Havrix Pediatric Side Effects

Generic name: hepatitis a pediatric vaccine

Note: This document provides detailed information about Havrix Pediatric Side Effects associated with hepatitis a pediatric vaccine. Some dosage forms listed on this page may not apply specifically to the brand name Havrix Pediatric.

Applies to hepatitis a pediatric vaccine: intramuscular suspension.

Important warnings This medicine can cause some serious health issues

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:

• extreme drowsiness, fainting;

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

• a seizure; or

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

Common side effects may include:

• fever;

• irritability, drowsiness;

• loss of appetite;

• headache; or

• 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]

Further information

Havrix Pediatric side effects can vary depending on the individual. 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.

Medical Disclaimer