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AEFI_WPRO

AEFI_WPRO

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Published by: VaccineInformation on Dec 27, 2011
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WPRO/EPI/99.01English only
IMMUNIZATION SAFETY SURVEILLANCE:
G
UIDELINES FOR MANAGERS OF IMMUNIZATION PROGRAMMESON REPORTING AND INVESTIGATING ADVERSE EVENTSFOLLOWING IMMUNIZATION
Acknowledgements: This document was prepared by Osman Mansoor, Susan Shin, ChrisMaher and the Immunization Focus of WPRO. The authors are grateful for helpfulcomments from Philippe Duclos, Mike Gold, Peter Abernethy, Robert Pless and RennieD’Souza. Source material is detailed in the bibliography, as well as, the New ZealandImmunization Handbook, South Australian Health Department Web site, the Canadianprocess for causality assessment, and the drafts of the revised WHO Geneva document,Field guide for AEFI surveillance.
 
 Immunization Safety Surveillance
2WPRO/EPI/99.01An electronic version of this document is available on the WPRO website: www.who.org.ph. Thecontents of this document are also available as a PowerPoint presentation, on request from theImmunization Focus, World Health Organization, Western Pacific Regional Office (WPRO).
Immunization FocusWorld Health Organization
Western Pacific Regional OfficeP.O. Box 2932 (United Nations Avenue)
1000 Manila
PhilippinesFax: +632-528-8001
E-mail: EPI@who.org.ph
This document is not a formal publication of the World Health Organization (WHO) and all rights arereserved by the Organization. The document may, however, be freely reviewed, abstracted, reproducedand translated, in part or in whole, but not for sale nor for use in conjunction with commercial purposes.The views expressed in documents by named authors are solely the responsibility of those authors.© World Health OrganizationManila, 1999
 
 Immunization Safety Surveillance
3WPRO/EPI/99.01
T
ABLE OF
C
ONTENTS
Glossary________________________________________________________________5Abbreviations___________________________________________________________61.Purpose____________________________________________________________72.Adverse events following immunization (AEFIs)___________________________9
2.1Vaccine reactions________________________________________________________92.1.1Common, minor vaccine reactions______________________________________92.1.2Rare, more serious vaccine reactions____________________________________102.1.3Prevention and treatment of vaccine reactions____________________________122.2Programme errors_______________________________________________________122.3Coincidental events______________________________________________________142.4Injection reactions_______________________________________________________172.5AEFIs during immunization campaigns______________________________________172.6Differences between surveillance of AEFIs and of adverse events to drugs___________18
3.Establishing immunization safety surveillance____________________________19
3.1Objectives_____________________________________________________________203.2Responsibility for immunization safety surveillance____________________________203.3Learning and training____________________________________________________213.4Steps for establishing a system_____________________________________________22
4.Reporting AEFIs___________________________________________________23
4.1What events should be reported?___________________________________________234.2Who should report?______________________________________________________244.3When to report?_________________________________________________________254.4How to report?__________________________________________________________254.5Barriers to reporting_____________________________________________________25
5.Investigating AEFIs_________________________________________________27
5.1Which reports should be investigated?_______________________________________275.2Who should investigate?__________________________________________________275.3When to investigate?_____________________________________________________275.4How to investigate?______________________________________________________285.4.1 Investigating AEFI clusters___________________________________________285.5Outline of an investigation________________________________________________305.6Causality assessment_____________________________________________________31
6.Responding to AEFIs________________________________________________33
6.1Communicating with the media____________________________________________346.1.1Understanding the media perspective___________________________________346.1.2Holding a media conference__________________________________________356.1.3Preparing a press statement___________________________________________356.2Fixing the problem______________________________________________________36
7.Evaluation of the immunization safety surveillance system__________________388.References & Bibliography___________________________________________39

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