# Williams v. Secretary of Health and Human Services

> United States Court of Federal Claims · December 9, 2024

URL: https://www.frixlaw.com/law-library/cases/10756899

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** December 9, 2024
- **Precedential status:** Unpublished
- **Opinion:** Opinion
- **Judges:** Nora Beth Dorsey
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/10756899

## How later opinions describe it (automated extraction)

- explaining that a “temporal relationship alone will not demonstrate the requisite causal link and that petitioner must posit a medical theory causally connecting the vaccine and injury.”
- noting that “close calls” are resolved in Petitioner’s favor
- noting that special masters are bound by both § 13(b)(1) and Vaccine Rule 8(b)(1) to consider only evidence that is both “relevant” and “reliable”

## Opinion text

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: November 13, 2024

* * * * * * * * * * * * * * *
MICHAEL RAY WILLIAMS, * PUBLISHED
*
Petitioner, * No. 19-1269V
*
v. * Special Master Nora Beth Dorsey
*
SECRETARY OF HEALTH * Dismissal; Influenza (“Flu”)
AND HUMAN SERVICES, * Vaccine; Fibromyalgia.
*
Respondent. *
*
* * * * * * * * * * * * * * *

Andrew Donald Downing, Downing, Allison & Jorgenson, Phoenix, AZ, for Petitioner.
Julianna Rose Kober, U.S. Department of Justice, Washington, DC, for Respondent.

DECISION 1

On August 26, 2019, Michael Ray Williams (“Petitioner”) filed a petition for
compensation under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the
Program”), 42 U.S.C. § 300aa-10 et seq. (2018), 2 alleging that he suffered from injuries,
including fibromyalgia (“FM”), neuropathy, fatigue, polyarthralgia, reactivated Epstein Barr
virus (“EBV”), and “unusual reactions to various stimuli including medical procedures, etc.” as a
result of receiving an influenza (“flu”) vaccine on September 4, 2016. Petition at Preamble (ECF
No. 1). Respondent argued against compensation, stating “this case is not appropriate for

1
Because this Decision contains a reasoned explanation for the action in this case, the
undersigned is required to post it on the United States Court of Federal Claims’ website and/or at
https://www.govinfo.gov/app/collection/uscourts/national/cofc in accordance with the E-
Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of
Electronic Government Services). This means the Decision will be available to anyone with
access to the Internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to
identify and move to redact medical or other information, the disclosure of which would
constitute an unwarranted invasion of privacy. If, upon review, the undersigned agrees that the
identified material fits within this definition, the undersigned will redact such material from
public access.
2
The National Vaccine Injury Compensation Program is set forth in Part 2 of the National
Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended,
42 U.S.C. §§ 300aa-10 to -34 (2018) (“Vaccine Act” or “the Act”). All citations in this Decision
to individual sections of the Vaccine Act are to 42 U.S.C.A. § 300aa.

1
compensation under the terms of the Act.” Respondent’s Report (“Resp. Rept.”) at 2 (ECF No.
19).

After carefully analyzing and weighing the evidence presented in accordance with the
applicable legal standards, 3 the undersigned finds Petitioner has failed to provide preponderant
evidence that the flu vaccine caused his alleged injury of FM. 4 Thus, Petitioner has failed to
satisfy his burden of proof under Althen v. Secretary of Health & Human Services, 418 F.3d
1274, 1280 (Fed. Cir. 2005). Accordingly, the petition must be dismissed.

I. ISSUES TO BE DECIDED

There are two factual issues to resolve. The parties dispute Petitioner’s diagnosis and the
onset of his injury. Joint Prehearing Submission (“Joint Submission”), filed Nov. 3, 2023, at 1
(ECF No. 108). Although Petitioner alleged several injuries in his Petition, in the joint
submission the parties narrowed the alleged injury to FM. Id. at 2; see also Petitioner’s
Prehearing Submission (“Pet. Submission”), filed Oct. 10, 2023, at 1 (ECF No. 97).

The parties also dispute causation, specifically whether Petitioner’s alleged FM was
caused by his flu vaccination. Joint Submission at 2.

II. BACKGROUND

A. Medical Terminology

Fibromyalgia, or FM, “is a commonly encountered disorder characterized by chronic
widespread musculoskeletal pain and related symptoms along with multiple painful tender
points.” Pet. Ex. BB.2 at 1. 5 The diagnosis of FM is made by using the diagnostic criteria
published by the American College of Rheumatology (“ACR”) based on “the presence of

3
While the undersigned has reviewed all of the information filed in this case, only those filings
and records that are most relevant will be discussed. See Moriarty v. Sec’y of Health & Hum.
Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We 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) (“Finding certain information not relevant does not lead
to—and likely undermines—the conclusion that it was not considered.”).
4
Petitioner narrowed his injury to FM to reflect his experts’ opinions, specifically the opinion of
Dr. Jeret, who opined that due to an absence of objective data, he could not confirm that
Petitioner had small fiber neuropathy. See Pet. Ex. BB at 11. Since the parties’ joint submission
and Petitioner’s prehearing submission confirm that the alleged injury is FM, the undersigned
does not discuss the parties’ experts’ opinions or medical literature related to small fiber
neuropathy or the other injuries alleged in the petition.
5
Dan Buskila et al., Etiology of Fibromyalgia: The Possible Role of Infection and Vaccination, 8
Autoimmunity Rev. 41 (2008).

2
widespread pain” of both sides of the body, above and below the waist, and including axial
skeletal pain along with points of tenderness. Pet. Ex. DD.6 at 2. 6 “[C]ore symptoms [] include
pain, fatigue, and mood and sleep disturbances.” Id.

This Decision references three different sets of diagnostic criteria for FM promulgated by
the ACR in 1990, 2010, and 2011.

The 1990 criteria required a history of widespread pain and pain in 11 of 18 “tender point
sites on digital palpation.” Pet. Ex. BB.14 at 12. 7 Pain was considered widespread when it was
bilateral (on both sides of the body), above and below the waist, and included “axial skeletal
pain.” Id. To assess the presence of tender points, the evaluator performed digital palpation
using “an approximate force of 4 kg.” Id. And the widespread pain “must have been present for
at least [three] months.” Id. The specific tender point sites included bilateral areas of the occiput
(back of the head), cervical spine, trapezius muscles, above the scapula spine, ribs, hips,
buttocks, and knees. Id.

The ACR 2010 diagnostic criteria eliminated the examination of tender points,
incorporated the presence of widespread pain in 19 different areas, 8 and added key symptoms
(“fatigue, waking unrefreshed, cognitive symptoms”) along with severity scales to measure
symptom severity. Pet. Ex. BB.16 at 8. 9 As with the 1990 criteria, symptoms should be present
for three months. Id. But in the 2010 criteria, the widespread pain index (“WPI”) was based on
the areas which the patient had experienced pain “over the last week.” Id.

The 2010 criteria were modified in 2011 to substitute a physician’s evaluation of
symptom sensitivity for the patient’s self-report of symptom intensity. Pet. Ex. BB.17 at 8. 10
The modified criteria are now referred to as the 2011 criteria. See, e.g., Resp. Ex. D at 3. Both
the 2010 and 2011 criteria require that the symptoms be present for “at least three months.” Pet.
Ex. BB.16 at 8; Pet. Ex. BB.17 at 9. And both the 2010 and 2011 criteria relative to the WPI use

6
Juan J. García et al., Altered Profile of Chemokines in Fibromyalgia Patients, 51 Annals
Clinical Biochemistry 576 (2013).
7
Frederick Wolfe et al., The American College of Rheumatology 1990 Criteria for the
Classification of Fibromyalgia, 33 Arthritis & Rheumatology 160 (1990).
8
The areas of pain in both the 2010 and 2011 ACR diagnostic criteria include bilateral pain in
the following areas: shoulder girdle, upper arm, lower arm, hip, upper leg, lower leg, jaw, chest,
abdomen, upper back, lower back, and neck. Pet. Ex. BB.16 at 8; Pet. Ex. BB.17 at 9.
9
Frederick Wolfe at el., The American College of Rheumatology Preliminary Diagnostic
Criteria for Fibromyalgia and Measurement of Symptom Severity, 62 Arthritis Care & Res. 600
(2010).
10
Frederick Wolfe et al., Fibromyalgia Criteria and Severity Scales for Clinical and
Epidemiological Studies: A Modification of the ACR Preliminary Diagnostic Criteria for
Fibromyalgia, 38 J. Rheumatology 1113 (2011).

3
an assessment based on the location of pain “over the last week.” Pet. Ex. BB.16 at 8; Pet. Ex.
BB.17 at 9.

B. Procedural History

Petitioner filed his petition on August 26, 2019. Petition. Along with his petition,
Petitioner filed medical records and other supporting documentation. Pet. Exs. A-M. The case
was reassigned to the undersigned on October 4, 2019. Order dated Oct. 4, 2019 (ECF No. 6).

On April 30, 2020, Respondent filed his Rule 4(c) report arguing against compensation.
Resp. Rept. at 1. Between April 2020 and December 2020, Petitioner filed additional medical
records and affidavits. Pet. Exs. N-Q.

On December 15, 2020, the undersigned held an onset hearing. Order dated Jan. 4, 2021
(ECF No. 35). The undersigned could not determine diagnosis or onset based solely on the
factual testimony at the hearing. Id. at 2. She directed the parties to obtain expert reports. Id.

On May 5, 2021, Petitioner filed an expert report from Dr. Curt Hagenau. Pet. Ex. R. On
July 2 and August 2, 2021, Respondent filed expert reports from Drs. Dara Jamieson and Roland
Staud. Resp. Exs. A, C.

The undersigned held a Rule 5 conference on September 14, 2021. Rule 5 Order dated
Sept. 14, 2021 (ECF No. 47). She was unable to provide her preliminary findings. Id. at 1. She
requested an entitlement hearing if the parties were unable to settle the case. Id. at 1-2. On July
13, 2022, an entitlement hearing was scheduled to begin on December 5, 2023. Prehearing
Order dated July 13, 2022 (ECF No. 64).

On December 9, 2022, Petitioner filed additional expert reports from Drs. Joseph Jeret
and Omid Akbari. Pet. Exs. BB, DD. Respondent filed supplemental reports from Drs.
Jamieson and Staud on March 27, 2023. Resp. Exs. D-E. On June 7, 2023, Petitioner filed
responsive reports from Drs. Jeret and Akbari. Pet. Exs. FF, GG. Between January 2022 and
October 2023, Petitioner continued to file updated medical records, affidavits, and other exhibits.
Pet. Exs. S-Y, AA, HH, II, JJ, KK, LL, MM, NN, OO, PP. QQ, RR, 1-7.

On November 17, 2023, Respondent requested the December 2023 entitlement hearing
be continued to early spring of 2024. Motion for Continuance, filed Nov. 17, 2023 (ECF No.
112). On November 21, 2023, a status conference was held where the December 2023
entitlement hearing was cancelled and the parties were offered a new hearing date in June 2024.
Order dated Nov. 21, 2023 (ECF No. 114). The parties subsequently chose to submit the case
for a ruling on the record in lieu of rescheduling the entitlement hearing. Joint Status Rept., filed
Nov. 29, 2023 (ECF No. 116). The record for the case was then closed. Order dated Nov. 29,
2023 (ECF No. 117).

This matter is now ripe for adjudication.

4
C. Factual History

1. Summary of Medical Records 11

a. Pre-vaccination and Vaccination Records

Prior to vaccination, Petitioner had a significant medical history including diagnoses of
hypertension, obstructive sleep apnea, hypercholesterolemia, Vitamin D deficiency, benign
prostatic hypertrophy, allergic rhinitis, edema, abnormality of the red blood cells, weight gain,
and right upper quadrant pain. Pet. Ex. C at 42. At a visit with his primary care physician, Dr.
John Thomas, on April 29, 2014, Petitioner complained of swelling in his lower extremities,
shortness of breath when bending over, rash, bruising easily, abdominal pain, and right upper
quadrant tenderness. Id. at 39-40. Petitioner also had multilevel degenerative disc disease as
evidenced by an magnetic resonance imaging (“MRI”) of the lumbar spine performed on May
21, 2014, that showed multilevel degenerative disc disease from L5 to S1. Id. at 54-55.

In November 2014, Petitioner had thrombophlebitis of the lower extremity (right calf)
and acute sinusitis. Pet. Ex. C at 32. In May 2016, Petitioner had a borderline elevated
hemoglobin A1C (5.7, normal range < 5.7 %), and records noted his prescription for
Metformin 12 was refilled. Id. at 22.

Petitioner also had infectious illnesses and allergies. See generally Pet. Ex. B. Records
from The Little Clinic show Petitioner was treated for otitis media (ear infection), allergic
rhinitis, sore throat, cough, congestion, and acute upper respiratory infection in 2014, 2015, and
2016. See generally id.

In addition to the above history, Petitioner was evaluated by Dr. Williams David Tissot
for kidney stones in 2015 and 2016. See Pet. Ex. MM. at 4. On July 15, 2015, he had kidney
stones in his left kidney, with the largest being 4 mm. Id. at 29. Petitioner also had
“microscopic hematuria,[13] [right] flank pain [] and back pain.” Id. On July 20, 2016, he
returned to see Dr. Tissot for benign prostatic hyperplasia and kidney stones. Id. at 26.
Abdominal X-rays showed possible left distal ureteral calculus. Id. at 40.

11
The undersigned has reviewed all of Petitioner’s medical records but for the sake of brevity
only summarizes those most relevant to the issues herein. For example, records related to dental
care, and Dr. Mowery’s records related to a nosebleed, sinusitis, rosacea, and facial pain have not
been summarized. Further, not all of Petitioner’s visits to his physicians are summarized.
12
Metformin hydrochloride is “a biguanide antihyperglycemic agent that potentiates the action
of insulin, used in the treatment of type 2 diabetes mellitus.” Metformin Hydrochloride,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=
30875 (last visited Sept. 26, 2024).
13
Hematuria, also known as erythrocyturia, is “blood (erythrocytes) in the urine.” Hematuria,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=
21814 (last visited Sept. 26, 2024).

5
Petitioner received the flu vaccination at issue on September 4, 2016. 14 Pet. Ex. A at 1-4.

b. Post-vaccination Records

Over two months post-vaccination, on November 18, 2016, Petitioner saw Dr. Tissot for
complaints of a kidney stone with hematuria. Pet. Ex. MM at 23. In the review of systems,
Petitioner denied fever, tiredness, back pain, neck pain, numbness, or tiredness. Id. at 24. Dr.
Tissot documented Petitioner had experienced gross hematuria (“GH”) and “right flank pain” but
that these symptoms had resolved. Id. at 25. If Petitioner continued to have pain or hematuria,
Dr. Tissot planned to order a computed tomography (“CT”) scan. Id. Dr. Tissot did not
document any back pain or back stiffness. Id. at 23-25.

Approximately one month later, on December 21, 2016, Petitioner presented to Nurse
Practitioner Salimah Jones at The Little Clinic with complaints of sinus pressure since December
7, 2016. Pet. Ex. B at 6. He reported congestion with associated ear pain for the past two weeks,
with a severity of 6 out of 10, discolored postnasal drainage, cough, dental pain, diffuse facial
pain, and headache. Id. He also complained of wheezing and shortness of breath. Id.
Petitioner’s prior receipt of the seasonal flu vaccine was documented, and no adverse effects
were noted. Id. Petitioner was diagnosed with an acute upper respiratory infection, and
prescriptions for Medrol Dosepak, Zithromax (“Z-Pak”), and Promethazine dextromethorphan
syrup were given. Id. at 7.

Moving forward to 2017, Petitioner returned to The Little Clinic on April 18, 2017 and
saw family Nurse Practitioner Tiffany Johnson, with complaints of seasonal allergies for 10
days. Pet. Ex. B at 4. Review of systems was positive for watery, itchy, red eyes and runny
nose. Id. Examination showed red eyes with clear drainage. Id. Diagnosis was seasonal
allergic conjunctivitis and rhinitis. Id. at 5. Eye drops were given. Id. Petitioner did not report
having pain, and his pain scale was documented as 0/10. Id. at 4.

On June 13, 2017, Petitioner saw Dr. Thompson for a physical examination with fasting
laboratory studies. Pet. Ex. C at 12. Under the category about “Other Concerns,” Petitioner
reported that his insurance did not cover lab studies for testosterone or Helicobacter pylori. Id.
There is no documented complaint of pain. See id. Review of symptoms did not include any
problems with pain. Id. at 14. Petitioner’s general appearance was “[n]ormal . . . in no acute
distress.” Id. Physical examination revealed normal skin, normal chest with “no costochondral
tenderness,” back and spine were “normal” with “no costovertebral angle tenderness,” and spine
was “nontender to palpation.” Id. Musculoskeletal examination was normal. Id. Neurological

14
Petitioner’s Vaccine Administration and Consent record notes two different dates, September
3, 2016, and September 4, 2016. Pet. Ex. A at 4. However, the billing record states the order for
vaccination was filled on September 4, 2016. Id. at 6. Also, the Vaccine Adverse Event
Reporting System (“VAERS”) report filed in 2019 states that the vaccination was administered
on September 4, 2016. Id. at 14. The parties have not raised an issue with the date of September
4, 2016, as the accurate date of vaccination. See, e.g., Joint Submission. Therefore, the
undersigned finds September 4, 2016, is the day that Petitioner received his flu vaccination.

6
examination was normal and nonfocal, and Petitioner’s “sensory exam[ination] [was] intact to
touch.” Id. at 14-15.

Petitioner sought chiropractic treatment on June 24, 2017, and at that visit he complained
of pain in his hips and neck while walking and bending. Pet. Ex. J at 1. He complained of low
back pain and “neck pain.” Id. at 5. Petitioner completed a questionnaire that stated, “Sept.
2016 Back stiffness.” Id. at 1. Petitioner also reported numbness and tingling, stating “arms get
numb/tingly.” Id. Laying on the left side relived the pain, and massage temporarily helped the
pain. Id. Petitioner returned for chiropractic treatment on June 26. Id. at 5. He reported low
back pain with pain 2-3/10. Id. He also complained of arm numbness that was better after
adjustment. Id. On June 30, he again complained of low back pain, and his pain was 2/10. Id.
Arm numbness and tingling was improved. Id. On July 6, Petitioner reported low back pain and
neck with arm numbness. Id.

On July 20, 2017, Petitioner sought treatment from Dr. Tissot for hematuria and
complaints of a kidney stone. Pet. Ex. MM at 20. He denied chills, nausea, or back pain. Id. at
20-21. Problem list included “right flank pain.” Id. A kidney, ureter, and bladder (“KUB”) X-
ray showed “[n]o definite radiopaque renal calculi” but “[c]alcified phlebolith versus small distal
LEFT ureteral stone.” Id. at 39. The study also showed “[l]ower lumbar facet sclerosis” 15 with
“bony bridging at the lumbosacral junction.” Id. Dr. Tissot noted that Petitioner had kidney
stones, stating “the current stone is in the left kidney (several (largest 4 mm)).” Id. at 20.

That same date, July 20, 2017, Petitioner saw Dr. Thompson complaining of “back
trouble.” Pet. Ex. C at 8. At this visit, he reported “having body aches since September 12,
2016.” Id. Onset was described as sudden. Id. Petitioner stated that one week after receiving
his flu shot, “his entire back seized up.” Id. The pain was “sharp/stabby,” and the pain was
better “laying flat on his back.” Id. Pain score was 5-6/10. Id. Petitioner complained of “pain
all over his body” and numbness in his hands and feet. Id. He expressed concern about his
inability to exercise, stating that he previously worked out three times per week, but “now
struggles working out [one] day [per week], and it takes him an entire day to recover.” Id.
Physical examination was normal, with full range of motion. Id. at 10. Neurological
examination was also normal, with normal upper and lower extremity strength, and “sensory
exam[ination] [was] intact to touch.” Id. Laboratory studies were normal, including normal
erythrocyte sedimentation rate (“ESR”), 16 normal rheumatoid factor (“RF”), 17 C-reactive protein

15
Sclerosis is “an induration or hardening, such as hardening of a part from inflammation,
increased formation of connective tissue, or disease of the interstitial substance.” Sclerosis,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?
id=45030 (last visited Oct. 29, 2024).
16
Erythrocyte sedimentation rate is “the rate at which erythrocytes precipitate out from a well-
mixed specimen of venous blood . . . . [ESR] is increased . . . due to inflammatory disease,
hyperfibrinogenemia, active inflammatory disease, and anemia.” Erythrocyte Sedimentation
Rate, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?
id=102146 (last visited Oct. 24, 2024).

7
(“CRP”), 18 and antinuclear antibody (“ANA”). 19 Id. at 10-11. Folic acid levels were slightly
low at 5.1 (with normal > 5.4 ng/mL). Id. at 10. Dr. Thompson assessed Petitioner with FM,
polyarthralgia, fatigue, obstructive sleep apnea, and hypotestosterone. Id.

Petitioner returned to see Dr. Thompson for follow-up on July 28, 2017, and on this date
his pain was 8/10. Pet. Ex. C at 2. Under musculoskeletal examination, Dr. Thompson noted
that Petitioner had “symmetric trigger points over classic [FM] sites.” Id. at 4.

Dr. Susan O. Harwell, rheumatologist, saw Petitioner on August 10, 2017, at the request
of Dr. Thompson for “polyarthralgia.” Pet. Ex. D at 5. Dr. Harwell noted that Petitioner had “a
largely unremarkable work-up” with normal creatine phosphokinase (“CPK”), 20 ESR, CRP, RF,
thyroid-stimulating hormone (“TSH”), 21 Vitamin D, 22 and negative ANA. Id. Petitioner
reported that in September, he had “abrupt onset severe back pain from cervical to sacrum down
spine and lateral spinal muscles.” Id. About seven months later, “his pain spread to include

17
Rheumatoid factors are “antibodies. . . are found in the serum of about 80 percent of persons
with classical or definite rheumatoid arthritis. . . . Rheumatoid factors also occur in other
connective tissue diseases and some infectious diseases.” Rheumatoid Factor, Dorland’s Med.
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=74591(last visited
Oct. 24, 2024).
18
C-reactive protein “is an acute-phase reactant protein used to indicate to indicate an
inflammatory disease.” C-Reactive Protein, Mosby’s Manual of Diagnostic and Laboratory
Tests 165 (6th ed. 2018).
19
Antinuclear antibodies are “antibodies directed against nuclear antigens . . . frequently found
in rheumatoid arthritis, scleroderma (systemic sclerosis), Sjögren syndrome, and mixed
connective tissue disease . . . .” Antinuclear Antibodies, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=56804 (last visited Oct. 24, 2024).
20
Creatine phosphokinase is “an Mg2+-activated enzyme of the transferase class that catalyzes
the phosphorylation of creatine by [adenosine triphosphate (“ATP”)] to form phosphocreatine. . .
. Differential determination of isoenzymes is useful for clinical diagnoses.” Creatine Kinase,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?
id=11582 (last visited Oct. 24, 2024).
21
Thyroid-stimulating hormone, also known as thyrotropin, is “a glycoprotein anterior pituitary
hormone [] that promotes the growth of, sustains, and stimulates hormonal secretion of the
thyroid gland.” Thyrotropin, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=50030 (last visited Oct. 24, 2024).
22
Vitamin D is one of “two fat-soluble compounds with antirachitic activity. . . . Deficiency of
vitamin D can result in rickets in children and osteomalacia in adults, while ingestion of excess
levels can lead to hypercalcemia, mobilization of calcium from bone, and renal dysfunction.”
Vitamin D, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=118584 (last visited Oct. 24, 2024).

8
bilateral thighs and arms.” Id. Petitioner reported a “progressive weakness, mostly proximal
[lower extremity] muscles and entire arms and shoulders.” Id. He stated he was unable to
exercise or lift weights, although he was able to conduct his activities of daily living. Id. He had
also developed numbness in the hands and feet, and over the “past few months” had leg cramps
that interfered with sleep. Id. Dr. Harwell wrote that Petitioner “[f]e[lt] profound fatigue and []
decreased endurance,” as well as myalgias, and that “[t]he pain [was] everywhere.” Id.

At the August 17, 2017 visit with Dr. Harwell, Petitioner’s physical examination was
normal except for pitting edema of the lower extremities. Pet. Ex. D at 6. Neurological
examination revealed normal strength in all muscles with 4/5 strength in distal intrinsic hand
muscles and proximal upper motor strength. Id. Range of motion was limited in the left ankle,
but otherwise normal. Id. Coordination was normal. Id. Petitioner had no tenderness of the
spinous process or paraspinal muscles. Id. Upper extremity and lower extremity examination
was normal with normal range of motion of wrists, elbows, shoulders, hips, knees, and feet. Id.
at 7. Petitioner had reduced range of motion with plantar flexion and extension of his left ankle.
Id. Dr. Harwell’s assessment was “muscle weakness.” Id. She noted “sudden onset of
progressive weakness in addition to peripheral neuropathy” with “reduced patellar reflexes.” Id.
She questioned whether Petitioner may have a neurological problem and recommended referral
to Dr. Curtis Hagenau, a neurologist. Id.

MRI of the brain was performed on September 26, 2017, and was unremarkable. Pet. Ex.
C at 48. Electromyography (“EMG”)/ nerve conduction study (“NCS”) 23 was done on October
6, 2017, and was “essentially normal . . . of both upper limbs.” Id. at 58. The study showed
decreased median sensory nerve amplitude, but this finding was interpreted as “technical in
nature.” Id. There was “no [] evidence of nerve entrapment or generalized peripheral
neuropathy.” Id.

Petitioner returned to see Dr. Harwell on October 20, 2017. Pet. Ex. D at 2. At this visit,
Petitioner reported he was about the same. Id. He had seen a neurologist and had a normal
EMG. Id. Dr. Harwell noted that Petitioner “fe[lt] strongly that the flu shot was to blame.” Id.
He was “stiff all over” and unable to exercise. Id. Dr. Harwell opined that Petitioner’s work-up
for connective tissue disorder (“CTD”) was negative and did not explain Petitioner’s muscle
weakness. Id. at 4. When asked about FM, Dr. Harwell explained that “[w]hile [FM] can cause
fatigue and subjective muscle weakness, it would not be responsible for actual muscle weakness
and reduced reflexes and should be thought of as a diagnosis of exclusion.” Id. She discussed
referring Petitioner to a tertiary referral center. Id.

23
Electromyography is “an electrodiagnostic technique for recording the extracellular activity
(action potentials and evoked potentials) of skeletal muscles at rest, during voluntary
contractions, and during electrical stimulation.” Electromyography, Dorland’s Med. Dictionary
Online, https://www.dorlandsonline.com/dorland/definition?id=15854 (last visited Oct. 24,
2024). Nerve conduction studies are “the measurement of the conduction velocity and latency of
peripheral nerves.” Nerve Conduction Studies, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=109043 (last visited Oct. 24, 2024).

9
On November 13, 2017, Petitioner saw neurologist Dr. Gretchen Campbell. Pet. Ex. E at
1-6. Chief complaints were “muscle weakness, pain[,] and fatigue.” Id. at 1. Petitioner repeated
his history of a flu shot in September 2016, followed the next week by “stiffness, spasm.” Id.
He stated that the spasms had progressed from his paraspinal muscles and his lower back, and
the spasms were now in his hips, thighs, across his shoulders, and down to his arms and hands.
Id. He also complained of “[l]ightning bolt pain” in his fingers and toes, exercise intolerance,
and constant fatigue. Id. Dr. Campbell documented that labs were essentially normal, brain
MRI was normal, cervical MRI showed minor disc bulges but a normal spinal cord, and EMG of
the upper extremities was “essentially normal.” Id. at 1-2. Petitioner was not employed and was
seeking social security disability. Id. at 2. Physical examination was normal except for 4/5
strength of the bilateral upper extremities, 4+/5 of bilateral hip flexors, mild tremor of the right
upper extremity, and decreased reflexes 1/4 in the “biceps, triceps, brachioradialis, patellar, and
ankle jerks.” Id. at 3. Dr. Campbell’s impression was numbness of the hands and feet, muscle
weakness of the proximal arms and legs. Id. at 5. Dr. Campbell recommended checking
Petitioner’s B12 level and testing for a Methylenetetrahydrofolate reductase (“MTHFR”) genetic
mutation. 24 Id. If these tests were normal, Dr. Campbell planned to refer Petitioner back to his
rheumatologist and primary care provider for future care. Id. The tests were performed, and
while the MTHFR DNA analysis showed two mutations, C677T and A1298C, these variants
were described as unlikely to be clinically significant based on published reports. Id. at 10.

Petitioner next saw Nurse Practitioner Anna Guessetto on January 4, 2018, for a “[f]lu
shot reaction.” Pet. Ex. F at 44. Petitioner reported that “shortly after” receiving the flu shot in
September 2016, he was diagnosed with the flu and had “back stiffness, hand swelling, limb
numbness, and extreme fatigue.” Id. Ms. Guessetto discussed “that the flu shot either caused an
immune reaction or [] an underlying immune reaction.” Id. In consultation with Dr. Daniel
Kalb, extensive lab work was ordered. Id. at 44-46.

Petitioner returned to see Dr. Kalb on February 6, 2018, and Dr. Kalb assessed Petitioner
with MTHFR deficiency 25 and FM. Pet. Ex. F at 38-42. Dr. Kalb wrote “[m]y assumption is
that the flu shot in 2016 affected his immune system and may have resulted in a reactivation of
EBV.” 26 Id. at 42. Dr. Kalb further postulated that the chronic EBV “may have led to the

24
MTHFR is “a key enzyme in the folate pathway and is responsible for the metabolism of
homocysteine.” See Pet. Ex. E at 10.
25
MTHFR deficiency is “a common, autosomal recessive, inborn error of folate metabolism
caused by mutation in the MTHFR gene . . . . Clinical manifestations, age of onset, and severity
are highly variable; characteristics include signs of neurologic damage ranging from psychiatric
symptoms to fatal developmental delay, microcephaly, ectopia lentis, and thrombosis.”
Methylenetetrahydrofolate Reductase (MTHFR) Deficiency, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=30976 (last visited Oct. 14, 2024).
26
EBV testing showed elevated EBV Nuclear Antigen IgG, VCA Antibodies IgG, and Early
Antigen IgG, indicative of “previous infection and early antigen antibody remains positive.” Pet.
Ex. F at 35; 29. EBV testing repeated on July 14, 2018 showed “early antigen antibody remains
positive.” Id. at 29.

10
development of his neuropathy and [FM] symptoms.” Id. Dr. Kalb recommended a diet to
reverse autoimmune diseases, The Plant Paradox diet (developed by Dr. Steven Gundry); an anti-
viral medication; an anti-fungal medication; low-dose naltrexone 27 as a supplement that “boosts
the immune system and treats any autoimmune disease;” as well as additional probiotic,
prebiotic, and enzyme supplements. Id. at 42.

On January 7, 2018, Petitioner presented to The Little Clinic with flu-like symptoms that
began the prior day. Pet. Ex. B at 1. He had fatigue and body aches “all over,” including his
hips and legs. Id. Testing for flu A was positive. Id. at 2. Petitioner was also diagnosed with
bronchitis. Id.

Dr. Kalb saw Petitioner for follow-up in April, May, July, and November 2018. Pet. Ex.
F at 3-37. Testing was done for heavy metals, urine mycotoxins, food sensitivities, and allergies,
and medications and supplements were prescribed and adjusted. Id. at 2-3. Dr. Kalb wrote that
EBV testing done November 19, 2018 showed “previous infection, early antigen antibody is
lower but remains positive.” Id. at 7. Quantitative polymerase chain reaction (“PCR”) testing
for EBV was negative. Id. at 8. Petitioner’s last visit with Dr. Kalb was March 8, 2019. Id. at 1.
Dr. Kalb’s notes from that visit state, “I am theorizing that the mild elevation in temperature
associated with activity, along with the flu-like symptoms that are relieved by rest, are due to an
abnormal immune reaction and not due to infection.” Id. The plan was to test for “heavy metals
and Mycotoxins” and start a “ketogenic diet.” Id. Dr. Kalb diagnosed FM, MTHFR deficiency,
obstructive sleep apnea, and hypertension. Id.

On May 12, 2019, Petitioner saw a new physician, Dr. Phaythoune Chothmounethinh,
with concerns about “daily fevers for about a year of 99 to 99.6, and . . . up to 101 [degrees],”
accompanied by extreme fatigue and his history of FM, which he attributed to his 2016 flu shot.
Pet. Ex. G at 1. His left hand had swelling and numbness. Id. Dr. Chothmounethinh’s
assessment was fatigue. Id. Other problems included EBV, MTHFR deficiency, obstructive
sleep apnea syndrome, and hypertension. Id. at 2. Petitioner returned for follow-up on July 23,
2019, complaining of dyspnea on exertion and having an adverse reaction to CT contrast dye.
Id. at 5.

Next, Petitioner saw Dr. Daniel N. Sacks on June 5, 2019, at the request of Dr.
Chothmounethinh, for complaints of nasal and sinus problems. Pet. Ex. H at 1. Petitioner
complained of years of chronic sinus symptoms, right submandibular gland swelling, and fevers.
Id. He also reported that a previous flu vaccine “resulted in an EBV infection.” Id. Dr. Sacks
recommended allergy testing and further evaluation with a CT scan and nasal endoscopy if
allergy testing failed to identify the etiology of Petitioner’s complaints. Id. at 3. Petitioner
returned two weeks later for follow-up. Id. at 9. Allergy testing was “relatively unremarkable.”

27
Naltrexone “is an opioid antagonist; administered . . . in the treatment of opioid or alcohol
abuse.” Naltrexone Hydrochloride, Dorland’s Med. Dictionary Online, https://www.dorlands
online.com/dorland/definition?id=33113 (last visited Oct. 14, 2024). Low-dose naltrexone
“refers to daily doses of naltrexone that are approximately 1/10th of the typical opioid addiction
treatment dosage.” Jarred Younger et al., The Use of Low-Dose Naltrexone (LDN) as a Novel
Anti-Inflammatory Treatment for Chronic Pain, 33 Clinical Rheumatology 451, 451-52 (2015).

11
Id. Petitioner reported improvement in symptoms since taking an antibiotic for a dental
infection. Id. Dr. Sacks recommended a trial of ipratropium 28 with further evaluation dependent
upon his response to treatment. Id. at 10.

Petitioner returned to see Dr. Tissot on July 10, 2019, complaining of the onset of
hematuria one week ago. Pet. Ex. MM at 14. Petitioner reported “gross hematuria, gross
hematuria with clots, flank pain (right)[,] and back pain.” Id. CT was performed on July 10 and
was normal. Id. at 15, 38.

A stress echocardiogram, with treadmill exercise testing, was performed October 2, 2019
and was negative for cardiac ischemia. Pet. Ex. LL at 4. Exercise time was 5.5 minutes, and
Petitioner tolerated the procedure well. Id. X-rays of Petitioner’s hips were performed on
October 4, 2019, and showed mild to moderate osteoarthritic changes of the left and right hip
with “joint space narrowing and osteophytic spurring.” Id. at 3.

On March 10, 2020, Petitioner sought care from rheumatologist Dr. James E. Gore at
Vanderbilt Medical Center Adult Hospital for “chronic joint and muscle pain.” Pet. Ex. N at 32.
After obtaining extensive laboratory studies and spinal X-rays, Petitioner returned to see Dr.
Gore on March 18, 2020. Id. at 3. Physical examination of muscles was normal with “no
proximal weakness; no distal weakness; [and] no atrophy.” Id. at 6. Petitioner had no abnormal
deep tendon reflexes or motor neuropathy, but he did have bilateral lower extremity neuropathy.
Id. Dr. Gore’s assessment was “chronic neuropathic symptoms of his hands and feet” with
normal folate level. Id. at 7. Regarding Petitioner’s neuropathy and fatigue, Dr. Gore noted that
his B6 and B12 vitamin levels were low, and recommended Petitioner supplement with a B
complex. Id. at 7-8. Dr. Gore assessed Petitioner with “[c]hronic midline low back pain without
sciatica,” noting his history of “low back pain and stiffness,” and commented that his X-rays
showed “mild multilevel degenerative changes on lumbar spine.” Id. at 8-9. He recommended
physical therapy for Petitioner’s low back. Id. at 8. Laboratory studies for inflammatory
markers were ordered for Petitioner’s left-hand pain; however, it does not appear that Petitioner
returned for follow-up. Id.

On August 24, 2020, Petitioner returned to see Dr. Thompson to reestablish care. Pet.
Ex. O at 3. He reported that he exercised twice per week. Id. Neurological examination was
normal with “[n]ormal strength and tone, [n]ormal sensation.” Id. at 4. Musculoskeletal
examination was also normal. Id. at 5. Dr. Thompson’s assessment was hypertension,
hypotestosteronemia, enlarged prostate, obstructive sleep apnea, polyarthralgia, degenerative
disc disease, anterior cervical lymphadenopathy, tinnitus, neurological dysfunction, fatigue, night
sweaters, chronic fever, and post-nasal drainage. Id.

28
Ipratropium bromide is “a synthetic congener of atropine with anticholinergic and
antimuscarinic effects . . . [used] in the maintenance treatment of chronic bronchitis, pulmonary
emphysema, and other forms of chronic obstructive pulmonary disease, and [ ] for the relief of
rhinorrhea associated with rhinitis or the common cold.” Ipratropium Bromide, Dorland’s Med.
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=26071 (last visited
Nov. 13, 2024).

12
On September 14, 2020, Petitioner sent a message to Dr. Gore through the electronic
health records and asked if he could “take or retake a test for chronic inflammatory
demyelinating polyneuropathy [(“CIDP”)]? I [feel] I have some [of] these symptoms and would
like to see if I have some form of this.” Pet. Ex. U at 58. Dr. Gore responded, “That would need
to be done by a neurologist, preferably who you saw before.” Id. Petitioner responded that he
would ask Dr. Thompson. Id.

Petitioner returned to Dr. Thompson for his annual examination on October 19, 2020.
Pet. Ex. O at 20. Petitioner reported that he was “sleeping well,” and that he was exercising
three to four times per week, except for the past month, due to a sinus infection. Id. The visit’s
problem list included his history of neurological dysfunction with pain and weakness of the
shoulder, arms and legs, and numbness of the hands and feet and noted “[o]nset of symptoms
occurred one week after receiving a[] [flu] vaccine.” Id. Dr. Thompson prescribed Wellbutrin 29
and to follow up in one month, or as needed. Id. at 23. The records do not reflect that Petitioner
requested testing for CIDP.

Petitioner and his wife, Lee Anne Williams, sent a message via the electronic health
record to Dr. Gore on January 30, 2021 stating, “We asked why [Petitioner’s] symptoms are not
[FM]. You gave us an answer[,] but we can’t remember what you said could you please tell us
again.” Pet. Ex. U at 41. Dr. Gore replied two days later, stating, “We discussed Periodic Fever
Syndromes.” Id.

In August 2021, Petitioner had a follow up visit with Dr. Gore. Pet. Ex. U at 9. Dr. Gore
stated that Petitioner had “an unusual presentation [of periodic fever syndrome] since his
symptoms began after a flu shot.” Id. at 10. Dr. Gore noted that Petitioner had “negative
serologies and only a slightly elevated CRP.” Id. History of present illness included that he was
seen by Dr. Kalb, who thought Petitioner had a viral infection, and prescribed anti-virals, which
helped Petitioner’s movement and overall pain and stiffness. Id. at 11. Petitioner was currently
complaining of episodes of fever with swelling of the right neck lymph nodes associated with
severe fatigue. Id. Petitioner reported that his previous numbness in his hands and feet had
improved with Vitamin B supplementation. Id. Petitioner tried taking colchicine for his right
neck swelling, but it caused excessive sleepiness. Id. at 10. Dr. Gore’s assessment was
“periodic fever syndrome” and “chronic pain of right knee.” Id. at 9. He considered low dose
Imuran 30 as treatment for the periodic fever syndrome. Id. at 13.

29
Wellbutrin, known generically as bupropion hydrochloride, is “a monocyclic compound
structurally similar to amphetamine, used as an antidepressant . . . .” Bupropion Hydrochloride,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=7289
(last visited Nov. 13, 2024).
30
Imuran, known generically as azathioprine, is “the imidazolyl derivative of 6-mercaptopurine,
its active metabolite. It is [used] as an immunosuppressive agent for prevention of transplant
rejection []; as a disease-modifying antirheumatic drug for treatment of severe, progressive
rheumatoid arthritis unresponsive to other agents; and in treatment of a number of autoimmune
disorders.” Azathioprine, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/
dorland/definition?id=7289 (last visited Nov. 13, 2024).

13
Petitioner had pneumonia due to Covid infection in December 2021 through February
2022. Pet. Ex. OO at 3. He was hospitalized due to Covid in January 2022. Id. at 45-47. On
March 28, 2022, he was diagnosed with post-Covid syndrome. Id. at 39. His symptoms
included alopecia, 31 and “[r]eceptive[32] and [e]xpressive [a]phasia.” 33 Id.

On June 6, 2022, Dr. Thompson’s records stated that he was referring Petitioner back to
neurology “specifically for skin biopsy to check for small fiber sensory neuropathy.” Pet. Ex.
OO at 4, 34. However, no records documenting a skin biopsy have been filed.

History taken by Dr. Thompson on November 1, 2022 noted that Petitioner felt well with
“minor complaints,” had decreased energy, but was sleeping well. Pet. Ex. OO at 21. He had
stopped using his continuous positive airway pressure (“CPAP”) machine for sleep apnea due to
claustrophobia. Id. Physical examination was normal, Petitioner had “full range of motion” and
“[n]o adenopathy.” Id. at 23. Neurological and musculoskeletal examinations were also normal.
Id.

Records from Petitioner’s virtual visit to Dr. Thompson from April 4, 2023 show that his
diagnoses on that day included hypertension, microalbuminuria, elevated liver enzymes, chronic
prostatitis, erythrocytosis, periodic fever syndrome, and polymyositis. Pet. Ex. OO at 4. Dr.
Thompson wrote, “[t]he patient feels well with minor complaints.” Id. It was noted that he
continued to follow up with rheumatology. Id. at 7. Petitioner returned to see Dr. Thompson on
June 13, 2023, for acute right flank pain, “[c]rampy in nature. Suggestive of kidney stone.” Pet.
Ex. QQ at 4. At that visit, it was documented that Petitioner continued to take Naltrexone 3 mg
per day for FM. Id.

Although additional records from various providers have been filed, they do not
materially relate to the issues in dispute here, and so they are not summarized.

31
Alopecia is a “lack or loss of hair from skin areas where it normally is present.” Alopecia,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=1905
(last visited Sept. 27, 2024).
32
Receptive aphasia is an “inability to understand written, spoken, or tactile speech symbols, due
to disease of the auditory and visual word centers.” Receptive Aphasia, Dorland’s Med.
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=57205 (last visited
Sept. 27, 2024).
33
Expressive aphasia, also called motor aphasia, is an “aphasia in which there is impairment of
the ability to speak and write . . . . The patient understands many written and spoken words but
has difficulty uttering the words.” Motor Aphasia, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=57201 (last visited Sept. 27, 2024).

14
2. 2019 VAERS Report

Petitioner filed two VAERS reports. The first one was filed May 2, 2019, and the form
was completed by Heather Graves, a healthcare staff person. Pet. Ex. A at 15. However, the
patient name on the report was erroneously listed as Lee Anne, Petitioner’s wife’s name. Id.

A second VAERS report was submitted by Petitioner on May 15, 2019. Pet. Ex. A at 17-
18. The date of vaccination was identified as September 4, 2016, and the date of onset of the
adverse event was documented as September 14, 2016. Id. at 17. Petitioner described that less
than a week after receiving the vaccination, he “started having tight sore muscles and hot
inflation along [the] spine in his back.” Id. at 18. This caused Petitioner to have aches and pains
in his back and “between his ribs.” Id. Additionally, he reported neurological problems,
including tremor, swelling of the left hand, and numbness, coldness, and weakness in his hands.
Id. Petitioner also reported that he had EBV and FM. Id.

3. Petitioner’s Affidavits

Petitioner filed several affidavits executed on August 15, 2019. Pet. Ex. 1 at 2-6. Two of
these address visits to The Little Clinic. See id. at 2, 5. In one affidavit, Petitioner averred that
he saw Ms. Jones, Physician Assistant, 34 on December 7, 2016, at The Little Clinic, and he
reported that since receiving the flu vaccine on September 4, he had back stiffness and
inflammation “that progressed to whole body aches and fatigue.” Id. at 2. He also reported a
pain level of 6/10, and they discussed the “vaccine and the symptoms.” Id. Petitioner assumed
that Ms. Jones documented the conversation in his records. 35 Id. He further averred that Ms.
Jones did not treat him or recommend that he seek any treatment. Id.

In another affidavit, Petitioner stated he saw Nurse Practitioner, Ms. Johnson, at The
Little Clinic on April 18, 2017, for “itchy watery eyes.” Pet. Ex. 1 at 5. He averred that he again
reported the same problems described above. See id. Again, Petitioner assumed the problem
had been noted in his records. 36 Id. Ms. Johnson did not treat him for his “general body ache
symptoms,” or recommend that he see a physician. Id.

In another affidavit, Petitioner averred that on September 10 or 11, 2016, he and his wife
went to the pharmacy where he received his flu vaccine, and told the pharmacist, Joan R.
Ratcliff, that “within [three] days of receiving the [flu] vaccine the muscles in [his] back became
inflamed and stiff.” Pet. Ex. 1 at 3. Ms. Ratcliff responded by stating that “the flu shot would
not have caused that.” Id.

34
While Petitioner described Ms. Jones as a Physician’s Assistant in his affidavit, medical
records describe Ms. Jones as a Nurse Practitioner. See Pet. Ex. 1 at 2; Pet. Ex. B at 7.
35
This conversation is not documented in the medical records. See Pet. Ex. B at 6-7.
36
This conversation is not documented in the medical records. See Pet. Ex. B at 4-5.

15
Petitioner also filed an affidavit describing a conversation he had with his dentist, Dr.
Chad Hutchison, on October 31, 2017. Pet. Ex. 1 at 4. The dentist “had a difficult time getting
[Petitioner] numb.” Id. at 4. Petitioner told his dentist of the problems he had experienced since
receiving the flu vaccination, and Petitioner averred that his dentist “agreed the neurological
symptoms [Petitioner] was experiencing elsewhere could be causing the issue with getting [him]
numb.” Id.

In the next affidavit, executed August 15, 2019, Petitioner recounted having a reaction to
contrast given for a CT scan on July 10, 2019. Pet. Ex. 1 at 6. After the contrast injection,
Petitioner “felt hot,” which he was told “was a normal reaction.” Id. Petitioner stated that the
“hot feeling last[ed] [five] days which is not normal.” Id. Also, when he was leaving the test,
“the nerve in [his] middle finger of his right hand started making his finger jump. [And] [t]he
other fingers felt like the nerves were firing. That evening the toes in his right foot were burning.
The tingling [and] burning lasted for [three] days.” Id.

Petitioner executed another affidavit on July 21, 2020. Pet. Ex. 1 at 1. In it, Petitioner
described statements made by Dr. Chothmounethinh during office visits. Id. These statements
included that Petitioner had “a million in one condition brought on by the flu shot vaccine,” that
he “could try and find a flu vaccine clinical study” to help “with the problems caused by the flu
vaccine,” that all test results were negative, and “the results circle back to the cause being the Flu
Shot Injection.” Id. In June 2020, when asked via the patient portal whether Dr.
Chothmounethinh had found a vaccine clinical study, he responded, “I have not come across any
yet but will let you know.” Id.

4. Petitioner’s Testimony

Petitioner testified at the onset hearing to support his contention that his symptoms
started in September 2016. Tr. 5-34.

Petitioner received his flu shot with his wife at the Target pharmacy. Tr. 6. He could not
recall having ever received the flu vaccine before. Id. Petitioner explained his “wife started
feeling pain in her left arm when [they] went to the grocery store right after Target” but he
“didn’t have any pain until later on.” Id. Petitioner’s pain began “a few days later after the flu
shot.” Tr. 7. He woke up with “burning pain in [his] back and achy muscles.” Id. Petitioner
described his symptoms as beginning around the spine, which “felt like it was on fire.” Tr. 15.
Then his left arm began getting weaker, and he developed tremors. Id. As of the date of the
onset hearing, December 15, 2021, he continued to have “achy back muscles and sharp pains in
his back.” Id. He also had a “gland in the right side of his throat that swells up” and “firing of []
nerves in [his] toes and [] fingers.” Id. Petitioner also testified that he is “very tired all the time”
and that after physical labor, he must rest or nap. Id.

Four or five days after receiving the vaccine, Petitioner returned to the pharmacy and
spoke to the pharmacist about whether the flu shot caused Petitioner’s pain. Tr. 7-8. The
pharmacist told Petitioner that “the flu shot wouldn’t have done that.” Tr. 8. The pharmacist
didn’t offer to take notes or fill out any paperwork. Id. Petitioner filed a formal report in 2019
after learning about VAERS. Tr. 8, 13. Petitioner explained he then amended the VAERS report

16
because the first VAERS report had his wife’s name and an adverse event date of September 11,
2016, but his adverse event date “was a few days earlier than that.” Tr. 11. However, the
amended VAERS report pushed the date further back to September 14, 2016. Tr. 12. Petitioner
testified that “[he] didn’t tell them that. [He] told them it was earlier than that.” Id.

Petitioner went to The Little Clinic on December 21, 2016, because he had an “upper
respiratory condition starting.” Tr. 15. At the appointment he said his pain levels were 6/10 and
he “brought up his flu shot because [he] thought that was [] causing [his] pain level.” Tr. 16. He
told the provider “about the flu shot, all of the problems [he] was having.” Id. Petitioner went
back to The Little Clinic on April 18, 2017, for seasonal allergies. Tr. 17. At this appointment,
Petitioner told the provider about the symptoms he was attributing to the flu vaccine. Tr. 17-18.
Petitioner testified that he regularly goes to appointments at The Little Clinic because “[y]ou
don’t have to get an appointment. You just walk up there and they let you in.” Tr. 23. Both his
December 2016 and April 2017 visits were walk-up visits. Tr. 25. Petitioner testified that he
never did a “walk up” appointment at The Little Clinic for his back pain. Tr. 25-26.

His next appointment was his yearly check-up with Dr. Thompson on June 13, 2017. Tr.
18-19. Petitioner did not tell Dr. Thompson about any vaccine-related symptoms. Tr. 19.
Petitioner was concerned that if he told Dr. Thompson about the vaccine symptoms, “[insurance]
wouldn’t pay for the examination . . . [b]ecause [he] had problems before mentioning something
at another doctor, and they wrote it up and [insurance] would not pay for the exam[ination]
then.” Id.

Petitioner also saw a chiropractor on June 24, 2017, because he was worried about his
back. Tr. 20. Petitioner told the chiropractor about “[his] back and all the pain [he] was having.
And [the chiropractor] said he had heard that flu shots cause problems and that’s why he
wouldn't take one.” Id.

Petitioner was first formally treated for his vaccine-related symptoms at his next
appointment with Dr. Thompson on July 20, 2017. Tr. 21-22. Petitioner explained he didn’t
seek formal treatment until July 2017 because “[w]ith professionals telling [him] that [his pain]
wasn’t the flu shot, [he] just thought [he] had [] aches and pains in his back.” Tr. 22. He sought
formal treatment because his symptoms got worse, and he had to stop doing activities. Id.

5. Lee Ann Williams’ Affidavits and Testimony

Ms. Williams is the wife of the Petitioner. Tr. 35. She received a flu vaccination at the
same time and place as Petitioner. Tr. 35-36. In the affidavits she executed in 2019 and 2020,
she generally testified that the onset of Petitioner’s symptoms occurred about three days or so
after vaccination. Pet. Ex. 2 at 1-3.

She also submitted an affidavit on August 15, 2019, that described Petitioner’s condition
before and after vaccination. See Pet. Ex. 2 at 4. Prior to vaccination, Petitioner “did not
complain of constant back stiffness, inflamed back muscles, whole body aches, tingling/feelings
of firing in hands and feet, [and] tiredness.” Id. He was able to work out at the gym three to five
times per week and work in the yard. Id. As of August 15, 2019, Petitioner was unable to do

17
“prolonged physical activity” and if he did “any type of physical activity,” he “require[d] daily
naps.” Id. She added that if he had a “day long activity,” he would plan to “rest the next [two to
three] days.” Id.

Ms. Williams testified at the onset hearing. Tr. 35. Ms. Williams was with Petitioner
when he received his flu vaccine. Tr. 36. That same day, after receiving her flu vaccine, Ms.
Williams experienced some stiffness and soreness in her arm. Id. She asked Petitioner “if he
had any symptoms, and he said no.” Id.

Petitioner received the vaccine on a Saturday and sometime the following week “he
started feeling inflammation in his back and the sore stiff muscles.” Tr. 36. Petitioner told Ms.
Williams that “he felt like [his] spine was on fire.” Tr. 37. Ms. Williams explained that “later on
he started being fatigued” and continued to have back pain. Id. Ms. Williams asked Petitioner if
the pain was due to the gym, or working around the house, or in the house, but Petitioner denied
those causes. Id. He just “woke up feeling that way that morning.” Id.

Ms. Williams and Petitioner returned to the pharmacist, Ms. Ratcliff, the next weekend
and told her about Petitioner’s symptoms. Tr. 37. The pharmacist told them the vaccine would
not have caused Petitioner’s symptoms. Id.

Ms. Williams attended an appointment with Petitioner on December 21, 2016. Tr. 38. At
the appointment, Petitioner told the provider his pain was 6/10 and “he had been having pain in
his back since receiving the flu shot in the beginning of September.” Id. Ms. Williams attended
Petitioner’s next appointment on April 18, 2017. Tr. 39. At that appointment, Petitioner told the
provider “that he was having back stiffness and again, that it had been going on since September
when he got the flu shot.” Tr. 40.

Ms. Williams did not attend Petitioner’s next appointment on June 13, 2017, which was
his annual physical. Tr. 40. Prior to the visit, Ms. Williams and Petitioner discussed not telling
his doctors about his vaccine symptoms to avoid being charged for a “special visit” by their
health insurance. Tr. 41. Ms. Williams was concerned about extraneous charges because at her
annual workup the nurse had informed her if “we talked about anything else other than the
normal annual physical-type thing, that [she] might have to pay for not just the doctor’s visit but
any lab work that would be run, which can be several hundred dollars.” Id. Ms. Williams and
Petitioner also thought a normal physical and bloodwork might show Petitioner’s “thyroid or
something else was out of whack and causing these symptoms.” Id.

6. Other Affidavits and/or Testimony

Affidavits and/or testimony were offered by four lay witnesses, as summarized below.

Petitioner’s sister, Ms. Susan Williams Kunczwka, offered two affidavits. Pet. Ex. 6. In
her first affidavit, executed on August 12, 2019, she described that before the vaccine, Petitioner
“always had energy and did many activities including going to the gym.” Id. at 2. She explained
the activities Petitioner performed during an August 2015 visit, and she explained that Petitioner
“was able to do very little” the next time he visited in June 2017. Id. at 2. In the second affidavit

18
executed on December 4, 2020, Ms. Kunczwka averred that Petitioner called her around
September 11 to complain about symptoms he developed from the September 4 flu vaccine. Id.
at 1.

Ms. Kunczwka provided additional detail in her testimony at the hearing. Tr. 44-47. Ms.
Kunczwka explained that she is in contact with Petitioner “on a regular basis.” Tr. 44. In the fall
of 2016, she would talk with Petitioner on the phone “at least twice a month” and they “would e-
mail [] two, three times a week.” Tr. 45. Ms. Kunczwka first became aware of Petitioner’s flu
vaccine after a phone call “around [Petitioner’s] birthday, at the end of September 2016.” Id.
Ms. Kunczwka explained she recalls the conversation because Petitioner was impressed that he
received a $5 gift card after receiving the flu vaccine at Target and was “just more ecstatic than
most people are” to receive a flu vaccine. Tr. 45-46. This call was probably “a week or less than
two weeks” after Petitioner received the vaccine. Tr. 46. Petitioner was very concerned about
possible side effects and was complaining that he was “just achy, miserable, there was a burning
in his back.” Id. Ms. Kunczwka testified that Petitioner would usually exchange calls or emails
with her after appointments. Tr. 47. She was pretty sure she had received emails from Petitioner
complaining about his symptoms. Id. Ms. Kunczwka no longer had copies of those emails at the
time of the hearing on December 15, 2020. Id.

Petitioner’s friend, Mr. Timothy Munsell executed an affidavit on July 15, 2020, and later
testified at the onset hearings. Pet. Ex. 4; Tr. 51-56.

In his affidavit, Mr. Munsell averred that Petitioner had a lot of back pain in the fall of
2016 and “[Petitioner] told [him] at that time that he suspected the flu shot he received in
September 2016 may have been the cause of the pain.” Pet. Ex. 4 at 1.

At the onset hearing, Mr. Munsell testified that Petitioner began complaining of “back
aches and headaches and [] a lot of fatigue” in the fall of 2016. Tr. 51. Mr. Munsell, Petitioner,
and their wives would often talk after Sunday school classes at their church. Id. During these
talks, Petitioner often mentioned “the health problems that he was experiencing and []the
frustration of trying to find a doctor with a good diagnosis and [] trying to get some treatment for
these problems.” Id. Mr. Munsell also explained that there were “a number of Sundays where
[Petitioner’s wife] was alone because [Petitioner] was not able to make it [to] church that day
just because he was feeling so bad.” Tr. 56. In the fall of 2017, Petitioner helped Mr. Munsell
replace broken stairs. Tr. 55. Petitioner was able to help Mr. Munsell with the project at that
time, although Mr. Munsell had some “concerns . . . beforehand.” Id.

Mr. Munsell explained he remembered that Petitioner’s health issues began in fall of
2016 rather than in “the spring or summer of [20]17” because Mr. Munsell remembered seeing
“the lawn and trees” out the windows of the classroom where he spoke with Petitioner and
because Mr. Munsell changed jobs in January of 2017. Tr. 52-53.

Petitioner’s hairdresser and friend, Ms. Krista Stevens, executed an affidavit on June 29,
2020. Pet. Ex. 3. Ms. Stevens averred Petitioner was “always full of life,” but in “September
2016 everything changed.” Id. Ms. Stevens explained that Petitioner complained after getting
the flu shot and he became “always tired, achy, and just never felt good.” Id.

19
Mr. Robert Williams, Petitioner’s neighbor, executed an affidavit on July 8, 2020. Pet.
Ex. 5. He stated that he has known Petitioner since 2014 and that “sometime in late 2016
[Petitioner] told [him] he had become ill after having the flu shot.” Id. Mr. Robert Williams
noted that Petitioner had discussed his “discomfort that occurred after that flu shot . . . in many
conversations.” Id.

7. Affidavits of Dr. John R. Thompson

Dr. Thompson submitted two affidavits. The first one was executed on October 19, 2019,
at the request of Petitioner. Pet. Ex. 7. In it, Dr. Thompson stated Petitioner “developed sudden
onset of back pain extending from his cervical spine to his sacrum within days of receiving a
seasonal [flu] vaccine on September 4, 2016.” Id. The “pain progressed over the ensuing
months to include his shoulders, arms, and thighs, bilaterally,” and was “associated with
progressive weakness of his proximal muscles . . . and progressive fatigue.” Id. Dr. Thompson
referred Petitioner to a rheumatologist and a neurologist, who both conducted extensive
evaluations that “failed to reveal an etiology for [Petitioner’s] symptoms.” Id. Dr. Thompson
opined that Petitioner’s “chronic symptoms represent an adverse reaction directly related to the
[flu] vaccine he received on [September 4, 2016].” Id.

The second affidavit from Dr. Thompson was executed on August 3, 2020. Pet. Ex. O at
1-2. Dr. Thompson stated that Petitioner “developed sudden onset of back pain from cervical
spine to sacrum” a week after receiving the flu vaccination on September 4, 2016. Id. at 1. “The
pain was associated with progressive weakness of his shoulders, arms, hands, and proximal leg
muscles; numbness involving his hands and feet; and profound fatigue.” Id. Initial tests were
normal, other than a low folate level which was supplemented. Id. Dr. Thompson referred
Petitioner to a rheumatologist and a neurologist, but their testing “failed to reveal an etiology for
his symptoms.” Id. As such, Dr. Thompson stated “[n]o etiology has been found to explain
[Petitioner’s] persistent neurologic symptoms, other than the circumstantial evidence pointing to
the fact his symptoms had their onset within days of receiving the seasonal [flu] vaccine.” Id.

8. Letter from Dr. James Gore

Dr. Gore authored a letter signed August 27, 2020 stating, “I have read the letter written
by Dr. John Thompson, dated [August 2, 2020]. I agree with the content and request of this
letter.” Pet. Ex. Q at 1.

Dr. Gore’s medical records include emails from Petitioner asking Dr. Gore to sign, date,
and mail the letter. Pet. Ex. U at 71, 73-74, 76-80.

20
9. Records of Gym Visits 37

Records of Petitioner’s gym visits to Franklin Recreation Center from January 1, 2015 to
December 31, 2016 show that in June 2016, Petitioner visited the gym seven times. Pet. Ex. L at
1. In July 2016, he went to the gym three times, and in August 2016, he visited eight times. Id.
at 1-2.

After his vaccination on September 4, 2016, the records show that Petitioner went to the
gym three times in September 2016, six times in October 2016, and three times in November
2016. Pet. Ex. L at 2-3.

There are no records documenting visits in December 2016 or the first six months of
2017 (January 2017 through July 2017). See Pet. Ex. L. It does not appear that the search
criteria used to identify Petitioner’s visits to the gym included dates after December 31, 2016, as
the inquiry was limited to dates from January 1, 2015 until December 31, 2016. Id. at 1.
Therefore, it is not clear whether complete records for 2017 were produced.

Planet Fitness records show that Petitioner went to the gym six times in July 2017, and
once in September, November, and December 2017. Pet. Ex. L at 13.

D. Expert Reports 38

1. Petitioner’s Expert, Dr. Curt Hagenau 39

a. Background and Qualifications

Dr. Hagenau is a board-certified neurologist. Pet. Ex. R at 1. He received his M.D. from
Vanderbilt University in 1982 after which he completed his internship in internal medicine,
residency in neurology, and a fellowship in neurodiagnostic medicine at Vanderbilt University.
Id. at 8. Dr. Hagenau works in private practice and has been in the general practice of adult
neurology since 1987. Id. at 1, 8-9. Dr. Hagenau was formerly the Chief of the Department of
Neurosciences at St. Thomas Midtown Hospital (formerly known as Baptist Hospital). Id. at 8.
He was formerly a clinical instructor at the University of Tennessee Internal medicine residency

37
These records also show visits to Franklin Recreation Center from 2007 to 2015. See Pet. Ex.
L at 4-10. These visits are not summarized herein, as they relate to earlier years. Only the visits
in the year prior to and after vaccination are summarized, as they are deemed most relevant.
38
The undersigned does not discuss the opinions of the experts related to small fiber neuropathy,
as the parties’ joint prehearing submission narrows the alleged vaccine related injury to FM. See
Joint Submission at 2.
39
Petitioner filed one report from Dr. Hagenau. Pet. Ex. R. Dr. Hagenau did not reference any
medical literature in his expert report.

21
program where he also gave monthly lectures on numerous neurological topics including FM.
Id. at 8-9.

b. Diagnosis Opinion

Dr. Hagenau opined that Petitioner has FM which is “the primary cause of his
generalized pain and fatigability.” Pet. Ex. R at 4. He further opined that Petitioner’s condition
is chronic, although it could improve with medication, “diet [,] and exercise.” Id. Regarding
alternative diagnoses, Dr. Hagenau opined that Petitioner did not have “a significant large fiber
polyneuropathy” and “certainly does not have an inflammatory/demyelinating polyneuropathy.”
Id. at 5.

In reaching his opinions as to diagnosis, Dr. Hagenau reviewed Petitioner’s medical
records and performed a physical examination of Petitioner on March 5, 2021. Pet. Ex. R at 1.
Physical examination revealed Petitioner to be “moderately overweight,” with “mild to moderate
pitting ankle edema.” Id. at 4. His radial and pedal pulses were strong. Id. There was
“[m]oderately diminished cervical range of motion, [n]o cranial tenderness,” and “[m]ild diffuse
thoracic, lumbar and limb tenderness.” Id. Petitioner had normal strength throughout, and
although he “mentioned weakness in his left hand, [his] finger spread and finger
flexion/extension strength [was] normal.” Id. Dr. Hagenau noted a “low amplitude rapid tremor
[in] both outstretched hands” but no resting tremor. Id. Sensation in the hands and feet was
normal. Id. Deep tendon reflexes were 2+ (on a scale of 4) at the elbow and 1+ at knees and
ankles. Id. Petitioner had a “poor level of conditioning,” but normal gait, and he was able to jog.
Id. Neurological examination was normal. Id. Dr. Hagenau opined that Petitioner had “no
excessive pain behavior[,]” and he did not “get the feeling that [Petitioner] was overstating his
symptoms.” Id.

Regarding the diagnosis of FM, Dr. Hagenau explained it is a common condition in
middle-aged patients. Pet. Ex. R at 4. FM “produces a symptom complex of muscle aching and
tenderness, with a feeling of heaviness and tiredness, even though actual muscle power is not
diminished. As in [Petitioner’s] case, it is often accompanied by diminished exercise
intolerance, poor sleep quality, cognitive sluggishness, and abnormal skin sensations.” Id.

c. Causation Opinion

i. Althen Prong One

According to Dr. Hagenau, the “primary problem in [FM] is dysfunction in the
central pain pathways in the brain and spinal cord” which “become hyperactive, hypersensitive,
generating the experience of pain, tingling or burning in areas of the body where there can be
found nothing wrong peripherally.” Pet. Ex. R at 5. Minor sensations are amplified into “painful
sensations.” Id. Moreover, “[the] dysfunction in the central and sensory pathways is often the
cause of the peripheral tingling sensations.” Id. FM patients are “predisposed to dysfunction in
the tiny sensory nerve endings in the skin (small fiber sensory neuropathy),” although this
“interaction between the central neurons and the peripheral neurons is not well understood.” Id.;

22
see also Pet. Ex. DD.29 at 1(noting “the pathogenesis of FM is not fully understood, especially
because compared to neuropathic conditions, in FM the source of sensory inputs is unknown”). 40

Dr. Hagenau opined that there can be a genetic predisposition to FM, as well as other
predisposing factors, including “chronic anxiety, depression, and generally poor health and
metabolic status.” Pet. Ex. R at 5. An “acute trigger” may bring the “condition to the surface.”
Id. Examples of triggers include physical trauma, psychological trauma, [and] infectious trauma.
Id. With infectious trauma trigger, “the body’s inflammatory response to the microbe initiates
persistent hyperactivity in the pain pathways and immune system.” Id.

Dr. Hagenau opined that “[v]accinations, by design, induce an inflammatory response . . .
to activate the immune system so that it will respond vigorously if exposed to the actual microbe
. . . in the future.” Pet. Ex. R at 5.

According to Dr. Hagenau, the lack of supportive studies to prove an association with
vaccination is because “[c]hronic neurological syndromes” like FM caused by vaccination are
rare and therefore, “it has been difficult for researchers to statistically prove a link through
demographic studies between flu vaccination and [FM].” Pet. Ex. R at 5.

ii. Althen Prongs Two and Three

Before providing his opinions specific to causation in Petitioner’s case, Dr. Hagenau
briefly summarized Petitioner’s course. Pet. Ex. R at 2-4. He noted that Petitioner received the
flu vaccination on September 4, 2016, and then reported that “[five to seven] days after the
vaccination[,] he acutely developed diffuse, intense[,] aching[,] [and] burning pain involving his
upper, mid[,] and lower back,” which was aggravated by movement. Id. at 2. The burning pain
resolved over the next month, but Petitioner continued to experience “constant aching and
tension,” and “the aching pain spread to involve his limbs diffusely.” Id. In the fall of 2016,
Petitioner developed numbness and tingling in the hands and feet, fatigue with activity, and
weakness. Id. at 3. He also had tremors in the hands, “heat and cold intolerance,” mild
temperature elevations, and “cognitive sluggishness/foggy headed feelings.” Id.

Dr. Hagenau agreed that Petitioner “did not seek medical attention for his symptoms in
the months after [] vaccination.” Pet. Ex. R at 3. Petitioner did not report his FM symptoms to a
physician, Dr. Thompson, until July 20, 2017. Id. Dr. Thompson’s physical examination was
normal and blood work was negative. Id. However, “Dr. Thompson felt that [Petitioner] had
[FM].” Id.

Dr. Hagenau opined that Petitioner’s flu vaccination on September 4, 2016 “contributed
substantially to the development of his [FM].” Resp. Ex. R at 4.

As explained by Dr. Hagenau, DNA testing is not generally done in patients with FM,
although there are some patients with a genetic predisposition to the illness. Pet. Ex. R at 5. In

40
Simona D’Agnelli et al., Fibromyalgia: Genetics and Epigenetics Insights May Provide the
Basis for the Development of Diagnostic Biomarkers, 15 Molecular Pain (2019).

23
addition to genetic predisposition, other contributing factors include physiological stressors,
generally poor health, or metabolic status. Id. In Petitioner’s case, Dr. Hagenau opined that “the
psychological stress [] of losing his job in 2016, and his obesity and sleep apnea were
predisposing factors.” Id. Moreover, Petitioner had a “laboratory documented [flu] infection a
few years previously, so it would be no surprise that he might have a vigorous immune response
to the September 2016 [flu] vaccination.” Id. This “resulted in activation of the nervous system
and immune system that was long lasting and self-perpetuating thereafter, resulting in
[Petitioner’s] [FM].” Id.

Although Dr. Hagenau noted that the onset of Petitioner’s symptoms occurred five to
seven days after vaccination, he did not offer an opinion about whether such time frame was
appropriate. See Pet. Ex. R at 2.

2. Petitioner’s Expert, Dr. Omid Akbari, Ph.D.41

a. Background and Qualifications

Dr. Akbari is a Professor of Immunology and Professor of Medicine at the University of
Southern California, Keck School of Medicine. Pet. Ex. DD at 2; Pet. Ex. EE at 2. He received
a Ph.D. in cellular and molecular immunology at the National Institute for Medical Research in
London, United Kingdom. Pet. Ex. EE at 1. Thereafter, he completed a postdoctoral fellowship
at Stanford University. Id. Dr. Akbari’s research focuses on the “the role of immune tolerance
and how immune cells induce autoimmune and allergic diseases.” Pet. Ex. DD at 2. His
laboratory research includes multiple studies regarding how an “antigen, allergen, or vaccine can
result in an appropriate or dysregulated immune response.” Id. at 2-3. Dr. Akbari serves as an
associate editor and reviewer on several journals. Id. at 2; Pet. Ex. EE at 4-5. He has authored
or co-authored numerous publications. Pet. Ex. DD at 2; Pet. Ex. EE at 9-18. Dr. Akbari is not a
medical doctor and is not qualified to diagnose or treat neurological conditions.

b. Diagnosis Opinion

Dr. Akbari did not offer any opinion about whether the diagnosis of FM was appropriate.
As he is not a medical doctor, he limited his opinions to immunology and causation.

c. Causation Opinion

i. Althen Prong One 42

41
Petitioner filed two expert reports from Dr. Akbari. Pet. Exs. DD, GG.

24
Regarding the general question of whether vaccines can cause FM, Dr. Akbari opined
that FM “is a heterogenous disease,” involving environmental, infectious, and genetic
predispositions, and that “induction of inflammasome[43] by vaccines play an important role as
[an] initial trigger” for development of the illness. Pet. Ex. DD at 8; Pet. Ex. GG at 2-5. In
addition to his hypothesis based on inflammasomes, Dr. Akbari offered several different theories
of causation in his expert reports.

Early in his initial expert report, Dr. Akbari addressed the question of whether FM is an
immune mediated illness. Pet. Ex. DD at 5. He opined that FM is immune mediated and that
both the innate 44 and adaptive 45 immune systems are involved in its development. Id. at 5-6.
Starting with the innate immune system, Dr. Akbari suggested “that [FM] could involve

42
Due to relevance and for the sake of brevity, the undersigned has not summarized large
sections of Dr. Akbari’s initial report which discuss Petitioner’s clinical course and general
principals of immunology. See Pet. Ex. DD at 3-7. Additionally, the undersigned does not
discuss Dr. Akbari’s explanation of self-tolerance or the regulatory T cells and their role in the
induction of autoimmune diseases. Id. at 7-8. The undersigned also does not discuss how
viruses activate the inflammasome pathway or the pattern recognition receptors. Id. at 10, 12.
Nor is the possibility of Rubella vaccination causing FM or the study of rare diseases and
adverse effects discussed. Id. at 19, 22-24. Instead, the undersigned has focused on the principal
causal hypotheses advanced by Dr. Akbari.
43
“Inflammasomes function as immune-signaling platforms that assemble following pathogen
detection.” Pet. Ex. DD.14 at 1 (Ella Hartenian & Petr Broz, Viral Protein Activates the NLRP1
Inflammasome, 23 Nature Immunology 818 (2022)). Inflammasomes are “a complex of
cryopyrin, caspase-1, and other proteins, found in phagocytic cells and related to the body’s
system of innate immunity. Assembly of the inflammasome leads to activation of caspase-1 and
resultant cleavage and activation of interleukins IL-1β and IL18 in the inflammatory response.”
Inflammasome, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/
dorland/definition?id=25203 (last visited Oct. 2, 2024).
44
The innate immune response is immunity that “does not require prior exposure to an antigen
(i.e. immunological memory) to be fully effective. . . . Components include Phagocytic cells
(e.g. neutrophils, monocytes, macrophages)[,] Polymorphonuclear leukocytes (in addition to
phagocytic neutrophils, including eosinophils and basophils)[,] [and] Innate lymphoid cells . . . .”
Peter J. Delves, Overview of the Immune System, Merck Manual, https://www.merckmanuals
.com/professional/immunology-allergic-disorders/biology-of-the-immune-system/overview-of-
the-immune-system (last visited Oct. 14, 2024).
45
The adaptive immune response is immunity that “requires prior exposure to an antigen to be
fully effective and takes time to develop after the initial encounter with a new invader.
Thereafter, response is quick. The system remembers past exposures and is antigen-specific.
Components include B cells [and] T cells.” Delves, supra note 44.

25
localized inflammation” due to increased levels of “proinflammatory cytokines[46] and
chemokines[47] . . . in the serum and cerebrospinal fluid” of patients with the illness. Id. at 5. He
explained that cytokines (IL-8, IL-1β, TNFα, IL-6, and IL-17) “could contribute to the
inflammatory response” in the central nervous system (“CNS”) and that the “pain in [FM]
involves neuroinflammatory processes triggered by mast cells[48] and microglia.” 49 Id. at 6. He
further stated that research studies “underline the role of cells and mediators of innate immunity
in maintaining pain conditions such as musculoskeletal pain and central sensitization.” 50 Id.

Regarding his opinion that cytokines and chemokines play a causal role in FM, Dr.
Akbari cited a study by Garcia et al. Pet. Ex. DD at 6 (citing Pet. Ex. DD.6). The purpose of the
study was to compare chemokine profiles of patients with FM (17 patients) as compared to
healthy controls (10 controls). Id. at 2-3. The FM patients had increased serum levels of some
inflammatory chemokines, but no differences in others. 51 Id. at 3. While the research suggested
that “an inflammatory state may contribute to pain[,]” additional research was recommended to
determine the role of chemokines in FM pathogenesis. Id. at 5.

46
Cytokine is “a generic term for nonantibody proteins released by one cell population (e.g.,
primed T lymphocytes) on contact with a specific antigen, which act as intercellular mediators,
as in the generation of an immune response.” Cytokine, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=12428 (last visited Oct. 2, 2024).
47
Chemokines are “a family of low-molecular-weight (8–10 kD) cytokines that induce
chemotaxis or chemokinesis in leukocytes . . . . Chemokines are regulators of the immune
system and may also play roles in the circulatory and central nervous systems.” Chemokine,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=9024
(last visited Oct. 2, 2024).
48
Mast cell is “a type of migrant connective tissue cell with basophilic, metachromatic,
cytoplasmic granules that contain histamine and heparin in humans.” Mast Cell, Dorland’s Med.
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=64240 (last visited
Oct. 2, 2024).
49
Microglia are “the small, nonneural, interstitial cells of mesodermal origin that form part of the
supporting structure of the central nervous system. . . . They are migratory and act as phagocytes
to remove waste products of nerve tissue.” Microglia, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=31308 (last visited Oct. 2, 2024).
50
Central sensitization is “a proposed mechanism for the cause of chronic pain conditions and
migraine, by which nociceptors in the [CNS] become hypersensitive to stimuli as a result of
tissue damage or inflammation.” Central Sensitization, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=105522 (last visited Oct. 2, 2024).
51
Garcia et al. provided an overview of chemokines, and discuss the three families of
chemokines, including those with “pro-inflammatory, homoeostasis[,] and mixed function.” See
Pet. Ex. DD.6 at 2.

26
After discussing cytokines and chemokines, Dr. Akbari moved to the topic of
inflammasomes. He opined that inflammasomes are activated after flu infection and vaccination,
citing a study by Crooke et al. 52 in support of this proposition. Pet. Ex. DD at 8 (citing Pet. Ex.
DD.11); Pet. Ex. GG at 2-3. Crooke et al. studied the blood tests of 147 adults separated into
two age groups, young (aged 18-39) and old (age 65-92), pre- and post-flu vaccination. Pet. Ex.
DD.11 at 1. Post-vaccination testing was done at 24 hours and 28 days. Id. at 2. There was no
significant age-related differences seen in inflammasome activity in macrophages. Id. at 9. Of
note, the authors stated that “inflammasome has been implicated as a critical component for
protective immunity after [flu] in several animal studies,” although this phenomenon has not
been studied in humans. Id. Although the study confirmed that inflammasomes are present after
flu vaccination, it did not describe any adverse effects related to these inflammasomes, rather the
focus of the research was on the protective immunity aspect of inflammasomes. See id. at 2.

Moreover, the Crooke et al. study did not show that inflammasomes were responsible for
the decreased immune response to the flu vaccine in older adults. Pet. Ex. DD.11 at 8. The
studies showed that P2XR7 gene 53 expression was lower in blood samples from older adults, and
that “lower expression of P2XR7 would be expected to result in decreased inflammasome
activation,” but they did not observe such a decline. Id. at 8-9. Thus, the researchers concluded
there were other factors that accounted for the “the decreased expression of P2XR7 or that an
alternative mechanism unaffected by age is responsible for stimulating inflammasome following
[flu] vaccination.” Id. at 8-9.

After citing Crooke et al. for the proposition that inflammasomes are present after flu
vaccination, Dr. Akbari asserted that inflammasomes “play[] an important role” in inducing FM.
Pet. Ex. DD at 11. In support of this aspect of his opinion, Dr. Akbari cited to articles by
Cordero et al. 54 and D’Amico et al. 55 Id. at 11-12 (citing Pet. Exs. DD.15, DD.16). Cordero et.
al. observed that previous studies have suggested that mitochondrial dysfunction and
inflammasome activation may be associated with FM. Pet. Ex. DD.15 at 1-2. The authors

52
Stephen N. Crooke et al., Inflammasome Activity in Response to Influenza Vaccination Is
Maintained in Monocyte-Derived Peripheral Blood Macrophages in Older Adults, 2 Frontiers
Aging 1 (2021).
53
The P2XR7 gene “encodes the purinergic receptor P2X7, which senses extracellular
concentrations of adenosine triphosphate and has been identified as one of the major drivers of
inflammasome activation.” Pet. Ex. D.11 at 8.
54
Mario D. Cordero et al., NLRP3 Inflammasome Is Activated in Fibromyalgia: The Effect of
Coenzyme Q10, 20 Antioxidants & Redox Signaling 1169 (2014).
55
Romana D’Amico et al., Inhibition of P2X7 Purinergic Receptor Ameliorates Fibromyalgia
Syndrome by Suppressing NLRP3 Pathway, 22 Int’l J. Molecular Sci. 6471 (2021).

27
studied the role of coenzyme Q10 (“CoQ10”) deficiency 56 and mitochondrial dysfunction in
inflammasome activation in FM. Id. at 2. They found that mitochondrial dysfunction occurred
with an increase in protein expression of interleukins (IL)-1β, NLRP3 inflammasome, and
caspase-1 as well as an increase in proinflammatory cytokines (IL-1β and IL-18). Id. at 2, 4.
The authors concluded that the results established an important role for inflammasome NLRP3 in
the etiology of FM and suggested that inflammasome inhibition was a potential for treatment of
the illness. Id. at 1. But they did not conclude that vaccination-induced inflammasomes were a
mechanism that induce FM. See id. at 4-5.

D’Amico et al., published more recently in 2021, addressed the role of nociceptors 57 in
the etiology of FM. Pet. Ex. DD.16. At the outset, the authors acknowledged that despite
significant developments in the understanding of FM, “the etiology . . . is still unknown.” Id. at
1. They noted that “there is evidence that FM is associated with disturbances in pain processing
by the [CNS].” Id. The authors suggested that the immune system and neuroinflammation may
play a role in this sensitization process, by activating nociceptors. Id. Nociceptors are, in turn,
“triggered by proinflammatory mediators such as [ATP] [58] or interleukin-1β (IL-1β).” Id. at 1-
2. The authors describe the nociceptive transmission system, which involves “the P2X7
receptor” and “ATP-gated ion channel[59] that play an important role in the inflammatory
response and in different pain states.” Id. at 2. The P2X7 receptor is “overactivated due to ATP
release, resulting in anion imbalance and triggering of microglia, that additionally exacerbate cell
damage.” Id. Further, they explain that “P2X7R activation is involved” in signaling “the

56
CoQ10 is “an antioxidant, produced naturally in humans, that is also a cofactor for
mitochondrial adenosine triphosphate (ATP) generation. The levels of CoQ10 seem to be lower
in older people and in people with chronic diseases . . . .” Laura Shane-McWhorter, Coenzyme
Q10 (CoQ10), Merck Manual, https://www.merckmanuals.com/professional/special-
subjects/dietary-supplements/coenzyme-q10-coq10?query=coenzyme%20q10%20(coq10) (last
visited Oct. 24, 2024).
57
Nociceptors are “a receptor for pain caused by injury to body tissues.” Nociceptor, Dorland’s
Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=34263 (last
visited Oct. 2, 2024).
58
ATP is “a nucleotide, the 5′-triphosphate of adenosine, involved in energy metabolism and
required for RNA synthesis; it occurs in all cells and is used to store energy in the form of high-
energy phosphate bonds.” Adenosine Triphosphate, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=54993 (last visited Oct. 2, 2024).
59
Ion channel is “a cell membrane protein with an ion-specific transmembrane pore, through
which ions and small molecules pass into or out of a cell by diffusion downward along their
electrochemical gradient; although some are always open, most open and close in response to a
stimulus. Movement of ions through channels controls the electrical potential across the
membrane and plays a vital role in depolarization and repolarization of nerve and muscle fibers.”
Ion Channel, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/
definition?id=64836 (last visited Oct. 2, 2024).

28
NLRP3 inflammasome pathway,” 60 and the release of IL-1β and IL-18, which “mediate painful
conditions.” Id.

The specific purpose of the D’Amico et al. study was to determine whether Brilliant Blue
G (“BBG”), a P2X7R antagonist, could block P2X7R in rats with reserpine 61-induced FM. Pet.
Ex. DD.16 at 2. They found that BBG significantly decreased P2X7R expression. Id. NLRP3
levels were also notably reduced in the animals that received BBG. Id. at 4. However, the study
did not examine whether the flu vaccination activated the nociceptive transmission system, the
ATP-gated ion channel, the NLRP3 inflammasome pathway, or otherwise induced FM. See id.

Next, Dr. Akbari proposed that Th17 cells 62 play a role in causing FM because they are
“potent inducers of tissue inflammation” associated with many autoimmune conditions,
including FM. Pet. Ex. DD at 12; Pet. Ex. GG at 4. He cited Pernambuco et al., 63 who explained
that Th17 lymphocytes produce the cytokine IL-17A. Pet. Ex. DD.18 at 2. The authors reported
elevated levels of IL-17A in 58 patients with FM as compared to 39 healthy controls. Id. at 1.
These findings “strengthened the hypothesis of inflammatory mechanisms” in the development
of FM. Id. at 2. However, the paper included a caveat, noting that IL-17A was produced not
only by Th17 lymphocytes, but also by natural killer cells, dendritic cells, and neutrophils, and
the study did not address the origin of IL-17A found in the FM patients. See id. Thus, the study
only showed that IL-17A was “possibly produced” by activated T lymphocytes (Th17 cells). Id.
The study did not show that vaccination triggered activation of Th17 cells which caused
inflammation that triggered FM. See id.

60
An NLRP3 inflammasome is a multi-protein complex which “includes NLRP3, a NOD-like
receptor that is a sensor for the activation of the inflammasome, an apoptosis-associated speck-
like protein containing a CARD complex (ASC), and the serine protease caspase 1 (Casp-1).
The activation of NLRP3 leads to the maturation of Casp-1, which is subsequently implicated in
the cleavage of pro-IL-1 β and pro-IL-18 into the biologically active cytokines.” Pet. Ex. DD.16
at 8-9; see supra note 43 (defining inflammasome).
61
Reserpine is “an alkaloid isolated from the root of Rauwolfia serpentina and other species of
Rauwolfia.” Reserpine, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com
/dorland/definition?id=43397 (last visited Oct. 2, 2024). Reserpine has been used in preclinical
research for many years to create animal models including for depression and Parkinson’s
disease. See, e.g., Lidia Telega et al., Reserpine-Induced Rat Model for Depression, 133
Progress Neuro-Psychopharmacology & Biological Psychiatry 111013 (2024).
62
Th17, or T helper 17 cells, are a “distinct lineage of T cells that produce the effector molecules
IL-17, IL-17F, IL-21 and IL-22.” Pet. Ex. DD.24 at 1 (Yinyao Lin et al., Th17 Cytokines and
Vaccine Induced Immunity, 32 Seminars Immunopathology 79 (2010)); see also infra note 65
(defining T cells).
63
A.P. Pernambuco et al., Increased Levels of IL-17A in Patients with Fibromyalgia, 31 Clinical
& Experimental Rheumatology S-60 (2013).

29
Continuing with the theme of Th17 cells, Dr. Akbari explained that the flu vaccination
“increases the level of IL-17 and Th17 cells” for the purpose of creating “effective long-lived
vaccine induced immunity against viruses.” Pet. Ex. DD at 13. He asserted that in some
patients, “Th17 induced by [the] flu vaccine is capable of inducing FM.” Id. He cited two
papers to support this opinion. Id. The first is by Bermejo-Martin et al., 64 which discussed Th17
secretion in the context of H1N1 flu infection. See Pet. Ex. DD.23. The article does not discuss
vaccination, and Dr. Akbari does not show that the flu vaccination is comparable to the H1N1
infection so as to make the results of the study applicable here.

The second paper by Lin et al., does discuss vaccination and the role of Th17 and IL-17
in “vaccine-induced memory immune responses” but does not discuss their role in inducing FM.
Pet. Ex. DD.24 at 1. Although IL-17 can protect against infections, the authors also discussed
the potential for pathological consequences, such as tissue destruction seen in models of certain
diseases (“arthritis, multiple sclerosis, and colitis”). Id. FM is not discussed, and the paper does
not stand for the proposition that IL-17 plays a role in the development of FM. See id.

Moving to another theory, Dr. Akbari discussed the importance of T cells, 65 citing a
study by Ganor et al. 66 Pet. Ex. DD at 6 (citing Pet. Ex. DD.4). The authors stated that T cells in
the CNS in various brain diseases may cause and/or augment pathology. Pet. Ex. DD.4 at 1.
One example is T-cell-mediated encephalomyelitis in multiple sclerosis. Id. In this context, T
cells “could possibly encounter glutamate,” a “the major excitatory neurotransmitter in the
[CNS],” that mediates “most of the excitatory transactions between CNS neurons.” Id. The
authors hypothesize that T cells “could possibly encounter glutamate” in traumatic brain injury,
stroke, epilepsy, meningitis, and brain neurodegenerative diseases like MS, amyotrophic lateral
sclerosis (“ALS”), and Alzheimer’s disease. Id. They do not identify FM as an illness in which
T cells could encounter glutamate, and the article does not mention FM. See id.

64
Jesus F. Bermejo-Martin et al., Th1 and Th17 Hypercytokinemia As Early Host Response
Signature in Severe Pandemic Influenza, 13 Critical Care R201 (2009).
65
T cells are “the cells primarily responsible for cell-mediated immunity; they originate from
lymphoid stem cells that migrate from the bone marrow to the thymus and differentiate under the
influence of the thymic hormones thymopoietin and thymosin. . . . T cell antigen receptors are
triggered by antigen only when associated with self MHC antigens, e.g., by antigens processed
and presented by macrophages, viral antigens on the surface of host cells, and tumor
neoantigens. When activated by antigen, T lymphocytes proliferate and differentiate into T
memory cells and the various types of regulatory and effector T cells. T Cells, Dorland’s Med.
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=87562 (last visited
Oct. 2, 2024).
66
Yonatan Ganor et al., Human T Cells Express a Functional Ionotropic Glutamate Receptor
GluR3, and Glutamate by Itself Triggers Integrin-Mediated Adhesion to Laminin and
Fibronectin and Chemotactic Migration, 170 J. Immunology 4362 (2003).

30
Another paper cited by Dr. Akbari 67 to emphasize the role of T cells, authored by
Kaufmann et al., 68 was a study of complex regional pain syndrome (“CRPS”) and FM. Pet. Ex.
DD.5 at 1. The authors studied 22 patients with FM and 15 patients with CRPS compared to 37
healthy controls and found that “[l]ymphocyte numbers did not differ between the groups.” Id.
However, “lymphocyte subpopulations showed a significant reduction of cytotoxic CD8+
lymphocytes” in both CRPS and FM patients as compared to the control group. Id. The authors
were unable to determine whether the reduction in the lymphocyte subpopulation was due to a
pathogenic role or “merely reflect the consequences of a pain-induced neurohumoral stress
response.” Id. Further research was recommended. Id. The study did not establish that
vaccination or T cells play a role in the cause of FM. See id.

Next, Dr. Akbari moved to his hypothesis about the role of regulatory T cells (“Tregs”) 69
in causing FM. Pet. Ex. DD at 14; Pet. Ex. GG at 5. He discussed the concept of self-tolerance
and the role of regulatory T cells in “maintaining tolerance to self-antigens and abrogating
autoimmune disease.” Pet. Ex. DD at 7. He stated that a decrease in T regulatory cells results in
a predisposition to develop an autoimmune illness. Id. at 7-8, 14. According to Dr. Akbari,
regulatory T cells could exert “suppressive activity by secreting a variety of cytokines including
a major immune suppressor cytokine, IL-10.” Id. at 14.

Dr. Akbari stated that regulatory T cells also produce IL-10. Pet. Ex. DD at 15. He cited
a study by Andrés-Rodríguez et al., 70 which “concluded that IL-10 is the best predictor of [a] FM
diagnosis.” Pet. Ex. DD at 14 (citing Pet. Ex. DD.26). The authors found lower levels of anti-
inflammatory cytokines IL-4 and IL-10 in patients who had chronic pain. Pet. Ex. DD.26 at 1.
Based on these findings, Dr. Akbari suggested another hypothesis, which “combines the effects
of lowered IL-10 and IL-6 in explaining FM symptoms.” Pet. Ex. DD at 14. This hypothesis,
however, seems to ignore the conclusion of the authors, that “[a]ll in all, the results show there is
a large heterogeneity among studies in cytokine-chemokine results,” and that “the immune
profile observed . . . indicate[d] there is no clear immune activation and no inflammatory

67
Dr. Akbari discussed another study about the role of T cells in his expert report, which was
“performed on 65 patients with FM, [and] that showed a decrease in CD3+T cells.” Pet. Ex. DD
at 6. However, Dr. Akbari did not provide a reference for this study.
68
Ines Kaufmann et al., Lymphocyte Subsets and the Role of Th1/Th2 Balance in Stressed
Chronic Pain Patients, 14 Neuroimmunomodulation 272 (2007).
69
Regulatory T cells, or Tregs, are “a subset of CD4+ T cells that can suppress activity of
effector cells such as helper cells and suppressor cells, and inhibit autoimmune diseases.”
Regulatory T Cells, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/
dorland/definition? id=64383 (last visited Oct. 2, 2024); see also Pet. Ex. DD.9 (Christian
Dejaco et al., Imbalance of Regulatory T Cells in Human Autoimmune Diseases, 117
Immunology 289 (2005) (providing a technical discussion of the imbalance of Tregs in
autoimmune illnesses).
70
Laura Andrés-Rodríguez et al., Machine Learning to Understand the Immune-Inflammatory
Pathways in Fibromyalgia, 20 Int’l J. Molecular Sci. 4231 (2019).

31
response (according to [the] classic biomarkers)” in the FM group studied. Pet. Ex. DD.26 at 8-
9.

After discussing regulatory T cells, Dr. Akbari turned to MTHFR gene mutations and
their role in “disease risk after vaccination.” Pet. Ex. DD at 16; Pet. Ex. GG at 7-8. He
explained that MTHFR is a critical enzyme required “for a metabolic process that repairs DNA,
switches genes on and off,” among other things, and is “essential to convert folate and folic acid .
. . into the biologically active form called L-methyl folate.” Pet. Ex. DD at 16. MTHFR
mutations have been linked with “disorders affecting the immune system and causing
inflammation and autoimmunity.” Id. Dr. Akbari asserted that these mutations have been
associated with post-vaccination adverse effects. Id. at 17. After a summary of two clinical
trials related to MTHFR genetic mutations, he concluded that “a comprehensive clinical trial is
required to determine the association between adverse effects after flu vaccination in patients
with MTHFR mutation.” Id. at 17-18. He did not conclude that the mutation played a role in
causing FM after flu vaccination.

The next subject raised by Dr. Akbari was the role of EBV infection in the pathogenesis
of FM. Pet. Ex. DD at 18; Pet. Ex. GG at 9-10. He observed that the symptoms of FM “overlap
considerably with those of a viral [] infection.” Pet. Ex. DD at 18. These symptoms include
fatigue, sore throat, rash, adenopathy, and recurring low-grade fever. Id. Dr. Akbari posited that
EBV and FM are related, “due to the similarity of symptoms and immune response of [FM] to
infectious agents.” Id. But he asserted that “EBV cannot cause [FM] alone,” since EBV
infections affect “more than 90%” of the world population, and FM is not as prevalent. Id. at 19.
According to Dr. Akbari, “the development of FM requires another trigger such as the flu
vaccine with the capability of inducing inflammasome.” Id. Dr. Akbari, however, did not
conclude that the flu vaccine can cause FM in a patient with an EBV infection.

Regarding any specific association between the flu vaccination and FM, Dr. Akbari stated
that “although current data are insufficient in order to establish a definite relationship between
flu vaccination and [FM], it appears clear that this vaccine is capable of causing acute FM
including musculoskeletal symptoms and certainly the frequency and induction of FM cannot be
ruled out after flu vaccination.” Pet. Ex. DD at 21. Here, Dr. Akbari agreed that current
information does not establish a causal association between the flu vaccination and FM, but he is
unable to rule out a casual association between flu vaccination and FM. Id. However, an
inability to rule out vaccination as a cause does not reach the preponderant standard of more
likely than not. See infra section V.A (discussing legal standards for causation).

Some of the medical articles cited by Dr. Akbari do not relate to FM but are about
polymyalgia and polymyalgia rheumatica (“PMR”). 71 A study by Falsetti et al. reviewed the
triggers of PMR in 58 patients, finding that six patients reported vaccination before onset of
symptoms, including four patients who had a flu vaccine. Pet. Ex. DD.25 at 3. The study did

71
PMR is “a common condition characterized by inflammatory pain and stiffness in the shoulder
and in the pelvic girdle and neck.” Pet. Ex. DD.25 at 1 (Paolo Falsetti et al., Polymyalgia
Rheumatica Following Infective Triggers or Vaccinations: A Different Subset of Disease?, 58
Rheumatologia 76 (2020)).

32
not include patients with FM. See id. In citing this article in his expert report, Dr. Akbari stated
that the six patients who reported vaccination prior to onset of symptoms had FM. Pet. Ex. DD
at 20. This statement is incorrect. The authors stated that the six patients had PMR, not FM.
Pet. Ex. DD.25 at 3. Dr. Akbari did not cite any evidence to show that PMR and FM are the
same or similar disease.

Dr. Akbari also cited several case reports of patients who he asserts developed FM after
flu vaccinations, but again, he is incorrect. The articles refer to PMR, not FM. See Pet. Ex. DD
at 21 (citing to Pet. Ex DD.39 (discussing PMR after flu vaccination); 72 Pet. Ex. DD.40 (same); 73
Pet. Ex. DD.41(same)). 74

Dr. Akbari dismissed the value of the 2015 Ablin et al. 75 study cited by Respondent’s
expert, Dr. Jamieson, which found the flu vaccine safe for patients with FM on the basis that the
study was conducted to address the safety of vaccination in patients with established FM, not
whether the vaccination could cause FM. Pet. Ex. DD at 21. He also distinguished the article on
the basis that it did not consider the importance of MTHFR genetic mutations. Id.

Dr. Akbari concluded by stating that he showed “numerous ways in which the scientific
evidence supports the biological mechanisms by which an immune-stimulated response to the flu
vaccination is able to trigger immune cells that cause inflammatory diseases such as FM.” Pet.
Ex. DD at 26.

ii. Althen Prongs Two and Three

Dr. Akbari opined that “to a reasonable degree of scientific certainty, and by []
preponderant evidence, had it not been for the flu vaccination, [Petitioner] would not have
developed FM.” Pet. Ex. DD at 26. He further opined that the “onset of symptoms following the
flu vaccine support that . . . the flu vaccine administered on September 4, 2016[] resulted in the
onset of headache and FM.” Id. According to Dr. Akbari, an onset of seven days is “textbook.”
Id. at 27. Specific to Petitioner’s MTHFR genetic mutation, Dr. Akbari opined that the onset
time was consistent with the development of FM in patients with these mutations. Id. at 26-27.

72
A. Soriano et al., Giant Cell Arteritis and Polymyalgia Rheumatica After Influenza
Vaccination: Report of 10 Cases and Review of the Literature, 21 Lupus 153 (2012).
73
Eric Liozon et al., Polymyalgia Rheumatica Following Influenza Vaccination, 48 J. Am.
Geriatric Soc’y 1533 (2000).
74
Carlos Perez & Ellas Maravl, Polymyalgia Rheumatica Following Influenza Vaccination, 23
Muscle & Nerve 824 (2000).
75
Jacob N. Ablin et al., Influenza Vaccination Is Safe and Effective in Patients Suffering from
Fibromyalgia Syndrome, 67 Reumatismo 57 (2015) (cited as Resp. Ex. A, Tab 9).

33
However, regarding his theory based on the “induction of inflammasome by innate
immune cells,” Dr. Akbari opined that onset would be “relatively fast” and the peak response
would be in one to three days. Pet. Ex. DD at 26.

While Dr. Akbari opined that Petitioner’s “initial symptoms of FM were noticeable and
significant” a week after vaccination, he noted that it took several months for Petitioner to
receive the appropriate diagnosis of FM. Pet. Ex. DD at 27. But he disagreed with Dr. Jamieson
that it took Petitioner ten months to develop FM after vaccination. Id.

3. Petitioner’s Expert, Dr. Joseph S. Jeret 76

a. Background and Qualifications

Dr. Jeret is a board-certified neurologist. Pet. Ex. BB at 1; Pet. Ex. CC at 1. He received
his medical degree from SUNY Downstate Medical Center. Pet. Ex. BB at 1. He did a general
internal medicine internship at Maimonides Medical Center followed by a residency in
neurology and a fellowship in clinical neurophysiology at SUNY Downstate. Id. at 1. Dr. Jeret
is a practicing neurologist. Id. at 1-2. He works as a physician at the Icahn School of Medicine
and maintains an active neurology practice in Long Island, NY. Id. He routinely cares for and
diagnoses patients with various neurological illness including FM and small fiber neuropathy.
Id. at 2. Dr. Jeret has authored or co-authored publications in many areas of neurology reflecting
his general neurology practice. Id.; Pet. Ex. CC at 2-7.

b. Diagnosis Opinion 77

At the outset, Dr. Jeret explained that FM is characterized by widespread pain. Pet. Ex.
BB at 4. Diagnostic criteria established by the ACR in 1990 included the patient’s complaint of
widespread pain as well as “pain on digital palpation in 11 of 18 specific locations.” Id. Dr.
Jeret explained that these criteria were rigid because a finding of only “10 tender spots” did not
meet the criteria, whereas 11 or more did. Id. Further, the examiner had to apply
“approximately 4 kg of pressure” during the evaluation or the results were invalid. Id.

Dr. Jeret opined that Petitioner’s diagnosis of FM satisfied the 2010 ACR diagnostic
criteria, which used the WPI and symptom severity score for three symptoms of fatigue, waking
unrefreshed, and cognitive symptoms. Pet. Ex. BB at 9-10. Even if the criteria were not
satisfied, Dr. Jeret opined that the diagnosis of FM was appropriate because Petitioner’s treating
physicians, Drs. Thompson, Kalf, and Chothmounethink, diagnosed Petitioner with FM. Id. at
10.

To diagnose a patient with FM, Dr. Jeret explained that “the history provided by the
patient is all that is needed.” Pet. Ex. BB at 9. Based on his review of Petitioner’s medical

76
Petitioner filed two expert reports from Dr. Jeret. Pet. Exs. BB, FF.
77
In his expert report, Dr. Jeret stated that all of his opinions are held to a “reasonable degree of
medical certainly except where noted otherwise.” Pet. Ex. BB at 13.

34
records, Dr. Jeret identified documentation of 13 instances of pain in Petitioner’s extremities,
buttocks, legs, back, and neck. Id. at 10. Therefore, he assessed Petitioner’s WPI score as 13.
Id. Next, Dr. Jeret assessed symptom severity, again, based on the medical records, and
determined that Petitioner scored 7 to 9 points due to fatigue, waking unrefreshed, cognitive
symptoms, and somatic symptoms. Id. Given a WPI index of 13 points and a SS score of at
least 7 points, Dr. Jeret opined that Petitioner met the 2010 ACR diagnostic criteria for FM. Id.
Dr. Jeret opined there was no other diagnosis made to explain Petitioner’s symptoms. Id.
Therefore, he concluded that Petitioner met the ACR diagnostic criteria for FM. Id.

Dr. Jeret explained that although Petitioner’s treating physicians did not use the “strict
ACR checklist,” they did reach a diagnosis of FM. Pet. Ex. BB at 10-11. He agreed it was
“appropriate for a clinician to diagnose [FM] even if the strict criteria [were] not satisfied.” Id.
at 10. This approach incorporates the “real world” practice where physicians often reach a
diagnosis even if strictly speaking, diagnostic criteria are not met. Id. at 6. Further, Dr.
Thompson documented that Petitioner had “symmetric trigger points over classic [FM] sites.”
Id. at 10. Based on this note, Dr. Jeret presumed Dr. Thompson thought Petitioner satisfied the
1990 ACR criteria, 78 although he acknowledged that “detail [was] certainly lacking in [Dr.
Thompson’s] note.” Id.

Dr. Jeret also reviewed Petitioner’s clinical course, and the onset of his FM symptoms.
Dr. Jeret noted that on June 13, 2017, Dr. Thompson did not identify FM as a diagnosis. Pet. Ex.
BB at 7. On June 24, 2017, Petitioner saw a chiropractor, Dr. Gil, and at that visit Petitioner
completed an intake form, stating that he had “pain in his neck, shoulder, upper back, midback,
low back, hip, and legs.” Id. (citing Pet. Ex. J at 2-3). Then on July 20, 2017, Petitioner reported
to Dr. Thompson that he had “aches all over his body: thighs, back, neck, [and] hands . . . since
September 12, 2016.” Id. At this visit, Dr. Thompson included FM as a diagnosis in Petitioner’s
medical records. Id.

In his second expert report, Dr. Jeret took issue with some of the opinions of
Respondent’s expert, Dr. Jamieson. See Pet. Ex. FF at 1-2. While Dr. Jamieson asserted that
since Petitioner’s neurologist and rheumatologist did not diagnose Petitioner with FM suggested
that he did not have FM, Dr. Jeret stated that these doctors did not apply the diagnostic criteria
for FM when they examined Petitioner. Id. at 1-2. When Dr. Jeret retroactively applied the
criteria, he was able to make the diagnosis of FM. Id. at 2.

c. Causation Opinion

i. Althen Prong One

Dr. Jeret opined that “[o]ccasionally, the immune system ‘gets the wrong message’ and
will attack an unintended target by creating an autoimmune response.” Pet. Ex. BB at 11. This
phenomenon is called “molecular mimicry due to the similarity of the body’s own peptides to the
foreign peptides in the vaccine.” Id. He explained this “same immune error” is the mechanism

78
Dr. Jeret discussed the 1990 ACR criteria for FM in his initial report which include
“widespread pain and pain on digital palpation in 11 of 18 specific locations.” Pet. Ex. BB at 4.

35
responsible for Guillain-Barré syndrome (“GBS”) 79 after flu vaccination, which he referenced as
“a well-recognized phenomenon.” Id.; see Pet. Ex. BB.12 (describing molecular mimicry as an
implicated mechanism for vaccine-related autoimmunity in numerous conditions, including GBS
but not FM). 80

According to Dr. Jeret, FM “has an immune basis.” Pet. Ex. BB at 11. He cited research
by Goebel et al., 81 published in 2021, showing that serum Immunoglobulin (“Ig”) G 82 from FM
patients injected into mice caused them to have “painful sensory hypersensitivities,” “increased
cold sensitivity,” and decreased activity. Id. (citing Pet. Ex. BB.5 at 1-5). Of note, the serum
IgG injected into mice from FM patients did not “induce cytokine production or systemic
inflammation.” Pet. Ex. BB.5 at 6. The authors concluded that passive transfer of serum IgG
from FM patients did not “alter systemic inflammatory and immunomodulatory cytokine levels.”
Id. at 6-7.

Regarding other proposed mechanisms by which the flu vaccination can cause FM, Dr.
Jeret referred to Dr. Akbari’s expert reports. Pet. Ex. BB at 11. Dr. Jeret noted “there are often
multiple factors at play—so it is hard to ‘tease out’ the role of a vaccine.” Id. He cited a review
article by Ablin et al., 83 which stated that “[m]ultiple putative triggers have been implicated” in
the pathogenesis of FM, including infections, chronic Lyme disease, mycoplasma, and human
immunodifiency virus (“HIV”). Pet. Ex. BB.1 at 1. The authors suggested that multiple factors,
including multiple vaccinations, along with other risk factors may possibly play a role in

79
Guillain-Barré syndrome (“GBS”) “is an acute/subacute onset polyradiculoneuropathy
typically presenting with sensory symptoms and weakness over several days.” Pet. Ex. BB.3 at 1
(Peter D. Donofrio, Guillain-Barré Syndrome, 23 Continuum 1295 (2017)). NCS “show
evidence for a multifocal demyelinating process.” Id. Dr. Jeret filed several articles about GBS
and CIDP, a demyelinating process and/or process that causes axonal injury. See, e.g., Pet. Ex.
BB.6 (Kenneth C. Gorson & Allan H. Ropper, Chronic Inflammatory Demyelinating
Polyradiculoneuropathy (CIDP): A Review of Clinical Syndromes and Treatment Approaches in
Clinical Practice, 4 J. Clinical Neuromuscular Disease 174 (2003)); Pet. Ex. BB.7 (Penina Haber
et al., Vaccines and Guillain-Barré Syndrome, 32 Drug Safety 309 (2009)). There is no evidence
filed in this case which shows FM is caused by a similar immune process or that it is a
demyelinating process or axonal injury like GBS or CIDP.
80
Yahel Segal & Yehuda Shoenfeld, Vaccine-Induced Autoimmunity: The Role of Molecular
Mimicry and Immune Crossreaction, 15 Cellular & Molecular Immunology 586 (2018).
81
Andreas Goebel et al., Passive Transfer of Fibromyalgia Symptoms from Patients to Mice, 131
J. Clinical Investigation e144201 (2021).
82
Immunoglobulin G, or IgG, is one class of “glycoproteins that function as antibodies.”
Immunoglobulin, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=24894 (last visited Oct. 22, 2024).
83
Jacob N. Ablin et al., Fibromyalgia, Infection and Vaccination: Two More Parts in the
Etiological Puzzle, 27 J. Autoimmunity 145 (2006).

36
initiating Gulf War syndrome, 84 which has some features in common with FM. Id. The authors
noted, however, that the cause of FM is “yet unclear.” Id. They also noted that “[FM] is
generally not considered an autoimmune disorder.” Id. at 2. After reviewing studies about
associations between infections and FM, they concluded that any association “remains obscure.”
Id. at 5. They also stated that “the possible relationship of [FM] with vaccination similarly
remains to be established.” Id.

Dr. Jeret concluded his discussion about the pathogenesis of FM by quoting from Buskila
et al.: “There is some anecdotal evidence for the role of vaccination in the development of FM[],
but more studies are needed to confirm this association.” Pet. Ex. BB at 11 (quoting Pet. Ex.
BB.2 at 3). He agreed that there was “a paucity of published data” about the association between
vaccination and FM. Pet. Ex. FF at 2.

ii. Althen Prongs Two and Three

Dr. Jeret opined that Petitioner developed FM “as a result of the flu vaccination he
received on September 4, 2016.” Pet. Ex. BB at 13. He asserted there was a “logical sequence
of cause-and-effect showing that the vaccination was the reason for the injury” based on the
temporal relationship and exclusion of other causative factors. Id. at 12. He explained that there
was “[n]o other cause” for the Petitioner’s “dramatic change” in symptoms other than
vaccination. Id. at 13. Dr. Jeret agreed that imaging studies, blood tests, cerebrospinal fluid
abnormalities, and EMG criteria do not factor into the diagnosis of FM. Pet. Ex. FF at 2.

Regarding the temporal association between vaccination and onset of FM, Dr. Jeret
opined that the medical records indicated that symptoms “began a week or so after vaccination.”
Pet. Ex. BB at 12. He opined this time frame was “consistent with the typical delay of at least
several days for other vaccine-triggered autoimmune responses, e.g., GBS.” Id. at 12-13.

4. Respondent’s Expert, Dr. Dara G. Jamieson 85

a. Background and Qualifications

Dr. Jamieson is a board-certified neurologist. Resp. Ex. A at 1; Resp. Ex. F at 2. She
received her medical degree from the University of Pennsylvania, followed by a neurology
residency and a cerebrovascular fellowship at the University of Pennsylvania Hospital. Resp.
Ex. F at 1. Dr. Jamieson was a practicing neurologist for 32 years before transiting to a
voluntary facility appointment. Resp. Ex. A at 1. She is currently a Clinical Associate Professor
of Neurology at Weill Cornell Medicine, where she teaches medical students, residents, and

84
Gulf War syndrome is “a group of symptoms of unknown cause, seen in military personnel of
the United States and its allies in the Persian Gulf conflict of the early 1990s, consisting of
widespread pain including [FM] and headaches, gastrointestinal distress, and memory disorders.”
Gulf War Syndrome, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=110690 (last visited Oct. 2, 2024).
85
Respondent filed two expert reports from Dr. Jamieson. Resp. Exs. A, E.

37
fellows. Id. Dr. Jamieson has lectured extensively on multiple neurological topics. Id. She
serves as an editor and reviewer for several neurology journals. Id. Dr. Jaimeson has authored
or co-authored numerous neurology papers, chapters, and review articles as well as authored two
books on vascular neurology. Id. at 2; Resp. Ex. F at 10-15.

b. Diagnosis Opinion

Dr. Jamieson disagreed that Petitioner has FM. Resp. Ex. A at 18. She opined that
“approximately 10 months after receiving the [flu] vaccine, [Petitioner] reported back pain and
stiffness, followed by diffuse pain and fatigue.” Id. at 19. She described these symptoms as
non-specific, noting “they do not correlate with any reproducible findings on examination or
abnormalities on extensive testing.” Id. She concluded that Petitioner’s “subjective complaints,
inconclusive physical examination, and unremarkable testing do not establish the diagnosis of []
[FM].” Id.

She explained that FM is a syndrome 86 “characterized by chronic widespread pain” and
“persistent non-inflammatory musculoskeletal pain.” Resp. Ex. A at 12-13. Accompanying
symptoms include “fatigue, insomnia, morning stiffness, depression, anxiety, and cognitive
problems.” Id. at 13. Most patients with FM have a “negative affect . . . and impaired health-
related quality of life.” Id. Diagnosis is based on patient symptoms without objective criteria
seen on physical examination or supported by diagnostic evaluation. Id. According to Dr.
Jamieson, the lack of objective findings has made it difficult to reach consensus on diagnostic
criteria and made it difficult to understand the “pathophysiological mechanism” of the illness.
Id. After describing the difficulty reaching consensus about diagnostic criteria, Dr. Jamieson
agreed that current diagnostic criteria are based on “pain in multiple regions . . . accompanied by
fatigue, waking unrefreshed, and cognitive symptoms.” Id.

In her second expert report, Dr. Jamieson reviewed the changing diagnostic criteria over
the past three decades, noting that such changes “emphasize [] the nebulous nature” of the
condition. Resp. Ex. E at 6.

c. Causation Opinion

i. Althen Prong One

Dr. Jamieson opined there was no “unifying theory of [FM] pathogenesis.” Resp. Ex. A
at 13. The theories “are varied and do not account for the wide array of [FM] manifestations and
co-morbid conditions.” Id. One hypothesis is that FM is a “disorder of pain regulation with
central sensitization causing an abnormal reaction to sensory stimuli.” Id. Another suggested

86
Dr. Jamieson used the abbreviation FMS, for fibromyalgia syndrome, instead of FM,
throughout her reports. For consistency, the undersigned uses the abbreviation FM in this
Decision.

38
mechanism is that FM is “a dysautonomia[87] related neuropathic pain syndrome.” Id. at 13-14.
She stated “[d]espite multiple proposed yet unproven theories, the pathophysiological cause of
[FM] is still unknown.” Id. at 13-14. Since the pathogenesis of FM is not known, Dr. Jamieson
opined that “it is not possible to speculate” about its causal mechanism relative to vaccination.
Id. at 18. Moreover, Dr. Jamieson opined that FM “is not caused by vaccination, and specifically
has not been associated with the flu vaccine.” Id. at 14. She cited medical articles in support of
this opinion.

In Cassisi et al., 88 the authors discussed the FM symptom of chronic widespread pain.
Resp. Ex. A, Tab 7 at 1. Based on a review of medical literature,

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10756899. Public record. Not legal advice.