Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Ankyloglossia congenital, Foetal exposure during pregnancy, Jaundice neonatal, Macrocephaly
Clinical narrative: MACROCEPHALY; TONGUE TIE; JAUNDICE NEONATAL; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male neonate unspecified race and ethnicity. The patient's mother was a 29 year old (race and ethnicity unspecified) enrolled in a non-company sponsored study (Agency number: PR004). The patient's weight was 3.43 kilograms, and height was 51 centimeters. No concurrent conditions were reported. The neonate's birth weight was 7 pounds and 9 ounces, body length 20 inches on the day of birth. The patient's parent's medical history included: e-cigarette smoker (before this pregnancy/ Less than monthly), recreational drug use (before this pregnancy/ Less than monthly), and ectopic pregnancy, and concurrent conditions included: attention deficit hyperactivity disorder. The patient's gravida was 2, and para was 1. Concomitant medications included Adderall Xr, Prenatal Vitamins Plus, Flonase Allergy Relief, Prenatal, DHA, Claritin, Zyrtec Allergy And Childrens Dimetapp Cold And Cough, Tdap and flu vaccine administered in the left arm. Maternal obstetrical history included one previous pregnancy, which ended in ectopic or tubal pregnancy. The mother had no history of exposure to tobacco and alcoholic beverage. Maternal first day of the last menstrual period (LMP) was reported to be 13-Mar-2021. The estimated delivery date (EDD) was calculated to be 18-Dec-2021. It was reported that this was singleton pregnancy. The pregnancy resulted in a live birth (vaginally), full-term, male neonate. The patient exposed to covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, transplacental, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total, administered at gestation age of 3 weeks and 5 days on 08-APR-2021 for COVID-19 immunization. On 08-APR-2021, the patient exposed to vaccine during pregnancy (duration for event 238 days) (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy. On 09-NOV-2021, the patient received additional non-company suspect vaccine: tozinameran (PFIZER BIONTECH COVID-19 VACCINE) (Dose number in series 2) suspension for injection, transplacental, and batch number were not reported) 1 total, dose was not reported, for covid-19 immunization. On DEC-2021, the patient experienced jaundice neonatal (dose number in series 2). Laboratory data included: Hearing test (NR: not provided) unspecified.  On an unspecified date, the baby was diagnosed with macrocephaly and tongue tie (Dose number in series 2). On 2021, the patient was hospitalized and Number of days of hospitalization was not specified.  The action taken with tozinameran was not applicable. The outcome of macrocephaly, tongue tie and jaundice was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and macrocephaly, and tongue tie as unassessable, and between covid-19 vaccine ad26.cov2.s, and jaundice neonatal as not related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy; and between tozinameran, and macrocephaly, tongue tie, jaundice neonatal, and fetal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and macrocephaly, tongue tie, and fetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged, Congenital Anomaly/Birth Defect, and Other Medically Important Condition). This parent/child case is linked to 20210801145.; Sender's Comments: V0: 20220365966-covid-19 vaccine ad26.cov2.s-Macrocephaly, Tongue tie . 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(Recreational drug use). Therefore, this event(s) is considered not related. 20220365966-covid-19 vaccine ad26.cov2.s-Jaundice neonatal. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. 20220365966-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.