Frequencies of adverse reactions are defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Adverse reactions from post-marketing spontaneous monitoring (frequency not known): Blood and lymphatic system disorders:
Thrombocytopenia; lymph nodes enlarged and (or) pain.
Immune system disorders:
Rhinitis; hypersensitivity reactions, including anaphylactic shock.
Nervous system disorders:
Headache; dizziness; hypotonic-hyporesponsive episode; syncope; loss of consciousness; tremor.
Ear and labyrinth disorders:
Nausea, vomiting, dry mouth.
Skin and subcutaneous tissue disorders:
Rash (including papular rash), urticaria, angioedema (Quincke's oedema), erythema nodosum, petechia.
Musculoskeletal and connective tissue disorders:
Pain in the injected extremity; pain in the injected arm; arthralgia.
Renal and urinary disorders:
General disorders and administration site conditions:
General adverse drug reactions: Subfebrile state, fever, chills, cold sensation, hyperhidrosis, weakness, malaise. These symptoms usually subside within 24-48 hours.
Adverse drug reactions at the administration site: Redness, erythema, pain, swelling, swelling of the limb, injected limb mobility decreased, rash, itching, burning sensation, inflammation, cyanosis, hematoma (most probably caused by incorrect administration of the vaccine), induration, injection site warmth. Itchy lymphatic infiltration may also develop. Such adverse reactions most often develop in individuals who receive multiple vaccinations. Subcutaneous nodules (granulomas) may occur, which sometimes develop into aseptic abscesses (1:100 000). Granulomas which do not subside within 6 weeks may be the result of developing hypersensitivity to aluminium.
Body temperature decrease.