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Updated: Jul 27, 2026

Trans-vivo Delayed Type Hypersensitivity Assay for Antigen Specific Regulation
Published on: May 2, 2013
Extensive limb swelling after immunization: reports to the Vaccine Adverse Event Reporting System
Emily Jane Woo1, Dale R Burwen, Sarah N M Gatumu
1Vaccine Safety Branch, Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20852, USA. wooj@cber.fda.gov
Extensive limb swelling (ELS) can occur after various vaccinations. This condition, characterized by significant swelling in vaccinated limbs, affects all age groups and can manifest with other inflammatory signs.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- Extensive limb swelling (ELS) is a known adverse event following vaccination.
- Previous reports have linked ELS to a limited range of vaccine types.
Purpose of the Study:
- To identify vaccine types associated with ELS.
- To describe the clinical characteristics of ELS cases reported to the Vaccine Adverse Event Reporting System (VAERS).
Main Methods:
- A case definition for ELS was established (edema extending to the elbow or knee of a vaccinated extremity).
- Data from 497 ELS cases reported to VAERS were analyzed.
- The proportion of ELS reports relative to total reports for each vaccine was calculated.
Main Results:
- ELS cases were identified across a wide age range (0.1 to 91 years).
- Swelling could involve proximal and distal limb segments (e.g., shoulder to hand, hip to foot).
- The incidence of ELS varied significantly among different vaccine types.
- Most ELS reactions occurred within 1 day of vaccination and were accompanied by other inflammatory signs.
Conclusions:
- Postvaccination ELS is not limited to specific vaccine types and can occur after a broad range of immunizations.
- ELS affects individuals across all age demographics.
- The clinical presentation of ELS involves significant limb edema and can be associated with other inflammatory symptoms.
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