이상반응 보고
| VAERS ID | 1029878 |
|---|---|
| 성별 | 남성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-01-05 |
| 발병일 | 2021-01-20 |
| 상태 | 입원 중증 사망 |
증상
- 혼란 상태(Confusional state)
- 무력증(Asthenia)
- SARS-CoV-2 테스트(SARS-CoV-2 test)
- 산소포화도 감소(Oxygen saturation decreased)
- 청색증(Cyanosis)
- 코로나 바이러스 감염증 -19 : 코로나 19(COVID-19)
- 비인두염(Nasopharyngitis)
- 호흡부전(Respiratory failure)
- 체온(Body temperature)
- 산소 포화도(Oxygen saturation)
- 약물 효과 없음(Drug ineffective)
- 호흡기 감염(Respiratory tract infection)
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임상 검사
Test Date: 20210127; Test Name: body temperature; Result Unstructured Data: Test Result:38.
0 Centigrade; Test Date: 20210126; Test Name: oxygen saturation; Test Result: 81 %; Test Date: 20210125; Test Name: COVID PCR test; Result Unstructured Data: Test Result:positive
증상 상세
oxygen saturation 81%; cold; livid discoloration of acra; respiratory infection with respiratory insufficiency; respiratory infection with respiratory insufficiency; slightly confused; very weak; COVID-19 PCR test positive; COVID-19 PCR test positive; This is a spontaneous report from a contactable physician via local license partner.
A 85-year-old male patient received first dose of BNT162B2 (COMIRNATY) on 05Jan2021 at single dose for COVID-19 immunization.
Medical history and concomitant medications were not reported.
The patient had respiratory infection with respiratory insufficiency on 20Jan2021.
On 20Jan2021 patient was in reduced general condition, slightly confused, very weak, no cough, no fever.
On 25Jan2021 positive PCR test (throat swab).
On 26Jan2021 very bad general condition, confused, cold and livid discoloration of acra, oxygen saturation 81%.
Palliative therapy with alleviation of symptoms after consultation of his daughter.
On 27Jan2021 further deterioration of general condition, temperature 38 degrees Celsius, "Exitus letalis" at 5:10 p.
m.
All events except COVID-19 PCR test positive required outpatient treatment, hospitalization and was life-threatening.
The patient died on 27Jan2021 at 5:10 p.
m due to all events except COVID-19 PCR test positive.
The outcome of COVID-19 PCR test positive was unknown.
Information on the lot/batch number has been requested.
; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.
However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given and due to only the first dose was administered.
Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the other reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray and autopsy results, counteractive treatment measures and concomitant medications.
This case will be reassessed once additional information is available.
The impact of this report on the benefit/risk profile of the Pfizer product 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: respiratory infection with respiratory insufficiency; respiratory infection with respiratory insufficiency; slightly confused; very weak; oxygen saturation 81%; cold; livid discoloration of acra