Applies to hepatitis b pediatric vaccine: intramuscular suspension.
Warning
Tell your child's doctor if he or she uses other medicines or have other medical conditions or allergies.
Get emergency medical help if your child has signs of an allergic reaction: hives; difficulty breathing; swelling of the 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.
Your child may feel faint after receiving this vaccine. Some people have had seizure like reactions after receiving this vaccine. The doctor may want your child to remain under observation for a short time after the injection.
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.
Call the doctor at once if your child has:
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breathing that stops during sleep;
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fever, chills, swollen glands.
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fussiness, irritability, crying for an hour or longer;
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unusual muscle weakness;
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changes in behavior; or
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severe skin reaction--fever, sore throat, swelling in the face or tongue, burning in the eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common side effects may include:
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diarrhea, loss of appetite;
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feeling weak or tired;
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mild fussiness or crying;
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low fever; or
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runny nose.
This is not a complete list of side effects and others may occur. Call the doctor for medical advice about side effects.
For Healthcare Professionals
Applies to hepatitis b pediatric vaccine: intramuscular suspension.
General
The most common adverse events were injection site reactions, headache, and fatigue.[Ref]
Local
Very common (10% or more): Injection site pain (33.8%), injection site soreness (22%), injection site redness (15.6%), injection site swelling (11.7%)
Common (1% to 10%): Injection site induration
Uncommon (0.1% to 1%): Injection site ecchymosis, injection site pruritus
Postmarketing reports: Injection site reaction[Ref]
Nervous system
Very common (10% or more): Headache (23.4%)
Common (1% to 10%): Dizziness, drowsiness
Uncommon (0.1% to 1%): Somnolence, tingling, paresthesia
Postmarketing reports: Encephalitis, encephalopathy, migraine, multiple sclerosis, neuritis, neuropathy including hypoesthesia, Guillain-Barre syndrome and Bell's palsy, optic neuritis, paralysis, paresis, seizures, syncope, transverse myelitis, vertigo, demyelinating disease of the central nervous system, exacerbation of multiple sclerosis[Ref]
Other
Very common (10% or more): Fatigue (33.8%)
Common (1% to 10%): Fever, malaise
Uncommon (0.1% to 1%): Chills, influenza-like symptoms, sweating, achiness, sensation of warmth, lightheadedness, flushing, earache
Postmarketing reports: Tinnitus[Ref]
Hypersensitivity
Postmarketing reports: Allergic reaction, anaphylactoid reaction, anaphylaxis, apparent hypersensitivity syndrome[Ref]
Apparent hypersensitivity syndrome (serum sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymosis, and erythema nodosum.[Ref]
Metabolic
Common (1% to 10%): Appetite lost
Uncommon (0.1% to 1%): Anorexia[Ref]
Psychiatric
Very common (10% or more): Irritability
Uncommon (0.1% to 1%): Agitation, insomnia[Ref]
Respiratory
Common (1% to 10%): Pharyngitis, upper respiratory infection
Uncommon (0.1% to 1%): Upper respiratory tract illnesses, rhinitis, cough, influenza
Frequency not reported: Pharyngitis
Postmarketing reports: Apnea, bronchospasm including asthma-like symptoms[Ref]
Musculoskeletal
Uncommon (0.1% to 1%): Arthralgia, back pain, myalgia, pain/stiffness in arm, shoulder, or neck
Postmarketing reports: Arthritis, muscular weakness[Ref]
Gastrointestinal
Common (1% to 10%): Gastrointestinal symptoms
Uncommon (0.1% to 1%): Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting
Postmarketing reports: Dyspepsia[Ref]
Hematologic
Uncommon (0.1% to 1%): Lymphadenopathy
Postmarketing reports: Thrombocytopenia, increased erythrocyte sedimentation rate[Ref]
Dermatologic
Uncommon (0.1% to 1%): Erythema, petechiae, pruritus, rash, sweating, urticaria
Postmarketing reports: Alopecia, angioedema, eczema, erythema multiforme including Stevens-Johnson syndrome, erythema nodosum, lichen planus, purpura[Ref]
Cardiovascular
Uncommon (0.1% to 1%): Flushing, hypotension
Postmarketing reports: Palpitations, tachycardia, vasculitis, syncope[Ref]
Ocular
Very rare (less than 0.01%): Uveitis
Postmarketing reports: Conjunctivitis, keratitis, visual disturbances, optic neuritis[Ref]
Genitourinary
Uncommon (0.1% to 1%): Dysuria[Ref]
Hepatic
Postmarketing reports: Abnormal liver function tests[Ref]
Immunologic
Postmarketing reports: Herpes zoster, meningitis[Ref]
