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Home » Adverse Event Reporting
Patient Initials*
Age*
Weight*
Country*
Date of Birth*
Sex* FemaleMale
Pregnant* YesNo
Tel No*
Date of Event*
Date of Report*
Description of adverse events*
Seriousness of Event* DeathInitial or Prolonged HospitalizationLife threateningInvolved persistent or significant disabilityCongenital anomalyMedically significant & other important condition
Lab test details(with dates, results & normal range)*
Other relavant history including pre-existing medical conditions*
Outcome of event* RecoveredRecoveringNot RecoveredRecovered with sequelaeFatalUnknown
Name of Drug*
Dosage*
Dose*
Indication*
Route of Administration*
Strength*
Frequency*
Exp Date*
Drug Discontinues?* YesNo
Start Date*
Stop Date*
Batch Number*
Additional suspect drug(if any) detais as above:*
Concomitant medications (provide with details)*
Name*
Address*
Tel no*
Email*
Occupation*
Also reported to* Regulatory authorityDistributorNone
Date*
Sign*
Date received:*
Name & sign of reciever*
Internal Assessment No*
