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Engerix-B Pediatric Side Effects

Generic Name: hepatitis b pediatric vaccine

Note: This page contains information about the side effects of hepatitis b pediatric vaccine. Some of the dosage forms included on this document may not apply to the brand name Engerix-B Pediatric.

Not all side effects for Engerix-B Pediatric may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to hepatitis b pediatric vaccine: intramuscular suspension

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 any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with hepatitis B is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

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

Call your doctor at once if your child has any of these serious side effects:

  • fussiness, irritability, crying for an hour or longer;

  • unusual muscle weakness;

  • changes in behavior; or

  • fever with red or purple skin rash that spreads and causes blistering and peeling.

Common side effects include:

  • nausea, diarrhea, loss of appetite;

  • redness, pain, swelling, or a lump where the shot was given;

  • general ill feeling;

  • mild fussiness or crying;

  • low fever;

  • tired feeling; or

  • runny nose.

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 hepatitis b pediatric vaccine: intramuscular suspension


Hepatitis B vaccine is generally well-tolerated. Most side effects were mild and primarily included injection site reactions and fatigue.[Ref]


Respiratory side effects have included rhinitis, cough, pharyngitis, upper respiratory tract illness, influenza-like symptoms, and bronchospasm including asthma-like symptoms.[Ref]


Other side effects have included fatigue, fever, chills, flushing, lightheadedness, sweating, weakness, malaise, tinnitus, and earache.[Ref]


Ocular side effects have included optic neuritis, conjunctivitis, keratitis, and visual disturbances.[Ref]

Nervous system

Nervous system side effects have included headache, dizziness, vertigo, somnolence, insomnia, irritability, agitation, migraine, syncope, paresis, neuropathy, hypoesthesia, paresthesia, convulsions, encephalitis, Guillain-Barre syndrome, radiculopathy, herpes zoster, muscle weakness, multiple sclerosis, exacerbation of multiple sclerosis, Bell's palsy, optic sclerosis, myelitis, and transverse myelitis.[Ref]


Musculoskeletal side effects have included arthritis, arthralgia, myalgia, back pain, and pain or stiffness in the arm, shoulder, or neck.[Ref]


Local side effects have included soreness, redness, swelling, induration, pain, pruritus, warmth, nodule formation, and ecchymosis at the injection site.[Ref]


Hypersensitivity reactions have included anaphylaxis, anaphylactoid reactions, rash, pruritus, urticaria, edema, dyspnea, chest discomfort, bronchial spasm, palpitation, hypotension, erythema multiforme, Stevens-Johnson syndrome, angioedema, arthritis, and serum sickness-like syndrome (arthralgia, arthritis, fever, urticaria, erythema multiforme, ecchymoses, and erythema nodosum).[Ref]


Hepatic side effects have included abnormal liver function tests.[Ref]


Hematologic side effects have included lymphadenopathy, thrombocytopenia, and increased erythrocyte sedimentation rate.[Ref]


Gastrointestinal side effects have included diarrhea, nausea, vomiting, abdominal pain, cramps, anorexia, constipation, and dyspepsia.[Ref]


Dermatologic side effects have included rash, urticaria, petechiae, erythema, hyperhidrosis, angioedema, eczema, herpes zoster, erythema nodosum, purpura, alopecia, and Stevens-Johnson syndrome.[Ref]


Cardiovascular side effects have included syncope, hypotension, tachycardia, and palpitations.[Ref]


Immunologic side effects including liver transplant rejection, diarrhea infections, pneumonia, and sepsis have been reported in greater than 10% of patients.[Ref]


Genitourinary side effects have included dysuria.[Ref]


1. "Product Information. Recombivax HB Pediatric/Adolescent (hepatitis B pediatric vaccine)." Merck & Company Inc, West Point, PA.

2. "Product Information. Engerix-B Pediatric (hepatitis B pediatric vaccine)." GlaxoSmithKline, Research Triangle Park, NC.

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