COVID-19 (coronavirus 2019, 5y-11) bivalent booster vaccine, Pfizer

What is the most important information I should know about this vaccine?

What is the COVID-19 vaccine?

COVID-19 is a serious disease caused by a coronavirus called SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). COVID-19 is spread from person to person through the air.

COVID-19 can affect your child's lungs or other organs. Symptoms may be mild or serious and include fever, chills, cough, sore throat, shortness of breath, tiredness, body aches, headache, loss of taste or smell, runny or stuffy nose, nausea, vomiting, or diarrhea.

The COVID-19 bivalent booster vaccine is used to help prevent severe disease and death from COVID-19 caused by SARS-CoV-2.

The FDA has authorized emergency use of the Pfizer bivalent booster vaccine in people who are 5 years and older.

COVID-19 vaccine does not contain coronavirus and cannot give your child COVID-19. This vaccine will not treat an active COVID-19 infection.

Like any vaccine, COVID-19 vaccine may not provide protection in every person.

What should I discuss with my healthcare provider before receiving this vaccine?

If your child is infected with COVID-19, is waiting for testing results, or is exposed to someone infected with COVID-19: Your child may not be able to receive this vaccine until he/she has no symptoms and/or his/her required quarantine period has ended. Receiving this vaccine will not make your child less contagious to other people if he/she is infected with COVID-19 but he/she has no symptoms.

Ask your child's doctor if you are unsure about any COVID-19 treatments your child received.

Tell your child's vaccination provider if:

• he/she has a fever;
• he/she has any allergies;
• he/she has had inflammation in or around the heart (myocarditis or pericarditis);
• he/she has bleeding problems, or if he/she uses a blood thinner (warfarin, Coumadin, Jantoven);
• he/she has a weak immune system caused by disease or by using certain medicine;
• he/she is pregnant, or breastfeeding;
• he/she has received any other COVID-19 vaccine; or
• he/she has fainted after receiving an injection.

How is this vaccine given?

Read all vaccine information sheets provided to you.

The Pfizer COVID-19 bivalent booster vaccine is given as a single injection (shot) at least 2 months after:

• primary vaccination is complete with any authorized or approved monovalent COVID-19 vaccine; or
• receiving the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

Your child's doctor or vaccination provider will determine whether he/she needs a booster dose.

You will receive a reminder card showing the date and type of each injection. Take this card with you each time your child receives a COVID-19 vaccine.

Receiving a COVID-19 vaccine will not cause your child to test positive on a coronavirus test. However, once his/her body develops immunity to COVID-19, your child could test positive on an antibody test (a test to detect immunity in the body from previous exposure to coronavirus).

It is not known how long this vaccine will protect your child from infection with COVID-19. It also is not known how long immunity will last in a person who's been infected with and recovered from COVID-19. COVID-19 vaccine is still being studied and all of its risks are not yet known. Updated federal public health recommendations may be found at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html

What happens if I miss a dose?

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid after receiving this vaccine?

Avoid receiving other vaccines without first seeking medical advice.

What are the possible side effects of this vaccine?

Your child's vaccination provider may want to watch him/her for a short time after the shot, to make sure your child does not have an allergic reaction. Your child will be treated quickly if he/she has a reaction right after he/she receives the vaccine.

Your child should not receive this vaccine if the first shot of COVID-19 vaccine caused an allergic reaction. The doctor or vaccination provider will determine if your child can safely receive this vaccine.

Not all possible side effects are known. Becoming infected with COVID-19 is much more dangerous to your child's health than receiving this vaccine.

• chest pain;
• shortness of breath; or
• fast or pounding heartbeats or fluttering in the chest.

Common side effects may include:

• fever, chills;
• redness or a hardness and swelling where the shot was given;
• swelling or tenderness under the arm;
• nausea, vomiting;
• feeling tired; or
• headache, muscle pain, joint pain.

This is not a complete list of side effects and others may occur. Call the doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

You may also use a smartphone-based program called V-safe to communicate with the Centers for Disease Control and Prevention (CDC) about any health problems your child has after receiving a COVID-19 vaccine: www.cdc.gov/vsafe.

What other drugs will affect this vaccine?

Before receiving this vaccine, tell the vaccination provider about all other vaccines your child has received and all medicines your child uses. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Where can I get more information?

The vaccination provider, pharmacist, or doctor can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.