Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Oligohydramnios
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; LOW AMNIOTIC FLUID; This solicited pregnancy report received from a consumer concerned a 35 year old female. The patient was enrolled in a non-company sponsored study. The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included: Patient was pregnant at the time of vaccination. Patient was gravida 1 and para 1. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 07-APR-2021 for covid-19 immunisation. The batch number was not reported and has been requested. Age at time of vaccination 35 years old. No concomitant medications were reported.  At gestational age 25 weeks and three days, the patient received vaccine while being pregnant (vaccine exposure during pregnancy. The date of the patient's last menstrual period was 11-OCT-2020 and and expected delivery date was 18-JUL-2021.  On an unspecified date in year 2021, the patient experienced low amniotic fluid.  On 20-JUL-2021, at gestational age 40 weeks and two days, the pregnancy resulted in a live birth, full-term neonate via caesarean method of delivery (C-section). Primary reason for C-section was reported as low amniotic fluid.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy on 20-JUL-2021, and the outcome of low amniotic fluid was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and low amniotic fluid, and vaccine exposure during pregnancy as not related. This report was serious (Other Medically Important Condition).  This case was reassessed as serious based on additional information received from consumer on 27-OCT-2021, the following information was updated and incorporated into case narrative: serious event low amniotic fluid added, vaccine exposure during pregnancy was made serious, batch number statement updated, patient delivery details added with outcome of pregnancy, and causality updated.; Sender's Comments: V1 : This follow up adds information about serious event low amniotic fluid added, vaccine exposure during pregnancy was made serious, batch number statement updated, patient delivery details added with outcome of pregnancy, and causality.   20210800933- covid-19 vaccine ad26.cov2.s- vaccine exposure during pregnancy. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.  20210800933- covid-19 vaccine ad26.cov2.s- low amniotic fluid. 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 not related.