PMID- 17154344
OWN - NLM
STAT- MEDLINE
DCOM- 20070809
LR  - 20070611
IS  - 1053-8569 (Print)
IS  - 1053-8569 (Linking)
VI  - 16
IP  - 6
DP  - 2007 Jun
TI  - Comparison of military and civilian reporting rates for smallpox vaccine adverse 
      events.
PG  - 597-604
AB  - INTRODUCTION: US smallpox vaccination (SMA) started most recently in December 
      2002. Military and civilian personnel report adverse events (AEs) to the Vaccine 
      Adverse Event Reporting System (VAERS), a surveillance system that relies on 
      spontaneous reports. Although reported rates of probable myo/pericarditis after 
      SMA in the literature are similar between military personnel and civilian 
      healthcare workers, some civilian AE reporting rates after SMA appeared higher 
      than those in the military. OBJECTIVE: Determine if SMA-associated reporting 
      rates are different in civilians than in the military, considering age, sex, 
      seriousness, and expectedness of the AE, as well as self-reporting. METHODS: 
      Numerators were SMA reports in VAERS from 12/12/02 to 3/1/04. Limitations of 
      VAERS include underreporting and lack of diagnostic confirmation. Denominators 
      were number of military and civilian vaccinees. RESULTS: Reporting rates 
      stratified by age and sex of serious and non-serious AEs were significantly 
      higher in civilian than military personnel ages <55 years (rate ratios 4-27). 
      These rate ratios decreased with increasing age. CONCLUSIONS: Reporting rates in 
      VAERS differed significantly and substantially in civilians compared to military 
      personnel <55 years of age. Differences in stimulated passive surveillance 
      systems, and AE reporting practices, including the 'threshold' for reporting most 
      likely explain these findings. These results suggest that in the case of smallpox 
      vaccine AEs, there may be systematic differences in reporting completeness 
      between the civilian and military sectors, and that passive surveillance data 
      should be interpreted with caution.
CI  - Copyright (c) 2006 John Wiley & Sons, Ltd.
FAU - McMahon, A W
AU  - McMahon AW
AD  - Office of Biostatistics and Epidemiology, Food and Drug Administration, 
      Rockville, MD, USA. ann.mcmahon@fda.hhs.gov
FAU - Zinderman, C
AU  - Zinderman C
FAU - Ball, R
AU  - Ball R
FAU - Gupta, G
AU  - Gupta G
FAU - Braun, M M
AU  - Braun MM
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Smallpox Vaccine)
SB  - IM
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Military Personnel
MH  - Smallpox Vaccine/*adverse effects
MH  - Vaccination
EDAT- 2006/12/13 09:00
MHDA- 2007/08/10 09:00
CRDT- 2006/12/13 09:00
PHST- 2006/12/13 09:00 [pubmed]
PHST- 2007/08/10 09:00 [medline]
PHST- 2006/12/13 09:00 [entrez]
AID - 10.1002/pds.1349 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2007 Jun;16(6):597-604. doi: 10.1002/pds.1349.