Docket Management
Docket: 01N-0464 - Vaccine Adverse Event Reporting System; Revised Form VAERS-2
Comment Number: EC -2

Accepted - Volume 1

Comment Record
Commentor Mr. Joe Beaver Date/Time 2001-11-26 10:22:32
Organization DHHS/CDC/NIP/IDS/POB
Category Health Professional

Comments for FDA General
Questions
1. General Comments VAERS Form-2 more clearly segregates requested information on adverse events. However, that clarity sacrifices readability as the font is considerably smaller. The addition of a toll-free fax number is a good idea as are addition of the web site URL and the e-mail address. Within the major divisions of the form, the numbers of some of the boxes are reverse highlighted. This implies that these are more important fields, but there are no instructions to clarify their significance. Section F, box 1 is specific in requesting physician diagnosed conditions that may have existed at the time of immunization. However, box 2 is not clear as to whether parent observed conditions are also acceptible to record. In regard to box 3, it might be helpful to emphasize whether information on non-prescription medications administered at home, prescription medications or both types is desired. For organizational clarity, it might be more helpful if the section of Box F that deals with vaccines received within the last 4 weeks were located as a part of box D, yet distinctly separated (perhaps by a reverse highlighted title bar) from vacines received on the most recent visit prior to the onset of the adverse event. The form references the table of reportable events. It might be helpful to include a URL for that table for practitioners with questions about which events are reportable.




EC -2