Docket Management
Docket: 01N-0464 - Vaccine Adverse Event Reporting System; Revised Form VAERS-2
Comment Number: EC -13

Accepted - Volume 1

Comment Record
Commentor Dr. Fernando Guerra Date/Time 2002-01-17 18:23:18
Organization San Antonio Metropolitan Health District
Category Health Professional

Comments for FDA General
1. General Comments Please consider the following comments and suggested changed to the VAERS-2 Form. With the increasing numbers of Hispanics populations locating to all parts of the county, having this form translated into Spanish would be extremely helpful. Especially if certain events are reported from a parent. Information about an adverse event to a prior dose of vaccine should be retained on the new form and would helpful epidemiologically. Regarding Box B, #7 -- 1) a box for ER/Dr visit should be retained since a hospital stay is not always indicated; 2) Since febrile seizures can be associated with certain adverse events, a separate Box denoting a Febrile Seizure should be included in this section.

EC -13