Note: This document contains side effect information about haemophilus b conjugate (prp-t) vaccine. Some dosage forms listed on this page may not apply to the brand name Hiberix.

Applies to haemophilus b conjugate (prp-t) vaccine: intramuscular powder for solution, intramuscular powder for suspension, intramuscular solution.

Serious side effects of Hiberix

Along with its needed effects, haemophilus b conjugate (prp-t) vaccine (the active ingredient contained in Hiberix) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking haemophilus b conjugate (prp-t) vaccine:

More common

• Diarrhea
• loss of appetite
• vomiting

Less common

• Earache
• redness or swelling in the ear

Rare

• Chest pain
• chills
• cough
• fever over 102 degrees F (39 degrees C)
• lack or loss of strength
• seizures
• sneezing
• sore throat
• tightness in the chest
• troubled breathing

Incidence not known

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• bluish lips or skin
• dizziness
• fast heartbeat
• hives or welts, skin rash
• itching (especially of the feet or hands)
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• reddening of the skin (especially around the ears)
• swelling of the eyes, face, or inside of the nose
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tingling of the hands or feet
• unusual tiredness or weakness (sudden and severe)
• unusual weight gain or loss

Other side effects of Hiberix

Some side effects of haemophilus b conjugate (prp-t) vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Fever less than 102 degrees F (39 degrees C)
• irritability
• redness, pain, swelling, tenderness, or warm feeling at the injection site
• reduced physical activity
• restlessness
• sleepiness

Less common

• Prolonged crying lasting more than 4 hours
• unusual high-pitched crying

For Healthcare Professionals

Applies to haemophilus b conjugate (prp-t) vaccine: intramuscular powder for injection.

General

The most common adverse events were pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, fussiness, and restlessness. Most symptoms occur in the first 48 hours, are mild, and resolve spontaneously.^[Ref]

Local

Very common (10% or more): Pain (49.4%), redness (29.4%), tenderness (20%), swelling (18.7%)

Common (1% to 10%): Induration

Very rare (less than 0.01%): Extensive swelling of vaccinated limb, injection site induration^[Ref]

Nervous system

Very common (10% or more): Drowsiness (59.9%), decreased activity/lethargy (51.1%), sleepiness (19.9%)

Rare (less than 0.1%): Seizure with apnea, convulsion

Very rare (less than 0.01%): Convulsions (with or without fever), hypotonic-hyporesponsive episode (e.g. sudden onset of hypotonia, hyporesponsiveness, and pallor or cyanosis), somnolence, syncope, vasovagal responses to injection^[Ref]

Psychiatric

Very common (10% or more): Irritability (70.4%), fussiness (25.9%), restlessness (21.8%)

Common (1% to 10%): Nervousness

Uncommon (0.1% to 1%): Emotional lability, insomnia^[Ref]

Other

Very common (10% or more): Inconsolable crying (58.5%), fever (34.8%)

Common (1% to 10%): Otitis media

Uncommon (0.1% to 1%): Asthenia, fatigue, injury

Postmarketing reports: Peripheral edema^[Ref]

Metabolic

Very common (10% or more): Loss of appetite (28.7%)^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (14.6%), vomiting

Common (1% to 10%): Gastroenteritis

Uncommon (0.1% to 1%): Abdominal pain^[Ref]

Dermatologic

Common (1% to 10%): Rash erythematous

Uncommon (0.1% to 1%): Sweating increased, purpura

Very rare (less than 0.01%): Angioedema, rash, urticaria

Postmarketing reports: Pruritus^[Ref]

Respiratory

Common (1% to 10%): Rhinitis, coughing, respiratory disorder, upper respiratory tract infection, bronchitis

Rare (less than 0.1%): Bilateral pneumonia

Very rare (less than 0.01%): Apnea in very premature infants^[Ref]

Hypersensitivity

Rare (less than 0.1%): Allergic reactions (including anaphylactic and anaphylactoid reactions)

Postmarketing reports: Other allergic/hypersensitivity reactions (including urticaria, angioedema)^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Spastic paralysis^[Ref]

Ocular

Common (1% to 10%): Conjunctivitis^[Ref]

Immunologic

Common (1% to 10%): Viral infection^[Ref]