이상반응 보고

VAERS ID	2293318
성별	여성
나이
주 코드	FR
제약회사	PFIZER\BIONTECH
로트 번호
예방접종 횟수	1
접종일	2021-06-10
발병일	2021-06-10
상태	입원

증상

• 호흡곤란(Dyspnoea)
• 말초 부종(Oedema peripheral)
• 전신 부종(Generalised oedema)
• 폐부종(Pulmonary oedema)
• 심부전(Cardiac failure)
• 임신 중 모성 노출(Maternal exposure during pregnancy)
• 사출 분수(Ejection fraction)

이환 중 질병

지병

Medical History/Concurrent Conditions: Normal pregnancy (2 normal pregnancies and births before)

기타 의료

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임상 검사

Test Name: Ejection fraction; Result Unstructured Data: Test Result:still reduced

증상 상세

Limited cardiac output continues in cardiology.
Monitoring/ ejection fraction still reduced; Massive oedema in the legs, later all over the body.
Water retention in the lungs and massive dyspnoea 2 days after delivery intensive med.
Admission; Massive oedema in the legs, later all over the body.
Water retention in the lungs and massive dyspnoea 2 days after delivery intensive med.
Admission; Massive oedema in the legs, later all over the body.
Water retention in the lungs and massive dyspnoea 2 days after delivery intensive med.
Admission; Massive oedema in the legs, later all over the body.
Water retention in the lungs and massive dyspnoea 2 days after delivery intensive med.
Admission; Maternal Exposure During Pregnancy, third trimester; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority.
Regulatory number: DE-PEI-CADR2022269985.
Other Case identifier(s): DE-CADRPEI-2022269985 (Webportal), DE-PEI-202200068925.
A 39-year-old female patient (pregnant) received BNT162b2 (COMIRNATY, strength: 0.
3 mL), on 10Jun2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation.
The patient's relevant medical history included: "Pregnancies" (unspecified if ongoing), notes: 2 normal pregnancies and births before.
The patient was 7 months pregnant at the event onset.
The patient's concomitant medications were not reported.
The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 10Jun2021, outcome "unknown", described as "Maternal Exposure During Pregnancy, third trimester"; PULMONARY OEDEMA (hospitalization, medically significant), GENERALISED OEDEMA (hospitalization), OEDEMA PERIPHERAL (hospitalization), DYSPNOEA (hospitalization) all with onset 12Jun2021, outcome "recovering" and all described as "Massive oedema in the legs, later all over the body.
Water retention in the lungs and massive dyspnoea 2 days after delivery intensive med.
Admission"; CARDIAC FAILURE (hospitalization, medically significant) with onset 13Jun2021, outcome "not recovered", described as "Limited cardiac output continues in cardiology.
Monitoring/ ejection fraction still reduced".
The patient underwent the following laboratory tests and procedures: Ejection fraction: still reduced.
Therapeutic measures were taken as a result of cardiac failure.
Health Authority Comments: The person concerned did not have any known allergies.
Information on risk factors or previous illnesses: no known cardiovascular diseases, no medication until vaccination, 2 normal pregnancies and births before.
08Aug2021, after birth intensive medical treatment, diuretics, antihypertensive, weaning, further cardiological monitoring and medication since then, ejection fraction still reduced, outcome uncertain according to cardiologists.
Relatedness of drug to reaction(s)/event(s): (For all events except Dyspnoea and Maternal Exposure During Pregnancy, third trimester) Source of assessment: RA; Result of Assessment: D.
Relatedness of drug to reaction(s)/event(s): (For Dyspnoea): Source of assessment: RA; Result of Assessment: B.
No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No further information is expected.