(with 4.0 or higher Internet Explorer or comparable Netscape) and obtain a digital certificate and password from CDC. HSVMS was ready for use beginning February 18, 2003.

Name and social security number will not be collected in HSVMS. This system will, however, collect the PVN (or state equivalent), gender, year of birth, occupation, and clinical specialty (for physicians). It also will include an optional category for race and ethnicity.

The HSVMS allows monitoring sites to create reports on all vaccinees seen at their site, vaccinees who are due for a take reading, vaccine symptoms seen at their site, physical findings for vaccinees, and the status of site care and dressings at their site, as well as summary reports by day and by each vaccinee seen at their site. Health departments can access HSVMS to view and obtain data from their specific state or jurisdiction. HSVMS data also can be exported into Excel or Access.

The committee supports CDC’s plan to use these data to evaluate progress and outcomes of phase I of the pre-event smallpox vaccination program. The HSVMS data will be only one component of the overall evaluation plan, but these data will be essential to the analysis and evaluation of the ongoing vaccination program.

The Active Surveillance System, HSVMS, and VAERS will all provide valuable data on vaccinees’ experiences following vaccination. Since these data systems are designed to work together, by offering one more place that serious adverse events can be identified, the likelihood of missing a serious adverse event following vaccination will be reduced even further. The committee recommends that CDC consider adding a data field to HSVMS to indicate whether a serious adverse event occurred or whether a VAERS report was filed (understanding that more complete information about circumstances surrounding the adverse event will be entered into VAERS and the Active Surveillance System).

Implications of Program Expansion for Collection of Data on Adverse Events

The relatively quick expansion of the vaccination program to include all health care workers, firefighters, law enforcement, and emergency workers creates a number of implications for the capacity to collect data on serious adverse events, common adverse events, and vaccinees’ experiences following smallpox vaccination. Up until now, CDC has designed the data systems for the smallpox vaccination program primarily for the logistical circumstances of the first phase of the program. CDC will have to consider if and how the data systems will need to be adapted for the expansion of the program (formerly “phase II”) and beyond.

Conducting active surveillance of vaccinees from the recently expanded



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