Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Foetal exposure during pregnancy, Gastrooesophageal reflux disease, Milk soy protein intolerance, Neonatal dyspnoea
Clinical narrative: PROBLEMS WITH BREATHING; MILK SOY PROTEIN INTOLERANCE; REFLUX; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from consumer (parent) concerned a male neonate of unspecified race and ethnic origin. The patient was enrolled in a non-company sponsored study. The patient's weight was 4.847 kilograms (as reported on 20-Sep-2021), and height was 55.88 centimeters. The patient's other pre-existing medical conditions included: The patient has not been diagnosed with any genetic or inherited disorder. The patient's parent's medical history: Maternal obstetrical history included three previous pregnancies, with outcomes reported as one miscarriage, one elective termination and one live newborn, mother did not use drugs for recreational use, tobacco or alcohol during pregnancy. On unknown dates during pregnancy, the mother of the foetus, underwent blood testing (such as cell-free DNA screening, alfa fetoprotein, or the quad screen) and nuchal translucency screen test. None of the results showed any problem or concern. The patient's mother initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin transplacental, batch number: 1802072, expiry: unknown) dose was not reported, 1 total administered on 10-MAR-2021 for covid-19 immunisation at gestational age 17 weeks and four days. The patient (baby) received it via foetal exposure (foetal exposure during pregnancy). Concomitant medications included Baby Aspirin (acetylsalicylic acid), Mylanta maximum strength (calcium carbonate/magnesium hydroxide), Colace (docusate sodium), Bonjesta (doxylamine succinate/pyridoxine hydrochloride), ferrous sulfate, folic acid, Prenatal vitamins (minerals nos;vitamins nos), omeprazole, and Zofran (ondansetron). at gestational age of 37 weeks, the mother delivered two full-term live neonates, one male and one female, by caesarean method of delivery (C-section) and the male neonate's birth weight was 3345 grams. On 2021, Laboratory data included: Acoustic stimulation tests (NR: not provided) passed the hearing test. Primary reason for the C-section was reported to be breech presentation of babies. The mother of the neonate spent four days in the hospital for the delivery. The male neonate spent four days in Neonate Intensive Care Unit due to problems with breathing and had breech presentation. On 09-AUG-2021, male neonate was diagnosed with milk soy protein intolerance and reflux and treatment medications included: Vitamin D (ergocalciferol), lactulose, omeprazole, and Maloxine (pyrimethamine/sulfadoxine). The hospital admission date, number of days hospitalized and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the problems with breathing, milk soy protein intolerance, reflux and foetal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and problems with breathing, milk soy protein intolerance, and reflux was related, and between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20210958552. This parent/child case is linked to 20210763712.; Sender's Comments: V0: 20210958843-Covid-19 vaccine ad26.cov2.s-problems with breathing, milk soy protein intolerance, and reflux. 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).