Sex: U
Vaccine: COVID19
Symptoms: Ventricular septal defect
Clinical narrative: Small muscular ventricular septal defect; This literature-non-study case was reported in a literature article and describes the occurrence of VENTRICULAR SEPTAL DEFECT (Small muscular ventricular septal defect) in a foetus patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE     The patient's past medical history included Maternal exposure during pregnancy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced VENTRICULAR SEPTAL DEFECT (Small muscular ventricular septal defect) (seriousness criteria medically significant and congenital anomaly). At the time of the report, VENTRICULAR SEPTAL DEFECT (Small muscular ventricular septal defect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Eligible participants were pregnant, planning to receive any COVID-19 mRNA vaccine (mRNA-1273 from Moderna or BNT162b2 from Pfizer-BioNTech) at any point in pregnancy.  This study assessed participants enrolled from December 1, 2020, to December 31, 2021, and maternal-infant outcomes through March 31, 2022.   Of 76 pregnant individuals 42 (55.3%) received the BNT162b2 vaccine and 34 (44.7%) received the mRNA-1237 vaccine.  Five pregnancies were affected by fetal anomalies (6.6%)  There were no significant differences in maternal characteristics between the 2 vaccine groups. Systemic symptoms were more common after receipt of the second vaccine dose than after the first dose  and after mRNA-1237 than after BNT162b2.  Reported that vaccination in all trimesters elicited a robust maternal IgG response. The IgG transfer ratio was highest among individuals vaccinated in the second trimester. Anti-SARS-CoV-2 IgG was detectable in cord blood regardless of vaccination trimester. In milk, IgG and IgA titers remained above the positive cutoff for at least 5-6 months after birth, and infants of mothers vaccinated in the second and third trimesters had positive IgG titers for at least 5 to 6 months of life.  Company comment: This is a literature non-study case concerning a foetus patient of an unknown gender from a Maternal exposure during pregnancy patient, who experienced the serious unexpected medically significant and Congenital Anomaly event Ventricular septal defect (reported as Small muscular ventricular septal defect). The event occurred 35 weeks after receiving the first dose of mRNA-1273 vaccine (event and vaccine dates were not provided). No genetic diagnosis was performed. Concomitant and treatment medications were not reported. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-734497 (Parent-Child Link).   See case MOD-2023-734497 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2023: Live Follow up received by safety on 21-JUL-2023 has email that contains significant information: Reporter information, literature information, parent details, medical history and product information were updated.