Published online January 26, 2009
PEDIATRICS Vol. 123 No. 2 February 2009, pp. e228-e234 (doi:10.1542/peds.2008-2384)
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ARTICLE

Varicella Vaccination and Ischemic Stroke in Children: Is There an Association?

James G. Donahue, DVM, PhDa, Burney A. Kieke, MSa, W. Katherine Yih, PhD, MPHb, Nicholas R. Berger, BAa, Jeremy S. McCauley, MBAa, James Baggs, PhDc, Kenneth M. Zangwill, MDd, Roger Baxter, MDe, Eileen M. Eriksen, MPHd, Jason M. Glanz, PhDf, Simon J. Hambidge, MD, PhDf,g, Nicola P. Klein, MD, PhDe, Edwin M. Lewis, MPHe, S. Michael Marcy, MDh, Allison L. Naleway, PhDi, James D. Nordin, MD, MPHj, Paula Ray, MPHe, Edward A. Belongia, MDa for the Vaccine Safety DataLink Team

a Marshfield Clinic Research Foundation, Marshfield, Wisconsin
b Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, Massachusetts
c Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia
d Los Angeles Biomedical Research Institute at Harbor-University of California Los Angeles Medical Center, Torrance, California
e Kaiser Permanente Vaccine Study Center, Oakland, California
f Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado
g Denver Health Community Health Services, Denver, Colorado
h Kaiser Permanente Southern California, Pasadena, California
i Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon
j HealthPartners Research Foundation, Minneapolis, Minnesota

BACKGROUND. Ischemic stroke is a known complication of varicella disease. Although there have been case reports of ischemic stroke after varicella vaccination, the existence and magnitude of any vaccine-associated risk has not been determined.

OBJECTIVE. The purpose of this work was to determine whether varicella vaccination is associated with an increased risk of ischemic stroke and encephalitis in children within 12 months after vaccination.

PATIENTS AND METHODS. We conducted a retrospective cohort study based on computerized data from children 11 months through 17 years old enrolled for ≥12 months in the Vaccine Safety DataLink from 1991 through 2004. International Classification of Disease codes identified cases of ischemic stroke (433–436, 437.1, 437.4, 437.6, 437.8–437.9) and encephalitis (052.0, 323.5, 323.8–9). Cox regression was used to model the risk in the 12 months after vaccination relative to all other person-time. Covariates included calendar time, gender, and stroke risk factors (eg, sickle cell disease).

RESULTS. Varicella vaccine was administered to 35.3% of the 3.2 million children in the cohort. There were 203 new inpatient ischemic stroke diagnoses, including 8 that occurred within 12 months after vaccination; there was no temporal clustering. The adjusted stroke hazard ratio was not elevated during any of the time periods in the 12 months after vaccination. Stroke was strongly associated with known risk factors such as sickle cell disease and cardiac disease. None of the 243 encephalitis cases occurred during the first 30 days after vaccination, and there was no association between encephalitis and varicella vaccination at any time in the 12 months after vaccination.

CONCLUSION. Our retrospective cohort study of >3 million children found no association between varicella vaccine and ischemic stroke.

Key Words: varicella vaccine • stroke • encephalitis • child

Abbreviations: VZV—varicella zoster virus • VAERS—Vaccine Adverse Event Reporting System • MCO—medical care organization • VSD—Vaccine Safety DataLink • ICD-9-CM—International Classification of Diseases, Ninth Revision, Clinical Modification • CI—confidence interval • HR—hazard ratio

Accepted Oct 10, 2008.


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