Undesirable effects were reported during clinical studies and after commercial use.
Undesirable effects are ranked in terms of frequency: Very common: ≥ 1/10, Common: ≥ 1/100 and < 1/10, Uncommon: ≥ 1/1000 and < 1/100, Rare: ≥ 1/10 000 and < 1/1 000, Very rare: < 1/10 000 including isolated cases.
Experience from clinical trials: Blood and lymphatic system disorders: Very common: adenopathy/lymphadenopathy.
Immune system disorders: Common: cutaneous allergic reactions such as rash, pruritus, oedema.
Uncommon: urticaria, angioedema, dyspnoea.
Nervous system disorders: Common: headache, dizziness, somnolence.
Gastrointestinal disorders: Common: abdominal pain, nausea.
Musculoskeletal and connective tissue disorders: Very common: myalgia.
Common: arthralgia, shivering.
General disorders and administration site conditions: Very common: Injection-site pain, fever, malaise.
Common: injection-site erythema, injection-site pruritus, injection-site haematoma, injection-site induration, asthenia, influenza-like syndrome.
Uncommon: injection-site swelling.
Experience after commercial use: In addition to the list previously mentioned, the following undesirable effects were reported. Their exact incidence cannot be calculated as they were spontaneously reported. However, given the number of doses sold, the occurrence of these undesirable effects is very rare (< 1/10 000).
Immune system disorders: Anaphylactic reactions, serum sickness-like reactions.
Nervous system disorders: Encephalopathy, convulsions.
Ear and labyrinth disorders: Sudden hearing loss.*
* Which may persist.
Respiratory, thoracic and mediastinal disorders: Apnoea in very premature infants (born ≤ 28 weeks of gestation) (see Precautions).
Gastrointestinal disorders: Vomiting.
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.