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Multicenter Study
. 2003 Oct;112(4):815-20.
doi: 10.1542/peds.112.4.815.

Risk of anaphylaxis after vaccination of children and adolescents

Kari Bohlke  1 , Robert L Davis, S M Marcy, M M Braun, Frank DeStefano, Steven B Black, John P Mullooly, Robert S Thompson; Vaccine Safety Datalink Team
Affiliations
Multicenter Study

Risk of anaphylaxis after vaccination of children and adolescents

Kari Bohlke et al. Pediatrics. 2003 Oct.

Abstract

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.

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