Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Ankyloglossia congenital, Foetal exposure during pregnancy
Clinical narrative: TONGUE TIE; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer(parent) concerned a male neonate of unknown race and ethnicity. The patient was enrolled in a non-company sponsored study Registryt number: C01429). The patient's weight was 3.17 kilograms, and height was 20 inches (as reported on 21-Oct-2021). No concurrent conditions were reported. The patient's parent's medical history included Hypothyroidism and COVID-19 infection and maternal obstetrical history included three previous pregnancies, all resulting in miscarriage. The estimated delivery date (EDD) was reported to be 28-Sep-2021. Type of pregnancy was reported as singleton. The mother had history of tobacco use before current pregnancy and no history of alcohol or recreational drug use. At gestational age 21 weeks and one day, the patient's mother initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported and expiry: Unknown) dose was not reported, 1 total, administered on 19-MAY-2021 for covid-19 immunisation. The patient (baby) received it via foetal exposure. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Maternal concomitant medications included acetylsalicylic acid for drug used for unknown indication, docosahexaenoic acid for drug used for unknown indication, levothyroxine for drug used for unknown indication, and progesterone for drug used for unknown indication.  On 19-MAY-2021, the patient experienced foetal exposure during pregnancy. On date, at gestational age 39 weeks and three days, the mother delivered a live, full-term, male neonate by caesarean method of delivery (C-section). Primary reason for the C-section was reported as labor not progressing. The neonate spent six days in the hospital for the delivery. The neonate's birth weight was 7 pounds, body length: 19 inches.  On 28-Sep-2021, the neonate underwent tongue clip surgery.  On SEP-2021, Laboratory data included: Acoustic stimulation tests (NR: not provided) Baby passed the hearing test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tongue tie and foetal exposure during pregnancy was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and tongue tie 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 tongue tie and foetal exposure during pregnancy was not related. This report was serious (Congenital Anomaly/Birth Defect, and Other Medically Important Condition). This parent/child case is linked to 20210761811.; Sender's Comments: V0: 20211103342-COVID-19 VACCINE AD26.COV2.S-Tongue tie. This event is considered not related. The event shows an incompatible temporal relationship. 20211103342-COVID-19 VACCINE AD26.COV2.S-Foetal exposure during pregnancy. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS