Marques Joana Isabel, Ribeiro Vaz Inês, Santos Cristina, Polónia Jorge
Centre for Research in Health Technologies and Information Systems (CINTESIS), Faculty of Medicine, University of Porto, Porto, Portugal.
Acta Med Port. 2013 Mar-Apr;26(2):107-12. Epub 2013 May 31.
Healthcare professionals were a priority group for Pandemrix® vaccination. Surveying this particularly committed group for vaccination related side effects could help to get valuable information about vaccine safety profile. Our aim was to identify the adverse events following immunization with Pandemrix® among healthcare professionals.
A questionnaire for active post-authorization monitoring of adverse events following immunization with the influenza vaccine A (H1N1) was designed and distributed to the vaccinated healthcare professionals working at 3 elected hospital centres in the Northern region, in the period from 26 October 2009 to 31 January 2010.
From the 2358 vaccinated healthcare professionals that accepted to participate in this study, 864 (37%) returned back the fulfill questionnaire on time. Among these, 634 (73%) of healthcare professionals experienced at least one adverse event following immunization, but only 8% experienced an unexpected one. The adverse events most frequently reported were expected and very common: local reactions at the injection site (57%), myalgia (31%), fatigue (including asthenia) (24%) and headache (19%). No cases of major episodes, such as death or life-threatening events were reported. Female gender and existence of underlying conditions were independent risk factors to develop at least one adverse event following immunization to the pandemic vaccine.
Our work suggests an acceptable safety profile of this pandemic flu vaccine among healthcare professionals. Both frequency and severity of the observed adverse event following immunization do not seem to be higher than expected.
医护人员是接种大流行疫苗（Pandemrix®）的优先群体。对这一特别积极接种的群体进行疫苗相关副作用调查，有助于获取有关疫苗安全性的宝贵信息。我们的目的是确定医护人员接种Pandemrix®疫苗后的不良事件。
设计了一份关于甲型H1N1流感疫苗接种后不良事件主动监测的问卷，并分发给2009年10月26日至2010年1月31日期间在北部地区3家选定医院中心工作且已接种疫苗的医护人员。
在2358名同意参与本研究的已接种疫苗医护人员中，864人（37%）按时交回了完整问卷。其中，634名（73%）医护人员在接种后经历了至少一次不良事件，但只有8%经历了意外不良事件。最常报告的不良事件是预期且非常常见的：注射部位局部反应（57%）、肌痛（31%）、疲劳（包括乏力）（24%）和头痛（19%）。未报告重大事件，如死亡或危及生命的事件。女性和存在基础疾病是接种大流行疫苗后发生至少一次不良事件的独立危险因素。
我们的研究表明，这种大流行流感疫苗在医护人员中的安全性是可接受的。接种后观察到的不良事件的频率和严重程度似乎并不高于预期。
