Please provide at least one piece of information regarding the patient's data.
Initials Date of birth or age Weight (kg) Height (cm)
Sex FemaleMale
Please provide the full name and telephone number or email address of the reporting person.
Last and first name Address (street, city, country)
Phone number Email Reporter Qualification PhysicianPharmacistAuthor of medical publicationOther healthcare professionalNon-healthcare professionalPatient Reported to medicine regulatory authorities YesNo
Description of adverse reaction/diagnosis. If no diagnosis, please provide symptoms.
Date of symptom onset Date of symptom resolution or duration Outcome RecoveredRecovered with sequelaeRecoveringFatalNot recoveredUnknown
Did the adverse reaction subside after discontinuation or dose reduction of the medicine? YesNoUnknown Did the adverse reaction recur after re-administration of the medicine? YesNoUnknownNot applicable
Is this a serious adverse reaction*? YesNo If yes, please select -Life-threateningHospitalization or prolongation of hospitalizationPersistent or significant disability or incapacityCongenital anomaly/birth defectOther medically important condition If 'Hospitalization' please provide date from Date to
If 'Death' please provide cause Date of death Was an autopsy performed? -YesNo Relationship of reported adverse reaction to product? Highly probableProbablePossibleUnlikelyNot relatedNot specified
*Serious adverse reaction means occurrence of: death, life-threatening, requiring hospitalization or prolongation of existing hospitalization, resulting in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
Name of the medicine and/or active substance Indication(s)
Batch number Expiration date Start date of administration End date of administration
Dosage, route of administration, pharmaceutical form Action taken with the medicine Dose increasedDose reducedMedicine withdrawnRe-administeredNo action takenUnknown
Name of the medicine or active substance Indication(s)
Dosage, form, route of administration Type of therapy* Start date of administration
End date of administration
*C - concomitant medication; T - treatment for adverse reaction; P - medicine withdrawn prior to the onset of the adverse reaction
SmokingAlcoholAllergy
