이상반응 보고
| VAERS ID | 2324581 |
|---|---|
| 성별 | 남성 |
| 나이 | 80세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | ACB7737 |
| 예방접종 횟수 | 4 |
| 접종일 | 2022-04-29 |
| 발병일 | 2022-04-29 |
| 상태 | 사망 |
증상
- 면제(Immunisation)
- 죽음(Death)
- 오프 라벨 사용(Off label use)
- 심근염(Myocarditis)
- 색전증(Embolism)
- 사출 분수(Ejection fraction)
- 장치 관련 혈전증(Device related thrombosis)
이환 중 질병
Arterial hypertension; Circumflex artery stenosis; Diabetes mellitus
지병
Medical History/Concurrent Conditions: Drug-eluting stent placement; Percutaneous transluminal coronary angioplasty
기타 의료
이전 예방접종
알레르기
임상 검사
Test Name: Ejection fraction; Test Result: 25 %
증상 상세
myocarditis; Unknown cause of death; cardiac embolism with thrombosis of this embolus; Cardiac thrombosis; Booster; off label use; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from the Agency Agency-WEB.
Regulatory number: DE-PEI-CADR2022298622.
Other Case identifier(s): DE-CADRPEI-2022298622, DE-PEI-202200117379.
An 80-year-old male patient received BNT162b2 (COMIRNATY), on 29Apr2022 as dose 4 (booster), 0.
.
3 ml single (Lot number: ACB7737) at the age of 80 years for covid-19 immunisation.
The patient's relevant medical history included: "Circumflex artery stenosis" (ongoing); "Diabetes mellitus" (ongoing); "Arterial hypertension" (ongoing); "percutaneous transluminal coronary angioplasty" (unspecified if ongoing); "drug-eluting stent" (unspecified if ongoing).
The patient's concomitant medications were not reported.
Vaccination history included: comirnaty (Dose number unknown, Batch/Lot number: unknown.
Strength: 0.
3ml), administration date: 09Nov2021, for Covid-19 immunization.
The following information was reported: IMMUNISATION (death, medically significant) with onset 29Apr2022, outcome "fatal", described as "Booster"; OFF LABEL USE (death, medically significant) with onset 29Apr2022, outcome "fatal"; DEVICE RELATED THROMBOSIS (medically significant) with onset 17May2022, outcome "recovering", described as "Cardiac thrombosis"; EMBOLISM (medically significant) with onset 17May2022, outcome "recovering", described as "cardiac embolism with thrombosis of this embolus"; DEATH (death, medically significant) with onset 25May2022, outcome "fatal", described as "Unknown cause of death"; MYOCARDITIS (medically significant), outcome "unknown".
The patient underwent the following laboratory tests and procedures: Ejection fraction: 25 %.
Therapeutic measures were taken as a result of device related thrombosis, embolism.
The patient date of death was 25May2022.
Reported cause of death: "Death".
It was not reported if an autopsy was performed.
Sender Comment: Do you or the person concerned have any known allergies? If yes, which? no.
Information on risk factors or previous illnesses: Art.
Hypertension, D.
mellitus (OAD) / Patient with new global red.
EF (Ejection fraction) of 25% in moderate to severe CX stenosis with PTCA (percutaneous transluminal coronary angioplasty) and double DES (drug-eluting stent) implantation RIVA (Ramus InterVentricularis Anterior) on 17May2022.
After he complained about cardiac problems shortly after the first booster vaccination and complained about a clear progression of these symptoms shortly after the second booster vaccination.
Now a week after treatment of the deposits called exitus letalis, which were described as thrombotic in the heart catheter findings.
There was at least an obvious temporal connection between complaints or death and vaccination.
In principle, an initial myocarditis is progressive.
red.
EF and/or cardiac embolism with thrombosis of this embolus and subsequent death conceivable.
Reaction(s) / Event(s) Assessed: Cardiac thrombosis, Unknown cause of death/Source of assessment: Agency/Result of Assessment: D.
Unclassifiable No follow-up attempts are possible.
No further information is expected.
; Reported Cause(s) of Death: Death