Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Exposure during pregnancy, Prolonged labour
Clinical narrative: LABOR NOT PROGRESSING; VACCINE EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 37 year old female. The patient was enrolled in a non-company sponsored study: (patient number: C12424). The patient's weight was 119.73 kilograms, and height was 170 centimeters. The patient's past medical history included: elective abortion (One past pregnancy), tobacco user (10 or fewer cigarettes per day before current pregnancy), recreational drug use (Less than monthly before current pregnancy), and e-cigarette smoker (Monthly before current pregnancy), and concurrent conditions included: multigravida (One past pregnancy), anxiety, asthma, depression, and body mass index increased, and other pre-existing medical conditions included: Type of pregnancy was reported as singleton. No history of alcohol use. The patient was gravida 2, para 1 (present pregnancy). The patient previously treated covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 01-APR-2021, at gestational age two weeks and five days for covid-19 immunisation. On 01-Apr-2021, at gestational age two weeks and five days, the patient received Janssen vaccine and had vaccine (maternal) exposure during pregnancy (dose number in series 1). The patient recovered from vaccine exposure during pregnancy on DEC-2021 (duration was 269 days). The patient received additional dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose was not reported, 1 total, administered on 03-NOV-2021, at gestational age 33 weeks and four days for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid, escitalopram oxalate and Prenatal vitamins.  03-NOV-2021, at gestational age 33 weeks and four days, the patient received second dose of Janssen vaccine and had reccurence of vaccine (maternal) exposure during pregnancy (dose number in series 2). On an unspecified date, the patient experienced labor not progressing (dose number in series 2). The date of the patient's last menstrual period was 13-MAR-2021 and expected delivery date was 18-DEC-2021. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) 41.341. At gestational age 41 weeks, the patient delivered a live, full-term, female neonate via caesarean method of delivery (C-section). Primary reason for C-section was reported to be labor not progressing. The patient spent four days in the hospital for the delivery. The neonate's birth weight was 8 pounds and 2 ounces (3.68 kilogram), and body length was 20 inches. 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 on DEC-2021. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and labor not progressing as unassessable, and between covid-19 vaccine ad26.cov2.s, and vaccine exposure during pregnancy as not related. Company causality between covid-19 vaccine ad26.cov2.s and vaccine exposure during pregnancy and labor not progressing was not related.  This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211151851 (dose number in series 1).; Sender's Comments: V0: 20220510763-covid-19 vaccine ad26.cov2.s-Labor not progressing. Follow-up received regarding Clinical Details. 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(anxiety, depression, nulliparity, body mass index- increased 41.341)  . Therefore, this event(s) is considered not related.