VigiCarib Reporting Form for suspected Adverse Drug Reactions or Substandard / Falsified / Unregistered Medical Products
Type of Report
ADR: Suspected Adverse Drug Reaction
SFU: Substandard / Falsified / Unregistered (SF) medical product
Brand name (where applicable)
Oral solution or suspension
Strength (include units)
Alimentary tract & metabolism
Blood and blood-forming products
Genitourinary and Sex Hormones
Antineoplastics / immunomodulators
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
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 Age (in years)
Race / Ethnicity
African / Black
To convert from pounds (lbs) to kilograms, multiply by 0.4536
To convert from inches to centimeters, multiply by 2.54
Dosage Regimen of suspected medicine
Other Medicines used within 3 months of reported medicine - indication for each
Enter as much information as possible based on availability
Reaction Onset Date
Reaction End 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
Caused or prolonged hospitalisation
Persistent or significant disability or incapacity
Outcome of Adverse Reaction
Fatal (Patient died)
If patient recovered, please provide the Recovery Date
If patient died, please indicate date of death
Did event subside after stopping the medicine or reducing dosage?
Not Applicable (medicine continued)
Did event reappear after reintroducing the medicine or dosage?
Not applicable (not reintroduced)
Other Relevant Information
Country where product was used or discovered
Local Report Date
Date stated by initial observer/reporter
Please insert any photos of the substandard / falsified / unregistered product, and its label
If only the packaging / label is available, please upload the photos here.
PV Record Number
Record number used by national or regional PV centre
Status of Case
SFU Category (primary)
Report has been submitted to:
UMC / VigiFlow
National regulatory authority
None of the above
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
Regulatory Focal point
Other health professional
Patient / caregiver
Pharma PV Officer
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: