title: Surveillance for adverse events following immunization (AEFI) for 7 years using a computerised vaccination system.
abstract: OBJECTIVE
  The surveillance of vaccine safety is an essential requirement in vaccination programmes. Computerized immunization registries such as the Vaccination Information System (SIV) of Valencian Community (Spain) offer the opportunity to estimate the incidence of adverse events according to individual information. The aim of the study was to analyze adverse events following immunization reported through SIV from 2005 to 2011 by age, sex, type of vaccine and dose, and adverse event, and highlight the advantages of this type of reporting.
  
  
  METHODS
  A retrospective cohort study of subjects vaccinated in the Valencian Community using population health databases was carried out.
  
  
  METHODS
  Analysis of vaccinations and reported AEFI via SIV in Valencian Community was carried out.
  
  
  RESULTS
  More than 13 million vaccines doses were administered during 2005 through 2011, the reporting rate of adverse events was 12.4/100,000 doses administered with the highest value in 2009 (27.4), with differences by age and sex. DTaP vaccine had the highest reporting in children (96.6/100,000) while influenza A(H1N1)pdm09 in adults (87.7/100,000). An increased reporting of adverse events was seen with DTaP in children 5-6 years of age, detected in real time, drove to swap this vaccine to a low dose Tdap which was followed by a decrease in administration site events.
  
  
  CONCLUSIONS
  SIV demonstrates advantages for passive surveillance. Reporting rates by individual characteristics are calculated accurately and it also allows detecting shifts in reporting rate on real time for specific vaccines. The study shows that vaccines included in the routine vaccination schedule for children and adult vaccination programs are safe.
authors.affiliation: Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain; Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO), Valencia, Spain; Universidad Católica de Valencia 'San Vicente Mártir', Valencia, Spain. Electronic address: alguacil_ana@gva.es.
authors.forename: A M
authors.initials: AM
authors.lastname: Alguacil-Ramos
authors.affiliation: Dirección General de Farmacia y Productos Sanitarios, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Muelas-Tirado
authors.affiliation: Facultad de Farmacia, Universitat de Valencia, Valencia, Spain.
authors.forename: T M
authors.initials: TM
authors.lastname: Garrigues-Pelufo
authors.affiliation: Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Portero-Alonso
authors.affiliation: Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO), Valencia, Spain; Universidad Católica de Valencia 'San Vicente Mártir', Valencia, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Diez-Domingo
authors.affiliation: Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Pastor-Villalba
authors.affiliation: Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.
authors.forename: J A
authors.initials: JA
authors.lastname: Lluch-Rodrigo
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012189:Retrospective Studies; D012449:Safety; D013030:Spain; D014612:Vaccines / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D014612:Vaccines
keywords: AEFI (adverse event following immunization); Immunization registry; Passive surveillance; Vaccine safety