Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Failure to thrive, Foetal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: FAILURE TO THRIVE; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned an neonate male. The mother of neonate was enrolled in a non-company sponsored study. The patient's weight was 3.68 kilogram, and height was 53 centimeters. The patient had no birth defects, genetic or inherited disorders have been diagnosed since birth. The patient's mother had 2 previous stillbirth, and 2 previous miscarriage, and concurrent conditions included: vaginal bleeding, and smokers cough. The mother had no history of exposure to tobacco, drugs for recreational use or alcoholic beverage. The mother's Last menstrual period was calculated on 22-DEC-2020 and On 16-SEP-2021 (gestation age of 38 weeks and 2 days), the mother delivered a live, male, full-term neonate via caesarean method of delivery (C-section). Delivery was induced due to gestational high blood pressure and as the labor was not progressing (primary indication). The neonate's birth weight was 7 pounds and 1 ounce, baby length 21 inches. The mother of neonate initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: Unknown) dose was not reported, frequency time 1 total was administered on 26-MAY-2021 (gestation age of 22 weeks and 1 day) (fetal exposure during pregnancy) for Covid-19 immunization. Concomitant medications included Prenatal plus (minerals NOS (unspecified)/vitamins NOS (unspecified).  On an unspecified date in SEP-2021, the patient had hearing test (NR: not provided) but the result was not reported. On 15-Oct-2021, the patient developed failure to thrive and was admitted to the hospital. On the same day, he tested negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 16-SEP-2021, and the outcome of failure to thrive was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and failure to thrive was related, and between covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This is linked to 20210800799 (mother case).; Sender's Comments: V0: 20211119816 -COVID-19 VACCINE AD26.COV2.S-Failure to thrive. 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).. 20211119816-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