title: Influenza H1N1 (swine flu) vaccination: a safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes.
abstract: OBJECTIVE
  During the global H1N1 influenza A (swine flu) pandemic 2009-2010, swine flu vaccines were expeditiously licensed and a mass vaccination programme for high risk groups, including pregnant women, was introduced in the UK. This pilot active safety surveillance study was performed to establish the feasibility of rapidly monitoring the new swine flu vaccines in large patient numbers receiving or offered the vaccination under normal conditions of use within a short time frame.
  
  
  METHODS
  A cohort design with safety data capture through modern technologies was carried out in Scotland, UK during the winter swine flu vaccination programme 2009-2010 in individuals receiving or offered the swine flu vaccination. The main outcome measures were self-reported serious adverse events (SAEs) and pregnancy outcomes.
  
  
  RESULTS
  The cohort comprised 4066 people; 3754 vaccinated and 312 offered the vaccination but not vaccinated. There were 939 self-reported events (838 different events), 53 judged to fit SAE criteria by the investigators, with nine judged as possibly, probably or definitely vaccine related. None of the seven deaths (six in vaccinees) were judged as vaccine related. One hundred and twenty-eight women reported 130 pregnancies during the study with 117 pregnant at study start. There were reports of four miscarriages in three women and six possible congenital abnormalities in live births.
  
  
  CONCLUSIONS
  Overall, no significant safety issues were identified. The methodology and use of modern technologies to collect safety data from large numbers of patients was successful and could be used again in similar safety studies.
authors.affiliation: Medicines Monitoring Unit, Division of Medical Sciences, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK. i.s.mackenzie@dundee.ac.uk
authors.forename: Isla S
authors.initials: IS
authors.lastname: Mackenzie
authors.forename: Thomas M
authors.initials: TM
authors.lastname: MacDonald
authors.forename: Saad
authors.initials: S
authors.lastname: Shakir
authors.forename: Moira
authors.initials: M
authors.lastname: Dryburgh
authors.forename: Brian J
authors.initials: BJ
authors.lastname: Mantay
authors.forename: Patrick
authors.initials: P
authors.lastname: McDonnell
authors.forename: Deborah
authors.initials: D
authors.lastname: Layton
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D015331:Cohort Studies; D005260:Female; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000276:immunology*; D011256:Pregnancy Outcome; D011446:Prospective Studies; D012606:Scotland
chemical_list: D007252:Influenza Vaccines
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