Carlene Schultz v. HHS - Influenza, stroke/spontaneous intracranial bleed (2020)

Carlene Schultz, a 62-year-old woman, received an influenza vaccine on October 25, 2013. Approximately five weeks later, on December 1, 2013, she experienced a sudden, severe headache, nausea, vomiting, and weakness, leading to her admission to the hospital.

A CT scan revealed a right-sided intracranial bleed. The medical records indicated the bleed was spontaneous, as she had no history of hypertension or anticoagulation, and no aneurysm was found.

She was treated and underwent rehabilitation, experiencing some cognitive deficits and mild slurred speech. Ms.

Schultz filed a petition alleging the flu vaccine caused her stroke, proposing a theory that it triggered an autoimmune reaction leading to cerebral vasculitis. She presented expert testimony from Dr.

Yehuda Shoenfeld and Dr. Laura Boylan, who opined that the vaccine could have caused an autoimmune response leading to cerebral vasculitis and the subsequent bleed.

Respondent presented expert testimony from Dr. Steven Messe, who opined that the flu vaccine did not cause Ms.

Schultz's stroke. Dr.

Messe concluded that her condition was most likely an idiopathic hemorrhagic stroke, a common occurrence with no clear explanation. The court reviewed the medical records and expert testimony, finding that Ms.

Schultz did not establish by a preponderance of the evidence that she suffered from cerebral vasculitis or that the flu vaccine caused her stroke. The court noted that no treating physician diagnosed her condition as vasculitis, and her symptoms were more consistent with an idiopathic stroke.

Furthermore, the court found the scientific evidence presented by the petitioner regarding the vaccine-autism link to be unreliable and insufficient to meet the Althen test for causation. Consequently, the petition was denied.