Abrysvo Adverse Reactions

Summary of the safety profile: Pregnant individuals: In pregnant women at 24-36 weeks of gestation the most frequently reported adverse reactions were vaccination site pain (41%), headache (31%) and myalgia (27%). The majority of local and systemic reactions in maternal participants were mild to moderate in severity and resolved within 2-3 days of onset.
Individuals 18 years of age and older: In individuals 18 years of age and older the most frequently reported adverse reactions were fatigue (23%), headache (20%), vaccination site pain (19%) and myalgia (16%). 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 18 years of age and older (n=20,275) was evaluated in 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 6.)

Click on icon to see table/diagram/image