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VAERS ID	2295234
성별	여성
나이
주 코드	FR
제약회사	PFIZER\BIONTECH
로트 번호
예방접종 횟수	2
접종일	2021-09-06
발병일	2021-09-14
상태

증상

피로(Fatigue)
사지의 통증(Pain in extremity)
메스꺼움(Nausea)
핫 플러시(Hot flush)
SARS-CoV-2 테스트(SARS-CoV-2 test)
인간 융모막 성선 자극 호르몬(Human chorionic gonadotropin)
혈액 갑상선 자극 호르몬(Blood thyroid stimulating hormone)
HIV 검사(HIV test)
조사(Investigation)
혈소판 수(Platelet count)
자연 낙태(Abortion spontaneous)
초음파 태아(Ultrasound foetal)
임신 중 모성 노출(Maternal exposure during pregnancy)
헤모글로빈(Haemoglobin)
백혈구 수(White blood cell count)
에스트라디올(Oestradiol)
성욕 감소(Libido decreased)
혈액 여포 자극 호르몬(Blood follicle stimulating hormone)
C형 간염 바이러스 검사(Hepatitis C virus test)
B형 간염 바이러스 검사(Hepatitis B virus test)
풍진 항체 검사(Rubella antibody test)
혈액 황체 형성 호르몬(Blood luteinising hormone)
톡소플라스마 혈청학(Toxoplasma serology)
니코틴 테스트(Nicotine test)

이환 중 질병

지병

Medical History/Concurrent Conditions: Birth control (has not been on contraception for at least 10 years.); Delivery (First child, pregnancy and delivery without problems.); Ectopic pregnancy (managed with methotrexate.); Miscarriage (G5P1; at 6 amenorrhea weeks); Tobacco user (smoking: 5 cigarettes/day)

기타 의료

이전 예방접종

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임상 검사

Test Date: 20220507; Test Name: FSH; Result Unstructured Data: Test Result:7.
18 IU/l; Test Date: 20220507; Test Name: LH; Result Unstructured Data: Test Result:10.
60 IU/l; Test Date: 20220507; Test Name: TSH; Result Unstructured Data: Test Result:0.
866 IU/l; Test Date: 20210917; Test Name: HB; Result Unstructured Data: Test Result:120 g/l; Test Date: 20211117; Test Name: HB; Result Unstructured Data: Test Result:130 g/l; Test Date: 20211117; Test Name: HBV; Test Result: Negative ; Test Date: 20211117; Test Name: HCV; Test Result: Negative ; Test Date: 20211117; Test Name: HIV; Test Result: Negative ; Test Date: 20210914; Test Name: b-HCG; Result Unstructured Data: Test Result:18326 IU/l; Test Date: 20210917; Test Name: b-HCG; Result Unstructured Data: Test Result:29981 IU/l; Test Date: 20211019; Test Name: anatomopathological analysis; Result Unstructured Data: Test Result:trophoblastic retention; Comments: trophoblastic retention without any worrying element that does not justify additional monitoring or management.
; Test Date: 20211117; Test Name: cotinine; Test Result: Negative ; Test Date: 20220507; Test Name: estradiol; Result Unstructured Data: Test Result:731 ng/L; Test Date: 20210917; Test Name: platelets; Result Unstructured Data: Test Result:266 x10 9/l; Test Date: 20211117; Test Name: platelets; Result Unstructured Data: Test Result:317 x10 9/l; Test Date: 20210917; Test Name: rubella serology; Result Unstructured Data: Test Result:IgG considered protective; Test Date: 20220412; Test Name: COVID test; Test Result: Negative ; Test Date: 20210917; Test Name: toxo; Result Unstructured Data: Test Result:not immunized; Test Date: 20211005; Test Name: Ultrasound; Result Unstructured Data: Test Result:no heartbeat; Comments: Consultation with a gynecologist who does not detect a heartbeat.
7 mm embryo without heartbeat.
; Test Date: 20211012; Test Name: Ultrasound; Result Unstructured Data: Test Result:without visible heartbeat; Comments: SGIU of 60 *25*25 mm with 9 mm embryo without visible heartbeat; Test Date: 20210917; Test Name: WBC; Result Unstructured Data: Test Result:4.
17 x10 9/l; Test Date: 20211117; Test Name: WBC; Result Unstructured Data: Test Result:4.
48 x10 9/l

증상 상세

good immediate tolerance except for a pain in the vaccination arm.
; The patient was 3 weeks pregnant at the time of exposure to BNT162b2; decreased libido; hot flashes; Fatigue; Early miscarriage; Onset of nausea.
; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP and Other HCP) from the Regulatory Authority-WEB.
Regulatory number: FR-AFSSAPS-LY20222377 (RA).
A 36-year-old female patient (pregnant) received BNT162b2 (COMIRNATY), on 06Sep2021 as dose 2, single (Lot number: Unknown) for covid-19 immunisation.
The patient's relevant medical history included: "Ectopic pregnancy", start date: Oct2018 (unspecified if ongoing), notes: managed with methotrexate; "Tobacco user" (unspecified if ongoing), notes: smoking: 5 cigarettes/day; "Miscarriage", start date: 2018 (unspecified if ongoing), notes: G5P1; at 6 amenorrhea weeks; "birth control" (not ongoing), notes: has not been on contraception for at least 10 years; "delivery", start date: 15Apr2020 (unspecified if ongoing), notes: First child, pregnancy and delivery without problems.
Date of last menstrual period: 14Aug2021.
The patient was 3 weeks pregnant at the time of exposure to BNT162b2.
The patient was 4 weeks pregnant at the event onset.
The patient is expected to deliver a baby(s) on 21May2022.
There were no concomitant medications.
Vaccination history included: comirnaty (dose 1, single), administration date: 12Aug2021, for covid-19 immunization, reaction(s): "pain in vaccination arm", "delay in menstruation of 1 day".
The following information was reported: NAUSEA (non-serious) with onset 14Sep2021, outcome "unknown", described as "Onset of nausea.
"; ABORTION SPONTANEOUS (medically significant) with onset 05Oct2021, outcome "recovered with sequelae", described as "Early miscarriage"; FATIGUE (non-serious) with onset 16Dec2021, outcome "unknown"; LIBIDO DECREASED (non-serious) with onset 16Dec2021, outcome "unknown", described as "decreased libido"; HOT FLUSH (non-serious) with onset 16Dec2021, outcome "unknown", described as "hot flashes"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "good immediate tolerance except for a pain in the vaccination arm.
"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "The patient was 3 weeks pregnant at the time of exposure to BNT162b2".
The events "early miscarriage" and "onset of nausea.
" required physician office visit.
The pregnancy resulted in spontaneous abortion.
The fetal outcome is intrauterine death.
The patient underwent the following laboratory tests and procedures: Blood follicle stimulating hormone: (07May2022) 7.
18 IU/l; Blood luteinising hormone: (07May2022) 10.
60 IU/l; Blood thyroid stimulating hormone: (07May2022) 0.
866 IU/l; Haemoglobin: (17Sep2021) 120 g/l; (17Nov2021) 130 g/l; Hepatitis B virus test: (17Nov2021) Negative; Hepatitis C virus test: (17Nov2021) Negative; HIV test: (17Nov2021) Negative; Human chorionic gonadotropin: (14Sep2021) 18326 IU/l; (17Sep2021) 29981 IU/l; anatomopathological analysis: (19Oct2021) trophoblastic retention, notes: trophoblastic retention without any worrying element that does not justify additional monitoring or management; Nicotine test: (17Nov2021) Negative; Oestradiol: (07May2022) 731 ng/L; Platelet count: (17Sep2021) 266 x10 9/l; (17Nov2021) 317 x10 9/l; Rubella antibody test: (17Sep2021) IgG considered protective; SARS-CoV-2 test: (12Apr2022) Negative; Toxoplasma serology: (17Sep2021) not immunized; Ultrasound foetal: (05Oct2021) no heartbeat, notes: Consultation with a gynecologist who does not detect a heartbeat.
7 mm embryo without heartbeat; (12Oct2021) without visible heartbeat, notes: SGIU of 60 x25x25 mm with 9 mm embryo without visible heartbeat; White blood cell count: (17Sep2021) 4.
17 x10 9/l; (17Nov2021) 4.
48 x10 9/l.
Therapeutic measures were taken as a result of abortion spontaneous.
he following clinical details of the evens were reported: 28Sep2021 - Patient is surprised that nausea has decreased.
05Oct2021 - Consultation with a gynecologist who does not detect a heartbeat.
Ultrasound: 7 mm embryo without CA.
12Oct2021 - Early pregnancy symptoms have almost disappeared.
Pregnancy termination confirmed today.
Ultrasound: SGIU of 60 x25x25 mm with 9 mm embryo without visible CA.
19Oct2021 - Operation aspiration curettage - uneventful under general anesthesia.
Simple immediate postoperative follow-up.
Ambulatory management.
anatomopathological analysis: trophoblastic retention without any worrying element that does not justify additional monitoring or management.
work stoppage in the aftermath.
EVOLUTION: on 19Nov2021, the patient had Return of menses.
16Dec2021 - Menstruation with different aspect (very clear blood).
Since then very variable cycles in terms of duration (36 days in Jan and 17 days in Feb), decreased libido, hot flashes and fatigue.
No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No further information is expected.
; Sender's Comments: Linked Report(s) : FR-PFIZER INC-202200747711 The same patient/reporter, different dose/events;FR-PFIZER INC-202200747712 The same reporter, different patient (Mother/foetus);FR-PFIZER INC-202200747713 The same patient/reporter, different dose/events