The adverse events are ranked according to the MedDRA terminology (by System Organ Class) and under headings of frequency using the following convention: Very common: ≥ 10%; Common: ≥ 1% and < 10%; Uncommon: ≥ 0.1% and < 1%; Rare: ≥ 0.01% and < 0.1%; Very rare: < 0.01%; Not known: cannot be estimated from the available data.
Based on spontaneous reporting, certain undesirable events were very rarely reported following the use of IMOVAX POLIO. Because events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. This is why these undesirable events are ranked under the << Not known >> frequency.
The events listed as follows were observed during clinical studies or were spontaneously reported after marketing.
The most common adverse events following administration of this vaccine are local injection-site reactions (pain, redness, induration) and fever over 38.1°C.
Immune system disorders:
Not known: type I hypersensitivity reaction to one of the components of the vaccine, such as urticaria, angioedema, anaphylactic reaction or anaphylactic shock.
Not known: agitation, somnolence and irritability in the first hour or days following vaccination and disappearing rapidly.
Nervous system disorders:
Not known: convulsions (isolated or associated with fever) in the days following vaccination, headache, moderate and transient paresthesia (mainly in the lower limbs) in the two weeks following vaccination.
Skin and subcutaneous tissue disorders:
Not known: rash.
Musculoskeletal and connective tissue disorders:
Not known: mild and transitory arthralgia, and myalgia have been reported in the days following vaccination.
General disorders and administration site conditions:
Very common: injection-site pain, fever over 38.1°C. Common: injection-site redness. Uncommon: injection-site induration. Not known: lymphadenopathy, local injection-site reactions such as oedema that can occur in the 48 hours following vaccination and lasting one or two days.
Complementary information concerning particular populations:
Apnoea in very premature infants (born ≤ 28 weeks of gestation) (see Precautions).
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.