Meet Moderna
 COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)

What should you mention to the vaccination provider before you or your child gets Moderna COVID-19 Vaccine, Bivalent? 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 or your child’s 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 Moderna COVID-19 Vaccine, Bivalent? Any adult or child who:

• had a severe allergic reaction after a previous dose of Moderna COVID-19 Vaccine (also called SPIKEVAX [COVID-19 Vaccine, mRNA]) or Moderna COVID-19 Vaccine, Bivalent

• had a severe allergic reaction to any ingredient in these vaccines

What are the risks of Moderna COVID-19 Vaccine, Bivalent? 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 Moderna COVID-19 Vaccine, Bivalent, Moderna COVID-19 Vaccine, or SPIKEVAX, 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

Additional symptoms, particularly in children, may include:

• 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 these vaccines 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 these vaccines. Serious and unexpected side effects may occur. The possible side effects of these vaccines are still being studied in clinical trials.

What should I do about side effects? If you or your child experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. Call the vaccination provider or healthcare provider if you or your child 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, Bivalent 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) or by visiting https://report.moderna.convergehealthsafety.com/. Please see the accompanying Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Fact Sheet for Recipients and Caregivers for more information.

• Bivalent Dose for 6+ months of age