There is no clinical data on the use of Hepatitis B vaccine on pregnant women. The vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
There is no clinical data on the use of hepatitis B vaccine on breast-feeding women.
There is no information regarding the presence of hepatitis B vaccine in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for hepatitis B vaccine and any potential adverse effects on the breastfed child from hepatitis B vaccine or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.
Hepatitis B vaccine has not been evaluated in fertility studies.
No studies on the effects on the ability to drive and use machines have been performed. However, Hepatitis B vaccine is expected to have no or negligible influence on the ability to drive and use machines.
The most common side effects seen are injection-site reactions: transient soreness, erythema, induration.
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 | |
| Thrombocytopaenia, 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) |
Apnoea in very premature infants (born ≤28 weeks of gestation).
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