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English (US)
VigiCarib Reporting Form for suspected Adverse Drug Reactions or Substandard / Falsified / Unregistered Medical Products
Today's Date
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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
*
Capsule
Tablet
Oral solution or suspension
Injection
Topical
Device
Strength (include units)
E.g. 800mg
Anatomic-Therapeutic-Chemical Classification
Alimentary tract & metabolism
Blood and blood-forming products
Cardiovascular
Dermatological
Genitourinary and Sex Hormones
Systemic Hormones
Anti-infectives (systemic)
Antineoplastics / immunomodulators
Musculoskeletal
Nervous system
Anti-parasitic, insecticides
Respiratory
Sensory organs
Various
Other
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
*
Female
Male
Not given
Patient Age (in years)
*
Age Group
0-11 mths
1-11 yrs
12-17 yrs
18-44 yrs
45-64 yrs
65-74 yrs
75+ yrs
Not available
Race / Ethnicity
African / Black
Asian (Indo)
Asian (Other)
Mixed
White
Other
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
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Month
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Day
Year
Date
Stop Date
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Month
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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
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Month
-
Day
Year
Date
Reaction End Date
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Month
-
Day
Year
Date
Was Treatment Given or Action Taken?
Yes
No
Don't know
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
Not Serious
Caused or prolonged hospitalisation
Life-threatening
Congenital anomaly
Persistent or significant disability or incapacity
Death
Outcome of Adverse Reaction
Fatal (Patient died)
Not Recovered
Recovering
Recovered
Unknown
If patient recovered, please provide the Recovery Date
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Month
-
Day
Year
Date
If patient died, please indicate date of death
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Month
-
Day
Year
Date
Did event subside after stopping the medicine or reducing dosage?
Yes
No
Unknown
Not Applicable (medicine continued)
Did event reappear after reintroducing the medicine or dosage?
Yes
No
Unknown
Not applicable (not reintroduced)
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
Under investigation
Confirmed
Unknown
SFU Category (primary)
Substandard (suspected)
Substandard (confirmed)
Falsified (suspected)
Falsified (confirmed)
Unregistered
Report has been submitted to:
UMC / VigiFlow
WHO GSMS
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
*
Your Role
Regulatory Focal point
Nurse
Pharmacist
Physician
Other health professional
Patient / caregiver
Pharma PV Officer
Other
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.
Submit
Should be Empty: