Adverse Effects

1. Patient Identifier:  2. Date of Birth:  3. Sex: Male    Female  4. Weight (indicate lbs or kgs):

Reporter

1. Name:* Address:* Phone:* Email:* 2. Health professional?:  Yes     No 3. Occupation: * Required Fields

Adverse Events | Medication/Herb/Supplement Section | Back to Top

Adverse Event Or Product Problem Information

1. Adverse event and/or product problem: 2. Outcomes attributed to adverse event: a. Death b. Life threatening c. Hospitalization Initial     Prolonged (more than two days) d. Disability e. Congenital anomaly f. Required intervention to prevent permanent impairment/damage g. Other (describe) 3. Date of event: (mo/day/yr) 4. Date of this report: (mo/day/yr) 5. Describe event or problem: 6. Relevant tests/laboratory data, including dates: 7. Other relevant history, including preexisting medical  conditions (e.g., allergies, race, pregnancy, smoking and alcohol use, hepatic/renal  dysfunction, etc.)

Adverse Events | Medication/Herb/Supplement Section | Back to Top

Suspect Medication(s)/Supplements/Herbs

1. Name: a. Labeled Strength b. Mfr/Labeler, If Known 2. Dose Frequency & Route Used a. Dose Frequency b. Route Used 3. Therapy Dates 4. Diagnosis for use (indication) 5. Event abated after use stopped Yes   No   Doesn't apply Dose Reduced Yes   No   Doesn't apply 6. Lot # (if known) 7. Exp. Date (if known) 8. Event reappeared after reintroduction Yes   No   Doesn't apply 9. NDC # (for product problems only) if applicable 10. Concomitant medical products and therapy dates (exclude date of treatment)

Adverse Events | Medication/Herb/Supplement Section | Back to Top