Pregnancy & Lactation: Risk data not available
What is Covid-19?
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 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 vaccine in people who are 5 years to 11 years.
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.
Warnings
Your child should not receive this vaccine if he/she has ever had a severe allergic reaction to a Pfizer COVID-19 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;
- she is pregnant, or breastfeeding;
- he/she has received any other COVID-19 vaccine; or
- he/she has fainted after receiving an injection.
How should I use Covid-19
Use Covid-19 (Coronavirus 2019, 5Y-11) Bivalent Booster Vaccine, Pfizer (Intramuscular) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Read all vaccine information sheets provided to you.
The Pfizer COVID-19 bivalent vaccine is given to:
- unvaccinated people: a single dose of Pfizer COVID-19 bivalent vaccine.
- people who have received one or more doses of a monovalent COVID-19 vaccine: a single dose of Pfizer COVID-19 bivalent vaccine is given at least 2 months after any monovalent COVID-19 vaccine.
- people 65 years of age and older who have received one dose of a bivalent COVID-19 vaccine: a dose of Pfizer COVID-19 bivalent vaccine may be given at least 4 months after the dose of the bivalent COVID-19 vaccine.
- immunocompromised people who have received one dose of a bivalent COVID-19 vaccine: an additional dose with Pfizer COVID-19 bivalent vaccine may be given at least 2 months after the dose of the bivalent COVID-19 vaccine.
Your child's doctor or vaccination provider will determine whether an additional dose is needed.
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.
Keep using infection control methods when your child is in public or around others who may not have been vaccinated. This includes social distancing, hand-washing, using protective face covering, disinfecting surfaces your child touches a lot, and not sharing personal items with others.
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
Contact your child's vaccination provider or health department if your child misses the bivalent dose.
Covid-19 side effects
Get emergency medical help if your child has signs of an allergic reaction: hives, rash; dizziness, weakness, fast heartbeats; difficult breathing; swelling of the face, lips, tongue, or throat.
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.
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 your child has:
- 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 Covid-19?
Avoid receiving other vaccines without first seeking medical advice.