Kraus Law Group, LLC recently prevailed in securing entitlement to compensation in a case involving an infant girl who developed a seizure disorder shortly after her 9-month-old vaccinations.

Our client, the mother of the child, took her daughter to the emergency room for a significant febrile seizure shortly after her vaccinations. While her daughter initially appeared to recover, her mother noticed that in the weeks after this initial seizure, her baby began acting strangely remote and she seemed to lose developmental milestones that she had previously attained.

A second febrile seizure occurred shortly thereafter. Ultimately, this little girl developed epilepsy and global developmental delays such that she will require complex medical care and constant supervision for the rest of her life.

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.

On February 23, 2021, Health and Human Services (HHS) published a rule on the Federal Register that effectively gives individuals that have experienced a shoulder injury or vasovagal syncope following vaccination, an additional two months, until April 23, 2021, to file a vaccine injury claim through the federal Vaccine Injury Compensation Program (VICP).

Originally, the rule which would change the way these injuries are handled within the VICP, making it more difficult for many vaccine injured individuals to pursue their claims, was due to take effect on February 22, 2021. The two month pause in the rule’s effective date was announced by HHS due to a request by the Biden administration for time to review all administrative actions that occurred during the sunset of the previous administration.

We have previously covered the rule changes, and the likely outcomes for vaccine injured individuals, in prior blog posts which you can find here and here.

On February 4, 2021, USA Today published an article about the upcoming removal of Shoulder Injury Related to Vaccine Administration (“SIRVA”) from the vaccine injury table. We discussed this rule change, which goes into effect on February 22, 2021, in a previous blog post. You can find our blog discussing that issue here.

The USA Today article discusses not only the rule change impacting SIRVA, but also touches on additional rule changes put in place by Health & Human Services (HHS) at the same time, all pushed through at the very end of the Trump administration with at best, minimal support, (chiefly from HHS). There was substantial pushback from players in the vaccine injury program, including the Advisory Commission on Childhood Vaccines (ACCV), the Vaccine Injured Petitioners Bar Association, members of the general public, physicians, pharmaceutical chains, etc., and individuals that have taken their SIRVA cases through the vaccine injury program.

You can find the USA Today article here.

On January 21, 2021, Health and Human Services (HHS) published a final rule in the Federal Register that changes a key part of the Vaccine Injury Compensation Program (VICP) addressing how shoulder injuries following vaccination, as well as vasovagal syncope, are dealt with in the Program.

While vaccine injuries are considered to be rare, shoulder injuries following vaccination are among the most common vaccine adverse events and so in 2017, the Vaccine Injury Table was amended to add Shoulder-Injury-Related-to-Vaccine-Administration (SIRVA) to the Table.

As the clamor grows for an effective Covid-19 vaccine, questions regarding vaccine safety have been foremost in the minds of the public. A recently published article in the pre-eminent journal, Science, by lead author, David M. Knipe, provides an overview into the vaccine safety regulatory framework in place in the United States and discusses how that framework came-to-be over the last several decades.

Among the common vaccine safety measures discussed by the authors are quality control checks to ensure that each batch of vaccine meets strict formulation standards and monitoring adverse events both before and after licensing to determine whether additional study, or alternate action, is needed. The article also discusses the Food and Drug Administration’s (“FDA”) specific guidance to pharmaceutical companies developing potential Covid-19 vaccines, including recommendations for post-licensure reporting and post-licensure studies in light of the likelihood for emergency-use approval of Covid-19 vaccines.

Given the news over the last few weeks of three different Covid-19 vaccines with encouraging Phase-3 clinical trial results, this informative article is extremely well-timed.

Last week, makers of the influenza vaccine began shipping their first doses of flu vaccine for the 2017 – 2018 flu season to healthcare providers, pharmacies, and immunizers. People will be able to begin getting immunized for the upcoming flu season beginning in late September. 

There are a small number of people who should take precautions when getting the flu vaccine, and a small number of people who should not get it at all. Suitability for the vaccine is determined by health status, age, and allergies to components of the flu vaccine. You should talk to your health care provider before getting immunized if you are concerned about your suitability for the influenza vaccine.

For the approximately 160 million people who will get the 2017-2018 flu vaccine, it a good time to learn or to review some tips how to protect yourself from Shoulder Injury Related to Vaccine Administration (SIRVA) injury. 

A quick survey of the news and media produces daily warnings that pertussis (whooping cough) is on the rise. These sources often blame low vaccination rates or under vaccination. However, that leaves out other important possible factors while stigmatizing parents that choose, for a variety of reasons, not to vaccinate their children.

For instance, researchers have recently found vaccine-resistant strains of bordatella pertussis (the bacteria that causes whooping cough) in the U.S. Researchers analyzed 30 samples of bordatella pertussis specimens from children hospitalized in Philadelphia and found 60% were a variant resistant to the vaccine. The current pertussis vaccine relies on pertactin (a protein on the outer membrane of the bacteria) as an antigen. Meanwhile, the study revealed the pertussis bacteria has developed at least two variants that halt the production of pertactin. This means the immune system, which has developed immunity from the pertussis vaccine, does not recognize the mutated pertussis strain. French studies of pertactin-negative mutated strains have shown that such strains are just as infectious as non-mutated strains.

Another cause of the uptick in cases of pertussis is related to the waning immunity provided by the DTaP vaccine administered to children. Studies have revealed that the protection from the fifth dose of DTaP (usually administered between 4 and 6 years old) decreases substantially during the five year period following vaccination.