SEARCH

SEARCH BY CITATION

REFERENCES

  • 1
    Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, Gubareva LV, Xu X, Bridges CB, Uyeki TM. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med 2009; 360: 260515.
  • 2
    The Scottish Government. Swine flu pandemic [online]. 2011. Available at http://www.scotland.gov.uk/Topics/Health/health/flu/swineflu (last accessed 13 April 2011). The Scottish Government 2011 March 1.
  • 3
    MHRA. Final Public Summary. UK suspected adverse reaction analysis. Swine Flu (H1N1) Vaccines – Celvapan and Pandemrix.[online]. 2010. Available at http://www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con078911.pdf (last accessed 10 May 2011).
  • 4
    Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med 2009; 361: 240513.
  • 5
    Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche MK, Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet 2010; 375: 418.
  • 6
    Vajo Z, Tamas F, Sinka L, Jankovics I. Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009-10 influenza season: a multicentre, randomised controlled trial. Lancet 2010; 375: 4955.
  • 7
    Liang XF, Wang HQ, Wang JZ, Fang HH, Wu J, Zhu FC, Li RC, Xia SL, Zhao YL, Li FJ, Yan SH, Yin WD, An K, Feng DJ, Cui XL, Qi FC, Ju CJ, Zhang YH, Guo ZJ, Chen PY, Chen Z, Yan KM, Wang Y. Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet 2010; 375: 5666.
  • 8
    Sencer DJ, Millar JD. Reflections on the 1976 swine flu vaccination program. Emerg Infect Dis 2006; 12: 2933.
  • 9
    Evans D, Cauchemez S, Hayden FG. ‘Prepandemic’ immunization for novel influenza viruses, ‘swine flu’ vaccine, Guillain-Barre syndrome, and the detection of rare severe adverse events. J Infect Dis 2009; 200: 3218.
  • 10
    Lehmann HC, Hartung HP, Kieseier BC, Hughes RA. Guillain-Barre syndrome after exposure to influenza virus. Lancet Infect Dis 2010; 10: 64351.
  • 11
    Destefano F, Tokars J. H1N1 vaccine safety monitoring: beyond background rates. Lancet 2010; 375: 11467.
  • 12
    ICH Harmonised Tripartite Guideline. Post-approval safety data management: definitions and standards for expedited reporting E2D. 2003.
  • 13
    Shakir S. Causality and correlation in pharmacovigilance. In: Stephens' Detection of New Adverse Drug Reactions, 5th edn. eds Talbot J, Waller P. Chichester: John Wiley & Sons Ltd, 2004; 32943.
  • 14
    Edwards IR, Biriell C. Harmonisation in pharmacovigilance. Drug Saf 1994; 10: 93102.
  • 15
    Mackenzie I, Dryburgh M, Rutherford D, MacDonald TM, Shakir SAW, Layton D. Abstract no: 733. Participation of general practices in a swine flu vaccination study. 26th International Conference on Pharmacoepidemiology & Therapuetic Risk management (ISPE). 19-22ndth August, 2010 – Brighton, UK. Pharmacoepidemiol Drug Saf 2010; 19: s328.
  • 16
    Harmark L, van HF, Hak E, van GK. Monitoring the safety of influenza A (H1N1) vaccine using web-based intensive monitoring. Vaccine 2011; 29: 19417.
  • 17
    Folkenberg M, Callreus T, Svanstrom H, Valentiner-Branth P, Hviid A. Spontaneous reporting of adverse events following immunisation against pandemic influenza in Denmark November 2009-March 2010. Vaccine 2011; 29: 11804.
  • 18
    Black S, Eskola J, Siegrist CA, Halsey N, Macdonald N, Law B, Miller E, Andrews N, Stowe J, Salmon D, Vannice K, Izurieta HS, Akhtar A, Gold M, Oselka G, Zuber P, Pfeifer D, Vellozzi C. Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines. Lancet 2009; 374: 211522.
  • 19
    Bryan P, Seabroke S, Davies C. H1N1 vaccine safety: real-time surveillance in the UK. Lancet 2010; 376: 4178.
  • 20
    European Medicines Agency. Press release. European Medicines Agency reviews further data on narcolepsy and possible association with Pandemrix Doc Ref: EMEA/CHMP/130422/2011. [online]. 2011. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/02/WC500102213.pdf (last accessed 12 December 2011). The European Medicines Agency (EMEA) 2011 February 18.
  • 21
    Rai R, Regan L. Recurrent miscarriage. Lancet 2006; 368: 60111.