Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (reported by more than 1 in 10 people): Injection site reactions such as pain, redness, swelling and/or inflammation, hardening (induration); irritability.
Common side effects (reported by less than 1 in 10 people but more than 1 in 100 people): crying (incontrollable or abnormal); fever; vomiting.
Uncommon side effects (reported by less than 1 in 100 people but more than 1 in 1000 people): fever (higher than 39°C).
Side effects with unknown frequency (because reported voluntarily and very rarely): Extensive swelling (large oedema) of the vaccinated limb that may spread to the whole arm or leg into which the vaccine was administered; Large injection site reactions, larger than 5 cm, such as pain, redness (erythema), swelling (oedema) and/or inflammation, or hardening of the skin (induration); Swelling of legs and feet (oedematous reactions affecting lower limbs). These reactions may be associated with crying, bluish skin colour (cyanosis) or redness and small transient red spots (purpura) occurring in the first hours of vaccination, resolving quickly without treatment (within 24 hours) and without sequelae; Swelling of the face and/or neck, allergic reactions (hypersensitivity reactions); Convulsions associated or not with fever; Skin eruption, sometimes swollen and itchy (urticaria, rash, pruritus), skin eruption over the whole body (rash generalised).
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 child gets any side effects, advise the parent to talk to the doctor, pharmacist or nurse. This includes any possible side effects not previously listed in this monograph. By reporting side effects, more information can be provided on the safety of this medicine.