Hannah Huelsenbeck v. HHS - HPV, psuedotumor cerebri/idiopathic intracranial hypertension (“IIH”) (2018)

On January 11, 2018, Leigh Rolshoven, as guardian of Hannah Huelsenbeck, filed a claim seeking compensation under the National Vaccine Injury Compensation Program. The petition alleged that Ms.

Huelsenbeck developed pseudotumor cerebri/idiopathic intracranial hypertension (IIH), persistent headaches, and other adverse reactions following her second dose of the human papillomavirus (HPV) vaccine, Gardasil, administered on August 5, 2011. Ms.

Huelsenbeck, who was 16 years old at the time, had a history of ADHD and had previously experienced headaches and vision problems. Following the second HPV vaccine dose, she reported headaches starting around August 15, 2011, which were initially diagnosed as migraines.

Her condition persisted, with increased severity and associated nausea and vomiting, leading to a hospitalization in February 2012. During this hospitalization, her symptoms were attributed to stress and anxiety, but a possible link to the HPV vaccination was noted.

Subsequently, Ms. Huelsenbeck was diagnosed with pseudotumor cerebri (PC), equivalent to IIH, due to elevated cerebrospinal fluid pressure.

Treatment with Diamox and Lasix led to improvement, and her headaches largely resolved. She received a third HPV vaccine dose on December 30, 2011, with no immediate documented reaction.

Headaches recurred later, and she was treated by various specialists, including an ophthalmologist and a neurologist, who managed her PC diagnosis. The medical records indicated that her headaches often resolved with treatment for PC, though they recurred at times.

Petitioner's expert, Dr. Lawrence Steinman, proposed a theory that the HPV vaccine, through molecular mimicry and the alum adjuvant, could cause headaches separate from the IIH diagnosis.

He suggested that the vaccine could trigger an immune response that stimulates cytokines, causing pain, and also enhance cross-reactions with myelin basic protein (MBP) in cerebral blood vessels, leading to increased CSF pressure. Respondent's expert, Dr.

Michael Kruer, opined that Ms. Huelsenbeck's symptoms were attributable to her underlying IIH diagnosis and that the medical literature did not support a link between vaccines and IIH.

Dr. Kruer also challenged the reliability of Dr.

Steinman's proposed mechanisms, including molecular mimicry and the role of alum. The Special Master, Brian H.

Corcoran, found that the petitioner failed to establish causation by a preponderance of the evidence. The court found Dr.

Steinman's theory to be unreliable, noting a lack of direct scientific evidence linking the HPV vaccine to IIH or similar chronic headache syndromes, and that the petitioner's medical records did not support the proposed mechanisms. The decision highlighted that Ms.

Huelsenbeck's headaches largely resolved after treatment for IIH, and there was no evidence of vasculitis. The claim was dismissed.