Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Alpha 1 foetoprotein, Foetal exposure during pregnancy, Gastrooesophageal reflux disease, Milk soy protein intolerance
Clinical narrative: Milk soy protein intolerance; Gastrooesophageal reflux disease; Foetal 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: COVID 19 Vaccines International Pregnancy Exposure Registry number: C02188) of unknown race and ethnicity. The patient's height was reported as 55.88 cm and weight was 4.904 kilogram. The patient's pre-existing medical conditions included: the mother did not use drugs for recreational use, tobacco or alcohol during pregnancy. The female foetus mother received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin trans-placental, batch number: 1802072 expiry: unknown) dose was not reported, 1 total, administered on 10-MAR-2021 for covid-19 immunisation. Concomitant medications included acetylsalicylic acid, calcium carbonate/magnesium hydroxide, docusate sodium, doxylamine succinate/pyridoxine hydrochloride, ferrous sulfate, folic acid, omeprazole, prenatal vitamins and ondansetron.  On 10-MAR-2021 (at gestational age 17 weeks and four days), the foetal exposure during pregnancy was occurred. On 30-JUL-2021 (at gestational age of 37 weeks), female foetus, was delivered by caesarean method of delivery (C-section). Primary reason for the C-section was reported to be breech presentation of baby. On 09-AUG-2021, the female neonate was diagnosed with milk soy protein intolerance (MSPI) and gastrooesophageal reflux disease and received treatment consisting of omeprazole, malox, lactulose and vitamin D. Baby has not been diagnosed with any genetic or inherited disorder. On unspecified date in 2021, Laboratory data included: Acoustic stimulation tests for which baby passed the hearing test. On unspecified date Laboratory data included: alphafetoprotein, foetal nuchal translucency, prenatal cell-free DNA screening and prenatal screening and results did not show any problem or concern. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the milk soy protein intolerance, gastrooesophageal reflux disease and foetal exposure during pregnancy was not reported.  The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and milk soy protein intolerance, and gastrooesophageal reflux disease was related, and between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy was not related.  This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210958843. This parent/child case is linked to 20210763712.; Sender's Comments: V0: 20210958552-Covid-19 vaccine ad26.cov2.s-milk soy protein intolerance, Gastrooesophageal reflux disease. 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).