A.Y. v. HHS - Varicella, reactivation of a varicella virus (2020)

On June 22, 2017, the parents of A.Y., a minor born in November 2006, filed a petition seeking compensation under the National Vaccine Injury Compensation Program. They alleged that a varicella vaccine administered to A.Y. in November 2007 caused the reactivation of the varicella virus in 2014 or 2015, leading to chickenpox-like symptoms, abdominal pain, and behavioral issues.

The claim was brought as an off-Table, causation-in-fact case, and also included a claim for significant aggravation. The petition noted that A.Y. and his siblings, triplets born in November 2006, had developmental delays and autism diagnoses, which were not alleged to be vaccine-related injuries.

A.Y. received the varicella vaccine at his one-year well-child visit in November 2007, with no immediate adverse reactions noted. His medical history was complex, including prematurity, NICU stay, reflux, developmental delays, autism diagnosis in 2009, and gastrointestinal issues.

He underwent numerous treatments between 2010 and 2014, including antiviral medications, antibiotics, supplements, hyperbaric oxygen therapy, and stem cell therapy. In September 2013, he was diagnosed with a "cycle of abdominal pain," and a colonoscopy in October 2013 showed normal results except for patchy erythema and reflux.

In January 2015, A.Y. developed a rash diagnosed as "possible atypical varicella," for which he received Acyclovir. His mother reported the rash cleared quickly.

Subsequent medical records in 2015 and 2016 continued to document various treatments for his ongoing symptoms. Dr.

Anne Gershon, a pediatric researcher, reported finding RNA transcripts of varicella genes in A.Y.'s intestinal biopsy from 2015, suggesting an intestinal infection consistent with the vaccine strain. However, other treaters, like Dr.

Raffi Tachdjian, noted negative varicella IgG antibodies and rashes that were viral but not classic varicella or HSV. Petitioners' experts included Dr.

Robinson, who treated A.Y. for autism and noted behavioral changes temporally associated with increased abdominal pain, but acknowledged these changes may have predated the January 2015 rash. Dr.

Richard Honaker, a family practice physician, provided a chronology and opined that reactivation likely occurred in January 2015, with subsequent exacerbation of GI pain and behavioral issues, but admitted a lack of specialization in the disputed medical areas. Dr.

Gershon opined that the vaccine's viral components could become latent and reactivate, citing her research on VZV latency in enteric neurons. She concluded that A.Y. had an active varicella infection consistent with the vaccine strain.

Respondent argued that the medical records were disorganized and incomplete, and that A.Y.'s symptoms could be attributed to numerous other factors, including his complex medical history and various treatments. Respondent also contended that the rapid clearing of the rash and the long latency period raised doubts about reactivation.

The Special Master, Chief Special Master Brian H. Corcoran, found that Petitioners failed to establish that the varicella vaccine could cause reactivation after a seven-year latency period or that A.Y. actually experienced reactivation and subsequent injuries.

The Special Master noted the complexity of A.Y.'s medical history and the presence of numerous potential alternative causes for his symptoms. The court determined that the evidence did not preponderantly establish that A.Y. had an active varicella infection in January 2015 attributable to the vaccine, nor that the alleged reactivation worsened his existing conditions.

The claim for significant aggravation was also denied, as the record did not sufficiently demonstrate worsening of symptoms post-reactivation or a medical link between varicella reactivation and A.Y.'s specific symptoms like abdominal pain and behavioral issues. The Special Master concluded that the seven-year timeframe from vaccination to alleged reactivation was not medically acceptable.

The petition was dismissed. Petitioner counsel was Renee Gentry.

Respondent counsel was Jennifer Reynaud. The decision was issued on September 2, 2020.