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133rd Annual Meeting & Exposition December 10-14, 2005 Philadelphia, PA |
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Ann W. McMahon, MD, MS, Craig Zinderman, MD MPH, Robert Ball, MD MSc, ScM, Ghanshyam Gupta, PhD, and M. Miles Braun, Md, MPH. Office of Biostatistics and Epidemiology, Division of Epidemiology, Food and Drug Administration, 1401 Rockville Pike, HFM-200, Rockville, MD 20852, 301-827-6082, mcmahon@cber.fda.gov
Introduction: The recent US smallpox vaccination (SPV) campaign started in 12/2002. Military and civilian populations report adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS). Civilians had a higher crude reporting rate of myopericarditis after SPV than military personnel. Objective: To determine if overall SPV-associated reporting rates are higher in the civilian than military population, after age and sex stratification. Methods: Numerators were SPV reports in VAERS from 12/12/02 to 3/1/04. Underreporting was possible and diagnoses were not necessarily confirmed. Denominators (number of vaccinees) were from the Defense Medical Surveillance System (military) and the Pre-event Vaccination System (civilian), large administrative databases.
Results:
Subject Gender Age (Years) |
Category of Reports |
Civ/Mil Rate Ratio |
95% LL |
95% UL |
Category of Reports |
Civ/Mil Rate Ratio |
95% LL |
95% UL |
All Female |
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<35 |
Serious |
13.0 |
5.8 |
29.3 |
NonSerious |
13.3 |
10.6 |
16.7 |
35-54 |
Serious |
4.5 |
2.1 |
9.3 |
NonSerious |
6.2 |
4.4 |
8.7 |
>54 |
Serious |
0.2 |
0.1 |
1.0 |
NonSerious |
3.9 |
0.5 |
27.5 |
All Male |
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<35 |
Serious |
11.3 |
5.8 |
22.1 |
NonSerious |
26.9 |
21.5 |
33.7 |
35-54 |
Serious |
8.2 |
5.0 |
13.5 |
NonSerious |
10.0 |
7.5 |
13.2 |
>54 |
Serious |
1.7 |
0.5 |
5.7 |
NonSerious |
3.3 |
1.5 |
7.3 |
Reporting rates to VAERS of AEs after SPV were significantly higher in civilian than military personnel aged <55 years. The civilian/military rate ratios decreased with age. Conclusions: Age and sex stratification did not resolve the differences in the military and civilian reporting rates. Reasons for higher civilian reporting rates may include differences in reporting requirements and/or practices, and the healthy “soldier” effect.
Learning Objectives: At the conclusion of the session, a participant in this session will be able to
Presenting author's disclosure statement:
I wish to disclose that I have NO financial interests or other relationship with the manufactures of commercial products, suppliers of commercial services or commercial supporters.
The 133rd Annual Meeting & Exposition (December 10-14, 2005) of APHA