Misti Fraser v. HHS - Hepatitis A, Raynaud's phenomenon (2019)

Misti Fraser, a 46-year-old adult, filed a petition on September 12, 2017, seeking compensation under the National Vaccine Injury Compensation Program. She alleged that she developed Raynaud's phenomenon and/or reactive arthritis after receiving Hepatitis A and B vaccines on September 18, 2014.

Petitioner reported noticing a significant loss of circulation in her hands approximately three weeks after vaccination, followed by blistering on her hands and a cold sore on her upper lip. Medical records from January 30, 2015, noted symptoms consistent with Raynaud's, and Dr.

Michael Allen diagnosed her with Raynaud's, vesicular eczema of the hands, and herpes labialis. Lab testing at this visit showed a positive ANA titer of 1:160.

Petitioner returned to healthcare providers in April 2016 and May 2016, reporting worsening Raynaud's symptoms, generalized joint aches, mouth ulcers, and body tingles. Dr.

Erin Arnold diagnosed Petitioner with Raynaud's, stiffness of unspecified joints, paresthesias, and a positive ANA. Lab testing in May 2016 revealed a positive ANA and a positive HLA-B27 biomarker.

Petitioner continued to experience joint pain and stiffness, with Dr. Arnold noting a "shot reaction" in June 2016 and diagnosing Raynaud's, sacroiliitis, and unspecified joint stiffness, but not reactive arthritis.

Subsequent medical records in October 2016 and February 2017 continued to document Raynaud's and generalized achiness, with a positive ANA and HLA-B27 biomarker, but no formal diagnosis of reactive arthritis or other spondyloarthropathy was made by any treating physician. Petitioner did not file an expert report.

The Special Master, Brian H. Corcoran, reviewed the case on the record.

Petitioner argued that literature supported a causal link between the vaccines and Raynaud's, that her medical records showed an ongoing inflammatory process, and that the onset of symptoms was medically reasonable. The Respondent conceded that Petitioner had Raynaud's but contested entitlement, arguing that Petitioner failed to establish that the vaccines could cause Raynaud's or that they did cause her condition, and that the timing of symptoms was not medically reasonable.

Respondent also argued that the claim for reactive arthritis failed due to the lack of diagnosis and delayed onset. Special Master Corcoran found that the medical record did not support a diagnosis of reactive arthritis, as no treating physician had made such a diagnosis, and the presence of biomarkers alone was insufficient.

Even if a spondyloarthropathy had been diagnosed, the onset of symptoms in April 2016 was too late to be medically reasonable following the September 2014 vaccination. Regarding Raynaud's, the Special Master found that Petitioner failed to establish by a preponderance of the evidence that the Hepatitis A or B vaccines could cause Raynaud's.

The sole literature cited, a case report (Selvaraj et al.), stated that no causative link had been demonstrated and had limited probative value. The Special Master also found that the record did not support the conclusion that the vaccines caused Petitioner's Raynaud's symptoms, as no treating physician proposed this link and the case facts differed from the cited literature.

While the temporal relationship between vaccination and symptom onset was considered potentially sufficient, the failure to establish the "can cause" and "did cause" prongs led to the denial of the claim. The petition was denied.