Canada Vigilance adverse reaction online database: Interpreting the dashboard output

Dashboard output

Consumer view

The following data summaries are available in the consumer view of the dashboard:

Patient sex: provides the percentage of reports received by Health Canada in the date range specified by patient sex, including the percentage of reports that did not contain patient sex
Date range: reflects the earliest and latest date Health Canada received a report for the date range specified in the search bar
- for most searches, the 2 date ranges should match
- there are a few dates where Health Canada did not receive any reports
Reports counts: provides the total number of reports received, number of serious reports received (excluding deaths) and number of reports involving a death received in the specified date range
- the existence of a report involving death doesn't mean that the health product caused the patient to die
- a fatal outcome may occur as a result of the natural progression of the disease being treated
Report timeline: shows the number of adverse reaction reports received by Health Canada, over time and in the date range specified
- the default view is from January 1, 2010 onward, but data are available back to 1965
- the data are categorized in 3 groups and shown in different colours: blue for death, green for serious, excluding death and dark green for non-serious
Guides and help: provides links to other important resources, such as instructions for using the database, glossary of database terms and alternative access to the data
Reasons for seriousness: shows the number of reports received by Health Canada in the date range specified that included at least 1 of the serious outcomes listed as follows:
- 1 or more of the following outcomes documented in the report is classified as serious:
  - death
  - hospitalization
  - life-threatening
  - disability
  - congenital anomaly
  - medically important condition
- including 1 or more serious outcomes for a report doesn't mean the suspect product(s) named in the report was the cause of that outcome
Reactions: provides the top 5 reactions listed in adverse reaction reports received by Health Canada in the date range specified and corresponding number of reports
- terms provided are the MedDRA preferred terms for the reaction(s) included in the report (refer to the glossary)
- information in adverse reaction reports is coded before or as it's entered into the database (we use MedDRA terminology for coding, which is composed of standardized terms for symptoms, signs, diseases, syndromes and diagnoses)
Reason for use: shows the proportion of reports by reason for use of the suspect product(s) listed in reports received by Health Canada in the date range specified
- this field was only implemented in 2008 so will be missing from reports received before then
Related services: provides links to the COVID-19 vaccines and treatments portal, reporting a side effect webpage, and recalls and safety alerts webpage

Advanced view

The advanced view of the dashboard includes the following additional data summaries:

Patient age: shows the distribution of patient ages among adverse event reports received by Health Canada in the date range specified
Reports without patient age: provides the number of reports received by Health Canada in the date range specified that do not contain the patient's age
Top 10 MedDRA SOCs: lists the top 10 MedDRA system organ classes (SOCs) in adverse reaction reports received by Health Canada in the date range specified
- a SOC contains hundreds of similar adverse reaction terms that relate to 1 specific organ system of the body (for example, cardiac disorders) (refer to the glossary)
- information in adverse reaction reports is coded before or as it is entered into the database (we use MedDRA terminology for coding, which is composed of standardized terms for symptoms, signs, diseases, syndromes and diagnoses)

Report listings output

A table of individual adverse reaction reports is available from the advanced view of the dashboard in the "Adverse Drug Reaction Drilldown" link in the "Navigation" panel. The following table provides the field names in the database. Definitions for each of the terms below is provided in the glossary.

Heading	Field name
Active ingredient: concomitant product	report_ingredient_concomitant
Active ingredient: suspect product	report_ingredient_suspect
Adverse event report number	report_no
Adverse event report version number	version_no
Adverse reaction term	reaction_pt_en
Age	patient_age
Age group	patient_age_group_en
Brand name: concomitant product	report_drugname_concomitant
Brand name: suspect product	report_drugname_suspect
COVID product	covid_product
Date received: initial	datintreceived
Date received: latest	datreceived
Sex	patient_gender_en
Height	patient_height
Height: units	patient_height_unit_en
Indication	report_indication_en
Market authorization holder AER number	mah_no
MedDRA system organ class	reaction_soc_en
Reason for seriousness: congenital anomaly	congenital_anomaly
Reason for seriousness: death	death
Reason for seriousness: disability	disability
Reason for seriousness: hospitalization	hosp_required
Reason for seriousness: life threatening	life_threatening
Reason for seriousness: other medically important condition	other_medically_imp_cond
Report outcome	outcome_en
Reporter type	reporter_type_en
Serious report	seriousness
Source of report	source_en
Type of report	report_type_en
Weight	patient_weight
Weight: units	patient_weight_unit_en

JSON data structure

The detailed adverse reaction report information is available in a table or JSON format. The following technical information is provided for users who are familiar with working with JSON objects.

The main JSON object consists of a series of values, some of which are nested arrays and nested objects. Details can be found in the following tables. Field names that begin with underscores refer to system fields. Note that there can be missing information for any of the values listed.

*fields* Nested object: This object provides information about the report and patient
Value logical name	Value physical name	Data type
Reason for seriousness: death	death	Logical (true/false)
Adverse event reaction number plus version number	aer_id	Number
Market authorization holder adverse event report number	mah_no	String
Detailed reaction information	reactions	Nested array
Adverse event report number (6 digits)	report_id	Number
Adverse event report number (9 digits)	report_no	String
Report source: English	source_en	String
Report source: French	source_fr	String
Disability	disability	Logical (true/false)
Report outcome: English	outcome_en	String
Report outcome: French	outcome_fr	String
Adverse event report version number	version_no	Number
Latest received date	datreceived	Date
Age	patient_age	Number
Serious adverse reaction	seriousness	Logical (true/false)
Date of last refresh	last_refresh	Date
COVID-19-related product	covid_product	Logical (true/false)
Hospitalization required	hosp_required	Logical (true/false)
Age in years	patient_age_y	Number
Initial received date	datintreceived	Date
Adverse reaction preferred terms: English	reaction_pt_en	Array
Adverse reaction preferred terms: French	reaction_pt_fr	Array
Type of report: English	report_type_en	String
Type of report: French	report_type_fr	String
Adverse reaction system organ class: English	reaction_soc_en	Array
Adverse reaction system organ class: French	reaction_soc_fr	Array
Life-threatening	life_threatening	Logical (true/false)
Reporter type: English	reporter_type_en	String
Reporter type: French	reporter_type_fr	String
Sex: English	patient_gender_en	String
Sex: French	patient_gender_fr	String
Congenital anomaly	congenital_anomaly	Logical (true/false)
Number of drugs included in the report	n_drugs_per_report	Number
Detailed drug information	report_drug_detail	Nested array
Age unit: English	patient_age_unit_en	String
Age unit: French	patient_age_unit_fr	String
Indications for all drugs included in the report: English	report_indication_en	Array
Indications for all drugs included in the report: French	report_indication_fr	Array
Brand name of suspect product(s)	report_drugname_suspect	String
Other medically important condition	other_medically_imp_cond	Logical (true/false)
Active ingredient of suspect product(s)	report_ingredient_suspect	Array
Brand name of concomitant product(s)	report_drugname_concomitant	Array
Active ingredient of concomitant product(s)	report_ingredient_concomitant	Array
Linked report details	report_links	Nested array

*reactions* Nested array: Objects in this array provide details on the reaction(s) listed in the report
Value logical name	Value physical name	Data type
Adverse reaction term: English	pt_name_en	String
Adverse reaction term: French	pt_name_fr	String
Reaction identifier	reaction_id	Number
System organ class: English	soc_name_en	String
System organ class: French	soc_name_fr	String
MedDRA version	meddra_version	String

*report_drug_detail* Nested array: Objects in this array provide details about the drug(s) listed in the report
Value logical name	Value physical Name	Data type
Adverse event reaction number plus version number	aer_id	Number
Brand name	drugname	String
Adverse reaction report number (6 digits)	report_id	Number
Suspect product identifier	product_id	Number
Active ingredient name	ingredients	String
Product record identifier	seq_product	Number
Therapy record identifier	seq_therapy	Number
Dose unit: French	dose_unit_fr	String
Dosage form: French	dosageform_fr	String
Dose unit: English	dose_unit_eng	String
Dosage form: English	dosageform_eng	String
Health product role: French	druginvolv_fr	String (concomitant/drug used to treat adverse effect/suspect)
Route of administration: French	routeadmin_fr	String
Dose	unit_dose_qty	Number
Health product role: English	druginvolv_eng	String (concomitant/drug used to treat adverse effect/suspect)
Route of administration: English	routeadmin_eng	String
Dosage form code	dosageform_code	String
Drug product identifier	drug_product_id	String
Health product role code	druginvolv_code	String
Route of administration code	routeadmin_code	String
Therapy duration	therapy_duration	Number
Frequency unit: French	freq_time_unit_fr	String
Frequency time: French	frequency_time_fr	String
Frequency unit: English	freq_time_unit_eng	String
Frequency time: English	frequency_time_eng	String
Indication: French	indication_name_fr	String
Frequency unit code	freq_time_unit_code	String
Indication: English	indication_name_eng	String
Therapy duration: French	therapy_duration_fr	String
Therapy duration: English	therapy_duration_eng	String
Therapy duration code	therapy_duration_code	String

*report_links* Nested array: Objects in this array provide details about the linked/duplicate report(s)
Value logical name	Value physical name	Data type
Record type: English	record_type_en	String (duplicate/linked)
Record type: French	record_type_fr	String (duplicate/linked)
Report link identifier	report_link_id	Number
Duplicate or linked adverse reaction report number	report_link	String

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Date modified:: 2022-06-20

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