Docket Management
Docket: 01N-0464 - Vaccine Adverse Event Reporting System; Revised Form VAERS-2
Comment Number: EC -19

Accepted - Volume 1

Comment Record
Commentor Ms. Theresa haedrich Date/Time 2002-01-22 18:43:57
Organization Aviron
Category Company

Comments for FDA General
Questions
1. General Comments Dates The revised VAERS form does not include directions for format. The previous form (VAERS-1) specified the preferred format in each date field (eg. mm/dd/yy). These instructions are critical for any company doing business outside the borders of the U.S. as the generally accepted international format is dd/mm/yyyy. BOX D: Time of adverse event The date and time of vaccination is collected on the VAERS-2 form. The date of the adverse event is also collected however the time of the adverse event is not requested. Although the time of the adverse event can be reported in the Description of Event, if the VAERS form is used as a data collection document, this information will likely be excluded since it is not specifically requested. I suggest that the question regarding the timing of event be re-phrased as “How soon after vaccination did these event(s) start? If less than 1 hour, give exact time.” Box G2 The box asks for the “Tracking Number”. It is not clear that the BLA number should go here or another number. E2b How are the changes to the VAERS form going to effect electronic submission of safety data?




EC -19