Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Biopsy, Breech presentation, Foetal exposure during pregnancy
Clinical narrative: BABY WAS IN BREECH OR ABNORMAL PRESENTATION; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a female neonate of unspecified race and ethnicity. The patient was enrolled in a non-company sponsored study. The patient's weight was 2.89 kilograms, and height was 53 centimeters. No concurrent conditions were reported. The patient's parent's maternal medical history included: The mother had no relevant medical history. Maternal obstetrical history included one previous pregnancy, resulting in a miscarriage. The mother had history of recreational drug use, however reported no history of tobacco or alcohol use. Maternal first day of the last menstrual period (LMP) was calculated to be 26-Mar-2021. The estimated delivery date (EDD) was reported to be 31-Dec-2021. Type of pregnancy was singleton. The female neonate mother received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration was not reported ,batch number: 203A21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-APR-2021 for covid-19 immunization and the neonate was exposed via transplacental route. Concomitant medications included prenatal vitamins (minerals nos; vitamins nos) once daily via transplacental route, bupropion hydrochloride, and sertraline. On 12-APR-2021, (at gestational age two weeks and three days) the patient experienced foetal exposure during pregnancy (dose number in series 1). The event duration was 259 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The female neonate mother additionally received non-company suspect vaccine included: pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin was not reported, batch number: 30230BD expiry: UNKNOWN) dose was not reported, administered on 25-OCT-2021 for covid-19 immunisation and neonate was exposed via transplacental route at gestational age 30 weeks and three days. On an unspecified date, the baby was in breech or abnormal presentation (dose number in series 2). At gestational age 39 weeks and two days, the mother delivered a live, full-term, female neonate via caesarean method of delivery (C-section). Primary reason for C-section was reported to be baby's breech or abnormal presentation. The mother spent two days at the hospital for the delivery. No birth defects, genetic or inherited disorders have been diagnosed since birth. The patient recovered from foetal exposure during pregnancy, and baby was in breech or abnormal presentation. On DEC-2021, the patient underwent hearing test (NR: not provided) not reported. On 25-JAN-2022, the patient underwent biopsy (NR: not provided) ruling out Hirschprung disease. The action taken with tozinameran was not applicable. The reporter and company considered the causality between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy, and baby was in breech or abnormal presentation as not related. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210761819.; Sender's Comments: V0: 20220535006- COVID-19 VACCINE AD26.COV2.S- Baby was in breech or abnormal presentation . The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. 20220535006-COVID-19 VACCINE AD26.COV2.S-Foetal 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.