Safety of the yellow fever vaccine during the September 2001 mass vaccination campaign in Abidjan, Ivory Coast

In 2001, a vaccination campaign against yellow fever was carried out in Abidjan, Cote d'Ivoire. During the campaign and 4 weeks after an active surveillance system for adverse events following immunization (AEFI) was set up. More then 2.6 million doses were administered and 87 AEFI were notified. Eight suspected YF cases were reported after vaccination and considered as AEFI. However, none had IgM for YF and all recovered without sequels. This surveillance system provided reassuring data about the safety of the YF vaccine and proved that it is feasible to set up an active surveillance system during a mass campaign.     

Immunogenicity and safety of yellow fever vaccine among 115 HIV-infected patients after a preventive immunisation campaign in Mali

The immune response to yellow fever (YF) vaccine and its safety among HIV-infected individuals living in YF endemic areas is not well understood. Following a national YF preventive immunisation campaign in Mali in April 2008, we assessed the immunogenicity and safety of 17D yellow fever vaccine (17DV) among HIV-infected patients in two HIV treatment centres in Bamako, Mali, by testing for neutralising antibodies and identifying serious adverse events following immunisation (AEFI). A YF neutralisation titre (NT) of 1:≥20 was considered to be adequate and protective. A serious AEFI included hospitalisation, any life-threatening condition, or death, occurring within 30 days following 17DV administration. Of 115 HIV-infected patients who reported having received 17DV, 110 (96%) were on combination antiretroviral therapy and 83 patients were tested for neutralising antibodies. Around the time of vaccination, median CD4 cell count was 389 cells/mm(3) (IQR 227-511cells/mm(3)); HIV-RNA was undetectable in 24 of 46 patients tested. Seventy-six (92%) of 83 participants had adequate immune titres 9 months after the immunisation campaign. Previous vaccination or flavivirus exposure could contribute to this finding. No serious AEFI was found in the 115 participants. In this small series, YF vaccine appeared to be immunogenic with a favourable safety profile in HIV-infected patients on antiretroviral therapy. Higher CD4 cell counts and suppressed HIV-RNA were associated with the presence of an adequate immune titre and higher NTs.     

甘肃省2012年甲型肝炎灭活疫苗群体性预防接种疑似预防接种异常反应分析

目的了解甘肃省2012年甲型肝炎（甲肝）灭活疫苗（Hepatitis A Vaccine,Inactivated;HepA-I）群体性预防接种中,疑似预防接种异常反应（Adverse Events Following Immunization,AEFI）的发生特征,评价HepA-I的安全性。方法采用描述性流行病学方法,对AEFI监测系统中的相关数据进行统计分析。结果甘肃省2012年接种HepA．I760451剂,发生AEFI95例,AEFI报告发生率124．92/100万剂。其中一般反应90例,报告发生率118．35/100万剂,异常反应3例,报告发生率3．94/100万剂,心因性反应2例,报告发生率2．63/100万剂。结论群体性接种HepA-I的AEFI发生率低,HepA-I具有良好的安全性。     

Monitoring of adverse events during the 2003 mass vaccination campaign with a trivalent meningococcal A/C/W135 polysaccharide vaccine in Burkina Faso

During a mass campaign with a newly licensed meningococcal polysaccharide ACW135 vaccine in Burkina Faso, adverse events following immunization (AEFI) were monitored up to 4 weeks after the campaign. Eighty-six AEFI cases (5.9 cases per 100,000 vaccine doses distributed) were reported. Among 22 serious events, 4 severe local reactions were considered very likely and 4 severe allergic reactions were considered probably related to the vaccination. One fatal case in a child followed protracted seizures of undetermined cause. In a setting with no prior surveillance system, adverse events were reported at rates comparable to documented rates for meningococcal polysaccharide vaccines in other settings. The findings confirm the benefits of the vaccine in the control of meningococcal meningitis.     

2015—2017年定西市安定区疑似预防接种异常反应监测分析

目的 分析安定区2015—2017年疑似预防接种异常反应（Adverse Event Following Immunization,AEFI）的发生特征,评价AEFI监测工作质量和预防接种的安全性。方法 采用描述流行病学的方法对安定区2015—2017年疑似预防接种异常反应信息管理系统报告的AEFI病例进行统计分析。结果 2015—2017年全区使用疫苗22种,共接种385 693剂次,报告983例AEFI,报告平均发生率25.49/万。AEFI中一般反应976例,占报告总数的99.29%,主要为发热、哭闹、局部红肿。AEFI在接种后24h内发生率为85.86%,发生后24h内就诊率91.45%。AEFI中前三位的疫苗依次为无细胞百白破疫苗、乙脑疫苗(减毒)、A群流脑疫苗。结论 AEFI监测系统的敏感性、完整性、及时性均达到国家监测要,预防接种的安全性较好。     

2011年上海市静安区疑似预防接种后不良反应监测数据分析

[目的]分析2011年静安区疑似预防接种后不良反应（AdverseEventFollowingImmunization,AEFI）数据,为提高监测工作质量,维护预防接种安全性提供依据。[方法]在常规监测的基础上,2011年7～9月对5家预防接种门诊接种对象开展主动监测,记录AEFI发生时间、疫苗接种时间、疫苗种类、报告时间、临床表现等信息,并分析比较。[结果]2011年静安区报告AEFI共249例次,平均报告率为289．49次／10万剂次,以一般反应为主。主动监测报告率为910．84次／10万剂次,常规监测报告率为84．99次／10万剂次,主动监测报告率为常规监测报告率的10．7倍。常规监测与主动监测中,AEFI报告率较高的疫苗较近似,但并不完全一致。[结论]静安区常规AEFI监测有效开展,但监测敏感度和监测质量尚存在进一步提高的空间,影响监测敏感性和监测质量的因素尚有待于进一步探讨。     

2008—2011年上海市静安区预防接种后不良反应监测系统评价

目的对2008—2011年上海市静安区预防接种后不良反应(Adverse Event Following Immunization,AEFI)监测数据进行分析,评价AEFI监测系统运行情况。方法用Excel2003对2008—2011年静安区AEFI监测数据和接种率监测数据进行分析,了解AEFI报告敏感度、AEFI发生时间、所报告AEFI临床症状分布情况及报告及时性。结果 2008—2011年静安区除2010年AEFI报告率为66/10万剂次以外,其余每年报告率均在150/10万剂次以上。89.6%的AEFI发生于接种后的3天内,50.0%以上的AEFI有不同程度的发热,25.0%以上的AEFI有不同程度的局部红肿,51.1%的AEFI在反应发生后的前3天内被报告。结论 2008—2011年静安区AEFI监测系统运转良好,监测数据质量较高,基本能够反映出疫苗安全性的真实水平。部分年份监测敏感度下降显著,一定程度上影响到监测数据质量,应探讨合适的管理方法,帮助维持AEFI监测系统高效运转。     

Neurological adverse events temporally associated to mass vaccination against yellow fever in Juiz de Fora, Brazil, 1999-2005

The identification of adverse events following immunization (AEFI) and their prompt investigation are important to allow a timely and scientifically based response to the users of immunization services. This article presents an analysis of notified AEFI cases between 1999 and 2005 and their temporal association with 2001 yellow fever vaccination campaign, AEFI notification attributed to yellow fever vaccination rose from 0.06 to 1.32 per 100,000 vaccinees in Brazil, between 1998 and 2000. During the 2001 yellow fever mass vaccination campaign held in Juiz de Fora, Brazil, 12 cases of aseptic meningitis were temporally associated to yellow fever vaccination, but clinical and laboratory data were not available to confirm nor deny causality. Epidemiological studies associated to enhanced surveillance and standardized protocols should take advantage of public health interventions like mass vaccination campaigns and implementation of new vaccination strategies in order to assess and investigate vaccine safety.     

上海市预防接种工作人员疑似预防接种异常反应监测认知和报告影响因素

目的了解上海市预防接种工作人员疑似预防接种异常反应(Adverse events following immunization,AEFI)监测的知识和态度以及影响AEFI报告的因素。方法采用方便抽样在上海市所有459个预防接种门诊选择预防接种工作人员开展问卷调查,分析AEFI监测知识得分(满分6分)和态度,采用多因素Logistic回归分析AEFI报告的影响因素。结果1379名调查对象的AEFI监测知识平均得分为3.30±1.31分;认为开展AEFI监测有必要、报告AEFI是自身职责、AEFI监测是额外工作负担的调查对象分别占98.84%、92.75%、30.38%。69.62%的调查对象近1年报告过AEFI;社区接种门诊、免疫规划专职人员、近1年接受过AEFI培训、AEFI监测知识得分高的调查对象报告AEFI的比例高[OR(95%CI):19.55(14.16-26.98)、1.95(1.45-2.64)、3.14(1.76-5.59)、1.91(1.38-2.63)]。结论上海市预防接种工作人员AEFI监测知识水平不高,对AEFI监测存在一定认识误区;需加强AEFI监测培训,进一步提高其AEFI报告意识。     

2005-2013年深圳市南山区疑似预防接种 异常反应监测分析

摘要:目的　分析2005-2013年深圳市南山区疑似预防接种异常反应发生情况及监测系统运转情况,评价监测系统运转灵敏性及预防接种疫苗的安全性。方法　通过疑似预防接种异常反应信息管理系统,收集整理2005-2013年深圳市南山区报告的疑似预防接种异常反应个案,采用描述性方法对相关指标进行分析。结果　2005-2013年深圳市南山区共报告疑似预防接种异常反应病例600例,其中≤1岁占42.50%,男女性别比为1.5∶1,9月份（92例,占15.33%）报告病例最多。一般反应436例,占61.1％,异常反应139例,占23.17%。282例（47.00%）在接种疫苗1 d内发生,54.83%发生在接种该种疫苗的第1剂次。59.17%出现发热症状,32.67%出现局部红肿,14.50%出现局部硬结。结论　深圳市南山区疑似预防接种异常反应监测工作逐步规范,疑似预防接种异常反应常发生在小年龄儿童、第1 剂次、接种后1 d 内,为监测重点。     

2009-2014年天津市河西区疑似预防接种异常反应 监测结果分析

摘要:目的　探讨2009-2014年天津市河西区预防接种不良反应监测系统报告的不良反应问题,为疫苗安全使用提供科学依据。方法　采取描述流行病学得方法对河西区监测系统收集的AEFI病例分析。结果　2009-2014年河西区通过AEFI信息管理系统接报15种疫苗引起的AEFI病例208例,总报告接种剂次为778172剂,AEFI发生率为26.73/10万,12个社区卫生服务中心均有AEFI病例发生。常见临床症状为发热、接种局部红肿及硬结。较为严重有两例,均为接种吸附无细胞百白破疫苗后,一例为血管性水肿、另一例为血小板过敏性紫癜。结论　全区12个社区卫生服务中心均有AEFI病例发生,AEFI报告发生率很低,预防接种的安全性良好。AEFI监测是科学评价接种疫苗的利弊,及时处置AEFI,增加大众对预防接种信心的有效措施。     

2012年山东省疑似预防接种异常反应监测分析

摘要:目的　分析2012年山东省疑似预防接种异常反应（Adverse Events Following Immunization,AEFI）发生特征,评价AEFI系统运转情况。方法　通过AEFI系统,收集2012年个案,采用描述性方法对系统进行评价,对病例进行流行病学分析。结果　2012年山东省142个县均有数据报告,48 h报告率99.22%,48 h调查率100%。全省共收到个案12 665例,其中≤1岁占77.43%,男女性别比1.44∶1。国家免疫规划（National Immunization Program,NIP）疫苗占76.67%,首剂接种占58.56%,85.94%发生在接种后≤1 d;一般反应占97.59%,异常反应占2.14%,其中以过敏反应和卡介苗淋巴结炎为主。全省NIP疫苗常见异常反应报告发生率为0.18/100万～43.62/100万。12656例治愈或好转;5例死亡,其中异常反应1例;4例后遗症。结论　山东省AEFI监测敏感性和质量仍需提高。小年龄、NIP疫苗、首剂接种、接种后≤1 d,为监测重点。     

Adverse events following immunization during mass vaccination campaigns at first introduction of a meningococcal A conjugate vaccine in Burkina Faso, 2010

MenAfriVac? is a new meningococcal A conjugate vaccine developed to prevent meningitis outbreaks in Africa. It was first introduced during the last quarter of 2010 in three West African countries. We report on the monitoring of adverse events following immunization (AEFI) in Burkina Faso where more than 11 million people aged 1-29 years were vaccinated. Vaccine pharmacovigilance relied on stimulated passive AEFI surveillance countrywide and active surveillance for 12 clinical conditions in one sentinel district (Ziniaré) with 97,715 people eligible for vaccination. All AEFI occurring during the 10 days of mass campaign or the 42 subsequent days were to be notified. Serious AEFI were submitted to a national expert committee (NEC) for causality assessment. A total of 11,466,950 people were vaccinated with 1471 vaccinees reported to have experienced at least one AEFI (12.83 cases per 100,000). 1444 AEFI were minor; the most common of which were fever, headache, gastro-intestinal disorders and local reactions (2-7 cases per 100,000). Of 27 serious AEFI reported, four cases were classified by the NEC as related to vaccine (1 case per 3 million vaccinated) including one case each of exanthematous pustulosis, angioedema, bronchospasm and severe vomiting. Active surveillance identified 71 cases of the 12 conditions of interest. Convulsions, urticaria and bronchospasm were more frequently reported. Attack rates for those conditions were similar to the baseline rates recorded in the same population, over the same time period, a year earlier. With the exception of convulsions in the days following vaccination the distribution of time intervals between vaccination and the occurrence of symptoms did not reveal any temporal clustering. The monitoring of AEFI of MenAfriVac? in Burkina Faso did not suggest special concern regarding the vaccine safety. However, reported possible hypersensitivity reactions to vaccine components would require further review to rule out any anaphylactic reaction.     

2009-2015年赣州市疑似预防接种异常反应监测分析

目的 了解2009-2015年赣州市疑似预防接种异常反应（AEFI）发生特征,评价全市AEFI监测系统运行质量和疫苗接种安全性。方法 运用国家AEFI信息管理系统收集个案数据,采用描述性方法进行流行病学分析。结果 全市乡报告覆盖率呈逐年上升趋势,7年来共报告AEFI 2 476例,发生率7.15/10万,异常反应发生率1.51/10万剂次。病例以0岁为主,占45.64%;9月报告病例最多,接种后＜1天出现反应2 140例,占86.43%;疫苗不良反应发生率居前3位的是百白破、白破和麻风疫苗,临床损害以过敏性皮疹为主。结论 全市监测工作取得了非常显著的进步,但监测系统的敏感性有待进一步提高。全市无接种事故,接种服务质量较好。     

广州市越秀区预防接种副反应监测分析

目的 了解掌握预防接种副反应(adverse events following immunization,AEFI)报告发生率,为安全实施预防接种提供依据.方法 按照《全国预防接种副反应监测试点工作指南的要求》,通过被动监测或主动监测,收集2006-2009年广州市越秀区预防接种后出现的AEFI病例,对符合监测上报的AEFI个案资料进行分析.结果 2006-2009年广州市越秀区AEFI监测系统报告AEFI个案286例,AEFI估算报告发生率为12.12/10万剂次,主要报告月份为3～8月份;AEFI涉及21种疫苗,其中一般反应134例,报告发生率为5.67/10万剂次,异常反应87例,报告发生率3.68/10万剂次,偶合反应65例,报告发生率为2.75/10万剂次,位居前3位的疫苗分别为:甲型H1N1流感疫苗75/10万剂次,麻风疫苗67.11/10万剂次,全细胞百白破疫苗66.99/10万剂次;一般反应中,发热占49.25%,局部红肿硬结,占29.1%,发热合并局部红肿硬结占11.94%;异常反应中以过敏性皮疹、无菌性脓肿、血管神经性水肿为前3位;偶合反应主要以偶合上呼吸感染为主;有稀释液与无稀释液疫苗(χ²=5.68,P=0.017)、不同注射方式(χ²=4.7,P=0.03)的AEFI一般反应与异常反应发生率差异有统计学意义.有无过敏史的一般反应与异常反应发生率差异无统计学意义(χ²=0.957,P>0.05),过敏史OR=2.1,提示有过敏史者发生预防接种异常反应的危险性是发生一般反应的2.1倍.结论 广州市越秀区预防接种工作服务质量良好,AEFI类型中无疫苗质量及差错事故;AEFI的估算报告发生率在预期发生范围内.     

上海市某区甲型H1N1流行性感冒疫苗接种安全性监测

[目的]监测2009-2010年上海市长宁区甲型H1N1流行性感冒（甲流）疫苗接种的安全性。[方法]通过上海市预防接种异常反应（adverse events following immunization,AEFI）监测系统,以被动监测方式收集长宁区甲流疫苗接种人群截至2010年12月31日的AEFI个案信息,同时通过问卷和电话随访的主动监测方式收集其中4所中小学校师生的AEFI个案信息开展评价。[结果]上海市长宁区共接种甲流疫苗86934人,甲流疫苗AEFI被动监测报告发生率为53．04／10万,其中异常反应报告发生率为8．25／10万;4所中小学校接种甲流疫苗2092人,甲流疫苗AEFI主动监测报告发生率为8221．80／10万,主动监测的AEFI报告发生率明显高于被动监测。甲流疫苗AEFI报告对象的临床表现以发热、局部反应和主诉不适为主,异常反应以过敏性反应为主,无严重不良反应发生。[结论]甲流疫苗AEFI被动监测的漏报情况主要发生在一般反应,甲流疫苗的安全性与季节性流行性感冒疫苗相当。     

江门市2012—2018年疑似预防接种异常反应监测数据分析

目的 分析江门市2012—2018年疑似预防接种异常反应(adverse events following immunization,AEFI)的发生特征,评价AEFI监测系统运转情况。方法 通过中国AEFI信息管理系统收集2012—2018年江门市报告的AEFI个案信息和疫苗接种信息,采用描述流行病学方法进行数据分析。结果 江门市2012—2018年共报告1 207例AEFI个案,年均增长率为13.45%,全市7个市(区)均有报告,98.76%的个案在48 h内报告,99.46%的个案在48 h内完成调查。男女性别比为1.39∶1,≤1岁占52.86%,AEFI发生在接种后1 d内占91.47%,各年报告发生率为7.20/10万~12.43/10万;异常反应发生率为2.55/10万~3.53/10万。一般反应以发热和局部红肿和硬结为主,异常反应以过敏性皮疹为主,严重异常反应少见。结论 江门市AEFI监测的敏感性逐步提高,达到全国监测方案标准。AEFI常发生在小年龄儿童和接种后≤1 d,以一般反应为主,严重异常反应报告发生率极低。     

Mass vaccination with a two-dose oral cholera vaccine in a long-standing refugee camp,Thailand

BackgroundDuring 2005–2012, surveillance in Maela refugee camp, Thailand, identified four cholera outbreaks, with rates up to 10.7 cases per 1000 refugees. In 2013, the Thailand Ministry of Public Health sponsored a two-dose oral cholera vaccine (OCV) campaign for the approximately 46,000 refugees living in Maela.MethodsWe enumerated the target population (refugees living in Maela who are ≥1 year old and not pregnant) in a census three months before the campaign and issued barcoded OCV cards to each individual. We conducted the campaign using a fixed-post strategy during two eight-day rounds plus one two-day round for persons who had missed their second dose and recorded vaccine status for each individual. To identify factors associated with no vaccination (versus at least one dose) and those associated with adverse events following immunization (AEFI), we used separate marginal log-binomial regression models with robust variance estimates to account for household clustering.ResultsA total of 63,057 OCV doses were administered to a target population of 43,485 refugees. An estimated 35,399 (81%) refugees received at least one dose and 27,658 (64%) received two doses. A total of 993 additional doses (1.5%) were wasted including 297 that were spat out. Only 0.05% of refugees, mostly children, could not be vaccinated due to repeated spitting. Characteristics associated with no vaccination (versus at least one dose) included age ≥15 years (versus 1–14 years), Karen ethnicity (versus any other ethnicity) and, only among adults 15–64 years old, male sex. Passive surveillance identified 84 refugees who experienced 108 AEFI including three serious but coincidental events. The most frequent AEFI were nausea (49%), dizziness (38%), and fever (30%). Overall, AEFI were more prevalent among young children and older adults.ConclusionsOur results suggest that mass vaccination in refugee camps with a two-dose OCV is readily achievable and AEFI are few.     

2011~2013年安阳市疑似预防接种异常反应监测

目的分析安阳市疑似预防接种异常反应(AEFI)的发生特征,评价AEFI监测系统运转状况。方法通过AEFI监测系统,收集全市2011~2013年报告的AEFI个案数据,采用描述性方法,对相关指标进行流行病学分析。结果 2011~2013年AEFI监测系统共收到个案363例,其中≤1岁占55.56%,男女性别比为1.66∶1,报告疫苗以全国计划免疫(NIP)疫苗为主;一般反应占88.43%,其中78.24%发生在接种后≤1d;异常反应占9.92%,以过敏性皮疹和卡介苗淋巴结炎为主。估算全市NIP疫苗疑似预防接种异常反应报告发生率为4.54/10万。结论全市AEFI系统的监测质量逐年提高。AEFI常发生在小年龄组儿童接种NIP疫苗时,应为监测重点;NIP疫苗不良反应报告发生率均在预期发生范围内。     

Vaccination coverage survey versus administrative data in the assessment of mass yellow fever immunization in internally displaced persons--Liberia, 2004

Yellow fever (YF) is a mosquito-borne vaccine-preventable disease with high mortality. In West Africa, low population immunity increases the risk of epidemic transmission. A cluster survey was conducted to determine the effectiveness of a mass immunization campaign using 17D YF vaccine in internally displaced person (IDP) camps following a reported outbreak of YF in Liberia in February 2004. Administrative data of vaccination coverage were reviewed. A cluster sample size was determined among 17,384 shelters using an 80% vaccination coverage threshold. A questionnaire eliciting demographic information, household size, and vaccination status was distributed to randomly selected IDPs. Data were analyzed to compare vaccination coverage rates of administrative versus survey data. Among 87,000 persons estimated living in IDP camps, administrative data recorded 49,395 (57%) YF vaccinated persons. A total of 237 IDPs were surveyed. Of survey respondents, 215 (91.9%, 95% CI 88.4-95.4) reported being vaccinated during the campaign and 196 (83.5%, 95% CI 78.6-88.5) possessed a valid campaign vaccination card. The median number of IDPs living in a shelter was 4 (range, 1-8) and 69,536 persons overall were estimated to be living in IDP camps. Coverage rates from a rapid survey exceeded 90% by self-report and 80% by evidence of a vaccination card, indicating that the YF immunization campaign was effective. Survey results suggested that administrative data overestimated the camp population by at least 20%. An emergency, mop-up vaccination campaign was avoided. Coverage surveys can be vital in the evaluation of emergency vaccination campaigns by influencing both imminent and future immunization strategies.