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

本国家级纵向数据集涵盖2015年至2023年间，参与加纳季节性疟疾化学预防（Seasonal Malaria Chemoprevention, SMC）项目并服用SPAQ的3至59月龄儿童的2097份匿名化药物不良反应（Adverse Drug Reactions, ADRs）自发报告。数据提取自加纳食品药品监督管理局（Food and Drugs Authority, FDA）的药物警戒（Pharmacovigilance）数据库，该数据库通过电话、纸质报告表单、Med Safety移动应用及在线报告门户汇总数据。每条记录包含以下内容：
• 人口统计学信息：月龄、性别（男、女）
• 报告者资质：医师、药师、其他卫生专业人员、消费者/非卫生专业人员、未知
• 药物不良反应详情：映射反应术语、十大常见症状（发热、呕吐、腹泻、咳嗽、乏力、腹痛、食欲减退、皮疹、瘙痒、头晕）、严重程度（是/否）及判定标准（危及生命、需住院治疗）
• 时间维度：反应发生年份
所有药物不良反应均按照《国际医学用语词典（Medical Dictionary for Regulatory Activities, MedDRA）》的对应首选术语进行编码。

关键词：SPAQ、季节性疟疾化学预防、药物不良反应、药物警戒、加纳、儿童