이상반응 보고
| VAERS ID | 2292023 |
|---|---|
| 성별 | 여성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | 1F1008A |
| 예방접종 횟수 | 3 |
| 접종일 | 2021-12-05 |
| 발병일 | 2021-12-05 |
| 상태 |
증상
- 사지의 통증(Pain in extremity)
- 체온 상승(Body temperature increased)
- 자연 낙태(Abortion spontaneous)
- 오프 라벨 사용(Off label use)
- 백신 제품의 교환(Interchange of vaccine products)
이환 중 질병
Nickel sensitivity
지병
Medical History/Concurrent Conditions: Maternal vaccine exposure (vaccine exposure during pregnancy week: 3)
기타 의료
이전 예방접종
알레르기
임상 검사
증상 상세
Pain in arm; Body temperature increased; Miscarriage; Off label; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB and product quality group.
Regulatory number: NL-LRB-00807912 (RA).
Other Case identifier(s): NL-LRB-00808591 (RA).
A 36-year-old female patient (pregnant) received BNT162b2 (COMIRNATY), on 05Dec2021 as dose 3 (booster), single (Lot number: 1F1008A) for covid-19 immunisation.
The patient's relevant medical history included: "Nickel sensitivity" (ongoing); "Maternal vaccine exposure" (unspecified if ongoing), notes: vaccine exposure during pregnancy week: 3.
The patient was 3 weeks pregnant at the time of exposure to BNT162b2.
The patient was 7 weeks pregnant at the event onset.
The patient's concomitant medications were not reported.
Vaccination history included: spikevax (0.
5 mL, DOSE 2), administration date: 09May2021, for COVID-19 Immunisation; spikevax (0.
5 mL, DOSE 1), administration date: 11Apr2021, for COVID-19 Immunisation.
The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Dec2021, outcome "unknown"; OFF LABEL USE (medically significant) with onset 05Dec2021, outcome "unknown", described as "Off label"; ABORTION SPONTANEOUS (medically significant) with onset 02Jan2022, outcome "unknown", described as "Miscarriage"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown".
The pregnancy resulted in spontaneous abortion.
Therapeutic measures were taken as a result of abortion spontaneous.
Clinical course: Miscarriage (other medically important condition), vaccine exposure during pregnancy, pain in arm, body temperature increased following administration of covid-19 vaccine Pfizer (action taken: not applicable) for covid 19 immunisation.
Treatment: Miscarriage is treated with Curettage ivm blood loss.
The outcome of body temperature increased is unknown, the outcome of miscarriage is unknown, the outcome of pain in arm is unknown and the outcome of vaccine exposure during pregnancy is unknown.
The miscarriage occurred at a pregnancy duration of about 7 weeks.
This was the booster (third) Covid vaccination, which took place at a pregnancy duration of about 3 weeks.
There were no other known factors that could have influenced the occurrence of the miscarriage.
Drugs and latency: miscarriage: 28 days after start.
vaccine exposure during pregnancy: latency unknown.
pain in arm: latency unknown.
body temperature increased: latency unknown.
Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the resource critera, the reaction was considered as serious by the Regulatory Authority.
Concomitant medication: no.
Miscarriage : Additional information ADR: Miscarriage 4 weeks after booster confounding factors" confounding factors, allergy: Nickel.
Vaccine exposure during pregnancy week: 3.
COVID19: Previous COVID-19 infection 9Feb2022 : hospitalization: no.
09May2022: After the booster, considerable pain in arm, some increase but no other side effects.
According to the doctor, there are no indications for the origin of the miscarriage.
However, I have heard several times (I work in a hospital) that the vaccinations are not recommended in the 1st trimester, but I did not yet know that I was pregnant.
The stop date for the event: Miscarriage reported as 05Jan2022.
No follow-up attempts are possible.
No further information is expected.
; Sender's Comments: Linked Report(s) : NL-PFIZER INC-202200725180 LOE case