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COVID-19 VACCINE SCREENING AND CONSENT FORM Moderna COVID-19 (Sabine County Hospital)

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COVID-19 (01/2021)
COVID-19 VACCINE SCREENING AND CONSENT FORM
Moderna COVID-19 Vaccine
SECTION 1: INFORMATION ABOUT YOU (PLEASE PRINT)
Last Name
Date of Birth
Age in Years
Sex (Gender assigned at birth)
Male Female
Month
Day
Year
Race
American Indian or Alaska Native Native Hawaiian or Other Other Asian Other
Asian Pacific Islander Other Nonwhite
Black or African American White Other Pacific Islander
Ethnicity
Hispanic or Latino
Not Hispanic or Latino
Unknown
Address
State
Zip Code
Cell Phone Number
Is this the patient’s first or second dose of the COVID-19 vaccination? First Dose Second Dose
SECTION 2: COVID-19 SCREENING QUESTIONS
Please check YES or NO for each question.
YES
NO
1. Are you sick today?
2. Have you had a severe allergic reaction to a previous dose of this vaccine or to any of the ingredients of this vaccine?
3. Do you carry an Epi-pen for emergency treatment of anaphylaxis?
4. For women, are you pregnant or is there a chance you could become pregnant?
5. For women, are you breastfeeding?
6. Have you had any other vaccinations in the previous 14 days?
7. In the past 90 days, have your received monoclonal antibodies or been diagnosed with COVID-19?
8. Have you had, in the last 10 days, fever, chills, cough, shortness of breath, difficulty breathing, fatigue, muscle or body aches,
headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, or diarrhea?
SECTION 3: IMMUNIZATION SCREENING GUIDANCE FOR COVID-19 VACCINE
Please check YES or NO for each question.
YES
NO
9. Do you have allergies or reactions to any medications, foods, vaccines, or latex? Please explain:
10. Are you immunocompromised or on a medicine that affects your immune system?
11. Do you have a bleeding disorder or are you on a blood thinner/blood-thinning medication?
12. Have you received a previous dose of any COVID-19 vaccine? If yes, please indicate which manufacturer's vaccine you received
and date the dose was administered:
Moderna COVID-19 vaccine
Pfizer-BioNTech COVID-19 vaccine
13. Did you experience a non-severe allergic reaction within 4 hours of a previous dose of COVID-19 vaccine? Non-severe allergic
reactions can include: hives, swelling, redness, wheezing, GI symptoms, etc)? If yes, please explain:
Date administered:
_________________________
First Name
Middle
Initial UTSA ID (abc123)
•
I certify that I am: (a) the patient and at least 18 years of age; (b) the parent or legal guardian of the patient and confirm
that the patient is at least 16 years of age; or (c) authorized to consent for vaccination for the patient named above.
Further, I hereby give my consent to the Sabine County Hospital (SCH) or their agents to administer the COVID-19
vaccine.
•
I understand that this product has not been approved or licensed by FDA, but has been authorized for emergency use by
FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 18 years of age and older; and
the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying
the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
•
I understand that it is not possible to predict all possible side effects or complications associated with receiving
vaccine(s). I understand the risks and benefits associated with the above vaccine and have received, read and/or had
explained to me the Emergency Use Authorization Fact Sheet on the COVID-19 vaccine I have elected to receive. I also
acknowledge that I have had a chance to ask questions and that such questions were answered to my satisfaction. I also
understand the need for continued masking/social distancing after receiving the COVID-19 vaccination
•
I acknowledge that I have been advised to remain near the vaccination location for approximately 15 minutes
after administration for observation and possibly up to 30 minutes if medical provider deems necessary. If I experience a
severe reaction, I will call 9-1-1 or go to the nearest hospital.
•
I acknowledge that: (a) I understand the purposes/benefits of ImmTrac2, Texas immunization registry and (b) TxDSHS will
include my personal immunization information in ImmTrac2 registry and my personal immunization information will be
shared with the Centers for Disease Control (CDC) or other federal agencies.
•
I acknowledge receipt of the Notice of Privacy Rights.
•
I voluntarily elect to receive the COVID-19 vaccination at SCH after carefully considering the risks and benefits.
•
SCH advised me to consult with my medical provider to discuss my personal risks, benefits, and potential side effects of
receiving the COVID-19 vaccination.
•
I understand that the COVID-19 vaccinations given at SCH will be tracked and reported to ImmTrac, and as otherwise
required by the local, state and federal government.
Signature of Patient or Authorized Representative: Date:
Print Name of Representative and Relationship to Person Receiving Vaccine:
Site
(LD/RD)
Route Manufacturer Lot #Unit of Use/ Unit of Sale Expiration Date
Date of EUA Fact Sheet
Administered by:
Sabine County Hospital
Location Address:
2301 Worth Street Hemphill, Texas 75948
Clinic Phone Number:
409-787-1416
Vaccinator
(Print Name):
Signature: Date:
Vaccine Administering Provider Suffix:
F
or Registration Purposes Only - Patient Will NOT be Billed
Insurance Type: _____________________________
Insured: ___________________________________
Group #: ___________________________________
F
or Registration Purposes Only - Emergency Contact/Next of Kin
Contact Name: ___________________________________
Phone Number: ___________________________________
Relationship: _____________________________________
click to sign
signature
click to edit
R
evised: 12/2020 1
FACT SHEET FOR RECIPIENTS AND CAREGIVERS
EMERGENCY USE AUTHORIZATION (EUA) OF
THE MODERNA COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019
(COVID-19) IN INDIVIDUALS 18 YEARS OF AGE AND OLDER
You are being offered the Moderna 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 Moderna COVID-19 Vaccine, which you may receive
because there is currently a pandemic of COVID-19.
The Moderna 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 Moderna COVID-19 Vaccine. Talk to the
vaccination provider if you have questions. It is your choice to receive the Moderna COVID-19
Vaccine.
The Moderna COVID-19 Vaccine is administered as a
2-dose series, 1 month apart, into the
muscle.
The Moderna COVID-19 Vaccine may not protect everyone.
This Fact Sheet may have been updated. For the most recent Fact Sheet, please visit
www.modernatx.com/covid19vaccine-eua.
WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE
WHAT IS COVID-19?
COVID-19 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 MODERNA COVID-19 VACCINE?
The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There
is no FDA-approved vaccine to prevent COVID-19.
The FDA has authorized the emergency use of the Moderna COVID-19 Vaccine to prevent
COVID-19 in individuals 18 years of age and older under an Emergency Use Authorization
(EUA).
For more information on EUA, see the “What is an Eme rge ncy Use Authorization (EUA)?”
section at the end of this Fact Sheet.
Revised: 12/2020 2
WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE
YOU GET THE MODERNA COVID-19 VACCINE?
Tell your 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 MODERNA COVID-19 VACCINE?
FDA has authorized the emergency use of the Moderna COVID-19 Vaccine in individua ls 18
years of age and older.
WHO SHOULD NOT GET THE MODERNA COVID-19 VACCINE?
You should not get the Moderna 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 MODERNA COVID-19 VACCINE?
The Moderna COVID-19 Vaccine contains the following ingredients: messenger ribonucleic acid
(mRNA), lipids (SM-102, polyethylene glycol [P EG] 2000 dimyristoyl glycerol [DMG],
cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine,
tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose.
HOW IS THE MODERNA COVID-19 VACCINE GIVEN?
The Moderna COVID-19 Vaccine will be given to you as an injection into the muscle.
The Moderna COVID-19 Vaccine vaccination series is 2 doses
given 1 month apart.
If you receive one dose of the Moderna COVID-19 Vaccine, you should receive a second dose of
the same vaccine 1 month later to complete the vaccination series.
HAS THE MODERNA COVID-19 VACCINE BEEN USED BEFORE?
The Moderna COVID-19 Vaccine is an unapproved vaccine. In clinical trials, approximately
15,400 individua ls 18 years of age and older have received at least 1 dose of the Moderna
COVID-19 Vaccine.
WHAT ARE THE BENEFITS OF THE MODERNA COVID-19 VACCINE?
In an ongoing clinical trial, the Moderna COVID-19 Vaccine has been shown to prevent
COVID-19 following 2 doses given 1 month apart. The duration of protection against COVID-19
is currently unknown.
Revised: 12/2020 3
WHAT ARE THE RISKS OF THE MODERNA COVID-19 VACCINE?
Side effects that have been reported with the Moderna COVID-19 Vaccine include:
• Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm
of the injection, swelling (hardness), and redness
• General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and
vomiting, and fever
There is a remote chance that the Moderna 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 Moderna COVID-19 Vaccine. For this reason, your vaccination provider
may ask you to stay at the place where you received your vaccine for monitoring after
vaccination. 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 Moderna COVID-19 Vaccine. Serious and
unexpected side effects may occur. The Moderna COVID-19 Vaccine is still being studied in
clinical tria ls.
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.
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 “Moderna COVID-19 Vaccine EUA” in
the first line of box #18 of the report form.
In addition, you can report side effects to ModernaTX, Inc. at 1-866-MODERNA (1-866-663-
3762).
You may also be given an option to enroll in v-s afe . V-s afe is a new voluntary smartphone-based
tool that uses text messaging and web surveys to check in with people who have been vaccinated
to identify potential side effects after COVID-19 vaccination. V-s afe asks questions that help
CDC monitor the safety of COVID-19 vaccines. V-s afe also provides second-dose reminders if
needed and live telephone follow-up by CDC if participants report a significant health impact
following COVID-19 vaccination. For more information on how to sign up, visit:
www.cdc.gov/vsafe.
Revised: 12/2020 4
WHAT IF I DECIDE NOT TO GET THE MODERNA COVID-19 VACCINE?
It is your choice to receive or not receive the Moderna 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
MODERNA COVID-19 VACCINE?
Currently, there is no FDA-approved alternative vaccine available for prevention of COVID-19.
Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization.
CAN I RECEIVE THE MODERNA COVID-19 VACCINE WITH OTHER VACCINES?
There is no information on the use of the Moderna 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 MODERNA COVID-19 VACCINE GIVE ME COVID-19?
No. The Moderna COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you
COVID-19.
KEEP YOUR VACCINATION CARD
When you receive your first dose, you will get a vaccination card to show you when to return for
your second dose of the Moderna COVID-19 Vaccine. Remember to bring your card when you
return.
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.
Moderna COVID-19 Vaccine we bs ite
Te le phone numbe r
www.modernatx.com/covid19vaccine-eua
1-866-MODERNA
(1-866-663-3762)
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-lega l-
regulatory-and-policy-framework/emergency-use-authorization
• Contact your state or local public health department
Revised: 12/2020 5
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 Moderna 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 Moderna 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, and available alternatives. In addition, the FDA
decision is based on the totality of the 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 and potential risks of the product. All of
these criteria must be met to allow for the product to be used during the COVID-19 pandemic.
The EUA for the Moderna 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).
©2020 ModernaTX, Inc. All rights reserved.
Patent(s): www.modernatx.com/patents
Revise d: 12/2020
• Anytime you move or change healthcare providers
• Childcare
• School enrollment
• Traveling
• Military enlistment
• Employment in health and safety fi elds
• First responders and members of military families
• Anyone displaced by a natural disaster
Benefits of Participating in the
Texas Immunization Registry (ImmTrac2)
ImmTrac2 is Texas’ opt-in registry that stores immunization records for children
and adults in one convenient secure location.
The Texas Immunization Registry makes a lifetime of Immunization records
accessible for:
Everyone in the state of Texas can register for the Texas Immunization Registry. Adults,
18 years and older, must complete an ImmTrac2 Adult Consent Form to participate. For
adults consent is required one time and is valid for life, unless consent is withdrawn.
To register children 17 years and younger, parents or legal guardians must sign an
ImmTrac2 Minor Consent Form. Consent is required one time and is valid until a child
turns 18 years old. Once a person is 18 years old, they may submit an ImmTrac2 Adult
Consent Form or their childhood records are destroyed.
To learn more about ImmTrac2, visit www.dshs.texas.gov/immunize/immtrac, call
(800) 348-9158, or email ImmTrac2@dshs.texas.gov.
Stock No. 11-99999
Rev. 02/2020
Infancy Daycare
School
Employment
Travel Emergency
Who can partcipate?
Visit ImmTrac.com to download and complete the ImmTrac2 Adult Consent Form
(F11-13366) or Minor Consent Form (C-7).
Send your completed ImmTrac2 Adult or Minor Consent Form to your authorized
healthcare provider, Local Health Department, or DSHS ImmTrac2 Service Offi ces.
Where can I register?
Infancy
Daycare
School
Employment
Travel
Emergency
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COVID-19 VACCINE SCREENING AND CONSENT FORM Moderna COVID-19 (Sabine County Hospital)

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Completed 15 August 2021

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