Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cardiac function test, Foetal exposure during pregnancy, Hospitalisation, SARS-CoV-2 test
Clinical narrative: This solicited pregnancy report received from a consumer concerned a male neonate of unspecified race and ethnicity. The patient was enrolled in a non-company sponsored study. The patient's weight at birth was 3.49 kilograms (7 pounds and 11 ounces), and height at birth was 19 inches and at the time of report weight was 13 pounds and 10 ounces, body length was 21 inches. The patient's pre-existing medical conditions included: The patient had no birth defects; genetic or inherited disorders have been diagnosed since birth. The patient-initiated treatment with covid-19 vaccine (dose number in series was 1) (suspension for injection, transplacental, batch number: 1805018, expiry: UNKNOWN) dose was not reported, 1 total, administered on 24-MAR-2021 for covid-19 immunisation. Concomitant medications included ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide for drug used for unknown indication. On an unspecified date in 2021, Laboratory data were performed: Acoustic stimulation tests (NR: not provided) baby passed the hearing test, and Cardiac function test (NR: not provided) baby's heart was fine (dose number in series 1). On 24-MAR-2021, the patient experienced foetal exposure during pregnancy (coded as drug exposure in utero). On 10-SEP-2021, Laboratory data included: SARS-CoV-2 test (NR: not provided) Negative. On 15-SEP-2021, the patient was admitted into hospital and the reason for hospitalisation was not specified. The patient spent two days in the hospital. Laboratory data included: SARS-CoV-2 test (NR: not provided) Negative (dose number in series 1). The action taken with covid-19 vaccine was not applicable. The outcome of the foetal exposure during pregnancy and hospitalisation was not reported. The reporter considered the causality between covid-19 vaccine, and hospitalisation as unassessable. The reporter did not provide a causality assessment between covid-19 vaccine, and foetal exposure during pregnancy. Company causality between covid-19 vaccine, and hospitalisation was related, and between covid-19 vaccine, and foetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20210753294.; Sender's Comments: V0: 20211260896-COVID-19 VACCINE hospitalisation. 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). 20211260896-COVID-19 VACCINE foetal 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.