이상반응 보고
| VAERS ID | 2295408 |
|---|---|
| 성별 | 여성 |
| 나이 | 32세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | EP2163 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-03-14 |
| 발병일 | 2022-02-08 |
| 상태 | 입원 회복 |
증상
- 임신 전 산모 노출(Maternal exposure before pregnancy)
- 배달(Delivery)
이환 중 질병
지병
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
기타 의료
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증상 상세
hospitalization associated with childbirth; pregnancy; GENERAL INVESTIGATION TARGETING THE VACCINES (HEALTH CARE PROVIDERS HCPS) WHO ARE VACCINATED IN EARLY POST-APPROVAL PHASE (FOLLOW-UP STUDY) This is a non-interventional study report received from contactable reporter(s) (Physician) for protocol C4591006.
A 33-year-old female patient (pregnant) received BNT162b2, solution for injection (COMIRNATY), on 21Feb2021 as dose 1, single (Lot number: EP2163, Expiration Date: 31May2021), in left arm and on 14Mar2021 as dose 2, single (Lot number: EP2163, Expiration Date: 31May2021) at the age of 32 years, in left arm for covid-19 immunization.
The patient had no relevant medical history.
There were no concomitant medications.
The following information was reported: MATERNAL EXPOSURE BEFORE PREGNANCY (hospitalization) with onset 2021, outcome "unknown", described as "pregnancy"; DELIVERY (hospitalization) with onset 08Feb2022, outcome "recovered" (14Feb2022), described as "hospitalization associated with childbirth".
Therapeutic measures were not taken as a result of delivery, maternal exposure before pregnancy.
clinical course: Influenza vaccine, administration date: 18Oct2021, when the patient was 33-year-old, for Influenza immunization.
The subject did not have allergy, ongoing medical history, or non-ongoing medical history.
The subject was not pregnant or breastfeeding at the time of the first and the second dose of vaccination.
The anatomical location of the first and the second dose of vaccination was left upper arm.
Information in the period from 28 days after the second vaccination to 6 months after the second vaccination was as follows: The subject was not pregnant or breastfeeding during the observation period.
The subject did not experience a serious adverse event.
The subject did not receive vaccine other than BNT162b2.
The subject did not receive COVID-19 pathogen (SARS-CoV-2) test and did not develop COVID-19.
Information in the period from 6 months after the second vaccination to 12 months after the second vaccination was as follows: The subject was pregnant but not breastfeeding during the observation period.
The subject experienced a serious adverse event.
The subject received vaccine other than BNT162b2.
The subject did not receive COVID-19 pathogen (SARS-CoV-2) test and did not develop COVID-19.
The investigator assessed the severity of the event "hospitalization associated with childbirth" as mild, the seriousness as serious (hospitalization), and considered that the event was unrelated to the study drug because the event was hospitalization associated with childbirth.
; Sender's Comments: Based on the information in the case report, a possible causal relationship between the reported events and the suspect drug BNT162B2 can be completely excluded.
As per the company assessment the reported events were assessed as Unelated to the suspect drug BNT162B2.
The impact of this report on the benefit/risk profile of the Pfizer drug 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.