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reporting-adverse-events

Structure adverse-event narratives into draft pharmacovigilance case reports.

5.0k|615|Updated Oct 4, 2025
Search Tags:#pharmacovigilance#e2b#drug safety#adverse events#faers#meddra#icsr
One-click install
npx skills add https://github.com/maziyarpanahi/openmed --skill reporting-adverse-events
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: reporting-adverse-events
Source: https://github.com/maziyarpanahi/openmed/tree/main/skills/reporting-adverse-events
Command: npx skills add https://github.com/maziyarpanahi/openmed --skill reporting-adverse-events

SYSTEM DOCUMENTATION & REQUIREMENTS

What problem does it solve?

This Skill converts unstructured adverse-event narratives into structured pharmacovigilance case drafts, reducing the manual effort required to prepare Individual Case Safety Reports while preserving traceability and regulatory context.

Core Features & Use Cases

  • E2B(R3) Structuring: Organize suspect and concomitant drugs, reactions, seriousness criteria, outcomes, and patient details into an ICSR-ready skeleton.
  • Safety Classification: Classify seriousness criteria, reaction outcomes, and drug characterization values for FAERS and related safety workflows.
  • MedDRA-Aware Coding: Preserve verbatim reaction terms for mapping to user-supplied MedDRA Preferred Terms without bundling or inventing licensed terminology.
  • Use Case: Turn a narrative describing a patient hospitalized after a suspected drug reaction into a de-identified, reviewer-ready FAERS or ICH E2B(R3) draft.

Quick Start

Use the adverse-event reporting skill to de-identify the narrative, extract drugs and reactions with OpenMed, and create an E2B(R3)-shaped ICSR draft for qualified safety review.

Frequently Asked Questions about reporting-adverse-events

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I structure adverse-event narratives into ICH E2B(R3) ICSR drafts?▼

Structure adverse-event narratives into ICH E2B(R3) ICSR drafts by de-identifying patient data, extracting suspect drugs and reactions, and mapping seriousness criteria to produce a reviewer-ready Individual Case Safety Report skeleton.

Can I generate FAERS case reports from unstructured drug safety narratives?▼

Yes, you can generate FAERS case reports from unstructured drug safety narratives by classifying seriousness criteria, reaction outcomes, and drug characterization values to produce structured safety database drafts.

How do I map MedDRA Preferred Terms without bundling licensed terminology?▼

Map MedDRA Preferred Terms by preserving verbatim reaction terms extracted from narratives for mapping to user-supplied licensed MedDRA coding, ensuring no proprietary terminology is invented or bundled.

Does the pharmacovigilance drafting process perform autonomous causality assessment?▼

No, the pharmacovigilance drafting process requires human review and does not perform autonomous causality assessment, focusing solely on traceable clinical entity extraction and regulatory value-set classification.

What is needed to de-identify narratives before preparing MedWatch safety reports?▼

On-device de-identification is required to prepare MedWatch safety reports, utilizing OpenMed entity extraction to remove protected health information while preserving clinical data for review.

Are serious adverse event outcomes classified automatically for safety databases?▼

Serious adverse event outcomes are classified using regulatory value-sets to produce structured safety database entries, but the resulting drafts require qualified human review before submission.

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