Applies to hepatitis a pediatric vaccine: intramuscular suspension.
Warning
Tell your doctor if you use 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 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 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 your child's doctor at once if the child has:
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extreme drowsiness, fainting;
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fussiness, irritability, crying for an hour or longer;
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a seizure; or
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high fever (within a few hours or a few days after the vaccine).
Common side effects may include:
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fever;
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irritability, drowsiness;
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loss of appetite;
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headache; or
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swelling, tenderness, redness, or warmth 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 hepatitis a pediatric vaccine: intramuscular suspension.
General
The most common adverse events were injection site reactions, irritability, drowsiness, loss of appetite and headache.[Ref]
Local
Very common (10% or more): Injection site soreness (56%), injection site pain (37%), injection site redness (22.8%)
Common (1% to 10%): Induration and swelling of the injection site, injection site bruising, injection site ecchymosis
Uncommon (0.1% to 1%): Injection site hematoma
Postmarketing reports: Injection site reaction[Ref]
Nervous system
Very common (10% or more): Headache (23.8%), drowsiness (22.3%),
Uncommon (0.1% to 1%): Dysgeusia, hypertonia, vertigo, seizure
Rare (less than 0.1%): Febrile seizure
Postmarketing reports: Convulsion, dizziness, encephalopathy, Guillain-Barre syndrome, hypoesthesia, multiple sclerosis, myelitis, neuropathy, paresthesia, somnolence, syncope, cerebellar ataxia, encephalitis[Ref]
Other
Very common (10% or more): Fever (16.4%)
Common (1% to 10%): Fatigue, malaise, crying
Uncommon (0.1% to 1%): Creatine phosphokinase increased
Postmarketing reports: Congenital anomaly, influenza-like symptoms[Ref]
Psychiatric
Very common (10% or more): Irritability (33.3%)
Common (1% to 10%): Insomnia[Ref]
Metabolic
Very common (10% or more): Loss of appetite (19.9%)
Common (1% to 10%): Anorexia
Rare (less than 0.1%): Dehydration[Ref]
Immunologic
Common (1% to 10%): Upper respiratory tract infection, conjunctivitis, otitis media, nasopharyngitis, viral infection, pharyngitis streptococcal, laryngotracheobronchitis, viral exanthema, gastroenteritis viral, roseola, pharyngitis[Ref]
Gastrointestinal
Common (1% to 10%): Nausea, diarrhea, teething, constipation, vomiting, abdominal pain
Rare (less than 0.1%): Gastroenteritis[Ref]
Dermatologic
Common (1% to 10%): Dermatitis diaper, rash vesicular, measles-like rash, varicella-like rash, rash morbilliform
Uncommon (0.1% to 1%): Pruritus, rash, urticaria
Rare (less than 0.1%): Cellulitis
Postmarketing reports: Angioedema, erythema multiforme, hyperhidrosis[Ref]
Musculoskeletal
Common (1% to 10%): Myalgia, back pain, stiffness
Uncommon (0.1% to 1%): Arthralgia
Postmarketing reports: Musculoskeletal stiffness, chills[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Allergic reactions (including injection site pruritus/rash, bronchial constriction, asthma, wheezing, edema/swelling, rash, generalized erythema, urticaria, pruritus, eye irritation/itching, dermatitis)
Postmarketing reports: Anaphylactic reaction, anaphylactoid reaction, serum sickness-like syndrome[Ref]
Hematologic
Uncommon (0.1% to 1%): Lymphadenopathy
Postmarketing reports: Thrombocytopenia[Ref]
Hepatic
Postmarketing reports: Hepatitis, jaundice[Ref]
Cardiovascular
Postmarketing reports: Vasculitis[Ref]
Ocular
Uncommon (0.1% to 1%): Photophobia[Ref]
Respiratory
Common (1% to 10%): Rhinorrhea, cough, nasal congestion, respiratory congestion
Postmarketing reports: Dyspnea[Ref]
