Quadracel

Diphtheria, pertussis acellular, 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.

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 affects the central nervous system and spinal cord. It can cause muscle weakness and paralysis. Polio is a life threatening condition because it 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.

Diphtheria, pertussis, and polio are spread from person to person. Tetanus enters the body through a cut or wound.

This vaccine is used to help prevent these diseases in children who are ages 4 through 6 years (before the 7th birthday) who have received prior vaccination with a DTaP and IPV series.

This vaccine works by exposing your child to a small dose of the virus, bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Like any vaccine, the diphtheria, pertussis acellular, polio, and tetanus vaccine may not provide protection from disease in every person.

Your child should not receive this vaccine if he or she has a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine).

Your child should not receive this vaccine if he or she has ever had a life-threatening allergic reaction to any vaccine containing diphtheria, pertussis, polio, or tetanus. Your child also should not receive this vaccine if he or she has a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine).

Your child may not be able to receive this vaccine if he or she has ever received a similar vaccine that caused any of the following:

• a very high fever (over 104 degrees), excessive crying for 3 hours or longer, fainting or going into shock (within 48 hours after receiving a vaccine containing pertussis);
• a seizure (within 3 days after receiving a vaccine containing pertussis);
• an allergy to neomycin, streptomycin or polymyxin B, and yeast; or
• Guillain-Barré syndrome (within 6 weeks after receiving a vaccine containing tetanus).

If your child has any of these other conditions, this vaccine may need to be postponed or not given at all:

• a history of seizures or premature birth; or
• a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments.

Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with diphtheria, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the child has any of these side effects:

• irritability, crying for an hour or longer;
• very high fever; or
• extreme drowsiness, fainting.

Common side effects may include:

• drowsiness;
• loss of appetite; or
• redness, pain, tenderness, or swelling 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.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Before your child receives this vaccine, tell the doctor if your child has recently received any drugs or treatments that can weaken the immune system. 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.

• Sanofi Pasteur, Inc

Side effects reported with Quadracel include:

• pain, redness, and swelling at the injection site
• increase in arm circumference
• muscle pain (myalgia)
• a general feeling of discomfort, illness, or uneasiness (malaise)
• headache
• fever

Tell your healthcare provider if you have any new or unusual symptoms after you receive Quadracel. For a complete list of side effects, ask your health care provider.

Quadracel is given by a healthcare provider as a shot into the upper arm. 

Quadracel is given by a healthcare provider as a single 0.5-mL dose injected into the upper arm. 

A single dose of Quadracel is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series, in children who have received 4 doses of Pentacel and/or Daptacel.

Diphtheria, tetanus, and acellular pertussis vaccine (also known as DTaP) combined with inactivated poliovirus vaccine (also known as IPV) is a combination vaccine that is given to protect against infections caused by diphtheria, tetanus (lockjaw), pertussis (whooping cough), and poliovirus. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. This vaccine is given only to children 4 to 6 years of age (before the child’s 7th birthday).

Diphtheria is a serious illness that can cause breathing difficulties, heart problems, nerve damage, pneumonia, and possibly death. The risk of serious complications is greater in very young children and the elderly.

Tetanus (also known as lockjaw) is a very serious illness that causes seizures and severe muscle spasms that can be strong enough to cause bone fractures of the spine. The disease continues to occur almost exclusively among people who do not get vaccinated or do not have enough protection from previous vaccines.

Pertussis (also known as whooping cough) is a serious disease that causes severe spells of coughing that can interfere with breathing. Pertussis can also cause pneumonia, long-lasting bronchitis, seizures, brain damage, and death.

Polio is a very serious infection that causes paralysis of the muscles, including the muscles that enable you to walk and breathe. A polio infection may leave a person unable to breathe without the help of a breathing machine. It may also leave a person unable to walk without leg braces or being confined to a wheelchair. There is no cure for polio.

This vaccine is to be given only by or under the supervision of your child’s doctor.

It is very important that the doctor check your child at regular visits to make sure this vaccine is working properly and to check for unwanted effects.

Tell your child’s doctor about all other vaccines your child has had, especially if those vaccines were part of a series. This vaccine might be used to finish a series of vaccines.

Contact your doctor immediately if your child has sudden weakness in the arms and legs. This could be a sign of a serious condition called Guillain-Barré syndrome.

It is very important to tell the doctor if your child is allergic to latex rubber. The tip caps of the prefilled syringes may contain dry natural latex rubber, which may cause an allergic reaction if your child has a latex allergy. .

This vaccine will not treat an active infection. If your child has an infection due to diphtheria, tetanus, pertussis, or polio, your child will need medicines to treat these infections.

Syncope (fainting) may occur after receiving this vaccine. Your doctor may want your child to be observed after receiving the injection to prevent and manage fainting.

Be sure to tell your child’s doctor about any serious side effects that occur after your child receives the vaccine. This may include seizures, a high fever, crying that will not stop, or severe redness or swelling where the shot was given.

Make sure your doctor knows if you are using medicines that weaken your immune system such as cancer medicines, radiation treatment, or steroids.

Applies to diphtheria toxoid / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid: intramuscular suspension

Along with its needed effects, diphtheria toxoid / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking diphtheria toxoid / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid:

• Abdominal or stomach pain
• blurred vision
• confusion
• decreased urination
• diarrhea
• difficulty having a bowel movement (stool)
• dizziness
• dry mouth
• fainting
• fast heartbeat
• fever
• inability to speak
• irritability
• itching, pain, redness, swelling, tenderness, or warmth on the skin
• lightheadedness
• loss of appetite
• muscle twitching
• nausea
• rapid breathing
• restlessness
• seizures
• severe or sudden headache
• slurred speech
• sunken eyes
• swelling of the feet or lower legs
• temporary blindness
• thirst
• unusual tiredness or weakness
• weakness
• weakness in the arm and/or leg on one side of the body, sudden and severe
• wrinkled skin

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• bluish lips or skin
• collapse or shock-like state
• cough
• difficulty swallowing
• hives
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash
• slow breathing
• swollen, painful, or tender lymph glands in neck, armpit, or groin
• tightness in the chest
• unusual bleeding or bruising

Some side effects of diphtheria toxoid / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Loss of appetite
• pain, redness, or swelling at the injection site
• sleepiness