Adverse Event Reporting

An adverse event is any undesirable occurrence after the use of an immunobiological product, including illness or reaction, whether or not the event was caused by the product. For products intended to diagnose disease, adverse events refer to anything that hinders discovery of the correct diagnosis.

The mission of the Center for Veterinary Biologics (CVB) is to ensure that animal immunobiologics are in compliance with the Virus-Serum-Toxin Act. Reports are assessed for the possibility of a product deficiency. When necessary, testing is performed or additional information sought. The CVB is, however, unable to make diagnoses or recommendations specific to individual cases. Some of the manufacturers do provide such services. Receipt of a report by the CVB does not necessarily imply that the product caused an adverse event, or even that a particular event actually occurred.

Adverse events may be reported to the:

* The Adverse Event Report Form is currently unavailable due to routine review by the Office of Management and Budget (OMB). It will be made available here as soon as this process is complete. In the meantime, please use the on-line method or call the CVB to report your adverse event.

See Frequently Asked Questions on adverse event reporting/pharmacovigilance.