Management of Previous Allergic Reaction to Hepatitis B Vaccine
Absolute Contraindications
- The Advisory Committee on Immunization Practices (ACIP) states that a previous hepatitis B vaccine dose that caused anaphylaxis or a severe allergic reaction is an absolute contraindication to future doses 1, 2, 3
- The Centers for Disease Control and Prevention (CDC) recommends that persons with a history of anaphylaxis after a previous dose of hepatitis B vaccine should not receive any further hepatitis B vaccine doses 1, 2, 3, 4
- The ACIP also recommends that persons with a known anaphylactic reaction to any vaccine component, including yeast, should not receive the hepatitis B vaccine 1, 2, 3, 4
Defining a Severe Allergic Reaction
- A severe allergic reaction to the hepatitis B vaccine includes anaphylaxis, generalized urticaria, angioedema, difficulty breathing or wheezing, and hypotension or shock, as defined by the CDC 4, 5
Clinical Decision Algorithm
- If a patient experiences anaphylaxis or a severe systemic allergic reaction to the hepatitis B vaccine, the vaccine series should be discontinued, and the patient should be counseled on hepatitis B prevention strategies, as recommended by the ACIP 1, 2, 3, 4
- If a patient experiences a mild reaction, such as local pain or low-grade fever, the vaccine series can continue as scheduled, according to the CDC 1, 2, 3
Safety Context
- The incidence of anaphylaxis from the hepatitis B vaccine is approximately 1 case per 1.1 million doses administered in children and adolescents, with no reported deaths, as stated by the CDC 1, 2, 3, 6
Vaccination Setting Requirements
- The CDC recommends that all vaccines, including the hepatitis B vaccine, should be administered in settings where personnel are trained to recognize and manage acute hypersensitivity reactions, and emergency equipment and medications are immediately available 5