Exanthema after dengue vaccine (TAK003): first data of passive surveillance in a private vaccination center in Argentina

Abstract Introduction : The tetravalent live virus vaccine devel oped by Takeda called Qdenga® is available in Argentina and approved for use from 4 years of age without age limit. The objective was to describe clinical characteristics and evolution of the initial reports of rash after the first dose. Material and methods : The records of Events Sup posedly Attributable to Vaccination or Immunization Reported in a Private Vaccination Center were reviewed between 15/11/2023 and 12/12/2023. Cases with skin rash that occurred outside the application site area were included. The main variables analyzed were age, sex, history of dengue, characteristics of the skin rash, accompanying symptoms, time elapsed from vaccination to the onset of the rash and evolution. The incidence of rash was calculated: cases/10,000 vaccinated. Results : Out of 12 551 doses applied, 15 cases were included. Median age: 35 years, female sex: 8/15. Clini cal forms of presentation: generalized micropapular (3/15), maculopapular (3/15), scarlatiniform (1/15), urti carian (1/15), multiform (1/15), erythematous in the face (1/15) and unspecified (5/15). Most common concomitant symptoms: pruritus (5/15), fever or low-grade fever (6/15), headache (3/15), retro-ocular pain (2/15), asthenia (2/15). Three cases reported a history of dengue. The median number of days of rash presentation was 8 days' post-vaccination. All patients progressed favorably. The over all incidence was 1.2/1000 vaccinated. Conclusions : In passive surveillance, after more than 12 000 first doses administered, the presence of rash was observed in less than 0.12% of those vaccinated. Everyone evolved favorably.