What is the Moderna COVID‑19 Vaccine?

Moderna COVID‑19 Vaccine is authorized to provide:

• a two-dose primary series to individuals 18 years of age and older;
• a third primary series dose to individuals 18 years of age and older with certain kinds of immunocompromise;
• a first booster dose to individuals 18 years of age and older who have completed a primary series with Moderna COVID‑19 Vaccine or SPIKEVAX (COVID‑19 Vaccine, mRNA);
• a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID‑19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series;
• a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID‑19 vaccine; and
• a second booster dose to individuals 18 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID‑19 vaccine.

FDA has approved SPIKEVAX (COVID‑19 Vaccine, mRNA) as a two-dose primary series one month apart for prevention of COVID‑19 in individuals ages 18 years of age and older.

Important Safety Information

What should you mention to your vaccination provider before you get the 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 vaccine?

You should not get the 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

What are the risks of the vaccine?

There is a remote chance that the 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 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 vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of the 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 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 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 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 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 either “SPIKEVAX (COVID-19 Vaccine, mRNA)” or “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).

What if I am immunocompromised?

If you are immunocompromised, you may receive a third primary series dose of the 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.

What if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, discuss your options with your healthcare provider.

Please see the Fact Sheet for Recipients and Caregivers for more information.

For information regarding SPIKEVAX, please see the SPIKEVAX Full Prescribing Information and Information for Recipients and Caregivers.