Abstract:
:The need for developing a case definition and guidelines for a local reaction at or near the injection site, methods for the development of the case definition and guidelines as an adverse event following immunization as well as the rationale for selected decisions about the case definition for a local reaction at or near the injection site are explained in the Preamble section. The case definition is structured in 2 levels of diagnostic certainty: level 1 includes any description of morphological or physiological change at or near the injection site that is described or identified by a healthcare provider. Level 2 is any description of morphological or physiological change at or near injection site that is described by any other person. In Guidelines section, the working group recommends to enable meaningful and standardized data collection, analysis, and presentation of information about a local reaction at or near the injection site. However, implementation of all guidelines might not be possible in all settings. The availability of information may vary depending upon resources, geographic region, and whether the source of information is a prospectively designed clinical trial, a post-marketing surveillance or epidemiologic study, or an individual report of a local reaction at injection site.
journal_name
Vaccinejournal_title
Vaccineauthors
Gidudu J,Kohl KS,Halperin S,Hammer SJ,Heath PT,Hennig R,Hoet B,Rothstein E,Schuind A,Varricchio F,Walop W,Brighton Collaboration Local Reactions Working Group for a Local Reaction at or near Injection Site.doi
10.1016/j.vaccine.2008.10.006subject
Has Abstractpub_date
2008-12-09 00:00:00pages
6800-13issue
52eissn
0264-410Xissn
1873-2518pii
S0264-410X(08)01386-8journal_volume
26pub_type
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