Postmarketing Safety Surveillance of a Hexavalent Vaccine in the Vaccine Adverse Event Reporting System

We assessed the safety of hexavalent vaccine diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, hepatitis b, and haemophilus influenzae b conjugate vaccine in the Vaccine Adverse Event Reporting System. Five hundred-one reports of adverse events (AEs) were identified; 21 (4.2%) were serious. Most frequently reported AEs were fever (10.2%) and injection site erythema (5.4%). AEs reported were consistent with findings from prelicensure studies. (J Pediatr 2023;262:113643).

Automated summary

The safety of hexavalent vaccine was assessed in this study using the Vaccine Adverse Event Reporting System. The reported adverse events were consistent with prelicensure studies, with fever and injection site erythema being the most frequently reported.