Injection given February 20th 2021 COVID - 19

“Fact Sheet For recipients and Caregivers”

Patient:  Ms. Marie Sylvia Ann Bonaparte

Birthday: February 1955

~~~ Please Read My Day by Day in Comments~~~~

EMERGENCY USE AUTHORIZATION (EUA) OF THE PRIZER-BIONTECH COVID – 19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVIDE-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 not 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.

                                                                                                     Revised: December   2020

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 14days 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. 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 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.

                                                                                                       Revised: December 2020

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 sever allergic reaction to any ingredient of the 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-phosphoscholine, 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 week later to complete the vaccination series.

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?

Side effects that have been reposted with the Pfizer-BioNTech COVID-19 Vaccine include:

                                                                                                          Revised: December 2020

·      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.  For this reason, 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 Pfizer – BioNTech COVID -19 Vaccine.  Serious and unexpected side effects may occur.   Pfizer-BioNTech  COVID-19 Vaccine is till being studied in clinical trials

WHAT SHOULD I DO ABOUT SIDE EFFECTS?                                                                                                            

If you experience 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.

Complete and submit reports to VAER at                                                                                                   https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800—822-7967. 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 provide below.

                      Website                                 Fax number                          Telephone number

www.pfizersafetyreporting.com                  1-866-635-8337                           1-800-438-1985

You may also be given an option to enroll in v-safe.  V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have be vaccinated to identify potential side effects after COVID-19 vaccines. V-safe 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.

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.                 

Other vaccines to prevent COVID – 19 may be available under Emergency Use Authorization.

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 O R 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 you second dose of Pfizer-BioNTech 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.

             Global website                                              Telephone number                    www.cvdvaccine.com               1-877-829-2619                                                     (1-877-VAX-CO19 )

                                                                                                         Revised: December 2020

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 products. 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 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 pandemics.

The EUA for the Pfizer-BioNTech COVID – 19 Vaccine is in effect for the duration of the COVID – 19 declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).

                                                                                                           Revised: December 2020

Pfizer

(212) 733-2323

Manufactured by

235 East 42nd Street

Pfizer Inc., New York, NY 10017

BIONTECH

Manufactured for

BioNTech Manufacturing GmbH

An der Goldgrub   12

55131 Mainz, Germany

LAB-1451-1.1

Revised: December 2020