Providing the Moderna COVID-19 Vaccine
Helping Recipients Understand What to Expect
EMERGENCY USE AUTHORIZATION
The Moderna COVID-19 Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA), to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 18 years of age and older. There is no FDA-approved vaccine to prevent COVID-19.
The EUA for the Moderna COVID-19 Vaccine 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.
Before you get the vaccine
Tell your vaccination provider if you:
- RHave any allergies
- RHave a fever
- RHave a bleeding disorder or take blood thinners
- RAre immunocompromised or are on a medicine that affects your immune system
- RAre pregnant, plan to become pregnant, or breastfeeding
- RHave received another COVID-19 vaccine
For more information, visit modernatx.com/covid19vaccine-eua/recipients/
After you get the vaccine
Side effects that have been reported with the Moderna COVID-19 Vaccine include:
- RInjection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness
- RGeneral side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and fever
Talk to your vaccination provider if you have side effects that bother you or do not go away.
If you think you’re having an allergic reaction to the vaccine, call 9-1-1.
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.
A second dose of the Moderna COVID-19 Vaccine is REQUIRED
Complete vaccination 1 month after your first dose of the Moderna COVID-19 Vaccine.
To help remember that appointment:
Immediately schedule your next appointment after the first dose of your vaccine
Ask for a 2nd Dose Reminder Card to display prominently at home
Set a reminder on your mobile phone or calendar
For more information, talk to your vaccination provider or call Moderna Customer Care at:
1-866-MODERNA (1-866-663-3762) | medinfo@modernatx.com
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 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 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
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. 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 a second dose of the same vaccine 1 month later to complete the vaccination series.
What are the risks of the Moderna COVID-19 Vaccine?
Side effects that have been reported 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, 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 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
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 also report side effects to
ModernaTX, Inc. at 1-866-MODERNA (1-866-663-3762).
