America's Vaccine Safety Watchdog            


GARDASIL VACCINE QUESTIONNAIRE
Gardasil Network Development Project 
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Answering this questionnaire is voluntary. Personal identifying information will not be shared with anyone outside of NVIC without permission. Published reports using information from questionnaires for the purpose of analyzing adverse health events following vaccination with Gardasil will not include any personal identifying information. Please note, because Gardasil is usually given to persons under 18 years of age, it is assumed that the person who has experienced an adverse event following vaccination (referred to as the “patient”) is not necessarily the person completing the questionnaire (referred to as the “reporter”). If the patient is a minor under the age of 18, the questionnaire should be completed with the assistance of the parent or legal guardian. Because it is important to know whether other vaccines were given at the same time Gardasil was given, it will be helpful to have the patient’s shot records available when completing the questionnaire. Thank you for your help in gathering information about Gardasil vaccine.

Section 1 . Demographic Information (Please answer each question)

1. Name of Reporter * Last

 First
2. EmailAddress * Primary Email

Secondary email 
3. Phone Number * Primary

 Secondary
4. Mailing Address * Street

 City
  State

 Zipcode
  Country
5. Name of Patient *
Last
MI
First
6. Reporter’s Relationship to Patient *
(Please check one)









 
7. Gender/sex of Patient *
(Please check one)


 
8. Patient’s Age *
(Please enter birthdate and check box for current age range. If patient is deceased, please enter patient’s age range at time of death.)
Birthdate
Now

AND Age range categories

Section 2. Patient and Family Health History Prior to First Gardasil Shot (Please answer each question.)
9. BEFORE Gardasil shots were given, did the patient have a history of any of the following problems?
(Please check "YES", "NO" or "UNSURE" for each problem.)
YES

 		 NO

 		 UNSURE
10. BEFORE Gardasil shots were given,
(Please check"YES", "NO" or "UNSURE" for eachquestion below.)
a. Was the patient in good health most of the time?

b. Was the patient an athlete?

c. Did the Patient have a 3.0 (B) or greater grade point average or above-average intelligence (115 I.Q. or greater)?

11. BEFORE Gardasil shots were given, did a member of the patient’s family have a history of any of the following problems?
(Please check "YES", "NO" or "UNSURE" for each problem if it occurred in the patient's mother, father, siblings or grandparents.)
YES

 		 NO

 		 UNSURE
3. Vaccination and Reaction History
Gardasil is recommended to be given in a series of three shots. The next set of questions will be repeated for each of the three Gardasil shots and will ask about other vaccines that may have been given along with the Gardasil and any reactions that may have occurred following each of the Gardasil shots. (Please answer each question.)
12. Regarding the FIRST Gardasil shot
Date the FIRST Gardasil shot was given
Now

Vaccine Lot number if known
13. What other vaccines, if any, did the patient receive at the SAME time the FIRST Gardasil shot was given?
(Please consult patient’s vaccination record and check "YES", "NO" or "UNSURE" for each vaccine.)
YES
NO

 		 UNSURE

 
14. What other medications and other over-the-counter products, if any, was the patient taking at the time the FIRST Gardasil shot was given?
(Please check "YES", "NO" or "UNSURE" for each product.)
YES

NO

UNSURE

 
15. Was the patient pre-menstrual or menstruating at the time the FIRST Gardasil shot was given?
(Please check "YES", "NO" or "UNSURE".)
YES

NO

UNSURE

 
16. What symptoms, if any, did the patient report after FIRST Gardasil shot was given (but before the SECOND shot, if given)?
(Please check "YES", "NO" or "UNSURE" for each symptom.)
YES
NO
UNSURE
 
Death
 
Others (specify)
17. How soon after the FIRST Gardasil shot was given did the FIRST SYMPTOM, if any, appear? (Please check the best choice.)

OR (Please select the best choice)

18. Regarding the SECOND Gardasil shot (Please enter date shot given OR indicate that second Gardasil shot was NOT given).
a. Date the SECOND Gardasil shot was given
Now

Vaccine Lot number if known
OR
b.

19. What other vaccines, if any, did the patient receive at the SAME time the SECOND Gardasil shot was given?
(Please consult patient’s vaccination record and check "YES", "NO" or "UNSURE" for each vaccine.)
YES

NO

UNSURE
20. What other medications and other over-the-counter products, if any, was the patient taking at the time the SECOND Gardasil shot was given? (Please check "YES", "NO" or "UNSURE" for each product.)
YES

NO

UNSURE
21. Was the patient pre-menstrual or menstruating at the time the SECOND Gardasil shot was given?
(Please check "YES", "NO" or "UNSURE".)
YES

NO

UNSURE
22. What symptoms, if any, did the patient report after SECOND Gardasil shot was given (but before the THIRD shot, if given)?
(Please check "YES", "NO" or "UNSURE" for each symptom.)
YES
NO
UNSURE
 
Death
 
Others (specify)
23. Were any of these symptoms present after the FIRST Gardasil shot? (Please check “YES”, “NO” or “UNSURE”.)



24. Did the symptoms that were present after the FIRST Gardasil shot get worse after the SECOND shot?
(Please check "YES", "NO" or "UNSURE".)



25. How soon after the SECOND Gardasil shot was given did the FIRST SYMPTOM (or worsening of existing symptoms), if any, appear?
(Please check the best choice.)


OR (Please select the best choice)

26. Regarding the THIRD Gardasil shot (Please enter date shot given OR indicate that third Gardasil shot was NOT given).
a. Date the THIRD Gardasil shot was given
Now

Vaccine Lot number if known
OR
27. What other vaccines, if any, did the patient receive at the SAME time the THIRD Gardasil shot was given?
(Please consult patient’s vaccination record and check "YES", "NO" or "UNSURE" for each vaccine.)
YES

NO

UNSURE
28. What other medications and other over-the-counter products, if any, was the patient taking at the time the THIRD Gardasil shot was given?
(Please check "YES", "NO" or "UNSURE" for each product.)
YES

NO

UNSURE
29. Was the patient pre-menstrual or menstruating at the time the THIRD Gardasil shot was given?
(Please check "YES", "NO" or "UNSURE".)
YES

NO

UNSURE
30. What symptoms, if any, did the patient report after THIRD Gardasil shot was given?
(Please check "YES", "NO" or "UNSURE" for each symptom.)
YES
NO
UNSURE
 
Death
 
Others
31. Were any of these symptoms present after the SECOND Gardasil shot? (Please check "YES", "NO" or "UNSURE".)


32. Did the symptoms that were present after the SECOND Gardasil shot get worse after the THIRD shot?
(Please check "YES", "NO" or "UNSURE".)



33. How soon after the THIRD Gardasil shot was given did the FIRST SYMPTOM (or worsening of existing symptoms), if any, appear?
(Please check the best choice.)


(Please select the best choice)

Section 4. Current Health Condition
34. What symptoms, if any, is the Patient continuing to experience today:
(Please check “YES”, “NO” or “UNSURE” for each symptom.)
YES
NO
 
 		 UNSURE