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: Headache*.
Skin and Subcutaneous Tissue Disorder: Sweating*.
Musculoskeletal and Connective Tissue Disorders: Myalgia, arthralgia*.
General Disorders and Administration Site Conditions: Fever, malaise, shivering, fatigue.
Local Reactions: Redness, swelling, pain, ecchymosis, induration*.
*These reactions usually disappear within 1-2 days without treatment.
From post-marketing surveillance additionally, the following adverse events have been reported: 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.
Vascular Disorders: Vasculitis associated in very rare cases with transient renal involvement.
Skin and Subcutaneous Tissue Disorders: Generalised skin reactions including pruritus, urticaria or nonspecific rash.