이상반응 보고
| VAERS ID | 1796042 |
|---|---|
| 성별 | 여성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FD0932 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-07-28 |
| 발병일 | 2021-08-07 |
| 상태 |
증상
- 혈액 검사(Blood test)
- 초음파 자궁(Ultrasound uterus)
- 낙태 실패(Abortion missed)
이환 중 질병
지병
Comments: The patient had no other reported health issues.
기타 의료
이전 예방접종
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임상 검사
Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result: No results reported; Test Date: 20210830; Test Name: Ultrasound uterus; Result Unstructured Data: Test Result: Fetal tissue not visible; Test Date: 20210830; Test Name: Ultrasound uterus; Result Unstructured Data: Test Result: Confirmation of missed abortion.
증상 상세
Missed abortion (Abnormal cell division in early stage of pregnancy); This is a spontaneous report from a contactable consumer or other non HCP (patient) and a physician downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0088833.
This consumer or other non HCP reported information for both mother and fetus/baby.
This is a maternal report.
A 39-year-old female patient received second dose of bnt162b2 (COMIRNATY; Batch/Lot Number: FD0932; Expiration Date: 30Sep2021), via an unspecified route of administration on 28Jul2021 as DOSE 2, SINGLE for covid-19 immunisation.
The patient medical history was not reported.
The patient had no other reported health issues.
The patient's concomitant medications were not reported.
The patient previously took first dose of bnt162b2 (COMIRNATY; Batch/Lot Number: FE2083; Expiration Date: 31Oct2021), via an unspecified route of administration on 30Jun2021 as DOSE 1, SINGLE for covid-19 immunisation.
The patient experienced missed abortion (abnormal cell division in early stage of pregnancy) on 07Aug2021.
Missed abortion was by the Regulatory Medicines Agency assessed medically significant due to Abortion missed being on the RA list.
Patient's clinical course was as follows: The mother reported she became pregnant while taking bnt162b2.
The patient was treated with a medically induced abortion.
The fetal outcome is intrauterine death.
The patient underwent lab tests and procedures which included blood test with result of 'no result reported' on Aug2021; ultrasound uterus with results of 'Fetal tissue not visible' and 'Confirmation of missed abortion' on 30Aug2021.
Outcome of the event was not recovered.
Sender Comment: REGULATORY AUTHORITY COMMENT: Version 002: Created because the second reporter, the physician, mistakely was placed under other contacts in version 001.
No follow up attempts possible.
No further information is expected.
; Sender's Comments: Linked Report(s) : DK-PFIZER INC-202101358184 baby case