Stiegler v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 21-1152V

*************************

* Chief Special Master Corcoran

*

ALISON STIEGLER, *

* Filed: October 10, 2024

Petitioner, *

*

v. *

*

SECRETARY OF HEALTH AND *

HUMAN SERVICES, *

*

Respondent. *

*

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Andrew Downing, Downing, Allison, & Jorgenson, Phoenix, Arizona, for Petitioner.

Sarah Duncan, U.S. Department of Justice, Washington, DC, for Respondent.

DECISION DENYING ENTITLEMENT1

On April 2, 2021, Alison Stiegler filed a Petition under the National Vaccine Injury

Compensation Program (the “Vaccine Program”),2 alleging that she developed Postural

Orthostatic Tachycardia Syndrome (“POTS”) and chronic fatigue syndrome (“CFS”) as a result of

receiving the tetanus, diphtheria, and acellular pertussis (“Tdap”) vaccine on April 4, 2018. ECF

No. 1 (“Petition”).

1

This Decision will be posted on the United States Court of Federal Claims’ website in accordance with the E-

Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Decision will be available to anyone with access

to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the published

Ruling’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has

fourteen (14) days within which to request redaction “of any information furnished by that party: (1) that is a trade

secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or

similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b).

Otherwise, the entire Decision will be available to the public in its current form. Id.

2

The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,

100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012)) (hereinafter “Vaccine Act” or “the Act”).

All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. § 300aa.

On October 2, 2023, I held a status conference, after which I ordered Petitioner to file a

brief explaining the theory offered in this case. ECF No. 68. On January 19, 2024, Petitioner filed

that brief. ECF No. 69 (“Brief”). Two months later, on March 25, 2024, I issued another order

reiterating the preliminary view (based on my experience adjudicating POTS claims) that the

Petition was not tenable, and expressing my willingness to entertain dismissal. ECF No. 72.

Respondent has now formally moved to dismiss the claim, and both sides have had an

opportunity to weigh in on the matter. See Respondent’s Rule 4(c) Report (ECF No. 73) and

associated Motion to Dismiss, filed April 30, 2024 (ECF No. 74) (collectively, “Mot.”);

Petitioner’s Response, filed July 2, 2024 (ECF No. 81) (“Opp.”); Petitioner’s Motion for Oral

Argument, filed July 8, 2024 (ECF No. 82); Respondent’s Reply, filed July 15, 2024 (ECF No.

83) (“Reply”); Respondent’s Response to Motion for Oral Argument, filed July 18, 2024 (ECF

No. 84); Petitioner Reply in Support of Motion for Oral Argument, filed July 24, 2024 (ECF No.

85).

Having reviewed the record and all associated filings, I hereby deny an entitlement award.

Although this case involves the Tdap vaccine, Petitioner relies heavily on the contention that the

human papillomavirus vaccine (“HPV”) can cause POTS. But claims involving an alleged

HPV/POTS association have been routinely rejected in numerous prior Program cases as lacking

reliable scientific support sufficient to meet the preponderant burden of proof. Otherwise,

Petitioner offers minimal, unpersuasive evidence specific to a purported Tdap/POTS association,

and does not advance sufficient basis to entertain further a CFS claim based on the same facts.

I. Factual Background

Pre-Vaccination History

In the three years prior to her vaccination, Ms. Stiegler saw medical providers for multiple

symptoms that continued after she received the Tdap vaccine. Thus, in October 2015, she presented

to the emergency room (“ER”) complaining of shortness of breath with diffuse chest tightness and

increased stress at work, and was diagnosed with a panic attack, given Ativan, and prescribed

albuterol for wheezing. Ex. 13 at 12, 15. In December 2015, Petitioner presented to the ER and

reported she had been experiencing almost daily abdominal discomfort or pain since April 2015,

and reported that at times it went up to her chest and shoulders and was accompanied by shortness

of breath. Id. at 56-59. She was diagnosed with gastritis versus gastroesophageal reflux disease

with an anxiety component. Id.

2

Vaccination and Subsequent Manifestations of Symptoms

On April 4, 2018, Petitioner received the Tdap vaccine after stepping on a nail three days

earlier. Ex. 13 at 140-41, 150, 153. At the appointment, she complained of mild, intermittent

headaches for the past month, fever, chills and stomach pain. Id. at 140-41. She also complained

of pain after injuring her knee doing jujitsu the day before. Id. She was diagnosed with a likely

tension headache, likely flu infection, a puncture wound, and a knee sprain or meniscal injury. Id.

at 142.

Over the next several months, Petitioner continued to report to her primary care physician

(“PCP”) complaining of chronic headaches and pain in her knee, ankle, and hand from jujitsu. Ex.

6 at 7-8, 17, 49, 59-61. In August 2018 (four months post-vaccination), Petitioner presented to her

PCP complaining of sciatic back pain that had worsened the day before, adding that she had been

experiencing comparable symptoms for several years. Ex. 6 at 66.

On October 31, 2018, more than six months post-vaccination, Petitioner saw her PCP and

reported three weeks of unusual fatigue. Ex. 6 at 108. Her exam was normal, but during the

appointment, she began sobbing and reported that she continuously checked her phone, calendar,

and tasks, thinking something was wrong or would happen. Id. at 110. She reported that she had

not slept well for a while because she would think about needing to wake up and urinate, which

prevented her from sleeping, and that her periods were becoming irregular. Id. The differential

diagnoses included likely obsessive-compulsive disorder with anticipatory anxiety, vitamin

deficiency, endocrine issue, and psychosomatic complaints. Id. Thus, by this date, Petitioner was

not reporting symptoms that might reflect POTS.

Treatment in 2020 and Beyond

Throughout 2019, Petitioner went to the ER three times for matters unrelated to the present

case. Ex. 7 at 2-3; Ex. 30 at 7, 11. During her third visit on September 15, 2019, Petitioner

complained of back pain, chest pain/pressure and shortness of breath for two weeks. Ex. 5 at 37.

She also reported that she had experienced palpitations while watching TV that night. Id. at 89.

She was diagnosed with nonspecific chest pain, lumbosacral strain, and left shin pain. Id. at 95. In

the following year, she had additional ER visits, where she complained of shortness of breath,

hyperventilation, and chest pain/tightness. Ex. 5 at 122-25, 174, 176, 198.

On April 27, 2020, Petitioner had a telehealth visit with a gastroenterologist (“GI doctor”).

Ex. 19 at 2. She reported that that she recently had difficulty breathing and explained that she never

had this issue before. Id. She also complained of five years of bloating, which she controlled by

avoiding certain foods. Id. The GI doctor diagnosed her with mixed irritable bowel syndrome

(“IBS”) and advised her to follow up with her PCP and OB-GYN regarding her other symptoms.

3

Id. at 3-4. On April 30, 2020, Petitioner had a follow-up appointment with her GI doctor, who

noted that her only finding after multiple ER and clinical visits was gallstones. Id. at 6-8. Petitioner

became extremely upset during this appointment, and the GI doctor recommended she go to the

ER where the doctor’s colleagues could evaluate her. Id. The surgical consult at the hospital

recommended that Petitioner have her gallbladder removed but Petitioner declined. Ex. 4 at 14-

15. Thus, as of two years post-vaccination, Petitioner had not reported the kinds of symptoms that

would be classically reflective of POTS, but instead constituted a variety of nonspecific

complaints. See, e.g., Ex. 19 at 18, 21.

On June 12, 2020, Petitioner presented to a chiropractor because she was “feeling ‘out of

whack,’” wanted “a neurological assessment to address any areas of imbalance,” “suspect[ed]

autoimmunity,” and was having numbness, tingling, and headaches. Ex. 27 at 11. She saw the

chiropractor six more times through July 8, 2020. Id. at 5-10. On June 19, 2020, a week later,

Petitioner presented to a new PCP for an annual exam and reported that she was feeling well and

had no specific complaints. Ex. 25 at 2. Nevertheless, Petitioner sought treatment from a variety

of other specialists through that summer, reporting concerns or asking about potential diagnoses

that could not be confirmed. See generally Ex. 9 at 2; Ex. 10 at 7; Ex. 22 at 7; Ex. 25 at 3, 23; Ex.

8 at 13; Ex. 29 at 51. These efforts continued into the fall, and some treaters eventually proposed

that the subjective and unsubstantiated nature of Petitioner’s complaints could reflect a

psychologic rather than physical issue. Ex. 8 at 3-5, 31, 85.

The closest Petitioner has come to a POTS diagnosis occurred in the context of a

cardiologic visit in March 2021 (now three years post-vaccination). Ex. 16 at 8. She reported to

the treater that when she stood or lied down, she had intermittent episodes where her heart raced,

her symptoms would thereafter last a few seconds to hours, were sometimes associated with

shortness of breath, and that these episodes began the year before. Id. at 8, 9. Petitioner felt that

she might have POTS and was very flexible, might be double jointed, and have Ehlers-Danlos

syndromes. Id. On exam, Petitioner had a heart murmur, but no cyanosis and her joints were

normal. Id. at 9. The cardiologist diagnosed her with palpitations, chest discomfort, a heart

murmur, abnormal EKG, shortness of breath, likely hypermobility syndrome, and shortness of

breath. Id. at 6, 9.

Petitioner thereafter continued to seek medical assistance for many different complaints

and symptoms. In her affidavit, Petitioner reported a myriad of symptoms (unrelated to her CF and

POTS claims) that she attributes to the Tdap vaccine, including chemical smell sensitivity, loss of

height, low blood pressure, becoming a magnet for animals, an allergic reaction to sandflies, and

fibrocystic breast disease. Ex. 1 at 6, 7.

4

II. Procedural History

As noted above, the case was initiated in April 2021. On October 2, 2023, I held a status

conference and explained my reasons for doubting Petitioner’s theory that POTS is predominantly

autoimmune and can be caused by certain vaccines. I acknowledged, however, that I had yet to

adjudicate a case in which Petitioner alleges that the Tdap vaccine specifically caused POTS, and

I found it conceivable that a causation theory involving the Tdap vaccine could be different from

other claims. I thus ordered Petitioner to file a brief explaining the theory offered in this case. After

Petitioner did so, Respondent filed a Rule 4(c) Report and moved to dismiss the claim. In the

course of briefing the topic, Petitioner also briefed the propriety of oral argument. No expert

reports have been filed, and the motion to dismiss is now ripe for resolution.

III. Parties’ Arguments

Petitioner3

Petitioner argues that POTS is an autoimmune disease that can be triggered by the Tdap

vaccine via molecular mimicry. Brief at 5, 20.4 She contends that recent research supports the

conclusion that autoimmunity is a widely-accepted cause of POTS, rendering the Program’s

previous conclusion – that POTS is not autoimmune – outdated. Id. at 1. And, she maintains,

patients with POTS often report an immunological trigger (like vaccination) prior to their onset of

symptoms, which is a feature of autoimmune disease. Id. at 2; Opp. at 38.

In support, Petitioner cites several items of literature – although most were submitted in

other cases alleging POTS as a vaccine injury, but deemed unreliable or unpersuasive.5 Brief at 2-

4, 8-9; Opp. at 40-41. In particular, she cites several articles that discuss a purported connection

between POTS and the HPV vaccine. Brief at 5-7 (citing6 S. Blitshteyn, Postural Tachycardia

Syndrome Following Human Papillomavirus Vaccination, 21 European J. of Neurology 135

(2014) (filed as pages 103-07 of ECF No. 71) (“Blitshteyn”); R. Chandler et al., Current Safety

Concerns with Human Papillomavirus Vaccine: A Cluster of Reports in VigiBase, 40 Drug Saf.

3

My summary of Petitioner’s arguments draws from both Petitioner’s initial filing in response to my concerns about

the claim’s viability, as well as her later brief opposing Respondent’s dismissal motion.

4

Although, as noted above, Petitioner has also alleged CFS as an injury in this case, her briefing has little to say about

it. She simply references the same molecular mimicry theory, claiming that impairment of certain adrenergic receptors

allegedly implicated in an autoimmune form of POTS can lead to symptoms of CFS. Opp. at 53.

5

For a review of these papers and articles, see generally A.F. v. Sec’y of Health & Hum. Servs., No. 19-446V, 2023

WL 251948, at *7, *15 n. 22, *23 (Fed. Cl. Spec. Mstr. Jan. 18, 2023).

6

Petitioner did not properly file the 39 articles cited in her Brief as separate and individual exhibits, but instead simply

included them in an appendix. ECF No. 71. I will therefore reference the page numbers of the relevant submission in

citing to these items of literature.

5

81 (2017) (filed as pages 133-42 of ECF No. 71) (“Chandler”); J. Schofield & J. Hendrickson,

Autoimmunity, Autonomic Neuropathy, and the HPV Vaccination: A Vulnerable Subpopulation,

Clin. Ped. 1 (2018) (filed as pages 119-122 of ECF No. 71) (“Schofield”); L. Brinth et al.,

Orthostatic Intolerance and Postural Tachycardia Syndrome as Suspected Adverse Effects of

Vaccination Against Human Papilloma Virus, 33 Vaccine 2602 (2015) (filed as pages 81-84 of

ECF No. 71) (“Brinth”)). But these articles also have been considered in prior cases, and thus do

not represent new or updated “takes” on the alleged POTS-HPV vaccine association that render a

causal relationship more likely. See, e.g., C.F. v. Sec’y of Health & Hum. Servs., No. 15-731V,

2023 WL 2198809 at *15, *17-19, *32 (Fed. Cl. Spec. Mstr. Jan. 20, 2023).

Petitioner also maintains other vaccines could be causal of POTS, even if the HPV vaccine

remains the most common and likely trigger. For example, several case studies have reported

patients developing POTS within weeks of receiving the COVID vaccine. Brief at 5 (citing P. TV

et al., Postural Orthostatic Tachycardia Syndrome-like Symptoms Following COVID-19

Vaccination: An Overview of Clinical Literature, 31 Hum Antibodies, 9-17 (2023) (filed as pages

69-77 of ECF No. 71) (“TV et al.”); Opp. at 38 (citing C. Pena et al., Autoimmunity in Syndromes

of Orthostatic Intolerance: An Updated Review, 14 J. Pers. Med., 2 (2024), filed as Ex. 37 (ECF

No. 79)). But the COVID vaccine is not at issue herein (nor could it be, as it is not at present a

Program-covered vaccine).

Turning to the alleged relationship between the Tdap vaccine and POTS/CFS, Petitioner

claims that the tetanus wild bacterium has been frequently connected to autonomic dysfunction.

Brief at 17 (citing Won Seo et al., Autonomic Instability in Severe Tetanus: A Case Report; 23

Ann. Clin. Neurophysiology 117-120 (2021) (filed as pages 394-97 of ECF No. 71) (“Won Seo”)

(individual patient case report). Petitioner thus assumes that the impact of the Tdap vaccine’s

tetanus toxoid component (which is understood not to be equivalent to a wild tetanus infection,

and thus inherently less dangerous) can also cause autonomic dysfunction.

To prove that the Tdap vaccine can cause POTS (or CFS for that matter), Petitioner points

to the mechanism of molecular mimicry, in which the body produces autoantibodies in response

to a vaccine’s antigens that then (due to similarity between the antigens and self-tissue structures

or components) erroneously cross-react, attacking the body. Brief at 9; Opp. at 47. Interference

with the Alpha-1 adrenergic receptor (found on the surface of sympathetic nerve cells) is suspected

to be causative of POTS. Opp. at 47. Antibodies generated in response to the Tdap vaccine bind

to these receptors, due to sequence homology between Tdap vaccine peptide components and those

found in the adrenergic receptors. Id. at 54. To prove this, Petitioner’s counsel conducted a

UnitProt analysis between tetanus toxoid and the human antigen target of the Alpha-1 adrenergic

receptor. Id. The results of the analysis revealed that there are nine homologous amino acids in the

6

run of twelve, and seven in a linear match. Id. at 57. This homology, Petitioner argues, is sufficient

to support the theory that Petitioner developed POTS via molecular mimicry. Id.7

As independent support for this causal theory, Petitioner referenced several items of

literature. Opp. at 50-51 (citing A. Fedorowski et al., Antiadrenergic Autoimmunity in Postural

Tachycardia Syndrome, 19 Europace 1211 (2017) (filed as pages 268-76 of ECF No. 71); H. Li et

al., Autoimmune Basis for Postural Tachycardia Syndrome, 3 J. Am. Heart. Ass’n. 2 (2014) (filed

as pages 257-66 of ECF No. 71); W. Gunning et al., Postural Orthostatic Tachycardia Syndrome

is Associated with Elevated G-Protein Coupled Receptor Autoantibodies, 8 J. Am. Heart Assoc.

1–10 (2019)) (filed as pages 311-320 of ECF No. 71)). But I have reviewed all these articles in

previous cases and found them to be unpersuasive. A.F. v. Sec'y of Health & Hum. Servs., No. 19-

446V, 2023 WL 251948 at *5, *24 (Fed. Cl. Spec. Mstr. Jan. 18, 2023).

Respondent

At the outset, Respondent disputes that Petitioner ever suffered from either POTS or CFS.

Mot. at 26. Petitioner never received either diagnosis from a treater, nor has she undergone testing

sufficient to meet the diagnostic criteria for these conditions. Id. At most, Petitioner expressed

concern that she might have POTS in March 2021, but her cardiologist did not diagnose her with

the condition or order further testing. Id. And when Petitioner reported fatigue to various providers,

she reported only brief periods of fatigue at sporadic times, and thus her complaints in this regard

were too nonspecific to amount to the conclusion she actually had CFS. Id. at 27.

Moreover, Respondent argues, even if Petitioner could show that she suffered from POTS

and/or CFS, Petitioner cannot establish causation. Mot. at 27. In particular, Petitioner has failed to

provide convincing evidence that POTS has an autoimmune basis. Id. at 30.

Respondent observes that most of Petitioner’s cited literature has already been evaluated

and rejected in previous Vaccine Program cases. Mot. at 28. And any new medical literature

offered by Petitioner does not constitute preponderant evidence that POTS is an autoimmune

condition. Id. at 30. One such article, for example, merely suggests that patients with POTS can

also suffer from antiphospholipid syndrome,8 which Petitioner does not have. Id. (discussing H.A.

Noureldine et al., Postural Tachycardia Syndrome (POTS) and Antiphospholipid Syndrome (APS):

What Do We Know So Far?, 178 Rev Neurol (Paris) 306-314 (2022) (filed as pages 38-41 of ECF

No. 71)). Another only suggests a possible genetic/inherited character for POTS, as opposed to it

7

Although in most cases an expert in immunology and/or molecular biology would be called for to perform this

homology analysis, counsel attempts to do so here – but given the posture of the case, I do not fault the effort (even if

I ultimately do not find that it aided Petitioner’s claim in the least).

8

“Antiphospholipid syndrome” is defined as “a multisystem inflammatory disorder characterized by the presence of

circulating antiphospholipid antibodies with thrombosis.” Antiphospholipid syndrome, Dorland’s Medical Dictionary

Online, https://www.dorlandsonline.com/dorland/definition?id=110221&searchterm=antiphospholipid+syndrome

(last visited Oct. 2, 2024).

7

commonly being the product of an autoimmune process. Id. at 30 (discussing J.R. Boris et al.,

Family History of Associated Disorders in Patients with Postural Tachycardia Syndrome, 30

Cardiol. Young 388-394 (2020) (filed as pages 44-67 of ECF No. 71)).

Other items of literature offered by Petitioner purport to establish indirect evidence of

POTS’s autoimmune character, by noting that IVIG9 treatments (known to ameliorate some

autoimmune disease processes) are effective for POTS. Mot. at 30 (discussing J.R. Schofield et

al., Intravenous Immunoglobulin Therapy in Refractory Autoimmune Dysautonomias: A

Restrospective Analysis of 38 Patients, 26 Am. J. Ther. 570-582 (2019) (filed as pages 374-86 of

ECF No. 71); B. Rodriguez et al., Immunomodulatory Treatment in Postural Tachycardia

Syndrome: A Case Series, 28 Eur. J. Neurol. 1692-1697 (2021) (filed as page 372 of ECF No. 71)).

But a different, recently-published article has confirmed that in a group of patients with POTS who

received IVIG versus a placebo, there was no statistically-significant difference in response. Id.

(discussing S. Vernino et al., Randomized Controlled Trials of Intravenous Immunoglobulin for

Autoimmune Postural Orthostatic Tachycardia Syndrome (iSTAND), 102 J. of Nuerol. 153-163

(2024), filed as Ex. B (ECF No. 75-2) (of the study’s 30 participants, 16 received IVIG treatment

and 14 received albumin. The participants received eight infusions over the course of twelve

weeks. While the IVIG patients had a slightly higher response rate, the difference was not

statistically significant.)).

Beyond the foregoing, Respondent argues that Petitioner has not offered sufficient

preponderant evidence to prove that the Tdap vaccine can itself likely cause POTS (regardless of

its autoimmune character). Mot. at 28. Again, Respondent notes that most of Petitioner’s literature

offered for this proposition has already been rejected in prior decisions, and the new articles are

equally unconvincing. Id. at 29-30. One article merely discusses self-reported antecedent events

in a three-month time frame – and does not otherwise conclude that any vaccine can cause POTS.

Id. at 29 (discussing B. Shaw et al., The Face of Postural Tachycardia Syndrome – Insights From

a Large Cross-Sectional Online Community-Based Survey, 286 J. of Intern Med. 438-448 (2019)

(filed as pages 12-22 of ECF No. 71). Another – TV et al. – discusses patients who were never

formally diagnosed with POTS. Id. at 30. And the vast majority of Petitioner’s evidence involves

the HPV rather than Tdap vaccine. Id. at 28. The only evidence Petitioner offers to link the Tdap

vaccine to POTS is a single case study in which a patient who was diagnosed with a life-threatening

tetanus infection developed various symptoms that the Petitioner claims are POTS symptoms –

severe neck muscle spasms, high blood pressure, sinus tachycardia, fever, and myoclonic leg

movement. Id. at 32 (referencing Won Seo). That case study thus does not involve the Tdap

vaccine, nor does it even mention POTS. Id.

9

“Intravenous Immunoglobulin (IVIG)” is defined as “[a] therap[y] prepared from a pool of immunoglobulins

(antibodies) from the plasma of thousands of healthy donors. Immunoglobulins are made by the immune system of

healthy people for the purpose of fighting infections…IVIG/SCIG work in different ways to prevent the body from

attacking itself and to decrease several types of inflammation in the body.” IVIG,

https://rheumatology.org/patients/intravenous-immunoglobulin-ivig (last visited Oct. 2, 2024).

8

Finally, Respondent denies that the Tdap vaccine can cause POTS/CFS via molecular

mimicry. Mot. at 31. Petitioner’s brief merely provided purportedly significant homologies

between tetanus toxoid and the Alpha-1 adrenergic receptor, but no corroborative evidence

suggesting that these homologies are likely capable of resulting in an immune-mediated form of

POTS. Id. at 32.10

IV. Applicable Legal Standards

A. Petitioner’s Overall Burden in Vaccine Program Cases

To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that

he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—

corresponding to one of the vaccinations in question within a statutorily prescribed period of time

or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table

Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §

11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed.

Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).11

Petitioner does not assert a Table claim, nor does there exist such a claim for POTS (or autonomic

disfunction generally) or CFS as the injury – regardless of the vaccine at issue.

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance

of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that

leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence

before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s

existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.

476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).

Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d

867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not

10

Furthermore, Respondent argues, Petitioner has failed to provide evidence with respect to the “did cause” causation

prong – that the Tdap vaccine caused or significantly aggravated her alleged POTS or CFS. Mot. at 33. Thus, no

medical provider attributed Petitioner’s condition to the Tdap vaccine. Id. Instead, Petitioner’s complaints were

deemed associated with a variety of other causes, including sports injuries, IBS, and anxiety. Id. And Petitioner’s

symptoms did not develop within a medically acceptable timeframe. Id. at 34. She first reported unusual fatigue in

October 2018, nearly four months after the vaccination, and she did not report symptoms associated with orthostatic

change until July 2020. Id. Although these arguments all underscore the overall weakness of the claim (and would

likely lead to its dismissal even if the “can cause” prong had been satisfied), my focus is on Petitioner’s inability to

show the Tdap vaccine can cause POTS in the first place, and therefore I do not include determinations specific to

these other points in my analysis.

11

Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding

authority. Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings

concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121,

124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V,

2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).

9

only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.”

Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344,

1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed.

Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions;

rather, the petition must be supported by either medical records or by the opinion of a competent

physician. Section 13(a)(1).

In attempting to establish entitlement to a Vaccine Program award of compensation for a

Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal

Circuit in Althen v. Sec’y of Health and Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(1) a

medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause

and effect showing that the vaccination was the reason for the injury; and (3) a showing of

proximate temporal relationship between vaccination and injury.” Each Althen prong requires a

different showing and is discussed in turn along with the parties’ arguments and my findings.

Under Althen prong one, petitioners must provide a “reputable medical theory,”

demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at

1355–56 (citations omitted). To satisfy this prong, a petitioner’s theory must be based on a “sound

and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d

543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or

scientifically certain.” Id. at 549.

In discussing the evidentiary standard applicable to the first Althen prong, the Federal

Circuit has consistently rejected the contention that it can be satisfied merely by establishing the

proposed causal theory’s scientific or medical plausibility. See Kalajdzic v. Sec’y of Health &

Hum. Servs., No. 2023-1321, 2024 WL 3064398, at *2 (Fed. Cir. June 20, 2024) (arguments “for

a less than preponderance standard” deemed “plainly inconsistent with our precedent” (citing

Moberly, 592 F.3d at 1322)); Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359

(Fed. Cir. 2019); see also Howard v. Sec'y of Health & Hum. Servs., 2023 WL 4117370, at *4

(Fed. Cl. May 18, 2023) (“[t]he standard has been preponderance for nearly four decades”), aff’d,

2024 WL 2873301 (Fed. Cir. June 7, 2024) (unpublished). And petitioners always have the

ultimate burden of establishing their overall Vaccine Act claim with preponderant evidence. W.C.

v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted); Tarsell

v. United States, 133 Fed. Cl. 782, 793 (2017) (noting that Moberly “addresses the petitioner’s

overall burden of proving causation-in-fact under the Vaccine Act” by a preponderance standard).

Petitioners may offer a variety of individual items of evidence in support of the first Althen

prong, and are not obligated to resort to medical literature, epidemiological studies, demonstration

of a specific mechanism, or a generally accepted medical theory. Andreu v. Sec'y of Health & Hum.

Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing Capizzano, 440 F.3d at 1325–26). No one

10

“type” of evidence is required. Special masters, despite their expertise, are not empowered by

statute to conclusively resolve what are essentially thorny scientific and medical questions, and

thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of

the laboratorian, but instead from the vantage point of the Vaccine Act's preponderant evidence

standard.” Andreu, 569 F.3d at 1380. Nevertheless, even though “scientific certainty” is not

required to prevail, the individual items of proof offered for the “can cause” prong must each

reflect or arise from “reputable” or “sound and reliable” medical science. Boatmon, 941 F.3d at

1359–60.

The second Althen prong requires proof of a logical sequence of cause and effect, usually

supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,

569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec'y of Health & Hum. Servs., 956

F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions

and views of the injured party's treating physicians are entitled to some weight. Andreu, 569 F.3d

at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored

in vaccine cases, as treating physicians are likely to be in the best position to determine whether a

‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”)

(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly

trustworthy evidence, since they are created contemporaneously with the treatment of the patient.

Cucuras v. Sec'y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

However, medical records and/or statements of a treating physician's views do not per se

bind the special master to adopt the conclusions of such an individual, even if they must be

considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,

conclusion, judgment, test result, report, or summary shall not be binding on the special master or

court”); Snyder v. Sec'y of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is

nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be

accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a

theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the

reasonableness of their suppositions or bases. The views of treating physicians should also be

weighed against other, contrary evidence also present in the record—including conflicting

opinions among such individuals. Hibbard v. Sec'y of Health & Hum. Servs., 100 Fed. Cl. 742,

749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians'

conclusions against each other), aff'd, 698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec'y of Health

& Hum. Servs., No. 06–522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011),

mot. for review den'd, 100 Fed. Cl. 344, 356–57 (2011), aff'd without opinion, 475 F. App’x. 765

(Fed. Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between

the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the

11

phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant

proof that the onset of symptoms occurred within a timeframe which, given the medical

understanding of the disorder's etiology, it is medically acceptable to infer causation.” de Bazan v.

Sec'y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is

a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine

can cause an injury (Althen prong one's requirement). Id. at 1352; Shapiro v. Sec'y of Health &

Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den'd after remand, 105 Fed. Cl. 353 (2012),

aff'd mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec'y of Health & Hum. Servs., No. 11–

355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den'd (Fed. Cl.

Dec. 3, 2013), aff'd, 773 F.3d 1239 (Fed. Cir. 2014).

B. Law Governing Analysis of Fact Evidence

The process for making determinations in Vaccine Program cases regarding factual issues

begins with consideration of the medical records. Section 11(c)(2). The special master is required

to consider “all [ ] relevant medical and scientific evidence contained in the record,” including

“any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained

in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability,

injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are

contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special

master is then required to weigh the evidence presented, including contemporaneous medical

records and testimony. See Burns v. Sec'y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir.

1993) (determining that it is within the special master's discretion to determine whether to afford

greater weight to contemporaneous medical records than to other evidence, such as oral testimony

surrounding the events in question that was given at a later date, provided that such determination

is evidenced by a rational determination).

As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as

trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. Servs., 95

Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his

contemporaneous medical records, the special master's decision to rely on petitioner's medical

records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Hum.

Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked

propositions explains why such records deserve some weight: (i) sick people visit medical

professionals; (ii) sick people attempt to honestly report their health problems to those

professionals; and (iii) medical professionals record what they are told or observe when examining

their patients in as accurate a manner as possible, so that they are aware of enough relevant facts

to make appropriate treatment decisions. Sanchez v. Sec'y of Health & Hum. Servs., No. 11–685V,

2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum.

Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to

12

conclude that petitioners would fail to accurately report the onset of their daughter's symptoms”).

Accordingly, if the medical records are clear, consistent, and complete, then they should

be afforded substantial weight. Lowrie v. Sec'y of Health & Hum. Servs., No. 03–1585V, 2005 WL

6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records

are often found to be deserving of greater evidentiary weight than oral testimony—especially

where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also

Murphy v. Sec'y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d

1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States

v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral

testimony which is in conflict with contemporaneous documents is entitled to little evidentiary

weight.”)).

However, the Federal Circuit has also noted that there is no formal “presumption” that

records are accurate or superior on their face when compared to other forms of evidence. Kirby v.

Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations

in which compelling oral testimony may be more persuasive than written records, such as where

records are deemed to be incomplete or inaccurate. Campbell v. Sec'y of Health & Hum. Servs., 69

Fed. Cl. 775, 779 (2006) (“like any norm based upon common sense and experience, this rule

should not be treated as an absolute and must yield where the factual predicates for its application

are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“[w]ritten records which are,

themselves, inconsistent, should be accorded less deference than those which are internally

consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination regarding a witness's

credibility may be required when determining the weight that such testimony should be afforded.

Andreu, 569 F.3d at 1379; Bradley v. Sec'y of Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed.

Cir. 1993).

When witness testimony is offered to overcome the presumption of accuracy afforded to

contemporaneous medical records, such testimony must be “consistent, clear, cogent, and

compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. Servs.,

No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the

accuracy and completeness of medical records, the Court of Federal Claims has listed four possible

explanations for inconsistencies between contemporaneously created medical records and later

testimony: (1) a person's failure to recount to the medical professional everything that happened

during the relevant time period; (2) the medical professional's failure to document everything

reported to her or him; (3) a person's faulty recollection of the events when presenting testimony;

or (4) a person's purposeful recounting of symptoms that did not exist. La Londe v. Sec'y of Health

& Hum. Servs., 110 Fed. Cl. 184, 203–04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir. 2014). In making

a determination regarding whether to afford greater weight to contemporaneous medical records

or other evidence, such as testimony at hearing, there must be evidence that this decision was the

13

result of a rational determination. Burns, 3 F.3d at 417.

C. Consideration of Medical Literature

Both parties filed numerous items of medical and scientific literature in this case, but not

every filed item factors into the outcome of this Decision. While I have reviewed all the medical

literature submitted in this case, I discuss only those articles that are most relevant to my

determination and/or are central to Petitioner’s case—just as I have not exhaustively discussed

every individual medical record filed. Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322,

1328 (Fed. Cir. 2016) (“[w]e generally presume that a special master considered the relevant record

evidence even though he does not explicitly reference such evidence in his decision”) (citation

omitted); see also Paterek v. Sec’y of Health & Hum. Servs., 527 F. Appx. 875, 884 (Fed. Cir.

2013) (“[f]inding certain information not relevant does not lead to—and likely undermines—the

conclusion that it was not considered”).

D. Disposition of Case Without Hearing

I am resolving Petitioner’s claim on the filed record. The Vaccine Act and Rules not only

contemplate but encourage special masters to decide petitions on the papers where (in the exercise

of their discretion) they conclude that doing so will properly and fairly resolve the case. Section

12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of hearing has been

affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed. Cir.

2020); see also Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V, 2016 WL 3456435, at *21

n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided

case on the papers in lieu of hearing and that decision was upheld). I am not required to hold a

hearing in every matter, no matter the preferences of the parties. Hovey v. Sec’y of Health & Hum.

Servs., 38 Fed. Cl. 397, 402–03 (1997) (determining that special master acted within his discretion

in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy v. Sec’y of Health & Hum. Servs.,

No. 90-882V, 1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr. 19, 1991).

ANALYSIS

As should be evident from the foregoing, this claim has any number of deficiencies that

would make early dismissal appropriate. In particular, it is clear from the record as it stands that

Petitioner would unlikely be able to substantiate either claimed injury – she was never formally

diagnosed with POTS or CFS,12 and it does not appear from her medical history that testing

12

Petitioner’s alleged CFS injury was particularly unsupported by the record. The first Vaccine Program case to find

a causal link between a vaccine and CFS was Jane Doe/52 v. Sec'y of Dep't of Health & Hum. Servs., 2009 WL

5206199 at *16 (Fed. Cl. Spec. Mstr. Dec. 15, 2009), and it provides a good contrast into the kind of presentation that

might reflect the existence of CFS. Within three days of receiving the hepatitis B vaccine, the Jane Doe/52 petitioner

14

necessary to confirm either was performed.13 Moreover, the timeframe between when the

vaccination occurred and when Petitioner could arguably claim either injury manifested was more

than a year, and thus facially far too long to be causally related.

Disposition of this claim, however, primarily turns on the first Althen prong, which requires

a claimant to provide a “persuasive medical theory” demonstrating that the vaccine received can

cause or significantly aggravate the type of injury alleged. Althen, 418 F.3d at 1278. While a

“persuasive medical theory” does not need to meet the standard of medical or scientific certainty

(and may be supported by a variety of items of circumstantial or indirect proof), it must still be

sound and reliable. Boatmon, 941 F.3d at 1351.

POTS is a circulation disorder characterized by a group of symptoms (not including

hypotension) that sometimes occur when a person assumes an upright position, including

tachycardia, tremulousness, lightheadedness, sweating, and hyperventilation. The condition is seen

more often in women than in men, and its etiology is uncertain. “Postural orthostatic tachycardia

syndrome,” Dorland's Medical Dictionary Online, https://www.dorlandsonline.com

/dorland/definition?id=111236 (last visited Sep. 25, 2024).

As I have concluded in numerous prior cases, POTS is most commonly not attributable to

an autoimmune process. See e.g., C.F., 2023 WL 2198809, at *32; E.S. v. Sec'y of Health & Hum.

Servs., No. 17-480V, 2020 WL 9076620, at *43 (Fed. Cl. Spec. Mstr. Nov. 13, 2020), mot. for

review den’d, 154 Fed. Cl. 149 (2021). Rather, POTS usually results from “deconditioning”

(physical changes in the body caused by physical inactivity and/or an extremely sedentary

lifestyle), hypovolemia (inadequate intake of fluids), or cardiac atrophy (a condition that occurs

when the heart muscles waste away). C.F., 2023 WL 2198809, at *30. While some evidence has

emerged in recent years that a small subset of POTS cases might have an autoimmune basis, this

is the exception to the rule. E.S., 2020 WL 9076620, at *43. And the independent medical or

scientific evidence that would support the possibility of an autoimmune version of the condition

is scant and incomplete – and certainly does not point to vaccination as a triggering factor. Id.

developed flu-like symptoms, malaise, low back pain, sore throat, lymph node swelling, musculoskeletal pain, and

extreme exhaustion – she was eventually bedridden. Id. at *2. These symptoms lasted for two years before the

petitioner was ultimately diagnosed with chronic fatigue syndrome. Id. But the symptoms Petitioner complains of that

might arguably reflect CFS involved sporadic reports of intermittent, transient fatigue. Mot. at 27. Otherwise, the

record only includes medical chart code references to CFS (Opp. at 37), and that diagnosis is not set forth as a treater

conclusion, based on clinical presentation or test results.

13

In previous cases, for example, I have noted that the tilt table test (in which an individual’s orthostatic readings are

continuously taken while the subject is secured to a flat tale that is then titled up), is the “gold standard” for diagnosing

POTS. See Yalacki v. Sec'y of Health & Hum. Servs., No. 14-278V, 2019 WL 1061429 at *5, *35 (Fed. Cl. Jan. 31,

2019), mot. for review den’d, 146 Fed. Cl. 80 (2019). Petitioner’s health care providers never ordered a tilt table test

for her.

15

Petitioner, however, insists that POTS is predominantly an autoimmune disease that can

be triggered by vaccination. Brief at 5. To prove this theory, Petitioner relies heavily on arguments

involving the HPV vaccine. Id. But I have repeatedly found such arguments unpersuasive – and I

have reached this conclusion after hearings, as well as evaluation of large amounts of relevant

independent medical and scientific literature. See, e.g., C.F., 2023 WL 2198809, at *36 (there is

not preponderant evidence of a reliable medical theory causally connecting Petitioner’s HPV

vaccine to her POTS); Hughes v. Sec'y of Health & Hum. Servs., No. 16-930V, 2021 WL 839092,

at *30 (Fed. Cl. Spec. Mast. Jan. 4, 2021) (finding that Petitioner was unable to preponderantly

demonstrate that the HPV vaccine can cause POTS); Otto v. Sec'y of Health & Hum. Servs., No.

16-1144, 2020 WL 4719285, at *2 (Fed. Cl. Spec. Mstr. June 17, 2020) (finding Petitioner’s

causation theory – that the HPV vaccine can cause POTS – unreliable and unsupported by

sufficient scientific/medical evidence); E.S., 2020 WL 9076620, at *42 (ruling that Petitioner has

not established that the HPV vaccine or flu vaccine can cause POTS). And my conclusion does

not reflect merely my own view on the subject – for no special masters have ever found POTS is

caused by the HPV vaccine. Kelly v. Sec'y of Health & Hum. Servs., No. 21-827V, 2024 WL

3498199, at *9 (Fed. Cl. Spec. Mstr. June 26, 2024).

Petitioner nevertheless relies heavily on this discredited association between POTS and the

HPV vaccine – and to do so, she offers an abundance of literature that I have previously rejected

as unreliable or unpersuasive. See e.g., C.F., 2023 WL 2198809, at *15, *17-19, *32 (discussing

Blitshteyn, Chandler, Schofield, and Brinth). Accordingly, she makes as a centerpiece of her

causation argument in this case a contention that itself is insufficiently preponderant – and one that

numerous prior cases directly address. Because of this – and given the obvious point that the HPV

vaccine is not at issue in any event – these arguments do nothing to advance Petitioner’s position.

This leaves open (if barely) the possibility that the Tdap vaccine could be shown to be

causal of POTS in a way the HPV vaccine has not been in past matters. But (and despite due

opportunity herein, via the briefing of this matter) the only evidence offered specific to the relevant

vaccine is a single case study, in which a patient with a life-threatening tetanus infection developed

POTS-like symptoms (Won Seo). Brief at 17-18. Won Seo says nothing about the Tdap vaccine,

and did not involve a POTS diagnosis either. None of the other filed materials involve either the

Tdap vaccine or its constituent wild analogs.

To compensate for the fact that no medical literature preponderantly supports her causal

theory, Petitioner invokes the general theory of molecular mimicry. Brief at 20. She argues that

there is significant homology between peptide components of the Tdap vaccine and Alpha-1

adrenergic receptor, allowing for the possibility that an antibody-driven cross-reaction could occur

and ultimately cause POTS. Id. But I have consistently held that establishing homology is not

enough to prove that molecular mimicry constitutes a likely mediating mechanism for a vaccine-

triggered injury. See Sullivan v. Sec'y of Health & Hum. Servs., No. 10-398V, 2015 WL 1404957,

16

at *17-18, n. 30 (Fed. Cl. Spec. Mstr. Feb. 13, 2015) (while the law does not require Petitioner to

“prove” homology in a Program case, mere assertion that HPV strain shares sequences with human

body such that molecular mimicry might occur resulting in injury was by itself insufficient to

satisfy burden); see also Yalacki v. Sec'y of Health & Hum. Servs., No. 14-278V, 2019 WL

1061429, at *34 (Fed. Cl. Spec. Mstr. Jan. 31, 2019), mot. for review den'd, 146 Fed. Cl. 80 (2019)

(commenting on petitioner's theory that the Hep B vaccine could trigger a pathogenic process

resulting in an autoimmune attack, but finding that it was “not enough for a claimant to invoke the

concept of molecular mimicry” as petitioner needed to “cite to evidence, circumstantial or

otherwise, suggesting reason to find it plausible that the proposed autoimmune cross-reaction

triggered by the relevant vaccine does occur”).

Put simply, the fact that molecular mimicry has been deemed applicable to some

autoimmune diseases, or has scientific reliability as a mechanism in certain circumstances, does

not mean the mechanism is applicable across the board to any vaccine injury claim. McKown v.

Sec'y of Health & Hum. Servs., No. 15-1451V, 2019 WL 4072113, at *50 (Fed. Cl. Spec. Mstr.

July 15, 2019) (“merely chanting the magic words ‘moleculary mimicry’ in a Vaccine Act case

does not render a causation theory scientifically reliable, absent additional evidence specifically

tying the mechanism to the injury and/or vaccine in question.”); see also Deshler v. Sec'y of Health

& Hum. Servs., No. 16-1070V, 2020 WL 4593162, at *20 (Fed. Cl. Spec. Mstr. July 1, 2020)

(“though molecular mimicry is a generally accepted scientific principle, mere invocation of the

scientific term does not carry a petitioner’s burden in a Program case.”).

Thus, there is insufficient evidence offered herein connecting the Tdap vaccine to POTS –

even less than what is offered to connect the HPV vaccine to POTS (but which has been repeatedly

rejected in prior well-reasoned decisions). And nothing new has been identified from the medical

or scientific community that would provide a basis for allowing this claim to continue.

The same is true for any putative association between CFS and the Tdap vaccine. As noted,

it is not evident that Petitioner ever had CFS. And even if she had properly received such a

diagnosis, and the record supported it, claimants in the Vaccine Program have been routinely

unsuccessful in arguing that vaccines can cause CFS. See e.g., Skinner-Smith v. Sec'y of Health &

Hum. Servs., No. 14-1212V, 2022 WL 4116896 (Fed. Cl. Spec. Mstr. Aug. 15, 2022),

reconsideration denied, 2022 WL 13461862 (Fed. Cl. Spec. Mstr. Sept. 9, 2022) (nothing in the

record to support the conclusion that the Tdap vaccine can cause immune dysregulation leading to

CFS); Johnson v. Sec. of Health & Human Servs., No. 14-254V, 2018 WL 2051760 (Fed. Cl. Spec.

Mstr. Mar. 23, 2018) (denying entitlement in case alleging CFS and POTS caused by HPV

vaccination); D'Angiolini v. Sec'y of Health & Hum. Servs., No. 99-5788V, 2014 WL 1678145

(Fed. Cl. Spec. Mstr. March 27, 2014) (denying entitlement for adverse reaction, including CFS,

17

allegedly caused by hepatitis B vaccine).14 These decisions do not control the disposition of this

case, but they underscore why (and in the absence of some independent basis for reevaluation)

rejection of this causal theory would be reasonable.

My determination to dismiss the case comes relatively early in the matter’s existence, and

before substantial expert input was sought, but is a reasonable outcome in light of the claim’s very-

evident deficiencies. Special masters are empowered to decide what discovery is needed to resolve

a given matter. 42 U.S.C. § 300aa–12(d)(3)(B); see also Felix v. Sec'y of Health & Hum. Servs.,

172 Fed. Cl. 626, 632 (2024) (“[n]ot all vaccine cases merit expert witness testimony”). They also

have “wide discretion in determining whether to conduct an evidentiary hearing.” Kreizenbeck.,

945 F.3d at 1365; see also Oliver v. Sec'y of Health & Hum. Servs., 900 F.3d 1357, 1364 n.6 (Fed.

Cir. 2018) (holding that “Chief Special Master acted within her discretion in denying” the

petitioner's request for a hearing). What matters at bottom is whether a claimant has been afforded

“a full and fair opportunity to present [their] case and creat[e] a record sufficient to allow review

of the special master's decision” through medical evidence and proffered affidavits in accordance

with Vaccine Rule 3(b)(2). See, e.g., K.A. v. Sec'y of Health & Hum. Servs., 164 Fed. Cl. 98, 115–

19 (2022) (decision to deny requests to retain and present particular expert witness did not deprive

the parties of “a full and fair opportunity to present his case” or otherwise amount to an abuse of

discretion), aff'd, No. 23-1315, 2024 WL 2012526 (Fed. Cir. May 7, 2024) (per curiam) (table).

Relying on my extensive experience with POTS cases, I noted a glaring problem with this

claim early on in its existence, and one that I expected would render the claim untenable. But

before I dismissed the matter, I invited the Petitioner to attempt to address my concerns – in

particular by offering whatever independent evidence she could that would suggest this claim

would fare better than similar prior matters, and thus should be allowed to progress. In reaction,

Petitioner filed extensive medical records and briefs to support her claim, along with a lengthy

appendix of medical and scientific articles. Yet this effort amounted to repeating what has been

rejected in numerous prior Program matters regarding the HPV vaccine and POTS. And she

otherwise has offered scant evidence specific to the Tdap vaccine, despite ample opportunity to do

so. Under such circumstances, it cannot be said that Petitioner has been deprived of a chance to

prove a claim that is so self-evidently unlikely to succeed.

14

At best, a special master in one case found that the petitioner preponderantly established the influenza vaccine as a

cause of chronic fatigue syndrome. Bryan v. Sec'y of Health & Hum. Servs., No. 14-898V, 2020 WL 7089841 at *1

(Fed. Cl. Spec. Mstr. Oct. 9, 2020). But Skinner-Smith noted that what was arguably true of the flu vaccine has not

been shown to be applicable to the Tdap vaccine. Skinner-Smith, 2022 WL 4116896., at *35.

18

CONCLUSION

Petitioner cannot substantiate her claim that the Tdap vaccine can cause POTS or CFS. I

therefore must DENY entitlement in this case.

In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the

Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision.15

IT IS SO ORDERED.

/s/ Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

15

Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices

renouncing their right to seek review.

19