title: Postlicensure safety evaluation of human papilloma virus vaccines.
abstract: OBJECTIVE
  A summary of postlicensure safety information of HPV vaccines from three sources: VigiBase, the global database of WHO's Programme for International Drug Monitoring, the VAERS report on Gardasil and the RIVM report on Cervarix.
  
  
  METHODS
  all AEFI from the three sources were recalculated to a percentage of all AEFI reported for each of the two vaccines. And the safety profile was compared to the safety data in the SPC.
  
  
  RESULTS
  Comparison of relative AEFI reporting proportions in the global VigiBase database with VAERS for Gardasil and with RIVM for Cervarix shows a safety profile in VigiBase similar to the result of PMS on a national level in 2 countries.
  
  
  CONCLUSIONS
  The post licensure safety profile of both vaccines is consistent with the data in the SPC of these vaccines.
authors.affiliation: Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden. jerry.labadie@who-umc.org
authors.forename: Jerry
authors.initials: J
authors.lastname: Labadie
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000367:Age Factors; D052685:Alphapapillomavirus / Q000187:drug effects*; D003257:Consumer Product Safety / Q000592:standards*; D016208:Databases, Factual; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D007115:Immunization Schedule; D030361:Papillomavirus Infections / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000592:standards; D018570:Risk Assessment
chemical_list: D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines; C510352:human papillomavirus vaccine, L1 type 16, 18