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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 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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Metadata
- 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 (medical) › 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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