SARS-COV-2 (COVID-19) Vaccine, mRNA (Moderna) (SARS-COV-2 (COVID-19), VAX-een, mRNA (moe-DER-na))

Prevents coronavirus disease 2019 (COVID-19). Monovalent Moderna COVID-19 vaccine is no longer authorized for use in the United States.

Brand Name(s):

Moderna COVID-19 Vaccine 2023-2024 Ages 6mo<12yrs, Spikevax 2023-2024 Formula

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles.
• A nurse or other health provider will give you this medicine.
• This vaccine comes with a Fact Sheet for Recipients and Caregivers. Read and follow the information in the Fact Sheet carefully. Ask your doctor if you have any questions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how SARS-CoV-2 (COVID-19) vaccine works. Tell your doctor if you are using a medicine that weakens your immune system.

Warnings While Using This Medicine:

• SARS-CoV-2 vaccine (mRNA-LNP, spike protein) is under investigation as an active immunization against COVID-19 caused by the SARS-CoV-2 virus in persons 6 months of age and older.
• Tell your doctor if you are pregnant or breastfeeding, or have a weak immune system (including patients who received an organ transplant) or a history of heart disease (including myocarditis, pericarditis).
• This vaccine may increase your risk of serious heart problems (including myocarditis, pericarditis), especially after you receive the second dose.
• This vaccine may not protect everyone who receives it. This vaccine will not treat symptoms of COVID-19 infection if you already have the disease.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, blue or pale skin, chest pain, fast heartbeat, trouble breathing
• Fainting
• Fever, chills, headache, joint or muscle pain
• Nausea, vomiting
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Pain, redness, or swelling where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088