VigiCarib Reporting Form - Confidential v2

Today's Date

Month Day Year
Date
Type of Report *

Adverse Medicine (Drug) Reaction (AMR/ADR) Substandard / Falsified / Unregistered (SF) medical product or Therapeutic Failure
Name(s) of Medicine - strength - formulation *
generic (brand name) E.g. acetaminophen (Tylenol)
Manufacturer name *
Batch or Lot Number - Expiry Date *
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 Date of Birth (preferred) or Age *
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
Medicine Dosage - Route - Frequency
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:
Seriousness of Adverse Reaction

Caused or prolonged hospitalization Life-threatening Congenital anomaly Persistent or significant disability or incapacity Death (provide date in next block) Not Serious
If patient died, please indicate date of death

Month Day Year
Date
Outcome of Adverse Reaction
If patient recovered, please provide the Recovery Date

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
Please insert any photos of the SF product and/or label that you are reporting

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Reporter Initials *
Profession or Role
Health Institution *
Country *
For additional information, we ask that you provide a contact (name & email or phone)
Local Report Date

Month Day Year
Date stated by initial observer/reporter
Local PV Record Number
Record number used by national or regional PV centre
Case status (Select all that apply)
You may add additional details under 'Other Relevant Information'
Causality Assessment or SFU Category / Other Notes
For VigiCarib staff: Record number
For VigiCarib staff: Report submitted to -
Should be Empty: