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Vaxelis Side Effects

Generic name: diphtheria toxoid / haemophilus b conjugate (prp-omp) vaccine / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid

Note: This document contains side effect information about diphtheria toxoid / haemophilus b conjugate (prp-omp) vaccine / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid. Some dosage forms listed on this page may not apply to the brand name Vaxelis.

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

Warning

Your child should not receive a booster vaccine if he or she had a life threatening allergic reaction after the first shot.

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.

Local

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

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

Other

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]

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

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

Nervous system

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

Postmarketing reports: Seizure, febrile seizure, hypotonic-hyporesponsive episode (HHE)[Ref]

Metabolic

Very common (10% or more): Decreased appetite (28.9%)[Ref]

Gastrointestinal

Very common (10% or more): Vomiting (13.1%)[Ref]

Hypersensitivity

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

Psychiatric

Very common (10% or more): Irritability (61.8%)[Ref]

More about Vaxelis (diphtheria toxoid / haemophilus b conjugate (prp-omp) vaccine / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid)

Patient resources

Professional resources

Related treatment guides

References

1. "Product Information. Vaxelis (diphtheria/haem/hepB/pert,acel/polio/tetan)." Merck & Company Inc (2022):

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.