title: Vaccine safety surveillance using large linked databases: opportunities, hazards and proposed guidelines.
abstract: Combined administrative databases are referred to as 'large linked databases' because of their relatively large size and the need for linkage of different data sets that were created separately from each other. Such linked databases have become popular in vaccine safety surveillance. Whereas their use offers some unique opportunities, their increasingly widespread use can also lead to wrongful linkage of vaccines to adverse events. We review the opportunities and hazards of using large linked databases for vaccine safety surveillance and propose some guidelines to increase the reliability of the outcomes. We also offer our opinion on the future use of large linked databases for vaccine safety surveillance purposes.
authors.affiliation: GlaxoSmithKline Biologicals, Rixensart, Belgium. Thomas.verstraeten@gskbio.com
authors.forename: Thomas
authors.initials: T
authors.lastname: Verstraeten
authors.forename: Frank
authors.initials: F
authors.lastname: DeStefano
authors.forename: Robert T
authors.initials: RT
authors.lastname: Chen
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Miller
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D016022:Case-Control Studies; D002487:Centers for Disease Control and Prevention, U.S.; D016000:Cluster Analysis; D015331:Cohort Studies; D003256:Community Participation; D015986:Confounding Factors, Epidemiologic; D003625:Data Collection; D016208:Databases, Factual; D020022:Genetic Predisposition to Disease; D017408:Guidelines as Topic; D006801:Humans; D008004:Licensure / Q000592:standards; D009017:Morbidity; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data; D010865:Pilot Projects; D012042:Registries; D012449:Safety; D014481:United States; D014612:Vaccines / Q000009:adverse effects*
chemical_list: D014612:Vaccines