Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cardiac function test, Foetal exposure during pregnancy, Gastroenteritis, Gastrooesophageal reflux disease
Clinical narrative: GERD; SLOW WEIGHT GAIN; GASTROENTERITIS; VIRAL PNEUMONIA; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male neonate. The patient was enrolled in a non-company sponsored study. The patient's weight was 3.99 kilograms, and height was 51 centimeters. No birth defects, genetic or inherited disorders had been diagnosed since birth. The maternal (parent's) medical history included: endometriosis, and had no history of alcohol, tobacco, or recreational drug use. Maternal obstetrical history included one previous pregnancy, resulting in a live birth. The maternal Body mass index (BMI) was 33.668 and type of pregnancy was reported as singleton. Maternal first day of the last menstrual period (LMP) was calculated to be 27-JAN-2021 and the estimated delivery date (EDD) based on the ultrasound was reported to be 19-NOV-2021. The patient's mother initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin (Transplacental for baby), batch number and expiry were not reported) dose was not reported, administered on 24-MAR-2021 for covid-19 immunization at gestational age eight weeks. The patient (baby) received it via foetal exposure (foetal exposure during pregnancy) (duration: 225 days). The batch number was not reported and has been requested. Concomitant medications included minerals NOS/vitamins NOS (Not otherwise specified), Prilosec (omeprazole), and Ursodiol (ursodeoxycholic acid) used for unspecified indication.  At gestational age 40 weeks the mother of the neonate delivered a live, male, full-term neonate via caesarean method of delivery (C-section). Primary reason for C-section was reported to be a previous C-section. The mother spent four days in the hospital for the delivery. On unspecified date in NOV-2021, Laboratory data included: Cardiac function test (NR: not provided), hearing test (NR: not provided) results was not reported.  On unspecified dates following birth, the baby was diagnosed with slow weight gain, gastroenteritis and gastroesophageal reflux disease (GERD). On 09-JAN-2022, Laboratory data included: SARS-CoV-2 test (NR: not provided) results was not reported. On 13-JAN-2022, the patient was diagnosed with viral pneumonia and received albuterol as treatment (dosage details unspecified). At the time of this report, baby's weight was 14 pounds and 1 ounce, body length 25 inches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 03-NOV-2021, and the outcome of viral pneumonia, GERD, slow weight gain and gastroenteritis was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and viral pneumonia, GERD, slow weight gain, gastroenteritis as not related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy.  The company causality between covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy, viral pneumonia, GERD, slow weight gain, gastroenteritis was not related. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20211222457.; Sender's Comments: V0: 20220424528-covid-19 vaccine ad26.cov2.s-Viral pneumonia . The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.  20220424528-covid-19 vaccine ad26.cov2.s-GERD, Slow weight gain, Gastroenteritis. The event(s) has an unknown/unclear 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 not related. 20220424528-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.