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Pediarix Side Effects

Generic Name: diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid

Note: This document contains side effect information about diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid. Some of the dosage forms listed on this page may not apply to the brand name Pediarix.

For the Consumer

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:

Incidence not known
  • 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:

More common
  • 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
Incidence not known
  • 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

For Healthcare Professionals

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]

References

1. "Product Information. Pediarix (diphtheria/hepB/pertussis,acel/polio/tetanus)." GlaxoSmithKline, Research Triangle Park, NC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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