Docket Management
Docket: 01N-0464 - Vaccine Adverse Event Reporting System; Revised Form VAERS-2
Comment Number: EC -16

Accepted - Volume 1

Comment Record
Commentor Dr. Adwoa Bentsi-Enchill Date/Time 2002-01-21 12:19:14
Organization WHO
Category Health Professional

Comments for FDA General
1. General Comments The revised form is comprehensive and very succinct however, it has some inconsistencies/errors in the directions for completion. General information, 3rd bullet: Box A6 and A7 should read A7 and A8 Specific Instructions Item C7: This information may be missing because of the current skip pattern if the reporter information has is already completed as per Box A or B (see instruction for C1). Item E3: should be E4 Item E8: should be E7

EC -16