Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pre-eclampsia, Prenatal screening test, Prolonged labour
Clinical narrative: LABOR NOT PROGRESSING; PREECLAMPSIA; GESTATIONAL DIABETES; MATERNAL EXPOSURE DURING PREGNANCY; SORE ARM; MUSCLE PAIN; FATIGUE; This solicited pregnancy report received from a consumer concerned a 32-year-old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 58.96 kilograms and height was not reported. The patient had no relevant obstetrical history and no history of use of drugs for recreational use, tobacco or alcohol. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: unknown) dose was not reported, frequency time 1 total administered on 05-MAR-2021 for COVID-19 immunisation. Concomitant medications included cetirizine hydrochloride, diphenhydramine hydrochloride, minerals nos/vitamins nos, and paracetamol.  On 05-MAR-2021, the patient experienced maternal exposure during pregnancy, sore arm, muscle pain, fatigue. The date of her last menstrual period was 20-OCT-2020.  On 02-APR-2021, the patient experienced preeclampsia and gestational diabetes. On an unspecified date, the patient underwent blood testing such as Prenatal cell-free DNA screening,  Alphafetoprotein or the quad screen and  chorionic villus sampling test and none of the results showed any problem or concern. On an unspecified date, the patient experienced labor not progressing. at gestational age 38 weeks and three days, the patient delivered a full term live male neonate, by caesarean method of delivery (C-section). Primary reason for the C-section was reported to be labor not progressing. The patient spent five days in the hospital for the delivery. The male neonate's birth weight was 7 pounds and 15 ounces, birth length 20 inches.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from gestational diabetes, and preeclampsia on 15-JUL-2021, and the outcome of maternal exposure during pregnancy, muscle pain, fatigue, sore arm and labor not progressing was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and gestational diabetes, labor not progressing, and preeclampsia as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, sore arm, muscle pain, and fatigue. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and sore arm, muscle pain, and fatigue was related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).  This case was reassessed as serious based on additional information received from Consumer on 30-SEP-2021, the following information was updated and incorporated into case narrative: weight of patient, events- gestational diabetes, preeclampsia, labor not progressing. laboratory data, medical history, Indication of suspect product updated, concomitant medication end date updated (benadryl A), Reporter causality of event  gestational diabetes, preeclampsia, labor not progressing.; Sender's Comments: V1: 20210762963-covid-19 vaccine ad26.cov2.s-gestational diabetes, labor not progressing, preeclampsia. 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). 20210762963-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