Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Breech presentation, Cardiac function test, Foetal exposure during pregnancy, Jaundice neonatal
Clinical narrative: BABY WAS IN BREECH OR ABNORMAL PRESENTATION; JAUNDICE; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male neonate of an unspecified race and ethnicity. The patient was enrolled in a non-company sponsored study C-VIPER: COVID 19 Vaccines Pregnancy Exposure Registryt number: C12316). The patient's weight was 3.628 kilograms and height was 20 inches. No concurrent conditions were reported.  The patient's parent's medical history include the mother had two vessel umbilical cord. Body mass index (BMI) was 30.711.  Maternal obstetrical history included two previous pregnancies, both resulting in an elective termination. The mother had no history of tobacco or recreational drug use however reported alcohol use during the first three months of the pregnancy. Maternal first day of the last menstrual period (LMP) was reported to be 23-APR-2021. The estimated delivery date (EDD) was calculated to be 28-JAN-2022. Type of pregnancy was reported as singleton. The mother of the neonate initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: UNKNOWN) dose was not reported,1 total administered on 19-MAY-2021, at gestational age three weeks and five days for covid-19 immunisation which was foetal exposure during pregnancy. Concomitant medications included prenatal vitamins(therapy start date on 23-APR-2021), prenatal DHA (Docosahexaenoic acid)(therapy start date on 23-APR-2021), magnesium oxide (therapy start date on 13-DEC-2021) and Tums (calcium carbonate) (therapy start date on 05-OCT-2021).  On date, at gestational age 39 weeks and five days, the mother of the neonate delivered a live, male, full-term neonate via caesarean method of delivery (C-section). Primary reason for C-section was reported to be baby's breech presentation. The mother spent five days in the hospital for the delivery. On 30-JAN-2022, the neonate was admitted in the Neonatal Intensive care unit (NICU) due to jaundice .Number of days of hospitalization was not reported. It was unknown if the neonate was discharged. On JAN-2022, Laboratory data included: Cardiac function test (NR: not provided) not reported, and Hearing test (NR: not provided) not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from baby was in breech or abnormal presentation, and foetal exposure during pregnancy on 26-JAN-2022, and the outcome of jaundice was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and jaundice, baby was in breech or abnormal presentation, and foetal exposure during pregnancy as unassessable. Company causality between covid-19 vaccine ad26.cov2.s, and jaundice was related. Company causality between covid-19 vaccine ad26.cov2.s, and baby was in breech or abnormal presentation, and foetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This parent/child case is linked to 20211143825.; Sender's Comments: 20220353317-covid-19 vaccine ad26.cov2.s-baby was in breech or abnormal presentation. 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: UNDERLYING DISEASE. (placenta praevia) Therefore, this event(s) is considered not related.  20220353317-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.  20220353317-covid-19 vaccine ad26.cov2.s-jaundice. 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). Therefore, this event(s) is considered related.