이상반응 보고
| VAERS ID | 2293703 |
|---|---|
| 성별 | 여성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-08-08 |
| 발병일 | 2021-08-08 |
| 상태 | 입원 중증 |
증상
- 부적절한 제품 관리 일정(Inappropriate schedule of product administration)
- 유방 부종(Breast swelling)
- 유방 통증(Breast pain)
- 엑스레이(X-ray)
- 신체 유방 검사(Physical breast examination)
- 유방 생검(Biopsy breast)
- 자궁외 임신(Ectopic pregnancy)
이환 중 질병
지병
기타 의료
이전 예방접종
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임상 검사
Test Name: tissue research; Result Unstructured Data: Test Result:Unknown; Test Name: Physical breast examination; Result Unstructured Data: Test Result:Unknown; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown
증상 상세
Ectopic pregnancy; Swelling in breasts.
; Swelling in breasts.
; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB.
The reporter is the patient.
Regulatory number: NL-LRB-00809218 (LRB).
Other Case identifier(s): NL-LRB-00810004 (LRB).
A 38-year-old female patient (pregnant) received BNT162b2 (COMIRNATY), on 08Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation.
The patient's relevant medical history was not reported.
The patient was 8 weeks pregnant at the event onset.
There were no concomitant medications.
Vaccination history included: comirnaty (DOSE 1, 0.
3 ML SINGLE), administration date: 23Jun2021, for covid-19 immunization.
The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Aug2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; ECTOPIC PREGNANCY (hospitalization, medically significant, life threatening) with onset 20Oct2021, outcome "recovered" (25Oct2021); BREAST PAIN (non-serious), BREAST SWELLING (non-serious) all with onset 03Jan2022, outcome "not recovered" and all described as "Swelling in breasts.
".
The patient underwent the following laboratory tests and procedures: Biopsy breast: Unknown; Physical breast examination: Unknown; X-ray: Unknown.
Therapeutic measures were taken as a result of ectopic pregnancy.
Clinical course: Treatment received for ectopic pregnancy was treated with surgery, the fallopian tube was removed.
From follow up information it became clear that exposure to the vaccination took place several weeks before onset of the pregnancy.
So this report does not refer to maternal exposure during pregnancy.
Ectopic Pregnancy.
Information CIOMS other or disabling information: Must choose something from the list .
But still have painful swellings in her breasts.
Right and left.
Have been checked and was hardened breast tissue.
Never had this before.
Hospitalization information: Fallopian tube surgery.
Additional information ADR: Bleeding fallopian tube.
This one had been removed.
Swelling in breasts.
Information CIOMS other or disabling information: Must choose something from the list .
But still have painful swellings in my breasts.
Right and left.
Have been checked and was hardened breast tissue.
Never had this before.
Additional information ADR: Found in January and in April 2022.
BSN available: yes.
Previous COVID-19 infection was reported as no.
diagnostic procedures reported as yes as X-ray and breast examination.
And tissue research.
FU dated 19May2022: She had surgery on 26Oct.
With bleeding in abdomen and almost burst fallopian tube.
And then turned out +/- 8 weeks pregnant.
No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No further information is expected.