이상반응 보고
| VAERS ID | 2247303 |
|---|---|
| 성별 | 여성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FP8191 |
| 예방접종 횟수 | 3 |
| 접종일 | 2022-01-13 |
| 발병일 | 2022-04-04 |
| 상태 | 입원 |
증상
- 질 출혈(Vaginal haemorrhage)
- 오프 라벨 사용(Off label use)
- 임신 중 모성 노출(Maternal exposure during pregnancy)
- 백신 제품의 교환(Interchange of vaccine products)
이환 중 질병
지병
Medical History/Concurrent Conditions: Pregnancy
기타 의료
이전 예방접종
알레르기
임상 검사
증상 상세
Off label use; Interchange of vaccine products; Maternal Exposure During Pregnancy, first trimester; currently pregnant with huge bleeding losses and clots.
I have always had a regular cycle with delays of 1 or 2 days at most, but since last year they are very abundant and 2 times / month; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB.
The reporter is the patient.
Regulatory number: IT-MINISAL02-860186 (RA).
A 36-year-old female patient (pregnant) received BNT162b2 (COMIRNATY), on 13Jan2022 as dose 3 (booster), single (Lot number: FP8191) intramuscular, in left arm for covid-19 immunisation.
The patient's relevant medical history included: "Pregnancy" (unknown if ongoing).
The patient was 8 weeks pregnant at the time of exposure to BNT162b2.
The patient's concomitant medications were not reported.
Vaccination history included: spikevax (DOSE 1, lot 3002545, left deltoid), administration date: 02Jun2021, for COVID-19 vaccination, reaction(s): "No adverse reaction"; spikevax (DOSE 2, lot 3003655, left deltoid), administration date: 07Jul2021, for COVID-19 vaccination, reaction(s): "No adverse reaction".
The following information was reported: VAGINAL HAEMORRHAGE (hospitalization) with onset 04Apr2022, outcome "not recovered", described as "currently pregnant with huge bleeding losses and clots.
I have always had a regular cycle with delays of 1 or 2 days at most, but since last year they are very abundant and 2 times / month"; OFF LABEL USE (hospitalization), outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization), outcome "unknown"; MATERNAL EXPOSURE DURING PREGNANCY (hospitalization), outcome "unknown", described as "Maternal Exposure During Pregnancy, first trimester".
The events "currently pregnant with huge bleeding losses and clots.
i have always had a regular cycle with delays of 1 or 2 days at most, but since last year they are very abundant and 2 times / month" required emergency room visit.
Therapeutic measures were taken as a result of vaginal haemorrhage.
Reporter Comment: Currently, despite the pregnancy I have bleeding losses with clots for days.
For the moment I went to the emergency room to temporarily resolve the problem.
No doctor dares to say it could be the vaccine (not even mine).
No follow-up attempts are possible.
No further information is expected.