이상반응 보고
| VAERS ID | 2295396 |
|---|---|
| 성별 | 여성 |
| 나이 | 29세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | EP2163 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-03-13 |
| 발병일 | 2021-06-05 |
| 상태 | 입원 회복 |
증상
- 임신 전 산모 노출(Maternal exposure before pregnancy)
- 핵산 테스트(Nucleic acid test)
- 제왕 절개(Caesarean section)
이환 중 질병
Dermatitis atopic (From 5 years ago)
지병
기타 의료
FEXOFENADINE HYDROCHLORIDE
이전 예방접종
알레르기
임상 검사
Test Date: 20220301; Test Name: Nucleic acid detection test; Test Result: Negative ; Comments: PCR method or LAMP method
증상 상세
Caesarean section; Pregnancy; 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 contactable reporter(s) (Physician and Other HCP) for protocol C4591006.
A 29-year-old female patient (pregnant) received BNT162b2, solution for injection (COMIRNATY), on 20Feb2021 at 11:53 as dose 1, single (Lot number: EP2163, Expiration Date: 31May2021), in right deltoid and on 13Mar2021 at 11:53 as dose 2, single (Lot number: EP2163, Expiration Date: 31May2021) at the age of 29 years, in left deltoid, all intramuscular for covid-19 immunisation.
The patient's relevant medical history included: "dermatitis atopic", start date: 2016 (ongoing), notes: From 5 years ago.
Date of last menstrual period: 05Jun2021.
The patient is expected to deliver a baby(s) on 12Mar2022.
Concomitant medication(s) included: FEXOFENADINE HYDROCHLORIDE oral taken for dermatitis atopic, start date: 2016, stop date: Jul2021.
The following information was reported: MATERNAL EXPOSURE BEFORE PREGNANCY (hospitalization) with onset 05Jun2021, outcome "unknown", described as "Pregnancy"; CAESAREAN SECTION (hospitalization) with onset 01Mar2022, outcome "recovered" (13Mar2022).
The baby was delivered full-term, via cesarean route, delivery date 07Mar2022.
The baby weighed 2036 grams.
APGAR Score was 8, 9.
The patient underwent the following laboratory tests and procedures: Nucleic acid test: (01Mar2022) negative, notes: PCR method or LAMP method.
Therapeutic measures were not taken as a result of caesarean section.
The subject was not breastfeeding during study observation period.
Serious adverse event did not occur.
The subject did not receive any other vaccinations.
SARS-CoV-2 test was not performed.
The subject did not have COVID-19.
Gestational age was 39 weeks and 2 days.
The baby was a boy.
APGAR score after 1 minute was 8 and after 5 minutes was 9.
Birth height was 47.
5 cm and head circumference was 32.
1 cm.
As of 16Apr2022, the subject was breastfeeding but formula (milk) was given once at night.
The child had no specific problem and was doing well.
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 during the second observation period.
The subject was not breastfeeding during the second observation period.
The subject underwent COVID-19 pathogen (SARS-CoV-2) test but had no COVID-19 during the second observation period.
The subject received influenza vaccine on 21Oct2021.
Details of the event caesarean section were as follows: The severity of the event was moderate.
The reporting investigator classified the event as serious (hospitalization), assessed the event as unrelated to BNT162b2, and considered caesarean section itself as the most possible cause of the event.
Follow-up (16Apr2022): This is a follow-up report from a Non-Interventional Study source for Protocol C4591006.
Updated information included: pregnancy information (Delivery Date, Birth Type, Fetal Outcome, Weight, APGAR Score) and event details (updated from "drug exposure during pregnancy" to "Maternal exposure before pregnancy").
Follow-up (18May2022): This is a non-interventional study follow-up report for protocol Updated information included: Updated information included: lab data (added nucleic acid detection test), new event details (caesarean section, Maternal exposure before pregnancy), seriousness (upgraded to hospitalization) and pregnancy information.
; 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.