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 MRl and so on.
Allergic reaction or anaphylactic shock may occur in very rare cases.
Transient disorders of systemic and local nervous system may rarely occur. And palsy, neuralgia, cerebral hemorrhage or inflammation of the nervous system (ex. Guillain-Barre syndrome) have been reported.
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%). See table.

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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 can not be excluded from GC FLU were 48 subjects (3.99%) as follows.
(Occasionally: 0.1%-<5%; Rare: <0.1%).
Respiratory System: Occasionally: Coryza, rhinorrhoea, throat sore, pharyngitis, rhinitis.
Rare: Upper respiratory tract infection, coughing, bronchitis.
Gastro-Intestinal System: Rare: Gastroenteritis, vomiting, diarrhoea, nausea.
Central and Peripheral Nervous System: Occasionally: Dizziness.
Rare: Cramps legs, migraine, muscle contractions involuntary.
Skin and Appendages: Occasionally: Pruritus.
Rare: Urticaria.
Vision Disorder: Rare: Abnormal sensation in eye, asthenopia.
Metabolic and Nutritional disorder: Rare: Edema uvula.
White Cell and Res Disorders: Rare: WBC abnormal nos.
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.