Docket Management
Docket: 01N-0464 - Vaccine Adverse Event Reporting System; Revised Form VAERS-2
Comment Number: EC -6

Accepted - Volume 1

Comment Record
Commentor Ms. Mary Vincellli Date/Time 2001-12-20 14:07:30
Organization Texas Department of Health
Category Health Professional

Comments for FDA General
1. General Comments Generally this form is too cramped. There is hardly enough room to write or type all the information you request and still have it legible. There needs to be room for listing more than 5 immuniztions as often more than 5 are given on the same day. Box F2 would better read list any acute illness the recipient was experiencing on the day he/she was vaccinated. Box F3 would better read List any medications the recipient was taking or took on the day he/she was vaccinated. The listing of For VAERS ONLY above Box C is confusing. Does this mean VAERS will complete Box C? It would be easier for the person completing the report to complete this information. I would also change number 8 under Box C to read Other (Specify) rather then describe below I would make the entire form 2 pages and allow more space for typing or writing the information.

EC -6