Adverse Reactions Observed from the Clinical Trials:
The safety of trivalent inactivated influenza vaccines is assessed in open-label, uncontrolled clinical trials performed as annual update requirement, including at least 50 adults 18-60 years and at least 50 elderly ≥61 years.
Safety evaluation is performed during the first 3 days following vaccination.
The following undesirable effects have been observed during clinical trials [frequency: Common (≥1/100, <1/10)].
Nervous System Disorder:
Skin and Subcutaneous Tissue Disorder:
Musculoskeletal and Connective Tissue Disorders:
General Disorders and Administration Site Conditions:
Fever, malaise, shivering, fatigue.
Redness, swelling, pain, ecchymosis, induration*.
*These reactions usually disappear within 1-2 days without treatment.
Adverse Reactions Reported from Post-Marketing Surveillance: Blood and Lymphatic System Disorders:
Transient thrombocytopenia, transient lymphadenopathy.
Immune System Disorders:
Allergic reactions, in rare cases leading to shock, angioedema.
Nervous System Disorders:
Neuralgia, paraesthesia, febrile convulsions, neurological disorders eg, encephalomyelitis, neuritis and Guillain-Barre syndrome.
Vasculitis associated in very rare cases with transient renal involvement.
Skin and Subcutaneous Tissue Disorders:
Generalised skin reactions including pruritus, urticaria or nonspecific rash.