이상반응 보고

VAERS ID	1199751
성별	여성
나이
주 코드	FR
제약회사	PFIZER\BIONTECH
로트 번호
예방접종 횟수
접종일	2018-01-18
발병일	2021-03-01
상태

증상

• 초음파 스캔(Ultrasound scan)
• 조사(Investigation)
• 자연 낙태(Abortion spontaneous)
• 미생물학 시험(Microbiology test)
• 약물 효과 없음(Drug ineffective)
• 자궁경부 혈종 자궁(Cervix haematoma uterine)
• 임베디드 장치(Embedded device)
• 히스테로메트리(Hysterometry)
• 피임 기구를 사용한 임신(Pregnancy with contraceptive device)
• 임신 중 정맥 혈전증(Venous thrombosis in pregnancy)

이환 중 질병

Overweight; Postpartum state (no periods)

지병

Medical History/Concurrent Conditions: Elective abortion (1, due to fetal Trisomy 21); Multigravida (3); Parity 1 (spontaneous); Spontaneous abortion (1)

기타 의료

이전 예방접종

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임상 검사

Test Date: 20180118; Test Name: Hysterometry; Result Unstructured Data: Test Result:8-9; Test Date: 202103; Test Name: Investigation; Result Unstructured Data: Test Result:Lower leg thrombosis; Test Date: 202103; Test Name: Microbiology test; Result Unstructured Data: Test Result:Unremarkable; Test Date: 20180215; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:IUS in situ; Test Date: 20180626; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:IUS in situ; Test Date: 20181127; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:IUS in situ; Test Date: 20191007; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:IUS in situ; Test Date: 20201006; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:IUS in situ; Test Date: 20210302; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:diagnosis of early pregnancy, 6+4; Mirena in situ; Comments: At position control diagnosis of early pregnancy, 6+4 weeks; Mirena in situ, cervical, mural, not removed; Test Date: 20210303; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:cervical hematoma requiring cervical dilation

증상 상세

lack of drug effect; Cervical hematoma; Mirena in situ, cervical, mural, not removed; Early pregnancy (6+4 weeks); Lower leg thrombosis in last week of pregnancy; Spontaneous abortion at week 8+3; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) -WEB, company number DE-BAYER-2021-093273.
A 41-years-old female patient received unspecified dose bnt162b2 (COMIRNATY, (Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as for covid-19 immunisation.
levonorgestrel (MIRENA), intra-uterine from 18Jan2018 (Batch/Lot Number: TU01D1D) to an unspecified date, at 20 ug, daily continuously for contraception.
Medical history included multigravida, abortion induced from Sep2016 to an unknown date 1, due to fetal Trisomy 21 , ongoing postpartum state no periods , abortion spontaneous , primiparous from Mar2015 to an unknown date spontaneous , ongoing overweight.
The patient's concomitant medications were not reported.
on 03Mar2021 The patient experienced spontaneous abortion at week 8+3 (abortion spontaneous), cervical hematoma (cervix haematoma uterine), lower leg thrombosis in last week of pregnancy (venous thrombosis in pregnancy), mirena in situ, cervical, mural, not removed (embedded device) (medically significant) on 02Mar2021, early pregnancy (6+4 weeks) (pregnancy with contraceptive device), lack of drug effect (drug ineffective).
The patient underwent lab tests and procedures which included hysterometry: 8-9 on 18Jan2018, investigation: lower leg thrombosis on Mar2021, microbiology test: unremarkable on Mar2021, ultrasound scan: ius in situ on 15Feb2018, ultrasound scan: ius in situ on 26Jun2018, ultrasound scan: ius in situ on 27Nov2018 , ultrasound scan: ius in situ on 07Oct2019, ultrasound scan: ius in situ on 06Oct2020, ultrasound scan: diagnosis of early pregnancy, 6+4; mirena in situ on 02Mar2021 At position control diagnosis of early pregnancy, 6+4 weeks; Mirena in situ, cervical, mural, not removed , ultrasound scan: cervical hematoma requiring cervical dilation on 03Mar2021.
The outcome of the events was recovered.
No follow-up attempts needed, follow-up automatically provided by RA.