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Shoulder injury related to vaccine administration

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Shoulder injury related to vaccine administration (SIRVA) is "shoulder pain and limited range of motion occurring after the administration of a vaccine intended for intramuscular administration in the upper arm . . . thought to occur as a result of unintended injection of vaccine antigen or trauma from the needle into and around the underlying bursa of the shoulder".[1][2]

Cause

SIRVA is caused by improper insertion of the needle used in injections. It is "a preventable occurrence caused by the injection of a vaccine into the shoulder capsule rather than the deltoid muscle. As a result, inflammation of the shoulder structures causes patients to experience pain, a decreased range of motion, and a decreased quality of life."[3]

A 2022 review of the literature suggested that SIRVA was a possible complication of COVID-19 vaccination, and that needle technique should be carefully monitored in view of the scale of the COVID-19 vaccination programme.[4]

Treatment

"Treatment for SIRVA is the same as treatment for routine inflammatory injuries."[3] People who suffer from SIRVA typically require physical therapy, pain management medications, and in some severe cases, surgery.[5]

Compensation

In the United States, SIRVA was added to the list of compensable injuries on the Vaccine Injury Table used by the National Vaccine Injury Compensation Program in 2017.[6][7] This inclusion allowed persons claiming an injury to seek compensation from a government fund set up under the program, while immunizing vaccine manufacturers and administrators from legal liability. By 2020, SIRVA injuries amounted to 54% of filings for vaccine injury compensation. [8] In April 2020, the U.S. Department of Health and Human Services began considering a proposal to remove the injury from that table, following a substantial increase in the number of claims asserting this injury,[9][10][11] and on July 20, 2020, the department posted its official notice that it would seek to remove SIRVA (as well as vasovagal syncope) from the vaccine injury compensation scheme.[12]

In support of its proposed removal of the injury from the table, the department asserted:

The scientific literature indicates that SIRVA likely results from poor vaccination technique, rather than the vaccine or its components alone. ... There is nearly uniform agreement in the scientific community that SIRVA is caused by improper vaccine administration, rather than by the vaccine itself. Since the Final Rule was promulgated, additional scientific research concluded that subdeltoid or subacromial bursitis and other shoulder lesions are "more likely to be the consequence of a poor injection technique (site, angle, needle size, and failure to take into account [a] patient's characteristics, i.e., sex, body weight, and physical constitution)," rather than "antigens or adjuvants contained in the vaccines that would trigger an immune or inflammatory response."[12]

A number of contrary opinions were filed in response to the proposal, but the removal was made final on January 21, 2021.[13] This removal was, in turn, reversed by a rule promulgated on April 21, 2021, restoring SIRVA to the table.[14]

References

  1. ^ Brian Dean Abramson, Vaccine, Vaccination, and Immunization Law (Bloomberg Law, 2019), 8-5.
  2. ^ VAERS Table of Reportable Events Following Vaccination (as of March 21, 2017).
  3. ^ a b Bancsi, Ashley; Houle, Sherilyn K.D.; Grindrod, Kelly A. (January 2019). "Shoulder injury related to vaccine administration and other injection site events". Canadian Family Physician. 65 (1): 40–42. ISSN 0008-350X. PMC 6347325. PMID 30674513.
  4. ^ Yuen WL, Loh SY, Wang DB (April 2022). "SIRVA (Shoulder Injury Related to Vaccine Administration) following mRNA COVID-19 Vaccination: Case discussion and literature review". Vaccine. 40 (18): 2546–2550. doi:10.1016/j.vaccine.2022.03.037. PMC 8934720. PMID 35339304.
  5. ^ Chu, Chun-Pu Eric (27 June 2022). "Shoulder Injury Related to Vaccine Administration (SIRVA) in 16 Patients Following COVID-19 Vaccination Who Presented to Chiropractic, Orthopedic, and Physiotherapy Clinics in Hong Kong During 2021". Medical Science Monitor. 28 (e937430): e937430. doi:10.12659/MSM.937430. PMC 9284989. PMID 35811393. Retrieved 28 June 2022.
  6. ^ Brian Dean Abramson, Vaccine, Vaccination, and Immunization Law (Bloomberg Law, 2019), 9-7.
  7. ^ 82 Fed. Reg. 6294 (January 19, 2017).
  8. ^ Lindstrom, Rebecca (May 26, 2020). "As labs work on COVID-19 vaccine, government tries to take away right to seek damages if injured by other shots". WXIA-TV. Retrieved July 19, 2020.
  9. ^ Wadman, Meredith (April 2, 2020). "United States wants to end most payouts for leading vaccination-related injury". Science.
  10. ^ Fleischer, Jodie; Yarborough, Rick; Piper, Jeff (April 20, 2020). "Feds Quietly Seek to Remove Leading Cause of Vaccine Injuries From Federal Payout Program". WRC-TV. Retrieved May 17, 2020.
  11. ^ Fleischer, Jodie; Yarborough, Rick; Piper, Jeff (May 20, 2020). "Feds a No-Show When Asked to Prove Why Leading Vaccine Injury Should Be Removed From Compensation Program". WRC-TV. Retrieved July 19, 2020.
  12. ^ a b "National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table". Health and Human Services Department. July 20, 2020.
  13. ^ "National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, 86 Fed. Reg. 6249". Health and Human Services Department. January 21, 2021.
  14. ^ "National Vaccine Injury Compensation Program: Rescission of Revisions to the Vaccine Injury Table, 86 Fed. Reg. 21209". Health and Human Services Department. April 22, 2021.
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