Uses

Janssen COVID-19 vaccine (also called Johnson and Johnson COVID-19 vaccine) is used to protect you against coronavirus disease, also known as COVID-19. The FDA and Health Canada are allowing this vaccine to be given for emergency/interim use to people 18 years old and older. You can get more information from your health care professional via the FDA Fact Sheet for Recipients and Caregivers for emergency use, the Health Canada Patient Medication Information for interim use, or the Informed Consent Form for a study.Vaccines may not fully protect everyone who receives them. However, studies show that the Janssen COVID-19 vaccine helps protect most people who receive it against COVID-19. The vaccine may help you fight the virus if you are exposed to it later. The vaccine may prevent the illness, or reduce the seriousness of it. Continue to wear a mask, practice social distancing (physical distancing), and follow other safety guidelines to protect yourself and those around you until otherwise directed by your health care professional and public health officials. The information in this document reflects early and recent data, which is still being studied and added to. Talk to your health care professional about the risks and benefits of this vaccine.

How to use COVID-19 Vaccine, Ad26.COV2.S (Janssen)(PF) 0.5 Ml IM Suspension (EUA)

Read all vaccine information available from your health care professional before receiving the vaccine. If you have any questions, ask your health care professional.

This vaccine is given by injection into a muscle by a health care professional. It is usually given in the upper arm. Closely follow the vaccination schedule provided by the health care professional. It may help to mark a calendar as a reminder. Keep all scheduled medical appointments.

Side Effects

Vaccine injections may cause pain, redness, or swelling at the injection site. Tiredness, headache, fever, muscle pain, or nausea may also occur. If any of these effects occur, tell your health care professional promptly.

Rarely, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care professional right away if you have any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.

Remember that the Janssen COVID-19 vaccine has been prescribed because your health care professional has judged that the benefit to you is greater than the risk of side effects. Most people who received this vaccine did not have serious side effects.

There have been rare reports of a serious condition (capillary leak syndrome) that occurred within a few days after receiving this vaccine. If you notice any of the following symptoms, get medical help right away: sudden swelling of the arms/legs, sudden weight gain, severe dizziness, fainting.

The Janssen COVID-19 vaccine may very rarely cause serious (sometimes fatal) blood clots with low platelets usually within 2 weeks of the vaccine injection. Get medical help right away if you have: stomach/abdominal pain that doesn't go away, shortness of breath, chest pain, swelling in the leg, sudden/severe headaches, sudden vision changes (such as blurred vision), small red/purple/brown spots on your skin.

There have been rare reports of a certain blood disorder (low number of platelets) that occurred within 42 days of receiving this vaccine. This can lower your body's ability to stop bleeding. Tell your doctor right away if you develop easy bleeding or bruising.

There have been rare reports of a certain nerve problem known as Guillain-Barre syndrome that occurred within 42 days of receiving this vaccine. Get medical help right away if you have: tingling in the hands/feet, weakness in legs, unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes.

A very serious allergic reaction to this vaccine is rare. Get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Contact the doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.

Precautions

Before you receive this vaccine, tell the health care professional if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as polysorbate), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccine, tell your health care professional your medical history, especially of: previous severe reaction (blood clots with low platelets) from the vaccine or related vaccines, bleeding/blood disorders (low platelet counts), current fever/illness, immune system disorders (such as those due to cancer/radiation treatment), capillary leak syndrome.

It is unknown at this time how safe and effective the Janssen COVID-19 vaccine is for children.

Tell your doctor if you are pregnant before using this vaccine.

It is unknown if this vaccine passes into breast milk. Consult your health care professional before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

It is unknown at this time if the Janssen COVID-19 vaccine interacts with other drugs.

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Overdose

Not applicable.

Notes

Keep all regular medical and lab appointments.

If you are given a COVID-19 Vaccination Card by the health care professional, keep the vaccination card. You may be required to share this information to help protect public health.

Missed Dose

Not applicable.

Storage

Not applicable. This vaccine is given in a hospital or clinic and will not be stored at home.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.