Lind v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 22-1016V

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

* Chief Special Master Corcoran

DAVID LIND, *

* Filed: February 17, 2026

Petitioner, *

*

v. *

*

SECRETARY OF HEALTH AND *

HUMAN SERVICES, *

*

Respondent. *

*

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

Kathleen Loucks, Lommen Abdo Law Firm, Minneapolis, MN, for Petitioner.

Nathaniel Trager, U.S. Department of Justice, Washington, DC, for Respondent.

ENTITLEMENT DECISION 1

On August 19, 2022, David Lind filed a petition for compensation under the National

Childhood Vaccine Injury Act of 1986, as amended, 42 U.S.C. §§ 300aa-10 et seq. (“Vaccine

Act”). 2 Petitioner alleges that as a result of receiving an influenza (“flu”) vaccine on September

23, 2020, he developed Chronic Pain Syndrome and/or Chronic Fatigue Syndrome (“CFS”). See

Petition at 1.

The parties agreed this matter could be appropriately resolved on the basis of the filed and

written record, and have offered briefs in support of their respective positions. Petitioner’s Motion

for Ruling on the Record, dated January 15, 2025 (ECF No. 46) (“Mot.”); Respondent’s

1

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 whole Decision will be available to the public

in its present 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. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (“Vaccine Act” or “the Act”).

Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix).

Opposition, dated June 18, 2025 (ECF No. 52) (“Opp.”); Petitioner’s Reply, dated August 13, 2025

(ECF No. 57) (“Reply”). Now, for the reasons set forth below, I deny entitlement.

I. Fact History

Pre-Vaccination History

Petitioner’s pre-vaccination history includes a wide variety of comorbidities, including

mental and physical conditions he was treated for that were thought to have caused pain, impacted

his vigor, and/or detracted from his ability to concentrate. Ex. 4 at 8, 12, 25, 73, 217. These include

autism spectrum disorder, posttraumatic stress disorder (“PTSD”), dysthymic disorder, attention

deficit hyperactivity disorder (“ADHD”), hyperlipidemia, diabetes mellitus, painful peripheral

neuropathy, sleep apnea, and a mild traumatic brain injury with associated headaches, neck pain,

and aphasia. Id. at 144, 10, 322, 183, 191, 1300; Ex. 3 at 1. Petitioner’s apnea was thought to be

associated with fatigue, hypertension, and obesity. Ex. 4 at 355.

Petitioner was prescribed medications for his ADHD and depression. See Ex. 4 at 217. In

January 2016, he was treated for memory and focus issues, and was diagnosed with chronic tension

headaches, temporo-mandibular joint disorder (a chronic facial pain condition), post-concussion

syndrome, insomnia, and PTSD. Id. at 8, 12. That same month, a neuropsychologist saw Mr. Lind

and proposed that his symptoms (including aphasia, difficulty with planning, and poor

concentration) could be attributable to severe emotional distress, adding that diagnostic testing

supported diagnoses of chronic anxiety and depression. Id. at 25.

In November 2017, Petitioner underwent a gallbladder removal that resulted in residual

pain weeks after surgery. Ex. 5 at 241–42, 832–33. Petitioner also was diagnosed in late 2019 with

a lesion of his right ulnar nerve and right wrist pain, which he attributed to protecting his dog from

a dog fight, and a sprain in his left ring finger, which (in occupational therapy) were later attributed

to a repetitive stress injury from drumming. Ex. 4 at 602, 684. And throughout 2018 into April

2019, Petitioner repeatedly reported fatigue to his psychiatrist, family doctor, and dermatologist.

See id. at 217, 222–23, 236, 296, 318–19, 471.

Receipt of Subject Vaccine and Subsequent Symptoms

On September 23, 2020, Mr. Lind was administered a flu vaccine at HealthPartners Hills

Family Practice (“AHFP”) in Arden Hills, MN. Ex. 1 at 2. Eight days later (October 1, 2020),

Petitioner had a telemedicine consultation at AHFP with family medicine physician Michael

Stiffman, M.D. Ex. 4 at 813. Petitioner reported post-vaccination headaches, muscle pain, lethargy,

and weakness, adding that while he had experienced comparable symptoms after vaccination, they

seemed to have lasted longer this time. Id. Dr. Stiffman deemed Petitioner’s myalgias and other

2

complaints to be “likely an immune reaction to the influenza vaccine,” and he proposed testing for

a COVID-19 infection. Id.

On October 6, 2020, Petitioner returned to Dr. Stiffman with complaints of body aches,

muscle pain, and joint pain. Ex. 4 at 823. He again reported that his symptoms had begun after his

September vaccination, and included “myalgias and arthralgias – [in his] shoulders, chest, ankles,

[and] knees.” Id. at 824. A physical exam yielded normal findings, and it was also noted that

Petitioner had tested negative for a COVID-19 infection. Id. but Dr. Stiffman diagnosed Petitioner

with “severe myalgias and arthralgias” beginning after vaccination (although this record does not

include speculation that the two were linked). Id. at 825.

Later that same month, Petitioner was referred by a different treater to a rheumatologist for

his ongoing complaints of lethargy, weakness, aches, and pains in his joints and muscles. Ex. 4 at

851. A tapering course of prednisone was prescribed, and Petitioner underwent an extensive lab

workup, which revealed normal findings. Id. Petitioner also at the end of October informed

psychiatric treaters that he had developed persistent aches and pains within hours of his September

23, 2020, vaccination, although it was noted at this time that his inflammatory marker testing did

not reveal concerns. Id. at 867.

On November 20, 2020, Mr. Lind saw Dr. Eric Miller at HealthPartners Rheumatology

Clinic for evaluation of diffuse arthralgias and myalgias, fatigue, and headaches. Petitioner again

reported a post-vaccination onset of symptoms beginning within a few hours of vaccination. Ex. 4

at 874. In the write-up for this visit, Dr. Miller deemed Petitioner’s clinical history to be “unusual

for inflammatory arthritis, ANA-related disease, myositis, [and] vasculitis.” Id. at 873. But Dr.

Miller noted a “clear association” with the vaccination, albeit one based on Petitioner’s self-

reporting symptoms onset. Id. Dr. Miller’s differential diagnosis included myalgia and fatigue, and

he increased petitioner’s dose of prednisone. Id.

Subsequent Pain Management Treatment

The next month (on December 10, 2020), Mr. Lind had a telemedicine visit with Dr. Alfred

Clavell at Anoka Pain Management (“Anoka”). Ex. 4 at 896. Petitioner noted he generally had

been experiencing pain, headaches, and fatigue for three months. Id. at 897. He also noted that his

previous complaints of intractable headaches had improved following resolution of his pending

workers’ compensation cases. Id. at 898. But he noted as well that within the eleven weeks that

had passed since his vaccination, he was experiencing myalgias “and pain and foggy headed,” and

that he “can’t organize thoughts.” Id. Dr. Clavell deemed Petitioner’s history to be “consistent

with early phase of chronic fatigue syndrome vs. fibromyalgia.” Id. at 901. Dr. Clavell diagnosed

Petitioner with myalgia at multiple sites and referred him to clinical health psychology and

physical therapy (“PT”). Id.

3

At the end of December 2020, Petitioner had his first telemedicine visit at Anoka with

psychologist Georgia Panopoulos, Ph.D., L.P. He reported a long history of “problems and

impairments due to pain” that included being on social security disability insurance for the prior

two years. Ex. 4 at 914–15. At a return visit on January 14, 2021, he “made a connection pain in

his shoulder and past trauma/traumatic memories.” Id. at 936. There was no mention of Petitioner’s

flu vaccine, or pain related to the flu vaccine at this appointment. Petitioner subsequently had

numerous additional visits with Dr. Panopoulos, through the end of 2022. 3 He was noted to have

been diagnosed with “pain [disorder] associated with psychological factors and a general medical

condition (chronic pain disorder).” See, e.g., id at 936; see also id. at 915, 984, 1006. Over the

course of seeing Dr. Panopoulos, Petitioner’s reported progress trended towards improvement,

with Petitioner generally claiming his progress towards his goals were good, he was increasing his

physical activity, and his pain and emotional state remained stable. Id. at 915, 936, 984, 1006,

1020, 1101, 1114, 1171; but see id. at 1161 (Petitioner relayed consistent improvements or stability

in mood and pain until his May 13, 2021, visit where he stated that his pain and emotional state

had worsened since his April 29, 2021, visit.).

Treatment in 2021 and Thereafter

On January 8, 2021, Mr. Lind initiated PT with NovaCare Rehabilitation for a “chronic

pain condition [which] contributed to myalgia following [his flu] vaccine.” Ex. 6 at 7. He attended

32 visits through late October 2021, by which time he had been deemed to have met his goals,

with a fair future prognosis. Id. at 122, 124. No other medical records filed in this case bear on

resolution of causation.

II. Experts

A. Petitioner’s Expert – Dr. Marcel Kinsbourne 4 – Dr. Kinsbourne, a pediatric

neurology specialist, prepared a single report in support of Petitioner’s claim. Report, dated Sep.

12, 2023, filed as Ex. 10 (ECF No. 28-1) (“Kinsbourne Rep.”). He opined that Mr. Lind

experienced CFS due to the flu vaccine he received in September 2020.

Dr. Kinsbourne was board certified in pediatrics. See Curriculum Vitae, dated Sep. 14,

2023, filed as Ex. 11 (ECF No. 28-2) (“Kinsbourne CV”) at 1. He received his medical degree in

3

See id at 915, 936, 984, 1006, 1020, 1101, 1114, 1161, 1171, 1180, 1219, 1282, 1307, 1310, 1330, 1346, 1362, 1367,

1370, 1382, 1385, 1395, 1408, 1411, 1414, 1417, 1429, 1432, 1435, 1438, 1441, 1444, 1447, 1450, 1453, 1456, 1459,

1462, 1465, 1467, 1469, 1472, 1475; Ex. 7 at 36, 49, 61, 158, 177, 190, 203, 261; Ex. 20 at 61.

4

Dr. Kinsbourne passed away during the pendency of this matter (as noted below). He was an erudite, courteous, and

committed expert advocate for Program claimants for many years.

4

England, and was licensed to practice medicine in North Carolina since 1967. Id. From 1967 to

1974, Dr. Kinsbourne served as an associate professor in pediatrics and neurology and a senior

research associate at Duke University Medical Center before holding a series of academic

positions, including professorships in pediatrics, neurology, and psychology. Id. at 1–2. His

clinical experience included serving as a senior staff physician in Ontario from 1974–1980, and a

clinical associate in neurology at Massachusetts General Hospital from 1981–1991, although (as

noted in other cases) many years had passed since he regularly saw patients. See, e.g., Strong v.

Sec'y of Health & Hum. Servs., No. 15-1108V, 2018 WL 1125666, at *6 (Fed. Cl. Spec. Mstr. Jan.

12, 2018); McCollum v. Sec'y of Health & Hum. Servs., No. 14-790V, 2017 WL 5386613, at *6

(Fed. Cl. Spec. Mstr. Sep. 15, 2017); Pope v. Sec'y of Health & Hum. Servs., No. 14-078V, 2017

WL 2460503, at *8 (Fed. Cl. Spec. Mstr. May 1, 2017). He authored over 400 peer-reviewed

articles over the course of his practice relating to pediatrics and neurology. Kinsbourne CV at 5–

33. Dr. Kinsbourne had not personally studied the immunologic issues raised by theories claiming

vaccine causation (although his general neurologic expertise rendered him competent to discuss

such matters).

Dr. Kinsbourne’s report began with a summary of Petitioner’s medical history. Kinsbourne

Rep. at 1–4. He acknowledged, and even reviewed, Petitioner’s ample pre-vaccination history of

conditions that at least facially could have some relationship to his CFS, but denied they in fact

were related. Id. at 1–2, 4.

CFS, Dr. Kinsbourne noted, is “characterized by fatigue lasting more than six months,”

plus muscle and joint pain, and is not relieved by rest, leading to constant debilitation. Kinsbourne

Rep. at 4. Its diagnosis requires evidence of new onset (without lifelong occurrence) not linked to

exertion, and which features persistent/relapsing chronic symptoms. K. Fukuda et al., The Chronic

Fatigue Syndrome: A Comprehensive Approach to Its Definition and Study, 121 Annals of Internal

Medicine 953, 956 (Dec. 15, 1994), filed as Ex. 14 (ECF No. 28-5) (“Fukuda”). In addition, at

least four of eight other symptoms must have been experienced during six or more months of

illness, but predate the resulting fatigue—memory impairment/concentration limits; sore throat;

tender lymph nodes; muscle pain; joint pain without swelling/redness; new pattern headache;

unrefreshing sleep; and post-exertional malaise lasting more than a day. Kinsbourne Rep. at 4–5;

Fukuda at 956.

Dr. Kinsbourne proposed that CFS could be attributed to “central sensitization”—which

he noted features persistent pain and other symptoms, despite treatment and in the absence of

evidence of inflammation. Kinsbourne Rep. at 5 (discussing A. Trouvin & S. Perrot, New Concepts

of Pain, 33 Best Practices and Research Clinical Rheumatology 245, 249 (June 2019) (“Trouvin

5

& Perrot”)). 5 Centralized sensation is defined as the “[i]ncreased responsiveness of nociceptive 6

neurons in the central nervous system.” Trouvin & Perrot at 249. Trouvin & Perrot outlined central

sensitization as a new classification of musculoskeletal pain based on studies on rheumatoid pain

that showed many patients continued to experience pain after receiving treatment for their

musculoskeletal conditions. Id. In effect, Dr. Kinsbourne proposed, central sensitization reflects

exaggeration and amplification of sensory stimuli, leading them to “feel” painful due to a

hyperexcited state that persists even without obvious stimuli. Kinsbourne Rep. at 6; M. Volcheck

et al., Central Sensitization, Chronic Pain and Other Symptoms: Better Understanding, Better

Management, 90 Cleveland Clinic Journal of Medicine 245, 247 (2023), filed as Ex. 18 (ECF No.

28-9) (CFS reflects a “trifecta” of hyperalgesia (painful stimuli become associated with additional

pain), allodynia (exaggerated sensitivity to otherwise non-painful stimuli), and global sensory

hyperresponsiveness to both external and internal stimuli). There is also a psychosomatic aspect

of CFS, in which “[p]ain catastrophizing and depression attend pain in CFS.” Kinsbourne Rep. at

6.

Mr. Lind clearly met the diagnostic criteria for CFS, Dr. Kinsbourne maintained.

Kinsbourne Rep. at 5. To substantiate this contention, Dr. Kinsbourne relied on post-vaccination

evidence of Petitioner’s subjective complaints, as well as self-reporting contained in Petitioner’s

witness statements. Id. at 2–4. Dr. Kinsbourne also disclaimed Petitioner’s prior comorbidities or

conditions as explanatory, deeming them (in a somewhat conclusory fashion) not “severe enough

to explain the recorded signs and symptoms,” or “either stable or treated and controlled.” Id. at 5.

The pathophysiology of CFS is, Dr. Kinsbourne maintained, “not known,” but he

contended (albeit without offering independent evidence in support) that it is “frequently triggered

by infections and vaccinations.” Kinsbourne Rep. at 5. Central sensitization likely occurred

because of a “prolonged increase in the excitability of neurons in central nociceptive pathways,”

uncoupled from the impact of a particular peripheral stimuli. Id. at 6; A. Latremoliere & C. Woolf

Central Sensitization: A Generator of Pain Hypersensitivity by Central Neuro Plasticity, 10 J. Pain

895, (2009), filed as Ex. 15 (ECF No. 28-6). It was also possible that “[u]nderlying, nitrogen and

oxidative stress” that result in “lowered pressure pain therapy in major muscles” contribute to the

process, explaining why CFS feelings of fatigue or pain increase after exercise. Kinsbourne Rep.

at 6.

5

While the article by Trouvin & Perrot is referenced and discussed in Dr. Kinsbourne’s expert report, the article does

not appear to have been filed as an exhibit in this matter.

6

Nociceptive is the adjective form of the noun “Nociceptor,” which is defined as “a receptor for pain caused by injury

to body tissues; the injury may be from physical stimuli such as mechanical, thermal, or electrical stimuli, or from

chemical stimuli such as the presence of a toxin or an excess of a nontoxic substance.” Nociceptor, Dorland’s Medical

Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=34163&searchterm=nociceptor (last

visited Feb. 11, 2026).

6

Thus, CFS likely reflects the concurrent presence of three factors:

1. Hyperexcitability of the cell membrane of central neurons, decreased action

Potential threshold, synaptic strength, decreased descending inhibitory

Transmission, reduced activation threshold, and enlarged receptive

Fields.

2. Heightened functional activity within the somatosensory cortex (sensory

processing), insula (emotional context of sensation, sensory appraisal), and

amygdala (mood processing).

3. Hyperactive sympathetic nervous system and endogenous opioid system.

Kinsbourne Rep. at 7. Dr. Kinsbourne did not, however, identify a source for this list of factors.

At most, he offered a study observing “a significant reduction in white matter volumes” in parts

of the brains of CFS patients, thus underscoring that there was a “role of central neural

mechanisms” in CFS’s onset. Id.; T. Yang et al., The Clinical Value of Cytokines in Chronic

Fatigue Syndrome, 17 J. Translational Medicine 213, 219 (2019), filed as Ex. 19 (ECF No. 28-10)

(“Yang”).

Dr. Kinsbourne next endeavored to show how the immune system’s response to

vaccination could create the circumstances necessary for CFS. Kinsbourne Rep. at 7–9. Patients

with CFS had been confirmed in studies to experience “highly attenuated” responses of a class of

T helper cell responsible for encouraging the production of certain cytokines, leading to an

“inflammatory milieu.” Id. at 7; G. Broderick et al., A Formal Analysis of Cytokine Networks in

Chronic Fatigue Syndrome, 24 Brian, Behavior and Immunity 1209 (2010), filed as Ex. 12 (ECF

No. 28-3) (“Broderick”). Thus, the neural changes likely at the center of CFS reflected central

nervous system inflammation. Yang at 219.

Vaccines, Dr. Kinsbourne maintained, could cause an immediate overproduction of

proinflammatory cytokines right after being administered. Kinsbourne Rep. at 7. Alternatively,

“repeated exposure to an initially subthreshold stimulus” (presumably receipt of a vaccine an

individual had been exposed to in the past) could trigger “kindling” of persistent hypersensitivity.

Id. Because of Petitioner’s pre-vaccination history, he was susceptible to such kindling (although

this argument somewhat runs contrary to Dr. Kinsbourne’s prior denial that Petitioner’s preexisting

conditions related to his CFS). Id. Dr. Kinsbourne did not explicitly set forth, however, why

vaccination would trigger this overstimulation (although reading his report in the most generous

light possible suggests he would contend the cytokine upregulation attributable to vaccination was

the trigger).

7

Another possible mechanism for how vaccination could spark CFS, Dr. Kinsbourne

contended, was simply the amplification of Petitioner’s underlying levels of stress. Kinsbourne

Rep. at 7–8. That stress would be enough to send the immune system “into a chronic state of

persisting subthreshold inflammation. Id. at 7; K. Louati & F. Berenbaum, Fatigue in Chronic

Inflammation – A link to Pain Pathways, 17 Arthritis Research & Therapy 254, 256 (2015), filed

as Ex. 16 (ECF No. 28-7). In such a state of persistent, if low-lying, inflammation, cytokines

prompted by vaccination could impact the kind of “nociceptive” pain characteristic of CFS.

Kinsbourne Rep. at 8.

Dr. Kinsbourne also proposed that the temporal relationship between Petitioner’s onset of

CFS symptoms (which he concluded began within hours of vaccination) was medically acceptable.

Kinsbourne Rep. at 4–5, 9. He emphasized the close timing of Petitioner’s symptoms to the

vaccination as suggestive of a causal relationship, and also observed treater opinions that at least

Petitioner’s initial symptoms might reflect vaccine-associated malaise. Id. at 5. In that short initial

timeframe, “the body’s overproduction of pro-inflammatory cytokines” would occur rapidly,

leading to symptoms. Id. at 7.

B. Respondent’s Expert – Dr. Roland Staud - Dr. Staud is a rheumatologist, and he

prepared a single written report responding to Dr. Kinsbourne’s opinion. Report, dated January 5

2024, filed as Ex. A (ECF No. 31-1) (“Staud Rep.”).

Dr. Staud earned his medical degree from Freie Universität in Berlin in 1972. Curriculum

Vitae, dated Jan. 29, 2024, filed as Ex. B (ECF No. 31-2) (“Staud CV”) at 1. After earning his

degree, he underwent two Internal Medicine residencies: one at Klinikum Charlottenburg of Freie

Universität, Berlin, Germany, and the second at Englewood Hospital located in Englewood, NJ

where he served as the Chief Resident. Id. After completing his residency at Englewood Hospital,

he underwent a Fellowship in Rheumatology at New York University. Id. Dr. Staud is board

certified in Rheumatology and Internal Medicine, and treats patients with rheumatological

conditions and musculoskeletal disorders, like CFS. Id.; Staud Rep. at 1. Dr. Staud currently serves

as the director of the Center for Chronic Musculoskeletal Pain and Fatigue Research at the

University of Florida, and has authored over 200 peer-reviewed articles on topics relating to

Rheumatology and Internal Medicine. Staud CV at 4–21; Staud Rep. at 1. Over the course of Dr.

Staud’s practice, he has treated many patients with CFS and other chronic musculoskeletal

disorders in his clinic, including rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s

syndrome, vasculitis, inflammatory myopathies, and chronic musculoskeletal disorders, including

fibromyalgia, complex regional pain syndrome, postural orthostatic tachycardia syndrome, and

myalgic encephalomyelitis, and systemic exercise intolerance disease. See Staud CV at 1; Staud

Rep. at 1.

8

Like Dr. Kinsbourne, Dr. Staud performed a records review inclusive of Petitioner’s pre

and post-vaccination treatment history, including a summary of it his report. See generally Staud

Rep. at 2–8. Dr. Staud observed that pre-vaccination, “[P]etitioner had been diagnosed with a large

number of chronic medical conditions associated with pain, fatigue, and decreased physical and

cognitive functioning,” that many of his conditions had been diagnosed up to six years before, and

that he had made an application for social disability in 2018 as a result of his medical issues. Id. at

9. Those preexisting conditions, however, were more likely explanatory of Petitioner’s post-

vaccination symptoms, which Dr. Staud felt were better characterized as PTSD or dysthymia7—

either of which had at their core a “strong emotional component.” Id. Dr. Staud thus rejected the

CFS diagnosis embraced by Dr. Kinsbourne, as well as the contention the flu vaccine had caused

it.

CFS, Dr. Staud explained, has existed as a diagnostic classification since the late 1980s,

replacing what was once referred to as “Epstein-Barr virus syndrome.” Staud Rep. at 11. He noted

that revisions to the diagnostic criteria have occurred over time, as medical understanding of CFS

evolved, adding that as of 2015 the National Academy of Medicine had updated the criteria to

include three primary elements:

(1) A substantial reduction or impairment in the ability to engage in pre-illness

levels of activity, persisting for more than six months and accompanied by

significant fatigue that is not due to exertion and that cannot be ameliorated with

rest;

(2) Post-exertional malaise (which can cause symptoms relapse and can even

occur simply as the result of sensory overload); and

(3) Unrefreshing sleep.

Institute of Medicine, Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining

an Illness, 145–46 (Nat’l Academies Press 2015), filed as Ex. 23 (ECF No. 42-1) (“IOM CFS

Report”). In addition, two manifestations of cognitive impairment or orthostatic intolerance

(worsening of symptoms in response to change in posture/body position, and reflected in evidence

of blood pressure or heart rate fluctuations) must be established. Staud Rep. at 12–13.

7

Dysthymic disorder, also referred to as dysthymia, is defined as “a mood disorder characterized by depressed feeling

(sad, blue, low), loss of interest or pleasure in one's usual activities, and by at least some of the following: altered

appetite, disturbed sleep patterns, lack of energy, low self-esteem, poor concentration or decision-making skills, and

feelings of hopelessness. Symptoms have persisted for more than 2 years but are not severe enough to meet the criteria

for major depressive disorder.” Dysthymic Disorder, Dorland’s Medical Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=71106 (last visited Feb. 11, 2026).

9

Dr. Staud opined that Petitioner could not be properly diagnosed with CFS. Staud Rep. at

16. First, the aforementioned criteria do not appear from the records to have been applied to

Petitioner’s presentation. Second, the actual clinical findings when Petitioner was examined did

not meet the criteria. Thus, there was no well documented evidence of post-exertional malaise. Id.

In Dr. Staud’s understanding, CFS is a “multifactorial condition,” with a number of

integrated and overlapping pathogenic features/causes. Staud Rep. at 13. But he allowed that

studies had identified some role for a “disturbance in immunity” for CFS patients, although those

immune irregularities involved possible cytokine profile alteration (with higher levels of

proinflammatory cytokines), decrease in function of some kinds of nonspecific immune cells, and

a heightened role for other T cells. M. Maes et al., Myalgic Encephalomyelitis (ME), Chronic

Fatigue Syndrome (CFS), and Chronic Fatigue (CF) are Distinguished Accurately: Results of

Supervised Learning Techniques Applied on Clinical and Inflammatory Data, 200 Psychiatry

Research 754, 758–59 (2012), filed as Ex. A-28 (ECF No. 33-8). Nevertheless, Dr. Staud

maintained that the flu vaccine was not itself reliably linked to CFS, even if an aberrant immune

response was likely responsible for some of its symptoms. Staud Rep. at 13–14. In so contending,

Dr. Staud began by comparing CFS to fibromyalgia, a “chronic musculoskeletal disorder of

widespread pain.” Id. at 13. 8

There are, Dr. Staud noted, some “observational research studies” speculating that

fibromyalgia may be related to infections, but support for that conclusion was not robust—and

studies looking at other possible external triggers (for example, motor vehicle accidents) not only

generated weak results, but even suggested that the symptoms often preceded the proposed adverse

trigger. G. Jones et al., Role of Road Traffic Accidents and Other Traumatic Events in the Onset

of Chronic Widespread Pain: Results from a Population-Based Prospective Study, 63 Arthritis

Care & Research 696, (2011), filed as Ex. A-35 (ECF No. 33-15). At most, single case reports

(which relied on the general proposition that “trauma or adverse reactions to vaccines cause[]

‘stress’”) existed, but are a poor kind of causation evidence. Staud Rep. at 13; J. Ablin et al.,

Fibromyalgia, Infection and Vaccination: Two More Parts in the Etiological Puzzle, 27 J.

Autoimmunity 145, 149 (2006), filed as Ex. A-37 (ECF No. 33-17). Rather, reliable evidence

suggested these kinds of chronic pain conditions were attributable to central nervous system

dysfunction, but little good evidence linked vaccination to initiating that process. R. Harris et al.,

Pregabalin Rectifies Aberrant Brain Chemistry, Connectivity, and Functional Response in

Chronic Pain Patients, 119 Anesthesiology 1453, 1463–64 (2013), filed as Ex. A-40 (ECF No.

33-20).

8

Dr. Staud’s report also included a discussion of fibromyalgia as an alternative diagnosis for Petitioner. Staud Rep. at

9–11. But Petitioner almost wholly seems to have contended in briefing his claim that his injury was CFS. Mot. at 17–

20. And Dr. Staud seems to have used it as an analog for explaining why vaccination was not likely to cause this kind

of presentation. I therefore do not include a discussion of the nature of fibromyalgia, or whether it fits diagnostically

with the medical record (although I have included some discussion of Dr. Staud’s comparison of CFS to fibromyalgia

as both featuring widespread complaints of pain and fatigue).

10

The evidence in this case, in Dr. Staud’s opinion, better supported the conclusion that Mr.

Lind’s condition was attributable to one of Petitioner’s previously-diagnosed mental conditions,

like PTSD. Staud Rep. at 14–15. PTSD is a well-accepted psychiatric disorder that has

“consistently been associated with general health symptoms and medical conditions,” including

“self-reported somatic symptoms or . . . chronic medical conditions,” with the same kind of

physical complaints reported by Petitioner. Id.; P. Schnurr & M. Jankowski, Physical Health and

Post-Traumatic Stress Disorder: Review and Synthesis¸ 4 Seminars in Clinical Neuropsychiatry

295, (Oct. 1999), filed as Ex. A-44 (ECF No. 34-4). And PTSD can be effectively treated with

cognitive behavioral therapy. Staud Rep. at 15.

Here, Petitioner’s medical history reveals persistent mental and physical concerns long

before his September 2020 vaccination, and which were affirmatively diagnosed and treated. Staud

Rep. at 16. Several of Petitioner’s pre-vaccination conditions (PTSD, autism, ADHD,

dysthymia/long-term depression, etc.) are themselves associated with chronic fatigue/chronic pain.

While Petitioner reported post-vaccination symptoms, they were intermittent/waxing and waning.

And ultimately the most effective treatment appeared to be from his visits with Dr. Panopoulos,

who saw Petitioner numerous times, and whose treatment records establish Petitioner’s improving

condition. Id.; Ex. 4 at 1475.

III. Other Medical Literature

As noted below, after Dr. Kinsbourne’s passing Petitioner was unable to retain a second

expert to respond to Dr. Staud’s criticisms. I therefore permitted Petitioner to file additional

literature to support his causation theory, and he did so on December 13, 2024, before offering his

brief in support of the claim. See generally ECF No. 42. (Petitioner later filed one additional item

at the time of submission of his brief. See ECF No. 44-2).

Petitioner has offered ten items of literature in further support of his claim. I have reviewed

all of them, and summarize those most relevant to my determination:

A. Articles on CFS Generally

Some of the recently-filed items were identical to items Respondent filed, and pertain to

how the medical community currently understands CFS. See, e.g., IOM CFS Report. The IOM

CFS Report does glancingly note that “immunizations” have previously been causally associated

with CFS, although it deems CFS’s causes still unknown. IOM CFS Report at 15. 9 It goes on to

9

Petitioner also filed a document entitled “A Report of the CFS/ME Working Group” from 2002 (see Ex. 28 (ECF

No. 42-6)) and it too also makes vague reference to the possibility that certain vaccinations might be associated with

11

note that CFS may involve immune dysregulation and/or autoimmunity (although it again notes

the overall paucity of scientific studies into the subject matter). Id. at 151–52. The Report later

discusses “early suspicion” that CFS could have an infectious etiology (the kind of possibility that

would tend to support a contention that a vaccine could have the same effect). Id. at 157. However,

it notes the only consistent findings of an association with an infection has been in connection with

the Epstein-Barr virus—and makes no mention of an influenza infection as similarly-associated.

Id. at 159–62.

B. Articles on Immune System Findings Relevant to CFS

Several items filed relate to the portion of Dr. Kinsbourne’s theory contending that CFS

could be caused or encouraged by immune system aberrancy—in particular, cytokine upregulation

(which vaccines are well-understood to cause, at least transiently, from their stimulation of the

innate immune response). See, e.g., S. Hardcastle et al., Serum Immune Proteins in Moderate and

Severe Chronic Fatigue Syndrome/Myalgic Encephalomyelitis Patients, 12 Int. J. Med. Sci. 10:764

(2015), filed as Ex. 24 (ECF No. 42-2) (“Hardcastle”), 771 (cytokine abnormalities demonstrated

in serum of CFS patients, with variable levels and kinds of cytokines present correlating with

severity of disease). But these articles not only say nothing about what would cause CFS, they also

did not evaluate when these cytokine levels were measured (and hence their presence could reflect

more on the immune “picture” in the context of ongoing and active disease than in what triggers

CFS in the first place).

Another article involved the propensity of the flu vaccine to impact “autonomic HRV [heart

rate variability] response.” S. Perring & E. Jones, Assessment of Changes in Cardiac Autonomic

Tone Resulting from Inflammation, 32 Clin. Physiol. Funct. Im. 437 (2012), filed as Ex. 32 (ECF

No. 42-10) (“Perring & Jones”). The Perring & Jones researchers measured heart rate and

breathing responses in a sample of 71 patients who received a flu vaccine, and also looked more

closely at a subset of 15 individuals who reported symptomatic responses to the vaccine for more

than a day post-vaccination. Id. at 438. The subset of patients most impacted by what the study’s

authors deemed “a significant inflammatory response to the vaccination” also displayed a

reduction in HRV response—consistent with the fact that “clinical conditions characterized by an

increase in inflammatory markers” often also involve a comparable response. Id. at 441, 443.

Perring & Jones does not directly involve CFS, however, and it does not consider whether a flu

vaccine could cause a dysautonomic condition, through this impact on cardiac performance was

thought to be attributable to vaccine-induced transient inflammation.

CFS. See Ex. 28 at 22, 38. The source of this publication is unclear, however, although it does appear it might have a

UK origin (see Ex. 28 at 71–74).

12

C. Articles Involving CFS and Vaccines

1. E. Brenu et al., The Effects of Influenza Vaccination on Immune Function

in Patients With Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, 3 Int. J. Clin. Med. 544

(2012), filed as Ex. 26 (ECF No. 42-4) (“Brenu”). Brenu involved a small sample of existing CFS

patients, comparing their serum after receiving a trivalent form of flu vaccine with a control group

that did not have CFS. Brenu at 545. Brenu’s authors did observe an increase in some kinds of T

cells and cytokines (both pro and anti-inflammatory). Id. at 547–48. The study did not conclude,

however, that the immune “hit” of vaccination was necessarily one likely to encourage worsening,

and Brenu’s authors noted that (a) CFS patients already were experiencing immune dysregulation,

(b) the flu vaccine was understood to encourage initial symptoms congruent with what individuals

with CFS experience, and (c) it may be more beneficial than harmful for CFS patients to receive

the flu vaccine, even if there were risks in administering a vaccine to individuals already

experiencing the effects of a compromised immune system. Id. at 548–49.

2. O. Ortega-Hernandez & Y. Shoenfeld, Infection, Vaccination, and

Autoantibodies in Chronic Fatigue Syndrome, Cause or Coincidence? Ann. N.Y. Acad. Sci.

1173:600 (2009), filed as Ex. 27 (ECF No. 42-5) (“Ortega-Hernandez”). Ortega-Hernandez is a

review article commenting on the possibility that CFS is autoimmune in pathogenesis, noting its

association with other autoimmune or infectious diseases, while also recognizing that “there is still

a lack of evidence for designating CFS as an autoimmune phenomena.” Ortega-Hernandez at 606.

It specifically discusses a case report in which CFS occurring in a patient who had both received

a hepatitis B vaccine and silicone breast implants suggested that the two “acted as specific

adjuvants for the CFS onset,” and that this in turn raised the possibility that autoantibodies could

cause CFS (thus rendering it an autoimmune disease). Id. at 601, 606. Yet at the same time, Ortega-

Hernandez specifically includes a table relying on other literature, and setting forth the

demonstrated risk of CFS after different vaccines—with the flu vaccine proposed to pose no risk.

Id. at 603 tbl. 2 (“[r]egarding immunization against influenza, vaccination appears to provide

protective antibody levels without worsening CFS symptoms or causing excessive adverse

effects”). Thus, although Ortega-Hernandez may include discussion about the overall context of

vaccination bearing on causation herein, it does not support the primary element of Petitioner’s

theory.

3. S. Lynch et al., Chronic Fatigue and Swine Flu Vaccination, Rapid

Responses—the BMJ (21 March 2014), filed as Ex. 29 (ECF No. 42-7) (“Lynch”). Lynch

discusses two case reports, in which individuals experienced CFS within two to three days of

receipt of a swine flu vaccine (not identical to the flu vaccine at issue, although somewhat

13

comparable). 10 Lynch at 1–4. Lynch’s authors do not propose there exists a “definite causal

relationship” between CFS and this vaccine, however. Id. at 5.

4. R. Gherardi et al., Myalgia and Chronic Fatigue Syndrome Following

Immunization: Macrophagic Myofasciitis and Animal Studies Support Linkage to Aluminum

Adjuvant Persistency and Diffusion in the Immune System, 18 Autoimm. Rev. 7:691 (2019), filed

as Ex. 31 (ECF No. 42-9) (“Gherardi”). Gherardi is a review article proposing that CFS might not

only be a vaccine-associated adverse event, but that it likely has as its pathologic mechanism

something referred to as “autoimmune/inflammatory syndrome induced by adjuvants,” or

“ASIA”—a theory that the aluminum-based adjuvant contained in many vaccines can build up in

the body, resulting in immune-mediated disease. Gherardi at 699. But the ASIA theory itself

(which does not bear on a case involving a non-adjuvanted vaccine like the flu vaccine) has been

wholly discredited in the Vaccine Program as unreliable. See, e.g., J. F. v. Sec'y of Health & Hum.

Servs., No. 13-799V, 2022 WL 5434214, at *32 (Fed. Cl. Spec. Mstr. Sept. 9, 2022) (discussing

weaknesses of ASIA as causation theory/injury).

IV. Procedural History

The claim was initiated in August 2022. After the matter’s activation, Respondent’s Rule

4(c) Report opposing compensation was filed in April 2023. ECF No. 26. I subsequently ordered

the filing of expert reports, and Dr. Kinsbourne’s report was filed that fall. Respondent’s expert

report followed in February 2024, and I subsequently offered Petitioner the opportunity to obtain

a responsive/supplemental report from Dr. Kinsbourne, but his death in the early spring of 2024

forced Petitioner to attempt to identify a substitute individual.

By October 2024, Petitioner reported that he had been unsuccessful in those efforts, and

requested instead a schedule for ruling on the record be established. ECF No. 39. I proposed a

schedule to do so. See Docket Entry Order, dated October 29, 2024. In the course of briefing,

however, Respondent filed a second expert report from Dr. Staud (ECF No. 53-1), leading

Petitioner to move to strike it as not in accordance with the scheduling orders I had set. ECF No.

54. 11 Otherwise, the parties completed briefing in August 2025, and the matter is ripe for

resolution.

10

The H1N1 virus, or swine flu virus, has had a vaccine developed against it, but it is not the same as the version of

flu vaccine covered by the Program (although an H1N1 viral strain is included in the version of the vaccine that is

covered). Davis v. Sec'y of Health & Hum. Servs., 94 Fed. Cl. 53, *58 n. 2 (2010), aff'd, 420 F. App'x 973 (Fed. Cir.

2011).

11

That motion is well-founded. The time to file a supplemental expert report had already passed when Respondent

filed Dr. Staud’s supplemental report. And in a case in which Petitioner’s primary expert became unavailable due to

death, and where Petitioner was subsequently unable despite due effort to locate another expert, it would work a

manifest unfairness on Petitioner to allow Respondent two reports to his one. Accordingly, Dr. Staud’s Supplemental

Report (ECF No. 53-1) is hereby ordered stricken.

14

V. Parties’ Arguments

Petitioner

Petitioner maintains that he has satisfied his requisite showing that the flu vaccine caused

his CFS by a preponderance of the evidence. Mot. at 17. He asserts that his medical records,

clinical presentation, diagnostic testing, treatment response, and Dr. Kinsbourne’s expert opinion

show that he suffers from CFS. Id. at 19–20. CFS is an unusual injury and requires a patient’s

presentation to meet extensive diagnostic criteria before confirming a diagnosis. Id. at 19.

However, Petitioner affirms that Dr. Kinsbourne’s expertise and evaluations provide fair grounds

for embrace of the diagnosis. And, even without Dr. Kinsbourne’s expert opinion, Petitioner holds

that his medical records show he has satisfied the basic diagnostic requirements, since he

experienced concomitant symptoms of muscle pain, extended fatigue, lethargy, and headaches. Id.

at 20.

Petitioner also argues that he has satisfied his causation showing. While the precise

physiologic cause of CFS is unknown, the theory for whether the flu vaccine “can cause” CFS is

predicated on the vaccine triggering an inflammatory response that results in the over-excitability

of neurons in the central nociceptive pathways. Mot. at 20–23. Multiple items of literature filed by

the Petitioner support a causal relationship between vaccines and CFS. Id. 20–21 (citing Ex. 28 at

32; IOM CFS Report at 15). Studies have shown patients with CFS have experienced “highly

attenuated” responses of a class of T helper cell responsible for encouraging the production of

proinflammatory cytokines, which creates circumstances necessary for CFS. Id. at 23 (citing

Broderick at 1209). Vaccines, Petitioner claims, could cause an immediate overproduction of

proinflammatory cytokines right after being administered. Id. (citing Brenu at 5). Petitioner also

adds that case reports and studies have shown CFS developing after vaccination. Id. at 20–21

(citing Ex. 28 at 32).

Petitioner next contends that he has shown by a preponderance of the evidence that the flu

vaccine “did cause” his CFS, and that his injury occurred within a medically appropriate

timeframe. Mot. at 27, 31. Petitioner mostly relies on his medical record to establish a causal

relationship between the vaccine and his injury. After his vaccine, Petitioner reported extended

headaches, muscle pain, lethargy, and weakness during multiple post-vaccination doctor’s

appointments. Id. at 29–30 (citing Ex. 4 at 813, 823–25, 846–58). Petitioner noted his symptoms

started the same day he received the vaccine, and his treating providers attributed his condition to

the flu vaccine. Id. (citing Ex. 4 at 813, 823–25, 846–58). Providers eventually diagnosed him with

CFS based on his post-vaccination symptoms (which contrasted to his pre-vaccine condition). Id.

at 31 (citing Kinsbourne Rep. at 2). Dr. Kinsbourne’s opinion, corroborated by medical literature,

15

also supports the acceptability of the acute onset of CFS symptoms within hours of vaccination.

Id. at 32 (citing Kinsbourne Rep. at 9; Ex. 28 at 48).

On Reply, Petitioner sought to rebut Respondent’s arguments pertaining to the reliability

of Dr. Kinsbourne’s opinion and Petitioner’s diagnosis. Petitioner conceded that Dr. Kinsbourne

had applied outdated CFS diagnostic criteria to diagnose Petitioner in his original report, but this

has been corrected. Reply at 3. And the differences in diagnostic criteria were “minimal,” and

should not affect Dr. Kinsbourne’s reliability as an expert. Id. Respondent argued that Dr.

Kinsbourne’s opinion should be given little weight in this matter, but Petitioner pointed to prior

vaccine cases where Dr. Kinsbourne was accepted as an expert in cases involving CFS. Id. at 1–2

(discussing LaBounty v. Sec’y of Health and Hum. Servs., No. 17-325V; 2020 WL 8768631 (Fed.

Cl. Spec. Mstr. Dec. 28, 2020); Bryan v. Sec’y of Health and Hum. Servs., No. 14-898V, 2020 WL

7089841 (Fed. Cl. Spec. Mstr. Oct. 9, 2020)). Dr. Kinsbourne’s history with the Vaccine Program

and his accepted expertise on a wide variety of injuries only substantiated the weight that should

be given to his opinion. Id. at 3.

In addition, Petitioner contended that his medical records were inconsistent with

Respondent’s argument that Petitioner’s symptoms were “purely psychological,” or related to his

underlying psychological diagnoses. Reply at 3. Dr. Panopolous, Petitioner’s treating

psychologist, determined that Petitioner’s pain and other symptoms were associated with another

diagnosis rather than one of his previously identified psychological conditions. Id. (citing Ex. 4 at

1307). Also, Petitioner’s documented pre-vaccination symptoms were not as widespread or

significant as those following his vaccination. Id.

Lastly, Petitioner relied on his expert’s opinion and medical literature to rebut

Respondent’s argument that Petitioner’s general causation theory was insufficient to establish the

flu vaccine can cause CFS. Reply at 5. Petitioner’s filed studies, case reports, and medical literature

articulated a link between the flu vaccine and CFS, and show a temporal association between the

two. Id. Dr. Kinsbourne’s medical opinion in favor of a causal relationship adds further support

for Petitioner’s theory. Id.

Respondent

Respondent’s opposition begins by arguing that Dr. Kinsbourne’s report deserves little

evidentiary weight. Opp. at 10–13. His medical specialties did not include CFS (treating,

diagnosing, or studying) or anything all that comparable to it. Id. at 11. In addition, it has been

observed in prior Program decisions from years ago that Dr. Kinsbourne was in the practice of

offering opinions unconnected to any current clinical expertise or exposure to the relevant injury

in a case. Id. at 12–13. Dr. Staud, by contrast, had demonstrated current and up-to-date familiarity

with CFS and conditions comparable to it. Id. at 13. And Dr. Kinsbourne’s methodology was

16

questionable as well, relying on stale CFS diagnostic criteria, and ultimately asserting a theory

unmoored from any substantive explanation. Id.

Next, Respondent denied that Petitioner’s condition met the current diagnostic criteria for

CFS. Opp. at 13–16. Dr. Staud, for example, emphasized the lack of evidence of post-exertional

malaise. Id. at 13–14. In addition, Dr. Kinsbourne had over-relied on 1994 criteria, and thus did

not take into account the criteria now applied (and reviewed in detail by Dr. Staud), and did not

establish they were satisfied. Id. at 14. It was not shown Petitioner’s treaters had themselves

considered these criteria in evaluating Petitioner. Id. And (significantly in Respondent’s

estimation), the ample evidence that Petitioner’s fatigue pre-dated vaccination was contrary to Dr.

Kinsbourne’s own applied criteria (which deemed the symptoms of CFS to begin before fatigue is

evident). Id. at 15 (citing Kinsbourne Rep. at 4 (“[t]he concurrent occurrence of four or more of

the following symptoms, all of which might have persisted or recurred during 6 or more months

of illness and must have predated the fatigue”) (emphasis added)).

Respondent went on to address the Althen prongs, maintaining none were met. Opp. at 16–

12

21. The first prong was unsatisfied by Dr. Kinsbourne’s expert report, which was “highly

generalized,” over-relying on the immune stimulation inherent to vaccination, but without more

specific evidence showing how the flu vaccine might cause CFS. Id. at 16, 17. The concept of

“kindling” hypersensitivity had not been shown to be something vaccines could accomplish, and

Petitioner otherwise in his brief had relied more on newly-filed literature not considered in Dr.

Kinsbourne’s report. Id. at 17. In the end, Petitioner’s causation theory did not rise above a level

of mere plausibility—insufficient to meet the preponderant standard applicable to each Althen

prong. Id. at 18.

The second, “did cause” prong was also unmet, Respondent contended. Opp. at 18–20.

While there is record evidence that treaters seemed to allow for the possibility that Petitioner’s

CFS-like symptoms were vaccine-associated, Program case law notes that “such evidence is not

sacrosanct,” but instead should be evaluated based on the totality of evidence. Id. at 18 (citations

omitted). The record in this case revealed many of these statements relied on the mere temporal

association between vaccination and Petitioner’s reported symptoms, and thus did not reflect

reasoned views by medical professionals that an actual/likely association with vaccination existed.

Id. at 19. Moreover, Petitioner’s Anoka treaters linked his pain complaints with long-standing

psychologic or medical factors—not vaccine-associated persistent inflammation. Id. at 19–20. And

the record otherwise did not reveal positive inflammation findings, and held other inconsistencies

with Petitioner’s contentions. Id. at 20.

12

Because the disposition of this case turns on the first two Althen prongs, I do not include any discussion of the third

prong.

17

VI. 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 ex rel. 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). 13 There is no Table claim for CFS (or anything comparable to it) due to receipt

of the flu vaccine.

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

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,

1352-43 (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 & 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.”

13

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).

18

Each of the Althen prongs requires a different showing. 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.

Petitioners may satisfy the first Althen prong without resort to medical literature,

epidemiological studies, demonstration of a specific mechanism, or even 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). 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.” Id. at 1380. Accordingly, special masters must take care not to increase the

burden placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v.

Sec'y of Health & Hum. Servs, 121 Fed. Cl. 230, 245 (2015), vacated and remanded, 844 F.3d

1363 (Fed. Cir. 2017).

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 Cerrone v. Sec'y of Health & Hum.

Servs., 146 F.4th 1113, 1122 (Fed. Cir. 2025); 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 Demore v. Sec'y of Health & Hum. Servs., No. 20-1265V, 2024 WL 4542934 (Fed. Cl.

Spec. Mstr. Sept. 26, 2024), aff'd, No. 20-1265V, 2025 WL 868902, at *4 (Fed. Cl. Mar. 20, 2025)

(rejecting the argument that a petitioner’s burden is to prove that a causation theory is plausible

and instead requiring petitioner to prove the theory by a preponderance of the evidence) (emphasis

added). 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).

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

19

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).

Medical records and statements of a treating physician, however, 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 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 Dept. 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 (2011), aff’d without opinion, 475 F. Appx. 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

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 align 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., 503 F. Appx. 952 (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 rev. den’d (Fed. Cl. Dec. 3,

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

B. Legal Standards Governing Factual Determinations

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

20

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

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

21

records are accurate or superior on their face 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 or written testimony (provided in the form of an affidavit or declaration) 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 is needed 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

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

C. Analysis of Expert Testimony

Establishing a sound and reliable medical theory often requires a petitioner to present

expert testimony in support of his claim. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357,

1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the

factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509

U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed.

Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999).

Under Daubert, the factors for analyzing the reliability of testimony are:

(1) whether a theory or technique can be (and has been) tested; (2) whether

the theory or technique has been subjected to peer review and publication;

22

(3) whether there is a known or potential rate of error and whether there are

standards for controlling the error; and (4) whether the theory or technique

enjoys general acceptance within a relevant scientific community.

Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592–95).

In the Vaccine Program the Daubert factors play a slightly different role than they do when

applied in other federal judicial settings, like the district courts. Typically, Daubert factors are

employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence

that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases these factors are

used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec'y of Health &

Hum. Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have

been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of

expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the

persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88

Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has not

been employed at the threshold, to determine what evidence should be admitted, but instead to

determine whether expert testimony offered is reliable and/or persuasive.

Respondent frequently offers one or more experts in order to rebut a petitioner’s case.

Where both sides offer expert testimony, a special master's decision may be “based on the

credibility of the experts and the relative persuasiveness of their competing theories.”

Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing

Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert's conclusion

“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too

great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743

(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec'y of Health & Hum.

Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for

review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x 999 (Fed. Cir. 2013) (citing Cedillo,

617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony, based on

a particular expert's credibility, is part of the overall reliability analysis to which special masters

must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325–26

(“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”);

see also Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court

has unambiguously explained that special masters are expected to consider the credibility of expert

witnesses in evaluating petitions for compensation under the Vaccine Act”).

23

D. Consideration of Medical Literature

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

all such items factor into the outcome of this case. 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., No. 2015-5072, 2016 WL

1358616, at *5 (Fed. Cir. Apr. 6, 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. App’x

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”).

ANALYSIS

I. Chronic Fatigue/Chronic Pain and Program Treatment of it as Vaccine Injury

Petitioner’s expert has focused on CFS as Mr. Lind’s injury, and I will treat it as if that

diagnosis has preponderant evidentiary support (despite Dr. Staud’s reasoned objections about

whether sufficient clinical and testing criteria, and based on prevailing/updated views about those

criteria, are met in this case). Kinsbourne Rep. at 9.

Both parties’ experts offered reasonable definitions of CFS and its accepted diagnostic

criteria. See, e.g., Mot. at 19; Opp. at 14 n. 12–13. The Program has resolved many petitions

alleging covered vaccines caused CFS. The majority of relevant reasoned decisions, however, have

rejected such claims. See, e.g., Zamora v. Sec’y of Health & Hum. Servs., No. 21-1414V, 2025

WL 1105282, at *5–10 (Fed. Cl. Spec. Mstr. Mar. 19, 2025) (flu vaccine not preponderantly shown

to be capable of causing CFS via the biologic mechanism of molecular mimicry); Kinney v. Sec’y

of Health & Hum. Servs., No. 18-1522V, 2024 WL 2831616, at *11, 16, 19 (Fed. Cl. Spec. Mstr.

May 8, 2024) (flu vaccine not shown to be capable of causing CFS; expert over relied on causation

theory specific only to context of narcolepsy); McCabe v. Sec'y of Health & Hum. Servs., No. 13-

570V, 2018 WL 3029175 (Fed. Cl. Spec. Mstr. May 17, 2018) (denying entitlement for CFS

allegedly caused by flu vaccine); 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, allegedly caused by hepatitis B vaccine).

I have also previously evaluated CFS as a vaccine injury, albeit in the context of other

vaccines, but not found comparable causation theories to have been preponderantly established.

E.S. v. Sec'y of Health & Hum. Servs., No. 17-480V, 2020 WL 9076620 (Fed. Cl. Spec. Mstr. Nov.

24

13, 2020), at *45 (petitioner did not establish HPV vaccine is likely causal of CFS), mot, for review

den’d, 154 Fed. Cl. 149 (2021); Yalacki v. Sec'y of Health & Hum. Servs., No. 14-278V, 2019 WL

1061429, at *38–39 (Fed. Cl. Spec. Mstr. Jan. 31, 2019), mot. for review den'd, 146 Fed. Cl. 80

(2019) (hepatitis B vaccine was not shown to be capable of causing 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 caused by HPV vaccination).

At bottom, the special masters have, in this series of reasoned decisions, routinely noted

that (a) it is not established that CFS even is autoimmune in nature, such that it could be attributed

to an aberrant self-attack by the immune system, (b) the proposed theories for how CFS occurs

have not been credibly associated with the relevant covered vaccines, and (c) claimants have

proposed mechanisms for pathogenesis, like molecular mimicry, that have not reliably been linked

to how CFS likely occurs.

Far fewer decisions, by contrast, have deemed CFS to be capable of being caused by

vaccination (including the flu vaccine). See, e.g., Bryan, 2020 WL 7089841 (flu vaccine found to

have caused CFS). But these matters are distinguishable, and/or less persuasive than the many

other decisions that have found the theory to lack preponderant support. In Bryan, for example,

there was particularly strong Althen prong two evidence (in the form of reasoned contemporaneous

treater opinions) that the petitioner’s CFS was likely attributable to vaccination. Bryan, 2020 WL

7089841, at * 24–26. And the theory accepted in that case—that vaccination can cause an aberrant

inflammatory response, primarily due to prompting production of cytokines by the innate immune

system, and resulting in chronic immune dysregulation—is one that has not been since embraced

(and reflects arguments about the generalized impacts of vaccination that I have often deemed

unreliable or over-general). Yalacki, 2019 WL 1061429, at *34. Thus, I do not deem Bryan worthy

of the same weight as guidance in this case as the many other contrary decisions on the subject

(some of which also emphasize epidemiologic evidence undercutting a vaccine-CFS association.

See, e.g., Zamora, 2025 WL 1105282, at *6–7).

II. Petitioner Did Not Carry His Burden of Proof under the Althen Test

Assuming Mr. Lind was properly diagnosed with CFS, he has not demonstrated entitlement

to damages, because he has not offered sufficient preponderant evidence to meet all of the Althen

prongs. Below, I discuss those prongs most relevant to my determination. 14

14

All prongs of the Althen test must be satisfied to grant entitlement. Dobrydnev v. Sec’y of Health & Hum. Servs.,

566 Fed. Appx. 976, 980 (Fed. Cir. 2014).

25

Althen Prong One

The evidence offered in this case does not preponderantly establish that the flu vaccine can

likely cause CFS. To substantiate causation, Petitioner relies on a collection of arguments I have

encountered numerous times in the Program (and with respect to a wide variety of illnesses or

disease conditions), but which are consistently deemed to merit low probative value. For example,

Petitioner proposes that the impact of vaccination on the immune system, coupled with evidence

that immune dysfunction is involved in CFS, means that receipt of a vaccine could trigger it. But

this amounts to the sort of routine “plausibility” argument often advanced—unsuccessfully—in

Program cases. See, e.g., Cerrone, 146 F.4th at 1122 (Fed. Cir. 2025). It is almost always

“plausible” that the understood impact of vaccination on the immune system (vaccines are

designed to promote an immune response) could spark an aberrant reaction—but this does not

mean it is likely a given vaccine can cause a particular injury due primarily to this possibility.

Aultman v. Sec'y of Health & Hum. Servs., No. 21-1802V, 2025 WL 2401983, at *24–25 (Fed. Cl.

July 11, 2025). Thus, the mere fact vaccines encourage transient cytokine production, cause

feelings of malaise, or simply stimulate the immune system (albeit in a targeted and limited

manner) does not elevate the vaccine into the likely driver of a longer-term disease.

Rather, to preponderantly demonstrate the capacity of a covered vaccine to actually spark

a process resulting in a claimed adverse effect, claimants need some mix of proof that builds that

case. Of course, the lack of a direct study saying “vaccine x likely causes disease y” is no hindrance

to success, if the totality of evidence otherwise makes it likely vaccine causation can occur. But

that totality is lacking here.

Petitioner offers, for example, a number of articles that vaguely allude to vaccination as

potentially triggering CFS, but without substantiation of the assertion. See, e.g., the IOM CFS

Report. Many articles support the contention that cytokine upregulation is observed in patients

already suffering from CFS (Hardcastle), or stand for the proposition that vaccination can cause

some autonomic changes in relevant patient populations (Perring & Jones, Brenu). But these items

of literature do not establish how vaccination would cause CFS at the outset. Other articles

seemingly exclude the flu vaccine as potentially causal of CFS. See Ortega-Hernandez. And case

reports filed in this case involved somewhat-distinguishable vaccines (Lynch)—and are otherwise

a kind of evidence not given much probative weight in Program matters. Porter, 663 F. 3d at 1253–

54 (single case studies “d[o]not contain any meaningful analysis about causation”); Campbell v.

Sec'y of Health & Hum. Servs., 97 Fed. Cl. 650, 668 (2011) (“[c]ase reports do not purport to

establish causation definitively, and this deficiency does indeed reduce their evidentiary value

compared particularly to formal epidemiological studies”); Martinez v. Sec’y of Health & Hum.

Servs., No. 16-738V, 2022 WL 4844923, at *29 (Fed. Cl. Spec. Mstr. Sept. 9, 2022) (“case reports

. . . as a general rule do[] not receive great weight when assessing causation”), mot. for review

den’d, 165 Fed. Cl. 76 (2023).

26

I also do not deem Dr. Kinsbourne’s opinion to be sufficiently persuasive or rooted in

reliable proof to stand as robust proof of causation. Experts can certainly help Program claimants

meet their preponderant burden, relying on their personal, hard-earned knowledge of a particular

disease or the study of its causes to bridge gaps in medical literature evidence, or to explain a

causation process that may be complex. Yet as many as 15 years ago, 15 it was recognized that Dr.

Kinsbourne specifically (who even at that time no longer had an active medical practice or research

lab, and thus could not invoke his more immediate personal experience with a given neurologic

injury when offering expert opinions in Vaccine Program cases) was often offering opinions that

clearly exceeded his demonstrated expertise—essentially stringing together propositions based on

literature cites he dug up for the case at hand, and then writing the whole thing into a report. Stone

v. Sec'y of Health & Hum. Servs., No. 04-1041V, 2010 WL 1848220, at *8 (Fed. Cl. Spec. Mstr.

Apr. 15, 2010) (citations omitted), mot. for review granted on other grounds, 95 Fed. Cl. 233

(2010). I myself have criticized him similarly, and after hearing him testify in another matter. See

L.M. v. Sec'y of Health & Hum. Servs., No. 14-714V, 2019 WL 4072130, at *27 (Fed. Cl. Spec.

Mstr. July 23, 2019) (“beyond his neurologic expertise, Dr. Kinsbourne has no demonstrated recent

(i.e., in the past twenty years) experience (a) treating pediatric patients, (b) treating individuals of

any age with a seizure disorder, or (c) studying seizure disorders and their potential triggers”).

Here, Dr. Kinsbourne’s report was comparably unpersuasive, for the same general reasons.

He clearly was not an up-to-date expert in adult neurologic conditions like CFS at the time he

authored his report in this case; had never personally studied the subject, or treated patients with

it (certainly not in the final years he was still active as a Program expert); and had no direct,

demonstrable experience in the capacity of any vaccine to cause CFS. All he has done in this case

is provide the framework of a medical professional for a number of items of literature (coupled

with the additional items filed herein by Petitioner directly, which Dr. Kinsbourne of course did

not have the opportunity to review or opine upon). Thus, Dr. Kinsbourne’s report in this matter

did not appreciably advance Petitioner’s effort to establish causation.

Even if I cabin off concerns about Dr. Kinsbourne’s proficiencies as an expert from the

causation opinion he actually offered, however, I do not deem his theory to have set forth a reliable

opinion for how CFS could be caused by the flu vaccine. He has embraced the kind of general

theory I often reject, in which a claimant contends that (a) vaccine-caused inflammation impacts

the innate immune response enough to cause disease, but without the needed connective proof

linking a vaccine’s expected impact with the injury in question, and/or (b) that evidence of immune

15

I take no pleasure in criticizing Dr. Kinsbourne. For many years in the Program, he was an indefatigable advocate

for Vaccine Act petitioners, who often struggle to find competent medical or scientific professionals willing to assist

them in these difficult cases. His report in this case, as in many others in which he served, was certainly legible,

organized, and offered some independent medical and scientific literature to support his contentions, even if the

opinion offered exceeded his personal/direct experience.

27

system dysregulation evident in the context of existing disease (during the condition’s pendency)

means that same immune dysfunction explains its cause. All this does is raise a plausible causal

explanation for how a vaccine might produce a specific injury. It does not rise to the level of a

preponderant showing that the vaccine likely does cause the injury—and it is the latter standard

that is unmet by Dr. Kinsbourne’s otherwise-deficient report.

Althen Prong Two

Independent of whether the flu vaccine can cause CFS, the medical record in this case does

not support the conclusion that it likely did cause Petitioner’s condition. First, there is a lack of

treater support for an association. Admittedly, some early treaters (even going so far as a month or

two post-vaccination) credited Petitioner’s self-reported immediate symptoms as vaccine-related,

likely based upon the view that they were indicative of a vaccine-associated malaise that many

individuals would experience. Ex. 4 at 881–94. This was not unreasonable to propose, as vaccines

are known to often cause transient malaise in individuals. Bielak v. Sec'y of Health & Hum. Servs.,

No. 18-761V, 2023 WL 35509, at *11, 14 (Fed. Cl. Spec. Mstr. Jan. 3, 2023). And certainly treaters

took seriously Petitioner’s self-reporting of symptoms in the wake of receipt of the vaccine,

deeming the temporal association somewhat suspicious.

Eventually, however, the record supports the conclusion that references to a vaccine

connection were more reflective of Petitioner’s continued reporting than of reasoned treater views

that his CFS symptoms were vaccine-associated. Thus, I do not give these treater statements about

vaccine association (which themselves are not supported by explanation, and which seem mostly

to rely on the temporal association between vaccination and reported onset) much weight in

deciding this particular Althen prong.

Second, Petitioner’s reported reaction may reflect the anticipated effects of vaccination

rather than something new/acute. As literature filed in this case acknowledges, there is similarity

between some of the symptoms vaccination inherently brings on and what patients with CFS

experience chronically. Brenu at 548–49. Petitioner has also maintained that he began feeling

symptoms the same day as his vaccination, which would be more akin to the expected, transient

response. Ex. 4 at 867.

This leads to the third, and arguably strongest, deficiency in Petitioner’s contention that

the flu vaccine “did cause” his CFS. It is difficult on this record to distinguish expected vaccine

malaise from ongoing CFS symptoms. But in attempting to do so, Petitioner’s overall medical

history—especially pre-vaccination—must be taken into account. And that history strongly

suggests that Petitioner’s CFS was far more likely the product of his long-standing comorbidities

than vaccination.

28

The substantial medical history filed in this case clearly establishes that Petitioner

experienced multi-factorial, interrelated conditions—some psychological, others somatic—in the

years before his receipt of the flu vaccine in September 2020. As well-elucidated by Dr. Staud,

some of those psychologic conditions are known to have somatic counterpart symptoms. And

many of the symptoms Petitioner reported post-vaccination have counterparts in his pre-

vaccination history. 16 Not only does this establish that Petitioner struggled with seemingly-chronic

symptoms comparable to what he experienced post-vaccination, but that he obtained counseling

both before and after vaccination. And the counseling noted in the record that Petitioner obtained

from Anoka and Dr. Panopoulos seems to have resulted in the conclusion that Petitioner’s ongoing

physical symptoms not only had a psychologic origin, but that the treatment of the psychologic

issues had physical benefits for Petitioner. See Ex. 4 at 914–19.

Petitioner’s briefs, as well as Dr. Kinsbourne’s report, have little to say about Petitioner’s

obvious medical history, and the reasonable likelihood it best explains his alleged CFS. Petitioner’s

Motion does mention the telemedicine visits with Dr. Panopoulos, but does not discuss why Dr.

Panopoulos’s assessment of “pain disorder associated with psychological factors and a medical

condition,” and times when Petitioner’s post-vaccination pain was stable or decreased in

conjunction with increased physical activity, does not undermine his argument. Mot. at 6, 19–20

(citing Ex. 4 at 935–1187). Rather, the Petitioner chooses to heavily rely on Dr. Kinsbourne’s

opinion, coupled with Petitioner’s Affidavit, as evidence that the Petitioner’s pain did not predate

his vaccine. Id. at 19–20.

Similarly, Dr. Kinsbourne stated in bare, conclusory form that Petitioner’s CFS diagnosis

did not overlap with his “extensive list of previous ailments[,]” and that none of his preexisting

diagnoses are explanatory as they “are either stable or treated and controlled.” Kinsbourne Rep. at

5. This lack of analysis is not credible in a case with such obvious evidence of so many pre-

vaccination symptoms likely related to what came later. And it is no defense for Petitioner to say

he need not disprove alternative explanations. See Exum v. Sec'y of Health & Hum. Servs., No. 21-

1513V, 2025 WL 1892440, at *38 (Fed. Cl. May 27, 2025), mot. for review den’d, 178 Fed. Cl.

627 (2025), appeal docketed, No. 26-1178 (Fed. Cir. Nov. 20, 2025). While this is literally true—

the Althen test does not obligate Petitioners to preponderantly disprove potential alternative

causes—any claimant’s prong two showing is weakened by record proof that other factors may

better explain a claimant’s injury than a purportedly causal vaccine. Austin v. Sec'y of Health &

Hum. Servs., No. 05-579V, 2018 WL 3238608, at *27 (Fed. Cl. Spec. Mstr. May 15, 2018), mot.

for review den’d, 141 Fed. Cl. 268 (2018), aff'd, 818 F. App'x 1005 (Fed. Cir. 2020). As a result,

special masters appropriately take into account this kind of record evidence when weighing a

16

I note that Petitioner does not in this case allege a significant aggravation claim, in which his CFS (or some other

illness/condition) was worsened by vaccination. And I do not find on this record otherwise that such a claim would be

tenable.

29

claimant’s prong two success—and it becomes far more difficult to find that a vaccine likely “did

cause” an injury when the record abounds in such evidence suggesting other factors were more

likely causal.

Here, Petitioner cannot ignore such a record, focusing solely on the flu vaccine while

conclusory sweeping aside his total medical history. The record in this case instead suggests that

his vaccination was likely only an intervening event in his existing medical course. He experienced

the vaccination while already suffering from a number of maladies, all of which had entirely

different explanations/origins but which could have been causal of his CFS. It is thus on this record

highly unlikely the flu vaccine caused Petitioner’s symptoms (even if it had a transient impact on

his health).

CONCLUSION

A Program entitlement award is only appropriate for claims supported by preponderant

evidence. Here, Petitioner has not made such a showing. Petitioner is therefore not entitled to

compensation.

I also hereby GRANT Petitioner’s Motion to Strike Respondent’s late-filed supplemental

expert report. The Clerk of Court is ordered to STRIKE ECF No. 53-1.

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. 17

IT IS SO ORDERED.

/s/ Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

17

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.

30