Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Vaxelis

Vaxelis suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated), and Haemophilus type b conjugate vaccine (adsorbed). · Abschnitt 4.8 · PDF-Seite 6–7

HOS-133263 · Präparat HOS-097404

6  MedDRA System Organ Frequency Adverse Reactions Class Metabolism and nutrition Very Common Decreased appetite disorders Uncommon Increased appetite Psychiatric disorders Uncommon Sleep disorders including insomnia, restlessness Nervous system disorders Very Common Somnolence Uncommon Hypotonia Not known Convulsions with or without fever†, hypotonic-hyporesponsive episode (HHE)† Vascular disorders Uncommon Pallor Respiratory, thoracic and Uncommon Cough mediastinal disorders Gastrointestinal disorders Very Common Vomiting Common Diarrhoea Uncommon Abdominal pain Skin and subcutaneous tissue Uncommon Rash, hyperhidrosis disorders General disorders and Very Common Crying, irritability administration site conditions Injection site erythema, injection site pain, injection site swelling Pyrexia Common Injection site bruising, injection site induration, injection site nodule Uncommon Injection site rash, injection site warmth, fatigue Rare Extensive swelling of vaccinated limb§ * Based on post-marketing reports. † Based on post-marketing reports. Because these events were reported from a population of uncertain size, it is generally not possible to reliably estimate their frequency or to establish, a causal relationship to the vaccine. See section 4.4. § Estimated frequency based on post-marketing reports and not reported in clinical trials with > 5,200 participants.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.