Boostrix Adverse Reactions

Summary of the safety profile: The safety profile presented as follows is based on data from clinical trials where Boostrix was administered to 839 children (from 4 to 8 years of age) and 1931 adults, adolescents and children (from 10 to 76 years of age).
The most common events occurring after Boostrix administration in both groups were local injection site reactions (pain, redness and swelling) reported by 23.7-80.6% of subjects in each trial. These usually had their onset within the first 48 hours after vaccination. All resolved without sequelae.
Tabulated list of adverse reactions: Adverse reactions reported are listed according to the following frequency: 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).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Clinical trials: See Table 4.

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Reactogenicity after repeat dose: Data on 146 subjects suggest that there might be a small increase in local reactogenicity (pain, redness, swelling) with repeated vaccination according to a 0, 1, 6 months schedule in adults (>40 years of age).
Data suggest that in subjects primed with DTP in childhood a second booster dose might give an increase of local reactogenicity.
Post-marketing surveillance: Because these events were reported spontaneously, it is not possible to reliably estimate their frequency. (See Table 5.)

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Following administration of tetanus toxoid containing vaccines, there have been very rare reports of adverse reactions on the central or peripheral nervous systems, including ascending paralysis or even respiratory paralysis (e.g. Guillain-Barré syndrome).