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 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 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 Moderna bivalent vaccine in people who are 6 months to 5 years.

COVID-19 vaccine does not contain coronavirus and cannot give you 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.

Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine.

Read all vaccine information sheets provided to you.

The Moderna COVID-19 bivalent vaccine is given to:

• unvaccinated people: two doses of Moderna COVID-19 bivalent vaccine. The second dose is given 1 month after the first dose.

• people who have received one dose of Moderna COVID-19 vaccine: a single dose of Moderna COVID-19 bivalent vaccine is given 1 month after the dose of Moderna COVID-19 vaccine.

• people who have received two doses of Moderna COVID-19 vaccine: a single dose of Moderna COVID-19 bivalent vaccine is given at least 2 months after the last dose of Moderna COVID-19 vaccine.

• immunocompromised people who have received two doses (Moderna COVID-19 vaccine or Moderna COVID-19 bivalent vaccine), a single additional dose of Moderna COVID-19 bivalent vaccine may be given at least 1 month following the most recent dose of Moderna COVID-19 bivalent vaccine.

Your doctor or vaccination provider will determine whether you need an additional dose.

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

Keep using infection control methods when you are in public or around others who may not have been vaccinated. This includes social distancing, hand-washing, using protective face covering, disinfecting surfaces you touch a lot, and not sharing personal items with others.

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

It is not known how long this vaccine will protect you 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

You should not receive this vaccine if you've ever had a severe allergic reaction to a Moderna COVID-19 vaccine.

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

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

Tell your vaccination provider if:

• you have a fever;

• you have any allergies;

• you have had inflammation in or around your heart (myocarditis or pericarditis);

• you have bleeding problems, or if you use a blood thinner (warfarin, Coumadin, Jantoven);

• you have a weak immune system caused by disease or by using certain medicine;

• you've received any other COVID-19 vaccine; or

• you have fainted after receiving an injection.

Contact your vaccination provider or health department if you miss your bivalent dose.

An overdose of this vaccine is unlikely to occur.

Avoid receiving other vaccines without first seeking medical advice.

Get emergency medical help if you have signs of an allergic reaction: hives, rash; dizziness, weakness, fast heartbeats; difficult breathing; swelling of your face, lips, tongue, or throat.

Your vaccination provider may want to watch you for a short time after your shot, to make sure you don't have an allergic reaction. You will be treated quickly if you have a reaction right after you receive the vaccine.

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

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

Some people receiving this vaccine had inflammation of the heart muscle or the lining around the heart within a few days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if you have:

• chest pain;

• shortness of breath; or

• fast or pounding heartbeats or fluttering in your chest.

Common side effects of Moderna COVID-19 (6m-5y) Bivalent Booster Vaccine PF may include:

• fever, chills;

• redness or a hardness and swelling where the shot was given;

• swelling or tenderness under your 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 your 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 you have after receiving a COVID-19 vaccine: www.cdc.gov/vsafe.

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