Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cardiac function test, Foetal exposure during pregnancy, Neonatal dyspnoea, Neonatal hypoxia
Clinical narrative: HYPOXIA; BIRTH AT GESTATIONAL AGE 36 WEEKS; PROBLEMS WITH BREATHING; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned an 1 day old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 3.03 kilograms, and height was 48 centimeters. No concurrent conditions were reported. The patient's maternal medical history included COVID-19, diabetes type II, and body mass index (BMI) was 46.933. Maternal obstetrical history included one previous pregnancy resulting in a live baby (para: 1, gravida:1) at the time of vaccination. The mother had no history of tobacco, alcohol or recreational drug use. The mother estimated delivery date (EDD) was calculated to be 01-Dec-2021. Type of pregnancy was reported as singleton. On 08-Jun-2021, at gestational age 14 weeks and six days, the mother of the neonate received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was transplacental, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered for covid-19 immunisation which is foetal exposure during pregnancy. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included metformin hydrochloride, and minerals nos/vitamins nos. On 08-Nov-2021, at gestational age 36 weeks and five days, the mother delivered a live, pre-term, female neonate (Premature birth) via caesarean method of delivery (C-section). Primary reason for C-section was reported to be a previous C-section. Labor was induced due to neonatal hypoxia. The mother spent four days in the hospital for the delivery. On NOV-2021, the neonate was admitted in the Neonatal Intensive Care Unit (NICU) due to problems with breathing (Neonatal dyspnea). Number of days hospitalization of neonate not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foetal exposure during pregnancy on 08-NOV-2021, and the outcome of problems with breathing, hypoxia and birth at gestational age 36 weeks was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and hypoxia, problems with breathing, birth at gestational age 36 weeks, and foetal exposure during pregnancy as not related, and company causality between covid-19 vaccine ad26.cov2.s, and hypoxia, problems with breathing, birth at gestational age 36 weeks, and foetal exposure during pregnancy was not related. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This parent/child case is linked to 20210805649 (Mother case).; Sender's Comments: V0: 20220320902-COVID-19 VACCINE Ad26.COV2.S-HYPOXIA, PROBLEMS WITH BREATHING. 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: MEDICAL HISTORY (Premature Birth). Therefore, this event(s) is considered not related. 20220320902-COVID-19 VACCINE Ad26.COV2.S- BIRTH AT GESTATIONAL AGE 36 WEEKS. 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: MEDICAL HISTORY (of mother: Diabetes type II, and Obesity). Therefore, this event(s) is considered not related. 20220320902-COVID-19 VACCINE Ad26.COV2.S- FOETAL 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.