Need for developing case definitions and guidelines for abscess at injection site as an adverse events following immunization:
An abscess at an injection site involving a localized soft tissue collection of material at the site of immunization is a rare local reaction. Despite its rarity, it is important to develop standardized diagnostic criteria to guide appropriate public health interventions, and to improve global comparability of vaccine safety data on abscess.
Sections 2 Case definition for abscess at injection site, 3 Guidelines for data collection, analysis, and presentation of abscess at the injection site of this paper provide the case definition and guidelines for data collection, analysis, and presentation that the Brighton Collaboration Local Reactions Working Group has developed for the standardized collection and assessment of information about abscess at the injection site. Widespread use of this definition with its guidelines will improve data comparability and allow a better understanding of the adverse event. The case definition and guidelines are intended to be applicable in diverse geographic, administrative, and cultural regions, regardless of differences in the availability of health care resources.
1.2. Methods for the development of the case definition and guidelines for abscess at injection site as an adverse event following immunization
Following the process described in the overview paper [1], a Brighton Collaboration Local Reactions Working Group was formed in December 2001 with 12 members with public health, regulatory, clinical, academic, and industry backgrounds. This initial Working Group identified 16 injection site reactions that needed to be defined based on their frequency or severity. It has previously published a case definition with guidelines for nodule at injection site [2], and has since developed four additional case definitions with guidelines published in this volume. The Working Group’s composition is slightly different for each of the case definitions and guidelines for each of the local reactions, depending on their availability and interest in a particular topic, The member composition and results of the web-based surveys completed by the reference group and subsequent discussions in the working group can be viewed at: http://www.brightoncollaboration.org/internet/en/index/working_groups.html.
