(VAERS), the HSVMS, inquiries received through CDC’s Clinician Information Line, and requests for vaccinia immune globulin (VIG) and cidofovir will allow CDC to systematically collect information on vaccinees’ experiences following vaccination and will greatly increase the likelihood that all serious adverse events following smallpox vaccination will be detected.

Active Surveillance System

The Smallpox Vaccine Adverse Event Active Surveillance System is designed to collect data on all vaccinees at the “close-out” of the vaccination process (this is usually 21 to 28 days after vaccination, when the scab falls off). The Active Surveillance System is a web-based system that is accessible through CDC’s Secure Data Network (SDN). State and local health departments, hospitals, and vaccination clinics can enter data into the Active Surveillance System as long as they have been given authorization to access the SDN. The Active Surveillance System will collect information on:

  1. Whether contraindications to vaccination among the vaccinee, or contacts of the vaccinee, were identified since the time of vaccination;

  2. Whether the vaccinee received medical care for an adverse event; and

  3. Whether vaccinia transmission to contacts of the vaccinee occurred.

Information from the Active Surveillance System will be supplemented with information from PVS, VAERS, the Clinician Information Line, and requests for VIG and cidofovir to help give a complete picture of the details of each adverse event.

Both PVS and HSVMS (discussed in more detail below) will include a link to the Active Surveillance System. When the Active Surveillance System is accessed through these means, many of the fields in the Active Surveillance System will be pre-populated with data from PVS or HSVMS. By the pre-population of as many data fields as possible with data from PVS or HSVMS, the risk of data entry error will be reduced.

By its nature, the Active Surveillance System is designed to obtain a confirmed outcome on every vaccinee. To ensure that the Active Surveillance System is truly “active,” CDC instructs vaccination monitors to make at least three attempts at contacting the vaccinee before the vaccinee is designated as “unable to contact vaccinee for follow-up.” The percentage of vaccinees that will be lost to follow-up should be relatively low, considering that phase I vaccinees are affiliated with a particular smallpox response team and monitors are instructed to make at least three attempts to contact the vaccinee for follow-up. However, it will be important to specifi-



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