이상반응 보고
| VAERS ID | 2576706 |
|---|---|
| 성별 | 여성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | |
| 접종일 | |
| 발병일 | |
| 상태 | 사망 |
증상
- 혈액 크레아틴 포스포키나제(Blood creatine phosphokinase)
- 트로포닌 T(Troponin T)
- 심폐정지(Cardio-respiratory arrest)
- 체액 저류(Fluid retention)
- 포부(Aspiration)
- 심근병증(Cardiomyopathy)
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임상 검사
Test Name: CK; Result Unstructured Data: Test Result:increased; Test Name: Troponin T; Result Unstructured Data: Test Result:increased
증상 상세
Cardio-respiratory arrest; a risk of aspiration; elevation of troponin T and CK was observed, and the possibility of myocardial disorder was also suggested; Fluid retention; This is a spontaneous report received from a contactable reporter(s) (Physician).
A female patient in her 90's received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation.
The patient's relevant medical history and concomitant medications were not reported.
The following information was reported: CARDIO-RESPIRATORY ARREST (death, medically significant), outcome "fatal"; ASPIRATION (death, medically significant), outcome "fatal", described as "a risk of aspiration"; CARDIOMYOPATHY (death, medically significant), outcome "fatal", described as "elevation of troponin T and CK was observed, and the possibility of myocardial disorder was also suggested"; FLUID RETENTION (death), outcome "fatal".
The event "cardio-respiratory arrest" required emergency room visit.
The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: increased; Troponin T: increased.
Therapeutic measures were taken as a result of cardio-respiratory arrest.
The patient date of death was unknown.
Reported cause of death: "cardio-respiratory arrest", "a risk of aspiration", "elevation of troponin T and CK was observed, and the possibility of myocardial disorder was also suggested", "Fluid retention".
No autopsy was performed.
Clinical course: It was unknown whether the patient had any other medical history or not.
On an unspecified date, the patient received the unknown single dose of BNT162b2 [COMIRNATY RTU I.
M.
(BA.
1) or (BA.
4-5), Dosage was 0.
3 ML] intramuscular for COVID-19 immunization (as reported).
On an unspecified day, the patient experienced Cardio-respiratory arrest.
The clinical course was reported as follows: 1-2 months ago, around 90s female patient who received the COVID-19 vaccine a day before at another hospital was transported emergently in cardio-respiratory arrest and died after performing a resuscitative measure.
Originally, the patient had a risk of aspiration, but fluid accumulation was observed in the trachea at the time of examination.
But as for the fluid accumulation, the effect of chest compression was also considered.
On the other hand, elevation of troponin T and Blood creatine phosphokinase (reported as CK) was observed, and the possibility of myocardial disorder was also suggested.
As a result of consultation with patient's family member, autopsy was not performed.
The day of the report, AE information was obtained from a Privacy Clinic, but other Privacy Hospital handled the patient.
Thus, Privacy wants to send queries such as follow-up investigation to other Privacy Hospital.
Regarding the vaccine administered the day before, the manufacturer was unknown in report day, so Privacy Clinic would ask the vaccination facility and write on the form.
The outcome of event was Fatal.
The reporter classified the event as serious (death).
The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded.
The case will be reassessed once new information is available.
The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: cardio-respiratory arrest; a risk of aspiration; elevation of troponin T and CK was observed, and the possibility of myocardial disorder was also suggested; Fluid retention