reporting-adverse-events
Structures adverse-event mentions that OpenMed extracts into FAERS / ICH E2B(R3) reportable fields — suspect drug, reaction (MedDRA PT), seriousness criteria, and outcome. Use when the user needs to build an individual case safety report (ICSR), populate a FAERS submission, map a narrative to E2B(R3) data elements, classify seriousness (death, life-threatening, hospitalization, disability, congenital anomaly), or assign reaction outcomes. Trigger keywords: adverse event, ADR, ICSR, FAERS, E2B, E2B(R3), suspect drug, seriousness, MedDRA, reaction outcome, pharmacovigilance case. Pairs after Ope
Profile →npx skills add maziyarpanahi/openmed --skill reporting-adverse-events --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# Reporting adverse events into FAERS / ICH E2B(R3) A pharmacovigilance case starts as free-text narrative ("68 yo on warfarin developed GI bleed, hospitalized"). To make it reportable you must structure it into the **ICH E2B(R3)** data elements that the FDA's **FAERS** (and EMA's EudraVigilance) expect: a **suspect drug**, one or more **reactions** coded to **MedDRA** Preferred Terms, **seriousness** criteria, and a **reaction outcome**. OpenMed extracts the drug and condition spans on-device; this skill turns those spans plus the narrative into the E2B(R3) skeleton. The reaction coding step needs **MedDRA**, which is **licensed by the MSSO and user-supplied** — it is never bundled with OpenMed and must be loaded from the user's own subscription. ## When to use - A narrative names a drug and an adverse reaction and you need an ICSR (Individual Case Safety Report) shell with the right E2B(R3) fields. - You must classify **seriousness** (E2B sections C.1.7 / E.i.3) — death, life-threatening, hospitalization/prolongation, disability, congenital anomaly, or "other medically important condition". - You need to characterize each drug as **suspect / concomitant / interacting** (the `drug
- When to use
- Quick start
- E2B(R3) seriousness and outcome value sets
- Workflow
- Hand-off to / from OpenMed
- Edge cases & gotchas
- Standards & references
What does the reporting-adverse-events skill do?
Structures adverse-event mentions that OpenMed extracts into FAERS / ICH E2B(R3) reportable fields — suspect drug, reaction (MedDRA PT), seriousness criteria, and outcome. Use when the user needs to build an individual case safety report (ICSR), populate a FAERS submission, map a narrative to E2B(R3) data elements, classify seriousness (death, life-threatening, hospitalization, disability, congenital anomaly), or assign reaction outcomes. Trigger keywords: adverse event, ADR, ICSR, FAERS, E2B, E2B(R3), suspect drug, seriousness, MedDRA, reaction outcome, pharmacovigilance case. Pairs after Ope
How do I install it?
Run `npx skills add maziyarpanahi/openmed --skill reporting-adverse-events --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From maziyarpanahi/openmed, a repository with 4,851 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.