Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Ankyloglossia congenital, Foetal exposure during pregnancy, Labial tie
Clinical narrative: TONGUE TIE; LIP TIE; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male neonate of an unspecified race and ethnicity. The patient's mother was enrolled in a non-company sponsored study. The patient's birth weight was 7.15 pounds, and height was 20 inches. No concurrent conditions were reported. The patient's parent's medical history Maternal medical history included bipolar disorder. Maternal obstetrical history included two previous pregnancies, both resulting in an elective termination. The mother had history of tobacco, e-cigarette and recreational drug use, however reported no alcohol use. Maternal first day of the last menstrual period (LMP) was calculated to be 15-MAR-2021. The estimated delivery date (EDD) was reported to be 20-DEC-2021. Type of pregnancy was reported as singleton. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number: 201A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 for covid-19 immunisation. Concomitant medications included carbamazepine, lamotrigine, minerals nos/vitamins nos, pantoprazole sodium sesquihydrate, and quetiapine fumarate.  On 09-APR-2021, at gestational age three weeks and four days, the mother of the neonate received the vaccine and patient experienced foetal exposure during pregnancy. At gestational age 40 weeks, the mother delivered a live, full-term, male neonate by cesarean method of delivery (C-section). Primary reason for C-section was reported as labor not progressing. On an unspecified date in DEC-2021, Laboratory data included: Hearing test Not reported. On an unspecified date after birth, the neonate was diagnosed with tongue tie and lip tie. On 08-JUN-2022, the infant underwent removal of tongue tie and lip tie. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tongue tie, and lip tie on 08-JUN-2022, and foetal exposure during pregnancy on 20-DEC-2021. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and tongue tie, and lip tie as unassessable, and between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy as not related. Company causality between covid-19 vaccine ad26.cov2.s, and tongue tie, and lip tie was related.  This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210800839.; Sender's Comments: V0: 20220754639-covid-19 vaccine ad26.cov2.s- Tongue tie, Lip tie. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered related.   20220754639-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.