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Hepatitis a pediatric vaccine Side Effects

For the Consumer

Applies to hepatitis a pediatric vaccine: intramuscular suspension

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.

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

Call your child's doctor at once if the child has:

  • extreme drowsiness, fainting;

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

  • seizure (blackout-out or convulsions); or

  • high fever (within a few hours or a few days after the vaccine).

Common side effects may include:

  • low fever, general ill feeling;

  • nausea, loss of appetite;

  • headache; or

  • swelling, tenderness, redness, warmth, or a hard lump 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]

References

1. "Product Information. Havrix (hepatitis A vaccine)." SmithKline Beecham, Philadelphia, PA.

2. "Product Information. Vaqta (hepatitis A vaccine)." Merck & Company Inc, West Point, PA.

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.

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