The GuillainBarré Syndrome and the 19921993 and 19931994 Influenza Vaccines
Tamar Lasky, Ph.D., Gina J. Terracciano, D.O., Laurence Magder, Ph.D., Carol Lee Koski, M.D., Michael Ballesteros, M.S., Denis Nash, M.P.H., Shelley Clark, M.S., Penina Haber, M.P.H., Paul D. Stolley, M.D., Lawrence B. Schonberger, M.D., and Robert T. Chen, M.D.
Background The number of reports of influenza-vaccineassociatedGuillainBarré syndrome to the national VaccineAdverse Event Reporting System increased from 37 in 19921993to 74 in 19931994, arousing concern about a possibleincrease in vaccine-associated risk.
Methods Patients given a diagnosis of the GuillainBarrésyndrome in the 19921993 and 19931994 influenza-vaccinationseasons were identified in the hospital-discharge data basesof four states. Vaccination histories were obtained by telephoneinterviews during 19951996 and were confirmed by thevaccine providers. Disease with an onset within six weeks aftervaccination was defined as vaccine-associated. Vaccine coveragein the population was measured through a random-digitdialingtelephone survey.
Results We interviewed 180 of 273 adults with the GuillainBarrésyndrome; 15 declined to participate, and the remaining 78 couldnot be contacted. The vaccine providers confirmed influenzavaccination in the six weeks before the onset of GuillainBarrésyndrome for 19 patients. The relative risk of the GuillainBarrésyndrome associated with vaccination, adjusted for age, sex,and vaccine season, was 1.7 (95 percent confidence interval,1.0 to 2.8; P=0.04). The adjusted relative risks were 2.0 forthe 19921993 season (95 percent confidence interval,1.0 to 4.3) and 1.5 for the 19931994 season (95 percentconfidence interval, 0.8 to 2.9). In 9 of the 19 vaccine-associatedcases, the onset was in the second week after vaccination, allbetween day 9 and day 12.
Conclusions There was no increase in the risk of vaccine-associatedGuillainBarré syndrome from 19921993 to19931994. For the two seasons combined, the adjustedrelative risk of 1.7 suggests slightly more than one additionalcase of GuillainBarré syndrome per million personsvaccinated against influenza.
Source Information
From the Department of Epidemiology and Preventive Medicine (T.L., L.M., M.B., D.N., S.C., P.D.S.) and the Department of Neurology (C.L.K.), School of Medicine, University of Maryland, Baltimore; the Vaccine Safety and Development Activity, Epidemiology and Surveillance Division, National Immunization Program (G.J.T., P.H., R.T.C.), and the Division of Viral and Rickettsial Diseases (L.B.S.), National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta.
Address reprint requests to Dr. Lasky at the Department of Epidemiology and Preventive Medicine, School of Medicine, University of Maryland, Baltimore, 660 West Redwood St., Baltimore, MD 21201.
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