Individuals 60 years of age and older: In individuals 60 years of age and older the most frequently reported adverse reaction was vaccination site pain (11%). The majority of reactions were mild to moderate in severity and resolved within 1-2 days of onset.
Tabulated list of adverse reactions: The safety of administering a single dose of Abrysvo to pregnant women at 24-36 weeks of gestation (n=3,682) and to individuals 60 years of age and older (n=18,575) was evaluated in phase 3 clinical trials.
Adverse reactions are listed 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); Not known (cannot be estimated from the available data).
Adverse reactions reported are listed per system organ class, in decreasing order of seriousness. (See Table 4.)
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