Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Prenatal screening test, Prolonged labour, Ultrasound antenatal screen
Clinical narrative: LABOR NOT PROGRESSING; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 32 year old female of unspecified ethnicity. The patient was enrolled in a non-company sponsored study: COVID 19 Exposure Registryt. The patient's weight was 97.052 kilograms, and height was 155 centimeters. The patient's concurrent conditions included: anxiety, alcohol use (once per month during the first three months of pregnancy), and body mass index (BMI) increased (40.428). The patient had no history of tobacco or recreational drug use. The patient had no relevant obstetrical history. The patient was gravida 1, para 1. The first day of the last menstrual period (LMP) was calculated to be 31-Jan-2021. The estimated delivery date (EDD) was reported to be 07-Nov-2021. The type of pregnancy was reported as singleton. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021, at gestational age of nine weeks and six days, for covid-19 immunisation. Concomitant medications included ascorbic acid/biotin/minerals nos/nicotinic acid/retinol/tocopherol/vitamin b nos/vitamin d nos, (prenatal vitamins) and sertraline. On 05-APR-2021, Laboratory data included: Antenatal sonogram (NR: not provided) No abnormalities detected, and Prenatal screening test (NR: not provided) No abnormalities detected.  On 10-Apr-2021, at gestational age nine weeks and six days, the patient experienced maternal exposure during pregnancy. On NOV-2021, the patient experienced labor not progressing. On 04-Nov-2021, at gestational age 39 weeks and four days, the patient delivered a live, female, full-term neonate via caesarean method of delivery (C-section). The primary reason for C-section was reported as labor not progressing. The patient had spent four days in the hospital. The neonate's birth weight was 8 pounds and 4 ounces, body length 19 inches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from labor not progressing, and maternal exposure during pregnancy on 04-NOV-2021. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and labor not progressing, and maternal exposure during pregnancy as not related. The company causality 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 is a duplicate of 20220139366.  It was determined that Manufacturer Case Number 20220139366 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20211141807. This case was reassessed as serious based on additional information received from consumer on 12-JAN-2022. The following information was updated and incorporated into case narrative: patient race, medical history, concomitant condition (BMI increased) added, condition updated (maternal alcohol use to alcohol use), pregnancy details added, event (labor not progressing) added, event (maternal exposure during pregnancy) upgraded to serious, outcome and cessation date added for event (maternal exposure during pregnancy), and concomitant drug updated (Sertalin to Sertraline).; Sender's Comments: V1: This follow up version updates that Manufacturer Case Number 20220139366 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20211141807. This case was reassessed as serious based on additional information received from consumer on 12-JAN-2022. The following information was updated and incorporated into case narrative: patient race, medical history, concomitant condition (BMI increased) added, condition updated (maternal alcohol use to alcohol use), pregnancy details added, event (labor not progressing) added, event (maternal exposure during pregnancy) upgraded to serious, outcome and cessation date added for event (maternal exposure during pregnancy), and concomitant drug updated (Sertalin to Sertraline).  20211141807-COVID-19 VACCINE AD26.COV2.S- Labor not progressing. Follow-up received regarding Clinical Details. 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  20211141807-COVID-19 VACCINE AD26.COV2.S- Maternal exposure during pregnancy. Follow-up received regarding Clinical Details. 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