Anaphylaxis following vaccination in South Korea: A large-linked database study

초록

Background: Anaphylaxis is a severe and potentially fatal systemic reaction that can be triggered by various allergens. The risk of anaphylaxis after vaccination has not been well understood in Asian population. Objectives: We sought to assess the vaccine-specific rates in occurrence of anaphylaxis in Korea, by linking National Immunization Program database with National Health Insurance Service database to create a vaccine safety large-linked database (LLDB). Methods: The LLDB included data for 4.3 million Korean children aged 0-9 years followed from 2008 to 2017. We included all cases that were diagnosed to have anaphylaxis and were treated with epinephrine and/or corticosteroid within 2 days of vaccination. Data on demographic information, type of vaccine, co-administered vaccines, prior history of allergy, atopy, or anaphylaxis were retrieved. We calculated the incidence of anaphylaxis after vaccination within the time window of 0-2 days. Results: From the LLDB, we identified 137 post-vaccination anaphylaxis cases that occurred after 112,799,043 doses, resulting 1.21 (95% CI, 1.02-1.44) per million doses. Vaccine-specific rates included 2.87 (95% CI, 1.15-5.92) per million doses for Vero cell cultured inactivated Japanese encephalitis vaccine and 2.72 (95% CI, 1.59-4.36) for measles-mumps-rubella vaccine. For trivalent inactivated influenza vaccine, a total of 36 cases were reported from 14,850,886 doses, resulting rate of 2.42 (95% CI, 1.70-3.36) per 1 million doses. The rates were generally lower for Hib, PCV10, and PCV13 vaccines. Conclusions: Anaphylaxis after vaccination is rare in South Korea, however, the vaccine providers should be prepared to treat the potentially life-threatening allergic reaction.