Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cardiac function test, Foetal exposure during pregnancy, Neonatal dyspnoea
Clinical narrative: PROBLEM WITH BREATHING; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a parent concerned a female neonate. The patient was enrolled in a non-company sponsored study. The patient's weight was 3.91 kilograms, and height was not reported. No concurrent conditions were reported. The patient's parent's medical history Maternal medical history included hypothyroidism. The mother had body mass index (BMI) 30.692. The mother had no relevant obstetrical history and no history of tobacco, alcohol or recreational drug use. The estimated delivery date (EDD) was reported to be 29-NOV-2021. Type of pregnancy was reported as singleton. On 12-APR-2021, at gestational age seven weeks, the patient's mother received the vaccine. at gestational age 40 weeks, the mother delivered vaginally a live, full-term, female. The mother spent two days in the hospital for the delivery. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine and prenatal vitamins.  On 12-APR-2021, the patient experienced fetal exposure during pregnancy. On an unspecified date, the patient experienced problem with breathing (neonatal dyspnea) and was hospitalized in the Intensive Care Unit (NICU) due to problems with breathing (date unspecified). Number of days of hospitalization was not reported. The date of the patient's last menstrual period was 22-FEB-2021.  On NOV-2021, Laboratory data included: Acoustic stimulation tests (NR: not provided) baby passed the hearing test, and Cardiac function test (NR: not provided) baby's heart is fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the problem with breathing and fetal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and problem with breathing was related, and between covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20210944596.; Sender's Comments: V0: 20220117123-covid-19 vaccine ad26.cov2.s-problem with breathing. 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).  20220117123-covid-19 vaccine ad26.cov2.s-fetal exposure during pregnancy. This event(s) is considered not related. 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.