title: Extensive limb swelling after immunization: reports to the Vaccine Adverse Event Reporting System.
abstract: Extensive limb swelling (ELS) has been reported after vaccination with a limited number of vaccine types. We sought to describe vaccine types involved in and the clinical characteristics of ELS cases reported to the Vaccine Adverse Event Reporting System (VAERS). A case of ELS was defined as any report of edema extending at least to the elbow or knee of a vaccinated extremity. Four hundred ninety-seven cases were identified, with some describing swelling from the shoulder to the hand or the hip to the foot. Patient age ranged from 0.1 to 91 years. The proportion of reports of ELS associated with a given vaccine, among all VAERS reports received for that vaccine, varied substantially among vaccines. Most reactions began within 1 day after vaccination and involved other signs of inflammation. Postvaccination ELS can involve both the proximal and distal segments of the extremity, affects all age groups, and occurs after vaccination with a broad range of vaccines.
authors.affiliation: Vaccine 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
authors.forename: Emily Jane
authors.initials: EJ
authors.lastname: Woo
authors.forename: Dale R
authors.initials: DR
authors.lastname: Burwen
authors.forename: Sarah N M
authors.initials: SN
authors.lastname: Gatumu
authors.forename: Robert
authors.initials: R
authors.lastname: Ball
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D004487:Edema / Q000139:chemically induced*; D005121:Extremities; D005260:Female; D006801:Humans; D007114:Immunization / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D014612:Vaccines / Q000009:adverse effects*
chemical_list: D014612:Vaccines