Gerald Temes v. HHS - Influenza, cryoglobulinemia (2020)

Gerald Temes, a 76-year-old retired surgeon, filed a claim under the National Vaccine Injury Compensation Program alleging that he developed cryoglobulinemia, a blood disorder that can lead to vasculitis, as a result of receiving the influenza and pneumococcal vaccines on October 19, 2015. He reported symptoms including fever, hand and leg pain, and discoloration of his fingers and toes, beginning approximately one week after vaccination.

His treating physicians suspected a link to the flu vaccine. The case proceeded as an off-Table claim, meaning Mr.

Temes had to prove causation. He presented expert testimony suggesting the vaccines triggered gene expression related to cryoglobulin production, potentially through epigenetics, molecular mimicry, or bystander activation, and cited case reports of vasculitis following vaccination.

The respondent presented expert testimony arguing that the scientific literature did not support a causal link between the vaccines and cryoglobulinemia, and that the onset timeframe was too short. The Special Master denied entitlement, finding that Mr.

Temes failed to establish a scientifically reliable theory of causation (Althen Prong One) due to insufficient evidence regarding epigenetics, hyperimmunization, molecular mimicry, and bystander activation. The Special Master also found that while treating physicians believed the vaccines caused the condition, their opinions relied heavily on temporal association and were not supported by robust scientific evidence.

Furthermore, the onset timeframe was deemed not medically acceptable. This decision was later affirmed by the Court of Federal Claims on review.

Therefore, Mr. Temes was not awarded compensation.