Tetraxim Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious allergic reactions: Serious allergic reactions, although very rare, may occur following vaccination, generally while the child is still present at the vaccination site.
If any of the signs or symptoms described as follows occur after leaving the place where the child was vaccinated, a doctor or emergency medical services should be contacted immediately: 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 side effects described as follows and if the sign(s)/symptom(s) persist or worsen, the doctor or pharmacist should be contacted.
Very common reactions (may affect more than one in 10 children): Loss of appetite; Nervousness, irritability; Abnormal crying; Somnolence; Headache; Vomiting; Muscle pain (myalgia); Injection site redness (erythema); Injection site pain; Injection site swelling (oedema); 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 1000 children): Fever >40°C.
Reactions for which the frequency is not known (cannot be estimated from the available data): 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 the legs and feet (oedematous reactions affecting the 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 by severe crying.
Potential side effects (i.e. they 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-Barré 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 for 2-3 days after vaccination.
Reporting of side effects: If any side effects occur, talk to the doctor, pharmacist or nurse. This includes any possible side effects not previously listed. By reporting side effects, more information on the safety of this medicine can be provided.