PMID- 22186078
OWN - NLM
STAT- MEDLINE
DCOM- 20121211
LR  - 20111221
IS  - 0040-5957 (Print)
IS  - 0040-5957 (Linking)
VI  - 66
IP  - 6
DP  - 2011 Nov-Dec
TI  - [National Campaign of Vaccination against the flu A (H1N1)v: National Follow-up 
      of Pharmacovigilance].
PG  - 527-40
LID - 10.2515/therapie/2011075 [doi]
AB  - OBJECTIVES: 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 francaise de 
      securite sanitaire des produits de sante]) 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((R)) and 1.6 million doses of Panenza((R)) were administered. Following 
      Pandemrix((R)), 4 183 adverse effects (AEs) were reported including 193 "serious" 
      AEs. Concerning Panenza((R)), 591 AEs were reported including 70 "serious" AE. The 
      most frequently reported "serious" AEs were neurological for both Pandemrix((R)) 
      (38.9%, mainly isolated ascending paresthesia without any other neurological 
      symptom and complication) and Panenza((R)) (28.9%). Febrile convulsions were the 
      most common neurological AEs with Panenza((R)) 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. CONCLUSION: For both vaccines, neurological AEs (isolated ascending 
      paresthesia with Pandemrix((R)) and febrile convulsions with Panenza((R))) 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.
CI  - (c) 2011 Societe Francaise de Pharmacologie et de Therapeutique.
FAU - Durrieu, Genevieve
AU  - Durrieu G
AD  - Universite de Toulouse, Faculte de Medecine, Centre Hospitalier Universitaire, 
      Toulouse, France. genevieve.durrieu@univ-tlse3.fr
FAU - Caillet, Celine
AU  - Caillet C
FAU - Lacroix, Isabelle
AU  - Lacroix I
FAU - Jacquet, Alexis
AU  - Jacquet A
FAU - Faucher, Angeline
AU  - Faucher A
FAU - Ouaret, Sheherazade
AU  - Ouaret S
FAU - Sommet, Agnes
AU  - Sommet A
FAU - Perault-Pochat, Marie-Christine
AU  - Perault-Pochat MC
FAU - Kreft-Jais, Carmen
AU  - Kreft-Jais C
FAU - Castot, Anne
AU  - Castot A
FAU - Damase-Michel, Christine
AU  - Damase-Michel C
FAU - Montastruc, Jean-Louis
AU  - Montastruc JL
CN  - le reseau francais des centres de pharmacovigilance
LA  - fre
PT  - English Abstract
PT  - Journal Article
PT  - Review
TT  - Campagne nationale de vaccination contre la grippe A (H1N1)v : suivi national de 
      pharmacovigilance.
DEP - 20111221
PL  - France
TA  - Therapie
JT  - Therapie
JID - 0420544
RN  - 0 (Adjuvants, Pharmaceutic)
RN  - 0 (Influenza Vaccines)
SB  - IM
MH  - Adjuvants, Pharmaceutic
MH  - France
MH  - Guillain-Barre Syndrome/epidemiology/etiology
MH  - Humans
MH  - Immunization Programs
MH  - Influenza A Virus, H1N1 Subtype/*immunology
MH  - Influenza Vaccines/*adverse effects
MH  - Influenza, Human/immunology/*prevention & control
MH  - Pharmacovigilance
FIR - Autret-Leca, Elisabeth
IR  - Autret-Leca E
FIR - Baldin, Bernadette
IR  - Baldin B
FIR - Bavoux, Francoise
IR  - Bavoux F
FIR - Benard-Laribiere, Anne
IR  - Benard-Laribiere A
FIR - Biour, Michel
IR  - Biour M
FIR - Beyens, Marie-Noelle
IR  - Beyens MN
FIR - Colin, Frederique
IR  - Colin F
FIR - Cocquerel, Antoine
IR  - Cocquerel A
FIR - Crepin, Sabrina
IR  - Crepin S
FIR - Decreau-Gaillon, Gaelle
IR  - Decreau-Gaillon G
FIR - Santos, Sylvia Dos
IR  - Santos SD
FIR - Eftekhari, Pirayeh
IR  - Eftekhari P
FIR - Favreliere, Sylvie
IR  - Favreliere S
FIR - Perrault-Pochat, Marie-Christine
IR  - Perrault-Pochat MC
FIR - Gautier, Sophie
IR  - Gautier S
FIR - Gras-Champel, Valerie
IR  - Gras-Champel V
FIR - Javot, Lucien
IR  - Javot L
FIR - Jean-Pastor, Marie-Josephe
IR  - Jean-Pastor MJ
FIR - Beller, Christine Le
IR  - Beller CL
FIR - Lebrun-Vignes, Benedicte
IR  - Lebrun-Vignes B
FIR - Millaret, Anne
IR  - Millaret A
FIR - Perrazi, Alexandre
IR  - Perrazi A
FIR - Pinzani, Veronique
IR  - Pinzani V
FIR - Riche, Christian
IR  - Riche C
FIR - Schir, Edith
IR  - Schir E
FIR - Sgro, Catherine
IR  - Sgro C
FIR - Tebacher-Alt, Martine
IR  - Tebacher-Alt M
FIR - Trenque, Thierry
IR  - Trenque T
FIR - Valnet-Rabier, Marie-Blanche
IR  - Valnet-Rabier MB
FIR - Veyrac, G
IR  - Veyrac G
EDAT- 2011/12/22 06:00
MHDA- 2012/12/12 06:00
CRDT- 2011/12/22 06:00
PHST- 2010/11/30 00:00 [received]
PHST- 2011/07/06 00:00 [accepted]
PHST- 2011/12/22 06:00 [entrez]
PHST- 2011/12/22 06:00 [pubmed]
PHST- 2012/12/12 06:00 [medline]
AID - th111954 [pii]
AID - 10.2515/therapie/2011075 [doi]
PST - ppublish
SO  - Therapie. 2011 Nov-Dec;66(6):527-40. doi: 10.2515/therapie/2011075. Epub 2011 Dec 
      21.