Westphal Darren W, Williams Stephanie A, Leeb Alan, Effler Paul V
Communicable Disease Control Directorate, Public Health Division, Western Australian Department of Health, Perth, WA, Australia; Westfarmer's Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Subiaco, WA, Australia; National Centre of Epidemiology and Population Health, Research School of Population Health, The Australian National University, ACT, Australia.
National Centre of Epidemiology and Population Health, Research School of Population Health, The Australian National University, ACT, Australia.
Vaccine. 2016 Jun 17;34(29):3350-5. doi: 10.1016/j.vaccine.2016.05.015. Epub 2016 May 17.
On-going post-licensure surveillance of adverse events following immunisation (AEFI) is critical to detecting and responding to potentially serious adverse events in a timely manner. SmartVax is a vaccine safety monitoring tool that uses automated data extraction from existing practice management software and short message service (SMS) technology to follow-up vaccinees in real-time. We report on childhood vaccine safety surveillance using SmartVax at a medical practice in Perth, Western Australia.
Parents of all children under age five years who were vaccinated according to the Australian National Immunisation Schedule between November 2011 and June 2015 were sent an SMS three days post administration to enquire whether the child had experienced a suspected vaccine reaction. Affirmative replies triggered a follow-up SMS requesting details of the reaction(s) via a link to a survey that could be completed using a smartphone or the web. Rates of reported AEFI including fever, headache, fatigue, rash, vomiting, diarrhoea, rigours, seizures, and local reactions were calculated by vaccination time point.
Overall, 239 (8.2%; 95% CI 7.2-9.2%) possible vaccine reactions were reported for 2897 vaccination visits over the 44 month time period. The proportion of children experiencing a possible AEFI, mostly local reactions, was significantly greater following administration of diphtheria-tetanus-pertussis-poliomyelitis vaccine at 4 years of age (77/441; 17.5%; 95% CI 13.9-21.0%) compared to the vaccinations given at 2-18 months (p<0.001). Across all time points, local reactions and fatigue were the most frequently reported AEFI.
Automated SMS-based reporting can facilitate sustainable, real-time, monitoring of adverse reactions and contribute to early identification of potential vaccine safety issues.
持续开展疫苗接种后不良事件(AEFI)的上市后监测对于及时发现和应对潜在的严重不良事件至关重要。SmartVax是一种疫苗安全监测工具,它利用从现有实践管理软件自动提取的数据和短消息服务(SMS)技术对疫苗接种者进行实时随访。我们报告了在澳大利亚西部珀斯的一家医疗机构使用SmartVax进行儿童疫苗安全监测的情况。
2011年11月至2015年6月期间按照澳大利亚国家免疫规划进行疫苗接种的所有五岁以下儿童的家长,在接种疫苗三天后会收到一条短信,询问孩子是否经历了疑似疫苗反应。肯定的回复会触发一条后续短信,通过一个可使用智能手机或网络完成的调查问卷链接,请求提供反应细节。按接种时间点计算报告的AEFI发生率,包括发热、头痛、疲劳、皮疹、呕吐、腹泻、寒战、惊厥和局部反应。
在44个月的时间段内,2897次疫苗接种中有239次(8.2%;95%CI 7.2 - 9.2%)报告了可能的疫苗反应。4岁时接种白喉-破伤风-百日咳-脊髓灰质炎疫苗后经历可能的AEFI(大多为局部反应)的儿童比例(77/441;17.5%;95%CI 13.9 - 21.0%)显著高于2 - 18个月龄时接种疫苗的情况(p<0.001)。在所有时间点,局部反应和疲劳是报告最频繁的AEFI。
基于短信的自动报告有助于对不良反应进行可持续的实时监测,并有助于早期识别潜在的疫苗安全问题。