Conclusion
Vaccines can cause shoulder injury related to vaccination (SIRVA), including deltoid bursitis, when administered incorrectly.
The primary evidence supporting a causal association includes clinical assessment and imaging studies of the area where the injection occurred. Injection in the upper third of the deltoid can result in inflammation of the subacromial (deltoid) bursa, the supraspinatus muscle, tendons, or bony structures 1-3. Damage to the radial nerve can occur when the injection is given too low 4. In its 2012 report, the Institute of Medicine (IOM), now called the National Academy of Medicine (NAM), stated that the clinical evidence was sufficient to determine that vaccine injection was a contributing cause of deltoid bursitis 5.
SIRVA can be prevented by administration of intramuscular vaccines into the middle of the deltoid muscle at a 90° angle using an appropriate length needle 6. The best method for identifying the middle of the deltoid muscle involves the following steps 7,8:
- Have the patient put their hand on their hip with the shoulder extended about 60 degrees;
- Put your index finger on the acromion and thumb at the deltoid insertion at the middle of the humerus; and
- Administer the vaccine in the middle of the triangle using an appropriate needle length for the patient 9,10.
For many years training institutions incorrectly indicated that measuring 2-3 fingerbreadths below the acromion process would identify the middle of the deltoid muscle. Unfortunately, using the fingerbreadth method results in the administration of vaccines in the upper third of the deltoid muscle in many adults 7.
Epidemiological Evidence
The primary evidence supporting a causal association includes clinical assessment and imaging studies of the area where the injection occurred. Injection in the upper third of the deltoid can result in inflammation of the subacromial(deltoid) bursa, the supraspinatus muscle, tendons, or bony structures [1,2,3]. Damage to the radial nerve can occur when the injection is given too low [4]. In 2012 the Institute of Medicine (IOM) determined that clinical evidence was sufficient to determine that vaccine injection was a contributing cause of deltoid bursitis [5].
Proposed Biological Mechanism
The 2012 IOM report described one study assessing an association between the injection of a vaccine and deltoid bursitis 11; however, this study did not provide convincing evidence due to a lack of validity and precision 5. A Vaccine Safety Datalink (VSD) study found a significant association between influenza vaccination and subdeltoid bursitis (IRR: 3.24; 95% CI: 1.85-5.68), though the attributable risk was small (8 cases per million vaccinations) 12.
Prevention
SIRVA has occurred following several different vaccines, and is caused by an immune-mediated inflammatory response 1-3,5,13-16. The most common contributing factors include administration in the upper one-third of the deltoid muscle and injection deep enough to pass through the muscle to the underlying tissues 2,9,10,17,18. The 2012 IOM report described several cases providing strong clinical evidence that vaccine injection was a contributing cause of the rapid development of deltoid bursitis 1,19.
SIRVA has become the most common injury awarded compensation by the Vaccine Injury Compensation Program (VICP) 13. Approximately 80% of individuals who develop SIRVA are female, and low body mass index is a risk factor because of smaller muscle mass 13.
References
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5. Institute of Medicine. In: Stratton K, Ford A, Rusch E, Clayton EW, eds. Adverse Effects of Vaccines: Evidence and Causality. Washington (DC): National Academies Press (US); 2012.
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13. Hesse EM, Atanasoff S, Hibbs BF, Adegoke OJ, Ng C, Marquez P, Osborn M, Su JR, Moro PL, Shimabukuro T, Nair N. Shoulder Injury Related to Vaccine Administration (SIRVA): Petitioner claims to the National Vaccine Injury Compensation Program, 2010-2016. Vaccine 2020; 38(5): 1076-83.
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19. Vellozzi C, Burwen DR, Dobardzic A, Ball R, Walton K, Haber P. Safety of trivalent inactivated influenza vaccines in adults: background for pandemic influenza vaccine safety monitoring. Vaccine 2009; 27(15): 2114-20.
