diphtheria, haemophilus B, hepatitis B, pertussis, polio, tetanus

What is the most important information I should know about this vaccine?

Your child should not receive a booster vaccine if he or she had a life threatening allergic reaction after the first shot.

What is diphtheria, haemophilus/hepatitis B, pertussis, polio, tetanus vaccine (Vaxelis)?

Diphtheria, haemophilus influenzae type B, hepatitis B, pertussis, polio, and tetanus are serious diseases caused by bacteria or virus.

Diphtheria causes a thick coating in the nose, throat, and airway. It can lead to breathing problems, paralysis, heart failure, or death.

Haemophilus influenzae type B (Hib) can cause breathing problems or meningitis. Hib infection usually affects children and can be fatal.

Hepatitis B causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

Pertussis (whooping cough) causes coughing so severe that it interferes with eating, drinking, or breathing. These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage, and death.

Polio is a life threatening condition that affects the central nervous system and spinal cord. It can cause muscle weakness and paralysis and can paralyze the muscles that help you breathe.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Vaxelis is used to help prevent these diseases in children. This vaccine helps the body develop immunity to these diseases. Your child will not get these diseases from getting this vaccine.

Diphtheria, haemophilus B, hepatitis B, pertussis, polio, tetanus vaccine (Vaxelis) is for use in children between the ages of 6 weeks and 4 years old (before the child has reached his or her 5th birthday).

Like any vaccine, Vaxelis may not provide protection from disease in every person.

What should I discuss with my healthcare provider before receiving this vaccine?

• a history of life-threatening allergic reaction to a vaccine containing diphtheria, pertussis, polio, tetanus, Hib, or hepatitis B;
• a history of decreased consciousness, seizures, or coma within 7 days after receiving a pertussis vaccine; or
• a progressive or untreated nervous system problem or brain disorder (such as infantile spasms or uncontrolled epilepsy).

Your child may not be able to receive this vaccine if he or she has ever received a pertussis vaccine that caused:

• within 48 hours after the vaccine --a very high fever (over 104 degrees), excessive crying for 3 hours or longer, fainting or going into shock; or
• within 3 days after the vaccine --a seizure.

Tell the vaccination provider if your child has ever had:

• seizures;
• chemotherapy or radiation;
• a weak immune system (caused by disease or by using certain medicine); or
• Guillain-Barré syndrome within 6 weeks after receiving a tetanus vaccine.

This vaccine will not protect against infection with hepatitis A, C, and E, or other viruses that affect the liver. It may also not protect against hepatitis B if your child is already infected with the virus, even if the child does not yet show symptoms.

How is this vaccine given?

This vaccine is given as an injection (shot) into a muscle.

Vaxelis is given in a series of shots. The first shot is usually given when the child is 2 months old (or as young as 6 weeks old). The booster shots are then given at 4 months and 6 months of age.

Your child's individual booster schedule may be different from these guidelines, especially if the child was born prematurely. Follow your doctor's instructions or the schedule recommended by your local health department.

Your child may receive other vaccines at the same time as receiving Vaxelis.

Your child may need to receive other vaccines to be completely protected from certain diseases. Be sure your child receives all recommended doses of this vaccine, or the child may not be fully protected against disease.

This vaccine can affect the results of certain medical tests. Tell any doctor who treats your child that the child has recently received Vaxelis.

What happens if I miss a dose?

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

Follow the vaccination provider's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of this vaccine?

• breathing that stops during sleep;
• unusual pain or discomfort;
• weakness; or
• problems with vision, hearing, or muscle movement.

Becoming infected with diphtheria, haemophilus B, hepatitis B, pertussis, polio, or tetanus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects.

Common side effects may include:

• fever of 100.4 degrees F or higher;
• fussiness, crying more than usual;
• vomiting, decreased hunger; or
• drowsiness; or
• pain, swelling, or redness where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What other drugs will affect this vaccine?

Also, tell the vaccination provider if your child has recently received drugs or treatments that can weaken the immune system, including:

• steroid medicine;
• cancer treatments;
• medicine to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders; or
• medicine to treat or prevent organ transplant rejection.

If your child is using any of these medications, he or she may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

This list is not complete. Other drugs may affect this vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your child's vaccination provider, pharmacist, or doctor can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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