Suspected Adverse Drug Event Reporting Form
PATIENT INFORMATION
1. Patient Name :
*
2. Patient Id # :
3. Sex :
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MALE
FEMALE
If Pregnant :
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YES
NO
Trimester :
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1
2
3
4. Age (years) :
5. Weight (kgs) :
6. Allergies :
7. Liver/ Kidney Dysfunction :
PRODUCT INFORMATION
1. Batch No :
2. Product & Strength Name :
*
3. Route :
4. Therapy Dates :
5. Dose :
6. Indication :
7. Did reaction stopped after stopping :
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YES
NO
(changed Dose, please specify dose) :
8. Did the reaction reappear after drug was reintroduced :
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YES
NO
9. Product available for evaluation :
*
---SELECT---
YES
NO
EVENT INFORMATION
1.Date of Onset :
2. You consider the problem related to which of the following :
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ADVERSE EVENT/ REACTION
QUALITY PROBLEM
MEDICATION ERROR
OTHER
Other :
3. OutCome :
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FATAL
UNKNOWN
RECOVERD
RECOVERING
OTHER
Other :
5. Do you consider this event serious :
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YES
NO
If yes please indicate why ?
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PATIENT DIED DUE TO REACTION
LIFE THREATENING
CAUSED DISABILITY/ INCAPACITY
INVOLVED/ PROLONGED INPATIENT HOSPITALIZATION
4. Describe the event with relevant lab tests or any data known :
*
OTHER DRUG/ ALTERNATIVE MEDICINE AND HISTORY
1. Concomitant Drugs used
(if any) (exclude those used to treat reaction) :
2. Other Relevant History
(diagnostics, lab tests,etc) :
REPORTER INFORMATION
1. Reporter’s Name :
*
2. Contact Number :
*
3.Email :
*
4. Affiliation :
5. Profession :
*
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PHYSICIAN
PHARMACTIST
NURSE
PATIENT
OTHER
Other :
6. Mailing address :
*
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