1 

In the United States Court of Federal Claims 

OFFICE OF SPECIAL MASTERS

No. 17-1474V 

Filed: April 28, 2023

PUBLISHED

LUCITA SINGLETON, 

 Petitioner,

v. 

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.

DECISION1

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. 

2 All references to “§ 300aa” below refer to the relevant section of the Vaccine Act at 42 U.S.C. § 300aa10-34. 

Special Master Horner

Influenza (“Flu”) vaccine; 

subclinical seizures; epilepsy; 

significant aggravation. 
2

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. § 300aa13(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: 
3

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: 
4

(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 threepart 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, 
5

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 
6

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). 
7

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 “localizationrelated (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 
8

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 
9

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 fullbody 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.) 
10

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.) 
11

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.) 
12

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 
13

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” postvaccination, which reproduced “the exact same response that one gets with the wildtype 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 
14

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 
15

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 alreadyestablished 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.) 
16

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, nonepileptic 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 
17

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 clinicallydiagnosable 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)).) 
18

hypertensive persons at a rate of 50-98%. (Ex. A, p.7 (citing Vincent Mok et al., Raceethnicity 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 
19

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 
20

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.) 
21

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 
22

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. 
23

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 prevaccination 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 
24

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 postvaccination seizure onset is not. As noted above, petitioner’s epilepsy was first 

documented in connection with her September 8, 2015 EEG, about a year postvaccination. (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 postvaccination, 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.)
25

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 postvaccination 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.) 
26

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.) 

11 Petitioner 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).)
27

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, 

12 A 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 
28

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.)
29

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 preexisting conditions. (Carty et al., supra at Ex. 20; McDonald et al., supra, at Ex. 19; 
30

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 EndotheliumDependent 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 endotheliumdependent 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)). 
31

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.
32

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 
33

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 
34

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 challengerechallenge 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 postvaccination 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.
35

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 
36

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

14 In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter 

judgment accordingly.