이상반응 보고

VAERS ID 2245418
성별 여성
나이
주 코드 FR
제약회사 JANSSEN
로트 번호
예방접종 횟수 1
접종일
발병일 2022-04-05
상태 입원
증상
  • 임신 중 노출(Exposure during pregnancy)
  • 진통(Labour pain)

이환 중 질병

지병

Comments: The patient was pregnant at the time of reporting. The patient was gravida 4, para 2.

기타 의료

이전 예방접종

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임상 검사

증상 상세

VACCINE EXPOSURE DURING PREGNANCY; LABOR PAIN; This spontaneous pregnancy report received from a health care professional by a Regulatory Authority (PHIFDA, PH-PHFDA-300143195) concerned a 39 year old female of an unspecified race and ethnic origin.
The patient's height, and weight were not reported.
The patient's pre-existing medical conditions included: The patient was pregnant at the time of reporting.
The patient was gravida 4, para 2.
The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) 1 in total, dose, start therapy date were not reported for an unspecified indication.
The batch number was not reported.
The Company is unable to perform follow-up to request batch/lot numbers.
No concomitant medications were reported.
On an unspecified date, the patient had vaccine exposure during pregnancy.
On 05-APR-2022, the patient experienced labor pain and was hospitalized (date unspecified).
The number of days of hospitalization was not reported and it was unsure the patient discharged from the hospital.
The date of the patient's last menstrual period and expected delivery date were not reported.
The outcome of pregnancy was unknown.
The action taken with covid-19 vaccine was not applicable.
The patient was recovering from labor pain, and the outcome of vaccine exposure during pregnancy was not reported.
This report was serious (Hospitalization Caused / Prolonged).
; Sender's Comments: V0:20220433506-COVID-19 VACCINE -Labor pain.
The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility.
There is no information on any other factors potentially associated with the event(s).
Therefore, this event(s) is considered unassessable.
20220433506 -COVID-19 VACCINE -Vaccine exposure during pregnancy.
The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility.
There are other factors more likely to be associated with the event than the drug.
Specifically: SPECIAL SITUATIONS.
Therefore, this event is considered not related.