Trends and Incidence of SPAQ-Related Adverse Drug Reactions in Seasonal Malaria Chemoprevention among Ghanaian Children Under Five: A Nine-Year Review (2015–2023)

Data were extracted from the Ghana Food and Drugs Authority (FDA) pharmacovigilance database which aggregates data using phone calls, paper-based reporting forms, the Med Safety mobile application, and the online reporting portal.

Each record includes: • Demographics: Age (in months), sex (male, female) • Reporter: Qualification (Physician, Pharmacist, Other Health Professional, Consumer/Non-Health Professional, Unknown) • ADR Details: Mapped reaction term, top 10 common symptoms (fever, vomiting, diarrhea, cough, weakness, abdominal pain, loss of appetite, rash, itch, dizziness), seriousness (yes/no), and criteria (life-threatening, hospitalization) • Temporal: Year of reaction All ADRs were coded using their corresponding preferred terms according to the Medical Dictionary for Regulatory Activities (MedDRA).