Safety of varicella vaccine after licensure in the United States: experience from reports to the vaccine adverse event reporting system, 1995-2005

J Infect Dis. 2008 Mar 1;197 Suppl 2:S170-7. doi: 10.1086/522161.

Abstract

Widespread use of varicella vaccine in the United States could enable detection of rare adverse events not identified previously. We reviewed data from 1995 to 2005 from the Vaccine Adverse Event Reporting System, including data from laboratory analyses, to distinguish adverse events associated with wild-type varicella-zoster virus (VZV) versus those associated with vaccine strain. Almost 48 million doses of varicella vaccine were distributed between 1995 and 2005. There were 25,306 adverse events reported (52.7/100,000 doses distributed); 5.0% were classified as serious (2.6/100,000 doses distributed). Adverse events associated with evidence of vaccine-strain VZV included meningitis in patients with concurrent herpes zoster. Patients with genetic predispositions may rarely have disease triggered by receipt of varicella vaccine. Overall, serious adverse events reported after varicella vaccination continue to be rare and must be considered relative to the substantial benefits of varicella vaccination. Ongoing safety surveillance and further studies may shed light on some of the hypothesized associations.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adverse Drug Reaction Reporting Systems* / statistics & numerical data
  • Centers for Disease Control and Prevention, U.S.
  • Chickenpox / epidemiology
  • Chickenpox / mortality
  • Chickenpox / prevention & control
  • Chickenpox Vaccine / administration & dosage
  • Chickenpox Vaccine / adverse effects*
  • Child
  • Child, Preschool
  • Herpes Zoster / epidemiology
  • Herpes Zoster / virology
  • Herpesvirus 3, Human / isolation & purification
  • Humans
  • Infant
  • Licensure
  • Meningitis, Viral / epidemiology
  • Meningitis, Viral / virology
  • United States / epidemiology

Substances

  • Chickenpox Vaccine