The adverse events are ranked 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 reports, certain undesirable events were very rarely reported following the use of Pentaxim. 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.
In clinical studies in children who received PENTAXIM as a primary series, the most frequently reported reactions are local injection-site reactions, abnormal crying, irritability and fever.
These signs and symptoms usually occur within 48 hours following the vaccination and may continue for 48-72 hours. They resolve spontaneously without specific treatment.
The frequency of injection-site reactions tends to increase at booster vaccination compared with the frequency observed for primary series.
Immune system disorders:
Reactions with a Not Known frequency: Immediate hypersensitivity reactions such as face oedema, angioedema, Quincke’s oedema, anaphylactic reactions and shocks.
Metabolism and nutrition disorders:
Very common reactions: Loss of appetite.
Very common reactions: Nervousness, irritability; Abnormal crying. Common reactions: Insomnia, sleep disturbances. Uncommon reactions: Prolonged inconsolable crying.
Nervous system disorders:
Very common reactions: Somnolence. Reactions with a Not Known frequency: Convulsions with or without fever; Hypotonic-hyporesponsive episodes.
Very common reactions: Vomiting. Common reactions: Diarrhoea.
Skin and subcutaneous tissue disorders:
Reactions with a Not Known frequency: Rash, erythema, urticaria.
General disorders and administration site conditions:
Very common reactions: Injection-site erythema; Fever ≥38°C; Injection-site oedema; Injection-site pain. Common reactions: Injection-site induration. Uncommon reactions: Fever ≥39°C; Injection-site redness and oedema ≥5 cm. Rare reactions: Fever >40°C.
Oedematous reactions on one or on both lower limbs may occur after vaccination with a Haemophilus influenzae
type b conjugate-containing vaccine. These reactions generally occur after primary series, within hours of the vaccination, and resolve without sequelae within 24 hours. These reactions may be accompanied with cyanosis, erythema, transient purpura and severe crying.
Reactions with a Not Known frequency: Large injection site reactions (> 50 mm), including extensive limb swelling that may spread from the injection site to one or both adjacent joints. These reactions start within 24 - 72 hours after vaccination and may be associated with symptoms such as erythema, warmth, tenderness or pain at the injection site. They resolve spontaneously within 3 - 5 days. The risk appears to be dependent on the number of prior doses of acellular pertussis-containing vaccines, with a greater risk following the 4th
Potential undesirable 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): Guillain-Barré Syndrome and brachial neuritis after administration of a tetanus toxoid-containing vaccine.
Complementary information concerning specific populations:
Apnoea in very premature infants (born ≤ 28 weeks of gestation) (see Precautions).
Reporting of Suspected Adverse Reactions: Reporting suspected adverse reactions after authorisation 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.