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Chart-confirmed guillain-barre syndrome after 2009 H1N1 influenza vaccination among the Medicare population, 2009-2010.
Am J Epidemiol. 2013 Sep 15; 178(6):962-73.AJ

Abstract

Given the increased risk of Guillain-Barré Syndrome (GBS) found with the 1976 swine influenza vaccine, both active surveillance and end-of-season analyses on chart-confirmed cases were performed across multiple US vaccine safety monitoring systems, including the Medicare system, to evaluate the association of GBS after 2009 monovalent H1N1 influenza vaccination. Medically reviewed cases consisted of H1N1-vaccinated Medicare beneficiaries who were hospitalized for GBS. These cases were then classified by using Brighton Collaboration diagnostic criteria. Thirty-one persons had Brighton level 1, 2, or 3 GBS or Fisher Syndrome, with symptom onset 1-119 days after vaccination. Self-controlled risk interval analyses estimated GBS risk within the 6-week period immediately following H1N1 vaccination compared with a later control period, with additional adjustment for seasonality. Our results showed an elevated risk of GBS with 2009 monovalent H1N1 vaccination (incidence rate ratio = 2.41, 95% confidence interval: 1.14, 5.11; attributable risk = 2.84 per million doses administered, 95% confidence interval: 0.21, 5.48). This observed risk was slightly higher than that seen with previous seasonal influenza vaccines; however, additional results that used a stricter case definition (Brighton level 1 or 2) were not statistically significant, and our ability to account for preceding respiratory/gastrointestinal illness was limited. Furthermore, the observed risk was substantially lower than that seen with the 1976 swine influenza vaccine.

Authors

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Pub Type(s)

Journal Article

Language

eng

PubMed ID

23652165

Citation

Polakowski, Laura L., et al. "Chart-confirmed Guillain-barre Syndrome After 2009 H1N1 Influenza Vaccination Among the Medicare Population, 2009-2010." American Journal of Epidemiology, vol. 178, no. 6, 2013, pp. 962-73.
Polakowski LL, Sandhu SK, Martin DB, et al. Chart-confirmed guillain-barre syndrome after 2009 H1N1 influenza vaccination among the Medicare population, 2009-2010. Am J Epidemiol. 2013;178(6):962-73.
Polakowski, L. L., Sandhu, S. K., Martin, D. B., Ball, R., Macurdy, T. E., Franks, R. L., Gibbs, J. M., Kropp, G. F., Avagyan, A., Kelman, J. A., Worrall, C. M., Sun, G., Kliman, R. E., & Burwen, D. R. (2013). Chart-confirmed guillain-barre syndrome after 2009 H1N1 influenza vaccination among the Medicare population, 2009-2010. American Journal of Epidemiology, 178(6), 962-73. https://doi.org/10.1093/aje/kwt051
Polakowski LL, et al. Chart-confirmed Guillain-barre Syndrome After 2009 H1N1 Influenza Vaccination Among the Medicare Population, 2009-2010. Am J Epidemiol. 2013 Sep 15;178(6):962-73. PubMed PMID: 23652165.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Chart-confirmed guillain-barre syndrome after 2009 H1N1 influenza vaccination among the Medicare population, 2009-2010. AU - Polakowski,Laura L, AU - Sandhu,Sukhminder K, AU - Martin,David B, AU - Ball,Robert, AU - Macurdy,Thomas E, AU - Franks,Riley L, AU - Gibbs,Jonathan M, AU - Kropp,Garner F, AU - Avagyan,Armen, AU - Kelman,Jeffrey A, AU - Worrall,Christopher M, AU - Sun,Guoying, AU - Kliman,Rebecca E, AU - Burwen,Dale R, Y1 - 2013/05/06/ PY - 2013/5/9/entrez PY - 2013/5/9/pubmed PY - 2013/11/14/medline KW - Fisher Syndrome KW - Guillain-Barré Syndrome KW - human influenza KW - vaccination SP - 962 EP - 73 JF - American journal of epidemiology JO - Am J Epidemiol VL - 178 IS - 6 N2 - Given the increased risk of Guillain-Barré Syndrome (GBS) found with the 1976 swine influenza vaccine, both active surveillance and end-of-season analyses on chart-confirmed cases were performed across multiple US vaccine safety monitoring systems, including the Medicare system, to evaluate the association of GBS after 2009 monovalent H1N1 influenza vaccination. Medically reviewed cases consisted of H1N1-vaccinated Medicare beneficiaries who were hospitalized for GBS. These cases were then classified by using Brighton Collaboration diagnostic criteria. Thirty-one persons had Brighton level 1, 2, or 3 GBS or Fisher Syndrome, with symptom onset 1-119 days after vaccination. Self-controlled risk interval analyses estimated GBS risk within the 6-week period immediately following H1N1 vaccination compared with a later control period, with additional adjustment for seasonality. Our results showed an elevated risk of GBS with 2009 monovalent H1N1 vaccination (incidence rate ratio = 2.41, 95% confidence interval: 1.14, 5.11; attributable risk = 2.84 per million doses administered, 95% confidence interval: 0.21, 5.48). This observed risk was slightly higher than that seen with previous seasonal influenza vaccines; however, additional results that used a stricter case definition (Brighton level 1 or 2) were not statistically significant, and our ability to account for preceding respiratory/gastrointestinal illness was limited. Furthermore, the observed risk was substantially lower than that seen with the 1976 swine influenza vaccine. SN - 1476-6256 UR - https://www.unboundmedicine.com/medline/citation/23652165/Chart_confirmed_guillain_barre_syndrome_after_2009_H1N1_influenza_vaccination_among_the_Medicare_population_2009_2010_ L2 - https://academic.oup.com/aje/article-lookup/doi/10.1093/aje/kwt051 DB - PRIME DP - Unbound Medicine ER -