이상반응 보고
| VAERS ID | 2166788 |
|---|---|
| 성별 | 여성 |
| 나이 | 34세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-07-28 |
| 발병일 | 2021-08-19 |
| 상태 |
증상
- 가려움증(Pruritus)
- 인간 융모막 성선 자극 호르몬(Human chorionic gonadotropin)
- 질 출혈(Vaginal haemorrhage)
- 자연 낙태(Abortion spontaneous)
- 초음파 태아(Ultrasound foetal)
- 부인과 검사(Gynaecological examination)
이환 중 질병
지병
Medical History/Concurrent Conditions: Ageusia (During Covid-19 infection); Anosmia (During Covid-19 infection); COVID-19 (Infection with body aches, anosmia, augueusia); Generalised muscle aches (During Covid-19 infection); Pregnancy (3 times, the last one in 2020 without incident); Sinus operation NOS
기타 의료
이전 예방접종
알레르기
임상 검사
Test Date: 20210820; Test Name: gynaecological emergency consultation; Result Unstructured Data: Test Result:unknown results; Test Date: 20210719; Test Name: beta human chorionic gonadotropin; Result Unstructured Data: Test Result:67,000 IU/l; Test Date: 202107; Test Name: ultrasound; Result Unstructured Data: Test Result:intrauterine gestational sac with an embryo; Comments: of 12 mm without corresponding cardiac activity, according to the information transmitted, at a term of 7 weeks + 3 days of amenorrhoea.
증상 상세
pruritus; Miscarriage; gynaecological bleeding; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority.
Regulatory number: FR-AFSSAPS-DJ20220491.
A 34-year-old female patient (pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 28Jul2021 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for covid-19 immunisation.
Relevant medical history included: "COVID-19", start date: Nov2020 (unspecified if ongoing), notes: Infection with body aches, anosmia, augueusia; "Sinus surgery" (unspecified if ongoing); "Pregnancy", start date: 2020 (unspecified if ongoing), notes: 3 times, the last one in 2020 without incident; "Body aches", start date: Nov2020 (unspecified if ongoing), notes: During Covid-19 infection; "anosmia", start date: Nov2020 (unspecified if ongoing), notes: During Covid-19 infection; "augueusia", start date: Nov2020 (unspecified if ongoing), notes: During Covid-19 infection.
Date of last menstrual period: 07Jun2021.
The patient was 51 days pregnant at the time of exposure to bnt162b2.
The patient was 10 weeks pregnant at the event onset.
The patient is expected to deliver a baby(s) on 14Mar2022.
The patient's concomitant medications were not reported.
The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 19Aug2021, outcome "recovered with sequelae", described as "Miscarriage"; VAGINAL HAEMORRHAGE (medically significant) with onset 19Aug2021, outcome "unknown", described as "gynaecological bleeding"; PRURITUS (non-serious), outcome "unknown", described as "pruritus".
The event "gynaecological bleeding" was evaluated at the emergency room visit.
Clinical summary: At a term of 7 weeks + 3 days of amenorrhoea, that is 3 weeks before the onset of symptoms of miscarriage.
In this context, the female patient received medical treatment.
In the report of 20Aug2021, "an episode of pruritus with application of MONAZOL (sertaconazole) a few weeks ago" was also noted.
For information, the female patient has started a new pregnancy.
The patient underwent the following laboratory tests and procedures: gynaecological examination: (20Aug2021) unknown results; human chorionic gonadotropin: (19Jul2021) 67,000 IU/l; ultrasound foetal: (Jul2021) intrauterine gestational sac with an embryo, notes: of 12 mm without corresponding cardiac activity, according to the information transmitted, at a term of 7 weeks + 3 days of amenorrhoea.
Therapeutic measures were taken as a result of abortion spontaneous, pruritus.