VAERS-1 Vaccine Adverse Event Reporting System

320621 10/11/02 11:07 AM Page 1

WEBSITE: www.vaers.hhs.gov

E-MAIL: [email protected]

FAX: 1-877-721-0366

VACCINE ADVERSE EVENT REPORTING SYSTEM

For CDC/FDA Use Only

24 Hour Toll-Free Information 1-800-822-7967
P.O. Box 1100, Rockville, MD 20849-1100
PATIENT IDENTITY KEPT CONFIDENTIAL
Patient Name:
First

Last

M.I.

Address

State

City

Telephone no. (____) ______________________
1. State

Form completed by (Name):

Responsible
Physician
Facility Name/Address

Relation
Vaccine Provider
Patient/Parent
to Patient
Manufacturer
Other
Address (if different from patient or provider)

State

Zip

4. Patient age

mm

dd

yy

9. Patient recovered

YES

NO

5. Sex
M

6. Date form completed
F

mm

12. Relevant diagnostic tests/laboratory data

dd

yy

Check all appropriate:
Patient died
(date
mm
dd
yy
Life threatening illness
Required emergency room/doctor visit
Required hospitalization (________days)
Resulted in prolongation of hospitalization
Resulted in permanent disability
None of the above

10. Date of vaccination

UNKNOWN

Zip

Telephone no. (____) ______________________

8.

7. Describe adverse events(s) (symptoms, signs, time course) and treatment, if any

State

City

Telephone no. (____) ______________________
3. Date of birth

2. County where administered

Date Received

Vaccine administered by (Name):

City

Zip

VAERS Number

mm

dd

)

11. Adverse event onset

yy

mm
dd
yy
AM
AM
Time ____________ PM Time ____________ PM

13. Enter all vaccines given on date listed in no. 10
Vaccine (type)

No. Previous
Doses

Route/Site

Lot number

Manufacturer

a.
b.
c.
d.
14. Any other vaccinations within 4 weeks prior to the date listed in no. 10
Vaccine (type)

Manufacturer

Lot number

Date
given

No. Previous
doses

Route/Site

a.
b.
15. Vaccinated at:
Private doctor's office/hospital
Public health clinic/hospital

Military clinic/hospital
Other/unknown

18. Illness at time of vaccination (specify)
20. Have you reported
this adverse event
previously?

No
To doctor

16. Vaccine purchased with:
Private funds
Military funds
Other/unknown
Public funds

17. Other medications

19. Pre-existing physician-diagnosed allergies, birth defects, medical conditions (specify)

Only for children 5 and under

To health department
To manufacturer

21. Adverse event following prior vaccination (check all applicable, specify)
Onset
Type
Dose no.
Adverse
Age
Vaccine
in series
Event

22. Birth weight
__________ lb. _________ oz.

23. No. of brothers and sisters

Only for reports submitted by manufacturer/immunization project
24. Mfr./imm. proj. report no.

25. Date received by mfr./imm.proj.

26. 15 day report?

27. Report type

In patient
In brother
or sister

Yes

No

Initial

Follow-Up

Health care providers and manufacturers are required by law (42 USC 300aa-25) to report reactions to vaccines listed in the Table of Reportable Events Following Immunization.
Reports for reactions to other vaccines are voluntary except when required as a condition of immunization grant awards.

Form VAERS-1(FDA)

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Page 2

"Fold in thirds, tape & mail — DO NOT STAPLE FORM"
NO POSTAGE
NECESSARY
IF MAILED
IN THE
UNITED STATES
OR APO/FPO

BUSINESS REPLY MAIL
FIRST-CLASS MAIL

PERMIT NO. 1895

ROCKVILLE, MD

POSTAGE WILL BE PAID BY ADDRESSEE

VAERS

P.O. Box 1100
Rockville MD 20849-1100

DIRECTIONS FOR COMPLETING FORM
(Additional pages may be attached if more space is needed.)
GENERAL

• Use a separate form for each patient. Complete the form to the best of your abilities. Items 3, 4, 7, 8, 10, 11, and 13 are considered
essential and should be completed whenever possible. Parents/Guardians may need to consult the facility where the vaccine was
administered for some of the information (such as manufacturer, lot number or laboratory data.)
• Refer to the Reportable Events Table (RET) for events mandated for reporting by law. Reporting for other serious events felt to be
related but not on the RET is encouraged.
• Health care providers other than the vaccine administrator (VA) treating a patient for a suspected adverse event should notify the
VA and provide the information about the adverse event to allow the VA to complete the form to meet the VA's legal responsibility.
• These data will be used to increase understanding of adverse events following vaccination and will become part of CDC Privacy
Act System 09-20-0136, "Epidemiologic Studies and Surveillance of Disease Problems". Information identifying the person who
received the vaccine or that person's legal representative will not be made available to the public, but may be available to the
vaccinee or legal representative.
• Postage will be paid by addressee. Forms may be photocopied (must be front & back on same sheet).
SPECIFIC INSTRUCTIONS

Form Completed By: To be used by parents/guardians, vaccine manufacturers/distributors, vaccine administrators, and/or the person
completing the form on behalf of the patient or the health professional who administered the vaccine.
Item 7:
Describe the suspected adverse event. Such things as temperature, local and general signs and symptoms, time course,
duration of symptoms, diagnosis, treatment and recovery should be noted.
Item 9:
Check "YES" if the patient's health condition is the same as it was prior to the vaccine, "NO" if the patient has not returned
to the pre-vaccination state of health, or "UNKNOWN" if the patient's condition is not known.
Item 10: Give dates and times as specifically as you can remember. If you do not know the exact time, please
and 11: indicate "AM" or "PM" when possible if this information is known. If more than one adverse event, give the onset date and
time for the most serious event.
Item 12: Include "negative" or "normal" results of any relevant tests performed as well as abnormal findings.
Item 13: List ONLY those vaccines given on the day listed in Item 10.
Item 14: List any other vaccines that the patient received within 4 weeks prior to the date listed in Item 10.
Item 16: This section refers to how the person who gave the vaccine purchased it, not to the patient's insurance.
Item 17: List any prescription or non-prescription medications the patient was taking when the vaccine(s) was given.
Item 18: List any short term illnesses the patient had on the date the vaccine(s) was given (i.e., cold, flu, ear infection).
Item 19: List any pre-existing physician-diagnosed allergies, birth defects, medical conditions (including developmental and/or
neurologic disorders) for the patient.
Item 21: List any suspected adverse events the patient, or the patient's brothers or sisters, may have had to previous vaccinations.
If more than one brother or sister, or if the patient has reacted to more than one prior vaccine, use additional pages to
explain completely. For the onset age of a patient, provide the age in months if less than two years old.
Item 26: This space is for manufacturers' use only.