- Indications Associated with Adverse Reports
- Canada Adverse Reaction Database
- Canada Vigilance Adverse Reaction Online Database
- Adverse Event Reporting System Vaccine Information
- Adverse Reactions
- Adverse Reactions Database
- Canada Vigilance Adverse Reaction Database
- Vaccination Reporting System
- Suspected Adverse Reactions
- Drug Products
- Drug Report Indications
- Drug Product Ingredients
- Vaccine Side Effects
- Adverse Reaction Online Database
This dataset provides the information about Canada Vigilance Adverse Reaction literature references. This dataset includes data from 1965 to 2022-07-31.
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The Canada Vigilance Adverse Reaction dataset contains information about suspected adverse reactions (also known as side effects) to health products, captured from adverse reaction reports submitted to Health Canada by consumers and health professionals, who submit reports voluntarily, as well as by market authorization holders (manufacturers and distributors), who are required to submit reports according to the Food and Drugs Regulations. Information concerning vaccines used for immunization have only been included in the database since January 1, 2011.
Adverse reaction reports are submitted by:
– Consumers and health professionals, who submit reports voluntarily
– Manufacturers and distributors (also known as market authorization holders), who are required to submit reports according to the Food and Drugs Act.
This dataset has been collected primarily by a spontaneous surveillance system in which suspected adverse reactions to health products are reported to market authorization holders (manufacturers) and Health Canada on a voluntary basis.
Note: Inclusion of a particular reaction does not necessarily mean that it was caused by the suspected health product(s). Certain reported reactions may occur spontaneously. They provide a background rate in the general population and may have a temporal, but not necessarily a causal, relationship with the health product. The purpose of the Canada Vigilance Program is to detect possible signals of adverse reactions associated with health products. Additional scientific investigations are required to validate signals from the Canada Vigilance Program and to establish a cause and effect relationship between a health product and adverse reaction. The data provided do not represent all known safety information concerning the suspected health product(s) and should not be used in isolation to make decisions regarding an individual’s treatment regimen; other sources of information, including the prescribing information for the product, should be consulted.
About this Dataset
1965 to 2022-07-31
John Snow Labs; Health Canada's Marketed Health Products Directorate;
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Adverse Event Reporting System Vaccine Information, Adverse Reactions, Adverse Reactions Database, Canada Vigilance Adverse Reaction Database, Vaccination Reporting System, Suspected Adverse Reactions, Drug Products, Drug Report Indications, Drug Product Ingredients, Vaccine Side Effects, Adverse Reaction Online Database
Indications Associated with Adverse Reports, Canada Adverse Reaction Database, Canada Vigilance Adverse Reaction Online Database
|Report_ID||The adverse reaction identification number of the report assigned by Health Canada.||integer||level : Ordinal|
|Adverse_Reaction_Report_Number||The adverse reaction report number is the identification number of the report assigned by Health Canada.||string||-|
|Version_No||The adverse reaction report version number of the report assigned by Health Canada. Version 0 is considered the initial version of the report. Subsequent version numbers refer to follow-up reports.||integer||level : Nominal|
|Literature_Reference_Sequence||Literature Reference Sequence Number||integer||level : Nominal|
|Literature_Reference||The reference to the literature article where the case(s) originated from.||string||-|
|Report ID||Adverse Reaction Report Number||Version No||Literature Reference Sequence||Literature Reference|