Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cardiac function test, Foetal exposure during pregnancy, Neonatal candida infection
Clinical narrative: SUSPECTED THRUSH; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a health care professional concerned a neonate male of an unspecified age, race and ethnic origin. The patient was enrolled in a non-company sponsored study. The patient's weight was 16 pounds, and height was 25 inches at the time of reporting. The patients mother had no relevant medical history. The patients mother was on prenatal vitamins (unspecified vitamins and minerals), had no relevant obstetrical history, had no history of tobacco, alcohol or recreational drug use. Maternal last menstrual period (LMP) was calculated to be 31-Aug-2020. The estimated delivery date (EDD) was reported to be 07-Jun-2021. Type of pregnancy was reported as a singleton. On unknown dates during pregnancy, the mother of the neonate had a nuchal translucency screen test. The test did not show any problem or concern.  The patients (mother) initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered on 11-APR-2021 (gestation age of 31 weeks and 6 days) for covid-19 immunization. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications of the patients mother included Famotidine administered to the patient via transplacental route for unknown indication.  On 11-APR-2021 (gestation age of 31 weeks and 6 days), the fetus was exposed during pregnancy. On 09-Jun-2021, at gestational age 40 weeks and two days, the mother vaginally delivered a live, male, full-term neonate The mother spent two days in the hospital for the delivery. The neonate's birth weight was 7 pounds and 12 ounces, body length 21 inches. The baby had been overall healthy. No birth defects, genetic or inherited disorders have been diagnosed since birth. On an unspecified date in JUN-2021, the baby underwent some laboratory tests including; Cardiac function test (NR: not provided) and Hearing test (NR: not provided), results for which were not reported. On 21-JUN-2021, the patient experienced suspected thrush. Treatment medications (dates unspecified) included: Nystatin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foetal exposure during pregnancy on 09-JUN-2021, and the outcome of suspected thrush was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and suspected thrush, and foetal exposure during pregnancy as not related. Company causality between covid-19 vaccine ad26.cov2.s, and suspected thrush was related and foetal exposure during pregnancy as not related. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210725431.; Sender's Comments: V0: 20211151171-Covid-19 vaccine ad26.cov2.s-Suspected thrush. This event(s) is considered related. 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).  Based on the information currently available, causality assessed as related for suspected thrush. Reassessment of causality will be done as per follow up query response. 20211151171-covid-19 vaccine ad26.cov2.s- Fetal exposure during pregnancy. This event(s) is considered not related. 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