VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-00259
Package ID: USCOURTS-cofc-1_17-vv-00259
Petitioner: Heather Goff
Filed: 2017-01-01
Decided: 2025-07-09
Vaccine: influenza
Vaccination date: 2016-03-22
Condition: ischemic stroke
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Heather Goff, a 43-year-old adult, received an influenza vaccination on March 22, 2016. Eight days later, she experienced symptoms including right arm weakness, facial drooping, and difficulty speaking, leading to a diagnosis of an acute ischemic stroke. Medical evaluations revealed a left middle cerebral artery territory infarct and a potential filling defect in her left internal carotid artery, later identified as atherosclerotic plaque or a carotid web. Ms. Goff filed a petition alleging the influenza vaccine caused her stroke, presenting expert testimony from Dr. Laura Boylan who theorized that the vaccine provoked an inflammatory response that, combined with her carotid web, led to the stroke. The respondent, the Secretary of Health and Human Services, presented expert testimony from Dr. Steven Messé, who opined that Ms. Goff's stroke was not related to the vaccine and was more likely caused by her underlying carotid web or atherosclerotic plaque. Dr. Messé also noted that influenza vaccination is generally associated with a reduced risk of stroke. The Special Master denied Ms. Goff's petition, finding she failed to establish causation under the Althen prongs. Specifically, the Special Master found insufficient evidence that a carotid web requires an inflammatory trigger, that the influenza vaccine produces the necessary inflammatory effects, or that Ms. Goff suffered inflammatory symptoms post-vaccination. The Special Master also found that Ms. Goff's carotid web was a more likely cause of her stroke and that the temporal relationship between the vaccination and stroke was not definitively established as medically acceptable for inferring causation. The Court of Federal Claims affirmed the Special Master's decision, finding it was not arbitrary or capricious and that Ms. Goff failed to meet her burden of proof.

Theory of causation field:
Influenza vaccine on March 22, 2016, age 43, followed eight days later by right arm weakness, facial droop, speech difficulty, and acute ischemic stroke in the left MCA territory. DENIED. Petitioner Heather Goff relied on Dr. Laura Boylan, who proposed vaccine-triggered inflammation interacting with a carotid web/plaque. Respondent's Dr. Steven Messe attributed the stroke to non-vaccine vascular risk factors. Special Master Shah dismissed the petition January 13, 2025; Judge Edward H. Meyers affirmed July 9, 2025. No injury compensation awarded.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_17-vv-00259-2
Date issued/filed: 2025-02-06
Pages: 34
Docket text: PUBLIC DECISION (Originally filed: 1/13/2025) regarding 83 DECISION Dismissing Petition. Signed by Special Master Jennifer A. Shah. (sl) Service on parties made.
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Case 1:17-vv-00259-EHM Document 85 Filed 02/06/25 Page 1 of 34
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-259V
Filed: January 13, 2025
* * * * * * * * * * * * * * * * * * * * * * * * * *
*
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HEATHER GOFF,
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Petitioner, *
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v.
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SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
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Respondent. *
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* * * * * * * * * * * * * * * * * * * * * * * * * *
Alison Haskins, Siri & Glimstad, LLP, Aventura, FL, for Petitioner;
Lara A. Englund, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION DENYING ENTITLEMENT1
Shah, Special Master:
On February 23, 2017, Heather Goff (“Petitioner”) filed a petition for compensation under
the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq.2 (the “Vaccine
Act” or “Program”). The petition alleges that Ms. Goff suffered strokes caused by an influenza
(“flu”) vaccination she received on March 22, 2016. Pet. at 3 (ECF No. 1).
1 Because this Decision contains a reasoned explanation for the action 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 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. For ease of citation,
all “§” references to the Vaccine Act in this Decision will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).

Case 1:17-vv-00259-EHM Document 85 Filed 02/06/25 Page 2 of 34
I have reviewed the evidence presented in this case, and I conclude that Petitioner has not
established by preponderant evidence that the vaccine she received caused her condition. The
petition is accordingly dismissed.
I. PROCEDURAL HISTORY
Petitioner filed a signed statement along with the petition. Ex. 1. Subsequently, Petitioner
filed medical records and a statement of completion. See ECF Nos. 6, 8, 9, 10. On September 11,
2017, Respondent filed a Rule 4(c) Report (“Report”), contending that the case was not appropriate
for compensation and should be dismissed. Report at 7-8 (ECF No. 18).
On November 14, 2017, Petitioner filed an expert report and curriculum vitae from Laura
S. Boylan, M.D. Exs. 16-17. On November 28, 2017, Petitioner filed medical literature in support
of Dr. Boylan’s opinions. Exs. 19-33. On June 14, 2018, Respondent filed an expert report from
Steven Messé, M.D., along with Dr. Messé’s curriculum vitae and medical literature. Exs. A &
Tabs 1-5, B. On November 12, 2019, Petitioner filed a supplemental expert report from Dr.
Boylan. Ex. 35. Respondent declined to file a supplemental expert report from Dr. Messé. ECF
No. 45.
Former Special Master Katherine E. Oler held an entitlement hearing on April 6-7, 2021,
by videoconference. Petitioner, Dr. Boylan, and Dr. Messé testified at the hearing. See generally
Transcript (ECF No. 60). Both parties filed pre- and post-hearing briefs. ECF Nos. 50, 53, 54,
67, 70, 72. After the hearing, Petitioner filed additional medical records and literature, and
Respondent filed additional literature. ECF Nos. 63, 65, 69.
On August 13, 2024, this case was reassigned to me. ECF No. 78. The case is ripe for
adjudication.
II. FACT EVIDENCE
A. Petitioner’s Statement
Petitioner was 43 years old at the time of the subject flu vaccination. Ex. 1 at 1. Her past
medical history included hyperthyroidism that was controlled by medication. Id. Before the
vaccination, she engaged in weightlifting, biking, hiking, and other outdoor activities, and she was
employed as a physiotherapist. Id.
On September 14, 2015, Petitioner was given a flu vaccination that was required by her
employer, Laporte Hospital. Ex. 1 at 1. She said that “[t]his was the first time I had a flu shot in
about 18 years.” Id. She did not have any lingering effects from that vaccination aside from a few
days’ worth of shoulder pain. Id.
In early 2016, Petitioner moved to Arizona and took a job with Banner University Medical
Center (“Banner”) as a physical therapy (“PT”) assistant. Ex. 1 at 1. She was again advised that
she would be required to receive a flu vaccination as a condition of employment. Id. Although
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she reported she had received a flu vaccination a few months earlier, Banner did not have the
record of that vaccination, so Petitioner was required to be vaccinated again. Id.
Petitioner received the subject flu vaccination on March 22, 2016. Ex. 1 at 1. Her left
deltoid was “sore and pink” for the next few days, but those symptoms “seemed to lessen over the
next week.” Id. at 2.
On March 30, 2016, Petitioner woke up with no feeling or control of her right arm, an
inability to speak, and right-sided facial drooping. Ex. 1 at 2. Petitioner’s roommate took her to
the nearest emergency room (“ER”), where she was diagnosed with a 20-30% blockage in her left
carotid artery, elevated cholesterol, and a transient ischemic attack (“TIA”) in the right parietal
lobe. Id.
Petitioner received PT and occupational therapy (“OT”) in the hospital, and she had a
cardiac loop monitor implanted in her left breast. Ex. 1 at 2. She was discharged from the hospital
on April 3, 2016. Id. On April 20, 2016, she experienced high blood pressure, as well as
“continued” left deltoid soreness that extended into her scapular area, shoulder, and jaw. Id. She
feared that she was having another TIA, so she went to the ER. Id. After medical tests came back
negative, she was discharged home. Id.
On June 24, 2016, Petitioner had a cerebral angiogram, which showed “non-significant
stenosis of the right carotid artery and ulcerated plaque on the left carotid artery, causing a
narrowing of about 35%[.]” Ex. 1 at 2.
On June 30, 2016, while Petitioner was at work, her supervisor noticed a change in her
speech. Ex. 1 at 2. She went to the ER, where she was diagnosed with acute, non-fluent aphasia
and admitted. Id. She underwent a brain biopsy, which revealed hemorrhage but no neoplasm or
infection. Id. at 3. She was hospitalized until July 7, 2016. Id.
In late July 2016, Petitioner returned to work on a restricted schedule. Ex. 1 at 3. She was
unable to fulfill her work duties, however, and was dismissed on September 23, 2016. Id. She
secured a new job in late 2016. Id. She said that she continues to experience numbness and
tingling on the right side of her body, along with memory problems and “trouble with numbers
and letters.” Id.
B. Petitioner’s Testimony
At the entitlement hearing, Petitioner testified that she was in excellent health and active
prior to the subject vaccination. Tr. at 5-6. She was under treatment for her thyroid. Id. at 6. She
had never suffered a stroke before her vaccination. Id.
Petitioner received a flu vaccination on September 14, 2015, at her previous place of
employment. Tr. at 6. She was required to receive the vaccination. Id. She experienced a few
days of arm soreness after that vaccination, but no other symptoms. Id.
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On March 22, 2016, Petitioner received another flu vaccination that was required by her
new employer, Banner. Tr. at 7. She was feeling well at the time of the vaccination. Id. After
being vaccinated, she had a red, swollen arm for a “couple months.” Id.
The morning of March 30, 2016, Petitioner went into the kitchen to make coffee. Tr. at 8.
She dropped the coffee pod twice. Id. She “was feeling kind of funny.” Id. She then looked in
the mirror and noticed that her “face was drooped” and that she could not speak. Id. When her
roommate saw her, he believed she was having a stroke, so he took her to the hospital. Id.
After Petitioner was discharged from the hospital, she had difficulty keeping up with her
work responsibilities. Tr. at 10. She still experienced impairments from her stroke, including
memory problems and a “constant headache,” along with weight gain and fatigue. Id. at 10, 12,
14.
Petitioner underwent a cerebral angiogram and had to take off work for the test. Tr. at 10-
11. On June 30, 2016, while at work, she was taken to her supervisor’s office because she “wasn’t
talking straight” and was “babbling.” Id. at 12. Her supervisor suspected another stroke and took
her to the ER at Banner. Id.at 12-13. She remained in the hospital for a few days and had to
undergo a brain biopsy, along with PT, OT, and speech therapy. Id. at 13. When she returned to
work after being discharged, she had work restrictions. Id. at 14. Ultimately, she was dismissed
after being unable to keep up with her caseload. Id.
Petitioner testified that, since her strokes, she depleted her retirement savings and had to
file for bankruptcy. Tr. at 14-15. She can work but has limited her patient load. Id. at 14-16. She
has had difficulty maintaining relationships. Id. at 15. She also has facial asymmetry, and the
right side of her face is “droopy and wrinkled.” Id. at 17. She has right-sided weakness. Id. She
takes 325mg of aspirin every day. Id. She rates her daily symptoms at a 6 out of 10 in severity.
Id.
On cross examination, Petitioner testified that she could not recall developing any new
symptoms, including new memory, speech, or numbness problems, between her first and second
strokes. Tr. at 20.
C. Medical Records
The medical records confirm that Petitioner was 43 years old at the time of the subject flu
vaccination. Ex. 2 at 1. Her prior medical history included thyroid disease, for which she took
Synthroid. Ex. 7 at 16. She had no prior history of stroke.
On September 14, 2015, Petitioner was given a flu vaccination at Indiana University
Health. Ex. 14 at 1. On March 22, 2016, she was given another flu vaccination at Banner. Ex. 2
at 1.
There are no medical records between March 22 and 30, 2016. The morning of March 30,
2016, Petitioner was transported to the Abrazo West Campus (“Abrazo”) ER complaining of
slurred speech, facial droop, and right arm weakness and numbness, with an onset of that morning.
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Ex. 6 at 12-14, 280-82. She recalled going to bed the previous night feeling well except for a
headache. Id. at 14. At the time of triage, the only symptom remaining was right arm numbness.
Id. at 12. She did not have a fever. Id. at 281. An exam showed no evidence of rash, swelling of
the left arm, or skin abnormalities. Id. The working diagnosis in the ER was an acute ischemic
stroke, which was characterized as a “wake-up stroke.” Id. at 13-14, 280-82. Petitioner was
admitted to the hospital. Id. at 282.
During an admission exam on March 30, 2016, Petitioner denied any history of prior
strokes, TIAs, irregular heartbeat, palpitations, or atrial fibrillation. Ex. 6 at 220. She reported
that she had been in “good chronic health.” Id. She stated that she smoked a little more than a
pack of cigarettes daily. Id. She also reported that several months earlier, she had a large
granuloma removed from the base of a tooth. Id. at 221. Again, an exam found no rash or other
skin abnormalities, and her extremities had no signs of clubbing, cyanosis, or edema. Id. at 222.
On March 30, 2016, Petitioner had a neurology consult with Ahmed El-Gengaihy, M.D.,
in the hospital. Ex. 6 at 227. Dr. El-Gengaihy noted that a CT scan of the head was normal, but
an MRI of the brain revealed a left middle cerebral artery acute infarct measuring 5 x 25 mm. Id.
at 230. An MRA of the neck without contrast revealed a possible filling defect of the left internal
carotid artery. Id. An MRA of the head showed no large vessel occlusion. Id. A CT angiogram
of the neck with and without contrast showed mild atherosclerotic changes in the left internal
carotid artery, with a small focal ulcerative plaque and stenosis of 30-40%. Id. A transesophageal
echocardiogram revealed mild atherosclerosis in the descending aorta but was otherwise normal.
Ex. 4 at 25-27; Ex. 6 at 306.
During a consult with cardiologist Rajkumar Sugumaran, M.D., on April 1, 2016,
Petitioner reported that “prior to her ER visit she was in her usual state of health.” Ex. 6 at 224.
She reported the removal of the granuloma and that she had received two flu vaccinations “7
months apart” that year. Id. Dr. Sugumaran implanted a cardiac loop recorder to monitor
Petitioner’s heart for arrhythmias. Ex. 8 at 21.
Lab work undertaken at Abrazo revealed an elevated cholesterol level, and Petitioner was
started on a statin. Ex. 6 at 5. Her troponin test was negative, as was urine toxicology. Id. at 5,
342. Her C-reactive protein3 (“CRP”) and erythrocyte sedimentation rate (“ESR”) levels4 were
3 C-reactive protein: a globulin that forms a precipitate with the somatic C-polysaccharide of the
pneumococcus in vitro; it is the most predominant of the acute-phase proteins. DORLAND’S MEDICAL
DICTIONARY ONLINE (“DORLAND’S”), https://www.dorlandsonline.com/dorland/definition?id=100489
(last accessed January 2, 2025).
4 Erythrocyte sedimentation rate: the rate at which erythrocytes precipitate out from a well-mixed specimen
of venous blood, measured by the distance the top of the column of erythrocytes falls in a given time interval
under specified conditions; an increase in rate is usually due to elevated levels of plasma proteins, especially
fibrinogen and immunoglobulins, which decrease the zeta potential on erythrocytes by dielectric shielding
and thus promote rouleau formation. It is increased in monoclonal gammopathy, hypergammaglobulinemia
due to inflammatory disease, hyperfibrinogenemia, active inflammatory disease, and anemia. DORLAND’S,
https://www.dorlandsonline.com/dorland/definition?id=102146 (last accessed January 2, 2025).
5

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normal. Id. at 342, 350. Her complete blood count (“CBC”) did not reveal any evidence of
inflammation. Id. at 349. Her hypercoagulable workup5 was normal. Id. at 344-48.
Petitioner was discharged from Abrazo on April 2, 2016. Ex. 6 at 5. Her diagnosis at the
time of discharge was acute cerebrovascular accident (“CVA”). Id.
On April 5, 2016, Petitioner followed up with Dr. Sugumaran. Ex. 8 at 7. Petitioner
reported left arm, shoulder, and left-sided neck tightness, with an onset of that morning. Id. at 7,
9. She also reported decreased facial sensations. Id. at 7. She denied any chest pain, chest
pressure, shortness of breath, orthopnea, dizziness, palpitations, presyncope, or syncope. Id. Her
physical exam was normal except for elevated blood pressure. Id. at 8-9. Dr. Sugumaran assessed
CVA, hyperlipidemia, hypertension, left arm pain, and tobacco abuse. Id. at 10. He counseled
Petitioner about quitting smoking. Id.
On April 15, 2016, Petitioner submitted a VAERS report in which she stated that she
received a flu vaccination on March 22, 2016, and experienced the onset of facial numbness, facial
drooping, difficulty speaking, arm and hand numbness, and decreased object recognition and
processing sensations beginning on March 30, 2016. Ex. 3 at 1.
On April 20, 2016, Petitioner was brought to the ER by ambulance, complaining of left
arm pain that was radiating to her neck and jaw. Ex. 6 at 494. She reported the symptoms began
while she was at home. Id. She also reported that “she received [the] flu vaccine two weeks ago
on [the] affected arm.”6 Id. Her neurological exam was normal, and the examining physician
noted that she was scheduled to see her neurologist two hours later. Id. at 497. Lab results were
normal. Ex. 4 at 10-19. She was discharged home with a diagnosis of arm pain of unknown cause.
Ex. 6 at 497.
Later that day, Petitioner saw Dr. El-Gengaihy. Ex. 10 at 9. On her intake form, she
described her complaint as “[follow-up] after TIA and [left] deltoid flu shot [with] ‘fever’ in my
shoulder, neck, chest and scapular region,” which had been ongoing “since” March 22, 2016. Id.
at 5. She further reported that she had suffered a TIA on March 22, 2016, the day of vaccination.
Id. Her exam was normal, with no evidence of edema or rashes. Id. at 6, 9. Dr. El-Gengaihy
ordered a cerebral angiogram to rule out vasculitis. Id. at 10.
On May 9, 2016, Petitioner had another follow-up with Dr. Sugumaran. Ex. 8 at 1. Her
cardiac loop recorder had detected only one episode of bradycardia since implantation. Id. She
complained of an itchy scalp but was otherwise doing well from a cardiac standpoint. Id. She had
no symptoms of angina. Id. She reported that she had stopped smoking. Id. at 4. Dr. Sugumaran
assessed “unchanged” CVA, hyperlipidemia, and hypertension, “improved” tobacco abuse, and
“resolved” left arm pain. Id. at 3-4.
5 Hypercoagulability: the state of being more readily coagulated than normal. Hypercoagulability,
DORLAND’S, https://www.dorlandsonline.com/dorland/definition?id=23731 (last accessed January 2,
2025).
6 In fact, the vaccine had been given 35 days earlier. Ex. 2 at 1.
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On June 24, 2016, Petitioner underwent a cerebral angiogram, which found an ulcerated
plaque in the left internal carotid artery, causing about 40% narrowing of the artery. Ex. 15 at 673-
77. She tolerated the procedure well. Id. at 677.
Six days later, on June 30, 2016, Petitioner presented to the ER at Banner with complaints
of expressive aphasia. Ex. 15 at 544. She was seen by neurologist Douglas Franz, M.D. Id. She
could not provide a history due to difficulty speaking. Id. Dr. Franz recorded her NIH stroke
scale7 as 1 for right-sided hemisensory changes and 1 for nonfluent aphasia. Id. On exam,
Petitioner was aphasic but could at times put three words together in a meaningful sentence. Id.
at 545. She had mild dysnomia, but her comprehension appeared intact. Id. She had difficulty
with repetition. Id. Her facial sensation was diminished on the right side, but her face, tongue,
and palate were symmetric. Id. Her motor exam and reflexes were normal, but she had diminished
light-touch sensation on the right side of her body. Id. Dr. Franz noted that Petitioner had a history
of stroke earlier that year, with a “probable residual sensory deficit on the right[.]” Id. at 546. He
recommended admission for treatment with IV tissue plasminogen activator (“tPA”) pursuant to
hospital protocol. Id. at 544-46.
In the hospital, Petitioner underwent another MRI of the brain that showed a 2.3-cm left
thalamic lesion, which was potentially consistent with a subacute infarct but was also concerning
for neoplasm. Ex. 15 at 550. She also had a CT angiogram of the neck, which was interpreted as
showing bilateral carotid webs, with the more prominent web in her left internal carotid artery. Id.
at 473. The interpretation was that neither web appeared hemodynamically significant. Id. at 474.
On July 3, 2016, Petitioner was seen by neurosurgeon Jose Menendez, M.D., who was
concerned she might have a high-grade glioma. Ex. 9 at 5. She underwent a brain biopsy on July
5, 2016, which showed that the tissue exhibited “hemorrhage, reactive gliosis and foamy histocyte
infiltrate.” Id. at 9-11. The foamy cells were felt to be consistent with a history of stroke. Id. at
7. There was no evidence of neoplasm or infection. Id. The pathology report stated that the tissue
showed “an inflammatory-reactive process characterized by sharply demarcated foci of damage
containing clusters of wall-to-wall macrophages, rimmed by enlarged/tortuous axonal profiles
(axonal spheroids), parenchymal and perivascular chronic inflammation and reactive vessels.” Ex.
15 at 785.
On July 7, 2016, Petitioner was discharged from Banner to home. Ex. 15 at 8-9. Her
discharge diagnoses included left thalamus lesion, status post left frontal burr hole for stereotactic
needle biopsy; history of left thalamic stroke; and aphasia, status post IV tPA given for concern
for CVA. Id. She had undergone PT, OT, and speech therapy in the hospital. Id. at 9. At the time
of discharge, she was able to walk without assistance, though she still had aphasia, which had
7 The NIH stroke scale is “widely used [to help] health care providers assess the severity of a stroke. Health
care providers use it to measure neurological function and deficits by asking the person to answer questions
and perform several physical and mental test…. Using a numerical scale to determine stroke severity, health
care providers record the person’s performance in 11 categories, such as sensory and motor ability.” NIH,
NIH Stroke Scale,
https://www.ninds.nih.gov/health-information/stroke/assess-and-treat/nih-stroke-scale (last accessed on
January 2, 2025). A score of 1 is defined as “1 = Not alert; but arousable by minor stimulation to obey,
answer, or respond.” Id.
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persisted throughout her hospitalization. Id. She was instructed not to drive. Id. She was referred
for outpatient speech therapy. Id.
On July 15, 2016, Petitioner followed up with her primary care physician (“PCP”), Peter
Young, M.D. Ex. 4 at 5. Her exam was normal. Id. at 7-8. Dr. Young advised her to stop
smoking. Id. at 9. On July 18, 2016, Petitioner returned to Dr. Young so that leave-related forms
could be completed. Id. at 1. On October 3, 2016, she saw Dr. Young to discuss lab results relating
to her thyroid condition. Id. at 28. Her exam was normal, but she had low TSH levels. Id. at 30.
The plan was to decrease her Synthroid dosage and recheck her TSH in two months. Id. at 31.
On February 13, 2018, Petitioner saw Dr. Franz. Ex. 37 at 1. Dr. Franz noted that she had
experienced two cryptogenic strokes. Id. He commented that she had a history of carotid web.
Id. At the time of the visit, Petitioner complained of right-sided sensation changes, skin sensitivity
to touch, post-stroke depression, and headaches. Id. Dr. Franz assessed depressive disorder,
central pain syndrome, and stroke. Id. at 2. He noted that Petitioner had a “history of left peri-
insular and left thalamic stroke the former of which may be related to left carotid web and the
second may have been a periprocedural [complication].” Id. He prescribed duloxetine for pain
and depression, along with aspirin, and referred Petitioner to a psychologist. Id.
In 2019, Petitioner was diagnosed with Crohn’s disease, for which she was prescribed
Lialda.8 See Ex. 40 at 159. She moved to California and established care with Kaiser Permanente.
See generally Ex. 40. On July 2, 2020, she had a telehealth visit with Florence Leung, M.D.,
during which she complained of gastrointestinal symptoms but no neurologic ones. Id. at 71. Her
records indicated a remote history of CVA. See, e.g., id. at 159.
On August 28, 2020, Petitioner sent electronic messages to Dr. Leung complaining of
headaches on the side of her head on which she had experienced the strokes. Ex. 40 at 178-79.
She requested a referral to a neurologist. Id. Dr. Leung prescribed nortriptyline, but Petitioner
later reported that the medication gave her unusual dreams and did not work, so she stopped taking
it. Id. at 178. There is no indication that Petitioner saw a neurologist for her headaches. There
are no further relevant medical records.
III. EXPERT EVIDENCE
A. Petitioner’s Expert: Laura S. Boylan, M.D.
1. Qualifications
Dr. Boylan authored two expert reports in this case. Ex. 16 (“First Boylan Rep.”); Ex. 35
(“Second Boylan Rep.”). She received her M.D. in 1994 from the Columbia University College
of Physicians & Surgeons. Ex. 18 (“Updated Boylan CV”) at 1. She completed a residency in
neurology at The Neurological Institute at Columbia-Presbyterian Medical Center, and a post-
doctoral clinical research fellowship at The Neurological Institute and New York State Psychiatric
Institute. Id. at 2.
8 Petitioner’s diagnosis was later changed to ulcerative colitis. Ex. 40 at 200.
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According to the documents in the record and the hearing testimony, Dr. Boylan is board
certified in neurology and is an attending neurologist at Bellevue Hospital Center in New York
City. Id. She has also worked as a neuro-hospitalist at Essentia Health in Duluth, Minnesota,
where she has covered the stroke service. First Boylan Rep at 1; Tr. at 25-26. She has taught
neurology at New York University School of Medicine in several different roles. Updated Boylan
CV at 2. She estimated that she has diagnosed and treated more than 1,000 patients with stroke
and more than 100 cases of post-infectious neurological symptoms. First Boylan Rep. at 2.
Dr. Boylan is a member of the American Academy of Neurology, the American
Neurological Association, and the Movement Disorder Society. Tr. at 24. She has served as an
ad hoc reviewer for Neurology, Brain, Epilepsia, BMJ Case Reports, Seizure, Epilepsy &
Behavior, and other publications. Updated Boylan CV at 3-4. She also served on the editorial
board of Practical Reviews in Neurology. Id. at 4. She has authored 11 peer-reviewed papers and
10 abstracts. Id. at 8-9, 12.
2. Dr. Boylan’s First Expert Report
Dr. Boylan explained that “[t]here is substantial evidence that inflammation plays a role in
stroke.” First Boylan Rep. at 3. Vaccinations provoke the immune/inflammatory system,
“inducing a series of cellular and molecular events in the body referred to as an ‘inflammatory
cascade.’” Id. Although this response is protective in the “vast majority of individuals,” it rarely
can be harmful. Id.
Dr. Boylan noted that “influenza vaccination has been shown to decrease cardiovascular
risk at the population level[.]” First Boylan Rep. at 3. But “this does not indicate that Ms. Goff’s
influenza vaccinations did not cause or contribute to her stroke.” Id. She observed that acute
infections, including flu infection, have been associated with an increased risk of vascular events.
Id. “[T]his observation has raised concern that vaccination itself could be associated with
increased short term stroke risk,” based on a “plausible scientific basis for causality.” Id.
Although the flu vaccination is generally recommended once a year, Dr. Boylan pointed
out that some populations, like infants and children, are given booster doses to ensure adequate
protection. First Boylan Rep. at 3-4. This suggests that the clinical response to vaccination –
including the potential for adverse response – is affected by the frequency of vaccination and the
total dose of vaccine given. Id. at 4. Petitioner received two flu vaccinations during one season,
which might have produced an enhanced immune provocation and a “higher risk of adverse
events.” Id.
Dr. Boylan stated that the “event of March 30, 2016 was clearly a stroke,” and the “event
of June 30, 2016 was most likely a second stroke, but there is a possibility that it represents
primarily inflammation or progression/extension of the first stroke.” First Boylan Rep. at 5.
Petitioner’s imaging revealed the presence of bilateral carotid webs, worse on the left than the
right. Id. at 9. A carotid web is “a particular abnormality in the wall of one of the major vessels
which provides blood to the brain.” Id. at 5. These carotid webs increased Petitioner’s propensity
for stroke. Id. Notably, “[t]he web is most prominent on Ms. Goff’s left side and that is the side
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where she had both strokes.” Id.
Petitioner’s June 30, 2016 brain imaging “showed a stroke in the territory supplied with
blood which passes through the carotid web.” First Boylan Rep. at 9. That imaging showed a
second lesion that was distinct from the first stroke on March 30, 2016, but adjacent to the previous
stroke. Id. Dr. Boylan agreed with Petitioner’s treating physicians that the lesion from the second
event “did not look like a stroke,” because it was deep and irregular, suggesting that it might have
been caused by a tumor or infection. Id.
Dr. Boylan explained that repeated strokes in a woman in her forties are “extremely rare,”
and the decision to perform a biopsy of the lesion illustrates “how atypical and unusual Ms. Goff’s
clinical situation and brain imaging were.” First Boylan Rep. at 9. The biopsy revealed abundant
inflammatory cells and demonstrated an active inflammatory process that was sufficient to light
up on an MRI, another unusual occurrence. Id. at 9-10. Dr. Boylan concluded that “[t]he tissue
biopsy provided [a] definitive diagnosis of an active inflammatory process and did not show
changes associated with tumors or infections.” Id. at 10.
Dr. Boylan noted that Petitioner’s “extensive stroke evaluation did not reveal any apparent
cause of stroke other than the carotid webs.” First Boylan Rep. at 10. The role of carotid webs in
predisposition to stroke is an “emerging area” of medicine. Id. In Dr. Boylan’s opinion, the carotid
webs made Petitioner particularly vulnerable to strokes. Id.
Dr. Boylan also identified a tendency toward inflammation as a risk factor for Petitioner.
Inflammation promotes blood clotting, or thrombosis, increasing the risk of stroke. First Boylan
Rep. at 10. Petitioner had a history of allergies, recurrent shingles, and thyroid disease, all of
which are “associated with abnormalities in the immune/inflammatory system and may have
predisposed her to stroke from either or both excessive clot formation or abnormalities in the vessel
walls in the setting of carotid webs.” Id. Furthermore, her history of granuloma requiring surgical
removal signified a propensity toward inflammation. Id.
Dr. Boylan noted that, according to the National Stroke Association Stroke Risk Calculator,
Petitioner’s history of smoking increased her risk of stroke by only 0.4% over ten years.9 First
Boylan Rep. at 10. Overall, her risk as a young adult was low. Id.
Dr. Boylan observed that flu infections are associated with strokes, but she acknowledged
that there have been few cases of stroke after the flu vaccine. First Boylan Rep. at 11. Nonetheless,
“in rare individuals, [stroke] will occur as a post-vaccine phenomenon even though vaccination
reduces overall risk in the population.” Id.
Dr. Boylan concluded that the September 14, 2015 and March 22, 2016 flu vaccines
together “most likely provoked an immune/inflammatory response which caused or contributed to
the occurrence and severity of the strokes [Petitioner suffered].” First Boylan Rep. at 11.
Petitioner had several risk factors that might have predisposed her to a stroke triggered by the
9 Dr. Boylan pointed out that this stroke risk calculator does not even permit calculation of risk for people
under age 45. First Boylan Rep. at 10.
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inflammatory response initiated by the vaccines. Id. Petitioner’s inflammation was “particularly
strong,” particularly with her second stroke, as evidenced by her imaging. Id.
3. Dr. Boylan’s Second Expert Report
In a brief response to Dr. Messé’s expert report (discussed below), Dr. Boylan clarified
that, in her opinion, Petitioner’s brain MRI following the second event was unusual because it
showed sufficient inflammation to cause a suspicion of tumor or infection, requiring biopsy.
Second Boylan Rep. at 1. Her conclusions were unchanged.
4. Dr. Boylan’s Testimony
Dr. Boylan was recognized as an expert in neurology. Tr. at 31. She defined a stroke as
“local damage to the brain in a particular area related to the blood flow and the vascular structures
of the brain.” Id. Strokes are generally categorized as either ischemic, characterized by choking
off blood supply to the brain, or hemorrhagic, characterized by bleeding into the brain. Id. at 32.
They can be caused by emboli that develop in the heart or other parts of the body, including arteries
or veins, and then break off and travel to the brain. Id. at 32-33. Dr. Boylan’s opinion was that
Petitioner suffered from an ischemic, artery-to-artery, thromboembolic stroke, likely arising in the
artery with the carotid web. Id. at 33-34.
Dr. Boylan testified that both chronic and acute inflammation play a major role in stroke.
Tr. at 34. Patients with severe systemic inflammation can develop strokes. Id. Inflammation from
non-infectious causes also can trigger stroke. Id. at 36. The walls of the blood vessels in the brain
are “very sensitive to the effects of inflammation.” Id. at 37. The more inflammation a person
experiences in response to a stroke, the worse the outcome might be. Id. at 50. Medications with
anti-inflammatory properties are given to treat strokes. Id. However, “not every inflammation
will provoke a stroke, and not every stroke will be caused by inflammation[.]” Id. at 39.
Furthermore, stroke itself causes an inflammatory response. Id.
According to Dr. Boylan, one of the main sources of inflammation is the endothelium,
which is the innermost lining of the blood vessels. Tr. at 40. The endothelium within the brain is
proximate to immune cells called glial cells. Id. at 52. The glial cells excrete endothelium-related
growth factor, along with chemokines and cytokines that “are actively in communication with the
blood and with messengers within the blood.” Id. Inflammation will cause changes in vascular
reactivity, or endothelial-dependent relaxation, which can impair the ability of blood to circulate
through the brain. Id. at 53-54. Dr. Boylan testified that a study showed that certain biomarkers
and changes in vascular reactivity were evident two weeks after flu vaccination in healthy
individuals. Id. (referencing Smeeth L, et al., Risk of Myocardial Infection and Stroke after Acute
Infection or Vaccination, N. ENGL. J. MED. (2004);351(25):2611-2618 (Ex. 31) (“Smeeth”)).
Dr. Boylan stated that Smeeth explored the possible association between vaccination and
stroke. Tr. at 37. The authors posited that systemic inflammation could “pull the trigger” for a
vascular event, such as a stroke, that might not have otherwise occurred. Id. at 37-38. Both
infections and vaccines are pro-inflammatory and could, theoretically, cause a stroke. Id. at 38.
Although the Smeeth study found that the flu vaccine reduced the risk of stroke in the population
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by 40-60%, according to Dr. Boylan, that finding does not rule out the possibility that “rare
individuals” will experience adverse effects from the vaccine, including stroke. Id. at 38.
Dr. Boylan testified that systemic inflammation affects stroke risk. Tr. at 54. She stated
that it was “conventional wisdom to the point of dogma[] that infection promotes thrombosis.” Id.
Also, according to the Cardenas paper, both viral infection and vaccination could promote blood-
brain barrier dysfunction, “producing neuroinflammation and neurological disorders.” Id. at 44;
see Cardenas G, et al., Neurological events related to influenza A (H1N1) pdm09, INFLUENZA AND
OTHER RESPIRATORY VIRUSES (2014);8(3):339-346 (Ex. 19) (“Cardenas”). The inflammatory
response in a given individual “may be modulated by individual biological factors, like age, sex,
[and] genetic background.” Tr. at 42-43. Additionally, the McColl article supported the notion
that an inflammatory response unfolds in a cascade of events, and people will have a broad range
of symptoms as a result. Id. at 45-46; see McColl BW, et al., Systemic Infection, Inflammation
and Acute Ischemic Stroke, NEUROSCIENCE (2009);158:1049-1061 (Ex. 27) (“McColl”). McColl
observed that the highest risk period for stroke occurs during the greatest pro-inflammatory phase
of the immune response. Tr. at 45.
Dr. Boylan next explained that a carotid web “is an abnormal formation on a vessel, like
a little ledge within the vessel.” Tr. at 56. Carotid webs are a risk factor for stroke because vascular
abnormalities “promote the creation of thrombus.” Id. at 55-56. The abnormal formation of the
vessel disturbs the usual flow within the vessel, similar to rocks disturbing the flow of water in a
river. Id. at 56, 61. Carotid webs are “one of the causes of stroke and recurring stroke in young
women who you would not otherwise expect to have a stroke.” Id. at 57. Even small carotid webs
are associated with increased stroke risk. Id. at 65.
Based on her review of Petitioner’s imaging, Dr. Boylan agreed that Petitioner had bilateral
carotid webs, with the larger one in her left internal carotid artery, which was located upstream
from where her first stroke occurred. Id. at 64. These carotid webs predisposed Petitioner to
strokes and would be classified as an “anatomic prothrombotic substrate.”10 Id. at 77. Further, the
combination of this anomaly with the inflammation induced by a vaccination would enhance this
risk. Id. at 79.
Dr. Boylan referenced the Lin case report, in which the authors broadly stated that
“vaccination provokes a variable magnitude of inflammatory and immunological response that
modifies the risk for ischemic stroke,” and “an inflammatory/immunological response after
vaccination may trigger thrombosis superimposing a preexisting prothrombotic state.” Tr. at 77-
78; see Lin YP, et al., Ischaemic stroke and influenza A H1N1 vaccination: a case report, ARCH
MED. SCI. (2011);7(2):345-348) (Ex. 26) (“Lin”). Furthermore, the fact that Petitioner had not had
a stroke prior to vaccination made it “very hard to say” that the vaccination and the stroke were
unrelated. Tr. at 77-78. Additionally, the March 22, 2016 vaccination could have elicited a booster
10 Dr. Boylan testified that she was somewhat confused by Petitioner’s June 30, 2016 CT angiogram, which
reported multiple infarcts or an “embolic shower” from multiple sources. Tr. at 74-75. The scan also
showed that Petitioner’s second stroke did not seem to have occurred downstream from the left carotid web.
Id. at 76. This confusion did not alter her opinion that Petitioner suffered from carotid webs, which
predisposed her to strokes. Id. at 77.
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effect, given that it was administered only six months after her previous flu vaccination. Id. at 83.
This could have produced additional inflammation. Id.
Dr. Boylan testified that carotid webs “are quite dangerous” and can cause recurrent
strokes. Tr. at 83. The fact that Petitioner had a stroke after receiving the vaccination, but had not
experienced any strokes since 2016, caused Dr. Boylan to conclude that “the vaccine triggered the
stroke to a level of certainty that I would make a clinical decision on that basis.” Id. at 84.
Dr. Boylan testified that Petitioner was feeling unwell and experienced localized arm pain
and swelling after vaccination, indicating a clinically notable inflammatory response to the
vaccination. Tr. at 47-48. Petitioner did not have any contemporaneous triggers for an acute
inflammatory response other than the flu vaccination. Id. at 69. A stroke occurring eight days
after vaccination was within the expected time frame for such an event. Id. at 48.
Dr. Boylan opined that she would recommend against Petitioner receiving future flu
vaccinations. Tr. at 85. Petitioner had a low risk of dying from the flu; therefore, the protection
she would receive from the flu vaccine would not outweigh the risk of another stroke. Id.
Regarding Petitioner’s second stroke, Dr. Boylan noted that it was “strange in a number of
ways.” Tr. at 85. That episode occurred after a needle angiogram, which is associated with a risk
of stroke. Id. at 86. The event did not occur in the carotid artery or around any anomalous
vasculature. Id. Dr. Boylan opined that the second stroke might have been triggered by the
angiogram procedure. Id. She clarified that she did not believe the second stroke was directly
caused by the vaccination; instead, it resulted from the treatment given for the first stroke, which
she maintained was vaccine caused. Id. at 87.
Dr. Boylan did not believe Petitioner’s history of smoking caused her stroke. Tr. at 88.
Based on her evaluation of Petitioner’s smoking habits, her carotid webs, and her flu vaccination,
Dr. Boylan did not think Petitioner’s smoking or carotid webs were enough to cause the first stroke
without the catalyst of the vaccination. Id. at 91.
In summary, Dr. Boylan opined:
[The vaccination,] through a direct effect or through its pro-
inflammatory stimulation possibly, and also with the booster effect,
adduced an acute inflammatory response, which, in turn, triggered
an inflammatory cascade, which includes a prothrombotic state, and
that triggered abnormal blood flow over her preexisting carotid
webs, formed a thrombus, which flew downstream and caused a
stroke.
Tr. at 94. She added that “the vaccine induced a pro-inflammatory state which promoted the
formation of a clot in Ms. Goff’s preexisting carotid web and that there was a subsequent breakup
of that clot, and it went downstream and caused her stroke.” Id. at 129.
On cross examination, Dr. Boylan acknowledged that the Smeeth study, which included
19,000 subjects, revealed a decreased risk of stroke after flu vaccination compared to after
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infection. Tr. at 95. She broadly agreed with the authors’ finding that flu vaccination is not
associated with a detectable increase in the risk of vascular events at the population level, but she
did not believe that finding was applicable to Petitioner, because the study was “not designed to
detect or capable of detecting rare events or exclusion of events.” Id. at 97-98. She allowed that,
in general, a natural flu infection would produce a more robust inflammatory response than the
typical response to a vaccination. Id. at 103.
Dr. Boylan testified that she did not believe every stroke was caused by inflammation. Tr.
at 101. It is difficult to ascertain whether a stroke has been caused by an inflammatory trigger. Id.
To make that determination, one would “look at certain inflammatory markers” like ESR and CRP.
Id. Dr. Boylan maintained that Petitioner “had all of the classical symptoms of an inflammatory
response of some magnitude, undefined magnitude, before she had a stroke,” but she
acknowledged that there was no evidence in the medical records that she had a fever, flu-like
symptoms, or lab work showing inflammation or a prothrombotic state. Id. at 101-02, 113.
Instead, she pointed out that Petitioner self-reported experiencing a “fever” in her shoulder, neck,
chest, and scapular region after the March 22, 2016 vaccination. Id. at 121-23.
Dr. Boylan acknowledged that her causal theory was not specific to the flu vaccine. Tr. at
104. Her theory suggests that any inflammatory stimulus could trigger a stroke, but she admitted
that other inflammatory events, such as poison ivy exposure, seasonal allergies, and bee stings, are
not associated with stroke. Id. at 104-05. She confirmed that most strokes in patients under 50
are idiopathic, and she agreed that none of Petitioner’s treating physicians attributed her stroke to
her vaccination. Id. at 106-07. She acknowledged that the studies she submitted involved strokes
in younger patients with carotid webs who had no identified inflammatory triggers. Id. at 106-09.
Dr. Boylan testified that her proposed causal mechanism involved both the innate and
adaptive immune systems, but primarily the innate immune system. Tr. at 114. She stated that
there was no specific time frame during which she would expect an inflammatory process to occur
and trigger a stroke. Id. at 115-16. She stated that the Vaccine Injury Table gives some guidance,
and she believed any injury occurring within six to eight weeks of vaccination might be considered
autoimmune in nature. Id. at 116. Any injury occurring six months after vaccination would not
be attributable to the vaccine. Id. She could not say how long the innate immune system response
to a flu vaccination would continue, but she was “confident that it lasts at least as long as the time
period from the second vaccine to the first stroke.” Id. at 119.
In response to a question from Special Master Oler, Dr. Boylan testified that certain types
of infections increase the risk of stroke, including flu, zoster, bacterial blood infections, syphilis,
tuberculosis, cryptococcus, and fungal infections. Tr. at 126. She opined that in principle, if a
viral infection can induce stroke, then the vaccination against that infection could as well. Id.
On redirect examination, Dr. Boylan clarified that the McColl study showed that the
highest risk of stroke occurred within one week of infection. Tr. at 130-31. This corresponded to
the time during which the systemic inflammatory response was strongest. Id.
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B. Respondent’s Expert: Steven Messé, M.D.
1. Qualifications
Dr. Messé authored one expert report in this case. See Ex. A (“Messé Rep.”). According
to the documents in the record and the hearing testimony, he is an Associate Professor in the
Division of Vascular Neurology at the University of Pennsylvania. Messé Rep. at 1. He received
his M.D. from the University of Michigan School of Medicine. Ex. B (“Messé CV”) at 1. He
completed his neurology residency and a stroke and neurocritical care fellowship at the University
of Pennsylvania. Id. He is board certified in neurology and vascular neurology, which is the area
of neurology that focuses on cerebrovascular diseases such as stroke. Id. at 2; Tr. at 142. His
clinical practice specializes in patients with cerebrovascular disease, and he has treated thousands
of stroke patients. Tr. at 142, 221. He also conducts clinical research, primarily focused on stroke.
Id. at 142.
Dr. Messé has served as an ad hoc reviewer for publications such as Neurology, Stroke,
Journal of Neuroimaging, The New England Journal of Medicine, and Lancet. Messé CV at 2-3.
He has published about 70 peer-reviewed papers. Id. at 6-13. He is a member of the American
Academy of Neurology, the American Heart Association, and the American Stroke Association.
Tr. at 144. At the time of the hearing in this case, he was serving as the chair of the American
Stroke Association’s Stroke Systems of Care Advisory group, which oversees a large database of
stroke incidents used by clinicians to improve treatment. Id. at 144-45.
2. Dr. Messé’s Expert Report
Dr. Messé opined that Petitioner’s recurrent ischemic strokes were not related to the March
22, 2016 flu vaccination. Messé Rep. at 3. He stated that the literature “strongly supports the
notion that influenza vaccination is associated with a reduced, not increased, risk of stroke.” Id.
(emphasis in original). For example, the Grau study showed that vaccination was less common in
stroke patients compared to control subjects. Id.; see also Grau AJ, et al., Influenza Vaccination
Is Associated With a Reduced Risk of Stroke, STROKE (2005);36:1501-1506 (Ex. 23) (“Grau”).
The Siriwardena study similarly reported a 24% reduced risk of stroke in those who were
vaccinated. Messé Rep.at 3; see also Siriwardena AN, et al., Influenza and pneumococcal
vaccination and risk of stroke or transient ischemic attack – Matched case control study, VACCINE
(2014);1354-1361 (Ex. 30) (“Siriwardena”). The Smeeth study found no increased risk of stroke
after flu vaccination. Id. The medical literature supplied by Dr. Boylan also mostly supported
the notion that flu vaccinations are “robustly protective” against stroke. Id. Dr. Boylan cited just
two case reports for her claim that a causal association exists between vaccination and stroke; one
of those involved a varicella vaccination, not flu. Id. at 3-4.
In describing Petitioner’s imaging, Dr. Messé noted that Petitioner’s first stroke was a “left
middle cerebral artery embolic-appearing stroke.” Messé Rep. at 4. She had an ulcerated plaque
in the internal carotid artery, resulting in 30-40% stenosis. Id. The risk of stroke is significantly
increased when there is greater than 50% stenosis, but lesser degrees of stenosis are also associated
with an increased risk. Id. Furthermore, ulcerated plaque is associated with an even higher risk
of stroke, because “[t]he rupture or endothelial erosion of an unstable, atherosclerotic plaque leads
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to thrombus formation, which then may embolize distally.” Id. Dr. Messé’s opinion was that
Petitioner’s stroke was related to her carotid lesion. Id.
In his report, Dr. Messé disagreed that Petitioner had a carotid web. Messé Rep. at 4. He
noted that she underwent a conventional angiogram, which is the gold standard for evaluation of
blood vessel abnormalities, and the radiologist interpreting the study concluded that her carotid
stenosis was caused by an ulcerated atherosclerotic plaque, not a carotid web. Id. Furthermore,
regardless of whether she had stenosis caused by a carotid web or plaque, “it seems unnecessary
to blame the vaccination . . . [which] is associated with a reduced stroke risk.” Id.
Dr. Messé strongly disagreed with the claim that Petitioner had an unusual degree of
inflammation in the brain following her second stroke. Messé Rep. at 4. He noted that
“[e]nhancement on MRI after stroke is very common after the first day or two, and typically
persists for weeks.” Id. Petitioner’s biopsy was clearly consistent with a subacute infarction, and
the pathologists analyzing the biopsied tissue did not report finding abnormal inflammation. Id.
Dr. Messé opined that the MRI indicated that Petitioner’s second, thalamic infarct occurred
at the time of her cerebral angiogram on June 24, 2016. Messé Rep. at 4. He noted that infarcts
visible on MRI are common after cerebral angiograms. Id. He concluded that the second stroke
was iatrogenic, meaning it was caused by the medical care given to her for the first stroke. Id. at
4-5.
Dr. Messé pointed out that it is very common for strokes to be cryptogenic, with no clear
cause identified, particularly in younger patients. Messé Rep. at 5. “This uncertainty . . . does not
provide support for the notion that the stroke was caused by the vaccination, particularly when the
evidence suggests that vaccinations are protective overall.” Id. He concluded that Petitioner’s
history as a tobacco user, coupled with her mild hyperlipidemia and ulcerated atherosclerotic
plaque, likely caused her initial stroke. Id. Further, if she did have a left carotid web, “that also
would be a plausible mechanism for the stroke.” Id. He opined that it was “highly likely that the
second stroke was related to the cerebral angiogram that [Petitioner] received one week prior to
the MRI.” Id.
3. Dr. Messé’s Testimony
Dr. Messé was recognized as an expert in neurology and vascular neurology. Tr. at 145.
He characterized Petitioner’s stroke on March 30, 2016, as a left middle cerebral artery stroke. Id.
at 155.
Dr. Messé testified that Petitioner had a number of risk factors for stroke, including
elevated LDL cholesterol, smoking, and an anomaly in her carotid artery, which was either a
carotid web or atherosclerosis. Tr. at 155. Addressing the imaging of Petitioner’s carotid arteries,
Dr. Messé explained that Petitioner had a conventional angiogram on June 24, 2016. Id. at 155.
A conventional angiogram is an invasive procedure during which a radiologist or interventional
neurologist inserts a catheter through the groin and into the blood vessels in the neck. Id. at 156.
Although this procedure is considered the gold standard for assessing the blood vessels, it does not
image the walls of the blood vessels, and it carries the risk of brain injury caused by the catheter
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dislodging a blood clot or plaque. Id. In Petitioner’s June 24, 2016 angiogram, a neurosurgeon
found a complex ulcerated atherosclerotic plaque, causing a 40% narrowing of the carotid artery.
Id. at 156-57.
When Petitioner went to the hospital on June 30, 2016, she had a CT angiogram of the head
and neck. Tr. at 157. Dr. Messé testified that a CT angiogram is a noninvasive procedure in which
contrast is injected into the blood vessels while the patient is in a CT scanner. Id. Petitioner’s
radiologist interpreted her CT angiogram to show a carotid web, not atherosclerosis. Id. at 158.
At the hearing, and in contrast to his expert report, Dr. Messé favored carotid web as the proper
diagnosis. Id. at 159; compare Messé Rep. at 4. This was, in part, because he did not see a
significant overall atherosclerosis burden in Petitioner’s body. Id. He clarified that the physicians
performing the June 24 and June 30, 2016 studies both observed the same lesion in Petitioner’s
carotid artery, but they interpreted it differently. Id.
Dr. Messé opined that ultimately, the characterization of Petitioner’s carotid abnormality
was irrelevant, because either a carotid web or an ulcerated atherosclerotic plaque with 30-40%
stenosis could be a plausible mechanism for stroke. Tr. at 160. Dr. Messé defined a carotid web
as an abnormal growth in the lining of a blood vessel, caused by abnormal collagen deposition in
the lining. Id. at 160-61. A carotid web tends to develop at the carotid bifurcation, where the
common carotid artery splits into the external and internal arteries. Id. at 161. A carotid web
could, by itself, cause a stroke, without the need for a catalyzing trigger such as a vaccination. Id.
Dr. Messé opined that typically stroke patients are older, but about 30% of strokes occur
in patients under the age of 65. Tr. at 166-67. The mechanisms for stroke in older patients are
typically different than in younger patients. Id. at 167. There is ample literature supporting carotid
web being a risk factor for stroke in younger people. Id. Petitioner was in the appropriate age
group for a carotid web-caused stroke. Id.
Dr. Messé also discussed the thalamic lesion on Petitioner’s June 30, 2016 MRI. Tr. at
167. He noted that Petitioner’s clinical presentation was consistent with a subacute stroke, rather
than an acute stroke. Id. at 168. The biopsy was performed because her treating physicians were
concerned the lesion was a tumor, not because of a concern about inflammation or vasculitis. Id.
A suspicion of an inflammatory or vasculitis-related stroke would not have required a biopsy. Id.
Dr. Messé testified that the biopsy was “completely consistent” with a subacute stroke and did not
show a tumor; the biopsy also confirmed there was inflammation, but, in his opinion, that
inflammation was a natural response to the stroke and not its cause. Id. at 168-69.
Dr. Messé opined that there was no evidence in the literature that the flu vaccine can cause
a stroke. Tr. at 169. He identified Smeeth as the best study addressing this question. Id. at 169-
70. That study was conducted in the United Kingdom, which has a nationalized health system and
a large collection of patient records. Id. at 170. The study subjects had an exposure to either an
infection, a tetanus vaccination, a pneumococcal vaccination, or a flu vaccination, and had suffered
a stroke within a year of exposure. Id. at 171. The investigators compared the risk of stroke during
the 90-day period following infection/vaccination with the risk during a baseline period with no
such exposures. Id. The study assessed more than 19,000 patients who had a flu vaccination and
a stroke. Id. at 171-72. The incidence of stroke was lower for flu vaccinated patients during the
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risk period than during the baseline period. Id. at 172. Conversely, subjects who had infections
were at increased risk of stroke during the risk period compared to the baseline period. Id. at 173.
Dr. Messé concluded that the Smeeth study was “very reassuring that the vaccinations are not
causing strokes.” Id. He felt that, if there was a safety signal of increased risk of stroke from flu
vaccination, it would have been detected by the study. Id. at 172-73.
Dr. Messé also discussed the Siriwardena paper, a retrospective case-control study that
compared vaccinated patients who suffered strokes to those who did not. Tr. at 173-74; see
generally Siriwardena. He explained that, “after adjusting for all known and obvious and known
risk factors for stroke . . . people who got the vaccination had much lower risk of stroke, and it
actually is kind of the opposite, because people who had a stroke were much less likely to have
been vaccinated[.]” Tr. at 174. The Siriwardena study concluded that vaccinated subjects had a
24% reduction in stroke risk. Id. Dr. Messé characterized the study as “well done.” Id. The Grau
study was similarly constructed and found that the odds of stroke were reduced by “more than
half” in vaccinated patients compared to unvaccinated patients. Id. at 174-75; see Grau at 1504.
This finding was “very reassuring[] that vaccinations are not causing strokes.” Tr. at 175.
Dr. Messé also discussed the Lin case report, which described a 75-year-old who
experienced a stroke after vaccination. Tr. at 175; see Lin at 345. He found the case report
“uncompelling,” stating that “a 75-year-old having a stroke is not a big surprise.” Tr. at 175. The
subject of the report had experienced a prior stroke, had hypertension, and was not taking aspirin,
all of which heightened his stroke risk. Id. at 224. The authors provided no evidence for their
statement that “an inflammatory immunological response after vaccination may trigger
thrombosis, superimposing a preexisting prothrombotic state.” Id. at 175. Dr. Messé pointed out
that flu vaccination is not contraindicated in patients with a preexisting prothrombotic state; in
fact, they are “important for people at risk of vascular disease in particular.” Id. at 176, 206.
Dr. Messé testified that the Cardenas paper addressed autoimmune responses to
vaccination, but it provided “no evidence that vaccinations are actually causing these disorders,”
other than observational case reports. Tr. at 176-77.
Contrary to Dr. Boylan’s view, Dr. Messé did not find any evidence in Petitioner’s medical
records that she had an inflammatory reaction to the subject flu vaccination prior to the stroke,
such as redness or swelling in her arm, edema, purpura, ecchymoses, rash, or fever. Tr. at 162-65.
He stated: “I didn’t see anything that a doctor or nurse documented about recently feeling unwell
prior to the stroke.” Id. at 162. Her records on the day of admission indicated that she had been
in her “usual state of health” before the onset of the stroke, indicating that she had no complaints
between the vaccination and the stroke. Id. at 162-63. Petitioner’s CRP, ESR, white blood cell
(“WBC”) count, and platelet levels were all normal at the time of her March 30, 2016 admission.
Id. at 165-66. Her hypercoagulable studies, which were done to check whether she had a condition
predisposing her to blood clots, were also normal. Id. at 166.
On cross examination, Dr. Messé maintained that Petitioner’s smoking habit was another
likely risk factor for stroke, despite her relatively young age. Tr. at 178. He explained that
smoking increases the risks of atherosclerosis and blood clots. Id. at 179.
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Dr. Messé testified that flu infection can contribute to stroke risk, in part due to
inflammation. Tr. at 182, 194. He agreed that inflammation plays a role in stroke and that the
Smeeth study was at least indirectly looking at the association between inflammatory conditions
and stroke. Id. at 181. He opined that strokes caused by a recent or ongoing inflammatory state
are “rare.” Id. at 221.
Dr. Messé acknowledged that in the Smeeth study, more than 170 subjects experienced a
stroke within a week of receiving a flu vaccination. Tr. at 181. In his view, this was coincidental,
but he conceded that these cases were not assessed individually. Id. at 182. He further agreed that
the study was not powered to detect rare adverse events. Id. at 192. He pointed out, however, that
the risk of stroke was most reduced in the first one to three days following flu vaccination; he
surmised that this could be because people receiving the flu vaccination tend to be healthier. Id.
at 222-23.
Dr. Messé disagreed with Dr. Boylan’s opinion that, if a wild-type infection has been
associated with a harm, it is reasonable to presume that vaccination against that infection could
cause the same harm. Tr. at 189. He explained that the body’s responses to infection and
vaccination are “different in severity and extent.” Id. at 190. He generally agreed, however, that
“immune system activation” can contribute to stroke risk and that vaccination is specifically
designed to activate the immune system. Id. at 191-92.
Regarding Petitioner’s second episode, Dr. Messé testified that there was some uncertainty
whether she suffered a second acute stroke caused by her carotid web or a vascular event due to
the June 24, 2016 angiogram procedure. Tr. at 204-05. He favored the procedure as the
precipitating event, in agreement with Dr. Boylan. Id. at 205.
Dr. Messé agreed that a carotid web is a preexisting thrombotic condition, but he
distinguished that from a hypercoagulable state or a generalized prothrombotic state. Tr. at 206-
07. He explained that the web increases the likelihood of developing a clot in the web’s location,
not elsewhere the body. Id. at 207. He allowed that recurrent strokes are seen in patients with
carotid webs, but he disagreed that the presence of a web would guarantee recurrent strokes. Tr.
at 214-15. Instead, he opined that carotid web is a meaningful risk factor for stroke. Id. at 215.
Regarding Petitioner’s presentation at the time of her first stroke, Dr. Messé agreed that
her CRP level might have been normal even in the presence of inflammation. Tr. at 219. However,
he maintained that there was no evidence of inflammation in Petitioner’s case. Id. He testified
that for “a systemic inflammatory state that’s bad enough to cause a stroke, I would expect to see
something.” Id. at 220.
Dr. Messé testified that the timing of Petitioner’s initial stroke fell within the range during
which the risk of stroke is increased due to the body’s “inflammatory and immunological ramp-up
responding to infection.” Tr. at 212. But he pointed out that her stroke also occurred in the
timeframe “where we saw a reduced risk of stroke in people who are vaccinated.” Id. at 212-13.
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IV. LEGAL FRAMEWORK
A. Petitioner’s Burden in Vaccine Program Cases
Under the Vaccine Act, a petitioner may prevail in one of two ways. First, a petitioner may
demonstrate that she suffered a “Table” injury—i.e., an injury listed on the Vaccine Injury Table
—that occurred within the time provided in the Table. § 11(c)(1)(C)(i). “In such a case, causation
is presumed.” Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006);
see § 13(a)(1)(B). Second, where the alleged injury is not listed in the Vaccine Injury Table, a
petitioner may demonstrate that she suffered an “off-Table” injury caused by the vaccination.
§ 11(c)(1)(C)(ii).
For both Table and non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. § 13(a)(1). That is, a petitioner must offer evidence that leads
the “trier of fact to believe that the existence of a fact is more probable than its nonexistence before
[he] may find in favor of the party who has the burden to persuade the judge of the fact’s
existence.” Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010); see
also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or speculation
is insufficient under a preponderance standard). The petitioner must demonstrate that the vaccine
was “not only [the] but-for cause of the injury but also a substantial factor in bringing about the
injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d
1344, 1352-53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355
(Fed. Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on her own
assertions; rather, the petition must be supported by either medical records or the opinion of a
competent physician. § 13(a)(1).
To establish entitlement to a Vaccine Program award of compensation for a non-Table
claim, a petitioner must satisfy all three of the elements established by the Federal Circuit in Althen
v. Secretary of Health and Human Services, 418 F.3d 1274 (Fed. Cir. 2005). Althen requires a
petitioner to establish by preponderant evidence that the vaccination she received caused 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 a proximate temporal relationship between vaccination and injury.” Id. at 1278.
Each of the Althen prongs requires a different showing. Under Althen prong one, petitioner
must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the
type of injury alleged. Pafford, 451 F.3d at 1355-56 (citations omitted). To satisfy this prong, a
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). Such a theory
must only be “legally probable, not medically or scientifically certain.” Id. at 549; Bunting v. Sec’y
of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991) (proof of medical certainty is not
required).
Petitioner may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or presentation of a generally
accepted medical theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378-79 (Fed.
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Cir. 2009) (citing Capizzano, 440 F.3d at 1325-26). Special masters, despite their expertise, are
not empowered by statute to conclusively resolve what are complex scientific and medical
questions, and thus the 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.” Id. at 1380. Special masters must take care not to increase the
burden placed on petitioners in offering a scientific theory linking vaccine to injury, but this does
not negate or reduce a petitioner’s ultimate burden to establish her overall entitlement to damages
by preponderant evidence. W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir.
2013) (citations omitted).
The second Althen prong requires proof of a logical sequence of cause and effect, 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 1326 (“medical records and medical opinion
testimony are favored in vaccine cases, as treating physicians are likely to be in the best position
to determine whether a ‘logical sequence of cause and effect show[s] that the vaccination was the
reason for the injury’”) (quoting Althen, 418 F.3d at 1278). Medical records are generally viewed
as particularly trustworthy evidence, because they are created contemporaneously with the
treatment of the patient. Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed.
Cir. 1993). However, medical records and/or statements of a treating physician’s views 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. § 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 & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“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”). As with expert testimony offered to establish a theory of
causation, the opinions or diagnoses of treating physicians are only as trustworthy as the
reasonableness of their suppositions or bases. The views of treating physicians should also be
weighed against other, contrary evidence also present in the record -- including conflicting
opinions among such individuals. Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742,
749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians’
conclusions against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Health
& Hum. Servs., No. 06-522V, 2011 WL 1935813 at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot.
for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 Fed. App’x. 765 (Fed.
Cir. 2012).
The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1278. That term has been equated to
the phrase “medically acceptable temporal relationship.” Id. at 1281. 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 & Hum. 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 (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of
Health & Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand on other grounds,
105 Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x. 952 (Fed. Cir. 2013); Koehn v. Sec’y of
Health & Hum. Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013),
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mot. for review den’d, 113 Fed. Cl. 757 (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir.
2014).
B. Law Governing Analysis of Fact Evidence
The process for making factual determinations in Vaccine Program cases begins with
analyzing the medical records, which are required to be filed with the petition. § 11(c)(2). The
special master is required to consider “all [] relevant medical and scientific evidence contained in
the record.” § 13(b)(1)(A). This includes “any diagnosis, conclusion, medical judgment, or
autopsy or coroner’s report which is contained in the record regarding the nature, causation, and
aggravation of the petitioner’s illness, disability, injury, condition, or death,” and the “results of
any diagnostic or evaluative test which are contained in the record and the summaries and
conclusions.” Id. The special master is then required to weigh the evidence presented, including
contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Hum. Servs., 3
F.3d 415, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether to
afford greater weight to contemporaneous medical records than to other evidence, such as oral
testimony surrounding the events in question that was given at a later date, provided that such
determination is evidenced by a rational determination).
Medical records created contemporaneously with the events they describe are generally
trustworthy, because they “contain information supplied to or by health professionals to facilitate
diagnosis and treatment of medical conditions,” where “accuracy has an extra premium.” Kirby
v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1382 (Fed. Cir. 2021) (citing Cucuras, 993 F.2d
at 1528). Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. See generally Lowrie v. Sec’y of Health & Hum. Servs., No. 03-
1585V, 2005 WL 6117475 at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous
medical records are often found to be deserving of greater evidentiary weight than oral testimony–
- especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;
see also Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam,
968 F.2d 1226 (Fed. Cir. 1992), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United
States v. U.S. Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral
testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.”)).
However, there are situations in which compelling oral testimony may be more persuasive
than written records, such as where records are deemed to be incomplete or inaccurate. Campbell
v. Sec’y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common
sense and experience, this rule should not be treated as an absolute and must yield where the factual
predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475 at *19 (“[w]ritten
records which are, themselves, inconsistent, should be accorded less deference than those which
are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination
regarding a witness’s credibility is needed when determining the weight that such testimony should
be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,
1575 (Fed. Cir. 1993).
In determining the accuracy and completeness of medical records, the Court of Federal
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Claims has listed four possible explanations for inconsistencies between contemporaneously
created medical records and later testimony: (1) a person’s failure to recount to the medical
professional everything that happened during the relevant time period; (2) the medical
professional’s failure to document everything reported to her or him; (3) a person’s faulty
recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of
symptoms that did not exist. LaLonde v. Sec’y of Health & Hum. Servs., 110 Fed. Cl. 184, 203-
04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In deciding whether to afford greater weight to
contemporaneous medical records or other evidence, such as testimony, a rational analysis must
be explicated. Burns, 3 F.3d at 417.
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory connecting the vaccine to the injury often
requires a petitioner to present expert testimony in support of his or her claim. Lampe v. Sec’y of
Health & Hum. Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony
is usually evaluated according to the factors for analyzing scientific reliability set forth in Daubert
v. Merrell Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Hum.
Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195
F.3d 1302, 1316 (Fed. Cir. 1999)). “The Daubert factors for analyzing the reliability of testimony
are: (1) whether a theory or technique can be (and has been) tested; (2) whether the theory or
technique has been subjected to peer review and publication; (3) whether there is a known or
potential rate of error and whether there are standards for controlling the error; and (4) whether the
theory or technique enjoys general acceptance within a relevant scientific community.” Terran,
195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592-95).
The Daubert factors play a slightly different role in Vaccine Program cases than in other
federal judicial proceedings. Those factors are employed by judges to exclude evidence that is
unreliable and potentially confusing to a jury. In Vaccine Program cases, the factors are used in
the weighing of the reliability of scientific evidence. Davis v. Sec’y of Health & Hum. Servs., 94
Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have been employed also
as an acceptable evidentiary-gauging tool with respect to persuasiveness of expert testimony
already admitted”). The flexible use of the Daubert factors to evaluate persuasiveness and
reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88 Fed. Cl. at 743. In
this matter (as in numerous other Vaccine Program cases), Daubert has not been employed at the
threshold to determine what evidence should be admitted, but instead to determine whether expert
testimony offered is reliable and/or persuasive.
Respondent frequently offers one or more experts of his own to rebut a petitioner’s case.
Where both sides offer expert testimony, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). Nothing requires the acceptance of an expert’s conclusion “connected
to existing data only by the ipse dixit of the expert,” especially if “there is simply too great an
analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743 (quoting
Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). A “special master is entitled to require some
indicia of reliability to support the assertion of the expert witness.” Moberly, 592 F.3d at 1324.
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Weighing the relative persuasiveness of competing expert testimony, based on a particular expert’s
credibility, is part of the overall reliability analysis to which special masters must subject expert
testimony in Vaccine Program cases. Id. at 1325-26 (“[a]ssessments as to the reliability of expert
testimony often turn on credibility determinations”); see also Porter v. Sec’y of Health & Hum.
Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously explained that special
masters are expected to consider the credibility of expert witnesses in evaluating petitions for
compensation under the Vaccine Act”).
D. Consideration of Medical Literature
Finally, although this decision discusses some but not all the record evidence in detail, I
have reviewed and considered all the materials submitted in this matter. See Moriarty v. Sec’y of
Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We generally presume that a special
master considered the relevant record evidence even though [s]he does not explicitly reference
such evidence in h[er] decision.”); Simanski v. Sec’y of Health & Hum. Servs., 115 Fed. Cl. 407,
436 (2014) (“[A] Special Master is ‘not required to discuss every piece of evidence or testimony
in her decision.’” (citation omitted)), aff’d, 601 F. App’x. 982 (Fed. Cir. 2015).
V. ANALYSIS
A. Diagnosis
Initially, it is important to clarify some areas of agreement between the parties concerning
Petitioner’s condition. Drs. Boylan and Messé agreed that Petitioner suffered an ischemic stroke
on March 30, 2016. First Boylan Rep. at 5; Messé Rep. at 4. They further agreed that she suffered
a stroke in late June 2016, which was either a new stroke or a continuation/expansion of the first
stroke. Id. Neither expert felt that the June 2016 stroke was a direct result of the March 22, 2016
flu vaccination. Instead, they concurred that the second stroke was likely triggered by the cerebral
angiogram Petitioner underwent on June 24, 2016, because stroke is a known risk of that
procedure.11 First Boylan Rep. at 5; Messé Rep. at 4-5; Tr. at 87, 207.
The operative question to resolve, then, is whether Petitioner’s first stroke on March 30,
2016, was caused by the subject flu vaccination.
B. Althen Prong One
1. Causation Theory
Petitioner has asserted an off-Table claim and thus must prove by preponderant evidence
that she suffered an injury caused by the vaccination at issue, satisfying all of the Althen prongs.
See Capizzano, 440 F.3d at 1320. Under Althen prong one, Petitioner must provide a reputable,
sound, and reliable medical theory that the vaccine can cause the injury. Boatmon v. Sec’y of
11 There also appears to be no dispute that the cerebral angiogram was necessitated by the first stroke. After
that event, Petitioner continued being seen by neurologist Dr. El-Gengaihy, who ordered the angiogram.
See Ex. 10 at 10.
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Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2013). “[T]o establish causation, the
standard of proof is preponderance of evidence, not scientific certainty.” Langland v. Sec’y of
Health & Hum. Serv., 109 Fed. Cl. 421, 441 (2013).
Petitioner’s theory of causation centers on the interaction of the inflammatory response
elicited by flu vaccination with a preexisting prothrombotic condition -- in this case, a carotid web.
Dr. Boylan opined that this combination of factors can lead to clot formation and embolization,
causing stroke. See Tr. at 94.
Petitioner provided some support for the proposition that inflammation, including from an
acute infection, can play a role in stroke. Dr. Boylan testified that patients with acute, severe
systemic illnesses, such as sepsis, are at higher risk of stroke. Tr. at 34-35. The more inflammation
a person experiences, the worse the outcome of a stroke might be. Id. at 50. Medications with
anti-inflammatory properties are given to treat strokes. Id.
Dr. Boylan cited to some medical literature that purports to support her theory. In Smeeth,
an increased risk of stroke was found across the first 90 days following diagnosis of a systemic
respiratory infection, with the highest risk during the first three days. Smeeth at 2614. In the
Esenwa review, the authors stated that proinflammatory conditions, “including acute and chronic
infections,” are associated with an increased risk of stroke. Esenwa CC, et al., Inflammatory risk
factors, biomarkers and associated therapy in ischaemic stroke, NATURE REVIEWS (NEUROLOGY)
(2016);12:594-604 (Ex. 42) (“Esenwa”) at 594. Moreover, the enhanced risk appears to be
temporally related to the inflammation produced by those conditions. Id. at 595. Esenwa discussed
studies reporting that the risk of stroke was associated with elevated levels of several inflammatory
markers, including CRP and IL-6.12 Id. at 597. The authors posited that the innate immune system
shares targets with the coagulation system, “with the potential to induce a hypercoagulable state
whenever the system is acutely activated.” Id. at 602.
Likewise, the McColl review reported that inflammation, including that produced by
infection, is implicated in “multiple phases of stroke etiology and pathology.” McColl at 1.
Discussing infections generally, the authors noted that “numerous clinical studies have suggested
a link between peripheral infection and increased stroke susceptibility and recent data have
provided compelling evidence to support these earlier studies.” Id. at 2. The Murray review
reported similar observations, concluding that “stroke risk and outcome can be modified by a pre-
existing inflammatory burden, be it from chronic disease or acute infection.” Murray KN, et al.,
Systemic immune activation shapes stroke outcome, MOLECULAR AND CELLULAR NEUROSCIENCE
(2013);14-25 (Ex. 28) (“Murray”) at 22. Cardenas proposed that neuroinflammation could result
from vaccination or infection; through a literature review, the authors identified seven cases of
stroke following H1N1 flu vaccination. Cardenas at 340, 343.
12 Interleukin-6: a lymphokine produced by antigen- or mitogen-activated T cells, fibroblasts, macrophages,
and adipose and other cells that serves as a differentiation factor for B cells and thymocytes and stimulates
immunoglobulin production by B cells; it also induces hepatocytes to synthesize various plasma proteins
involved in the acute phase response and is a cofactor in initiation of the cell cycle in primitive
hematopoietic cells in vitro. Interleukin-6, DORLAND’S,
https://www.dorlandsonline.com/dorland/definition?id=83023 (last accessed on December 31, 2024).
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It is not enough, however, to point to an association between stroke and inflammation
without providing some evidence characterizing the inflammatory properties of the subject
vaccine. On cross, Dr. Boylan acknowledged that “not every inflammation will provoke a stroke,
and not every stroke will be caused by inflammation[.]” Tr. at 39. She further conceded that
strokes after vaccination are coincidental “in most cases.” See id. at 104-06. She admitted that
inflammatory triggers like bee stings, seasonal allergies, and poison ivy are not associated with
stroke. Id. at 104-05; see also id. at 180, 221 (Dr. Messé stating that, although inflammation plays
a role in stroke, it is “rare” to see a stroke caused by an acute inflammatory condition). She also
admitted that the immune response to a natural flu infection would be more inflammatory than the
response to a vaccine. Id. at 103.
Notably, Petitioner failed to provide any evidence of the type, quantity, or duration of the
inflammatory products of the flu vaccine. None of the submitted literature addresses this question.
Dr. Boylan testified that inflammation affects the endothelium in the blood vessels, impairing the
ability of the vessels to relax, which in turn causes dysfunction of blood flow, inducing clotting.
Tr. at 53-54. She attempted to tie this to the flu vaccine, but her testimony on this point was
unpersuasive. Discussing Smeeth, she referenced a different study (the Hingorani paper, cited
below), which she said involved healthy individuals who were given the flu vaccine and
experienced inflammation that suppressed endothelium-dependent relaxation for “two weeks after
the vaccination.” Id. at 54. However, Dr. Boylan incorrectly recited Smeeth’s description of the
Hingorani study: the Smeeth authors simply reported that “in an experimental model, the
vaccination of healthy volunteers induced a short-lived inflammation that was associated with
profound suppression of endothelium-dependent relaxation.” Smeeth at 2612. In fact, the
Hingorani study, which was submitted into evidence after the hearing, did not investigate
endothelium-dependent relaxation following flu vaccination. Instead, it tested the inflammatory
effects of the Salmonella typhi vaccine and found that the inflammatory markers returned to normal
within 32 hours after that vaccination. Hingorani AD, et al., Acute Systemic Inflammation Impairs
Endothelium-Dependent Dilatation in Humans, CIRCULATION (2000);994-999 (Ex. C)
(“Hingorani”) at 997; see Resp’t’s Post-Hr’g Br. at 6-7. Thus, it appears that Dr. Boylan’s
testimony on this topic was erroneous, weakening her opinion.13
2. “Booster effect” of repeated vaccinations
Pointing to the fact that Petitioner received a flu vaccination six months before the subject
vaccination, Dr. Boylan opined that repeated flu vaccinations might produce a “booster effect”
that amplified Petitioner’s inflammatory response and the risk of stroke. See Tr. at 92-93. But Dr.
Boylan admittedly had no evidence supporting this proposition. Id. at 93. No literature was
provided. Instead, she relied on the fact that, in her personal experience, COVID-19 vaccine
recipients have experienced strong reactions to second doses of that vaccine. Id. at 92-93. Her
testimony on this question was unpersuasive.
13 Even accepting that the Hingorani study did show a transient effect of vaccination on endothelium-
dependent relaxation of the vessels, Smeeth found a significantly reduced risk of stroke during the period
of inflammatory response for flu vaccination. Smeeth at 2615 (Table 1) (reporting a 23% reduction in
stroke risk in the first three days after flu vaccination, a 28% reduction in risk from days 4-7, and a 16%
reduction in risk from days 8-14).
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When given the opportunity to submit additional evidence after the entitlement hearing,
Petitioner filed a printout of a CDC webpage entitled “Children, the Flu, and the Flu Vaccine,”
which reported that children between six months and eight years old require two doses of the
influenza vaccine to receive full protection. Ex. 41 at 1-2. On the same webpage, though, the
CDC stated that “[d]ifferent products are approved for different age groups, including children as
young as 6 months of age.” Id. at 1. In other words, childhood vaccines are typically formulated
differently from those for adults. Further, this site provides no evidence that a second dose of flu
vaccine in anyone amplifies the inflammatory response. This reference does not support Dr.
Boylan’s claim about a “booster effect” in this case, nor has Petitioner submitted any other
evidence to support this opinion.
3. Interaction between flu vaccination and carotid webs
Dr. Boylan further opined that flu vaccination can cause stroke in a person with a carotid
web. She hypothesized that the inflammation elicited by the vaccine can exacerbate thrombosis
in the carotid artery, leading to clotting, embolization, and stroke. Tr. at 94.
There was some disagreement among Petitioner’s treating physicians about whether the
appropriate diagnosis was carotid web or an ulcerated atherosclerotic plaque in the left carotid
artery. Compare Ex. 6 at 230 with Ex. 15 at 473, 673-77. Dr. Messé initially interpreted the
imaging to show an ulcerated plaque. Messé Rep. at 4. Ultimately, though, both parties’ experts
agreed Petitioner had a carotid web, a conclusion that is supported by the medical records. Tr. at
64, 158-59.
The experts concurred that carotid web is associated with an increased risk of stroke, due
to a heightened tendency toward thrombosis. Tr. at 78-79, 83, 161. This proposition is uniformly
supported by the literature. See Choi PMC, et al., Carotid Webs and Recurrent Ischemic Strokes
in the Era of CT Angiography, AM. J. NEURORADIOL. (2015);36:2134-2139 (Ex. 21) (“Choi”) at
2134 (surmising that carotid web contributes to stroke due to impaired blood flow and
thrombogenicity); Haussen DC, et al., Carotid Web (Intimal Fibromuscular Dysplasia) Has High
Stroke Recurrence Risk and Is Amenable to Stenting, STROKE (2017);48:1-4 (Ex. 24) (“Haussen”)
at 1 (reporting an association between carotid web and high risk of recurrent stroke/TIA; carotid
webs are “high-risk lesions,” likely due to a causing a predisposition to thromboembolism); Sajedi
PI, et al., Carotid Bulb Webs as a Cause of “Cryptogenic” Ischemic Stroke, AM. J. NEURORADIOL.
(2017);38:1399-1404 (Ex. 29) (“Sajedi”) at 1399 (study finding a statistically significant
association between cryptogenic stroke and carotid web).14 Similar to other parts of her theory,
though, Dr. Boylan failed to submit any supportive evidence illustrating how the flu vaccine could
produce a stroke in a person with this condition. She did not present any clinical or other data
concerning the putative interaction of vaccination, carotid web, and stroke. None of the literature
on carotid web and stroke hypothesized that any type of vaccination could exacerbate the risk. See
generally Choi, Haussen, Sajedi.
14 As Dr. Messé clarified, although a carotid web predisposes one to thrombosis in the location of the web,
that condition does not equate to a generalized prothrombotic state. Tr. at 206-07.
27

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Dr. Boylan also suggested that a carotid web in someone Petitioner’s age would not itself
be sufficient to cause a stroke. Tr. at 91. Instead, a catalyst, such as the inflammation produced
by a vaccination, would be needed. Id. But the literature she submitted identified carotid web as
an independent risk factor for stroke in Petitioner’s age group. The authors in Choi, for example,
concluded that “[t]he carotid web may be an important cause of ischemic stroke in patients with
otherwise no determined mechanism of stroke and present a high risk of recurrent stroke.” Choi
at 2138; see also Haussen at 1 (“Carotid web is associated with high recurrent stroke/TIA risk,
despite antithrombotic use”); Sajedi at 1399 (noting that “carotid webs exhibit a strong association
with ischemic stroke, and their presence should be suspected in patients lacking other risk factors,
particularly African American women”).
4. Epidemiologic Data
Epidemiologic evidence is not required to prove a Vaccine Act case. It is appropriate,
however, for a special master to consider such evidence as part of the overall assessment of the
case. See Druery v. Sec'y of Health & Hum. Servs., No. 17-1213V, 2023 WL 5094088, at *17
(Fed. Cl. July 11, 2023), mot. for rev. den’d, 169 Fed. Cl. 557 (2024) (observing that “[n]othing in
Althen or Capizzano requires the Special Master to ignore probative epidemiological evidence that
undermines petitioner's theory.”) (quoting D'Tiole v. Sec'y of Health & Hum. Servs., 726 F. App'x.
809, 811 (Fed. Cir. 2018)). “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.” Andreu, 569
F.3d at 1379.
The epidemiologic literature in the record strongly indicates that flu vaccination is
associated with a reduced, not increased, risk of stroke. The Smeeth study, which included more
than 19,000 flu-vaccinated patients, found that there was no increase in the rate of stroke during
the first 90 days following vaccination, compared to the baseline period.15 Smeeth at 2614-15.
Moreover, as Dr. Messé explained, the study found a significantly reduced risk of stroke during
the first 28 days following flu vaccination. Tr. at 172; see also Smeeth at 2615 (Table 1) (reporting
significantly decreased risks of stroke at 1-3 days, 4-7 days, 8-14 days, and 15-28 days after flu
vaccination). Petitioner’s stroke occurred during this initial timeframe. Notably, Dr. Boylan did
not question the Smeeth study’s methodology, and she agreed with the authors’ finding that the
vaccine is not associated with an increased stroke risk at the population level. Id. at 97-98.
In the Siriwardena study, the authors compared stroke patients to controls to assess the
potential association between flu vaccination and stroke. Siriwardena at 1354. The study reported
that flu-vaccinated patients had a 24% reduction in the risk of stroke compared to unvaccinated
15 For the flu-vaccinated participants in Smeeth, the baseline period for assessing the risk of stroke did not
include any time preceding a first flu vaccination. This is because one of the indications for receiving the
flu vaccination is preexisting cardiovascular disease; thus, the receipt of a flu vaccination is “itself
associated with the risk of vascular events.” Smeeth at 2613. The authors explained that “[t]o ensure that
during the observation period there was minimal variation in the opportunity to be vaccinated, the
observation period used in the analysis with regard to influenza vaccination did not include the time before
a participant’s first influenza vaccination.” Id.
28

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patients. Id. at 1354, 1358 (Table 3). Dr. Messé testified that this study was “well done” and was
“very reassuring that there’s no association at all with stroke risk.” Tr. at 174. The Grau study
similarly found that the risk of stroke following flu vaccination was reduced compared to the risk
in unvaccinated controls. Grau at 1501. Dr. Boylan did not dispute the methodologies or findings
of these studies.
Dr. Boylan referenced the Lin case report as a clinical example of the possibility that a flu
vaccine can trigger stroke. Lin at 345. Lin described a 75-year-old patient who suffered an
ischemic stroke the same day as an influenza A/H1N1 vaccination. Id. at 345-346. Lin is
distinguishable in several ways from this case. The patient was substantially older than Petitioner,
had suffered a previous stroke, and had several comorbidities. Id. The other case report produced
by Petitioner, Wirrell, is also distinguishable, as it described strokes following varicella
vaccinations in two children. Wirrell E, et al., Stroke After Varicella Vaccination, J PEDIATR
(2004);145:845-47 (Ex. 33) (“Wirrell”) at 845. Furthermore, case reports are inferior scientific
evidence of causation and generally do not, on their own, support a causal attribution. See, e.g.,
R.V. v. Sec’y of Health & Hum. Servs., No. 11-504V, 2016 WL 3882519, *41 (Fed. Cl. Spec. Mstr.
Feb. 19, 2016) (noting that “individual patient case reports . . . are not in general, strong evidence
of causation”) (internal quotation marks omitted)), mot. for rev. den'd, 127 Fed. Cl. 136 (2016).
Overall, I conclude that Petitioner failed to produce preponderant evidence of a sound,
reliable theory demonstrating how the flu vaccine is capable of causing stroke. Instead, she offered
disjointed evidence of risk factors for stroke, without evidence tying them to the properties of the
flu vaccine, with respect to which the epidemiologic data is reassuring. Althen prong one was not
satisfied.
C. Althen Prong Two
Under Althen’s second prong, a petitioner must “prove a logical sequence of cause and
effect showing that the vaccination was the reason for the injury.” Althen, 418 F.3d at 1278. The
sequence of cause and effect must be “'logical' and legally probable, not medically or scientifically
certain.” Id. A petitioner is not required to show “epidemiologic studies, rechallenge, the presence
of pathological markers or genetic disposition, or general acceptance in the scientific or medical
communities to establish a logical sequence of cause and effect.” Id. (omitting internal citations);
Capizzano v. Sec'y of Health & Hum. Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006). Instead,
circumstantial evidence and reliable medical opinions may be sufficient to satisfy the second
Althen prong. Isaac v. Sec'y of Health & Hum. Servs., No. 08-601V, 2012 WL 3609993, at *24
(Fed. Cl. Spec. Mstr. July 30, 2012), mot. for rev. den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F.
App'x. 999 (Fed. Cir. 2013).
I conclude that Petitioner has not demonstrated a logical sequence of cause and effect
between her March 22, 2016 flu vaccination and her initial stroke on March 30, 2016. Initially, it
is undisputed that, although Petitioner was diagnosed and treated by a number of specialists,
including several neurologists, no treating physician attributed her stroke to her flu vaccination.
Dr. Boylan acknowledged this. Tr. at 106. Moreover, the contemporaneous medical records do
not indicate that Petitioner suffered a significant inflammatory response to the vaccination, as
would be expected under Dr. Boylan’s mechanistic theory. See id. at 220 (Dr. Messé testifying
29

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that for “a systemic inflammatory state that’s bad enough to cause a stroke, I would expect to see
something.”); see also Hibbard v. Sec’y of Health & Hum. Servs., No. 07-446V, 2011 WL
1766033, at *9 (Fed. Cl. Spec. Mstr. Apr. 12, 2011) (finding Althen prong two unsatisfied where
the petitioner failed to prove her injury was consistent with the mechanistic theory of vaccine
causation she advanced), mot. for rev. den’d, 100 Fed. Cl. 742, 749 (2011), aff’d, 698 F.3d 1355
(Fed. Cir. 2012).
During the eight days between the vaccination and Petitioner’s stroke, she made no
complaints to any medical providers of symptoms that might be indicative of inflammation, such
as fever, rash, edema, bruising, or purpura, which are common post-vaccination reactions.16
Likewise, when she went to the hospital on March 30, 2016, the records show she did not report
recently feeling unwell. To the contrary, she reported being in “good chronic health” and that
“[p]rior to her ER visit she was in her usual state of health.”17 Ex. 6 at 220, 224. She underwent
multiple examinations at the hospital, with no observations of clinical signs of inflammation. See
id. at 222 (admission exam on March 30, 2016, finding no signs of skin abnormalities or rash); id.
at 281 (March 30, 2016 ER exam showing no evidence of fever, rash, or impaired range of motion).
Lab work done in the hospital showed normal levels of inflammatory markers such as CRP and
ESR, as well as a negative hypercoagulable workup, signifying that she did not have a blood
condition predisposing her to thrombosis.18 Id. at 342, 344-48, 349, 350; Tr. at 165-66. There are
some records in which Petitioner reported having some continuing left-arm soreness/tightness in
the weeks after her stroke, but the most contemporaneous records – those from her initial
presentation to the hospital – consistently reflected no complaints or findings indicative of
inflammation before or at the time of the stroke. See Tr. at 121-23; Ex. 6 at 594; Ex. 10 at 5. Her
VAERS report also failed to mention any symptoms consistent with inflammation in the days
between the vaccination and the stroke. Ex. 3.
At the hearing, Petitioner testified that she experienced left arm redness, swelling, and
soreness for a “couple months” after vaccination. Tr. at 7. This testimony contravened her earlier
sworn statement in this litigation, where she stated that her left arm was “sore and pink” for a few
days after the vaccination, but those symptoms lessened over the next week. Ex. 1 at 2. I do not
find Petitioner’s testimony on this subject persuasive, particularly given her admitted memory
problems since her stroke, and it is insufficient to overcome the contemporaneous medical records.
See Tr. at 14; Cucuras, 993 F.2d at 1528.
16 CDC, Possible Side Effects from Vaccines, https://www.cdc.gov/vaccines/basics/possible-side-
effects.html (last accessed on January 6, 2025).
17 Dr. Messé explained that the note that Petitioner was in her “usual state of health” signified that she had
no other complaints prior to the stroke. Tr. at 163.
18 As discussed above, the Esenwa review proposed that elevated inflammatory markers like CRP are
associated with stroke. Esenwa at 594, 597. The authors surmised that the inflammatory products of the
innate immune system might induce a hypercoagulable state, leading to stroke. Id. at 602. Petitioner,
however, had normal inflammatory markers and a negative hypercoagulable workup, suggesting her stroke
was not causally related to acute inflammation.
30

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Dr. Boylan did not dispute that the hospital records did not show clinical or laboratory
indications of inflammation before or at the time of the initial stroke. Tr. at 101-02, 113. She
instead cited the intake form completed by Petitioner for her April 20, 2016 visit with Dr. El-
Gengaihy. Id. at 121-23. On that form, Petitioner described her complaint as “[follow-up] after
TIA and [left] deltoid flu shot [with] ‘fever’ in my shoulder, neck, chest and scapular region,”
which had been ongoing “since” March 22, 2016. Ex. 10 at 5. But on the same form, Petitioner
stated that she had experienced a TIA on March 22, 2016, when her stroke actually occurred on
March 30. Id. This suggests a faulty memory of the events preceding this visit, which is consistent
with Petitioner’s testimony that she had had memory problems since her stroke. See Tr. at 14. An
exam conducted by Dr. El-Gengaihy that day showed no evidence of ongoing inflammatory
symptoms. Ex. 10 at 9. This form is unpersuasive evidence of pre-stroke inflammation and
insufficient to override the contemporaneous records.
There is also evidence of an alternative cause of Petitioner’s stroke: her carotid web.
Although a petitioner does not bear the burden of eliminating all alternative causes for her injury,
it is appropriate for a special master to consider evidence relating to such alternative causes in
assessing the Althen prongs. See, e.g., Doe 11 v. Sec’y of Health & Hum. Servs., 601 F.3d 1349,
1357-58 (Fed. Cir. 2010); Walther v. Sec’y of Health & Hum. Servs., 485 F.3d 1146, 1151 (Fed.
Cir. 2007). As discussed above, both experts agreed that Petitioner had this condition and that it
is a risk factor for stroke. Furthermore, according to the literature supplied by Dr. Boylan, that
risk affects patients around Petitioner’s age, even if the general risk of stroke is low in younger
patients. See Choi at 2135 (reporting that the mean age of the patients with carotid web who
suffered stroke was 50, with an age range of 41-55); Haussen at 1 (reporting that the median age
of 24 patients with carotid web and stroke was 46, with an age range of 41-59); Sajedi at 1399
(reporting that the mean age of patients with stroke and carotid web was 38.9, with an age range
of 30-48). And, as discussed, the literature does not suggest that a catalyzing agent is needed to
trigger a stroke in a person with carotid web.19
For the reasons articulated above, I find that Petitioner has not preponderantly
demonstrated a logical cause-and-effect sequence connecting the subject vaccination and her initial
stroke, and therefore she has not established the second prong of Althen.
D. Althen Prong Three
The timing prong contains two parts. First, a petitioner must establish the “timeframe for
which it is medically acceptable to infer causation,” and second, he must demonstrate that the onset
of the disease occurred in this period. Shapiro v. Secʼy of Health & Hum. Servs., 101 Fed. Cl. 532,
542-43 (2011), recons. denied after remand on other grounds, 105 Fed. Cl. 353 (2012), aff’d
without op., 503 F. App’x. 952 (Fed. Cir. 2013). Here, it is undisputed that Petitioner suffered her
initial stroke eight days after her March 22, 2016 flu vaccination. Thus, the operative question is
19 Dr. Boylan opined that because Petitioner did not have strokes before or after the events in 2016, her
vaccine was probably the causal factor precipitating her initial stroke. Tr. at 84. This is unpersuasive. The
mere temporal relationship between a vaccination and an injury is insufficient to establish causation.
Moreover, Dr. Messé persuasively explained that a carotid web poses a risk of, but does not “guarantee,”
recurrent strokes. Tr. at 214-15. He pointed out that although Petitioner had not yet experienced any further
strokes, she remained at risk for further strokes due to her carotid webs. Id. at 215.
31

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whether this onset was within the appropriate interval.
Dr. Boylan gave inconsistent opinions on the medically appropriate time for onset of stroke
following vaccination. In her expert report, she stated that post-infectious neurological symptoms
“typically start within 2-6 weeks following exposure.” First Boylan Rep. at 3. That is longer than
the onset period here. Also, the basis for Dr. Boylan’s opinion was the Marchioni paper, which
concerned encephalitis, myelitis, and encephalomyelitis, not stroke. Marchioni E, et al.,
Postinfectious neurological syndromes, NEUROLOGY (2013);80:882-889 (Ex. 32) (“Marchioni”)
at 883. Moreover, Marchioni did not report a 2-6-week timeframe for onset of those conditions
following exposure. Instead, the inclusion criteria for the study specified that onset had to have
occurred within 30 days of infection/vaccination.20 Id.
At hearing, Dr. Boylan testified that she could not identify a specific time frame during
which the inflammation from vaccination – her proposed causal mechanism – could precipitate a
stroke. Tr. at 115-16. She stated: “The timing . . . on the inflammation is really not known[.]” Id.
at 115. She maintained, however, that an eight-day onset following flu vaccination was medically
appropriate and consistent with her mechanistic theory. Id. at 48. Dr. Messé agreed that the stroke
occurred during the period that the body would produce an inflammatory response to an infection,
but he noted that the Smeeth study showed a reduced risk of stroke during that same period
following vaccination. Id. at 212-13.
Overall, Dr. Boylan’s equivocation on the appropriate onset timeframe further undermined
the persuasiveness of her testimony. She did not attempt to characterize the inflammatory
properties of the flu vaccine, and thus she also could not define the timeframe during which
vaccine-caused inflammation could trigger a stroke. Because Petitioner did not supply reliable
expert testimony or other evidence supporting an eight-day onset of stroke following flu
vaccination, I conclude that she has not satisfied Althen prong three.
E. Other Vaccine Cases
A limited number of cases alleging stroke caused by flu vaccination have been filed in the
Vaccine Program. Although prior decisions from different cases do not control the outcome here,
they can inform my analysis. See Boatmon, 941 F.3d at 1358-59.
First, Petitioner submitted Irwin, in which Special Master Gowen found entitlement to
compensation, as an additional authority for my consideration. Irwin v. Sec’y of Health & Hum.
Servs., No. 16-1454V, 2024 WL 863690 (Fed. Cl. Spec. Mstr. Jan. 23, 2024). Unlike this case,
the petitioner in Irwin felt ill immediately after receiving a seasonal flu vaccination and suffered a
stroke two days later. Id. at *2-3. The petitioner’s expert relied on two case reports describing
patients who had strokes within two days of vaccination, along with the Hingorani study. Id. at
*17-18. Here, Dr. Boylan did not adequately substantiate her causal theory. Moreover, the theory
she advanced is not consistent with the facts of this case, which, as noted, involved a stroke eight
days after vaccination, without evidence of a significant inflammatory response in the interim.
20 The study also identified an average period of 8.2 days from onset to maximum dysfunction, which is
irrelevant to the question posed here. Marchioni at 883.
32

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Another case I have identified is Sokol. Sokol v. Sec’y of Health & Hum. Servs., No. 16-
1631V, 2020 WL 553842 (Fed. Cl. Spec. Mstr. Jan. 9, 2020). The petitioner in Sokol suffered
from a subarachnoid hemorrhagic stroke approximately 10 days after vaccination. Id. at *2.
Special Master Moran found that the theory of causation, which was similar to that presented here,
was inadequate. Id. at *6. Specifically, he found that the theory that “inflammation” can cause
stroke to be too generalized to satisfy Althen prong one. Id. at *5. Further, although a cytokine-
driven response within four days of vaccination was medically acceptable, that timeline was
inconsistent with the 10-day onset of the petitioner’s stroke. Id. at *8.
Another case involving the flu vaccine and hemorrhagic stroke is Schultz. Schultz v. Sec’y
of Health & Hum. Servs., No. 16-539V, 2020 WL 1039161 (Fed. Cl. Spec. Mstr. Jan. 24, 2020).
In Schultz, Dr. Boylan served as a petitioner’s expert and, as here, relied on case reports and broad
generalizations, without specific evidence tying the flu vaccination to the injury. Id. at *22. Chief
Special Master Corcoran was unpersuaded by Dr. Boylan and found Dr. Messé more credible. Id.
at *22-23. Further, although the petitioner in Schultz suffered from normal arm soreness and a
low-grade fever after vaccination, her stroke occurred more than 30 days after vaccination, which
was too nonspecific a course to support vaccine causation. Id. at *13, 24.
Although none of these decisions are binding here, I am persuaded by the reasoning in
Sokol and Schultz. As in Schultz, Dr. Boylan here failed to substantiate her theory of causation
with vaccine-specific information. Instead, she rested on the broad proposition that inflammation
can cause stroke, and vaccines produce an inflammatory response of some kind. Tellingly, it
appears that Dr. Boylan presented a similar theory in this ischemic stroke case as she did in Schultz,
a hemorrhagic stroke case, even though she testified that hemorrhagic stroke is mechanistically
distinct from ischemic stroke. See Tr. at 32 (testifying that a hemorrhagic stroke is caused by
rupture of a blood vessel, while ischemic stroke is caused by choking off the blood supply to the
brain). This broad-brush theorizing across different fact patterns and conditions lessens the
persuasiveness of Dr. Boylan’s opinions here. Cf. Schultz, 2020 WL 1039161, at *22 (“Petitioner’s
experts too often relied on literature that conflated ischemic with hemorrhagic strokes, or other
types of vasculitis, without showing that the specific kind at issue in this case could reliably be
associated with the flu vaccine.”). Furthermore, as in both Sokol and Schultz, the records in this
case do not comport with the mechanistic theory advanced, in that they do not signify a significant
inflammatory response in the days following Petitioner’s vaccination.
VI. CONCLUSION
I am sympathetic to Petitioner’s ordeal. However, upon careful evaluation of all the
evidence submitted in this matter, including the medical records, Petitioner’s statement, the expert
reports, the testimony, and the medical literature, I conclude that she has not shown by
preponderant evidence that she is entitled to compensation under the Vaccine Act. Her petition
is therefore DISMISSED. The clerk shall enter judgment accordingly.21
IT IS SO ORDERED.
21 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by each filing (either jointly
or separately) a notice renouncing their right to seek review.
33

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s/ Jennifer A. Shah
Jennifer A. Shah
Special Master
34

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_17-vv-00259-3
Date issued/filed: 2025-07-24
Pages: 32
Docket text: JUDGE VACCINE REPORTED OPINION (PUBLIC VERSION) re: 94 Order on Motion for Review. Signed by Judge Edward H. Meyers. (th) Service on parties made.
--------------------------------------------------------------------------------
Case 1:17-vv-00259-EHM Document 100 Filed 07/24/25 Page 1 of 32
In the United States Court of Federal Claims
No. 17-259
Filed: July 9, 2025
Reissued: July 24, 20251
________________________________________
)
HEATHER GOFF, )
)
Petitioner, )
)
v. )
)
SECRETARY OF HEALTH AND HUMAN )
SERVICES, )
)
Respondent. )
________________________________________ )
Courtney Jorgenson, Siri & Glimstad LLP, Phoenix, Arizona, for Petitioner.
Michael S. Bliley, Trial Attorney, Torts Branch, Civil Division, United States Department of
Justice, Washington, DC, for Respondent, with whom were Yaakov M. Roth, Acting Assistant
Attorney General, C. Salvatore D’Alessio, Director, Torts Branch, Civil Division, Heather L.
Pearlman, Deputy Director, Torts Branch, Civil Division, and Lara A. Englund, Assistant
Director, Torts Branch, Civil Division.
OPINION AND ORDER
MEYERS, Judge.
In her petition, Heather Goff contends that the influenza vaccinations she received during
the 2015–16 flu season caused her to suffer two strokes.2 After considering the petition, the
expert reports, medical records, and witness testimony, the Special Master concluded that Ms.
Goff failed to carry her burden of establishing by a preponderance of the evidence that the
1 The court issued this Opinion and Order to the parties on July 9, 2025, and, pursuant to Vaccine
Rule 18(b), gave them an opportunity to propose redactions. Because they did not propose any,
the court reissues this Opinion and Order in its entirety.
2 The term “stroke” refers to various medical conditions involving “local damage to the brain in a
particular area related to the blood flow and the vascular structures of the brain.” Hr’g Tr.
31:21–24 (ECF Nos. 59–60) (testimony of Dr. Laura S. Boylan); accord id. at 145:25–146:4
(testimony of Dr. Steven Messé).

Case 1:17-vv-00259-EHM Document 100 Filed 07/24/25 Page 2 of 32
influenza vaccines she received caused her to suffer her stroke.3 The Special Master found Ms.
Goff’s expert’s causation theory unpersuasive, that another condition was more likely the cause
of the stroke than the vaccine, and that the stroke did not occur within a medically appropriate
timeframe after the vaccination. In other words, the Special Master concluded that Ms. Goff
failed to establish any of the three things that she must prove to prevail on her claim. Because
the Special Master considered all the evidence under the proper legal framework, explained her
weighing of that evidence and testimony, and provided a reasoned explanation for her decision
that is supported by the record, her decision was neither arbitrary nor capricious. As a result, the
court sustains the Special Master’s decision.
I. Background
A. Factual Background
Ms. Goff received the influenza vaccine on September 14, 2015. Pet’r’s Ex. 1 ¶ 3 (ECF
No. 6-1); Pet’r’s Ex. 14 (ECF No. 8-6).4 This was the first time in about 18 years she got
vaccinated for influenza, and she did so because her employer at the time required it. Pet’r’s Ex.
1 ¶ 3. Following the vaccine, Ms. Goff experienced “shoulder pain, which lasted a few days,”
but otherwise had no “lingering effects.” Id.
On March 22, 2016, Ms. Goff received a second influenza vaccine in her left arm. Id.
¶ 4; Pet’r’s Ex. 2 (ECF No. 6-2). She got this second influenza vaccine as a requirement of her
new employer, Banner University Medical Center (“Banner”). Pet’r’s Ex. 1 ¶ 4. At the time of
the March influenza vaccine, Ms. Goff was 43 years old and in good health. Pet’r’s Ex. 2
(indicating Ms. Goff was not sick); Hr’g Tr. 6:25–7:7 (ECF Nos. 59–60) (testimony of Ms. Goff)
(testifying she was “feeling just fine”). Based on Ms. Goff’s statement from 2017, after the
March 2016 influenza vaccine her left arm was “sore and pink” for the “following few days . . .
but [that] seemed to lessen over the next week.” Pet’r’s Ex. 1 ¶ 5. Ms. Goff testified in 2021
that she “was red, swollen all the way down [her] arm and into [her] forearm for a couple
months” after the March 2016 influenza vaccine. Hr’g Tr. 7:20–22. The record does not include
any medical records for Ms. Goff between March 22, 2016, and March 30, 2016. Goff v. Sec’y
3 Because both experts agreed that Ms. Goff’s second stroke was likely caused by a cerebral
angiogram that she underwent because of the first stroke, the Special Master focused on the
potential connection between her influenza vaccinations, particularly the second vaccination, and
the first stroke. Goff v. Sec’y of Health & Hum. Servs., No. 17-259V, 2025 WL 431582, at *20
(Fed. Cl. Spec. Mstr. Jan. 13, 2025) (ECF No. 85). Similarly, the parties’ arguments (with one
exception regarding a claimed “booster effect” of the combination of the two vaccinations)
focused on the connection between the second influenza vaccination and the first stroke,
particularly with respect to Althen prong three’s timing requirement. Therefore, the court’s
analysis is similarly focused on the vaccine’s potential connection to the first stroke.
4 Because the parties’ exhibits span multiple CM/ECF entries, the court cites the parties’ exhibit
numbers rather than their CM/ECF numbers.
2

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of Health & Hum. Servs., No. 17-259V, 2025 WL 431582, at *3 (Fed. Cl. Spec. Mstr. Jan. 13,
2025) (ECF No. 85).5
Then on March 30, 2016, Ms. Goff woke up lacking “feeling or control of [her] right
arm,” babbling, experiencing “drooping on the right side of [her] face,” and “feeling
progressively weaker.” Pet’r’s Ex. 1 ¶ 6; see Pet’r’s Ex. 6 at 12, 14 (ECF Nos. 6-6 to 6-8); Hr’g
Tr. 8:2–12. She was taken to the Abrazo West Campus Emergency Room (“Abrazo ER”) and
treated for an acute ischemic stroke.6 Pet’r’s Ex. 6 at 12–13. Her admission records reveal that
Ms. Goff had no prior history of stroke and had been in “good chronic health” other than having
hypothyroidism. Id. at 220. The records also indicate that she did not have a fever, rash, or
swelling at the time of admission, although she had elevated blood pressure. Id. at 222, 280–81.
Her lab results reflect that her C-reactive protein (“CRP”)7 level, erythrocyte sedimentation rate
(“ESR”)8 level, complete blood count, and hypercoagulable9 workup were normal. Id. at 342,
344–50.
Ms. Goff underwent additional medical testing while at the Abrazo ER. Id. at 331–37.
Magnetic resonance imaging (“MRI”) without contrast of the brain revealed a “left middle
5 The court cites the Special Master’s public decision filed on February 6, 2025, throughout this
Opinion and Order because all the information pertinent to the present motion for review appears
in the public decision.
6 An ischemic stroke occurs when a part of the brain does not receive sufficient blood flow
because a blood vessel is blocked. Pet’r’s Ex. 39 (ECF No. 57-1); accord Hr’g Tr. 32:1–33:12
(testimony of Dr. Boylan); id. at 146:8–11 (testimony of Dr. Messé).
7 CRP is “a globulin that forms a precipitate with the somatic C-polysaccharide of the
pneumococcus in vitro; it is the most predominant of the acute-phase proteins.” Goff, 2025 WL
431582, at *4 n.3 (citing Dorland’s Medical Dictionary Online).
8 The erythrocyte sedimentation rate is:
[T]he rate at which erythrocytes precipitate out from a well-mixed
specimen of venous blood, measured by the distance the top of the
column of erythrocytes falls in a given time interval under
specified conditions; an increase in rate is usually due to elevated
levels of plasma proteins, especially fibrinogen and
immunoglobulins, which decrease the zeta potential on
erythrocytes by dielectric shielding and thus promote rouleau
formation. It is increased in monoclonal gammopathy,
hypergammaglobulinemia due to inflammatory disease,
hyperfibrinogenemia, active inflammatory disease, and anemia.
Goff, 2025 WL 431582, at *4 n.4 (citing Dorland’s Medical Dictionary Online).
9 Hypercoagulability is “the state of being more readily coagulated than normal.” Goff, 2025
WL 431582, at *4 n.5 (citing Dorland’s Medical Dictionary Online).
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cerebral artery territory 5 x 25 mm acute infarct.”10 Id. at 5, 230, 232, 274, 278, 336–37.
Magnetic resonance angiography (“MRA”) without contrast of the neck revealed a potential
“filling defect” in her left internal carotid artery. Id. at 230, 274, 278, 336. A computed
tomography (“CT”) angiogram11 of her neck revealed “mild” atherosclerotic plaque causing 30–
40% narrowing of her left internal carotid artery. Id. at 5, 230, 232, 274, 277, 331–32. Ms. Goff
was discharged from the Abrazo ER on April 2, 2016, with a diagnosis of an acute
cerebrovascular accident.12 Id. at 5.
On April 5, 2016, Ms. Goff reported left arm pain that started that morning during a
follow-up appointment. Pet’r’s Ex. 8 at 7, 10 (ECF No. 6-10). Her follow-up appointment
records reflect that she had elevated blood pressure, but report an otherwise normal physical
examination. Id. at 7–10.
Ms. Goff completed a Vaccine Adverse Event Reporting System (“VAERS”) report on
April 15, 2016. Pet’r’s Ex. 3 (ECF No. 6-3). In it, she noted her influenza vaccine on March 22,
2016, subsequent facial numbness and droop, difficulty speaking, arm and hand numbness, and
reduced sensation processing on March 30, 2016. Id. Ms. Goff testified that she completed the
VAERS report because she felt “very strongly that [her stroke] had everything to do with this flu
shot.” Hr’g Tr. 11:19–21.
On April 20, 2016, Ms. Goff returned to the Abrazo ER because she had “high blood
pressure and continued to have left [arm] soreness extending to [her] scapular area, shoulder and
jaw,” and she feared she was having another stroke. Pet’r’s Ex. 1 ¶ 10; Pet’r’s Ex. 6 at 494. Her
admission records note Ms. Goff complained of “left arm pain/burning for 2 weeks following flu
shot,” and that she felt “her symptoms [we]re [an] adverse reaction to the flu shot and no one is
listening [to] her.” Pet’r’s Ex. 6 at 494; see also id. at 503. Her physical examination records
indicate Ms. Goff did not have a fever or rash, her neurological examination was normal, and her
lab results were normal. Pet’r’s Ex. 6 at 494–97; Pet’r’s Ex. 4 at 10–16, 19 (ECF No. 6-4). Her
diagnosis upon discharge was left arm pain. Pet’r’s Ex. 6 at 503.
Ms. Goff also had a follow-up appointment at Neuropro, Inc., on April 20, 2016. Pet’r’s
Ex. 10 at 9–10 (ECF No. 8-2). On the Neuropro new patient evaluation form, Ms. Goff reported
that she experienced “[f]ever” in her “shoulder, neck, chest and scapular region” since her
influenza vaccine. Id. at 5. She reported that she suffered a transient ischemic attack13 on March
10 An infarct “is when the nervous tissue actually dies and [is] irreversibly injured as a result of
that reduced flow of blood.” Hr’g Tr. 146:14–16 (testimony of Dr. Messé). An infarct is
evidence that a stroke occurred. Id. at 146:24–147:1.
11 “A CT angiogram is “a noninvasive procedure[] . . . [where the physician] inject[s] contrast,
and as the contrast is filling up the blood vessels in the neck and the head, . . . [t]he patient is
moving through the CT scanner,” which “take[s] pictures.” Hr’g Tr. 157:12–17 (testimony of
Dr. Messé).
12 A cerebrovascular accident is another term for an “ischemic stroke.” Hr’g Tr. 147:10, 147:15
(testimony of Dr. Messé).
13 Transient ischemic attacks “are transient neurological symptoms, typically focal neurologic
systems, that are attributed to reduced blood flow in a particular blood vessel . . . . The
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22, 2016, the same day that she received the influenza vaccine. Id. Her Neuropro appointment
records indicate Ms. Goff did not have a rash. Id. at 6, 9. The Neuropro physician ordered that
Ms. Goff undergo a cerebral angiogram14 to “rule out vasculitis.” Id. at 10; see Pet’r’s Ex. 1
¶ 11.
Ms. Goff had another follow-up appointment on May 9, 2016. Pet’r’s Ex. 8 at 1. Her
records indicate her left arm pain was “resolved” at the time of that appointment. Id. at 1, 4.
On June 24, 2016, Ms. Goff underwent a cerebral angiogram. Pet’r’s Ex. 1 ¶ 12; Pet’r’s
Ex. 38 at 679–82 (ECF Nos. 49-3 to 49-5). The cerebral angiogram discovered atherosclerotic
plaque in her left internal carotid artery causing about 35–40% narrowing, consistent with her
testing at the Abrazo ER. Pet’r’s Ex. 38 at 681–82.
Then, while at work on June 30, 2016, Ms. Goff’s “boss noticed an obvious change in
[her] speech . . . and immediately took [Ms. Goff] to the emergency room at Banner.” Pet’r’s
Ex. 1 ¶ 13; cf. Hr’g Tr. 12:20–13:2 (testimony of Ms. Goff) (stating she “ask[ed] a colleague to
take [her] to [her] boss’ office because [she was not] talking straight”). Upon admission to the
Banner emergency room (“Banner ER”), Ms. Goff was aphasic. Pet’r’s Ex. 38 at 9, 544–46,
567, 570, 897, 900. Her treating physicians assessed her to be at a 1 or 2 on the National
Institutes of Health stroke scale.15 Id. at 247–52.
At the Banner ER, Ms. Goff underwent another CT angiogram, and its results indicate
that she “has . . . small linear filling defect[s], most consistent with . . . carotid web[s]”16 in her
left and right internal carotid arteries. Pet’r’s Ex. 37 at 36–37 (ECF No. 49-2); Pet’r’s Ex. 38 at
symptoms would last less than 24 hours and be without any evidence of injury on neuro-
imaging.” Hr’g Tr. 146:17–23 (testimony of Dr. Messé).
14 A cerebral angiogram “is an invasive procedure where a radiologist or interventional
neurologist or neurosurgeon will insert a catheter . . . into an artery in the groin, called the
femoral artery, and then move that catheter up into the blood vessels in the neck and in the aortic
arch.” Hr’g Tr. 156:4–11 (testimony of Dr. Messé).
15 The National Institutes of Health stroke scale is used by health care providers to “assess the
severity of a stroke. Health care providers use it to measure neurological function and deficits by
asking the person to answer questions and perform several physical and mental test[s].” Goff,
2025 WL 431582, at *5 n.7 (quoting Nat’l Inst. Neurological Disorders & Stroke, NIH Stroke
Scale, Nat’l Insts. Health, https://www.ninds.nih.gov/health-information/stroke/assess-and-
treat/nih-stroke-scale). “A score of 1 is defined as . . . ‘Not alert; but arousable by minor
stimulation to obey, answer, or respond.’” Id. (quoting Nat’l Inst. Neurological Disorders &
Stroke, supra). A score of 2 is defined as “Not alert; requires repeated stimulation to attend or is
obtunded and requires strong or painful stimulation to make movements.” Nat’l Inst.
Neurological Disorders & Stroke, supra.
16 A carotid web “is a[n] abnormal growth in the lining of the blood vessel. [T]here’s three
layers to the arteries, and with a carotid web, the intimal layer, which is the innermost layer, has
collagen deposited abnormally, and so there is this outgrowth that occurs.” Hr’g Tr. 160:22–
161:3 (testimony of Dr. Messé); accord id. at 56:9–12, 56:19–57:1 (testimony of Dr. Boylan).
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34, 473–74, 508. The “more prominent” web appeared to be in her left internal carotid artery.
Pet’r’s Ex. 37 at 37; Pet’r’s Ex. 38 at 34, 474, 508.
She had another MRI that showed an approximately 2 cm left thalamic lesion. Pet’r’s
Ex. 37 at 24; Pet’r’s Ex. 38 at 9, 521, 550. The lesion raised concerns of a brain tumor. Pet’r’s
Ex. 37 at 24; Pet’r’s Ex. 38 at 9, 521, 550–51. Accordingly, Ms. Goff underwent a brain biopsy
to determine whether she had a brain tumor. Pet’r’s Ex. 38 at 9, 591–94. Her treating physician
initially determined her biopsy results were “more suggestive of stroke than tumor.” Id. at 594;
see Pet’r’s Ex. 9 at 7 (ECF No. 8-1). Upon review of her results after Ms. Goff’s discharge from
the Banner ER, a Mayo Clinic physician explained the biopsy tissue results showed “an
inflammatory-reactive process” that was “consistent with a subacute ischemic infarct.” Pet’r’s
Ex. 38 at 785.
Ms. Goff’s subsequent medical records describe her March 30, 2016, and June 30, 2016,
medical events as strokes. Pet’r’s Ex. 36 at 1 (ECF No. 49-1); Pet’r’s Ex. 37 at 1; see Pet’r’s Ex.
40 at 1 (ECF No. 63-1). Those records indicate her March 30, 2016, stroke was possibly related
to the carotid webs, and her June 30, 2016, stroke was possibly related to the June 24, 2016,
cerebral angiogram. Pet’r’s Ex. 37 at 2, 4. Her subsequent medical records clarify that the 35%
narrowing of her left internal carotid artery “looks like a typical carotid web.” Id. at 7. Those
records also explain that her “second stroke involved [a] significant portion of her left thalamus,
which is in a different circulation in the carotid artery.” Id. at 7, 14. One of her subsequent
treating physicians described her two strokes as cryptogenic.17 Id. at 1. As recently as 2020, Ms.
Goff reported to a treating physician that she “felt like” her strokes resulted from “a flu shot.”
Pet’r’s Ex. 40 at 1.
In her testimony, Ms. Goff mentioned that she has “trouble remembering things” because
of her strokes. Hr’g Tr. 12:7–11, 12:14–15. She also testified to the continuing impact of the
strokes on her life. Id. at 10:11–21, 13:17–18:4.
B. Procedural History
Ms. Goff filed her petition for compensation in 2017. ECF No. 1. She claimed that the
influenza vaccine she received on March 22, 2016, caused her strokes. Id. ¶¶ 1, 6, 12, 17. She
filed her medical records and two expert reports in support of her petition.
1. Dr. Boylan’s First Report
Ms. Goff filed an expert report from Dr. Laura S. Boylan and supporting medical
literature. Dr. Boylan has worked as an attending neurologist and neuro-hospitalist. Pet’r’s Ex.
18 at 1 (ECF No. 24-1); Pet’r’s Ex. 16 at 1 (ECF No. 23-1). She also has taught neurology, is a
member of neurology-related professional groups, has served as a reviewer for medical
17 “A cryptogenic stroke is a stroke with no clear etiology following a thorough workup . . . .”
Hr’g Tr. 147:20–21 (testimony of Dr. Messé).
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publications, and has authored peer-reviewed papers. Pet’r’s Ex. 18 at 2–5, 8–11. Dr. Boylan
estimated that she has diagnosed and treated over 1,000 stroke patients. Pet’r’s Ex. 16 at 2.18
In her expert report, Dr. Boylan reviewed Ms. Goff’s medical history and relevant
medical literature. Id. at 2–11. Dr. Boylan opined that Ms. Goff’s two influenza vaccines
“caused or contributed to the occurrence and severity of” Ms. Goff’s two strokes in 2016. Id. at
11.
Dr. Boylan’s opinion focused on immune and inflammatory responses. She explained
that “[i]mmune and inflammatory responses are key components of the body’s defense system,”
but “provocations” of the immune system “can cause neurologic illness.” Id. at 3. She cited
medical literature showing “substantial evidence that inflammation plays a role in stroke.” Id.
(first citing Liam Smeeth et al., Risk of Myocardial Infarction and Stroke after Acute Infection or
Vaccination, 351 New England J. Med. 2611 (2004), filed as Pet’r’s Ex. 31 (ECF No. 25-4); then
citing Armin J. Grau et al., Influenza Vaccination is Associated with a Reduced Risk of Stroke, 36
Stroke 1501 (2005), filed as Pet’r’s Ex. 23 (ECF No. 24-6); then citing B.W. McColl et al.,
Systemic Infection, Inflammation and Acute Ischemic Stroke, 158 Neuroscience 1049 (2009),
filed as Pet’r’s Ex. 27 (ECF No. 24-10); then citing Katie N. Murray et al., Systemic Immune
Activation Shapes Stroke Outcome, 53 Molecular & Cellular Neuroscience 14 (2013), filed as
Pet’r’s Ex. 28 (ECF No. 25-1); then citing A. Niroshan Siriwardena et al., Influenza and
Pneumococcal Vaccination and Risk of Stroke or Transient Ischaemic Attack, 32 Vaccine 1354
(2014), filed as Pet’r’s Ex. 30 (ECF No. 25-3); and then citing Heather J. Fullerton et al.,
Infection, Vaccination, and Childhood Arterial Ischemic Stroke, 85 Neurology 1459 (2015), filed
as Pet’r’s Ex. 22 (ECF No. 24-5)). According to Dr. Boylan, “[i]nflammation promotes blood
clotting . . . and hence a state of inflammation promotes stroke.” Id. at 10. Thus, she opined that
provocations of inflammation, including “infection, trauma, surgery, and, rarely, vaccination,”
can cause neurologic illness, including strokes. Id. at 3.
Dr. Boylan explained that infections, including influenza infections, “have been
associated with an increased risk of vascular events.” Id. Specifically, “medical literature
supports a relationship between influenza infection and stroke.” Id. at 11 (citing Pet’r’s Ex. 22).
She also cited medical literature to support that “[p]ost infectious neurological syndromes
typically start within 2-6 weeks following exposure.” Id. at 3 (citing Enrico Marchioni, et al.,
Postinfectious Neurologic Syndromes, 80 Neurology 882 (2013), filed as Pet’r’s Ex. 32 (ECF
No. 25-5)). Dr. Boylan acknowledged that “[i]nfections cause immune provoked neurological
illness much more frequently than do vaccines.” Id. at 11.
Even so, Dr. Boylan explained there is “concern that vaccination itself could be
associated with increased short term stroke risk.” Id. at 3, 11. This is because vaccines can also
provoke the inflammatory system. Id. at 3. Such provocation is “protective” for most people,
but “[i]n rare cases, it is harmful.” Id. (citing Ctrs. for Disease Control & Prevention, Prevention
and Control of Seasonal Influenza with Vaccines Recommendations of the Advisory Committee
on Immunization Practices —United States, 2016–17 Influenza Season, 65 Morbidity &
18 The Special Master detailed far more of Dr. Boylan’s qualifications than the court does. Goff,
2025 WL 431582, at *7. Because the Government does not challenge the Special Master’s
qualification of Dr. Boylan as an expert, the court provides only a limited summary.
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Mortality Wkly. Rep. (2016), filed as Pet’r’s Ex. 20 (ECF No. 24-3)). With respect to the
influenza vaccine, she acknowledged it “has been shown to decrease cardiovascular risk at the
population level.” Id. (citing Pet’r’s Exs. 23, 30–31). But “in rare individuals,” she opined that a
neurological illness “will occur as a post-vaccine phenomenon even though vaccination reduces
overall risk in the population.” Id. at 11. As further support, Dr. Boylan cited medical literature
that reported “[c]ases of strokes thought to possibly have been caused by vaccines.” Id. (first
citing Yi-Pin Lin et al., Ischaemic Stroke and Influenza A H1N1 Vaccination: A Case Report, 7
Archives Med. Sci. 345 (2011), filed as Pet’r’s Ex. 26 (ECF No. 24-9); then citing Graciela
Cárdenas et al., Neurological Events Related to Influenza A (H1N1) pdm09, 8 Influenza & Other
Respiratory Viruses 339 (2014), filed as Pet’r’s Ex. 19 (ECF No. 24-2); and then citing Elaine
Wirrell et al., Stroke After Varicella Vaccination, 145 J. Pediatrics 845 (2004), filed as Pet’r’s
Ex. 33 (ECF No. 25-6)).
Dr. Boylan also explained that when someone gets two vaccines in a single season, the
second vaccine is called a “booster,” and “clinical responses” from a booster vaccine “may be
adverse as well as beneficial.” Id. at 3–4. She explained that children receive influenza vaccine
boosters, so the response to the vaccine may be affected by the frequency of and total dose of
vaccination. Id. (citing Pet’r’s Ex. 20). She noted that Ms. Goff received the influenza vaccine
and a booster during the 2015–16 influenza season. Id. at 4.
Dr. Boylan characterized the March 30, 2016, event as a stroke, and the June 30, 2016,
event as “most likely a second stroke.” Id. at 5, 10. Upon review of Ms. Goff’s medical records,
Dr. Boylan concluded that “[i]t is clear that Ms. Goff’s treating physicians considered her stroke
to be unusual from the outset” because her initial evaluation “went beyond the usual evaluation
in a search for the many rare conditions which can cause or be associated with stroke in a
relatively young adult.” Id. at 6. She explained that “[s]trokes at age 43, even in the presence of
one or several risk factors . . . are rare.” Id. Based on the National Stroke Association Stroke
Risk Calculator, Ms. Goff, when treated as if she were 45 years old at the time of her stroke
(because the calculator does not accept ages below 45) and with her history of smoking, would
be predicted to have “a 0.4% risk of having a stroke over the course of ten years.” Id. at 10.
Dr. Boylan found Ms. Goff’s medical test results “unusual” because “inflammation
sufficient to light up on an MRI and produce suspicion of tumor or infection is rare.” Id. at 9–10.
Ms. Goff’s tissue taken for the biopsy “provided definitive diagnosis of an active inflammatory
process and did not show changes associated with tumors or infections.” Id. at 10. Ms. Goff’s
inflammation appeared “particularly strong” to Dr. Boylan. Id. at 11. Dr. Boylan further opined
that Ms. Goff’s “history of allergic sensitivity, recurrent shingles and thyroid disease . . . are
associated with abnormalities in the immune/inflammatory system and may have predisposed her
to stroke.” Id. at 10.
Additionally, Dr. Boylan agreed with Ms. Goff’s treating physician that Ms. Goff had
carotid webs. Id. at 4, 9. She opined that Ms. Goff “was likely predisposed to having a stroke
. . . because she has bilateral carotid webs.” Id. at 10–11. Dr. Boylan identified a carotid web as
an “abnormalit[y that] predispose[s] to stroke.” Id. at 4. Carotid webs are associated with
stroke, “particularly among young women,” because “abnormal blood flow through the vessels
causes clots to form[, and t]he clots then are prone to dislodge and clog arteries downstream,
starving parts of the brain of oxygen and glucose.” Id. (first citing P.M.C. Choi et al., Carotid
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Webs and Recurrent Ischemic Strokes in the Era of CT Angiography, 36 Am. J. Neuroradiology
2134 (2015), filed as Pet’r’s Ex. 21 (ECF No. 24-4); then citing Diogo C. Haussen et al., Carotid
Web (Intimal Fibromuscular Dyplasia) Has High Stroke Recurrence Risk and Is Amenable to
Stenting, 48 Stroke 1 (2017), filed as Pet’r’s Ex. 24 (ECF No. 24-7); and then citing P.I. Sajedi et
al., Carotid Bulb Webs as a Cause of “Cryptogenic” Ischemic Stroke, 38 Am. J. Neuroradiology
1399 (2017), filed as Pet’r’s Ex. 29 (ECF No. 25-2)). Because Ms. Goff has carotid webs, Dr.
Boylan considered Ms. Goff “prone to have strokes.” Id. at 4, 10. She observed that “Ms.
Goff’s extensive stroke evaluation did not reveal any apparent cause of stroke other than the
carotid webs.” Id. at 10.
Based on her analysis, Dr. Boylan opined Ms. Goff’s carotid webs predisposed her to
stroke before vaccination, and “[v]accines activate the immune/inflammatory system,” which
also “predisposes an individual to the formation of clots.” Id. at 11. Dr. Boylan concluded that
“within a reasonable degree of medical certainty,” Ms. Goff’s influenza vaccines “most likely
provoked an immune/inflammatory response which caused or contributed to the occurrence and
severity of” Ms. Goff’s strokes. Id.
With respect to Ms. Goff’s second stroke, Dr. Boylan concluded that the location of the
lesion “suggested it might not be able to be attributed to the carotid web.” Id. at 9. That lesion
could be “due to late changes from the first stroke, a new stroke and/or possible inflammation of
cerebral blood vessels.” Id. at 10. Nonetheless, she concluded that Ms. Goff’s influenza
vaccines “caused and/or contributed to the occurrence and severity of Ms. Goff’s subsequent
strokes occurring March 30, 2016, and June 30, 2016 and subsequent neurologic deficit.” Id. at
12.
2. Dr. Messé’s Report
The Government filed an expert report and supporting medical literature from Dr. Steven
Messé. Dr. Messé is a professor of neurology and the director of the vascular neurology
fellowship at the University of Pennsylvania. Resp’t’s Ex. A at 1 (ECF No. 32-1); Resp’t’s Ex.
B at 1 (ECF No. 32-7). He has also served as a reviewer of medical publications, is a member of
several professional groups, and has authored peer-reviewed papers. Resp’t’s Ex. B at 2–3, 6–
13. Dr. Messé estimated that he has treated thousands of stroke patients. Resp’t’s Ex. A at 1.19
Based on his review of the medical literature and Ms. Goff’s medical records, Dr. Messé
opined Ms. Goff’s strokes “were not related to the influenza vaccination.” Id. at 3. Dr. Messé
emphasized that medical literature supports that the “influenza vaccination is associated with a
reduced, not increased, risk of stroke.” Id. He explained that several studies Dr. Boylan relied
upon indicate the influenza vaccine is “protective.” Id. (referring to Pet’r’s Ex. 31). And he
clarified that the case studies Dr. Boylan cited include one study of a different vaccine and two
studies of “a series of patients with a broad array of neurologic events peri-vaccination or
19 The Special Master detailed far more of Dr. Messé’s qualifications than the court does. Goff,
2025 WL 431582, at *12. Because Ms. Goff does not challenge the Special Master’s
qualification of Dr. Messé as an expert, the court provides only a limited summary.
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infection, yet with no control group to determine whether these events were more, or less, likely
to occur during this time.” Id. at 3–4 (referring to Pet’r’s Exs. 19, 26, 33).
Dr. Messé then discussed how ulcerated plaque could have caused Ms. Goff’s stroke. Id.
at 4. Upon his review of Ms. Goff’s records, Dr. Messé determined she had “ulcerated plaque in
the internal carotid artery, resulting in 30-40% stenosis,” and “carotid plaque with <50% stenosis
has . . . been associated with increased stroke risk.” Id. (citing Jonathan M. Coutinho et al.,
Nonstenotic Carotid Plaque on CT Angiography in Patients with Cryptogenic Stroke, 87
Neurology 665 (2016), filed as Resp’t’s Ex. A, Tab 1 (ECF No. 32-2)). He observed that
“ulcerated plaque is associated with an even higher risk for stroke.” Id. (citing A.C. van Dijk et
al., Intraplaque Hemorrhage and the Plaque Surface in Carotid Atherosclerosis: The Plaque At
RISK Study (PARISK), 36 Am. J. Neuroradiology 2127 (2015), filed as Resp’t’s Ex. A, Tab 2
(ECF No. 32-3)). To explain how plaque leads to stroke, Dr. Messé discussed how the “rupture
or endothelial erosion” of plaque may cause a clot to form, which may then dislodge in the artery
and block the blood flow. Id. (citing G. Alistair Lammie, Recently Occluded Intracranial and
Extracranial Carotid Arteries, 30 Stroke 1319 (1999), filed as Resp’t’s Ex. A, Tab 3 (ECF No.
32-4)). Dr. Messé concluded that Ms. Goff’s atherosclerotic plaque was more likely the cause of
her stroke. Id.
In his report, Dr. Messé disagreed with Dr. Boylan that Ms. Goff had a carotid web
because the cerebral angiogram indicated Ms. Goff had atherosclerotic plaque. Id. He reasoned
that the cerebral angiogram is the “gold standard to assess blood vessel abnormalities,” so its
finding of plaque instead of a carotid web was compelling to Dr. Messé. Id. Regardless, Dr.
Messé concluded that, if Ms. Goff has carotid webs, the carotid web could be a “plausible
mechanism for the stroke.” Id. at 5. Because Ms. Goff either had ulcerated plaque or a carotid
web, Dr. Messé viewed it “unnecessary to blame” the influenza vaccine as the cause of the
stroke. Id. at 4.
Dr. Messé also disagreed with Dr. Boylan that the inflammation on Ms. Goff’s MRI was
abnormal. Id. He explained that inflammation “after stroke is very common after the first day or
two, and typically persists for weeks.” Id. (citing Martin Bendszus & Guido Stoll, Silent
Cerebral Ischaemia: Hidden Fingerprints of Invasive Medical Procedures, 5 Neurology 364
(2006), filed as Resp’t’s Ex. A, Tab 4 (ECF No. 32-5)). Further, Ms. Goff’s biopsy results were
consistent with a stroke, and “there was no suggestion from the pathologists that there was
abnormal inflammation present.” Id.
As for the second stroke, Dr. Messé explained that the cerebral angiogram likely caused
it. Id. at 4–5. He relied medical literature finding that strokes “are common after cerebral
angiogram[s].” Id. at 4 (citing Resp’t’s Ex. A, Tab 4).
Finally, Dr. Messé explained that cryptogenic strokes are common, especially among
“young stroke patients.” Id. at 5 (citing Robert G. Hart, Embolic Strokes of Undetermined
Source: The Case for a New Clinical Construct, 13 Neurology 429 (2014), filed as Resp’t’s Ex.
A, Tab 5 (ECF No. 32-6)). The lack of a clear explanation of Ms. Goff’s strokes should not
mean that the influenza vaccine, which is generally “protective,” caused her strokes. Id.
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In sum, Dr. Messé did not “believe that the influenza vaccination played any significant
role in” Ms. Goff’s strokes. Id. Rather, the medical literature supports that the influenza vaccine
reduces the risk of stroke, and Ms. Goff “was actively using tobacco and had mild
hyperlipidemia, with an ulcerated atherosclerotic plaque in the left internal carotid artery . . .
strongly suggesting that this was likely the cause of her stroke.” Id.
3. Dr. Boylan’s Rebuttal Report
Ms. Goff submitted a second report from Dr. Boylan in response to Dr. Messé’s report.
In her rebuttal report, Dr. Boylan agreed with Dr. Messé and the medical literature that vaccines
reduce strokes at the population level, but countered that vaccines could still cause strokes in
some people. Pet’r’s Ex. 35 (ECF No. 43-1). She reiterated that Ms. Goff’s MRI results were
abnormal, and that Ms. Goff has carotid webs. Id. Dr. Boylan’s “conclusion remain[ed]
unchanged.” Id.
4. The Entitlement Hearing
Special Master Oler held an entitlement hearing from April 6–7, 2021.
a) Dr. Boylan’s Testimony
Dr. Boylan was recognized as an expert in neurology at the entitlement hearing. Hr’g Tr.
31:7–9, 31:15. She summarized her opinion as follows: “[T]he vaccine induced a pro-
inflammatory state which promoted the formation of a clot in Ms. Goff’s preexisting carotid web
and that there was a subsequent breakup of that clot, and it went downstream and caused her
stroke.” Id. at 129:10–14.
Dr. Boylan concluded that inflammation “plays a major role in stroke” because
inflammation promotes clotting. Id. at 34:11–15, 54:18–20. The mechanism by which
inflammation promotes clotting, according to Dr. Boylan, involves the endothelium, or the
“innermost lining of the vessels.” Id. at 39:23–40:3. The endothelium in blood vessels pulsates
to send blood into the brain and then relaxes to allow the blood to flow away from the brain, so
endothelium-dependent relaxation causes “poor circulation . . . that can predispose to stroke.”
Id. at 53:2–13. Dr. Boylan admitted this mechanism of stroke is not specific to the influenza
vaccine. Id. at 104:16–19.
Dr. Boylan acknowledged a range of provocations can cause inflammation. Id. at 36:6–
19. Given that range, Dr. Boylan testified that “not every inflammation will provoke a stroke,
and not every stroke will be caused by inflammation by any means. . . . [And] stroke itself
causes an inflammatory response.” Id. at 39:17–22, 101:5–20. She explained Katie N. Murray
et al., Systemic Immune Activation Shapes Stroke Outcome, 53 Molecular & Cellular
Neuroscience 14 (2013) (the “Murray study”) provides that “the insult of stroke itself will
provoke an immune response, and . . . you can have a worse outcome from stroke if you have a
lot of inflammation.” Hr’g Tr. 49:24–50:5 (discussing Pet’r’s Ex. 28).
And infections, including the influenza infection, “are . . . associated with stroke.” Hr’g
Tr. 35:10–11. Although recognizing that a natural infection “produces more of an inflammatory
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response than a vaccine,” id. at 103:6–8, Dr. Boylan testified that vaccines generally produce
“very dramatic inflammatory responses,” id. at 42:1–9.
Dr. Boylan relied on the “concern” in Liam Smeeth et al., Risk of Myocardial Infarction
and Stroke after Acute Infection or Vaccination, 351 New England J. Med. 2611 (2004) (the
“Smeeth study”) about “the well established association between vaccines and inflammation.”
Hr’g Tr. 38:7–13 (discussing Pet’r’s Ex. 31). Although the Smeeth study “is not about the
influenza vaccine,” it “used the flu vaccine to promote an inflammatory response.” Hr’g Tr.
53:22–54:6 (discussing Pet’r’s Ex. 31). The study’s authors found “certain markers and changes
in vascular reactivity . . . were evident two weeks after the vaccination.” Id. at 54:6–10
(discussing Pet’r’s Ex. 31). Dr. Boylan explained that the Smeeth study sought to discern
whether “vaccines could cause strokes to such a degree that . . . it was not a good idea to give
them at least to some people in the population.” Id. at 38:11–13 (discussing Pet’r’s Ex. 31).
Given that the Smeeth study “found that in their population, the vaccine prevented stroke,” Dr.
Boylan agreed that “at the population level, . . . vaccination for influenza reduces rates of
influenza.” Id. at 38:15–21 (discussing Pet’r’s Ex. 31).
Regardless, Dr. Boylan testified the Smeeth study does not mean “that in rare individuals
there [will not] be adverse effects” from the influenza vaccine. Id. at 38:15–21. People may
have “idiosyncratic responses[ that] . . . depend on genetic factors, epigenetic factors, hormonal
status, age, a whole range of environmental and individual risk factors.” Id. at 42:10–13. She
testified the potential for idiosyncratic responses concurred with the results of Graciela Cárdenas
et al., Neurological Events Related to Influenza A (H1N1) pdm09, 8 Influenza and Other
Respiratory Viruses 339 (2014) (the “Cárdenas study”). Hr’g Tr. 43:5–12 (discussing Pet’r’s Ex.
19).
Dr. Boylan then explained that a person has an increased risk of stroke during an
inflammatory response, such as an inflammatory response to the influenza vaccine, if the person
has a vascular abnormality that promotes clotting. Hr’g Tr. 55:12–56:2, 79:2–12. She pointed to
Yi-Pin Lin et al., Ischaemic Stroke and Influenza A H1N1 Vaccination: A Case Report, 7
Archives Med. Sci. 345 (2011) (the “Lin study”), which observed that the influenza vaccine may
trigger clotting “if you have anything [that is] going to make you likely to form clots . . .
something systemic, like a cancer, or it could be something anatomic, like an abnormal carotid
web or atherosclerosis.” Hr’g Tr. 78:6–79:12 (discussing Pet’r’s Ex. 26).
Dr. Boylan identified carotid webs as a cause of stroke, but also recognized they are a
rare condition. Hr’g Tr. 57:13–18. Dr. Boylan testified that Ms. Goff had a carotid web in her
left internal carotid artery, and that her first stroke occurred downstream from the web. Id. at
64:16–65:2, 71:18–72:20. As Dr. Boylan explained, carotid webs can create an irregular
turbulence in blood flow that produces a “stasis” (i.e., a stoppage or slowdown) of blood. Id. at
61:5–24. That stasis of blood can then become a clot that can dislodge and flow downstream in
the blood vessel to cause damage. Id. at 62:21–63:17. The clot may block blood flow to the
brain and thus cause an ischemic stroke. Id. at 64:6–15. Dr. Boylan acknowledged that the
studies she cited discussing carotid webs do not mention that an inflammatory trigger is
necessary to cause a stroke in a person with carotid webs, and that those studies involved
younger patients like Ms. Goff. Id. at 106:20–108:7 (reviewing Pet’r’s Exs. 21, 24).
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Dr. Boylan opined Ms. Goff suffered a thromboembolic ischemic stroke. Id. at 33:17–21.
Dr. Boylan explained that having a stroke at age 43 is “highly unusual.” Id. at 70:25–71:9. She
discussed the stroke calculator results from her expert report and Ms. Goff’s low risk of stroke at
her age. Id. at 89:4–90:22. And Dr. Boylan acknowledged that Ms. Goff “fit[s] more of a
profile of someone who might have a carotid web, and . . . that would increase your risk of
having a stroke, but it [does not] mean [you are] predetermined to have a stroke.” Id. at 70:25–
71:9. Rather, Dr. Boylan testified that Ms. Goff’s stroke was “much more likely to have been
the reaction to the flu shot” than the carotid web because “the underlying carotid web alone has
not been sufficient, in the absence of an angiogram, for any prior or subsequent events.” Id. at
91:4–9. Dr. Boylan believed the influenza vaccine, “a known pro-inflammatory, prothrombotic
stimulus,” and Ms. Goff’s stroke were “related” because the stroke occurred “shortly” after the
vaccine. Id. at 81:3–6.
To explain Ms. Goff’s reaction to the influenza vaccine before her first stroke, Dr.
Boylan testified Ms. Goff was “feeling ill before she had the stroke, and she had local pain in the
arm before she had the stroke[, s]o she was having an inflammatory reaction.” Id. at 47:20–24,
68:15–16, 68:23–69:16. Dr. Boylan saw no other potential triggers for Ms. Goff’s inflammatory
response around March 22, 2016, in Ms. Goff’s records other than the influenza vaccine. Id. at
69:17–22. But the only record citation Dr. Boylan identified to support her conclusion that Ms.
Goff experienced inflammatory symptoms was Ms. Goff’s report of “fever” on her April 20,
2016, new patient form. Id. at 121:8–18, 121:22–122:4, 122:22–123:15 (discussing Pet’r’s Ex.
10). Dr. Boylan also pointed to Ms. Goff’s right arm weakness at the time of admission at the
Abrazo ER on March 30, 2016, but Ms. Goff received the influenza vaccine in her left arm. Id.
at 121:22–123:15.
Dr. Boylan testified that the timing of Ms. Goff’s influenza vaccine, inflammatory
reaction, illness, and stroke eight days later was “the timing that you would expect.” Id. at
48:13–21. In support, Dr. Boylan discussed B.W. McColl et al., Systemic Infection,
Inflammation and Acute Ischemic Stroke, 158 Neuroscience 1049 (2009) (the “McColl study”)
that observed the risk of stroke is the highest within a week of the onset of the inflammatory
response. Hr’g Tr. 130:1–132:24 (discussing Pet’r’s Ex. 27). Dr. Boylan acknowledged that she
did not know how long the immune system response to the influenza vaccine lasts. Hr’g Tr.
119:18–25. Yet she is “confident” the immune response lasts “at least as long as the time period
from the [March 22, 2016] vaccine to the first stroke. [That is] not unusual to [Dr. Boylan]. To
[her], [that is] not a stretch.” Id. at 120:3–6. She explained the Vaccine Injury Table provides
guidance on timing. Id. at 116:9. She also stated that “conventionally” six to eight weeks is “an
operational way to define what might be autoimmune,” but after six months, Dr. Boylan would
not attribute any reaction to the inflammation. Id. at 115:23–116:25. She agreed that someone
having a stroke after a vaccine could be a coincidence, but did not think that was the case for Ms.
Goff. Id. at 105:20–106:8. In addition, Ms. Goff’s lack of recurrent strokes, setting aside the
June 30, 2016, stroke, also indicated to Dr. Boylan that “the vaccine triggered the stroke”
because the carotid web on its own has not caused other strokes. Id. at 84:14–23.
Turning to Ms. Goff’s second stroke, Dr. Boylan testified that stroke did not occur
downstream from the carotid web. Id. at 76:21–22. Dr. Boylan was “not sure” about the cause
of the second stroke and explained Ms. Goff “had an angiogram the week prior, . . . and an
angiogram is itself associated with a risk of stroke.” Id. at 85:24–86:15. Dr. Boylan explained
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that Ms. Goff got the cerebral angiogram because of the first stroke, so “the angiogram was a
consequence of the first stroke, but that second stroke may well have been a consequence of the
angiogram.” Id. at 86:17–22, 87:9–18.
When asked about her booster effect theory, Dr. Boylan explained that her opinion does
not “depend or hinge on” Ms. Goff’s September 2015 influenza vaccine, but that the September
vaccine “makes [her] feel more confident . . . because [it is] yet another thing that is pro-
inflammatory.” Id. at 91:15–18. Dr. Boylan testified that the first influenza vaccine may have
enhanced Ms. Goff’s reaction to the second vaccine, but she admitted she did not file any
medical literature about the booster effect of receiving two influenza vaccines. Id. at 92:6–21.
In brief, Dr. Boylan summarized her opinion as follows:
I believe that [the March 22, 2016, influenza] vaccine, through a
direct effect or through its pro-inflammatory stimulation possibly,
and also with the booster effect, adduced an acute inflammatory
response, which, in turn, triggered an inflammatory cascade, which
includes a prothrombotic state, and that triggered abnormal blood
flow over her preexisting carotid webs, formed a thrombus, which
flew downstream and caused a stroke.
Id. at 94:7–14; see also id. at 129:10–14. As a result, Dr. Boylan would not recommend that Ms.
Goff receive future influenza vaccines. Id. at 84:24–85:18. Dr. Boylan also did not view Ms.
Goff’s history of smoking as the likely cause of the strokes. Id. at 88:19–24.
b) Dr. Messé’s Testimony
Dr. Messé was recognized as an expert in neurology and vascular neurology at the
entitlement hearing. Id. at 145:8–13. He did not believe the influenza vaccine caused Ms.
Goff’s strokes. Id. at 154:20–155:1.
Dr. Messé admitted that “there is some evidence that inflammation can contribute to
stroke risk.” Id. at 180:17–18. And he acknowledged that the Smeeth study noticed an increase
in stroke risk after an influenza infection. Id. at 170:3–173:7 (discussing Pet’r’s Ex. 31). He
disagreed with Dr. Boylan’s conclusion that the response to an influenza vaccine could produce
the same harm as the response to an influenza infection because he saw no support for that
equivalence. Id. at 189:7–190:9. He testified that “there is no evidence whatsoever that . . . [the]
influenza vaccine can cause a stroke.” Id. at 169:11–13.
To the contrary, Dr. Messé explained that the Smeeth study does not indicate an
increased risk of stroke after the influenza vaccine. Id. at 172:6–173:2, 222:9–223:4 (discussing
Pet’r’s Ex. 31). He clarified that the Smeeth study does not suggest that the vaccine helps reduce
stroke risk by “thin[ning] the blood or something that would prevent stroke.” Id. at 222:9–14
(discussing Pet’r’s Ex. 31). For the individuals reported in the Smeeth study who had strokes
within a week of their influenza vaccines, Dr. Messé explained those cases as “coincidental,” and
the incidence rate was “much lower than you would expect in that time period,” supporting that
stroke is not caused by the vaccine. Id. at 181:24–182:8 (discussing Pet’r’s Ex. 31). He
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admitted the Smeeth study would not detect “if something happens [in] one in 10 million
people.” Id. at 192:20–193:1 (discussing Pet’r’s Ex. 31).
Dr. Messé also explained that two other studies Dr. Boylan relied upon—A. Niroshan
Siriwardena et al., Influenza and Pneumococcal Vaccination and Risk of Stroke or Transient
Ischaemic Attack, 32 Vaccine 1354 (2014) (the “Siriwardena study”) and Armin J. Grau et al.,
Influenza Vaccination is Associated with a Reduced Risk of Stroke, 36 Stroke 1501 (2005) (the
“Grau study”)—also indicated a reduced risk of stroke after influenza vaccination. Hr’g Tr.
173:18–175:5 (discussing Pet’r’s Exs. 23, 30). The Siriwardena study identified a “24 percent
reduction in stroke risk” after the influenza vaccine. Hr’g Tr. 174:10–18 (discussing Pet’r’s Ex.
30). And the Grau study reflected a reduction of stroke risk in around half of the patients. Id. at
175:1–4 (discussing Pet’r’s Ex. 23).
Dr. Messé criticized Ms. Goff’s reliance on the Cárdenas study because it pertained to
“autoimmune responses in general” and “provides no evidence that the vaccinations are actually
causing these disorders.” Id. at 176:18–22 (discussing Pet’r’s Ex. 19). He explained the only
support in the Cárdenas study for its theory that the influenza vaccine causes neurological
disorders were “observational case reports.” Id. at 177:2–4 (discussing Pet’r’s Ex. 19). And
neither of the two case reports highlighted in the study involved a stroke patient. Id. at 177:5–10
(discussing Pet’r’s Ex. 19).
Based on Ms. Goff’s medical records, Dr. Messé opined that her first stroke was a “left
middle cerebral artery stroke.” Id. at 155:2–7. Dr. Messé did not view Ms. Goff’s stroke at 43
years old as unusual. Id. at 167:3–23. He recognized that strokes among 43-year-olds are less
common than 83-year-olds, but that does not make them abnormal in younger people. Id. at
166:23–23, 180:9–14. “[L]ots of younger people . . . are having strokes,” and their “mechanisms
of stroke tend to be different than they are for older people.” Id. at 167:3–9.
Dr. Messé testified that Ms. Goff had three risk factors for stroke: her smoking, “elevated
LDL, which is cholesterol,” and an “abnormality in her carotid artery, which is either a web or
atherosclerosis.” Id. at 155:8–14. Dr. Messé “favor[ed]” that Ms. Goff had a carotid web in her
left internal carotid artery based on her CT angiogram performed on June 30, 2016. Id. at
158:11–159:17. He also considered it possible that Ms. Goff had ulcerated plaque causing a 30–
40% narrowing of her artery because that was the conclusion of her cerebral angiogram
performed on June 24, 2016. Id. at 157:6–8, 159:3–17. Because Ms. Goff had no significant
amount of other plaque throughout her body, Dr. Messé still favored that she had a carotid web
over plaque. Id. at 159:3–17. Dr. Messé explained that the carotid web is a “condition[] that
would predispose to stroke in a younger person.” Id. at 167:10–12. Given the presence of the
carotid web, Dr. Messé opined it is a “very plausible mechanism for her stroke, and [it is] the
best . . . explanation that we have.” Id. at 160:7–9. Regardless, Dr. Messé testified that if Ms.
Goff had atherosclerotic plaque with a 30–40% narrowing of her artery or a carotid web, both are
“extremely plausible mechanism[s] for a stroke.” Id. at 160:14–20.
Given the presence of the carotid web, Dr. Messé also did not believe that Ms. Goff
would need a catalyst to cause a stroke because the web itself “would be a very plausible
mechanism to have a stroke.” Id. at 161:14–20. He did not view the Lin study as providing
support that a catalyst was needed to trigger a stroke in a person with a preexisting prothrombotic
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state. Id. at 175:17–25 (discussing Pet’r’s Ex. 26). The Lin study involved a 75-year-old man,
and Dr. Messé explained a stroke at that age is unsurprising. Id. at 175:14–16, 208:24, 223:23–
224:17 (discussing Pet’r’s Ex. 26). And the Lin study discusses prothrombotic hypercoagulable
states, which increase the risk of producing clots throughout the body, while a carotid web is a
preexisting prothrombotic risk factor for stroke that can only cause clots in the vicinity of the
web. Id. at 206:10–19, 207:9–20 (discussing Pet’r’s Ex. 26). To the extent the Lin study
supports that an influenza vaccine can trigger a stroke in a person with a hypercoagulable state
like the man reported in that study, Dr. Messé distinguished it from Ms. Goff’s case involving a
carotid web. Id. at 208:2–20, 223:23–224:21.
Dr. Messé testified that he saw “no evidence [in Ms. Goff’s medical records] that there
was a systemic inflammatory state that was going on when she had her stroke.” Id. at 162:13–
15. Rather, some of Ms. Goff’s medical records indicated no redness or swelling of her arms.
Id. at 164:12–16. Dr. Messé observed that Ms. Goff’s records reflected that she did not have a
fever upon admission to the ER, and her lab results did not provide evidence of inflammation.
Id. at 165:17–166:10. He also recognized that Ms. Goff’s treating physicians “checked her
coagulation studies . . . to see whether she had any relatively rare conditions that can predispose
to form clots, and those were all normal.” Id. at 166:13–16. Dr. Messé acknowledged that not
all testing is perfect and may not catch all symptoms of inflammation, but for a “systemic
inflammatory state [that is] bad enough to cause a stroke, [he] would expect to see something.”
Id. at 219:5–8, 219:12–220:13. Dr. Messé also addressed the inflammation found in Ms. Goff’s
biopsy by explaining that inflammation “is the natural response to a stroke, not the cause of the
stroke.” Id. at 169:2–5. He testified that the biopsy of Ms. Goff’s thalamus was “completely
consistent with subacute stroke.” Id. at 168:23–169:1.
With respect to timing, Dr. Messé admitted Ms. Goff’s first stroke occurred during the
inflammatory period after the influenza vaccine. Id. at 212:19–22. He explained, however, that
the stroke also occurred when studies show a reduced stroke risk in people who are vaccinated.
Id. at 212:24–213:2.
Turning to Ms. Goff’s second stroke, Dr. Messé “favor[ed]” that Ms. Goff’s cerebral
angiogram was the cause, but he did not want to “rule out that the web caused that second
stroke.” Id. at 195:20–196:7. Dr. Messé explained that the cerebral angiogram requires a
catheter to travel “through the aortic arch and all those blood vessels that go up to the head, [and]
it is not uncommon for a little blood clot or plaque to be knocked off and cause additional brain
injury at that time.” Id. at 156:12–16. Thus, he believed it more likely than not that the cerebral
angiogram caused Ms. Goff’s second stroke. Id. at 195:20–196:7. But he was uncertain about
the cause of the second stroke and considered it possible that it was caused by the carotid web.
Id. at 203:2–204:4.
c) Post-Hearing Exhibits
Following the entitlement hearing, Ms. Goff filed two more articles. ECF No. 65;
Children, the Flu, and the Flu Vaccine, Ctrs. for Disease Control & Prevention, filed as Pet’r’s
Ex. 41 (ECF No. 65-1); Charles C. Eswena & Mitchell S. Elkind, Inflammatory Risk Factors,
Biomarkers and Associated Therapy in Ischaemic Stroke, 12 Neurology 594 (2016), filed as
Pet’r’s Ex. 42 (ECF No. 65-2). The first is a copy of a Centers for Disease Control and
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Prevention webpage discussing guidance on influenza for children, including the need for
“[s]ome children 6 months through 8 years of age” to get “two doses of influenza vaccine.”
Pet’r’s Ex. 41 at 1. The second is a study that discusses the risk of stroke increasing following
inflammation from infections, including the influenza infection. Pet’r’s Ex. 42.
The Government also filed additional medical literature. ECF No. 69. It filed Aroon D.
Hingorani et al., Acute Inflammation Impairs Endothelium-Dependent Dilation in Humans, 102
Circulation 994 (2000) (the “Hingorani study”) that examined responses to the Salmonella typhi
vaccine and noted endothelium-dependent relaxation in response to that vaccine. Resp’t’s Ex. C
(ECF No. 69-1). The Smeeth study cites the Hingorani study. Pet’r’s Ex. 31 at 2 n.15. The
Government also filed the tables that accompany the Cárdenas study. Resp’t’s Ex. D (ECF No.
69-2). Finally, the Government filed a study on the causation of serious neurologic events after
the 2009 H1N1 influenza vaccine. Resp’t’s Ex. E (ECF No. 69-3).
5. The Special Master’s Decision
After Special Master Oler’s appointment to the D.C. Superior Court, this case was
reassigned to Special Master Shah on August 13, 2024. ECF No. 78. Special Master Shah
issued her decision on January 13, 2025. ECF No. 83; Goff, 2025 WL 431582. The Special
Master explained that “[n]either expert felt that the June 2016 stroke was a direct result of the
March 22, 2016 flu vaccination,” so “[t]he operative question to resolve, then, is whether [Ms.
Goff]’s first stroke on March 30, 2016, was caused by the subject flu vaccination.” Goff, 2025
WL 431582, at *20. The Special Master decided Ms. Goff had not met her burden to prove the
influenza vaccine caused her March 2016 stroke under any of the Althen prongs and denied her
petition. Id. at *1.
Ms. Goff now moves for review of the Special Master’s decision. ECF No. 86.
II. Standard of Review
The National Childhood Vaccine Injury Act of 1986 created the National Vaccine Injury
Compensation Program to provide compensation for “a vaccine-related injury or death.” 42
U.S.C. § 300aa-10(a). To receive compensation under the Program, the person “who has
sustained a vaccine-related injury” files a petition, naming the Secretary of Health and Human
Services as the respondent, with the United States Court of Federal Claims Office of Special
Masters. See 42 U.S.C. § 300aa-11(a)(1), (b)(1)(A).
A petitioner seeking compensation under the Vaccine Act must have suffered an injury
from a vaccine either listed on the Vaccine Injury Table or “not set forth in the Vaccine Injury
Table but which was caused by a vaccine.” Id. § 300aa-11(c)(1)(C). Ms. Goff did not seek
compensation for an injury listed on the Vaccine Injury Table. See ECF No. 67 at 15; 42 U.S.C.
§ 300aa-14; 42 C.F.R. § 100.3. The Vaccine Act “does not relax proof of causation in fact for
non-Table Injuries.” Grant v. Sec’y of Health & Hum. Servs., 956 F.2d 1144, 1148 (Fed. Cir.
1992). A petitioner alleging a non-table injury must prove by a preponderance of the evidence
that “the vaccine more likely than not caused the condition alleged.” LaLonde v. Sec’y of Health
& Hum. Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014).
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To prove causation in a non-table injury case, a petitioner must present “(1) a medical
theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and
effect showing that the vaccination was the reason for the injury; and (3) a showing of a
proximate temporal relationship between vaccination and injury.” Althen v. Sec’y of Health &
Hum. Servs., 418 F.3d 1274, 1279 (Fed. Cir. 2005). A theory of causation cannot be proven
through “a mere showing of a proximate temporal relationship between vaccination and injury,
nor a simplistic elimination of other potential causes of the injury . . . without more.” Id. at
1278. The petitioner must prove each of the Althen prongs by a preponderance of the evidence
to satisfy the petitioner’s prima facie case that the vaccine was the “but-for” cause of the injury.
See de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1351 (Fed. Cir. 2008) (“[T]he
petitioner need not show that the vaccine was the sole or predominant cause of her injury, just
that it was a substantial factor.”); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355
(Fed. Cir. 2006) (explaining that the Althen “prongs must cumulatively show that the vaccination
was a ‘but-for’ cause of the harm”); Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344,
1352 (Fed. Cir. 1999) (adopting the tort theory of causation for vaccine cases).
The preponderance of the evidence standard does not require “scientific certainty” to
establish causation. LaLonde, 746 F.3d at 1338; Bunting v. Sec’y of Health & Hum. Servs., 931
F.2d 867, 873 (Fed. Cir. 1991). “[S]uccessfully proving the elements of the Althen test
establishes that the medical evidence indicating that the vaccine may have caused the petitioner’s
injury is strong enough to infer causation-in-fact absent proof that some other factor was the
actual cause.” de Bazan, 539 F.3d at 1354 (emphasis omitted); see Broekelschen v. Sec’y of
Health & Hum. Servs., 618 F.3d 1339, 1342 (Fed. Cir. 2010) (“Once the petitioner has
demonstrated causation, she is entitled to compensation unless the government can show by a
preponderance of the evidence that the injury is due to factors unrelated to the vaccine.”).
After the special master renders a decision, a party may seek review in this court. 42
U.S.C. § 300aa-12(e)(1). The filing of a motion for review gives this court jurisdiction “to
undertake a review of the record of the proceedings.” Id. § 300aa-12(e)(2). The Act allows the
court to do one of the following:
(A) uphold the findings of fact and conclusions of law of the
special master and sustain the special master’s decision,
(B) set aside any findings of fact or conclusion of law of the
special master found to be arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with law and issue its
own findings of fact and conclusions of law, or
(C) remand the petition to the special master for further action in
accordance with the court’s direction.
Id. This court reviews the decisions of the special masters to determine whether “any findings of
fact and conclusion of law . . . [are] arbitrary, capricious, an abuse of discretion, or otherwise not
in accordance with law.” Id. § 300aa-12(e)(2)(B).
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The arbitrary or capricious review of a special master’s findings of fact is a “highly
deferential standard of review.” Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed.
Cir. 1993); Munn v. Sec’y of Health & Hum. Servs., 970 F.2d 863, 889 (Fed. Cir. 1992); see
Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000) (explaining the
court must “uphold a special master’s findings unless the court concludes that those findings are
arbitrary or capricious”). Under that standard, this court does not “reweigh the factual evidence,
assess whether the special master correctly evaluated the evidence, or examine the probative
value of the evidence or the credibility of the witnesses” because “these are all matters within the
purview of” the special master as the fact finder. Porter v. Sec’y of Health & Hum. Servs., 663
F.3d 1242, 1249 (Fed. Cir. 2011); Munn, 970 F.2d at 871. In other words, this court does not
“second guess the Special Masters fact-intensive conclusions.” Hodges, 9 F.3d at 961. “If the
special master has considered the relevant evidence of record, drawn plausible inferences and
articulated a rational basis for the decision, reversible error will be extremely difficult to
demonstrate.” Hines ex rel. Sevier v. Sec’y of Health & Hum. Servs., 940 F.2d 1518, 1528 (Fed.
Cir. 1991); see Lampe, 219 F.3d at 1362 (describing a special master’s evaluations of credibility
and persuasiveness to be “virtually unchallengeable on appeal”).
III. Discussion
Ms. Goff moves the court to set aside the Special Master’s decision because the Special
Master’s findings on each prong of Althen were arbitrary or capricious. ECF No. 86 at 1–2. She
seeks a remand to the Special Master “with instructions to enter a finding that [Ms. Goff] should
be entitled to compensation and instructing the Special Master to conduct further proceedings
consistent with [that] determination.” Id. at 2. But Ms. Goff’s motion asks the court to reweigh
the evidence considered by the Special Master. See ECF No. 88 at 3, 15–18. The court is not
permitted to do so. Because the Special Master considered all the relevant evidence, drew
plausible inferences from the evidence, and provided a rational explanation for her decision, see
Hines, 940 F.2d at 1527, the court denies the motion for review.
A. The Special Master rationally explained that Ms. Goff failed to meet her
burden under Althen prong one.
Althen prong one requires proof by the preponderance of the evidence of a “medical
theory causally connecting the vaccination and the injury.” 418 F.3d at 1278. The petitioner
“must provide a ‘reputable medical or scientific explanation’ for [the] theory.” Boatmon v. Sec’y
of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019) (quoting Moberly ex rel.
Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010)). Although the
theory must be “sound and reliable,” the petitioner need not prove it with “medical or scientific
certainty.” Id. (quoting Knudsen ex rel. Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543,
548–49 (Fed. Cir. 1994)). “The assessment of whether a proffered theory of causation is
‘reputable’ can involve assessment of the relevant scientific data. Medical literature and
epidemiological evidence must be viewed, however, not through the lens of the laboratorian, but
instead from the vantage point of the Vaccine Act’s preponderant evidence standard[.]” Andreu
ex rel. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1380 (Fed. Cir. 2009).
To satisfy prong one, Ms. Goff’s expert, Dr. Boylan, presented a theory that “carotid
webs are a pre-existing condition that, when coupled with an inflammatory response to
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vaccination, can cause an ischemic stroke.” ECF No. 88 at 15. In other words, her causation
theory has four components: (1) Ms. Goff had a preexisting prothrombotic condition, the carotid
web, that had not caused a stroke on its own, (2) she received the influenza vaccine, (3) the
vaccine triggered an inflammatory response, and (4) the inflammatory effects paired with the
prothrombotic condition caused a stroke. The Special Master found Ms. Goff did not prove her
prong one theory by the preponderance of the evidence because Ms. Goff did not provide
sufficient evidence to support that (1) a carotid web needs a catalyst to cause a stroke, and (2) the
influenza vaccine produces the inflammatory effects associated with strokes. Goff, 2025 WL
431582, at *21–24. Ms. Goff contends she proved that the influenza vaccine can cause strokes
by a preponderance of the evidence through Dr. Boylan’s expert reports, testimony, and
supporting medical literature. ECF No. 88 at 5.
1. The record adequately supports the Special Master’s conclusion that Ms.
Goff did not prove by a preponderance of the evidence that an inflammatory
trigger is necessary to cause a stroke in a person with carotid webs.
The Special Master found “both parties’ experts agreed [Ms. Goff] had a carotid web, a
conclusion that is supported by the medical records.” Goff, 2025 WL 431582, at *22. That said,
she also found that “Dr. Boylan failed to submit any supportive evidence illustrating how the flu
vaccine could produce a stroke in a person with this condition.” Id.
Dr. Boylan’s theory provides in part that Ms. Goff’s carotid webs needed an
inflammatory trigger to cause a stroke. The Special Master found none of the supporting
medical literature in the record indicated an inflammatory trigger is needed to cause a stroke in
someone with a carotid web. Id. at *22–23. To the contrary, she surveyed the literature and
found that none “hypothesized that any type of vaccination could exacerbate the risk” of a stroke
in a person with carotid webs. Id. at *22. And the “literature she submitted identified carotid
web as an independent risk factor for stroke in [Ms. Goff]’s age group.” Id. at *23. In fact, the
Special Master identified several studies discussed the high stroke risk of carotid webs and that
doctors should suspect them to be the cause of a stroke in people with no other risk factors. Id.
(discussing Pet’r’s Exs. 21, 24, 29). Based on the lack of support in medical literature, the
Special Master did not credit Dr. Boylan’s theory that an inflammatory trigger was necessary to
cause Ms. Goff’s stroke. Id. at *22–23.
Ms. Goff does not argue that she provided medical literature on the relationship between
carotid webs, influenza vaccines, and strokes. Rather, she contends the rarity of carotid webs
justifies the lack of supporting literature on the relationship between influenza vaccines and
carotid webs in causing strokes. ECF No. 88 at 15. The absence of medical literature to support
Dr. Boylan’s theory does not establish the Special Master reached an arbitrary or capricious
finding. Quite the opposite. Althen prong one requires some evidence that the theory proposed
actually applies to the vaccine and injury at issue. Caves v. Sec’y of Health & Hum. Servs., 100
Fed. Cl. 119, 135 (2011), aff’d per curiam, 463 F. App’x 932 (Fed. Cir. 2012). The absence of
support for Dr. Boylan’s theory reflects that the Special Master properly reviewed the record and
rationally determined Ms. Goff did not meet her burden.
Dr. Boylan’s testimony is the only support that Ms. Goff presents to support that carotid
webs cause strokes when paired with an inflammatory trigger. ECF No. 88 at 15. Dr. Boylan
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testified that a “vascular abnormality,” like a carotid web, “increase[s] your risk of having a
stroke” during an inflammatory response. Hr’g Tr. 55:14–57:21. But the Special Master found
no support for Dr. Boylan’s testimony in the medical literature. Goff, 2025 WL 431582, at *23.
Again, the medical literature indicates carotid webs are risk factors for strokes, and it does not
suggest that an additional trigger is necessary to cause strokes in a patient with carotid webs. See
Pet’r’s Ex. 21 at 1, 5–6; Pet’r’s Ex. 24 at 1, 4; Pet’r’s Ex. 29 at 1, 5. The Special Master found
this literature, if anything, runs contrary to Dr. Boylan’s testimony because the medical literature
“identifie[s] [a] carotid web as an independent risk factor for stroke in [Ms. Goff]’s age group.”
Goff, 2025 WL 431582, at *23. Given the medical literature, the Special Master did not reach an
arbitrary or capricious finding that Dr. Boylan’s testimony standing alone failed to carry Ms.
Goff’s burden to prove an inflammatory trigger is needed to cause a stroke in a person with
carotid webs. It was rational to conclude that it was more likely than not that the carotid webs
caused Ms. Goff’s stroke and that the influenza vaccine had nothing to do with it.
2. Based on the record below, the Special Master rationally concluded that
Ms. Goff did not prove by a preponderance of the evidence the inflammatory
effects of the influenza vaccine.
The Special Master considered all the evidence in the record and acknowledged that Ms.
Goff “provided some support for the proposition that inflammation . . . can play a role in stroke.”
Goff, 2025 WL 431582, at *21. Even so, the Special Master decided Ms. Goff did not meet her
burden on prong one because “[i]t is not enough . . . to point to an association between stroke and
inflammation without providing some evidence characterizing the inflammatory properties of the
[influenza] vaccine.” Id. Ms. Goff disagrees with the Special Master’s characterization of her
evidence on the role of inflammation in causing strokes. ECF No. 88 at 6–7. Upon its review,
the court finds no arbitrary or capricious error in the Special Master’s consideration of Ms.
Goff’s evidence on inflammation and stroke.
a) Inflammation and Stroke
The Special Master reviewed Ms. Goff’s evidence to support that some kinds of
inflammation are associated with stroke. Goff, 2025 WL 431582, at *21. But she recognized
that not all kinds of inflammation are associated with stroke, so she sought evidence that the
influenza vaccine produced the kinds of inflammatory effects associated with causing strokes.
Id. at *21–22. Ms. Goff, however, did not provide “any evidence of the type, quantity, or
duration of the inflammatory products of the flu vaccine.” Id. at *22. Thus, the Special Master
found Ms. Goff did not meet her burden to prove her causation theory.
Ms. Goff contends the Special Master went to “great lengths to minimize the strength of
Dr. Boylan’s argument regarding inflammation and stroke.” ECF No. 88 at 7. Ms. Goff also
argues that the Special Master heightened her burden on prong one to require proof “that every
possible immune provocation . . . can lead to a stroke.” Id.
As Ms. Goff highlights in her motion, Dr. Boylan’s first expert report stated that
“[p]rovocations which cause a surge in the body’s auto-immune response can cause neurologic
illness. Such provocations include infection, trauma, surgery and, rarely, vaccination.” Id. at 6
(quoting Pet’r’s Ex. 16 at 3). Dr. Boylan cited six studies in support of her statement that
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“[t]here is substantial evidence that inflammation plays a role in stroke.” Pet’r’s Ex. 16 at 3
(citing Pet’r’s Ex. 31; then citing Pet’r’s Ex. 23; then citing Pet’r’s Ex. 27; then citing Pet’r’s Ex.
28; then citing Pet’r’s Ex. 30; and then citing Pet’r’s Ex. 22). Although those studies indicate
certain inflammatory triggers are associated with strokes, they do not prove all inflammatory
triggers are associated with strokes. See Pet’r’s Ex. 22 at 1, 6–7 (concluding infections may
trigger strokes in children, but “routine vaccinations appear protective”); Pet’r’s Ex. 23 at 1, 5–6
(acknowledging studies that found infections may affect stroke risk and concluding the
“influenza vaccination may be associated with reduced stroke risk”); Pet’r’s Ex. 27 at 1, 9
(recognizing that inflammation is known to have a significant impact on stroke risk and that the
influenza vaccine may reduce stroke risk); Pet’r’s Ex. 28 at 1, 9 (explaining that stroke risk may
increase in light of inflammation from “chronic disease or acute infection”); Pet’r’s Ex. 30 at 1,
5–7 (mentioning studies finding an increased stroke risk after respiratory infections, and
observing a reduced risk of stroke after influenza vaccination); Pet’r’s Ex. 31 at 1, 5–8
(concluding “acute infections are associated with a transient increase in the risk of vascular
events[, but b]y contrast, influenza, tetanus, and pneumococcal vaccinations do not produce a
detectable increase in the risk of vascular events”); see also infra Sections III.A.2.b–c
(discussing Pet’r’s Exs. 23, 30–31). Consistent with those studies, Dr. Boylan testified that
inflammation “plays a major role in stroke,” and infections are associated with stroke. Hr’g Tr.
34:11–35:25. Dr. Boylan also testified that not all inflammatory triggers are associated with
stroke. Id. at 39:17–22, 101:5–20. Further, Dr. Boylan acknowledged that infections are more
inflammatory than vaccines. Id. at 42:1–9, 103:6–8.
But the Special Master sought evidence that described the inflammatory effects of the
influenza vaccine to determine whether the vaccine Ms. Goff received could cause the kind of
inflammatory effects associated with strokes. This does not heighten Ms. Goff’s burden to prove
that all inflammation causes stroke. To the contrary, it narrows the scope by focusing on
influenza-vaccine-specific evidence. And Ms. Goff does not, and cannot, assert that the
submitted medical literature speaks to the inflammatory effects of the influenza vaccine. See
ECF No. 92 at 8. Dr. Boylan did not report or testify that the influenza vaccine was associated
with stroke. Nor does the medical literature cited in her report indicate such an association.
Indeed, the literature found that the data indicated a reduction in stroke risk rather than
increasing that risk. See Goff, 2025 WL 431582, at *23; Pet’r’s Ex. 23 at 5–6; Pet’r’s Ex. 27 at
9; Pet’r’s Ex. 30 at 5–7; infra Sections III.A.2.b–c. As this court has observed, “the first prong
of Althen would be rendered meaningless” if petitioners can meet their burden “[w]ithout any
empirical evidence that the theory actually applies” to the vaccine and injury at issue. Caves,
100 Fed. Cl. at 135. Here, the record reflects that Ms. Goff and her expert Dr. Boylan provided
no evidence that the influenza vaccine provokes the kind of inflammation needed to cause a
stroke. The Special Master did not arbitrarily or capriciously require evidence of the
inflammatory effects of the influenza vaccine, nor did Ms. Goff meet that requirement.
b) Endothelium-Dependent Relaxation Theory
The Special Master also found unpersuasive Dr. Boylan’s theory that inflammation from
the influenza vaccine impairs endothelium-dependent relaxation that in turn causes stroke. Goff,
2025 WL 431582, at *22 & n.13. Ms. Goff contends that she satisfied Althen prong one with Dr.
Boylan’s testimony on how inflammation can impair endothelium-dependent relaxation in the
blood vessels leading to the brain. ECF No. 88 at 7–8. Dr. Boylan explained that the
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endothelium is the innermost lining of the blood vessels, and the endothelium pulses and relaxes
to send blood into the brain and allow blood to flow away from the brain. Hr’g Tr. 51:20–52:10,
53:2–14. When the blood vessels undergo impaired endothelium-dependent relaxation, Dr.
Boylan testified the blood does not properly flow to the brain and may lead to stroke. Id. at
53:2–14. Dr. Boylan posited that inflammation can impair endothelium-dependent relaxation
that in turn causes stroke. Id. at 51:15–54:10. The Special Master specifically acknowledged
Dr. Boylan’s testimony on this possible mechanism of stroke. Goff, 2025 WL 431582, at *22.
Yet the Special Master found that Dr. Boylan’s “attempt[] to tie” her theory involving
inflammation causing impaired endothelium-dependent relaxation to the influenza vaccine was
“unpersuasive.” Id.
Dr. Boylan discussed the Smeeth and Hingorani20 studies to tie the influenza vaccine to
impaired endothelium-dependent relaxation. See Hr’g Tr. 53:2–54:10. The Smeeth study cites
the Hingorani study as indicative that “vaccination . . . induced a short-lived inflammation that
was associated with profound suppression of the endothelium-dependent relaxation.” Pet’r’s Ex.
31 at 2 & n.15 (citing Resp’t’s Ex. C). The Hingorani study measured the effects of the
Salmonella typhi vaccination on endothelium-dependent relaxation. Resp’t’s Ex. C. Notably,
the Smeeth study “accept[ed] that the Hingorani study did show a transient effect of vaccination
on endothelium-dependent relaxation of the vessels.” Goff, 2025 WL 431582, at *22 n.13;
Pet’r’s Ex. 31 at 2, 7–8. Thus, the Smeeth study itself assumed that proposition. Pet’r’s Ex. 31
at 7–8 (“We do not know whether the transient increase in [vascular event] risk is due to a short-
term alteration of endothelial function or to other mechanisms . . . .”). The Smeeth study
reviewed the United Kingdom’s national healthcare database for patients who had an influenza
infection or vaccine and then suffered a heart attack or stroke within a year of the infection or
vaccine.21 Id. at 2–4. The study categorized the resulting data to determine whether the patients
had a heart attack or a stroke during the first 90 days after the infection or vaccine, which was
treated as the “risk period.” Id. at 4–6. The Smeeth study did not measure markers for
endothelium-dependent relaxation.
In her discussion of the Smeeth and Hingorani studies, Dr. Boylan stated the Hingorani
study measured biomarkers in the blood after administering the influenza vaccine as an
inflammatory trigger to determine the effects of inflammation on the endothelium. Hr’g Tr.
53:22–24. The Special Master found that testimony to be “incorrect[],” which “weaken[ed]” the
strength of Dr. Boylan’s opinion testimony tying the endothelium-dependent relaxation theory to
the influenza vaccine. Goff, 2025 WL 431582, at *22. Ms. Goff does not argue in her motion
that Dr. Boylan’s testimony was correct. See ECF No. 92 at 9. And upon the court’s review, the
20 Dr. Boylan did not name the Hingorani study in her testimony, but she discussed “the
experiment [the Smeeth study authors are] referencing” that involves an experimental model
testing endothelium-dependent relaxation, which is the Hingorani study. Hr’g Tr. 51:9–13,
52:22–53:17 (describing the Smeeth study “referencing” a study “where they were trying to
study the effects of inflammation and measure them”); Pet’r’s Ex. 31 at 2 & n.15 (citing Resp’t’s
Ex. C).
21 The Smeeth study also included patients who had acute urinary tract infections, acute
bronchitis, chest infections, pneumonia, pneumococcal vaccinations, or tetanus vaccinations.
Pet’r’s Ex. 31 at 2, 5–6.
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record adequately supports the Special Master’s conclusion that her testimony was incorrect.
Neither study tested the effects of the influenza vaccine on endothelium-dependent relaxation as
Dr. Boylan’s testimony suggested. The court will not disturb the Special Master’s well-reasoned
determination that Dr. Boylan’s endothelium-dependent relaxation theory lacked credibility
because of her incorrect testimony.
c) Epidemiological Studies
The Special Master further found that the epidemiological studies were “reassuring”
about the properties of the influenza vaccine, and if anything, they indicate the vaccine “is
associated with a reduced, not increased, risk of stroke.” Goff, 2025 WL 431582, at *23–24.
Ms. Goff argues that the influenza vaccine’s protective effect against stroke at the population
level, shown in epidemiological studies, does not preclude the possibility that the vaccine will
cause stroke in some individuals. See ECF No. 88 at 6 n.1. Here, Dr. Boylan testified about
“idiosyncratic” responses to vaccines that depend on individual risk factors, id. at 10 (quoting
Hr’g Tr. 42:1–13), and Dr. Messé agreed that population-level studies do not consider the cause
of every individual’s case, id. at 12 (quoting Hr’g Tr. 192:24–193:1). The Government contends
the Special Master’s finding on prong one was based on “reasonably weigh[ing] the
epidemiological evidence as part of the record as a whole.” ECF No. 92 at 12. On the court’s
review, the Special Master appropriately considered the epidemiological studies in the record.
While epidemiological studies are not required evidence in vaccine cases, special masters
do not need to “ignore probative epidemiological evidence that undermines [a] petitioner’s
theory.” D'Tiole v. Sec’y of Health & Hum. Servs., 726 F. App’x 809, 811 (Fed. Cir. 2018);
Grant, 956 F.2d at 1149 (describing epidemiological studies as “probative medical evidence
relevant to causation”). The Federal Circuit has also recognized the limitations of
epidemiological studies: “[E]pidemiological studies are designed to reveal statistical trends only
for a carefully constructed test group[, so s]uch studies provide no evidence pertinent to persons
not within the parameters of the test group.” Moberly, 592 F.3d at 1324. Most importantly for
this court’s review, the Special Master recognized these limits as well. Goff, 2025 WL 431582,
at *23–24. It was not arbitrary or capricious for the Special Master to consider the
epidemiological studies in this case.
Three epidemiological studies in the record reflect that the influenza vaccine does not
increase the risk of stroke:
• The Grau study found the influenza vaccine “is associated with reduced risk of
stroke.” Pet’r’s Ex. 23 at 5.
• The Siriwardena study observed that the influenza vaccine “was associated with
[a] 24% reduction in stroke risk.” Pet’r’s Ex. 30 at 5.
• The Smeeth study discovered the influenza vaccine does not increase the risk of
stroke. Pet’r’s Ex. 31 at 6–8; see also ECF No. 88 at 12.
The Special Master found these epidemiological studies did not support that the influenza
vaccine causes sufficient inflammation to lead to a stroke; if anything, they were “reassuring”
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about the effect of the influenza vaccine on stroke risk. Goff, 2025 WL 431582, at *22–24 &
n.13.
The Special Master did not construe these studies to preclude a theory the influenza
vaccine could not cause a stroke in rare cases, only that the data showed that the vaccine
correlated to a lower stroke risk in the general population. See id. at *23–24. Although these
studies would not reveal if the influenza vaccine may cause a stroke in an incredibly rare
instance, it was not arbitrary or capricious for the Special Master to find they complement the
lack of evidence that the influenza vaccine causes stroke. These studies do not provide the
support that Ms. Goff needed—they do not indicate that the influenza vaccine causes strokes.
And the Special Master distinguished the case reports where strokes occurred after vaccines from
Ms. Goff’s case because one case report involved a “substantially older” patient with a history of
stroke and other comorbidities and the other involved the varicella vaccine, not the influenza
vaccine. Id. at *24. Thus, it was not arbitrary or capricious for the Special Master to conclude
these case reports did not outweigh the epidemiological evidence that the influenza vaccine is not
associated with an increased stroke risk at the population level. See id. The possibility that the
influenza vaccine caused a stroke in a patient beyond the scope of these epidemiological studies
is not sufficient for the court to set aside the Special Master’s well-reasoned decision.
d) The Cárdenas Study
Ms. Goff next contends that the Cárdenas study provided preponderant evidence that her
vaccination caused her stroke. The Cárdenas study reviewed existing medical literature
reporting neurological illnesses following the H1N1 influenza vaccine. Pet’r’s Ex. 19 at 1–2. Of
the reported patients, seven suffered strokes after their influenza vaccinations. Id. at 2. The
study also provided thorough case studies of two patients who experienced neurological illness
following their vaccinations; neither of whom suffered a stroke. Id. at 3–4. Based on its
findings, the Cárdenas study observed the H1N1 influenza vaccine “may promote an exacerbated
peripheral inflammatory response,” and a “peripheral inflammatory response may promote
neuroinflammation, which may underlie the neurological symptoms observed in the two cases
reported herein, and in those published elsewhere.” Id. at 4–5; see also ECF No. 88 at 9 (quoting
Pet’r’s Ex. 19 at 4).
The Special Master acknowledged that the Cárdenas study “proposed that
neuroinflammation could result from vaccination” and “identified seven cases of stroke
following H1N1 flu vaccination.” Goff, 2025 WL 431582, at *21. Still, the Special Master
found this study did not supply “evidence characterizing the inflammatory properties of the
subject vaccine.” Id. As the Government explains, the Cárdenas study “couche[s]” potential
effects of the influenza vaccine “in terms of possibilities and effects that ‘may’ occur,” and
therefore “does not offer any evidence regarding the inflammatory effects of the flu vaccine.”
ECF No. 92 at 8. And the study identifies patients who received a vaccine and then experienced
neurologic illnesses without a clear explanation of the mechanism by which the vaccine caused
the neurologic illness, if the vaccine caused the illness at all. The Cárdenas study’s theories of
causation, including neuroinflammation from the vaccine, are inconclusive. As a result, the
Special Master did not reach an arbitrary or capricious finding that the Cárdenas study did not
prove that the influenza vaccine produces inflammatory effects that cause strokes.
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e) Booster Effect Theory
The Special Master also found that Ms. Goff did not present sufficient evidence to
support the “booster effect” theory. Goff, 2025 WL 431582, at *22. Ms. Goff challenges that
finding. ECF No. 88 at 13–14. Recall that receiving multiple vaccines in one flu season is
“often referred to as giving a ‘booster,’” and a booster influenza vaccine is recommended for
children. Pet’r’s Ex. 16 at 3–4 (citing Pet’r’s Ex. 20). Dr. Boylan theorized that the “frequency
and total dose of vaccine administered are considered to be relevant to clinical response.
Theoretically, such clinical responses may be adverse as well as beneficial. An enhanced
immune provocation may result in higher risk of adverse events.” Id. at 4. At the entitlement
hearing, Dr. Boylan testified that Ms. Goff’s September 2015 and March 2016 influenza
vaccines combined might have produced a greater inflammatory response. Hr’g Tr. 91:15–
92:21. After the hearing, Ms. Goff submitted a copy of a Centers for Disease Control and
Prevention webpage that recommends children up to 8 years old receive two influenza vaccines
per season. Pet’r’s Ex. 41 at 1. The webpage further explains “[t]he first dose ‘primes’ the
immune system; the second dose provides immune protection.” Id. Additionally, the webpage
mentions that different influenza vaccines “are approved for different age groups.” Id.
The Special Master discussed Dr. Boylan’s booster effect theory, but she found Dr.
Boylan’s testimony “unpersuasive” and that her supporting medical literature did not support the
booster effect theory. Goff, 2025 WL 431582, at *22. As the Special Master explained, Dr.
Boylan did not point to any supporting medical literature at the entitlement hearing for her theory
that Ms. Goff’s September 14, 2015, influenza vaccine “primed” her to have a response to her
second influenza vaccine on March 22, 2016. Id. And the evidence that Ms. Goff produced after
the entitlement hearing pertained to the effect of two influenza vaccines on children, which “are
typically formulated differently from those for adults.” Id. The Special Master’s view of the
evidence is consistent with the record, so the court sees nothing arbitrary or capricious in the
Special Master’s finding that no evidence corroborates Dr. Boylan’s booster effect theory
testimony.
3. The Special Master did not require that Ms. Goff prove her causation
theory with scientific certainty.
As a general matter for prong one, Ms. Goff contends that the “preponderance of the
evidence standard does not require scientific certainty,” so her theory need not rely on
“epidemiological studies or ‘general acceptance in the scientific or medical communities.’” ECF
No. 88 at 4 (quoting Moberly, 592 F.3d at 1325). She also cites Cloer v. Secretary of Health and
Human Services, 654 F.3d 1322, 1332 n.4 (Fed. Cir. 2011), to support that a petitioner may
prevail on Althen prong one by providing sufficient circumstantial evidence of a link between the
vaccine and the injury before a theory receives objective recognition in the medical community.
ECF No. 88 at 5.
While Ms. Goff is correct that she need not “present proof of causation to the level of
scientific certainty,” the Special Master was “entitled to require some indicia of reliability to
support” Dr. Boylan’s theory. Moberly, 592 F.3d at 1324; see LaLonde, 746 F.3d at 1341
(“[P]etitioners must proffer trustworthy testimony from experts who can find support for their
theories in medical literature in order to show causation under the preponderance of the evidence
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standard.”); see also Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed. Cir.
2010) (“By inclusion of the terms ‘relevant and reliable,’ Vaccine Rule 8(b)(1) necessarily
contemplates an inquiry into the soundness of scientific evidence to be considered by special
masters.”). The Special Master weighed Ms. Goff’s evidence against the Government’s, and
ultimately found Ms. Goff “failed to produce preponderant evidence of a sound, reliable theory
demonstrating how the flu vaccine is capable of causing stroke.” Goff, 2025 WL 431582, at
*21–24.
This finding “does not mean that the Special Master was demanding scientific certainty;
[s]he might simply have been demanding some degree of acceptable scientific support when
concluding” that Ms. Goff’s claim “was not supported by a preponderance of the evidence.”
Hodges, 9 F.3d at 962. The record makes clear that the Special Master did not require scientific
certainty; she sought some evidence that Dr. Boylan’s theory actually applied to patients with
carotid webs and actually applied to the influenza vaccine. Ms. Goff presented no such
evidence. As a result, the Special Master’s finding that Ms. Goff did not meet her burden on
Althen prong one by a preponderance of the evidence was not arbitrary or capricious.
B. The Special Master rationally found Ms. Goff’s medical records and
supporting medical literature did not support her causation theory on Althen prong
two.
Because the Special Master found Ms. Goff did not meet her burden on Althen prong one,
the Special Master did not have to discuss Althen prong two. W.C. v. Sec’y of Health & Hum.
Servs., 704 F.3d 1352, 1358 (Fed. Cir. 2013) (explaining that the failure to satisfy one of the
Althen prongs renders the rest of the prongs unnecessary to address); DePena v. Sec’y of Health
& Hum. Servs., 133 Fed. Cl. 535, 549 (2017) (“[T]o prove causation-in-fact, a petitioner must
satisfy all three prongs of the Althen test; a failure to satisfy one prong is fatal to the case.
Because petitioners failed to establish that the special master erred in rejecting their theory of
causation, the special master’s conclusion regarding the Althen test’s second prong is of no
moment.” (internal citations omitted)), aff’d per curiam, 730 F. App’x 938 (Fed. Cir. 2018);
Druery v. Sec’y of Health & Hum. Servs., 169 Fed. Cl. 557, 585 (2024) (“[B]ecause a petitioner
must meet all three Althen prongs, [the special master] was not obligated to evaluate the Althen
prong 2 or Althen prong 3 after determining [the] petitioner did not meet her burden of proof on
Althen prong 1.”). The Special Master nevertheless reviewed the evidence on Althen prong two,
and Ms. Goff challenges the Special Master’s finding that she failed to satisfy this prong. Thus,
the court likewise addresses Althen prong two.
Althen prong two requires the petitioner to establish by a preponderance of the evidence
“a logical sequence of cause and effect showing that the vaccination was the reason for the
injury.” 418 F.3d at 1279; see Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1327
(Fed. Cir. 2006) (“There may well be a circumstance where it is found that a vaccine can cause
the injury at issue and where the injury was temporally proximate to the vaccination, but it is
illogical to conclude that the injury was actually caused by the vaccine.”). Like with prong one,
Ms. Goff argued on prong two that “the inflammation caused by vaccination coupled with the
carotid web [led] to the creation of a clot and ultimately an ischemic stroke.” ECF No. 67 at 40.
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The Special Master offered two primary reasons why Ms. Goff did not meet her burden
of proof on prong two: (1) Ms. Goff did not suffer inflammatory symptoms following the
influenza vaccine and leading to her stroke, and (2) the preponderance of the evidence indicating
her carotid web was more likely the cause of her stroke. Goff, 2025 WL 431582, at *24–25. Ms.
Goff challenges both reasons as arbitrary or capricious. ECF No. 88 at 16–17.
1. Ms. Goff’s medical records do not indicate that she suffered inflammation
from her March 2016 influenza vaccine to support her prong two theory.
The Special Master considered Ms. Goff’s medical records in detail and found that none
contained objective indications of an inflammatory response to the influenza vaccine:
During the eight days between the vaccination and Petitioner’s
stroke, she made no complaints to any medical providers of
symptoms that might be indicative of inflammation, such as fever,
rash, edema, bruising, or purpura, which are common post-
vaccination reactions. Likewise, when she went to the hospital on
March 30, 2016, the records show she did not report recently
feeling unwell. To the contrary, she reported being in “good
chronic health” and that “[p]rior to her ER visit she was in her
usual state of health.” She underwent multiple examinations at the
hospital, with no observations of clinical signs of inflammation.
Lab work done in the hospital showed normal levels of
inflammatory markers such as CRP and ESR, as well as a negative
hypercoagulable workup, signifying that she did not have a blood
condition predisposing her to thrombosis.
Goff, 2025 WL 431582, at *24 (internal citations and footnotes omitted). And Dr. Boylan “did
not dispute that the hospital records did not show clinical or laboratory indications of
inflammation before or at the time of the initial stroke.” Id. at *25. But as Dr. Messé explained,
an inflammatory response sufficient to cause a stroke “would be expected” to be recognized, but
no such inflammation appears in Ms. Goff’s medical records. Id. at *24. The Special Master
also recognized that no treating physician attributed her stroke to the influenza vaccine and that
Ms. Goff’s VAERS report did not describe inflammatory symptoms. Id. The Special Master
found Ms. Goff did not prove she suffered from inflammation after her March 2016 influenza
vaccine, so Ms. Goff failed to meet her burden on prong two. Id.
Ms. Goff does not challenge the accuracy of her medical records. “Medical records, in
general, warrant consideration as trustworthy evidence.” Cucuras v. Sec’y of Health & Hum.
Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). As a result, the court does not see any error in the
Special Master’s treatment of Ms. Goff’s medical records as accurately reflecting her lack of
inflammatory symptoms. Ms. Goff’s lack of inflammation undercuts her theory of causation on
prong two.
Even if the court accepted Dr. Boylan’s theory of causation, Ms. Goff could not prove
causation. Recall that Dr. Boylan’s theory is premised on the influenza vaccine causing
inflammation that in turn caused a stroke. The record does not reflect that Ms. Goff suffered
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inflammation after she received her influenza vaccine on March 22, 2016, and before her stroke
on March 30, 2016. As Dr. Messé testified, he “would expect to see something” if Ms. Goff had
suffered a “systemic inflammatory state . . . bad enough to cause a stroke.” Hr’g Tr. 220:9–13.
Thus, the record adequately supports the Special Master’s conclusion that Ms. Goff did not
suffer inflammation from her influenza vaccine, which would be necessary under Dr. Boylan’s
theory.
Ms. Goff first challenges this conclusion because the Special Master relied in part on the
fact that none of Ms. Goff’s treating physicians attributed her first stroke to the influenza
vaccine. ECF No. 88 at 16. It is true, as Ms. Goff contends, that “the opinion of a treating
physician is not required for [her] to prevail under Althen.” Id.; Moberly, 592 F.3d at 1325.
Still, such an opinion “can provide supporting evidence of causation.” Moberly, 592 F.3d at
1325. Given Dr. Messé’s testimony he would expect to see something in the record if Ms. Goff
had sufficient inflammation to cause the stroke, the Special Master’s recognition that no such
record exists is appropriate. It reflects a conclusion that the Special Master considered that
portion of Dr. Messé’s testimony persuasive. This court does not second guess that conclusion.
Thus, the Special Master did not act arbitrarily or capriciously by noting the absence of a treating
physician opinion tying Ms. Goff’s strokes to her influenza vaccine. Cf. Greene v. Sec’y of
Health & Hum. Servs., 841 F. App’x 195, 202 (Fed. Cir. 2020) (upholding the special master’s
finding that the petitioner did not meet his burden on prong two, and mentioning that the special
master considered that none of the patient’s treating physicians attributed his injury to his
vaccine).
Next, Ms. Goff argues the Special Master’s consideration of her VAERS report is
arbitrary or capricious because “Ms. Goff is not a doctor” and she “did not draft this document
with the intent of meeting her burden of proof under Althen.” ECF No. 88 at 16. But the Special
Master considered the lack of any symptoms of inflammation on the VAERS report as another
indication that there was not sufficient evidence of inflammation in the record. ECF No. 92 at
14–15. In fact, the Special Master only mentioned the VAERS report after recounting all the
contemporaneous objective medical records that showed no inflammatory symptoms. Goff, 2025
WL 431582, at *24. Thus, the Special Master’s consideration of the VAERS report was not
improper.
2. The Special Master did not arbitrarily or capriciously find that Ms. Goff’s
carotid web is an alternative cause of her stroke.
The Special Master could consider alternative causes of Ms. Goff’s stroke as part of the
prong two analysis. See Capizzano, 440 F.3d at 1327 (explaining a petitioner may fail to meet
the prong two burden “where the probability of coincidence or another cause prevents the
claimant from proving that the vaccine caused the injury by preponderant evidence”). Here, the
Special Master explained “both experts agreed” that Ms. Goff had carotid webs and that carotid
webs are a risk factor for stroke. Goff, 2025 WL 431582, at *25. The experts agreed the medical
literature supported that people at Ms. Goff’s age may suffer strokes from carotid webs without
suggesting the need for a “catalyzing agent” to cause a stroke. Id.
Ms. Goff, however, contends that Dr. Boylan’s testimony is sufficient to counter that the
carotid web was more likely the cause of her stroke than the vaccine. ECF No. 88 at 16–17. Dr.
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Boylan testified that Ms. Goff’s stroke was “much more likely to have been the reaction to the
flu shot than . . . [the] carotid web [because] the underlying carotid web alone has not been
sufficient [to cause] . . . any prior or subsequent events.” Hr’g Tr. 91:4–9. The Special Master
explained why she did not credit that testimony from Dr. Boylan—her testimony was not
supported in her submitted medical literature. Goff, 2025 WL 431582, at *25. Again, the
Special Master reviewed the relevant medical literature on the relationship between carotid webs
and strokes and rationally found that the literature does not support that an inflammatory trigger
is needed to cause a stroke in a person with carotid webs. See supra Section III.A.1. The
Special Master thus gave less weight to Dr. Boylan’s opinion than Ms. Goff would have liked.
But this court does not reweigh the evidence, it ensures the Special Master considered the
evidence and came to a rational conclusion. Hines, 940 F.2d at 1527 (explaining that “arguments
as to the weighing of evidence . . . do not demonstrate reversible error[ r]egardless of whether the
Claims Court . . . would have found different facts on a retrial of the case” because “the issue the
Claims Court resolve[s] . . . is only whether the findings and conclusions of the special master
were ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law’”
(quoting 42 U.S.C. § 300aa-12(e)(2)(B))).
In the end, the Special Master’s conclusion that Ms. Goff failed to satisfy Althen prong
two was not arbitrary or capricious.
C. The Special Master did not arbitrarily or capriciously find that Ms. Goff did
not meet her burden of proof on Althen prong three.
Like prong two, the Special Master did not need to reach Althen prong three. Because
she did, the court reviews her conclusions and Ms. Goff’s arguments that those conclusions were
arbitrary or capricious.
To satisfy Althen prong three, a petitioner must show “a proximate temporal relationship
between vaccination and injury.” 418 F.3d at 1279. This showing requires proof of both a
“medically acceptable time frame” and that the petitioner’s injury occurred in that time frame.
Pafford, 451 F.3d at 1358; de Bazan, 539 F.3d at 1352 (“[T]he proximate temporal relationship
prong requires preponderant proof that the onset of symptoms occurred within a timeframe for
which, given the medical understanding of the disorder’s etiology, it is medically acceptable to
infer causation-in-fact.”). Here, the Special Master found that Ms. Goff “did not supply reliable
expert testimony or other evidence supporting an eight-day onset of stroke following flu
vaccination.” Goff, 2025 WL 431582, at *26.
Ms. Goff contends this holding is arbitrary and capricious because Dr. Boylan testified
that eight days is an appropriate timeframe for onset of a stroke following vaccination. This,
according to Ms. Goff, was sufficient to “establish[] that the onset of her condition occurred
within a medically acceptable timeframe.” ECF No. 88 at 18. But the Special Master explained
that she did not find this testimony persuasive or credible because it contradicted Dr. Boylan’s
first export report. Goff, 2025 WL 431582, at *26. That report cited medical literature providing
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neurological illness22 typically occurs two to six weeks after infection. Pet’r’s Ex. 16 at 3 (citing
Pet’r’s Ex. 32). Yet, at the entitlement hearing, Dr. Boylan testified that Ms. Goff’s stroke,
which occurred eight days after her vaccination, was “within the time frame [of] . . . other
inflammatory responses.” Hr’g Tr. 48:13–49:3. Thus, Dr. Boylan’s opinion changed from two
to six weeks being the appropriate timeframe to eight days being within the appropriate
timeframe, and it was unclear how she got there. In fact, Dr. Boylan admitted that she did not
know how long the immune system’s response to the influenza vaccine lasts, but she said that the
response “lasts at least as long as the time period from the [March 2016] vaccine to the first
stroke.” Hr’g Tr. 119:18–120:6. The Special Master, however, found Dr. Boylan’s testimony
equivocal and inconsistent with her first report, which “undermined the persuasiveness” of her
opinion. Goff, 2025 WL 431582, at *26. Again, it is not the role of this court to second-guess
the weight the Special Master gave to Dr. Boylan’s testimony. The Special Master gave a
reasoned explanation why she did not credit Dr. Boylan’s testimony on the eight-day timeframe,
so her finding was not arbitrary or capricious.
Ms. Goff next takes issue with the Special Master’s decision based on its reference to Dr.
Messé’s opinion that although eight days would be within the expected time of onset of a stroke
following infection, he concluded that it was also within the time that the medical literature
found a reduced risk of stroke from vaccination. ECF No. 88 at 17 (quoting Goff, 2025 WL
431582, at *26). Dr. Messé testified that eight days after an influenza vaccine is “in the time
frame where we saw a reduced risk of stroke in people who are vaccinated; certainly no evidence
that it increases the risk of stroke in that time frame.” Hr’g Tr. 212:19–213:2. Ms. Goff argued
that the Special Master’s reasoning does not align with the reasoning in Irwin v. Secretary of
Health and Human Services, No. 16-1454V, 2024 WL 863690 (Fed. Cl. Spec. Mstr. Jan. 23,
2024). ECF No. 88 at 17–18.
But a “[s]pecial [m]aster is not bound to follow the opinions of other [s]pecial [m]asters,”
and “special masters are not required to distinguish non-binding decisions of other special
masters.” Boatmon, 941 F.3d at 1358 (quoting Boatmon v. Sec’y of Health & Hum. Servs., 138
Fed. Cl. 566, 571 (2018)). Although not required, the Special Master did compare this case to
similar cases, including Irwin. Goff, 2025 WL 431582, at *27.23 That said, she recognized the
22 The Special Master recognized that the literature did not concern strokes, it addressed
“encephalitis, myelitis, and encephalomyelitis.” Goff, 2025 WL 431582, at *26 (discussing
Pet’r’s Ex. 32); see also Pet’r’s Ex. 32.
23 Although Ms. Goff does not address them, the Special Master considered two other cases
asserting that the influenza vaccine caused strokes. In Sokol v. Secretary of Health and Human
Services, another Special Master found that a subarachnoid hemorrhagic stroke ten days after
vaccination was outside the medically acceptable time frame of four days. No. 16-1631V, 2020
WL 553842, at *7–8, *10 (Fed. Cl. Spec. Mstr. Jan. 9, 2020); see also Goff, 2025 WL 431582, at
*27 (analyzing Sokol, 2020 WL 553842, at *2, *5–6, *8). And in Schultz v. Secretary of Health
and Human Services, the Chief Special Master found that the petitioner’s medical record did not
support that her hemorrhagic stroke thirty days after an influenza vaccination was “likely caused
by the flu vaccine.” No. 16-539V, 2020 WL 1039161, at *24 (Fed. Cl. Spec. Mstr. Jan. 24,
2020); see Goff, 2025 WL 431582, at *27 (analyzing Schultz, 2020 WL 1039161, at *13, *22–
24). Here, the Special Master recognized that Dr. Boylan has previously distinguished between
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proper legal standard when considering these other cases, explaining that although the prior
decisions did not control the analysis, they could inform that analysis. Id. at *26.
As for Irwin, the Special Master meaningfully distinguished it because Ms. Goff did not
fall ill immediately after her vaccine like the Irwin petitioner did. Id. at *27. In Irwin, Special
Master Gowen concluded that a 24-hour timeframe for onset of symptoms followed by a stroke
within two days was a “medically acceptable timeframe to infer causation.” 2024 WL 863690,
at *22. As Special Master Shah stated: “the petitioner in Irwin fell ill immediately after
receiving a seasonal flu vaccination and suffered a stroke two days later.” Goff, 2025 WL
431582, at *27. But in this case, Special Master Shah found that conclusion inapplicable
because Ms. Goff’s stroke was eight days post-vaccination and there was no history of
significant inflammation between Ms. Goff’s vaccination and her stroke. Id. The record
adequately supports this conclusion. Recall that Ms. Goff did not fall ill immediately after she
received her influenza vaccine. She reported she was in good health during the days before her
stroke. Pet’r’s Ex. 6 at 220. Some of Ms. Goff’s self-reports following her stroke and her
testimony indicate her left arm was red or swollen following her influenza vaccine. Pet’r’s Ex. 1
¶ 5; Pet’r’s Ex. 3; Hr’g Tr. 7:20–22. But Ms. Goff’s medical records from her admission at the
Abrazo ER do not reflect such symptoms when she was receiving treatment for her stroke.
Pet’r’s Ex. 6 at 220, 222, 280–81. The Special Master credited Ms. Goff’s medical records more
than her self-reporting documents and testimony. Goff, 2025 WL 431582, at *25. And the court
will not second-guess the Special Master’s well-reasoned weighing of the evidence.
Thus, the court upholds the Special Master’s conclusion that Ms. Goff failed to meet her
burden under Althen prong three.
IV. Conclusion
For these reasons, the court DENIES Petitioner’s motion for review, ECF No. 86. The
Clerk’s Office is DIRECTED to enter judgment accordingly.
It is so ORDERED.
s/ Edward H. Meyers
Edward H. Meyers
Judge
the hemorrhagic strokes in these cases and ischemic strokes like Ms. Goff suffered, and found
Dr. Boylan less persuasive because she conflated the two. Goff, 2025 WL 431582, at *27.
32