Nebenwirkungen · Prevenar 20 (previously Apexxnar)
Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.8 · PDF-Seite 8
HOS-147515 · Präparat HOS-099678
Studies 1011, 1013 and 1003, were double-blind, randomised, active-controlled trials that included 2 232 healthy infants, vaccinated with Prevenar 20 in a 4-dose series. The most frequently reported (> 10%) adverse reactions observed after any dose of Prevenar 20 in infants were irritability (58.5% to 70.6%), drowsiness/increased sleep (37.7% to 66.2%), pain at injection site (32.8% to 45.5%), decreased appetite (23.0% to 26.4%), redness at the injection site (22.6% to 24.5%), and swelling at the injection site (15.1% to 17.6%). Most adverse reactions were mild or moderate following vaccination and most reactions resolving within 1 to 3 days. Severe reactions were reported infrequently.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-18T11:35:00Z · SHA-256 dfbc64c4baaa139cb8a19b75051b25fafe4ef25223c0b54cadf2fd05f2c80f98 · Passage 1b57dcafd0bd957aeb49b88b0735b30368bfde0ddd458401493219f0f3787079 · Zeichen 2805–3500 im Abschnitt