Shoulder soreness following vaccination is commonly experienced, but not all post- vaccination shoulder pain, particularly if severe, is normal. In the mid 2000’s, two physicians published an article about severe, chronic shoulder pain triggered in two patients by their recent vaccinations. A few years later, another piece of medical literature used the acronym SIRVA, or Shoulder Injury Related to Vaccine Administration, for the first time to refer to these post-vaccination injuries.

SIRVA refers to a set of medical conditions impacting a shoulder following vaccination and can include bursitis, tendinitis, rotator cuff tearing, and adhesive capsulitis, among others.  While some individuals experience mild symptoms with a good recovery within a few months, for others, SIRVA injuries may be persistent and require medical interventions like physical therapy, cortisone injections, or even surgery. While the exact mechanism of SIRVA injures is unknown, it is suspected to be caused by improper vaccination administration technique and/or by the inflammatory response triggered by vaccination.

Since the mid 2010’s, SIRVA injuries have been recognized on the Vaccine Injury Table for all program covered vaccines. In the vaccine injury compensation program (VICP), SIRVA has a particular legal definition that includes no prior history of pain in the impacted shoulder, onset of symptoms within 48 hours post-vaccination, symptoms that are limited to the shoulder that received the vaccination and the absence of another condition, such as cervical radiculopathy, that would explain the symptoms that are being experienced.

Guillain-Barre syndrome, also known as GBS, is a rare condition in which an individual’s own immune system attacks their nerve endings. While there are different subvariants of GBS, the hallmark symptoms of the condition include weakness, numbness, tingling and for some individuals, paralysis. Fatigue is also often reported. More information about GBS can be found here.

The association between GBS and vaccination was initially suspected after a large-scale influenza vaccination effort in 1976 revealed an increased signal of GBS among the vaccinated population. Subsequent studies confirmed an association between GBS and the 1976 flu vaccination efforts.

While vaccine induced GBS is still considered a rare event, the association with flu vaccines is well established. As a result of this association, GBS is listed as a Table injury in the Vaccine Injury Compensation Program (VICP). As a Table injury, if a person who receives the vaccine (referred to as the “petitioner”) can establish that they developed GBS within 3-42 days of receiving the vaccination, then the injured person is likely to receive compensation.

As more Americans undergo vaccination for Covid-19, it is inevitable that rare adverse events will occur. 

While we represent individuals injured by vaccines covered under the Vaccine Injury Compensation Program (VICP), vaccine injuries stemming from a Covid-19 vaccination are, at present, not handled through the VICP.

Instead, Covid-19 vaccine injuries are litigated through the Countermeasures Injury Compensation Program (CICP).

On April 22, 2021, Health and Human Services (HHS) published the final rule on the Federal Register withdrawing the proposed rule change previously published on January 21, 2021 which would have changed how cases involving shoulder injuries and vasovagal syncope were handled in the Vaccine Injury Compensation Program (VICP).

In explaining this action, HHS noted that members of the public had expressed concern that the agency’s process while pursuing the proposed rule removing shoulder injuries and vasovagal syndrome from the Vaccine Injury Table was irregular in its haste. HHS also observed that from a public health policy perspective, removing these injuries from the Vaccine Injury Table may dissuade individuals from undergoing vaccinations, which would be counter to the public’s interest in promoting vaccination. You can find HHS’s full rationale for withdrawing the rule here.

For individuals with shoulder injuries or vasovagal syncope stemming from a vaccine covered under the VICP, the move by HHS to withdraw the proposed Table amendment is good news and means that these vaccine injury cases can continue to be pursued as before.

On March 17, 2021, Health and Human Services (HHS) published a notice on the Federal Register alerting the public that the proposed rule change previously published on January 21, 2021 changing how cases involving shoulder injuries and vasovagal syncope are handled in the Vaccine Injury Compensation Program (VICP), is likely to be withdrawn following a thirty day comment period for public response ending on April 16, 2021.

The January 2021 rule by HHS would have removed shoulder and vasovagal injuries from the Vaccine Injury Table, requiring injured parties to pursue these injuries through “causation-in-fact” claims which often require the retention of medical experts and very often, an in-person hearing years down the line before a Special Master (Judge) in Washington, D.C. That rule change was initially due to go into effect on February 22, 2021, however, the effective date was pushed back two months until April 23, 2021 following a request by the Biden administration for time to review all administrative actions that occurred during the sunset of the previous administration.

Now, it appears that HHS is moving to withdraw that rule entirely. If that comes to pass, shoulder injuries and vasovagal syncope would continue to be included in the Vaccine Injury Table, allowing the claims to continue to be resolved more efficiently than if they were causation-in-fact cases.