R.F. v. HHS - Hepatitis B, systemic inflammatory response syndrome (2025)

On December 4, 2017, Stephane and Anthony Fiorello, on behalf of their minor child R.F., filed a petition under the National Childhood Vaccine Injury Act alleging that a hepatitis B vaccination received by R.F. on December 4, 2014, caused him to develop systemic inflammatory response syndrome (SIRS). The case proceeded as an off-Table claim, requiring the petitioners to prove causation-in-fact.

R.F., born prematurely at 29 weeks, had a history of developmental delays, sensory processing disorder, ADHD, and mild anxiety. He received his first hepatitis B vaccine on August 28, 2014, and the second dose on December 4, 2014.

The day after his second vaccination, R.F. presented with pallor and altered mental status, which his parents alleged was a vaccine-induced SIRS. Medical records from this initial episode showed elevated white blood cell count and low creatinine, and he was transferred to a hospital.

Subsequent episodes of hypotonia, pallor, and altered mental status occurred, which petitioners alleged were triggered by viral infections. Petitioners' expert, Ravi Durvasula, M.D., opined that R.F. suffered an initial hypersensitivity reaction resembling SIRS following the vaccine, leading to chronic immune system dysregulation and recurrent episodes triggered by viral infections.

He also noted R.F.'s diagnosis of osteopenia as evidence of immune dysregulation. Respondent's expert, Hayley Gans, M.D., countered that SIRS and hypersensitivity reactions are acute, not chronic or recurrent, and that there is no known biological mechanism by which a vaccine could cause chronic dysregulation leading to reactions from unrelated triggers.

Dr. Gans suggested R.F. had an underlying, likely genetic, condition.

The Special Master, Daniel T. Horner, agreed with Dr.

Gans. He found that petitioners failed to establish a sound medical theory connecting the vaccine to R.F.'s chronic condition, a logical sequence of cause and effect, or a proximate temporal relationship.

The Special Master noted that the initial episode, even if vaccine-related, did not meet the Vaccine Act's severity requirement on its own, and the subsequent chronic condition remained unidentified and its link to the vaccine unproven. The Court of Federal Claims, in reviewing the Special Master's decision, found that the Special Master's findings were neither arbitrary and capricious nor contrary to law, and denied the petitioners' motion for review.

Consequently, the petition was denied.