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 four clinical studies performed with healthy children, adults, and elderly.
In children aged 6 through 35 months who received the vaccine, 115 subjects (67.6%) out of 170 subjects showed adverse events. Adverse drug reactions were 82 subjects (48.2%) and no serious adverse drug reactions were reported. In children aged 3 through 18 years who received the vaccine, 218 subjects (68.3%) out of 319 subjects showed adverse events. Adverse drug reactions were 204 subjects (63.9%) and no serious adverse drug reactions were reported.
In adults aged 19 through 64 years who received the vaccine, 415 subjects (71.2%) out of 583 subjects showed adverse events. Adverse drug reactions were 399 subjects (68.4%) and no serious adverse drug reactions were reported.
In elderly over 65 years of age who received the vaccine, 148 subjects (43.8%) out of 338 subjects showed adverse events. Adverse drug reactions were 140 subjects (41.4%) 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 1.)

Click on icon to see table/diagram/image

Unsolicited adverse drug reactions occurring within 28 days or 21 days of vaccination were reported in 4 subjects (2.4%) from children aged 6 through 35 months (Infections and infestations: 3 subjects, Skin and subcutaneous tissue disorders: 1 subject), 3 subjects (0.9%) from children aged 3 through 18 years (General disorders and administration site conditions: 2 subjects, Infections and infestations: 1 subject), 13 subjects (2.2%) from adults (Infections and infestations: 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 (1.2%) from elderly (Infections and infestations: 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 13 subjects (7.6%) from children aged 6 through 35 months (Pneumonia: 4 cases, Influenza: 3 cases, Bronchitis: 2 cases, Pneumonia respiratory syncytial viral: 1 case, Bronchiolitis: 1 case, Croup infectious: 1 case, Gastroenteritis norovirus: 1 case, Gastroenteritis rotavirus: 1 case, Urinary tract infection: 1 case, Gastrointestinal infection: 1 case, Impaired healing: 1 case, Foreign body in gastrointestinal tract: 1 case, Febrile convulsion: 1 case), 5 subjects (1.6%) from children aged 3 through 18 years (Pharyngitis: 1 case, Headache: 1 case, Mesenteric lymphadenitis: 1 case, Acute gastroenteritis: 1 case, Peritonsillar Abscess: 1 case, Acute appendicitis: 1 case), 5 subjects (0.9%) from adults (Cystitis: 1 case, Pulmonary Tuberculosis: 1 case, Breast mass: 1 case, Ileus : 1 case, Gastric cancer: 1 case), and 4 subjects (1.2%) 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.
Results of post-marketing surveillance in South Korea: The results of post-marketing surveillance conducted domestically for 4 years on 2,060 adult subjects aged 19 years and older in order to go through a re-examination showed that the incidence of adverse events was 10.49% (216 out of 2,060 subjects, 578 cases in total), regardless of causal relationship.
Among these, no serious adverse events and serious adverse drug reactions have been reported.
In addition, unexpected adverse events and unexpected adverse drug reactions are listed in the following table according to their frequency of onset. (See Table 2.)

Click on icon to see table/diagram/image

The results of post-marketing surveillance conducted domestically for 4 years on 2,033 pediatric subjects aged ≥ postnatal 6 months and <19 years showed that the incidence of adverse events was 30.74% (625 out of 2,033 subjects, 1,221 cases in total), regardless of causal relationship. Among these, serious adverse events and serious adverse drug reactions are listed in the following table according to their frequency of onset. (See Table 3.)

Click on icon to see table/diagram/image

In addition, unexpected adverse events and unexpected adverse drug reactions are listed in the following table according to their frequency of onset. (See Table 4.)

Click on icon to see table/diagram/image

Adverse events from domestic post-marketing surveillance and spontaneously reported data on side effects were comprehensively assessed at the end of post-marketing surveillance along with the adverse events data (1989 to December 31, 2020) reported for all drugs that have been licensed for domestic marketing. Among the adverse events that were reported more frequently with statistical significance for this drug than the adverse events reported for all other drugs, following adverse events were newly identified. However, these results do not mean that the causal relationship between the relevant ingredient and the following adverse events has been demonstrated.
Systemic and injection site adverse events: Injection site inflammation, injection site warmth, injection site pruritus, injection site bruising.
Infection: Rhinitis (rhinorrhea).