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

This national-level longitudinal dataset contains 2,097 anonymized spontaneous reports of adverse drug reactions (ADRs) in children aged 3–59 months who received SPAQ as part of Ghana’s Seasonal Malaria Chemoprevention (SMC) programme from 2015 to 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).

Keywords: SPAQ, Seasonal Malaria Chemoprevention, Adverse Drug Reactions, Pharmacovigilance, Ghana, Children