KEYWORDS:
Vaccine safety, vaccine adverse events reporting, vaccine exemptions

BACKGROUND:
Healthcare providers need improved understanding of clinical immunization healthcare, to include adverse events diagnosis and management. Vaccines are prescription drugs with potential for adverse events (1-2%) and safety concerns with future doses. There is a need for a standardized approach to vaccine temporally associated adverse events diagnosis and management.

OBJECTIVE(S):
To develop practical tools for educational outreach regarding vaccine-related adverse events diagnosis and treatment, medical exemptions, improved quality reporting and balanced risk communication.

METHOD(S):
Walter Reed Army Medical Center Allergy-Immunology Department, in response to clinical experience, including recurrent electronic and telephonic requests for advice, developed clinical guidelines for adverse events temporally associated with vaccines, particularly anthrax and other non-live vaccines. Clinical guidelines for vaccine-associated adverse events diagnosis and management were subsequently critiqued and refined by a representative multi-disciplinary group within the Department of Defense.

RESULT(S):
These guidelines have been available through a centralized web site for 2 years and have achieved widespread acceptance supporting quality improvements in the VAERS process as well as individual patient management.

CONCLUSIONS(S):
Standards of care applied to adverse drug reaction management should be applied to immunization temporally associated adverse events, to include the involvement of specialists in vaccine safety assessment for complex cases. Clinical guidelines focused on improved vaccine-related adverse events treatment are useful tools to address public concerns and distrust of vaccine safety.

LEARNING OBJECTIVES:
1. To improve understanding of the minimum standards for quality immunization services particularly relating to temporally associated adverse events.
2. To enhance understanding of balanced risk communication in the setting of a prior vaccine-associated adverse event to include indications for referral to a specialist in vaccine safety.
3. To review special concerns regarding rare adverse events related to certain vaccines such as Lyme, hepatitis B, tetanus, hemophilus influenza type b, and anthrax.