Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cardiac function test, Foetal exposure during pregnancy, Infantile apnoea
Clinical narrative: APNEA; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a female neonate. The patient was enrolled in a non-company sponsored study. The patient's weight was 3.46 kilograms, and height was 51 centimeters. No concurrent conditions were reported. The patient's parent's medical history Maternal medical history included anxiety and endometriosis. Body mass index (BMI) was 31.88. The mother had no relevant obstetrical history. 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 05-FEB-2021. The estimated delivery date (EDD) was reported to be 12-NOV-2021. Type of pregnancy was reported as singleton. The female fetus mother received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: unknown) dose was not reported, 1 total,  administered on 21-MAY-2021 for covid-19 immunization at gestational age 15 weeks. the child route of administration was reported as transplacental (Fetal exposure during pregnancy). Concomitant medications included fluoxetine hydrochloride, and prenatal vitamins. On 07-NOV-2021, at gestational age 39 weeks and two days, the mother of the neonate delivered a live, female, full-term neonate via caesarean method of delivery (C-section). Primary reason for C-section was labor lasting for 15 hours. The mother was stuck' at 9cm for 6 hours due to a hematoma on her cervix. The mother spent three days in the hospital for the delivery. The neonate's birth weight was 7 pounds and 10 ounces, body length 20 inches. On NOV-2021, the neonate was admitted in the Intensive Care Unit (ICU) after the delivery due to apnea. The patient was hospitalized (days and date not specified). Laboratory data included: Cardiac function test (NR: not provided) not reported, and Hearing test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 07-NOV-2021, and the outcome of apnea was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and apnea, and fetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This parent/child case is linked to 20210801118.; Sender's Comments: V0: 20220232600 - covid-19 vaccine ad26.cov2.s -Apnea. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. 20220232600 - 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.