Fluarix Tetra Adverse Reactions

Clinical trials: Summary of the safety profile: In all age groups the most frequently reported local adverse reaction after vaccination was injection site pain (15.6% to 40.9%).
In adults 18 years of age and above, the most frequently reported general adverse reactions after vaccination were fatigue (11.1%), headache (9.2%) and myalgia (11.8%).
In subjects aged 6 to 17 years, the most frequently reported general adverse reactions after vaccination were fatigue (12.6%), myalgia (10.9%) and headache (8.0%).
In subjects aged 3 to 5 years, the most frequently reported general adverse reactions after vaccination were drowsiness (9.8%) and irritability (11.3%).
In subjects aged 6 months to 3 years, the most frequently reported general adverse reactions after vaccination were irritability/fussiness (14.9%) and loss of appetite (12.9%).
Tabulated list of adverse reactions: Adverse reactions reported for Fluarix Tetra in the different age groups are listed per dose according to the following frequency categories: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).
Adults: A clinical study with Fluarix Tetra in adults has evaluated the incidence of adverse reactions in subjects ≥18 years who received one dose of Fluarix Tetra (N = 3,036) or Fluarix (trivalent influenza vaccine) (N = 1,010).
The following adverse reactions per dose have been reported: See Table 6.

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Children aged 6 months to <18 years: Two clinical studies evaluated the reactogenicity and safety of Fluarix Tetra in children who received at least one dose of Fluarix Tetra or a control vaccine.
One study enrolled children 3 to <18 years of age who received Fluarix Tetra (N = 915) or Fluarix (N = 912). The second study enrolled children 6 to <36 months of age who received Fluarix Tetra (N = 6,006) or a non-influenza vaccine control (N = 6,012) (see Pharmacology: Pharmacodynamics under Actions).
The following adverse reactions per dose have been reported: See Table 7.

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Post-marketing data: The following adverse reactions have been observed for Fluarix and/or Fluarix Tetra during post-marketing surveillance¹. (See Table 8.)

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