2026/01/01 by Márcia Paulliny Soares Bahia, Silon de Souza Gomes Júnior, Argus Leão Araújo +3 · 1 voice
Medicine · Pharmacology, Toxicology and Pharmaceutics · #Drug-Induced Adverse Reactions #Pharmacovigilance and Adverse Drug Reactions #Respiratory viral infections research
paper · doi:10.1590/0037-8682-0198-2026
openalex publication_date 2026/01/01 · openalex created_date 2026/06/16 · openalex updated_date 2026/08/04
BACKGROUND: A national dengue vaccination campaign using TAK-003 was launched in 2024, targeting adolescents. Post-licensure surveillance suggested higher-than-expected hypersensitivity reactions. METHODS: We conducted a descriptive study using vaccine adverse event data and vaccination records from Belo Horizonte among individuals aged 6-14 years. RESULTS: Of the 146,115 doses administered, 28 hypersensitivity reactions were reported (191.6 per million), including nine cases of anaphylaxis and two of anaphylactic shock. All events followed the first dose. Mean age was 9.4 years, and mean time to symptom onset was 31 minutes. CONCLUSIONS: Hypersensitivity rates exceeded expected vaccine-associated levels, reinforcing the need for continued pharmacovigilance.