VIGILANCE REPORT FORM
ADVERSE EVENT REPORT
To turn over imperatively to the Vigilance Department Fax: + 380445662203, e-mail:
[email protected]
Reception date :
_________________________
DECLARATION DATE :
_________________
TRANSMITTER: ☐ DOCTOR
☐
CALL DATE TO THE DEPARTMENT: _________________
PHARMACIST
☐ PATIENT ☐ OTHER
(specify) ..................................
Mr
Mrs
Ms
Address :
Zip Code:
Country :
Phone:
Fax:
Email :
Tampon and Signature
PATIENT :
Initials :
Sex :
Weight :
☐
☐
F
☐ Pregnancy
Height :
M
Age at the event :
☐ Lactation
Birthdate :
ADVERSE EVENT REACTION (NAME) :
Time of appearance after 1st use of the drug
(hours, days, years) :
Resolved date:
Date of onset :
Duration of the event :
Symptoms description :
Intensity :
☐
weak
☐ moderate
☐ strong
1/4
SERIOUSNESS:
☐ yes
☐
no
If yes,
☐ Other medically important event
☐ Congenital anomaly
☐ Involved or prolonged patient hospitalisation
☐ Involved persistence or significant disability or incapacity
☐ Life threatening
☐ Death
SUSPECT DRUG (NAME) :
Pharmaceutical form :
Strenght :
Indication :
Route of administration :
Batch number :
Dose
Daily dose
Unit (mg. g)
Therapy dates
Start :
Number of units per day :
Stop :
Duration :
Did treatment stop?
Disappearance of the effect due to treatment stop :
No disappearance :
No interpretable information :
Treatment followed with dose reduced
Disappearance of the effect:
No disappearance :
No interpretable information :
Treatment followed with no change
Treatment reintroducted ?
Did reaction reappear after reintroduction :
No reintroduction or no interpretable information :
Corrective treatment :
☐ yes
☐ yes
☐ yes
☐ yes
☐ yes
☐ yes
☐ yes
☐ yes
☐ yes
☐ yes
☐ yes
☐ yes
☐ yes
Which dose :
☐ no
☐ no
☐ no
☐ no
☐ no
☐ no
☐ no
☐ no
☐ no
☐ no
☐ no
☐ no
☐ no
Lequel :
2/4
CONCOMITANT DRUG(S) :
☐ yes
☐ no
☐ Unknown
If yes :
Product
Indication
Start of treatment
(dd/mm/yy)
Ongoing
(yes / no)
Stop of treatment
(dd/mm/yy
Posology
Comments :
ANTECEDENTS OF THE PATIENT AND FACTORS OF RISK :
Personnal :
Family :
MEDICAL EXAMINATIONS
(blood, radiography, etc)
☐ yes
☐
no
If yes, which :
Results :
OUTCOME :
☐ Unknown
☐ Improved
☐ Resolved with sequelae
precise the date :
3/4
☐ Resolved
☐ Ongoing
☐ Death related to event
☐ Death possibly related to event
☐ Death not related to event
precise the date :
RELATION BETWEEN DRUG AND ONSET REACTION :
☐ Excluded
☐ Unlikely
☐ Probable
☐ Possible
☐ Certain
COMMENTS:
Fax imperatively this report form to the Vigilance Department :
Fax: + 380445662203, e-mail: [email protected]
Received by Vigilance Department on:
___________________________
4/4