Vaxelis (DTaP-IPV-Hib-HepB)

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

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

Haemophilus influenzae type B (Hib) bacteria can infect the lungs or throat and can spread to the blood, bones, joints, brain, or spinal cord. It can cause breathing problems or meningitis, and these infections 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 severe, long-lasting coughing episodes that can interfere with eating, drinking, or breathing. Pertussis can lead to pneumonia, seizures, brain damage, and death.

Polio is a life-threatening condition that affects the brain and spinal cord, causing muscle weakness and paralysis. Polio can be fatal if it paralyzes muscles that help you breathe.

Tetanus (lockjaw) causes painful muscle tightening that can lead to "locking" of the jaw, preventing the person from opening their mouth, swallowing, or breathing. Tetanus can lead to death.

The diphtheria, haemophilus B (Hib), hepatitis B, pertussis, polio, and tetanus vaccine is used to help prevent these diseases in children ages 6 weeks through 4 years (before the 5th birthday). This vaccine helps your child's body develop immunity to these diseases, but it will not treat an active infection the child already has.

Like any vaccine, the DTaP-IPV-Hib-HepB vaccine may not provide protection from disease in every person.

Becoming infected with Vaxelis (DTaP-IPV-Hib-HepB) may be much more dangerous to your child's health than getting this vaccine.

Your child should not receive this vaccine if he or she has ever had a similar vaccine that caused any of the following:

• a severe allergic reaction to a Vaxelis (DTaP-IPV-Hib-HepB) vaccine or any ingredient in the vaccine;
• decreased consciousness, seizures, or coma within 7 days after receiving a pertussis vaccine; or
• nervous system problems or brain disorders (such as infantile spasms or uncontrolled epilepsy).

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

• within 48 hours after the vaccine--a very high fever (105°F (40.5°C) or higher), excessive crying for 3 hours or longer, fainting or going into shock; or
• within 3 days after the vaccine--a seizure.

Tell your vaccination provider if your child has or has ever had:

• seizures;
• a weak immune system caused by disease or by taking certain medicines or receiving cancer treatments; or
• Guillain-Barré syndrome (within 6 weeks after receiving a tetanus vaccine).

Tell the vaccination provider if your child was born prematurely.

Get emergency medical help if your child shows signs of an allergic reaction: hives, trouble breathing, or swelling of the face, lips, tongue, or throat.

Your child should not get another shot if he or she had a life-threatening allergic reaction after the first shot.

Keep track of all side effects your child experiences. If the child gets a booster dose, inform the vaccination provider if the previous shot caused any side effects.

Getting infected with diphtheria, haemophilus B (Hib), hepatitis B, pertussis, polio, or tetanus may pose a greater risk to your child's health than receiving the vaccine to prevent these diseases. Like any medicine, this vaccine can cause side effects, but the chances of serious side effects are very low.

Call your child's doctor immediately if your child has a fever of 105°F (40.5°C) or higher, collapses or has a shock-like episode, or cries nonstop for 3 hours or longer within 48 hours after receiving a Vaxelis (DTaP-IPV-Hib-HepB) vaccine, or if your child has a seizure within 3 days after getting the vaccine.

Also contact your doctor right away if your child experiences:

• nervous system problems, such as numbness, pain, tingling, weakness, burning or prickly feelings, vision or hearing issues, or trouble breathing.

Common side effects of Vaxelis (DTaP-IPV-Hib-HepB) may include:

• fever of 100.4 degrees F or higher;
• fussiness, crying more than usual;
• vomiting, reduced appetite;
• drowsiness; or
• pain, swelling, or redness at the injection site.

This is not a complete list of side effects and others may occur. Contact 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.

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

This vaccine is given as a series of 3 doses, usually at 2, 4, and 6 months of age. The first dose may be given as early as 6 weeks of age.

Your child's individual 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 this vaccine.

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.

Vaxelis (DTaP-IPV-Hib-HepB) can affect the results of certain medical tests. Tell any doctor who treats your child that your child has received the diphtheria, Haemophilus influenzae type b, hepatitis B, pertussis, polio, and tetanus vaccine.

Contact your vaccination provider if your child misses a dose or gets off schedule. The next dose should be given as soon as possible. There is no need to start over.

Make sure your child gets all recommended doses of this vaccine, or the child may not be fully protected against disease.

An overdose of this vaccine is not likely to happen.

Follow the vaccination provider's instructions regarding any limits on food, drinks, or activities.

Before your child gets this vaccine, inform the vaccination provider about all other vaccines your child has had.

Also, tell the vaccination provider if your child has recently taken any drugs or treatments that can weaken the immune system, such as:

• steroid medicine;
• cancer treatments;
• medicine for psoriasis, rheumatoid arthritis, or other autoimmune disorders; or
• medicine for preventing organ transplant rejection.

If your child is taking 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 does not cover everything. Other medications may influence this vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all potential drug interactions are mentioned here.