Docket Management
Docket: 01N-0464 - Vaccine Adverse Event Reporting System; Revised Form VAERS-2
Comment Number: EC -5

Accepted - Volume 1

Comment Record
Commentor Ms. Tara King Date/Time 2001-12-05 13:06:09
Organization Walter Reed Regional Vaccine Healthcare Center
Category Health Professional

Comments for FDA General
1. General Comments These comments are from the Nurse Practitioners at the Walter Reed Regional Vaccine Healthcare Center: Tara King, Jeannette Williams and Mary Minor. 1. You should be able to complete the form on line. 2. Box C, #1: State that if the reporter is identified in box A or box B they should not fill out box C. 3. Box C, #8: the Physcians' Assistant line should read NP/PA. 4. Box C: at the bottom of the box it should ask if this is an initial or follow up vaers. 5. Box E: The sub boxes should be numbered, as they are in A,B,C, and F. 6. Box E: The section regarding whether the patient visited a doctor...this should be part of the longer option list in the far right of box E (the check below if the patient died, etc section). 7. Box E: In the far right section, the option of required medical intervention to prevent any of the above outcomes is unclear. Myself and the other NPs in our clinic deal solely with adverse events to vaccines and have found that the options in this section rarely if ever, apply to our patients. We need an option that deals with chronic or ongoing medical problems or disability rather than using the word permanent. 8. Box E, #5: With such little space there, it should read attach results... instead of list results... 9. Box F, #3: You should also include OTC medications and herbal supplements.

EC -5