Risk of Anaphylaxis After Vaccination of Children and Adolescents
* Center for Health Studies, Group Health Cooperative, Seattle, Washington
Departments of Pediatrics and Epidemiology, University of Washington Schools of Medicine and Public Health, Seattle, Washington
Kaiser Foundation Hospital, Panorama City, California
|| Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland
¶ National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia
# Pediatric Vaccine Study Center, Northern California Kaiser Permanente, Oakland, California
** Center for Health Research, Northwest Kaiser Permanente, Portland, Oregon
Department of Preventive Care, Group Health Cooperative, Seattle, Washington
Objective. To quantify the risk of anaphylaxis after vaccination of children and adolescents.
Methods. The study population consisted of children and adolescents who were enrolled at 4 health maintenance organizations that participated in the Vaccine Safety Datalink Project. For the period 1991–1997, we identified potential cases by searching for occurrences of International Classification of Diseases, Ninth Revision (ICD-9) code 995.0 (anaphylactic shock), E948.0 through E948.9 (adverse reaction from bacterial vaccines), and E949.0 through E949.9 (adverse reaction from other vaccines and biological substances). At 1 study site, we also included a range of other allergy codes. We restricted to diagnoses on days 0 to 2 after vaccination (ICD-9 995.0) or day 0 (all other ICD-9 codes). We then reviewed the medical record to confirm the diagnosis.
Results. We identified 5 cases of potentially vaccine-associated anaphylaxis after administration of 7 644 049 vaccine doses, for a risk of 0.65 cases/million doses (95% confidence interval: 0.21–1.53). None of the episodes resulted in death. Vaccines that were administered before the anaphylactic episodes were generally given in combination and included measles-mumps-rubella, hepatitis B, diphtheria-tetanus, diphtheria-tetanus-pertussis, Haemophilus influenzae type b, and oral polio vaccine. One case of anaphylaxis followed measles-mumps-rubella vaccine alone. At the site at which we reviewed additional allergy codes, we identified 1 case after 653 990 vaccine doses, for a risk of 1.53 cases/million doses (95% confidence interval: 0.04–8.52).
Conclusions. Patients and health care providers can be reassured that vaccine-associated anaphylaxis is a rare event. Nevertheless, providers should be prepared to provide immediate medical treatment should it occur.
Key Words: anaphylaxis • vaccination • vaccine adverse reactions
Abbreviations: MMR, measles-mumps-rubella • HMO, health maintenance organization • VSD, Vaccine Safety Datalink • ICD-9, International Classification of Diseases, Ninth Revision • CI, confidence interval • DT, pediatric diphtheria-tetanus • DTP, diphtheria-tetanus-whole cell pertussis • Hib, Haemophilus influenzae type b • OPV, oral polio vaccine • VAERS, Vaccine Adverse Event Reporting System
Received for publication Mar 28, 2003; Accepted Jun 10, 2003.
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