Overview for Vaccine Recipients

AUTHORIZED USE

• Emergency uses of the vaccine have not been approved or licensed by the FDA, but have been authorized by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID‑19) in either individuals 6 months of age and older or as a booster dose in individuals 18 years of age and older, as appropriate.
• The EUA for this product is in effect for the duration of the COVID‑19 EUA declaration justifying emergency use of the product, unless the declaration is terminated or the authorization is revoked sooner.
• For more information on the EUA authorized uses of the vaccine, refer to the Vaccine Fact Sheets for Recipients and Caregivers.

IMPORTANT SAFETY INFORMATION

What should you mention to the vaccination provider before you or your child gets the vaccine?

Tell your vaccination provider about all medical conditions, including if you or your child:

• have any allergies
• have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
• have a fever
• have a bleeding disorder or are on a blood thinner
• are immunocompromised or are on a medicine that affects your immune system
• are pregnant or plan to become pregnant
• are breastfeeding
• have received another COVID-19 vaccine
• have ever fainted in association with an injection

Who should not get the vaccine?

Any adult or child who:

• had a severe allergic reaction after a previous dose of this vaccine
• had a severe allergic reaction to any ingredient of this vaccine

What are the risks of the vaccine?

Severe allergic reactions: there is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually happen within a few minutes to one hour after getting a dose of the vaccine. Signs of a severe allergic reaction can include:

• Difficulty breathing
• Swelling of your face and throat
• A fast heartbeat
• A bad rash all over your body
• Dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have happened in some people who have received the vaccine, most most commonly in adult males under 40. The chance of this happening is very low. Seek medical attention right away if you or your child has any of the following symptoms after receiving the vaccine:

• Chest pain
• Shortness of breath
• Feelings of having a fast-beating, fluttering, or pounding heart
• Fainting
• Unusual and persistent irritability
• Unusual and persistent poor feeding
• Unusual and persistent fatigue or lack of energy
• Persistent vomiting
• Persistent pain in the abdomen
• Unusual and persistent cool, pale skin

Side effects that have been reported in clinical trials with the vaccine include:

• Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection or in the groin, swelling (hardness), and redness
• General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, fever, rash, irritability/crying, sleepiness, and loss of appetite

These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials.

What should I do about side effects?

If you experience a severe allergic reaction, call 9‑1‑1, or go to the nearest hospital.

Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‑800‑822‑7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Moderna COVID‑19 Vaccine EUA,” as appropriate, in the first line of box #18 of the report form.

In addition, you can report side effects to ModernaTX, Inc. at 1‑866‑MODERNA (1‑866‑663‑3762).

Please see the Moderna COVID-19 Vaccine Fact Sheets for Recipients and Caregivers for more information:

• For 6 months-5 years of age

• For 6-11 years of age

• For 12 years of age and older