이상반응 보고
| VAERS ID | 2249035 |
|---|---|
| 성별 | 여성 |
| 나이 | 30세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | EP2163 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-03-17 |
| 발병일 | 2022-02-28 |
| 상태 | 회복 |
증상
- SARS-CoV-2 테스트(SARS-CoV-2 test)
- 코로나 바이러스 감염증 -19 : 코로나 19(COVID-19)
- 임신 전 산모 노출(Maternal exposure before pregnancy)
- 예방접종 실패(Vaccination failure)
이환 중 질병
지병
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
기타 의료
이전 예방접종
알레르기
임상 검사
Test Date: 20220215; Test Name: COVID-19 PCR, LAMP test; Test Result: Negative ; Test Date: 20220228; Test Name: COVID-19 PCR, LAMP test; Test Result: Positive
증상 상세
Pregnancy; COVID-19; COVID-19; GENERAL INVESTIGATION TARGETING THE VACCINES WHO ARE VACCINATED IN EARLY POST-APPROVAL PHASE (FOLLOW-UP STUDY) This is a non-interventional study report received from a contactable reporter(Physician) from product quality group.
A 31-year-old female subject (pregnant) received BNT162b2, solution for injection (COMIRNATY), on 24Feb2021 as dose 1, single (Lot number: EP2163, Expiration Date: 31May2021), in left arm and on 17Mar2021 as dose 2, single (Lot number: EP2163, Expiration Date: 31May2021) at the age of 30 years, in right arm for covid-19 immunisation.
The subject had no relevant medical history.
There were no concomitant medications.
The subject had no complication, allergy, underlying disease or treatment drug, there was no suspicion of pregnancy or breastfeeding at the time of the first vaccination.
There was no suspicion of pregnancy or breastfeeding at the time of the second vaccination.
The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Feb2022, outcome "recovered" (10Mar2022) and all described as "COVID-19"; MATERNAL EXPOSURE BEFORE PREGNANCY (non-serious), outcome "unknown", described as "Pregnancy".
The subject underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Feb2022) Negative; (28Feb2022) Positive.
Clinical course included From 28 days after the second vaccination to 6 months after the second vaccination was as follows: The subject was not pregnant during the observation period.
The subject was not breastfeeding during the observation period.
The subject did not experience serious adverse event.
The subject did not receive other vaccination.
COVID-19 pathogen (SARS-CoV-2) test was not performed.
The subject did not develop COVID-19.
From 6 months after the second vaccination to 12 months after the second vaccination was as follows: The subject was pregnant during the observation period.
The subject was not breastfeeding during the observation period.
The subject did not experience serious adverse event.
The subject received other vaccination(influenza vaccine on 10Nov2021).
COVID-19 pathogen (SARS-CoV-2) test was performed.
The subject developed COVID-19.
For the event COVID-19: The subject was not hospitalized.
The subject was not administered oxygen.
The subject did not enter ICU.
The subject did not use ventilator or Extracorporeal Membrane Oxygenation (ECMO).
The seriousness of the events COVID-19 and pregnancy and the causal relationship between the events and the study drug were not provided.
The reporter's assessment of the causal relationship of "covid-19" with the suspect product BNT162b2 was not provided at the time of this report.
Since no determination has been received, the case is managed based on the company causality assessment.
; Sender's Comments: Based on the information in the case report, a causal relationship between reported events and suspect BNT162B2 cannot be excluded.