---
name: adverse-event-reporting-14d8abaa2507
description: Guide veterinary adverse drug event reporting through FDA CVM and query the openFDA animal adverse event database. Use when a suspected adverse drug reaction occurs in an animal.
---

# Veterinary Adverse Event Reporting

## Overview

Support adverse drug event reporting for veterinary products through FDA CVM channels and query existing adverse event data from the openFDA database. Pharmacovigilance in veterinary medicine follows different pathways than human medicine, with reporting through FDA CVM Form 1932a rather than MedWatch.

## When to Use

- An animal experienced a suspected adverse reaction to a drug, vaccine, or pesticide product
- User wants to check reported adverse events for a veterinary product
- User asks how to report a veterinary adverse event
- User asks about adverse event patterns for a specific drug in animals
- Keywords: adverse event, adverse reaction, side effect, report, ADE, pharmacovigilance, FDA report, vaccine reaction

## Key Resources

- **FDA CVM Adverse Event Reporting:** https://www.fda.gov/animal-veterinary/safety-health/report-problem
- **openFDA Animal & Veterinary Adverse Events API:** https://open.fda.gov/apis/animalandveterinary/event/
- **FDA CVM Safety Reporting Portal** for electronic submission

## Workflow

### Querying Existing Adverse Event Data

1. Search the openFDA animal adverse events endpoint by drug name, species, or reaction type.
2. Aggregate results by reaction type, species, and outcome severity.
3. Present findings with appropriate context (reporting bias, denominator unknown).
4. Note any FDA safety communications or label changes resulting from adverse event signals.

### Reporting a New Adverse Event

1. Gather required information:
   - Animal signalment (species, breed, age, weight, sex)
   - Product involved (name, manufacturer, lot number if available)
   - Adverse event description (signs, timing, severity)
   - Outcome (recovered, ongoing, died)
   - Concurrent medications
   - Whether the veterinarian considers the event drug-related
2. Guide the user through FDA CVM reporting options:
   - Online: FDA Safety Reporting Portal
   - Phone: 1-888-FDA-VETS (1-888-332-8387)
   - Manufacturer reporting (companies are required to forward reports to FDA)

## Limitations

- openFDA adverse event data represents spontaneous reports, not incidence rates. Reporting rates are unknown.
- Absence of adverse event reports does not mean a product is safe.
- Adverse event reports do not establish causality.
- The openFDA API has rate limits and data may lag behind real-time reporting.


---
Source attribution: OpenVet-Projects
Original project: https://github.com/OpenVet-Projects/VetClaw/blob/a989b1cbf93c703bb95974616c4285c5e2098b3f/skills/pharma/adverse-event-reporting/SKILL.md
License: MIT
License information: https://opensource.org/license/mit
Original upstream instructions; downloaded from Mega AI Hub.

## Upstream license notice

MIT License

Copyright (c) 2026 OpenVet AI (openvet.ai)

Permission is hereby granted, free of charge, to any person obtaining a copy
of this software and associated documentation files (the "Software"), to deal
in the Software without restriction, including without limitation the rights
to use, copy, modify, merge, publish, distribute, sublicense, and/or sell
copies of the Software, and to permit persons to whom the Software is
furnished to do so, subject to the following conditions:

The above copyright notice and this permission notice shall be included in all
copies or substantial portions of the Software.

THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR
IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE
AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER
LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM,
OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE
SOFTWARE.



# Mega AI Hub resource metadata

Creator / publisher: OpenVet-Projects
Original project: https://github.com/OpenVet-Projects/VetClaw/blob/a989b1cbf93c703bb95974616c4285c5e2098b3f/skills/pharma/adverse-event-reporting/SKILL.md
Attribution basis: Source repository record

Fields of work: Healthcare & Life Sciences
Roles: Clinical Research, Pharmacy / Drug Info
Specialties: Specialty not specified
Tools: OpenAI API, Openfda
Country applicability: United States
Classification basis: Source catalog labels
Instruction SHA-256: 89c2330a6225ebc8079fb87b0656f97b4d506198c0d363ac7c41de93c47369d8