A local reaction at or near injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data

被引：41

作者：

Gidudu, Jane ^{[1
]}

Kohl, Katrin S. ^{[1
]}

Halperin, Scott ^{[2
]}

Harnmer, Sandra Jo ^{[3
]}

Heath, Paul T. ^{[4
]}

Hennig, Renald ^{[5
]}

Hoet, Bernard ^{[6
]}

Rothstein, Edward ^{[7
]}

Schuind, Anne ^{[8
]}

Varricchioi, Frederick ^{[9
]}

Walop, Wikke ^{[10
]}

机构：

[1] Ctr Dis Control & Prevent, Atlanta, GA 30333 USA

[2] Dalhousie Univ, Halifax, NS, Canada

[3] Calif Dept Publ Hlth, Richmond, CA USA

[4] St Georges Univ, London, England

[5] Scratch GbR, Pharmacovigilance Serv, Butzbach, Germany

[6] GlaxoSmithKline Biol, Rixensart, Belgium

[7] Pennridge Pediat Associates, Sellersville, PA USA

[8] GlaxoSmithKline, King Of Prussia, PA USA

[9] US FDA, Rockville, MD 20857 USA

[10] Publ Hlth Agcy Canada, Ottawa, ON, Canada

来源：

VACCINE | 2008年 / 26卷 / 52期

关键词：

A local reaction; Adverse event; Immunization; Guidelines; Case definition;

D O I：

10.1016/j.vaccine.2008.10.006

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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 I includes any description of morphological OF physiological change at OF 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 ail individual report of a local reaction at injection site. (C) 2008 Elsevier Ltd. All rights reserved.

引用

页码：6800 / 6813

页数：14

共 46 条

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