Date Of Awareness (DD/MM/YY)

Time of Awareness (h/min/s)

Type of Report Initial Followup

Followup on ID#

Initials (first, last)

Country

Date Of Birth (DD/MM/YY)

Sex (M/F)

Height (cm)

Weight (Kg)

For Female Patients: Pregnant? No Yes

Expected Delivery Date: (DD/MM/YY)

    

Medical History
(concomitant and past conditions, including allergies, risk factors, surgical procedures, alcoholic, smoker, hypertension etc.)

Suspect Drug

Batch Number

Expiry Date (DD/MM/YY)

Indication

Route Of Administration

Daily Dose

Regimen

Start Date (DD/MM/YY)

Stop Date (DD/MM/YY)

Action Taken with suspect drug: Maintained Permanently discontinued Temporarily discontinued then resumed Dose reduced Dose increased Unknown

Did event stop when suspect
drug was discontinued or dose reduced? Yes No Unknown

Did event reappear when
suspect drug was reintroduced? Yes No Unknown

Concomitant medication (excluding those treating the adverse event)

Drug Name	Indication	Route of Administration	Daily Dose	Regimen	Start Date (DD/MM/YY)	End Date (DD/MM/YY)

Drugs used to treat the event(s):

Drug Name	Indication	Route of Administration	Daily Dose	Regimen	Start Date (DD/MM/YY)	End Date (DD/MM/YY)

Onset Date(DD/MM/YY)

Resolution Date(DD/MM/YY)

Duration of event, if < 24h (h/min/s)

Adverse Event Full Description
(Please provide information of the event and procedure of treatment as described by reporter; including lack of efficacy, exposure during pregnancy, exposure via breastfeeding, exposure during conception, misuse, off label use, abuse, overdose, medication error, infectious agent transmission via a medical product, unexpected benefit)

Relevant Test Results

Therapeutic Measures

According to the reporter, was the event: Serious Not Serious

If serious, check all the appropritate to the event:
Death of Patient
Life threatening
Disability/Incapacity
Hospitalization needed
Hospitalization prolonged
Congenital anomaly/Birth defect
Other medically significant condition

Hospitalization admission date

Hospitalization discharge date (DD/MM/YY)

Date of Death (if died) (DD/MM/YY)

Outcome of Event Recovered Recovered with sequelae Recovering Not Recovered Fatal Unknown

Relation to Drug Related Unrelated Unknown

Is this adverse event(s) associated
with a product quality complaint: Yes No

If yes, Please describe the complaint:

Reporter’s Information

Name of reporter (first/last)

Reporter Details
If Health care professional (HCP) Specify

Reporter Details
If Other Specify

Permission to contact the HCP
(if different from reporter): Yes No

If Yes, please provide HCP details
Name and title of HCP

If Yes, please provide HCP details
Contact Details (Phone/E-mail)

Name and title of person
completing the form

Conact Details: Phone

Contact Details: E-mail

Contact Details: Address

Date of Submission (DD/MM/YY)