Docket Management
Docket: 01N-0464 - Vaccine Adverse Event Reporting System; Revised Form VAERS-2
Comment Number: EC -10

Accepted - Volume 1

Comment Record
Commentor Dr. John Iskander Date/Time 2002-01-16 12:03:11
Organization Centers for Disease Control and Prevention
Category Other

Comments for FDA General
Questions
1. General Comments CDC National Immunization Program Epidemiology and Surveillance Division Vaccine Safety and Development Activity 1600 Clifton Road MS E-61 Atlanta, GA 30333 Dear Sirs; Thank you for the opportunity to comment on the proposed revisions to the VAERS reporting form. Our group, which co-manages VAERS along with the FDA and administers the VAERS contract, has the following general comments: 1. There was a general preference to retain the current sequential numbering system rather than the proposed alphanumeric one due to less potential for confusion, e.g. current form has only one box 8 vs. five on the new form. Alternatively the boxes could retain their capital letter designation but individual fields could be numbered sequentially starting with 1 and continuing sequentially across boxes, e.g. current box B1 would become box 12 and so on. 2. There was also a preference to retain the current one page format, however if needed the box “For Secondary Reporters’ Use Only” could be put on a second page. This would allow more space for “free text” fields. We would also like to make the following comments regarding specific fields listed on the form: Box D: Vaccination Information Item 2, Time of vaccination: We suggest removing this item since it is rarely captured accurately. This could be replaced with a field for Indication/Reason for Vaccination, which could either be a free text field or could offer choices such as Routine/Recommended, High Risk/Risk Factor, Travel, or other/miscellaneous. Column 8, Dose # in series, should be combined with Vaccine Name to create an item that would say “Vaccine Name and Dose # in series”. Box E: Adverse Event Information General Comments: The Brighton Collaboration requests addition of an item for Fever that would have options of Yes/No. If Yes, there should be items requesting highest measured temperature and route of measurement (rectal/oral/axillary/tympanic/other). Their highest priority items are presence/absence of fever and height of measured fever. Item 2. We propose changing the wording of this question to “How soon after vaccination did THE FIRST SYMPTOM occur?” Item 4. We propose changing the wording to “Did these events cause the patient to visit the doctor OR EMERGENCY DEPARTMENT (ED)?” Item 6. We suggest adding an additional category such as “partially recovered”. Item 7. We agree with the inclusion of all boxes except “ Required intervention to prevent permanent impairment or damage”. Box F: Patient’s Prior Health History Item 1. Our group recommends changing the wording to “List recipient’s pre-existing medical conditions and/or allergies and/or previous adverse events after vaccination”. Items 4-10. “List any other vaccines administered to the recipient within 4 weeks of the date given in Box D above” WE FEEL THAT THIS FITS MORE LOGICALLY IN BOX D AS A SEPARATE LIST AFTER ITEMS 1-8. Respectfully submitted, John Iskander MD MPH VAERS Project Officer Writing for the National Immunization Program Vaccine Safety and Development Activity




EC -10