Overview for Vaccine Recipients

What is the Moderna COVID‑19 Vaccine?

The Moderna COVID‑19 Vaccine is an unapproved vaccine that may prevent COVID‑19. The FDA has authorized the emergency use of the Moderna COVID‑19 Vaccine to prevent COVID‑19 in individuals 18 years of age and older under an Emergency Use Authorization (EUA).

Important Safety Information

What should you mention to your vaccination provider before you get the Moderna COVID‑19 Vaccine?

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

• 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 Moderna COVID‑19 Vaccine?

You should not get the Moderna COVID‑19 Vaccine if you:

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

How is the Moderna COVID‑19 Vaccine given?

The Moderna COVID‑19 Vaccine will be given to you as an injection into the muscle.

Primary Series: The Moderna COVID‑19 Vaccine is administered as a 2‑dose series, one month apart. A third primary series dose may be administered at least one month after the second dose to individuals who are determined to have certain kinds of immunocompromise.

Booster Dose:

• A single booster dose of the Moderna COVID-19 Vaccine may be administered at least 6 months after completion of a primary series to individuals:
  • 65 years of age and older
  • 18 through 64 years of age at high risk of severe COVID‑19
  • 18 through 64 years of age with frequent institutional or occupational exposure to SARS‑CoV‑2
• A single booster dose of the Moderna COVID‑19 Vaccine may be administered to eligible individuals who have completed primary vaccination with a different authorized or approved COVID‑19 vaccine. Please check with your healthcare provider regarding eligibility for and timing of the booster dose.

What are the risks of the Moderna COVID‑19 Vaccine?

There is a remote chance that the Moderna COVID‑19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Moderna COVID‑19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. 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 occurred in some people who have received the Moderna COVID‑19 Vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of the Moderna COVID-19 Vaccine. The chance of having this occur is very low. You should seek medical attention right away if you have any of the following symptoms after receiving the Moderna COVID‑19 Vaccine:

• Chest pain
• Shortness of breath
• Feelings of having a fast-beating, fluttering, or pounding heart

Side effects that have been reported in clinical trials with the Moderna COVID‑19 Vaccine include:

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

Side effects that have been reported during post‑authorization use of the Moderna COVID‑19 Vaccine include:

• Severe allergic reactions
• Myocarditis (inflammation of the heart muscle)
• Pericarditis (inflammation of the lining outside the heart)
• Fainting in association with injection of the vaccine

These may not be all the possible side effects of the Moderna COVID‑19 Vaccine. Serious and unexpected side effects may occur. The Moderna COVID‑19 Vaccine is 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” 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).

What if I am immunocompromised?

If you are immunocompromised, you may receive a third primary series dose of the Moderna COVID‑19 Vaccine. The third dose may still not provide full immunity to COVID‑19 in people who are immunocompromised, and you should continue to maintain physical precautions to help prevent COVID‑19. In addition, your close contacts should be vaccinated as appropriate. Discuss your options with your healthcare provider.

Please visit Fact Sheet for Recipients and Caregivers for more information.