Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cardiac function test, Foetal exposure during pregnancy, Large for dates baby, Neonatal dyspnoea
Clinical narrative: BABY WAS LARGE FOR GESTATIONAL AGE; PROBLEMS WITH BREATHING; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male neonate. The patient was enrolled in a non-company sponsored study.  The patient's weight was 3.63 kilograms, and height was 48.26 centimeters. No past medical history or concurrent conditions were reported. The patient's parent's (mother) medical history included depression and endometriosis, maternal body mass index (BMI) was 24.49, mother had maternal obstetrical history included one previous pregnancy, which resulted in live birth and no history of alcohol, tobacco but used drugs for recreational use before this pregnancy. The mother's first day of the last menstrual period (LMP) was calculated to be 11-SEP-2020. The estimated delivery date was reported to be 18-JUN-2021. Type of pregnancy was reported as singleton. At gestational age 28 weeks and 6 days, the patient's parent (mother) initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-2021 for covid-19 immunisation. The patient (baby) received it via transplacental route exposure. No concomitant medications were reported. On 01-APR-2021, the patient experienced foetal exposure during pregnancy. On an Unknown date during pregnancy it was diagnosed that baby was large for gestational age. At a gestational age of 40 weeks and 4 days, the mother delivered live male neonate vaginally. The mother of neonate spent two days in the hospital for the delivery. The neonate birth weight was 8 pounds, body length was 19 inches. The neonate spent seven days in the hospital after birth. The neonate was in neonate intensive care unit due to problems with breathing. On JUN-2021, Laboratory data included: Acoustic stimulation tests (NR: not provided) passed the hearing test, Cardiac function test (NR: not provided) heart is fine, and SARS-CoV-2 test (NR: not provided) Negative, tested with a sample from the nose or back of the throat.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foetal exposure during pregnancy, and the outcome of problems with breathing and baby was large for gestational age was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and problems with breathing, baby was large for gestational age was related and foetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20211016227.; Sender's Comments: V0: 20220130798-COVID-19 VACCINE AD26.COV2.S- problems with breathing, baby was large for gestational age. 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).  20220130798-COVID-19 VACCINE AD26.COV2.S-Foetal exposure during pregnancy. This event is considered not related. 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 than the drug. Specifically: SPECIAL SITUATIONS