# Pahos v. Secretary of Health and Human Services

> United States Court of Federal Claims · March 11, 2026

URL: https://www.frixlaw.com/law-library/cases/11275249

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** March 11, 2026
- **Precedential status:** Unpublished
- **Opinion:** Opinion
- **Judges:** Thomas L. Gowen
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

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## How later opinions describe it (automated extraction)

- explaining that a special master must decide what weight to give evidence including oral testimony and contemporaneous medical records

## Opinion text

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: February 9, 2026

* * * * * * * * * * * * *
GINGER PAHOS, *
*
Petitioner, * No.17-1455V
*
v. * Special Master Gowen
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * *
David J. Carney, Green & Schafle LL, Philadelphia, PA, for petitioner.
Debra A. Filteau Begley, U.S. Department of Justice, Washington, D.C., for respondent.

DECISION DISMISSING PETITION1

On October 5, 2017, Ginger Pahos (“petitioner”) filed her claim in the National Vaccine
Injury Compensation Program2, alleging that the influenza (“flu”) vaccine she received on
October 8, 2014, caused her to suffer from neuromyelitis optica (“NMO”). Petition (ECF No. 1).
After a review of the medical records, medical experts’ opinions, medical literature, and an
entitlement hearing, I find that petitioner has failed to demonstrate by a preponderant of evidence
that she is entitled to compensation, and her petition must be dismissed.

I. Procedural History

Petitioner filed her claim on October 5, 2017, alleging that the flu vaccination she
received on October 8, 2014, caused her to suffer neuromyelitis optica. Petition. Petitioner also
1
Pursuant to the E-Government Act of 2002, see 44 U.S.C. § 3501 note (2012), because this decision contains a
reasoned explanation for the action in this case, I am required to post it on the website of the United States Court of
Federal Claims. The court’s website is at http://www.uscfc.uscourts.gov/aggregator/sources/7. This means the
decision will be available to anyone with access to the Internet. Before the decision is posted on the court’s
website, each party has 14 days to file a motion requesting redaction “of any information furnished by that party:
(1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that
includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of
privacy.” Vaccine Rule 18(b). “An objecting party must provide the court with a proposed redacted version of the
decision.” Id. If neither party files a motion for redaction within 14 days, the decision will be posted on the
court’s website without any changes. Id.
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 (2012)
(hereinafter “Vaccine Act” or “the Act”). Hereinafter, individual section references will be to 42 U.S.C. § 300aa of
the Act.
filed medical records to accompany her claim. See Petitioner’s Exhibits (“Pet’r. Exs.”) 1-10.
(ECF No. 5).

On September 12, 2018, respondent filed the Rule 4(c) report recommending against
compensation. Respondent Report (“Resp’t. Rept.”) (ECF No. 20). Petitioner filed an expert
report from Justin Willer, M.D.3 on February 19, 2019. Pet’r. Ex. 12 (ECF No. 24). Respondent
filed a responsive expert report from Dr. Subramniam Sriram4 on June 3, 2019. Resp’t Ex. A
(ECF No. 28).

The undersigned held a Rule 5 status conference on August 7, 2019, in which I ordered
petitioner to file a supplemental expert report and gave respondent the option to engage in
litigative risk settlement negotiations or file an additional expert report. Rule 5 Order (ECF No.
29).

Petitioner filed another report from Dr. Justin Willer and respondent filed supplemental
expert reports from Dr. Thomas Forsthuber5 and Dr. Sriram. See Pet’r Ex. 21; Resp’t Exs. C, E.
After which, petitioner filed an expert report from Dr. Lawrence Steinman.6 Pet’r Ex. 33 (ECF

3
Dr. Justin Willer is a board-certified neurologist. Pet’r. Ex. 47 (ECF No. 75). He received his medical degree
from The Chicago Medical School in 1987 is board certified to practice medicine in New York, New Jersey, and
Florida. Id. at 3. After medical school, Dr. Willer was a resident in neurology at Mount Sinai Hospital Medical
Center in New York and did fellowships at the University of Miami International Center for Epilepsy and SUNY
Health Science Center in at Brooklyn in EMG/Neuromuscular Diseases. Id. at 3. He is board certified in psychiatry
and neurology with an added qualification for Clinical Neurophysiology. Id. at 2. Dr. Willer has been an Assistant
Professor of Clinical Neurology at State University of New York, HSC at Brooklyn and a neuromuscular consultant
at the STAR Clinic at State University of New York, HSC at Brooklyn. Id. Dr. Willer has co-authored numerous
articles regarding neurological conditions. Id. at 3-4. Dr. Willer maintains a private neurology practice in New
York City. Tr. 80. He has testified as an expert in the Vaccine Program prior to this case. Id. The undersigned
admitted Dr. Willer as an expert in neurology. Tr. 81.
4
Dr. Subramaniam Sriram is board-certified neurologist. Resp’t. Ex. J. He received his medical degree from the
University of Madras in Madras, India and became a medical intern and resident at Wayne State University in
Detroit, Michigan. Id. at 1. He is board certified in internal medicine and psychiatry and neurology. Id. Dr. Sriram
is licensed to practice medicine in California, Vermont, and Tennessee. Id. At the time of the hearing, Dr. Sriram
was a Professor of Experimental Neurology at Vanderbilt University Medical Center in Nashville, Tennessee. Id. at
2. Prior to his position at Vanderbilt University, Dr. Sriram was a professor at the University of Vermont in
Neurology and Cell Biology. Id. at 1. Dr. Sriram has co-authored numerous articles regarding different
neurological conditions, including demyelinating conditions. Id. at 9-21. Dr. Sriram was admitted as an expert in
neurology and neuroimmunology. Tr. 222.
5
At the time of the hearing, Dr. Thomas Forsthuber was a professor of immunology at the University of Texas at
San Antonio in Texas and he is an Endowed Chair in Biotechnology at USTA. Resp’t. Ex. I (ECF No. 65); Tr. 287.
Dr. Forsthuber received his medical degree from the University of Tubingen in Germany. Id. at 1. He passed
various United States Licensing examinations, including in basic medical sciences, clinical sciences, and he received
his Ohio medical license. Id. From 1991-1998, Dr. Forsthuber was a resident in pathology at the University
Hospitals in Cleveland, OH. Id. In 2005, Dr. Forsthuber became a Professor of Immunology at the University of
Texas at San Antonio, in San Antonio, TX. Id. at 3. Dr. Forsthuber has authored numerous articles on immunology.
Id. at 23-31. Dr. Forsthuber was admitted as expert in the field of immunology. Tr. 291.
6
Dr. Lawrence Steinman is a board-certified neurologist and is the Incumbent of GA Zimmerman Chair as
Professor of Neurological Sciences, Neurology, and Pediatrics at Stanford University. Pet’r. Ex. 49. Dr. Steinman
received his medical degree from Harvard University and was a resident at Stanford University Hospital. Id. at 1.

2
No. 43). The undersigned held another status conference in this matter and directed petitioner to
transmit a demand to respondent. Scheduling Order (ECF No. 48). After unsuccessful
settlement negotiations, both parties filed additional expert reports. See Pet’r Exs. 36; Resp’t
Exs. F, G.

An entitlement hearing was held November 16, 2022, where Dr. Justin Willer and Dr.
Lawrence Steinman testified on behalf of petitioner and Dr. Thomas Forsthuber and Dr.
Subramaniam Sriram testified on behalf of respondent. After the entitlement hearing, the parties
filed post-hearing briefs. See Pet’r Post-Hearing Brief (“Pet’r Br.”) (ECF No. 87); Resp’t Post-
Hearing Brief (“Resp’t Br.”) (ECF No. 90).

This matter is now ripe for adjudication.

II. Summary of Facts

a. Medical Records

1. Prior to Vaccination Medical Record Summary

Prior to receiving the flu vaccine at issue, petitioner, a fifty year old nurse, went to her
primary care physician on September 17, 2014 for treatment for a swollen right ear. Pet’r Ex. 5
at 18. Petitioner reported having a swollen right ear with erythema that started three days prior.
Id. Additionally, petitioner had an elevated temperature and a tender lymph node. Id. Petitioner
was diagnosed with cellulitis of the right ear and given a prescription for an antibiotic,
Cephalexin. Id.

Petitioner was also seeking treatment at the Physicians Neck and Back Center for lower
back pain. See generally Pet’r. Ex. 4. On July 31, 2014, a record titled, “Initial Exam: Lumbar
Report,” stated that petitioner’s primary concern was “low back pain,” and that she has
experienced lower back pain for 15 years. Pet’r. Ex. 4 at 1. Petitioner’s gait was recorded as
normal and her lower extremity motor exam strength was normal. Id. at 3. It was recommended
that petitioner engage in a short, active rehabilitation program to restore her to “optimal
functioning.” Id. at 4.

On August 21, 2014, petitioner had a re-evaluation appointment after 7 sessions and it
was noted that her pain in her back had improved, but that she could still benefit from additional
sessions. Id. at 9.

The Physicians Neck and Back Center also includes treatment flow summary, which has
handwritten notes for each session. Given the volume of sessions petitioner attended prior to
vaccination, the most relevant ones are summarized. On September 15, 2014, petitioner reported

He has held teaching positions at Stanford University Department of Neurology and Pediatrics since 1980. Id. Dr.
Steinman is board certified in psychiatry and neurology and was elected to the National Academy of Sciences in
2015. Id. at 2. Dr. Steinman has authored or co-authored numerous articles on neurology and immunology. Id. at
5-50. He has served on different advisory commissions and committees, including the Advisory Committee on
Pertussis Immunization, Institute of Medicine. Id. at 4. Dr. Steinman was admitted as an expert in neurology and
immunology. Tr. 143.

3
pain in her lower back from moving bricks and landscaping. Pet’r Ex. 4 at 31. The next
notation, on September 18, 2014, states that “pt feeling worn down from cellulitis, is taking
antibiotics, [lower-back] is feeling good.” Id. at 32.

2. Vaccination and Post-Vaccination Medical Record Summary

On October 8, 2014, petitioner received her flu vaccine at the flu vaccine clinic at
Children’s Hospital in Minneapolis/St. Paul. Pet’r. Ex. 3 at 1. On October 9, 2014, the day after
petitioner received the vaccine, she reported sleeping in different positions and that her neck pain
was greater than her back pain. Id. at 32. On October 13, 2014, petitioner reported that her
lower back pain was improving but her neck pain and stiffness continued. Id. at 33

Ten days later, petitioner went to the emergency department of the Maple Grove Hospital
on October 18, 2014 for “worsening pain in [the] neck.” Pet’r. Ex. 7 at 3. Petitioner explained
that approximately one month prior she developed right-sided facial swelling and cellulitis, but
the antibiotic prescription helped her condition. Id. However, “over the same timeframe”
petitioner developed neck discomfort, which was slightly to the left and some intermittent
radiating pain up the back of her head. Id. Petitioner was evaluated by Dr. Roline, who opined
that the cause of petitioner’s neck pain was a muscle spasm and not likely associated with an
infection. Id. at 5. Petitioner was given a prescription of Percocet and Robaxin. Id.

Petitioner had a follow-up appointment with her primary care physician for her cellulitis
on October 20, 2014. Pet’r. Ex. 5 at 15. Petitioner reported that her cellulitis had improved, but
she was now experiencing left-sided neck pain. Id. Petitioner reported that the Robaxin
improved her symptoms, but the Percocet made her nauseous. Id. At this appointment,
petitioner endorsed “brief left-hand tingling,” but her neck pain was constant with intermittent
stabbing with different positions. Id. The physical examination showed “no evidence of right
auricular cellulitis,” but petitioner had “decreased range of motion due to pain with lateral
flexion and rotation,” along with “significant paraspinal muscle and upper trapezius tenderness.”
Id. Petitioner had no weakness during her examination. Id. Nurse Rydlund diagnosed petitioner
with neck muscle spasm, gave her a prescription for Prednisone, and ordered an X-ray. Id. at 16.

Two days later, on October 22, 2014, petitioner returned to her PCP for “ongoing neck
pain.” Pet’r. Ex. 5 at 12. Petitioner reported that the prednisone initially relieved her symptoms,
but then her neck pain became acute at night, making it difficult to sleep. Id. Petitioner stated
that she took the prednisone again in the morning, which relieved the pain, but the Vicodin and
Robaxin did not help at all. Id. Petitioner endorsed tingling in her upper arm and shoulder,
which was radiating down her left arm. Id. Nurse Rydlund also wrote, “What has changed and
is more worrisome is that she has also noticed she is unable to lift [her] left shoulder/arm >90
degrees. She has significant weakness. If she tries really hard, she can actually lift it, but with
much effort and her arm shakes. She does not actually have shoulder pain.” Id. Petitioner was
given an order for a cervical spine MRI and diagnosed with both neck pain and left arm
weakness. Id. at 13. Nurse Rydlund included a clinical note which extended petitioner’s
prednisone taper, and wrote, “Differential diagnosis includes shoulder pathology such as frozen
shoulder or rotator cuff injury. Her exam seems to indicate this could be muscular in nature,

4
however, she did not have any injury and I find it odd that it seemed to occur in conjunction with
the neck pain.” Id.

The next day, October 23, 2014, petitioner presented to orthopedist, Dr. Patrick Kraft, for
a left shoulder evaluation. Pet’r. Ex. 8 at 8. Petitioner explained that her left shoulder pain and
weakness began two weeks ago, and also reported that she had cellulitis, which was treated with
antibiotics. Id. Petitioner stated that she had increasing pain along the left side of her neck and
was given Prednisone, but has developed significant pain and weakness. Id. Petitioner also
reported associated tingling. She could not lift her arm actively and when lifted passively, she
cannot bring it down. Id. The physical examination revealed “some discomfort in the cervical
spine, particularly with motion [to the right],” and her shoulder exam showed, “marked weakness
with abduction, active range of motion and external rotation.” Id. at 9. She had a positive horn
blowers sign7 and “struggled to get her arm to the level of the belt line.” Id. Dr. Kraft assessed
petitioner with a “shoulder injury” and “left shoulder rotator cuff dysfunction and weakness,”
and ordered an MRI of her left shoulder. Id. at 9-10.

The same day, on October 23, 2014, petitioner left shoulder MRI showed minimal
supraspinatus tendinopathy without evidence of a rotator cuff tear and minimal
acromioclavicular and glenohumeral degenerative changes. Pet’r. Ex. 8 at 20. Petitioner had a
follow-up appointment on October 24, 2014 at Twin City Orthopedics, where she was seen by
PA David Winecoff. Id. at 11. PA Wincoff noted that petitioner still has pain and weakness in
her left shoulder, and she was having difficult raising her arm past 40 degrees of forward flexion
and abduction secondary to weakness. Id. Petitioner was given a prescription of Gabapentin and
Hydrocodone-Acetaminophen until she could be seen by Dr. Kraft the following week for an
EMG/NCS. Id. at 12.

On Friday, October 24, 2014, petitioner went to the emergency department of Maple
Grove Hospital for neck and shoulder pain. Pet’r. Ex. 7 at 26. Petitioner reported that she began
having pain “since last Tuesday after receiving the influenza vaccine” and that she was unable to
lift her arm voluntarily. Id. Petitioner was seen by Dr. David Brooks at 1:40 AM on October 25,
2014, where she related her left shoulder pain and issues to the flu shot. Id. at 27. Dr. Brooks
noted that petitioner presented him with “a paper that explains this is what she thinks her
diagnosis is.” Id. at 28. Petitioner reported that the only time her symptoms improved was when
she was on Prednisone at a higher dosage. Id. Dr. Brooks gave her an IV of
methylprednisolone and Robaxin and gave her a prescription of oral steroids to take at a higher
dosage for five days. Id. Petitioner was discharged with a diagnosis of neck and shoulder pain.
Id.

Two days later, on Sunday, October 26, 2014, petitioner returned to the emergency
department of Maple Grove Hospital with shoulder pain. Pet’r. Ex. 7 at 48. The emergency
department’s nurse’s note states that petitioner’s “right arm is worsening. Has constant bilateral
elbow, back and scapula pain, not relieved by any medications above.” Id. Additionally, the
nurse’s note stated that petitioner was feeling constipated despite taking Miralax twice a day. Id.

7
A hornblower’s sign is positive in a shoulder exam when a patient cannot externally rotate their arm while it is
elevated 90 degrees in the scapular plane. It is a test for a tear or fatty degeneration in the teres minor and
infraspinatus muscles in the shoulder.

5
The “History of Present Illness” taken by emergency room’s physician, Dr. Christopher Borger
on October 26,, stated:

[Petitioner] is a 50-year-old female with a history of hypothyroidism who presents for
evaluation of left shoulder pain. The onset was 16 days ago. The quality is described as
onset of pain two days after flu vaccine placed unusually high in the left shoulder….She
has been on escalating doses of steroids, Robaxin, Ibuprofen, Vicodin, Percocet, and
Neurontin. The pain continues to worsen….She did research on her own and brings a
2010 paper published in Vaccine (journal) by S. Atanasoff that describes a syndrome of
pain following accidental vaccine injection into the joint space that she feels perfectly
describes what she is facing. She also had some weakness with abduction of the shoulder
bilaterally and some tingling in her ulnar nerve area.

Id. During the physical examination, also by Dr. Borger, petitioner demonstrated slight
weakness with abduction of her left shoulder, normal symmetric grip strength and flexion of the
biceps. Id. at 50. Petitioner’s gait was normal, and she was able to get on her tip-toes and
dorsiflex with the “great toes.” Id. Dr. Borger assessed petitioner with “left shoulder pain after
vaccination, possible due to inflammatory response to accidental joint injection,” and agreed to
admit her for observation and an orthopedic consultation. Id. at 51.

After admission, petitioner was seen by Dr. Rodney McFadden, who wrote that
petitioner’s left arm pain and weakness began two days after the flu vaccine. Pet’r. Ex. 7 at 54.
The HPI also explained that petitioner could not actively abduct her left arm past 45-degrees and
that she had developed paresthesias in her fingertips and thumbs of her left arm. Id. Dr.
McFadden noted that petitioner also was experiencing paresthesias in her right hand as well and
some weakness of the right arm that started the night before. Id. Dr. McFadden performed a
physical examination and found that petitioner’s left arm demonstrated decreased range of active
motion and decreased strength. Id. at 58. Petitioner’s reflexes in her upper extremities were 0 to
1+ symmetrically and bilaterally. Id. Dr. McFadden assessed petitioner with “acute left arm
pain with weakness and mild anesthesia in fingertips with acute right arm paresthesias and
weakness,” and noted the etiology was unclear. Id. Dr. McFadden stated that the cause of
petitioner’s left arm issue could be related to a possible SIRVA injury, or a possible neurologic
syndrome related to the flu vaccine such as Guillain-Barre. Id. at 60. He requested a neurology
consult and an EMG. Id. Dr. McFadden also discontinued petitioner’s prednisone taper and
instead prescribed the use of an intravenous steroid, dexamethasone. Id.

The following day, October 27, 2014, petitioner explained that she was experiencing
“numbness shooting in her arms,” and some numbness in her abdomen. Pet’r Ex. 7 at 63. Dr.
Knot Khandurao recorded that petitioner described an “area of altered sensation around the belly
above the umbilicus.” Id. Petitioner demonstrated left arm weakness and limited mobility, and
had parathesias in both hands. Id. at 64. Dr. Khandurao opined if petitioner had polyneuritis and
wrote, “It could be related to the vaccine or it may not be related to it…I agree with [having] and
EMG. Neurology consult requested….And MRI cervical spine if not already done.” Id. at 65.

Petitioner had a neurology consult by Dr. Irfan Altafullah on October 27, who took
petitioner’s History of Present Illness, which is recited below:

6
50-year-old nurse who received a flu shot in her left arm about 18-days ago. A few days
later, she developed pain around the left shoulder. The pain also seemed to involve the
left trapezius and paracervical region. Gradually, the pain involved the left upper arm o
the level of the elbow, but she did not have classic radicular type symptoms. The pain
was bad enough that she came to the ED a couple of times. She was treated with various
analgesics. She had an MRI of the cervical spine on 10/22 that was reported to show
some low grade disc bulges and DJD at C4-7. She also had a shoulder MRI that showed
mild supraspinatus tendinopathy.

About five days ago, (10/22) she began noticing weakness of the left upper extremity
which progressed over the next couple of days. She has noticed some paresthesia in the
left hand, and since last night, also some in the right hand. She has also noticed a band of
paresthesia around her trunk.

Pet’r Ex. 7 at 72. Petitioner had decreased strength in the left upper extremity, with a 2/5 in the
supraspinatus and deltoid area and 3/5 in the biceps and supinator. Id. at 73. She had decreased
sensation in her left upper extremity and diminished deep tendon reflexes in both arms. Id. Dr.
Altafullah wrote that petitioner’s “history and examination are most consistent with brachial
plexitis or Parsonage Turner Syndrome,” and that “Parsonage-Turner syndrome has been well
described as a consequence of vaccination and is presumably an immune mediated response.”
Id. at 74. He recommended discontinuing the Decadron and begin a prednisone taper and start
physical therapy. Id.

The following day, October 28, 2014, petitioner reported having a lot of pain in her left
arm and her weakness had not improved. Pet’r. Ex. 7 at 80. Dr. Khot wrote that petitioner had
“a band of altered sensation in the abdomen above the umbilicus,” along with her left arm
weakness and bilateral parathesias in her hands. Id. at 81. Orthopedist, Dr. Brian O’Neill, saw
petitioner on October 27, 2014, who found petitioner’s upper extremity strength “intact distally”
and “good supraspinatus testing bilaterally.” Id. at 86. He wrote that a shoulder injection would
not be helpful to petitioner because she had no pain with range of motion and indicated that
petitioner’s problem appeared to be more neurologic in nature than orthopedic. Id.

Petitioner was discharged on October 29, 2014 with a discharge diagnosis of
“polyneuritis-etiology unclear,” and “brachial plexitis.” Pet’r, Ex. 7 at 87. The discharge
summary also indicated that petitioner had “new onset left arm pain and weakness associated
with bilateral paresthesias in hands and fingers, now has a band of altered sensation in the
abdomen above the umbilicus. Symptoms started after influenza vaccine.” Id. at 89.
Additionally, the note explains that petitioner’s “periumbilical band like symptoms won’t be
explained” by “idiopathic brachial plexitis,” as suggested by the neurology consult. Id.
However, she was still discharged with instructions to follow-up with physical therapy and
neurology. Id.

The following day, October 30, 2014, petitioner returned to the Maple Grove Hospital
Emergency room, this time with leg weakness, along with the continued weakness in her left arm
and occasional weakness in her right arm. Pet’r, Ex. 7 at 239. Petitioner called Dr. Altafullah

7
and was told to return to the emergency department due to her progressing weakness. Id. The
neurological examination showed “weak biceps and triceps in the left arm and full range of
motion and strength in the right arm,” and she had retained deep tendon reflexes as the knees,
however, petitioner endorsed bilateral paresthesias. Id. at 240. Dr. Altafullah ordered an MRI of
petitioner’s thoracic and lumbar spine to “look for any evidence of transverse myelitis.” Id. at
241. The MRI of petitioner’s lumbar spine showed degenerative disc changes at L4-5 and L5-S1
and asymmetric narrowing of the superior aspect of the lateral recess L5-S1 nerves, and the
impression was “no evidence of transverse myelitis.” Id. at 245. Petitioner’s thoracic spinal
MRI was normal. Id. at 246. A lumbar puncture demonstrated 104 white blood cells and an
elevated protein of 149. Id. Given the elevated protein in petitioner’s CSF, she was transferred
to North Memorial Hospital, with orders to get an MRI of her cervical spine. Id. at 241. The
differential discharge diagnoses included “possible transverse myelitis or unusual presentation of
Guillain-Barre.” Id.

The HPI of petitioner at North Memorial explained that the neurology department at
Maple Grove believed that petitioner had “brachial plexitis-immune mediated response to
vaccination,” and stated, “of note had been treated for a cellulitis of the face prior to the flu shot
and onset of neuro symptoms.” Pet’r. Ex. 9 at 5. Petitioner’s neurological exam upon admission
at North Memorial was positive for weakness in her left upper extremity. Id. at 8. Petitioner’s
differential diagnoses included “transverse myelitis vs. meningitis vs. Lyme related neuritis.” Id.
at 9.

Petitioner was evaluated by neurologist, Dr. Jason Cornelius, and he suspected petitioner
had “post-vaccination autoimmune/inflammatory polyradiculoneuropathy similar to GBS
spectrum disorder,” after petitioner’s physical examination showed absent reflexes in the upper
extremities and knees, and petitioner had weakness in her left upper extremity. Pet’r. Ex. 9 at
20-22. Dr. Cornelius ordered a three-day course of IVIG. Id. at 22. Additionally, petitioner was
started on an intravenous course of antibiotics after her Lyme tests came back positive.

After one-day of IVIG, petitioner reported that her pain level had reduced, but her
bilateral upper extremity weakness remained. Pet’r. Ex. 9 at 24. Additionally, she reported
having spasms/paresthesias in a band around her abdomen. Id. Petitioner still had absent
reflexes in her bilateral upper extremities and knees bilaterally. Id. at 24. Neurology Physician
Assistant Teague wrote, “It seems likely now that her symptoms are related to Lyme infection,
but there remains a possibility that the recent influenza immunization could have played a role.”
Id. at 25. Dr. Ivan Brodsky agreed with PA-C Teague’s note and wrote, “Symptoms probably
related to Lyme’s disease but many confusing co-morbidities.” Id. at 25-26.

While petitioner was hospitalized at North Memorial Hospital Dr. Cornelius ordered an
NMO-Aquaporin-4 antibody test, which was returned the following day that showed petitioner
had a “positive” NMO/AQP4 antibody that was “high.” Pet’r. Ex. 9 at 99. However, during the
hearing, petitioner testified that none of her treating physicians at the time actually told her or
apparently acted on this finding. See Tr. 48.

Infectious disease doctor, Dr. Sarah Peglow, saw petitioner on November 1, 2014 and
assessed petitioner with “polyradiculoneuropathy with sensory and motor component with

8
positive Lyme serology and lymphocytic pleocytosis of CSF concerning for Neuroborreliosis.
Alternatively, she also fits multiple different spectrums of disorders, including post-vaccine
autoimmune process similar to GBS and/or inflammatory brachial plexitis. Given the degree of
her symptoms and complex nature, would favor treatment for possible neuroborreliosis.” Pet’r.
Ex. 9 at 26. Dr. Peglow agreed with continuing treatments for possible GBS spectrum
syndrome, and also suggested “treatment for neuroborreliosis based on [petitioner’s] clinical
picture and her serology positivity. Although these can be falsely elevated in the setting of other
autoimmune syndromes going on, it is also plausible that these symptoms are related borrelia
infection.” Id. at 26. Dr. Peglow also noted that “[t]he myriad of symptoms are also fitting with
her recent influenza immunization resulting in possible autoimmune reaction however, her EMG
is not fitting at this time per neurology….but possible underlying autoimmune disease which
can lead to falsely positive Lyme serologies.” Id. at 27. Petitioner was started on intravenous
Ceftriaxone (antibiotics). Id. at 26.

By November 2, 2014, petitioner reported that her weakness and numbness has stayed the
same if not getting worse, despite getting a second dose of IVIG. Pet’r. Ex. 9 at 39. Petitioner
stated that she was experiencing neck and back pain, similar to the pain around her abdomen. Id.
The neurological exam was positive for decreased grip strength bilaterally, decreased
coordination, and decreased sensation diffusely. Id. Petitioner was seen again by infectious
disease physician, Dr. Peglow on November 2, 2014, and she assessed petitioner with,
“Polycariculoneuropathy with sensory and motor components with positive Lyme serology and
lymphocytic pleocytosis of CSF concerning for NEUROBORELLIOSIS. Alternatively, she also
fits multiple different spectrums of disorders, including post-vaccine autoimmune process similar
to GBS and/or inflammatory brachial plexitis. Given the degree of her symptoms and complex
nature, would favor treatment for possible neuroborreliosis.” Id. at 42. Treatment of intravenous
antibiotics was added to petitioner’s treatment plan.

That same day petitioner had a consult with neurologist, Dr. Xiaoming Dong and she
demonstrated absent reflexes in her upper extremities and knees, with trace ankle reflexes. Pet’r.
Ex. 9 at 44. Dr. Dong explained:

This is a very interesting case. A 50-year-old woman who received influenza vaccination
at left shoulder area on 10/8. Shen then developed severe pain at injection site. About
two weeks later, she developed left [upper extremity] weakness. Her symptoms had
continued to progress with more left upper extremity and mild right upper extremity
weakness. She also developed sensory level and lost [deep tendon reflexes] on follow-up
exam. MRI of cord showed no evidence of transverse myelitis or nerve root
inflammation. CSF is very abnormal with elevated cell count and protein. A post-
vaccination autoimmune/inflammatory polyradiculoneuropathy was suspected. She has
been started with Prednisone and IVIG. Current Prednisone 20 mg [as needed]. She
seemed responding to treatment well. Will finish IVIG for 5 days. Her case is
complicated with positive Lyme western blot. Lyme disease can also cause
polyradiculopathy. [Infectious Disease] plan to start 28 day course of IV antibiotics.

Id. at 43-44.

9
The following day, November 3, 2014, petitioner was on her third day of IVIG. Pet’r. Ex
9 at 48. Neurologist, Dr. Cornelius, consulted with petitioner and noted that petitioner was
experiencing “ongoing abdominal paresthesias, left upper extremity weakness greater than
right,” and she had altered sensation in her left upper extremity, greater than right, and absent
reflexes. Id. Dr. Cornelius’s assessment was “suspected peripheral nervous system
manifestation of neuroborreliosis with possible contribution of post-vaccination
autoimmune/inflammatory response to this polyradiculoneuropathy presentation.” Id. at 48.
Petitioner was to complete the five-day course of IVIG and the prednisone taper. Id.

Petitioner had a post-hospitalization appointment with neurologist Dr. Altafullah on
November 10, 2014. Pet’r. Ex. 6 at 11. In the “History of Present Illness” Dr. Altafullah wrote
that petitioner responded immediately to the five-day course of IVIG and that she was being
treated with intravenous antibiotics for positive Lyme IgG and IgM. Id. Petitioner reported still
having numbness and tingling in all of her fingers of her left hand and weakness in her left arm.
Id. Additionally, petitioner reported that the band of tightness remained around her abdomen and
she was having numbness in her pelvic area and belly. Id. Dr. Altafullah wrote, “This is a really
puzzling case. It is possible that she does have neurological manifestations of Lyme disease and
the vaccine was just a red herring. Alternatively, it is possible that the vaccination process
somehow activated her Lyme disease. In any event, she does not seem to have had classical
Guillain-Barre syndrome because of the very high [white] cell count in the CSF…I have asked
her to return for follow-up in one month and will get an EMG and nerve conduction study at that
time as well.” Id. at 12. The diagnoses were, “Inflammatory neuropathy” and “lyme disease.”
Id.

Petitioner returned to Dr. Altafullah on December 10, 2014, reporting feeling better and
her left-hand symptoms had improved. Pet’r. Ex. 6 at 19. Petitioner had finished her course of
intravenous Rocephin for Lyme disease. Id. Petitioner still demonstrated weakness in the left
deltoid and triceps, along with difficulty lifting her arm above her head, but the numbness in her
rib cage had decreased. Id. Dr. Altafullah wrote that petitioner’s left arm had much improved
since when he had first seen her and that petitioner’s deep tendon reflexes had returned. Id. at
20. He wrote, “[Petitioner] continues to improve. I am optimistic that she will be close to her
baseline after she is done with the exercise program at Physicians Neck and Back Clinic. She
might have poor endurance for awhile longer.” Id. at 20.

On December 19, 2014, petitioner went to the Physicians Neck and Back Clinic for
treatment. Pet’r. Ex. 4 at 39. The physical therapist wrote, “Symptoms: upper back pain,
interscap pain, R upper arm pain,” and that the “onset/incident: 9/28/2014-after flu shot, then
lyme/GB.” Id.

Petitioner had another follow-up appointment with Dr. Altafullah on January 13, 2015.
Pet’r. Ex. 6 at 22. Petitioner reported difficulty lifting her left arm beyond shoulder height and
her weakness in her left leg. Id. She also endorsed a burning sensation in the middle of her back
and chest. Id. Petitioner stated that she was attending physical therapy sessions at Physicians
Neck and Back Clinic and trying to go to the gym on her own. Id. The physical exam showed
normal strength in her right upper limb and lower limbs, but her left upper limb still exhibited
slight weakness in the deltoid and triceps areas. Id. at 23. She also had weakness in her left leg.

10
Id. Dr. Altafullah noted that petitioner was making “slow progress” and that her predominant
deficit was endurance and “fatigue dependent left sided weakness.” Id. at 24. Dr. Altafullah
filled out petitioner’s long-term disability forms as well.

The next month, on February 25, 2015, petitioner returned to Dr. Altafullah stating that
she is in more pain than in January and her arms and legs hurt. Pet’r Ex. 6 at 27. Petitioner
reported a burning pain in her lower neck and upper back that radiates down to her mid-to-low
back. Id. She also still had difficulty lifting her arms above her shoulder, especially with the left
arm, and she still had poor endurance. Id. Dr. Altafullah wrote that he was “somewhat
disappointed at her lack of progress and continuing symptoms,” and recommended that petitioner
have a check-in with an infectious disease physician and have an MRI of her thoracic spine
because of her “persistent midback paresthesia.” Id. at 28.

Petitioner’s thoracic spine MRI done on March 5, 2015 showed “interval development of
central intramedullary T2 prolongation of the distal spinal cord from mid-T12 to lower L1
compatible with transverse myelitis or other inflammatory myelitis. No associated enhancement
to suggest active inflammation.” Pet’r. Ex. 6 at 31. On March 30, 2015, petitioner had another
appointment with Dr. Altafullah, who acknowledged the MRI finding of a central, intra-
medullary region of prolonged T2 signal from mid-T12 to lower L1, and wrote, “I am somewhat
surprised to see the MRI abnormality in the lower thoracic spine.” Id. at 33. He recommended
she get a cervical spine MRI and he increased her gabapentin. Id. Petitioner’s cervical MRI did
not demonstrate any changes from October 2014. Id. at 39.

Petitioner returned to Dr. Altafullah on April 29, 2015, still experiencing pain between
her shoulder blades that radiates “to 2 points just underneath the clavicle in front, especially with
deep breathing” and “tingling in her left triceps and rarely in her right.” Pet’r. Ex. 6 at 40.
Petitioner reported seeing a physical therapist twice a week and exercising vigorously. Id. Dr.
Altafullah wrote, “[Petitioner] is holding her own and I am pleased that her symptoms are
slightly better. As she is already having some excessive daytime sleepiness, I don’t think we can
go further up on the gabapentin. I encouraged her to increase her level of physical activity and
strengthening. She does not appear ready to return to work just yet.” Id. at 41.

On June 8, 2015, petitioner had another Lyme West Blot IgG and IgM test, which was
positive for Lyme IgM. Pet’r. Ex. 6 at 43. The next day, June 9, 2015, petitioner had an
appointment with Dr. Altafullah, when she reported waking up with a swollen lymph node in the
left submandibular region and numbness of the left side of her face, which was ongoing. Id. at
46. Petitioner also had numbness over the crown of her head, occasionally crossing to the right
side of her face. Id. Petitioner acknowledged the elevated levels of IgM Lyme antibody and
took a double Medrol dosepak, which initially helped, but not after the first day. Id. Petitioner’s
pinprick perception was normal over her face, arms, and legs, and her fine finger movements
were normal. Id. Dr. Altafullah opined that he was “not sure what to make of her recent
symptoms” and that he did not have a good neurological explanation. Id. He wrote, “I am still
wondering whether the symptoms could be a manifestation of underlying Lyme disease and
wonder consider doing another spinal fluid examination. However, first I would like to get a
second infectious disease opinion.” Id. at 46.

11
Petitioner had a follow-up MRI of her thoracic spine on July 8, 2015, which showed no
new thoracic spinal cord lesion, abnormal cord enhancement, or cord caliber alteration. Pet’r Ex.
6 at 48. The lesion that was demonstrated on the previous MRI from her T12 to lower L1 was
stable. Id.

On August 11, 2015, petitioner had a second opinion at the Mayo Clinic with neurologist,
Dr. Sean Pittock. Pet’r. Ex. 10 at 1. In the History of Present Illness, petitioner reported onset of
pain in her left shoulder and neck two days after her October 8, 2014 flu vaccination, which
developed into left arm weakness from October 10 to 22. Id. She described hand and thumb
weakness and some sensory symptoms affecting both of her upper extremities, and a band-like
sensation in her abdomen. Id. Without specifically identifying the date the MRI of her thoracic
spine showing a longitudinally extensive area of signal abnormality, she indicated she was
admitted to the hospital. Id. Petitioner endorsed improvement after her hospitalization with
treatment of IVIG, methylprednisolone, and Ceftriaxone for Lyme. Id. She explained that in
June 2015 she developed painful lymph node swelling and some numbness affecting her left face
and then extending to her whole body and oral prednisone gave her some improvement. Id. Dr.
Pittock performed a physical examination and found petitioner to have “an essentially normal
neurological examination,” but slight reduction in reflexes throughout and her plantar responses
were equivocal. Id. at 2. Dr. Pittock also noted that petitioner was positive for aquaporin-4
antibodies, which raised the “possibility of neuromyelitis optica spectrum disorder.” Id. He
wrote:

…should the final diagnosis be neuromyelitis optica spectrum disorder, given the fact
that she has had one attack in October 2014, and another attack in February 2015, and a
third attack in June 2015, she would be a candidate for the Eculizumab study.

Id. Dr. Pittock wanted the Mayo Clinic neuroradiologists to interpret petitioner’s MRIs and
comment on the evolution of abnormalities. Id. Petitioner’s diagnoses were, “Longitudinally
extensive transverse myelitis; Aquaporin-4 antibody positivity; History of Lyme Disease.” Id. at
3.

Petitioner also saw infectious disease physician on August 14, 2015, Dr. Varatharaj
Palraj, at the Mayo Clinic. Pet’r Ex. 10 at 7. After reviewing her history, noting that petitioner
was positive for Lyme IgG and IgM in October and was treated with intravenous ceftriaxone for
four weeks, he stated, “She probably had Lyme disease in October 2014 based on serological
workup, but she has had appropriate treatment with four weeks of intravenous ceftriaxone. I
would not recommend any further testing or treatment regarding that.” Id. at 9.

On August 13, 2015, neuroradiologist at the Mayo Clinic, Dr. C.H. Rydberg, reviewed
petitioner’s previous MRIs from October 30, 2014 and compared them to the MRIs from March
5, 2015, April 1, 2015 and July 8, 2015 and wrote:

Impression: Longitudinal area of increased T2 signal in the distal thoracic cord and conus
consistent with the clinical diagnosis of NMO. Findings: Abnormally increased T2
signal centrally within the cord at the T12-L1 levels does not change appreciably over the
series or examinations.

12
Pet’r. Ex. 10 at 112.

Petitioner had a follow-up appointment with Dr. Pittock on August 27, 2015. Pet’r. Ex.
10 at 30. Dr. Pittock noted that petitioner complained of new onset eye pain the previous week
and neuro-ophthalmology found “no abnormality and did not feel there was any evidence of
optic neuritis.” Id. He also wrote that petitioner’s neurological examination by Dr. Alfugham
was “unchanged” despite petitioner complaining of some tingling in her upper extremities. Id.
Dr. Pittock wrote, “Furthermore, looking back over her prior history and the lack of any signal
abnormality in the upper cervical cord or in the brainstem, raises concern regarding whether or
not there were definitive brainstem or cervical cord attacks that might explain her symptoms in
the past, but certainly no doubt on her neuroimaging of the thoracic cord that she has had a
longitudinally extensive lesions and in the setting of NMO, I do think that the likely diagnosis is
that of an NMO spectrum disorder.” Id. (emphasis added). He recommended a Prednisone taper,
along with CellCept. Id. Dr. Pittock’s diagnosis remained neuromyelitis optica. Id. at 31.

On February 16, 2016, petitioner had a follow-up appointment with Dr. Pittock, where
she reported no new neurological symptoms and “no symptoms suggestive of an attack.” Pet’r.
Ex. 30 at 35. Petitioner reported occasional pins and needles in her upper extremities and some
“burning affect in her neck,” but no numbness or weakness in her lower extremities. Id. Dr.
Pittock recommended a repeat MRI of her cervical spine and repeat of the Aquaporin-4 antibody
test. The following day, after petitioner’s MRI, she met with Dr. Pittock again who explained
that her MRI does not show any evidence of demyelination. Id. at 36. He also recommended
petitioner begin to take prednisone every other day, and explained that there is “an increased risk
of neuromyelitis optica spectrum disorder attack in the setting of stopping steroid, but steroid
side effects over the long-term may cause significant problems.” Id. at 36. He opined that
petitioner may be having a “mild attack,” and that “the neuroimaging abnormalities have not yet
developed.” Id.

Petitioner messaged Dr. Pittock on February 24, 2016, stating that “the burning in my
mid-thoracic spine to base of my skull persists,” and she was experiencing tingling on the left
side of her fact, along with some pain and tingling in her biceps and triceps intermittently. Pet’r.
Ex. 10 at 40. A message was sent back to petitioner indicating that sensory symptoms typically
wax and wane. Id. Petitioner messaged the Neurology Clinic again on March 3, 2016, stating
that she had gone to a NMO Conference in Los Angelos, CA, and was using some OxyCodone
to manage ongoing neuropathy in her arms and legs and along the trigeminal nerve. Id. at 41. It
was recommended that petitioner come back for an evaluation and MRI of her spinal cord, along
with scheduling an appointment at the Pain Clinic. Id. at 42.

Petitioner had the follow-up appointment on March 10, 2016 with Dr. Pittock. Pet’r. Ex.
10 at 44. Dr. Pittock noted that petitioner’s dosage of Cellcept was decreased to the “lower end
of the therapeutic range” after the last appointment and now she was experiencing persistent
burning discomfort between her shoulder blades and back of the neck, along with a burning-
tingling down her arms. Id. Dr. Pittock recommended that petitioner increase her dosage of
Neurontin to 600 mg three times and a day and increase her Cellcept dosage to 1500 mg in the
morning and 1000 mg in the evening. Id. Dr. Pittock characterized the symptoms petitioner was

13
experiencing as “the possibility of an attack” but noted she had no changes in her neurological
examination. Id. Her repeat MRI and lumbar punctures were normal and Dr. Pittock explained
to petitioner, “The most important thing is to make sure that she does not experience an attack
which has been reasonably ruled out by normal MRI and negative CSF for inflammation.” Id. at
50.

Petitioner had an annual neurological evaluation with Dr. Pittock the following year, on
March 21, 2017. Pet’r. Ex. 10 at 75. Petitioner was taking Cellcept daily, but did not experience
any ongoing symptomology. Id. Concerned about ongoing neuromyelitis attacks, Dr. Pittock
ordered a re-check of petitioner’s Aquaporin-4 and MRI of her cervical spine. Id. Petitioner’s
Aquaporin-4 testing was negative. Id. at 76.

On July 31, 2017, petitioner had an appointment with Dr. Fredericks for managing lower
back and right hip pain. Pet’r. Ex. 10 at 99. She reported re-starting physical therapy and that
her back pain was well controlled. Id. Petitioner’s strength in her bilateral upper and lower
extremities were normal. Id. at 102. Dr. Fredericks noted that petitioner was taking a low dose
of hydromorphone for acute flares of her neuromyelitis optica and for neuropathic pain and that
petitioner was seeking another prescription. Id.

On September 24, 2018, petitioner had an appointment with neurologist, Dr. Andrew
Smith, at the Fairview Neurology Clinic in Maple Grove. Pet’r. Ex. 41 at 101. Dr. Smith noted
that petitioner had “first developed symptoms in fall of 2014 after a flu vaccine,” and that she
was initially treated for GBS, but after developing weakness and numbness again, an MRI
revealed a lesion in her thoracic cord. Id. Petitioner was diagnosed with NMO after a positive
antibody finding at the Mayo clinic, but has no new lesions. Id. Petitioner reported “rare
tingling in her hands and feet,” which occur mostly if she works multiple 12-hour shifts in a row.
Id. at 102. After a physical examination and a review of her previous imaging, Dr. Smith
diagnosed petitioner with NMOSD and wrote:

The patient is a 54-year-old woman with a past medical history of NMOSD, who is
presenting today as a new consult. The patient has a history of transverse myelitis with
evidence on MRI…The patient does have one reported positive NMO antibody. Given
how well she has done and the negative testing one could question the diagnosis.
Moreover, her symptoms would not clearly be explained by the lesions in her spine.
With this said, given her CSF, I feel it more probably than not NMOSD.

Id. at 106. Dr. Smith continued petitioner on CellCept. Id.

She continued to see Dr. Smith for management of her NMOSD. The last appointment
relating to her NMOSD in the medical records occurred on February 11, 2021, with Dr. William
Schmalstieg, where she reported no new changes in her vision, strength or sensation suggestive
of relapse. Pet’r Ex. 48 at 66. Dr. Schmalstieg wrote that petitioner’s NMOSD was “stable with
no evidence of active inflammatory or demyelination,” and he recommend that she return in six
months. Id.

14
b. Petitioner’s Testimony

Petitioner testified that prior to receiving the flu vaccine on October 8, 2014, she had
developed cellulitis of her right ear in September 2014. Transcript (“Tr.”) 10. Her right ear was
“swollen, hot, [and] painful,” and she received antibiotics for treatment. Id. She took a 10-day
course of antibiotics. When asked when the swelling of her right ear began, she stated, “mid-
September” and that the cellulitis had resolved when she received the flu shot in October. Id.
She explained that her cellulitis caused some pain on the right side of her face, but once she
began the antibiotics, all of her pain related to the cellulitis went away. Tr. 65.

Petitioner testified that she typically gets the nasal flu vaccine, but in 2014 opted for the
intramuscular flu shot. Tr. 11. The day after she received the flu vaccination, on October 9,
2014, petitioner experienced pain in her shoulder that radiated up from the injection site. Id.
Petitioner stated that these symptoms never went away, they only got worse. Id. at 12. She took
Tylenol and ibuprofen for the pain, but the pain was persistent over the weekend. Id. at 13. She
stated that the pain also restricted her movement of her neck and shoulder. Id. When she got off
her shift on October 17, 2014, she made an appointment for her physician for the following
Monday. Id. However, the pain in her shoulder was so severe that she went to the Maple Grove
emergency department on October 18, 2014. Id.; see also Pet’r Ex. 7 at 3. The pain medication
petitioner was given in the emergency department hadn’t worked and she kept her appointment
with her primary care physician on October 20, 2014. Tr. 17.

When petitioner saw her primary care physician on Monday, October 20, 2014, she was
put on steroids. Tr. 17. She testified that on Wednesday, October 22, 2014, she was unable to
lift her arm above mid-chest level and the pain was “intense.” Id. at 18. At that point, petitioner
was unable to move her left arm herself and she also had numbness and tingling in her fingers of
her left hand. Id. at 19. This was the first day she noticed numbness and weakness in her left
arm. Id. Petitioner testified that PA Rylund suggested that she see an orthopedist, but petitioner
“felt like it more neurologic with the numbness and tingling and the loss of function,” but that it
was going to be easier to get an orthopedic appointment and a neurologic appointment could take
another month to schedule. Id. at 20. Petitioner testified that prior to October 22, 2014, she had
“this constant pain” that was followed by loss of function in her left arm. Tr. 24.

When she went to the orthopedist on October 23, 2014, petitioner stated that Dr. XXX
told her that there was nothing structural in her shoulder causing her left arm weakness, but
recommended an MRI to rule out any possible rotator cuff problems. Tr. 20. By Friday,
October 24, 2014, the pain in her left arm was “intense” and the numbness feeling had increased,
petitioner went to the walk-in orthopedic clinic and reported that her condition “felt much more
neurologic.” Tr. 25. Petitioner testified that the MRI of her shoulder appeared to be normal for
her age and she was prescribed Gabapentin. Tr. 26. While she was waiting for the pharmacy to
fill her prescription, she stated that the “pain was unbearable.” Id. She took the first dose of
Gabapentin and waited, but it provided no relief, so she decided to have a friend drive her to the
emergency room. Id. Petitioner went to the emergency department and was given steroids and
additional pain medication, but would not have been able to have a neurologist consult until
Monday, so she opted to be discharged. Id. at 27.

15
However, by Sunday night, October 26, 2014, her pain remained “unbearable despite all
the medications [she] was taking,” and asked her husband to drive her back to the emergency
room. Tr. 27. Petitioner testified that she had “no relief from the pain, it was constant,” and,
“The numbness, tingling sensation in my left arm was constant,” and her arm weakness had
increased. Tr. 28. During her admission on Sunday evening, October 26, 2014, while admitted,
she noticed paresthesia and numbness, “like a belt around my middle, from just below my breast
to my bellow button.” Id. She saw the neurologist, Dr. Altafullah on Monday, October 27,
2014, and she reported the paresthesia around her middle, but he appeared to be focused on a
possible brachial plexus injury. Id. at 29. Petitioner testified that she had received IV
prednisone and IV pain medication, but that had stopped prior to her being seen by Dr.
Altafullah. Id. She stated that once she was put back on steroids, as well as the stronger pain
medication, she finally got some relief, but even when she was discharged on October 29, 2014,
her pain was “as high as 10,” but would drop to a 4 or 5 with the medication. Id. at 31.

Petitioner testified that after she was discharged, she still had left arm weakness and then
she stumbled down a few steps “feeling like my legs were weak.” Tr. 32. Petitioner called Dr.
Altafullah’s office and left a message, and also called her primary care physician’s office to try
to get an appointment because she was concerned about this new leg weakness. Id. Dr.
Altafullah called petitioner and told her to straight to the emergency room of Maple Grove
Hospital. Tr. 33.

Petitioner went to Maple Grove emergency room and had a lumbar puncture, then
transferred to North Memorial Hospital and admitted to the neurologic ward. Id. Petitioner saw
Dr. Altafullah’s partner, Dr. Cornelius, who diagnosed petitioner with GBS related to the flu shot
and she was treated with IVIG. Id. Petitioner testified that her treating physicians explained the
diagnosis of GBS was “not typical” and how her symptoms were “atypical,” but “that was the
closest thing they could think of, and that was why they decided to try IVIG.” Id. Petitioner
testified that the IVIG did help her left shoulder movement and that by December 2014, her left
shoulder movement was improving, and her pain was decreasing. Tr. 39-41. However, the
paresthesia around her abdomen area was worse. Tr. 36-37.

Petitioner stated that through November and December 2014, she felt that she had been
improving, but in January 2015, she was unable to run or even maintain a reasonable walking
speed on the treadmill. Tr. 42. Petitioner was asked if her leg weakness had resolved, and she
stated that “I still had that [parathesia] belt” and that she would tell Dr. Altafullah. Tr. 42. She
went to see Dr. Altafullah late February 2015, when he ordered an MRI of her thoracic spine.
Tr. 42. She stated that he called her and told her the MRI revealed transverse myelitis and to
come back into the clinic. She testified that “it was literally three or four weeks after I had that
MRI before I was told that the MRI was abnormal.” Tr. 43.

Petitioner testified that she was not hospitalized in 2015, but did see an infectious disease
specialist. Tr. 45. Petitioner stated that the infectious disease physician “did not think that my
symptoms were consistent with long-term post-Lyme syndrome.” Tr. 45. Petitioner testified
that in July 2015, she received a letter from Dr. Pittock from the Mayo Clinic, inviting her to be
in a research study for patients with neuro-inflammatory disease. Id. at 46.

16
Petitioner testified that she learned of her positive aquaporin-4 test in July 2015 and that
Dr. Altafullah went back to review her hospital records from October 2014 which indicated that
there was a test for the NMO antibody, which was positive. Tr. 48; see also Pet’r Ex. 9 at 99
(finding a positive NMO/AQP4 antibody on October 31, 2014). Petitioner testified that after her
evaluations at the Mayo Clinic, she was treated with Cellcept, which she continued to take
through the hearing and afterwards as evidenced in the medical records.

At the hearing, petitioner testified that she has not had many symptoms related to her
NMO and was able to wean off of gabapentin. Tr. 50. She explained she continued to take
Cellcept due to the possible recurrence of NMO. Id. at 51. Petitioner testified that her shoulder
pain ended in January or February 2015, but her neurological symptoms of burning, numbness
and tingling resolved in 2018. Id.

c. Petitioner’s Expert’s Opinions

1. Dr. Justin Willer, Neurologist

Petitioner submitted three expert reports from Dr. Justin Willer, a neurologist, and he
testified at the entitlement hearing. See Pet’r. Exs. 12, 21, & 32. Dr. Willer opined that
petitioner developed neuromyelitis optica spectrum disorder (NMOSD) as a result of receiving
the flu vaccine on October 8, 2014 and that the onset of her NMOSD approximately 2 to 3 days
post-vaccination. Pet’r. Ex. 12 at 10; Tr. 84. He stated that that “the reported onset of NMOSD
following viral infection or vaccination generally ranges from 3 days to months.” Id. During the
hearing, he clarified that his position was that petitioner’s NMOSD could not have started any
later than October 20th or 22nd, but he could not say that her condition “had not started earlier.”
Tr. 128.

Dr. Willer explained that NMOSD is a an “autoimmune disorder of the central nervous
system that classically patients present with recurrent attacks of optic neuritis and transverse
myelitis.” Id. at 87. Dr. Willer described the symptoms associated with NMOSD, which can
include visual loss, or painful eye movement, paraparesis, dysesthesias, numbness, tingling,
burning, potentially bladder and bowel involvement depending on which level is affected. Tr.
88-89. He explained that transverse myelitis will accompany the eye pain. Pet’r. Ex. 12 at 3.
Additionally, aquaporin-4 antibodies are associated with NMOSD, which petitioner was found
positive for on October 31, 2014. Id. at 4. He stated that petitioner’s diagnosis was “pretty
clear” based on her positive aquaporin-4 antibody test and appearance of lesions on the MRI
involving the central area [of her spine]. Tr. 85. He explained that petitioner’s symptoms of
NMOSD could not have started any later than October 22, 2014, when she developed weakness
and a band-like sensation. Id.

Dr. Willer disagreed with Dr. Sriram’s opinion that petitioner’s NMOSD began prior to
vaccination. Pet’r. Ex. 12; Pet’r. Ex. 32 at 2. In his reports, Dr. Willer observed that petitioner’s
medical records include inconsistent dates of onset, but most of the records put onset after
vaccination and the two records from Physicians Neck and Back from December 2014 simply
record the wrong date of vaccination and that petitioner’s treatment records from the same office
do not include any neck or left shoulder treatment prior to the date of vaccination. Pet’r. Ex. 21

17
at 1-2. Addressing respondent’s expert’s opinion that petitioner’s NMOSD began prior to the
vaccination, Dr. Willer observed that the medical records referred to by Dr. Sriram were not
necessarily clear or consistent with petitioner’s medical history. For example, he noted that the
December 19, 2014 record indicates that petitioner’s flu shot was on 9/28/2014, which of course,
is the wrong date. Pet’r. Ex. 4 at 39; see also Pet’r. Ex. 32 at 2. Dr. Willer also argued that the
chiropractor records Dr. Sriram references as evidence that her NMOSD symptoms began either
too close to the vaccination or even prior to the vaccination, only mention treatment to
petitioner’s lower back. The records from July 31, 2014 and August 21, 2014 only reference
petitioner being treated for lower-back pain. See Pet’r. Ex. 4 at 1-10. Similarly, the October 9,
2014 record, which was one day after the vaccination, petitioner’s treatment was focused on her
lumbar spine and she was assessed with “mechanical low back pain.” Pet’r. Ex. 4 at 11.
Further, Dr. Willer argued that Dr. Sriram ignores the history in the medical records which
demonstrate that petitioner reported left shoulder pain post-vaccination. Pet’r. Ex. 21 at 2.

In his three expert reports, Dr. Willer appeared to relate petitioner’s reports of neck pain
and left shoulder pain to the onset of her NMOSD. See Pet’r. Ex. 21 at 3; Pet’r. Ex. 32 at 1-2. In
his third report, he identified multiple records where petitioner reported onset of pain since
receiving the flu vaccine. Pet’r. Ex. 32 at 2. For example, he wrote, “Dr. Rodney McFadden on
October 26, 2014, reported that she had gotten a flu vaccine 18 days earlier and “then
approximately 16 days ago she developed left shoulder pain” which would be an onset of 2 days
after vaccination. Pet’r. Ex. 32 at 1. He also wrote, “On October 25, 2014, [petitioner] made a
report to employee health services that on October 10, 2014 she developed “some left sided neck
and shoulder pain.” This would also indicate a 2-day onset from the time of vaccination to the
development of symptoms.” Id. at 2. Dr. Willer wrote, “As I wrote in my original report, the
earliest onset date from vaccination to onset of symptoms for neuromyelitis is 3 days. Therefore,
even if the true onset were 2 days, this would not be outside the realm of possibility to be
casually related to the vaccination. However, as outlined above, it is my opinion that the actual
time from vaccination to onset was more likely than not about 3 to 4 days rather than 2 days.”
Id.

During the hearing, however, Dr. Willer opined that petitioner’s initial neck and left
shoulder pain could have been caused by an improper injection into petitioner’s shoulder or a
possible brachial neuritis, rather than initial symptoms of NMOSD. Tr. 93. He testified that
petitioner’s description of left shoulder pain was inconsistent with neuropathic pain, which
would be seen with NMOSD and not affected by sleeping or movement. Id. at 97. Instead, Dr.
Willer argued that the onset of petitioner’s NMOSD was not two days post-vaccination, but
instead more likely closer to October 20, 2014, when petitioner began to describe feelings of
tingling. Tr. 110; see also Pet’r. Ex. 5 at 15. He noted that by October 22, 2014, petitioner was
taking prednisone which appeared to reduce her pain, but now petitioner was experiencing left
arm weakness, and her tingling had not yet subsided. Tr. 111; see also Pet’r. Ex. 5 at 12.

However, Dr. Willer was unable to opine to a degree of medical certainty whether
petitioner’s symptoms of neck and left shoulder pain were related to the brachial neuritis
diagnosis or a transient injection-site injury. Tr. 85-86. He testified that the diagnosis of
brachial neuritis could not be verified because petitioner’s two EMGs did not examine any of her
shoulder girdle muscles and her shoulder was not examined for a brachial plexus injury. Tr. 86.

18
He testified that there were “no reports of scapular winging,” and that her teres minor and
supraspinatus and infraspinatus were never examined. Id. Dr. Willer testified that there would
be a “number of explanations” for petitioner experiencing shoulder pain a day after the
vaccination, including initial pain from the injection, but that a one-day onset for brachial
neuritis “is a little quick…although not impossible.” Tr. 114.

In order to form his opinion that petitioner’s symptoms of NMOSD could not have
started after October 20th or October 22nd, Dr. Willer relied upon petitioner’s records from her
primary care physician and the October 27, 2014 neurology consult. Pet’r. Ex. 32 at 2; Tr. 104,
111. Dr. Willer testified that the notation of intermittent tingling in petitioner’s left hand on
October 20th, could have been the beginning of neurological symptoms and potentially
represented the e onset of her neurological condition. Tr. 104. He then testified that the October
22nd appointment, when petitioner returned to PA Rylund with significant left arm weakness was
likely related to the transverse myelitis. Tr. 105. Later, he clarified that the weakness and
paresthesia of petitioner’s left hand was “coming from her spinal cord,” and not the brachial
plexus. Tr. 111. He testified that the earlier note of left-hand paresthesia could have been “very
early onset of [the NMOSD],” but it’s not 100%, but the band-like sensation “pretty much
basically rules out this being anything related to brachial neuritis.” Tr. 111-12. He explained
that even though the medical record from October 22nd with PA Rylund did not mention a band-
like sensation around petitioner’s abdomen, the record from Dr. Altafullah dated October 27,
2014, indicates it had started by then. Tr. 105; see also Pet’r. Ex. 6 at 1. The October 27, 2014
neurology consult with Dr. Altafullah states:

HPI: 50-year-old nurse who received a flu shot in her left arm about 18 days ago. A few
days later, she developed pain around the left shoulder. The pain also seemed to involve
the left trapezius and paracervical level. Gradually, the pain involved in the left upper
arm to the level of the elbow, but she did not have classic radicular type symptoms…

About five days ago, she began noticing weakness of the left upper extremity which
progressed over the next couple of days. She has noticed some paresthesia in the left
hand, and since last night, also some in the right hand. She has also noticed a band of
paresthesia around her trunk.

Pet’r. Ex. 7 at 71-42; see also Pet’r. Ex. 32 at 2. During the hearing, Dr. Willer testified that in
the second paragraph of this “History of Present Illness” provides detail regarding the onset of
symptoms that are associated with NMOSD, such as weakness and paresthesia in her left hand,
along with the band of paresthesia around her trunk suggesting spinal cord involvement, and not
brachial neuritis. Tr. 111. He testified that this notation which describes petitioner’s symptoms
that are related to NMOSD puts onset at no later than October 22, 2014. Tr. 110 (“…it tells us
that it couldn’t have started any later than when she first noticed the band around her trunk.”).

Dr. Willer discussed the Cho et al. article, which was a case report about a patient
developing NMOSD following the flu vaccine. Tr. 121; Pet’r. Ex. 24.8 Cho describes a patient

8
Cho, J. et al., A Case of Neuromyelitis Optica Spectrum Disorder Following Seasonal Influenza Vaccination, 30
Mult. Scel. & Related Disorders, 110-13. [Pet’r Ex. 24].

19
who developed left hand paresthesia three days after receiving the flu vaccine, and then went on
to develop a longitudinal lesion form her cervicomedullary junction to the level of T10. Pet’r.
Ex. 24 at 1. Cho explains that NMOSD is an autoimmune disorder and while the “mechanism of
NMOSD associated with infection has not yet been elucidated,” it has been suggested that
“infectious pathogens may potentially trigger autoimmune reaction of NMOSD, either by
molecular mimicry or by inducing inflammatory molecules through nonspecific inflammatory
stimuli.” Id. at 3. Dr. Willer stated that this case report demonstrates that the onset of NMOSD
can occur three days after administration of the flu shot. Tr. 122. Dr. Willer also referred to the
Menge et al. article which described four cases of neuromyelitis optica following the HPV to
support a temporal association between vaccines and NMOSD. Pet’r. Ex. 12 at 10; Pet’r. Ex.
17.9 The Menge article describes 4 VAERS reports in which neuromyelitis optic was reported
following the administration of the HPV vaccine, although the onset of symptoms was 4-5
months post-vaccination. Pet’r. Ex. 17 at 2. Menge also explains that their VAERS search also
found two cases of NMO after the hepatitis B vaccine and then 1 case each after the influenza
and DPT vaccinations. Id.

While discussing the findings of the Cho case report, Dr. Willer acknowledge that case
reports do not provide definitive proof of causation, but he also stated that epidemiological
studies would also not be able to address the relationships between vaccinations and autoimmune
injuries. Tr. 123.

Dr. Willer opined that the flu vaccine petitioner received on October 8, 2014 was the
cause of her developing NMOSD, and it was unrelated to the later finding of her positive Lyme
serology. Pet’r Ex. 21at 3. He acknowledged that petitioner was treating for cellulitis in
September, but did not believe that cellulitis can cause NMOSD. Tr. 125.

Ultimately, he concluded that petitioner developed NMOSD, which was caused by the flu
vaccine and her symptoms began approximately between 3-4 days post-vaccination and no later
than 12 days.

2. Dr. Lawrence Steinman

Petitioner submitted two expert reports by Dr. Steinman in support of vaccine causation
and he testified at the entitlement hearing. Dr. Steinman agreed that the correct diagnosis of
petitioner was NMOSD, as confirmed by her aquaporin-4 antibodies. Pet’r. Ex. 33 at 8; Tr. 152.

He opined that the flu vaccine petitioner received caused her to develop NMOSD through
the mechanism of molecular mimicry. Pet’r Ex. 33 at 10; Tr. 146-47. Dr. Steinman explained
that molecular mimicry occurs when a virus or bacteria share similar peptides with a host and
then the immune response to the microbes can also result in an autoimmune disease. Pet’r. Ex.
33 at 11. Dr. Steinman stated that the theory of molecular mimicry is well accepted and that the
Fujinami et al. article describes how molecular mimicry can result in autoimmune conditions.

9
Menge, T. et al., Clinical/Scientific Notes: Neuromyelitis Optica Following Human Papillomavirus Vaccination,
79 Neurol. 285-287. [Pet’r. Ex. 17; Resp’t Ex. C, Tab 2].

20
Id. at 11; Pet’r Ex. 35(j).10 Fujinami states that “molecular mimicry represents a shared
immunologic epitope with a microbe and the host….viruses have been shown to have cross-
reactive epitopes with host-self proteins.” Id. at 1-2. Additionally, Fujinami explained that the
hepatitis B virus shared an immunologic epitope with myelin basic protein and when the viral
hepatitis B viral was injected into rabbits, some of the animals developed experimental
autoimmune encephalitis.” Id. at 2. Dr. Steinman also referenced the Gautam et al. article to
show how autoimmune diseases can occur through molecular mimicry even when the shared
peptides is limited. Pet’r. Ex. 33 at 13; Pet’r. Ex. 35(n).11 In his expert report, Dr. Steinman,
stated that Gautam and his colleagues, were able to induce experimental encephalomyelitis in
mice when exposing them to herpesvirus with limited homology of just five amino acids to
myelin basic protein. Pet’r. Ex. 33 at 2.

He stated that NMOSD is known to be triggered by an immune response, an antibody
response and there is also a T-cell response to aquaporin-4. Tr. 155. Dr. Steinman testified that
“we know that petitioner had an immune response to aquaporin-4 and that the onset was
sometime after she received the October 8th flu vaccine.” Id.

Specific to how the flu vaccine could cause NMOSD, Dr. Steinman stated that the 2014-
2015 flu vaccine shares sequence homologies with aquaporin-4. Pet’r Ex. 33 at 16; Tr. 147.
Using a BLAST search, he identified six out of 9 identical amino acids between the aquaporin-4
antigen and the influenza B component of the influenza vaccine. Id. at 19; Tr. 158-59. Dr.
Steinman went beyond the BLAST search, and he refined his opinion by reference to the
Immune Epitope Database (“IEDB”), to identify other references to the peptide that he identified
as occurring in both the flu vaccine petitioner received and aquaporin-4. Pet’r. Ex. 33 at 23; Tr.
171-73. Then through a search of the IEDB, Dr. Steinman found that others had written about
this peptide. Pet’r. Ex. 33 at 24-26. He explained that the sequence he found, which has six out
of 9 identical amino acids, which is “capable of causing clinically relevant neuroinflammation.”
Id. at 24; Tr.

Responding to Dr. Forsthuber’s criticism that his e-value on the BLAST search was too
high, Dr. Steinman testified that the BLAST search was only the starting place for his theory,
and he set the results as low as possible to get a string of consecutive amino acids. Tr. 439-40.
Then after identifying six out of nine amino acids that were similar, he searched the IEDB and
found that the nine amino acid sequence he was searching had four “hits” to influenza B. Pet’r.
Ex. 33 at 25; Tr. 171-73. He found that for the T-cell assay, there was attribution to cytotoxicity
in three out of three human samples. Pet’r. Ex. 33 at 25; Tr. 435. Dr. Steinman explained that
this finding shows that the influenza B peptide drives a cytotoxic T-cell response that can kill the
target virus, but since it also shares sequence homology with aquaporin-4, it may also drive a T-
cell response to the aquaporin-4 water channel, resulting in NMO. Tr. 435-36.

10
Fujinami, R. et al., Molecular Mimicry, Bystander Activation, or Viral Persistence: Infections and Autoimmune
Disease, 19 Clin. Micro. Bio. Revs. 80-96 (2006). [Pet’r Ex. 35(J)].
11
Gautam, A. et al., A Viral Peptide with Limited Homology to a Self Peptide Can Induce Clinical Signs of
Experimental Autoimmune Encephalomyelitis, 161 J. Immunol. 60-64 (2020). [Pet’r Ex. 35(n)].

21
During the hearing, Dr. Steinman testified that the Matsuya article, which respondent’s
expert referred to in his report, demonstrated that three out of 12 people with neuromyelitis
optica respond to the aquaporin-4 antigen that is shared with influenza. Tr. 174. Dr. Steinman,
refuting Dr. Forsthuber’s expert reports, testified that it is “a misclassification to say that no one
responds to that area of mimicry between the influenza B in [petitioner’s] vaccine and the
aquaporin-4,” when 3 out of 12 responded. Tr. 175. He testified that Matsuya identifies “three
humans with NMO” that responded to the influenza B amino acid sequence, and that it was
likely this finding was not “statistically significant” because of the 9 MS patients who did not
have a response the sequence. Tr. 434. Dr. Steinman testified, “I don’t really care about the nine
who didn’t respond…but it is really poignant because three people with NMO did respond.” Tr.
434.

With respect to the onset of petitioner’s NMOSD, Dr. Steinman opined that antibodies to
aquaporin-4 can develop within four days, especially in a person that had previously been
exposed to the same antigen through a recall response. Pet’r. Ex. 33 at 28. He observed that
petitioner had previously been vaccinated with the flu vaccine in 2012 and 2013 and that those
vaccines shared identical or nearly identical influenza B viruses as the one she received in 2014.
Id. While Dr. Steinman opined in his reports that the onset of petitioners NMOSD could occur
between 2- and 4-day post-vaccination, during the hearing he testified that he agreed with Dr.
Willer’s assessment that petitioner was likely experiencing injection site pain two days post-
vaccination and that her neurological symptoms likely started later. Tr. 196-97. Dr. Steinman
testified that onset of 12-20 days would be “the sweet spot for [an immune] response.” Tr. 197.
He referenced the Shoenberger article, which examined cases of Guillain-Barre Syndrome
(“GBS”) after the 1976-77 flu vaccine, to demonstrate that the onset of a neurological disease
can occur between 2- and 42-days post vaccination. Pet’r. Ex. 28.12 Dr. Steinman testified that
an onset of NMOSD symptoms between 3 and 18 days would be an appropriate timeframe for an
immune response to the vaccine to develop and cause damage through the mechanism of
molecular mimicry. Tr. 205.

During the hearing, Dr. Steinman testified that it was his opinion that petitioner did not
have any NMOSD symptoms prior to the October 8, 2014 flu vaccine and that there was nothing
else in the records that could have caused her to develop NMOSD. Tr. 205.

d. Respondent’s Expert Opinions

1. Dr. Subramaniam Sriram

Respondent submitted three expert reports from Dr. Sriram and he also testified at the
entitlement hearing. See Resp’t. Ex. A, E, & F. Dr. Sriram did not dispute the diagnosis of
NMOSD, instead he argued that her condition began prior to the vaccination and that the flu
vaccine was not the cause of petitioner’s condition. Resp’t Ex. A at 5; Tr. 225.

A) Opinion relating to onset of petitioner’s NMOSD

12
Schonberger, L. et al., Guillain-Barre Syndrome Following Vaccination in the National Influenza Immunization
Program, United States 1976-1977, 110 Am. J. of Epidem. (1979). [Pet’r Ex. 28].

22
Dr. Sriram argued that the flu vaccine could not have caused petitioner’s NMOSD, in
part, because her symptoms began prior to the vaccination, and if not prior, immediately
following the vaccination. Resp’t. Ex. A at 3; Resp’t Ex. E at 4; Tr. 226, 247, 269.

Dr. Sriram asserted that petitioner’s initial complaints of neck and left shoulder pain
following the flu vaccine were the first symptoms of her NMOSD and that her medical records
demonstrate that those symptoms began on or around September 28, 2014. Resp’t. Ex. F at 2;
citing Pet’r. Ex. 4 at 14 (referring to petitioner’s chiropractor’s records from December 4, 2014).
Dr. Sriram argued that the two medical records from Physicians Neck & Back Center dated on
December 4, 2014 and on December 19, 2014 demonstrate that petitioner’s neck and shoulder
pain began prior to the vaccination. Resp’t. Ex. E at 2; Tr. 257-59 (testifying that he relied on
the December 4, 2014 record to opine that petitioner’s NMOSD began prior to the vaccination).
However, during the hearing, he conceded that the note from petitioner’s appointment on
October 6, 2014, did not mention neck or shoulder pain. Tr. 262. Dr. Sriram also conceded that
petitioner’s medical treatment records from Physicians Neck & Back Pain do not document any
neck or shoulder pain prior to October 9, 2014. Tr. 259. When he was asked to review the
October 9, 2014 appointment note by the physical therapist, Dr. Sriram acknowledged that the
therapist “related [petitioner’s] neck pain…secondary to sleeping in different positions.” Tr.
259; see also Pet’r. Ex. 4 at 32 (S: c/o neck pain > [lower back pain]; sleeping in different
positions; s/p cellulitis).

Dr. Sriram stated that her initial pain “has all the features of neuropathic pain…The pain
had a stabbing nature, was intermittent in frequency and associated with tingling sensation in the
hand.” Resp’t. Ex. F at 2. Further, he explained that petitioner’s pain was only “modestly
responsive to muscle relaxants and narcotic medication,” and she got relief with steroids, which
is the appropriate treatment for NMOSD. Resp’t. Ex. F at 2-3; Tr. 226-27. In his third report,
Dr. Sriram referred to an article by Zhao et al. , which described the characteristics and
frequency of neuropathic pain in patients with neuromyelitis optica, to support his opinion that
the petitioner’s neck and left arm pain corresponded to her NMOSD diagnosis. Resp’t. Ex. F at
1-2; Resp’t. Ex. F, Tab 1.13 Zhao states that “neuropathic pain is a prevalent symptom in NMO-
related myelitis, with the majority of patients complaining of constant pain.” Resp’t. Ex. F, Tab
1 at 2.

Dr. Sriram was also asked to review the petitioner’s medical record from Dr. Altafullah’s
consultation on October 27, 2014 during the hearing and testified that he “agreed with the
timeline” of petitioner’s clinical symptoms as provided in the “History of Present Illness.” Tr.
267; see also Pet’r. Ex. 6 at 1. He acknowledged that the record stated that petitioner’s left arm
weakness began “about five days ago,” and that weakness is a symptom of a neurological spinal
cord injury, such as NMOSD. Tr. 268. Dr. Sriram testified that he reviewed petitioner’s
neurological medical records, and he testified that he relied on those notes to form his opinion
about the onset of petitioner’s condition, but then stated, “I mean, they didn’t come to the
diagnosis of NMO, and they sort of overlooked the serological test, and it only came into view
six months later on when she developed the lesions in the thoracic spine. Then we put the two
and two together and said, well what she had in October was most likely her first event.” Tr. 266

13
Zhao, S. et al., Neuropathic Pain in Neuromyelitis Optica Affects Activities of Daily Living and Quality of Life,
20(12) Mult. Scel. J. 1658-61 (2014). [Resp’t. Ex. F, Tab 1].

23
(emphasis added). Dr. Sriram also acknowledged that petitioner’s treating physicians were not
considering a neurological autoimmune condition for the first ten days post-vaccination. Tr. 268.
Regardless of these admissions, Dr. Sriram maintained that petitioner’s NMOSD began prior to
the vaccination. Tr. 269.

B) Opinion related to vaccine causation

Dr. Sriram also opined that the flu vaccine could not have caused petitioner’s NMOSD
because “there is no evidence that the influenza vaccination leads to the development of an
autoimmune response directed toward the aquaporin-4 antigen causation an inflammatory
response in the spinal cord.” Resp’t. Ex. A at 4.

Dr. Sriram stated that he accepts molecular mimicry as a viable, plausible, and well-
respected medical theory by which autoimmune diseases can be triggered. Tr. 242. He stated
that molecular mimicry has “been better seen in the experimental models, but not in clinical
medicine, save a few [examples].” Tr. 242.

Dr. Sriram acknowledged that vaccines can trigger autoimmune diseases and gave the
examples between the swine flu vaccine from 1976 and GBS and the rabies vaccine and
autoimmune encephalitis. Tr. 241. He stated, “there are many vaccines that are known to cause
neurological disease.” Id. Dr. Sriram also stated that the “Institute of Medicine requires a six-
week window” as an acceptable link to a vaccine and an autoimmune condition. Id.14 Dr.
Sriram also agreed that the onset of symptoms of 12 to 14 days post-vaccination would also be a
reasonable timeframe “to link a vaccine to an autoimmune disease.” Id.

Dr. Sriram also opined that if the onset of petitioner’s NMOSD was found to be two days
post-vaccination, that would be too soon to infer vaccine causation. Resp’t. Ex. E at 4; Resp’t.
Ex. F at 3; Tr. 272. In his third report, Dr. Sriram stated, “Even if we agree that the onset of
symptoms of NMO (pain in shoulder) occurred within two days, there is insufficient evidence to
support the idea that the increase in antibody titers to influenza caused the worsening of an
NMO.” Resp’t. Ex. F at 3. He acknowledged that the Shoenfeld article showed some GBS cases
occurring two days after vaccination and stated, “I think it can happen, but an extreme rarity.”
Tr. 274. When he was asked about the association between the flu vaccine and NMOSD in the
Cho article, Dr. Sriram testified that the patient described in the Cho case report was postpartum,
which was “more likely a cause for…the development of the NMO rather than the vaccine.” Tr.
275; citing Pet’r. Ex. 24. He testified that it was a “well known fact in 2018, there were
published reports on an increased risk of relapses in NMO often in postpartum.” Tr. 275.
However, when asked by the Court if the case report in Cho was a “relapse” or new onset, Dr.
Sriram characterized the Cho patient’s onset as “the first relapse.” Tr. 232. He agreed that the
authors of Cho did not actually discuss postpartum being the cause of the patient’s NMO, but
stated, “The fact that they didn’t allude to that is a little disappointing.” Tr. 275, 276.

14
For clarity Dr. Sriram was referring to a six week window as the outside limit for vaccine causation which he
agreed was not inviolate but he was not testifying that it would take six weeks for an immune cross response.

24
Ultimately, Dr. Sriram opined that the flu vaccine was not the cause of petitioner’s
diagnosed NMOSD and even if her symptoms began two days after the receipt of the vaccine,
her NMOSD had begun prior to the vaccination. Resp’t. Ex. E at 4; Resp’t. Ex. F at 4; Tr. 269.

2. Dr. Thomas Forsthuber

Dr. Forsthuber offered his opinion against vaccine causation in two expert reports and
testified at the entitlement hearing. Resp’t. Exs. C & G.15 The focus of Dr. Forsthuber’s opinion
was regarding vaccine causation and petitioner’s proposed mechanism for how the flu vaccine
could cause NMOSD and he deferred to Dr. Sriram on petitioner’s clinical diagnosis.

Dr. Forsthuber stated that molecular mimicry “is a concept that’s well accepted in the
field,” but Dr. Steinman’s theory of molecular mimicry between the flu vaccine and aquaporin-4
is not sound and reliable. Tr. 295. He testified that there are known molecularly mimic
examples, including between group A streptococcus M protein and the cardiac myosin,
campylobacter pylori and Guillain-Barre syndrome (explaining that the mimic is between a
liposaccharide and a similar lipid in sugar on the peripheral nerve myelin), or even between the
Epstein Barr virus and glialCAM protein resulting in MS. Tr. 324. Dr. Forsthuber distinguished
the Epstein-Barr and glialCAM protein finding from the BLAST search done by Dr. Steinman in
this matter, stating that Dr. Steinman’s MS-EBV research and finding was a result of identifying
the antibody that reacted against EBV and also bound to the glialCAM protein. Tr. 326. Later in
the hearing, Dr. Forsthuber conceded that proving molecular mimicry in humans would be
difficult. Tr. 345. However, Dr. Forsthuber argued that Dr. Steinman’s three step process to
validate molecular mimicry between the flu vaccine and aquaporin-4 was unreliable. Resp’t. Ex.
G at 21; Tr. 296.

First, Dr. Forsthuber criticized Dr. Steinman’s use of the Basic Local Alignment Search
Tool (BLAST) to identify sequence homology between aquaporin-4 and the influenza B as
overly broad. Tr. 329-330. Dr. Forsthuber explained that BLAST searches can identify
sequence proteins between different molecules, but argues that it was never intended to “identify
immunological relationships,” between proteins found in viruses or bacteria and humans. Id. at
2. In his responsive report to Dr. Steinman’s theory and during the hearing, Dr. Forsthuber
discussed the importance of the “E-value” in BLAST searches, and criticized Dr. Steinman’s
BLAST search between aquaporin-4 and influenza B as having too low of an E-value such that
“it fails to achieve statistical significance.” Resp’t. Ex. G at 7. Dr. Forsthuber argued that
BLAST searches can identify significant similarities between proteins, but Dr. Steinman was
only able to identify molecular mimics once he changed the parameters to the E-value such that
the value was not statistically significant. Resp’t. Ex. G at 6-7; Tr. 330.

When Dr. Forsthuber was asked how he would identify an amino acid sequence between
a vaccine and an autoimmune condition, he responded that he would do a BLAST search. Tr.
405. Dr. Forsthuber also testified that doing both BLAST searches and searches in IEDB would

15
Dr. Forsthuber’s first expert report responds to an expert report authored by Dr. Christina Price, who also posited
a theory of molecular mimicry. See Pet’r. Ex. 22. However, Dr. Price did not continue as the immunology expert in
this matter and therefore, the undersigned will focus on Dr. Forsthuber’s opinion relating to the theory of vaccine
causation proposed by petitioner’s experts, Drs. Willer and Steinman.

25
be a reasonable “first step” to “begin to test your hypothesis” to determine if molecular mimics
exist, but then to test the hypothesis, studies of the blood of human patients with autoimmune
diseases would be the next step. Tr. 410-11.

Then Dr. Forsthuber argued that Dr. Steinman’s second step in his theory that
neuroinflammation can be triggered even when there is only 5 out of 12 amino acids shared
between the viral peptide and the human antigen, is unreliable. Resp’t. Ex. G at 11; Tr. 331. Dr.
Forsthuber asserted that Dr. Steinman’s second step is reliant upon knowing which amino acids
of immunogenic aquaporin-4 peptides activate T-cells through their receptors, and that these
peptides also need to be in a specific position to be activated. Resp’t. Ex. G at 9; Tr. 335. Dr.
Forsthuber asserted that Gautam paper Dr. Steinman relied upon shows that the researchers
actually maintained two positions of amino acids while changing out the other amino acids, and
therefore, the neuroinflammatory response remained. Tr. 337. Dr. Forsthuber testified,
“therefore, you cannot simply look at this influenza peptide and say, ‘I have six out of nine
amino acids matching.’ That is not enough, it only matters if they are in the correct position.”
Tr. 337. Dr. Forsthuber argued that it was extremely unlikely if there are a “short sequence
where only a few amino acids match that something would activate an autoimmune T cell.” Tr.
339. He testified that he “[does not] have an explanation why we get autoimmunity,” but that in
this case, there was “no reliable evidence that there is a similarity that could induce pathogenic
T-cells.” Tr. 341.

Finally, with respect to Dr. Steinman’s third step of the process, the search of IEDB for
results of homology between the influenza B and aquaporin-4 was also flawed because the
sequence Dr. Steinman found (TGEHAKAIG) was only partially contained in a much larger
amino acid sequence and it cannot be determined if that sequence induced the immune response.
Resp’t. Ex. G at 14. Dr. Forsthuber performed his own search of IEDB as shown in his
responsive expert report, and he stated that he did not find any reports in the IEDB database that
the influenza sequence Dr. Steinman found could induce an immune response. Id. at 15.

During the hearing Dr. Forsthuber was asked to review the Matsuya paper, which Dr.
Steinman asserted demonstrated that three out of 12 patients responded to the area of the
influenza B he identified through IEDB. Tr. 424. Dr. Forsthuber testified that he agreed that the
article showed that 3 out of 12 patients with NMO responded to the same peptide “that we have
in [this] case, but that the finding was not statistically significant. Tr. 422, 424.

With respect to onset, Dr. Forsthuber argued that even if he accepted Dr. Steinman’s
theory, the onset of symptoms of NMOSD one to four days post-vaccination would not be
biologically plausible. Tr. 361; see also Resp’t. Ex. G at 18-19. Dr. Forsthuber argued that the
earliest onset of disease after vaccination based on a recall response would be five to six days.
Tr. 366. He argued that a memory T-cell response, five-day onset would be a “reasonable
estimate,” but for a naïve T-cell response, five-day onset would be a “conservative estimate” to
see immunopathology. Tr. 367. Dr. Forsthuber testified that for a B-cell antibody response, it
would take about five days for “meaningful antibody levels.” Id. He referred to the Krammer et
al. article which studied antibody responses to SARS-CoV2 vaccination, and testified that the
article demonstrates that the most evident antibodies to the vaccine was seen 9 to 12 days later.

26
Tr. 370; Resp’t. Ex. G, Tab 13.16 The article explains that patients that had not previously been
exposed to SARS-CoV2, had relatively low antibody responses until nine days post-vaccination,
but those who had been previously exposed, “rapidly developed uniform, high antibody titers
within days after vaccination.” Resp’t. Ex. G, Tab 13 at 1.

Dr. Forsthuber testified that if petitioner had a memory response to the vaccine, as
asserted by Dr. Steinman, then he would expect onset of symptoms of NMOSD earlier than 12
days post-vaccination, as Dr. Willer suggested. Tr. 379. Dr. Forsthuber reiterated if petitioner
had a memory response, one would expect to see onset of an autoimmune disease five to ten days
post-vaccination. Tr. 380.

III. Legal Standard

I. Legal Standard

The Vaccine Act was established to compensate vaccine-related injuries and deaths.
Section 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 & Human Servs., 35 Fed. Cl. 1, 7 (1996) (quoting H.R.
No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344).

A petitioner bears the burden of establishing his or her entitlement to compensation from
the Vaccine Program. The burden of proof is by a preponderance of the evidence. Section
13(a)(1).

a. Factual Issues

A petitioner must prove, by 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.” Curcuras 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 circumstances 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).

16
Krammer, F. et al., Antibody Responses in Seropositive Persons after a Single Dose of SARS-CoV-2 mRNA
Vaccine, Correspondence N. Engl. J. Med. (2021). [Resp’t. Ex. G, Tab 13].

27
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 v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726,733
(1991), aff’d per curiam, 968 F.2d 1226 (Fed. Cir. 1992)). Ultimately, a determination regarding
a witness’s credibility 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 1575.

Despite the weight afforded to medical records, special masters are not bound rigidly 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) (Section 13(b)(2) “must be construed so as to give effect also 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 the,”).

Relevant to this inquiry, the Vaccine Act provides that a special master must consider the
record as a whole including any medical diagnosis contained therein. Section 300aa-13(b)(1).
However, no diagnosis in the medical records is “binding on the special master.” Id. Rather, “[i]n
evaluating the weight to be afforded to any such diagnosis… the special master… shall consider
the entire record and the course of the injury, disability, illness, or condition until the date of the
judgment of the special master.” Id. The special master shall also consider any expert opinions
and additional medical scientific evidence in the record. Id.

b. Causation

A petitioner may prevail by proving either that (1) the vaccinee suffered an injury listed
on the Vaccine Injury Table with onset beginning within a corresponding time period following
receipt of a corresponding vaccine (a “Table Injury”), for which causation is presumed or that (2)
the vaccinee suffered an injury that was actually caused by a vaccine. Under either method,
however, the petitioner must also show that the vaccinee “suffered the residual effects or
complications of the illness, disability, injury, or condition for more than six months after the
administration of the vaccine.” Section 11(c)(1)(D)(i).

In the present case, petitioner does not and cannot allege a Table injury. Thus, he bears
the burden of establishing actual causation. To do so, he must “show by preponderant evidence
that the vaccination brought about the injury by providing 1) a medical theory connecting the
vaccination and injury; 2) a logical sequence of cause and effect showing that the vaccination
was the reason for the injury; and 3) a showing of proximate temporal relationship between
vaccination and injury.” Althen v. Sec’y of Health & Human Servs., 418 F. 3d 1274, 1278 (Fed.

28
Cir. 2005). There must be preponderant evidence for each Althen prong. Caves v. Sec’y of
Health & Human Servs., 100 Fed. Cl. 119, 132 (2011), aff. per curiam, 463 Fed. Appx. 932 (Fed.
Cir. 2012).

Under Althen prong one, the causation theory must relate to the injury alleged. Thus, a
petitioner must provide a “reputable” medical or scientific explanation that the vaccine received
can cause the type of injury alleged. Pafford, 451 F.3d at 1355-56. The theory must be based on
a “sound and reliable medical or scientific explanation.” Knudsen, 35 F.3d at 548. It must only
be “legally probable, not medically or scientifically certain.” Id. at 549. However, the theory
still must be based on a “sound and reliable medical or scientific explanation.” Id. at 548. The
Federal Circuit explained in Althen that “while [that petitioner’s claim] involves the possible link
between [tetanus toxoid] vaccination and central nervous system injury, a sequence hitherto
unproven in medicine, the purpose of the Vaccine Act’s preponderance standard is to allow the
finding of causation in a field bereft of complete and direct proof of how vaccines affect the
human body.” Althen, 418 F.3d at 1280 (emphasis added). Recently in Doles, the Federal
Circuit clarified that a petitioner does not need to proffer a theory that is grounded in medical
certainty and backed by medically certain (statistically significant) evidence. Doles v. Sec’y of
Health & Hum. Servs., No. 17-642, 2025 WL 1177875 (Fed. Cir. Apr. 23, 2025), (citing Andreu
ex rel. v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1380 (Fed. Cir. 2009) (“In medical
research, “attribution of causation is typically not made until a level of very near certainty—
perhaps 95% probability—is achieved. In contrast, “determination of causation in fact under the
Vaccine Act involves ascertaining whether a sequence of cause and effect is ‘logical’ and legally
probable, not medically or scientifically certain.”).

Under Althen prong two, petitioner must prove “a logical sequence of cause and effect
showing that the vaccination was the reason for [her] injury.” Althen, 418 F.3d at 1278. This
prong is sometimes referred to as the “did it cause” test; i.e. in this particular case, did the
vaccine(s) cause the alleged injury. Broekelschen, 618 F. 3d at 1345 (“Because causation is
relative to the injury, a petitioner must provide a reputable medical or scientific explanation that
pertains specifically to the petitioner’s case”). Temporal association alone is not evidence of
causation. See Grant v. Sec’y of Health & Human Servs., 9556 F.2d 1144, 1148 (Fed. Cir.
1992). This sequence of cause and effect is usually supported by facts derived from petitioner’s
medical records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375-77; Capizzano, 440 F.3d at
1326; Grant, 956 F.2d at 1148.

Althen prong three requires establishing a “proximate temporal relationship” between the
vaccination and the injury alleged. Althen at 1281. That term has equated to the phrase
“medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant proof
that the onset of symptoms occurred within a timeframe which, given the medical understanding
of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan v. Sec’y of
Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is
medically acceptable timeframe must align with the theory of how the relevant vaccine can cause
an injury (Althen prong one). Id. at 1352.

The preponderance of the evidence standard requires the petitioner to demonstrate that it
is “more likely than not” that the vaccine caused the injury. Moberly v. Sec’y of Health &

29
Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010). Proof of medical certainty is not
required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). A
petitioner must demonstrate 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 v.
Sec’y of Health & Human Servs., 135 F.3d 1344, 1352-53 (Fed. Cir. 1999); Pafford v. Sec’y of
Health and Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). Causation is determined on a
case-by-case basis, with “no hard and fast per se scientific or medical rules.” Knudsen v. Sec’y
of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). A fact-finder may rely upon
“circumstantial evidence” which is consistent with the “system created by Congress, in which
close calls regarding causation are resolved in favor of injured claimants.” Althen, 418 F. 3d at
1280.

The petitioner often presents expert testimony in support of his or her claim. Lampe v.
Sec’y of Health & Human Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Expert testimony in the
Vaccine Program is usually evaluated according to the factors set forth in Daubert v. Merrell
Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993); see also Cedillo, 617 F.3d at 1339 (citing
Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999). A special
master may use the Daubert framework to evaluate the reliability of expert testimony, but expert
testimony need not meet each Daubert factor to be reliable. Boatmon v. Sec’y of Health &
Human Servs., 941 F.3d 1351 (Fed. Cir. 2019). The Daubert factors are “meant to be helpful,
not definitive,” and all factors “‘do not…necessarily apply even in every instance in which the
reliability of scientific testimony is challenged.’” Boatmon, 941 F. 3d at 1359 (citing Kumho
Tire Co. v. Carmichael, 526 U.S. 137, 151, 119 S. Ct. 1167, 143 L.Ed.2d 238 (1999). Thus, for
Vaccine Act claims, a “special master is entitled to require some indicia of reliability to support
the assertion of the expert witness.” Moberly at 1324. Where both sides offer expert testimony,
a special master’s decision may be “based on the credibility of the experts and the relative
persuasiveness of their competing theories.” Broekelschen v. Sec’y of Health & Human Servs.,
219 F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe, 219 F.3d 1357 at 1362).

If the petitioner makes a prima facie case supporting vaccine causation-in-fact, the
burden shifts to respondent to show by a preponderance of the evidence that the injury is instead
due to factors unrelated to the administration of the vaccine. Deribeaux v. Sec’y of Health &
Human Servs., 717 F.3d 1363, 1367 (Fed. Cir. 2013) (citing Section 13(a)(1)(B)). Respondent
has the burden of demonstrating that: “[A] factor unrelated to the vaccination is the more likely
or principal cause of injury alleged. Such a showing establishes that the factor unrelated, not the
vaccination, was ‘principally responsible’ for the injury. If the evidence or alternative cause is
seen in equipoise, then the government has failed in its burden of persuasion and compensation
must be awarded.” Knudsen, 35 F.3d at 551.

IV. Analysis

a) Onset of Petitioner’s NMOSD Symptoms

1) Petitioner’s Symptoms of Neck and Left Shoulder Pain Began One Day after
the October 8, 2014 Vaccination

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In this matter, the parties agree that petitioner was diagnosed with NMOSD, as confirmed
by her aquaporin-4 antibody finding, but dispute when the onset of her condition began. Pet’r.
Br. at 1; Resp’t. Br. at 9.

Petitioner argued that the onset of her symptoms attributable to her NMOSD began “12 to
14 days post-vaccination, but no sooner than three days after she received the flu vaccine.”
Pet’r. Br. at 93. Petitioner asserted that the neck pain she experienced was documented only
after the vaccination and that it is unclear if her initial complaints of neck and left shoulder pain
are attributable to the later diagnosed NMOSD or a transient injection site injury unrelated to her
ultimate diagnosis, such as a SIRVA or brachial neuritis. Id. at 88-91.

Respondent argued that petitioner’s initial symptoms of NMOSD was left sided neck pain
which began prior to the vaccination or at least one day post-vaccination. Resp’t. Br. at 8; see
also Tr. 225-29, 247-48. Respondent argued that petitioner’s initial neck pain was a prominent
feature of her NMOSD, that was well documented as beginning prior to vaccination, and her
initial symptoms of neck pain and left shoulder pain were not separate injuries but features of her
NMOSD. Resp’t. Br. at 13-14.

The undersigned finds that there is preponderant evidence that petitioner’s neck pain
began one day after the October 8, 2014 flu vaccination and that her neck and left arm pain were
consistent with her later diagnosed NMOSD. The finding that petitioner’s neck and left shoulder
pain began after the October 8, 2014 is based on the contemporaneous medical records and her
testimony during the hearing.

Petitioner’s treatment records demonstrate that onset of neck and left shoulder pain began
after the vaccination and no record indicates that the onset of neck or shoulder pain began prior
to the October 8, 2014. See Pet’r. Ex. 4 at 32. The closest appointments to her vaccination at
Physicians Neck and Back Center were on September 18, 2014 and October 6, 2014, neither
which included documentation of reported neck pain or treatment for neck pain. Pet’r. Ex. 4 at
32. During the hearing, Dr. Sriram acknowledged that these treatment records do not document
any neck or shoulder pain. Tr. 259-60.

To formulate his opinion that petitioner’s symptoms began prior to the vaccination, Dr.
Sriram relied heavily on the records from Physicians Neck and Back Center that were created in
December 2014. However, these records include internal inconsistencies and also conflict with
other, more reliable contemporaneously created medical records. The Neck and Back Institute
record from December 9, 2014 written by Dr. Sturm states:

[Petitioner] dates her symptoms to 9/28/2014….[Petitioner] underwent 17 sessions in the
lumbar program and found that to be helpful. She began treatment on July 31, 2014. Her
last treatment was October 16, 2014. She stopped coming because she developed
cellulitis of the face. This ultimately turned out to be Lyme disease. She also received a
flu shot and came down with a form of Guillain-Barre syndrome.

Pet’r. Ex. 4 at 14. Importantly, this records state that petitioner stopped treatment when
she developed cellulitis, which is inconsistent with petitioner’s treatment records for her

31
cellulitis, but also with the internal treatment records from the same office. Pet’r. Ex. 4 at 32
(9/18/2014: Pt feeling worn down from cellulitis); see also Pet’r. Ex. 5 at 18 (appointment from
9/17/2014 for swollen right ear, diagnosed with cellulitis). Next, the December 19, 2014 record
from Physician Back and Neck also incorrectly records petitioner’s date of vaccination,
indicating that the “Onset” of petitioner’s symptoms began “9/28/14-after flu shot, then the
Lyme/GB.” Pet’r. Ex. 4 at 39.

Respondent also argued that petitioner’s records from her initial emergency department
visit on October 18, 2014, and her appointment with PA-C Rydlund on October 20, 2014,
include histories that describe the neck pain being present for a month, and pre-dating her
vaccination. Resp’t. Br. at 10-11. The note taken by RN Cody on October 18, 2014 states,
“Patient reports recent history of neck/facial cellulitis which was treated and improved, though
pain has never completely gone away.” Pet’r. Ex. 7 at 3. Then on October 20, 2014 the treating
emergency room physician, Dr. Roline took petitioner’s history and writes:

…one month ago [petitioner] started to develop some right-sided facial swelling and
cellulitis. It ended up spreading toward her right ear. She was treated with antibiotics
and that seemed to resolve. However, over this timeframe, she has had some neck
discomfort. It has been worse in the back of her neck, slightly more to the left. With
some intermittency she gets some radiating pain up the back of her head. She tells me
that has been present over a month. In addition, her neck has felt stiff. She has been
taking some ibuprofen which has been helping, but over the last few days, she has been
more uncomfortable.

Pet’r. Ex. 7 at 3. These notations are vague at best as to when petitioner’s neck pain began.
Both records discuss the treatment for petitioner’s cellulitis, which is consistent with her other
medical records, but are imprecise as to the exact onset of her neck pain.

Similarly, the record from October 20, 2014 with PA-C Rydlund also appears to combine
petitioner’s cellulitis symptoms and her new symptoms of neck and shoulder pain. The record
from October 20, 2014 states, “50-year old female here today for neck pain. She feels it has
been present ever since her bout of cellulitis about 4 weeks ago, however, the cellulitis did
improve.” Pet’r. Ex. 5 at 15. However, both records do indicate some new onset of neck pain
being left sided. See Pet’r. Ex. 7 at 3 (“It has been worse in the back of her neck, slightly more
to the left….but over the last few days she has been more uncomfortable.”); Pet’r Ex. 5 at 15
(“Acute worsening two days ago.”).

During the hearing, petitioner credibly explained that when she initially went to the
emergency department on October 18, 2014, she thought her neck pain was related to her
cellulitis. Tr. 62. She testified, “…my only thought at that point was that this must be related to
the cellulitis, although in hindsight the cellulitis was on the right side of my face, my ear
basically, and that was kind of where it was localized. And the pain I was having now on my left
side and into my neck.” Id.

Petitioner testified that she did not experience any left sided neck or shoulder pain prior
to vaccination. Tr. 64-65. She testified that the day after the vaccination, her neck and left

32
shoulder began to hurt, and she decided to get a massage before visiting friends from out of
town. Tr. 64-65. Petitioner stated that two days after the vaccination, she began to take Tylenol
and Ibuprofen for her pain. Tr. 12. She testified that her pain was “persistent through that first
weekend,” and by the end of the weekend she was “taking Tylenol and ibuprofen probably every
8 hours, each of them, to try to control the pain.” Tr. 13. The Saturday of that weekend was
October 11, 2014.

Petitioner’s testimony that her neck and left shoulder pain began after her vaccination
does not conflict with the majority of her records. For example, on October 23, 2014, petitioner
went to Twin City Orthopedics and reported “shoulder pain and weakness for two weeks.” Pet’r.
Ex. 8 at 8. This timeline would put onset of left shoulder pain to one day after the vaccination,
consistent with petitioner’s testimony. Then on October 24, 2014 when petitioner went back to
the Maple Grove emergency department, the record indicates that petitioner was having neck and
left shoulder pain that began “after receiving the influenza vaccine.” Pet’r. Ex. 7 at 26.
Petitioner explained to emergency physician, Dr. Brooks that her shoulder and neck pain “has
been going on for some time, what she believes is since a flu shot she had in her left deltoid.” Id.
at 28. On October 26, 2014, the “History of Present Illness” provides that petitioner was seeking
an evaluation for “left shoulder pain,” and that “The onset was 16 days ago.” (October 10,
2014)Pet’r. Ex. 7 at 48. The note also states, “The quality is described as onset of pain two days
after a flu vaccine place[d] unusually high in the left shoulder.” Id.

Petitioner was evaluated by Dr. Rodney McFadden the same day, Sunday, October 26,
2014, and the “History of Present Illness” provides, “The patient states that she received a flu
vaccine approximately 18 days ago and then approximately 16 days ago she developed left
shoulder pain. Of note, the patient states that she received the flu vaccine in her upper shoulder
at a higher location than is usually given…On Wednesday of this week, (which was October 22)
the patient began noticing left arm weakness. On Thursday, she could not abduct her arm above
mid chest and subsequently the weakness has progressed so at the present time she can only
abduct her arm up approximately 45 degrees.” Id. at 54. Finally, when petitioner first saw
neurologist, Dr. Altafullah on October 27, 2014 during her hospitalization, the “History of
Present Illness” also indicates that petitioner’s left shoulder pain began after the flu vaccination.
See Pet’r. Ex. 6 at 1.

The Mayo Clinic records from August 2015, also support an onset of her NMOSD
symptoms beginning after her flu vaccination. At her first appointment with Dr. Pittock on
August 11, 2015, the record states, “On October 8, 2014, she had a flu vaccination; two days
later, she developed pain in her left shoulder and neck.” Pet’r. Ex. 10 at 1. This history is
repeated to neurologist, Dr. Alfugham, on August 14, 2015, “October 8, 2014: received flu
vaccine. The second day, patient started to have severe pain and paresthesia in the left shoulder
region.” Pet’r. Ex. 10 at 12.

Medical records generally “warrant consideration as trustworthy evidence.” Cucuras,
993 F.2d at 1528. However, greater weight is typically given to contemporaneous records.
Vergara v. Sec’y of Health & Hum. Servs., No. 08-882V, 2014 WL 2795491, at *4 (Fed. Cl.
Spec. Mstr. May 15, 2014) (“Special Masters frequently accord more weight to
contemporaneously-recorded medical symptoms than those recorded in later medical histories,

33
affidavits or trial testimony.”). However, there are situations in which compelling oral testimony
may be more persuasive than written records, such as where records are deemed to be incomplete
or inaccurate. Campbell v. Sec'y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“[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) (“Written 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.

Taken as a whole, petitioner’s medical records and her testimony support a finding that
the onset of her NMOSD began one day after her October 8, 2014 flu vaccination, not before as
opined by Dr. Sriram.

2) Petitioner’s Neck and Left Shoulder Pain were Consistent with her NMOSD
Diagnosis

The second factual issue is if petitioner’s neck and left shoulder pain were consistent with
her NMOSD diagnosis or a transient injection site reaction, such as a SIRVA, or a brachial
neuritis.

Neuromyelitis optica is described as a demyelinating disease of the central nervous
system characterized by recurrent optic neuritis and acute transverse myelitis. Resp’t. Ex. A,
Tab 2; Pet’r. Ex. 48(a) at 1. Typical features of NMOSD include ocular pain with loss of vision
and myelitis with severe symmetric paraplegia, sensory loss below the lesion, and bladder
dysfunction. Resp’t Ex. A, Tab 2 at 2. Common treatments include intravenous corticosteroid
therapy for acute attacks of optic neuritis or myelitis. Id. at 8. Dr. Willer described the “classical
symptoms” of NMOSD as “painful eye movements, blurry vision, transverse myelitis,” and that
a patient would present with “paraparesis, quadriparesis—depending on the level affected---
dysesthesias, numbness, tingling, burning, really painful unpleasant tingling sensations, [and]
potentially bowel and bladder involvement depending on which level is affected.” Tr. 88.
Consistent with the medical literature, Dr. Willer testified that neuromyelitis optica includes
longitudinally extensive transverse myelitis, which he described as “long lesions which span
three or more levels [of the spinal cord].” Tr. 89; see also Pet’r. Ex. 14 at 1.17

In his written expert reports, Dr. Willer repeatedly associated her neck and shoulder pain
to the onset of her NMOSD but later testified that these complaints could have been related to a
transient injection site injury or brachial neuritis. See Pet’r. Ex. 12 at 8; Pet’r Ex. 21 at 3; Pet’r.
Ex. 32 at 2; Tr. 111-14. However, he was unable to render his opinion about whether she had an
injection site injury or brachial neuritis to a degree of reasonable certainty. Pet’r. Br., at 92; see
also Tr. 85-86; 130. He stated that “on a more likely than not basis,” petitioner’s symptoms of
NMOSD can be established by October 20th or 22nd. Tr. 130.

17
Wingerchuk, D. et al., International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorders,
85 Neurol. 177-189 (2015). [Pet’r. Ex. 14].

34
Respondent’s expert, Dr. Sriram, opined that the neck and left arm pain petitioner
experienced were the first symptoms of her NMOSD, based on the characteristics of her pain, the
response to treatment, and the continued presence of those symptoms during repeat NMOSD
attacks. Resp’t. Br. at 12-14; see generally Resp’t. Ex. F at 2. He testified that petitioner’s
initial neck pain then began to radiate down her left arm and appeared with tingling. Tr. 227.
Dr. Sriram explained that when petitioner received steroids, her pain improved, which suggested
an inflammatory component to the pain. Tr. 227. Dr. Sriram stated that predominant symptoms
of NMOSD are weakness and pain, which may include paresthesias, but the predominant effect
of the spinal cord inflammation is weakness. Tr. 245. While Dr. Sriram’s opinion that the onset
of petitioner’s NMOSD began prior to the October 8, 2014 vaccination has no support in the
record, he conceded that the contemporaneous treatment records do not document neck pain or
left shoulder

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/11275249. Public record. Not legal advice.