Adverse Event Reporting Form

Patient Information
Patient Name or Initial * Age * Age Group Gender *
Suspeucted Product Information
Trade Name/Generic Name & Strength* Indication Dose Route
Frequency Duration Date Batch No.
Adverse Event Information
Adverse Event Event Onset Date Event End Date Outcome Causality
Treatment Medication, Diagnostic & Lab Values (associated with adverse event(s))
Action Taken: What happened after adverse reaction?

Seriousness
Concomitant Drugs
Were any concomitant drugs taken?
Concomitant Drug Name * Indication* Dose/Route/Frequency* Start Date* End Date*
Reporter information
Reporter name * Profession (Specialty) Address E-mail
Phone / Mobile * Fax Country* Date