Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Cholestasis of pregnancy, Maternal exposure during pregnancy, Ultrasound scan
Clinical narrative: CHOLESTASIS; COVID-19; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 35 year old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 97.506 kilograms, and height was 170 centimeters. The patient's concurrent conditions included: multigravida, endometriosis, body mass index increased (33.668), non alcoholic and no tobacco use, and other pre-existing medical conditions included: The patient's obstetrical history included one previous pregnancy, resulting in a live birth. Para was 2 and gravida was 2. The patient had no history of recreational drug use.  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 24-MAR-2021 at gestational age eight weeks for covid-19 immunisation. Age at time of vaccination 35 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included minerals nos; vitamins nos (prenatal vitamins), omeprazole and ursodeoxycholic acid were used for unknown indication. On 24-MAR-2021, the patient experienced maternal exposure during pregnancy. On an unspecified date, the patient experienced cholestasis, and covid-19. On 03-Nov-2021, at gestational age 40 weeks, the patient delivered a live, male, full-term neonate via caesarean method of delivery (C-section). Primary reason for C-section was reported to be a previous C-section. Patient spent four days in the hospital for the delivery. The neonate's birth weight was 8 pounds and 13 ounces, body length 20 inches. Type of pregnancy was reported as singleton. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) 33.668 (increased) and diagnostic ultrasound (NR: not provided) EDD reported 19-Nov-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from maternal exposure during pregnancy on 03-NOV-2021, and the outcome of cholestasis and covid-19 was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and cholestasis, and covid-19 as not related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and cholestasis, covid-19 and maternal exposure during pregnancy was not related.  This report was serious (Other Medically Important Condition). This parent/child case is linked to 20220424528.  This case was reassessed as serious based on additional information received from consumer on 01-APR-2022, the following information was updated and incorporated into case narrative: Patient's demographics were added. Patient concurrent conditions were added. Pregnancy details were added. Additional events cholestasis and covid-19 were added. Lab test BMI and ultrasound was added. Concomitant products  minerals nos; vitamins nos (prenatal vitamins), omeprazole and ursodeoxycholic were added. Narrative was updated.; Sender's Comments: V1: 20211222457-covid-19 vaccine ad26.cov2.s-Cholestasis. The event(s) has an unknown/unclear 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: UNDERLYING DISEASE(Pregnancy). Therefore, this event(s) is considered not related. 20211222457-covid-19 vaccine ad26.cov2.s-COVID-19. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered not related. 20211222457-covid-19 vaccine ad26.cov2.s-Maternal exposure during pregnancy. 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. Therefore, this event(s) is considered not related.