Like all medicines, PENTAXIM 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 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 the doctor or emergency services 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 and shock).
Other side effects:
If the child experiences any of the following side effects listed below and it persists or gets serious, please contact the doctor or pharmacist.
Very common reactions (may affect more than one in 10 children): Loss of appetite; Nervousness, irritability, abnormal crying; Somnolence; Vomiting; Injection-site redness (erythema), fever 38°C or higher, injection-site swelling (oedema), injection-site pain.
Common reactions (may affect less than one in 100 children): Diarrhoea; Injection-site hardening (induration); Insomnia, sleep disorder.
Uncommon reactions (may affect less than one in 100 children but more than one in 1000 children): Injection site redness and swelling (oedema) of 5 cm or more; Fever 39°C or higher; Inconsolable and prolonged crying (for more than 3 hours).
Rare reactions (may affect less than one in 1000 children but more than one in 10 000 children): Fever over 40°C; Swelling in legs and feet (oedematous reactions affecting lower limbs) 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.
Reactions with a Not Known frequency (frequencies cannot be estimated because these reactions are reported very rarely): Convulsions with or without fever; Drops in energy or periods during which the child is pale, unresponsive or seems in a shock-like state (hypotony-hyporesponsiveness); Skin rash, redness (erythema), itching (urticaria); Large injection-site reactions, larger than 5 cm, including limb swelling (oedema) that may spread to the joints on both sides of the injection site. These reactions start within 24-72 hours after vaccination and may be associated with symptoms such as redness (erythema), warmth, tenderness or pain at the injection site. They resolve spontaneously within 3-5 days.
Potential side effects (i.e. that have not been reported directly with PENTAXIM, but with other vaccines containing one or more of the antigenic constituents of PENTAXIM) 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 for 2-3 days after vaccination.