Sex: M
Vaccine: COVID19
Symptoms: Foetal exposure during pregnancy, Neonatal dyspnoea
Clinical narrative: FOETAL EXPOSURE DURING PREGNANCY; PROBLEMS WITH BREATHING; 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 3.002 kilograms, and height was 51 centimeters. No past medical history or concurrent conditions were reported. The parent's medical history included hypothyroidism. Mother did not have history of alcoholic beverage or tobacco use. Mother had history of recreational drugs use before this pregnancy, less than monthly. Maternal Body Mass Index (BMI) was 21.28. Maternal obstetrical history included two previous pregnancies, of which two ended in ectopic or tubal pregnancy. The estimated delivery date (EDD) was reported. Type of pregnancy was reported as a singleton. On 19-MAR-2021, at gestational age 24 weeks, the patient's mother initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number: 1808609, expiry: UNKNOWN) dose was not reported, one total administered on 19-MAR-2021 for covid-19 immunisation. Maternal concomitant medications included levothyroxine, vitamin D, Ritual prenatal vitamin, Diclegis (doxylamine succinate, pyridoxine hydrochloride), Pepcid Complete (calcium carbonate, famotidine, magnesium hydroxide) and Ambien (zolpidem tartrate) for drug used for unknown indication. On 19-MAR-2021, the patient experienced fetal exposure during pregnancy, and was hospitalized (date unspecified).On an unspecified date, at gestational age of 38 weeks and 1 day, the mother delivered live male neonate by vaginal method of delivery. The mother of the neonate spent three days in the hospital for the delivery. The neonate's birth weight was 6 pounds 10 ounces and body length was 20 inches. On JUN-2021, the patient experienced problems with breathing, and was hospitalized (date unspecified) for 3 days. The neonate was in Neonate Intensive Care Unit due to problems with breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 26-JUN-2021, and the outcome of problems with breathing was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and problems 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 20210800644.; Sender's Comments: V0: 20211106701-covid-19 vaccine ad26.cov2.s-problems 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). 20211106701 -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