# Brancheau v. Secretary of Health and Human Services

> United States Court of Federal Claims · April 15, 2024

URL: https://www.frixlaw.com/law-library/cases/10735628

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** April 15, 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- **Precedential status:** Unpublished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/10735628

## How later opinions describe it (automated extraction)

- 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: March 21, 2024

*************************
LISA BRANCHEAU, * PUBLISHED
*
Petitioner, * No. 21-1209V
*
v. * Special Master Nora Beth Dorsey
*
SECRETARY OF HEALTH * Dismissal; Influenza (“Flu”) Vaccine;
AND HUMAN SERVICES, * Transverse Myelitis (“TM”); One Day
* Onset.
Respondent. *
*
*************************

Maximillian J. Muller, Muller Brazil, LLP, Dresher, PA, for Petitioner.
Nina Ren, U.S. Department of Justice, Washington, DC, for Respondent.

DECISION 1

I. INTRODUCTION

On April 14, 2021, Lisa Brancheau (“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 Petitioner alleges that she developed transverse myelitis
(“TM”) as the result of an influenza (“flu”) vaccination administered on September 19, 2019.
Petition at Preamble (ECF No. 1). Respondent argued against compensation, stating that this

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). All citations in this Decision to individual sections of the
Vaccine Act are to 42 U.S.C. § 300aa.
petition “should be denied and the case should be dismissed.” Respondent’s Report (“Resp.
Rept.”) at 1, 14 (ECF No. 16).

After carefully analyzing and weighing the evidence presented in this case in accordance
with the applicable legal standards, the undersigned finds that Petitioner has failed to provide
preponderant evidence that her flu vaccine caused her TM. 3 Thus, Petitioner has failed to satisfy
her 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.

II. ISSUES TO BE DECIDED

Diagnosis is not in dispute. See Petitioner’s Exhibit (“Pet. Ex.”) 14 at 4-5; Resp. Ex. A at
6. At dispute is causation, specifically all three Althen prongs: “(1) whether the [flu] vaccine can
cause [TM]; (2) whether [P]etitioner’s [TM] was caused by receipt of the vaccination at issue,
and; (3) whether the time between [P]etitioner’s vaccinations and the onset of symptoms would
be considered medically acceptable to infer causation-in-fact.” Joint Pre-Hearing Submission
(“Joint Submission”), filed Apr. 10, 2023, at 2 (ECF No. 43).

III. BACKGROUND

A. Procedural History

On April 14, 2021, Petitioner filed her petition along with medical records. Petition; Pet.
Exs. 1-10. Petitioner filed additional medical records in January and February 2022. Pet. Exs.
11-13. On January 10, 2022, Respondent filed his Rule 4(c) Report, recommending against
compensation. Resp. Rept. at 1, 14.

On May 17, 2022, Petitioner filed an expert report from Dr. David Simpson. Pet. Ex. 14.
Respondent filed an expert report from Dr. Marcelo Matiello on September 15, 2022. Resp. Ex.
A. On January 10, 2023, Petitioner filed a responsive expert report from Dr. Simpson. Pet. Ex.
28.

Thereafter, the parties indicated that they wished to submit this case for adjudication on
the record and a briefing schedule was set. Joint Status Rept., filed Feb. 9, 2023 (ECF No. 37);
Ruling on the Record Order dated Feb. 9, 2023 (ECF No. 38). Petitioner filed a supplemental
declaration on March 16, 2023 and her motion for a ruling on the record on April 10, 2023. Pet.
Ex. 35; Pet. Motion for Ruling on the Record (“Pet. Mot.”), filed Apr. 10, 2023 (ECF No. 42).
Respondent filed his response on June 8, 2023, and Petitioner filed a reply on July 6, 2023.
Resp. Response to Pet. Mot. (“Resp. Response”), filed June 8, 2023 (ECF No. 45); Pet. Reply to
Resp. Response (“Pet. Reply”), filed July 6, 2023 (ECF No. 46).

3
TM “describes a heterogeneous collection of acute and subacute infectious and noninfectious
inflammatory spinal cord syndromes.” Resp. Ex. A-1 at 7 (Dean M. Wingerchuk & Brian G.
Weinshenker, Acute Disseminated Encephalomyelitis, Transverse Myelitis, and Neuromyelitis
Optica, 19 Continuum 944 (2013)).

2
This matter is now ripe for adjudication.

B. Factual History

1. Medical History 4

a. Pre-Vaccination Medical History

Petitioner’s past medical history included obesity, high cholesterol, gastroesophageal
reflux disease (“GERD”), an overactive bladder/urinary incontinence, hypothyroidism, fatigue,
myalgia, arthralgia, and chronic back pain. Pet. Ex. 2 at 27, 40, 46, 65; Pet. Ex. 5 at 11; Pet. Ex.
9 at 10.

On September 4 and 18, 2015, Petitioner presented to chiropractor Charles Gilcher, D.C.,
P.C. “complaining of discomfort and or paresthesia in the right sacroiliac region.” Pet. Ex. 8 at
3-4. Dr. Gilcher diagnosed Petitioner with lumbar, thoracic, and cervical region (multiple sites)
subluxation. Id.

On October 5, 2015, Petitioner returned to Dr. Gilcher with the same “complain[t] of
discomfort and or paresthesia in the right sacroiliac region,” as well as “complain[ts] of
discomfort and or paresthesia in the right cervical dorsal region” and “left cervical dorsal
region.” Pet. Ex. 8 at 5. Dr. Gilcher changed his diagnoses to segmental and somatic
dysfunction in the lumbar, thoracic, and cervical regions. Id. Dr. Gilcher continued to treat
Petitioner on November 9 and 30, 2015. Id. at 6-7.

Approximately one year later, on October 17, 2016, Petitioner presented to her primary
care provider (“PCP”) at Metro Shores Internal Medicine (“Metro Shores”) reporting a
“cramping sensation [that] start[ed] at her right shoulder and [went] down her arm to her hand”
and that her right hand would shake. Pet. Ex. 2 at 46. She reported taking naproxen 5 for her
symptoms. Id. Petitioner reported she received a flu vaccine at work. 6 Id. at 10, 46. Holle

4
This summary of medical records is taken from Petitioner’s Motion and Respondent’s
Response, as the undersigned finds the parties provided an accurate representation of the records.
See Pet. Mot. at 2-7; Resp. Response at 3-12.
5
Naproxen is “a nonsteroidal antiinflammatory drug that is . . . used in the treatment of pain,
inflammation, osteoarthritis, rheumatoid arthritis, gout, calcium pyrophosphate deposition
disease, fever, and dysmenorrhea and in the prophylaxis and suppression of vascular headache.”
Naproxen, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/
definition?id=33163 (last visited Mar. 1, 2024).
6
Petitioner’s records indicate Petitioner received a flu vaccine in 2009, 2010, 2012, 2016, 2017,
and 2019 (the flu vaccination at issue here). Pet. Ex. 2 at 10. Petitioner’s records do not
identify, nor does Petitioner argue, any adverse effects related to any vaccination prior to the flu
vaccination in 2019. See Pet. Ex. 35 at ¶ 6 (indicating no issues with the flu vaccine prior to
2019).

3
Janeski, D.O., diagnosed Petitioner with, inter alia, trigger finger of the right thumb, myalgia,
tremor of the right hand, and upper extremity pain (central, right). Id. at 46. An X-ray of
Petitioner’s cervical spine, taken that day, showed “moderate to severe [osteoarthritis] of the
neck,” 7 based on “[m]oderate disc degeneration and uncovertebral joint spondylosis 8 bilaterally
at the C5-6 and C6-7 levels” and “[f]acet arthritis in the mid right cervical spine.” Id. at 261.

On October 28, 2016, Petitioner visited Zubair Sarmast, M.D., at Hand Surgery
Associates of Michigan, P.C., to discuss “her right thumb triggering, as well as her mild carpal
tunnel symptoms and her right shoulder rotator cuff tendinitis.” Pet. Ex. 2 at 22. He treated her
trigger finger with a cortisone injection. Id.

Petitioner returned to Dr. Gilcher on multiple occasions for chiropractic care in
November and December 2016, variously describing pain in her cervical and thoracic regions
that radiated down both arms and pain in her lumbosacral region. Pet. Ex. 8 at 8-17. Dr. Gilcher
diagnosed Petitioner with segmental and somatic dysfunction in the lumbar, thoracic, and
cervical regions, cervical radiculopathy, muscle spasms, and low back pain. Id.

From approximately January 9 to April 22, 2017, Petitioner continued to complain of and
receive treatment for her right trigger thumb. See Pet. Ex. 2 at 57, 62, 139, 141-43; Pet. Ex. 9 at
7, 10-17, 21.

Additionally, on April 18, 2017, Petitioner presented to Metro Shores with “[a]ll over
joint pain,” constant fatigue, and muscle aches for two weeks. Pet. Ex. 2 at 64. Dr. Janeski
diagnosed Petitioner with arthralgia, bilateral hip pain, acute bilateral knee pain, acute bilateral
low back pain without sciatica, iron deficiency anemia, and electrolyte imbalance. Id. at 65. An
X-ray of Petitioner’s lumbar spine taken on April 19, 2017 showed “arthritis and disc
degeneration at the L4-5 level with a minimal grade 1 degenerative spondylolisthesis of L4 on
L5” and “facet arthritis bilaterally at the L5-S1 level.” Id. at 268.

On September 2, 2017, Petitioner went to Oakwood Southshore Medical Center
(“Oakwood”) 9 Emergency Department (“ED”) with right hip pain that radiated to her leg. Pet.
Ex. 3 at 222. Review of systems was “[p]ositive for gait problem,” secondary to pain. Id. at
223. Physical examination revealed tenderness in right hip and leg. Id. A lumbar spine
computed tomography (“CT”) showed “[s]pondylitic changes.” Id. at 225. Petitioner was

7
This quote was handwritten on the medical record by an unknown author.
8
Spondylosis is “ankylosis of a vertebral joint” and “degenerative spinal changes due to
osteoarthritis.” Spondylosis, Dorland’s Med. Dictionary Online
https://www.dorlandsonline.com/dorland/definition?id=46749 (last visited Mar. 1, 2024).
Ankylosis is the “immobility and consolidation of a joint.” Ankylosis, Dorland’s Med.
Dictionary Online https://www.dorlandsonline.com/dorland/definition?id=2997 (last visited Mar.
1, 2024).
9
Oakwood Southshore is also referenced as Beaumont Hospital/Health throughout the medical
records.

4
prescribed non-steroidal anti-inflammatory drugs and muscle relaxants and instructed to follow
up with her PCP. Id. Petitioner’s discharge diagnoses were right leg pain and right-sided
sciatica. Id. at 242.

On September 5, 2017, Petitioner followed up with her PCP at Metro Shores for
“excruciating pain” in her right hip and through her leg to her knee. Pet. Ex. 2 at 70. Dr.
Janeski’s diagnoses included acute right-sided low back pain (with sciatica presence
unspecified), right lower back radicular pain, and right lower leg iliotibial band syndrome. Id. at
71. Petitioner was prescribed a prednisone taper, narcotic pain medication, back stretches, and
ice packs. Id.

On January 2, March 12, and April 24, 2018, Petitioner visited Metro Shores with a
cough, pink eye, and a right eye infection, respectively. Pet. Ex. 2 at 75, 81, 87. On each
occasion, Petitioner reported thumb locking, low back issues, and tenderness along her iliotibial
band. Id. at 79, 85, 92.

On August 21, 2018, Petitioner presented to her PCP at Metro Shores with urinary
incontinence. Pet. Ex. 2 at 93. Dr. Janeski diagnosed Petitioner with an overactive bladder and
stress incontinence. Id. at 94.

b. Vaccination and Post-Vaccination Medical History

On September 19, 2019, Petitioner saw Dr. Janeski to discuss her continued urinary
incontinence. Pet. Ex. 2 at 105. Petitioner reported leakage when she coughed or sneezed and
needing “pads all the time.” Id. In a handwritten self-evaluation, Petitioner reported she did not
have numbness, tingling, wobbliness in legs, unsteadiness, trembling hands, or shaking. Id. at
112. Dr. Janeski’s diagnoses included overactive bladder and urinary incontinence. Id. at 106.
Petitioner also received a flu vaccine at this visit at 54 years of age. Id. at 10-11; Pet. Ex. 1 at 1.

About two weeks later, on October 3, 2019, Petitioner returned to Dr. Janeski. Pet. Ex. 2
at 115. Petitioner reported “tingling in the last two fingers[] after the flu shot last week,” a “pins
and needle feeling in both feet at the heels and all toes,” and constant numbness and tingling. Id.
On physical examination, Dr. Janeski noted Petitioner had “[s]ensation intact [in] bilateral hands
and feet, normal gait, [and] no problems walking. Id. at 121. Dr. Janeski diagnosed Petitioner
with paresthesia. Id. at 117.

Three days later, on October 6, 2019, Petitioner presented to Oakwood ED “with
complaints of generalized weakness and bilateral peripheral neuropathy for the past two weeks
since she received a flu vaccination in her right upper extremity.” Pet. Ex. 3 at 108. Petitioner
“state[d] that the morning following . . . the vaccination, she woke with paresthesia in her
[fourth] and [fifth] upper extremity digits bilaterally as well as paresthesia in her bilateral feet.”
Id. She explained “her symptoms ha[d] gradually progressed since onset and now involve[d] her
entire hands and feet.” Id. Petitioner reported her numbness and tingling in both hands and feet
“started after [the] flu shot” and had been “getting progressively worse [over the] last [two]
weeks” and “now . . . travelled up her arms and legs.” Id. at 94, 113. Petitioner “denie[d]
history of [] recent infections, fevers, difficulty walking or carrying items, shortness of breath,

5
headache, visual symptoms, speech changes, chest pain, abdominal pain, trauma, bowel or
bladder incontinence, [and] rashes.” Id. at 108. Physical examination revealed tachycardia and
tremors, but was otherwise normal. Id. at 110. A head CT was also normal. Id. at 111. A
cervical spine CT showed “[s]pondylosis and spondyloarthrosis[10] at C5-C6 and C6-C7.” Id.
The attending ED provider, Karla Kasza, D.O., ordered a neurology consult and admitted
Petitioner with an initial assessment of peripheral neuropathy, generalized weakness, and
cervical spinal canal stenosis. Id. at 105, 111-12.

On October 7, 2019, Petitioner was evaluated by neurologist Christopher Whitty, M.D.
Pet. Ex. 3 at 120. Petitioner reiterated her complaints of tingling in her hands and feet that had
worsened over the last two weeks following receipt of a flu vaccination. Id. Dr. Whitty
documented that Petitioner “fe[lt] that she ha[d] weakness and a heavy sensation that [was]
traveling up her arms and legs.” Id. Petitioner reported “[n]o fever or chills, no
nausea/vomiting, no diarrhea/constipation, no shortness of breath/cough, no headache, no
changes in vision, no changes in urination, no rashes.” Id. at 122. Neurological examination
was normal. Id. Dr. Whitty recommended an outpatient electromyography (“EMG”)/nerve
conduction study (“NCS”). 11 Id. He did not believe Petitioner had Guillain-Barré syndrome
(“GBS”). 12 Id.

That same afternoon, Dr. Kasza evaluated Petitioner and explained that, despite
Petitioner’s concerns, there was no evidence to suggest she had GBS. Pet. Ex. 3 at 114. Dr.
Kasza added that “[t]here was no evidence of ascending weakness” and neurology confirmed her
reflexes and strength were normal. Id. Dr. Kasza believed Petitioner’s cervical spine disease
“could certainly be giving [Petitioner] some of the pain and tingling in her fingertips.” Id. On
examination, Dr. Kasza observed decreased cervical and lumbar lordosis, 13 “tissue texture
changes in the cervical spine bilaterally,” and “[m]ajor correlations with the musculoskeletal
system.” Id. at 116. Petitioner was prescribed Neurontin for the nerve pain as well as anti-
inflammatories, directed to follow up with neurology for an EMG, and was discharged. Id. at 88,
114.

On October 11, 2019, Petitioner returned to Dr. Gilcher. Pet. Ex. 8 at 18-19. Petitioner
reported that prior to her flu vaccination on September 19, 2019, “she had some neck tightness
occasionally in her upper back and neck” two to three times per week and she rated the “tight
feeling . . . as a level 5.” Id. at 18. She attributed the neck tightness to stress and treated it with

10
Spondyloarthropathy is the “disease of the joints of the spine.” Spondyloarthropathy,
Dorland’s Med. Dictionary Online https://www.dorlandsonline.com/dorland/definition?id=46736
(last visited Mar. 1, 2024).
11
Petitioner does not appear to have pursued the referral for an EMG/NCS.
12
“GBS is an acute monophasic peripheral neuropathy.” 42 C.F.R. § 100.3(c)(15)(i).
13
Lordosis is “a dorsally concave portion of the vertebral column.” Lordosis, Dorland’s Med.
Dictionary Online https://www.dorlandsonline.com/dorland/definition?id=28750 (last visited
Mar. 1, 2024).

6
monthly massages. Id. Petitioner also alleged she “experienced new symptoms” the day after
her flu vaccine, or on September 20, 2019. Id. Dr. Gilcher wrote Petitioner described

[n]umbness, pins and needles in hands and fingers bilaterally and equal []on both
sides and equal in all fingers and thumbs. [T]he intensity level is an 8-9 and is
constant and does [not] go away. The intensity gradually increased daily until it
reached its current level of 9. She is also getting weakness []in her arms
bilaterally and they fatigue easily and she has cramping in her elbows and
shoulders bilaterally that comes and goes[.] [Petitioner] also developed similar
symptoms in both of her feet with numbness and pins and needles into both feet.
These symptoms also began the day following the flu shot and came on gradually
and have reached an intensity level of a 4. She also feels that she has cramping
feeling of both ankles that comes and goes and can be right side, left side[,] or
both with no pattern. . . . [She] also developed a feeling of pressure in her head
causing her to have a constant headache that is rated as a 7. The pressure is
behind both eyes and the back of her neck and on the sides of her head behind
both ears.

Id. Petitioner returned on October 14 and October 16, 2019 with “symptoms [that] ha[d]
continued to increase over the last couple days as she ha[d] more fatigue in her arms and more
cramping in her wrists[,] [] elbows[,] and shoulders.” Id. at 20, 22 (emphasis omitted). On both
occasions, Petitioner stated that “her ability to walk ha[d] changed” and that she was “a little
jerky or less fluid with her movement.” Id. (emphasis omitted).

Petitioner followed up with Dr. Kasza on October 14, 2019 and requested a second
opinion and lumbar puncture. Pet. Ex. 2 at 122. Dr. Kasza summarized Petitioner’s clinical
course and noted Petitioner “fe[lt] her weakness [was] worse-her legs [felt][] weak and again
persistent tingling.” Id. Petitioner did not have shortness of breath but was very anxious. Id.
Petitioner “was sure she had GB[S] and is a nurse and went to CDC website.” Id. Dr. Kasza
“explained in detail that [n]eurology [] did not think [there were] any symptoms of GB[S]” and
indicated that she cannot order a lumbar puncture as “[n]eurology typically orders this type of
testing if needed.” Id. Physical examination was unremarkable. Id. at 128-29. Diagnoses
included weakness of bilateral lower extremities and paresthesia of bilateral hands and legs. Id.
at 124-45. Dr. Kasza renewed Petitioner’s Neurontin prescription and referred her to neurologist
Fadi Delly, M.D. Id. at 125.

Two days later, on October 16, 2019, Petitioner saw Dr. Delly, describing her clinical
course, reporting “tingling in her fingers and toes” the day after vaccination. Pet. Ex. 10 at 1.
Petitioner noted “weakness in her arms and legs,” fatigue, and temperature changes in her
fingers. Id. Petitioner also reported a new and severe aching, burning, and cramping pain,
accompanied by constant numbness and tingling in both wrists, hands, and elbows that was
“rapidly worsening.” Id. On examination, Petitioner had a positive Romberg test, a “slight
sway” in her gait, normal strength, normal reflexes, and a sensory deficit. Id. at 4. Dr. Delly
diagnosed Petitioner with cervical radiculopathy, a balance problem, numbness and tingling, and
cervical spondylosis. Id. at 4-5. A cervical spine magnetic resonance imaging (“MRI”) and

7
EMGs were ordered. Id. at 5. Petitioner was advised to return in a week and go to the ED if
symptoms worsened. Id. at 5.

On October 20, 2019, Petitioner returned to Oakwood ED complaining of “‘nerve pain’
[in] [bilateral] hands and feet since receiving the flu shot on [September 19, 2019],” as well as
neck pain. Pet. Ex. 4 at 39, 41. She indicated her arms felt heavy and she had leg weakness. Id.
at 52. Petitioner “describe[d] her symptoms as [] constant and worsening since [] onset.” Id.
Petitioner reported “no abdominal pain, no chest pain, no congestion, no cough, no diarrhea, no
fatigue, no fever, no headaches, no nausea, no shortness of breath, no vomiting[,] and no
wheezing.” Id. Examination conducted by Jonathan Leischner, D.O., was normal. Id. at 54.
Petitioner was admitted for observation under Andrew Zazaian, D.O., internal medicine, and for
a neurology consultation. Id. at 56. A lumbar puncture was ordered and conducted that night in
the ED. Id. at 52, 57.

The following day, October 21, Petitioner was examined by Dr. Zazaian. Pet. Ex. 4 at
59. Petitioner reported developing “a pins and needles sensation in her fourth and fifth digits of
bilateral hands along with her toes” on September 20, 2019, which “then progressed to all the
fingers on her hands along with her elbows and dorsum of bilateral feet.” Id. at 60. “[S]he
denied any weakness but felt as though her extremities were ‘tired.’” Id. Petitioner denied
saddle paresthesias, loss of bowel or bladder function, low back pain, or neck pain. Id.
Petitioner expressed concern that she had GBS. Id. Her physical examination and brain MRI
and magnetic resonance angiograph (“MRA”) were all normal. Id. at 62, 65. Dr. Zazaian’s
differential diagnoses were paresthesias of bilateral upper and lower extremities and cervical
radiculopathy. Id. at 65.

Later that day, Petitioner had a neurology consultation with Amy Kodrik, D.O. Pet. Ex. 4
at 69. Petitioner summarized her clinical course and maintained “her symptoms first developed
on [September 20, 2019].” Id. at 70. An outpatient cervical spine MRI report confirmed
degenerative changes at C5-C6 and C6-C7. Id. Neurological examination revealed motor
testing of 5/5 in all extremities; 2/4 reflexes in biceps, triceps, brachioradialis, patellar, and trace
at the Achilles; and plantar response down going bilaterally. Id. at 73. Dr. Kodrik found no
evidence for acute inflammatory demyelinating polyneuropathy (“AIDP”). Id. at 70.
Petitioner’s cerebrospinal fluid (“CSF”) protein was normal. Id. Petitioner had mild
degenerative joint disease but was otherwise unremarkable. Id. Dr. Kodrik concluded Petitioner
was “stable for discharge from a neurologic standpoint.” Id.

Petitioner also had a neurosurgery consultation on October 21 with Fred Song Junn, M.D.
Pet. Ex. 4 at 73-74. Petitioner recounted her symptoms and clinical course. Id. “She stated that
she noticed the issue of paresthesias shortly after receiving the flu vaccine last month,
approximately September 19.” Id. at 74. Dr. Junn noted “[h]er examination show[ed] subjective
paresthesia affecting the upper extremity to the wrists bilaterally.” Id. Dr. Junn also noted
Petitioner’s cervical spine MRI without contrast “show[ed] a T2 signal change in the upper
cervical region without expansion.” Id. Differential diagnoses included “inflammatory myelitis

8
versus neoplasm” 14 and he ordered a cervical spine MRI with contrast. Id. Petitioner was started
on intravenous steroids. Id. at 79, 98.

On October 22, 2019, Petitioner attended inpatient physical therapy (“PT”) and
occupational therapy (“OT”) evaluations. Pet. Ex. 4 at 87-95. At PT, Petitioner reported “numb
patches on the bottom of feet.” Id. at 88. The physical therapist recommended outpatient PT and
a wheeled walker. Id. at 90. At OT, Petitioner additionally reported “burning/numbness
sensation in [both] hands” and hypersensitivity. Id. at 93. The occupational therapist
recommended a shower chair and outpatient OT for the decreased sensation in her hands. Id. at
95. Petitioner was seen again by OT on October 23. Id. at 83-86.

On October 23, 2019, Dr. Junn reviewed Petitioner’s cervical spine MRI, performed on
October 22, 2019, which appeared to show “inflammatory changes of the spinal cord.” Pet. Ex.
4 at 103, 132-33. Specifically, the MRI showed “[a]bnormal hyperintense T2 intramedullary
signal within the spinal cord at C2-C3 with subtle associated enhancement. Findings
nonspecific[,] however[,] suspect[ed] to be demyelinating in nature or inflammatory in nature
considering presentation of symptoms following flu vaccine[,] however clinical correlation is
recommended. Neoplasm [was] not entirely excluded.” Id. at 27, 103. Dr. Junn determined that
Petitioner did not require surgical intervention, and he recommended steroids, a repeat cervical
spine MRI, and continued Neurontin, but otherwise deferred treatment to neurology. Id. at 103.

Subsequently, Dr. Kodrik called Petitioner to discuss the cervical spine MRI, which she
opined was consistent with “[TM] from recent flu[] vaccination.” Pet. Ex. 4 at 104. Prednisone
taper and continued use of Neurontin were recommended, as well as follow up and repeat
cervical spine MRI. Id. Thereafter, Dr. Zazaian discharged Petitioner home on October 23. Id.
at 32, 83, 104.

On December 19, 2019, Petitioner saw Dr. Kodrik in follow up to her hospitalization.
Pet. Ex. 5 at 22. Petitioner recalled that “[s]he developed severe burning pain and numbness in
her upper extremities within 24 hours of the flu vaccination.” Id. Petitioner felt the steroids
“[h]elped significantly” and had stopped taking Neurontin “over the last few weeks since her
symptoms have improved.” Id. She no longer experienced numbness but complained of
Lhermitte’s 15 and a “band like sensation around her thorax” that occurred “[two] weeks ago[,]
[l]asted for several minutes[,] and then resolved.” Id. at 22, 24. Dr. Kodrik’s assessment was
numbness and TM. Id. at 24. Petitioner was instructed to follow up after she completed updated
cervical and thoracic spine MRIs. Id.

14
Neoplasm is “any new and abnormal growth; specifically a new growth of tissue in which the
growth is uncontrolled and progressive.” Neoplasm, Dorland’s Med. Dictionary Online
https://www.dorlandsonline.com/dorland/definition?id=33438 (last visited Mar. 1, 2024).
15
Lhermitte sign is “the development of sudden, transient, electric-like shocks spreading down
the body when the patient flexes the head forward; seen mainly in multiple sclerosis but also in
compression and other disorders of the cervical cord.” Lhermitte Sign, Dorland’s Med.
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=106344 (last visited
Mar. 1, 2024).

9
At this visit, Dr. Kodrik provided Petitioner with “documentation that she [was] not to
have the [flu] vaccination in the future.” Pet. Ex. 5 at 24. This letter stated, “[Petitioner] is
under my neurologic care and is unable to receive the [flu] vaccination as she has a history of
[TM] associated with the [flu] vaccination.” Id. at 20.

On December 27 and 31, 2019, Petitioner sought treatment from Dr. Gilcher without
reporting any new symptoms. Pet. Ex. 8 at 24-27.

Petitioner’s thoracic spine MRI, performed on January 10, 2020, showed “[m]inimal
degenerative changes” and “[n]o intramedullary cord signal lesions . . . to suggest
demyelination.” Pet. Ex. 5 at 27. Petitioner’s cervical spine MRI, performed that same day,
showed degenerative changes without central canal stenosis, neural foraminal stenosis, a “[l]ess
pronounced/smaller demyelinating lesion at C3-4 with no enhancement,” and “[n]o new
demyelinating lesions.” Id. at 28. Dr. Kodrik concluded that Petitioner’s TM was
“improving/healing.” Id. at 30.

On February 11, 2020, Petitioner followed up with Dr. Kodrik and reported “[s]he [was]
having intermittent symptoms usually exacerbated by stress or upper extremity activity.” Pet.
Ex. 5 at 32. She still experienced “Lhermitte’s with neck movement,” but she no longer felt the
“‘band’ around her abdomen.” Id. Dr. Kodrik decided to “hold off on treatment for
breakthrough symptoms” as Petitioner’s “symptoms [were] improving.” Id. at 34. Petitioner
was instructed to follow up in six months, in October. Id.

Petitioner retuned to Dr. Kodrik on October 7, 2020. Pet. Ex. 6 at 3. Petitioner reported
“[s]he continue[d] to have high blood pressure issues since [] episode of [TM].” Id. Petitioner
said her incontinence had improved since October 2019. Id. She rarely experienced
“Lhermitte’s with neck movement.” Id. “No pain or new symptoms” were reported. Id. Dr.
Kodrik noted Petitioner was present “for [a] re-evaluation of history of C3-4 [TM] following a[]
[flu] vaccination with rare intermittent breakthrough symptoms.” Id. at 6. Dr. Kodrik continued
to “hold off on treatment for breakthrough symptoms” and instructed Petitioner to follow up “as
needed.” Id.

In a letter dated September 23, 2021, Angela D. Brennan, N.P., at Dr. Kodrik’s office,
wrote Petitioner was under Dr. Kodrik’s care for TM. Pet. Ex. 11 at 54. Additionally, the letter
stated, “[Petitioner] received the flu vaccine back in 2019 and she had a reaction [] which caused
the [TM]. [Petitioner] should be exempt from receiving the Covid [v]accine . . . .” Id.

No additional medical records were provided.

2. Petitioner’s Declaration

Prior to the subject flu vaccination on September 19, 2019, Petitioner was on medication
for GERD and her thyroid, had no pre-existing neurological issues, and received treatment from
a chiropractor for her back. Pet. Ex. 35 at ¶ 2; Pet. Ex. 7 at ¶ 3.

10
At the time of vaccination, Petitioner was a registered nurse who received yearly flu
vaccinations from her employer. Pet. Ex. 35 at ¶¶ 1, 3. On September 19, 2019, Petitioner
received a flu vaccine while at her doctor’s office. Id. at ¶ 3; Pet. Ex. 7 at ¶ 2. On the day of
vaccination, “nothing unusual” occurred after her vaccination. Pet. Ex. 35 at ¶ 3.

The next day, September 20, 2019, Petitioner “noticed a very faint sensation of pins and
needles in [her] hands and last two toes. It was very faint, hardly noticeable and [she] figured
[she] slept in an odd position or something and it would resolve on its own.” Pet. Ex. 35 at ¶ 4.
“Within a week[,] the sensation in [her] fingers and toes was [] more pronounced.” Id. at ¶ 5.
She would “shak[e] [her] hands . . . and stomp[] [her] feet to alleviate the feeling,” but “[t]he
sensation continued without relief.” Id. Petitioner added “the sensation [was] becoming more
pronounced” and “spread[] from the finger tips [to] the entire fingers” and from her toes to
“numb patches on the bottoms of [her] feet.” Id.

She began to investigate her symptoms and equated them to symptoms of GBS. Pet. Ex.
35 at ¶ 6. Petitioner went to her doctor 16 and shared her symptoms and concerns. Id. at ¶ 7. She
disagreed with her doctor that it was electrolyte imbalance or vitamin deficiency, and later went
to the ED when her symptoms continued to worsen. Id. at ¶¶ 7-8. At the time of her ED visit, 17
“[her] entire hand had the pins and needles sensation with an added burning pain in the palms of
[her] hands. [Her] feet also had the increased sensation of pins and needles but [she had] more
pronounced numbness patches which felt like [she] was walking on spongy material.” Id. at ¶ 8.
She “felt like [her] legs could give out, but [she] felt the spongy sensation on the soles of [her]
feet which was throwing off [her] balance.” Id. Petitioner also reported “cramping down [her]
arms and legs with increased fatigue with little exertion,” including fatigue with holding her cell
phone and walking short distances. Id. At the ED she “[u]tiliz[ed] [her] own medical training”
and explained her symptoms and concerns. Id. at ¶ 9. “[She] tried to be as accurate as possible,
so an accurate and speedy diagnosis could be made and corrective action taken.” Id. She was
told her symptoms were due to degeneration in her neck and she was prescribed Neurontin. Id.
at ¶ 10.

Petitioner explained her symptoms continued to progress and she did not find the
Neurontin effective. Pet. Ex. 35 at ¶ 11. She “was having great difficulty working.” Id. She
was experiencing pain in her hands and fingers and cramping in her arms and legs. Id.
Petitioner returned to her chiropractor, but the adjustments were not effective. Id. at ¶ 12. Her
symptoms continued to worsen and she requested a lumbar puncture at a follow-up appointment

16
Although Petitioner did not indicate the date of this visit, she first saw a provider post-
vaccination on October 3, 2019. See Pet. Ex. 35 at ¶ 7; Pet. Ex. 2 at 115.
17
Petitioner did not indicate the date of this visit in her declaration. See Pet. Ex. 35 at ¶ 8.
However, an examination of the medical records reveals Petitioner’s first ED visit post-
vaccination was October 6, 2019. See Pet. Ex. 3 at 108.

11
with Dr. Kasza. 18 Id. at ¶¶ 13-14. Petitioner stated Dr. Kasza told her there was “nothing to
indicate . . . an autoimmune disease.” Id. at ¶ 14. Dr. Kasza gave Petitioner a referral to
neurologist, Dr. Delly. Id. By the time Petitioner saw Dr. Delly, 19 she “developed a jerking
motion when ambulating[] in addition to all the other symptoms.” Id. at ¶ 15. Petitioner averred
she “tried to be as accurate as possible.” Id. An MRI was ordered. Id.

She returned to the ED, 20 received blood work, lumbar puncture, X-rays, and MRIs, and
was diagnosed with TM. Pet. Ex. 35 at ¶¶ 17-18. She averred that neurosurgeon Dr. Junn told
her TM “was rare and was caused by an autoimmune response to the [flu] vaccine.” Id. at ¶ 18.
Petitioner received intravenous steroids for three days before she was discharged. Id. at ¶¶ 18-
19.

Petitioner averred she had “periodic symptoms,” including “an electrical shock that
would travel down her spinal cord or a sensation of a tight band around [her] upper torso that
affected [her] breathing,” “[f]or at least a year.” Pet. Ex. 35 at ¶ 21. She “ha[s] been advised by
[her] neurologist and primary care physician not to get any other vaccines in the future.” Id.
Petitioner declared “[a]s a result of [her] vaccination, [she] developed [TM] and she “suffered no
other injuries or accidents that would explain [her] [TM]. Pet. Ex. 7 at ¶¶ 4-5.

C. Expert Reports

1. Petitioner’s Expert, Dr. David M. Simpson M.D. 21

a. Background and Qualifications

Dr. Simpson is a Neurology Professor and the Director of the Neuromuscular Division
and Clinical Neurophysiology Laboratories at the Icahn School of Medicine at Mount Sinai
Hospital, where he has worked as an Attending Neurologist since 1984. Pet. Ex. 14 at 1. After
receiving his M.D. from SUNY at Buffalo School of Medicine in 1979, he completed an internal
medicine internship at University Hospitals of Cleveland, Case Western Reserve in Ohio, a
neurology residency at Cornell University Medical Center in New York, and a clinical
neurophysiology fellowship at Massachusetts General Hospital. Pet. Ex. 15 at 1. He is board
certified in neurology, with subspecialty certifications in clinical neurophysiology and
neuromuscular medicine, and electrodiagnostic medicine. Id. He is a member of various

18
Petitioner did not indicate the date of this follow up visit in her declaration, but a review of the
medical records indicates Petitioner requested a second opinion and lumbar puncture at her
follow-up appointment with Dr. Kasza on October 14, 2019. See Pet. Ex. 35 at ¶ 14; Pet. Ex. 2
at 122.
19
Medical records indicate Petitioner saw Dr. Delly on October 16, 2019. Pet. Ex. 10 at 1.
20
Medical records show Petitioner next returned to the ED on October 20, 2019. Pet. Ex. 4 at
39.
21
Petitioner submitted two expert reports from Dr. Simpson. Pet. Exs. 14, 28.

12
professional societies and has extensively published, presented, and lectured on central and
peripheral neurological disorders. Id. at 3, 20-94; Pet. Ex. 14 at 1. Dr. Simpson’s “specialty
areas in neurology include neuromuscular disorders, neuro-infectious disease, and clinical use of
botulinum toxin. [He] ha[s] diagnosed and treated many patients with GBS over the course of
[his] career[;] [he] teach[es] medical students, neurology residents[,] and EMG/Neuromuscular
Fellows about [GBS;] and [he] frequently lecture[s] on GBS.” Pet. Ex. 14 at 1.

b. Opinion

Dr. Simpson opined that “more likely than not,” Petitioner’s flu vaccine is “causally
related to [her] development of TM.” Pet. Ex. 28 at 1; see also Pet. Ex. 14 at 9. Dr. Simpson
found “the sequence of events, with neurological symptoms beginning as early as one day
following [flu] vaccine, followed by progressive neurological signs of TM, with consistent spinal
MRI findings, support the diagnosis of TM.” Pet. Ex. 14 at 9. In addition, “[t]here is a strong
biological rationale and ample evidence in the medical literature that [the flu] vaccine is
associated with TM.” Id. He further stated Petitioner’s “treating physicians repeatedly
documented a causal association,” there was “no alternative explanation for causation,” and
“[t]he temporal relationship support[s] that TM was related to vaccination.” Id.

i. Diagnosis

Dr. Simpson opined Petitioner “exhibited clinical symptoms and signs consistent with
TM, with typical MRI findings,” and “[a]ll [] treating physicians concurred with the diagnosis of
TM.” Pet. Ex. 14 at 4-5. Dr. Simpson also noted that Respondent’s expert, Dr. Matiello, agreed
with the diagnosis of TM. Pet. Ex. 28 at 1.

ii. Althen Prong One

To explain how the flu vaccine can cause TM, Dr. Simpson opined “the most likely
mechanism is molecular mimicry.” 22 Pet. Ex. 14 at 5. He explained that molecular mimicry is
the concept by which shared structures in a vaccine can trigger a cross-reactive response to self,
leading to an immune response that can cause inflammation in the spinal cord that is seen in TM.
Id. (citing Pet. Ex. 18 at 8 (“Molecular mimicry may occur when an immune response mounted
against an environmental antigen cross-reacts with a host antigen, which in turn leads to
autoimmunity, organ-specific damage, and possibly disease.”)). 23

22
Dr. Simpson noted “[t]here are numerous biologic mechanisms by which vaccines may lead to
neurologic illness, including direct neurotoxic effects and development of autoimmunity, in
which the vaccine’s antigenic effects result in an abnormal immunologic response.” Pet. Ex. 14
at 5. He also noted other “potential mechanisms,” including “[n]eurotoxic effect,” “[i]mmune
complex formation,” and “[l]oss of self-tolerance.” Id. Because Dr. Simpson did not discuss
these concepts or mechanisms more fully, or explain how they were at play here, the undersigned
does not discuss them in her Decision.
23
Michel C. Levin et al., Neuronal Molecular Mimicry in Immune-Mediated Neurologic
Disease, 44 Annals Neurology 87 (1998).

13
In response to Dr. Matiello’s argument that Dr. Simpson did not provide specific
homology, Dr. Simpson acknowledged it is not known and argued testing for specific homology
is not standard when assessing patients. Pet. Ex. 28 at 2.

Additionally, “[w]hile it is true that our understanding of the primary pathogenetic
mechanisms of TM is incomplete, it is certainly tenable that innate immunological mechanisms,
triggered by molecular mimicry, underlies the pathogenesis of vaccine-induced TM as proposed
by numerous authors.” Pet. Ex. 28 at 2. He did not explain what he meant by “innate
immunological mechanisms, triggered by molecular mimicry.” Nor did he explain who the
“numerous authors” were.

To support his theory of molecular mimicry, Dr. Simpson cited literature discussing an
association between vaccinations and TM, 24 including case reports documenting the
development of TM following flu vaccination. Pet. Ex. 14 at 5. He first cited Fenichel (1982) 25
and noted several case reports of TM were discussed by the author. Id. (citing Pet. Ex. 20).
Fenichel reviewed adverse events following multiple vaccines, including TM following the flu
vaccine. Pet. Ex. 20 at 4. Fenichel noted “[r]abies and smallpox are the only associated
immunizations” with TM and “data concerning a cause-and-effect relationship between
immunization and []TM is circumstantial and based upon the temporal relationship.” Id.
Fenichel discussed only one article related to TM post-flu vaccination, which was not cited in
this matter. Id. This article was a case report of two patients who developed TM seven and 29
days following flu vaccination. Id. Vaccine causation was not discussed by Fenichel. See id.

Next, Dr. Simpson cited Agmon-Levin et al. (2009), 26 “a comprehensive literature
review” that “identified 37 reported cases of TM following vaccination of various types.” Pet.
Ex. 14 at 5 (citing Pet. Ex. 21). Two of the 37 cases of TM followed flu vaccination. Pet. Ex. 21
at 2. The authors noted “[t]he rarity of post-[flu]-vaccination neurological complications
reported in recent years makes it impossible to establish a definite causal relation.” Id. at 4.
However, they discussed mechanisms by which vaccines may induce TM, and acknowledged

24
Although the undersigned reviewed all of the medical literature, she does not discuss the
literature cited by Dr. Simpson that does not relate to the material issues here or that was not
discussed or mentioned in his reports. See Pet. Ex. 19 (discussing two case reports of giant cell
arteritis post-flu vaccine and rheumatoid arthritis post-flu and tetanus toxoid vaccines) (Maria
Antonia Pou et al., Development of Autoimmune Diseases After Vaccination, 14 J. Clinical
Rheumatology 243 (2008)); Pet. Ex. 34 (Silva Markovic-Plese et al., High Level of Cross-
Reactivity in Influenza Virus Hemagglutinin-Specific CD4+ T-Cell Response: Implications for
the Initiation of Autoimmune Response in Multiple Sclerosis, 169 J. Neuroimmunology 31
(2005)).
25
Gerald M. Fenichel, Neurological Complications of Immunization, 12 Annals Neurology 119
(1982).
26
N. Agmon-Levin et al. Transverse Myelitis and Vaccines: A Multi-Analysis, 18 Lupus 1198
(2009). This article was also cited by Respondent’s expert. Resp. Ex. A-8.

14
“[m]olecular mimicry between infectious antigens and self antigens is the most common
mechanism.” Id. (emphasis omitted). Agmon-Levin et al. added that a “host’s response to a
vaccine, originally generated to produce protective immunity, is similar to its response to an
infectious invasion.” Id. The authors concluded that “the temporal association between []
vaccines and TM, and the possible mechanism associating these phenomena cannot be ignored.
The rarity of TM makes it a difficult disease to study.” Id. at 5.

Dr. Simpson also cited “a case of acute TM following tetanus toxoid vaccination”
discussed in Read et al. 27 Pet. Ex. 14 at 5 (citing Pet. Ex. 22). Read et al. discussed a case of a
50-year-old man who received a tetanus toxoid booster vaccination after suffering a penetrating
foot wound. Pet. Ex. 22 at 1. The patient was diagnosed with a viral illness about ten days later
after complaining of myalgia, lethargy, fatigue, and mild bifrontal headache. Id. Twelve days
after initial presentation, he was admitted to the hospital with “flaccid, areflexic paralysis of the
legs, associated with sensory loss to T6, moderately severe midthoracic back pain, and urinary
retention.” Id. After diagnostic testing, he was diagnosed with acute TM. Id. at 2. The authors
concluded that “[a]lthough it is possible that the myelopathy in [their] patient occurred
independently of vaccination, the timing and absence of an alternative explanation may implicate
tetanus toxoid.” Id.

Akkad et al., 28 another case report cited by Dr. Simpson, concerned a patient who
developed TM four days after receipt of a flu vaccine. Pet. Ex. 14 at 5 (citing Pet. Ex. 23).
Following extensive laboratory testing, “effectively eliminat[ing] the most probable causes for
[their] patient’s condition, [the authors] attributed it to postvaccination TM following novel [flu]
A(H1N1) vaccination.” Pet. Ex. 23 at 2. The authors noted “vaccine-associated TM cases are . .
. scarce,” but have been reported to occur following administration with various vaccines,
including the flu vaccine. Id. They added that “the temporal relationship of TM with such a
wide variety of vaccines suggest[s] . . . that a common denominator such as an adjuvant might
trigger the syndrome;” however, because “[t]he 2009 novel [flu] A(H1N1) vaccines[] [] do not
contain an adjuvant[,] . . . it is something other than the adjuvant in [their] case.” Id.

Korn-Lubetzki et al. 29 similarly reported a case of TM following flu vaccination. Pet. Ex.
24. Their patient developed symptoms one month following flu H1N1 (Focetria) 30 vaccination.
Id. at 1. Testing was consistent with TM. Id. A complete etiological workup was negative. Id.

27
Stephen J. Read et al., Acute Transverse Myelitis After Tetanus Toxoid Vaccination, 339
Lancet 1111 (1992).
28
Wafa Akkad et al., Longitudinally Extensive Transverse Myelitis Following Vaccination with
Nasal Attenuated Novel Influenza A (H1N1) Vaccine, 67 Archives Neurology 1018 (2010).
29
Isabelle Korn-Lubetzki et al., H1N1 Vaccine-Related Acute Transverse Myelitis, 13 Isr. Med.
Ass’n J. 249 (2011).
30
Focetria is an adjuvanted flu vaccine. Focetria, Eur. Meds. Agency,
https://www.ema.europa.eu/en/medicines/human/EPAR/focetria (last updated Feb. 11, 2016).
Petitioner did not file evidence to show there was an adjuvant in her flu vaccine.

15
at 2. The authors found “[t]he fact that the symptoms and signs had occurred a month after the
H1N1 vaccination suggest[ed] the pathogenesis of post-vaccinal myelitis due to an
immunological reaction to the vaccine.” Id. They hypothesized that because the vaccine their
patient received contained an adjuvant, the adjuvant may have had a “role . . . in the development
of an immune mediated neurological complication.” Id.

In his supplemental expert report, Dr. Simpson “agree[d] with Dr. Matiello that the
literature providing an association between [flu] vaccination and TM is provided predominantly
in case reports and series.” Pet. Ex. 28 at 2. However, he explained that “the detection of rare
effects of vaccines and other therapeutics are often not found in initial prospective, placebo-
controlled trials, as they are underpowered to detect such low-incidence occurrences.” Id. (citing
Pet. Ex. 30 at 1 (“Post-licensure monitoring may be superior to pre-licensure reviews in detecting
rare adverse events.”)). 31 For support, he cited to the 2012 Institute of Medicine (“IOM”)
report, 32 where the Chair of the Committee, Dr. Ellen Wright Clayton, stated that “some issues
simply cannot be resolved with currently available epidemiological data . . . . In addition, even
very large epidemiological studies may not detect or rule out rare events.” Id. (quoting Pet. Ex.
25 at 10-11); see also Pet. Ex. 31 at 2 (indicating “epidemiological studies focusing specifically
on [autoimmune disease] risk have remained few and their power to detect any increase in rare
events was limited”). 33

Dr. Simpson concluded “[t]here is a strong biological rationale and ample evidence in the
medical literature that [the flu] vaccine is associated with TM.” Pet. Ex. 14 at 9.

iii. Althen Prong Two

Dr. Simpson opined the sequence of events in this case supports a finding that
Petitioner’s flu vaccination caused her to develop TM within one day of vaccination. Pet. Ex. 14
at 5-6, 9. First, he explained Petitioner developed rapidly progressive sensory and motor
symptoms in her upper and lower extremities typical of TM. Id. at 5. Her early neurological
examinations were unremarkable, however, she was later found to have “diffuse hyperreflexia
and [an] unsteady gait, indicative of corticospinal tract abnormalities consistent with
myelopathy/myelitis.” Id. Her cervical spine MRI revealed a T2 hyperintense signal with
associated contrast enhancement, which Dr. Simpson also noted was consistent with TM. Id.

31
Louise Brinth et al., Suspected Side Effects to the Quadrivalent Human Papilloma Vaccine, 62
Danish Med. J. 1 (2015). Even though this study concerns only the human papillomavirus
vaccine, and does not discuss the flu vaccine or TM, Dr. Simpson maintained “the concept is
clearly transferable to rare neurological events associated with other vaccines, such as TM
following [flu] vaccination in the current case.” Pet. Ex. 28 at 3.
32
Inst. of Med., Adverse Effects of Vaccines: Evidence and Causality (Kathleen Stratton et al.
eds., 2012).
33
Sara Miranda et al., Human Papillomavirus Vaccination and Risk of Autoimmune Diseases: A
Large Cohort of Over 2 Million Young Girls in France, 35 Vaccine 4761 (2017). TM and the flu
vaccine were not investigated or discussed in this study. See supra note 31.

16
Thereafter, Petitioner received steroid treatment, which Dr. Simpson noted improved Petitioner’s
symptoms as is typically seen in TM patients. Id. at 6. Additionally, residual neurological
symptoms and deficits, which Petitioner has, can persist following treatment. Id. at 6, 9.

Regarding Petitioner’s pre-existing symptoms of joint pain and carpal tunnel syndrome,
Dr. Simpson agreed these symptoms were not consistent with a myelopathy or myelitis. Pet. Ex.
14 at 6.

Additionally, he noted Petitioner’s “treating physicians repeatedly documented a causal
association between the flu vaccine and the onset of her TM, in the absence of any other
identifiable factor.” Pet. Ex. 14 at 9. He noted that Dr. Kodrik, on October 23, 2019, told
Petitioner her cervical spine MRI was consistent with “[TM] from recent flu[] vaccination.” Pet.
Ex. 4 at 104; see Pet. Ex. 14 at 4. At a visit on December 19, 2019, Dr. Kodrik provided
Petitioner with “documentation that she [was] not to have the [flu] vaccination in the future.”
Pet. Ex. 5 at 24; see Pet. Ex. 14 at 4. And in a letter dated September 23, 2021, Nurse Brennan at
Dr. Kodrik’s office wrote “[Petitioner] received the flu vaccine back in 2019 and she had a
reaction in which caused the [TM]. [Petitioner] should be exempt from receiving the Covid
[v]accine [so that] [] this reaction does not occur again.” Pet. Ex. 11 at 54; see Pet. Ex. 14 at 4.

Further, Dr. Simpson noted no alternative cause for Petitioner’s TM was found during
“[a]n extensive diagnostic evaluation.” Pet. Ex. 14 at 5, 9. Specifically, he noted her serum
markers, including vitamin B12, were normal. Id. at 5. Therefore, he concluded that the “[flu]
vaccine remains [] the only identifiable cause of [Petitioner’s] TM.” Id.

iv. Althen Prong Three

Dr. Simpson opined Petitioner developed “neurological symptoms [] as early as one day
following [flu] vaccination,” which is within the “medically acceptable time[ ]frame for the
occurrence of neurological disease following vaccination.” Pet. Ex. 14 at 6, 9.

Although he opined Petitioner’s symptom onset was one day post-flu vaccination, Dr.
Simpson questioned the accuracy of Petitioner’s recall of the onset of her neurological symptoms
following vaccination. Pet. Ex. 14 at 6; Pet. Ex. 28 at 3. For support, he noted Petitioner first
reported her post-vaccination symptoms to a medical provider (Dr. Janeski) on October 3, 2019.
Pet. Ex. 14 at 6 (citing Pet. Ex. 2 at 115). Dr. Janeski documented Petitioner’s complaints “of
tingling of her last [two] fingers and both feet following the flu shot.” Id. (citing Pet. Ex. 2 at
115 (“[s]tat[ing] she [had] been having tingling in the last two fingers, after the flu shot last
week”)). Dr. Simpson noted “a specific time frame of the onset of her neurological symptoms
[was] not documented” during this visit. Id.

Dr. Simpson next cited to Petitioner’s visit with Dr. Whitty on October 7, 2018, where
Dr. Whitty noted “onset of neurological symptoms following flu vaccination [two] weeks
earlier,” and Dr. Simpson again noted “a specific date of onset [was] not documented.” Id.
(citing Pet. Ex. 2 at 158 (noting symptoms of tingling in bilateral hands and feet was
“progressively getting worse over the past [two] weeks after getting a flu shot”)). Dr. Simpson
next cited a record from October 11, 2019, approximately three weeks post-vaccination, when

17
Dr. Gilcher documented that Petitioner indicated her onset of hand paresthesias and weakness
was one day after her flu vaccination. Id. (citing Pet. Ex. 8 at 18 (“The day after the flu shot
[Petitioner] experienced new symptoms.”)).

Dr. Simpson opined that “even if one were to assume that neurological symptoms
occurred within one day of vaccination, this is a medically acceptable time frame for the
occurrence of neurological disease following vaccination.” Pet. Ex. 14 at 6. In his supplemental
expert report, he explained he was not persuaded by Dr. Matiello’s latency time frame argument.
Pet. Ex. 28 at 4. He then opined Petitioner “likely [had] a recall response” given her previous flu
vaccinations, explaining “[a] recall response can be swift and must be swift, otherwise immune
memory would be too slow to protect us from microbial attacks.” Id.

He noted the 2012 IOM report stated, “the lag phase in a memory response can begin at
[one] day.” Pet. Ex. 28 at 4. Specifically, he quoted the following passage from the 2012 IOM
report discussing latency between antigen exposure and peak adaptive immune response:

For both B and T cells in a typical immune response to an antigen exposure, the
latency between the first (primary) exposure and development of the primary
response is characterized by a lag phase, logarithmic phase, and plateau phase.
The lag phase is characterized by the initial activation of B and T cells upon
encounter with the antigen for which they are specific, and this triggers the cells’
differentiation into effector and memory cells. The lag phase between primary
exposure to an antigen and the logarithmic phase is classically thought to be
[four] to [seven] days, but it varies depending on route of exposure and the
antigen itself. For B cells, the logarithmic phase is characterized by an increase in
serum antibody levels that classically is logarithmic. The plateau phase is
characterized by the maintenance of peak antibody levels for a length of time that
is followed by a decline in the serum antibody levels. For many antigens the
latency (lag phase) between primary exposure and development of the primary
antibody response is [seven] to 10 days. Due to the development of memory B
and T cells during the primary immune response, the latency between subsequent
exposure to the antigen and development of the immune response will usually be
shorter. The lag phase is generally [one] to [three] days; the logarithmic phase of
the secondary antibody response occurs over the next [three] to [five] days. As
mentioned for the primary immune response, these time periods will vary
depending on the route of exposure, the timing of the subsequent exposure, the
antigen itself, and the antigen dose. While this discussion is not specific to a
particular antigen, it can be used as a reference point for the latency between
antigen exposure and the initiation of some of the immune-mediated mechanisms
described below.

Id. (quoting Pet. Ex. 25 at 86-87).

Dr. Simpson also cited literature concerning GBS post-flu vaccination to draw inferences
from TM literature “given potential similarities in pathogenetic mechanisms underlying several
post-vaccination neurological disorders.” Pet. Ex. 28 at 3-4; see also Pet. Ex. 14 at 6.

18
Schonberger et al., 34 according to Dr. Simpson, indicated “the true range of attributable risk is
both shorter than [three] days and longer than 42 days” despite the Vaccine Injury Table period
of three to 42 days for GBS post-flu vaccination cases. Pet. Ex. 14 at 6 (citing Pet. Ex. 26). He
cited two figures in Schonberger et al. that placed GBS cases post-flu vaccination within the first
week for onset. Id. at 6-7 (citing Pet. Ex. 26 at 9 figs. 6-7). However, neither figure indicated
onset by day or an onset of one day. See Pet. Ex. 26 at 9 figs. 6-7.

Schonberger et al. found “[t]he period of increased risk [for GBS] was concentrated
primarily within the [five]-week period after vaccination, although it lasted for approximately
[nine] or 10 weeks.” Pet. Ex. 26 at 1. When the authors examined two-day intervals between
vaccination and onset, from day zero to day 41, they found the largest percentage of cases
occurred on day 16 and 17 day post-vaccination. Id. at 6-7, 8 fig.5. It appears eleven cases
occurred between day zero (date of vaccination) to day one. See id. at 8 fig.5.

Safranek et al. 35 reassessed the findings in Schonberger et al. and excluded cases (18
vaccinated and 13 unvaccinated) of GBS that were misclassified due to onset or diagnosis. Pet.
Ex. 17 at 1, 5. Upon reassessment, they found “an increased risk of developing [GBS] during the
[six] weeks following vaccination in adults” and no increased risk beyond six weeks. Id. at 1.
The authors noted four cases of GBS occurred within day one and day seven following
vaccination. Id. at 8 tbl.3. The authors, however, did not specify whether any cases were
characterized by an onset of only one day.

Dr. Simpson also cited Park et al., 36 a study that reviewed post-vaccination GBS cases
submitted to the Advisory Committee Vaccination Injury Compensation in Korea from 2002 to
2014. Pet. Ex. 27 at 1-2. During this period, 590 cases were submitted for evaluation for
vaccination-related compensation. Id. at 2. Sixty-eight cases were related to GBS, and 48 of
these cases were approved for compensation. 37 Id. Of these 48 cases, all had a history of flu
vaccination, a previous infection could not be excluded as a causative factor in five cases, and 18
cases were classified as “possible” cases of GBS. Id. at 2, 5. The authors noted “[t]his
suggest[ed] a very low incidence for vaccine-related GBS.” Id. at 5. “Of the total 48 cases, 47
(97.9%) developed symptoms within [three] weeks, and in particular, more than half (54.2%)
within [two] days.” Id. at 2. Dr. Simpson opined “[Petitioner’s] symptom onset within [one]-
[three] days of flu vaccination is concordant with these findings.” Pet. Ex. 14 at 7.

34
Lawrence B. Schonberger et al., Guillain-Barre Syndrome Following Vaccination in the
National Influenza Immunization Program, United States, 1976-1977, 110 Am. J. Epidemiology
105 (1979).
35
Thomas J. Safranek et al., Reassessment of the Association Between Guillain-Barré Syndrome
and Receipt of Swine Influenza Vaccine in 1976-1977: Results of a Two-State Study, 133 Am. J.
Epidemiology 940 (1991).
36
Yong-Shik Park et al., Clinical Features of Post-Vaccination Guillain-Barré Syndrome (GBS)
in Korea, 32 J. Korean Med. Sci. 1154 (2017).
37
The authors in Park et al. included cases of “possible” GBS in their study. Pet. Ex. 27 at 5.

19
With regard to TM cases specifically, Agmon-Levin et al. noted 27 (73%) of the 37
reported cases of TM occurred within the first month after vaccination. Pet. Ex. 21 at 2. Two of
the 37 cases occurred following flu vaccination, with onset periods of seven and nine days post-
vaccination. Id. at 3 tbl.1. Fenichel mentioned two patients who developed TM seven and 29
days following flu vaccination. Pet. Ex. 20 at 4. Read et al. discussed a 50-year-old man who
received a tetanus toxoid booster vaccination three weeks prior to developing TM. Pet. Ex. 22 at
1. Akkad et al. reported a patient who developed TM four days after receipt of a flu vaccine.
Pet. Ex. 23 at 1. And Korn-Lubetzki et al. reported a patient who developed symptoms
consistent with TM one month following flu vaccination. Pet. Ex. 24 at 1. Dr. Simpson did not
provide any literature or case reports describing the onset of TM occurring one day following
any vaccination.

2. Respondent’s Expert, Dr. Marcelo Matiello 38

a. Background and Qualifications

Dr. Matiello is a neuro-immunologist and board-certified neurologist who has focused his
career on “clinical and biological susceptibility aspects of central nervous system (CNS)
inflammatory and demyelinating disease[s], including optic neuritis, [TM], multiple sclerosis [],
neuromyelitis optica spectrum disorders[,] and myelin oligodendrocyte glycoprotein antibody
associated disease [].” Resp. Ex. A at 1-2. After he received his M.D. in Brazil, he completed an
internal medicine and neurology residency in Brazil. Resp. Ex. B at 1. Dr. Matiello then
completed residencies and fellowships at the Mayo Clinic, Yale New Haven Hospital,
Massachusetts General Hospital, Brigham and Woman’s Hospital, and Harvard Medical School
from 2006 to 2018. Id. at 1-2. He has worked as an Assistant Professor of Neurology at Harvard
Medical School since 2017. Id. at 2. He has also worked as a neurologist at various hospitals
since 2016 and “actively evaluate[s] and treat[s] patients with [CNS] inflammatory diseases.”
Resp. Ex. A at 2; see also Resp. Ex. B at 2-3. He has authored or co-authored over 50
publications during his career. Resp. Ex. A at 2; Resp. Ex. B at 28-36.

b. Opinion

Dr. Matiello opined that “based on the clinical facts and the relevant science, . . . more
likely than not that [Petitioner’s] vaccination is not the cause of her partial [TM] and resulting
sporadic symptoms.” Resp. Ex. A at 11.

i. Diagnosis

Even though Dr. Matiello found Petitioner’s presentation atypical for TM due to her (1)
progressive hand and feet numbness, (2) lack of sensory or muscle weakness, and (3) lack of
inflammation seen with CSF, he agreed with the diagnosis of incomplete, isolated TM based on
her cervical MRI. Resp. Ex. A at 6.

38
Respondent submitted one expert report from Dr. Matiello. Resp. Ex. A.

20
ii. Althen Prong One

Dr. Matiello does not appear to take issue with the theory of molecular mimicry
generally. See Resp. Ex. 7-11. An article Dr. Matiello cited from Walker and Abbas 39 described
molecular mimicry as “the situation in which T cells that are activated by microbial peptides . . .
also crossreact with self-proteins.” Resp. Ex. A-5 at 6 fig.4. If “a T cell that is specific for a
foreign protein is also able by chance to recognize a self-protein, . . . mounting an immune
response to a pathogen might have the unfortunate side effect of triggering an autoimmune
response.” Id.; see also Resp. Ex. A-10 (further describing molecular mimicry and discussing
vaccine-induced molecular mimicry and autoimmunity). 40

However, Dr. Matiello takes issue with Dr. Simpson’s theory because it is “not specific
and does not correlate with the clinical presentation in this case.” Resp. Ex. A at 7. He
explained that in order for molecular mimicry to apply, “one would need to demonstrate that the
inflammation in the spinal cord can be induced by exposure to a specific foreign antigen (e.g.
vaccine peptide) through cross-reactive epitopes of the nervous tissue in the spinal cord.” Id. at
7-8. However, “no comparison of cross-reactive epitopes (molecular structure of flu vaccine)
was done for sequence or structural homology of target antigen epitopes (human spinal cord
tissue).” Id. at 8.

Next, Dr. Matiello opined studies have not found a significant association between
vaccines and CNS demyelinating conditions. Resp. Ex. A at 8. For support, he cited a large case
control study from Langer-Gould et al. 41 examining the association of first onset CNS acute
demyelinating syndromes and vaccines. Resp. Ex. A-4 at 2. Langer-Gould et al. identified 780
patients with newly diagnosed CNS acute demyelinating syndromes, with 122 patients diagnosed
with TM and 33 patients diagnosed with other forms of clinically isolated syndromes. 42 Id. at 3.
The authors found no association with any CNS acute demyelinating syndrome and any vaccine
in the three years prior to onset. Id. “The risk of CNS [acute demyelinating syndromes] was
increased 30 days after any type of vaccine in individuals younger than 50;” however, “[t]here
was no association between any vaccination and CNS [acute demyelinating syndromes] in other
individuals during any time interval.” Id. at 3-4.

Langer-Gould et al. determined there was “no long-term association between vaccines
and . . . CNS [acute demyelinating syndromes].” Resp. Ex. A-4 at 4. They further opined

39
Lucy S.K. Walker & Abul K. Abbas, The Enemy Within: Keeping Self-Reactive T Cells at
Bay in the Periphery, 2 Nature Revs. 11 (2002).
40
Yahel Segal & Yehuda Shoenfeld, Vaccine-Induced Autoimmunity: The Role of Molecular
Mimicry and Immune Crossreaction, 15 Cellular & Molecular Immunology 586 (2018).
41
Annette Langer-Gould et al., Vaccines and the Risk of Multiple Sclerosis and Other Central
Nervous System Demyelinating Diseases, 71 JAMA Neurology 1506 (2014).
42
The authors indicated “clinically isolated syndrome” included optic neuritis, TM, and
monofocal or multifocal clinically isolated syndrome. Resp. Ex. A-4 at 3.

21
“[their] data do[es] not support a causal link between current vaccines and the risk of CNS [acute
demyelinating syndromes].” Id. at 5. Dr. Matiello opined this finding in Langer-Gould et al.
“argues against a common or uncommon molecular mimicry causal association.” Resp. Ex. A at
8. The Langer-Gould et al. study did not provide data on how many of their patients with TM
received the flu vaccine, or the time frame for onset of the patients.

Next, Dr. Matiello argued case reports do not establish or prove a causal relationship.
Resp. Ex. A at 9. He cited Nisse and Wynn, 43 who stated, “[c]ausality cannot be inferred from
an uncontrolled observation. An association does not imply a cause-effect relationship. The
observation or event in question could be a mere coincidence. This is a limitation shared by all
the descriptive studies.” Resp. Ex. A-6 at 4. Nisse and Wynn further noted “case reports cannot
be generalized” because “to generalize[,] we need both a cause-effect relationship and a
representative population.” Id. Based on Nisse and Wynn, Dr. Matiello opined “[t]o date, no
study has shown an increased incidence of myelitis among those receiving vaccinations,” and
thus, any proposed association is at most “likely coincidental.” Resp. Ex. A at 9 (quoting Resp.
Ex. A-7 at 12-13). 44

Dr. Matiello also cited Agmon-Levin et al. Resp. Ex. A at 9. He noted Agmon-Levin et
al. “emphasized that pathogenic proof of causality was accepted only in the case of post-oral
poliovirus vaccine (OPV) TM,” which is a live attenuated vaccine. Resp. Ex. A at 9 (citing Pet.
Ex. 21).

In conclusion, Dr. Matiello noted that well-conducted, large studies have not shown a
causal association between vaccines and CNS diseases, such as TM. Resp. Ex. A at 9.
Furthermore, there is a “lack of scientific proof of a true molecular mimicry between the vaccine
structure and the human tissue.” Id. at 10. Therefore, case reports “most likely represent
coincidental temporal associations,” not a causal relationship. Id.

iii. Althen Prong Two

Dr. Matiello opined that “more likely than not,” Petitioner’s flu vaccine did not cause her
to develop TM. Resp. Ex. A at 11. He first noted, “[a]s discussed above, vaccine association is
not validated by epidemiological studies, which instead substantiate the lack of association
between vaccines and the development of TM.” Id. at 10.

Next, with regard to Petitioner’s molecular mimicry theory, Dr. Matiello took issue with
the fact that testing for any specific cross-reaction was not done and therefore, the specific target
for the inflammation is not known in Petitioner’s case. Resp. Ex. A at 8. He noted Petitioner’s
diagnostic work up did not include specific testing that would determine the target for the
inflammation, including testing for “antibody cross-reaction with epitopes on myelin (e.g. myelin

43
Trygve Nissen & Rolf Wynn, The Clinical Case Report: A Review of its Merits and
Limitations, 7 BMC Rsch. Notes 1 (2014).
44
Timothy W. West et al., Acute Transverse Myelitis: Demyelinating, Inflammatory, and
Infectious Myelopathies, 32 Seminars Neurology 97 (2012).

22
oligodendrocyte glycoprotein[] [(“MOG”)]) or other cells of the nervous system (e.g. water
channel aquaporin-4).” Id.

Dr. Matiello added that based on “the current body of knowledge regarding the
pathogenesis of immune cross-reactivity, it is reasonable to assume that the risk of autoimmunity
is mainly relevant for those with previous history or family history of autoimmune diseases,
subjects known to have autoantibodies, and those carrying a certain genetic profile,” which he
noted is not the case for Petitioner. Resp. Ex. A at 8.

Lastly, Dr. Matiello explained that while Petitioner’s treating physicians may have
documented a “suspected relationship” between Petitioner’s flu vaccine and development of
TM, “clinicians will often record their first impressions[] without the opportunity to look at the
full picture in great detail, analyze it over time[,] or perform in-depth analysis of the
epidemiologic and scientific literature.” Resp. Ex. A at 10.

iv. Althen Prong Three

Dr. Matiello disagreed with Dr. Simpson’s opinion that Petitioner’s one day onset of
neurological symptoms post-flu vaccination is consistent with vaccine causation. Resp. Ex. A at
10.

Specifically, Dr. Matiello disagreed with Dr. Simpson’s suggestion that a one-day onset
is consistent with “the most rigorously conducted epidemiological investigation of post-[flu]
vaccine GBS medical literature.” Resp. Ex. A at 10 (quoting Pet. Ex. 14 at 6). Dr. Matiello
explained the “most common accepted timing” for onset is three to 42 days for post-flu vaccine
GBS as recognized by the Vaccine Table and studies. Id. (citing 42 C.F.R. § 100.3(a); Resp. Ex.
A-10 at 3).

Additionally, Dr. Matiello argued data related to timing for GBS is not specific to this
case because Petitioner did not have GBS. Resp. Ex. A at 9.

Lastly, Dr. Matiello, like Dr. Simpson, discussed the latency between antigen exposure
and antibody response. Resp. Ex. A at 10-11 (citing Resp. Ex. A-11); 45 see Pet. Ex. 28 at 4
(quoting Pet. Ex. 25 at 86-87). “[A]n exposure to a particular antigen[] initiates an array of
reactions involving the immune system.” Resp. Ex. A at 10. He explained

[t]he lag phase between primary exposure to an antigen and the logarithmic phase
is classically thought to be [four] to [seven] days, but it varies depending on route
of exposure and the antigen itself. For many antigens, the latency between
primary exposure and development of the primary antibody response is even
higher is [seven] to 10 days. Memory B and T cells during the primary immune
response—which is not proved to be the case here—the latency between
subsequent exposure to the antigen and development of the immune response will

45
Basic Concepts in Immunology, in Immunobiology: The Immune System in Health and
Disease 13 (Charles A Janeway et al. eds., 5th ed. 2001).

23
usually be shorter, but include a lag phase ([one] to [three] days) and the
logarithmic phase of the secondary antibody response to occurs over the next
[three] to [five] days.

Id. at 11.

In summary, Dr. Matiello opined that Petitioner’s onset of one day “refutes the
hypothesis of direct causal association of [Petitioner’s] [f]lu vaccination and her TM.” Resp. Ex.
A at 11.

IV. DISCUSSION

A. Standards for Adjudication

The Vaccine Act was established to compensate vaccine-related injuries and deaths. §
10(a). “Congress designed the Vaccine Program to supplement the state law civil tort system as
a simple, fair and expeditious means for compensating vaccine-related injured persons. The
Program was established to award ‘vaccine-injured persons quickly, easily, and with certainty
and generosity.’” Rooks v. Sec’y of Health & Hum. Servs., 35 Fed. Cl. 1, 7 (1996) (quoting
H.R. Rep. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344).

Petitioner’s burden of proof is by a preponderance of the evidence. § 13(a)(1). The
preponderance standard requires a petitioner to demonstrate that it is more likely than not that the
vaccine at issue caused the injury. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315,
1322 n.2 (Fed. Cir. 2010). Proof of medical certainty is not required. Bunting v. Sec’y of Health
& Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). Petitioner need not make a specific type of
evidentiary showing, i.e., “epidemiologic studies, rechallenge, the presence of pathological
markers or genetic predisposition, or general acceptance in the scientific or medical communities
to establish a logical sequence of cause and effect.” Capizzano v. Sec’y of Health & Hum.
Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006). Instead, Petitioner may satisfy her burden by
presenting circumstantial evidence and reliable medical opinions. Id. at 1325-26.

In particular, Petitioner must prove that the vaccine was “not only [the] but-for cause of
the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321
(quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999));
see also Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). The
received vaccine, however, need not be the predominant cause of the injury. Shyface, 165 F.3d
at 1351. A petitioner who satisfies this burden is entitled to compensation unless Respondent
can prove, by a preponderance of the evidence, that the vaccinee’s injury is “due to factors
unrelated to the administration of the vaccine.” § 13(a)(1)(B). However, if a petitioner fails to
establish a prima facie case, the burden does not shift. Bradley v. Sec’y of Health & Hum.
Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).

“Regardless of whether the burden ever shifts to the [R]espondent, the special master
may consider the evidence presented by the [R]espondent in determining whether the [P]etitioner
has established a prima facie case.” Flores v. Sec’y of Health & Hum. Servs., 115 Fed. Cl. 157,

24
162-63 (2014); see also Stone v. Sec’y of Health & Hum. Servs., 676 F.3d 1373, 1379 (Fed. Cir.
2012) (“[E]vidence of other possible sources of injury can be relevant not only to the ‘factors
unrelated’ defense, but also to whether a prima facie showing has been made that the vaccine
was a substantial factor in causing the injury in question.”); de Bazan v. Sec’y of Health & Hum.
Servs., 539 F.3d 1347, 1353 (Fed. Cir. 2008) (“The government, like any defendant, is permitted
to offer evidence to demonstrate the inadequacy of the [P]etitioner’s evidence on a requisite
element of the [P]etitioner’s case-in-chief.”); Pafford, 451 F.3d at 1358-59 (“[T]he presence of
multiple potential causative agents makes it difficult to attribute ‘but for’ causation to the
vaccination. . . . [T]he Special Master properly introduced the presence of the other unrelated
contemporaneous events as just as likely to have been the triggering event as the vaccinations.”).

B. Factual Issues

A petitioner must prove, by a preponderance of the evidence, the factual circumstances
surrounding her claim. § 13(a)(1)(A). To resolve factual issues, the special master must weigh
the evidence presented, which may include contemporaneous medical records and testimony.
See Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a
special master must decide what weight to give evidence including oral testimony and
contemporaneous medical records). Contemporaneous medical records, “in general, warrant
consideration as trustworthy evidence.” Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d
1525, 1528 (Fed. Cir. 1993). But see Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378,
1382 (Fed. Cir. 2021) (rejecting the presumption that “medical records are accurate and complete
as to all the patient’s physical conditions”); Shapiro v. Sec’y of Health & Hum. Servs., 101 Fed.
Cl. 532, 538 (2011) (“[T]he absence of a reference to a condition or circumstance is much less
significant than a reference which negates the existence of the condition or circumstance.”
(quoting Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam,
968 F.2d 1226 (Fed. Cir. 1992))), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d
mem., 503 F. App’x 952 (Fed. Cir. 2013).

There are situations in which compelling testimony may be more persuasive than written
records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec’y of
Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“[L]ike any norm based upon common
sense and experience, this rule should not be treated as an absolute and must yield where the
factual predicates for its application are weak or lacking.”); Lowrie v. Sec’y of Health & Hum.
Servs., No. 03-1585V, 2005 WL 6117475, at *19 (Fed. Cl. Spec. Mstr. Dec. 12, 2005)
(“[W]ritten records which are, themselves, inconsistent, should be accorded less deference than
those which are internally consistent.” (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a
determination regarding a witness’s credibility is needed when determining the weight that such
testimony should be afforded. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379
(Fed. Cir. 2009); Bradley, 991 F.2d at 1575.

Despite the weight afforded to medical records, special masters are not rigidly bound by
those records in determining onset of a petitioner’s symptoms. Valenzuela v. Sec’y of Health &
Hum. Servs., No. 90-1002V, 1991 WL 182241, at *3 (Fed. Cl. Spec. Mstr. Aug. 30, 1991); see
also Eng v. Sec’y of Health & Hum. Servs., No. 90-1754V, 1994 WL 67704, at *3 (Fed. Cl.
Spec. Mstr. Feb. 18, 1994) (noting Section 13(b)(2) “must be construed so as to give effect also

25
to § 13(b)(1) which directs the special master or court to consider the medical records (reports,
diagnosis, conclusions, medical judgment, test reports, etc.), but does not require the special
master or court to be bound by them”).

C. Causation

To receive compensation through the Program, Petitioner must prove either (1) that she
suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a
vaccine that she received, or (2) that she suffered an injury that was actually caused by a
vaccination. See §§ 11(c)(1), 13(a)(1)(A); Capizzano, 440 F.3d at 1319-20. Petitioner must
show that the vaccine was “not only a but-for cause of the injury but also a substantial factor in
bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface, 165 F.3d at 1352-53).

Because Petitioner does not allege she suffered a Table Injury, she must prove a vaccine
she received caused her injury. To do so, Petitioner must establish, by preponderant evidence:
“(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence
of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing
of a proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278.

The causation theory must relate to the injury alleged. Petitioner must provide a sound
and reliable medical or scientific explanation that pertains specifically to this case, although the
explanation need only be “legally probable, not medically or scientifically certain.” Knudsen v.
Sec’y of Health & Hum. Servs., 35 F.3d. 543, 548-49 (Fed. Cir. 1994). Petitioner cannot
establish entitlement to compensation based solely on his assertions; rather, a vaccine claim must
be supported either by medical records or by the opinion of a medical doctor. § 13(a)(1). In
determining whether a petitioner is entitled to compensation, the special master shall consider all
material in the record, including “any . . . conclusion, [or] medical judgment . . . which is
contained in the record regarding . . . causation.” § 13(b)(1)(A). The undersigned must weigh
the submitted evidence and the testimony of the parties’ proffered experts and rule in Petitioner’s
favor when the evidence weighs in his favor. See Moberly, 592 F.3d at 1325-26 (“Finders of
fact are entitled—indeed, expected—to make determinations as to the reliability of the evidence
presented to them and, if appropriate, as to the credibility of the persons presenting that
evidence.”); Althen, 418 F.3d at 1280 (noting that “close calls” are resolved in Petitioner’s
favor).

Testimony that merely expresses the possibility—not the probability—is insufficient, by
itself, to substantiate a claim that such an injury occurred. See Waterman v. Sec’y of Health &
Hum. Servs., 123 Fed. Cl. 564, 573-74 (2015) (denying Petitioner’s motion for review and
noting that a possible causal link was not sufficient to meet the preponderance standard). The
Federal Circuit has made clear that the mere possibility of a link between a vaccination and a
petitioner’s injury is not sufficient to satisfy the preponderance standard. Moberly, 592 F.3d at
1322 (emphasizing that “proof of a ‘plausible’ or ‘possible’ causal link between the vaccine and
the injury” does not equate to proof of causation by a preponderance of the evidence); Boatmon
v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359-60 (Fed. Cir. 2019). While certainty is
by no means required, a possible mechanism does not rise to the level of preponderance.
Moberly, 592 F.3d at 1322; see also de Bazan, 539 F.3d at 1351.

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V. CAUSATION ANALYSIS

A. Althen Prong One

Under Althen prong one, Petitioner must set forth a medical theory explaining how the
received vaccine could have caused the sustained injury. Andreu, 569 F.3d at 1375; Pafford, 451
F.3d at 1355-56. Petitioner’s theory of causation need not be medically or scientifically certain,
but it must be informed by a “sound and reliable” medical or scientific explanation. Boatmon,
941 F.3d at 1359; see also Knudsen, 35 F.3d at 548; Veryzer v. Sec’y of Health & Hum. Servs.,
98 Fed. Cl. 214, 223 (2011) (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”). If
Petitioner relies upon a medical opinion to support her theory, the basis for the opinion and the
reliability of that basis must be considered in the determination of how much weight to afford the
offered opinion. See Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed.
Cir. 2010) (“The special master’s decision often times is based on the credibility of the experts
and the relative persuasiveness of their competing theories.”); Perreira v. Sec’y of Health &
Hum. Servs., 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (stating that an “expert opinion is no better
than the soundness of the reasons supporting it” (citing Fehrs v. United States, 620 F.2d 255, 265
(Ct. Cl. 1980))).

The experts do not dispute the theory of molecular mimicry generally, or that it is sound
and reliable. Both experts provided literature explaining the theory of molecular mimicry. See,
e.g., Pet. Ex. 18 at 8; Pet. Ex. 21 at 4; Resp. Ex. A-5 at 6 fig.4; Resp. Ex. A-10. However, they
dispute whether the flu vaccine specifically can cause TM via molecular mimicry.

Assuming that Petitioner has proven a sound and reliable causal mechanism under Althen
prong one, the undersigned finds Petitioner did not provide preponderant evidence of a logical
sequence of cause and effect or a proximate temporal relationship between the flu vaccination
and Petitioner’s TM. Due to the facts and circumstances of this case, specifically the fact that
Petitioner developed symptoms of TM one day after receipt of a flu vaccine, the undersigned’s
determination as to causation turns on an analysis of Althen prongs two and three, and thus, the
undersigned focuses on Althen prongs two and three. See Vaughan ex rel. A.H. v. Sec’y of
Health & Hum. Servs., 107 Fed. Cl. 212, 221-22 (2012) (finding the special master’s failure to
rule on Althen prong one not fatal to his decision because Althen prong two was fatal to
Petitioner’s case); Hibbard v. Sec’y of Health & Hum. Servs., 698 F.3d 1355, 1364 (Fed. Cir.
2012) (“discern[ing] no error in the manner in which the special master chose to address the
Althen [prongs]” when he focused on Althen prong two after “assuming the medical viability of
[the] theory of causation”).

While the undersigned is not making a finding as to whether Petitioner has provided
preponderant evidence of Althen prong one, the undersigned notes that a one-day onset is not
compatible with the theory of molecular mimicry. See, e.g., Forrest v. Sec’y of Health & Hum.
Servs., No. 14-1046V, 2019 WL 925495, at *6, *8 (Fed. Cl. Spec. Mstr. Jan. 28, 2019) (finding
“a preponderance of the evidence shows that molecular mimicry is not likely to happen within 36
hours, even for a recall response”); Martinez v. Sec’y of Health & Human Servs., No. 16-736V,

27
2022 WL 4884923, at *27 (Fed. Cl. Spec. Mstr. Sept. 9, 2022) (finding “a relative short onset” of
one day “not medically acceptable” because “TM is reasonable understood to be mediated by an
autoimmune reaction involving antibodies or other immune cells associated with the adaptive[] []
immune response in reaction to antigenic exposure” (emphasis omitted)).

B. Althen Prong Two

Under Althen prong two, Petitioner must prove by a preponderance of the evidence that
there is a “logical sequence of cause and effect showing that the vaccination was the reason for
the injury.” Capizzano, 440 F.3d at 1324 (quoting Althen, 418 F.3d at 1278). “Petitioner must
show that the vaccine was the ‘but for’ cause of the harm . . . or in other words, that the vaccine
was the ‘reason for the injury.’” Pafford, 451 F.3d at 1356 (internal citations omitted).

In evaluating whether this prong is satisfied, the opinions and views of the vaccinee’s
treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d
at 1326 (“[M]edical records and medical opinion testimony are favored in vaccine cases, as
treating physicians are likely to be in the best position to determine whether a ‘logical sequence
of cause and effect show[s] that the vaccination was the reason for the injury.’” (quoting Althen,
418 F.3d at 1280)). Medical records are generally viewed as trustworthy evidence, since they are
created contemporaneously with the treatment of the vaccinee. Cucuras, 993 F.2d at 1528.
Petitioner need not make a specific type of evidentiary showing, i.e., “epidemiologic studies,
rechallenge, the presence of pathological markers or genetic predisposition, or general
acceptance in the scientific or medical communities to establish a logical sequence of cause and
effect.” Capizzano, 440 F.3d at 1325. Instead, Petitioner may satisfy her burden by presenting
circumstantial evidence and reliable medical opinions. Id. at 1325-26.

The undersigned finds there is not preponderant evidence in the record to support a
logical sequence of cause-and-effect showing the September 19, 2019 flu vaccine to be the cause
of Petitioner’s TM. See Althen, 418 F.3d at 1278.

First, the records show a clinical course that is not consistent with the mechanism
presented due to Petitioner’s onset of one day. Petitioner received a Tdap vaccine on September
19, 2019. She reported to multiple treating providers that she developed neurological symptoms
one day later on September 20, 2019. See, e.g., Pet. Ex. 3 at 108 (presenting to Dr. Kasza at the
Oakwood ED and stating “that the morning following . . . the vaccination, she woke with
paresthesia in her [fourth] and [fifth] upper extremity digits bilaterally as well as paresthesia in
her bilateral feet”); Pet. Ex. 8 at 18 (reporting to Dr. Gilcher that her symptoms “began the day
following the flu shot”); Pet. Ex. 10 at 1 (reporting to Dr. Delly that on “Sept[ember] 19[] she
went to go see her doctor and got the flu shot” and “[t]he next day, she started to get tingling in
her fingers and toes”); Pet. Ex. 4 at 39, 41 (returning to Oakwood ED and complaining of
“‘nerve pain’ [in] [bilateral] hands and feet since receiving the flu shot on [September 19,
2019]”); Pet. Ex. 4 at 60 (reporting to Dr. Zazaian that she developed “a pins and needles
sensation in her fourth and fifth digits of bilateral hands along with her toes” on September 20,
2019); Pet. Ex. 4 at 69 (maintaining “her symptoms first developed on [September 20, 2019]”
during a consultation with Dr. Kodrik). The undersigned finds an onset of one day inconsistent

28
with the theory of molecular mimicry for the reasons described in the Althen prong three
analysis.

Second, although Petitioner’s treating physicians documented an association, the
undersigned does not find the notes to be persuasive evidence of causation.

On October 23, 2019, Dr. Junn found the MRI “[f]indings nonspecific[,] however
suspect[ed] to be demyelinating in nature or inflammatory in nature considering presentation of
symptoms following flu vaccine[,] however clinical correlation is recommended.” Pet. Ex. 4 at
103. In this statement, although he notes a temporal association, Dr. Junn does not provide the
reasons that he suspects the flu vaccine as a cause.

The other provider who documented an association was Dr. Kodrik. Dr. Kodrik noted
Petitioner’s cervical spine MRI was consistent with “[TM] from recent flu[] vaccination.” Pet.
Ex. 4 at 104. However, Dr. Kodrik does not explain her statement that attributes causation to the
flu vaccine.

On December 19, 2019, Dr. Kodrik wrote a letter stating “[Petitioner] is under my
neurologic care and is unable to receive the [flu] vaccination as she has a history of [TM]
associated with the [flu] vaccination.” Pet. Ex. 5 at 20. And in another letter, dated September
23, 2021, Dr. Kodrik’s office wrote “[Petitioner] received the flu vaccine back in 2019 and she
had a reaction in which caused the [TM]. [Petitioner] should be exempt from receiving the
Covid [v]accine as this reaction does not occur again.” Pet. Ex. 11 at 54. Again, in these letters,
Dr. Kodrik offers no explanation for the basis of her opinions. Further, she does not explain how
an immune response to the flu vaccine could result in symptoms of TM in the time frame of one
day.

Generally, treating physician statements are typically “favored” as treating physicians
“are likely to be in the best position to determine whether a ‘logical sequence of cause and effect
show[s] that the vaccination was the reason for the injury.’” Capizzano, 440 F.3d at 1326
(quoting Althen, 418 F.3d at 1280). However, no treating physician’s views bind the special
master, per se; rather, their views are carefully considered and evaluated. § 13(b)(1); Snyder, 88
Fed. Cl. at 746 n.67. “As with expert testimony offered to establish a theory of causation, the
opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their
suppositions or bases.” Welch v. Sec’y of Health & Hum. Servs., No. 18-494V, 2019 WL
3494360, at *8 (Fed. Cl. Spec. Mstr. July 2, 2019).

The balance of these statements appear to be based on the proximity and temporal
association between vaccination and TM. A “treating physician’s recognition of a temporal
relationship does not advance the analysis of causation.” Isaac v. Sec’y of Health & Hum.
Servs., No. 08-601V, 2012 WL 3609993, at *26 (Fed. Cl. Spec. Mstr. July 30, 2012), aff’d, 108
Fed. Cl. 743 (2013), aff’d, 540 Fed. App’x 999 (Fed. Cir. 2013). And a temporal relationship
between a vaccine and an injury, standing alone, does not constitute preponderant evidence of
vaccine causation. See, e.g., Veryzer v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 344, 356
(2011) (explaining that “a temporal relationship alone will not demonstrate the requisite causal

29
link and that [P]etitioner must posit a medical theory causally connecting the vaccine and
injury”), aff’d, 475 Fed. App’x 765 (Fed. Cir. 2012).

Lastly, although it appears the parties agree there was no identifiable alternative cause,
this fact alone does not reach the level of preponderance Petitioner must meet in order to satisfy
the second Althen prong. de Bazan, 539 F.3d at 1351-52.

Accordingly, the undersigned finds that Petitioner has not satisfied her burden under
Althen prong two.

C. Althen Prong Three

Althen prong three requires Petitioner to establish a “proximate temporal relationship”
between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been
defined as a “medically acceptable temporal relationship.” Id. The Petitioner must offer
“preponderant proof that the onset of symptoms occurred within a time frame for which, given
the medical understanding of the disorder’s etiology, it is medically acceptable to infer
causation-in-fact.” de Bazan, 539 F.3d at 1352. The explanation for what is a medically
acceptable time frame must also be consistent with the theory of how the relevant vaccine can
cause the injury alleged (under Althen Prong One). Id.; Koehn v. Sec’y of Health & Hum.
Servs., 773 F.3d 1239, 1243 (Fed. Cir. 2014); Shapiro, 101 Fed. Cl. at 542; see Pafford, 451 F.3d
at 1358.

Petitioner received her flu vaccination on September 19, 2019. The parties and experts
generally agree that Petitioner’s onset of neurological symptoms began one day later, on
September 20, 2019. Although Dr. Simpson questions the accuracy of Petitioner’s recall of the
onset of her neurological symptoms, Petitioner’s medical records consistently place Petitioner’s
onset the day after her flu vaccination, even if the specific calendar date is not mentioned in
some records. Petitioner’s declaration maintains her symptoms began on September 20, 2019,
the day after vaccination. Petitioner also noted her job as a nurse and how she “[u]tiliz[ed] [her]
own medical training” to ensure she was providing accurate information to providers. Pet. Ex.
35 at ¶ 9. For these reasons, the undersigned finds onset to be on September 20, 2019, one day
after vaccination.

In Dr. Simpson’s first expert report, he opines that a one-day onset is medically
acceptable. In his second expert report, he opines that Petitioner “likely [had] a recall response”
given her previous flu vaccinations. Pet. Ex. 28 at 4. However, Dr. Simpson did not explain
“recall response” or how it could account for an onset of one day.

30
Both experts cited similar literature describing the latency period 46 between antigen
exposure and peak adaptive immune response. This literature explains that with subsequent
exposures—i.e., multiple flu vaccinations—the latency period is shorter, with a lag phase 47 of
one to three days followed by a logarithmic phase 48 of three to five days, resulting in a latency
period ranging from four to eight days.

There are several problems with Petitioner’s position as to prong three. First, in order to
conclude that there was a shortened latency period due to the recall response, foundational
evidence is needed to establish that Petitioner received prior flu vaccinations that contained the
same antigens as those she received in her 2019 flu vaccination. Although the records show that
she received prior flu vaccinations, there is no evidence to show what strains of the flu were in
each vaccine she received, or what antigens were in any of the prior vaccinations or the 2019
vaccination. Thus, there is no evidence that Petitioner had repeated exposures to the same
antigens that were in the 2019 vaccination that she received.

Second, a latency period “is characterized by a lag phase, logarithmic phase, and plateau
phase.” Pet. Ex. 25 at 87. Petitioner failed to explain how this would allow for an onset of one
day. Dr. Simpson only stated that the 2012 IOM report “states that the lag phase in a memory
response can begin at [one] day.” Pet. Ex. 28 at 4. However, Dr. Simpson did not consider both
the lag phase and the logarithmic phase together. And he did not explain how a shortened lag
phase, reflecting activation of B and T cells upon an encounter for the antigen for which they
were specific, would translate to the initial manifestation of symptoms Petitioner experienced on
September 20, 2019. In other words , Dr. Simpson failed to account for all of the phases of the
latency period, that period between vaccination and manifestation of symptoms, or explain how
they could occur in one day.

46
A latent period is “a seemingly inactive period, such as that between exposure to an infection
and manifestation of symptoms (incubation p[eriod]) or between the presentation of a stimulus
and the response (latency []).” Latent Period, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=97284 (last visited Mar. 1, 2024).
Latency refers to “the time between the instant of stimulation and the beginning of a response.”
Latency, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/
dorland/definition?id=27698 (last visited Mar. 1, 2024). The IOM explained “the latency
between the first (primary) exposure and development of the primary response is characterized
by a lag phase, logarithmic phase, and plateau phase.” Pet. Ex. 25 at 87. “[T]he latency between
subsequent exposure to the antigen and development of the immune response will usually be
shorter. The lag phase is generally [one] to [three] days; the logarithmic phase of the secondary
antibody response occurs over the next [three] to [five] days.” Id.
47
A lag phase is characterized by “activation of B and T cells upon encounter with the antigen
for which they are specific, and this triggers the cells’ differentiation into effector and memory
cells.” Pet. Ex. 25 at 87.
48
“For B cells, the logarithmic phase is characterized by an increase in serum antibody levels
that classically is logarithmic.” Pet. Ex. 25 at 87.

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Additionally, Petitioner’s one-day onset of symptoms is not consistent with the case
reports cited by Dr. Simpson. In Agmon-Levin et al., the two patients who developed TM post-
flu vaccination had onset periods of seven and nine days. Fenichel mentioned two patients who
developed TM seven and 29 days following flu vaccination. Read et al. discussed a case of TM
three weeks following a tetanus toxoid booster vaccination. Akkad et al. reported a patient who
developed TM four days after receipt of a flu vaccine. And Korn-Lubetzki et al. reported a
patient who developed symptoms consistent with TM one month after flu vaccination. None of
the literature provided by Petitioner supports a one-day onset of TM.

Dr. Simpson attempts to rely on GBS data to support his opinion that a one-day onset is
medically acceptable. He cited to Schonberger et al., who found approximately 11 cases of GBS
occurred between day zero (date of vaccination) and day one. However, Schonberger et al. did
not explain or discuss these cases and thus, there are foundational concerns about whether the
data is reliable or applicable in the context of TM, which affects the spinal cord and is a different
illness than GBS, which is a peripheral nervous system demyelinating illness.

Further, when Safranek et al. reassessed the findings in Schonberger et al., they noted
four cases of GBS that occurred between day one and day seven after vaccination, and did not
examine the cases in two-day intervals like Schonberger et al. Nor did they provide data on the
specific onsets for those four cases. Thus, the undersigned does not find this data persuasive as
she is unable to analyze or confirm the data presented.

Dr. Simpson also cited Park et al., a study from Korea that found more than half of their
48 cases developed symptoms of GBS within two days of flu vaccination. However, the authors
included cases of “possible” GBS and they acknowledged they could not exclude a possible
infection as a cause in some cases. Thus, it is impossible to determine whether their cases with
an onset within two days had “possible” GBS or an infection. Additionally, the cases in Park et
al. likely received a different flu vaccine since all of the cases occurred in Korea.

Moreover, the onset period for GBS following flu vaccination as set forth in the Vaccine
Injury Table is three to 42 days. 42 C.F.R. § 100.3(a)(XIV)(D). Thus, even if the undersigned
used GBS data for this TM case, the timing would be inconsistent.

Lastly, the undersigned notes decisions from other special masters where petitions
alleging vaccine-induced TM in the Program have been dismissed for similar onset found too
close in time to vaccination to be medically reasonable. See, e.g., Palattao v. Sec’y of Health &
Hum. Servs., No. 13-591V, 2019 WL 989380, *35 (Fed. Cl. Spec. Mstr. Feb. 4, 2019) (citing
dismissals of cases with 24-hour onset for vaccine-related TM and finding a 30- to 36-hour onset
to not be medically acceptable); Forrest, 2019 WL 925495, at *6, *8 (finding “a preponderance
of the evidence shows that molecular mimicry is not likely to happen within 36 hours, even for a
recall response”); Mosley v. Sec’y of Health & Human Servs., No. 08-724V, 2015 WL 2354316,
at *19 (Fed. Cl. Spec. Mstr. Apr. 27, 2015) (denying compensation where “onset of TM one day
after tetanus vaccination [was] too soon to support vaccine causation”); Jagoe v. Sec’y of Health
& Human Servs., No. 08-678V, 2012 WL 13036265, at *28 (Fed. Cl. Spec. Mstr. Aug. 3, 2012)
(finding a 24-hour onset not medically appropriate for a vaccine-induced TM injury); Crosby v.

32
Sec’y of Health & Human Servs., No. 08-799V, 2012 WL 13036266, at *38-39 (Fed. Cl. Spec.
Mstr. June 20, 2012) (same).

While the above cases are not binding here, the undersigned agrees with the reasoning of
other special masters as it relates to onset and Althen prong three. See Boatmon, 941 F.3d at
1358; Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998), aff’d, 191 F.3d
1344 (Fed. Cir. 1999).

In Forrest, Petitioner’s expert proposed that the flu vaccine can cause TM via molecular
mimicry. 2019 WL 925495, at *3. To explain the 36-hour onset, Petitioner’s expert proposed
the Forrest Petitioner had a recall response due to previous flu vaccinations. Id. at *4. The
special master found that “[e]ven if molecular mimicry could be accepted to explain how the flu
vaccine can cause [TM] abstractly, . . . a preponderance of the evidence shows that molecular
mimicry is not likely to happen within 36 hours, even for a recall response.” Id. at *6. The
special master similarly discussed the IOM report that referenced the immune response latency
period to include a lag phase and logarithmic phase. Id. Petitioner’s expert in Forrest, like Dr.
Simpson, “cited the IOM for the basis that the lag phase generally can be as short as one day,”
but failed to persuasively address the logarithmic phase and the timing and presentation of
symptoms associated with the logarithmic phase. 49 Id.

Petitioner attempts to cite to “a number of additional [P]rogram cases in which
Petitioners have been awarded entitlement to damages with an onset of initial symptoms between
one and four days.” Pet. Reply at 9-10. However, these cases either do not relate to TM or do
not rely on molecular mimicry, and they are therefore not relevant to the facts and circumstances
here.

In summary, the undersigned finds by preponderant evidence that the onset of
Petitioner’s TM was September 20, 2019, one day after her flu vaccination. Further, there is a
lack of preponderant evidence to show that an onset of one day is appropriate given the proposed
mechanism of molecular mimicry.

Therefore, the undersigned finds the temporal association is not appropriate given the
mechanism of injury. Petitioner has failed to satisfy the third Althen prong.

VI. CONCLUSION

The undersigned extends her sympathy to Petitioner for all that she has suffered due to
her TM. The undersigned’s Decision, however, cannot be decided based upon sympathy, but
rather on the evidence and law.

49
Forrest also provides a more thorough explanation of the latency period of the immune
response and the lag and logarithmic phases. See Forrest, 2019 WL 925495, at *6-7. In the
present case, these concepts were not discussed.

33
For the reasons discussed above, the undersigned finds that Petitioner has failed to
establish by preponderant evidence that the flu vaccination she received caused her to develop
TM. Therefore, Petitioner is not entitled to compensation and the petition must be dismissed.

In the absence of a timely filed motion for review pursuant to Vaccine Rule 23, the Clerk
of Court SHALL ENTER JUDGMENT in accordance with this Decision.

IT IS SO ORDERED.

s/Nora Beth Dorsey
Nora Beth Dorsey
Special Master

34

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10735628. Public record. Not legal advice.