Description of a common (not rare as claimed here) adverse event from anthrax vaccine--reported many hundreds of times to VAERS

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http://cdc.confex.com/cdc/nic2004/techprogram/paper_5034.htm

Thursday, May 13, 2004 - 11:45 AM

5034

Reproducible Prolonged Myalgia Syndrome (RPMS) Following Multiple

Anthrax Vaccinations: Draft of A New Rare Adverse Event Case

Definition Developed by The Vaccine Healthcare Centers (VHC) Network

Renata Engler1, Jeanette 2, Limone C. 2, and

R. 2. (1) Allergy-Immunology Department, Walter Army

MEdical Center - US Army, 6900 Georgia Ave, NW, Washington, DC, USA,

(2) Walter 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.

* Recorded presentation

See more of The Military Experience with Vaccine Safety

See more of The 38th National Immunization Conference