Today's Date
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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
*
Patient Initials (& Record number, if available)
*
Patient Sex
*
Female
Male
Not given
Patient Date of Birth (preferred) or Age
*
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
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Month
-
Day
Year
Date
Stop Date
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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
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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 / UNK
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
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Month
-
Day
Year
Date
Outcome of Adverse Reaction
Fatal
Not Recovered
Recovering
Recovered
Unknown
If patient recovered, please provide the Recovery Date
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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
Please insert any photos of the SF product and/or label that you are reporting
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of
Reporter Initials
*
Profession or Role
Focal point
Nurse
Pharmacist
Physician
Other health professional
Patient / caregiver
Other
Health Institution
*
Country
*
For additional information, we ask that you provide a contact (name & email or phone)
Local Report Date
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Month
-
Day
Year
Date stated by initial observer/reporter
Local Record Number
Record number used by national or regional PV centre
Case status
To be sampled or collected
Sample sent for confirmation
Manufacturer contacted
Market suspension
Market withdrawal (de-registered)
Reported to regulatory authority
None / Unknown
You may add additional details under 'Other Relevant Information'
Causality Assessment or SF Category
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