이상반응 보고
| VAERS ID | 2561279 |
|---|---|
| 성별 | 남성 |
| 나이 | 54세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | 2 |
| 접종일 | |
| 발병일 | |
| 상태 | 사망 |
증상
- 코로나19 예방접종(COVID-19 immunisation)
- 백신 제품의 교환(Interchange of vaccine products)
- 뇌간 출혈(Brain stem haemorrhage)
이환 중 질병
Diabetic nephropathy; Hypertension
지병
Medical History/Concurrent Conditions: Dialysis (with a history of dialysis for 5 years.); Percutaneous coronary intervention; Thalamic infarction
기타 의료
이전 예방접종
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임상 검사
증상 상세
Brain stem haemorrhage; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; This literature-non-study case was reported in a literature article and describes the occurrence of BRAIN STEM HAEMORRHAGE (Brain stem haemorrhage) in a 54-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 prophylaxis.
The occurrence of additional non-serious events is detailed below.
LITERATURE REFERENCE: Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.
The patient's past medical history included Thalamic infarction, Dialysis (with a history of dialysis for 5 years.
) and Percutaneous coronary intervention.
Previously administered products included for Drug use for unknown indication: ACETYLSALICYLIC ACID;CLOPIDOGREL (oral aspirin/clopidogrel).
Past adverse reactions to the above products included No adverse reaction with ACETYLSALICYLIC ACID; andCLOPIDOGREL.
Concurrent medical conditions included Diabetic nephropathy and Hypertension.
On an unknown date, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form.
On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form.
On an unknown date, the patient experienced BRAIN STEM HAEMORRHAGE (Brain stem haemorrhage) (seriousness criteria death and medically significant), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products).
The patient died on an unknown date.
The reported cause of death was Brain stem haemorrhage.
It is unknown if an autopsy was performed.
At the time of death, COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.
For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.
Concomitant and treatment medications were not provided.
Patient was living alone and working.
The patient was vaccinated with the vaccines Pfizer at the first and second doses.
Twelve days after the third vaccination with the vaccine Moderna, the patient was transferred to another hospital by ambulance and died of brain stem haemorrhage.
Author stated cerebrovascular disorder is considered to account for 5.
9% of the causes of deaths among dialysis patients.
At present, there had been no cases in which vaccination has been considered related to death.
It was necessary to consider including the relief ways.
Company comment: This is a literature non-study case concerning a 54-year-old male with concurrent condition of diabetic nephropathy currently in dialysis for the last 5 years, hypertension and, history of PCI, and thalamic infarction.
He was treated with oral aspirin/clopidogrel as concomitant medication.
The patient experienced the unlisted fatal and medically significant AESI of brain stem hemorrhage.
The event occurred approximately 12 days after the booster dose of mRNA-1273 vaccine.
He had been vaccinated with the vaccines manufactured by Pfizer.
as the first and second doses, date of application not reported.
Revaccination with a different COVID-19 vaccine and interchange of vaccine products it is noticed in this case.
The outcome of the event was reported as fatal.
It is unknown if an autopsy was performed.
The patient died when he was transferred in ambulance to the hospital.
No further clinical information was available for medical review.
Anticoagulant therapy is a confounder factor for the event.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
; Sender's Comments: This is a literature non-study case concerning a 54-year-old male with concurrent condition of diabetic nephropathy currently in dialysis for the last 5 years, hypertension and, history of PCI, and thalamic infarction.
He was treated with oral aspirin/clopidogrel as concomitant medication.
The patient experienced the unlisted fatal and medically significant AESI of brain stem hemorrhage.
The event occurred approximately 12 days after the booster dose of mRNA-1273 vaccine.
He had been vaccinated with the vaccines manufactured by Pfizer.
as the first and second doses, date of application not reported.
Revaccination with a different COVID-19 vaccine and interchange of vaccine products it is noticed in this case.
The outcome of the event was reported as fatal.
It is unknown if an autopsy was performed.
The patient died when he was transferred in ambulance to the hospital.
No further clinical information was available for medical review.
Anticoagulant therapy is a confounder factor for the event.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
; Reported Cause(s) of Death: Brain stem haemorrhage