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Influenza H1N1 (swine flu) vaccination

Influenza H1N1 (swine flu) vaccination: a safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes

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  • Isla S Mackenzie
  • Thomas M Macdonald
  • Saad Shakir
  • Moira Dryburgh
  • Brian J Mantay
  • Patrick McDonnell
  • Deborah Layton

Research units


Original languageEnglish
Pages (from-to)801-811
Number of pages11
JournalBritish Journal of Clinical Pharmacology
Issue number5
StatePublished - 2012


WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • While the new H1N1 vaccines underwent the usual rigorous safety and efficacy testing, concerns remained that there may be unexpected side effects of the vaccines. • The strategy for H1N1 vaccine pharmacovigilance in the UK consisted of two patient studies by the two vaccine manufacturers, 14 small scale studies supported by the National Institute of Health Research, monitoring by specialist neurologists and the MHRA. • There were calls to investigate the feasibility of a large-scale prospective active surveillance system for 'near real-time' vaccine safety monitoring that would be complementary to the other aforementioned initiatives. WHAT THIS STUDY ADDS • This pilot study demonstrated that collecting 'near real-time' reporting of event data from patients who experienced side effects as well as those who reported no problems after swine flu vaccination is feasible. • The use of information technologies improves patient involvement in research as well as dramatically limiting the cost of the study. • The online methodology facilitates rapid surveillance in response to urgent safety issues.



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