Diphtheria & Tetanus Tox, Acell Pertussis, Hep B (Recomb), Polio Vacc

• It is used to prevent diphtheria, tetanus, pertussis, hepatitis B, and polio.

• Tell all of your child's health care providers that your child is taking diphtheria & tetanus tox, acell pertussis, hep B , polio vacc. This includes your child's doctors, nurses, pharmacists, and dentists.
• If your child has a latex allergy, talk with the doctor.
• This medicine may not protect all people who use it. Talk with the doctor.
• Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks of using this medicine.
• Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child's doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• High fever.
• Very bad dizziness or passing out.
• Change in eyesight.
• Seizures.
• A burning, numbness, or tingling feeling that is not normal.
• Trouble controlling body movements.
• Crying that lasts.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child's doctor or get medical help if your child has any side effects that bother your child or do not go away.

• Pain where the shot was given.
• Redness or swelling where the shot is given.
• Feeling sleepy.
• Feeling fussy.
• Not hungry.
• Fever.

These are not all of the side effects that may occur. If you have questions about side effects, call your child's doctor. Call your child's doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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

Along with its needed effects, a vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. It is very important that you tell your doctor about any side effect that occurs after a dose of DTaP-HepB-IPV vaccine, even if the side effect goes away without treatment. Some types of side effects may mean that your child should not receive any more doses of DTaP-HepB-IPV vaccine.

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

• Abdominal or stomach pain
• agitation
• back pain
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• bluish color of the fingernails, lips, skin, palms, or nail beds
• blurred vision
• chills
• clay colored stools
• collapse or shock-like state
• coma
• confusion
• cough
• dark urine
• diarrhea
• difficulty with swallowing
• dizziness
• drowsiness
• fast heartbeat
• fever
• hallucinations
• headache
• heavier menstrual periods
• hives or hive like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• hoarseness
• irritability
• irritation
• itchiness, puffiness or swelling of the eyelids or around the eyes, face, lips, tongue, hands, or feet
• itching
• joint pain
• loosening of the skin
• mood or mental changes
• nausea
• pain or cramping in the abdomen or stomach
• pinpoint red spots on the skin
• redness of the skin
• red, irritated eyes
• seizures
• shortness of breath
• skin rash
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stiff neck
• stiffness or swelling
• Sudden Infant Death Syndrome (SIDS)
• swelling
• tightness in the chest
• troubled breathing
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting or vomiting of blood
• weight loss
• wheezing
• yellow eyes or skin

Some side effects of diphtheria toxoid / hepatitis b pediatric vaccine / 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:

• Bleeding
• blistering
• burning
• coldness
• discoloration of the skin
• fussiness
• feeling of pressure
• infection
• inflammation
• lumps
• numbness
• pain
• restlessness
• scarring
• sleeping more than usual
• soreness
• stinging
• tenderness
• tingling
• ulceration
• unusual cry
• warmth on the skin

• Arm or leg swelling
• difficulty with moving
• dullness, tiredness, weakness, or feeling of sluggishness
• feeling of warmth
• general feeling of discomfort or illness
• hair loss
• itching skin
• lack or loss of strength
• loss of appetite
• loss of strength or energy
• muscle pain, weakness, or stiffness
• pain in the joints
• paleness of the skin
• redness of the face, neck, arms, and occasionally, upper chest
• sneezing
• sores, ulcers, or white spots in the mouth or on the lips
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• thinning of the hair

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

Local

Local side effects have included pain, redness, and swelling.[Ref]

Nervous system

Nervous system side effects have included irritability, fussiness, drowsiness, afebrile and febrile seizures. Postmarketing reports have included bulging fontanelle, convulsions, depressed level of consciousness, febrile convulsion, hypotonia, hypotonic-hyporesponsive episode, lethargy, and somnolence.[Ref]

Cardiovascular

Cardiovascular side effects have included postmarketing reports of cyanosis, pallor, and petechiae.[Ref]

Psychiatric

Psychiatric side effects have included postmarketing reports of crying, insomnia, irritability, nervousness, restlessness, screaming, and unusual crying.[Ref]

Gastrointestinal

Gastrointestinal side effects have included postmarketing reports of anorexia, diarrhea, and vomiting.[Ref]

Respiratory

Respiratory side effects have included postmarketing reports of upper respiratory infection, apnea, and dyspnea.[Ref]

Dermatologic

Dermatologic side effects have included angioedema, erythema, rash, and urticaria.[Ref]

General

General side effects have included fever.[Ref]

Immunologic

Immunologic side effects have included postmarketing reports of anaphylactic reaction, anaphylactoid reaction, and hypersensitivity.[Ref]

Some side effects of diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3:
6 months to 5 years:
3 doses of 0.5 mL, given intramuscularly, at 6- to 8-week intervals (preferably 8 weeks). The customary age for the first dose is 2 months of age, but it may be given starting at 6 weeks of age. The preferred administration site is the anterolateral aspect of the thigh for children younger than 1 year. In older children, the deltoid muscle is usually large enough for an intramuscular injection. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk. Gluteal injections may result in suboptimal hepatitis B immune response.

Modified Schedules:
Children Previously Vaccinated With One or More Doses of Hepatitis B Vaccine: Infants born of HBsAg-negative mothers and who received a dose of hepatitis B vaccine at or shortly after birth may be administered 3 doses of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) according to the recommended schedule.

Children Previously Vaccinated With One or More Doses of INFANRIX (diphtheria/tetanus/pertussis,acel): diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) may be used to complete the first 3 doses of the DTaP series in infants who have received 1 or 2 doses of INFANRIX and are also scheduled to receive the other vaccine components of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX).

Children Previously Vaccinated With One or More Doses of Poliovirus vaccine, inactivated (IPV):
diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) may be used to complete the first 3 doses of the IPV series in infants who have received 1 or 2 doses of IPV and are also scheduled to receive the other vaccine components of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX).