Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Prolonged labour
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; LABOR NOT PROGRESSING; This solicited pregnancy report received from a consumer concerned a 24 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 past medical history included: miscarriage (One previous pregnancy), and recreational drug use (Weekly, before current pregnancy, no history of tobacco use), and concurrent conditions included: multigravida (One previous pregnancy), and alcohol use (A few days per week), and other pre-existing medical conditions included: The patient was pregnant at the time of vaccination. The patient was gravida 2, para 1. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, 1 total, administered on 24-MAR-2021 for covid-19 immunisation. Age at time of vaccination 24 years old. Concomitant medications included minerals nos/vitamins nos for drug used for unknown indication.  On 24-MAR-2021, at gestational age 11 weeks and four days, the patient received vaccine while being pregnant (vaccine exposure during pregnancy). The date of the patient's last menstrual period was 02-JAN-2021 and expected delivery date was 09-OCT-2021. The type of pregnancy was reported as singleton.  On an unspecified date in 2021, the patient had labor not progressing. At gestational age 39 weeks and one day, the patient delivered a live full-term neonate by caesarean method of delivery (C-section) (the outcome of pregnancy was live birth). Primary reason for C-section was reported as labor not progressing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from labor not progressing, and vaccine exposure during pregnancy. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and labor not progressing, 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 07-FEB-2022. The following information was updated and incorporated into case narrative: gestational age updated, disease history, para gravida, expected delivery date, outcome of pregnancy was added, outcome of the event vaccine exposure during pregnancy was updated from unknown to recovered, event added as labor not progressing and concomitant medication prenatal vitamins added.; Sender's Comments: V2: This follow up adds information about serious event labor not progressing  gestational age, race, disease history, para gravida, expected delivery date, outcome of pregnancy, outcome and concomitant medication.   20210761820 - 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.  20210761820- covid-19 vaccine ad26.cov2.s- labor not progressing. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. (Nulliparity considered as a potential risk factor)