이상반응 보고
| VAERS ID | 1841883 |
|---|---|
| 성별 | 여성 |
| 나이 | 28세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FH4092 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-10-05 |
| 발병일 | 2021-10-05 |
| 상태 | 입원 중증 |
증상
- 임신 중 모성 노출(Maternal exposure during pregnancy)
- 태반의 조기 분리(Premature separation of placenta)
- 비정상적인 자궁 출혈(Abnormal uterine bleeding)
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임상 검사
증상 상세
Placental separation in gestational week 26/ massive intrauterine haemmorhage; Placental separation in gestational week 26; pregnancy week 26, 12 days after receiving the second dose; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number NO-NOMAADVRE-FHI-2021-Urmqw8.
The physician reported different events for two doses and a child.
This is the first of three reports.
A 28-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Lot Number: FH4092), via intramuscular, administered in right arm on 05Oct2021 (28-year-old at time of vaccination) as single dose for COVID-19 immunisation.
The patient's medical history and concomitant medications were not reported.
The patient previously received the first dose of bnt162b2 (COMIRNATY, Lot Number: FG2975) on 27Aug2021 for COVID-19 immunisation and experienced maternal exposure during pregnancy, second trimester.
The patient experienced "placental separation in gestational week 26/ massive intrauterine haemmorhage" on 17Oct2021, "placental separation in gestational week 26" on 17Oct2021.
The events were assessed as serious with criteria of life threatening.
The mother was 26 weeks pregnant at the onset of the event.
The mother delivered the pregnancy on an unknown date via cesarean delivery.
The baby was delivered premature.
Narrative: A 28-year-old pregnant woman experienced probable premature separation of placenta, antepartum in pregnancy week 26, 12 days after receiving the second dose of COVID-19 vaccine Comirnaty.
The patient was admitted to hospital with massive intrauterine haemmorhage.
The child was delivered by emergency Caesarean section.
The patient is retrospectively evaluated for possible risk factors but none was found.
The outcome of the events was unknown.
Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible.
No follow-up attempts are possible.
No further information is expected.
; Sender's Comments: Linked Report(s) : NO-PFIZER INC-202101474306 mother/child case;NO-PFIZER INC-202101474307 Same reporter, same patient, different doses, different events