Fillable Form Fda Vaers-2.0 - Vaccine Adverse Event Reporting System printable pdf download

Adverse events are possible reactions or problems that occur during or after vaccination.

VAERS

Vaccine Adverse Event Reporting System

Items 2, 3, 4, 5, 6, 17, 18 and 21 are ESSENTIAL and should be completed.

Patient identity is kept confidential. Instructions are provided on the last two pages.

INFORMATION ABOUT THE PATIENT WHO RECEIVED THE VACCINE (Use Continuation Page if needed).

1. Patient name:

9. Prescriptions, over-the-counter medications, dietary supplements, or

(first)

(last)

herbal remedies being taken at the time of vaccination:

Street address:

City:

State:

County:

(

)

ZIP code:

Phone:

Email:

10. Allergies to medications, food, or other products:

2. Date of birth:

3. Sex:

�

Male

�

Female

�

Unknown

(mm/dd/yyyy)

�AM

4. Date and time of vaccination:

11. Other illnesses at the time of vaccination and up to one month prior:

hh:mm

(mm/dd/yyyy)

Time:

�PM

�AM

5. Date and time adverse event started:

hh:mm

(mm/dd/yyyy)

Time:

�PM

6. Age at vaccination:

Years

Months 7. Today’s date:

12. Chronic or long-standing health conditions:

(mm/dd/yyyy)

8. Is the report about vaccine(s) given to a pregnant woman?:

Unknown

Yes

�

(If yes, describe the event, any pregnancy complications, and estimated due date if known in item 18).

INFORMATION ABOUT THE PERSON COMPLETING THIS FORM

INFORMATION ABOUT THE FACILITY WHERE VACCINE WAS GIVEN

13. Form completed by:

15. Facility/clinic name:

16. Type of facility:

(name)

(Check one).

�

Doctor’s office or hospital

Relation to patient:

Healthcare professional/staff

Patient

�

(yourself)

�

Pharmacy or drug store

Fax:

(

)

�

Parent/guardian/caregiver

�

Other:

Street address:

� Check if same as item 13.

�

Workplace clinic

Street address:

� Check if same as item 1.

�

Public health clinic

City:

State:

ZIP code:

�

Nursing home or senior living facility

(

)

Phone:

Email:

City:

�

School/student health clinic

14. Best doctor/healthcare

Name:

State:

ZIP code:

�

Other:

professional to contact

Phone:

Ext:

(

)

about the adverse event:

(

)

�

Unknown

Phone:

WHICH VACCINES WERE GIVEN? WHAT HAPPENED TO THE PATIENT?

17. Enter all vaccines given on the date listed in item 4:

(Route is HOW vaccine was given, Body site is WHERE vaccine was given).

Use Continuation Page if needed.

Dose no.

Vaccine

Manufacturer

Lot number

Route

Body site

in series

(type and brand name)

select

18. Describe the adverse event(s), treatment, and outcome(s), if any:

21. Result or outcome of adverse event(s):

(symptoms, signs, time course, etc.)

(Check all that apply).

�

Doctor or other healthcare professional office/clinic visit

�

Emergency room or emergency department visit

�

Hospitalization: Number of days

(if known)

Hospital name:

City:

State:

�

Prolongation of existing hospitalization

(vaccine received during existing hospitalization)

�

Life threatening illness

Use Continuation Page if needed.

(immediate risk of death from the event)

�

Disability or permanent damage

19. Medical tests and laboratory results related to the adverse event(s):

(include dates)

�

Patient died: Date of death

(mm/dd/yyyy)

�

Congenital anomaly or birth defect

Use Continuation Page if needed.

�

None of the above

20. Has the patient recovered from the adverse event(s)?:

�

Yes

�

Unknown

ADDITIONAL INFORMATION (Use Continuation Page if needed).

22. Any other vaccines received within one month prior to the date listed in item 4:

Dose no.

Vaccine

Manufacturer

Lot number

Route

Body site

in series

(type and brand name)

select

23. Has the patient ever had an adverse event following any previous vaccine?:

(If yes, describe adverse event, patient age at vaccination, vaccination dates, vaccine type, and brand name).

�

Unknown

�

Yes

24. Patient’s race:

�

American Indian or Alaska Native

�

Asian

�

Black or African American

�

Native Hawaiian or Other Pacific Islander

(Check all that apply).

�

White

�

Unknown

�

Other:

25. Patient’s ethnicity:

Unknown 26. Immuniz. proj. report no.:

�

Hispanic or Latino

�

Not Hispanic or Latino

�

(Health Dept use only).

COMPLETE ONLY FOR U.S. MILITARY/DEPARTMENT OF DEFENSE (DoD) RELATED REPORTS

28. Vaccinated at Military/DoD site:

�

Yes

�

27. Status at vaccination:

�

Active duty

�

Reserve

�

National Guard

�

Beneficiary

�

Other:

FORM FDA VAERS-2.0 (6/17)

Form Fda Vaers-2.0 - Vaccine Adverse Event Reporting System

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