Diphtheria toxoid / haemophilus b conjugate (prp-omp) vaccine / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid Side Effects

Applies to diphtheria toxoid / haemophilus b conjugate (prp-omp) vaccine / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid: intramuscular suspension.

Get emergency medical help if your child has signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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 all side effects your child has. If the child receives a booster dose, tell the vaccination provider if the previous shot caused any side effects.

Call your doctor at once if your child has:

• breathing that stops during sleep;

• unusual pain or discomfort;

• weakness; or

• problems with vision, hearing, or muscle movement.

Becoming infected with diphtheria, haemophilus B, hepatitis B, pertussis, polio, or tetanus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects.

Common side effects may include:

• fever of 100.4 degrees F or higher;

• fussiness, crying more than usual;

• vomiting, decreased hunger; or

• drowsiness; or

• pain, swelling, or redness 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.

For Healthcare Professionals

Applies to diphtheria toxoid/haemophilus b conjugate (prp-omp) vaccine/hepatitis b pediatric vaccine/pertussis, acellular/poliovirus vaccine, inactivated/tetanus toxoid: intramuscular suspension.

General

The most frequently reported adverse reactions were irritability, crying, somnolence, injection site reactions (pain, erythema, swelling), fever, decreased appetite, and vomiting.^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Pallor^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, hyperhidrosis^[Ref]

Gastrointestinal

Very common (10% or more): Vomiting (up to 13.1%)

Common (1% to 10%): Diarrhea

Uncommon (0.1% to 1%): Abdominal pain^[Ref]

Hematologic

Uncommon (0.1% to 1%): Lymphadenopathy^[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity (includes rash, urticaria, dyspnea, erythema multiforme), anaphylactic reaction (includes urticaria, angioedema, edema, face edema, and shock)^[Ref]

Local

Very common (10% or more): Injection site pain (up to 53.3%), injection site erythema (up to 31.8%), injection site swelling (up to 23.4%)

Common (1% to 10%): Injection site bruising, injection site induration, injection site nodule

Uncommon (0.1% to 1%): Injection site rash, injection site warmth, tenderness

Postmarketing reports: Extensive swelling of injected limb (includes adjacent joints)^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 28.9%)

Uncommon (0.1% to 1%): Increased appetite^[Ref]

Nervous system

Very common (10% or more): Somnolence (up to 56.3%)

Uncommon (0.1% to 1%): Hypotonia

Postmarketing reports: Seizure, febrile seizure, hypotonic-hyporesponsive episode (HHE), convulsions with or without fever^[Ref]

Other

Very common (10% or more): Crying (up to 52%), fever (38C or higher) (up to 29.3%)

Uncommon (0.1% to 1%): Death, fatigue^[Ref]

In 2 US studies, death was reported in 6 participants (0.2%). None were assessed as vaccine related. Causes of death included asphyxia, hydrocephalus, unknown cause, sepsis, and 2 cases of sudden infant death syndrome occurring 1, 2, 10, 42, 44, and 49 days post-vaccination, respectively.^[Ref]

Psychiatric

Very common (10% or more): Irritability (up to 61.8%)

Uncommon (0.1% to 1%): Sleep disorders (includes insomnia, restlessness)^[Ref]

Respiratory

Uncommon (0.1% to 1%): Rhinitis, cough

Frequency not reported: Apnea^[Ref]

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.

Medical Disclaimer