Surveillance of adverse events following vaccination in the French armed forces, 2011-2012

Public Health. 2015 Jun;129(6):763-8. doi: 10.1016/j.puhe.2015.03.003. Epub 2015 Apr 15.

Abstract

Objectives: French military personnel are subject to a compulsory vaccination schedule. The aim of this study was to present the results of surveillance of vaccine adverse events (VAEs) reported from 2011 to 2012 in the French armed forces.

Study design: VAEs were surveyed among all French armed forces from 2011 to 2012 by the epidemiological departments of the military health service. For each case, a notification form providing patient and clinical information was provided.

Methods: Case definitions were derived from the French drug safety guidelines. Three types of VAE were considered: non-serious, serious and unexpected. Incidence rates were calculated by relating VAEs to the number of vaccine doses delivered.

Results: In total, 161 VAE cases were reported. The overall VAE reporting rate was 24.6 VAEs per 100,000 doses, and the serious VAE rate was 1.3 per 100,000 doses (nine cases). The serious VAEs included two cases of Guillain-Barré syndrome, one case of optic neuritis, one case of a meningeal-like syndrome, one case of rheumatoid purpura, one case of acute asthma and three cases of fainting. The highest rates of VAE were observed with the Bacille Calmette-Guérin vaccine (BCG) (482.3 per 100,000 doses), inactivated diphtheria-tetanus-poliovirus with acellular pertussis vaccine (dTap-IPV) (106.1 per 100,000 doses) and meningococcal quadrivalent glycoconjugate vaccine (MenACWY-CRM) (39.3 per 100,000 doses).

Conclusions: The global rates of VAE observed in 2011 and 2012 confirm the increase that has been observed since 2009 in the French armed forces, which could reflect improved practitioner awareness about VAEs and the use of certain vaccines added to the vaccination schedule recently (dTap-IPV in 2008 and MenACWY-CRM in 2010). VAEs appear to be relatively rare, particularly serious VAEs, which indicates acceptable tolerance of vaccines.

Keywords: Armed forces; Vaccine; Vaccine adverse event.

MeSH terms

  • Adult
  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • BCG Vaccine / administration & dosage
  • BCG Vaccine / adverse effects
  • Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage
  • Diphtheria-Tetanus-Pertussis Vaccine / adverse effects
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Female
  • France / epidemiology
  • Humans
  • Immunization Schedule
  • Male
  • Meningococcal Vaccines / administration & dosage
  • Meningococcal Vaccines / adverse effects
  • Middle Aged
  • Military Personnel / statistics & numerical data*
  • Poliovirus Vaccine, Inactivated / administration & dosage
  • Poliovirus Vaccine, Inactivated / adverse effects
  • Product Surveillance, Postmarketing*
  • Vaccines / administration & dosage
  • Vaccines / adverse effects*
  • Vaccines, Combined / administration & dosage
  • Vaccines, Combined / adverse effects
  • Vaccines, Conjugate / administration & dosage
  • Vaccines, Conjugate / adverse effects
  • Young Adult

Substances

  • BCG Vaccine
  • DTPP vaccine
  • Diphtheria-Tetanus-Pertussis Vaccine
  • MenACWY
  • Meningococcal Vaccines
  • Poliovirus Vaccine, Inactivated
  • Vaccines
  • Vaccines, Combined
  • Vaccines, Conjugate