Sars-cov-2 (covid-19) vaccine, adenovirus 26 vector (janssen) (Intramuscular)

SARS-CoV-2 vaccine (adenovirus 26 vector) is being studied as a way to help the body fight COVID-19 caused by the SARS-CoV-2 virus in people aged 18 and older. The SARS-CoV-2 (COVID-19) vaccine is used to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Janssen COVID-19 vaccine is for patients who cannot access or use other authorized or approved COVID-19 vaccines, or for those who choose this vaccine because they would not otherwise receive a COVID-19 vaccine.

This vaccine should only be given by your doctor or under their direct supervision.

It is very important for your doctor to monitor you closely for any issues that may arise from this vaccine. Blood tests may be necessary to check for unwanted effects. Be sure to inform your doctor about any side effects that happen after you receive this vaccine.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Contact your doctor right away if you experience a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling in your hands, face, or mouth after getting the vaccine.

See your doctor immediately if you have blurred vision, chest pain, headache, stomach pain, swelling in your leg, trouble breathing, pinpoint red spots on your skin, or unusual bleeding or bruising. These may be signs of a serious blood clotting issue called thrombosis with thrombocytopenia syndrome (TTS).

This vaccine may increase the risk of autoimmune issues, including immune thrombocytopenia. Contact your doctor right away if you experience black, tarry stools, bleeding gums, blood in your urine or stools, a bloody nose, fever, heavier menstrual periods, pinpoint red spots on your skin, a rash, unusual tiredness or weakness, or unusual bleeding or bruising within 42 days after receiving the vaccine.

This medicine reduces the number of certain types of blood cells in your body. As a result, you may bleed more easily. Avoid rough sports or other activities where you could get bruised, cut, or injured. Brush and floss your teeth gently. Be cautious when using sharp objects, including razors and fingernail clippers.

This vaccine may increase the risk of nervous system issues, including Guillain-Barré syndrome. Contact your doctor immediately if you experience sudden numbness and weakness in your arms and legs or an inability to move your arms and legs within 42 days after receiving the vaccine.

Fainting can occur after you receive this vaccine. Your doctor may want you to be monitored after the injection to prevent and manage fainting.

This vaccine may not provide protection for everyone who receives it. This vaccine will not treat symptoms of COVID-19 infection if you already have the disease. It is crucial that you take precautions to minimize the risk of COVID-19.

Inform your doctor if you have received another SARS-CoV-2 (COVID-19) vaccine.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies, like those to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how the SARS-CoV-2 (COVID-19) vaccine affects children. Safety and effectiveness have not been established for this age group.

Geriatric

Studies done so far have not shown any specific problems in older adults that would limit how useful the SARS-CoV-2 (COVID-19) vaccine is for them.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits and risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In these situations, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while you receive this medicine. The following interactions have been chosen for their potential significance but are not an exhaustive list.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some cases. If both are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Elivaldogene Autotemcel
• Rituximab
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times or with certain foods due to possible interactions. Drinking alcohol or using tobacco with some medicines can also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Be sure to inform your doctor about any other medical issues, especially:

• Autoimmune disorder (e.g., immune thrombocytopenia), history of or
• Bleeding problem—Use with caution. This may worsen the condition.

• Blood clotting problem (e.g., thrombosis with thrombocytopenia) after receiving this vaccine or another COVID-19 vaccine (e.g., AstraZeneca COVID-19 vaccine), history of—Should not be used in patients with this condition.

• Immune system problems—This may reduce the effectiveness of the vaccine.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if you have any of the following side effects:

More common

• Difficulty in moving
• Fever
• Headache
• Joint pain or swelling
• Muscle aches, cramping, pains, or stiffness
• Nausea
• Unusual tiredness or weakness

Incidence not known

• Anxiety
• Black, tarry stools
• Bleeding gums
• Blood in the urine or stool
• Bloody nose
• Blue or pale skin
• Blurred vision
• Chest pain or discomfort
• Chills
• Confusion
• Continuing ringing or buzzing or other unexplained noise in the ears
• Cough
• Dizziness or lightheadedness
• Fainting
• Fast heartbeat
• Hearing loss
• Heavier menstrual periods
• Hives or welts, itching, skin rash
• Inability to move the arms and legs
• Numbness, weakness, or tingling in the arms or legs
• Pain, redness, or swelling in the arm or leg
• Pinpoint red spots on the skin
• Redness of the skin
• Seizures
• Slurred speech
• Stomach pain
• Sudden, severe weakness or numbness in the arm or leg
• Sudden loss of coordination
• Trouble breathing
• Unusual bleeding or bruising
• Vision changes
• Vomiting blood

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your healthcare professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Pain, redness, or swelling at the injection site

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

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

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot into one of your muscles.

Primary vaccination: This vaccine is given as a single dose.

Booster dose: You may be given a single booster dose of Janssen COVID-19 vaccine at least 2 months after your primary vaccination with this vaccine. You may also receive a single booster dose of this vaccine after your primary vaccination with another authorized or approved COVID-19 vaccine (eg, Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine). It is usually given to patients 18 years of age and older.

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.