Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cardiac function test, Cardiac septal defect, Foetal exposure during pregnancy, Gastrooesophageal reflux disease
Clinical narrative: ISSUE WITH BABYS HEART HOLES PRESENT; INFANT DELIVERED AT 35 WEEKS AND 2 DAYS; PROBLEMS WITH BREATHING; REFLUX; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned an 8 week old female. The patient was enrolled in a non-company sponsored prorgam. The patient's weight was 11.2 pounds, and height was not reported. The patient's pre-existing medical conditions included: mother did not use drugs for recreational use, tobacco or alcohol during pregnancy. The patient has not been diagnosed with any genetic or inherited disorder. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number: unknown) dose was not reported. On 24-Mar-2021, at gestational age 20 weeks and five days, the mother of the neonate received the Janssen or Johnson & Johnson(Ad26.COV2-S) vaccine for the prevention of COVID-19. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included docosahexaenoic acid, insulin aspart, insulin detemir, labetalol, nifedipine, and saccharated iron oxide. On 24-MAR-2021, the patient experienced cardiac septal defect, and was hospitalized (date unspecified). The patient delivered infant. On 24-MAR-2021, the patient experienced neonatal dyspnoea. On 24-MAR-2021, the patient experienced gastrooesophageal reflux disease. On 24-MAR-2021, the patient experienced foetal exposure during pregnancy. On an unspecified date in Jul-2021, the neonate underwent heart screening test which showed two holes in the heart. Laboratory data included: Acoustic stimulation tests (NR: not provided) baby passed the hearing test, and Cardiac function test (NR: not provided). On an unspecified date in SEP-2021, Laboratory data included: Cardiac function test (NR: not provided) Holes closed. On 04-SEP-2021, treatment medications included: lansoprazole. On an unspecified date in Sep-2021, during two-month check-up, it was confirmed that the holes in the baby's heart closed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the issue with baby's heart holes present, infant delivered at 35 weeks and 2 days, problems with breathing, reflux and foetal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and issue with baby's heart holes present, infant delivered at 35 weeks and 2 days, problems with breathing, reflux, and foetal exposure during pregnancy was not related. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210800681.; Sender's Comments: V0: 20211009718-covid-19 vaccine ad26.cov2.s Issues with baby's heart holes present, problems with breathing, reflux. 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: MEDICAL HISTORY  20211009718-covid-19 vaccine ad26.cov2. s.-Foetal exposure during pregnancy, and Infant delivered at 35 weeks and 2days.  This event(s) is considered not related. 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.