title: [Post-licensure safety surveillance for Prevenar 13®in France].
abstract: OBJECTIVE
  To describe the profile and the incidence of adverse events (AEs) reported with Prevenar 13®since its commercialization.
  
  
  METHODS
  Analysis of all adverse events reported with Prevenar 13®in France between 1st July 2010 and 31 October 2014.
  
  
  RESULTS
  In 4 years and 4 months, 376 AEs, including 252 severe (67%), were recorded, 83 of which occurred following an injection of Prevenar 13®alone: 39 cutaneous AEs, 16 neurological AEs, four cases of collapse or shock, nine cases of fever, and one of thrombocytopenia. For the serious AEs, the outcome was favorable in 88% of cases and none of the 12 reported deaths were attributed to a side effect of vaccination. Fifty-nine cases of pneumococcal disease that suggest an ineffective vaccine were reported, but only 16 can be considered as a real failure of the vaccination.
  
  
  CONCLUSIONS
  In many cases, Prevenar 13®was administered on the same day as a hexavalent vaccine with which the AEs reported were expected. The profile of AEs reported following Prevenar 13®alone is similar to that seen with Prevenar 7®.
  
  
  CONCLUSIONS
  Since its release in 2010, the Prevenar 13®pharmacovigilance survey, which includes more than 11,800,000 distributed doses, did not show any new information in terms of tolerance safety.
authors.affiliation: Service de pharmacologie, centre régional de pharmacovigilance et d'information sur le médicament, CHRU de Tours, 2, boulevard Tonnellé, 37044 Tours cedex 09, France.
authors.forename: M-S
authors.initials: MS
authors.lastname: Agier
authors.affiliation: Service de médecine pédiatrique, hôpital Clocheville, CHRU de Tours, 49, boulevard Béranger, 37044 Tours cedex 09, France.
authors.forename: S
authors.initials: S
authors.lastname: Marchand
authors.affiliation: Centre de pharmacovigilance, centre antipoison, hospices civils de Lyon, 162, avenue Lacassagne, 69003 Lyon, France.
authors.forename: N
authors.initials: N
authors.lastname: Paret
authors.affiliation: Centre régional de pharmacovigilance, CHRU de Lille, 1, place de Verdun, 59045 Lille cedex, France.
authors.forename: S
authors.initials: S
authors.lastname: Gautier
authors.affiliation: Service de pharmacologie, centre régional de pharmacovigilance et d'information sur le médicament, CHRU de Tours, 2, boulevard Tonnellé, 37044 Tours cedex 09, France. Electronic address: jonville-bera@chu-tours.fr.
authors.forename: A-P
authors.initials: AP
authors.lastname: Jonville-Béra
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence; D002648:Child; D002675:Child, Preschool; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D000071497:Immunogenicity, Vaccine / Q000276:immunology*; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008586:Meningitis, Pneumococcal / Q000276:immunology* / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D011018:Pneumonia, Pneumococcal / Q000276:immunology* / Q000517:prevention & control*; D011358:Product Surveillance, Postmarketing
chemical_list: C538862:13-valent pneumococcal vaccine; D022242:Pneumococcal Vaccines