Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Foetal exposure during pregnancy, Neonatal dyspnoea, Premature baby
Clinical narrative: Birth at gestational age 36 weeks; Problems with breathing; Foetal exposure during pregnancy; This solicited pregnancy report received from a consumer concerned a female Neonate of unspecified age. The patient's mother was enrolled in a non-company sponsored study, with unknown race and ethnicity. The patient's weight was 2.38 kilograms, and height was 48 centimeters. No past medical history or concurrent conditions were reported. The maternal (mother age was 32 Years old) medical history included anxiety, asthma, depression, polycystic ovary syndrome. The mother had body mass index (BMI) of 35.422. The mother had no relevant obstetrical history and no history of tobacco, alcohol or recreational drug use. The patient's mother initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route not provided, batch number: 1805025, expiry: Unknown) dose was not reported, administered on 22-MAR-2021 for covid-19 immunisation (Dose number in series 1). neonate route of administration was transplacental. Concomitant medications included amoxicillin/clavulanic acid, salbutamol sulfate, sertraline hydrochloride and prenatal multivitamins. On 22-MAR-2021, the patient experienced foetal exposure during pregnancy. On unspecified date in OCT-2021, the patient experienced problems with breathing. Laboratory data included: Hearing test (NR: not provided) Unknown. At gestational age 36 weeks and two days, the mother delivered a live, premature, female neonate via caesarean method of delivery (C-section). Primary reason for C-section was reported as labor not progressing. Labor was induced due to pre-eclampsia. The mother spent five days in the hospital for the delivery. The neonate was admitted in the Neonatal Intensive Care Unit (NICU) due to problems with breathing. No birth defects, genetic or inherited disorders have been diagnosed since birth.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foetal exposure during pregnancy on 12-OCT-2021, and the outcome of problems with breathing and birth at gestational age 36 weeks were not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and birth at gestational age 36 weeks, and problems with breathing as not related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy, birth at gestational age 36 weeks, and problems with breathing was not related. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210727879.; Sender's Comments: V0: 20211205280- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Birth at gestational age 36 weeks. 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 OF MOTHER (Pre-Eclampsia). 20211205280- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Problems with breathing. 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 (Premature birth). 20211205280-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Foetal 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.