SARS-COV-2 (COVID-19) Vaccine, Adenovirus 26 Vector (Janssen) (SARS-COV-2 (COVID-19), VAX-een, AD-e-noe-vye-rus (JAN-sen))

Prevents coronavirus disease 2019 (COVID-19).

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles.
• A nurse or other health provider will give you this medicine.
• This vaccine comes with a Fact Sheet for Recipients and Caregivers. Read and follow the information in the Fact Sheet carefully. Ask your doctor if you have any questions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how SARS-CoV-2 (COVID-19) vaccine works. Tell your doctor if you are using a blood thinner or medicine that weakens your immune system.

Warnings While Using This Medicine:

• Janssen COVID-19 Vaccine is under investigation as an active immunization against COVID-19 caused by the SARS-CoV-2 virus in patients 18 years of age and older.
• Tell your doctor if you are pregnant or breastfeeding, or if you have a weak immune system, allergies, a fever, bleeding problems, or have received another COVID-19 vaccine.
• This vaccine may cause the following problems:
  • Increased risk of a blood clotting problem, including thrombosis with thrombocytopenia syndrome (TTS)
  • Increased risk of autoimmune problems, including immune thrombocytopenia
  • Increased risk of nervous system problems, including Guillain-Barré syndrome
• This vaccine may not protect everyone who receives it. This vaccine will not treat symptoms of COVID-19 infection if you already have the disease.
• This medicine lowers the number of certain blood cells, so you may bleed or bruise more easily. Be careful to avoid injuries.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, coughing up blood
• Fainting
• Fast heartbeat, dizziness, weakness
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Sudden or severe headache, problems with vision, speech, or walking
• Tiredness, muscle aches, nausea, fever
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088