Frequencies per dose are defined as follows: Very common: ≥10%.
Common: ≥1% an <10%.
Uncommon: ≥0.1% and <1%.
Rare: ≥0.01% and <0.1%.
Very rare: <0.01%.
Clinical trial data: Applicable site disorders: Uncommon: Injection site reaction, such as redness and swelling, pain at the injection site.
Body as a whole-general disorders: Common: Fever.
Hearing and vestibular disorders: Rare: Ear pain.
Immune system disorders: Rare: Anaphylaxis.
Nervous system disorders: Uncommon: Headache.
Gastrointestinal disorders: Uncommon: Vomiting, abdominal pain.
Respiratory system disorders: Uncommon: Coughing.
Skin and appendages disorders: Rare: Rash.
General disorders: Uncommon: Sore throat.
Post-marketing surveillance: Application site disorders: Induration at the injection site.
Psychiatric disorders: Agitation.
Nervous system disorders: Convulsions, tetany, somnolence.
Respiratory system disorders: Upper respiratory tract infection.
Skin and appendages disorders: Pruritus, urticaria, urticaria acute, erythema induratum, angioedema.
Vascular (extracardiac) disorders: Purpura allergic.