Guillain-Barré syndrome and H1N1 (2009) pandemic influenza vaccination using an AS03 adjuvanted vaccine in the United Kingdom: Self-controlled case series

Vaccine

Volumn 29, Issue 45, 2011, Pages 7878-7882

  Andrews, Nick ^a   Stowe, Julia ^a   Al Shahi Salman, Rustam ^b   Miller, Elizabeth ^a  

^a PUBLIC HEALTH ENGLAND   (United Kingdom)

^b UNIVERSITY OF EDINBURGH   (United Kingdom)

Author keywords

Guillain Barr syndrome; Influenza like illness; Pandemic influenza vaccine; Self controlled case series; Vaccine safety

Indexed keywords

AS 03; IMMUNOLOGICAL ADJUVANT; INFLUENZA VACCINE; UNCLASSIFIED DRUG; WATER OIL CREAM;

ARTICLE; CASE STUDY; CLINICAL ARTICLE; FEMALE; GENERAL PRACTITIONER; GUILLAIN BARRE SYNDROME; HUMAN; INCIDENCE; INFLUENZA A (H1N1); INFLUENZA VACCINATION; MALE; MEDICAL HISTORY; PRIORITY JOURNAL; RISK ASSESSMENT; SELF CONTROLLED CASE SERIES; UNITED KINGDOM; VACCINATION REACTION;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; CHILD; CHILD, PRESCHOOL; DRUG TOXICITY; ENGLAND; FEMALE; GUILLAIN-BARRE SYNDROME; HUMANS; INCIDENCE; INFANT; INFANT, NEWBORN; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; VACCINATION; YOUNG ADULT;

EID: 80053630336     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2011.08.069     Document Type: Article

References (23)

1. McGrogan A., Madle G.C., Seaman H.E., de Vries C.S. The epidemiology of Guillain-Barré syndrome worldwide. A systematic literature review. Neuroepidemiology 2009, 32:150-163.
2. Seneviratne U. Guillain-Barré syndrome. Post Grad Med J 2000, 76:774-782.
3. Stowe J., Andrews N., Wise L., Miller E. Investigation of the temporal association between Guillain-Barré syndrome and influenza vaccine and influenza-like illness using the UK General Practice Research Database. Am J Epidemiol 2009, 169:382-388.
4. Schonberger L.B., Bregman D.J., Sullivan-Bolyai J.Z., Keenlyside R.A., Ziegler D.W., Retailliau H.F., et al. Guillain-Barré syndrome following vaccination in the National Influenza Immunization Program, United States, 1976-1977. Am J Epidemiol 1979, 110:105-123.
5. Haber P., DeStefano F., Angulo F.J., Iskander J., Shadomy S.V., Weintraub E., et al. Guillain-Barré syndrome following influenza vaccination. JAMA 2004, 292:2478-2481.
6. The H1N1 swine flu vaccination programme 2009-2010 Chief Medical Officer Letter. Department of Health 15 October 2009. Available at [last accessed 30/06/2011]. http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Dearcolleagueletters/DH_107169.
7. A (H1N1) swine flu influenza: phase two of the vaccination programme; children over 6 months and under 5 years Chief Medical Officer Letter. Department of Health, 8 December 2009. Available at [last accessed 30/06/2011]. http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Dearcolleagueletters/DH_109826.
8. MHRA Swine flu pandemic vaccines and antivirals: safety review Drug Safety Update - Pandemic vaccines and antivirals: safety review October 2010. Available at [last accessed 30/06/2011]. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON096812.
9. Black S., Eskola J., Siegrist C.A., Halsey N., Macdonald N., Law B., et al. Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines. Lancet 2009, 374. [Erratum in: Lancet 2010;375-6].
10. Rosenthal S., Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995, 85:1706-1709.
11. Whitaker H.J., Farrington C.P., Spiessens B., Musonda P. Tutorial in biostatistics: the self-controlled case series method. Stat Med 2006, 25:1768-1797.
12. Association of British Neurologists' British Neurological Surveillance Unit (BNSU). Available at [last accessed 30/06/2011]. http://www.theabn.org/AboutTheABN/BNSU.aspx.
13. Verity C, Stellitano L, Winstone AM, Andrews N, Stowe J, Miller E. Guillain-Barré syndrome and pandemic H1N1 (swine) influenza vaccination in UK children. The Lancet; in press.
14. British Society for Clinical Neurophysiology. Available at [last accessed 30/06/2011]. http://www.bscn.org.uk/.
15. Guillain-Barré syndrome Support Group. Available at [last accessed 30/06/2011]. http://www.gbs.org.uk/.
16. Hospital Episode Statistics. The Health and Social Care Information Centre. Available at [last accessed 30/06/2011]. http://www.hesonline.org.uk/.
17. Farrington C.P., Whitaker H.J., Hocine M.N. Case series analysis for censored, perturbed, or curtailed post-event exposures. Biostatistics 2009, 10:3-16.
18. Sejvar J.J., Kohl K.S., Gidudu J., Amato A., Bakshi N., Baxter R., et al. Guillain-Barré syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine 2011, 29:599-612.
19. Jones T.F., McMillian M., Boothe E., Hanna S., Ingram L.A. Hospital discharge data for Guillain-Barré syndrome and influenza A (H1N1) vaccine adverse events. Emerg Infect Dis 2010, 16:1500-1501.
20. Vaccine adverse event, safety and communication consortium. Available at [last accessed 30/06/2011]. http://vaesco.net/vaesco.html.
21. Black S. Global: International Evaluation of the Risk of GBS following Pandemic Influenza Vaccine: April 2011. IABS conference on post-licensure evaluation of vaccine safety: current status and future directions. A [last accessed 30/06/2011]. http://www.iabs.org/index.php/docs/cat_view/36-events-brochures-and-programs/56-post-licensure-evaluation-barcelona-2011.
22. Centers for Disease Control and Prevention (CDC). Preliminary results: surveillance for Guillain-Barré syndrome after receipt of influenza A (H1N1) 2009 monovalent vaccine - United States, 2009-2010. MMWR Morb Mortal Wkly Rep 2010;59:657-61.
23. Dieleman J, Romio S, Johansen K, Weibel D, Bonhoeffer J, Sturkenboom M, et al. Guillain-Barré syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccine: multinational case-control study in Europe. BMJ 2011;343:d3908.