کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2407529 1103129 2008 14 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
A local reaction at or near injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data
موضوعات مرتبط
علوم زیستی و بیوفناوری ایمنی شناسی و میکروب شناسی ایمونولوژی
پیش نمایش صفحه اول مقاله
A local reaction at or near injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data
چکیده انگلیسی

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.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Vaccine - Volume 26, Issue 52, 9 December 2008, Pages 6800–6813
نویسندگان
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