4.7 Effects on ability to drive and use machines Abrysvo has no or negligible influence on the ability to drive and use machines. 4.8 Undesirable effects 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=3 698) 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 Uncommon (≥1/1 000 to Rare (≥1/10 000 to Very rare ( Not known (cannot be estimated from the available data). Adverse reactions reported are listed per system organ class, in decreasing order of seriousness.
5 Table 1 Adverse reactions following administration of Abrysvo System organ class Adverse reactions pregnant individuals ≤49 years Adverse reactions individuals ≥18 years Blood and lymphatic system disorders Lymphadenopathy Rare Rare Immune system disorders Anaphylaxis Very rare Hypersensitivity reactions (includes rash, urticaria) Rare Rare Nervous system disorders Headache Very common Very common Guillain-Barré syndrome Very rare Musculoskeletal and connective tissue disorders Myalgia Very common Very common Arthralgia Common General disorders and administration site conditions Fatigue Very common Vaccination site pain Very common Very common