First French experience of ADR reporting by patients after a mass immunization campaign with Influenza A (H1N1) pandemic vaccines: a comparison of reports submitted by patients and healthcare professionals.

Background: Available data concerning the contribution of patient adverse drug reaction (ADR) reporting in practice are scarce. Few studies have compared patients' reports with reports from healthcare professionals (HCPs). During the 2009-10 mass immunization campaign with A (H1N1)v2009 pandemic influenza vaccines, a reinforced pharmacovigilance plan was introduced in France according to European Medicines Agency recommendations.

[National Campaign of Vaccination against the flu A (H1N1)v: National Follow-up of Pharmacovigilance].

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 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.