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*

Country*

Occupation*

Also reported to*
Regulatory authorityDistributorNone