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CDC INFORMATIONMODERNA EUA FACT SHEETV-SAFE INFORMATION FLYER
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 COVID19 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.
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). For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this Fact Sheet.
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
FDA has authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18
years of age and older.
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
The Moderna COVID-19 Vaccine 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 trihydrate, and sucrose.
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.
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
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.
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
Side effects that have been reported in a clinical trial 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
Side effects that have been reported during post-authorization use of the Moderna COVID-19 Vaccine include:
• Severe allergic reactions
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.
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).
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 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 Revised: Mar/26/2021 4 needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe.
It is your choice to receive or not receive the Moderna COVID-19 Vaccine. Should you decide
not to receive it, it will not change your standard medical care.
Currently, there is no FDA-approved alternative vaccine available for prevention of COVID-19. Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization.
There is no information on the use of the Moderna COVID-19 Vaccine with other vaccines.
If you are pregnant or breastfeeding, discuss your options with your healthcare provider.
No. The Moderna COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.
When you receive your first dose, you will get a vaccination card to show you when to return for
your second dose of the Moderna COVID-19 Vaccine. Remember to bring your card when you
If you have questions, visit the website or call the telephone number provided below.
• Ask the vaccination provider
• Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html
• Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-legalregulatory-and-policy-framework/emergency-use-authorization
• Contact your state or local public health department
The vaccination provider may include your vaccination information in your state/local
jurisdiction’s Immunization Information System (IIS) or other designated system. This will
ensure that you receive the same vaccine when you return for the second dose. For more
information about IISs, visit: https://www.cdc.gov/vaccines/programs/iis/about.html.
No. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged
an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19
vaccination. However, vaccination providers may seek appropriate reimbursement from a
program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient
(private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured
Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination
Program requirements are encouraged to report them to the Office of the Inspector General, U.S.
Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.
The Countermeasures Injury Compensation Program (CICP) is a federal program that may help
pay for costs of medical care and other specific expenses of certain people who have been
seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim
must be submitted to the CICP within one (1) year from the date of receiving the vaccine. To
learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427.
The United States FDA has made the Moderna COVID-19 Vaccine available under an
emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health
and Human Services (HHS) declaration that circumstances exist to justify the emergency use of
drugs and biological products during the COVID-19 pandemic.
The Moderna COVID-19 Vaccine has not undergone the same type of review as an FDAapproved or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of Revised: Mar/26/2021 6 these criteria must be met to allow for the product to be used during the COVID-19 pandemic.
The EUA for the Moderna COVID-19 Vaccine is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).
We will be getting the Moderna COVID-19 vaccine.
The allocation by CDC determines the number of doses we get for the vaccine, which can change freqeuntly. We do not control how many doses are allocated to our location.
Book the appointment online, on the top of this webpage
Yes, you will have to sign up for both doses at the same time.
Timing and eligibility is based on state guidelines. Here is a link for your reference. You can place yourself in the waiting list to be notified when appointments are available.
Depending on which vaccine you receive, you will be prompted to schedule a second dose if needed at the same time when you book appointment for the first dose.
The COVID-19 vaccine is no cost with insurance or through a federal program for the uninsured.
An appointment will be required to receive a COVID-19 vaccination. Customers will be able to easily schedule their vaccinations—both the initial shot and the second dose (if required) on our website.
Our immunizers are trained in the safe administration of the COVID-19 vaccines authorized for use by the FDA, including identifying and treating allergic reactions. The vaccination procedures include a patient screening checklist to assess the risk of reaction. All patients are monitored for 15 minutes after administration of the injection, or longer for people with a history of severe allergic reactions. Our immunizers are equipped with appropriate medications, such as epinephrine and antihistamines
As more doses are allocated to our pharmacy, we will open up more slots. Please sign up for the waiting list to be notified when appointments are available.
You may contact us via email@example.com email or phone 908-443-7020