이상반응 보고
| VAERS ID | 2173996 |
|---|---|
| 성별 | 남성 |
| 나이 | 55세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | ACB5318 |
| 예방접종 횟수 | 2 |
| 접종일 | 2022-01-15 |
| 발병일 | 2022-02-04 |
| 상태 | 입원 중증 사망 |
증상
- 급성 심근경색(Acute myocardial infarction)
- 대동맥 박리(Aortic dissection)
- 심실 중격 결손(Ventricular septal defect)
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증상 상세
Ventricular septal defect; Acute myocardial infarction / acute myocardial infarction with ST elevation; Type A aortic dissection with cardiogenic shock; This is a spontaneous report received from non-contactable reporter (Consumer and Other HCP) from the regulatory authority-WEB.
Regulatory number: DE-PEI-202200085125 (regulatory authority).
A 55-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15Jan2022 (Lot number: ACB5318) at the age of 55 years as dose 2, single for covid-19 immunisation.
The patient's relevant medical history and concomitant medications were not reported.
Vaccination history included: Comirnaty (DOSE 1, 0.
3 ml), administration date: 21Dec2021, for covid-19 immunisation.
The following information was reported: AORTIC DISSECTION (death) with onset 05Feb2022, outcome "fatal", described as "Type A aortic dissection with cardiogenic shock"; VENTRICULAR SEPTAL DEFECT (hospitalization, life threatening) with onset 04Feb2022, outcome "not recovered", described as "Ventricular septal defect"; ACUTE MYOCARDIAL INFARCTION (hospitalization, life threatening) with onset 04Feb2022, outcome "not recovered", described as "Acute myocardial infarction / acute myocardial infarction with ST elevation".
The patient was hospitalized for ventricular septal defect, acute myocardial infarction (start date: 04Feb2022).
The event "acute myocardial infarction / acute myocardial infarction with st elevation" was evaluated at the physician office visit.
Therapeutic measures were taken as a result of aortic dissection, ventricular septal defect, acute myocardial infarction.
The patient date of death was 09Feb2022.
The reported cause of death was aortic dissection.
The autopsy revealed "cardiogenic shock as a result of an aortic dissection with pericardial tamponade and a hemodynamically critical ventricular septal defect treated with emergency ecmo implantation in the condition after an acute myocardial infarction with ST elevation.
" (aortic dissection).
Clinical course: Cardiogenic shock as a result of an aortic dissection with pericardial tamponade and a hemodynamically critical ventricular septal defect treated with emergency ECMO implantation in the condition after an acute myocardial infarction with ST elevation.
Patient was presented to the clinic on 04Feb2022, 20 days after the 2nd partial vaccination with the Covid 19 vaccine Comirnaty with an acute myocardial infarction with ST segment elevation, which despite maximum intensive care therapy via a ventricular septal defect and a subsequent proximal aortic dissection with pericardial tamponade led to death and was therefore to be regarded as the primary cause of death.
Regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all reported events as D.
Unclassifiable.
No follow-up attempts are possible.
No further information is expected.
; Reported Cause(s) of Death: Type A aortic dissection; Autopsy-determined Cause(s) of Death: Cardiogenic shock as a result of an aortic dissection with pericardial tamponade and a hemodynamically critical ventricular septal defect treated with emergency ECMO implantation in the condition after an acute myocardial infarction with ST elevation