이상반응 보고
| VAERS ID | 1993366 |
|---|---|
| 성별 | 여성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FG4493 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-07-26 |
| 발병일 | 2021-08-12 |
| 상태 | 회복 |
증상
- 인간 융모막 성선 자극 호르몬(Human chorionic gonadotropin)
- 질 출혈(Vaginal haemorrhage)
- 임신 테스트(Pregnancy test)
- 초음파 스캔(Ultrasound scan)
- 임신 테스트 소변(Pregnancy test urine)
- 자연 낙태(Abortion spontaneous)
이환 중 질병
지병
Medical History/Concurrent Conditions: Contraception (I had a copper IUD without hormone that I removed at the end of January.)
기타 의료
FOLIC ACID
이전 예방접종
알레르기
임상 검사
Test Date: 20210803; Test Name: BHCG; Result Unstructured Data: Test Result:239; Test Name: Blood pregancy test; Test Result: Positive ; Comments: I did a urine test: positive.
I did a blood test which confirmed the result.
I do a second one which confirms the increase of BHCG even if they should have increased a bit more.
; Test Name: Urine pregnancy test; Test Result: Positive ; Comments: I did a urine test: positive.
; Test Date: 20210812; Test Name: Ultrasound; Result Unstructured Data: Test Result:empty gestational sac without visualization of the; Comments: empty gestational sac without visualization of the VV (Yolk sac); Test Date: 20210816; Test Name: Ultrasound; Result Unstructured Data: Test Result:miscarriage; Comments: finally had another ultrasound on 16Aug2021 which confirmed the miscarriage.
증상 상세
Miscarriage; vaginal blood loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency WEB.
Regulatory number: FR-AFSSAPS-RS20214156 (RA).
A 29 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 26Jul2021 (Lot number: FG4493) as dose 1, single for covid-19 immunisation.
Relevant medical history included: "I had a copper IUD without hormone" (unspecified if ongoing), notes: I had a copper IUD without hormone that I removed at the end of January.
Date of last menstrual period: 28Jun2021.
The patient was 4 weeks pregnant at the time of exposure to bnt162b2.
The patient was 6 weeks pregnant at the event onset.
The patient is expected to deliver a baby(s) on 04Apr2022.
Concomitant medication(s) included: FOLIC ACID.
The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 12Aug2021, outcome "recovered" (2021), described as "Miscarriage"; VAGINAL HAEMORRHAGE (non-serious) with onset 12Aug2021, outcome "recovered" (2021), described as "vaginal blood loss".
The event "miscarriage" was evaluated at the physician office visit.
The event "vaginal blood loss" was evaluated at the emergency room visit.
The pregnancy resulted in spontaneous abortion.
The patient underwent the following laboratory tests and procedures: human chorionic gonadotropin: (03Aug2021) 239; pregnancy test: (unspecified date) positive, notes: I did a urine test: positive.
I did a blood test which confirmed the result.
I do a second one which confirms the increase of BHCG even if they should have increased a bit more; pregnancy test urine: (unspecified date) positive, notes: I did a urine test: positive; ultrasound scan: (12Aug2021) empty gestational sac without visualization of the, notes: empty gestational sac without visualization of the VV (Yolk sac); (16Aug2021) miscarriage, notes: finally had another ultrasound on 16Aug2021 which confirmed the miscarriage.
Clinical Course: It was stated that Patient case, not medically confirmed.
No specific history.
No COVID test or COVID disease.
Patient stated that: Not knowing that she was pregnant (she was vaccinated on the first day of my last period on 28 June), she did not test.
What was the point knowing that the vaccination was compulsory as she work in the hospital ward.
About a week later, not having my period, she did a urine test: positive.
She did a blood test which confirmed the result.
She did a second one which confirms the increase of BHCG even if they should have increased a bit more.
On 12Aug2021, she go to the gynaecological emergency room because of blood loss.
An ultrasound was done and found an empty gestational sac without visualization of the VV.
She had to do another check-up at one week.
On August 14 and 15 blood loss.
She finally had another ultrasound on 16Aug2021 which confirmed the miscarriage.
She knows that miscarriages are frequent but she still wonder if this one was not linked to the vaccine.
Additional information collected by the regional pharmacovigilance center: no ER but info given by the declarant: she had no gynaecological or family history.
In total, spontaneous miscarriage in a 29-year-old patient with no previous gynaecological history during her 1st pregnancy.
The patient was at 6SA (week of amenorrhea) and 3 days.
No follow-up attempts are possible.
No further information is expected.