Suspected Drug Adverse Event (Side Effect) Reporting Form for Non-Healthcare Professionals

Name of Suspected Drug Product

Nature of Event
Please tick () the box(es) as applicable
Adverse event (Side effect)
Lack of drug efficacy
Drug overdose
Drug misuse
Unintended use while being pregnant / lactating / breastfeeding
Other   

Patient Details
Patient Name or Initials

Gender
Male    Female    Other

Date of Birth

Age
  Years       Months

Age Group
Neonate
Infant
Child
Adolescent
Adult
Elderly

Weight (kgs.)
  Kg.

Height (cms.)
  cms.

Hospital Ref. No.

If female, is the patient pregnant?
Yes    No
If 'Yes',   
   

Description of the Event
Sr.
Event
Date Started
Date Stopped
Whether Ongoing
 1.
Yes    No
 2.
Yes    No
 3.
Yes    No
 4.
Yes    No
 5.
Yes    No
Present Status
What is the present status / outcome on this day of reporting?
Completely recovered
Recovering
Ongoing
Death
Unknown
Other   

Suspected INTAS Drug Details
Sr
Drug Name, Strength, Pharmaceutical Form
Brand Name
Condition / Symptom for which it was given
Details of Dosing
Route of Administration
 1.
 2.
History of the Suspected INTAS Drug Given (as listed above)
Sr
Date Started
Ongoing?
Date Ended
Lot No. / Batch No.
Expiry Date
 1.
Yes    No
 2.
Yes    No
Other Medication Given with the INTAS Drug, If Known
Sr
Drug Name, Strength, Pharmaceutical Form
Brand Name
Condition / Symptom for which it was given
Details of Dosing
Route of Administration
 1.
 2.
 3.
 4.
Additional Relevant Information, If Known
Any Other Disease or Allergy
Yes    No
If 'Yes', please specify   

Reporter Details
Full Name

Address

PIN Code

Country

Email address

Tel. No. (with STD code)