Hiberix Adverse Reactions

Clinical Trial Data: The following frequencies were based on the analysis of approximately 3000 infants enrolled in study Hib-097 and of approximately 1200 infants enrolled in study DTPa-HBV-IPV-011.
Adverse reactions reported are listed according to the following frequency: Very common: ≥ 1/10 / Common: ≥ 1/100 to < 1/10 / Uncommon: ≥ 1/1000 to < 1/100 / Rare: ≥ 1/10000 to < 1/1000 / Very rare: < 1/10000.
Metabolism and nutrition disorders: Very common: loss of appetite.
Psychiatric disorders: Very common: crying, irritability, restlessness.
Nervous system disorders: Very common: somnolence.
Rare: convulsions (including febrile convulsions).
Gastrointestinal disorders: Very common: diarrhoea.
Common: vomiting.
General disorders and administration site conditions: Very common: fever, swelling, pain and redness at the injection site.
Post Marketing Data: Immune system disorders: Very rare: allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema.
Nervous system disorders: Very rare: hypotonic-hyporesponsive episode, syncope or vasovagal responses to injection.
Respiratory, thoracic and mediastinal disorders: Very rare: apnoea [see Precautions for apnoea in very premature infants (≤ 28 weeks of gestation)].
Skin and subcutaneous tissue disorders: Very rare: urticaria, rash.
General disorders and administration site conditions: Very rare: extensive swelling of vaccinated limb, injection site induration.