Docket Management
Docket: 01N-0464 - Vaccine Adverse Event Reporting System; Revised Form VAERS-2
Comment Number: EC -12

Accepted - Volume 1

Comment Record
Commentor Dr. Ali Rashidee Date/Time 2002-01-17 15:51:59
Organization Centers for Disease Control and Prevention
Category Health Professional

Comments for FDA General
1. General Comments I have four suggestions/comments regarding VAERS II form; a. During the development of our web-based VAERS reporting form, we noticed that this form will become available world-wide through the Internet for the US citizens working abroad, either civil or military. We need accommodation for foreign addresses, namely the provision for including Country’s name, and APO/FPO addresses. b. In box E7 do we need ‘Required medical intervention to prevent…’ since we will already have information whether the vacinee was hospitalized and/or was visited by a Doctor (E4)? c. Change in E4 to read ‘…visit a Doctor’ (Instead of ‘the Doctor’) d. In box E2: Multiple events could start at different times, but there is provision for entering 1 time only. May be we need provisions for entering multiple 'time' for multiple signs/symptoms.

EC -12