Mackenzie Laura J, Bushell Mary-Jessimine A, Newman Phillip, Bousie Jaquelin A
University of Canberra, Faculty of Health (Physiotherapy), Bruce, ACT, Australia.
University of Canberra, Faculty of Health (Pharmacy), Bruce, ACT, Australia.
Explor Res Clin Soc Pharm. 2022 Sep 26;8:100183. doi: 10.1016/j.rcsop.2022.100183. eCollection 2022 Dec.
Shoulder injury related to vaccine administration (SIRVA) has been recognised as the compensable term for any shoulder injury that may result from an improper vaccination technique since 2017, however, its incidence and impact remain poorly understood.
To examine knowledge of SIRVA through reported cases, determine SIRVA incidence related to COVID-19 vaccinations, and investigate recovery rates.
Six pharmacovigilance agencies in the United States of America (USA), Canada, United Kingdom, European Union, Australia, and New Zealand were systematically search to identify all reported cases of SIRVA between January 2017 to July 2021. Primary outcome measures were SIRVA case reports. Secondary outcome measures included recovery status as well as vaccine received, age, and sex. SIRVA-related outcome measures were retrieved between July 18th and July 22nd 2021, with UK data received via personal correspondence.
Retrospective analysis yielded 505 SIRVA cases since 2017, with 330 (65%) of cases reported from January to July 2021. Sub-analysis, using COVID-19 data of 189 SIRVA cases from 891,906,986 vaccinations, estimated incidence to be 2 per 10 million. 32 cases (7%) had recovered from symptoms at the time of reporting, with 311 (62%) reported as 'not recovered', and 162 cases (32%) 'unknown'. Females represented 75% of reported cases.
SIRVA case report numbers and incidence from COVID-19 data, compared with prior evidence, raises questions around health practitioner knowledge and reporting accuracy of SIRVA. Recovery rates are poorly understood. A global consensus definition of SIRVA and more transparent and routine reporting is required. The disproportionate representation of females is of concern with no known reasons for this disparity. Further research is needed on SIRVA knowledge in healthcare practitioners, reporting rates, incidence, management, and long-term outcomes for those impacted. Pharmacist vaccinators should be aware of their role in preventing SIRVA and be active in its detection.
自2017年以来，与疫苗接种相关的肩部损伤（SIRVA）已被认定为因接种技术不当可能导致的任何肩部损伤的可补偿术语，然而，其发病率和影响仍知之甚少。
通过报告病例检查对SIRVA的了解，确定与新冠疫苗接种相关的SIRVA发病率，并调查恢复率。
对美国、加拿大、英国、欧盟、澳大利亚和新西兰的六个药物警戒机构进行系统检索，以确定2017年1月至2021年7月期间所有报告的SIRVA病例。主要结局指标为SIRVA病例报告。次要结局指标包括恢复状态以及接种的疫苗、年龄和性别。2021年7月18日至7月22日期间检索SIRVA相关结局指标，英国数据通过个人通信获得。
回顾性分析得出自2017年以来有505例SIRVA病例，其中2021年1月至7月报告了330例（65%）。使用来自891906986次接种的189例SIRVA病例的新冠数据进行亚分析，估计发病率为每1000万人中有2例。32例（7%）在报告时症状已恢复，311例（62%）报告为“未恢复”，162例（32%）“情况不明”。报告病例中75%为女性。
与先前证据相比，新冠数据中的SIRVA病例报告数量和发病率引发了关于医疗从业者对SIRVA的了解以及报告准确性的问题。恢复率情况不明。需要对SIRVA进行全球共识定义，并进行更透明和常规的报告。女性比例过高令人担忧，且这种差异的原因不明。需要进一步研究医疗从业者对SIRVA的了解、报告率、发病率、管理以及对受影响者的长期结局。药剂师接种人员应意识到其在预防SIRVA方面的作用，并积极进行检测。
