GC Flu Adverse Reactions

There is the possibility of local reactions such as redness, swelling and pain, or systemic reactions such as fever, rigor, headache, fatigue and vomiting. But they usually disappear within 2~3 days.
Encephalomyelitis: In rare cases, acute diffuse encephalomyelitis (ADEM) may occur.
Fever, headache, convulsions, dyskinesia and consciousness disorder usually occur within 2 weeks following the administration of the vaccine. When these symptoms are suspected, appropriate medical treatment should be available by diagnosis with MRI and so on.
Severe allergic reactions including anaphylaxis shock may occur in very rare cases.
Transient disorders of systemic and local nervous system may rarely occur. Palsy, neuralgia, cerebral hemorrhage or inflammation of the nervous system (ex. Guillain-Barre syndrome, encephalitis/encephalopathy, myelitis, or optic neuritis) have been reported after immunization with influenza vaccines. Myelitis may occur in conjunction with encephalitis and transverse myelitis in conjunction with ADEM. Deferral of further immunization may be considered until the neurologic condition has been diagnosed or is stable.
Vasculitis may occur in very rare cases. Caution should be required when patients with small vessel vasculitis or post-influenza vaccination-reactivated IgA vasculitis receive influenza vaccination again.
Oculo-respiratory Syndrome (ORS), a transient condition that is characterized by bilateral red eyes, facial edema, and upper respiratory symptoms may occur in extremely rare instances after influenza immunization. Individuals who experienced ORS with lower respiratory tract symptoms should have an expert consultation prior to immunization with influenza vaccine.
Vaccination failure, convulsion/seizure, Impaired efficacy by immunosuppressant and Inference with HIV 1, HCV, HTL V1 ELISA (serological test) may occur in very rare cases.
Safety of GC FLU was evaluated regarding 226 children (6 months ~ under 18 years), 803 adults (18 years ~ under 60 years) and 173 elderly (60 years ~), and the adverse events are as follows. 849 (70.63%) out of 1,202 subjects showed adverse events; Children 74.78%, adults 74.10% and elderly 49.13%. Most of them were solicited adverse events (68.55%), and unsolicited adverse events were 139 (11.56%). Drug related adverse events were 48 (3.99%).
Adverse events which were collected for 6 days after vaccination are listed as follows. (See table.)

Click on icon to see table/diagram/image

Serious adverse events were reported 5 subjects. Except for 1 case (convulsion), the rest were evaluated as 'not related' (acute convulsive abdominal pain: 1 case, atelectasis: 1 case), or 'possibly not related' (gastroenteritis: 2 cases, bronchitis: 1 case).
Adverse events were collected for 21 days after vaccination, and they were reported 139 subjects (11.56%) among 1,202 subjects. The most frequent events were respiratory adverse events (64 subjects, 5.32%), and all subjects who had experienced adverse events were recovered without sequela. Adverse events of which relativity cannot be excluded from GC FLU were 48 subjects (3.99%) as follows.
(Occasionally: 0.1%~<5%; Rare: <0.1%).
Respiratory System: Occasionally: Coryza, rhinorrhoea, sore throat, pharyngitis, rhinitis.
Rare: Upper respiratory tract infection, coughing, bronchitis.
Gastro-Intestinal System: Rare: Gastroenteritis, vomiting, diarrhoea, nausea.
Central & Peripheral Nervous System: Occasionally: dizziness.
Rare: Cramps legs, migraine, involuntary muscle contractions.
Skin & Appendages: Occasionally: Pruritus.
Rare: Urticaria.
Vision Disorder: Rare: Abnormal sensation in eye, asthenopia.
Metabolic and Nutritional Disorder: Rare: Edema uvula.
White Cell and Reticuloendothelial System Disorders: Rare: WBC abnormal nos. (Eosinophils increase).
Psychiatric Disorders: Rare: Sleep disorder.
Local and Systemic Adverse Events: Occasionally: Injection site pruritus, swelling and pruritus.
Rare: Injection site erythema, syncope, fatigue, pallor.
Cardiovascular Disorder: Rare: Palpitation.