이상반응 보고
| VAERS ID | 2003099 |
|---|---|
| 성별 | 여성 |
| 나이 | 94세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-06-01 |
| 발병일 | 2021-11-02 |
| 상태 | 입원 사망 |
증상
- 호흡곤란(Dyspnoea)
- 떨어지다(Fall)
- SARS-CoV-2 테스트(SARS-CoV-2 test)
- 코로나 바이러스 감염증 -19 : 코로나 19(COVID-19)
- 예방접종 실패(Vaccination failure)
이환 중 질병
Arterial hypertension; Chronic renal failure; Hypercholesterolaemia; Type 2 diabetes mellitus (insulin-requiring type 2 diabetes)
지병
기타 의료
LANTUS; ASPIRIN CARDIO; BELOC ZOK; RAMIPRIL; ZANIDIP; TORASEMIDE; PRAVASTATINE [PRAVASTATIN SODIUM]; JANUVIA; ALLOPURINOL
이전 예방접종
알레르기
임상 검사
Test Date: 20211129; Test Name: SARS-CoV-2 test; Test Result: Positive
증상 상세
She was initially admitted to hospital for a fall on 02Nov2021; The patient had high oxygen demands and required dexamethasone corticosteroid therapy.
; SARS-CoV-2 nosocomial infection, Comirnaty vaccine on 05May2021 and second dose on 01Jun2021; During her hospitalization, she developed a nosocomial SARS-CoV-2 infection with a positive test on 29Nov2021; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority.
Regulatory number: CH-SM-2021-29618.
A 94 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 01Jun2021 (Batch/Lot number: unknown) at the age of 94 years as dose 2, single and intramuscular, administration date 05May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation.
Relevant medical history included: "Type 2 diabetes mellitus" (ongoing), notes: insulin-requiring type 2 diabetes; "Chronic renal insufficiency" (ongoing); "Arterial hypertension" (ongoing); "Hypercholesterolaemia" (ongoing).
Concomitant medication(s) included: LANTUS; ASPIRIN CARDIO; BELOC ZOK; RAMIPRIL; ZANIDIP; TORASEMIDE; PRAVASTATINE [PRAVASTATIN SODIUM]; JANUVIA; ALLOPURINOL.
The following information was reported: VACCINATION FAILURE (death, prolonged hospitalization, medically significant) with onset 29Nov2021, outcome "fatal", described as "SARS-CoV-2 nosocomial infection, Comirnaty vaccine on 05May2021 and second dose on 01Jun2021"; COVID-19 (death, prolonged hospitalization, medically significant) with onset 29Nov2021, outcome "fatal", described as "During her hospitalization, she developed a nosocomial SARS-CoV-2 infection with a positive test on 29Nov2021"; DYSPNOEA (prolonged hospitalization, medically significant), outcome "not recovered", described as "The patient had high oxygen demands and required dexamethasone corticosteroid therapy.
"; FALL (hospitalization) with onset 02Nov2021, outcome "not recovered", described as "She was initially admitted to hospital for a fall on 02Nov2021".
The patient was hospitalized for fall (start date: 02Nov2021); the patient prolonged hospitalization for vaccination failure (start date: 02Dec2021); for covid-19, dyspnoea (start date: 02Nov2021).
The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) positive.
Therapeutic measures were taken as a result of vaccination failure, covid-19, dyspnoea.
The patient date of death was 04Dec2021.
The reported cause of death was "Due to a lack of response, it was decided with the palliative care consultation and the family to move to comfort care.
The patient died on 04Dec2021.
", covid-19, dyspnoea.
No autopsy was performed.
Clinical course was reported as, the patient was initially hospitalized for a fall on 02Nov2021.
The patient had high oxygen demands and required dexamethasone corticosteroid therapy.
At the time of reporting the most recent information (10Dec2021), Drug ineffective, SARS-CoV-2 PCR test positive, Acute dyspnea were reported as not recovered.
A causal relationship between Comirnaty and Drug ineffective, SARS-CoV-2 PCR test positive, Acute dyspnea and SARS-CoV-2 infection was assessed according to WHO as being possible.
They assessed this case as serious with fatal outcome and medically significant seriousness criteria.
No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No further information is expected.
; Reported Cause(s) of Death: Due to a lack of response, it was decided with the palliative care consultation and the family to move to comfort care.
The patient died on 04Dec2021.
; nosocomial SARS-CoV-2 infection; The patient has high oxygen demands