Victoria Pusateri v. HHS - HPV, significant aggravation of her immunodeficiency disorder, inflammatory bowel condition, esophagitis, bronchitis, and alopecia areata (2024)

On April 13, 2016, Victoria Pusateri, born October 10, 1997, filed a petition for compensation under the National Vaccine Injury Compensation Program. She alleged that the human papillomavirus (HPV) vaccine administered on February 18, 2013, and again on April 22, 2013, significantly aggravated her immunodeficiency disorder, inflammatory bowel condition, esophagitis, bronchitis, and alopecia areata.

Petitioner was represented by Scott W. Rooney of Nemes, Rooney P.C., and the respondent was the Secretary of Health and Human Services, represented by Catherine E.

Stolar of the U.S. Department of Justice.

Special Master Thomas L. Gowen issued the decision on October 21, 2024.

Petitioner's medical history prior to the HPV vaccinations revealed several health issues. She experienced mild esophagitis in 2003, episodic hypertension, and gastrointestinal symptoms that subsided with medication.

In 2004, she had a cyst removed from her eye. In August 2009, she was hospitalized for vomiting and abdominal pain, diagnosed with gastroenteritis, intermittent hypertension, and generalized lymphadenopathy.

In 2011, she was treated for sinusitis and recurrent urticaria (hives), with symptoms persisting for several weeks despite various treatments. She also experienced chronic urticaria and possible dust mite sensitivity.

In late 2011 and early 2013, she had recurrent sinusitis and bronchitis, requiring multiple courses of antibiotics. On February 18, 2013, the day she received her first HPV vaccine, she was diagnosed with bronchitis.

Between the first and second HPV vaccinations, on April 20, 2013, she presented with a runny nose, coughing, green discharge, and returning hives, diagnosed with urticaria and acute bronchitis and rhinitis. She received a course of prednisone and Azithromycin before her second HPV vaccine on April 22, 2013.

Following the second vaccination, her symptoms continued and evolved. By April 29, 2013, her hives were widespread, and her cough and congestion returned.

She experienced ongoing hives for three months, and by June 12, 2013, she reported hair loss (eyelashes and eyebrows) for two months and diarrhea for one week. By June 28, 2013, she reported diarrhea for three weeks and a history of ulcerative colitis, and was diagnosed with urticaria and alopecia eyebrow.

Blood work in July 2013 revealed extremely low levels of IgA and IgE, and later, nearly undetectable levels of IgG, IgA, IgM, and IgE. Endoscopy and colonoscopy revealed a fungal infection in her esophagus and diffuse active chronic colitis.

In August 2013, she was diagnosed with hypogammaglobulinemia, likely Crohn's disease, and chronic urticaria. Initially, her hypogammaglobulinemia was thought to be secondary to her colitis, but by September 2013, her diarrhea had subsided, yet her immunoglobulin levels remained undetectable.

Her physicians began to suspect primary immunodeficiency, such as atypical agammaglobulinemia or a WHIM syndrome variant, and she began monthly IVIG infusions. By December 2013, she reported hair loss on her scalp, eyelashes, and extremities, which had begun about a year prior.

She was assessed with hypogammaglobulinemia, chronic IVIG infusions, plantar warts, inflammatory bowel disease, history of candida esophagitis, and alopecia areata. Further evaluations considered diagnoses like Common Variable Immune Deficiency (CVID) and WHIM syndrome.

Her medical history continued to involve ongoing management for her immune deficiency, gastrointestinal issues, alopecia, and warts. Petitioner's experts, Dr.

John Santoro (gastroenterologist) and Dr. Marc Glashofer (dermatologist), proposed theories of molecular mimicry and innate inflammatory response to explain how the HPV vaccine could cause her gastrointestinal injuries and aggravate her alopecia.

Dr. Alan Cutler (gastroenterologist) opined that the HPV vaccine caused gastroparesis, leading to esophagitis, also suggesting molecular mimicry and adjuvant effects.

Respondent's expert, Dr. Randy Longman (gastroenterologist), argued that petitioner's pre-existing primary immunodeficiency disorder, likely CVID, was the cause of her symptoms.

He contended that her lack of immune response to vaccines made vaccine causation unlikely and that her gastrointestinal issues were consistent with CVID. Dr.

Longman also noted that her history of recurrent infections and other symptoms predated vaccination and were consistent with CVID. The Special Master reviewed the medical records and expert opinions.

He found that petitioner had a history of chronic infections and other symptoms prior to vaccination consistent with CVID. Crucially, the Special Master noted that petitioner had no discernible immune response to the HPV vaccine or other vaccines she had received, which undermined the theories of vaccine causation that rely on an immune response.

Furthermore, the onset of her gastrointestinal symptoms approximately 44 days after the second vaccine was found to be more consistent with her underlying immunodeficiency than a vaccine reaction. Regarding alopecia, the Special Master found that petitioner had pre-existing hair loss, and while it worsened post-vaccination, the evidence pointed more strongly to her underlying immunodeficiency as the cause, especially given her lack of immune response to the vaccine.

The Special Master concluded that Victoria Pusateri failed to prove by a preponderance of the evidence that the HPV vaccines caused her gastrointestinal illnesses or significantly aggravated her alopecia. Therefore, her petition was dismissed.