What are the recommendations to identify and manage Shoulder Injury Related to Vaccine Administration (SIRVA)?

Introduction
Shoulder injury related to vaccine administration (SIRVA) can occur when a vaccine intended for intramuscular (IM) administration in the upper arm is administered in or around the deltoid into adjacent tissues, such as the bursae, ligaments, or tendons. While the exact incidence is unknown, it is thought to be a rare adverse event associated with improper vaccine administration in the shoulder area.

SIRVA was officially added to the Vaccine Injury Compensation Program (VICP) Table in February 2017 and is defined by the VICP as “shoulder pain with limited range of motion within 48 hours after vaccine receipt in individuals with no prior history of pain inflammation, or dysfunction of the affected shoulder before vaccine administration.”¹ The proposed mechanism may be related to trauma from the needle or from unintentional injection of antigenic material into the synovial tissues, which produces an immune-mediated inflammatory reaction to the vaccine or adjuvants.² SIRVA is thought to be related to the vaccine being administered too high in the deltoid region.

Clinical presentation
SIRVA was initially described by Atanasoff and colleagues in 2010, in a published case series that describes 13 claims of vaccine-related injury reported to the VICP from 2006 through 2010.² More recently, three larger reviews analyzed reports submitted to the Vaccine Adverse Event Reporting System (VAERS) and the VICP. ^3,4 Across all of these reviews, women in their early fifties represented the most common demographic. Reports consistently note significant shoulder pain and limited range of motion, with the onset of pain occurring within 24 hours of the vaccine administration (Table). In the summaries of published reports, symptoms did not readily resolve for most patients, and more than half required further evaluation, treatment, or in some instances, surgical intervention. While an attributing factor was not identified in most of the reports, there was consistent mention of receiving the injection “too high” in those that did.

The clinical manifestations of SIRVA pain may be due to a local, prolonged inflammatory response in the bursa, due to the inadvertent administration of antigenic material into the synovial space of the shoulder.² Inappropriate needle length or injection technique has also been associated with SIRVA. It is recommended that needles not be inserted into the upper third of the deltoid muscle.

Prevention Strategies
Education and training of immunizers is the best strategy for preventing SIRVA. Healthcare professionals administering vaccines should be trained on appropriate injection technique. Intramuscular (IM) injection should be given in the central and thickest portion of the deltoid muscle for adults or the anterolateral thigh muscle for infants and toddler.⁶ Ideally, the patient should be sitting when the vaccine is administered and the administrator should be either kneeling or sitting so that they are eye-level with the patient; this ensures a 90-degree angle of administration which is recommended for IM injections.^6,7 Prior to administration, the healthcare provide should ensure that the deltoid can be properly identified; it is located about 2 inches, or 2 to 3 fingerbreadths below the acromion process of the shoulder. Exposing the patient’s entire arm can help in identifying these landmarks. The recommended needle size is 22 to 25 gauge, and the needle length should be long enough to penetrate the deltoid; a length from 5/8 to 1 ½ inch may be necessary depending on the injection site, patient age, and patient weight.

Management and Treatment
Effective management of suspected SIRVA involves accurate diagnosis and implementation of timely treatment. Due to the rare incidence, a patient-centered treatment approach is recommended.⁸ Initial, noninfectious and non-neurologic treatment strategies include rest/activity modification, physical therapy, and anti-inflammatory medication. Non-invasive imaging such as magnetic resonance imaging (MRI) or high-resolution ultrasound is recommended prior to administering any steroid injection to identify any pre-existing anatomic abnormalities. Patients with severe or refractory symptoms may benefit from oral or locally injected corticosteroids. Up to a third of cases may require surgery.

Patient Counseling
Patients should be encouraged to contact their healthcare provider if they have worsening shoulder pain that persists longer than 48 hours post-vaccination. In addition to a physical exam, healthcare providers should obtain a thorough history to rule out any comorbidities or previously existing shoulder injuries or pathology. X-rays or MRI may be warranted based on clinical presentation. Healthcare provides should submit any adverse reaction thought to be related to vaccines to VAERS.

Conclusion
An analysis of claims data to the VICP from 2010-2016 noted an increase in SIRVA reports over time, with only 7 reports in 2011 and over 400 reports in 2016.³ Healthcare providers play a pivotal role in identifying and managing SIRVA. Consistent use of appropriate injection technique is the best method of preventing SIRVA. Any suspected cases of SIRVA should be referred for further evaluation and management and reported to the FDA VAERS program.

References

1. National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table. Fed Regist. 2025;90(1):123-135. Available at: https://www.federalregister.gov/documents/2025/01/16/2025-01234/national-vaccine-injury-compensation-program-revisions-to-the-vaccine-injury-table. Accessed January 16, 2025.
2. Atanasoff S, Ryan T, Lightfoot R, Johann-Liang R. Shoulder injury related to vaccine administration (SIRVA). Vaccine. 2010 Nov 29;28(51):8049-52. doi: 10.1016/j.vaccine.2010.10.005.
3. 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 Jan 29;38(5):1076-1083. doi: 10.1016/j.vaccine.2019.11.032.
4. Hibbs BF, Ng CS, Museru O, Moro PL, Marquez P, Woo EJ, Cano MV, Shimabukuro TT. Reports of atypical shoulder pain and dysfunction following inactivated influenza vaccine, Vaccine Adverse Event Reporting System (VAERS), 2010-2017. Vaccine. 2020 Jan 29;38(5):1137-1143. doi: 10.1016/j.vaccine.2019.11.023.
5. Bass JR, Poland GA. Shoulder injury related to vaccine administration (SIRVA) after COVID-19 vaccination. Vaccine. 2022 Aug 12;40(34):4964-4971. doi: 10.1016/j.vaccine.2022.06.002. Epub 2022 Jun 8.
6. Immunization Action Coalition. How to administer intramuscular and subcutaneous vaccine injections. Immunization Action Coalition. https://www.immunize.org/wp-content/uploads/catg.d/p2020.pdf. Published 2020. Accessed January 16, 2025.
7. Shoemaker S. Preventing Shoulder Injury Related to Vaccine Administration. Am J Nurs. 2021 Jun 1;121(6):45-47. doi: 10.1097/01.NAJ.0000753660.62075.69.
8. Wood CT, Ilyas AM. Shoulder Injury Related to Vaccine Administration: Diagnosis and Management. J Hand Surg Glob Online. 2022 Mar;4(2):111-117. doi: 10.1016/j.jhsg.2021.12.009. Epub 2022 Jan 28.

Prepared by:
Jen Phillips, PharmD, BCPS, FCCP, FASHP
Clinical Professor, Drug Information Specialist
University of Illinois at Chicago College of Pharmacy

January 2025

The information presented is current as January 16, 2025. This information is intended as an educational piece and should not be used as the sole source for clinical decision-making