Safety surveillance of respiratory syncytial virus (RSV) vaccine among pregnant individuals: a real-world pharmacovigilance study using the Vaccine Adverse Event Reporting System

The AEs reported to VAERS among pregnant individuals vaccinated with RSVpreF largely aligned with the safety profile observed in prelicensure studies; however, this analysis also highlights the previously observed safety signal for preterm birth. Active surveillance studies focusing on maternal and perinatal outcomes are needed to further evaluate this signal and guide future clinical recommendations.