Canada Vigilance adverse reaction online database: How to search the database
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Health Canada receives adverse reaction reports daily, including new reports and additional information for reports previously submitted. This database is updated monthly to reflect this new information.
Only suspected adverse reactions to Canadian marketed health products that occur in Canada and are reported to Health Canada are found in the database.
All search criteria entry errors (for example, missing date) will result in an error message being displayed at the top of the page. The error message will explain the problem and the affected field will be highlighted.
For help while using the database, select the "Help with this section" links throughout the database to return to specific sections of this page. You may also select the purple buttons with question marks to learn more about particular terms.
Note that the database times out if there is no activity for 30 minutes. Any criteria entered or results retrieved will be lost.
Report search criteria
This section allows you to narrow your search based on certain report elements, including dates received, whether the reports are considered serious and the source of reports.
An Initial Received Date range or Latest Received Date range must be entered for the search to be executed. The date range is defaulted to include all the reports in the database. You may adjust the dates in these fields to obtain fewer reports. Be sure to use the format YYYY-MM-DD.
Patient search criteria
This section allows you to specify criteria related to the patient(s) who experienced the adverse reaction(s) described in each report, including gender, age and outcome.
If originally provided by the person submitting the adverse reaction report (the 'reporter'), age is displayed by number of years, which has been rounded up to the closest year. For example, when searching for patients less than 1 year of age, select the age range 0-1 year.
Suspected health product search criteria
To specify health product search criteria, you may either select all health products or perform a keyword search by brand name or active ingredient. The keyword search by brand name is most common among users.
For brand name or active ingredient keyword searches, simply enter a minimum 3 letters of the brand name or active ingredient you would like to retrieve. When you select the "Find Health Products" button, a list of brand names or active ingredients will appear. You may select either "Select All Below" or select specific items from the list, holding down the Ctrl key for multiple selections. The selected brand names or active ingredients, highlighted in blue, will be included in your search criteria. Once you have made your selection, proceed to the Adverse Reaction Term Search Criteria.
When conducting a keyword search by brand name or by active ingredient in this database, use the English version of the brand name or active ingredient. International characters, such as accents and symbols, are not recognized in the database and should be avoided as part of keywords. To find the brand name and active ingredient of a product, use the following databases:
Product information found within the DPD and LNHPD databases originates from organizations that are not subject to the Official Languages Act.
You can also do a keyword search by brand name to retrieve adverse reactions specific to the product's brand name selected. However, there may be multiple brand names for the same active ingredient. To expand the scope of a search, consider a keyword search by active ingredient.
Adverse reaction term search criteria
Adverse reaction information is coded in the database using terminology from the Medical Dictionary of Regulatory Activities (MedDRA). The dictionary includes standardized terms for symptoms, signs, diseases, syndromes and diagnoses.
To specify adverse reaction term criteria when searching the database, select all adverse reaction terms or perform a keyword search by adverse reaction term or system organ class.
It is most common for users to select all adverse reaction terms for their search. To select all adverse reaction terms for a search, choose "Select All Adverse Reaction Terms". Then select the "Search" button at the bottom of the page to retrieve the results of your search.
To search for a single adverse reaction term or System Organ Class, choose the appropriate selection "By Adverse Reaction Term" or "By System Organ Class". Then enter a minimum 3 letters of the adverse reaction term or System Organ Class you would like to retrieve. Upon selecting the "Find Terms" button, a list of adverse reaction terms or system organ classes will appear. You may either "Select All Below" or select specific items from the list, holding down the control (Ctrl) key for multiple selections. The selected adverse reaction terms or system organ classes, highlighted in blue, will be included in your search criteria. Once you have made your selection, then select the "Search" button at the bottom of the page to retrieve the results of your search. To start over, simply select the "Reset" button.
Searching by system organ class can be useful when searching for reports associated with a set of similar adverse reaction terms (for example, cardiac arrest and heart attack). Alternatively, a single adverse reaction term can be selected when searching for 1 specific adverse reaction.
MedDRA contains over 18,000 unique adverse reaction terms. It may be difficult to retrieve all the cases associated with 1 broad medical concept without using a system organ class or doing multiple searches using a variety of similar adverse reaction terms. Depending on the number of cases included in the search results, it may be advantageous to search "All Adverse Reaction Terms" and then review each case separately.
Note: It's not possible to search all health products and all adverse reactions terms. If "Select All Health Products" was chosen in section 3, a keyword search must be done in section 4 and if "Select All Adverse Reaction Terms" is chosen in section 4, a keyword search would have to be done in section 3.
Once you start your search, you will be prompted to select the type of view to display the search results. The "Standard View" results table, which is adequate for most users, includes the following columns:
- Adverse Reaction Report (AER) Number
- Market Authorization Holder (MAH) AER Number
- Initial Received Date
- Suspected Brand Name
- Adverse Reaction Terms
The "Custom View" allows you to choose which fields you would like to see when the results of your search are displayed. In addition to an AER Number, a maximum of 6 elements can be selected for the initial results display. Standard View report elements have been preselected. To replace a standard report element with one of your choice, simply select a new element and deselect the one you do not wish to include.
Complete information on specific reports is available by selecting corresponding AER Numbers in the results table.
This section displays a table of adverse reaction reports submitted to Health Canada that correspond to the search criteria specified and the view selected. A summary of the search criteria specified is displayed at the top of the page. Search criteria can be modified by selecting the "Modify Search Criteria" button located above and below the results table.
The total number of reports retrieved is also displayed in the "Search Result" table. A maximum of 20 matching records will be displayed per page. Select "next result" for the next 20 results.
Table results are sorted by Adverse Reaction Report (AER) Number. The following underlined titles allow you to sort the results according to a specific column, in ascending order:
- Market Authorization Holder (MAH) AER Number
- Initial Received Date
Blank fields mean that no information was provided by the reporter for a particular field.
To access complete information for a specific report, select the corresponding AER Number in the first column of the results table.
Export/save search results
This section allows you to export and save the search results to your computer. Results can be saved in portable document format (PDF) or Microsoft Excel (XLS) format.
Exported files are limited to 1,000 adverse reaction reports. For search results that exceed this limit, we recommend that you return to the Search Criteria. Specify additional criteria or reduce the time period of the reports requested to obtain fewer results. Or, you can ask for a summary of adverse reaction information by contacting the Canada Vigilance Program. If you're familiar with database structures, you may download the data extract files.
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