IMPORTANT SAFETY INFORMATION
WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE JANSSEN COVID-19 VACCINE?
Tell the 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
- have ever fainted in association with an injection
WHO SHOULD NOT GET THE JANSSEN COVID‑19 VACCINE?
You should not get the Janssen COVID-19 Vaccine if you:
- had a severe allergic reaction to any ingredient of this vaccine.
HOW IS THE JANSSEN COVID-19 VACCINE GIVEN?
The Janssen COVID-19 Vaccine will be given to you as an injection into the muscle. The Janssen COVID-19 Vaccine vaccination schedule is a single dose.
WHAT ARE THE RISKS OF THE JANSSEN COVID‑19 VACCINE?
Side effects that have been reported with the Janssen COVID-19 Vaccine include:
- Injection site reactions: pain, redness of the skin, and swelling.
- General side effects: headache, feeling very tired, muscle aches, nausea, fever.
- Swollen lymph nodes.
- Unusual feeling in the skin (such as tingling or a crawling feeling) (paresthesia), decreased feeling or sensitivity, especially in the skin (hypoesthesia).
- Persistent ringing in the ears (tinnitus).
- Diarrhea, vomiting.
Severe Allergic Reactions
There is a remote chance that the Janssen 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 Janssen 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
Blood Clots with Low Levels of Platelets
Blood clots involving blood vessels in the brain, lungs, abdomen, and legs along with low levels of platelets (blood cells that help your body stop bleeding), have occurred in some people who have received the Janssen COVID-19 Vaccine. In people who developed these blood clots and low levels of platelets, symptoms began approximately one to two-weeks after vaccination. Reporting of these blood clots and low levels of platelets has been highest in females ages 18 through 49 years. The chance of having this occur is remote. You should seek medical attention right away if you have any of the following symptoms after receiving Janssen COVID-19 Vaccine:
- Shortness of breath,
- Chest pain,
- Leg swelling,
- Persistent abdominal pain,
- Severe or persistent headaches or blurred vision,
- Easy bruising or tiny blood spots under the skin beyond the site of the injection.
These may not be all the possible side effects of the Janssen COVID-19 Vaccine. Serious and unexpected effects may occur. The Janssen COVID-19 Vaccine is still being studied in clinical trials.
Guillain Barré Syndrome
Guillain Barré syndrome (a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who have received the Janssen COVID-19 Vaccine. In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is very low. You should seek medical attention right away if you develop any of the following symptoms after receiving the Janssen COVID-19 Vaccine:
- Weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body.
- Difficulty walking.
- Difficulty with facial movements, including speaking, chewing, or swallowing.
- Double vision or inability to move eyes.
- Difficulty with bladder control or bowel function.
WHAT SHOULD I DO ABOUT SIDE EFFECTS?
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 1-800-822-79671-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Janssen COVID-19 Vaccine EUA” in the first line of box #18 of the report form. In addition, you can report side effects to Janssen Biotech Inc. at 1-800-565-40081-800-565-4008.
Please read Emergency Use Authorization (EUA) Fact Sheet for Recipients and Caregivers available at www.JanssenCOVID19vaccine.com/EUA-Recipient-factsheet and discuss any questions you have with the vaccination provider.
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