이상반응 보고
| VAERS ID | 2084393 |
|---|---|
| 성별 | 여성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-07-30 |
| 발병일 | 2021-12-22 |
| 상태 |
증상
- 통증(Pain)
- 자연 낙태(Abortion spontaneous)
- 임신 중 출혈(Haemorrhage in pregnancy)
이환 중 질병
지병
Medical History/Concurrent Conditions: Bell's palsy; Oral contraception (The patient reported to stop taking oral contraception after dose no.1 due to heavy bleedings.)
기타 의료
FOLIC ACID; LYRICA
이전 예방접종
알레르기
임상 검사
증상 상세
spontaneous abortion/ MISCARRIAGE (DOSE NO.
2); Bleeding/ HAEMORRHAGE IN PREGNANCY (DOSE NO.
2); extremely more pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority.
Regulatory number: NO-NOMAADVRE-PASRAPP-2022-V9g7q3 (Agency).
Other Case identifier(s): NO-NOMAADVRE-E2B_00069241 (Agency).
A 31 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 30Jul2021 (Lot number: Unknown) as dose 2, single for covid-19 immunisation.
Relevant medical history included: "Oral contraception" (unspecified if ongoing), notes: The patient reported to stop taking oral contraception after dose no.
1 due to heavy bleedings.
; "bell's palsy" (unspecified if ongoing).
Concomitant medication(s) included: FOLIC ACID; LYRICA taken for bell's palsy (ongoing); and MULTIVITAMINS.
Vaccination history included: Comirnaty (dose 1, batch #unknown), administration date: 02Jul2021, for COVID-19 immunisation, reaction(s): "Heavy menstrual bleeding".
Due to heavy menstrual bleeding after dose 1, patient stopped taking oral contraception before dose 2.
Shortly after dose 2, the patient got pregnant.
The patient reported to have had normal pregnancy with the usual ailments during the first trimester.
The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 22Dec2021, outcome "unknown", described as "spontaneous abortion/ MISCARRIAGE (DOSE NO.
2)"; HAEMORRHAGE IN PREGNANCY (medically significant) with onset 22Dec2021, outcome "recovering", described as "Bleeding/ HAEMORRHAGE IN PREGNANCY (DOSE NO.
2)"; PAIN (non-serious) with onset 22Dec2021, outcome "unknown", described as "extremely more pain".
The patient described the miscarriage as brutal as she lost a lot of blood.
She reported to have lost 2 units of blood and to be scheduled for operation 03Jan2021.
The pregnancy resulted in spontaneous abortion.
Sender's Comment: Due to available information in Regulatory Authority the date for no.
2 was changed to 30Jul2021 and dose no.
1 was added.
The patient reported Latency for side effect HAEMORRHAGE IN PREGNANCY as 2 months, but dose no.
2 was taken 30Jul2021 and Onset Date for ADRs was reported as 22Dec2021.
There are almost 5 months between these two dates, which might mean the patient meant she experienced HAEMORRHAGE IN PREGNANCY 2 months after getting pregnant.
Due to the uncertainties Latency was removed.
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) : NO-PFIZER INC-202200118057 Same patient, different dose/ events