FACT SHEET FOR RECIPIENTS AND CAREGIVERS
EMERGENCY USE AUTHORIZATION (EUA) OF
THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS
DISEASE 2019 (COVID-19)
IN INDIVIDUALS 16 YEARS OF AGE AND OLDER
You are being offered the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus
Disease 2019 (COVID-19) caused by SARS-CoV-2. This Fact Sheet contains
information to help you understand the risks and benefits of the Pfizer-BioNTech
COVID-19 Vaccine, which you may receive because there is currently a pandemic ofCOVID-19.
The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting
COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine toprevent COVID-19.
Read this Fact Sheet for information about the Pfizer-BioNTech COVID-19 Vaccine.
Talk to the vaccination provider if you have questions. It is your choice to receive thePfizer-BioNTech COVID-19 Vaccine.
The Pfizer-BioNTech COVID-19 Vaccine is administered as a 2-dose series, 3 weeks
apart, into the muscle.
The Pfizer-BioNTech COVID-19 Vaccine may not protect everyone.
This Fact Sheet may have been updated. For the most recent Fact Sheet, please see
www.cvdvaccine.com.
WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE?
WHAT IS COVID-19?
COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type ofcoronavirus has not been seen before. You can get COVID-19 through contact withanother person who has the virus. It is predominantly a respiratory illness that canaffect other organs. People with COVID-19 have had a wide range of symptoms
reported, ranging from mild symptoms to severe illness. Symptoms may appear 2
to 14 days after exposure to the virus. Symptoms may include: fever or chills;
cough; shortness of breath; fatigue; muscle or body aches; headache; new loss oftaste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

WHAT IS THE PFIZER-BIONTECH COVID-19 VACCINE?
The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent
COVID-19. There is no FDA-approved vaccine to prevent COVID-19.

1
Revised: December 2020

The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19
Vaccine to prevent COVID-19 in individuals 16 years of age and older under anEmergency Use Authorization (EUA).
For more information on EUA, see the "What is an Emergency Use Authorization(EUA)? " section at the end of this Fact Sheet.
WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFOREYOU GET THE PFIZER-BIONTECH COVID-19 VACCINE?
Tell the vaccination provider about all of your medical conditions, includingif you:•••••••

have any allergies
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects your immune
systemare pregnant or plan to become pregnant
are breastfeeding
have received another COVID-19 vaccine

WHO SHOULD GET THE PFIZER-BIONTECH COVID-19 VACCINE?0
FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine inindividuals 16 years of age and older.
WHO SHOULD NOT GET THE PFIZER-BIONTECH COV1D-19 VACCINE?
You should not get the Pfizer-BioNTech COVID-19 Vaccine if you:• had a severe allergic reaction after a previous dose of this vaccine• had a severe allergic reaction to any ingredient of this vaccine
WHAT ARE THE INGREDIENTS IN THE PFIZER-BIONTECH COVID-19
VACCINE?
The Pfizer BioNTech COVID-19 Vaccine includes the following ingredients: mRNA,lipids ((4-hydroxybutyl)azanediyObis(hexane-6,1-diy1)bis(2-hexyldecanoate), 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero3- phosphocholine, and cholesterol), potassium chloride, monobasic potassium
phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.
HOW IS THE PFIZER-BIONTECH COV1D-19 VACCINE GIVEN?
The Pfizer-BioNTech COVID-19 Vaccine will be given to you as an injection into themuscle.
The Pfizer-BioNTech COVID-19 Vaccine vaccination series is 2 doses given 3 weeks
apart.
If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive
a second dose of this same vaccine 3 weeks later to complete the vaccination series.
HAS THE PFIZER-BIONTECH COVID-19 VACCINE BEEN USED BEFORE?
2Revised: December 2020

The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine. In clinical trials,
approximately 20,000 individuals 16 years of age and older have received at least 1
dose of the Pfizer-BioNTech COVID-19 Vaccine.
WHAT ARE THE BENEFITS OF THE PFIZER-BIONTECH COV1D-19 VACCINE?
In an ongoing clinical trial, the Pfizer-BioNTech COVID-19 Vaccine has been shown toprevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection
against COVID-19 is currently unknown.
WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?
Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine
include:• injection site pain
• tiredness• headache• muscle pain
• chills• joint pain
• fever• injection site swelling• injection site redness• nausea• feeling unwell• swollen lymph nodes (lymphadenopathy)
There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause asevere allergic reaction. A severe allergic reaction would usually occur within a few
minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine.
Signs of a severe allergic reaction can include:• Difficulty breathing• Swelling of your face and throat• A fast heartbeat• A bad rash all over your body
• Dizziness and weakness
These may not be all the possible side effects of the Pfizer-BioNTech COVID-19
Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19
Vaccine is still being studied in clinical trials.
WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
Call the vaccination provider or your healthcare provider if you have any side effects
that bother you or do not go away.

3
Revised: December 2020

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System(VAERS). The VAERS toll-free number is 1-800-822-7967 or report online tohttps://vaers.hhs.govireportevent.html. Please include "Pfizer-BioNTech COVID-19
Vaccine EUA" in the first line of box #18 of the report form.
In addition, you can report side effects to Pfizer Inc. at the contact information provided
below.
Websitewww.pfizersafereporting.com

Fax number
1-866-635-8337

Telephone number
1-800-438-1985

WHAT IF I DECIDE NOT TO GET THE PFIZER-BIONTECH COVID-19 VACCINE?
It is your choice to receive or not receive the Pfizer-BioNTech COVID-19 Vaccine. Should
you decide not to receive it, it will not change your standard medical care.
ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDESPFIZER-BIONTECH COVID-19 VACCINE?
Currently, there is no approved alternative vaccine available for prevention of COVID-19.
FDA may allow the emergency use of other vaccines to prevent COVID-19.
CAN I RECEIVE THE PFIZER-BIONTECH COVID-19 VACCINE WITH OTHERVACCINES?
There is no information on the use of the Pfizer-BioNTech COVID-19 Vaccine with othervaccines.
WHAT IF I AM PREGNANT OR BREASTFEEDING?
If you are pregnant or breastfeeding, discuss your options with your healthcare provider.
WILL THE PFIZER-BIONTECH COVID-19 VACCINE GIVE ME COVID-19?
No. The Pfizer-BioNTech COVID-19 Vaccine does not contain SARS-CoV-2 and cannot
give you COVID-19.
KEEP YOUR VACCINATION CARD
When you get your first dose, you will get a vaccination card to show you when toreturn for your second dose of Pfizer-BioNTech COVID-19 Vaccine. Remember to bringyour card when you return.

4
Revised: December 2020

ADDITIONAL INFORMATION
If you have questions, visit the website or call the telephone number provided below.
To access the most recent Fact Sheets, please scan the QR code provided below.
Global website
Telephone number
www.cvdvaccine.com
1-877-829-2619(1-877-VAX-CO19)

HOW CAN I LEARN MORE?
• Ask the vaccination provider.
• Visit CDC at https://www.cdc.govicoronavirus/2019-ncov/index.html• Visit FDA at https://www.fda.qov/emergency-preparedness-and-response/mcmlegal-regulatory-and-policy-framework/emergency-use-authorization.
• Contact your local or state public health department.
WHERE WILL MY VACCINATION INFORMATION BE RECORDED?
The vaccination provider may include your vaccination information in your state/local
jurisdiction's Immunization Information System (IIS) or other designated system. This
will ensure that you receive the same vaccine when you return for the second dose. For
more information about 1lSs visit: htips://www.cdc.qov/vaccinesiprogramsiiisiabouthtml.
WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM?
The Countermeasures Injury Compensation Program(CICP) is a federal program that
may help pay for costs of medical care and other specific expenses of certain people whohave been seriously injured by certain medicines or vaccines, including thisvaccine. Generally, a claim must be submitted to the CICP within one (1) year from thedate of receiving the vaccine. To learn more about this program, visit
www.hrsa.gov/cicp/ or call 1-855-266-2427.
WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?
The United States FDA has made the Pfizer-BioNTech COVID-19 Vaccine available
under an emergency access mechanism called an EUA. The EUA is supported by a
Secretary of Health and Human Services (HHS) declaration that circumstances exist to
justify the emergency use of drugs and biological products during the COVID-19
pandemic.
The Pfizer-BioNTech COVID-19 Vaccine has not undergone the same type of review as an
FDA-approved or cleared product. FDA may issue an EUA when certain criteria are met,
which includes that there are no adequate, approved, available alternatives. Inaddition, the FDA decision is based on the totality of scientific evidence available
showing that the product may be effective to prevent COVID-19 during the COVID-19

5
Revised: December 2020

pandemic and that the known and potential benefits of the product outweigh the known
and potential risks of the product. All of these criteria must be met to allow for theproduct to be used in the treatment of patients during the COVID-19 pandemic.
The EUA for the Pfizer-BioNTech COVID-19 Vaccine is in effect for the duration of theCOVID-19 EUA declaration justifying emergency use of these products, unlessterminated or revoked (after which the products may no longer be used).

Manufactured by
Pfizer Inc., New York, NY 10017
Manufactured for
BioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz, Germany
LAB-1451-0.7
Revised: December 2020

6
Revised: December 2020