• Steven Black, Juhani Eskola, Claire-Anne Siegrist, Neal Halsey, Noni MacDonald, Barbara Law, Elizabeth Miller, Nick Andrews, Julia Stowe, Daniel Salmon, Kirsten Vannice, Hector S Izurieta, Aysha Akhtar, Mike Gold, Gabriel Oselka, Patrick Zuber, Dina Pfeifer, and Claudia Vellozzi.
• Center for Global Health and Division of Infectious Diseases, Cincinnati Children's Hospital, Cincinnati, OH, USA. Electronic address: Steven.Black1@cchmc.org.
• Lancet. 2009 Dec 19; 374 (9707): 211521222115-2122.

AbstractBecause of the advent of a new influenza A H1N1 strain, many countries have begun mass immunisation programmes. Awareness of the background rates of possible adverse events will be a crucial part of assessment of possible vaccine safety concerns and will help to separate legitimate safety concerns from events that are temporally associated with but not caused by vaccination. We identified background rates of selected medical events for several countries. Rates of disease events varied by age, sex, method of ascertainment, and geography. Highly visible health conditions, such as Guillain-Barré syndrome, spontaneous abortion, or even death, will occur in coincident temporal association with novel influenza vaccination. On the basis of the reviewed data, if a cohort of 10 million individuals was vaccinated in the UK, 21.5 cases of Guillain-Barré syndrome and 5.75 cases of sudden death would be expected to occur within 6 weeks of vaccination as coincident background cases. In female vaccinees in the USA, 86.3 cases of optic neuritis per 10 million population would be expected within 6 weeks of vaccination. 397 per 1 million vaccinated pregnant women would be predicted to have a spontaneous abortion within 1 day of vaccination.Copyright 2009 Elsevier Ltd. All rights reserved.

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