Sex: F
Vaccine: COVID19
Symptoms: Neonatal seizure, SARS-CoV-2 test, Spina bifida, Urinary tract infection neonatal, Vesicoureteric reflux
Clinical narrative: URINARY TRACT INFECTION; FOETAL EXPOSURE DURING PREGNANCY; KIDNEY REFLUX; SPINA BIFIDA; HYDROCEPHALUS; SEIZURE; LOW FETAL HEART RATE; This solicited pregnancy report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient was enrolled in a non-company sponsored study Registry number: C05587). The patient's weight was 2.95 kilograms, and height was not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025 expiry: UNKNOWN) dose was not reported, 1 total, administered on 23-MAR-2021 for covid-19 immunisation. Concomitant medications included amitriptyline hydrochloride, atorvastatin calcium, and sertraline hydrochloride. The baby route of administration was transplacental. On 07-JUN-2021, the mother had prenatal ultrasound which showed open neural tube defect. On 24-AUG-2021, at gestational age 38 weeks and three days, the mother delivered a live, full-term, female neonate by caesarean method of delivery (C-section). Primary reason for the C-section was low fetal heart rate. Mother spent two days in the hospital for the delivery. The neonate spent more than 10 days in the Neonatal Intensive Care Unit (NICU) after delivery due to birth defects. Neonate was born with spina bifida (myelomeningocele) and hydrocephalus. She was treated with endoscopic third ventriculostomy with choroid plexus cauterization (ETV/CPC), which failed. On 15-SEP-2021, the neonate developed a urinary tract infection (UTI), treated with amoxicillin. On 29-OCT-2021, the baby had shunt placement procedure for treatment of hydrocephalus. Shunt placement had a long recovery. The baby experienced seizures post-surgery, treated with Keppra (levetiracetam) and Vimpat (lacosamide). On 14-NOV-2021, the baby was hospitalized for UTI. Treatment required catheter and amoxicillin, administered every 4 hours as kidney infection prophylaxis because of kidney reflux. On the same day, the baby was tested for SARS-CoV-2 virus. Result was negative. On unspecified date patient was hospitalized for unspecified number of days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low fetal heart rate, hydrocephalus, spina bifida, urinary tract infection, seizure, kidney reflux and foetal exposure during pregnancy was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and low fetal heart rate, hydrocephalus, spina bifida, seizure, urinary tract infection, and kidney reflux 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 spina bifida, hydrocephalus, seizure, low fetal heart rate, urinary tract infection, kidney reflux, and foetal exposure during pregnancy was not related. This report was serious (Hospitalization Caused / Prolonged, and Congenital Anomaly/Birth Defect). This parent/child case is linked to 20210800843.; Sender's Comments: V0: 20211157053-covid-19 vaccine ad26.cov2.s -Spina bifida. This event(s) is considered not related. The event(s) shows an incompatible temporal relationship. 20211157053-covid-19 vaccine ad26.cov2.s -Hydrocephalus, Seizure, Low fetal heart rate, Urinary tract infection, Kidney 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: UNDERLYING DISEASE-Spina bifida. 20211157053-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