Unexpected Adverse Event Initial Report Form
Reporter Information
Name
Position
Contact Information
Date Reported
Patient Information
Patient ID
Age
Gender
Female
Male
Other
Relevant Medical History
Adverse Event Details
Event Date & Time
Description of Event
Severity
Mild
Moderate
Severe
Life-threatening
Action Taken
Outcome
Suspected Product/Drug Information
Product/Drug Name
Batch/Lot Number
Dose
Route of Administration
Date Started
Date Stopped (if applicable)
Other Relevant Information
Other Information