Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cardiac function test, Congenital aortic valve stenosis, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Baby was large for gestational age; Ventricular septal defect; Aortic valve stenosis; Foetal exposure during pregnancy; On 31-May-2024, this serious, initial non-interventional study safety report was received from a consumer via the COVID-19 Vaccines Registry and was received by Novavax on 29-Aug-2024.  A Male of an unspecified age was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (Transplacental) dose 5 microgram(s)(LOT: 5683MF012) on 20-Oct-2023 (Lot number was not provided in the report) and on 29-Dec-2023.  No medical history was reported.  The following concomitant medications were reported: HYDROXYCHLOROQUINE SULFATE (hydroxychloroquine sulfate) and PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS] (vitamins nos).  On 20-Oct-2023, 1 Day after vaccination the patient experienced Foetal exposure during pregnancy (Foetal exposure during pregnancy). On an unknown date in 2024, the patient experienced Ventricular septal defect(Ventricular septal defect)(Serious: Congenital Anomaly/Birth Defect and Other Medically Important Condition) and Aortic valve stenosis(Congenital aortic valve stenosis)(Serious: Congenital Anomaly/Birth Defect and Other Medically Important Condition). On 12-Jan-2024, 85 Days after vaccination the patient experienced Baby was large for gestational age (Large for dates baby).  Relevant lab tests included: HEARING TEST (Result: Baby passed the hearing test, Test Date: Mar-2024), HEART SCREENING TEST (Result: Small / medium hole and valve issue, Test Date: Mar-2024), NUCHAL TRANSLUCENCY (Result: The test detected potential abnormalities or complications., Test Date: 15-Sep-2023) and ULTRASOUND SCAN (Result: Baby was large for gestational age, Test Date: 12-Jan-2024).  At the time of reporting, the event outcome of Foetal exposure during pregnancy was Recovered/Resolved, Ventricular septal defect was Unknown, Congenital aortic valve stenosis was Unknown and Large for dates baby was Recovered/Resolved.  The reporter did not assess the causality between the vaccine and reported events: Ventricular septal defect, Congenital aortic valve stenosis and Large for dates baby.  The reporter assessed the causality between the vaccine and reported event Foetal exposure during pregnancy as Not applicable.  Agenxy's narrative was provided as follows: This case, received on 31-May-2024, refers to a male foetus whose mother was a 39-year-old female participant in the post-marketing study.   Maternal medical history included anxiety and depression. Concomitant medications included hydroxychloroquine sulfate and prenatal vitamins.   The mother of foetus had no relevant obstetrical history. The mother had no history of tobacco and recreational drug use, however reported alcohol use during the first three months of current pregnancy.  Maternal first day of the last menstrual period (LMP) was calculated to be 23-Jun-2023. The estimated delivery date (EDD) was reported to be 29-Mar-2024. Type of pregnancy was reported as singleton.  On 20-Oct-2023, at gestational age 17 weeks, the mother of the foetus received the first dose of Novavax (NVX-CoV2373) vaccine for the prevention of COVID-19. Batch number reported was 5683MF012.  On 29-Dec-2023, at gestational age 27 weeks, the mother of the foetus received the first dose of Novavax (NVX-CoV2373) vaccine for the prevention of COVID-19. Batch number was not reported.  On 12-Jan-2024. it was identified that the baby was large for gestational age.   at gestational age 39 weeks and one day, the mother delivered vaginally a live, full-term, male neonate. The mother spent one day in the hospital for the delivery. The neonate's birth weight was 8 pounds and 10 ounces, body length 21 inch. Heart screening test post delivery showed an issue with the neonate's heart - ventricular septal defect and aortic valve stenosis.  On the same day, the baby recovered from event large for gestational age. At the time of the initial report, baby's weight was 12 pounds and one ounce, body length 23 inches.  Outcome of events was not reported.   The study participant did not provide causality assessment.  The case is linked with 2023-US-00180 (corresponding mother case). Principal Investigator's assessments: The events of ventricular septal defect and congenital aortic valve stenosis are serious and unexpected for the Novavax (NVX-CoV2373)  vaccine. The heart is fully formed by 8 weeks into the pregnancy. Mother of the neonate received NVX-CoV2373 at gestational age 17 weeks and 27 weeks. Hence, causality for both mentioned events is assessed as not related to NVX-CoV2373.  Based on an internal review on 03-Dec-2024, it was determined that case 2024-NVX-US-00444's Initial Receipt Date was captured incorrectly as 29-Aug-2024 in the structured field. Therefore, this case 2024-NVX-US-01123 has been created with the correct Initial Receipt Date of 31 May 2024. Case 2024-NVX-US-00444 will be invalidated.; Sender's Comments: This Male of an unspecified age experienced Foetal exposure during pregnancy, Ventricular septal defect, Congenital aortic valve stenosis and Large for dates baby after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula).  The events Foetal exposure during pregnancy, Large for dates baby were reported as non-serious.   The event Ventricular septal defect and Congenital aortic valve stenosis were reported as serious.   Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Ventricular septal defect and Congenital aortic valve stenosis is considered Not Related,  COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Foetal exposure during pregnancy is considered Not applicable, COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Large for dates baby is considered Possible.