Monitoring vaccine safety using case series cumulative sum charts

Vaccine. 2008 Oct 3;26(42):5358-67. doi: 10.1016/j.vaccine.2008.08.010. Epub 2008 Aug 22.

Abstract

We adapt the self-controlled case series method for routine surveillance of vaccine safety using cumulative sum (CUSUM) charts. The CUSUM surveillance method we propose is applicable for detecting associations that arise in a short pre-determined risk period following vaccination. The performance of the case series CUSUM is investigated through simulations. We illustrate the method using retrospective analyses of influenza vaccine and Bell's palsy, and MMR vaccine and febrile convulsions.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Age Factors
  • Bell Palsy / etiology*
  • Computer Simulation
  • Data Interpretation, Statistical
  • Humans
  • Influenza Vaccines / adverse effects*
  • Measles-Mumps-Rubella Vaccine / adverse effects*
  • Models, Biological
  • Product Surveillance, Postmarketing / methods*
  • Retrospective Studies
  • Safety
  • Seizures, Febrile / etiology*

Substances

  • Influenza Vaccines
  • Measles-Mumps-Rubella Vaccine