Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cardiac function test, Foetal exposure during pregnancy, Foetal heart rate deceleration abnormality, Heart rate
Clinical narrative: Baby's heart was decelerating; 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. The patient's weight was 3.231 kilograms, and height was 21 inches. No concurrent conditions were reported. The patient's mother's medical history included anxiety and depression and COVID-19 in NOV-2020. The patient's mother's had no relevant obstetrical history and no history of tobacco, alcohol or recreational drug use. The patient's mother's estimated delivery date (EDD) based on the ultrasound was 31-OCT-2021 and last menstrual period (LMP) was calculated to be 24-JAN-2021 and type of pregnancy was reported as singleton. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number was not reported and expiry: Unknown) dose was not reported, 1 total was administered on 08-MAY-2021 for covid-19 immunization (prevention of COVID-19). The batch number was not reported and has been requested. Concomitant medications included calcium carbonate (tums), lansoprazole (prevacid), minerals nos/vitamins nos (prenatal vitamins) and sertraline. On 08-MAY-2021, the patient experienced foetal exposure during pregnancy. The duration for the event, foetal exposure during pregnancy was 170 days. at gestational age of 39 weeks, the patient's mother delivered a live, male neonate via cesarean section. The cesarean section was performed because the baby's heart was decelerating. The patient's mother's spent four days in hospital for the delivery. Laboratory data included: Heart rate (not reported). On an unspecified date in OCT-2021, Laboratory data included: Cardiac function test (not reported), and Hearing test (not reported).  On an unspecified date in OCT-2021, the heart screening test was performed after delivery which showed that the baby's heart was fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from baby's heart was decelerating on OCT-2021, and foetal exposure during pregnancy on 25-OCT-2021. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy as not related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and baby's heart was decelerating. Company causality between covid-19 vaccine ad26.cov2.s, and baby's heart was decelerating was not related.  This report was serious (Other Medically Important Condition). This parent/child case is linked to 20211140173.; Sender's Comments: V0: 20230518170-baby's heart was decelerating. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.  20230518170- Foetal exposure during pregnancy. The event 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. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.