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.

Resources

Resource Name Resource Type Format Language Links
Adverse Reactions Data Dataset ZIP English
French
Access
Data dictionary Guide Other English Access
Data dictionary Guide Other French Access

Comments

  • Hao Yi

    2014-03-02

    Please consolidate the dose units in report_drug such that all the doses are in the same order of magnitude. (e.g. mg --> grams) (mg/kg --> mg taken since weight is reported). Also, please check for the integrity of the data with respect to dosages as some are off by orders of magnitude. Lastly, please check for typographical errors when inputting drug names. Thanks!

  • Nick

    2015-02-24

    Is it possible to link either REPORT_DRUG_ID or DRUG_PRODUCT_ID in the Table labelled as Report_Drug with National Drug Identification numbers that are found in the National Drug Product Database (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/dpd_read_me-bdpp_lisez-moi-eng.php) ref: http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/structure-eng.php#a11

  • AP

    2016-11-29

    Hello, I have some valuable inputs but first can you please confirm if questions or comments here are replied by owner on this page?

  • open-ouvert

    2016-11-30

    AP - we share comments and questions on our site with the dataholder - in this case, we'll forward your comment to Health Canada. This database can also be found here http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index-eng.php and if you prefer to forward suggestions or comments directly to Health Canada offices, have a look here for some specific ways to get in touch http://www.hc-sc.gc.ca/contact/index-eng.php. Hope this is helpful! Karin - the open-ouvert team

  • AP

    2016-12-01

    Dear Karin, Indeed that was helpful to know. I will email them. Thanks.