Engerix-B Pediatric Side Effects

Generic name: hepatitis b pediatric vaccine

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

Applies to hepatitis b pediatric vaccine: intramuscular suspension.

Important warnings This medicine can cause some serious health issues

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:

• breathing that stops during sleep;

• fever, chills, swollen glands.

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

• unusual muscle weakness;

• changes in behavior; or

• 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:

• diarrhea, loss of appetite;

• feeling weak or tired;

• mild fussiness or crying;

• low fever; or

• 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 adverse events

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]

Further information

Engerix-B 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