/deterioration of condition/death/ Inpatient admission on 26Apr2022 - Patient died in the PRIVACY hospital on 27Apr2022 Relatedness of drug to reactions/events Source of assessment: Regulatory Authority Result of Assessment: D.
Unclassifiable No follow-up attempts are possible.
No further information is expected.
; Sender's Comments: Linked Report(s) : DE-PFIZER INC-202200658912 same patient, different drug; Reported Cause(s) of Death: Unknown cause of death