Renata Engler1, Jeanette Williams
2, Limone C. Collins
2, and Michael R. Nelson
2. (1) Allergy-Immunology Department, Walter Reed Army MEdical Center - US Army, 6900 Georgia Ave, NW, Washington, DC, USA, (2) Walter Reed Vaccine Healthcare Center, US government, 6900 Georgia Ave, NW, Washington, DC, USA
BACKGROUND:
The Vaccine Healthcare Centers Network is a Department of Defense (DoD) new medical advance developed in response to increasing concerns about rare adverse events temporally linked with mandatory vaccines and the need to provide clinical support services for persistent or more severe adverse events. Myalgias and body aches with varying features of fatigue and arthralgias (without any evidence of joint inflammation or stiffness) are a common side effects reported following routine vaccination. The symptoms are generally of short duration resolving in a few days and responding to over-the-counter analgesics. A small percent of vaccinees develop more severe or prolonged symptoms raising concerns about the safety of continued vaccination in a series.
OBJECTIVE:
To present a draft vaccine adverse event case definition from a vaccine safety clinical case review program focusing on a subset of patients who experienced reproducible prolonged myalgia syndrome following multiple doses of anthrax vaccination.
METHOD:
The VHC Network provides clinical expert consultations and case management services for DoD beneficiaries who experience adverse events that are more severe and/or prolonged than expected side effects. A systematic review process to identify patients with adverse events identified the cluster of patients described.
RESULT:
Five cases (male, age range 29 to 52 years, 3 Caucasian, 2 African Americans) who had received 19 doses of anthrax vaccine are described to include details of an informed consent re-challenge that resulted in symptoms lasting more than 4 months and responding to corticosteroid therapy.
CONCLUSION:
Prolonged and more severe myalgias, arthralgias and fatigue, particularly when recurring and worsening with each subsequent dose of a vaccine, results in fear of long term disability. Further studies are needed to improve understanding of this syndrome with a focus on prevention and treatment.
LEARNING OBJECTIVES:
To understand the post anthrax vaccine clinical presentation of prolonged and more severe myalgias.