ADVERSE REACTION REPORTING FORM
Pharmacovigilance
A. PATIENT DETAILS
Age
Date of Birth
Gender
Male
Female
Weight(kg)
Name / Folder Number
Phone
Hospital / Treatment Centre
B. DETAILS OF ADVERSE REACTION AND ANY TREATMENT GIVEN
Enter those details here
Date reaction started
Date reaction stopped
C. OUTCOME OF ADVERSE REACTION
Select an outcome
Recovered
Not yet recovered
Unknown
Did the adverse reaction result in any untoward medical condition
Yes
No
Seriousness
Death
Life threatening
Disability
Hospitalisation
Others
For others, specify
D. SUSPECTED PRODUCTS
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
Did adverse reaction re-appear upon re-use?
Yes
No
E. CONCOMITANT DRUGS INCLUDING HERBAL MEDICINES TAKEN PRIOR TO REACTION
Name of drug
Daily dose
Date started
Date stopped
Reasons for use
F. REPORTER DETAILS
Name of Reporter
Profession
Address
Phone
Email
Date
Signature
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