SARS-CoV-2 Virus (COVID-19) Vaccine Suspension for Injection (Janssen COVID-19 Vaccine)

What is this medication?

COVID-19 VACCINE (koh-vid 19 vak SEEN) reduces the risk of COVID-19. It does not treat COVID-19. It is still possible to get COVID-19 after receiving this vaccine, but the symptoms may be less severe or not last as long. It works by helping your immune system learn how to fight off a future infection. The FDA has allowed the emergency use of this vaccine.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Janssen COVID-19 Vaccine

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Any allergies
• Bleeding disorder
• Blood clots
• Immune system problems
• Recent or upcoming vaccine including previous COVID-19 vaccine
• An unusual or allergic reaction to COVID-19 vaccine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This vaccine is injected into a muscle. It is given by your care team.

Booster doses may be needed after finishing the primary series. Talk to your care team about your vaccination schedule.

A copy of the Fact Sheet for Recipients and Caregivers will be given before each vaccination. Be sure to read this information carefully each time. This sheet may change often.

Talk to your care team about the use of this vaccine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use.

What may interact with this medication?

This medication may interact with the following:

• Certain medications that thin your blood
• Chemotherapy or radiation therapy
• Medications that lower your chance of fighting infection
• Steroid medications, such as prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team regularly.

This vaccine can cause a blood clotting problem called thrombosis with thrombocytopenia syndrome (TTS). TTS is a rare but serious medical condition that can be deadly. Get medical help right away if you have a severe headache, change in vision, stomach pain, nausea, vomiting, back pain, chest pain, trouble breathing, pain, swelling, or warmth in leg, or unusual bruising or bleeding.

This vaccine, like all vaccines, may not fully protect everyone. Continue to follow all guidelines to prevent exposure.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Change in vision
• Fast or irregular heartbeat
• Severe headache
• Severe stomach pain
• Trouble breathing
• Usual bruising or bleeding

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Chills
• Fatigue
• Fever
• Headache
• Joint pain
• Muscle pain
• Nausea
• Pain, redness, or irritation at injection site
• Swollen lymph nodes
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This vaccine is only given by your care team. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.