이상반응 보고
| VAERS ID | 2568516 |
|---|---|
| 성별 | 여성 |
| 나이 | 91세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | GJ9259 |
| 예방접종 횟수 | 5 |
| 접종일 | 2022-12-05 |
| 발병일 | 2023-01-08 |
| 상태 | 입원 중증 |
증상
- 발열(Pyrexia)
- 심전도(Electrocardiogram)
- 컴퓨터 단층 촬영(Computerised tomogram)
- 심장초음파(Echocardiogram)
- 혈액 크레아틴 포스포키나제(Blood creatine phosphokinase)
- 혈액 젖산 탈수소효소(Blood lactate dehydrogenase)
- 폐렴(Pneumonia)
- 체온(Body temperature)
- 트로포닌 T(Troponin T)
- 아스파르테이트 아미노전이효소(Aspartate aminotransferase)
- 심근염(Myocarditis)
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임상 검사
Test Date: 20230110; Test Name: AST; Result Unstructured Data: Test Result:389; Comments: Blood test on 10Jan2023 showed markedly elevated cardiac enzymes; Test Date: 20230110; Test Name: CPK; Result Unstructured Data: Test Result:2479; Comments: Blood test on 10Jan2023 showed markedly elevated cardiac enzymes; Test Date: 20230110; Test Name: LDH; Result Unstructured Data: Test Result:819; Comments: Blood test on 10Jan2023 showed markedly elevated cardiac enzymes; Test Date: 20221205; Test Name: body temperature; Result Unstructured Data: Test Result:Unknown Centigrade; Comments: before vaccination; Test Date: 20230109; Test Name: CT; Result Unstructured Data: Test Result:revealed bilateral pleural effusion; Comments: and infiltrative shadows in bilateral lower lobes; Test Date: 202301; Test Name: Echocardiography; Result Unstructured Data: Test Result:no asynergy of the anterior wall; Test Date: 202301; Test Name: electrocardiogram; Result Unstructured Data: Test Result:ST elevated from V1 to V4; Test Date: 202301; Test Name: electrocardiogram; Result Unstructured Data: Test Result:QS pattern disappeared from changes on ECG; Test Date: 20230110; Test Name: Troponin T; Result Unstructured Data: Test Result:1534; Comments: Blood test on 10Jan2023 showed markedly elevated cardiac enzymes
증상 상세
Myocarditis; suspected pneumonia; Pyrexia; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority.
Regulatory number: v2210003670 (RA).
A 91-year-old female patient received BNT162b2, BNT162b2 omi ba.
4-5 (COMIRNATY RTU FOR BA.
4-5), on 05Dec2022 as dose 5 (booster), single (Lot number: GJ9259, Expiration Date: 31Aug2023) at the age of 91 years for covid-19 immunisation.
It was specified that the patient was a 91-year and 10-month-old female at time of vaccination.
The patient's relevant medical history and concomitant medications were not reported.
There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status).
The patient's family history was nothing special.
Vaccination history included: Covid-19 vaccine (Dose 1, Manufactuerer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Manufactuerer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3, Manufactuerer unknown), for COVID-19 immunisation; Comirnaty (Dose 4, Lot.
FP9647, Expiration date: 31Jan2023), for COVID-19 immunisation.
The following information was reported: MYOCARDITIS (hospitalization, life threatening) with onset 08Jan2023, outcome "recovering"; PYREXIA (hospitalization, life threatening) with onset 08Jan2023, outcome "recovering"; PNEUMONIA (hospitalization, life threatening) with onset 08Jan2023, outcome "recovering", described as "suspected pneumonia".
On 19Jan2023, the outcome of the event was tendency to recovering.
The patient was hospitalized for myocarditis, pneumonia, pyrexia (start date: 09Jan2023).
The events "myocarditis", "suspected pneumonia" and "pyrexia" required physician office visit.
The patient underwent the following laboratory tests and procedures: Aspartate aminotransferase: (10Jan2023) 389, notes: Blood test on 10Jan2023 showed markedly elevated cardiac enzymes; Blood creatine phosphokinase: (10Jan2023) 2479, notes: Blood test on 10Jan2023 showed markedly elevated cardiac enzymes; Blood lactate dehydrogenase: (10Jan2023) 819, notes: Blood test on 10Jan2023 showed markedly elevated cardiac enzymes; Body temperature: (05Dec2022) Unknown, notes: before vaccination; Computerised tomogram: (09Jan2023) revealed bilateral pleural effusion, notes: and infiltrative shadows in bilateral lower lobes; Echocardiogram: (Jan2023) no asynergy of the anterior wall; Electrocardiogram: (Jan2023) ST elevated from V1 to V4; (Jan2023) QS pattern disappeared from changes on ECG; Troponin T: (10Jan2023) 1534, notes: Blood test on 10Jan2023 showed markedly elevated cardiac enzymes.
Therapeutic measures were taken as a result of myocarditis, pneumonia, pyrexia.
The course of the event was as follows: patient experienced pyrexia on 08Jan2023.
On 09Jan2023, she presented to reporter's Medical Center and was emergently admitted to the hospital with suspected pneumonia.
CT revealed bilateral pleural effusion and infiltrative shadows in bilateral lower lobes.
Blood test on 10Jan2023 showed markedly elevated cardiac enzymes with CPK of 2479, AST of 389, LDH of 819 and Troponin T of 1534.
An electrocardiogram showed ST elevated from V1 to V4.
At first, Acute myeloid leukaemia (reported as AML) was considered, however, QS pattern disappeared from changes on ECG.
Echocardiography also revealed no asynergy of the anterior wall.
Treatment with steroid pulse therapy and gamma-globulin therapy was initiated, and the patient responded to the treatment.
She had gone into anuria but was recovering from it, and her condition is currently in remission.
The reporter classified the event as serious (Life-threatening and hospitalization period: from 09Jan2023) and assessed that the event was related to suspected product.
There was no other possible cause of the event such as any other diseases.
The reporter commented as follows: the condition was definitively severe acute myocarditis due to the COVID-19 vaccine.