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ADVERSE DRUG REACTION REPORTING/ PRODUCT COMPLAINT FORM
PATIENT DETAILS
Name/Folder Number
Age
Date Of Birth
What is your gender?
Male
Female
Phone Number
Hospital/Treatment Center
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Details of Adverse Reaction and treatment given
Date reaction started
Date reaction stopped
OUTCOME OF ADVERSE REACTION
Recovered
Yes
No
Not yet recovered
Yes
No
Unknown
Yes
No
Did the adverse reaction result in any untoward medical conditions?
Yes
No
If yes specify
SERIOUSNESS
Death
Yes
No
Life threatening
Yes
No
Disability
Yes
No
Hospitalization
Yes
No
Others (Specify)..
SUSPECTED PRODUCT/ DEVICE
Brand name
Generic name
Batch no
Expiry date
Manufacturer
Reason(s) for use (Indication)
Daily dose
Route of Administration
Date started
Date stopped
Did the adverse reaction subside when the drug was stopped (de - challenge)?
Yes
No
Was the product prescribed ?
Yes
No
Source of Drug
Was product re - used after detection of adverse reaction (re - challenge)?
Yes
No
CONCOMITANT DRUGS INCLUDING HERBAL MEDICINES TAKEN PRIOR TO THE ADVERSE REACTION
Name of Drug
Daily dose
Date started
Date stopped
Reason(s) for use
Did adverse reaction re-appear upon re-use?
Yes
No
REPORTER DETAILS
Your Name
Profession
Address
Phone Number
Your Email
Date
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