title: [National Campaign of Vaccination against the flu A (H1N1)v: National Follow-up of Pharmacovigilance].
abstract: OBJECTIVE
  The present study was performed to evaluate safety data collected by the French Network of Pharmacovigilance centres network, from October 21, 2009 to June 15, 2010.
  
  
  METHODS
  French Health Authorities (Afssaps [Agence française de sécurité sanitaire des produits de santé]) heightened awareness to extensive notifications with online health practitioners' reports and patients' reports via the Regional Centre concerned.
  
  
  RESULTS
  During the campaign, 4.1 millions doses of Pandemrix(®) and 1.6 million doses of Panenza(®) were administered. Following Pandemrix(®), 4 183 adverse effects (AEs) were reported including 193 "serious" AEs. Concerning Panenza(®), 591 AEs were reported including 70 "serious" AE. The most frequently reported "serious" AEs were neurological for both Pandemrix(®) (38.9%, mainly isolated ascending paresthesia without any other neurological symptom and complication) and Panenza(®) (28.9%). Febrile convulsions were the most common neurological AEs with Panenza(®) in children. All reported deaths (n = 22) described causes other than recent A(H1N1)v vaccination. No causal relationship was established between these AEs and vaccination. Among AEs of "special" interest, 13 reports of confirmed GBS and 15 reports of demyelinating disorders were notified. No report of narcolepsy was made during the study period.
  
  
  CONCLUSIONS
  For both vaccines, neurological AEs (isolated ascending paresthesia with Pandemrix(®) and febrile convulsions with Panenza(®)) were among the most frequently reported "serious" AEs. Despite limits of this survey based on spontaneous reporting, the study did not detect any safety signals, at least with an 8-month follow-up.
authors.affiliation: Université de Toulouse, Faculté de Médecine, Centre Hospitalier Universitaire, Toulouse, France. genevieve.durrieu@univ-tlse3.fr
authors.forename: Geneviève
authors.initials: G
authors.lastname: Durrieu
authors.forename: Céline
authors.initials: C
authors.lastname: Caillet
authors.forename: Isabelle
authors.initials: I
authors.lastname: Lacroix
authors.forename: Alexis
authors.initials: A
authors.lastname: Jacquet
authors.forename: Angeline
authors.initials: A
authors.lastname: Faucher
authors.forename: Shéhérazade
authors.initials: S
authors.lastname: Ouaret
authors.forename: Agnès
authors.initials: A
authors.lastname: Sommet
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Perault-Pochat
authors.forename: Carmen
authors.initials: C
authors.lastname: Kreft-Jaïs
authors.forename: Anne
authors.initials: A
authors.lastname: Castot
authors.forename: Christine
authors.initials: C
authors.lastname: Damase-Michel
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Montastruc
mesh_terms: D000277:Adjuvants, Pharmaceutic; D005602:France; D020275:Guillain-Barre Syndrome / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D017589:Immunization Programs; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D060735:Pharmacovigilance
chemical_list: D000277:Adjuvants, Pharmaceutic; D007252:Influenza Vaccines