The Vaccine Safety Datalink project

Pharmacoepidemiol Drug Saf. Aug-Sep 2001;10(5):403-6. doi: 10.1002/pds.613.

Abstract

The Vaccine Safety Datalink (VSD) is a collaborative project between the National Immunization Program of the Centers for Disease Control and Prevention (CDC) and several large health maintenance organizations (HMOs) in the United States. The project began in 1990 with the primary purpose of rigorously evaluating concerns about the safety of vaccines. Computerized data on vaccination, medical outcome (e.g. hospital discharge, outpatient visits, emergency room visits, and deaths), and covariate data (e.g. birth certificates and census) are prospectively collected at multiple HMOs (initially four) and linked under joint protocol for analyses. Approximately 6 million people (2% of the US population) are members of HMOs participating in the VSD. The VSD has proven to be a valuable resource that has provided important information on a number of vaccine safety issues. The databases and infrastructure created for the VSD have also provided opportunities to address other immunization questions including vaccination coverage and cost-effectiveness. In a recent investigation of intussusception following rotavirus vaccination, the VSD methodology was expanded to include 10 managed care organizations. A cohort study was conducted that allowed estimation of incidence rates of intussusception and attributable risks associated with rotavirus vaccine.

MeSH terms

  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • Centers for Disease Control and Prevention, U.S. / organization & administration
  • Child
  • Community Health Planning / organization & administration
  • Cost-Benefit Analysis
  • Databases as Topic*
  • Female
  • Health Maintenance Organizations / organization & administration
  • Humans
  • Intussusception / chemically induced
  • Measles-Mumps-Rubella Vaccine / adverse effects
  • Meningitis, Aseptic / chemically induced
  • Product Surveillance, Postmarketing / economics
  • Product Surveillance, Postmarketing / methods
  • Risk Assessment
  • Rotavirus Vaccines / adverse effects
  • Rubella Vaccine / adverse effects
  • United States
  • Vaccination / adverse effects
  • Vaccines / adverse effects*

Substances

  • Measles-Mumps-Rubella Vaccine
  • Rotavirus Vaccines
  • Rubella Vaccine
  • Vaccines