Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound antenatal screen
Clinical narrative: HEMORRHAGE; LABOR NOT PROGRESSING; ECLAMPSIA; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 33 year old white female of unspecified ethnicity. The patient was enrolled in a non-company sponsored study Registry number: C01112, site number: 5). The patient's weight was 64.4 kilograms, and height was not reported. The patient's past medical history included: intracytoplasmic sperm injection/in vitro fertilization, and recreational drug use (reported as less than monthly before this pregnancy), and concurrent conditions included: attention deficit disorder (attention deficit hyperactivity disorder), no tobacco use, and no alcohol use. The patient was pregnant at the time of vaccination. The patient had history of using fertility medications. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 and expiry: UNKNOWN) dose was not reported, 1 total administered on 18-MAR-2021 for covid-19 immunisation. The patient was pregnant when she had vaccine. The date of the patient's last menstrual period was on 04-NOV-2020 and expected delivery date was on 11-AUG-2021. Type of pregnancy was reported as singleton. Concomitant medications included lamotrigine (Lamictal), and prenatal vitamins (minerals nos/vitamins nos). On 18-MAR-2021, at gestational age 19 weeks and one day, the patient experienced maternal exposure during pregnancy. On 17-AUG-2021, the patient, developed pre-eclampsia and subsequently, eclampsia, and labor was induced due to pre-eclampsia and the gestational age (past due date). On 20-Aug-2021, at gestational age 41 weeks and two days, delivered a late term live male neonate, by caesarean method of delivery (C-section). The male neonate's birth weight was 9 pounds and 8 ounces, birth length 21 inches. And reported that, the primary reason for the C-section (caesarean section) was reported to be labor not progressing. The patient was hospitalized for six days, for the delivery and was in the hospital intensive care unit (ICU) after the delivery due to hemorrhage. On an unspecified date, the patient underwent nuchal translucency screen test (Fetal nuchal translucency ultrasound) and chorionic villus sampling (CVS) test (Biopsy chorionic villous), and reported that, neither of the results showed no problem or concern. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eclampsia on 21-AUG-2021, and the outcome of maternal exposure during pregnancy, hemorrhage and labor not progressing was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and eclampsia, hemorrhage, maternal exposure during pregnancy, and labor not progressing was not related.  This report was serious (Hospitalization Caused / Prolonged).  This case was reassessed as serious based on additional information received from COVID-19 Vaccines International Pregnancy Exposure Registry on 01-OCT-2021, the following information was updated and incorporated into case narrative: patient demographics (race), patient concomitant condition, pregnancy details, event (eclampsia, hemorrhage, labor not progressing), lab investigation, concomitant drug (prenatal vitamins). Upon review following information was amended seriousness of the event maternal exposure during pregnancy updated from non serious to serious, pregnancy type updated from prospective to retrospective and gestation period updated from 17 weeks to 41 weeks.; Sender's Comments: V2: 20210760812-covid-19 vaccine ad26.cov2.s-Eclampsia, hemorrhage, 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, UNDERLYING DISEASE  20210760812-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