Form Vaers 1 PDF Details

In a world where vaccine safety remains a paramount concern, the Vaccine Adverse Event Reporting System (VAERS) offers a crucial platform for gathering data on the side effects that may occur after vaccination. The VAERS-1 form is a vital component of this system, designed to be completed by vaccine providers, patients, or their guardians to report any adverse events following immunization. This form, easily accessible online and through other means such as fax or mail, ensures the confidentiality of the patient's identity while enabling a thorough documentation of the event. It captures detailed information, including patient demographics, the vaccine administered, a description of the adverse event, and any subsequent treatment received. Reporting through this system, which is mandatory for certain reactions to vaccines listed in the Reportable Events Table and encouraged for all other significant events perceived to be vaccine-related, plays a key role in identifying potential patterns that may warrant further investigation or action. Health care providers are also encouraged to notify vaccine administrators of adverse events to fulfill legal reporting obligations, ensuring a collaborative effort in monitoring vaccine safety. By contributing to a better understanding of the nature and frequency of adverse reactions, the VAERS-1 form underscores the ongoing commitment to public health and vaccine safety.

QuestionAnswer
Form NameForm Vaers 1
Form Length2 pages
Fillable?No
Fillable fields0
Avg. time to fill out30 sec
Other namesvaers printable form, vaers pdf, vaers online form, vaers report pdf

Form Preview Example

WEBSITE: www.vaers.hhs.gov E-MAIL: info@vaers.org FAX: 1-877-721-0366

 

VACCINE ADVERSE EVENT REPORTING SYSTEM

For CDC/FDA Use Only

 

 

 

24 Hour Toll-Free Information 1-800-822-7967

VAERS Number

 

 

 

P.O. Box 1100, Rockville, MD 20849-1100

 

 

 

 

 

 

 

 

PATIENT IDENTITY KEPT CONFIDENTIAL

Date Received

 

Patient Name:

 

 

Vaccine administered by (Name):

Form completed by (Name):

 

Last

First

M.I.

Responsible

Relation

Vaccine Provider

Patient/Parent

 

 

 

 

 

 

Physician

to Patient

Manufacturer

Other

Address

 

 

Facility Name/Address

Address (if different from patient or provider)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

City

 

 

 

State

 

Zip

 

 

City

State

Zip

City

 

 

 

 

 

State

 

Zip

 

 

 

 

 

Telephone no. (____) ______________________ Telephone no. (____) ______________________

Telephone no. (____) ______________________

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1. State

 

2. County where administered

 

 

3.

Date of birth

 

4.

Patient age

5. Sex

 

 

6. Date form completed

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

M

F

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

mm dd

yy

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

mm

dd

yy

 

 

 

 

 

7.

 

 

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

 

 

 

 

8.

Check all appropriate:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Patient died

 

(date

 

 

 

 

 

 

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Life threatening illness

 

mm

dd

yy

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Required emergency room/doctor visit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Required hospitalization (________days)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Resulted in prolongation of hospitalization

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Resulted in permanent disability

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

None of the above

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

9. Patient recovered

YES

NO

UNKNOWN

 

 

 

 

 

 

 

10.

Date of vaccination

11.

Adverse event onset

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

12. Relevant diagnostic tests/laboratory data

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

mm

dd

yy

AM

 

 

 

mm

dd

yy

AM

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Time ____________ PM

Time ____________ PM

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

13.

Enter all vaccines given on date listed in no. 10

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

No. Previous

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vaccine (type)

 

 

 

 

Manufacturer

Lot number

 

 

Route/Site

 

 

 

 

 

 

 

Doses

 

 

 

 

 

a.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

b.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

c.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

d.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14. Any other vaccinations within 4 weeks prior to the date listed in no. 10

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Date

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

No. Previous

 

 

 

 

 

 

 

 

 

 

 

 

 

Vaccine (type)

Manufacturer

 

 

 

Lot number

 

 

 

Route/Site

 

 

doses

 

 

 

 

 

 

 

 

given

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a.

b.

15. Vaccinated at:

 

Private doctor's office/hospital

Military clinic/hospital

Public health clinic/hospital

Other/unknown

16. Vaccine purchased with:

Private funds

Military funds

Public funds

Other/unknown

17. Other medications

18. Illness at time of vaccination (specify)

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

20. Have you reported

 

No

 

To health department

 

 

Only for children 5 and under

 

this adverse event

 

 

 

To manufacturer

22. Birth weight

 

 

23. No. of brothers and sisters

previously?

 

To doctor

 

__________ lb. _________ oz.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

21. Adverse event following prior vaccination (check all applicable, specify)

Only for reports submitted by manufacturer/immunization project

 

Adverse

Onset

Type

 

 

Dose no.

 

 

 

 

 

 

 

 

 

24. Mfr./imm. proj. report no.

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

 

Event

Age

Vaccine

 

 

in series

 

 

 

 

 

 

 

 

 

In patient

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

In brother

 

 

 

 

 

 

 

 

 

26. 15 day report?

 

27. Report type

 

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)

"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.

Form Vaers 1 isn’t the one you’re looking for?

Related Documents