Singleton v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 17-1474V

Filed: April 28, 2023

PUBLISHED

Special Master Horner

LUCITA SINGLETON,

Petitioner, Influenza (“Flu”) vaccine;

v. subclinical seizures; epilepsy;

significant aggravation.

SECRETARY OF HEALTH AND

HUMAN SERVICES,

Respondent.

Renee J. Gentry, Vaccine Injury Clinic, George Washington University Law School

Washington, DC, for petitioner.

Zoe Wade, U.S. Department of Justice, Washington, DC, for respondent.

DECISION 1

On October 10, 2017, Lucita Singleton (“petitioner”) filed a petition for

compensation under the National Childhood Vaccine Injury Act, 42 U.S.C. §300aa-10-

34 (2018). 2 (ECF No. 1.) Petitioner alleges that the influenza (“flu”) vaccination that

she received on October 21, 2014, caused her subclinical seizures and epilepsy. Id.

For the reasons set forth below I conclude that petitioner is not entitled to an award of

compensation.

1 Because this decision contains a reasoned explanation for the action taken in this case, it must be made

publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or

at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government

Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic

Government Services). This means the decision will be available to anyone with access to the

internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact

medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy.

If, upon review, I agree that the identified material fits within this definition, I will redact such material from

public access.

2All references to “§ 300aa” below refer to the relevant section of the Vaccine Act at 42 U.S.C. § 300aa-

10-34.

1

I. Applicable Statutory Scheme

Under the National Vaccine Injury Compensation Program, compensation

awards are made to individuals who have suffered injuries after receiving vaccines. In

general, to gain an award, a petitioner must make a number of factual demonstrations,

including showing that an individual received a vaccination covered by the statute;

received it in the United States; suffered a serious, long-standing injury; and has

received no previous award or settlement on account of the injury. Finally – and the key

question in most cases under the Program – the petitioner must also establish a causal

link between the vaccination and the injury. In some cases, the petitioner may simply

demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be

shown that the vaccine recipient suffered an injury of the type enumerated in the

“Vaccine Injury Table,” corresponding to the vaccination in question, within an

applicable time period also specified in the Table. If so, causation is presumed and the

petitioner is automatically entitled to compensation, unless it is affirmatively shown that

the injury was caused by some factor other than the vaccination. § 300aa-13(a)(1)(A);

§ 300 aa-11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B).

In many cases, however, the vaccine recipient may have suffered an injury not of

the type covered in the Vaccine Injury Table. In these cases, the presumptions

available under the Vaccine Injury Table are inoperative. Instead, the petitioner bears

the burden of showing by preponderant evidence that the vaccine recipient’s injury was

actually caused by the alleged vaccination, often referred to as “causation-in-fact”.

§ 300aa-13(a)(1)(B); § 300aa-11(c)(1)(C)(ii); see also Althen v. Sec’y of Health &

Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005); Hines v. Sec’y of Health &

Human Servs., 940 F.2d 1518, 1525 (Fed. Cir. 1991).

To show actual causation, petitioner must satisfy the “preponderance of the

evidence” standard, the same standard ordinarily used in tort litigation. § 300aa-

13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines, 940 F.2d at 1525. Under that

standard, the petitioner must show that it is “more probable than not” that the

vaccination caused the alleged injury. Althen, 418 F.3d at 1279. The petitioner need

not show that the vaccination was the sole cause of the injury or condition, but must

demonstrate that the vaccination was a “substantial factor” and a “but for” cause.

Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999).

This standard has been interpreted to require “proof of a logical sequence of cause and

effect showing that the vaccination was the reason for the injury;” the logical sequence

must be supported by “reputable medical or scientific explanation, i.e., evidence in the

form of scientific studies or expert medical testimony.” Althen, 418 F.3d at 1278; Grant

v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). A petitioner

may not receive a Vaccine Program award based solely on his or her assertions; rather,

the petition must be supported by either medical records or by the opinion of a

competent physician. § 300aa-13(a)(1).

In what has become the predominant framing of this burden of proof, the Althen

court described the “causation-in-fact” standard, as follows:

2

Concisely stated, Althen’s burden is to show by preponderant evidence that

the vaccination brought about her injury by providing: (1) a medical theory

causally connecting the vaccination and the injury; (2) a logical sequence

of cause and effect showing that the vaccination was the reason for the

injury; and (3) a showing of proximate temporal relationship between

vaccination and injury. If Althen satisfies this burden, she is “entitled to

recover unless the [government] shows, also by a preponderance of the

evidence, that the injury was in fact caused by factors unrelated to the

vaccine.”

Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner

need not necessarily supply evidence from medical literature supporting petitioner’s

causation contention, so long as the petitioner supplies the medical opinion of an

expert. Id. at 1279-80. That expert’s opinion must be “sound and reliable.” Boatmon v.

Sec’y of Health & Human Servs., 941 F.3d 1351, 1359-60 (Fed. Cir. 2019). The Althen

court also indicated, however, that a Program fact finder may rely upon “circumstantial

evidence,” which the court found to be 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.

A petitioner may also allege that a vaccine caused a “significant aggravation” of a

pre-existing condition. The Vaccine Act defines a significant aggravation as any change

for the worse in a pre-existing condition which results in markedly greater disability,

pain, or illness accompanied by substantial deterioration of health. § 300aa-33(4).

Where a petitioner in an off-Table case is seeking to prove that a vaccination

aggravated a pre-existing injury, petitioners must also establish three additional factors.

See Loving v. Sec’y of Health & Human Servs., 86 Fed. Cl. 135, 144 (Fed. Cl. 2009)

(combining the first three Whitecotton factors for claims regarding aggravation of a

Table injury with the three Althen factors for off table injury claims to create a six-part

test for off-Table aggravation claims); see also W.C. v. Sec’y of Health & Human Servs.,

704 F.3d 1352, 1357 (Fed. Cir. 2013) (applying the six-part Loving test.). The additional

Loving factors require petitioners to demonstrate aggravation by showing: (1) the

vaccinee’s condition prior to the administration of the vaccine, (2) the vaccinee’s current

condition, and (3) whether the vaccinee’s current condition constitutes a “significant

aggravation” of the condition prior to the vaccination. W.C., 704 F.3d at 1357.

II. Issues to be Decided

In this case, petitioner initially alleged in her petition that her flu vaccine caused

her to suffer subclinical seizures and epilepsy. (ECF No. 1.) After the exchange of

expert opinions, petitioner refined her contentions in her prehearing brief. She contends

that she “was vascularly compromised prior to her influenza vaccination and, as such,

must demonstrate significant aggravation” under the six-part Loving test. (ECF No. 56,

p. 10.) Specifically, petitioner characterizes her burden as follows:

3

(1) She must demonstrate that she had preexisting asymptomatic

microvascular angiopathy (2) that ultimately evolved into Epilepsy (3) which

is clearly a significant aggravation of her preexisting condition under the

Loving/Sharpe criteria. Then she must show (4) a medical theory causally

connecting the influenza vaccine with microvascular angiopathy, that theory

must be reputable and based on reliable science, (5) a logical sequence of

cause and effect between the influenza vaccine and her symptoms, that is,

that her clinical picture fits the theory proposed, and (6) an appropriate

temporal relationship between the influenza vaccine and the onset of her

symptoms. In totality, Ms. Singleton needs to make a showing of these six

prongs by a simple preponderance of the evidence, however the 4th Loving

prong, i.e., the 1st Althen prong, need only be demonstrated to be

biologically plausible.

(Id. at 11.)

For his part, respondent initially addresses this case in the context of the three-

part Althen test, but also filed a reply addressing petitioner’s contentions under the

Loving test. (ECF Nos. 60, 61.) He contests petitioner’s characterization of the burden

of proof under Althen prong one. (ECF No. 60.) Respondent also asserts that,

assuming arguendo petitioner had met her prima facie burden of proof, then petitioner’s

epilepsy would still be more likely to have been caused by a factor unrelated to

vaccination, namely a viral infection diagnosed shortly after vaccination. (Id. at 25-26.)

In the interest of completeness, the analysis below will address the full six-part

Loving test advocated by petitioner, though the analysis conducted pursuant to the

overlapping Loving and Althen prongs (i.e., Loving prongs four through six/Althen

prongs one through three) is substantially the same and dispositive under either type of

analysis. Because petitioner has not met her burden of proof, it is not necessary to

determine whether respondent has demonstrated petitioner’s diagnosed viral syndrome

as an alternative cause of her condition.

III. Procedural History

This case was originally assigned to Special Master Millman on October 10,

2017. (ECF No. 4.) Following an initial order issued on October 19, 2017, petitioner

filed a series of medical records on October 25, and a statement of completion on

November 29, 2017. (ECF Nos. 6-9.) Respondent subsequently filed his Rule 4(c)

report recommending against compensation on August 7, 2018. (ECF No. 16.) In

response, petitioner filed an expert report from Dr. Carlo Tornatore on January 22,

2019, and the accompanying medical literature on March 28, 2019. (ECF Nos. 20, 24.)

On June 4, 2019, this case was reassigned to my docket. (ECF No. 27.)

Respondent filed a responsive expert report and medical literature from Dr. M.

Steven Evans on August 16, 2019. (ECF No. 34.) Petitioner then filed a supplemental

report from Dr. Tornatore on March 2, 2020. (ECF No. 41.) On April 7, 2020,

4

respondent filed his own supplemental expert report from Dr. Evans. (ECF No. 42.) On

April 8, 2020, the parties filed a joint status report indicating that they believed this case

was ripe for an entitlement hearing. (ECF No. 43.) On October 20, 2020, a two-day

entitlement hearing was scheduled to commence on June 21, 2022. (ECF No. 45.) In

the interim, petitioner filed additional medical records, medical literature, and an affidavit

describing her condition. (ECF Nos. 46-49, 53, 57.) A prehearing order setting a

briefing schedule and close of the record was issued on April 5, 2022. (ECF No. 50.)

The parties filed their prehearing briefs on May 31, 2022. (ECF Nos. 56, 60.)

Respondent filed a reply brief on June 7, 2022. (ECF No. 61.) A two-day entitlement

hearing was held on June 21, 2022. (See ECF No. 65, Transcript of Proceedings (“Tr”),

filed 07/07/2022.) Respondent filed additional medical literature on June 22, 2022.

(ECF No. 63; Ex. FF.) On July 7, 2022, petitioner filed a status report confirming she

“d[id] not wish to file a written response to Respondent’s exhibit FF.” (ECF No. 66.)

This case is now ripe for a decision on entitlement.

IV. Factual History

a. As reflected in the medical records

Prior to her vaccination, petitioner showed no signs or symptoms of central

nervous system disorder or neurologic or cognitive dysfunction. (See Ex. 4, p. 3 (noting

no neurologic symptoms).) Petitioner’s earliest record from February 17, 2012,

documents a history of hypertension, anemia, and seasonal allergies. (Id.; Ex. 11, pp.

2-4, 33-34.) Based on her medical records, it appears that petitioner’s upper respiratory

symptoms were primarily the result of environmental allergies and only occasionally a

viral infection. (Ex. 11, pp. 2-5, 33.) In addition to these physical health issues,

petitioner also suffered from mild depression triggered by the passing of her sister and

cousin (as evidenced in her mental health assessments). (Ex. 5, pp. 2-13.) On

September 18, 2014, petitioner presented for a psychotherapy session wherein she

reported an instance of crying at work and also described “cloudy thoughts” and “not

being able to get it together.” (Id. at 23.)

Petitioner received the flu vaccination at issue in this case on October 21, 2014.

(Ex. 1, p. 1.) On October 27, 2014, she reported to the Community Clinic of Shelbyville

& Bedford County (“Community Clinic”) for an examination. (Ex. 6, p. 2.) During this

visit, petitioner reported that she received the flu shot “at 2:30 [and] got sick at

5:30 . . . .” (Id.) Petitioner reported that she lost her appetite, could not think, had no

energy, and had been sleeping a lot. (Id.) Petitioner’s symptoms had reportedly lasted

for six days and were becoming progressively worse. (Id.) She reported that she

received a flu shot the year prior with no problems. (Id.) She was diagnosed with a viral

syndrome “with complications,” and treated with Biaxin, ibuprofen, fluids, and rest. (Id.)

Petitioner had a follow up for her viral syndrome on November 3, 2014, where

she reported feeling better but noted that her appetite had not returned and that her

energy level remained low. (Ex. 6, p. 4.) Augmentin and “flu vaccine?” were listed

under allergies. (Id.) On November 17, 2014, petitioner returned for further follow up

5

on her condition and reported that she felt “much better” and was ready to resume

working. (Id. at 3.) Petitioner continued to report memory issues and fatigue. (Id.) She

was diagnosed with viral syndrome and recommended continued fluids and rest when

needed. (Id.) Petitioner was seen again for further therapy and counseling of her

depression on November 24, 2014, where she reported that after she received the flu

vaccine she felt “so bad [she] thought [she] was going to die at one point.” (Ex. 5, p.

25.)

More than six months later, on June 27, 2015, petitioner reported to Saint

Thomas health for dental, blood pressure medication, and vision issues. (Ex. 7, p.2.)

Petitioner’s review of symptoms included fever and memory loss. (Id. at 3.) Petitioner

was also seen for complaints of “memory impairment” at Saint Louise clinic by Social

Worker Tiffany Thomas, Nurse Practitioner Cassandra Gladkowski, and Dr. Jessica

Thomas. (Ex. 9, pp. 1-4.) Petitioner’s medications included hydrochlorothiazide, iron,

and metoprolol. (Id. at 1.) She reported that after receiving the flu shot in October of

2014, she did not “feel right” and developed fever and chills which worsened over

several days. (Id. at 4.) Petitioner described “an explosion of colors,” but denied any

headaches. (Id.) She reported feeling “normal” approximately 3-4 months after her

vaccination, though she still suffered from short term memory loss. Petitioner denied

loss of memory of personal information, falling, and recent visual changes, but reported

that she was “not as strong as [she] used to be.” (Id.) On examination, she showed “no

gross deficit of memory...but slightly abnormal neuro exam noted today.” (Ex. 9, p. 5.)

Petitioner had positive Romberg and nystagmus tests. 3 (Id.) Dr. Gladkowski did not

feel a CT scan was necessary, but petitioner was referred to neurology with a history of

“systemic symptoms with short term memory loss x 1 year.” (Id.) Petitioner’s labs

showed elevated folate and glucose levels but were otherwise within normal ranges.

(Id. at 10-12.)

Petitioner returned to Dr. Thomas on August 14, 2015, for a follow up on her

memory problems. (Ex. 12, pp. 14–15.) Petitioner further explained her post-vaccine

condition, noting that she received her vaccination on a Tuesday, and that by Thursday

she would forget how she arrived at her place of employment. (Id. at 15.) She

explained that she began “seeing expulsions [sic]” after taking Nyquil during the days

after her vaccination and that at the time of this exam she had been experiencing

episodes of hand spasms, described by Dr. Thomas as “draw[ing] up.” (Id.) Petitioner

did not report any gross deficits of memory or abnormal behavior like placing her keys in

the freezer, but explained that she would forget to turn the water off and that she could

not use the stove. (Id.) Petitioner’s physical exam did not reveal any new issues. (Id.

3 Romberg sign refers to “swaying of the body or falling when standing with the feet close together and

the eyes closed; the result of loss of joint position sense, seen in tabes dorsalis and other diseases

affecting the posterior columns.” Romberg sign, DORLAND’S MEDICAL DICTIONARY ONLINE,

https://www.dorlandsonline.com/dorland/definition?id=106448 (last accessed Mar. 6, 2023). A

Nystagmus test, also called a Barany or caloric test, is conducted for ocular and vestibular functioning—

"irrigation of the normal ear with warm water produces rotatory nystagmus (caloric nystagmus) toward the

irrigated side; irrigation with cold water produces similar nystagmus away from that side.” Caloric test,

DORLAND’S MEDICAL DICTIONARY ONLINE, https://www.dorlandsonline.com/dorland/definition?id=112479

(last accessed Mar. 6, 2023).

6

at 16–17.) Dr. Thomas believed that petitioner may have experienced hypertensive

urgency and “maybe [posterior reversible encephalopathy syndrome],” (“PRES”). (Id. at

17.) Dr. Thomas was concerned that petitioner “had a stroke or seizures that should

now be treated.” (Ex. 12, p. 17.) Dr. Thomas prescribed vitamin D, additional blood

tests, an EEG, and a brain MRI. (Id.) Petitioner’s brain MRI was conducted on August

20, 2015, revealing no restricted diffusion, “[v]ery mild periventricular increased flair

signal,” suggesting “minimal periventricular demyelinization [sic] likely from chronic

small vessel [ischemic] disease, [and] chronic paranasal sinus changes.” (Id. at 22.)

Petitioner received her EEG on September 8, 2015, at Saint Thomas Rutherford

Hospital. (Ex. 10, p. 9.) Her results showed abnormalities “due to right anterior

temporal sharp waves concerning for an epileptogenic focus at this region,” without any

ictal discharges observed. (Id.)

On September 11, 2015, petitioner returned to Dr. Thomas who noted that

petitioner’s EEG showed “left temporal sharp[] waves.” (Ex. 12, p. 10.) Dr. Thomas

also suggested petitioner’s memory loss “could be due to subclinical seizures,” and

prescribed a trial of Keppra. (Id.) Dr. Thomas wrote a letter noting that petitioner had a

severe reaction to the flu vaccine and recommended against further flu immunization on

October 23, 2015. (Ex. 11, p. 1.) On December 11, 2015, petitioner reported that

Keppra had relieved her hand spasms and Dr. Thomas added amlodipine to petitioner’s

Keppra regimen. (Ex. 12, pp. 2-4.) At this point, Dr. Thomas assessed petitioner with

unspecified convulsions. (Id. at 3.)

On February 18, 2016, petitioner was seen at the Community Clinic of Shelbyville

& Bedford County. (Ex. 11, p. 16.) She reported increased weakness lowered blood

pressure and was assessed with hypertension and “seizure disorder.” (Id.)

Petitioner was seen by Dr. Thomas again on March 11, 2016. (Ex. 13, p. 1.)

She reported that her right-hand spasms were returning, and that it felt “like how [it] gets

with a seizure.” (Id.) Petitioner also reported fatigue and depression “which she rates

as a 9/10 (used to be 10/10).” (Id. at 1, 3.) Petitioner’s physical exam did not reveal

any new problems, and Dr. Thomas recommended switching from Keppra to

oxcarbazepine (“OXC”). (Id. at 3.) Dr. Thomas assessed petitioner with “localization-

related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial

seizures, not intractable, without status epilepticus.” (Id.)

Petitioner was seen by Dr. Paul Buechel at Saint Thomas on May 20, 2016, for a

follow up on her memory issues. (Ex. 28, p. 32.) Petitioner reported that her memory

had been poor ever since her flu vaccination in October of 2014. (Id.) She described

not being able to remember bible verses as she did in the past and that she had

difficulty cooking very familiar recipes. (Id.) Petitioner explained that she had never

experienced an “actual seizure,” but noted that “every 15 minutes, her hands tighten.”

(Id.) Petitioner also reported that Dr. Thomas had witnessed “both of her hands

tightening and twisting at the same time,” which led Dr. Thomas to the conclusion that

petitioner was experiencing minor seizures. (Id.) However, because petitioner

explained that she was “completely awake throughout these episodes,” Dr. Buechel was

7

of the opinion that her hand spasms were “not at all likely seizures.” (Id.) Dr. Buechel

did however recommend that petitioner avoid further flu immunizations due to her

reaction. (Id.)

Petitioner began psychiatric counseling at Centerstone Clinic on November 2,

2016. (Ex. 29, p. 9.) She reported anger, low motivation, low energy, stress,

forgetfulness, and denied any depression, suicidal/homicidal ideations, or psychosis.

(Id.) Petitioner further reported that she experienced an allergic reaction to the flu

vaccine and developed epilepsy. (Id.) She also explained that she suffered from a

stroke during the previous year. (Id.) Petitioner’s intake summary noted that her

presentation was consistent with a diagnosis of adjustment disorder, epilepsy, and

hypertension, and was recommended individual therapy once to twice per month. (Id.

at 10.)

Petitioner returned to Saint Thomas on September 1, 2017, and was seen by Dr.

Rejane Lisboa with a chief complaint of seizures and memory problems. (Ex. 28, p. 28.)

Petitioner reported the same history of present illness as she had to her previous care

providers, adding that she suffered an episode “when [her] head and arms were

moving” but had not experienced any seizure-type episodes since mid-late 2016. (Id. at

29.) She also reported that she believed her memory problems were becoming

progressively worse, she described forgetting dates and where she placed objects, but

that she had not had any trouble driving so long as she was not distracted. (Id. at 29-

30.) Petitioner’s exam was normal and Dr. Lisboa noted that early symptoms of

Alzheimer’s were not excluded. (Id. at 30.)

On May 22, 2018, petitioner underwent a two-day traumatic brain injury (“TBI”)

vocational assessment. (Ex. 24, p. 12.) The assessment noted petitioner experienced

a prior back injury with minimal spondyltiic endplate degenerative changes at the C4,

C5, and C6 levels with “mild degenerative changes in the vertebral endplates and facets

with mild disc bulging causing a disc/osteophyte complex, cervicalgia, calcifying

shoulder tendonitis, and left index finger bursitis.” (Id. at 12–13.) Petitioner also

reported memory impairments, inability to multi-task, difficulty sequencing, and

decreased attention. (Id. at 13.) Petitioner’s occupational therapist reported that

petitioner suffered from “(1) decreased function use of right upper extremity; (2)

decreased executive functioning; (3) decreased insight into viable vocational

possibilities; [and] (4) transportation [problems].” (Id. at 14.) Petitioner’s assessment

team recommended a neuropsychological evaluation, hearing evaluation, extending the

two-day assessment to four-days, and outpatient physical therapy if petitioner chose not

to complete the extended assessment. (Id. at 16.) Petitioner returned for further TBI

assessment on August 9, 2018. (Ex. 24, p. 18.) Of note, petitioner’s cognitive testing

showed that she was severely, moderately, or mildly impaired in all measures of

memory function with her “recent memory” score being the lowest, at 43. (Id. at 22.)

Petitioner received a neuropsychological evaluation at Sabin Behavioral Health

on December 20, 2018. (Ex. 23, p. 5.) She reported generally the same history as she

had up to this point, with the addition of experiencing full-body tremors at some point

8

before the evaluation, though not specified. (Id.) She also explained that she had

trouble remembering names, the things that people said, where she placed her personal

belongings and had issues finding words, understanding directions, and maintaining

focus. (Id.) Petitioner’s memory indices were all observed to be “very low,” with the

exception of her visual working memory index, which was recorded as “low average.”

(Id. at 9.)

Petitioner was seen by physician’s assistant John Kramer at Saint Thomas on

October 18, 2019, for a follow up on her seizure disorder. (Ex. 28, p. 12.) Petitioner

reported that her most recent seizure occurred seven months prior, and that her full-

body tremors had returned. (Id. at 14.) PA Kramer noted that although petitioner

carried a diagnosis of “localization-related epilepsy,” this was “a working diagnosis,” and

asked petitioner to follow up with the hospital’s epilepsy specialist. (Id. at 17.) He also

noted that some of petitioner’s symptoms were concerning for “functional neurological

disorder,” and classified petitioner’s possible epilepsy as idiopathic and scheduled an

EEG. (Id.) Petitioner’s memory impairment was noted to be chronic, and the medical

code lists “other amnesia.” (Id.) Petitioner’s EEG was conducted on December 4,

2019, and was interpreted as normal with “no evidence of focal or abnormal epileptiform

discharges.” (Id. at 38.)

Petitioner returned to Saint Thomas on April 8, 2020 and was seen by Dr.

Vanderkolk for a follow up on her seizures and memory problems. (Ex. 28, p. 7.) Dr.

Vanderkolk reviewed petitioner’s medical history in detail, noting that her initial EEG

was unavailable, and that petitioner’s earlier brain MRI appeared normal with the

ischemic changes typical for petitioner’s age “and nothing apparently abnormal by my

view.” (Id. at 10.) Dr. Vanderkolk noted that, although the testing was limited due to

being conducted via phone, petitioner’s memory scores were quite poor. (Id.)

Petitioner was also observed to have a short temper and sporadic thoughts. (Id.) Dr.

Vanderkolk reviewed petitioner’s December 2019 EEG, which “was within normal

limits.” (Id. at 11.) Dr. Vanderkolk also noted that petitioner was insistent on changing

her medication, noting her “mood-related issues,” though Dr. Vandkerkolk noted that

Oxcarbazepine usually does not cause irritability or anger, and she wondered whether

petitioner suffered an underlying psychiatric condition or bipolar disease. (Id. at 11.)

Petitioner’s remaining medical records document routine requests for prescription

refills or unrelated exams. (See Ex. 27, pp. 55-96.) On April 15, 2021, petitioner

presented to nurse practitioner Shanna Gaither or a follow-up complaining of multiple

side effects with her antiepileptic medications. (Id. at 73-75.) NP Gaither noted

petitioner had not been seen by her neurologist in some time due to financial difficulties.

(Id. at 74.) Petitioner denied any new complaints and was recommended to follow-up

with her neurologist at St. Thomas or with a Vanderbilt neurologist. (Id. at 75.)

9

b. As reflected in Petitioner’s Affidavit4

Petitioner filed an affidavit in support of her petitioner on February 7, 2022. (Ex.

25.) In her petition, petitioner affirms that she has never filed a civil action in relation to

her vaccination or alleged vaccine reaction. She also affirms that she has experienced

her symptoms for longer than six months and that she had no history of seizures,

cognitive issues, or memory problems. She further affirms that she received the flu shot

at her place of employment on October 21, 2014, that she received the shot “high on

[her] arm” and that it was “very painful and burning.” Petitioner also reports that she

experienced swelling at the injection site and began to feel really cold and dizzy

approximately three hours after receiving the vaccination. (Id. at 1.)

Petitioner then affirms that she took NyQuil and slept until 1:40 PM the following

day. She struggled to make it in to work and continued to feel sick and cold. Petitioner

also experienced hallucinations and felt dizzy and delirious. Petitioner states that she

experienced a seizure lasting approximately two minutes at 7:00 PM where both of her

hands seized and spasmed, but she did not report this to her supervisors for fear of

being fired. (Ex. 25, p. 2.) The following day, petitioner was asked to operate a tow

motor, but declined, explaining to her supervisor that she did not feel safe operating the

machinery. Petitioner reported that she fell asleep during the drive home from work that

day. (Id.) The second day after her vaccination, petitioner was let go from her job. She

states that she was able to drive home but did not remember the drive to or from work.

(Id.) Petitioner further affirms that she spent that weekend in bed, hardly able to get out

and experiencing continued chills and significant swelling of her injection site. (Id.) She

experienced “explosions in [her] head like fireworks” and “saw colors.” Petitioner

explains that she felt as though “cold air was pouring down” her brain through “a hole” in

her head. (Id.)

Petitioner’s symptoms led her to seek treatment at a free clinic on October 27,

2014. (Ex. 25, p. 2.) She was observed to have a fever of 101 degrees and flu was

suspected. (Id.) Petitioner was discharged after receiving a negative flu test and told to

seek help at the ER if she continued to feel ill. (Id.) Petitioner affirms that by October

27, 2014, she had a cough, fever, and chills all lasting for six days, but no sore throat.

(Id.) Petitioner’s symptoms slowly resolved in the subsequent weeks, but she continued

to seek treatment after being referred to Dr. Thomas, a neurologist. (Id.) Petitioner

affirms that Dr. Thomas diagnosed her with epilepsy which was believed to have been

triggered by her reaction to the flu shot. (Id.) Dr. Thomas prescribed the anti-epileptic

drug Keppra, which petitioner believed caused “horrible depression and suicidal

thoughts,” in addition to making her often angry, upset, and easily agitated. (Id.) Due to

these side effects, Dr. Thomas ceased Keppra and prescribed Oxcarbazepine which

petitioner indicated caused her to feel rage and experience homicidal thoughts without

stopping her seizures. (Id.) Ultimately, petitioner was prescribed lamotrigine which she

states has lessened the effects of her seizures. (Id. at 3.)

4 Petitioner did not testify at the entitlement hearing held on June 21, 2022. (Tr. 4.)

10

Petitioner explains that she has had severe issues with her short-term memory

and reading comprehension. (Id.) Petitioner concludes her affidavit by writing that she

feels angry about her situation. (Id.) Specifically, she mentions being unable to able to

work; being a burden on her family; failing to meet her financial obligations; and losing

independence and community connection. (Id. at 3-4.)

V. Summary of Expert Opinions and Qualifications

a. Petitioners’ Expert – Carlo Tornatore, M.D.

Dr. Tornatore provided two expert reports in this case and testified at the

entitlement hearing. (Exs. 15, 22, Tr 5-202, 277-88.) He has been offered by petitioner

without objection as an expert in neurology and neuroimmunology. 5 (Tr. 10-11.)

i. Expert reports

Dr. Tornatore opines petitioner had “no symptoms referable to the central

nervous system” prior to her vaccination, and that she developed systemic neurological

symptoms shortly thereafter. (Ex. 15, p. 5.) Dr. Tornatore opines that petitioner’s

neurologic symptoms, which were primarily cognitive symptoms, persisted and could be

explained by the microvascular angiopathy/small vessel ischemic disease evidenced by

her initial MRI. (Id. (citing Johann Selvarajah et al., Potential Surrogate Markers of

Cerebral Microvascular Angiopathy in Asymptomatic Subjects At Risk Of Stroke, 19

EUR. RADIOLOGY 1011 (2009) (Ex. 17)).) Dr. Tornatore explains that small vessel

ischemic disease “is a result of atherosclerotic narrowing of the small caliber vessels of

the brain due to either hypertension, diabetes, or hyperlipidemia.” (Ex. 15, p. 5.) He

concedes that petitioner had hypertension, and thus, “clearly” had risk factors for

cerebrovascular disease, but was never symptomatic prior to her vaccination. (Id.) Dr.

Tornatore also opines that petitioner’s cognitive symptoms are consistent with ischemic

disease and that it is likely she had “significant aggravation of pre-existing risk factors,”

which were confirmed by petitioner’s subsequent EEG testing showing sharp waves

consistent with neuronal irritation. (Id. at 6.) According to Dr. Tornatore, the two most

common causes of “EEG changes” in a patient over the age of 50 are ischemic disease

and tumor. Petitioner’s MRI showed no evidence of any malignancy, therefore Dr.

Tornatore opines it is likely that petitioner suffered from ischemic disease. (Id.) Dr.

Tornatore concludes that petitioner’s symptoms did not arise until after her vaccination,

5 Dr. Tornatore is currently Chair and Neurologist-in-Chief of the Georgetown University Hospital

department of neurology and regional director for neurology at Medstar Health. He previously served as

vice chair of Georgetown’s department of neurology, and professor of neurology at Georgetown

University Medical Center. (Ex. 26, p. 3.) Dr. Tornatore received his bachelor’s degree in neurobiology at

Cornell University and holds a master’s degree in physiology and a medical degree from Georgetown

University. (Id. at 2.) Dr. Tornatore completed his internship in internal medicine at Providence Hospital

in Washington, DC and his residency in neurology at Georgetown University Hospital. (Id.) Dr. Tornatore

is currently licensed to practice medicine in the District of Columbia and board certified in Neurology by

the National Board of Psychiatry and Neurology. (Id. at 1.) He testified that he “also attend[s] on

service…[and] [sees] stroke patients, so I’m very familiar with vascular disease of the nervous system as

well as coronary artery disease, which is part and parcel with it.” (Tr. 10.) Dr. Tornatore has published 58

different peer reviewed articles and five book chapters on neurology and virology. (Ex. 26, pp. 8–14.)

11

and therefore, there is a logical sequence of cause and effect suggesting that her

vaccination triggered her ischemic disease which led to her neurologic symptoms. (Id.)

Dr. Tornatore opines it is biologically plausible that vaccination can cause or

aggravate vascular disease / microvascular angiopathy. (Id.) According to Dr.

Tornatore, it is “well recognized that vascular disease is caused by a cascade of

inflammatory changes in the wall of blood vessels.” (Ex. 15, p. 6.) He explains that

atherosclerosis involves an ongoing inflammatory response. (Id. (citing Peter Libby et

al., Inflammation and Atherosclerosis, 105 CIRCULATION 1135 (2002) (Ex. 18)).) Dr.

Tornatore opines it “is well recognized that the influenza vaccination results in a variety

of inflammatory responses.” (Ex. 15, p. 6.) He cites a study finding a measurable acute

phase response following influenza vaccination in men with and without severe carotid

artery disease. (Id. (citing Cara L. Carty et al., Inflammatory Response After Influenza

Vaccination in Men With and Without Carotid Artery Disease, 26 ARTERIOSCLER

THROMBOSIS VASCULAR BIO. 2738 (2006) (Ex. 20)).) Based on these studies, Dr.

Tornatore concludes that “a vaccine-induced inflammatory cascade” could result in

vascular disease similar to what was seen on petitioner’s MRI and EEG. (Ex. 15, pp. 6–

7.)

Dr. Tornatore cites a case report of a 75-year-old man who developed a stroke

after influenza/H1N1 vaccination. (Ex. 15, p. 7 (citing Yi-Pin Lin et al., Ischaemic Stroke

and Influenza A H1N1 Vaccination: A Case Report, 2 ARCHIVES MED. SCI. 345 (2011)

(Ex. 21)).) The authors noted that the VAERS data suggested that the seasonal flu

vaccine was the most common vaccine associated with ischemic stroke, that ischemic

stroke occurred within a day of vaccination in 18% of patients, and that flu vaccination

may result in a pro-thrombotic state due to immune upregulation. (Ex. 15, p. 7.) Dr.

Tornatore opines that this medical literature is relevant to petitioner’s case because she

“already had risk factors for atherosclerotic disease/narrowing of the small vessels,”

which could have been aggravated by a flu vaccination causing the cognitive issues and

sharp waves seen on EEG. (Id.) Ultimately, Dr. Tornatore opines that petitioner’s

October 21, 2014, flu vaccination aggravated her pre-existing atherosclerotic disease

causing the neuronal irritability and cognitive symptoms she alleges. (Id.)

In his supplemental report, Dr. Tornatore focuses primarily on what he considers

points of agreement with Dr. Evans. (Ex. 22.) Dr. Tornatore summarizes his opinion as

follows: “[petitioner] developed symptomatic microvascular disease of the central

nervous system attributable to the influenza vaccination she received on October 21,

2014. (Id. at 2.) This [is] based on a striking temporal relationship between the onset of

her symptoms, a logical sequence of cause and effect and a biologically plausible

mechanism by which vaccination could cause aggravation of pre-exiting microvascular

disease.” (Id.) By Dr. Tornatore’s account, the primary, if not only, point of

disagreement between the experts is whether petitioner’s pre-vaccination complaints of

cognitive concerns during therapy are grief related (per Dr. Tornatore) or consistent with

her later cognitive complaints (per Dr. Evans). (Id. at 3-4.) Dr. Tornatore suggests that

Dr. Evans contradicts himself when he suggests that petitioner complained of cognitive

issues prior to her vaccination, e.g., her complaints of “cloudy thoughts” and “not being

12

able to get it together,” while also writing that they appeared to be related to her

depression. (Id. at 3.)

ii. Testimony

Dr. Tornatore also testified during the hearing. (Tr. 5-203, 277-88.) He clarified

that his opinion is “the influenza vaccination that [petitioner] received on October 21st,

2014, resulted in an inflammatory response that significantly aggravated her underlying

microvascular angiopathy, resulting in a convulsive disorder and the symptomatically

cognitive issues that were persistent.” (Id. at 12.) Specifically, Dr. Tornatore opines

that petitioner received the flu vaccine at issue, suffered “clear systemic symptoms

related to the vaccine, which are chemokine- and cytokine-related that happen within a

short period” causing endothelial changes or changes in blood vessel tone that mimic a

wild-type influenza virus, “which we know can cause cerebrovascular disease.” (Id. at

62.) In turn, “cerebrovascular disease is the most common…cause of epilepsy when

you can identify a cause for it.” (Id.)

Animal models, according to Dr. Tornatore, have demonstrated inflammatory

responses to vaccination. (Id. at 42 (citing Jacqueline McDonald et al., Inflammatory

Responses to Influenza Vaccination at the Extremes of Age, 151 IMMUNOL. 451 (2017)

(Ex. 19)).) Dr. Tornatore referred to results from a mouse study that reported a positive

correlation between an animal’s inflammatory response and its age. (Id. (citing

McDonald et al, supra at Ex. 19.).) Specifically, Dr. Tornatore pointed out that neonatal

mice had more IL-1 alpha; young adult mice had more TNF alpha; and elderly mice had

more IL-1 receptor agonist. (Tr. 42.) Dr. Tornatore asserted that the post-vaccine

increase in inflammatory markers in mice is identical to an increase observed in

humans. (Id. (citing Libby et al., supra at Ex. 18).)

Dr. Tornatore proposes that petitioner experienced a “cytokine response” post-

vaccination, which reproduced “the exact same response that one gets with the wild-

type infection.” (Tr. 30.) He referred to two studies that support this theory. (Id. at 29-

30.) The first study examined recipients of solid organ transplant and compared

responses to vaccination versus natural infection. (Id. at 29 (citing Arnaud G. L’Huillier

et al., T-cell responses following Natural Influenza Infection or Vaccination in Solid

Organ Transplant Recipients, 10 SCI. RPT. 1 (2020) (Ex. 34)).) Dr. Tornatore

acknowledged that petitioner did not have an organ transplant. (Id.) He nevertheless

relies on the cytokine response observed in this study to infer that petitioner

experienced a cytokine response to vaccination, which was of a similar amplitude to an

expected response to wild-type infection. (Id. at 30.) The second study examined

serum cytokines and chemokines after vaccination. (Id. (citing Kawsar Talaat et al.,

Rapid Changes in Serum Cytokines and Chemokines in Response to Inactivated

Influenza Vaccination, 12 INFLUENZA OTHER RESPIR. VIRUSES 202 (2018) (Ex. 35)).)

Dr. Tornatore highlighted an outlier in this study, who showed the most robust cytokine

response: a 32-to-64-fold increase in hemagglutination-inhibition titer. (Tr. 31 (citing

Talaat et al., supra, at Ex. 35).) Dr. Tornatore suggested this increase could be due to

prior exposure to either to the virus or to a similar vaccine. (Id. at 32.) Regardless, he

13

stressed that this study demonstrates that patients may experience a significant

cytokine and chemokine response within a short period of time, even within hours of

vaccination – “as was the case with [petitioner].” (Tr. 32.)

Dr. Toratore opines, “whether you get an infection or whether you get vaccinated,

the cytokine patterns are identical[,] [though] [t]he amplitude may be less noted.” (Id. at

29-30.) Dr. Tornatore testified that the Nichols paper, cited by Dr. Evans, speaks to this

same concept. (Id. at 55.) Dr. Tornatore testified “[p]ossible mechanisms of the

increased risk of cerebrovascular and cardiovascular events after upper respiratory tract

infection, such as influenza, include alterations in circulating clotting factors, platelet

aggregation and lysis, concentration of inflammatory response proteins and alteration in

cytokine concentrations.” (Id. (quoting Kristin Nichols et al., Influenza vaccination and

reduction in hospitalizations for cardiac disease and stroke among the elderly, 34 N.

ENGL. J. MED. 1 (2003) (Ex. EE)).) These changes, according to Dr. Tornatore, “might

enhance thrombotic tendencies, impair basal dilation, or cause endothelial injury.” (Tr.

55.) To Dr. Tornatore, the evidence suggesting flu infection can cause an increased

risk of cerebrovascular and cardiovascular events supports the theory that the flu

vaccine can significantly aggravate thrombotic tendencies or endothelial injury in a

vaccinee like petitioner who is predisposed to such cerebrovascular events. (Id. at 33.)

During the hearing Dr. Tornatore offered an additional case report by Thoon and

Chan, describing a pediatric stroke case post influenza vaccination. (Tr. 46-7 (citing

Koh Cheung Thoon & Derrick Wei Shih Chan, Childhood stroke after influenza

vaccination, 21(2) PROC. SINGAPORE HEALTHCARE 296 (2012) (Ex. 31)).) The authors

acknowledged that this was the first reported case, and Dr. Tornatore likewise opined

that “[t]his is very unusual – you know, children don’t get strokes.” (Tr. 47 (citing Thoon

& Chan, supra, at Ex. 31).) The ten-year-old developed a stroke in the cerebellum one

day after receiving the seasonal trivalent influenza vaccine. (Tr. 47.) Dr. Tornatore

acknowledges the possibility that the child may have been predisposed to stroke but

maintained that “this may have been an inflammatory event that caused this stroke due

to the vaccine, given the very striking temporal relationship and the…absolute rarity of

stroke in children.” (Id.) He stresses the usefulness of case reports in teaching the

“clinical tempo” of disease, including rare diseases. (Id.) Among the case reports filed

in this case, Dr. Tornatore underscores the fact that each had “the same kinetics of a

stroke within a very short period of the vaccinations.” (Id. at 48.)

b. Respondent’s Expert – Steven Evans, M.D.

Dr. Evans likewise provided two reports and testified at the entitlement hearing.

(Ex. A, CC, Tr. 203-277.) He has been offered by respondent without objection as an

expert in neurology and epilepsy. 6 (Tr. 208.)

6 Dr. Evans received his medical degree in 1982 and his Master of Science degree in physiology in 1984

from the University of Louisville. (Ex. B.) He completed his neurology residency training and chief

residency at Barnes Hospital and the Washington University School of Medicine. (Id.) He completed a

research fellowship in neuropharmacology at the same institution. (Id.) Dr. Evans currently serves as a

practicing neurologist, partially retired, subspecializing in the diagnosis and treatment of epilepsy. (Ex. A,

p. 1; Tr. 204.) He attends the epilepsy monitoring unit at the University of Louisville, where he sees

14

i. Expert reports

Dr. Evans opines that petitioner simply suffered from influenza or a flu-like

syndrome after her vaccination which triggered her symptoms. (Ex. A, p. 4.) He writes

that petitioner’s complaints of “cloudy thoughts” and “not being able to get it together,”

were thought to be related to her depression and that her subsequent memory issues

were never objectively observed on physical exam. (Id.) Dr. Evans concludes that

isolated memory loss has not been reported as an adverse reaction to vaccination and

characterizes her pre-vaccination complaints as similar to her memory complaints. (Id.)

With regard to petitioner’s epilepsy diagnosis, he opines that her “neurological

symptoms and results of testing point to a diagnosis of right temporal lobe epilepsy.”

(Id. at 4.) He explains that epilepsy is a condition that predisposes an individual to

seizures, and that the condition precedes the seizures, but cannot be definitively

diagnosed before seizures occur. (Id.) He further explains that seizures may be

generalized or focal in onset and that seizures affecting or originating in the temporal

lobe characteristically produce temporary amnesia in the ictal and postictal state, with

occasional long-lasting temporary amnesia or other memory-related symptoms such as

déjà vu or jamais vu. (Ex. A, p. 4 (citing Olivier Felician et al., Transient epileptic

amnesia: Update on a slowly emerging epileptic syndrome, 171 REVUE NEUROLOGIQUE

289 (2015) (Ex. K)).)

Dr. Evans notes that temporal lobe epilepsy is usually associated with chronic

memory loss and cognitive deficits specifically associated with memory. (Ex. A, p. 4

(citing Eve Tramoni-Negre et al., Long-term memory deficits in temporal lobe epilepsy,

173 REVUE NEUROLOGIQUE 490 (2017) (Ex. X); Cettina Allone et al., Neuroimaging and

cognitive functions in temporal lobe epilepsy: A review of the literature, 381 J. OF

NEUROLOGICAL SCI. 7 (2017) (Ex. C)).) Dr. Evans writes that the chronic memory loss of

epilepsy “causes difficulty making new memories, not the forgetting of already-

established memories . . .” (Ex. A, p. 4.) Further, “the memory complaint[s] of persons

with epilepsy is chronic and bothersome, but nonprogressive,” which also appears

consistent with petitioner’s symptoms. (Id.) According to Dr. Evans, the causes of

memory dysfunction in temporal lobe epilepsy include brain tissue damage, seizures,

medications, and associated mood disorders, especially depression. (Id. (citing

Matthew J. Knight & Bernhard T. Baune, Cognitive dysfunction in major depressive

disorder, 31 CURRENT OPINIONS IN PSYCHIATRY 26 (2017) (Ex. P)).)

Dr. Evans agrees that petitioner’s EEG showing right temporal epileptiform

discharges is an inter-seizure pattern highly suggestive of right temporal lobe epilepsy.

(Ex. A, p. 5.) However, he writes, evidence of “small vessel ischemic disease on MRI is

very common, and is associated with age, hypertension, and diabetes. Non-lesional

temporal lobe epilepsy is very common, almost the rule rather than the exception. (Id.

(citing Wolfgang Muhlhofer et al., MRI-negative temporal lobe epilepsy–What do we

patients and reads EEGs. (Tr. 204.) He also currently serves as a full Professor in the Department of

Neurology at the University of Louisville. (Ex. A, p. 1.) He is board-certified in Neurology and also

boarded in Clinical Neurophysiology and Epilepsy. (Id.)

15

know?, 58 EPILEPSIA 727 (2017) (Ex. U)).) Dr. Evans writes that additional confirmatory

testing for epilepsy such as formal validation of bedside mental status,

neuropsychological testing, and prolonged EEG monitoring was not done. (Ex. A, p. 5.)

Despite the above, Dr. Evans emphasizes that “no definite occurrence of

seizures” were ever documented. (Ex. A, p. 5.) With regard to petitioner’s hand

spasms, he explains that spasms with retained consciousness are only very rarely

seizures. (Id.) Further, Dr. Evans writes that focal onset epilepsy with focal motor

seizures causes unilateral hand convulsions in the limb opposite to the epileptic brain

tissue, while petitioner complained of bilateral spasms and later, right hand spasms and

cramping. (Id.) Although Dr. Evans concedes that unilateral limb convulsions can occur

in temporal lobe epilepsy, “the more prominent symptoms in this seizure type is sudden

alteration of consciousness, and amnesia is the rule, so the convulsion symptoms must

be reported by witnesses.” (Id.) With no indication that any of petitioner’s alleged

seizures were witnessed by treating physicians or lay witnesses, Dr. Evans concludes

that the characterization of her hand spasms as seizures is “very questionable.” (Id.)

Moreover, petitioner’s physicians believed that she suffered from subclinical

seizures; and Dr. Evans notes that “[t]he concern was that non-convulsive or subtle

seizures may have been occurring, and could be the cause of her complaint of memory

loss.” (Ex. A, p. 5.) He opines this condition is “relatively rare, and can only be

substantiated by prolonged video-EEG monitoring and subsequent relief of seizures and

symptoms by treatment with antiepileptic drugs.” (Id.) Notably, in 30 to 50% of cases,

symptoms thought to be the result of seizures were found to be psychogenic, non-

epileptic events. (Id.) Dr. Evans emphasizes that “the effect of the therapeutic trial of

Keppra on her memory was not specifically noted by clinicians.” (Id.) As for petitioner’s

reported hallucination, Dr. Evans opines that this symptom “does not help to refine a

neurological diagnosis,” as “psychosis and seizures are symptoms of limbic

encephalitides, especially anti-NMDA-receptor encephalitis [and] only one case report

has appeared linking vaccination to anti-NMDA-receptor encephalitis . . . .” (Id. (citing L

Hozakova et al., Anti-NMDAR encephalitis as a serious adverse event probably related

to yellow fever vaccination, 24 CLIN. MICROBIO. INFECTION 17 (2018) (Ex. O)).) Thus, the

link between these symptoms and vaccination must be considered “extremely tenuous.”

(Ex. A, p. 5.) In Dr. Evans opinion, petitioner’s epilepsy diagnosis is “very reasonable,”

but because “no epileptic seizures were noted, the diagnosis would be provisional.”

(Id.)

Turning to the question of whether petitioner’s vaccination could cause her

epilepsy, Dr. Evans reports that he was unable to locate any cases of temporal lobe

epilepsy following vaccination, but that seizures in epileptic patients are commonly

precipitated by viral illness, bacterial infection, and fever. (Id. at 6.) Dr. Evans notes

that petitioner complained of fever and was diagnosed with a viral syndrome shortly

after her vaccination. (Id.) He explains that studies of pediatric patients have found that

fever is associated with seizures even in those without epilepsy, and that while

vaccinations have been found to slightly, or not at all, increase the risk of seizure in

epileptic children, no association between epilepsy and vaccination has ever been

16

found. 7 (Id. (citing Lisen Arnheim-Dahlstrom et al., Risk of presentation to hospital with

epileptic seizures after vaccination with monovalent AS03 adjuvanted pandemic

A/H1N1 2009 influenza vaccine (Pandemrix): self controlled case series study, 345 BMJ

e7594 (2012) (Ex. F); Inger Johanne Bakken et al., Febrile seizures after 2009 influenza

A (H1N1) vaccination and infection: a nationwide registry-based study, 15 BMC

INFECTIOUS DISEASES 506 (2015) (Ex. G); Xin Li et al., The influence of vaccine on febrile

seizure, 16 CURRENT NEUROPHARMACOLOGY 59 (2018) (Ex. S); Karina A. Top et al., Risk

of seizures after immunization in children with epilepsy: a risk interval analysis, 18 BMC

PEDIATRICS 134 (2018) (Ex. W); Siri E. Haberg et al., Epilepsy in children after pandemic

influenza vaccination, 141 PEDIATRICS e20170752 (2018) (Ex. M)).) Dr. Evans reports

that he was unable to find any reported cases of temporal lobe epilepsy where the first

seizures were precipitated by vaccination, but indicates that he has treated patients

whose first seizures were precipitated by a viral illness. (Ex. A, p. 7.) Ultimately, Dr.

Evans concludes that the medical records suggest that petitioner’s epilepsy was

triggered by a viral illness and not her vaccination. (Id.)

Finally, Dr. Evans addresses several claims made by Dr. Tornatore in his initial

expert report. (Ex. A, p. 7.) First, Dr. Evans contends that the medical evidence does

not suggest that petitioner suffered a detectable stroke and that “if stroke were found it

would poorly explain her memory loss.” (Id.) Dr. Evans notes that isolated memory

dysfunction caused by stroke is rare when not accompanied by other signs or

symptoms. (Id.) Further, when isolated memory loss is present, it is suggestive of

bilateral stroke of the medial temporal lobes or thalamus. (Id.) Although “multi-infarct

dementia” is relatively common in stroke victims, it is usually associated with clinically-

diagnosable stroke and accompanied by other signs and symptoms. (Id. (citing

Alzheimer’s Ass’n, Vascular Dementia 1–4, (2018) (Ex. D); Didier Leys, Poststroke

dementia, 4 LANCET NEUROLOGY 752 (2005) (Ex. R)).) Dr. Evans notes that petitioner’s

radiographic imaging did not reveal signs of a stroke, but rather a very common and

nonspecific finding of “minimal periventricular white matter demyelinization likely from

chronic small vessel ischemic disease” regularly found in middle aged, elderly, and

7 Dr. Evans acknowledges there are some cases of vaccine-associated encephalopathy and severe

seizures in children, but that “[t]hese mostly turned out to be cases of Dravet syndrome (severe myoclonic

epilepsy of infancy) with the first symptoms precipitated by malaise and fever after vaccination.” (Ex. A, p.

6.) However, Dravet syndrome is usually caused by a mutation in the SCN1A gene. (Id. (citing

Tarannum M. Lateef et al., Seizures, encephalopathy, and vaccines: experience in the national vaccine

injury compensation program, 166 J. OF PEDIATRICS 575 (2015) (Ex. Q); Lieve Claes et al., De novo

SCN1A Mutations are a major cause of severe myoclonic epilepsy of infancy, 21 HUM. MUTATION 615

(2003) (Ex. J)).) Dr. Evans stresses that in these cases, “vaccination did not cause but did appear to

precipitate the first observable seizures of a catastrophic genetically-determined epilepsy,” with similar

precipitation of seizures observed in other childhood epilepsies such as Doose syndrome. (Id. (citing

Samuel F. Berkovic et al, De-novo mutations of the sodium channel gene SCN1A in alleged vaccine

encephalopathy: a retrospective study, 5 LANCET NEUROL. 488 (2006) (Ex. H); Natasha J. Brown et al.,

Vaccination, seizures and ‘vaccine damage’, 20 CURR. OP. NEUROL. 181 (2007) (Ex. I); Nienke E. Verbeek

et al., Etiologies for seizures around the time of vaccination, 134 PEDIATRICS 658 (2014) (Ex. Y); Sarah

von Spiczak et al., A retrospective population-based study on seizures related to childhood vaccination,

52 EPILEPSIA 1506 (2011) (Ex. Z)).)

17

hypertensive persons at a rate of 50-98%. (Ex. A, p.7 (citing Vincent Mok et al., Race-

ethnicity and cerebral small vessel disease – Comparison between Chinese and white

populations, 9 INT’L J. OF STROKE 36 (2014) (Ex. T)).) Dr. Evans notes that, while chronic

small vessel ischemic disease is not known to cause symptoms by itself, it has been

correlated with increased dementia and demyelinating lesions in dementia patients.

(Ex. A, p. 7 (citing Doeschka A. Ferro et al., Clinical relevance of acute cerebral

microinfarcts in vascular cognitive impairment, 92 NEUROLOGY e1 (2019) (Ex. L)).)

Finally, although confluent demyelination has been associated with vascular dementia,

Dr. Evans notes that petitioner’s MRI showed minimal, and not confluent demyelination,

and therefore, petitioner is unlikely to have suffered from vascular dementia. (Ex. A, p.

7.)

Dr. Evans concludes that in contrast to ischemic disease, where isolated memory

dysfunction rarely occurs, it is quite common in temporal lobe epilepsy. (Id.) Further,

petitioner’s EEG was highly suggestive of right temporal lobe epilepsy. (Id.) Dr. Evans

writes that Dr. Tornatore was mistaken to suggest that the two most common causes of

EEG changes are tumor and ischemic disease, because the most common cause of

EEG changes is epilepsy which “may in turn be associated with ischemic disease or

tumor, and both increase the risk of epilepsy.” (Id.) Dr. Evans ultimately opines that

petitioner’s correct diagnosis was epilepsy but that it is highly unlikely to have been

caused by her vaccination and could have been triggered by fever or petitioner’s viral

syndrome. (Id.)

In his supplemental expert report, Dr. Evans suggests that petitioner’s complaints

of “cloudy thoughts” and “not being able to get it together” were cognitive, not

behavioral, complaints that preceded her vaccination. (Ex. CC, p. 1 (citing Ex. 5, p. 23;

Ex. 11, p. 35).) Dr. Evans agrees that petitioner was correctly diagnosed with epilepsy,

but reiterates that petitioner’s MRI finding of chronic small vessel ischemic disease is

very common and does not support a finding of symptomatic microvascular disease.

(Ex. CC, pp. 1-2.) Dr. Evans agrees that systemic exposure to viral or bacterial

elements can precipitate seizures or neuronal irritability, but he stresses that they

“precipitate acute symptomatic seizures in non-epileptic patients (rarely) or seizure

breakthroughs in epileptic patients (commonly),” and are not expected to cause

epilepsy. (Id. at 2.) Dr. Evans acknowledges that vaccinations can be temporally

associated with epilepsy because they may induce a fever and lower the seizure

threshold. (Id. at 3.) That fact alone, however, is not enough to infer causation. (Id.)

ii. Testimony

Dr. Evans also testified at the entitlement hearing. (Tr. 203-277.) Regarding

petitioner’s causation theory, and whether vascular disease is caused by inflammation,

Dr. Evans cautioned that the term “inflammation” is used commonly in the literature

though it holds many different meanings. (Id. at 258-59.) In fact, he testified that

inflammation is thought to be involved “in almost every neurological disease right now.”

(Id. at 259.) Migraines, spinal cord trauma, brain trauma, as well as epilepsy and stroke

and are all associated with inflammatory changes, according to Dr. Evans. (Id.) He

18

testified that whether inflammation causes stroke is up for debate. (Id. at 259-60.) Dr.

Evans explained that the “ultimate cause” of most stroke is either platelet emboli or

fibrin emboli—“[s]o something, whether inflammatory or noninflammatory, causes clots

to form on vessels that then embolize to other vessels or cause a large enough clot

inside you to occlude blood vessels.” (Id. at 260.) Other cases may involve chronic,

increasingly greater stenosis, causing stroke, though Dr. Evans opines that gradually

developing stenosis isn’t considered a significant risk factor for stroke. (Tr. 260.) In

petitioner’s case, no sedimentation rate or CRP tests were performed that could have

revealed inflammation in petitioner’s central nervous system. (Id. at 261.) If Dr. Evans

were treating petitioner as a patient, and believed petitioner suffered inflammation of the

nervous system, he testified that he would have ordered a lumbar puncture to look for

leukocytes or lymphocytes in the spinal fluid, for example. (Id.) In petitioner’s case

none of these tests were done, and according to Dr. Evans, “the obvious reason for that

is because they weren’t concerned about that.” (Id.)

Of the case reports cited by petitioner, Dr. Evans testified that only the Thoon

and Chan report showed some evidence suggesting the flu vaccine is associated with

stroke. (Tr. 263.) The ten-year-old patient suffered a cerebellar stroke post flu

vaccination. (Id.) However, Dr. Evans stresses that the authors did not test any

inflammatory markers or demonstrate any inflammatory marks in that case. (Id.) To be

sure, the authors performed an MRI scan and EEG. (Id.) “So, yes, the patient clearly

had a stroke and it clearly showed on MRI, and it clearly happened shortly after a

vaccination,” but Dr. Evans contends the authors fail to show signs of inflammation that

might be the base of physiologic significance. (Id.)

During his testimony, Dr. Evans amended his opinion in two regards. First, Dr.

Evans testified that he opines petitioner “may have epilepsy.” (Tr. 266.) This is not

inconsistent with his expert reports, however, at the hearing, he explained that “[i]t’s

been…two, three years since I wrote my initial opinion on it…I do not disagree with the

treating physicians having a working diagnosis of epilepsy. However, three years is

plenty of time to reduce the working diagnosis to a certainty, and that hasn’t been

done.” (Id.) Moreover, based on the little evidence in favor of epilepsy, Dr. Evans

opines “I would not tell her she has epilepsy and not treat her for epilepsy until I have

more evidence in favor of epilepsy.” (Id. at 266-67.) Relatedly, Dr. Evans testified that

petitioner’s depression, not her provisional diagnosis of epilepsy, is the most likely

cause of her memory dysfunction. (Id. at 271-72.) He explains that the two diagnoses

that would be associated with poor performance on her neuropsychological test (that

demonstrated cognitive dysfunction) would be depression or possibly epilepsy. (Id.)

Again, while epilepsy was a “good working diagnosis in 2019,” he stresses it has not

been proven in petitioner’s case. (Id. at 272.) That leaves depression as the most likely

cause of her memory dysfunction.

Dr. Evans also amended his opinion regarding the results of petitioner’s EEG

monitoring. (Tr. 211-12, 216.) In particular, he testified that petitioners first EEG results

revealed unilateral discharges. (Id. at 211.) The second, later EEG was interpreted as

normal. (Id.) Dr. Evans testified the first EEG showed temporal lobe discharges, which

19

is common in temporal lobe epilepsy. (Id.) The confusion regarding the EEG stems

from the fact that the EEG report indicated right temporal lobe discharges, but Dr.

Thomas, one of petitioner’s treating neurologists opined that petitioner had left temporal

lobe discharges. (Id. (discussing Ex. 10, p. 9; Ex. 12, p. 10).) On further examination,

Dr. Evans testified that petitioner likely had left temporal lobe discharges because the

EEG report specifically mentioned F7 and T3 electrodes were affected, which are

electrodes in the left side of the head. (Tr. 211-12.) He concludes that the impression

in the report was incorrect. (Id. at 212.) Dr. Evans testified that, either way, the results

indicated focal epileptic discharges in the temporal lobe. (Id.) Focal seizures are

considered unilateral, occurring in only one half of the brain. (Id.) Given the foregoing,

Dr. Evans opines that petitioner did not experience epileptic seizures—what she

describes were bilateral hand movements that occurred in the absence of other

symptoms. (Id.)8

VI. Discussion

In light of petitioner’s framing of the case, the analysis below utilizes the first

three Loving prongs to address several key factual predicates to petitioner’s claim.

However, the resolution of these factual issues is the same regardless of whether

petitioner’s claim is ultimately analyzed as a significant aggravation under the Loving

test or as an injury caused-in-fact by vaccination under the Althen test. This is primarily

addressed within the analysis pursuant to Loving prong five/Althen prong two, which

requires a logical sequence of cause and effect linking the vaccine and the injury under

either type of analysis.

a. Loving prong one

The first Loving prong involves an examination of petitioner’s pre-vaccination

condition. In this case, two factual points relating to petitioner’s pre-vaccination

condition help to inform whether petitioner’s overall explanation of events is likely. First,

petitioner must establish that she had preexisting asymptomatic microvascular

angiopathy. (ECF No. 56, p. 11; Tr. 12.) Second, in order to ultimately establish

petitioner’s epilepsy first arose post-vaccination under Loving prong two, petitioner must

be persuasive in contending that the cognitive complaints attributable to that epilepsy

also first arose post-vaccination. That requires examination of respondent’s contention

that petitioner’s pre-vaccination counseling records document cognitive complaints

approximately one month prior to the vaccination at issue. (ECF No. 61, p. 2; ECF No.

60, pp. 23-24.)

8 However, Dr. Evans also testified that, based on this opinion, the discharges were on the left side could

“at least be consistent with that particular symptom of spasm in the right hand” and the “writing discomfort

may be related to that.” (Tr. 217.) However, he maintains, “[b]ilateral hand symptoms do not make

sense.” (Id.)

20

i. Asymptomatic microvascular angiopathy

Dr. Tornatore’s suggestion that petitioner had preexisting microvascular

angiopathy is based on two considerations. (Tr. 15-16, 59.) First, he notes petitioner

had risk factors for microvascular disease, including hypertension, obesity, and

hyperlipidemia. (Id. at 15.) Second, he suggests that petitioner’s August 20, 2015 MRI

had some evidence of “minimal” abnormality constituting chronic small vessel vascular

disease. (Ex. 12, p. 22.) He opines that the changes seen on the MRI would not have

happened within the span of a year. Thus, he suggests the changes necessarily

predated her vaccination. (Tr. 17.)

Importantly, however, Dr. Tornatore also suggests, based on his interpretation of

petitioner’s history, that the alleged microvascular angiopathy was having no impact on

her health prior to vaccination – “it was not presenting at all.” (Tr. 20-21.) In that regard,

petitioner’s treating neurologists interpreted petitioner’s MRI as being “within normal

limits” for her age. (Tr. 72-74.) Specifically, Dr. Thomas, the physician that initially

ordered the MRI to evaluate petitioner’s memory problems, interpreted the resulting MRI

as “wnl [within normal limits] for age.” (Ex. 12, p. 10.) Subsequently, Dr. Buechel

additionally characterized the MRI as “normal.” (Ex. 28, p. 32.) Later providers likewise

concluded the MRI was essentially normal. (Ex. 28, p. 12 (PA-C Kramer); Ex. 28, p. 10

(Dr. Vanderkolk, indicating “minimal periventricular white matter ischemic changes were

seen typical for her age and nothing apparently abnormal by my view.”).)

For his part, Dr. Evans limited his opinion because he has not reviewed the MRI

and allowed the possibility that the MRI “might be evidence of ischemia,” but stressed

that what petitioner’s treating physicians described is a “very common finding,”

explaining that “if normal means most people have it, then it would be normal.” (Tr. 231-

32.) When challenged on cross-examination, Dr. Tornatore maintained that an

abnormality was present, but also acknowledged that “I don’t disagree” that the findings

are normal for someone of petitioner’s age. (Tr. 73.)

On the whole, while Dr. Tornatore is persuasive in suggesting that the changes

evidenced by the August 20, 2015 MRI are likely to have predated the vaccination given

that they are chronic and age-related, he has not preponderantly supported that they

are clinically significant.

ii. Cognitive impairment

Prior to vaccination, petitioner sought counseling for mild depression triggered by

the passing of her sister and cousin. (Ex. 5, pp. 2-13.) On September 18, 2014, about

a month prior to the vaccination at issue, petitioner presented for a psychotherapy

session wherein she reported “cloudy thoughts” and “not being able to get it together.”

(Id. at 23.) There is no dispute as to the fact of this report of cognitive complaints.

However, in order to support his assertion of a “striking” relationship between

petitioner’s post-vaccination illness and her cognitive problems, Dr. Tornatore opines

21

that these reports are entirely unrelated to any subsequent complaints of memory

issues.

According to Dr. Tornatore, this pre-vaccination cognitive complaint is distinct

from petitioner’s later cognitive complaints that were reported post-vaccination because

it is grief related and best understood as “pseudodementia,” which he characterizes as

“where somebody’s so depressed that they can’t think right.” (Tr. 26.) He adds that it is

also distinct because it reflects “somebody who has great insight into what their

problems are and recognizing it as such.” (Id.) For his part, Dr. Evans describes

pseudodementia as representing depression so profound that it can be misdiagnosed

as dementia. (Id. at 252-53.) Absent that, Dr. Evans suggests that there is no reliable

way to parse petitioner’s lay reports of cognitive difficulties. Dr. Evans opines that,

whether related to depression or epilepsy, petitioner’s pre- and post-vaccination

cognitive complaints should be considered together rather than trying to distinguish one

type of complaint from another. (Id.) Importantly ,Dr. Tornatore does acknowledge that,

but for his assessment of the specific context in this case, a report of “cloudy thoughts”

could be representative of a cognitive complaint, even in the context of a history of

depression. (Id. at 149.) In that regard, Dr. Tornatore’s assessment of the record as

clearly evidencing pseudodementia is not well supported.

Petitioner first presented for therapy related to a “rough patch” in her life in July of

2014. At that time, her initial assessment documented age-appropriate memory and

thought processes. (Ex. 5, p. 10.) She was initially assessed as having bereavement,

not depression. (Id. at 12.) Petitioner was not assessed as having any pseudodementia

and no other notations in the therapy records suggest that petitioner was experiencing

grief-related cognitive difficulties. Viewing the therapy records as a whole, the

September 18, 2014 notation of a cognitive complaint is an isolated instance rather than

constituting any clear part of her pattern of depression. Additionally, while her course of

therapy was targeted to depression and grief counseling overall, the records reflect

discussion of issues that were not limited to grief. The record of the session at which

the statements were made indicates that three goals were addressed at that session:

“relationship building, grief[,] and current functioning.” (Id. at 23.) Nor does the record

notation in any way suggest that petitioner had “insight” into the nature of her reported

difficulties as Dr. Tornatore suggests. Rather, the notation was limited merely to the

fact of the cognitive complaint. 9

9 Critical to Dr. Tornatore’s assessment of the statements at issue are their juxtaposition against other

statements in the same record. Specifically, the record states: “. . . CI reports she continues to struggle

with the grief related to the loss of her sister and cous[in] approximately a year ago. CI states ‘I think they

know something is wrong where I work. I cried the other day but did not let anyone see.’ CI report

‘cloudy thoughts’ and ‘not being able to get it together.’ CI shows pattern of high expectation of herself in

multiple areas of her life. CI reports that she is going to make the church she is going to her home church

. . .” (Ex. 5, p. 23.) Dr. Tornatore specifically links the statement regarding crying at work to the

statements regarding cloudy thoughts; however, given the scope of the reports summarized without

transitions in just a few short sentences in this and other session records, Dr. Tornatore is not persuasive

in suggesting that the sentence reporting an episode of crying at work must necessarily be related to the

following sentence relating to the clarity of her thoughts.

22

Further, petitioner’s overall medical records do not clearly reflect the distinction

Dr. Tornatore raises between petitioner’s pre- and post-vaccination cognitive

complaints. Whereas the reference to “cloudy thoughts” and “not being able to get it

together,” are an isolated instance within the therapy record, this complaint was made

only one month prior to what petitioner otherwise contends became an ongoing pattern

of memory loss. In fact, petitioner’s first report of post-vaccination symptoms on

October 27, 2014, employed language very similar to the prior therapy record in

reporting that petitioner “can’t think.” (Ex. 6, p. 2.) It was not until she returned for follow

up that this was specifically noted to be an issue of memory. (Id. at 3 (“memory still

bothersome”).) Moreover, consistent with “cloudy thoughts” and “not being able to get it

together,” when petitioner later presented for a vocational assessment, she was noted

to have both memory impairment and executive function difficulty. (Ex. 24.) Thus, even

if petitioner subjectively believed at the time that she was reporting grief related

cognitive difficulties to her therapist in September of 2014, Dr. Evans is persuasive in

suggesting that there is little to no medical basis for parsing petitioner’s earliest

cognitive complaints from her later cognitive complaints. (Tr. 252-53.)

For all these reasons, Dr. Tornatore is not persuasive in suggesting that the

notations in petitioner’s contemporaneous therapy records demonstrate her pre-

vaccination cognitive complaints to be of a distinctly different character. Thus, Dr.

Tornatore is not persuasive in dismissing petitioner’s pre-vaccination report of “cloudy

thoughts” and “not being able to get it together” as a separate pseudodementia

unrelated to her subsequent cognitive complaints.

b. Loving prong two

The second Loving prong examines petitioner’s post-vaccination condition. In

order for petitioner’s preferred explanation of events to be likely, she must

preponderantly prove three underlying points with respect to her post-vaccination

condition. First, she must establish that she does suffer epilepsy. Second, if she does

suffer epilepsy, then she must establish that onset of any seizure disorder was after the

time of the acute-post-vaccination cerebral vascular event that allegedly caused it.

Third, and relatedly, she must demonstrate that she actually suffered an acute

cardiovascular event.

i. Epilepsy

On September 8, 2015, petitioner underwent EEG which was abnormal due to

sharp waves concerning for an epileptogenic focus. (Ex. 10, p. 10.) Dr. Thomas initially

suspected subclinical seizures and later records accept a history of focal epilepsy. (Ex.

12, p. 10; Ex. 28, p. 10.) Thus, Dr. Tornatore endorses a seizure disorder. (Tr. 12.)

Respondent disputes that any epilepsy diagnosis is preponderantly established (ECF

No. 60, pp. 10-12); however, his own expert agrees that petitioner’s EEG demonstrated

epileptic discharges and that “I don’t disagree with the clinician’s diagnosis of possible

subclinical seizures causing memory problems. That’s typical. Memory loss is very

commonly associated with epilepsy.” (Tr. 219.) Although Dr. Evans has significant

23

doubts that there is sufficient clinical evidence to confirm the diagnosis, he agrees that it

is “more than possible” and “quite plausible.” (Tr. 219-21.)

In light of all of the above, while it is not certain that petitioner suffers epilepsy, I

conclude that petitioner has established that there is preponderant evidence that she

suffers left temporal focal epilepsy.

ii. Epilepsy/seizure onset

Although the fact of petitioner’s epilepsy is preponderantly established, a post-

vaccination seizure onset is not. As noted above, petitioner’s epilepsy was first

documented in connection with her September 8, 2015 EEG, about a year post-

vaccination. (Ex. 10, p. 9.) At that time, it was viewed as a possible explanation for her

memory problems dating back earlier. (Ex. 12, p. 10.) In that regard, both Dr.

Tornatore and Dr. Evans agree. (Tr. 35-36, 107, 219.)

However, Dr. Evans explained that the discharges seen on EEG are only

biomarkers of epilepsy. They are not evidence of seizures in themselves. (Tr. 223.)

Moreover, while seizures typically include temporary amnesia during the seizure and

post-ictal period, permanent memory loss like that displayed by petitioner would take

“lots and lots of seizures over years” and it “doesn’t happen overnight or quickly.” (Id. at

223-24.) Thus, even accepting arguendo that her memory complaints began shortly

after vaccination, her epilepsy would have begun much earlier. Additionally, for the

reasons discussed under Loving prong one, above, petitioner actually began

complaining of cognitive concerns no later than about a month prior to her vaccination.

All of this strongly suggests that, if petitioner had epilepsy-related permanent memory

loss as alleged, then the epilepsy must have been chronic and preexisted her

vaccination.

Dr. Tornatore cites petitioner’s hand spasms, which were first documented post-

vaccination, as evidencing seizure activity. (Tr. 28, 101-03.) However, petitioner’s own

treating physician, Dr. Buechel, specifically opined that the hand spasms were not

related to seizures. (Ex. 28, p. 32.) Furthermore, Dr. Evans persuasively explained that

the hand spasms are not consistent with petitioner’s EEG, because they manifested

bilaterally. 10 (Tr. 210-12.) The focal discharges evidenced by the EEG would not result

in bilateral symptoms and in the absence of other symptoms, bilateral hand movements

“is not a seizure semiology.” (Id. at 212.) It would also be unusual for petitioner to be

aware of her hand spasming if they were in fact seizures, because seizures generally

involve temporary amnesia. (Tr. 223.) This latter point also appears to have partly

informed Dr. Buechel’s opinion. (Ex. 28, p. 32.)

10 Petitioner’s separate symptom of right hand cramping could potentially be consistent with left focal

discharges insofar as the bilateral presentation would not be an issue (Tr. 216-17); however, the other

issues would remain and petitioner’s treating physician felt this was due to “organic writer’s cramp.” (Ex.

28, p. 35.)

24

In light of all of this, there is not preponderant evidence that petitioner ever

suffered a clinically apparent seizure, meaning her epilepsy only ever consisted of

subclinical seizures. It is therefore not possible to identify the initial onset of the

epilepsy on this record. However, to the extent the epilepsy is viewed as the cause of

petitioner’s memory problems, this would likely place the onset of epilepsy prior to the

vaccination at issue, especially, but not only, because of the analysis of petitioner’s

cognitive complaints under Loving prong one.

iii. Acute cerebrovascular event

One of petitioner’s treating physicians, Dr. Thomas, questioned whether

petitioner may have experienced an acute cardiac episode such as a stroke or

hypertensive event. (Ex. 12, p. 17.) This was not based on any direct evidence, but

rather upon the seeming coincident nature of petitioner’s post-vaccination illness and

her reports of cognitive complaints. (Id.) The assessment was first notated prior to

petitioner undergoing the MRI study that Dr. Thomas would later interpret as being

within normal limits for age. (Id. at 10.) The majority of petitioner’s treating physicians,

including her other neurologists, offered no such opinion. Apart from her reported

cognitive complaints, petitioner never presented for care with symptoms of a stroke. (Tr.

236-39, 246-48.) Based on Dr. Evan’s assessment, a stroke would be implausible

given petitioner’s history. (Id. at 249.)

Nonetheless, Dr. Tornatore applies the same reasoning as Dr. Thomas. During

the hearing, Dr. Tornatore acknowledged that petitioner’s MRI scan itself is incapable of

detecting whether any acute event had previously happened. (Id. at 20.) Rather, to the

extent it is interpreted abnormal at all, it reflects only chronic changes. However, he felt

the abrupt timing of onset of petitioner’s seizures and memory problems following

petitioner’s constitutional symptoms supported the existence of an acute cardiovascular

event. (Id. at 56-58.) Following resolution of the above-discussed facts, this opinion is

not tenable.

Because petitioner’s epilepsy was only ever subclinical, there is no evidence to

support that a seizure disorder began after petitioner’s constitutional symptoms. To the

extent her cognitive complaints are attributable to epilepsy, there is also not

preponderant evidence clearly placing onset of those cognitive complaints post-

vaccination as petitioner alleges. Without persuasive evidence supporting Dr.

Tornatore’s preferred coincident timing, there is no basis to speculate that any acute

cardiovascular episode ever occurred. Dr. Tornatore acknowledged that the type of

cognitive difficulties at issue in this case can be the result of accumulated damage. (Tr.

74.) Thus, even if petitioner had demonstrated her preexisting microvascular

angiopathy to have been clinically significant, and even if it were a contributor to

petitioner’s epilepsy (a point Dr. Evans would dispute (Tr. 275)), this would still not imply

the presence of any acute cerebrovascular event.

Furthermore, Dr. Tornatore acknowledged that, to the extent he characterizes

acute ischemia as a stroke, if a stroke occurred, it was a “small” stroke. (Tr. 65.)

25

However, Dr. Evans explained that typically when a minor stroke causes later epilepsy,

the epilepsy arises months after the stroke. (Tr. 226.) In order for a stroke to acutely

cause epilepsy as proposed by Dr. Tornatore, it would most likely have to be of a

severity that would be “obvious” and detectable on MRI, even an MRI performed as

remotely as the MRI available in this case. (Tr. 226-29, 240, 245.)

c. Loving prong three

Under Loving prong three, a comparison of the pre- and post-vaccination

conditions examined under the first two prongs must indicate that petitioner has

experienced a change for the worse in her pre-existing condition which results in

markedly greater disability, pain, or illness accompanied by substantial deterioration of

health. § 300aa-33(4). This aspect of the analysis does not reach the question of

vaccine-causation and petitioner is not obligated to show that her outcome is worse

than the expected outcome for a person with her condition. Sharpe v. Sec’y of Health &

Human Servs., 964 F.3d 1072, 1081-82 (Fed Cir. 2020).

In this case, petitioner’s claim is that she ultimately suffers cognitive issues

related to epilepsy. It is beyond meaningful dispute that petitioner’s cognitive condition

is worse post-vaccination than it was pre-vaccination. However, the pre-existing

condition petitioner alleges to have been worsened is her alleged asymptomatic

microvascular angiopathy. Thus, based on petitioner’s framing of the issues in this

case, Loving prong three turns on whether petitioner has shown that her alleged

epilepsy is a sequela of her cardiovascular health. (In her brief, petitioner characterizes

this as whether her preexisting microvascular angiopathy “evolved into” epilepsy. (ECF

No. 56, p. 11).)

While epilepsy can be a sequela to ischemic disease, that is certainly not the

only cause and new onset of epilepsy in adults is “not rare.”11 (Ex. A, pp. 6-8.) Dr.

Tornatore’s opinion is based on the “striking” nature of petitioner’s clinical presentation

and his assertion that “it doesn’t make sense” that petitioner’s post-vaccination

constitutional symptoms (i.e. her diagnosed viral syndrome) and cognitive complaints

would arise at the same time, but be unrelated. (Tr. 56-57.) Here, however, a

comparison of the separate analyses discussed relative to Loving prongs one and two

above finds that petitioner has not preponderantly shown that this striking coincidence

occurred or that her epilepsy is related to any prior microvascular angiopathy

First, petitioner has not preponderantly shown either under Loving prong one that

her preexisting microvascular disease was clinically significant in the first place or under

Loving prong two that she suffered any acute cardiovascular event following her

vaccination. While Dr. Evans agrees that either stroke or “extensive” ischemic disease

can cause epilepsy, he explained that a mild chronic small vessel ischemic disease is

not associated with epilepsy. (Tr. 275; Ex. CC, pp. 2-3.)

11Petitioner did report a family history of epilepsy. (Ex. 28, p. 32; Ex. 12, p. 15 (noting petitioner has a

brother who had epilepsy since childhood).)

26

Second, petitioner has not demonstrated under Loving prong one she was free of

cognitive difficulties pre-vaccination nor under Loving prong two that she suffered overt

seizures post-vaccination. Thus, the actual onset of her epilepsy, which has remained

subclinical, is unknown, and may well have begun prior to vaccination.

For these reasons, petitioner has not preponderantly demonstrated that her

cerebrovascular health deteriorated post vaccination nor that her epilepsy was caused

by any post-vaccination acute cerebrovascular event. Thus, petitioner’s epilepsy and its

consequences do not constitute a significant aggravation of microvascular angiopathy.

Petitioner therefore has not preponderantly satisfied her burden under Loving prong

three.

d. Althen prong one/Loving prong four

i. Petitioner’s burden of proof

Petitioner’s burden under the first Althen prong/fourth Loving prong is to provide,

by preponderant evidence, “a medical theory causally connecting the vaccination and

the injury.” Althen, 418 F.3d at 1278. Such a theory must only be “legally probable, not

medically or scientifically certain.” Knudsen v. Sec’y of Human & Health Servs., 35 F.3d

543, 548-49 (Fed. Cir. 1994). Moreover, scientific evidence offered to establish Althen

prong one is viewed “not through the lens of the laboratorian, but instead from the

vantage point of the Vaccine Act's preponderant evidence standard.” Andreu v. Sec’y of

Health & Human Servs., 569 F.3d 1367, 1380 (Fed. Cir. 2009). However, to satisfy this

prong, petitioner’s theory must be based on a “sound and reliable medical or scientific

explanation.” Knudsen, 35 F.3d at 548; Boatmon, 941 F.3d at 1359. Petitioner’s burden

under Loving prong four varies from her burden under Althen prong one in that a

significant aggravation claim requires petitioner only to show that the vaccine at issue

can worsen the condition at issue rather than being its cause. Sharpe, 964 F.3d at 1083

(explaining that “[u]nder Loving prong 4, a petitioner need only provide ‘a medical theory

causally connecting [petitioner]’s significantly worsened condition to the vaccination.’ In

other words, Petitioner was required to present a medically plausible theory

demonstrating that a vaccine ‘can’ cause a significant worsening of [petitioner’s injury].”)

Petitioner’s prehearing brief includes a recitation of the applicable legal standard

comparable to the above. However, she urges that her burden under Althen prong

one/Loving prong four is specifically limited to a showing of “biologic plausibility” based

on a more recent Court of Federal Claims decision. (ECF No. 56, p. 10 (quoting J. v.

Sec’y of Health & Human Servs., 155 Fed. Cl. 20, [pin pg] (2021).) In sum, petitioner

argues that in 2009 the Federal Circuit in Andreu articulated “biological plausibility” as

the standard for evaluating a theory pursuant to Althen prong one and that this

articulation has never been overturned. 12 (ECF No. 56, p. 10.) Importantly, however,

12A subsequent Court of Federal Claims decision has come to a different conclusion following a review of

the same prior precedents. K.A. v. Sec’y of Health & Human Servs., 164 Fed. Cl. 98, 125-26 (2022)

(characterizing petitioner’s reliance on a “biologically plausible” standard as an attempt to “refashion the

27

this does not indicate that a theory must be couched or addressed specifically by that

terminology. The Federal Circuit has explained in Knudsen that “[c]ausation in fact

under the Vaccine Act is thus based on the circumstances of the particular case, having

no hard and fast per se scientific or medical rules.” 35 F.3d at 548. Regardless of the

specific reference to “biologic plausibility,” the Federal Circuit’s decision in Andreu

explains that a petitioner’s burden is to provide a theory “supported by a ‘reputable

medical or scientific explanation.’” 569 F.3d at 1379 (quoting Althen, 418 F.3d at 1278).)

The Circuit further explained that the assessment of whether a theory is reputable “can

involve assessment of the relevant scientific data” but stressed that such an

assessment must be based on preponderant evidence as contrasted against the type of

“very near certainty – perhaps 95% probability” generally required by medical research.

(Id. at 1380.) Nothing in Andreu implies that the “biologically plausible” theory

presented in that case constituted anything less than preponderant evidence or that a

theory that is not “sound and reliable” could be considered “biologically plausible.”

While scientific certainty is clearly not required, the Federal Circuit has also repeatedly

held that theories that are “plausible,” as in merely “possible,” do not meet petitioner’s

preponderant burden of proof. Boatmon, 941 F.3d at 1360.

ii. Application to Dr. Tornatore’s opinion

During the hearing, Dr. Tornatore summarized his causal opinion as follows:

“[P]etitioner had underlying microvascular angiopathy as seen by her MRI . . . there was

a [flu] vaccination that she received . . . that resulted in cytokine and chemokine release,

which in turn led to small vessel changes . . . leading to either contraction or frank

ischemia in the small [] blood vessels, which led to a scar, which in turn led to neuronal

irritability, and then the more permanent seizure disorder thereafter with the memory

and the cognitive issues being part of the symptomology.” (Tr. 35-36.) In other words,

Dr. Tornatore’s theory of vaccine causation is that the cytokine response to vaccination

can cause cardiovascular changes resulting in stroke. 13 Stroke, in turn, can then

explain this petitioner’s clinical history.

Several of the points contributing to Dr. Tornatore’s theory are not disputed. Dr.

Evans agrees that epilepsy can cause permanent memory loss. (Tr. 219, 223.) He also

agrees that a stroke can cause epilepsy. (Id. at 224.) In fact, he characterizes it as

“very common.” (Id.) Further, Dr. Evans agrees that strokes are associated with

inflammation. (Id. at 259-60.) The question on which the experts disagree is whether

the flu vaccine itself can cause or trigger a stroke. (Id. at 262-63.)

first Althen prong standard” and citing approvingly to the “sound and reliable” language included in the

Federal Circuit’s Boatman decision).

13 During cross-examination, Dr. Tornatore seemed to characterize his opinion as being based on either

“ischemic events or strokes.” (Tr. 64.) However, he also provided testimony suggesting that he is using

the terms interchangeably, stating “any way you look at it, this is vascular disease, and it would be

considered a stroke.” (Tr. 65.) Asked if his opinion is that petitioner had “an acute stroke,” he answered

“Yes, I think there was an acute event that happened . . .” (Tr. 67.) On further questioning he indicated

that stroke is “too generic” and that “vascular event” gets closer to what he opines happened; however,

he was clear in expressing that his theory requires an event causing permanent damage, as opposed to a

hypertensive urgency or PRES, which were also referenced by Dr. Thomas. (Tr. 172-78.)

28

As a starting point, Dr. Tornatore relies on a 2002 review article by Libby, et al.,

positing a relationship between inflammation and atherosclerosis (i.e. the deposition of

fatty plaques on artery walls). (Libby et al., supra, at Ex. 18.) The authors suggest that

atherosclerosis should not be viewed merely as a bland lipid storage disease. (Id. at 1.)

Instead, they conclude that “[c]urrrent evidence supports a central role for inflammation

in all phases of the atherosclerotic process.” (Id. at 7.) The authors further suggest that

“[c]irculating acute-phase reactants elicited by inflammation may not only mark

increased risk for vascular events, but in some cases may contribute to their

pathogenesis.” (Id.) This is characterized as being a “new insight” at the time. (Id.)

Importantly, however, this paper discusses inflammation as arising in the context of

otherwise accepted risk factors for cardiovascular disease, including obesity,

hypertension, diabetes, and infection. (Id. at 3-4.) Notwithstanding his citation to outlier

cases, Dr. Tornatore acknowledged that for most patients there is a difference in the

potency of the immune response to vaccination as compared to infection and that

infection would be a more likely cause of the type of inflammatory cascade he proposes.

(Tr. 145, 158.) Nothing in the Libby, et al., paper implicates vaccinations broadly or the

flu vaccine specifically as a cause of stroke.

In contrast, it is undisputed that the flu vaccine has been shown epidemiologically

to have a cardio-protective effect. (Armin J. Grau et al., Influenza Vaccination is

Associated with a Reduced Risk of Stroke. 36 STROKE 1501 (2005) (EX. 32); Nichols et

al., supra, at Ex. EE; Philippa Lavallee et al., Association Between Influenza

Vaccination and Reduced Risk of Brain Infarction, 33 STROKE 513 (2002) (Ex. DD).)

This is not dispositive, but provides some important context. Accord Baldwin v. Sec’y of

Health & Human Servs., No. 13-957V, 2020 WL 4197937, at n. 14 (Fed. Cl. Spec. Mstr.

June 4, 2020) (explaining that because influenza infection is associated with increased

deaths from cardiovascular disease “assessment of the true significance of this

epidemiologic evidence [is] very difficult. Accordingly, epidemiologic evidence of a

cardio protective effect from the influenza vaccine, though relevant, is not in itself

dispositive”), mot. rev. denied, 151 Fed. Cl. 431 (2020). The Federal Circuit has

previously stressed that a petitioner is not obligated to present an epidemiological case

supporting her claim. Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317,

1325 (Fed. Cir. 2006). Nonetheless, “[n]othing in Althen or Capizzano requires the

Special Master to ignore probative epidemiological evidence that undermines

petitioner’s theory.” D'Tiole v. Sec’y of Health & Human Servs., 726 F. App’x 809, 811

(Fed. Cir. 2018) (citing Andreu, 569 F.3d at 1379 (“Although Althen and Capizzano

make clear that a claimant need not produce medical literature or epidemiological

evidence to establish causation under the Vaccine Act, where such evidence is

submitted, the Special Master can consider it in reaching an informed judgment as to

whether a particular vaccination likely caused a particular injury.”).

Set against the lack of epidemiologic support for this theory, Dr. Tornatore

provides three studies seeking to establish that the flu vaccine does create a cytokine

response that can vary depending on individual characteristics, such as age or pre-

existing conditions. (Carty et al., supra at Ex. 20; McDonald et al., supra, at Ex. 19;

29

Talaat et al., supra, at Ex. 35.) However, none of these studies demonstrates that this

cytokine response leads to relevant adverse events. Of the three, only Carty et al.,

specifically examined cardiovascular health, comparing post-vaccination cytokine levels

in those with preexisting carotid artery disease against controls without the disease.

Although the group with preexisting disease had higher cytokine levels, individuals from

both groups had “mild, but measurable” levels. Additionally, the authors did not record

any adverse events attributable to elevated cytokine levels for either group. (Carty et

al., supra, at Ex. 20, p. 1 (abstract).) McDonald, et al., focused on vaccine efficacy

using a mouse model. (McDonald et al., supra, at Ex. 19.) Talaat, et al., reported an

association between adverse events and cytokine levels post-vaccination. However,

the adverse events examined were non-severe and are in no way comparable to what is

hypothesized in Dr. Tornatore’s theory. About half of the subjects in their study reported

either post-vaccination myalgia or injection site pain, which were described most often

as mild. Single subjects reported adverse events such as abnormal sweating

(diaphoresis); sore throat; vomiting; and syncope during a blood draw. (Talaat et al.,

supra, at Ex. 35, p. 5.)

An additional study sought to examine whether response to vaccination could

contribute to endothelial dysfunction that could lead to the risk of cardiovascular events.

(Aroon D. Hingorani et al., Acute Systemic Inflammation Impairs Endothelium-

Dependent Dilatation in Humans, 102 CIRCULATION 994 (2000) (Ex. 33).) Subjects were

administered a vaccination against Salmonella typhi. Subsequently, the subjects were

tested to measure cytokine levels, resistance blood vessel response, and conduit vessel

response. The results showed a progressive rise in cytokines, but with no effect on

blood pressure, resting heartrate, or baseline forearm blood flow. (Id. at 2.)

Nonetheless, the results showed “profound, but temporary, suppression of endothelium-

dependent relaxation in the forearm circulation. These findings demonstrate that even a

relatively mild systemic inflammatory response is associated with significant alteration in

endothelial function of a type commonly thought to be associated with increased

cardiovascular risk.” (Id. at 3.) The authors explained, however, that the mechanism by

which inflammation may be acting to impair endothelium-dependent relations is not

understood and would require further study. (Id. at 5-6.) Moreover, the authors

acknowledge that the systemic inflammation that has been implicated by infective

disorders is “far more severe and long lasting.” Although the study demonstrates that

even mild inflammation disturbs endothelial regulation, it is yet to be determined

whether the observations of the study are seen in a clinical context. (Id.)

Apart from these studies, Dr. Tornatore presents two case reports of stroke

following influenza vaccination. “[C]ase reports ‘do not purport to establish causation

definitively, and this deficiency does indeed reduce their evidentiary value’…. [but] ‘the

fact that case reports can by their nature only present indicia of causation does not

deprive them of all evidentiary weight.’” See Paluck v. Sec'y of Health & Human Servs.,

104 Fed. Cl. 457, 475 (2012) (quoting Campbell v. Sec'y of Health & Human Servs., 97

Fed. Cl. 650, 668 (2011), aff’d 786 F.3d 1373 (Fed. Cir. 2015)).

30

In the first case report, the authors reported on a 75-year-old male who suffered

posterior circulation ischemia after receiving an H1N1 flu vaccination. (Lin et al., supra,

at Ex. 21).) The patient began experiencing episodes of spontaneously resolving

dizziness and unsteady gait on the left side beginning about seven hours after

vaccination. He did not seek care until seven days later when MRI showed indications

of new infarctions. The authors acknowledge that “[t]he causal relation between

vaccination and ischemic stroke is seriously challenged . . . especially when our patient

does have a few stroke risk factors, such as hypertension, previously stroke, intracranial

atherosclerosis, old age, and hypertriglyceridemia.” (Id. at 2.) The authors hypothesize

that “an inflammatory/immunological response after vaccination may trigger thrombosis

superimposing a pre-existing prothrombotic state (Id. at 1 (abstract)), but ultimately

acknowledge that “it is uncertain if an enhancement of inflammatory/immunological

activity after vaccination is sufficient for initiating symptomatic vascular occlusion” (Id. at

4).

In the second case report, Thoon and Chan report on a 10-year-old child who

suffered a cerebellar stroke one day after receiving the seasonal trivalent influenza

vaccine. (Thoon & Chan, supra, at Ex. 31.) Contrasting this case against limited prior

case reports involving older individuals with other stroke risk factors, the authors note

that their evaluation of this patient did not reveal any underlying prothrombotic

conditions. (Id. at 4.) Contrasting this case against limited prior case reports involving

post-vaccination stroke in children, this patient did not have any imaging consistent with

cerebral angiopathy to explain the nature of the ischemic stroke. (Id.) The authors

ultimately conclude that “[t]he close temporal relationship between an ischemic stroke in

an otherwise healthy 10-year-old child with recent receipt of seasonal influenza

vaccination may be entirely coincidental, and does not alter our stance in

recommencing the influenza vaccination for all children, especially those at risk of

developing complications from an influenza infection.” (Id. at 4-5.)

In sum, petitioner has provided some evidence to suggest a possible role for

mostly chronic or infection-related inflammation in contributing to stroke. Petitioner has

also provided some experimental evidence to suggest that at least one vaccine not at

issue in this case - Salmonella typhi – can affect human blood vessels to at least some

degree in an experimental context, though the actual clinical significance of that finding,

if any, is unclear. Further to that, petitioner has presented some evidence to support the

uncontroversial point that the flu vaccine produces an inflammatory cytokine response,

but without any evidence this results in relevant adverse events. Thus, evidence

directly suggesting that a flu vaccination itself can result in stroke consists only of two

tentative and unsimilar case reports set against epidemiologic data that fails to detect

the flu vaccine as carrying a risk for stroke.

Considering all of this collectively and in the context of the record as a whole, I

conclude that this is inadequate to preponderantly establish that the flu vaccine can

cause a worsening of preexisting microvascular angiopathy leading to or otherwise

causing stroke or other acute ischemic event. Thus, petitioner has not preponderantly

satisfied Althen prong one/Loving prong four.

31

e. Althen prong two/Loving prong five

The second Althen prong/fifth Loving prong requires proof of a logical sequence

of cause and effect showing that the vaccine was the reason for the injury, usually

supported by facts derived from a petitioner's medical records. Althen, 418 F.3d at

1278; Andreu, 569 F.3d at 1375-77; Capizzano., 440 F.3d at 1317, 1326; Grant, 956

F.2d at 1148. However, medical records and/or statements of a treating physician do

not per se bind the special master to adopt the conclusions of such an individual, even if

they must be considered and carefully evaluated. See 42 U.S.C. §300aa-13(b)(1)

(providing that “[a]ny such diagnosis, conclusion, judgment, test result, report, or

summary shall not be binding on the special master or court”); Snyder v. Sec’y of Health

& Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (stating that “there is nothing . . . that

mandates that the testimony of a treating physician is sacrosanct—that it must be

accepted in its entirety and cannot be rebutted”).

In this case, analysis of Althen prong two/Loving prong five begins with

petitioner’s initial post-vaccination illness. On October 27, 2014, petitioner presented for

care at a community clinic with a complaint of six days of illness consisting of loss of

appetite, cough, fever and “no energy,” but with no sore throat. (Ex. 6, p. 2.) It was

noted as part of the history that this illness arose about three hours after her flu

vaccination, however, she was diagnosed as having a “viral syndrome.” (Id.) Petitioner

returned for follow up twice and the diagnosis of viral syndrome was never altered. (Id.

at 3-4.) Significantly, a vaccine reaction was questioned (“flu vaccine?” listed with

allergies (Ex. 6, p. 5)), but a viral syndrome with complications was instead diagnosed

(Id.). According to Dr. Tornatore, this episode should be revisited as a cytokine

response to vaccination. (Tr. 27-30.) Dr. Tornatore suggests that, in severe cases, a

cytokine response to vaccination can mimic a viral infection. (Id. (citing L’Huillier et al.,

supra, at Ex. 34).) However, the L’Hullier paper he cites for this point examines only

cytokine levels and does not address the symptoms associated with a cytokine

response to vaccination. (L’Huillier et al., supra, at Ex. 34.)

In petitioner’s case, Dr. Tornatore focuses on constitutional symptoms of fever

and chills as well as local injection-site swelling as being consistent with a cytokine

response. (Tr. 27-30.) Importantly, however, petitioner’s actual treatment records for

this illness did not record the injection site swelling she later included in her affidavit

account. (Compare Ex. 6 (treatment records) and Ex. 25 (petitioner’s affidavit).)

Petitioner did not report that her arm swelled until she sought care from Dr. Thomas in

August of 2015, about ten months post-vaccination. (Ex. 12, p. 15.) However, the

records reflect that petitioner’s account had changed in multiple ways over time, tending

toward petitioner’s subjective belief that her vaccination was ultimately responsible for

her circumstances. For example, at the time petitioner first presented to Dr. Thomas in

August of 2015 and thereafter, she indicated that her post-vaccination illness had

resulted in her being fired for being unable to do her job. (Ex. 12, p. 15.) However, in

her more contemporaneous therapy records she discussed both her firing and her post

vaccination illness without linking the two, instead attributing her firing to “politics”

related to an interpersonal conflict at work. (Ex. 5, p. 25.) Additionally, the

32

hallucinations and visual changes she would later retrospectively report beginning in the

summer of 2015 were not documented in any of petitioner’s medical records from the

autumn of 2014. (Exs. 5-6.) Thus, Dr. Tornatore’s assumption of injection site swelling

as a tell-tale of a vaccine reaction, for which there is no contemporaneous evidence, is

not well supported. See e.g., R.K. v. Sec’y of Health & Human Servs., No. 03-632V,

2015 WL 10936124, at *76 (Fed. Cl. Spec. Mstr. Sept. 28, 2015) (holding that more

remote histories of illness do not have sufficient indicia of reliability to be credited over

conflicting contemporaneous medical records and earlier reported histories), mot. rev.

denied 125 Fed Cl. 57 (2016), aff’d 671 Fed. Appx. 792 (Fed. Cir. 2016); see also e.g.,

Vergara v. Sec’y of Health & Human Servs., 08-882V, 2014 WL 2795491, *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” (emphasis added).).

Nor does Dr. Tornatore persuasively account for the fact that both petitioner’s

contemporaneous medical record and her own affidavit confirm that her core symptoms

included cough. (Ex. 6, p. 2; Ex. 25, p. 2.) Dr. Evans, by contrast, testified that

petitioner’s cough is consistent with a viral illness, but not a vaccine reaction. (Tr. 256.)

Dr. Tornatore relies on the prescribing information (“package insert”) for the Fluzone

Quadrivalent vaccine as support for the notion that a cough could be consistent with a

vaccine reaction. (Tr. 278-79; Ex. 36.) The package insert lists adverse reactions for

four different age groups. For none of the groups is either cough or any upper

respiratory complaint listed as an adverse reaction. For adults the most common

adverse events were injection site pain, myalgia, headache, and malaise. (Ex. 36, pp. 6-

7.) Instead, Dr. Tornatore relies on a discussion of the clinical trials for the vaccine.

Specifically, the clinical trials disclose that “cough” was among the most commonly

reported unsolicited non-serious adverse events. (Tr. 279-80; Ex. 36, p. 11.)

Importantly, however, the package insert cautions against using the adverse event rates

as reflecting “the rates observed in practice.” (Ex. 36, p. 7.) Additionally, the rates for

each of the listed unsolicited adverse events (headache, cough, and oropharyngeal

pain) is not specified. All that is indicated is that 33 people reported such events and

that this was lower than what was reported among either of the two control groups who

received different vaccines. (Id. at 15.) Nothing in the document suggests that any

significance was found in the reports of cough. Thus, for example, cough was not

observed as an adverse event in the Talaat study that Dr. Tornatore relied upon to

support his theory that vaccine-related inflammation can lead to acute cardiovascular

events. (Talaat et al, supra, at Ex. 35, p. 5.) Moreover, nothing in the document

explains whether these reports of cough occurred in the context of broader illnesses

such as what petitioner experienced.

Both of these points – the cough and the failure to initially report injection site

swelling - accord with the diagnosis of the treating physician, who considered, but

rejected, a vaccine reaction in favor of a diagnosis of viral syndrome. There is therefore

not preponderant evidence that petitioner’s contemporaneous diagnosis of a viral

syndrome should be set aside in favor of an undiagnosed post-vaccination cytokine

response. Absent this, Dr. Tornatore’s theoretical causal chain is broken with respect to

33

any link to vaccination regardless of the resolution of any of the other factual issues in

the case. In that regard, Dr. Tornatore agrees that an infection would be capable of

setting off the series of events underlying his theory of causation. (Tr. 157.) Similarly,

Dr. Evans has opined that, even if petitioner did suffer epilepsy beginning shortly after

her these events, it is more likely that it was brought on simply by the infection

documented in her medical records. (Ex. A, p. 8.)

Additionally, as explained under Loving prong three, temporal lobe epilepsy

occurs in the absence of any ischemia. Moreover, for the reasons explained under

Loving prong one, it is not clear that petitioner’s minimal, age-related MRI changes are

indicative of any meaningful ischemic disease. And, as explained under Loving prong

two, there is not preponderant evidence petitioner suffered an acute cerebrovascular

event. And, in any event, petitioner’s epilepsy more likely predated either her

vaccination or her alleged acute cerebrovascular event. Thus, there is little linking

petitioner’s epilepsy to her cardiovascular health other than Dr. Tornatore’s say-so,

which is based on assumptions that are not supported by preponderant evidence.

Burns v. Sec’y of Health & Human Servs., 3 F. 3d 415 (Fed. Cir. 1993) (holding that

“[t]he special master concluded that the expert based his opinion on facts not

substantiated by the record. As a result, the special master properly rejected the

testimony of petitioner's medical expert.”); see also Rickett v. Sec’y of Health & Human

Servs., 468 Fed. Appx. 952, 958 (Fed. Cir. 2011) (holding that “it was not error for the

Special Master to assign less weight to Dr. Bellanti's conclusion regarding challenge-

rechallenge to the extent it hinged upon Mr. Rickett's testimony that was inconsistent

with the medical records.”); Dobrydnev v. Sec’y of Health & Human Servs., 566 Fed.

Appx. 976, 982–83 (Fed. Cir. 2014) (holding that the special master was correct in

noting that “when an expert assumes facts that are not supported by a preponderance

of the evidence, a finder of fact may properly reject the expert's opinion”) (citing Brooke

Group Ltd. v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993)); Bushnell

v. Sec'y of Health & Human Servs., No. 02-1648V, 2015 WL 4099824, at *12 (Fed. Cl.

Spec. Mstr. June 12, 2015) (finding that “because Dr. Marks' opinion is based on a false

assumption regarding the onset of J.R.B.'s condition, and the incorrect assumption of a

“stepwise regression” after each vaccine administration, it should not be credited.”)

These factors prevent petitioner from preponderantly establishing that any logical

sequence of cause and effect links her vaccination to her alleged injury based on Dr.

Tornatore’s opinion. Although parts of this analysis call upon the prior discussion of

Loving prongs one through three, for the reasons discussed in this section, these same

factors prevent petitioner from meeting her burden of proof under either a Loving or

Althen analysis. That is, petitioner has failed to show that she suffered an initial post-

vaccination reaction. She has also failed to show in turn that her vaccine thereby either

significantly aggravated any preexisting microvascular disease or acted in concert with

her cardiovascular risk factors to cause-in-fact an acute cerebrovascular episode. And,

under either approach, she has not preponderantly linked her epilepsy to her

cardiovascular health or identified any clear onset of seizures that could place her

alleged seizure disorder as occurring post-vaccination.

34

Of all the treating physicians that cared for petitioner, only Dr. Thomas expressed

any opinion that is consistent with Dr. Tornatore’s opinion. Specifically, Dr. Thomas

took a history from petitioner that included bilateral hand spasms, hallucinations, and

memory problems, all arising for the first time post-vaccination in the context of

constitutional symptoms such as fever and chills. From that clinical picture, she

suggested a hypertensive urgency or stroke as a possible explanation. (Ex. 12, p. 17.)

Later, she wrote a letter indicating that petitioner should refrain from future flu vaccines

due to a prior severe reaction to flu vaccination. (Ex. 11, p. 1.) However, for all the

reasons discussed throughout this decision, Dr. Thomas’s opinion necessarily suffers all

of the same infirmities as Dr. Tornatore’s. And, like Dr. Tornatore, she was not

petitioner’s treating physician with respect to the initial illness that petitioner has

characterized as a vaccine reaction, but which was diagnosed as a viral illness. On the

whole, petitioner’s treating physicians did not express opinions consistent with either Dr.

Tornatore’s theory specifically or with vaccine causation of petitioner’s condition more

generally.

In light of all of the above, petitioner has not met her preponderant burden of

proof with respect to Althen prong two/Loving prong five.

f. Althen prong three/Loving prong six

The third Althen prong/sixth Loving prong requires establishing a “proximate

temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d

at 1281. That term has been equated to the phrase “medically-acceptable temporal

relationship.” Id. A petitioner must offer “preponderant proof that the onset of symptoms

occurred within a timeframe which, given the medical understanding of the disorder's

etiology, it is medically acceptable to infer causation.” de Bazan v. Sec’y of Health &

Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is a

medically acceptable timeframe must also coincide with the theory of how the relevant

vaccine can cause an injury. Id.; Shapiro v. Sec'y of Health & Human Servs., 101 Fed.

Cl. 532, 542 (2011), recons. den'd after remand, 105 Fed. Cl. 353 (2012), aff'd mem.,

503 Fed. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec'y of Health & Human Servs., No. 11-

355V, 2013 WL 3214877, at *26 (Fed. Cl. Spec. Mstr. May 30, 2013), aff'd, 773 F.3d

1239 (Fed. Cir. 2014).

Here, Dr. Evans is persuasive on two points that defeat petitioner’s claim under

Loving prong six/Althen prong three. First, Dr. Evans is persuasive in explaining that

permanent memory loss due to epilepsy requires repeated seizures occurring over an

extended period. (Tr. 223-24.) Thus, even accepting arguendo that petitioner’s

memory problems began soon after vaccination and in the context of what is discussed

above as a viral illness, this would suggest that her epilepsy and seizure activity, which

were otherwise subclinical, would have begun prior to vaccination. Second, in the

context of a more minor stroke or cerebral vascular accident of the type that would

necessarily be implicated here based on the lack of subsequent MRI evidence, Dr.

Evans explains that the onset of epilepsy usually does not occur until months after the

initiating event. (Tr. 226.) Here, however, Dr. Tornatore places the onset of seizure

35

activity contemporaneous to the alleged cerebral vascular accident in the context of

petitioner’s presentation with constitutional symptoms and memory problems. Even if a

three-hour period of onset is potentially consistent with a cytokine response to

vaccination, petitioner has not established that the temporal relationship between the

allegedly resulting cerebrovascular event and the epilepsy is appropriate.

Thus, petitioner has not met her burden of proof with respect to Althen prong

three/Loving prong six.

VII. Conclusion

Notwithstanding the lack of any definitive diagnosis, there is no question that

petitioner suffers a condition that has profoundly affected her life. She has my

sympathy and I do not question her sincerity in bringing this claim. However, for all the

reasons discussed above, I find that petitioner has not met her burden of proof in this

case. Therefore, this case is dismissed. 14

IT IS SO ORDERED.

s/Daniel T. Horner

Daniel T. Horner

Special Master

14In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter

judgment accordingly.

36