Pharmaceutical Care Services, Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia.
King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
Expert Rev Vaccines. 2021 Aug;20(8):1037-1042. doi: 10.1080/14760584.2021.1940145. Epub 2021 Jun 17.
: Several cases of unusual thrombotic events with thrombocytopenia were reported in several countries, in association with AstraZeneca's COVID-19 vaccine. The European medicines agency conducted a detailed review and concluded that there was no evidence to suggest an association of thrombotic events with the use of COVID-19 vaccine AstraZeneca.: King Abdulaziz Medical City is a 1500 bed tertiary care hospital in Riyadh, Saudi Arabia; this study describes spontaneously reported vaccine adverse effects received through the hospital's internal electronic safety reporting system from December 2020 to 13 April 2021.We assessed each report for causality association utilizing the world health organization's (WHO) causality assessment of an adverse event following immunization (AEFI) classification 2nd Edition 2019.: The majority of the reported events were mild to moderate, there were five serious events, one reported cardiac arrest, two cerebral venous sinus thrombosis, and two pulmonary embolism. Clinical and laboratory summary of the five patients are presented in detail.: Efforts of pharmacovigilance in mediating the rare risk of thrombosis associated with COVID-19 vaccine are crucial in providing awareness on the possible risk factors and signs/symptoms that should raise red flags.
在一些国家,与阿斯利康的 COVID-19 疫苗相关,报告了几例罕见的血栓形成事件伴血小板减少症。欧洲药品管理局进行了详细审查,结论是没有证据表明血栓形成事件与使用 COVID-19 疫苗阿斯利康有关。
沙特阿拉伯利雅得的阿卜杜勒阿齐兹国王医疗城是一家拥有 1500 张床位的三级保健医院;本研究描述了 2020 年 12 月至 2021 年 4 月 13 日通过医院内部电子安全报告系统收到的疫苗不良反应的自发报告。我们利用世界卫生组织(世卫组织)对免疫后不良事件(AEFI)分类的因果关系评估 2019 年第二版评估了每一份报告的因果关系。
报告的大多数事件为轻度至中度,有 5 例严重事件,1 例报告心脏骤停,2 例脑静脉窦血栓形成,2 例肺栓塞。详细介绍了 5 名患者的临床和实验室总结。
药物警戒在调解与 COVID-19 疫苗相关的罕见血栓形成风险方面的努力至关重要,因为这可以提高对可能的危险因素和体征/症状的认识,这些危险因素和体征/症状应该引起警惕。