Adverse-event narrative generator
Draft a de-identified event chronology from structured facts. One free successful draft; reporter assessments stay separate from facts.
What this is not: a clearance, approval, consent, signed record or submission. Responsible professional review is required. Jurisdiction: US / EU reporting links; local reporting rules require review.
Structured information
Only de-identified, non-confidential information. No names, birth dates, contact details or patient record numbers. Examples are synthetic.
Provider: OpenAI via Agno and the AnswerThis backend. Use synthetic or de-identified non-confidential facts only. Brief retry caching applies. Inputs and drafts remain in this tab’s memory; reload clears them. Only the allowance and input hash are stored in your browser. Copy or download before leaving. Not a controlled clinical record system.
Build the supporting evidence
Copy or download your draft first. Signup opens the AnswerThis app and does not transfer this result.
How to use this workspace
- Prepare product, event and relative-day facts without identifiers.
- Enter structured information or load the synthetic example, then confirm the de-identification attestation.
- Draft the chronology and check every fact against the inputs.
- Review the result with its responsible owner and export it into the controlled project workflow.
What to check
- Source edition and local applicability are distinct from the date of your document.
- Use only supported facts; a blank does not establish a negative finding.
- Keep identifiers, population, document versions and evidence consistent.
- Review drafts in the responsible institution’s controlled system before use.
Prepare a de-identified chronology
Enter only the supplied facts in the labelled fields. The form accepts a product, dose and route, event terms, an onset day relative to first exposure, a duration, actions and outcome. Age is grouped into bands. Leave a fact blank when it is not available; do not convert uncertainty into a plausible estimate. For example, a synthetic report can describe headache on relative day 2 after a 10 mg oral dose, with a duration of 3 days and a reported recovery. The example is instructional and describes no real person.
Choose a consistent reference point for relative days before entering the event. The onset field uses first exposure as that reference. Duration is a length of time, not an end date, and the tool does not calculate either from patient calendar dates. Multiple terms in the event field refer to the same supplied timing. Separate events with different onset times require separate controlled case documentation outside this single-chronology form. Do not compress a complicated history into one timing field and expect the generator to reconstruct the sequence.
The attestation applies to indirect identifiers as well as names. Rare events, locations and combinations of attributes can reveal a person even without a record number. Use the example to understand the form before entering any non-confidential material. No narrative upload or patient-history text box is provided. Input screening catches common identifiers and calendar-date patterns, but it is not a de-identification service.
Understand the constrained drafting step
Agno with OpenAI drafts two to four short prose paragraphs covering exposure, onset in relative days, course and actions, and the supplied outcome. Controlled prose preserves every supplied field verbatim. A deterministic check verifies the chronology and rejects new numbers, dates, clinical terms, products, outcome words, changed associations or omitted facts. If drafting or validation fails, the page says “AI narrative unavailable; structured listing shown” and provides only the supplied structured facts without using the free run. The structured listing also accompanies a successful narrative for comparison.
Reporter assessments have their own optional fields. When supplied, causality, seriousness, expectedness and reporting obligations appear separately as quoted reporter-assessed statements. The generator does not decide whether those assessments are correct and does not infer missing assessments from an outcome or an action. Product withdrawal followed by recovery does not, by itself, justify a causal conclusion in the generated document.
The guard checks fidelity to the supplied inputs, not truth about the event. Incorrect information entered into a field can still be copied faithfully. A responsible reviewer must reconcile the chronology with authorised source documentation in the appropriate system. The tool does not perform medical coding, duplicate detection, follow-up management, case validity assessment or regulatory clock calculations.
Review and use official reporting channels
Read the entire draft against the structured input before copying it. Check dose units, administration route, the onset reference point, duration, event spelling and whether the stated outcome is final or still uncertain. Editing is free, but edited prose is marked as requiring review and is not revalidated by the model guard. Keep the draft warning with exports so that a downstream reader can distinguish the working narrative from an approved case record.
The Markdown download preserves the draft as readable text. Rich copy and the Word-compatible HTML export preserve headings for an editor that supports them; neither is an electronic individual case safety report. FDA MedWatch and the EMA page for national suspected-side-effect reporting are linked in the source panel. Use the appropriate official reporting route under responsible professional guidance. This page neither submits a report nor determines which route, obligation or deadline applies.
Structured inputs are sent through the AnswerThis generator backend to OpenAI via Agno for this task. The service retains quota metadata and briefly caches request responses for retry handling; this page offers no controlled clinical storage. Do not send sensitive or confidential information. Copy an allowed draft before navigating away: signup opens a separate app and does not transfer the result or unlock additional runs on this page.
Sources, versions and jurisdiction
Jurisdiction: US / EU reporting links; local reporting rules require review. Source review as of 2026-09-14. Source retrieval: 2026-09-13T22:50:11Z (editorial review, not a live document lookup). No agency endorsement. Original concise outlines with links; source documents remain the work of their respective owners. ICH materials © ICH; prompts are adapted summaries, not official templates.
- ICH E3 — 1995-11-30
Chronology context: ICH E3 §12.3.2; this page does not determine whether a narrative or report is required. Official reporting: FDA MedWatch and EMA national suspected-side-effect reporting.
Frequently asked questions
What is the relative-day reference point?
Onset is relative to first exposure. Use a consistent reference point in the supplied facts. The single onset field does not represent separate timelines for several events; prepare separate cases when their reference points differ.
How are reporter assessments handled?
Causality, seriousness, expectedness and reporting obligations are quoted as supplied assessments. Preserving their wording does not validate medical truth or establish a reporting decision.
What happens when the chronology fails its fact check?
The service can return an uncharged structured fallback for review. It is not a successful validated narrative; inspect the supplied fields and any missing or contradictory facts before retrying.
Can I edit the narrative?
Yes, through the Markdown editor. Later edits are not checked against the original fields. Review every fact, export the draft and use the responsible case-review workflow.
Can I enter patient records or confidential information?
No. Use only de-identified, non-confidential information. Do not enter names, birth dates, contact details, record numbers, signed forms or source records. The tools do not de-identify records for you.
How many free runs are included?
This page includes one successful free input set per browser. Failed requests and re-exporting a result are free.
Does signup transfer my work or unlock more page runs?
Signup opens the AnswerThis app. It does not unlock more runs here or transfer your draft. Copy or download the result first.