Applies to haemophilus b conjugate (prp-t) vaccine: intramuscular powder for solution, intramuscular powder for suspension, intramuscular solution.
Serious side effects
Along with its needed effects, haemophilus b conjugate (prp-t) vaccine 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
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]