417 - SIRVA Reprise, COVID Vaccine Injury Fund

From the Literature and the Vaccine Injury Compensation Program

1) Shoulder Injury Related to Vaccine Administration (SIRVA)

Vaccines, both as a public health measure and as a clinical prevention intervention are very safe, but all interventions have the risk of adverse effects. A relatively newly recognized vaccine adverse event in adults due to vaccination technique is shoulder injury related to vaccine administration (SIRVA). More than just deltoid muscle soreness, this is an inflammation of the subacromial-subdeltoid bursa (SASDB) resulting in shoulder pain, limited range of motion, etc. temporally related to vaccine administration.

In 2010, a review of 13 cases of shoulder injury collected from the Vaccine Injury Compensation Program (VICP) was published that documented the predominant clinical factors of the condition the authors named SIRVA: absence of a history of shoulder dysfunction prior to vaccination, restricted range of motion, an absence of neurological symptoms or muscle weakness. Only a minority of patients in this report resolved completely – the rest had persistent symptoms and dysfunction. The authors quoted earlier work suggesting that in adults, the SASDB extended 3-6 cm beyond the edge of the acromion, and the presumed etiology of SIRVA was thought to be vaccine injection “too high” on the shoulder and into the SASDB.

In 2012, the Institute of Medicine included SIRVA in its review of Adverse Events from Vaccines.(2) In 2017, SIRVA was added to the VICP “Table” of known adverse events from vaccination, and a study was commissioned to review the VICP claims from 2010-2016, as they were seen to be increasing, especially related to influenza vaccination.

Last summer, that review was published and noted the following:

• Most cases were in adult women (~82%)
• Most cases occurred in pharmacies (35%) and physicians’ offices (31%)
• Most cases occurred with inactivated influenza (84%) and TdaP (12%) vaccines
• The most common presenting symptoms were shoulder pain (94%) and limited range of motion (31%). Most petitioners to the VICP have noted that they thought the injection had been “too high” on the shoulder or “particularly painful.”
• MRI findings frequently show rotator cuff tendon tears and ruptures as well as shoulder arthritis, but these are common in adults and are not necessarily considered indicative of SIRVA. Instead, other common findings – bursitis and tendinopathy – are more consistent with the presumed mechanism of the injury.
• The most common treatments for SIRVA include physical therapy, NSAIDs and corticosteroid injection into the bursa. There is a list of surgical treatments in this article, but most of them are appropriate for the arthritic and mechanical rotator cuff issues that confound the interpretation of these cases.

The articles recommend the following to prevent SIRVA:

• Appropriate selection of needle length for age and weight.
• Full exposure of shoulder so all anatomical landmarks are visible (not pulling shirt down over shoulder)
• Appropriate selection of injection site – mid-deltoid, 2-3 finger breadths below the acromion.
• Appropriate angle for intramuscular injection – 90 degrees to skin.

John’s and Mark’s Comments:

With the number of vaccines presently being giving for both COVID and influenza, it is essential to ensure that preventable adverse events are minimized. Anyone who administers deltoid injections should watch the two-minute video (2^nd reference) and care teams should review together. Having cared for some patients who likely were experiencing SIRVA, the morbidity from it can be quite substantial and healing slow.

The Vaccine Injury Compensation Program is one aspect of an important overall safety program to manage vaccine adverse events in this country. The articles by Atanasoff and Hesse illustrate the value of programs like this in recognizing and understanding vaccine adverse events. See 2^nd Pointer for how this relates to COVID vaccines.

References:

• CDC guidance on vaccine administration and a video: Guidance  Video  
• Video on preventing SIRVA (with soundtrack!): Video
• Atanasoff S, Ryan T, Lightfoot R, Johann-Liang R. Shoulder injury related to vaccine administration (SIRVA). Vaccine. 2010 Nov 29;28(51):8049–52. Link
• Hesse EM, et al. Risk for Subdeltoid Bursitis After Influenza Vaccination: A Population-Based Cohort Study. Ann Intern Med. 2020 Jun 23;M19-3176. Link
• Wiesel B and Keeling L. Shoulder Injury Related to Vaccine Administration. J Am Acad Orthop Surg, 2021 Sep 1;29(17):732-739. Abstract

A Vaccine-Related Question from a Colleague

2) COVID Vaccine Injury Fund

Question:

“Any idea if there is a vaccine injury fund for patients who were legitimately injured by the COVID vaccines? Some of the patients who are scared about the vaccine may be somewhat reassured if they knew there was a fund to help them financially if they did have a significant complication from the vaccine.”

Answer:

Epidemic related vaccines such as the COVID-19 vaccines are covered by a Health Resources and Services Administration (HRSA) program called the Countermeasures Injury Compensation Program or CICP. This is not under the Vaccine Injury Compensation Program (VICP), which is a separate HRSA program for approved vaccines. The CICP was established for the H1N1 vaccine.

HRSA defines a “countermeasure” as “a vaccination, medication, device, or other item recommended to diagnose, prevent or treat a declared pandemic, epidemic or security threat.” The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the CICP to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of covered countermeasures identified in and administered or used under a PREP Act declaration. The CICP also may provide benefits to certain survivors of individuals who die as a direct result of the administration or use of such covered countermeasures.

The PREP Act declaration for medical countermeasures against COVID-19 states that the covered countermeasures are:

• any antiviral, any drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any vaccine manufactured, used, designed, developed, modified, licensed, or procured:
  • to diagnose, mitigate, prevent, treat, or cure COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom; or
  • to limit the harm that COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, might otherwise cause;
• a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described above;
• a product or technology intended to enhance the use or effect of a product described in the first two bullets above; or
• any device used in the administration of any such product, and all components and constituent materials of any such product.

Mark’s Comments:

My thanks to John for the initial background research on this Pointer.

In further reading about this, a spokesperson for HRSA indicated that the CICP covers "eligible serious injuries" – generally meaning those that require hospitalization or that lead to significant disability. Additionally, claimants must prove the intervention caused the injury, unless it's covered under an Injury Table for CICP. This Table has not yet been established for the COVID-19 medical countermeasures due to insufficient data presently to meet the “compelling, reliable, valid, medical and scientific evidence” standard indicating that the covered countermeasure directly causes a particular injury.

As you can see, there’s a lot of legal jargon contained within the CICP, and this will likely spill over into the Injury Table and interpretation of it as well.

When the Countermeasures Injury Table is developed, those who can’t establish a "Table" injury have a year to file a request for benefits even if their previous request was denied. Pending establishment of an Injury Table for present COVID-19 countermeasures, claims may be filed as non-Table injuries and eligibility for compensation will be determined on a case-by-case basis by the Program. Attorneys specializing in SIRVA litigation are speculating that such injuries would likely not be compensated under the CICP as it likely would not meet the “eligible serious injuries” threshold. Only time will tell.

Note as well that despite the recent full FDA approval for the Pfizer COVID-19 vaccine, any injuries attributed to it at the present time still remain covered under the CICP.

References:

• HRSA Countermeasures Injury Compensation Program: Link or toll-free number 1-855-266-2427

RSA Vaccine Compensation Program Frequently Asked Questions: LInk

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Mark and John

Carilion Clinic Department of Family and Community Medicine

Feel free to forward Take 3 to your colleagues. Glad to add them to the distribution list.

Email: mhgreenawald@carilionclinic.org