Suspected Adverse Event Reporting Form

Suspected Adverse Event Reporting Form

Step 1

Step 2

Step 3

Step 4

A. Patient and Hospital Information

Name of the hospital

Patient name

Gender:

Male

Female

Age

Weight (kg)

Pregnant

Yes

Unknown

Not Applicable

B. Suspected Adverse Event Information

B1. Type of event

Adverse drug reaction

Product quality problem

Medication error

B2. Suspected product

Brand name

Generic name

Indication

Start date

End date

Batch/Lot number

Manufacture

Dose (strength, unit)

Doses Form

Frequency

B3. Description of the event

Event start date

Event reported date

Event stop date

Was the adverse event treated?

Yes

If yes, please specify

Action taken after the reaction

Dose stopped

Dose reduced

No action taken

B4. Seriousness of the adverse event

Not serious

Hospitalization or prolongation of hospitalization

Disability or permanent damage

Congenital anomaly or birth defect

Life threatening

Other serious

Death

B5. Outcome attributed to adverse event

Recovered

Recovered/Resolved with sequela

Not recovered

Unknown

Fatal

B6. Other relevant history

C. Other Concominant Product Information

Brand Name	Generic Name	Indication	Dosage form	Route	Dose	Frequency	Date Started	Date Stopped

D. Reporter Information

Name

Designation

Mobile

Address