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Adverse Drug Reaction/Event Report

Classification of adverse reactions
Organization type/individual

Organization name

Department

Telephone

Report date

Patient name

Gender of patient

Date of birth

Ethnic group

Body weight (KG)

Contact information

Does he/she agree to the follow-up?
Does he/she have family drug adverse reaction/event?
Previous drug adverse reaction/event
Name of adverse reaction/event
The time of occurrence of adverse reaction/event
Medical record number/Clinic number (for enterprises, please fill in the hospital name)
Description of adverse reaction/event process (including symptom, sign, clinical examination, etc.) and handling:
Suspected drug

Generic name

Manufacturer

Batch number

Dosage and Administration

The start and end time of medication

Reason for medication

Concomitant medication

Generic name

Manufacturer

Batch number

Dosage and Administration

The start and end time of medication

Reason for medication

The outcome of adverse reaction/event
Preexisting medical Condition
The impact on the preexisting medical condition
Confirm and submit
Note：

1.The suspected drug is considered by the reporter to be the cause of adverse reaction. Concomitant medication is the use of other drug by the patient in combination with the suspected drug.

2.The patient information section on the form must be completed completely..

3.It is recommended to use the following format to describe the adverse reaction process: The patient took the drug of XX on XX DD XX MM XX YY as he/she had the disease of XX. He/she experienced the adverse reaction of XX at XX (related symptom, sign and related examination). The measures of XX were taken at XX. The adverse reaction disappeared or was relieved at XX (related symptom, sign and related examination).