Guillain-Barré syndrome after vaccination in United States: data from the Centers for Disease Control and Prevention/Food and Drug Administration Vaccine Adverse Event Reporting System (1990-2005)

J Clin Neuromuscul Dis. 2009 Sep;11(1):1-6. doi: 10.1097/CND.0b013e3181aaa968.

Abstract

Background: There are isolated reports of Guillain-Barré syndrome (GBS) after receiving vaccination.

Objective: To determine the rates and characteristics of GBS after administration of vaccination in United States

Methods: We used data for 1990 to 2005 from the Vaccine Adverse Event Reporting System, which is a cooperative program of the Centers for Disease Control and Prevention and the US Food and Drug Administration.

Results: There were 1000 cases (mean age, 47 years) of GBS reported after vaccination in the United States between 1990 and 2005. The onset of GBS was within 6 weeks in 774 cases, >6 weeks in 101, and unknown in 125. Death and disability after the event occurred in 32 (3.2%) and 167 (16.7%) subjects, respectively. The highest number (n = 632) of GBS cases was observed in subjects receiving influenza vaccine followed by hepatitis B vaccine (n = 94). Other vaccines or combinations of vaccines were associated with 274 cases of GBS. The incidence of GBS after influenza vaccination was marginally higher in subjects <65 years compared with those >or=65 years (P = 0.09); for hepatitis vaccine, the incidence was significantly higher (P < 0.0001) in the <65 group. Death was more frequent in subjects >or=65 years compared with those <65 years (P < 0.0001).

Conclusions: Our results suggest that vaccines other than influenza vaccine can be associated with GBS. Vaccination-related GBS results in death or disability in one fifth of affected individuals, which is comparable to the reported rates in the general GBS population.

MeSH terms

  • Adult
  • Adverse Drug Reaction Reporting Systems
  • Centers for Disease Control and Prevention, U.S.
  • Cohort Studies
  • Female
  • Guillain-Barre Syndrome / epidemiology*
  • Guillain-Barre Syndrome / immunology
  • Hepatitis B Vaccines / adverse effects
  • Hepatitis B Vaccines / immunology
  • Humans
  • Incidence
  • Influenza Vaccines / adverse effects
  • Influenza Vaccines / immunology
  • Male
  • Middle Aged
  • Mortality / trends
  • Product Surveillance, Postmarketing
  • United States / epidemiology
  • United States Food and Drug Administration
  • Vaccination / adverse effects*
  • Vaccines / adverse effects*
  • Vaccines / immunology

Substances

  • Hepatitis B Vaccines
  • Influenza Vaccines
  • Vaccines