8 Hepatitis B

8.7 Expected responses and adverse events following immunisation (AEFI)

See section 14.7 for expected responses and adverse events following immunisation with DTaP-IPV-HepB/Hib vaccine.

8.7.1 Expected responses

Minor side-effects – including local tenderness and redness, nausea, diarrhoea, general malaise and fever – are more common in adults than in children and, except for local reactions, occur at rates close to those seen with a placebo. Minor reactions reported after receiving the vaccine include a temperature >37.7oC in 1–6 percent, pain in 3–29 percent, and erythema, headache or swelling in 3 percent of vaccinees.

8.7.2 Adverse events following immunisationTop

Allergic reactions have been reported but are rare. Anaphylaxis is extremely rare.

A number of studies have examined and failed to find disease events linked to hepatitis B immunisation.47 These studies have documented no increased risk of multiple sclerosis,48, 49 diabetes, chronic fatigue syndrome,50 encephalomyelitis or hair loss.51 Rarely, transient thrombocytopenia52 and myalgia and arthralgia53, 54 have been reported after hepatitis B vaccine.