Applies to diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid: intramuscular suspension.
Serious side effects
Along with its needed effects, a vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. It is very important that you tell your doctor about any side effect that occurs after a dose of DTaP-HepB-IPV vaccine, even if the side effect goes away without treatment. Some types of side effects may mean that your child should not receive any more doses of DTaP-HepB-IPV vaccine.
Check with your doctor or nurse immediately if any of the following side effects occur while taking diphtheria toxoid/hepatitis b pediatric vaccine/pertussis, acellular/poliovirus vaccine, inactivated/tetanus toxoid:
Incidence not known
- Abdominal or stomach pain
- agitation
- back pain
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- bluish color of the fingernails, lips, skin, palms, or nail beds
- blurred vision
- chills
- clay colored stools
- collapse or shock-like state
- coma
- confusion
- cough
- dark urine
- diarrhea
- difficulty with swallowing
- dizziness
- drowsiness
- fast heartbeat
- fever
- hallucinations
- headache
- heavier menstrual periods
- hives or hive like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- hoarseness
- irritability
- irritation
- itchiness, puffiness or swelling of the eyelids or around the eyes, face, lips, tongue, hands, or feet
- itching
- joint pain
- loosening of the skin
- mood or mental changes
- nausea
- pain or cramping in the abdomen or stomach
- pinpoint red spots on the skin
- redness of the skin
- red, irritated eyes
- seizures
- shortness of breath
- skin rash
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stiff neck
- stiffness or swelling
- Sudden Infant Death Syndrome (SIDS)
- swelling
- tightness in the chest
- troubled breathing
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting or vomiting of blood
- weight loss
- wheezing
- yellow eyes or skin
Other side effects
Some side effects of diphtheria toxoid/hepatitis b pediatric 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
- Bleeding
- blistering
- burning
- coldness
- discoloration of the skin
- fussiness
- feeling of pressure
- infection
- inflammation
- lumps
- numbness
- pain
- restlessness
- scarring
- sleeping more than usual
- soreness
- stinging
- tenderness
- tingling
- ulceration
- unusual cry
- warmth on the skin
Incidence not known
- Arm or leg swelling
- difficulty with moving
- dullness, tiredness, weakness, or feeling of sluggishness
- feeling of warmth
- general feeling of discomfort or illness
- hair loss
- itching skin
- lack or loss of strength
- loss of appetite
- loss of strength or energy
- muscle pain, weakness, or stiffness
- pain in the joints
- paleness of the skin
- redness of the face, neck, arms, and occasionally, upper chest
- sneezing
- sores, ulcers, or white spots in the mouth or on the lips
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- thinning of the hair
For Healthcare Professionals
Applies to diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid: intramuscular suspension.
Other
In clinical trials 5 deaths occurred in 8088 vaccinees. Causes of death included 2 cases of sudden infant death syndrome (SIDS), 1 convulsive disorder, 1 congenital immunodeficiency with sepsis, and 1 neuroblastoma. One case of SIDS occurred in the comparator group.
Very common (10% or more): Fever 39%
Rare (less than 0.1%): Death
Local
Very common (10% or more): Local redness (40%), local pain (36%), local swelling (29%)[Ref]
Nervous system
Very common (10% or more): Drowsiness (57%)
Uncommon (0.1% to 1%): Pyrexia[Ref]
Immunologic
Uncommon (0.1% to 1%): Culture-negative clinical sepsis[Ref]
Psychiatric
Very common (10% or more): Irritability/fussiness (65%)[Ref]
Gastrointestinal
Uncommon (0.1% to 1%): Gastroenteritis[Ref]
Metabolic
Very common (10% or more): Loss of appetite (31%)
