Volume: 26S1 - February 2000

Guidelines for Reporting Adverse Events Associated with Vaccine Products

Supplementary guidelines for the Canadian Pharmaceutical Industry

Adobe Downloadable Document (399 KB)

Table of Contents

I. Introduction

• A. Background - Drugs and Vaccines
• B. Principles of Adverse Reaction Reporting for Vaccines
• C. The Vaccine Associated Adverse Events Surveillance System
• D. Guidelines for Industry to Report Vaccine Associated Adverse Events
• E. Confidentiality of Case Reports - Industry Access to Data

II. General Procedures for Reporting - Features Unique to Vaccines

• A. What Constitutes a VAAE Report
• B. Domestic VAAE Reports
• C. Foreign Adverse Reaction Reports
• D. Unusual Failure in Efficacy - Domestic Reports
• E. Summary Reports or Periodic Safety Update Reports (PSURs)
• F. Reports From Studies on Marketed Vaccines
• G. Audit
• H. Forms

References

Appendices

1. Common Acronyms
2. Summary of Reporting Requirements
3. Caveat Statement
4. Important Addresses
5. Vaccine Associated Adverse Events Reporting Form

For more information, please contact:

Head, Vaccine Associated Adverse Event Surveillance Section
Division of Immunization
Bureau of Infectious Diseases
Laboratory Centre for Disease Control
(613) 957-1340

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