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Canada Communicable Disease Report

[Table of Contents]

 

 

Volume: 26S1 - February 2000

Guidelines for Reporting Adverse Events Associated with Vaccine Products
Supplementary guidelines for the Canadian Pharmaceutical Industry

Appendix 2 - Summary of Reporting Requirements Definition of Serious

Type of Reaction

Report Within 15 Days

Report Within 30 Days1

Supply Annual
Summary (PSUR)2

Type of Vaccine
New or All

DOMESTIC REPORTS
(Spontaneous/Published)

All Serious (see below)

x

-

x

All

Non Serious, Unexpected

-

x

x

All

Non Serious, Expected

-

x

x

All

Lack of Efficacy (see text)

-

-

-

Ad hoc
(see text)

FOREIGN REPORTS
(Spontaneous/Published)

Serious Unexpected

x

-

x

All

Serious Expected

-

-

x

All

Non Serious Unexpected

-
-

x

All

Unusual situations (see text)

-

x

x

All

DOMESTIC REPORTS3

Serious Unexpected

x

-

x

All

Serious Expected

x

-

x

All

Lack of Efficacy

x

-

x

Some
(see text)

FOREIGN REPORTS3

Serious Unexpected

x

-

x

All

1 This 30 day provision is not covered under the Regulations. It is, however, a special request of the Division of Immunization.

2 As a minimum, the types of reaction to include in the Annual Summary are based on the recommendations in the Final Report of CIOMS Working Group II (see Appendix 3 for ordering address). However, for VAAE, all reports received by a manufacturer are requested.

3 Studies not under an IND submission.

Definition of "Serious"

"Serious" is defined as any reaction that

  • results in death or is life-threatening
  • requires in vaccine recipient hospitalization or prolongation of existing hospitalization
  • results in persistent or significant disability or incapacity
  • is a congenital anomaly/birth defect.

In addition, LCDC defines "serious" for the purpose of database extraction for review by the ACCA as meeting the following diagnoses or criteria (see the VAAE reporting form in Appendix 5):

  • anaphylaxis - all cases
  • convulsion - afebrile and hospitalized
  • febrile seizure with hospitalization for 3 days or more
  • encephalopathy and encephalitis/meningitis - all cases
  • anesthesia/paresthesia and paralysis - all cases
  • Guillain Barré syndrome - all cases
  • thrombocytopenia - all cases
  • other severe or unusual events with hospitalization

 

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