Background 

Claims of shoulder injury now account for half of all claims to the Vaccine Injury Compensation Program. Reports from databases of claims or potential adverse events note a relatively high mean age and high prevalences of rotator cuff tendinopathy and adhesive capsulitis—common shoulder problems that might be incidental to vaccination. Published case reports provide much more detail about individual patients than is available in databases. A review of published cases provides an opportunity for more detailed review of symptoms, diagnoses, pathology, treatment, and prognosis. Such a review can better assess the relative likelihood that pathologies associated with new persistent shoulder symptoms after vaccination are coincidental or unique to and caused by vaccine.

Questions/purposes 

Regarding published case reports addressing persistent shoulder pain after vaccination: (1) In what proportion of patients was a specific diagnosis made? (2) What diagnoses were most common? (3) Among patients treated nonsurgically, what proportion resolved, and over what time span did they resolve?

Methods 

In August 2020, we searched PubMed and Embase between 2006 and 2020 using the following search strategy: Search 1: (shoulder dysfunction OR shoulder pain OR shoulder bursitis OR rotator cuff tendonitis OR adhesive capsulitis OR glenohumeral arthritis AND [vaccine OR vaccination OR immunization]); Search 2: (shoulder injury related to vaccine administration or SIRVA). The search was supplemented by reviewing reference lists of identified studies. Inclusion criteria were any detailed report of three or fewer cases involving shoulder pain after vaccine administration. Twenty published reports of 29 patients were identified and assessed by two reviewers independently. One reported glenohumeral joint infection was excluded because the relationship between this type of relatively uncommon, discrete diagnosis and vaccination raises different considerations. We assumed a high risk of bias, although we are not aware of bias assessment tool for case reports. We recorded and summarized patient demographics, symptoms, examination and imaging findings, surgery findings, diagnoses, treatments, and outcomes. Seventy-five percent (21 of 28) of patients were women, with a mean age of 54 ± 19 years. In search of an underlying pathology, at least one diagnostic study was performed in 82% (23 of 28) of patients including radiographs in seven, ultrasound in seven, and MRI in 16 patients (some patients underwent more than one type of imaging). We distinguished specific pathophysiological diagnosis from shoulder pain and stiffness, counted the most common diagnoses among patients a specific diagnosis, and tracked symptom resolution among patients treated nonoperatively.

Results 

A specific diagnosis was made in 57% (16 of 28) of patients. Twelve patients had pain and limitation of motion due to pain but no specific pathological diagnosis. The most common specific diagnoses were rotator cuff tendinopathy (9 of 16) and adhesive capsulitis (4 of 16). Less common specific diagnoses included rotator cuff arthropathy (and rheumatoid arthritis) and suspected septic arthritis with nonspecific synovitis on arthroscopy. One patient had transient MRI signal change in the humeral head, which was interpreted as osteonecrosis that resolved in a manner not typical for that diagnosis. Of the 17 patients treated nonsurgically, 15 reported resolution, and two had incomplete symptom resolution with the mean 6-month evaluation period.

Conclusion 

The observation that persistent shoulder pain after vaccination overlaps with common shoulder pathology—both in large databases as well as in more detailed reports of specific patients as analyzed in this review—establishes a high probability of a coincidental rather than a causal association. In the absence of high-quality experimental evidence of vaccine-specific shoulder pathology, in our opinion, it seems safest and healthiest to assume that perceived shoulder injury related to vaccine administration (SIRVA) is due to misinterpretation of new symptoms from established pathology rather than a new, vaccine-specific pathology.

Level of Evidence 

Level IV, therapeutic study.

中文翻译：

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疫苗接种后持续性肩部疼痛与常见的偶然病理学相关：系统评价

背景 

目前，肩伤索赔占疫苗伤害赔偿计划所有索赔的一半。来自索赔或潜在不良事件数据库的报告指出，平均年龄相对较高，肩袖肌腱病和粘连性囊炎（疫苗接种可能附带的常见肩部问题）患病率较高。已发表的病例报告提供了比数据库中提供的更多有关个体患者的详细信息。对已发表病例的回顾为对症状、诊断、病理、治疗和预后进行更详细的回顾提供了机会。这样的审查可以更好地评估与疫苗接种后新的持续性肩部症状相关的病理是巧合的或独特的且由疫苗引起的相对可能性。

问题/目的 

关于已发表的针对疫苗接种后持续性肩痛的病例报告：(1) 做出具体诊断的患者比例是多少？(2) 什么诊断最常见？(3) 在接受非手术治疗的患者中，治愈的比例是多少？治愈的时间跨度是多少？

方法 

2020 年 8 月，我们使用以下检索策略检索了 2006 年至 2020 年期间的 PubMed 和 Embase： 检索 1：（肩部功能障碍 OR 肩部疼痛 OR 肩部滑囊炎 OR 肩袖肌腱炎 OR 粘连性囊炎 OR 盂肱关节炎 AND [疫苗 OR 疫苗接种 OR 免疫接种]） ; 搜索 2：（与疫苗接种或 SIRVA 相关的肩部损伤）。通过审查已确定研究的参考文献列表来补充搜索。纳入标准是疫苗接种后涉及肩部疼痛的三例或更少病例的详细报告。20 名已发表的 29 名患者的报告由两名评审员独立识别和评估。一项报道的盂肱关节感染被排除在外，因为这种相对罕见、离散的诊断与疫苗接种之间的关系引起了不同的考虑。尽管我们不知道病例报告的偏倚评估工具，但我们假设偏倚风险很高。我们记录并总结了患者的人口统计数据、症状、检查和影像学结果、手术结果、诊断、治疗和结果。75% 的患者（28 名患者中的 21 名）是女性，平均年龄为 54 ± 19 岁。为了寻找潜在的病理学，对 82% 的患者（28 名患者中的 23 名）至少进行了一项诊断研究，其中包括 7 名患者的 X 光检查、7 名患者的超声检查以及 16 名患者的 MRI（有些患者接受了不止一种类型的成像）。我们将特定的病理生理学诊断与肩部疼痛和僵硬区分开来，统计了特定诊断患者中最常见的诊断，并跟踪了非手术治疗患者的症状缓解情况。

结果 

57%（28 名患者中的 16 名）做出了具体诊断。12例患者出现疼痛并因疼痛而活动受限，但无具体病理诊断。最常见的具体诊断是肩袖肌腱病（16 例中有 9 例）和关节囊粘连炎（16 例中有 4 例）。不太常见的特异性诊断包括肩袖关节病（和类风湿性关节炎）和关节镜检查疑似化脓性关节炎伴非特异性滑膜炎。一名患者的肱骨头有短暂的 MRI 信号变化，这被解释为骨坏死，但以一种不典型的诊断方式解决。在 17 名接受非手术治疗的患者中，15 名患者报告症状得到缓解，其中 2 名患者的症状未完全缓解，平均评估期为 6 个月。

结论 

疫苗接种后持续性肩部疼痛与常见的肩部病理学重叠——无论是在大型数据库中还是在本综述中分析的特定患者的更详细报告中——这一观察结果表明，很可能是巧合而不是因果关系。在缺乏疫苗特异性肩部病理学的高质量实验证据的情况下，我们认为，似乎最安全和最健康的假设是，与疫苗接种相关的感知肩部损伤 (SIRVA) 是由于对现有病理学新症状的误解，而不是误解一种新的、疫苗特异性的病理学。

证据水平 

IV级，治疗研究。