Anita Burgess v. HHS - Tdap, significant aggravation of her pre-existing autoimmune condition (2022)

On May 24, 2017, Anita Burgess, a 61-year-old woman, filed a petition for compensation under the National Vaccine Injury Compensation Program. She alleged that a tetanus-diphtheria-acellular pertussis (Tdap) vaccination administered on August 8, 2014, significantly aggravated her pre-existing autoimmune condition, specifically Chronic Fatigue Syndrome (CFS) and Undifferentiated Connective Tissue Disease (UCTD).

Petitioner claimed the vaccine triggered reactivation of latent Epstein-Barr Virus (EBV), leading to a worsening of her symptoms. Respondent filed a report arguing the case was not appropriate for compensation.

The Special Master, Nora Beth Dorsey, found that Petitioner failed to provide preponderant evidence that her pre-existing autoimmune condition was significantly aggravated by the Tdap vaccination, and thus failed to satisfy her burden of proof. The petition was dismissed.

Petitioner's expert, Dr. Joseph A.

Bellanti, opined that the Tdap vaccine caused reactivation of latent EBV, which in turn caused a significant worsening of her autoimmune/auto-inflammatory disease. Dr.

Bellanti proposed three mechanisms for this causation: epigenetic changes, dysregulation of immune cells (microglia, dendritic cells, B-cells) leading to CD8+ T cell activation, and molecular mimicry. He asserted that EBV reactivation could lead to a significant aggravation of autoimmune disorders like CFS and UCTD.

Dr. Bellanti also contended that Petitioner experienced a serum sickness-like reaction following vaccination, which overwhelmed her immune system and caused EBV reactivation.

He noted Petitioner's symptoms began within one day of vaccination, which he considered appropriate for an immune-mediated response and subsequent exacerbation. Respondent's experts, Dr.

Erin M. Wilfong and Dr.

Evan J. Anderson, opined that there was no evidence that the Tdap vaccine causes EBV reactivation or aggravates autoimmune conditions like CFS or UCTD.

Dr. Wilfong stated that Petitioner never had MCTD and did not have consistently elevated RNP antibodies, a requirement for MCTD.

She also noted that Petitioner did not have serum sickness and that vaccination does not cause autoimmune disease flares. Dr.

Anderson agreed that EBV can serve as a trigger for CFS but does not drive ongoing symptoms through active replication or reactivation, and that it was unclear if Petitioner had CFS. He found no data suggesting Tdap vaccination is associated with EBV reactivation or causes or worsens CFS or MCTD.

Both experts reviewed the literature cited by Dr. Bellanti and found it did not support his theories regarding EBV reactivation or vaccine causation.

Dr. Anderson specifically noted that Petitioner's medical records did not include any lab results showing post-vaccination EBV reactivation, and that her immune system had controlled her initial EBV infection without evidence of CD8+ deficiency or dysregulation.

He also opined that osteoarthritis was the most likely cause of Petitioner's joint pain, unrelated to vaccination. The Special Master found that Petitioner had two relevant diagnoses prior to vaccination: CFS and UCTD, characterized by fatigue and occasional joint aching.

Post-vaccination, Petitioner experienced an increase in joint pain, particularly in her hands, which was a symptom of her underlying UCTD. However, her fatigue did not worsen, and her UCTD did not evolve into a distinct CTD or MCTD.

The Special Master found insufficient evidence of an aggravation of her CFS post-vaccination, noting her ability to return to walking long distances. The Special Master concluded that Petitioner had an increase in joint pain, which was a symptom of her underlying CTD, but this did not constitute a "significant aggravation" as defined by the statute, which requires markedly greater disability, pain, or illness accompanied by substantial deterioration in health.

Furthermore, the Special Master found that Petitioner failed to establish a sound and reliable medical theory connecting the Tdap vaccine to EBV reactivation or the aggravation of her autoimmune condition. The proposed mechanisms by Dr.

Bellanti were found to be unsupported by medical literature or lacking in foundational evidence. The Special Master also found the alleged one-day onset of symptoms was not medically acceptable given the proposed mechanisms and the nature of EBV reactivation.

Consequently, the petition was denied.