COVID-19 (coronavirus 2019, 6y-11y) vaccine, Moderna
Generic name: COVID-19 (coronavirus 2019, 6y-11y) vaccine, Moderna (KOE vid (koe ROE na vye rus) VAX een)
Brand name: Moderna COVID-19 (Booster Only) Vaccine PF
Dosage form: intramuscular suspension (preservative-free 50 mcg/0.5 mL)
Drug class: Viral vaccines
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 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 vaccine is used to help prevent severe disease and death from COVID-19 caused by SARS-CoV-2.
The US Food and Drug Administration (FDA) has fully approved the Moderna vaccine for active immunization to prevent COVID-19 in people 18 years of age and older.
The FDA has authorized emergency use of the Moderna vaccine in people who are 6 months to 17 years old.
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.
Warnings
Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine.
Before taking this medicine
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:
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you have a fever;
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you have any allergies;
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you have had inflammation in or around your heart (myocarditis or pericarditis);
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you have bleeding problems, or if you use a blood thinner (warfarin, Coumadin, Jantoven);
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you have a weak immune system caused by disease or by using certain medicine;
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you are pregnant or breastfeeding;
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you've received any other COVID-19 vaccine; or
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you have fainted after receiving an injection.
COVID-19 is more likely to cause serious illness or death in a pregnant woman. Not all risks are known yet, but this vaccine is likely to be less harmful than becoming infected with COVID-19 during pregnancy.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of COVID-19 vaccine on the baby.
How is this vaccine given?
Read all vaccine information sheets provided to you.
The Moderna COVID-19 vaccine is given as an injection (shot) into a muscle, in a series of 2 shots given 4 to 8 weeks apart.
The Moderna vaccine may be given in a series of 3 shots to adults who have received an organ transplant or have certain types of immunosuppression. The first 2 shots are given 4 weeks apart and the third shot is given at least 4 weeks after the second shot.
Your doctor or vaccination provider will determine whether your child 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 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
What happens if I miss a dose?
Be sure to receive all recommended doses of COVID-19 vaccine or you may not be fully protected. Contact your vaccination provider or health department if you miss your second 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.
This vaccine side effects
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 again if the first shot caused an allergic reaction. Your doctor or vaccination provider will determine if you can safely receive another COVID-19 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:
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chest pain;
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shortness of breath; or
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fast or pounding heartbeats or fluttering in your chest.
Common side effects of COVID-19 (coronavirus 2019, 6y-11y) vaccine, Moderna may include:
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fever, chills;
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redness or a hardness and swelling where the shot was given;
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swelling or tenderness under your arm;
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nausea, vomiting;
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feeling tired; or
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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.
COVID-19 (coronavirus 2019, 6y-11y) vaccine, Moderna dosing information
Usual Adult Dose for COVID-19:
For investigational use only
First Booster Dose: 0.25 mL IM, at least 5 months after completing a primary vaccination series with this or another authorized/approved coronavirus disease 2019 (COVID-19) vaccine.
Second Booster Dose: 0.25 mL IM, at least 4 months after receiving a booster dose with this or another authorized/approved COVID-19 vaccine.
Comments:
-The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of this unapproved product for active immunization to prevent COVID-19. This product is not approved by the US FDA for this use.
-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
Use: Active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Usual Pediatric Dose for COVID-19:
For investigational use only
6 through 11 years:
-Primary Series: 0.2 mL IM for 2 doses, administered 21 days apart
---Third primary series dose (if indicated): 0.2 mL IM at least 28 days after the second dose
Comments:
-The US FDA issued an EUA to allow the emergency use of this unapproved product for active immunization to prevent COVID-19. This product is not approved by the US FDA for this use.
-A third primary series dose is authorized for patients who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
Use: Active immunization to prevent COVID-19 caused by SARS-CoV-2
What other drugs will affect this vaccine?
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.
Where can I get more information?
- Your 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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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