Applies to diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid: intramuscular powder for suspension, intramuscular suspension.
Serious side effects
Along with its needed effects, diphtheria toxoid/haemophilus b conjugate (prp-t) vaccine/pertussis, acellular/poliovirus vaccine, inactivated/tetanus toxoid 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 immediately if any of the following side effects occur while taking diphtheria toxoid/haemophilus b conjugate (prp-t) vaccine/pertussis, acellular/poliovirus vaccine, inactivated/tetanus toxoid:
More common
- Chest pain or tightness
- confusion
- coughing
- crying, persistent and inconsolable, occurring within 48 hours and lasting 3 or more hours
- decreased urination
- diarrhea
- dizziness
- dry mouth
- fainting
- fever
- increase in heart rate
- lightheadedness
- loss of appetite
- nausea
- noisy, rapid, or trouble breathing
- sneezing
- sore throat
- stomach pain
- sunken eyes
- thirst
- unusual tiredness or weakness
- wrinkled skin
Incidence not known
- Bluish color of the fingernails, lips, skin, palms, or nail beds
- chills
- cold or flu-like symptoms
- drowsiness
- fainting
- fast heartbeat
- general feeling of illness
- hives
- hoarseness
- irritation
- itching
- joint pain, stiffness, or swelling
- rash
- redness of the skin
- runny nose
- severe headache
- slow breathing
- sneezing
- stiff neck or back
- stuffy nose
- swelling of the eyelids, face, lips, hands, or feet
Other side effects
Some side effects of diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid 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
- Irritability
- tenderness at the injection site
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Incidence not known
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- change in skin color at the injection site
- paleness of the skin
- sleepiness or unusual drowsiness
- vomiting
For Healthcare Professionals
Applies to diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid: intramuscular kit.
Psychiatric
Very common (10% or more): Fussiness/irritability (76.9%)
Postmarketing reports: Screaming
Other
Four deaths occurred in the clinical trials. Causes of death were asphyxia due to suffocation, head trauma, Sudden Infant Death Syndrome, and neuroblastoma which occurred at 8, 23, 52, and 256 days post-vaccination respectively.[Ref]
Very common (10% or more): Inconsolable crying (59.3%), fever (16.3%)
Rare (less than 0.1%): Death
Postmarketing reports: Vaccination failure/therapeutic response decreased[Ref]
Nervous system
Very common (10% or more): Decreased activity/lethargy (45.8%)
Rare (less than 0.1%): Seizures, encephalopathy
Frequency not reported: Hypotonia[Ref]
Four patients experienced a seizure within 7 days of vaccination. One case of encephalopathy occurred 30 days post-vaccination and was secondary to cardiac arrest after cardiac surgery.[Ref]
Local
Very common (10% or more): Injection site tenderness (56.1%), increase in arm circumference (33.6%), injection site redness (17.3%)
Common (1% to 10%): Injection site swelling
Postmarketing reports: Injection site reactions (including inflammation, mass, abscess, sterile abscess), extensive swelling of the injected limb (including swelling involving adjacent joints)[Ref]
Hypersensitivity
Postmarketing reports: Anaphylaxis/anaphylactic reaction, hypersensitivity (such as rash and urticaria)[Ref]
Respiratory
Asthma was a serious adverse event that occurred within 30 days following the 4th dose of vaccine.[Ref]
Frequency not reported: Asthma
Postmarketing reports: Apnea, cough[Ref]
Immunologic
Bronchiolitis, gastroenteritis, and pneumonia were serious adverse events that occurred within 30 days following the 4th dose of vaccine.[Ref]
Frequency not reported: Bronchiolitis, gastroenteritis, pneumonia
Postmarketing reports: Meningitis, rhinitis, viral infection[Ref]
Cardiovascular
Postmarketing reports: Cyanosis, pallor[Ref]
Dermatologic
Postmarketing reports: Erythema, skin discoloration[Ref]
Metabolic
Postmarketing reports: Decreased appetite[Ref]
Gastrointestinal
Postmarketing reports: Vomiting, diarrhea[Ref]
