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

Pedro L Moro; Bicheng Zhang; Paige Marquez; Jonathan Reich

doi:10.1016/j.jpeds.2023.113643

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

J Pediatr. 2023 Nov:262:113643. doi: 10.1016/j.jpeds.2023.113643. Epub 2023 Jul 28.

Authors

Pedro L Moro¹, Bicheng Zhang², Paige Marquez², Jonathan Reich³

Affiliations

¹ Immunization Safety Office, Division of Healthcare Quality Promotion CDC, Silver Spring, MD. Electronic address: pmoro@cdc.gov.
² Immunization Safety Office, Division of Healthcare Quality Promotion CDC, Silver Spring, MD.
³ Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD.

PMID: 37517652
DOI: 10.1016/j.jpeds.2023.113643

Abstract

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.

Keywords: epidemiology; hexavalent vaccine; surveillance; vaccine safety.

Published by Elsevier Inc.

Publication types

Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

Diphtheria-Tetanus-Pertussis Vaccine* / adverse effects
Haemophilus Vaccines* / adverse effects
Hepatitis B Vaccines / adverse effects
Humans
Poliovirus Vaccine, Inactivated / adverse effects
Vaccines, Combined / adverse effects
Vaccines, Conjugate

Substances

Diphtheria-Tetanus-Pertussis Vaccine
Haemophilus Vaccines
Hepatitis B Vaccines
Poliovirus Vaccine, Inactivated
Vaccines, Combined
Vaccines, Conjugate