Like all medicines, TETRAXIM can cause side effects, although not everybody gets them.
Serious allergic reaction:
Serious allergic reactions, although very rare, may occur following vaccination, generally while the child is still present on the place where he/she was vaccinated.
If any of the symptoms listed below occurs after leaving the place where the child was vaccinated, contact IMMEDIATELY a doctor or the emergency services.
Swelling of the face (face oedema), sudden swelling of the face and neck (angioedema, Quincke's oedema).
Sudden and serious malaise with drop in blood pressure causing dizziness and loss of consciousness, accelerated heart rate associated with respiratory disorders (anaphylactic reaction).
Other side effects:
If the child experiences any of the following side effects listed below and it persists or gets serious, please contact a doctor or pharmacist.
Very common reactions: Loss of appetite; Nervousness, irritability, abnormal crying; Somnolence, headache; Vomiting; Muscle pain (myalgia); Injection-site redness (erythema), injection-site pain, injection-site swelling, fever ≥38°C, malaise.
Common reactions (may affect up to 1 in 10 children): Insomnia, sleep disorder; Diarrhoea; Injection-site hardening (induration).
Uncommon reactions (may affect up to 1 in 100 children): Inconsolable and prolonged crying; Injection-site redness and swelling (oedema) ≥5 cm, fever ≥39°C.
Rare reactions (may affect up to 1 in 1,000 children): Fever >40°C.
Reactions with a not Known frequency (frequencies cannot be estimated because these reactions are reported very rarely): Convulsions with or without fever, loss of consciousness (syncope); Skin rash, redness (erythema), itching (urticaria); Increase in volume of the lymph nodes close to the injection site (lymphadenopathy).
Drops in energy or periods during which the child is pale, unresponsive or seems in a shock-like state (hypotony-hyporesponsiveness) were reported after administration of pertussis-containing vaccines.
Also, when TETRAXIM is administered with a Haemophilus influenzae
type-b containing vaccine, swelling in legs and feet (oedematous reactions affecting lower limbs) were reported, with a bluish discoloration of the skin (cyanosis) or redness, small transient red spots (purpura) occurring within hours of vaccination, and disappearing without treatment and without sequelae. Swelling may be accompanied with severe crying.
Potential side effects (i.e. children have not been reported directly with TETRAXIM, but with other vaccines containing one or more of the antigenic constituents of TETRAXIM) are the following: Guillain-Barre syndrome (abnormal sensitivity, paralysis) and brachial neuritis (paralysis, diffuse pain in the arm and shoulder) following the administration of a vaccine containing tetanus toxoid.
Additional information concerning specific populations:
In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur 2-3 days after vaccination.