Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cardiac function test, Foetal exposure during pregnancy, Large for dates baby, Neonatal dyspnoea
Clinical narrative: FETAL EXPOSURE DURING PREGNANCY; BABY WAS BORN WEIGHING 9 POUNDS AND 2 OUNCES; PROBLEM WITH BREATHING; This solicited pregnancy report received from a consumer concerned a male neonate of unspecified race and ethnic origin, whose mother was a 27-year-old White female. The patient was enrolled in a non-company sponsored study: COVID 19 Vaccines International Pregnancy Exposure Registryt number: C12490). The patient's weight was 13.375 pounds (birth weight was 9 pounds and 2 ounces), and height was 24 inches (height at the time of birth was 20 inches). The patient's other pre-existing medical conditions included: No birth defects, genetic or inherited disorders have been diagnosed since birth. The patient's parent (maternal) medical history included anxiety and polycystic ovary syndrome. The mother had no history of tobacco, alcohol or recreational drug use. Her concomitant medications included prenatal vitamins, sertraline hydrochloride (Zoloft) and metformin ER. Maternal first day of the last menstrual period (LMP) was calculated to be 05-APR-2021. The estimated delivery date (EDD) was reported to be 10-JAN-2022. Type of pregnancy was reported as singleton. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, Transplacental, batch number: 1808980 expiry: JUN-2021) dose was not reported, 01 total was administered on 03-APR-2021 for covid-19 immunization. Concomitant medications included metformin hydrochloride (Metformin ER) for drug used for unknown indication, and sertraline hydrochloride (Zoloft) for drug used for unknown indication. On an unspecified date, the patient experienced fetal exposure during pregnancy. On 06-JAN-2022, at gestational age 39 weeks and three days, the mother delivered vaginally a live, full-term, male neonate. The mother spent two days in the hospital for the delivery. The neonate's birth weight was 9 pounds and 2 ounces, body length 20 inches (Large for dates baby). On JAN-2022, the patient experienced problem with breathing (Neonatal dyspnea), and was hospitalized in the Intensive Care Unit (NICU) (date unspecified). Number of days hospitalized and discharge information was not reported. 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 fetal exposure during pregnancy, and the outcome of problem with breathing and baby was born weighing 9 pounds and 2 ounces was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and problem with breathing, baby was born weighing 9 pounds and 2 ounces, and fetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20211056779.; Sender's Comments: V0: 20220356029-Covid-19 vaccine ad26.cov2.s-Fetal exposure during pregnancy. 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: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.     20220356029-Covid-19 vaccine ad26.cov2.s-The problem with breathing and baby was born weighing 9 pounds and 2 ounces. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.