Patient Information Patient Name or Initial Age Age Group SelectElderlyAdultPediatric Gender SelectMaleFemale Suspeucted Product Information Trade Name/Generic Name & Strength Indication Dose Route Frequency Duration Date Batch No. Adverse Event Information Adverse Event Description Adverse Event Description 2 Adverse Event Description 3 Event Onset Date Event Onset Date 2 Event Onset Date 3 Event End Date Event End Date 2 Event End Date 3 Outcome SelectRecoveredRecoveringNot RecoveredUnknownFatalRecovered w/ sequelae Outcome 2 SelectRecoveredRecoveringNot RecoveredUnknownFatalRecovered w/ sequelae Outcome 3 SelectRecoveredRecoveringNot RecoveredUnknownFatalRecovered w/ sequelae Causality SelectRelatedNot RelatedNot Reported Causality SelectRelatedNot RelatedNot Reported Causality SelectRelatedNot RelatedNot Reported Treatment Medication, Diagnostic & Lab Values (associated with adverse event(s)) Diagnostic & Lab Values Action Taken: What happened after adverse reaction? Action Taken: What happened after adverse reaction? SelectDrug discontinuedDose reducedDose increasedDosage maintainedUnknown Seriousness Seriousness SelectUnknownSeriousNon-Serious If serious indicate event seriousness criteria: Select CriteriaPatient diedLife threateningPermanent disabilityHospitalizationProlonged hospitalization more than 24 hoursCongenital anomalyRequired intervention to prevent permanent impairment/damageRequired Emergency Room (ER) visitOther Death Date Concomitant Drugs Were any concomitant drugs taken? Yes No Concomitant Drug Name Concomitant Drug Name 2 Concomitant Drug Name 3 Indication Indication 2 Indication 2 Dose/Route/Frequency Dose/Route/Frequency 2 Dose/Route/Frequency 3 Start Date Start Date Start Date End Date End Date 2 End Date 2 Reporter Information Reporter name: Profession (Specialty): Address: E-mail: Phone/Mobile: Fax: Country Date: * Mandatory fields Submit
