이상반응 보고

VAERS ID 2295115
성별 여성
나이
주 코드 FR
제약회사 PFIZER\BIONTECH
로트 번호 FD5996
예방접종 횟수 2
접종일 2021-06-17
발병일 2021-07-23
상태 입원
증상
  • 혈액 검사(Blood test)
  • 핫 플러시(Hot flush)
  • 출혈(Haemorrhage)
  • 자연 낙태(Abortion spontaneous)
  • 오프 라벨 사용(Off label use)
  • 임신 중 모성 노출(Maternal exposure during pregnancy)
  • 백신 제품의 교환(Interchange of vaccine products)
  • 폐경기(Menopause)
  • 불임 여성(Infertility female)
  • 항뮐러 호르몬 수치(Anti-Muellerian hormone level)

이환 중 질병

지병

Medical History/Concurrent Conditions: Asthma

기타 의료

이전 예방접종

알레르기

임상 검사

Test Name: anti-Mullerian hormone; Result Unstructured Data: Test Result:0.
02; Test Date: 20220103; Test Name: BLOOD TEST; Result Unstructured Data: Test Result:MENOPAUSE

증상 상세

off label use; interchange of vaccine products; After the 2nd vaccination miscarriage, then menopause, now infertile!!!; After the 2nd vaccination miscarriage, then menopause, now infertile!!!; On 23JUL2021 started the miscarriage, at that time I was in the 9th week of pregnancy.
The bleeding lasted 29 days.
; MENOPAUSE; Maternal exposure during pregnancy, first trimester; hot flashes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority.
The reporter is the patient.
Regulatory number: DE-PEI-CADR2022272464.
Other Case identifier(s): DE-CADRPEI-2022272464, DE-PEI-202200072612.
A 34-year-old female patient (pregnant) received BNT162b2 (COMIRNATY), on 17Jun2021 as dose 2 (initial pfizer dose), single (Lot number: FD5996) for covid-19 immunisation.
The patient's relevant medical history included: "Asthma" (unspecified if ongoing).
The patient was 1 months pregnant at the time of exposure to BNT162b2.
The patient was 9 weeks pregnant at the event onset.
The patient's concomitant medications were not reported.
Vaccination history included: Astrazeneca vaccine (DOSE 1, Lot ABV5839), administration date: Mar2021, for COVID-19 IMMUNISATION.
The following information was reported: ABORTION SPONTANEOUS (hospitalization, medically significant), INFERTILITY FEMALE (hospitalization) all with onset 23Jul2021, outcome "recovered with sequelae" and all described as "After the 2nd vaccination miscarriage, then menopause, now infertile!!!"; HOT FLUSH (non-serious) with onset Oct2021, outcome "unknown", described as "hot flashes"; HAEMORRHAGE (hospitalization, medically significant), outcome "recovered", described as "On 23JUL2021 started the miscarriage, at that time I was in the 9th week of pregnancy.
The bleeding lasted 29 days.
"; OFF LABEL USE (hospitalization), outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization), outcome "unknown"; MENOPAUSE (non-serious), outcome "unknown"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Maternal exposure during pregnancy, first trimester".
The pregnancy resulted in spontaneous abortion (23Jul2021).
The patient underwent the following laboratory tests and procedures: Anti-Muellerian hormone level: (unspecified date) 0.
02; Blood test: (03Jan2022) MENOPAUSE.
Clinical course: The patient had no known allergies.
At that time of vaccination, she was 1 month pregnant but didn't know anything about it.
On 23JUL2021 started the miscarriage, at that time she was in the 9th week of pregnancy.
The bleeding lasted 29 days.
On 11sep2021 her next period started.
That was her last.
She haven't had her period until today and was going through menopause at 34.
RA assessment for events Miscarriage and Secondary infertility (female) and Comirnaty was D.
Unclassifiable.
No follow-up attempts are possible.
No further information is expected.