Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Foetal exposure during pregnancy, Premature baby
Clinical narrative: PREMATURE BIRTH; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 2 month old female. The patient was enrolled in a non-company sponsored study. Maternal medical history included anxiety, bipolar disorder type I and post-traumatic stress disorder. Concomitant medications included prenatal vitamins, Zofran (ondansetron), vitamin B6 and Seroquel (quetiapine fumarate). The mother had no relevant obstetrical history. The mother had history of tobacco and e-cigarette use, however reported no history of alcohol or recreational drug use. Maternal first day of the last menstrual period (LMP) was calculated to be 04-JUN-2021. The estimated delivery date (EDD) was reported to be 11-MAR-2022. Type of pregnancy was not reported. On 17-JUN-2021, at gestational age one week and six days, the mother of the neonate received covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered for covid-19 immunization. The batch number was not reported and has been requested. Drug start period was reported as 243 days, drug last period was reported as 243 days. Concomitant medications included transplacental Zofran (ondansetron) on 18-OCT-2021 when required, Vitamin B6 (pyridoxine hydrochloride) on 27-JUL-2021, prenatal vitamins (minerals nos/vitamins nos) on 22-JUL-2021 daily, and Seroquel (quetiapine fumarate) on 04-JUN-2021. On 17-JUN-2021, the patient experienced fetal exposure during pregnancy. Reaction first time was reported as 244 days, and reaction last time was reported as 244 days. On 13-FEB-2022, the mother of the neonate went into a preterm labor, caused by excess amniotic fluid. On 15-FEB-2022, at gestational age 36 weeks and four days, the mother delivered vaginally a live, pre-term, female neonate. The study participant spent four days at the hospital for the delivery. The neonate's weight was 6 pounds and 2 ounces, body length 17 inches. At the time of the initial report, no birth defects, genetic or inherited disorders have been diagnosed. At the time of this report, the patient's (baby infant) weight was 2.78 kilograms and height was 43 centimeters. No concurrent conditions were reported.  On 15-FEB-2022, the patient experienced premature birth. Reaction first time was reported as 1 day, and reaction last time was reported as 1 day. On an unspecified date in FEB-2022, Laboratory data included: 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 15-FEB-2022, and the outcome of premature birth was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and premature birth, and fetal exposure during pregnancy as not related. Company causality between covid-19 vaccine ad26.cov2.s, and premature birth, and fetal exposure during pregnancy were not related. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20211040520 (Mother case).; Sender's Comments: V0: 20220541134-COVID-19 VACCINE AD26.COV2.S-premature birth. 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(maternal medical history: anxiety, bipolar disorder type I and post-traumatic stress disorder). Therefore, this event(s) is considered not related.  20220541134-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.