Demonstration system — not validated. Do not enter real patient or reporter data.

Built to show how intake, duplicate detection and timeliness tracking would work. A production system requires validation, authenticated access, an immutable audit trail, backup and retention controls before any live case is entered.

Report a suspected side effect

You do not need to be certain the medicine caused the problem, and you do not need to complete every box. A report that arrives today is worth far more than a complete report that never arrives.

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Reporter Information

Required

Your name *

Phone / WhatsApp *

You are a *

How this is being sent

State

Country

Date you became aware *

This starts the reporting clock — Day 0. Submission due —.

Patient Information

Required

Patient initials *

Never the full name.

Age

Sex

Weight (kg)

Pregnancy status

Ethnicity

Product Information

Required

Product name *

Manufacturer

Batch / lot number

Dose

Route of administration

Dosage form

Indication for use

Therapy start date

Therapy stop date

Adverse Reaction

Required

Describe the problem in the reporter's own words *

Write what was actually said. Do not convert it into a diagnosis.

MedDRA preferred term

Outcome

Onset date

Stop date

How serious *

Serious sets a 15-day clock. Non-serious sets 90 days.

If serious, why

Causality assessment

Action taken with product

Dechallenge

Rechallenge

Everything else is optional. Leave it blank rather than delaying the report. The pharmacovigilance team will follow up for anything missing.

Medical History, Concomitant Medication & Laboratory Results

Optional

Relevant medical history

Concomitant medication

Laboratory results

Anything else

Regulatory Information

Optional

Report type

Regulator

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