FORM FDA VAERS-2.0 (9/15)

DRAFT

VAERS Vaccine Adverse Event Reporting System

www.vaers.hhs.gov

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

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

INFORMATION ABOUT THE PATIENT WHO RECEIVED THE VACCINE

1. Patient name: (First) (Last) 9. Prescriptions, over-the-counter medications, dietary supplements or 

herbal remedies being taken at time of vaccination: Street address: 

City: State: County: 

ZIP code: Tele: ( ) Email: 10. Allergies to medications, food, or other products:

2. Date of birth: (mm/dd/yyyy) 3. Sex: � Male � Female � Unknown

4. Date and time of vaccination: (mm/dd/yyyy) Time: 11. Other illness at the time of vaccination and up to one month prior:

5. Date and time adverse event started: (mm/dd/yyyy) Time: 

6. Age at vaccination: Years Months 7. Today’s date: (mm/dd/yyyy) 12. Chronic or long-standing health conditions:

8. Report is about vaccine administered to a pregnant woman: 

� No or unknown � Yes, estimated or actual date of delivery: (mm/dd/yyyy)

INFORMATION ABOUT FACILITY WHERE VACCINE WAS GIVEN

15. Facility/clinic name: 16. Type of facility: 

� Doctor’s office or hospital

� Pharmacy or drug store

� Workplace clinic

� Public health clinic

� Nursing home or senior living facility

� School/student health clinic

� Other:

� Unknown

Fax: ( )

Street address: � Check if same as no. 13

City:

State: ZIP code:

Tele: ( )

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 INFORMATION ABOUT THE PERSON COMPLETING THIS FORM

13. Form completed by: (Name)

Relation to patient: � Healthcare professional/staff � Patient (yourself)

� Parent/guardian/caregiver � Other:

Street address: � Check if same as no. 1

City: State: ZIP code:

Tele: ( ) Fax: ( )

14. Best doctor/healthcare 

professional to contact 

about the patient:

Name:

Tele: ( ) Ext:

/

FOR U.S. MILITARY/DEPT OF DEFENSE (DoD) RELATED REPORTS (Complete only if applicable)

27. Status at time of vaccination: � Active duty � Reserve � National Guard � Other: 28. Vaccinated at Military/DoD site: � Yes � No

ADDITIONAL INFORMATION

22. Any other vaccines received within one month prior to the date listed in no. 4: Use Continuation Page for no. 22, if necessary Dose no. 

Vaccine (type and brand name) Manufacturer Lot number Route Body site in series

23. Has the patient ever had an adverse event following any previous vaccine: (If yes, describe and include patient age, vaccination dates, and vaccine type and brand name)

� No or unknown � Yes

24. Patient’s race:

(Check all that apply)

� American Indian or Alaska Native � Asian � Black or African American � Native Hawaiian or Other Pacific Islander

� White � Unknown � Other:

25. Patient’s ethnicity � Hispanic or Latino � Not Hispanic or Latino � Unknown 26. Immuniz. proj. report no.: (Health Dept use only)

�AM

�PM

�AM

�PM

WHAT VACCINES WERE GIVEN? WHAT HAPPENED TO THE PATIENT?

17. Enter all vaccines given on date listed in no. 4: (Route is HOW vaccine was given, body site is WHERE vaccine was given) Use Continuation Page for no. 17, if necessary Dose no. 

Vaccine (type and brand name) Manufacturer Lot number Route Body site in series

18. Describe event(s), treatment and outcome(s), if any: (symptoms, signs, time course, etc.,) 21. Result or outcome of event: (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

19. Medical tests and laboratory results related to event(s): (Include dates) � Disability or permanent damage

� Patient died: Date of death (mm/dd/yyyy)

� Congenital anomaly or birth defect

20. Patient has recovered from event: � Yes � No � Unknown � None of the above
FORM FDA VAERS-2.0 (9/15)

DRAFT 

17. Enter all vaccines given on date listed in no. 4 (CONTINUED): Dose no. 

Vaccine (type and brand name) Manufacturer Lot number Route Body site in series

22. Any other vaccines received within one month prior to the date listed in no. 4 (CONTINUED): Dose no. 

Vaccine (type and brand name) Manufacturer Lot number Route Body site in series

Use the space below to provide any additional information:

VAERS CONTINUATION PAGE (Use only if you need more space from front page)
DRAFT

GENERAL INSTRUCTIONS 

y Submit this form electronically using the internet. For instructions, visit www.vaers.hhs.gov/esub/index. 

y If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366.

y If you experience difficulties you may call the VAERS toll-free information line at 1-800-822-7967.

y Fill out the VAERS form as completely as possible. Use a separate VAERS form for each patient. 

y If you do not know exact numbers, dates or times, please provide your best guess (you may leave these spaces blank if you are 

not comfortable guessing). 

y Please report all significant adverse events that occur after vaccination of adults and children, even if you are not sure whether 

the vaccine caused the adverse event.

y Healthcare professionals should refer to the VAERS Table of Reportable Events at www.vaers.hhs.gov/reportable.htm for the 

list of adverse events that must be reported by law (42 USC 300aa-25). 

y Healthcare professionals treating a patient for a suspected vaccine adverse event may need to contact the person who 

administered the vaccine in order to exchange information and decide how to best complete and submit the VAERS form. 

SPECIFIC INSTRUCTIONS

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

y Items 4 and 5: Provide dates and times as specifically as you can and enter as much information as possible (e.g., enter the 

month and year even if you don’t know the day). If you do not know the exact time, but know if it was in the morning (“AM”) or 

afternoon or evening (“PM”), please provide that information. 

y Item 6: Provide age in years for people who are 24 months or older (2 years or older). If a child is less than 1 year old, provide 

months of age. If a child is more than 1 year old but less than 2 years old, list year and months (e.g., 1 year 6 months).

y Item 8: If report is about a vaccine given to a pregnant woman, select “Yes” and describe pregnancy history, estimated date of 

delivery, birth weight of child if available, and the adverse event in no. 18. Otherwise, check “No or unknown.”

y Item 9: List any prescriptions, over-the-counter medications, dietary supplements, or other non-traditional/alternative medicines 

being taken when the vaccine(s) was given. 

y Item 10: List any allergies to medications, foods, or other products.

y Item 11: List any short-term or acute illnesses the patient had on the date the vaccine(s) was given AND up to one month prior 

to this date (e.g. cold, stomach flu, ear infection, etc.). This does NOT include the adverse event you are reporting. 

y Item 12: List any chronic or long-standing health conditions the patient has (e.g., asthma, diabetes, heart disease).

y Item 13: State the name of the person who is completing the form. Select “Check if same as no. 1” box if you are the patient 

or if you live at the same address as the patient. The contact information you provided in no. 1 will be automatically entered for 

you. Otherwise, please provide new contact information. 

y Item 15: Select “Check if same as no. 13” box if the person completing the form works at the facility where the vaccine(s) 

was given. The contact information provided in no. 13 will be automatically entered for you. Otherwise, provide new contact 

information. 

y Item 16: Select the single best answer for the type of facility where the vaccine(s) was given. 

y Item 17: Include only vaccines given on the date listed in no. 4. For vaccines given as a series (i.e., 2 or more doses of the 

same vaccine given to complete a series), list the dose number for the vaccine in the last column named “Dose no. in series” 

(e.g., if this is the second time you are getting the same vaccine, write “2”).

COMPLETING THE VAERS FORM
DRAFT

y Item 18: Describe the adverse event(s), treatment and outcome(s). Include signs and symptoms, when the symptoms occurred, 

diagnosis, and treatment. Provide specific information if you can (e.g., if patient had a fever, provide the temperature).

y Item 19: List any medical tests and laboratory results related to the adverse event(s). Include abnormal findings as well as 

normal or negative findings. 

y Item 20: Select “Yes” if the patient’s health is the same as it was prior to the vaccine or “No” if the patient has not returned 

to the same state of health as before the vaccine, and provide details in no. 18. Select “Unknown” if the patient’s present 

condition is not known.

y Item 21: Select the result(s) or outcome(s) for the patient. If the patient did not have any of the outcomes listed, select “None 

of the above.” Prolongation of existing hospitalization means the patient was hospitalized and received a vaccine during their 

hospital stay. An adverse event following vaccination occurred and resulted in the patient spending extra time in the hospital. 

Life threatening illness means you believe this event could have resulted in the death of the patient.

y Item 22: List any other vaccines the patient received within one month prior to the vaccination date listed in no. 4.

y Item 23: List adverse events following any previous vaccine(s). Include patient age at vaccination, dates of vaccination, vaccine 

type and brand name. 

y Item 24: Check all races that apply.

y Item 25: Check the single best answer for ethnicity. 

y Item 26: This is for health department use only. 

y Items 27 and 28: These items should only be completed if the patient is associated with the U.S. Military or Department of 

Defense.

GENERAL INFORMATION 

y VAERS (www.vaers.hhs.gov) is a national vaccine safety monitoring system that collects information about adverse events 

(possible reactions or problems) that occur after administration of vaccines licensed in the United States.

y VAERS protects patient identity and keeps patient identifying information confidential. 

y 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 vaccinated person or legal representative.

y The HIPAA Privacy Rule permits reporting of protected health information to public health authorities including CDC and FDA 

(45 CFR § 164.512(b)).

y VAERS accepts all reports without judging the importance of the adverse event or whether a vaccine caused the adverse event. 

y Acceptance of a VAERS report by CDC and FDA does not constitute admission that the vaccine or healthcare personnel caused 

or contributed to the reported event. 

y VAERS is primarily concerned with monitoring adverse health events. Using clinical judgment, healthcare professionals can 

decide whether or not to report a medical error at their own discretion. 

y The National Vaccine Injury Compensation Program (VICP) is administered by the Health Resources and Services Administration 

(HRSA). The VICP is separate from the VAERS program and reporting an event to VAERS does not constitute filing a claim for 

compensation to the VICP (see www.hrsa.gov/vaccinecompensation/index.html). 

y Knowingly filing a false VAERS report with the intent to mislead the Department of Health and Human Services is a violation of 

Federal law (18 U.S. Code § 1001) punishable by fine and imprisonment.