VigiCarib Reporting Form - Confidential v2

VigiCarib Reporting Form for suspected Adverse Drug Reactions or Substandard / Falsified / Unregistered Medical Products
Today's Date

Month Day Year
Date
Type of Report *

ADR: Suspected Adverse Drug Reaction SFU: Substandard / Falsified / Unregistered (SF) medical product
Non-proprietary name *
E.g. Acetaminophen
Brand name (where applicable)
E.g. Panadol
Dosage form *
Strength (include units)
E.g. 800mg
Anatomic-Therapeutic-Chemical Classification
Manufacturer name *
Batch / Lot Number and Expiry Date (mm-yyyy) *
Description of Adverse Reaction or Product Quality Issue and Sector *
Please indicate if the event or issue was identified in Public or Private sector; and where the product is usually distributed
Patient Initials *
If you are reporting a suspected SF product where a patient has been harmed, create a new report for the ADR and patient details.
Patient Sex *
Patient Age (in years) *
Age Group
Race / Ethnicity
Weight (kg)
To convert from pounds (lbs) to kilograms, multiply by 0.4536
Height (cm)
To convert from inches to centimeters, multiply by 2.54
Dosage Regimen of suspected medicine
Indication
Start Date

Month Day Year
Date
Stop Date

Month Day Year
Date
Other Medicines used within 3 months of reported medicine - indication for each
Enter as much information as possible based on availability
Reaction Onset Date

Month Day Year
Date
Reaction End Date

Month Day Year
Date
Was Treatment Given or Action Taken?
If treatment was given, or Action taken, briefly describe here:
Action may include contacting the manufacturer, product seizure, market suspension / withdrawal.
Seriousness of Adverse Reaction
Outcome of Adverse Reaction
If patient recovered, please provide the Recovery Date

Month Day Year
Date
If patient died, please indicate date of death

Month Day Year
Date
Did event subside after stopping the medicine or reducing dosage?
Did event reappear after reintroducing the medicine or dosage?
Other Relevant Information
Country where product was used or discovered *
Local Report Date

Month Day Year
Date stated by initial observer/reporter
Please insert any photos of the substandard / falsified / unregistered product, and its label

Browse Files
If only the packaging / label is available, please upload the photos here. Cancel of
PV Record Number
Record number used by national or regional PV centre
Status of Case
SFU Category (primary)
Report has been submitted to:
Please indicate if the report has been submitted to any of the WHO international monitoring systems or the national regulatory authority.
Reporter Name or Alias *
Your Role
Institution or Company Name *
For additional information, we ask that you provide a contact (name & email or phone)
For VigiCarib staff: Record number
Format: CountryYear_### (ADR) or CountryYear_SF### (SFU) e.g. TTO2020_005, or TTO2020_SF002.
Should be Empty:

VigiCarib Reporting Form for suspected Adverse Drug Reactions or Substandard / Falsified / Unregistered Medical Products