Complementary Medicine Product Adverse Event/Safety Incident Note

Date/Time: [date and time of documentation]

Author/Role: [author name, credentials, role]

Patient: [name, DOB, MRN]

Reason for Note: [Suspected adverse event / Product quality problem / Use error / Other safety concern]

Suspect Product(s)

(Repeat for each suspect product. Use "Unknown" for unavailable data rather than omitting fields.)

Product Name: [brand name as labeled]

Category: [dietary supplement / herbal / homeopathic / traditional medicine / probiotic / other]

Ingredients: [transcribe from label; include botanical names and extract ratios if listed]

Dose/Form: [strength, formulation, route]

Manufacturer/Lot: [manufacturer]; [lot/batch number]; [expiration]

Source: [retail store / online / practitioner / other]

Product Available: [Yes / No]; Photos Obtained: [Yes / No]

Exposure Details: Start [date]; Stop [date]; Dose [amount]; Frequency [schedule]; Duration [timeframe]. (Note any dose change, overdose, or rechallenge with outcome.)

Event Description

[Chronological narrative of the event] (Include baseline status before exposure, symptom onset timing relative to first dose, symptom progression, pertinent exam findings and vitals, relevant labs/imaging with dates, treatments and response, and current status. For product quality or use error, describe the issue and circumstances.)

• Concomitant medications/supplements: [list with doses] (Flag high interaction risk: anticoagulants, serotonergic agents, narrow therapeutic index drugs.)
• Medication reconciliation: [Complete / Incomplete—pending items]

Assessment

Primary Event: [suspected clinical syndrome and relationship to suspect product(s)]

Seriousness: (Select all that apply per FDA serious adverse event definitions.)

• Death: [Yes / No]
• Life-threatening: [Yes / No]
• Hospitalization (initial or prolonged): [Yes / No]
• Persistent/significant disability: [Yes / No]
• Congenital anomaly/birth defect: [Yes / No]
• Required intervention to prevent permanent impairment: [Yes / No]
• Other medically important event: [Yes / No]

Seriousness Justification: [brief factual justification]

Causality (WHO-UMC): [Certain / Probable-Likely / Possible / Unlikely / Conditional / Unassessable] — [justification addressing temporal plausibility, alternative causes, and dechallenge/rechallenge if applicable]

Differential: [key alternative explanations considered]

Plan

Actions Taken:

• Product discontinued: [Yes / No]; Date: [date]
• Poison control contacted: [Yes / No]; Reference #: [number]
• Specialist consult(s): [service and date]
• Product retained/quarantined: [Yes / No]; Location: [location]
• Label/packaging photos obtained: [Yes / No]

Counseling: [summary of discussion] (Address causality uncertainty, re-exposure risks, red-flag symptoms, and instruction to disclose supplement use to all clinicians.)

Reporting Status: [Not indicated / Considered / Completed] — (If completed: destination and tracking number. If deferred: reason and plan to revisit.)

Follow-up: [timeframe, planned monitoring, pending documentation tasks]