Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Exposure during pregnancy, Polyhydramnios, Prolonged labour
Clinical narrative: POLYHYDRAMNIOS; LABOR NOT PROGRESSING; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 29-year-old female of unknown ethnic origin. (PR004). The patient's weight was 109.75 kilograms, and height was 168 centimeters. The patient's past medical history included: ex-tobacco user (before pregnancy 10 or fewer Cigarettes per week), and recreational drug use (before the pregnancy weekly), and concurrent conditions included: anxiety, asthma, alcohol use, and body mass index increased, and other pre-existing medical conditions included: the patient had no relevant obstetrical history, the type of pregnancy was singleton. The first day of the last menstrual period (LMP) was calculated to be 09-Oct-2020. The estimated delivery date (EDD) was reported to be 16-Jul-2021. The body mass index was 39(Unit unspecified). The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 05-MAR-2021 for prevention of covid-19 (covid-19 immunisation). The batch number was not reported and has been requested.  Concomitant medications included ascorbic acid/biotin/minerals nos/nicotinic acid/retinol/tocopherol/vitamin b nos/vitamin d nos, budesonide, celecoxib, cetirizine hydrochloride, famotidine, and salbutamol sulfate. On 05-Mar-2021, the patient experienced maternal exposure during pregnancy. On 19-Jul-2021, the patient was diagnosed with excessive amniotic fluid (polyhydramnios). Due to this condition, the labor was induced. On 21-Jul-2021, at gestational age 40 weeks and five days, the patient delivered a live male, full-term, neonate via caesarean method of delivery (C-section) (Hospitalization). It was reported that the primary reason for C-section was reported as labor not progressing. The patient spent five days in the hospital for the delivery. The neonate's birth weight was 9 pounds and 3 ounces, body length: 21 inches.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from polyhydramnios on 21-Jul-2021, and the outcome of maternal exposure during pregnancy and labor not progressing was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and polyhydramnios was related, and between covid-19 vaccine ad26.cov2.s, and labor not progressing, and maternal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged).  This case was reassessed as serious based on additional information received from Patient on 05-Nov-2021, the following information was updated and incorporated into case narrative: Patient disease (body mass index increased added), additional event of (polyhydramnios and labor not progressing), lab details was added, details of Neonate, Pregnancy details.; Sender's Comments: V1: 20210805766-covid-19 vaccine ad26.cov2.s-polyhydramnios. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210805766-covid-19 vaccine ad26.cov2.s-labor not progressing. This event(s) is considered not related. 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: MEDICAL HISTORY 20210805766-covid-19 vaccine ad26.cov2.s-maternal exposure during pregnancy. This event(s) is considered not related. 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