Vaccine Adverse Event Reporting

December 8, 2010 — 

The USDA Center for Veterinary Biologics (CVB) maintains an Adverse Event Reporting (AER) program to ensure that animal veterinary biologics are in compliance with the Virus Serum Toxin Act. This pharmacovigilance program relies, in part, on the reporting of adverse events associated with the administration of vaccines and other biologicals. The CVB would like to remind veterinarians of the importance of reporting such events.

Pharmacovigilance of veterinary biologics has two main functions. One is to serve as an alert system for detecting the possibility that a product may not be performing as intended. Secondly, pharmacovigilance also provides an essential source of descriptive baseline information about the behavior of a vaccine or other veterinary biologics when used under everyday field conditions.

An adverse event is any undesirable occurrence after the use of a veterinary biological product, including illness or reaction, whether or not the event was caused by the product. Potential adverse events may occur immediately (e.g. hypersensitivity or anaphylaxis) or for up to 2 weeks following administration of the product (e.g. anorexia, fever, lethargy, nasal or ocular discharge, distress, vomiting, diarrhea, etc.).

While these events may or may not be associated with the administration of the vaccine, adverse event reports are assessed for the possibility of a product deficiency. When necessary, testing is performed or additional information sought. Receipt of a report by the USDA does not necessarily imply that the product caused an adverse event, or even that a particular event actually occurred.

Adverse events may be reported either to the manufacturer or to CVB directly. CVB may be contacted at (800) 752-6255 to request reporting directions. A report of an adverse event may be filed by submitting the information via the Web at http://www.aphis.usda.gov/animal_health/vet_biologics/vb_adverse_event.shtml or by downloading or requesting a blank form and faxing the completed form to (515) 232-7120 or by mailing it back to the CVB.

Source: USDA, CVB