Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cardiac function test, Foetal exposure during pregnancy, Neonatal dyspnoea, Premature baby
Clinical narrative: PROBLEMS WITH BREATHING; BIRTH AT GESTATIONAL AGE 36 WEEKS AND TWO DAYS; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer (parent) concerned a male neonate. The patient was enrolled in a non-company sponsored study. The patient's weight was 2.92 kilograms, and height was 18 inches (as reported on 16-Aug-2021). The patient's parent's medical history Maternal obstetrical history included two previous pregnancies; one resulting in a live baby, while the outcome for the other pregnancy was not reported. The estimated delivery date (EDD) was reported to be 11-Sep-2021. Type of pregnancy was reported as a singleton, mother had history of anxiety and attention deficit disorder while, no history of tobacco, recreational drug, or alcoholic beverage consumption. On unknown dates, the mother of the neonate had blood tests, such as cell-free DNA screening, alfa fetoprotein, or the quad screen and a nuchal translucency screen test. None of the results showed any problem or concern. The patient's mother initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 for covid-19 immunisation. The patient (baby) received it via foetal exposure (foetal exposure during pregnancy). Maternal concomitant medications included Prozac (fluoxetine hydrochloride), Unisom Sleep (doxylamine succinate) and Prenatal Plus (minerals nos/vitamins nos). The mother vaginally delivered a live, pre-term, male neonate. The mother of the neonate spent two days in the hospital for the delivery. The neonate's birth weight was 6 pounds and 7 ounces, body length was 18 inches. The neonate spent more than 10 days in the hospital after birth and was in the neonatal intensive care unit (NICU). On an unknown date on AUG-2021, laboratory data included: Acoustic stimulation tests (NR: not provided) showed baby passed the hearing test and Cardiac function test (NR: not provided) showed baby's heart was fine. The discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the problems with breathing, birth at gestational age 36 weeks and two days and foetal exposure during pregnancy was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and problems with breathing, birth at gestational age 36 weeks and two days, and foetal exposure during pregnancy as not related. The Company causality between covid-19 vaccine ad26.cov2.s, and problems with breathing, birth at gestational age 36 weeks and two days, and foetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20210728727.; Sender's Comments: V0: 20211011488-Covid-19 vaccine ad26.cov2.s-3.Fetal exposure during pregnancy . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS   20211011488-Covid-19 vaccine ad26.cov2.s-2. Problems with breathing as not related . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS.