title: Passive surveillance of adverse events of an MF59-adjuvanted H1N1v vaccine during the pandemic mass vaccinations.
abstract: BACKGROUND
  Systemic safety surveillance is an essential component of vaccination programmes to elucidate the full safety profile of a vaccine and to detect previously unrecognized adverse reactions that might be related to new vaccines. This article summarizes the spontaneous adverse drug reactions (ADR) from approximately 12 million administered doses of the pandemic MF59-adjuvanted H1N1v vaccine (Focetria®, Novartis Vaccines and Diagnostics) from the mass vaccination programmes in Europe.
  
  
  METHODS
  All ADR reports from October 2009 to March 2010 were included in the analyses and classified according to Medical Dictionary for Regulatory Activities. Adverse events of special interest were compared with pooled spontaneous case reports for seasonal influenza vaccines, and signal detection analyses were performed.
  
  
  RESULTS
  In the reporting period we received a total of 5315 pandemic vaccine ADR reports, of which 19.9% were serious. The reporting rate was higher after H1N1 pandemic vaccines, i.e. 44.3 cases/100.000 doses, than for seasonal influenza vaccines covering the same time period, i.e. 1.7 cases/100.000 doses. The majority of reports included expected local and systemic postvaccination reactions. Rates for adverse events of special interest, for example, Guillain-Barré syndrome, anaphylaxis, and convulsions showed no signs of disproportionality between the pandemic and the seasonal vaccines. There were 36 deaths reported after use of the pandemic vaccine; however, no evidence for a causal relationship with the vaccine was found.
  
  
  CONCLUSIONS
  The analyses of the spontaneously reported adverse events support the good safety profile of the MF59-adjuvanted H1N1v pandemic influenza vaccine.
authors.affiliation: Novartis Vaccines and Diagnostics, Marburg, Germany. angelika.banzhoff@novartis.com
authors.forename: Angelika
authors.initials: A
authors.lastname: Banzhoff
authors.forename: Sabine
authors.initials: S
authors.lastname: Haertel
authors.forename: Michaela
authors.initials: M
authors.lastname: Praus
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D007251:Influenza, Human / Q000453:epidemiology / Q000517:prevention & control*; D008297:Male; D032541:Mass Vaccination / Q000009:adverse effects*; D008875:Middle Aged; D058873:Pandemics; D011136:Polysorbates / Q000008:administration & dosage / Q000009:adverse effects*; D013185:Squalene / Q000008:administration & dosage / Q000009:adverse effects*; D016019:Survival Analysis; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D013185:Squalene