Flublok Trivalent Adverse Reactions

Summary of the safety profile: Safety data for Flublok Trivalent are derived from the quadrivalent recombinant influenza vaccine as both vaccines are manufactured using the same process and have overlapping compositions.
Quadrivalent recombinant influenza vaccine (Flublok Quadrivalent) has been administered to and safety data collected from 998 adults 18-49 years of age (Study 1) and 4,328 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 Quadrivalent 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.