Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious allergic reactions: Serious allergic reactions (hypersensitivity reactions), although very rare, may occur after vaccination. Usually patients are still at the vaccination place.
If any of the symptoms described as follows occurs after the patient left the place where the patients were vaccinated, contact the doctor or the emergency services IMMEDIATELY: Skin eruption with itching (urticaria); Sudden swelling of the face and neck and breathing difficulty (angioedema, Quincke's oedema); Sudden and serious malaise with drop in blood pressure causing dizziness and loss of consciousness, acceleration of heart rhythm associated with respiratory disorders (anaphylactic reaction and shock).
Other side effects: If the patient experiences any of the side effects described as follows, if it persists or if it worsens, contact the doctor or pharmacist.
Very common (may affect more than one in 10 people): Injection-site pain; Fever over than 38.1°C.
Common (may affect less than one in 10 people but more than one in 100 people): Injection-site redness.
Uncommon (may affect less than one in 100 people but more than one in 1000 people): Injection-site hardening (induration).
Reactions with a Not Known frequency (frequency which cannot be estimated because these reactions are reported very rarely): Agitation, somnolence and irritability in the first hour or days following vaccination, and disappearing rapidly; Convulsions (isolated or associated with fever) in the days following vaccination, headache (cephalalgia), moderated and transient tingling sensations (paraesthesia) (mainly in lower limbs) occurring in the two weeks following vaccination; Widespread skin eruption (rash); Moderate and transient joint pain (arthralgia) and muscle pain (myalgia) in the days following vaccination.
Local injection-site reaction: increase in size of lymph nodes (lymphadenopathy); Swelling (oedema) that may occur in the 48 hours following vaccination and persisting one or two days.
Complementary information concerning particular 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 the patient gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed previously. By reporting side effects, the patient can help provide more information on the safety of this medicine.