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American Public Health Association
133rd Annual Meeting & Exposition
December 10-14, 2005
Philadelphia, PA
APHA 2005
 
4126.0: Tuesday, December 13, 2005 - 1:15 PM

Abstract #118411

Comparison of military and civilian reporting rates of adverse events after smallpox vaccine

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

 

 

 

 

 

 

 

 

     <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

 

 

 

 

 

 

 

 

<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.

Infectious Disease Epidemiology

The 133rd Annual Meeting & Exposition (December 10-14, 2005) of APHA