이상반응 보고
| VAERS ID | 1392259 |
|---|---|
| 성별 | 남성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-03-13 |
| 발병일 | 2021-03-28 |
| 상태 | 사망 |
증상
- 발열(Pyrexia)
- SARS-CoV-2 테스트(SARS-CoV-2 test)
- 코로나 바이러스 감염증 -19 : 코로나 19(COVID-19)
- 코로나19 폐렴(COVID-19 pneumonia)
- 예방접종 실패(Vaccination failure)
이환 중 질병
Hairy cell leukaemia (for 10 years,he was controlled semi-annually,no related medication necessary,last control stable); Lumbar foraminal stenosis (lumbar vertebrostenosis); Multifocal seizure (multifocal seizures); Polyneuropathy
지병
Medical History/Concurrent Conditions: Aneurysm atrial (atrial septal aneurysm 2015); B-Lymphocytic, CLL (Kiel Classification) (condition after B-cell small lymphocytic lymphoma 2008); Basalioma (condition after basal cell removal at ear shortly before corona infection); Squamous cell carcinoma (squamous cell carcinoma 2020)
기타 의료
NEURONTIN; DONEPEZIL; CENTRUM A TO ZINC; THYREX; LAMOTRIGIN
이전 예방접종
알레르기
임상 검사
Test Date: 20210329; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Ct 21.
06 variant
증상 상세
1st vaccination on 20FEB2021,2nd vaccination on 13MAR2021 and PCR positive on 29MAR2021; Symptom onset with fever; 1st vaccination on 20FEB2021,2nd vaccination on 13MAR2021 and PCR positive on 29MAR2021; Respiratory insufficiency in covid-19 pneumonia; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB.
The regulatory authority report number is AT-BASGAGES-2021-29101.
A 90-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via intramuscular on 13Mar2021 (Batch/Lot Number: unknown) as single dose, dose 1 via an unspecified route of administration on 20Feb2021 (Batch/Lot number unknown) as single dose for covid-19 immunisation.
Medical history included ongoing polyneuropathy, hairy cell leukaemia from 2011 and ongoing there was a hair cell - leukemia for 10 years, he was controlled semi-annually at the hematology, no related medication in this regard necessary, last control stable, ongoing vertebral foraminal stenosis (lumbar vertebrostenosis), B-Lymphocytic, CLL (Kiel Classification), B-cell small lymphocytic lymphoma from 2008 and not ongoing, ongoing multifocal seizure, basalioma condition after basal cell removal at ear shortly before corona infection from Mar2021 and not ongoing, Aneurysm atrial, atrial septal aneurysm from 2015 and not ongoing, squamous cell carcinoma from 2020 and unknow if it was ongoing.
It was not known that the patient had an immune deficiency.
Concomitant medications included gabapentin (NEURONTIN) taken for an unspecified indication, start and stop date were not reported; donepezil taken for an unspecified indication, start and stop date were not reported; minerals nos, vitamins nos (CENTRUM A TO ZINC) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (THYREX) taken for an unspecified indication, start and stop date were not reported; lamotrigin taken for multifocal seizures, start and stop date were not reported.
On 28Mar2021: symptom onset with fever, PCR positive on 29Mar2021 (Ct 21.
06), "clinical manifestation: respiratory symptoms with/without cough", variant: -> vaccination failure, death on 06Apr2021 from COVID-19 in the hospital.
The final exact cause of death was reported as Respiratory insufficiency associated with Covid-19 pneumonia.
The patient's wife did not have the vaccination certificate anymore - but she herself was vaccinated at the same time as her deceased husband - her batch was COMIRNATY EJ 6136 and ET 1831, it could be assumed that the husband was vaccinated with the same batch, but this could no longer be traced with certainty.
The husband was free of infections during both vaccinations and had no side effect after the vaccination.
A good 2 weeks after the 2nd vaccination, the onset of symptoms of the Corona infection occurred, source unknown, PCR positive on 29Mar2021, death from COVID-19 in hospital on 06Apr2021.
Probably a reduced immune response due to the existing leukemia and therefore infection despite vaccination and finally unfortunately death from COVID-19.
An autopsy was not performed.
On 28Mar2021 the patient experienced Fever, other, Vaccination failure.
On 29Mar2021 the patient experienced COVID-19 PCR test positive, other, other.
On 28Mar2021 the patient experienced COVID-19 pneumonia death.
The patient's outcome was unknown for Fever, unknown for Vaccination failure, unknown for COVID-19 PCR test positive, fatal for COVID-19 pneumonia.
The patient underwent lab tests and procedures which included COVID-19 PCR test: positive (Ct 21.
06, variant (as reported)) on 29Mar2021.
The patient died on 06Apr2021.
An autopsy was not performed.
The outcome of the event fever was unknown, of the other events was fatal outcome.
No follow-up attempts needed, batch/lot.
no.
will be followed-up by Regulatory Authority and automatically provided as soon as available.
No further information is expected.
; Reported Cause(s) of Death: PCR positive on 29Mar2021; Respiratory insufficiency associated with Covid-19 pneumonia; Respiratory insufficiency associated with Covid-19 pneumonia; vaccination failure