Fact Sheet For Recipients And Caregivers
Emergency Use Authorization (EUA) Of The Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019
(COVID-19) In Individuals 18 Years of Age and Older
You are being offered the Moderna COVID-19 Vaccine to prevent Coronavirus Disease 2019 (Covid-19) caused by SARS-COV-2. This Factsheet contains information to help you understand the risks and benefits of the Moderna COVID-19 Vaccine, which you may receive because there is currently a pandemic of COVID-19.
The Moderna COVID-19 Vaccine is a vaccine and may prevent you from getting Covid-19.
There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19.
Read this fact sheet for information about Moderna COVID-19 Vacine. Talk to the vaccination provider if you have questions. It is your choice to receive the Moderna COVID-19 Vaccine.
The Moderna COVID-19 Vaccine is administered as a 2-dose series, 1 month apart, into the muscle.
The Moderna COVID-19 Vaccine may not protect everyone.
This fact sheet may have been updated for the most recent factsheet, please visit www.modernatx.com/covid19vaccine-eua .
What you need to know before you get this vaccine
What is COVID-19?
COVID-19 is caused by a coronavirus called SARS-COV-2. This type of Coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness.
Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include; fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.
What is The Moderna COVID-19 Vaccine
The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.
The FDA has authorized the emergency use of Moderna COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older under an Emergency Use Authorization (EUA).
For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this factsheet.
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 a Fever
Have a Bleeding Disorder or are on Blood Thinner
are immunocompromised or on medicine that affects your immune system
are pregnant or plan to become pregnant
are breastfeeding
have received anothe COVID Vaccine
Who Should Get the Moderna COVID-19 Vaccine?
FDA has authorized the emergency use of Moderna COVID-19 Vaccine in individuals 18 years of age and older.
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 of the ingredients of this vaccine
What Are The Ingredients In The Moderna COVID-19 Vaccine?
The Moderna COVID-19 Vacine contains the following ingredients: Messenger ribonucleic acid (mRNA), Lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG] cholesterol, and 1.2-distearoyl-sn-glycero-3-phosphocholine [DSPC], tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose.
How is the Moderna COVID-19 Vaccine Given?
The Moderna COVID-19 Vaccine will be given to you as an injection into the muscle.
The Moderna COVID-19 Vaccine vaccination series is 2 doses given 1 month apart.
If you receive one dose of the Moderna COVID-19 Vaccine, you should receive the second dose of the same vaccine 1 month later to complete the vaccination series.
Has The Moderna COVID-19 Vaccine Been Used Before?
The Moderna COVID-19 Vaccine is an unapproved vaccine. In clinical trials, approximately 15,400 individuals 18 years of age and older have received at least 1 dose of the Moderna COVID-19 Vaccine.
What are the Benefits of the Moderna COVID-19 Vaccine?
In an ongoing clinical trial, the Moderna COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 1 month apart. The duration of protection against COVID-19 is currently unknown.
What are the Risks of the Moderna COVID-19 Vaccine?
Side effects that have been reported with Moderna COVID-19 Vaccine include:
Injection site reaction: 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, and fever.
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 severe allergic reaction can include:
Difficulty breathing
Swelling of your face and throat
a fast heart beat
a bad rash all over your body
dizziness and weakness
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 health care provider if you have any side effects that bother you or do not go away.
Report vacine 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 VAERS – Report an Adverse Event. 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 (1-86-663-3762).
You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with the people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC is participants report significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe.