Safety Signals Detected for Multiple Vaccines for Infants

Introduction: Safety signals were detected for infants aged 0 for epilepsy, bradycardia, cardiac arrest, and gastrointestinal adverse events (AEs) for specific vaccines and coadministered vaccine combinations. From these observations, additional elevated infant age 0 AEs safety signals are suspected. This study examines additional AEs, examining elevated infant age 0 AEs safety signals to provide etiology insights. Methods: Herein, the Vaccine Adverse Events Reporting System (VAERS) was retrospectively examined for candidate AE safety signals for infants aged 0. Results: Additional safety signals were identified for multiple AEs affecting infants. Safety signals were detected for specific vaccines, specific concomitantly administered vaccines, and live attenuated vaccines. Conclusions: Specific vaccines (including live, attenuated viral vaccines) and specific concomitant vaccine combinations are resulting in elevated frequencies of multiple infant AEs. Elevated normalized frequencies of AEs for multiple concomitant vaccine combinations have additive normalized frequencies. Elevated normalized frequencies for multiple manufacturing lots are consistent with possible manufacturing contaminants (e.g., endotoxins) as causative components for multiple elevated AE frequencies.