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Diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid Side Effects

For the Consumer

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

In addition to its needed effects, some unwanted effects may be caused by a vaccine. In the event that any of these side effects do occur, they may require 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.

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

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

Minor Side Effects

Some of the side effects that can occur with diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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.

Not all side effects for diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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