GC FLU Quadrivalent Adverse Reactions

There is possibility of local reactions such as redness, swelling and pain, or systemic reactions such as fever, chills, headache, fatigue and vomiting. But they usually disappear within 2-3 days.
In rare cases, acute disseminated 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.
Allergic reaction or anaphylactic 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) have been reported.
Safety of the vaccine was evaluated for the three clinical studies performed with healthy adults, children-adolescent and elderly.
In children-adolescent aged 3 through 18 years who received the vaccine, 218 subjects (68.3%) out of 319 subjects showed adverse events. Adverse drug reactions were 63.9% and no serious adverse drug reactions were reported.
In adults aged 19 through 64 years who received the vaccine, 415 (71.18%) subjects out of 583 subjects showed adverse events. Adverse drug reactions were 68.4% and no serious adverse drug reactions were reported.
In adults aged 65 years and older who received the vaccine, 148 (43.79%) subjects out of 338 subjects showed adverse events. Adverse drug reactions were 41.42% and no serious adverse drug reactions were reported.
Solicited adverse drug reactions within 7 days of vaccination are listed in the table as follows. (See table.)

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Unsolicited adverse drug reactions occurring within 28 days or 21 days of vaccination were reported in 3 subjects (0.9%) from children-adolescent (General disorders and administration site conditions: 2 subjects, Infections: 1 subject), 13 subjects (2.23%) from adults (Infections: 5 subjects, investigations: 2 subjects, Respiratory thoracic and mediastinal disorders: 2 subjects, Musculoskeletal and connective tissue disorders: 1 subject, Nervous system disorders: 1 subject, Skin and subcutaneous tissue disorders: 1 subject, General disorders and administration site conditions: 2 subjects), and 4 subjects (1.18%) from elderly (Infections: 1 subject, General disorders and administration site conditions: 1 subject, investigations: 1 subject, Nervous system disorders: 1 subject).
Serious adverse events occurring within 6 months of vaccination were reported in 5 subjects (1.6%) from children-adolescent (Pharyngitis: 1 case, Headache: 1 case, Mesenteric lymphadenitis: 1 case, Acute gastroenteritis: 1 case, Peritonsillar Abscess: 1 case, Acute appendicitis: 1 case), 5 subjects (0.86%) from adults (Cystitis: 1 case, Pulmonary Tuberculosis: 1 case, Breast mass: 1 case, Ileus: 1 case, Gastric cancer: 1 case), and 4 subjects (1.18%) from elderly (Pain: 1 case, Arthralgia: 1 case, Herpes zoster: 1 case, Gastric cancer: 1 case), but they were evaluated as 'not related' to the product.