FAQ: What if a “mandated immunization” results in adverse side effects?

What if a “mandated immunization” results in adverse side effects – what do you do (tracking side effects and compensation)?  [FAQ Date: April 1, 2013]
Health care institutions should already be operating under relevant OSHA guidelines and existing policies may cover some aspects of an adverse reaction to a vaccine (offered or required in the workplace) as part of a general employee safety and workplace injury policy.

Of course, no vaccine is perfectly “safe” and no vaccine is perfectly efficacious. The standard of informed consent should be in place in any employee immunization initiative, including one for seasonal influenza and any mandatory program involving influenza vaccines. Overall, integrating informed consent processes would require that HCPs understand the efficacy, benefits and risks associated with influenza immunization.

Hospitals and healthcare facilities should follow best practices in monitoring for and reporting any vaccine adverse events, although  these will be extremely rare for influenza vaccination of HCPs. We believe that, in most cases, current policies active in healthcare facilities provide for both reporting and response to adverse events in general.

More generally, the Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of vaccines licensed for use in the United States.

VAERS provides a nationwide mechanism by which adverse events following immunization may be reported, analyzed and made available to the public. VAERS also provides a vehicle for disseminating vaccine safety-related information to parents and guardians, healthcare providers, vaccine manufacturers, state vaccine programs and other constituencies: http://vaers.hhs.gov/index.





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