Docket Management
Docket: 01N-0464 - Vaccine Adverse Event Reporting System; Revised Form VAERS-2
Comment Number: EC -14

Accepted - Volume 1

Comment Record
Commentor Mrs. Shelly Goodman Date/Time 2002-01-21 11:12:19
Organization Chiron Corporation
Category Company

Comments for FDA General
Questions
1. General Comments COMMENTS ON VAERS-2 FORM CHIRON CORPORATION Chiron Corporation has reviewed the new VAERS-2 form, and is providing comments on the proposed form. GENERAL COMMENTS In the Contact Information Box, provide phone/fax numbers for non-U.S. countries. The form asks more questions regarding the patients' demographic information, such as race/ethnicity, occupation, and parent name. Some patients may choose not to report the adverse event, as they are not willing to share information and prefer patient confidentiality. The form should have a page 2 to allow more information to be added, such as the vaccine history in Box F, which only provides 2 lines. The reporter would have to write on the back of the form, so further lines and a second page should be available. Formatting observations made were that some fields, such as Box D, Date of vaccination had a small checkmark in front it, and Time of vaccination had a small dash in front of it. In Box E, Describe the signs and symptoms that occurred after this vaccination and treatment, if any, had a small checkmark in front of it, and How soon after vaccination did these event(s) start? had a small dash in front of it. Box E also had only 2 numbered boxes in two fields, Has the patient recovered to his/her original state of health listed as box 6, and List results of relevant diagnostic procedures or lab testing listed as box 5. We are asking if this is a matter of printing/formatting issues. SPECIFIC COMMENTS Box C: Reporter Information Field 1: Reporter is the person listed: Comment: This box may be confusing to the lay person, as all three boxes may be checked as an option. Recommend to change as: [checkbox] Box A OR [checkbox] Box B OR [checkbox] Below Box D: Vaccination Information Field - Provide information for all vaccines given on this date: Comment: It may not be clear to the lay person to enter the last date of vaccination before the first event occurred. Recommend to rephrase to: Provide the last date of vaccination given before the first adverse event occurred. Box D: Vaccination Information Field - Date of vaccination Comment: Specify date format (DD/MM/YY) Box D: Vaccination Information Field - Time of vaccination Comment: Recommend military time, to delete confusion. Box D: Vaccination Information Field: Vaccine Name/Manufacturer/Lot Number/Vaccination Route/Site/Dose # in series Comment: As there are rarely any occurrences when more than 5 vaccines are given, the fifth line is not needed. Recommend to delete one line. Box E: Adverse Event Information Field: Describe the signs and symptoms that occurred after this vaccination and treatment, if any. Comment: Each event should be addressed, as events occur at different times after the vaccination. Recommend to provide a table similar to Box D which will be placed on the Describe the signs and symptoms that occurred…… field. Provide the following fields with an additional line to provide general comments (which may be used for parents who want to add more information): ________________________________________________________________________________________ Adverse Start Date Time From Stop Date Did this event cause Has the patient Event DD/MM/YY Last DD/MM/YY the patient to visit the recovered to Vaccination doctor? his/her original state of health ____________ [checkbox] Yes [checkbox] Yes If Yes, Date of visit: [checkbox] No [checkbox] Hours [checkbox] Improving [checkbox] Days ___________ [checkbox] Unknown [checkbox} Weeks DD/MM/YY [checkbox] Months [checkbox] No General Comments: -------------------------------------------________________________________________________________________________________________ Box E: Adverse Event Information Field: Has the patient recovered to his/her original state of health? Comment: Delete Not Yet - as this may mean that the patient is recovering but not completely recovered. Recommend to enter instead: Improving Box E: Adverse Event Information Field: List results of relevant diagnostic procedures or lab testing: Comment: Recommend to change to, List or attach results of relevant diagnostic procedures or lab testing: Box E: Adverse Event Information Field: Check below if the patient:……. Comment - recommend to rephrase to: Check below if the event resulted in: [checkbox ] Death Date (DD/MM/YY) ___________ [checkbox] Life-threatening Event List event: ____________ [checkbox] Hospitalization after vaccination Date admitted (DD/MM/YY): __/__/__ [checkbox] Prolonged hospitalization by _____ days [checkbox] Permanent disability List disability: ________ [checkbox] Medical Intervention to prevent any of the above outcomes [checkbox] None of the above Box F: Patient's Prior Health History Field 4: Date vaccine given/Vaccine Name/Manufacturer/Lot Number/Vaccination Route/Site/Dose # in Series Comment: Add two additional lines. Box F: For Secondary Reporters' Use only, Field 5: Other Medically Important Conditions (OMIC) Comment: The phrase Other Medically Important Conditions is not clear, and does not appear different from Box F, Field 1: List recipient's pre-existing physician-diagnosed illnesses, allergies, and/or medical conditions. Clarification of OMIC is needed.




EC -14