Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Serious allergic reactions (anaphylactic reaction):
If any of these symptoms occur after leaving the place where the child received his/her injection, patient must consult a doctor immediately: difficulty in breathing, blueness of the tongue or lips, a rash, swelling of the face or throat, sudden and serious malaise with drop in blood pressure causing dizziness and loss of consciousness, accelerated heart rate associated with respiratory disorders.
When these signs or symptoms (signs or symptoms of anaphylactic reaction) occur they usually develop quickly after the injection is given and while the child is still in the clinic or doctor's surgery.
Serious allergic reactions are a rare possibility (may affect up to 1 in 1,000 people) after receiving this vaccine.
Other side effects:
If the child experiences any of the following side effects, please tell the doctor, nurse or pharmacist.
Very common side effects (may affect more than 1 in 10 people) are: Loss of appetite (anorexia), crying, sleepiness (somnolence), vomiting, pain, redness or swelling at the injection site, irritability, fever (temperature 38°C or higher).
Common side effects (may affect up to 1 in 10 people) are: Abnormal crying (prolonged crying), diarrhoea, injection site hardness (induration).
Uncommon side effects (may affect up to 1 in 100 people) are: Allergic reaction, lump (nodule) at the injection site, high fever (temperature 39.6°C or higher).
Rare side effects (may affect up to 1 in 1,000 people are) are: Rash, large reactions at the injection site (larger than 5 cm), including extensive limb swelling from the injection site beyond one or both joints. These reactions start within 24-72 hours after vaccination, may be associated with redness, warmth, tenderness, or pain at the injection site, and get better within 3-5 days without the need for treatment, fits (convulsions with or without fever.
Very rare side effects (may affect up to 1 in 10,000 people) are: Episodes when the child goes into shock-like state or is pale, floppy and unresponsive for a period of time (hypotonic reactions or hypotonic hyporesponsive episodes HHE).
Potential side effects:
Other side effects not listed above have been reported occasionally with other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines and not directly with HEXAXIM: Temporary inflammation of nerves causing pain, paralysis and sensitivity disorders (Guillain-Barre syndrome) and severe pain and decreased mobility of arm and shoulder (brachial neuritis have been reported after administration of a tetanus containing vaccine.
Inflammation of several nerves causing sensory disorders or weakness of limbs (polyradiculoneuritis), facial paralysis, visual disturbances, sudden dimming or loss of vision (optic neuritis), inflammatory disease of brain and spinal cord (central nervous system demyelination, multiple sclerosis) have been reported after administration of hepatitis B antigen containing vaccine.
Swelling or inflammation of the brain (encephalopathy/encephalitis).
In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Swelling of one or both feet and lower limbs which may occur along with bluish discoloration of the skin (cyanosis), redness, small areas of bleeding under the skin (transient purpura) and severe crying following vaccination with Haemophilus influenzae
type b containing vaccines. If this reaction occurs, it is mainly after first injections and within the first few hours following vaccination. All symptoms should disappear completely within 24 hours without need for treatment.