TetraFlu Adverse Reactions

Adverse events reported for TetraFlu in previous clinical trials are listed according to the following frequency categories: Very common ≥1/10, Common ≥1/100 to <1/10, Uncommon ≥1/1,000 to <1/100.
The local and systemic adverse events reported in the clinical trial in healthy subjects aged over 18 years are listed as follows: Nervous system disorders: Very common: headache.
Uncommon: drowsiness.
Gastrointestinal disorders: Common: nausea, vomiting.
Uncommon: diarrhoea.
Musculoskeletal and connective tissue disorders: Very common: muscle aches.
Uncommon: back soreness pain.
General disorders and administration site conditions: Very common: injection site pain, injection site swelling, malaise.
Common: injection site redness, injection site ecchymosis, decreased limb mobility, fever, chest tightness, face edema.
Uncommon: fatigue, injection site pruritus.
Respiratory, Thoracic and Mediastinal disorders: Very common: nasal congestion, cough, sore throat.
Common: respiratory distress.
Uncommon: chronic bronchitis.
Eye disorders: Common: eye redness.
Infections and infestations: Uncommon: nasopharyngitis, upper respiratory tract infection.
The local and systemic adverse events reported in the clinical trial in healthy children aged over 3 years are listed as follows: Nervous system disorders: Common: headache.
Gastrointestinal disorders: Common: nausea, vomiting, gastroenteritis, gastritis.
Musculoskeletal and connective tissue disorders: Very common: muscle aches (myalgia).
Common: dental caries.
General disorders and administration site conditions: Very common: injection site pain, injection site swelling, malaise.
Common: injection site redness, injection site ecchymosis, decreased limb mobility, fever, chest tightness, face edema.
Respiratory, Thoracic and Mediastinal disorders: Very common: nasal congestion, cough.
Common: respiratory distress, sore throat, bronchitis, pneumonia, epistaxis.
Eye disorders: Common: eye redness, conjunctivitis.
Infections and infestations: Very common: upper respiratory tract infection.
Common: nasopharyngitis, acute sinusitis, tonsillitis, pharyngitis, cellulitis, hand-foot-and-mouth disease, otitis media acute, herpangina.
Metabolism and nutrition disorders: Common: dehydration.
Skin and subcutaneous tissue disorders: Common: eczema.
Postmarketing experience: The adverse drug reactions listed as follows are not cases reported in previous TetraFlu trials; rather, they are cases of adverse reactions extracted from the leaflet of Adimflu trivalent influenza vaccine.
Blood and lymphatic system disorders: Thrombocytopenia, Lymphadenopathy.
Gastrointestinal disorders: Abdominal pain, Dysphagia, Anhepatia.
Metabolism and nutrition disorders: Lack of appetite.
General disorders and administration site conditions: Malaise, Influenza-like symptoms, Severe swelling.
Musculoskeletal and connective tissue disorders: Arthritis, Back pain, Pain of limbs.
Nervous system disorders: Neurologic abnormality (Facial palsy symptoms), Dizziness, Somnolence, Syncope, Nerves pain, Abnormal gait, Facial palsy, Hypesthesia, Dysesthesia, Seizure, Febrile Seizure, Guillain-Barre syndrome (GBS), Shake, Acute disseminated encephalomyelitis (ADEM), myelitis, neuritis.
Vascular disorders: Pale, Hot flashes, Vasculitis, Transient renal involvement (very rare).
Hypersensitivity: Shock, Asthma, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Rash.