Documentation concerning the severe side effects in children on immunization of Hepatitis B vaccine

Fråga: Documentation concerning the severe side effects in children on immunization of Hepatitis B vaccine is requested.

Sammanfattning: Considering the frequent use, serious adverse reactions in children after immunization with Hepatitis B vaccine are very rare.

Svar: Both plasma derived and recombinant Hepatitis B (HB) vaccines are considered to be generally well tolerated (1,2,3). The most frequently encountered adverse reactions are injection site reactions (swelling, erythema, induration), and general reactions (fever, headache, arthralgia, myalgia, rash, gastrointestinal symptoms, dizziness and fatigue for adults and children; fever, gastrointestinal symptoms, sleeping problems and feeding problems for neonates) (1,2,3,4). These reactions generally resolve within 24 to 48 hours of vaccine administration (5,6).

Serious adverse reactions have been infrequently reported in adults and rarely in infants and children (1,2,3). In these reactions, there is no correlation between frequency or severity and the amount of HBsAg given per dose (5). Since recombinant HB vaccine became available, a case of Guillain-Barre syndrome (7), a case of transverse myelitis (8), a case of convulsion (9), and a case of thrombocytopenic purpura (10) in children have been reported in the literature. According to the authorized committee organized by the members of the National Academy of Sciences in the USA, an established causality was found between HB vaccine and anaphylaxis; however, this is an unpublished report (11).