Malar v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

Filed: November 19, 2025

Refiled as Redacted: February 17, 2026

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

ANGELA MALAR, * PUBLISHED

*

Petitioner, * No. 18-1429V

*

v. * Special Master Nora Beth Dorsey

*

SECRETARY OF HEALTH * Dismissal; Influenza (“Flu”) Vaccine;

AND HUMAN SERVICES, * Neuromyelitis Optica (“NMO”);

* Neuromyelitis Optica Spectrum Disorder

Respondent. * (“NMOSD”).

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

Mark Theodore Sadaka, Law Offices of Sadaka Associates, LLC, Englewood, NJ, for Petitioner.

Felicia Langel, U.S. Department of Justice, Washington, DC, for Respondent.

DECISION 1

On September 19, 2018, Angela Malar (“Petitioner”) filed a petition for compensation

under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42

U.S.C. § 300aa-10 et seq. (2018). 2 Petitioner alleges that as a result of receiving an influenza

(“flu”) vaccine on October 4, 2015, she suffered neuromyelitis optica (“NMO”). 3 Petition at

1

When this Decision was originally filed, I advised my intent to post it on the United States

Court of Federal Claims’ website, and/or at https://www.govinfo.gov/app/collection/uscourts/

national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018)

(Federal Management and Promotion of Electronic Government Services). In accordance with

Vaccine Rule 18(b), Petitioner filed a motion to redact certain information. This Decision is

being reissued with these redactions. Except for those changes and this footnote, no other

substantive changes have been made. This Decision will be posted on the court’s website, and/or

at https://www.govinfo.gov/app/collection/uscourts/national/cofc, with no further opportunity to

move for redaction.

2

The National Vaccine Injury Compensation Program is set forth in Part 2 of the National

Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended,

42 U.S.C. §§ 300aa-10 to -34 (2018). All citations in this Decision to individual sections of the

Vaccine Act are to 42 U.S.C. § 300aa.

3

The petition also alleged an injury of migraine aura and a claim of significant aggravation.

However, Petitioner’s filings and the joint submission specified the claim is a causation-in-fact

for NMO. Therefore, the undersigned does not discuss migraine aura or significant aggravation.

Preamble (ECF No. 1). Respondent argued against compensation, stating that “this case is not

appropriate for compensation under the terms of the [Vaccine] Act.” Respondent’s Report

(“Resp. Rept.”) at 1 (ECF No. 62).

After carefully analyzing and weighing the evidence presented in this case in accordance

with the applicable legal standards, 4 the undersigned finds that Petitioner failed to provide

preponderant evidence that her flu vaccine caused her NMO. Thus, Petitioner has failed to

satisfy her burden of proof under Althen v. Secretary of Health & Human Services, 418 F.3d

1274, 1280 (Fed. Cir. 2005). Accordingly, Petitioner is not entitled to compensation.

I. ISSUES TO BE DECIDED

The parties agree that Petitioner received a flu vaccination on October 4, 2015 in the

United States, and that following vaccination, her providers diagnosed her with NMO, an

autoimmune condition. 5 Joint Prehearing Submissions (“Joint Sub.”), filed Nov. 22, 2024, at 1

(ECF No. 133). The parties also stipulate that Petitioner suffered from NMO for more than six

months following vaccination, that her petition was timely filed, and that there has been no prior

award or settlement of a civil action for damages as a result of Petitioner’s NMO. Id.

The parties dispute Petitioner’s date of onset. Joint Sub. at 2. The parties also dispute

whether Petitioner has provided preponderant evidence of all three Althen prongs. Id.

4

While the undersigned has reviewed all of the information filed in this case, only those filings

and records that are most relevant will be discussed. See Moriarty v. Sec’y of Health & Hum.

Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We generally presume that a special master

considered the relevant record evidence even though he does not explicitly reference such

evidence in his decision.”); see also Paterek v. Sec’y of Health & Hum. Servs., 527 F. App’x

875, 884 (Fed. Cir. 2013) (“Finding certain information not relevant does not lead to—and likely

undermines—the conclusion that it was not considered.”).

5

Although the parties identify Petitioner’s diagnosis as NMO, the experts interchangeably refer

to Petitioner’s diagnosis as NMO and NMOSD. See Petitioner’s Exhibit (“Pet. Ex.”) 14

(consistently documenting Petitioner’s diagnosis as NMOSD except when citing to certain

medical records that document diagnosis as NMO); Resp. Ex. A (opining “[t]here is little doubt

as to the diagnosis of [NMOSD] in [Petitioner]” but otherwise characterizing her diagnosis as

NMO); Resp. Ex. C (same). After a review of the expert reports, medical literature, as well as

case law, the undersigned finds NMOSD more accurately reflects Petitioner’s pathology given

her lack of spinal cord lesions. See Pet. Ex. 2 at 139 (“Limited forms of [NMO], such as isolated

[optic neuritis] . . . have been referred to as NMO[SD].”) However, this distinction does not

affect the undersigned’s Decision. Regardless of Petitioner’s diagnosis (NMOSD or NMO), the

undersigned finds Petitioner has not provided preponderant evidence of causation. The

undersigned will refer to Petitioner’s alleged vaccine-related injury as NMO in accordance with

the parties’ Joint Submission.

2

II. BACKGROUND

A. Procedural History

Petitioner filed her petition on September 19, 2018, followed by medical records 6 and an

expert report from Dr. Alberto Martinez-Arizala from October 2018 to July 2020. Petition; Pet.

Exs. 1-40. Respondent filed an expert report from Dr. Subramaniam Sriram on December 28,

2020. Resp. Ex. A. On February 25, 2021, Respondent filed his Rule 4(c) report, arguing

against compensation. Resp. Rept. at 1.

On July 8, 2021, the undersigned held a Rule 5 conference. Rule 5 Order dated July 9,

2021 (ECF No. 70). The undersigned noted her concerns regarding onset and recommended

further expert opinion from the parties on this issue. Id. at 2-4. Thereafter, Petitioner filed an

expert report from Dr. David M. Yousem on March 28, 2023, and Respondent filed an expert

report from Dr. Sriram on August 10, 2023. Pet. Ex. 54; Resp. Ex. C.

Afterwards, the parties filed a joint status report requesting to resolve entitlement through

a hearing, which was set for December 2024. Joint Status Rept., filed Oct. 11, 2023 (ECF No.

116); Prehearing Order dated Nov. 28, 2023 (ECF No. 121). However, on October 16, 2024,

Petitioner filed a status report requesting the December 2024 hearing be cancelled and that

entitlement be resolved through a ruling on the record. Pet. Status Rept., filed Oct. 16, 2024

(ECF No. 127). On October 21, 2024, Respondent filed a status report indicating no objection to

Petitioner’s request. Resp. Status Rept., filed Oct. 21, 2024 (ECF No. 129). The entitlement

hearing was cancelled and a briefing schedule issued. Order dated Oct. 21, 2024 (ECF No. 130).

Petitioner filed a motion for a ruling on the record on December 6, 2024. Pet. Motion for

a Ruling on the Record (“Pet. Mot.”), filed Dec. 6, 2024 (ECF No. 139). Respondent filed a

response on January 6, 2025, and Petitioner filed a reply on January 27, 2025. Resp. Response to

Pet. Mot. (“Resp. Response”), filed Jan. 6, 2025 (ECF No. 140); Pet. Reply to Resp. Response

(“Pet. Reply”), filed Jan. 27, 2025 (ECF No. 141).

This matter is now ripe for adjudication.

B. Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder

NMO is “a severe relapsing inflammatory [central nervous system (“CNS”)]

demyelinating disease that predominantly affects the optic nerves and spinal cord.” Pet. Ex. 18

at 1; 7 see also Pet. Ex. 2 at 139 (“NMO . . . is an immune-mediated chronic inflammatory disease

that predominantly affects the optic nerve and spinal cord and presents with optic neuritis [] and

myelitis.”).

6

Medical records were filed throughout litigation.

7

P.J. Waters et al., Serologic Diagnosis of NMO: A Multicenter Comparison of Aquaporin-4-

IgG Assays, 78 Neurology 665 (2012).

3

NMOSD includes patients with NMO as well as those who do not meet the criteria for

NMO. See, e.g., Morgan v. Sec’y of Health & Hum. Servs., 850 F. App’x 775, 779 n.4 (Fed.

Cir. 2021) (“[NMOSD] was first introduced in 2007 to cover patient groups with various clinical

features and AQP4-IgG antibody test results. In 2013, . . . NMO [was] subsumed into the single

descriptive term NMOSD because the clinical behavior, immunopathogenesis, and treatment of

patients who have NMOSD are not demonstrably different than for those with NMO and patients

with incomplete forms of NMO frequently later fulfill NMO criteria.” (internal citations and

quotations omitted)); Inyang v. Sec’y of Health & Hum. Servs., No. 20-57V, 2024 WL 4063883,

at *1 n.2 (Fed. Cl. Spec. Mstr. Aug. 8, 2024) (noting NMOSD includes NMO and

acknowledging the experts used these terms interchangeably). Patients with only optic neuritis 8

or transverse myelitis 9 are classified under NMOSD since they have “incomplete forms of

NMO.” Pet. Ex. 18 at 1; Resp. Ex. A, Tab 1 at 1; 10 see also Pet. Ex. 17 at 8 (“[NMOSD] . . .

may present with optic neuritis or transverse myelitis.”). 11 This expanded definition includes

those with unilateral optic neuritis, like Petitioner. Resp. Ex. A, Tab 1 at 2; see Pet. Ex. 2 at 139

(“Limited forms of [NMO], such as isolated [optic neuritis] . . . have been referred to as

NMO[SD].”).

Research shows that autoantibodies against aquaporin-4 (“AQP4”) are associated with

NMO and NMOSDs. Pet. Ex. 2 at 139; Pet. Ex. 18 at 1; Pet. Ex. 31; 12 Resp. Ex. A, Tab 1; Resp.

Ex. A, Tab 2. 13 However, the exact role of these antibodies “is not clear.” Pet. Ex. 30 at 6; 14 see

also Resp. Ex. A, Tab 1 at 1; Resp. Ex. A, Tab 2.

8

Optic neuritis is “inflammation of the optic nerve.” Optic Neuritis, Dorland’s Med. Dictionary

Online, https://www.dorlandsonline.com/dorland/definition?id=92519 (last visited Oct. 31,

2025).

9

Transverse myelitis is “myelitis in which the functional effect of the lesions spans the width of

the entire cord at a given level.” Transverse Myelitis, Dorland’s Med. Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=91212 (last visited Oct. 31, 2025).

10

Brian G. Weinshenker et al., NMO-IgG: A Specific Biomarker for Neuromyelitis Optica, 22

Dis. Markers 197 (2006).

11

Andrew J. Solomon, Diagnosis, Differential Diagnosis, and Misdiagnosis of Multiple

Sclerosis, 25 Continuum 611 (2019).

12

Vanda A. Lennon et al., A Serum Autoantibody Marker of Neuromyelitis Optica: Distinction

from Multiple Sclerosis, 364 Lancet 2106 (2004).

13

Dean M. Wingerchuk et al., The Spectrum of Neuromyelitis Optica, 6 Lancet Neurol. 805

(2007).

14

Dimitrios Karussis & Panayiota Petrou, The Spectrum of Post-Vaccination Inflammatory CNS

Demyelinating Syndromes, 13 Autoimmun. Revs. 215 (2014).

4

C. Factual History

1. Relevant Medical History 15

Petitioner was forty-three years old when she received the subject flu vaccine on October

4, 2015. Pet. Ex. 6 at 1. Petitioner’s medical history included fibromyalgia, migraine without

aura, intervertebral disc disease, depression and generalized anxiety, and [REDACTED]. Pet.

Ex. 13 at 2-3; Pet. Ex. 40 at 1. Petitioner’s pharmacy records show that she was prescribed

gabapentin from October 1, 2015 through March 8, 2016. Pet. Ex. 46 at 2; Pet. Ex. 47 at 1-2.

The record does not reflect the purpose of Petitioner’s gabapentin prescription. 16

Petitioner executed a declaration in which she averred she does not recall seeking

medical care from October 4, 2015 until March 29, 2016. Pet. Ex. 41 at ¶ 2.

On March 28, 2016, Petitioner presented to her primary care provider (“PCP”) for an

upper respiratory infection. Pet. Ex. 11 at 29. On examination, Petitioner had nasal discharge

and swelling. Id. at 30. Her pupillary responses were normal. Id. She was diagnosed with an

acute upper respiratory infection. Id. Petitioner had no additional complaints, and she was

prescribed antibiotics. Id. at 29-31.

The next day, March 29, 2016, Petitioner presented to ophthalmology as a walk-in for

vitreous floaters in her left eye. Pet. Ex. 8 at 1. On examination, Petitioner’s vision was mildly

reduced in both eyes with the left eye worse than the right. Id. Petitioner reported that she was

taking gabapentin, trazodone (antidepressant), and Wellbutrin (antidepressant). Id.

On April 3, 2016, six months post-vaccination, Petitioner presented to the emergency

department (“ED”) at Thomas Jefferson University Hospital (“Thomas Jefferson”) reporting a

one-day history of left eye “curtain” and flashes, left eye visual “black spots” for one week,

right-sided lower lip numbness that “started this morning,” and bilateral foot paresthesias for two

months. Pet. Ex. 2 at 15-16. Petitioner was admitted for possible optic neuritis. Id. at 38.

A brain magnetic resonance imaging (“MRI”) with and without contrast on April 4, 2016

showed “diffuse avid enhancement of the entire left optic nerve, consistent with optic neuritis,”

as well as “scattered foci of abnormal hyperintense T2/FLAIR signal in the juxtacortical white

matter and at the callososeptal attachment, which most likely represent demyelination.” Pet. Ex.

2 at 155. Impression was “[l]eft optic neuritis in combination with demyelinating lesions in the

juxtacortical and callososeptal distribution, concerning for multiple sclerosis” (“MS”). Id. at

154. MR venography without contrast, conducted April 5, showed “[n]o evidence of major dural

sinus or major deep vein thrombosis. Petitioner was treated with three days of solumedrol

15

This summary of medical records is largely taken from the parties’ briefs, as the undersigned

finds the parties provided an accurate representation of the records. See Pet. Mot. at 2-5; Resp.

Response at 3-8. The undersigned has edited the summary.

16

Petitioner maintains she had no visits with a medical provider during this period of time. See

Pet. Ex. 41 at ¶ 2. Thus, the purpose of this prescription is not clear.

5

infusions, and “[she] felt that her vision was improving.” Id. at 38. On April 6, 2016, Petitioner

was discharged on a tapering dose of prednisone and referred to outpatient neuro-ophthalmology.

Id. At the time of discharge, NMO Immunoglobulin G (“IgG”) antibody testing was pending.

Id.

Following her hospitalization, NMO IgG testing revealed abnormal levels of anti-AQP4

antibodies (6.8; reference range is less than 3.0 U/ml), “consistent with [NMO].” Pet. Ex. 2 at

138.

On April 12, 2016, Petitioner presented to her PCP reporting left eye blindness, mouth

numbness, burning pain in her body, insomnia, and increased urinary frequency. Pet. Ex. 11 at

22. Petitioner also reported that she had been diagnosed with MS. Id. Petitioner’s PCP

prescribed baclofen (antispasmodic) and a higher dose of gabapentin and referred her to

neurology “asap.” Id. at 24.

On April 21, 2016, Petitioner presented to neurologist Tooba Fayyaz, D.O., reporting a

diagnosis of MS two weeks prior. Pet. Ex. 3 at 21. Petitioner reported intermittent tingling in

her legs and “a shooting sensation going down her back” that began “around Christmas time of

2015.” Id. At this visit, Petitioner complained of blurry vision in her left eye that “[was] much

improved,” “constant pain down her back and into her upper arms,” “numbness and tingling

down both her legs,” fatigue, urinary urgency, difficulty with balance, difficulty sleeping, and

headaches. Id. Based on Petitioner’s clinical presentation and brain MRI, Dr. Fayyaz tentatively

diagnosed her with MS. Id. at 22-23. Dr. Fayyaz noted that Petitioner “only had [one] attack” of

MS, ordered a cervical spine MRI, and prescribed Copaxone (MS therapeutic). Id. at 23.

Petitioner’s April 29, 2016 cervical spine MRI with and without contrast did not show

demyelinating lesions and was normal. Id. at 54.

On May 3, 2016, Petitioner followed up with Dr. Fayyaz, who confirmed her diagnosis of

NMO after review of her NMO antibody testing the previous month. Pet. Ex. 3 at 16-18.

Petitioner reported ongoing body pain and blurry vision. Id. at 16. Dr. Fayyaz prescribed

Imuran (immunosuppressive) and prednisone and ordered a thoracic spine MRI. Id. at 18.

Petitioner’s May 10, 2016 thoracic spine MRI with and without contrast showed mild

degenerative disc disease, did not show demyelination, and was otherwise normal. Id. at 52.

Petitioner presented to the ED at Cape Regional Medical Center on June 1, 2016,

reporting pain in her right eye for three days. Pet. Ex. 4 at 936. Petitioner was admitted. Id. at

919. A repeat brain MRI with and without contrast on June 3, 2016 was unremarkable, showing

no areas of abnormal enhancement. Id. at 919, 998. Cervical spine MRI, with and without

contrast, conducted the same day showed mild disc bulging but was otherwise normal. Id. at

1000. She was discharged on June 4, 2016 in stable condition. Id. at 919. Her discharge

6

diagnoses were “[q]uestionable [NMO] with negative findings on [MRI]” and “[n]o evidence to

prove this was [NMO],” with secondary diagnoses of chronic pain and [REDACTED]. 17 Id.

On July 14, 2016, Petitioner returned to Dr. Fayyaz. Pet. Ex. 3 at 12. Petitioner reported

hand tremors, muscle spasms, and constant pain in her feet and ankles. Petitioner also reported

that her left eye vision continued to improve. Id. Diagnosis remained NMO. Id. at 14.

Petitioner continued her Imuran, prednisone, gabapentin, and baclofen. Id. at 14-15.

Petitioner had a lumber spine MRI on August 15, 2016 that showed mild degenerative

disc disease. Pet. Ex. 4 at 879-80.

On October 4, 2016, one year post-vaccination, Petitioner presented to the ED at Cape

Regional Medical Center reporting two days of blurry vision in both eyes (particularly the left),

eye pain, generalized weakness, headache, and body pains. Pet. Ex. 4 at 758, 761, 772.

Petitioner was admitted to the hospital. Id. at 765. An October 5 brain MRI with and without

contrast showed “stable [findings] with no new abnormalities.” Id. at 801. Petitioner had a low

vitamin B12 (140.6 pg/ml; reference range 211-911 pg/ml) and was started on monthly vitamin

B12 injections. 18 Id. at 742, 798. Petitioner was also treated with three days of solumedrol

infusions. Id. at 742, 791. She was discharged on October 6 with diagnoses of “[a]cute

exacerbation of [NMO],” vitamin B12 deficiency, anxiety, and chronic post-traumatic stress

disorder. Id. at 742.

Petitioner returned to Dr. Fayyaz on October 19, 2016, reporting ongoing whole-body

pain, tremors in both hands, muscle spasms, and extreme fatigue. Pet. Ex. 3 at 6. She

“sometimes” had a burning sensation in her face and behind her eyes, worsening blurry vision in

left eye with stress, numbness in hands and feet, and “sometimes” had a tingling sensation

throughout her body. Id. Dr. Fayyaz noted that Petitioner’s “overwhelming complaint [was]

pain and her MRIs [] remained stable.” Id. at 8. Petitioner was referred to Thomas Jefferson

neurology for evaluation. Id. Dr. Fayyaz also noted Petitioner’s vitamin B12 deficiency and

opined it was “a large contributing factor” to her complaints of numbness and tingling. Id.

Petitioner continued to report pain (“neuropathic pain” on December 12, 2026 and “pain

in her legs” on March 22, 2017) and fatigue through 2016 and into the summer of 2017. See Pet.

Ex. 4 at 361-69, 616-17. During this period, Petitioner also obtained treatment from pain

management for her chronic pain. See generally Pet. Ex. 42. A repeat brain MRI with and

17

Later that day, on June 4, 2016, Petitioner was transported to the ED for [REDACTED]. Pet.

Ex. 4 at 881-94. Petitioner was observed and then discharged to home without further treatment.

Id.

18

A vitamin B12 deficiency “can present with non-specific clinical features” and neurological

manifestations, including paresthesias, peripheral neuropathy, and subacute combined

degeneration of the spinal cord. Resp. Ex. A, Tab 4 at 1-2, 3 tbl.2 (Michael J. Shipton & Jacko

Thachil, VitaminB12 Deficiency – A 21st Century Perspective, 15 Clin. Med. 145 (2015)).

Additionally, “[s]equelae of untreated vitamin B12 deficiency includes . . . permanent

neurological symptoms.” Id. at 5.

7

without contrast on December 13, 2016 showed “[s]light progression in a white matter lesion”

while “other scattered patchy hyperintensities remain[ed] stable,” “no new lesions,” and “no

areas of abnormal enhancement.” Pet. Ex. 4 at 688. Overall, the findings were “nonspecific.”

Id. Petitioner underwent an inpatient laparoscopic cholecystectomy on December 30, 2016 at

Cooper University Hospital. Pet. Ex. 12 at 57-58. A neurology consultation noted “[no]

evidence to suggest NMO exacerbation at the moment.” Id. at 61.

On August 29, 2017, almost two years post-vaccination, Petitioner presented to

neurologist Vikram Bhise, M.D., at Robert Wood Johnson Medical School. Pet. Ex. 9 at 23.

Petitioner reported that her symptoms “began in October 2015 following a flu shot.” Id.

Symptoms at that time were “‘zapping’ going up and down her spine as well as burning of the

feet.” Id. She reported she then lost her vision in her left eye in April 2016, after which she was

diagnosed with NMO. Id. Petitioner complained of continued “mild blurred vision in her left

eye” and “pseudo-flares.” Id. Under history of present illness, Dr. Bhise summarized pertinent

medical records and documented a timeline of events. Id. at 23-24. The timeline indicated

“10/2015 Lhermitte sign, paresthesias” 19 followed by “04/2016 left optic neuritis, lip numbness.”

Id. at 24. On examination, Petitioner had normal vision in both eyes and no neurological

abnormalities. Id. at 27-28. Dr. Bhise diagnosed Petitioner with NMO, with an “initial symptom

onset nearly [two] years ago” and “relapse free since April 2016.” Id. at 28. Dr. Bhise adjusted

the dosage of Petitioner’s medications, ordered updated MRIs and labwork, and recommended

physical therapy for her chronic pain. Id. at 28-29. On August 29, 2017, Petitioner’s AQP4 IgG

was negative and her vitamin B12 was normal. Id. at 36, 39.

Petitioner continued to report pain and fatigue in 2017 and 2018 and repeat MRIs, with

and without contrast, were conducted. See, e.g., Pet. Ex. 4 at 49-59, 197-200, 248-51; Pet. Ex. 7

at 5-7. Repeat thoracic and lumbar spine MRIs on September 19, 2017 “show[ed] no areas of

abnormal enhancement” and mild degenerative disc disease. Id. at 248-51. Repeat cervical

spine MRI on November 27, 2017 was normal. Id. at 197. And repeat brain MRI on November

27, 2017 showed “[s]table white matter hyperintensities consistent with the patient’s history of

[NMO]” and “the left optic nerve appear[ed] slightly enlarged, with peripheral and subtle central

enhancement.” Id. at 199-200.

On December 7, 2017, Petitioner saw Elissa M. Wierman, PAC, to start care with a new

PCP and for medication refills. Pet. Ex. 7 at 5. Petitioner reported “eye pain and periorbital

pain” that occurred frequently as well as “muscle pain and joint pain.” Id. Assessment included

NMO, for which PAC Wierman indicated medication refills would not be given at that time. Id.

19

Lhermitte’s sign is “the development of sudden, transient, electric-like shocks spreading down

the body when the patient flexes the head forward; seen mainly in [MS] but also in compression

and other disorders of the cervical cord.” Lhermitte Sign, Dorland’s Med. Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=106344 (last visited Oct. 31, 2025).

“[S]ymptoms typical of spinal cord demyelination that are seen in [] [NMO] . . . include . . .

Lhermitte’s symptom (spinal or limb dysaesthesias caused by neck flexion).” Resp. Ex. A, Tab

2 at 2. Lhermitte’s sign has also been reported in patients with vitamin B12 deficiency. Resp.

Ex. A, Tab 3 at 1 (William M. Butler et al., Lhermitte’s Sign in Cobalamin (Vitamin B12)

Deficiency, 245 JAMA 1059 (1981)).

8

at 7. Assessment also included vitamin B12 deficiency and PAC Wierman opined this deficiency

“[was] a large contributing factor in her . . . numbness/tingling.” Id.

At an ED visit on January 14, 2018, Petitioner reported feeling “exhausted weak and

dehydrated. . . . She describe[d] her weakness as a sensation that her legs feel weak and she has

burning in her legs and feet. She does not feel they will hold her up.” Pet. Ex. 4 at 49.

Petitioner was noted to have “chronic pain issues” and was “followed by pain management.” Id.

Petitioner further reported “[s]he did not get a flu vaccine this year as she state[d] the flu vaccine

precipitated her [NMO].” Id. Repeat MRIs of the brain, cervical spine, and thoracic spine on

January 15, 2018 “demonstrated no enhancing lesions.” Id. at 42, 74. She was discharged home

the following day. Id. at 42.

In February 2018, Petitioner returned to the ED, reporting “nerve pain going up back,

seeing flashes of light and black spots, stinging feeling all over.” Pet. Ex. 4 at 3. Testing was

normal other than a urinary tract infection and high blood pressure. Id. at 13. Petitioner was

discharged home that same day. Id.

On March 22, 2018, Petitioner presented to neurologist Donald Barone, D.O., who

diagnosed Petitioner with “[r]esidual findings [of NMO] on exam[ination] [] but no definite

clinical disease activity.” Pet. Ex. 1 at 1-4. Dr. Barone suspected that Petitioner’s “current

visual symptoms [were] migraine aura without headache.” Id. at 5.

Petitioner’s next repeat MRIs were conducted on November 6, 2018, over three years

post-vaccination. Pet. Ex. 13 at 37-43. Petitioner’s brain MRI without contrast showed a

“potential mild right optic nerve T2 hyperintense signal and edema versus motion artifact. No

diffusion restriction to specify an active lesion.” Id. at 37-38. Petitioner’s cervical spine MRI

without contrast showed “no convincing cord signal abnormality.” Id. at 38-39. Similarly, no

cord signal abnormalities were noted on Petitioner’s thoracic and lumbar spine MRIs. Id. at 39-

43.

From 2019 through the spring of 2021, Petitioner periodically requested NMO

medication refills from her PCP. Pet. Ex. 44 at 2-68. No additional medical records were filed.

2. Petitioner’s Declarations 20

Petitioner executed a declaration on December 5, 2024. Pet. Ex. 56. Petitioner received

a flu vaccination on October 4, 2015. Id. at ¶ 3. She averred that she “first started experiencing

burning/zapping sensation in [her] back and legs around Thanksgiving 2015.” Id. at ¶ 5. She felt

“really fatigued” to the point she could not assist with Thanksgiving meal preparations and

cleaning. Id. She first attributed the “burning/zapping sensations in [her] back and legs” to her

new job, which she began a few months prior to vaccination, because she was on her feet all day

and often would lift heavy items. Id. at ¶¶ 4, 6.

20

Although titled affidavits, they were not notarized and are therefore referenced as declarations.

See Pet. Exs. 41, 56.

9

Petitioner stated that she “then started experiencing issues with [her] vision.” Pet. Ex. 56

at ¶ 7. She first developed floaters and blurriness, which she attributed to age. Id. Her vision

then began to get darker until she could no longer see out of her left eye. Id. Petitioner did not

indicate when her vision issues began other than the fact they began sometime after the

“burning/zapping sensations in [her] back and legs” and before she went to Thomas Jefferson

University Hospital in April 2016. See id. at ¶¶ 6-8.

Regarding the lack of treatment following vaccination, Petitioner averred that she did not

“recall seeking any medical care during the time period between October 4, 2015 and March 29,

2016.” Pet. Ex. 41 at ¶ 2. She did not have a PCP during this period of time, and she did not

establish care with a PCP until April 21, 2016. Id. She did not seek medical treatment for her

vaccine-related injury until April 4, 2016 at Thomas Jefferson University Hospital. Id. at ¶ 3.

D. Expert Reports

1. Petitioner’s Expert, Dr. Alberto Martinez-Arizala 21

a. Background and Qualifications

Dr. Martinez-Arizala has been a professor of clinical neurology, neurosurgery, and

physical medicine and rehabilitation at the University of Miami Miller School of Medicine for

over 30 years. Pet. Ex. 14 at 1; Pet. Ex. 15 at 1-2. He obtained his M.D. from the university of

Miami School of Medicine, after which he completed an internship and neurology residency

through the U.S. Army and served until 1994. Pet. Ex. 14 at 1; Pet. Ex. 15 at 1-3. He is board

certified in neurology and spinal cord medicine. Pet. Ex. 14 at 1; Pet. Ex. 15 at 1-2. Dr.

Martinez-Arizala also worked as the Chief of the Spinal Cord Injury Service at the Miami VA

Health Care System where he treated patients with spinal cord disorders, including patients with

transverse myelitis and NMOSD. Pet. Ex. 14 at 1. Throughout his career, Dr. Martinez-Arizala

has co-authored or authored various publications on the spinal cord and has been a member of

professional organizations. Pet. Ex. 15 at 3-11. Since 2018, he has also served on the editorial

board of The Journal of Spinal Cord Medicine. Id. at 10.

b. Opinion

Dr. Martinez-Arizala opined “[t]he weight of the evidence implicates the [flu] vaccine

[Petitioner] was administered on [October 4, 2015] as triggering the optic neuritis and associated

[NMO].” Pet. Ex. 14 at 5.

i. Althen Prong One

Dr. Martinez-Arizala opined the flu vaccine can cause optic neuritis and NMO via

molecular mimicry. Pet. Ex. 14 at 4-6.

21

Dr. Martinez-Arizala provided one expert report. Pet. Ex. 14.

10

“Molecular mimicry i.e. the molecular similarity between the proteins of the viruses used

for the vaccination and self antigens (for instance, CNS myelin components) [] represents one of

the main immunopathogenetic mechanisms in post-vaccination CNS demyelination.” Pet. Ex. 30

at 7. Dr. Martinez-Arizala explained that with molecular mimicry, “components of the vaccine

possess sequence similarities between it and specific human proteins that result in the cross-

activation of autoreactive T or B cells,” which “causes a reaction of the immune system towards

the pathogenic antigens that may harm the similar human proteins, essentially causing

autoimmune disease.” Pet. Ex. 14 at 4. Specific to this case, “components of the vaccine

resemble myelin in the optic nerve and [CNS] and trigger the inflammatory response that

damage[] the optic nerve and cerebral white matter.” Id. at 6. He stated components of the flu

vaccine in 2014-2015 22 contained a protein that was cross-reactive with myelin oligodendrocyte

glycoprotein (“MOG”), 23 which he contended is associated with optic neuritis. Id. at 4 (citing

Pet. Ex. 18; Pet. Ex. 19 at 1 (noting “antibodies against MOG are found in patients with . . .

[NMO]”)). 24

In his expert report, Dr. Martinez-Arizala discussed a literature review by Karussis and

Petrou. Pet. Ex. 14 at 4 (citing Pet. Ex. 30). Karussis and Petrou conducted a PubMed search

from 1979 to 2013 and found articles that reported 71 cases of CNS demyelinating diseases

following vaccination. Pet. Ex. 30 at 1. Of the 71 cases, 21 were following flu vaccines. Id.

However, none of the flu vaccination cases resulted in NMO. Id. at 4 tbl.2. NMO was the injury

in seven of the 71 cases, and most of these cases were following human papillomavirus

vaccination. Id. at 4-5 tbl.2, 6. In the 21 flu vaccination cases, eight developed optic neuritis and

only four of the eight had a documented onset (three weeks, two weeks, 15 days, and two

weeks). Id. at 4 tbl.2. The authors noted that “[u]sually the symptoms of the CNS demyelinating

syndrome appear [a] few days following the immunization (mean: 14.2 days) but there are cases

where the clinical presentation was delayed (more than [three] weeks or even up to [five] months

post-vaccination) (approximately a third of all the reported cases).” Id. at 1. They concluded

“[t]here is no absolute way to definitely link the onset or exacerbation of demyelination with the

vaccine, but the close temporal association with the time of vaccination strongly argues in favor

of such pathogenetic correlation.” Id. at 7. They noted the risk of onset or relapse of CNS

demyelinating diseases following infections are “substantially higher.” Id.

22

For the strains used in 2014-2015 flu vaccination, see Pet. Ex. 17. However, the exact make

up of Petitioner’s flu vaccination, or the package insert, was not provided.

23

MOG “is a myelin protein localized at the surface of myelin sheath and is a potential target of

demyelinating diseases,” including CNS demyelinating disorders. Pet. Ex. 28 at 1 (Kimihiko

Kaneko et al., CSF Cytokine Profile in MOG-IgG+ Neurological Disease Is Similar to AQP4-

IgG+ NMOSD but Distinct from MS: A Cross-Sectional Study and Potential Therapeutic

Implications, 89 J. Neurol. Neurosurg. & Psychiatry 927 (2018)). It does not appear Petitioner

was tested for MOG.

24

Hideki Nakajima et al., Antibodies to Myelin Oligodendrocyte Glycoprotein in Idiopathic

Optic Neuritis, 5 BMJ Open 1 (2015).

11

Dr. Martinez-Arizala noted the existence of case reports, citing seven articles discussing

case reports of optic neuritis post-flu vaccination and one article discussing a case of NMOSD

post-flu vaccination. Pet. Ex. 14 at 4 (citing Pet. Exs. 19-25, 39). However, he did not discuss

these case reports or their applicability to this case.

He also cited case reports of NMO and other CNS demyelinating disorders following

yellow fever, human papillomavirus, hepatitis B, 23-valent pneumococcal polysaccharide,

Japanese encephalitis, and rabies vaccinations. Pet. Ex. 14 at 4-5 (citing Pet. Exs. 32-38). Dr.

Martinez-Arizala also did not discuss any of these case reports. Nor did he discuss their

applicability here or how they relate to the flu vaccine or his proposed theory.

Despite the fact that Dr. Martinez-Arizala did not discuss the case reports, the

undersigned finds a brief review of the reports of optic neuritis and NMOSD post-flu vaccination

informative.

Kawasaki et al. 25 reported two cases of bilateral optic disc edema following flu

vaccination. Pet. Ex. 19. Both patients developed vision loss in one eye with eye pain or

headache within four weeks of flu vaccination, with involvement of the second eye occurring

shortly thereafter. Id. at 4. The authors believed “[a]n immune-mediated demyelinative injury

of the optic nerve” was “an unlikely mechanism in [their] first patient.” Id. Instead, they

“speculate[d]” the mechanism at play was an anterior ischemic optic neuropathy due to the

temporal relationship to flu vaccination and bilateral involvement in both patients. Id.

The next case report is from Bienfang et al. 26 Pet. Ex. 20 at 1. Eleven days after H1N1

vaccination, the patient developed myalgias, arthralgias, and fever. Id. One week later, the

symptoms worsened, and the patient began a course of oral prednisone. Id. On the third day of

prednisone and about 20 days after vaccination, the patient developed blurred vision and eye

pain. Id. He was diagnosed with iritis 27 in one eye and optic neuritis in the other eye. Id. The

authors did not opine to the cause of the optic neuritis. Id. They did note that the time course

between vaccination and systemic illness “is appropriate for an allergic reaction to injected

foreign protein.” Id.

25

Aki Kawasaki et al., Bilateral Anterior Ischemic Optic Neuropathy Following Influenza

Vaccination, 18 J. Neuro-Ophthalmolo. 56 (1998).

26

Don C. Bienfang et al., Ocular Abnormalities After Influenza Immunization, 95 Arch.

Ophthalmol. 1649 (1977).

27

Iritis is “inflammation of the iris, usually marked by pain, congestion in the ciliary region,

photophobia, contraction of the pupil, and discoloration of the iris.” Iritis, Dorland’s Med.

Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=26154 (last visited

Oct. 31, 2025).

12

Perry et al. 28 reported a case of bilateral optic neuritis that occurred in a patient 20 days

following a flu vaccination and six days following a flu vaccination booster. Pet. Ex. 21 at 1.

The authors noted the temporal relationship with vaccination but did not opine the bilateral optic

neuritis was caused by flu vaccination. Id. at 5.

Similarly, Ray and Dreizin 29 reported a case of bilateral optic neuritis three weeks post-

flu vaccination. Pet. Ex. 22 at 1. The authors ruled out various causes and concluded “[t]his

case supports [flu] vaccine as a cause of optic neuropathy,” relying on the similar onset periods

described in the Perry et al. and Bienfang et al. case reports. Id. at 3 (citing Pet. Exs. 20-21).

Cangemi and Bergen 30 documented a case of acute optic neuritis two weeks after swine

flu vaccination. Pet. Ex. 23 at 1. They authors concluded the temporal relationship “may very

well indicate a causal relationship. . . . However, we must emphasize that this is speculative.”

Id. at 3.

Macoul 31 described a case of bilateral optic nerve atrophy two to three weeks following

swine flu vaccination. Pet. Ex. 24 at 1. Macoul opined that this three-week interval “correlates

well with the period of viral replication” and concluded “[i]t is most probable” that the swine flu

vaccine was causal. Id.

Lastly, Hull and Bates 32 documented a case of bilateral optic neuritis in one patient on

two consecutive occasions, both two weeks after flu vaccination. Pet. Ex. 25 at 2. The authors

concluded “[their] case provides compelling clinical evidence that implicates [flu] vaccination as

a cause of optic neuritis.” Id. The authors noted the cause of post-vaccination neuropathies are

not known, acknowledged that molecular mimicry has been suggested, but found that theory

“unlikely.” Id.

28

Henry D. Perry et al., Reversible Blindness in Optic Neuritis Associated with Influenza

Vaccination, 11 Annals Ophthalmol. 545 (1979).

29

Cheryl L. Ray & Ivy J. Dreizin, Bilateral Optic Neuropathy Associated with Influenza

Vaccination, 16 J. Neuro-Ophthalmol. 182 (1996).

30

Francis E. Cangemi & Robert L. Bergen, Optic Atrophy Following Swine Flu Vaccination, 12

Annals Ophthalmol. 857 (1980).

31

Kenneth L. Macoul, Bilateral Optic Nerve Atrophy and Blindness Following Swine Influenza

Vaccination, 14 Annals Ophthalmol. 398 (1982).

32

Thomas P. Hull & James H. Bates, Optic Neuritis After Influenza Vaccination, 124 Am. J.

Ophthalmol. 703 (1997).

13

And for NMOSD post-flu vaccination, Dr. Martinez-Arizala cited Cho et al., 33 who

documented a case of longitudinally extensive transverse myelitis, later diagnosed as NMOSD

following positive anti-AQP4 antibodies, that occurred three days after flu vaccination. Pet. Ex.

39 at 1. The patient had previously received the flu vaccine annually for years without side

effects. Id. Two months prior to admission, the patient gave birth. Id. This patient did not

develop optic neuritis. Id. at 1-3. The authors acknowledged that “the precise etiology and

pathogenesis of NMOSD have not yet been established.” Id. at 3. Infections have been

suggested as a trigger because 30% of NMOSD patients report an infection before the onset of

neurological symptoms. Id. The authors also noted molecular mimicry has been suggested as a

mechanism. Id. The authors did not opine the vaccine in the reported case was causal, noting “it

is difficult to determine whether the relationship between vaccination and autoimmune disease is

causal or coincidental.” Id.

ii. Althen Prongs Two and Three

Dr. Martinez-Arizala opined there is a logical sequence of cause and effect because

Petitioner’s “[flu] vaccine contains components that triggered the optic neuritis” and “[t]he onset

of her neurological symptoms was well within the time boundaries of the vaccine

administration.” Pet. Ex. 14 at 5-6.

First, Dr. Martinez-Arizala did not explain how his theory, which relied upon the

existence of MOG, applied here, when it appears Petitioner was not tested for MOG antibodies.

Second, regarding an alternative cause, he noted Petitioner had no evidence of optic

neuritis prior to vaccination. Pet. Ex. 14 at 5. Dr. Martinez-Arizala also opined Petitioner had

no other illness or infection that could have triggered her optic neuritis and NMO. Id.

Next, as to whether Petitioner’s course was consistent with vaccine causation, this turns

on when Petitioner’s neurological symptoms of NMO began. Dr. Martinez-Arizala did not

explain what he meant by “neurological symptoms.” However, he consistently cited records

describing Petitioner’s reports of lower extremity paresthesias and zapping sensations. Thus, it

appears the “neurological symptoms” he discusses and relies upon in regard to prongs two and

three are Petitioner’s lower extremity paresthesias and burning/zapping sensations, and not her

visual symptoms.

Dr. Martinez-Arizala provided conflicting opinions for onset of lower extremity

paresthesias and zapping sensations. He opined Petitioner’s “contemporaneous medical records

are consistent in pinning the start of her neurological symptoms about 4-8 weeks after

vaccination.” Pet. Ex. 14 at 2, 5. Then, on the following page of his report, Dr. Martinez-

Arizala concluded that “[t]he vaccination was administered on [October 4, 2015] and the onset of

the neurological symptoms occurred approximately 8-12 weeks [after,] which is clearly within

the expected time period reported in the published medical literature.” Id. at 6.

33

Jeong Hee Cho et al., A Case of Neuromyelitis Optic Spectrum Disorder Following Seasonal

Influenza Vaccination, 30 Mult. Scler. & Relat. Disord. 110 (2019).

14

To support his opinions as to onset, Dr. Martinez-Arizala cited to three of Petitioner’s

medical records. Pet. Ex. 14 at 2, 5. First, he cited to Petitioner’s records from her first

hospitalization on April 3, 2016, in which he maintained Petitioner’s “neurological symptoms

started shortly after receiving the vaccination.” Id. at 5. However, as Dr. Martinez-Arizala

acknowledged, the records from this hospitalization document Petitioner complained of bilateral

foot paresthesias for two months, which would place onset approximately February 3, 2016, four

months post-vaccination, not “shortly after” vaccination. Id. at 2, 5; see Pet. Ex. 2 at 15-16.

Dr. Martinez-Arizala also cited to records from Dr. Fayyaz and contended they also

document Petitioner’s “neurological symptoms started shortly after receiving the vaccination.”

Pet. Ex. 14 at 5. As he noted, however, Petitioner first saw Dr. Fayyaz on April 21, 2016 and

reported intermittent tingling in her legs and “a shooting sensation going down her back” that

began “around Christmas time of 2015.” Pet. Ex. 3 at 21; see also Pet. Ex. 14 at 2. This would

place onset around 11 to 12 weeks post-vaccination, not “shortly after” vaccination. See Pet. Ex.

14 at 2, 5.

And third, Dr. Martinez-Arizala cited to a record from Dr. Bhise, dated August 29, 2017,

almost two-years post vaccination, that documented Petitioner reported her symptoms

“[beginning] in October 2015 following a flu shot.” Pet. Ex. 14 at 2, 5 (quoting Pet. Ex. 9 at 23).

This would place onset the same month as Petitioner’s flu vaccination. He opined “this clearly

establishes that the onset of neurological symptoms preceded her optic neuritis and occurred

approximately 4-8 weeks following the vaccination.” Id. at 2.

Lastly, the cited case reports of optic neuritis following flu vaccination report an onset

range of three days up to four weeks after vaccination. Kawasaki et al. reported two cases of

bilateral optic disc edema within four weeks of flu vaccination. Pet. Ex. 19 at 4. Bienfang et al.

and Perry et al. discussed patients who developed bilateral optic neuritis approximately 20 days

post flu-vaccination. Pet. Ex. 20 at 1; Pet. Ex. 21 at 1. Ray and Dreizin reported a case of

bilateral optic neuritis three weeks post-flu vaccination. Pet. Ex. 22 at 1. Cangemi and Bergen

documented a case of acute optic neuritis two weeks after swine flu vaccination. Pet. Ex. 23 at 1.

Macoul described a case of bilateral optic nerve atrophy two to three weeks following swine flu

vaccination. Pet. Ex. 24 at 1. Hull and Bates discussed a patient who developed bilateral optic

neuritis twice, both two weeks following flu vaccinations in consecutive years. Pet. Ex. 25 at 2.

And Cho et al. discussed a patient who received a flu vaccination, and three days later

developed longitudinally extensive transverse myelitis, later confirmed as NMOSD. Pet. Ex. 39

at 1.

2. Petitioner’s Expert, Dr. David M. Yousem 34

a. Background and Qualifications

Dr. Yousem is a board-certified radiologist with a subspecialty certification in

neuroradiology. Pet. Ex. 54 at 1. After receiving his M.S. from University of Michigan, he

34

Dr. Yousem provided one expert report. Pet. Ex. 54.

15

completed a diagnostic radiology residency at The Johns Hopkins Hospital, a general

radiology/neuroradiology fellowship at The Johns Hopkins Hospital, and a neuroradiology

fellowship at the Hospital of the University of Pennsylvania. Pet. Ex. 55 at 1. He has held

positions at Johns Hopkins and University of Pennsylvania since 1990. Id. He has authored or

co-authored almost 400 publications, he has held appointments on editorials and journals, he has

been a member of numerous societies, and he has won various awards and honors throughout his

career. Id. at 1-21, 29-34.

Dr. Yousem was retained to examine Petitioner’s MRI studies. Pet. Ex. 54 at 1. He

offered no opinions about vaccine causation. Id. at 5.

b. Opinion

Dr. Yousem opined Petitioner “had active left optic neuritis” seen on her April 3, 2016

brain MRI and “may have had additional flares” as demonstrated by her MRIs on October 5,

2016 and November 27, 2017. Pet. Ex. 54 at 5.

Petitioner’s first brain MRI was conducted on April 3, 2016. Pet. Ex. 54 at 2; see Pet. Ex.

2 at 154-55. Dr. Yousem opined that the MRI “show[ed] non-specific periventricular and

juxtacortical white matter lesions bilaterally that do not enhance and do not show restricted

diffusion.” Pet. Ex. 54 at 2. He explained these are not normal findings for an individual of

Petitioner’s age (44). Id. Because there was no evidence of enhancement, he opined that the

lesions seen “[were] not active or recent in age” and “[were] more likely than not greater than

days to [two] weeks old.” Id.

Secondly, he opined that the April 3, 2016 MRI images of her orbits showed

enhancement of the left optic nerve, meaning Petitioner “had active left optic neuritis” on April

3, 2016. Pet. Ex. 54 at 3, 5.

Petitioner’s next brain MRI, done June 2016, showed the left optic nerve was no longer

enhancing and was otherwise unchanged. Pet. Ex. 54 at 3.

Additionally, Petitioner’s next brain MRI in October 2016 was stable. Pet. Ex. 54 at 3.

Dr. Yousem noted the left optic nerve was “slightly brighter” and “smaller” than the right optic

nerve in this study, which he opined “could be [evidence of] faint enhancement on the left.” Id.

However, because there was no orbital study to clearly identify these findings, Dr. Yousem

explained he would need clinician confirmation of visual complaints at this time to determine

whether Petitioner was having active disease. Id. at 3-4.

The next brain MRI from December 2016, according to Dr. Yousem, was stable with no

new abnormalities or enhancement. Pet. Ex. 54 at 4.

With regard to the November 2017 brain MRI, Dr. Yousem had concerns about

Petitioner’s left optic nerve on one image. Pet. Ex. 54 at 4. Again, he noted orbital views were

not performed and thus, he would need clinical confirmation. Id.

16

In January 2018, an orbital MRI examination was conducted and showed no

enhancement of the left optic nerve. Pet. Ex. 54 at 4.

He also reviewed Petitioner’s cervical, thoracic, and lumbar spine MRIs from 2016 to

2020 and noted no areas of demyelination were seen. Pet. Ex. 54 at 5.

Dr. Yousem concluded Petitioner “had active left optic neuritis” on April 3, 2016, as

depicted by her MRI. Pet. Ex. 54 at 5. Dr. Yousem did not offer an opinion as to the onset of

Petitioner’s optic neuritis or NMO. See id. at 1-5.

3. Respondent’s Expert, Dr. Subramaniam Sriram 35

a. Background and Qualifications

Dr. Sriram currently works as a Professor of Neurology and Microbiology Immunology

and Director of the MS Clinic at Vanderbilt Medical Center. Resp. Ex. A at 1. He received his

M.B. and B.S. from University of Madras in India in 1973. Resp. Ex. B at 1. Thereafter, he was

an intern and internal medicine resident at Wayne State University in Michigan, as well as a

neurology resident, chief neurology resident, and post-doctoral fellow in neuroimmunology at

Stanford University. Id. Dr. Sriram is board certified in internal medicine and psychiatry and

neurology, and is licensed to practice in California, Vermont, and Tennessee. Id. He has

authored or co-authored over 150 publications. Id. at 9-22. “[He] follow[s] approximately 50

patients with [NMO]” and is “a recognized expert in the field of Neuroimmunology and MS.”

Resp. Ex. A at 1.

b. Opinion

Dr. Sriram opined “to a reasonable degree of medical certainty that the development of

NMO in [Petitioner] was not caused by the receipt of the flu vaccine on October 4, 2015.” Resp.

Ex. A at 7; see also Resp. Ex. C at 5.

i. Althen Prong One

Dr. Sriram did not discuss or address Petitioner’s theory of molecular mimicry in detail.

See Resp. Exs. A, C. In response to Dr. Martinez-Arizala’s opinions about MOG and its

relevance here, Dr. Sriram opined that MOG is not the antigen known to cause NMO. Resp. Ex.

A at 7. He further opined there is no known cross-reactivity between the flu vaccine and AQP4,

the autoantigen that causes NMO. Id.

Dr. Sriram responded to the medical literature discussed in Dr. Martinez-Arizala’s expert

report. 36 Resp. Ex. A at 7. As to the paper authored by Karussis and Petrou, Dr. Sriram noted

35

Dr. Sriram provided two expert reports. Resp. Exs. A, C.

36

One article from Mealy et al. was mentioned in Dr. Martinez-Arizala’s expert report but was

not cited or otherwise filed by Petitioner.

17

the authors did not identify any cases of NMO following the flu vaccine. Id. (citing Pet. Ex. 30

at 4 tbl.2).

ii. Althen Prongs Two and Three

Dr. Sriram opined the flu vaccination administered on October 4, 2015 did not cause

Petitioner’s NMO. Resp. Ex. A at 5-7. He opined the cause of Petitioner’s optic neuritis was

well identified—AQP4 antibodies. Resp. Ex. C at 2.

He explained that “loss of myelin is the dominant feature of NMO,” but with AQP4, “the

destruction of myelin is indirect since the [AQP4] antibodies are present on another CNS cell

type, the astrocytes.” 37 Resp. Ex. A at 4. More specifically, “[b]inding by antibodies to [AQP4]

antigens leads to the fixation of complement proteins on astrocytes leading to loss of astrocytes.

Since astrocytes are necessary for the functioning of the oligodendrocytes, loss of myelin is

therefore the result of collateral damage done to the astrocytes by the [AQP4] antibodies.” Id.

Regarding the onset of Petitioner’s NMO, Dr. Sriram looked to “[t]he cardinal feature of

the neurologic deficit, optic neuritis associated with inflammation of the optic nerve seen on

subsequent neuroimages,” which was around April 4, 2016. Resp. Ex. C at 4. He opined that

Petitioner’s earlier neurologic complaints (i.e., paresthesias) were not attributable to her NMO.

Id. at 4-5; Resp. Ex. A at 6.

With regard to the foot paresthesias and “zapping” sensation Petitioner described, Dr.

Sriram opined these symptoms were not consistent with NMO. Resp. Ex. A at 4-6; Resp. Ex. C

at 4. Dr. Sriram agreed NMO can cause lesions in the spinal cord, which could lead to the

neurological symptoms described by Petitioner. Resp. Ex. A at 6. However, Petitioner had

numerous MRIs of her entire spine and each was normal. Id. Petitioner’s expert, Dr. Yousem

agreed there was a lack of any evidence of spinal cord inflammation. Resp. Ex. C at 4 (citing

Pet. Ex. 54 at 5). Further, no contemporaneous medical records document that Petitioner

experienced “neurologic deficits between the receipt of the vaccine and the development of optic

neuritis.” Id. at 4-5. Dr. Sriram opined this lack of clinical evidence does not support spinal

cord involvement related to NMO which could explain Petitioner’s complaints of paresthesias or

“zapping” sensations. Resp. Ex. A at 6.

Dr. Sriram next noted that “[e]ven if we assume[d] that her lower extremity paresthesias

was the earliest evidence of NMO, . . . the historical record is inconsistent with the onset of her

paresthesias of her legs.” Resp. Ex. A at 6. Dr. Sriram cited to the same three medical records

as Dr. Martinez-Arizala and noted these records document Petitioner reporting three different

dates for onset of her lower extremity paresthesias. Id. First, during her April 2016

hospitalization, Petitioner reported two months of neurological symptoms (bilateral foot

paresthesias), placing onset in February 2016, four months after vaccination. Id. Then, at her

37

An astrocyte is “a neuroglial cell of ectodermal origin, characterized by fibrous, protoplasmic,

or plasmatofibrous processes.” Astrocyte, Dorland’s Med. Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=4587 (last visited Oct. 31, 2025).

18

first visit to Dr. Fayyaz, later in April 2016, Petitioner reported her symptoms began around

Christmas of 2015, which is 11 to 12 weeks post-vaccination. Id. Lastly, Dr. Bhise’s records

from August 2017 described Petitioner’s neurological symptoms as beginning in October 2015.

Id. Overall, he concluded “[t]here is [] a wide discrepancy on the date of onset of [these]

symptoms” in her medical records. Id.

Even if onset was in October 2015, the earliest date mentioned in her medical records,

though not the date of onset identified in her most contemporaneous medical records, Dr. Sriram

maintained this “does not establish that the symptoms she had were due to the vaccine” as there

was a “normal MRI of the spine and lack of clinical evidence of myelitis.” Resp. Ex. A at 6.

Furthermore, there was no medical record evidence between vaccination (October 2015) and the

development of optic neuritis (April 2016) documenting Petitioner’s neurologic deficits. Resp.

Ex. C at 4-5.

As stated earlier, Dr. Sriram explained Petitioner did not have signs or symptoms of optic

neuritis until April 2016, six months after vaccination. Resp. Ex. A at 5. He maintained there is

no indication in Petitioner’s medical records that she suffered symptoms of optic neuritis prior to

then. Id. This time interval of six months “is much longer than what would be considered a

causal connection for a logical sequence of cause and effect,” making “a causal connection”

between vaccination and NMO unlikely. Id. at 5-6.

Dr. Sriram agreed with Dr. Yousem that Petitioner’s April 2016 brain MRI showed

enhancement (active inflammation) of the left optic nerve. Resp. Ex. C at 3. Dr. Sriram opined

it was “unlikely” that this inflammation was present for months prior to Petitioner’s onset of

visual symptoms. Id. at 4. Thus, he opined Petitioner’s April 2016 brain MRI abnormality seen

in the optic nerve “occurred hand-in-hand with the clinical symptoms of decreased vision.” Id.

Petitioner first complained of issues with her vision on March 29, 2016, when she had floaters in

her left eye, and a few days later, she presented to the ED for a one-day history of left eye

“curtain” and flashes. Resp. Ex. A at 2 (citing Pet. Ex. 2 at 15; Pet. Ex. 8 at 1).

Regarding Petitioner’s Lhermitte’s-like symptoms, Dr. Sriram opined these symptoms

can be seen in both NMO and vitamin B12 deficiency. Resp. Ex. A at 4-6; Resp. Ex. C at 4.

Spinal cord demyelination seen in NMO can result in symptoms consistent with Lhermitte’s

sign. Resp. Ex. A, Tab 2 at 2. However, Petitioner had no evidence of demyelination seen on

spinal cord MRI, and thus, Dr. Sriram opined that Petitioner’s vitamin B12 deficiency can cause

Lhermitte’s-like symptoms, including tingling of the feet and the “zapping” sensation described

by Petitioner. Resp. Ex. A at 4-6; Resp. Ex. C at 4; see Resp. Ex. A, Tabs 3-4. He explained

that severe cases of vitamin B12 deficiency can cause neurological abnormalities, including

“[n]umbness, tingling of extremities, weakness[,] and sometimes electric shock like sensations of

the back due to spinal cord involvement.” Resp. Ex. A at 4-5 (citing Resp. Ex. A, Tabs 3-4).

And these “clinical symptoms of B12 deficiency [] match the symptoms that [Petitioner]

described in her spine and extremities.” Id. at 5.

19

III. DISCUSSION

A. Standards for Adjudication

The Vaccine Act was established to compensate vaccine-related injuries and deaths. §

10(a). “Congress designed the Vaccine Program to supplement the state law civil tort system as

a simple, fair and expeditious means for compensating vaccine-related injured persons. The

Program was established to award ‘vaccine-injured persons quickly, easily, and with certainty

and generosity.’” Rooks v. Sec’y of Health & Hum. Servs., 35 Fed. Cl. 1, 7 (1996) (quoting

H.R. Rep. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344).

Petitioner’s burden of proof is by a preponderance of the evidence. § 13(a)(1). The

preponderance standard requires a petitioner to demonstrate that it is more likely than not that the

vaccine at issue caused the injury. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315,

1322 n.2 (Fed. Cir. 2010). Proof of medical certainty is not required. Bunting v. Sec’y of Health

& Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). Petitioner need not make a specific type of

evidentiary showing, i.e., “epidemiologic studies, rechallenge, the presence of pathological

markers or genetic predisposition, or general acceptance in the scientific or medical communities

to establish a logical sequence of cause and effect.” Capizzano v. Sec’y of Health & Hum.

Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006). Instead, Petitioner may satisfy her burden by

presenting circumstantial evidence and reliable medical opinions. Id. at 1325-26.

In particular, Petitioner must prove that the vaccine was “not only [the] but-for cause of

the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321

(quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999));

see also Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). The

received vaccine, however, need not be the predominant cause of the injury. Shyface, 165 F.3d

at 1351. A petitioner who satisfies this burden is entitled to compensation unless Respondent

can prove, by a preponderance of the evidence, that the vaccinee’s injury is “due to factors

unrelated to the administration of the vaccine.” § 13(a)(1)(B). However, if a petitioner fails to

establish a prima facie case, the burden does not shift. Bradley v. Sec’y of Health & Hum.

Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).

“Regardless of whether the burden ever shifts to the [R]espondent, the special master

may consider the evidence presented by the [R]espondent in determining whether the [P]etitioner

has established a prima facie case.” Flores v. Sec’y of Health & Hum. Servs., 115 Fed. Cl. 157,

162-63 (2014); see also Stone v. Sec’y of Health & Hum. Servs., 676 F.3d 1373, 1379 (Fed. Cir.

2012) (“[E]vidence of other possible sources of injury can be relevant not only to the ‘factors

unrelated’ defense, but also to whether a prima facie showing has been made that the vaccine

was a substantial factor in causing the injury in question.”); de Bazan v. Sec’y of Health & Hum.

Servs., 539 F.3d 1347, 1353 (Fed. Cir. 2008) (“The government, like any defendant, is permitted

to offer evidence to demonstrate the inadequacy of the [P]etitioner’s evidence on a requisite

element of the [P]etitioner’s case-in-chief.”); Pafford, 451 F.3d at 1358-59 (“[T]he presence of

multiple potential causative agents makes it difficult to attribute ‘but for’ causation to the

vaccination. . . . [T]he Special Master properly introduced the presence of the other unrelated

contemporaneous events as just as likely to have been the triggering event as the vaccinations.”).

20

B. Factual Issues

A petitioner must prove, by a preponderance of the evidence, the factual circumstances

surrounding her claim. § 13(a)(1)(A). To resolve factual issues, the special master must weigh

the evidence presented, which may include contemporaneous medical records and testimony.

See Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a

special master must decide what weight to give evidence including oral testimony and

contemporaneous medical records). Contemporaneous medical records, “in general, warrant

consideration as trustworthy evidence.” Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d

1525, 1528 (Fed. Cir. 1993). But see Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378,

1382 (Fed. Cir. 2021) (rejecting the presumption that “medical records are accurate and complete

as to all the patient’s physical conditions”); Shapiro v. Sec’y of Health & Hum. Servs., 101 Fed.

Cl. 532, 538 (2011) (“[T]he absence of a reference to a condition or circumstance is much less

significant than a reference which negates the existence of the condition or circumstance.”

(quoting Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam,

968 F.2d 1226 (Fed. Cir. 1992))), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d

mem., 503 F. App’x 952 (Fed. Cir. 2013).

There are situations in which compelling testimony may be more persuasive than written

records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec’y of

Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“[L]ike any norm based upon common

sense and experience, this rule should not be treated as an absolute and must yield where the

factual predicates for its application are weak or lacking.”); Lowrie v. Sec’y of Health & Hum.

Servs., No. 03-1585V, 2005 WL 6117475, at *19 (Fed. Cl. Spec. Mstr. Dec. 12, 2005)

(“[W]ritten records which are, themselves, inconsistent, should be accorded less deference than

those which are internally consistent.” (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a

determination regarding a witness’s credibility is needed when determining the weight that such

testimony should be afforded. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379

(Fed. Cir. 2009); Bradley, 991 F.2d at 1575.

Despite the weight afforded to medical records, special masters are not rigidly bound by

those records in determining onset of a petitioner’s symptoms. Valenzuela v. Sec’y of Health &

Hum. Servs., No. 90-1002V, 1991 WL 182241, at *3 (Fed. Cl. Spec. Mstr. Aug. 30, 1991); see

also Eng v. Sec’y of Health & Hum. Servs., No. 90-1754V, 1994 WL 67704, at *3 (Fed. Cl.

Spec. Mstr. Feb. 18, 1994) (noting Section 13(b)(2) “must be construed so as to give effect also

to § 13(b)(1) which directs the special master or court to consider the medical records (reports,

diagnosis, conclusions, medical judgment, test reports, etc.), but does not require the special

master or court to be bound by them”).

C. Causation

To receive compensation through the Program, Petitioner must prove either (1) that she

suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a

vaccine that she received, or (2) that she suffered an injury that was actually caused by a

vaccination. See §§ 11(c)(1), 13(a)(1)(A); Capizzano, 440 F.3d at 1319-20. Petitioner must

21

show that the vaccine was “not only a but-for cause of the injury but also a substantial factor in

bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface, 165 F.3d at 1352-53).

Because Petitioner does not allege she suffered a Table Injury, she must prove a vaccine

she received caused her injury. To do so, Petitioner must establish, by preponderant evidence:

“(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence

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

of a proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278.

The causation theory must relate to the injury alleged. Petitioner must provide a sound

and reliable medical or scientific explanation that pertains specifically to this case, although the

explanation need only be “legally probable, not medically or scientifically certain.” Knudsen v.

Sec’y of Health & Hum. Servs., 35 F.3d. 543, 548-49 (Fed. Cir. 1994). Petitioner cannot

establish entitlement to compensation based solely on her assertions; rather, a vaccine claim must

be supported either by medical records or by the opinion of a medical doctor. § 13(a)(1). In

determining whether a petitioner is entitled to compensation, the special master shall consider all

material in the record, including “any . . . conclusion, [or] medical judgment . . . which is

contained in the record regarding . . . causation.” § 13(b)(1)(A). The undersigned must weigh

the submitted evidence and the testimony of the parties’ proffered experts and rule in Petitioner’s

favor when the evidence weighs in her favor. See Moberly, 592 F.3d at 1325-26 (“Finders of

fact are entitled—indeed, expected—to make determinations as to the reliability of the evidence

presented to them and, if appropriate, as to the credibility of the persons presenting that

evidence.”); Althen, 418 F.3d at 1280 (noting that “close calls” are resolved in Petitioner’s

favor).

Testimony that merely expresses the possibility—not the probability—is insufficient, by

itself, to substantiate a claim that such an injury occurred. See Waterman v. Sec’y of Health &

Hum. Servs., 123 Fed. Cl. 564, 573-74 (2015) (denying Petitioner’s motion for review and

noting that a possible causal link was not sufficient to meet the preponderance standard). The

Federal Circuit has made clear that the mere possibility of a link between a vaccination and a

petitioner’s injury is not sufficient to satisfy the preponderance standard. Moberly, 592 F.3d at

1322 (emphasizing that “proof of a ‘plausible’ or ‘possible’ causal link between the vaccine and

the injury” does not equate to proof of causation by a preponderance of the evidence); Boatmon

v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359-60 (Fed. Cir. 2019). While certainty is

by no means required, a possible mechanism does not rise to the level of preponderance.

Moberly, 592 F.3d at 1322; see also de Bazan, 539 F.3d at 1351.

IV. ONSET ANALYSIS

Here, the parties disagree as to Petitioner’s onset of NMO. For the following reasons, the

undersigned finds onset was April 2, 2016.

Petitioner reported two different neurologically related signs and symptoms. The first set

of symptoms related to her lower extremity paresthesias and “zapping”-like sensations. The

second set of symptoms related to vision in her left eye.

22

Regarding the symptoms related to paresthesias and “zapping” sensations, Petitioner

offered four conflicting reports. The first contemporaneous medical record evidence is dated

April 3, 2016, when Petitioner reported two months of lower extremity paresthesias, placing

onset in February 2016, four months after vaccination. Pet. Ex. 2 at 15-16. Later that month, on

April 21, Petitioner reported intermittent tingling in her legs and “a shooting sensation going

down her back” that began “around Christmas time of 2015,” which is an onset of 11 to 12

weeks after vaccination. Pet. Ex. 3 at 21. Moving forward to August 29, 2017, Petitioner

reported her zapping and burning symptoms “began in October 2015 following a flu shot,”

which would place onset within 30 days of vaccination. Pet. Ex. 9 at 23. Seven years later, in

December 2024, Petitioner executed a declaration reporting her burning/zapping symptoms

began around Thanksgiving 2015 (November 26, 2015), approximately seven to eight weeks

after vaccination. Pet. Ex. 56 at ¶ 5.

Petitioner’s declaration, placing onset of her burning/zapping sensations around

Thanksgiving 2015, was not documented in any medical record. Moreover, Petitioner’s

declaration was executed more than nine years after vaccination and after this case was filed.

See, e.g., Zumwalt v. Sec’y of Health & Hum. Servs., No. 16-994V, 2019 WL 1953739, at *19

(Fed. Cl. Spec. Mstr. Mar. 21, 2019) (rejecting opinion from a treating provider when he

presented an opinion two-and-one-half years after treatment and after litigation was initiated),

mot. for rev. den’d, 146 Fed. Cl. 525 (2019).

Further, the declaration is inconsistent with the contemporaneous medical records, and

thus, the undersigned finds it reasonable to give greater weight to the contemporaneous medical

records. See Cucuras, 993 F.2d at 1528 (noting that “the Supreme Court counsels that oral

testimony in conflict with contemporaneous documentary evidence deserves little weight”);

Doe/70 v. Sec’y of Health & Hum. Servs., 95 Fed. Cl. 598, 608 (2010); Stevens v. Sec’y of

Health & Hum. Servs., No. 90-221V, 1990 WL 608693, at *3 (Cl. Ct. Spec. Mstr. Dec. 21, 1990)

(noting that “clear, cogent, and consistent testimony can overcome such missing or contradictory

medical records”); Vergara ex rel. J.A.V. 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, affidavits, or trial testimony.”); Campbell, 69 Fed. Cl. at 779 (“It is, of course,

true that where later testimony conflicts with earlier contemporaneous documents, courts

generally give the contemporaneous documentation more weight.”); Ricci v. Sec’y of Health &

Hum. Servs., 101 Fed. Cl. 385, 391 (2011) (“Medical records from years later, merely

chronicling a timeline between vaccination and injury, are not worthy of the same consideration

as contemporaneous records.”).

Moreover, the differing time periods reported by Petitioner for the onset of her

paresthesias and “zapping” sensations renders her reports less persuasive. In medical records

from April 2016, which are the most contemporaneous records, Petition reports her lower

extremity paresthesias and “zapping” sensations began two months prior (February 2016) and

around Christmas 2015. Over a year later, in August 2017, Petitioner reported her symptoms

dating back to vaccination. Yet, no medical records document these symptoms between October

2015 and February 2016. Therefore, the undersigned finds Petitioner’s statements less

23

persuasive. See Cucuras, 993 F.2d at 1528 (noting that “the Supreme Court counsels that oral

testimony in conflict with contemporaneous documentary evidence deserves little weight”).

The experts disagree as to whether Petitioner’s paresthesias and “zapping” sensations

were the first manifestations of her NMO.

Petitioner’s expert, Dr. Martinez-Arizala, relates the onset of Petitioner’s NMO to her

reports of paresthesias and burning/zapping sensations. As described above, Dr. Martinez-

Arizala relies upon medical records in April 2016 and August 2017 referring to onset of lower

extremity paresthesias in October 2015, around Christmas 2015, and in February 2016. See Pet.

Ex. 14 at 2, 5. His inconsistency renders his opinion less persuasive.

Respondent’s expert, Dr. Sriram, opines that Petitioner’s lower extremity paresthesias

and zapping sensations were not due to her NMO. He bases his opinion on the fact that

Petitioner’s spinal cord MRIs do not show abnormalities that would explain symptoms of

paresthesias or abnormal zapping sensations. Additionally, because of this lack of spinal cord

evidence, such symptoms are not consistent with NMO. Lastly, he opines that Petitioner’s lower

extremity paresthesias were caused by her vitamin B12 deficiency and cited supportive medical

literature discussing Lhermitte’s-like symptoms, including tingling of the feet and the “zapping”

sensation, is seen in patients with vitamin B12 deficiency. See Resp. Ex. A, Tabs 3-4

The undersigned finds Dr. Sriram’s opinions about the significance of Petitioner’s lower

extremity paresthesias and abnormal sensations to be persuasive for several reasons.

First, Petitioner’s spinal cord MRIs consistently showed no abnormality that would

explain her reports of burning/zapping sensations and paresthesias. Petitioner received numerous

spinal cord MRIs from 2016 to 2020 and none showed evidence of inflammation or

demyelination. Both parties’ experts, Dr. Yousem and Dr. Sriram, agreed.

Second, Dr. Sriram and Petitioner’s treating physicians related her burning/zapping

sensations and paresthesias to her vitamin B12 deficiency. Dr. Fayyaz opined Petitioner’s

vitamin B12 deficiency was “a large contributing factor” to her complaints of numbness and

tingling. Pet. Ex. 3 at 8. An examination and assessment from PAC Wierman included

Petitioner’s vitamin B12 deficiency as “a large contributing factor in her . . . numbness/tingling.”

Pet. Ex. 7 at 7.

For these reasons, the undersigned finds that Petitioner’s complaints of leg paresthesias

and zapping sensations were not manifestations of her NMO. The undersigned finds that

Petitioner’s complaints on April 2, 2016, including the “curtain” over her left eye, were the

initial manifestations of her NMO.

Petitioner received her flu vaccine on October 4, 2015. The first neurological

abnormality characteristic of NMO documented in her medical records was on April 3, 2016,

when she presented to the ED reporting a one-day history of left eye “curtain” and flashes,

placing onset on April 2. Pet. Ex. 2 at 15. A brain MRI the following day, April 4, showed

24

“[l]eft optic neuritis in combination with demyelinating lesions.” Id. at 154-55. NMO IgG

antibody testing confirmed her diagnosis of NMO.

The undersigned’s finding regarding onset is also supported by expert testimony of Dr.

Sriram as discussed above.

Therefore, based on the most contemporaneous medical records, the undersigned finds

Petitioner’s onset of NMO occurred April 2, 2016, approximately six months after her October 4,

2015 flu vaccination.

V. CAUSATION ANALYSIS

A. Althen Prong One

Under Althen prong one, Petitioner must set forth a medical theory explaining how the

received vaccine could have caused the sustained injury. Andreu, 569 F.3d at 1375; Pafford, 451

F.3d at 1355-56. Petitioner’s theory of causation need not be medically or scientifically certain,

but it must be informed by a “sound and reliable” medical or scientific explanation. Boatmon,

941 F.3d at 1359; see also Knudsen, 35 F.3d at 548; Veryzer v. Sec’y of Health & Hum. Servs.,

98 Fed. Cl. 214, 223 (2011) (noting that special masters are bound by both § 13(b)(1) and

Vaccine Rule 8(b)(1) to consider only evidence that is both “relevant” and “reliable”). If

Petitioner relies upon a medical opinion to support his theory, the basis for the opinion and the

reliability of that basis must be considered in the determination of how much weight to afford the

offered opinion. See Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed.

Cir. 2010) (“The special master’s decision often times is based on the credibility of the experts

and the relative persuasiveness of their competing theories.”); Perreira v. Sec’y of Health &

Hum. Servs., 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (stating that an “expert opinion is no better

than the soundness of the reasons supporting it” (citing Fehrs v. United States, 620 F.2d 255, 265

(Ct. Cl. 1980))).

The experts do not dispute the theory of molecular mimicry generally, or that it is sound

and reliable. However, they dispute whether the flu vaccine specifically can cause NMO via

molecular mimicry.

First, the undersigned notes that Petitioner’s onset, April 2, 2016, is not compatible with

vaccine causation or with the theory of molecular mimicry. See, e.g., Barone v. Sec’y of Health

& Hum. Servs., No. 11-707V, 2014 WL 6834557, at *13 (Fed. Cl. Spec. Mstr. Nov. 12, 2014)

(“[S]pecial masters have never gone beyond a two-month (meaning eight week) interval in

holding that a vaccination caused a demyelinating illness.”).

The undersigned also notes Petitioner failed to provide evidence to show that components

of the flu vaccination “resemble myelin in the optic nerve and [CNS] and trigger the

inflammatory response” so as to cause NMO. Pet. Ex. 14 at 6. Simply asserting a causal theory

without context or a supportive factual framework based on medical literature, research, or other

evidence is insufficient. The causal theory must be specific to Petitioner’s case. Moberly, 592

F.3d at 1322. Merely identifying a mechanism for a disease process without additional evidence

25

specific to Petitioner’s case is insufficient to preponderantly show causation. See Monzon v.

Sec’y of Health & Hum. Servs., No. 17-1055V, 2021 WL 2711289, at *29 (Fed. Cl. Spec. Mstr.

June 2, 2021); Baron v. Sec’y of Health & Hum. Servs., No. 14-341V, 2019 WL 2273484, at *17

(Fed. Cl. Spec. Mstr. Mar. 18, 2019); Duncan v. Sec’y of Health & Hum. Servs., No. 16-1367V,

2020 WL 6738228, at *11 (Fed. Cl. Spec. Mstr. Oct. 19, 2020), aff’d, 153 Fed. Cl. 642 (2021);

Boatmon, 941 F.3d at 1360; LaLonde v. Sec’y of Health & Hum. Servs., 746 F.3d 1334, 1339

(Fed. Cir. 2014) (citing Moberly, 592 F.3d at 1322); W.C. v. Sec’y of Health & Hum. Servs.,

704 F.3d 1352, 1356 (Fed. Cir. 2013).

Further, although molecular mimicry is an accepted scientific mechanism, generally

opining that molecular mimicry is a causal theory, without more, is insufficient. See, e.g., Loyd

ex rel. C.L. v. Sec’y of Health & Hum. Servs., No. 16-811V, 2021 WL 2708941, at *31 (Fed. Cl.

Spec. Mstr. May 20, 2021) (“[T]hough molecular mimicry is a generally accepted scientific

concept, and is frequently invoked in Program cases, the mere mention of it does not constitute

satisfaction of the preponderant evidentiary standard. Rather, it must be shown that the

mechanism likely does link the vaccine in question to the relevant injury.” (internal citations

omitted)); McKown v. Sec’y of Health & Hum. Servs., No. 15-1451V, 2019 WL 4072113, at

*50 (Fed. Cl. Spec. Mstr. July 15, 2019) (explaining that “merely chanting the magic words

‘molecular mimicry’ in a Vaccine Act case does not render a causation theory scientifically

reliable, absent additional evidence specifically tying the mechanism to the injury and/or vaccine

in question” (emphasis omitted)); Sheets v. Sec’y of Health & Hum. Servs., No. 16-1173V, 2019

WL 2296212, at *17 (Fed. Cl. Spec. Mstr. Apr. 30, 2019) (determining Petitioner had not

satisfied Althen prong one when he did not relate molecular mimicry “to either the vaccines in

question or Petitioner’s own specific condition”).

Moreover, as illustrated by the medical literature, mechanisms other than molecular

mimicry have been discussed in association with vaccinations. Bienfang et al. suggested “an

allergic reaction to injected foreign protein.” Pet. Ex. 20 at 1. Macoul described viral

replication. Pet. Ex. 24 at 1. And Hull and Bates acknowledged the theory of molecular

mimicry but opined it was “unlikely.” Pet. Ex. 25 at 2.

Even assuming Petitioner has proven a sound and reliable causal mechanism under

Althen prong one, the undersigned finds Petitioner did not provide preponderant evidence of a

logical sequence of cause and effect or a proximate temporal relationship between the flu

vaccination and Petitioner’s NMO. Due to the facts and circumstances of this case, specifically

the fact that Petitioner developed symptoms of NMO months after receipt of a flu vaccine, the

undersigned’s determination as to causation turns on an analysis of Althen prongs two and three,

and thus, the undersigned focuses on Althen prongs two and three. See Vaughan ex rel. A.H. v.

Sec’y of Health & Hum. Servs., 107 Fed. Cl. 212, 221-22 (2012) (finding the special master’s

failure to rule on Althen prong one not fatal to his decision because Althen prong two was fatal

to Petitioner’s case); Hibbard v. Sec’y of Health & Hum. Servs., 698 F.3d 1355, 1364 (Fed. Cir.

2012) (“discern[ing] no error in the manner in which the special master chose to address the

Althen [prongs]” when he focused on Althen prong two after “assuming the medical viability of

[the] theory of causation”).

26

B. Althen Prong Two

Under Althen prong two, Petitioner must prove by a preponderance of the evidence that

there is a “logical sequence of cause and effect showing that the vaccination was the reason for

the injury.” Capizzano, 440 F.3d at 1324 (quoting Althen, 418 F.3d at 1278). “Petitioner must

show that the vaccine was the ‘but for’ cause of the harm . . . or in other words, that the vaccine

was the ‘reason for the injury.’” Pafford, 451 F.3d at 1356 (internal citations omitted).

In evaluating whether this prong is satisfied, the opinions and views of the vaccinee’s

treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d

at 1326 (“[M]edical records and medical opinion testimony are favored in vaccine cases, as

treating physicians are likely to be in the best position to determine whether a ‘logical sequence

of cause and effect show[s] that the vaccination was the reason for the injury.’” (quoting Althen,

418 F.3d at 1280)). Medical records are generally viewed as trustworthy evidence, since they are

created contemporaneously with the treatment of the vaccinee. Cucuras, 993 F.2d at 1528.

Petitioner need not make a specific type of evidentiary showing, i.e., “epidemiologic studies,

rechallenge, the presence of pathological markers or genetic predisposition, or general

acceptance in the scientific or medical communities to establish a logical sequence of cause and

effect.” Capizzano, 440 F.3d at 1325. Instead, Petitioner may satisfy her burden by presenting

circumstantial evidence and reliable medical opinions. Id. at 1325-26.

The undersigned finds there is not preponderant evidence in the record to support a

logical sequence of cause-and-effect showing the October 4, 2015 flu vaccine to be the cause of

Petitioner’s NMO. See Althen, 418 F.3d at 1278.

First, Petitioner’s clinical course is not consistent with a vaccine-related condition.

Petitioner received the flu vaccine on October 4, 2015. Petitioner did not see a medical provider

for almost six months, until March 28, when she complained of an upper respiratory infection.

The following day, March 29, she presented to ophthalmology as a walk-in for vitreous floaters

in her left eye. And on April 3, 2016, Petitioner presented of the ED, reporting a one-day history

of left eye “curtain” and flashes, placing onset on April 2, 2016. Pet. Ex. 2 at 15-16. She was

diagnosed with optic neuritis during her hospitalization and later diagnosed with NMO following

antibody testing results.

Second, none of Petitioner’s treating physicians offered an opinion associating her NMO

with flu vaccination. In cases with such evidence, it can be considered in an analysis of Althen

prong two. See Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326 (“[M]edical records and

medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in

the best position to determine whether a ‘logical sequence of cause and effect show[s] that the

vaccination was the reason for the injury.’” (quoting Althen, 418 F.3d at 1280)). Here, there is

no such supportive evidence.

Further, to the extent that Petitioner asserts that her neurological symptoms of lower

extremity paresthesias and zapping sensations relate to her NMO, there is evidence of an

alternative cause—vitamin B12 deficiency—based on the opinions of Petitioner’s treating

physicians and Dr. Sriram as well as medical literature.

27

Dr. Fayyaz opined Petitioner’s vitamin B12 deficiency was “a large contributing factor” to

her complaints of numbness and tingling. Pet. Ex. 3 at 8. An examination and assessment from

PAC Wierman Assessment included Petitioner’s vitamin B12 deficiency as “a large contributing

factor in her . . . numbness/tingling.” Pet. Ex. 7 at 7.

Dr. Sriram explained severe cases of vitamin B12 deficiency can cause neurological

abnormalities, including “[n]umbness, tingling of extremities, weakness[,] and sometimes

electric shock like sensations of the back due to spinal cord involvement,” and these “clinical

symptoms of B12 deficiency [] match the symptoms that [Petitioner] described in her spine and

extremities.” Resp. Ex. A at 4-5. For support, he cited literature confirming a vitamin B12

deficiency can present with neurological manifestations, including Lhermitte’s sign. See Resp.

Ex. A, Tab 3 at 1; Resp. Ex. A, Tab 4 at 1-2, 3 tbl.2, 5.

Accordingly, the undersigned finds that Petitioner has not satisfied her burden under

Althen prong two.

C. Althen Prong Three

Althen prong three requires Petitioner to establish a “proximate temporal relationship”

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

defined as a “medically acceptable temporal relationship.” Id. The Petitioner must offer

“preponderant proof that the onset of symptoms occurred within a time frame for which, given

the medical understanding of the disorder’s etiology, it is medically acceptable to infer

causation-in-fact.” de Bazan, 539 F.3d at 1352. The explanation for what is a medically

acceptable time frame must also be consistent with the theory of how the relevant vaccine can

cause the injury alleged (under Althen prong one). Id.; Koehn, 773 F.3d at 1243; Shapiro, 101

Fed. Cl. at 542; see Pafford, 451 F.3d at 1358.

As discussed above, the undersigned finds Petitioner’s NMO onset was April 2, 2016,

almost six months after her October 4, 2015 flu vaccination.

The undersigned finds this six-month period is not a medically acceptable time frame for

the posited theory of molecular mimicry, or for any other proffered theory relevant to a post-

vaccination autoimmune illness. Petitioner’s experts provided no literature or evidence to

suggest a flu vaccine can cause NMO six months following a flu vaccination. In fact, a review

28

of all optic neuritis and NMO case reports post-flu vaccination provided by Petitioner show onset

periods between three days and four weeks. 38

Lastly, Vaccine Program cases have found such a long onset interval is not medically

appropriate in demyelinating diseases, including CNS diseases, and/or cases where the proffered

causal theory is molecular mimicry. See, e.g., Barone, 2014 WL 6834557, at *13 (noting eight

weeks/two months is the longest reasonable timeframe for a flu/GBS injury); Corder v. Sec’y of

Health & Hum. Servs., No. 08-228V, 2011 WL 2469736, at *27-29 (Fed. Cl. Spec. Mstr. May

31, 2011) (finding petitioner failed to prove that the flu vaccine can cause GBS four months after

vaccination); Lopez ex rel. Lopez v. Sec’y of Health & Hum. Servs., No. 14-270V, 2014 WL

2584436, at *1 (Fed. Cl. Spec. Mstr. May 20, 2014) (dismissing a case of Tdap/TM due to a

three-month onset and listing cases where a petition in a demyelinating injury case was

dismissed for an onset period greater than two months); Doe/29 v. Sec’y of Health & Hum.

Servs., No. [Redacted]V, 2009 WL 180078, at *3-4 (Fed. Cl. Spec. Mstr. Jan. 21, 2009)

(granting entitlement in an NMO case where the theory was molecular mimicry and onset was

either 18 days or two months/eight weeks).

Therefore, the undersigned finds the temporal association is not appropriate given the

mechanism of injury. Petitioner has failed to satisfy the third Althen prong.

VI. CONCLUSION

The undersigned extends her sympathy to Petitioner for all that she has suffered. Her

Decision, however, cannot be decided based upon sympathy, but rather on the evidence and law.

For the reasons discussed above, the undersigned finds that Petitioner has failed to

establish by preponderant evidence that the flu vaccination she received caused her to develop

NMO. Therefore, Petitioner is not entitled to compensation and the petition must be dismissed.

In the absence of a timely filed motion for review pursuant to Vaccine Rule 23, the Clerk

of Court SHALL ENTER JUDGMENT in accordance with this Decision.

38

This also includes the Nakamura et al. article cited by Petitioner’s counsel. See Pet. Ex. 57

(Yoshikazu Nakamura et al., Influenza-Associated Monophasic Neuromyelitis Optica, 50 Inter.

Med. 1605 (2011)). Nakamura et al. reported a case of NMO post-flu infection. Id. Petitioner’s

experts failed to explain the relationship between flu infection and an inactivated flu vaccination.

“An expert may ‘extrapolate from existing data,’ and use ‘circumstantial evidence,’ [b]ut the

reasons for the extrapolation should be transparent and persuasive.” K.O. v. Sec’y of Health &

Hum. Servs., No. 13-472V, 2016 WL 7634491, at *12 (Fed. Cl. Spec. Mstr. July 7, 2016)

(internal citations omitted) (first quoting Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl.

706, 743 (2009); and then quoting Althen, 418 F.3d at 1280); see also, e.g., Zikeli v. Sec’y of

Health & Hum. Servs., No. 20-564V, 2025 WL 2306208, at *29 (Fed. Cl. Spec. Mstr. July 16,

2025) (finding Petitioner’s expert “failed to explain how data from the live flu virus could be

extrapolated to the inactivated flu vaccine at issue.”).

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IT IS SO ORDERED.

s/Nora Beth Dorsey

Nora Beth Dorsey

Special Master

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