Sex: F
Vaccine: COVID19
Symptoms: Foetal exposure during pregnancy, Kabuki make-up syndrome, Premature baby
Clinical narrative: KABUKI SYNDROME; PREMATURE BIRTH; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a female neonate of an unspecified race and ethnicity. The patient's mother was enrolled in a non-company sponsored study: COVID 19 Vaccines Registry. The patient's height, and weight were not reported. No concurrent conditions were reported. The patient's parent's medical history included: The estimated delivery date (EDD) was calculated to be 23-OCT-2021. On 06-APR-2021 (at gestational age 11 weeks and 3 days), the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number was not reported and expiry: Unknown) dose was not reported, 1 total administered for COVID-19 immunisation. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the patient experienced foetal exposure during pregnancy. The duration for the event, foetal exposure during pregnancy was reported as 150 days. The reaction first time and last time of the event foetal exposure during pregnancy was reported as 1 days. On 02-SEP-2021, at gestational age 32 weeks and five day, the patient's mother delivered delivered a live, pre-term, female neonate. The neonate (patient) was admitted in the neonatal intensive care unit (NICU) due to Kabuki syndrome.  The number of days of hospitalization was not reported and it was unspecified if the patient discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 02-SEP-2021, had not recovered from kabuki syndrome, and the outcome of premature birth was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and kabuki syndrome, premature birth, and fetal exposure during pregnancy as not related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This parent/child case is linked to 20210800656.; Sender's Comments: V0: 20220809242-covid-19 vaccine ad26.cov2.s- Kabuki syndrome. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. (Kabuki syndrome is a rare, multisystem disorder characterized by multiple abnormalities including distinctive facial features, growth delays, varying degrees of intellectual disability, skeletal abnormalities, and short stature. It is caused by mutations in the KMT2D gene (also known as MLL2) or the KDM6A gene. The mother of the neonate received suspect vaccine at gestational age 11 weeks and three days, which makes temporal relationships implausible.) 20220809242-covid-19 vaccine ad26.cov2.s-premature birth. The case causality is considered NOT RELATED. Rationale: Concurrent event of Kabuki syndrome provide plausible explanation. 20220809242-covid-19 vaccine ad26.cov2.s-fetal exposure during pregnancy. 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. Therefore, this event(s) is considered not related.