C.F. v. HHS - HPV, postural orthostatic tachycardia syndrome (POTS) (2023)

On July 15, 2015, C.F.'s parents filed a petition under the National Childhood Vaccine Injury Act, alleging that the human papillomavirus (HPV) vaccine, Gardasil, caused postural orthostatic tachycardia syndrome (POTS). The petition focused on the third Gardasil dose administered on July 19, 2012.

C.F. was a minor at the time of vaccination, but her name was later changed to initials after she reached the age of majority. Respondent, the Secretary of Health and Human Services, disputed causation and argued that the medical record did not support a vaccine-caused autonomic disorder.

Special Master Daniel T. Horner denied entitlement on January 20, 2023, finding that C.F. failed to establish a reliable medical theory linking the vaccine to POTS, a proximate temporal relationship, or a logical sequence of cause and effect.

The case was dismissed without award. Before her third Gardasil dose, C.F. was generally healthy, with a history of childhood illnesses, minor injuries, a tonsillectomy and adenoidectomy, and headaches since kindergarten.

Her first two Gardasil doses were given in July and November 2011. On the day of her third dose, July 19, 2012, she reported a one-week frontal headache.

Approximately three months later, in October 2012, she began experiencing daily headaches, for which she was prescribed medication and recommended to see a neurologist. By March 2013, her headaches had become more constant and painful, leading to missed school and soccer.

She was admitted to the hospital in April 2013 for persistent headaches, where mild tachycardia was noted. Subsequent testing, including Holter monitoring, showed significant heart rate fluctuations, but a pediatric cardiologist found no primary cardiac disorder, attributing the tachycardia to secondary issues like headaches or anxiety.

Over the next few years, C.F. saw numerous specialists for an expanding range of symptoms including chest pain, fatigue, myalgias, dizziness, sleep disturbance, rashes, joint color changes, and abdominal pain. A POTS diagnosis was first made at the Mayo Clinic in July 2015, following autonomic testing including a tilt table test, which showed orthostatic tachycardia.

C.F. testified that her symptoms began a few weeks after the third Gardasil dose, initially with severe headaches, followed by fatigue, body pain, joint pain, nausea, brain fog, blurred vision, and eventually the POTS diagnosis. She stated her post-vaccination headaches were different and more debilitating than her prior allergy-related headaches.

Petitioner's expert, neurologist and autonomic specialist Dr. Svetlana Blitshteyn, opined that C.F. had POTS triggered by Gardasil through an autoimmune process, possibly involving molecular mimicry and cross-reacting antibodies against autonomic receptors, with the aluminum adjuvant acting as an immune stimulator.

She cited C.F.'s autonomic testing, treating diagnoses, and literature on post-HPV vaccine symptom clusters. Dr.

Blitshteyn acknowledged that C.F.'s autoimmune tests were negative but noted that specific adrenergic and muscarinic antibody tests are not available in the U.S. She proposed a twelve-week window for POTS onset post-vaccination and believed C.F.'s symptoms began within two weeks of her third dose.

Respondent's expert, neurologist and autonomic specialist Dr. Christopher Gibbons, disputed the causal theory.

He agreed C.F. had orthostatic intolerance symptoms but questioned the POTS diagnosis due to potential medication effects and borderline test results. He stated the record showed no evidence of autoimmune or small fiber neuropathy and no credible link between HPV vaccine and POTS, suggesting deconditioning as a possible contributor.

He noted C.F. was not suspected of having POTS until nearly a year after vaccination. Special Master Horner found that C.F. had established POTS at the time of diagnosis but that the onset was not shown to be shortly after vaccination.

He determined that orthostatic symptoms, not headaches, were the best marker for POTS onset, placing it no earlier than late May 2013 to July 2014, at least ten months post-vaccination. He rejected the argument that headaches indicated earlier POTS onset due to C.F.'s history of headaches and treating physicians' diagnoses of migraine.

He also found the claim of undetected tachycardia soon after vaccination speculative. Applying the Althen test, the Special Master found prong one failed because the evidence was insufficient to establish a reliable theory that the HPV vaccine causes POTS, particularly regarding its potential autoimmune basis and link to vaccination.

Prong three failed because the timing was too remote, exceeding the twelve-week window proposed by petitioner's expert. Prong two failed due to a lack of a logical sequence of cause and effect, noting the absence of treating physician opinions linking the vaccine to POTS and the lack of expected autoimmune findings.

Consequently, entitlement was denied, and the case was dismissed.