Adverse Event Reporting Form Step 1/5: Leave this field blank Patient Details: Patient’s Name Country Age/Date of Birth Weight in Kg. Height Sex Male Female Pregnancy Status Date of Adverse Event Seriousness Death Life Threatening Hospitalization- Initial /Prolonged Disability Congenital-anomaly Other Medically Important Required intervention to prevent permanent impairment/ damage Adverse Event Description Adverse Event Outcome Not Recovered Recovering Unknown Recovered with sequelae Recovered Fatal Recovered Date Date of Death Related Tests/ Laboratory data (If available) Other Medical History (Including Pre-existing Condition) Tests/ Laboratory Reports (If any) Choose file Uploading… (0%) Browse A file with this name has already been uploaded. This file type isn’t allowed. This file size is too big. Delete Delete Delete 0/3 Files uploaded Product Name For multiple products, please fill: ProductName1 , ProductName2 Batch/Lot No. For multiple products, please fill: Batch1, Batch2 Mfg. Date For multiple products, please fill: Mfg. Date1 , Mfg. Date2 Exp. Date For multiple products, please fill: Exp.Date1 , Exp.Date2 Dose and Frequency Therpay Start Date Therpay Stopped Date Reason for Use/ Indication Action taken after reaction Drug withdrawn Dose reduced Dose increased Dose continued Reaction abated after use stopped or dose reduced Yes No Not Applicable Reaction reappeared after reintroduction Yes No Not Applicable Product Name (optional) For multiple products, please fill: ProductName1 , ProductName2 Batch/Lot No. (optional) For multiple products, please fill: Batch1, Batch2 Mfg. Date (optional) For multiple products, please fill: Mfg. Date1 , Mfg. Date2 Exp. Date (optional) For multiple products, please fill: Exp.Date1 , Exp.Date2 Dose and Frequency (optional) Therpay Start Date (optional) Therpay Stopped Date (optional) Reason for Use/ Indication (optional) Name Profession Contact No. Country code + Phone number E-mail Address Date of Reporting Continue
