Canada Vigilance Adverse Reaction Online Database

The data extract is a series of compressed ASCII text files of the full data set contained in the Canada Vigilance Adverse Reaction Online Database. It is intended for users who are familiar with database structures and setting up their own queries. Find details on the data structure required for the data file in the Canada Vigilance Adverse Reaction Online Database - Data Structure. In order to use the data, the file must be loaded into an existing database or information system provided by the user. The Canada Vigilance Adverse Reaction Online Database 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. Indication data has recently been added to the data extract files and the Detailed Adverse Reaction Report. Indication refers to the particular condition for which a health product was taken. For example, diabetes is an indication for insulin. Health products are often authorised for use in treating more than one indication. Note: The database cannot be used on its own to evaluate a health product's safety profile. It does not provide conclusive information on the safety of health products, and is not a substitute for medical advice. Should you have an issue of medical concern, consult a qualified health professional.

Data and Resources

Additional Info

Field	Value
Last Updated	April 17, 2026, 20:11 (UTC)
Created	April 17, 2026, 20:11 (UTC)
contact_email	hpfb.im.info-gi.dgpsa@hc-sc.gc.ca
contact_person	{}
criticality_level	[]
data_dictionary	[]
geographic_scope	[]
open_canada_collection	primary
open_canada_date_modified	2015-02-19 00:00:00
open_canada_date_published	2009-02-12 00:00:00
open_canada_keywords	{"en": ["online database", "suspected adverse reactions", "drugs", "health products", "prescription", "non-prescription medication", "natural health products", "radiopharmaceuticals", "canada vigilance program", "reports", "submit", "health professionals", "consumers", "market authorization holders", "manufacturers", "distributors", "voluntary basis", "mandatory reporting", "adverse reaction reports", "data extraction", "ascii", "data extract text files"], "fr": ["base de données en ligne", "effets indésirables présumés", "médicaments", "produits de santé", "médicaments sur ordonnance", "vente libre", "produits de santé naturels", "produits radiopharmaceutiques", "programme canada vigilance", "déclarations", "professionnels de la santé", "consommateurs", "détenteurs d'une autorisation de mise en marché", "fabricants", "distributeurs", "base volontaires", "déclaration obligatoire", "effets indésirables", "extrait des données", "fichiers", "ascii"]}
open_canada_subject	["health_and_safety"]
sensitivity_level	unrestricted
title_fr	Base de données en ligne des effets indésirables de Canada Vigilance - Version française
update_frequency	P3M