adverse-event-reporting

Automate veterinary adverse event reporting to FDA CVM and query openFDA data.

27|6|Updated Mar 17, 2026
One-click install
npx skills add https://github.com/OpenVet-Projects/VetClaw --skill adverse-event-reporting
Or copy as Structured Prompt for Agent
Please help me install this Agent Skill.
Skill: adverse-event-reporting
Source: https://github.com/OpenVet-Projects/VetClaw/tree/main/skills/pharma/adverse-event-reporting
Command: npx skills add https://github.com/OpenVet-Projects/VetClaw --skill adverse-event-reporting

SYSTEM DOCUMENTATION & REQUIREMENTS

What problem does it solve?

This skill guides veterinary teams through reporting suspected adverse drug reactions to FDA CVM and retrieving related data from the openFDA veterinary adverse events database, reducing manual effort and increasing compliance.

Core Features & Use Cases

  • Regulatory reporting: Walks users through FDA CVM reporting steps, including required data fields and submission channels.
  • Data lookup: Queries the openFDA Animal & Veterinary Adverse Events API to surface prior events by drug, species, or reaction type.
  • Context & safety: Provides guidance on data limitations, signal interpretation, and when to escalate to a licensed veterinarian.

Quick Start

Gather the animal's species, product involved, signs, timing, and outcome to start the adverse event reporting workflow.

Frequently Asked Questions about adverse-event-reporting

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

FAQPage Schema
How do I report a veterinary adverse drug reaction to the FDA CVM?

To report a veterinary adverse drug reaction to the FDA CVM, you must compile structured data including the animal species, product involved, clinical signs, timing, and outcome, then submit it through FDA CVM reporting channels.

What information is needed for veterinary pharmacovigilance reporting?

Veterinary pharmacovigilance reporting requires structured data collection detailing the affected species, suspected product, observed clinical signs, reaction timing, and the final outcome to accurately document the adverse event.

How can I query the openFDA database for prior animal adverse events?

You can query the openFDA Animal and Veterinary Adverse Events API to retrieve and review historical pharmacovigilance data by searching for prior events using specific drug names, animal species, or reaction types.

Does adverse event reporting apply to both companion and production animals?

Yes, adverse event reporting applies to both companion and production animals, enabling investigators to systematically compile reports and support pharmacovigilance across all suspected veterinary drug reactions.

What are the limitations of using openFDA data for veterinary adverse event signals?

When using openFDA data for veterinary adverse event signals, you must consider data limitations and signal interpretation guidelines, and know when to escalate the suspected reaction to a licensed veterinarian.

What is the best way to streamline the veterinary adverse event reporting workflow?

The best way to streamline veterinary adverse event reporting is to automate the workflow, which guides you through required FDA CVM data fields and simultaneously queries openFDA to surface related historical events.