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Risk of confirmed Guillain-Barre syndrome following receipt of monovalent inactivated influenza A (H1N1) and seasonal influenza vaccines in the Vaccine Safety Datalink Project, 2009-2010.
Am J Epidemiol. 2012 Jun 01; 175(11):1100-9.AJ

Abstract

An increased risk of Guillain-Barré syndrome (GBS) following administration of the 1976 swine influenza vaccine led to a heightened focus on GBS when monovalent vaccines against a novel influenza A (H1N1) virus of swine origin were introduced in 2009. GBS cases following receipt of monovalent inactivated (MIV) and seasonal trivalent inactivated (TIV) influenza vaccines in the Vaccine Safety Datalink Project in 2009-2010 were identified in electronic data and confirmed by medical record review. Within 1-42 days following vaccination, 9 cases were confirmed in MIV recipients (1.48 million doses), and 8 cases were confirmed in TIV-only recipients who did not also receive MIV during 2009-2010 (1.72 million doses). Five cases following MIV and 1 case following TIV-only had an antecedent respiratory infection, a known GBS risk factor; furthermore, unlike TIV, MIV administration was concurrent with heightened influenza activity. In a self-controlled risk interval analysis comparing GBS onset within 1-42 days following MIV with GBS onset 43-127 days following MIV, the risk difference was 5.0 cases per million doses (95% confidence interval: 0.5, 9.5). No statistically significant increased GBS risk was found within 1-42 days following TIV-only vaccination versus 43-84 days following vaccination (risk difference = 1.1 cases per million doses, 95% confidence interval: -3.1, 5.4). Further evaluation to assess GBS risk following both vaccination and respiratory infection is warranted.

Authors+Show Affiliations

Department of Population Medicine, Harvard Medical School, Boston, Massachusetts, USA. sharon_greene@harvardpilgrim.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

22582210

Citation

Greene, Sharon K., et al. "Risk of Confirmed Guillain-Barre Syndrome Following Receipt of Monovalent Inactivated Influenza a (H1N1) and Seasonal Influenza Vaccines in the Vaccine Safety Datalink Project, 2009-2010." American Journal of Epidemiology, vol. 175, no. 11, 2012, pp. 1100-9.
Greene SK, Rett M, Weintraub ES, et al. Risk of confirmed Guillain-Barre syndrome following receipt of monovalent inactivated influenza A (H1N1) and seasonal influenza vaccines in the Vaccine Safety Datalink Project, 2009-2010. Am J Epidemiol. 2012;175(11):1100-9.
Greene, S. K., Rett, M., Weintraub, E. S., Li, L., Yin, R., Amato, A. A., Ho, D. T., Sheikh, S. I., Fireman, B. H., Daley, M. F., Belongia, E. A., Jacobsen, S. J., Baxter, R., Lieu, T. A., Kulldorff, M., Vellozzi, C., & Lee, G. M. (2012). Risk of confirmed Guillain-Barre syndrome following receipt of monovalent inactivated influenza A (H1N1) and seasonal influenza vaccines in the Vaccine Safety Datalink Project, 2009-2010. American Journal of Epidemiology, 175(11), 1100-9. https://doi.org/10.1093/aje/kws195
Greene SK, et al. Risk of Confirmed Guillain-Barre Syndrome Following Receipt of Monovalent Inactivated Influenza a (H1N1) and Seasonal Influenza Vaccines in the Vaccine Safety Datalink Project, 2009-2010. Am J Epidemiol. 2012 Jun 1;175(11):1100-9. PubMed PMID: 22582210.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Risk of confirmed Guillain-Barre syndrome following receipt of monovalent inactivated influenza A (H1N1) and seasonal influenza vaccines in the Vaccine Safety Datalink Project, 2009-2010. AU - Greene,Sharon K, AU - Rett,Melisa, AU - Weintraub,Eric S, AU - Li,Lingling, AU - Yin,Ruihua, AU - Amato,Anthony A, AU - Ho,Doreen T, AU - Sheikh,Sarah I, AU - Fireman,Bruce H, AU - Daley,Matthew F, AU - Belongia,Edward A, AU - Jacobsen,Steven J, AU - Baxter,Roger, AU - Lieu,Tracy A, AU - Kulldorff,Martin, AU - Vellozzi,Claudia, AU - Lee,Grace M, Y1 - 2012/05/11/ PY - 2012/5/15/entrez PY - 2012/5/15/pubmed PY - 2012/8/17/medline SP - 1100 EP - 9 JF - American journal of epidemiology JO - Am J Epidemiol VL - 175 IS - 11 N2 - An increased risk of Guillain-Barré syndrome (GBS) following administration of the 1976 swine influenza vaccine led to a heightened focus on GBS when monovalent vaccines against a novel influenza A (H1N1) virus of swine origin were introduced in 2009. GBS cases following receipt of monovalent inactivated (MIV) and seasonal trivalent inactivated (TIV) influenza vaccines in the Vaccine Safety Datalink Project in 2009-2010 were identified in electronic data and confirmed by medical record review. Within 1-42 days following vaccination, 9 cases were confirmed in MIV recipients (1.48 million doses), and 8 cases were confirmed in TIV-only recipients who did not also receive MIV during 2009-2010 (1.72 million doses). Five cases following MIV and 1 case following TIV-only had an antecedent respiratory infection, a known GBS risk factor; furthermore, unlike TIV, MIV administration was concurrent with heightened influenza activity. In a self-controlled risk interval analysis comparing GBS onset within 1-42 days following MIV with GBS onset 43-127 days following MIV, the risk difference was 5.0 cases per million doses (95% confidence interval: 0.5, 9.5). No statistically significant increased GBS risk was found within 1-42 days following TIV-only vaccination versus 43-84 days following vaccination (risk difference = 1.1 cases per million doses, 95% confidence interval: -3.1, 5.4). Further evaluation to assess GBS risk following both vaccination and respiratory infection is warranted. SN - 1476-6256 UR - https://www.unboundmedicine.com/medline/citation/22582210/Risk_of_confirmed_Guillain_Barre_syndrome_following_receipt_of_monovalent_inactivated_influenza_A__H1N1__and_seasonal_influenza_vaccines_in_the_Vaccine_Safety_Datalink_Project_2009_2010_ L2 - https://academic.oup.com/aje/article-lookup/doi/10.1093/aje/kws195 DB - PRIME DP - Unbound Medicine ER -