Martín Arias L H, Sanz Fadrique R, Sáinz Gil M, Salgueiro-Vazquez M E
Centre for Drug Surveillance (CESME), Valladolid University, Spain.
Centre for Drug Surveillance (CESME), Valladolid University, Spain.
Vaccine. 2017 Sep 5;35(37):4870-4876. doi: 10.1016/j.vaccine.2017.07.055. Epub 2017 Jul 31.
While vaccination injection site adverse reactions are usually mild and transient in nature, several cases of bursitis and other shoulder injuries have been reported in the medical literature. However, these lesions are not included in vaccine label inserts. To identify the characteristics of post-vaccination shoulder injuries and those of patients and involved vaccines, as well as their potential causes, a systematic review of the cases of vaccination-related bursitis and other shoulder injuries reported in the literature and notified to the Spanish Pharmacovigilance System database (FEDRA) have been conducted. We found 45 cases of bursitis and other shoulder injuries that appeared following the vaccine intramuscular injection given into the deltoid muscle (37 from the systematic review of the literature, and 8 from the scrutiny in the Spanish Pharmacovigilance System database, FEDRA). All the patients were adult, 71.1% females, with a mean and median age of 53.6years (range: 22-89). The most frequently involved vaccines were influenza and pneumococcal vaccines, respectively; followed by diphtheria-tetanus-pertussis, diphtheria-tetanus toxoid, human papillomavirus, and hepatitis A vaccines. The most frequent shoulder lesion was bursitis. Most of patients required medical care due to severe local pain and arm mobility restriction. In a majority of cases, symptoms started 48h post vaccination. Subdeltoid or subacromial bursitis and other shoulder lesions may be more common than suspected. Such lesions predominantly affect women. The cause may be related to antigens or adjuvants contained in the vaccines that would trigger an immune or inflammatory response. However, they are more likely to be the consequence of a poor injection technique (site, angle, needle size, and failure to take into account patient's characteristics, i. e., sex, body weight, and physical constitution). Therefore, vaccination-related shoulder injuries would be amenable to prevention.
虽然疫苗接种注射部位的不良反应通常性质轻微且短暂，但医学文献中已报道了几例滑囊炎和其他肩部损伤的病例。然而，这些损伤并未包含在疫苗标签说明书中。为了确定接种疫苗后肩部损伤的特征、患者及相关疫苗的特征及其潜在原因，我们对文献中报道并通报至西班牙药物警戒系统数据库（FEDRA）的与疫苗接种相关的滑囊炎和其他肩部损伤病例进行了系统评价。我们发现45例滑囊炎和其他肩部损伤病例出现在三角肌肌内注射疫苗之后（37例来自文献系统评价，8例来自西班牙药物警戒系统数据库FEDRA的审查）。所有患者均为成年人，女性占71.1%，平均年龄和中位数年龄为53.6岁（范围：22 - 89岁）。最常涉及的疫苗分别是流感疫苗和肺炎球菌疫苗；其次是白喉 - 破伤风 - 百日咳疫苗、白喉 - 破伤风类毒素疫苗、人乳头瘤病毒疫苗和甲型肝炎疫苗。最常见的肩部损伤是滑囊炎。大多数患者因严重的局部疼痛和手臂活动受限而需要医疗护理。在大多数病例中，症状在接种疫苗后48小时开始出现。肩峰下或肩峰下滑囊炎及其他肩部损伤可能比怀疑的更为常见。此类损伤主要影响女性。其原因可能与疫苗中所含的抗原或佐剂有关，这些抗原或佐剂会引发免疫或炎症反应。然而，它们更可能是注射技术不佳（部位、角度、针头尺寸以及未考虑患者特征，即性别、体重和身体体质）的结果。因此，与疫苗接种相关的肩部损伤是可以预防的。
