| a. Summary of the safety profile The most common side effects seen are injection-site reactions: transient soreness, erythema, induration.b. Tabulated summary of adverse reactions The following undesirable effects have been reported following the widespread use of the vaccine.As with other hepatitis B vaccines, in many instances, the causal relationship to the vaccine has not been established.| Adverse reactions | Frequency | | General disorders and administration site conditions | | Local reactions (injection site): Transient soreness, Erythema, Induration | Common ( 1/100 to, <1/10) | | Fatigue, Fever, Malaise, Influenza-like symptoms | Very rare (<1/10,000)
| | Blood and the lymphatic system disorders | | Thrombocytopenia, Lymphadenopathy
| Very rare (<1/10,000)
| | Immune system disorders | | Serum sickness, Anaphylaxis, Polyarteritis nodosa
| Very rare (<1/10,000)
| | Nervous system disorders | | Paresthesia, Paralysis (including Bell's palsy, facial paralysis), Peripheral neuropathies (polyradiculoneuritis, Guillain Barre Syndrome), Neuritis (including optical neuritis), Myelitis (including transverse Myelitis), Encephalitis, Demyelinating disease of the central nervous system, Exacerbation of multiple sclerosis, Multiple sclerosis, Seizure, Headache, Dizziness, Syncope
| Very rare (<1/10,000)
| | Eye disorders | | Uveitis
| Very rare (<1/10,000)
| | Vascular disorders | | Hypotension, Vasculitis
| Very rare (<1/10,000)
| | Respiratory, thoracic and mediastinal disorders | | Bronchospasm-like symptoms
| Very rare (<1/10,000)
| | Gastrointestinal disorders | | Vomiting, Nausea, Diarrhoea, Abdominal pain
| Very rare (<1/10,000)
| | Skin and subcutaneous tissue disorders | | Rash, Alopecia, Pruritus, Urticaria, Erythema multiforme, Angioedema, Eczema
| Very rare (<1/10,000)
| | Musculoskeletal, connective tissue and bone disorders | | Arthralgia, Arthritis, Myalgia, Pain in extremity
| Very rare (<1/10,000)
| | Investigations | | Elevation of liver enzymes
| Very rare (<1/10,000)
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