Risk of anaphylaxis after vaccination of children and adolescents.
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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For each 1.1 million doses of vaccine administered, approximately one recipient will experience anaphylaxis; however, no deaths have been reported among these patients.
“For each 1.1 million doses of vaccine administered, approximately one recipient will experience this type of reaction (1328); however, no deaths have been reported among these patients (1318,1328).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [1328]
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- Authors
- Bohlke, K., Davis, R. L., Marcy, S. M., Braun, M. M., DeStefano, F., Black, S. B., Mullooly, J. P., Thompson, R. S., & for the Vaccine Safety Datalink Team
- Affiliations
- Group Health Cooperative (US)
- Kaiser Foundation Hospital (US)
- Center for Biologics Evaluation and Research (US)
- Centers for Disease Control and Prevention (US)
- Kaiser Permanente (US)
- Venue
- PEDIATRICS
- Publisher
- American Academy of Pediatrics (AAP)
- Published
- 2003-10-01
- Volume
- 112
- Issue
- 4
- Pages
- 815-820
- ISSN
- 0031-4005 (ISSN-L)
- 1098-4275
- OpenAlex
- W2111371073
- Cited by
- 320
- References
- 24
- Citations by year
- 2026: 2 · 2025: 7 · 2024: 9 · 2023: 8 · 2022: 11 · 2021: 14 · 2020: 5 · 2019: 14 · 2018: 16 · 2017: 11 · 2016: 16 · 2015: 17 · 2014: 16 · 2013: 14 · 2012: 25
- FWCI
- 6.71
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- PEDIATRICS (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Kaiser Permanente
- Centers for Disease Control and Prevention
- Topics
- Health Sciences › Medicine › Immunology and Allergy › Food Allergy and Anaphylaxis Research
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Pharmacology › Drug-Induced Adverse Reactions
- Keywords
- vaccine anaphylaxis, vaccine safety, children and adolescents, MMR vaccine, hepatitis B vaccine, diphtheria-tetanus vaccine, Haemophilus influenzae type b vaccine, oral polio vaccine, vaccine adverse events, anaphylactic shock
- MeSH terms
- Adolescent, Anaphylaxis, California, Child, Child, Preschool, Female, Health Maintenance Organizations, Humans, Infant, Infant, Newborn, Male, Oregon, Risk, Vaccination, Vaccines, Washington, Cohort Studies, Adverse Drug Reaction Reporting Systems
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