Flublok Adverse Reactions

Summary of the safety profile: Flublok has been administered to and safety data collected from 998 adults 18-49 years of age (Study 1) and 4328 adults 50 years of age and older (Study 2).
The most common reactions occurring after vaccine administration were injection-site reactions (tenderness and pain) reported overall by 48% and 37% of study participants 18-49 years of age receiving Flublok respectively. In study participants 50 years of age and older, injection site tenderness was reported by 34% and injection site pain reported by 19%.
The severity of the reactions was mild to moderate. Onset usually occurred within the first 3 days after vaccination. All resolved without sequelae.
Tabulated list of adverse reactions: The adverse reactions are listed by MedDRA system organ class under headings of frequency using the following convention: 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); Frequency not known (adverse reactions from post-marketing experience; cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. (See Table 6.)

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Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.