Objectives: Tracking vaccine reactions and adverse events during a large-scale vaccination program such as the recent smallpox program or a pandemic flu outbreak will be a challenge. We report on vaccine reaction data collected using a novel telephone-and web-based electronic reporting system. The system was used to monitor vaccinees during the U.S. Army's smallpox vaccination campaign, which was part of the national program to prepare against biological attack. In addition, we report on the time course of events after smallpox vaccination based on the self-reported data and evaluate the validity and reliability of self-reported take information after smallpox vaccination.Methods: A prospective cohort of subjects receiving the smallpox vaccination volunteered to use an electronic monitoring system to track and report their vaccination reactions.Results: Users made 6.8 ± 6.2 (mean ± SD) reports using the electronic monitoring system. The sensitivity and positive predictive value of self-reported takes were high, 98.8% and 99.6%, respec tively. The vaccination-site reactions progressed faster for revaccinees than first-time vaccinees.Conclusions: Simple-to-use telephone/internet-based technology allowed detailed self-recording of response to smallpox vaccination among outpatients. Self-reports on site appearance were sufficient to determine vaccine takes in most vaccinees. During a mass vaccination event, an electronic moni toring system could facilitate tracking of vaccine reactions, including providing an early warning system for adverse events, and might reduce the burden associated with follow-up visits with health care professionals.T ihe Department of Health and Human Services develop plans for an influenza pandemic. In addition to ^ (DHHS) and the Centers for Disease Control and the usual surveillance functions of health departments. Prevention (CDC) have emphasized the importance of these agencies may need to set up mass vaccination clinpublic health planning for bioterrorism events such as a ics, handle vaccine or prophylactic drugs, determine who smallpox attack and emerging infectious diseases such as should get vaccinated, and monitor clinical reactions to pandemic flu. CDC cooperative agreements have re-the vaccines.' However, few methods exist for real-time quired state public health departments to develop small-tracking of vaccinee experiences. The Vaccine Adverse pox vaccination plans, and stales are now being asked to Events Reporting System (VAERS) collects spontaneous S
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