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中国循证儿科杂志

中国循证儿科杂志 ›› 2022, Vol. 17 ›› Issue (3): 225-234.DOI: 10.3969/j.issn.1673-5501.2022.03.010

• 论著 • 上一篇    下一篇

有过敏性疾病史儿童接种新型冠状病毒灭活疫苗后不良事件的病例系列报告

朱燕凤1a,常海岭1a,马文洁1,王相诗1,葛艳玲1,冯天行2,曾玫1   

  1.  1 复旦大学附属儿科医院感染传染科上海，201102；2 上海瑞慈水仙妇儿医院儿科上海，200040；a 共同第一作者
  • 收稿日期:2022-04-23 修回日期:2022-05-17 出版日期:2022-06-25 发布日期:2022-06-25
  • 通讯作者: 曾玫，email：zengmeigao@aliyun.com；冯天行，email：tianxing@fudan.edu.cn

Adverse events after inactivated COVID-19 vaccination in children with a history of allergy: A case series report

ZHU Yanfeng1a, CHANG Hailing1a, MA Wenjie1, WANG Xiangshi1, GE Yanling1，FENG Tianxing2, ZENG Mei1   

  1. 1 Department of Infectious Disease, Children's Hospital of Fudan University, Shanghai 201102, China; 2 Department of Pediatrics, Shanghai Rici Children's and Women's Hospital, Shanghai 200040, China；a Co-first author
  • Received:2022-04-23 Revised:2022-05-17 Online:2022-06-25 Published:2022-06-25
  • Contact: ZENG Mei, email: zengmeigao@aliyun.com；FENG Tianxing, email: tianxing@fudan.edu.cn

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摘要： 背景：新型冠状病毒疫苗（简称新冠疫苗）接种对于控制疫情大流行并减少新冠肺炎重症发生率具有重要作用，有过敏性疾病史儿童人群接种新冠疫苗中的安全性是现实问题。 目的：为有过敏性疾病史的儿童接种新冠疫苗提供建议。 设计：病例系列报告。 方法：纳入2021年8月12日至2021年12月3日至复旦大学附属儿科医院疫苗咨询门诊咨询新冠疫苗接种的3～17岁儿童和青少年。根据儿童的既往史、目前健康状态以及家长的问题进行个体化评估，给予暂缓接种或推荐接种建议，电话随访接种后72 h内、28 d内和3个月时有无征集的疫苗接种后不良事件（AEFI）以及家长主动报告的任何非征集的不良事件；行AEFI与疫苗的因果关联评估。 主要结局指标：新冠疫苗AEFI。 结果：接受新冠疫苗接种咨询的儿童116例，男67例（57.8%），女49例，年龄（10.1±3.1）岁，经疫苗咨询门诊个体化评估后推荐接种（组）77例（66.4%），暂缓接种（组）39例。有过敏性疾病史70例（60.3%），其中 25例因处于过敏性疾病急性期建议暂缓接种，既往其他疫苗或药物过敏史11例（9.5%）中5例因严重过敏反应期建议暂缓接种，非药物过敏史13例（11.2%）中5例因处于疾病急性期、特应性体质21例（18.1%）中3例因患急性疾病（呼吸道感染），1例（0.9%因既往接种新冠疫苗1剂过敏）建议暂缓接种。暂缓接种组儿童于疫苗咨询门诊咨询后后3个月行电话随访均未接种新冠疫苗。推荐接种组77例儿童均完成了3次随访，实际接种亚组54例（47例接种了2剂次疫苗，7例接种了1剂次疫苗）；实际未接种亚组23例，两亚组性别、过敏性疾病史、其他疫苗或药物过敏史、非药物过敏史和特应性体质差异均无统计学意义, 年龄差异有统计学意义［（10.4±3.0）岁vs（9.0±3.1）岁，P=0.04］。接种后4 d和28 d的电话随访未报告征集的严重过敏反应。接种后72 h内18例（17.8%）报告征集的不良反应事件，其中皮疹和咳嗽各5例（5.0%），流涕4例（4.0%），纳差和发热各3例（3.0%），咽痛2例 （2.0%），乏力、肌痛、恶心、呕吐各1例（1.0%），经判断与新冠疫苗接种有因果关联。接种后28 d和3个月电话随访未再报告征集的不良反应。接种后28 d内家长主动报告5例非征集不良事件，其中特发性皮炎或湿疹发作3例（3.0%）、 过敏性鼻炎发作2例（2.0%），初步判断与新冠疫苗接种无因果关联。接种后28 d内新冠疫苗AEFI发生率 33.3% （18/54）。 结论：过敏性疾病缓解期、有其他疫苗或药物非严重过敏史、非药物过敏史、特应性体质儿童接种新冠病毒灭活疫苗是安全的，新冠疫苗AEFI均发生在接种后72 h内，与新冠疫苗接种有因果关联。

关键词: 新型冠状病毒, 疫苗, 过敏史, 儿童, 安全性, 过敏反应, 预防接种不良事件

Abstract: Background：Coronavirus Disease 2019 (COVID19) vaccination plays an important role in controlling the pandemic and protecting population from developing into a severe type. The vaccination safety in children with a history of allergy has been a common concern. Objective：To provide the best immunization practice and recommendations for children with a history of allergy. Design：Case series report. Methods：Children and adolescents aged 3 to 17 who were consulted at the designated pediatric COVID19 vaccine advisory clinic in Children's Hospital of Fudan University between August 12nd, 2021 and December 3rd, 2021 were included. Based on individual's past medical history, current health status, and parental concerns, individualized assessments are made, and recommendations for deferring and recommending vaccinations are given. Telephone followup was conducted to collect adverse events following immunization (AEFI) within 72 h and 28 d after vaccination and any unsolicited adverse events reported by parents. The causal association between AEFI and vaccine was assessed. Main outcome measures：AEFI of COVID19 vaccine. Results：A total of 116 children consulted for COVID19 vaccination, including 67 boys (57.8%) and 49 girls, aged (10.1±3.1) years old. Seventyseven (66.4%) were recommended to start vaccination, and 39 were recommended to defer vaccination after individualized assessment in the immunization advisory clinic. The followings were recommended to defer the vaccination 25 cases in the acute phase of allergic disease among 70 cases (60.3%) with a history of allergy, 5 cases of severe allergic reactions among 11 cases (9.5%) with a history of other vaccine or drug allergy, 5 cases in the acute phase of the disease in 13 cases (11.2%) with a history of nondrug allergy, and 3 cases of acute illness (respiratory tract infection) among 21 cases (18.1%) with atopy, and 1 case（0.9%）with a history of allergic to the first dose of COVID19 vaccine. All patients in the deferring vaccination group completed the telephone followup 3 months after the consultation. Seventyseven children in the recommended starting vaccination group were followed up for 3 times, among which 54 cases were in the vaccinated subgroup (47 children receiving 2 doses of vaccine, 7 children receiving 1 dose of vaccine), and 23 cases were in the unvaccinated subgroup. There were no significant differences in gender, allergic disease history, other vaccine or drug allergy history, nondrug allergy history and atopy between the two subgroups. The age ［(10.4±3.0) years vs (9.0±3.1) years old, P=0.04］ between the two subgroups had statistically significant difference. No severe allergic reactions were collected during the telephone followup at 4 d and 28 d after vaccination. Within 72 hours after vaccination, 18 cases (17.8%) were solicited with 10 systemic adverse events, 5 cases (5.0%) of rash and cough respectfully, 4 cases (4.0%) of runny nose, 3 cases (3.0%) of anorexia and fever respectfully, 2 cases (2.0%) of sore throat, 1 case (1.0%) of fatigue, myalgia, nausea and vomiting respectively. There was a causal relationship with the AEFIs and COVID19 vaccine after preliminary judgement. No additional solicited adverse reactions were reported in the 28 d and 3month telephone followup. Within 28 days after vaccination, parents voluntarily reported 5 cases of unsolicited adverse events, 3 cases (3.0%) of idiopathic dermatitis or eczema, and 2 cases (2.0%) of allergic rhinitis. No causal relationship with COVID19 vaccine was found. The incidence of AEFIs of COVID19 vaccine within 28 days was 33.3% (18/54). Conclusion：It is safe for children whose allergic diseases are in remission status, those who had nonsevere allergic reactions to nonCOVID19 vaccines or other drugs, those who had nondrug allergy history, and those who had atopy to receive inactivated COVID19 vaccines. The systemic adverse reactions of AEFIs of COVID19 vaccine all occurred within 72 hours after vaccination, and were causally related to the COVID19 vaccination.

Key words: SARS-COV-2, Vaccine, Allergy history, Children, Safety, allergy, Adverse events following immunization