ADR Reporting Form

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PATIENT INFORMATION
Patient initials: File No:
Age: Weight(kg):
Sex: Male Female 
Date Of Birth: Height:
DETAILS OF ADVERSE DRUG REACTION OR PRODUCT QUALITY PROBLEM
I am reporting on: 1) an Adverse Drug Reaction  Date of onset of reaction:
2) a Product Quality Problem  Category: Medicine  Medicine Device 
Description of Adverse Drug Reaction or Product Quality Problem:
1. MEDICINES/ VACCINES/ MEDICAL DEVICES: Tick against the suspected medicine/ vaccine
Indicate all medicines the patient is taking
Tick Trade/ Generic Name & Batch Number Dosage & dosing frequency Route of administration Start date(dd/mm/yy) Stop date(dd/mm/yy) Reasons for use
ADVERSE DRUG REACTION OUTCOME: (Tick all that apply)
Outcome:  Death Life Threatening Disability Hospitalization Congenital Abnormality
Other (specify):
Recovered:  Yes No If YES, date of recovery:
Additional information (e.g. Relevant medical history, medicines taken in the last 28 days, allergies, previous exposure, baseline test results/ lab data)
2. PRODUCT QUALITY PROBLEM
Trade Name Batch Number Registration Number Dosage Form & Strength Expiry Date(mm/yyyy) Size/ Type of container
Product sample(s) have been submitted for evaluation:  Yes No Number of submitted samples:
DETAILS OF REPORTER
Name: Profession: Signature: Date (dd/mm/yyyy):
Contact address: Phone: Email: