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VACCINATION CONSENT FORM Pfizer-BioNTech COVID-19 Vaccine (Texas Secretary of State)

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VACCINATION CONSENT FORM
Pfizer-BioNTech COVID-19 Vaccine
The novel coronarvirus SARS-CoV-2 (a/k/a COVID-19) is an infectious disease that appeared in late 2019. 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 at this time.
I request that the Pfizer-BioNTech COVID-19 Vaccine be given to me or to the person named hereafter for
whom I am authorized to make this request (select one): ☐ MYSELF ☐ PERSON NAMED BELOW
Recipient’s Information:
Last Name First Name Date of Birth Gender
Address:
City: State: Zip:
Authorized Individual’s Information (complete if different from vaccine recipient):
Last Name First Name Date of Birth Gender
Address:
City: State: Zip:
Relationship to recipient:
Vaccine is for (check one): ☐ Physician ☐ Contractor ☐ Employee ☐ Volunteer ☐ Other:
Company/Organization:
ACKNOWLEDGEMENTS (INITIAL EACH STATEMENT):
Prior to vaccination, I was given a copy of the FDA’s Fact Sheet for Recipients and Caregivers in
connection with the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine
or was directed to the FDA’s COVID-19 vaccination website at: Pfizer-BioNTech COVID-19 Vaccine |
cvdvaccine.com.
FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine, which is not an
FDA-approved vaccine.
The recipient or their caregiver has the option to accept or refuse Pfizer-BioNTech COVID-19 Vaccine.
The significant known and potential risks and benefits of Pfizer-BioNTech COVID-19 Vaccine, and the
extent to which such risks and benefits are unknown, have been disclosed to me. Information about
available alternative vaccines and the risks and benefits of those alternatives, to the extent reasonably
known, have been disclosed to me.
The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.3
mL each) 3 weeks apart. Recipients must receive both doses of the Pfizer-BioNTech COVID-19
Vaccine to complete vaccination.
Recipient is 16 years of age or older.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have
a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.
Vaccine may not protect all vaccine recipients.
The Pfizer-BioNTech COVID-19 Vaccine includes the following ingredients: mRNA, lipids ((4-
hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-
ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3- phosphocholine, and cholesterol), potassium
chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and
sucrose.
I have read or have had explained to me the information identified in the FDA’s Fact Sheet for
Recipients and Caregivers regarding the Pfizer-BioNTech COVID-19 Vaccine. I have had an
opportunity to discuss the benefits and risks of this COVID-19 vaccine with a healthcare provider of my
choice before vaccination. I have had a chance to ask questions which were answered to my
satisfaction.
I believe I understand the benefits and risks of this vaccine and ask that this vaccine be given to me or
the person named for whom I am authorized to make this request.
MEDICAL SCREENING QUESTIONS: Check yes or no to each question below. Tell your vaccination provider
about all your medical conditions, including if you answer “yes” to any question. Except for the last two (2) questions,
a “yes” response to any other question means you may wish to consult with your individual healthcare provider
before proceeding. Answering “yes” to either of the last two (2) questions means you should not be vaccinated
today.
Question
Yes
No
Do you have any allergies?
Do you have a fever?
Do you have a bleeding disorder or are on a blood thinner?
Are you immunocompromised or are you on a medicine that affects your immune
system?
Are you pregnant or plan to become pregnant?
Are you breastfeeding?
Have you received another COVID-19 vaccine?
Have you had a severe allergic reaction after a previous dose of this vaccine?
Have you had a severe allergic reaction to any ingredient of this vaccine?
Signature of Recipient OR Recipient’s Authorized Individual Date
DO NOT WRITE IN THIS SPACE—OFFICE USE ONLY VIS Edition Provided:
Vaccine: Administration Date:
Manufacturer: Lot #:
Exp. Date: Route:
Site: Volume (ml):
Nurse/ Provider’s Signature Date Time
click to sign
signature
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signature
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1 Revised: December 2020
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 of
COVID-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 to
prevent 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 the
Pfizer-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 of
coronavirus has not been seen before. You can get COVID-19 through contact with
another person who has the virus. It is predominantly a respiratory illness that can
affect 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 of taste 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.
2 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 an Emergency 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 BEFORE
YOU GET THE PFIZER-BIONTECH COVID-19 VACCINE?
Tell the vaccination provider about all of your medical conditions, including if
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 system
are pregnant or plan to become pregnant
are breastfeeding
have received another COVID-19 vaccine
WHO SHOULD GET THE PFIZER-BIONTECH COVID-19 VACCINE?
FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine in
individuals 16 years of age and older.
WHO SHOULD NOT GET THE PFIZER-BIONTECH COVID-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)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2
[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-
phosphocholine, and cholesterol), potassium chloride, monobasic potassium
phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.
HOW IS THE PFIZER-BIONTECH COVID-19 VACCINE GIVEN?
The Pfizer-BioNTech COVID-19 Vaccine will be given to you as an injection into the
muscle.
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.
3 Revised: December 2020
HAS THE PFIZER-BIONTECH COVID-19 VACCINE BEEN USED BEFORE?
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 COVID-19 VACCINE?
In an ongoing clinical trial, the Pfizer-BioNTech COVID-19 Vaccine has been shown to
prevent 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 a
severe 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.
4 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 to
https://vaers.hhs.gov/reportevent.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.
Website Fax number Telephone number
www.pfizersafetyreporting.com 1-866-635-8337 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 BESIDES
PFIZER-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 OTHER
VACCINES?
There is no information on the use of the Pfizer-BioNTech COVID-19 Vaccine with
other vaccines.
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 to
return for your second dose of Pfizer-BioNTech COVID-19 Vaccine. Remember to bring
your card when you return.
5 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
ebsite
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.gov/coronavirus/2019-ncov/index.html.
Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-
legal-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 IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html.
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
who have been seriously injured by certain medicines or vaccines, including this
vaccine. Generally, a claim must be submitted to the CICP within one (1) year from the
date 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. In
addition, 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
pandemic and that the known and potential benefits of the product outweigh the known
6 Revised: December 2020
and potential risks of the product. All of these criteria must be met to allow for the
product 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 the
COVID-19 EUA declaration justifying emergency use of these products, unless
terminated or revoked (after which the products may no longer be used).
Manufactured by
Pfizer Inc., New York, NY 10017
Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany
LAB-1451-1.0
Revised: December 2020
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VACCINATION CONSENT FORM Pfizer-BioNTech COVID-19 Vaccine (Texas Secretary of State)

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Completed 29 May 2021

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