Reporting Date *
First Name *
Family Name *
Institution
Department
Mobile / Phone number *
Fax
E-mail
Reporter Qualification(Profession) PharmacistPhysicianNurseDentistPatient / relativesOthers
Please specify
Is the case medically confirmed YesNo
Initial *
Date of Birth*
Age at time of onset
Sex * MaleFemale
If Female (date of last menstruction)
Past medical history
Current medical condition
Name
Indication
Date From
Date To
Free Text
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Test
Date
Result
Unit
Seriousness —Please choose an option—SeriousNon-serious
If Serious Results in deathIs life threatening, or places the participant at immediate risk of death from the event as it occurredRequires hospitalization or prolongs hospitalizationCauses persistent or significant disability or incapacityResults in congenital anomalies or birth defectsIs another condition which investigators judge to represent significant hazards
Onset Date
End Date
Duration
Reaction/ event as reported by primary source ( reporter )
Treatment of reaction YesNo
Outcome of reaction RecoveredResolved
Expectedness
Seriousness SeriousNon-serious
Pharmaceutical Form
Rout of administration
Dosage regimen ( dose /time)
Start of administration
End of administration
All administration duration
Action Taken
Did the Adverse Drug Reaction (ADR) stopped after stopping ( reducing ) the drug ( Dechallenge ) YesNoNA
Did the reaction reappear after Rechallenge YesNoNA
Country
Company name
