이상반응 보고
| VAERS ID | 1852128 |
|---|---|
| 성별 | 여성 |
| 나이 | 51세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FF2752 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-07-29 |
| 발병일 | 2021-07-29 |
| 상태 |
증상
- 부적절한 제품 관리 일정(Inappropriate schedule of product administration)
- 조사(Investigation)
- 월경 출혈(Intermenstrual bleeding)
- 폐경 후 출혈(Postmenopausal haemorrhage)
- 생검 자궁내막(Biopsy endometrium)
- 자궁 폴립(Uterine polyp)
이환 중 질병
Amenorrhea
지병
기타 의료
이전 예방접종
알레르기
임상 검사
Test Date: 20210901; Test Name: endometrial biopsy; Result Unstructured Data: Test Result:mucus that includes fragments of inactive endometr; Comments: mucus that includes fragments of inactive endometrium and areas suggestive of endometrial polyp; Test Date: 20210901; Test Name: examination; Result Unstructured Data: Test Result:finding no alterations on examination
증상 상세
Endometrial polyp; Metrorrhagia; Metrorrhagia; 1st dose 04Jun2021 / 2nd dose 29Jul2021; This is a spontaneous report from a contactable physician.
This is the second of two reports.
The first report is a report downloaded from the WEB, regulatory authority number ES-AEMPS-942238.
A 51-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular at age of 51 years on 29Jul2021 (Lot Number: FF2752) as dose 2, 0.
3 ml, single for covid-19 immunisation.
The patient medical history included ongoing amenorrhea for 3 years (since 2018).
Concomitant medication included corticosteroids and antiH1 as premedication.
Historical vaccine included bnt162b2 (COMIRNATY, Lot Number: FD1921), intramuscularly on 04Jun2021 as dose 1, 0.
3 ml, single for covid-19 immunisation and experienced rash urticarial, minimal uvula edema, Pruritus, skin reaction with erythematous and pruritic lesions all over the body.
The patient previously took ASA in 1998 and had Nettle rash.
An allergy consultation is requested to assess the administration of the 2nd dose of the vaccine.
The patient experienced endometrial polyp on 01Sep2021, metrorrhagia on 10Aug2021, metrorrhagia on 10Aug2021, '1st dose 04Jun2021 / 2nd dose 29Jul2021' on 29Jul2021.
The clinical course details reported as follows: the patient received the 2nd dose of the vaccine without problems, premedicating herself with corticosteroids + antiH1 according to the gynecology recommendation.
She had metrorrhagia since 10Aug2021, being with amenorrhea for 3 years (since 2018).
She was referred to gynecology, which evaluated the 01Sep2021, finding no alterations on examination, and performing an endometrial biopsy, the result of which was "mucus that includes fragments of inactive endometrium and areas suggestive of endometrial polyp.
" The outcome of the events was unknown.
No follow-up attempts are needed.
No further information is expected.
; Sender's Comments: Linked Report(s) : ES-PFIZER INC-2021905450 same patient, different dose/AE