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Within a few hours of getting her first COVID-19 shot, Leah Jackson had severe pain in her left shoulder.

The New York City-based veterinarian said the nurse lodged the shot "extraordinarily high" into her left shoulder, hitting the bursa rather than the deltoid muscle. When the nurse got resistance, she redirected the vaccination into the joint space, Jackson said.

As a veterinarian, Jackson is well versed in giving injections: "This was just poor administration technique," she told MedPage Today.

For weeks, she had severe pain that didn't respond to over-the-counter anti-inflammatory medications. Her primary care doctor referred her to a physical medicine & rehabilitation specialist who, after confirming bursa and joint inflammation on imaging, prescribed steroid and lidocaine injections along with physical therapy.

The pain largely resolved but returned, albeit to a lesser extent, after 6 weeks, and a follow-up MRI confirmed persistent bursa inflammation.

Jackson can still do her job as a veterinarian, but it can be painful lifting animals during surgery, for instance. Sometimes it hurts while driving.

"I just can't move my arm in certain motions," she said.

Shoulder injury related to vaccine administration, or SIRVA, has been documented long before COVID-19 vaccination, and is most frequently reported after influenza vaccination. However, the medical community cautions that it's more of a medicolegal determination rather than a distinct diagnosis at this point.

The condition is also plagued by the lack of a solid evidence base, and causality is difficult to pin down.

Still, most physicians interviewed by MedPage Today say it's likely that improper injection technique could lead to shoulder injury, and that these problems should be taken seriously and treated appropriately.

"We're certainly not seeing a pandemic of SIRVA" with COVID vaccines, D.J. Kennedy, MD, chair of physical medicine & rehabilitation at of Vanderbilt University Medical Center in Nashville, told MedPage Today. "It's really rare and the literature to date is mostly case reports. But I do think it's possible, absolutely" for vaccine-related shoulder injury to occur.

What Is SIRVA?

Laura Keeling, MD, an orthopedic surgeon at MedStar Georgetown University Hospital in Washington, D.C., told MedPage Today that part of the reason SIRVA remains in the medicolegal realm is that it's "more of a constellation of symptoms and findings" rather than a specific diagnosis.

Symptoms can vary depending on where the aberrant shot landed, resulting in various manifestations such as bursitis, tendonitis, or adhesive capsulitis (also known as "frozen shoulder").

Generally, it's characterized as a "constellation of shoulder pain and reduced range of motion that occurs within 48 hours of vaccination and does not resolve within 1 week," according to a recent paper Keeling co-authored. It's also different from typical post-injection soreness, as the pain is more severe and it can impact mobility and function.

Treatments generally include anti-inflammatory drugs, corticosteroid injections, and physical therapy. Sometimes surgery is needed to treat an underlying pathology such as an exacerbated rotator cuff injury.

Patients with SIRVA often land in their primary care physician's office first. They may be referred out to a specialist such as a physiatrist or an orthopedic surgeon.

"It's the patients who have persistent symptoms who are referred to orthopedic surgeons," Keeling said. "If physical therapy and injection don't work, then primary care refers to us."

Physical medicine & rehabilitation physicians, or physiatrists, also play a large role in treating SIRVA.

"We treat based on a full evaluation including history and physical findings, and imaging if needed," Kennedy said. "Then we develop a comprehensive rehabilitation plan ... that usually involves doing range of motion and strengthening exercises on a daily basis."

Scott Noren, DDS, an oral surgeon in Ithaca, New York, said he also developed significant pain in his left shoulder after his second COVID shot in early February: "It went in pretty deep and pretty high," he told MedPage Today.

An MRI revealed fluid collecting in his joint, as well as adhesive capsulitis, he said. Physical therapy helped improve his range of motion to an extent, but his pain lingers. It's difficult to take x-rays and do long procedures as an oral surgeon: "I have pretty good pain even with just normal function now," he said.

Both Noren and Jackson said their insurance covers their medical bills, and they both feel relieved that they can still work, but they're frustrated that there's no federal protection for SIRVA related to COVID-19 vaccines.

"There's no compensation for something that's painful and debilitating that was a medical error," Jackson said.

History of SIRVA

Keeling and Brent Wiesel, MD, also an orthopedic surgeon at MedStar Georgetown University Hospital in Washington, D.C., recently published an , stating that it's a "rare yet increasingly recognized complication of immunization."

They noted that the term "SIRVA" was introduced in 2010 by a team of physicians with the Vaccine Injury Compensation Program (VICP) who reported on 13 petitioners presenting with severe vaccine-related shoulder pain that persisted for longer than 6 months.

In 2012, a concluded that deltoid bursitis may be causally associated with immunization. Five years later, SIRVA was added to the Vaccine Injury Table, which guides allowable claims in federal vaccine court.

Since then, SIRVA claims have ballooned, rising from 10 in 2011 to 433 in 2016, according to the paper. As a total percentage of claims, SIRVA rose from 1.8% to 40.7% during that time, they reported.

The Trump administration recently from the $4 billion VICP -- which was initially authorized by the National Childhood Vaccine Injury Act of 1986, in response to a rush of lawsuits against vaccine manufacturers -- arguing that it was due to improper administration of vaccines, rather than the vaccine itself. But the Biden administration in April. Nonetheless, it would not have applied to COVID vaccines, which fall under a different compensation program.

Wiesel and Keeling's paper notes that since the VICP was created in the late 1980s for childhood vaccine injury, the demographic has shifted, with more than 50% of claims now involving adults.

While healthcare providers anticipate a sharp increase in reported cases in the coming year given the large volume of COVID vaccinations, Wiesel and Keeling warned that data on the condition are still limited -- they're "virtually absent from the orthopedic literature" -- and that the "current understanding of the diagnostic workup of SIRVA is limited to the medicolegal realm."

Shoulder Injury and Vaccine Court

Instead of falling under the VICP, COVID-19 vaccines are covered under the Countermeasures Injury Compensation Program (CICP). Both programs are administered by the Health Resources and Services Administration (HRSA).

A spokesperson for HRSA confirmed to MedPage Today via email that despite full FDA approval, Pfizer's COVID-19 vaccine (Comirnaty) still remains covered under the CICP and does not yet move to the VICP.

The HRSA spokesperson said the CICP covers "eligible serious injuries" -- generally, those that require hospitalization or that lead to significant disability.

Claimants must prove the vaccine caused the injury, unless it's covered under an injury table for CICP. However, such a table does not exist yet for the CICP, the spokesperson said.

"An injury table for COVID-19 medical countermeasures will be developed when there is sufficient data to meet the 'compelling, reliable, valid, medical and scientific evidence' standard indicating that the covered countermeasure directly causes a particular injury," the spokesperson stated.

When that table is developed, those who couldn't establish a "Table" injury have a year to file a request for benefits even if their previous request was denied.

"Pending establishment of COVID-19 Countermeasures Injury Table, claims may be filed as non-Table injuries and eligibility for compensation will be determined on a case-by-case basis by the Program," the spokesperson said.

Jackson and Noren said SIRVA attorneys advised that their injuries would not likely be compensated under the CICP.

Keeling and Kennedy both emphasized that while SIRVA requires further study, it does appear to be rare, and that the benefits of vaccination against COVID-19 far outweigh any potential risks.

"Despite the risk of SIRVA, given the notable personal and public health benefits of vaccinations, particularly in light of the coronavirus pandemic, we strongly recommend that patients receive vaccinations," the Wiesel and Keeling paper stated.

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