1

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 16-848V

(to be published)

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

HOLLY D. PATEL, *

*

Petitioner, * Filed: May 1, 2020

*

v. *

*

SECRETARY OF HEALTH * Influenza vaccine; Althen

AND HUMAN SERVICES, * prong three; Timeframe;

* Chronic inflammatory

Respondent. * demyelinating polyneuropathy;

* Headaches and fatigue

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

Andrew D. Downing, Van Cott & Talamante, Phoenix, AZ, for Petitioner.

Robert Coleman III, U.S. Department of Justice, Washington, DC, for Respondent.

DECISION1

On July 19, 2016, Holly D. Patel filed a petition seeking compensation under the National 

Vaccine Injury Compensation Program (“Vaccine Program”)2alleging that she experienced

Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”) because of vaccines that she 

received on August 20, 2013, and November 13, 2013. Petition (ECF No. 1). Petitioner later 

amended her claim to the allegation that the influenza (“flu”) vaccine she received in November 

2013 was causal of her CIDP. Joint Status Report at 1, filed on August 1, 2018 (ECF No. 47).

 

1 This Decision will be posted on the Court of Federal Claims’ website in accordance with the E-Government Act of 

2002, 44 U.S.C. § 3501 (2012)). This means that the Decision will be available to anyone with access to the 

internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the Decision’s inclusion 

of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days 

within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial 

or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the 

disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the 

whole Decision will be available to the public. Id.

2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 

100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the 

Act”]. Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix).
2

The parties acceded to my proposal that the matter be resolved by a ruling on the record. 

Now, after review of all submissions in the case, I DENY an entitlement award. As discussed in 

greater detail below, Petitioner has not successfully established that onset of her CIDP occurred in 

a medically acceptable timeframe when measured from her November 2013 vaccination. 

I. Factual Background

A. Pre-Vaccination History & Status After Receipt of Flu Vaccine

Two months before the vaccination at issue, Ms. Patel gave birth to her second daughter 

on September 22, 2013, while living in England. Hertfordshire Community Records at 1, filed on 

Jan. 8, 2019 as Ex. 61 (ECF No. 69-1). Before this time, she had a medical history of Grave’s 

disease, hyperthyroidism, goiter, and a benign systolic mummer. Lister Hospital Records at 3, filed 

on March 3, 2017 as Ex. 17 (ECF No. 13-2). Her labor was difficult, and in it she lost a significant 

amount of blood and declined transfusion. Hertfordshire Community Records II at 1, filed on Oct. 

25, 2018 as Ex. 59 (ECF No. 64-1). On October 4, 2013, Petitioner was advised of the symptoms 

of anemia and prescribed iron and ferrous sulphate supplements. Id. at 2. Right around this time, 

Petitioner reported feeling “tired, emotional, and some dizziness”, symptoms which persisted for 

several days. Id. at 1, 2.

On November 18, 2013, Petitioner received a seasonal flu vaccination in the United 

Kingdom.3 Vaccination Record, filed on Oct. 17, 2016 as Ex. 1 (ECF no. 7-2). She returned to the 

United States at the end of that month. Pet’r’s Aff. at 1, filed on Mar. 13, 2018 as Ex. 20 (ECF No. 

30-1). The medical record does not suggest that Ms. Patel experienced any reaction to the receipt 

of this vaccine. Indeed, there is a subsequent gap of a few months in the medical records revealing 

no treatment history at all. But Petitioner attributes this gap to the fact that she was then arranging 

for health insurance, and had to wait for an appointment to see her new primary care provider. 

Pet’r’s Aff. at 1–2. Petitioner also maintains that beginning the first week of December 2013, she 

“began experiencing dizziness, fatigue, and headaches.” Id. at 1. To treat these symptoms she 

started taking various over-the-counter medications (e.g., Tylenol, Ibuprofen, and Dramamine) but 

they did not help. Id.

B. 2014 and Headache/Dizziness Symptoms

The next medical record is from February 10, 2014, when Ms. Patel visited Elizabeth 

O’Connor, D.O., at Abrazo Healthcare in Scottsdale, Arizona. Abrazo Healthcare Records, filed 

as Ex. 15 on February 3, 2017 (ECF No. 11-2) (“Abrazo Healthcare”) at 69; see also Pet’r’s Aff. 

at 1. The purpose of the visit was to establish a new treatment provider. Abrazo Healthcare at 69. 

At this initial visit, Ms. Patel raised only three problems: gestational diabetes mellitus, 

hypothyroidism (for which she reported taking medication), and an iron deficiency. Id. at 69–70. 

 

3 The parties have agreed that this vaccine is covered under the Vaccine Act. Joint Status Report at 1, filed on August 

1, 2018 (ECF No. 47). 
3

The history section of these records does not mention headaches, lightheadedness, or dizziness, 

however. Id.

A review of Ms. Patel’s symptoms by Dr. O’Connor did not note headaches, 

lightheadedness, or a change in an any preexisting headache pattern. Abrazo Healthcare at 70. The 

physical exam section also noted that Petitioner was ambulating normally and had normal muscle 

strength and tone. Id. Petitioner was assessed with gestational diabetes mellitus, hypothyroidism, 

and iron deficiency, and labs were ordered in reference to these problems. Id. Test results obtained 

on February 25, 2014, at a follow-up visit showed normal iron levels and low TSH levels. Id. at 

95–98. As with the first visit, these records reference no neurologic problems, headaches, 

dizziness, or fatigue, and no neurologic consult was proposed. See generally id. at 69–70.

On February 27, 2014, however, Petitioner called Abrazo Healthcare complaining of 

dizziness. Ex. 53, filed on September 25, 2018 (ECF No. 56-1), at 1. Her blood sugar levels came 

back normal, ruling out diabetes mellitus as an explanation for dizziness. In response to Ms. Patel’s 

request to look for alternative etiologies for her symptoms, she was given a neurology referral. Id.

Petitioner followed up with Dr. O’Connor at Abrazo Healthcare the next month, on March 

21, 2014. Abrazo Healthcare at 67–68. Her chief complaints at this visit were dizziness, 

lightheadedness, and headaches which she now reported occurred almost daily, plus fatigue, 

malaise, and some vision issues. Id. at 67–68. These records set forth her presenting issues as

hypothyroidism, iron deficiency, obesity, gestational diabetes mellitus, and dizziness. Id. at 67. A 

review of systems reflected Petitioner’s symptoms, although a physical exam noted normal muscle 

tone and strength. Id. at 68. Ms. Patel also stated that she had a consult scheduled with a neurologist 

in a few weeks, but wanted to see if there was anything Dr. O’Connor could do for her before then. 

Id. at 68. There is no evidence that Petitioner followed up thereafter with Dr. O’Connor.

There is then another medical records gap of a month. Then on April 23, 2014, Petitioner 

visited Jack Anderson, M.D., for an injury she claimed to have sustained in mid-February to her 

jaw and right side of her face when a shelf in her home fell off the wall and struck her. Arizona 

Pain Institute Records, filed as Ex. 51 on September 19, 2018 (ECF No. 53-1) (“Arizona Pain”) at 

11. Notably, the medical treatment Petitioner did obtain in this gap period says nothing about any

such injury (despite the fact that clearly she could have sought medical intervention in this MarchApril timeframe). Nevertheless, Ms. Patel informed Dr. Anderson that she had experienced several 

weeks of pain since the incident, along with more frequent headaches. Previously she reported 

suffering headaches in the occipital4area, but since the injury those headaches had shifted to the 

right temporal area. Id. At this visit she denied any vision problems, other facial sensitivity, or 

 

4

“Occipital” refers to the occiput or occipital bone located at the back of the skull near the base. Dorland’s Illustrated 

Medical Dictionary 1292 (33d ed. 2020) (hereinafter “Dorland’s”).
4

other medical problems. Id. A physical exam showed normal motor strength, reflexes, and 

sensitivity. Id. at 13. Petitioner was diagnosed with an unspecified TMJ disorder. Id. at 14.

On May 6, 2014, Ms. Patel finally had her previously-scheduled neurology consult with

Andrew Gorman, D.O., at Arizona Neurological Institute. Core Records, filed as Ex. 28 on May 

24, 2018 (ECF No. 38-1) (“Core”) at 29. She now reported a six-month history of dizziness, “a

characterized by a spinning sensation like [a] ‘drunk type feeling’” that could occur on standing 

or walking around. Id. Petitioner added that she felt her symptoms had begun within two to three 

weeks of her delivery of her daughter (which would have been prior to receipt of the flu vaccine)5, 

noting that she had taken supplements in this period for an iron deficiency. Id. Petitioner also 

reported a history of migraine headaches in the past, and relayed her reported February 2014 

accident with a falling shelf, stating that she had experienced headaches more frequently since 

then. Id. Episodes would occur a few times per month, but she could not identify any particular 

trigger. Id.

A physical exam proved largely normal. Petitioner’s cranial nerves showed normal visual 

fields and extraocular movements and corneal reflexes. Core at 30. She also displayed full (5/5) 

motor abilities and strength, her reflexes were 2/4 and symmetric with flexor plantar responses,

her sensory exam was intact to light touch, and her gait was normal with no shuffling. Id. Ms. Patel 

was assessed with vertigo, common migraine, abdominal pregnancy with intrauterine pregnancy, 

and unspecified head injury. Id. at 30. As a result, Dr. Gorman could propose no etiology for her 

symptoms Id. at 31. Instead, he favored a diagnosis of peripheral vestibulopathy but would need 

to rule out intracranial abnormality given the onset of symptoms after giving birth. Id. Basilar 

migraine events could also explain Petitioner’s symptoms. Id. Regarding Petitioner’s increasing 

headaches, he informed her that worsening headaches after head injury is known to occur. Id. A 

follow-up visit was requested in six weeks. Id.

Two weeks later, Petitioner returned to Dr. Anderson at Arizona Pain Institute on May 15, 

2014. Arizona Pain at 6. She again reported associated headaches in the right temporal side of her 

head, along with an inability to fully open her mouth. Id. However, she denied dizziness, 

numbness, tingling, and instability while walking. Id. at 7–9. On physical exam Petitioner had full 

strength, reflexes, and sensation—the only abnormalities noted were specific to her reported jaw 

injury. Id. at 8–9. 

C. Increasing Evidence of Peripheral Neuropathic Injury

On June 30, 2014, Petitioner returned to Abrazo Healthcare reporting the onset of a new 

and more recent kind of symptom - slight aches in both arms accompanied by muscle tenderness, 

beginning two weeks before. Abrazo Healthcare at 59–63. The aching was mild, aggravated by 

 

5 Petitioner delivered her daughter on September 22, 2013. This would put the onset of her dizziness around early 

October 2013—at least a month before her November 18, 2013 flu vaccination. 
5

lifting and carrying things; but was not associated with numbness, tingling, swelling, or redness. 

Id. at 60–61. A physical exam revealed “no tenderness to her forearms on palpation,” normal motor 

strength, and normal tone. Id. The treating nurse practitioner was unsure what might be causing 

Petitioner’s muscle pain and ordered several tests. Id. at 64.

A month later, on July 28, 2014, an MRI was taken of Petitioner’s head. Abrazo Healthcare 

at 81. The results were normal except for a mild Chiari-I malformation.6Id. The same day Ms. 

Patel visited Dr. O’Connor for muscle weakness and loss of feeling and numbness in her fingers. 

Id. at 57. Petitioner now specifically reported that “something is wrong with me.” Id. at 58 (internal 

quotations omitted). In particular, she claimed to have “difficulty with lifting things, different than 

6 months ago,” felt “heavy,” and could not “get through the day without a nap.” Id. A neurological 

exam revealed bilateral numbness in two or three fingers of both hands but was otherwise normal. 

Id.

Then, on August 12, 2014, Petitioner visited Dr. O’Connor again because of her 

progressively worsening symptoms. Abrazo Healthcare at 51. She felt that she was getting worse 

every day, had muscle twitching, and decreased strength. Id. at 52. Additionally, Petitioner noted 

she was fatigued, had shortness of breath, was lightheaded, and had abdominal pain and appetite 

changes. Id. Dr. O’Connor assessed Petitioner with fatigue, ordered labs and specialist referrals, 

but did not opine on what could be causing the fatigue. Id.

The next day, August 13, 2014, Petitioner was hospitalized at Scottsdale Healthcare at 

Thompson Peak for fatigue, weakness, and numbness in her extremities. Scottsdale Healthcare 

Records, filed as Ex. 9 on Oct. 17, 2016 (ECF No. 7-10) (“Scottsdale Healthcare”) at 26. Triage 

notes taken on intake stated that Ms. Patel had noticed her symptoms began six weeks before, or 

the end of June 2014 at the earliest, starting bilaterally in her upper extremities and then 

progressing to her biceps and thighs.

7

Id. at 25–26. Petitioner could no longer open containers, 

hold her child, or ambulate normally. Id. at 26–27. Petitioner also reported that she had ocular 

weakness with fuzzy vision that occurred with an intermittent headache. Id. A physical exam noted 

that Petitioner had an abnormal gait, decreased tone and weakness in the upper and lower 

extremities, abnormal deep tendon reflexes, and no abnormalities on inspection of the eyes. Id. at 

27.

At the same visit, the attending physician’s notes recorded a similar onset and problems. 

Scottsdale Healthcare at 28. Petitioner reported “weakness that has been going on for a number of 

 

6 This refers to a “prolapse of the cerebellar tonsils into the spinal canal without elongation of the brainstem; it is often 

asymptomatic.” Chiari I Malforamtion, Dorland’s Medical Dictionary Online, 

https://www.dorlandsonline.com/dorland/definition?id=119469 (last visited April 16, 2020) (“Dorland’s Online”).

7 The same note also records that “10.5 months ago pt gave birth and had large blood loss.” Scottsdale Healthcare at 

25. This indicates that, at this visit, Petitioner was considering her health history from at least 10 months ago—around 

October 2013. 
6

months, however, has worsened in recent weeks.” Id. Petitioner also reported “weakness and 

tingling of her extremities that progressed over the past 6 weeks.” Id. The attending doctor also 

took note that Petitioner “gave birth 11 months ago” and lost a significant amount of blood. Id.

Petitioner had a neurology consultation on August 14, 2014, at which time she repeated 

her prior assertions about onset and also recounted her history of headaches. Scottsdale Healthcare

at 37. The consulting physician, Jeffery Becker, D.O., also noted that Petitioner had a mild Chiari 

malformation type I. Id. Petitioner denied any previous history of neurological symptoms, or 

“episodic symptoms such as visual loss, double vision, numbness, tingling, weakness, [or] 

clumsiness.” Id. Her father was present at Petitioner’s bedside and affirmed there was no previous

history or family history of any neurologic disorders.” Id.

At the same consultation Dr. Becker performed a neurologic examination on Petitioner. 

Scottsdale Healthcare at 38. He examined Petitioner’s cranial nerves II–XII and no abnormalities 

were noted. Id. Funduscopic8exam revealed no hemorrhages or papilledema. Id. Exam also 

showed normal facial sensation, visual fields, and no facial weakness, although it reflected the 

weakness and numbness that Petitioner reported. See id. Dr. Becker thus proposed that Petitioner 

likely had Guillain-Barré syndrome (“GBS”), and noted that plasma exchange or IVIG could both 

treat her condition. Id. A lumbar puncture performed the next day showed high cerebrospinal fluid

(“CSF”) protein count. See id. at 182, 188. Over the next several days Petitioner received plasma 

exchange therapy to treat her symptoms. Scottsdale Healthcare at 13, 40–41, 441. Eventually she 

recovered enough to be discharged on August 23, 2014. Id. at 13. The discharge summary report 

stated that Petitioner “began having dizziness and headaches approximately eight weeks ago.” Id.

at 13. Her discharge diagnoses were GBS, weakness, and hypothyroidism. Id.

D. Subsequent Treatment and Proposal of CIDP Diagnosis

After a brief recovery, Petitioner’s symptoms returned in September 2014. On September 

16, 2014, Petitioner again visited Dr. Gorman at Arizona Neurologic Institute. Core at 16.

Petitioner reported that her “symptoms began in [M]ay [and became] progressively worse.” Id.

She had recovered since receiving plasma exchange but recently began to decline again with 

increasing weakness, more sensory symptoms, and some blurred vision. Id. Dr. Gorman noted 

Petitioner’s lumbar puncture and presumptive GBS diagnosis, and ordered labs to assess how to 

treat her relapsing symptoms. Id. at 18.

On September 20, 2014, Petitioner was hospitalized again at Scottsdale Healthcare at 

Thompson Peak when her symptoms of dizziness, lightheadedness, worsening peripheral vision,

and proximal muscle weakness returned. Scottsdale Healthcare Records II, filed as Ex. 55 on Oct. 

 

8 This refers to the examination of the interior of the eye with the ophthalmoscope—an instrument containing a 

perforated mirror and lenses used to examine the interior of the eye. Ophthalmoscope, Dorland’s Online, 

https://www.dorlandsonline.com/dorland/definition?id=35274 (last visited April 16, 2020) (“called also 

funduscope”).
7

8, 2018 (ECF No. 59-1) (“Scottsdale Healthcare II”) at 2, 6–7. The history from this hospitalization 

notes that “[t]here was no obvious precipitating infectious illness,” and [p]rior to her symptoms 

starting in June [2014] she had never had anything like this before.” Id. at 6–7. Throughout her 

September hospitalization Petitioner had several consultations with specialists—one of whom 

recorded that Petitioner’s recurrence was odd for GBS, and proposed consideration of other 

diagnoses, including CIDP. Scottsdale Healthcare II at 26. And an infectious disease consult 

identified no other possible antecedent illnesses. Id. at 20. At most, Ms. Patel reported “an illness 

that began [December 2013] which was characterized by dizziness and 10–12 episodes between 

December [and] March of this year which prompted a neurologic work-up and MRI,” but no 

diagnosis was made, and the symptoms went away “spontaneously and did return on this 

admission, not so much on the recent admission of August.” Id. Petitioner received another round 

of plasma exchange treatment and was eventually well enough to be discharged on September 29, 

2014. Scottsdale Healthcare II at 2. 

On October 13, 2014, Petitioner visited Dr. Gorman again. Ex. 5, filed on Oct. 17, 2016 

(ECF No. 7-6), at 5. She now presented with numbness in her limbs and extremities which 

improved with plasma exchange treatment (plasmapheresis)—although she had started to feel 

weaker in the last few days. Id. at 5. Dr. Gorman discussed the possibility of CIDP, opining that 

Petitioner’s overall course made GBS unlikely. Id. Petitioner returned to Arizona Neurology 

Associates on October 20, 2014. Ex. 5 at 8. At this visit, the history section states Petitioner was 

“symptomatic since December 2013 when she started to have dizzy spells.” Id. Lab results 

obtained later that month were now consistent with a demyelinating neuropathy. Id. at 16–17.

From October 27 to November 1, 2014, Petitioner’s symptoms recurred and she was 

hospitalized again. Dignity Health Records, filed as Ex. 13 on Oct. 17, 2016 (ECF No. 8-5) 

(“Dignity Health”), at 114. Her history now reported both onset of headaches in December 2013, 

with different kind of neurologic symptoms (characterized by fingertip numbness) presenting in 

June 2014, with more severe symptoms plus fatigue and weakness after that. Id. at 116, 128; see 

also id. at 131–32, 177. In this time period, she obtained an EMG9from Erik Ortega, M.D. Barrow 

Neurological Institute Records, filed as Ex. 12 on Oct. 17, 2016 (ECF No. 8-4) (“Barrow 

Neurological Institute”) at 57. Notes from this visit state that Petitioner presented with “a history 

of an evolving sensorimotor symptoms that began in June of this year.” Id. Based on his 

interpretation of EMG labs and other tests, Dr. Ortega expressed the view that Petitioner likely had 

CIDP. See id.

 

9 Electromyography, or EMG, is “an electrodiagnostic technique for recording the extracellular activity (action 

potentials and evoked potentials) of skeletal muscles at rest, during voluntary contractions, and during electrical 

stimulation; performed using any of a variety of surface electrodes, needle electrodes, and devices for amplifying, 

transmitting, and recording the signals.” Electromyography, Dorland’s Online, 

https://www.dorlandsonline.com/dorland/definition?id=15854&searchterm=electromyography (last visited April 16, 

2020).
8

Around the same time, treaters proposed other possible explanations for some of 

Petitioner’s symptoms, some of which were thought to reflect pregnancy complications. Thus, she 

was evaluated for Sheehan syndrome,

10 reporting in connection therewith her pregnancyassociated blood loss the prior year. Dignity Health at 122. Since that time, Petitioner had

experienced trouble nursing her child and instances of “intermittent positional 

dizziness/lightheadedness accompanied by nausea without vomiting.” Id. In addition, two weeks 

before her hospitalization she had seen an endocrinologist and “reportedly failed ACTH stim 

testing for these symptoms, and was placed on hydrocortisone and fludrocortisone.”11 Id. The 

consulting physician diagnosed Petitioner with Sheehan’s syndrome with possible 

panhypopituitarism, in addition to her CIDP diagnosis. Id. at 112. 

On November 8, 2014, Ms. Patel had a consultation visit for her CIPD. Dignity Health at 

729. The history section of the records from this visit mostly place her presentation of neurologic 

symptoms as having begun June 2014. Id.; see also id. at 731, 1216 (onset of symptoms in June 

2014); id. at 739, 748, 754, 758, 770 (noting that CIPD symptoms began June 2014—note in 

“impression and plan” section). Some, however, placed onset far earlier, at the start of the time

Petitioner reported experiencing headaches. Id. at 1143 (reporting in the HPI section that 

Petitioner’s “lightheadedness and numbness in the extremities began in 12/2013”). A neurological 

consultation at Barrow Neurological Associates from February 2015 took the onset issue a step 

further, placing it as not long after giving birth in September 2013, with Petitioner’s symptoms 

progressing to headaches, then numbness and tingling of her fingers in 2014, although the “onset 

of problem” section stated that the problem started in June 2014. Id.

Petitioner’s CIDP diagnosis does not appear since then to have been revised or reexamined, 

and she has responded well to IVIG treatment. Ex. 4, filed on Oct. 17, 2016 (ECF No. 7-5), at 4. 

 

10 Sheehan syndrome references “hypopituitarism developing postpartum as a result of pituitary necrosis; caused by 

ischemia due to a hypotensive episode during delivery.” Sheehan syndrome, Steadman’s Medical Dictionary, 

https://1 next.westlaw.com/Document/Idbaf520070ec11e4b9b9ea2bcc83d096/View/FullText.html?navigationPath=

Search%2Fv1%2Fresults%2Fnavigation%2Fi0ad7401100000171849387d2fc862dd8%3FNav%3DANALYTICAL

%26fragmentIdentifier%3DIdbaf520070ec11e4b9b9ea2bcc83d096%26parentRank%3D0%26startIndex%3D1%26c

ontextData%3D%2528sc.Search%2529%26transitionType%3DSearchItem&listSource=Search&listPageSource=1a

e87afcbc757f4945c0142eb8551482&list=ANALYTICAL&rank=3&sessionScopeId=f9cfd325ef76ed70d8f254fc76

de9b1716fea7ad6bacf315daa9e166f52edb88&originationContext=Search%20Result&transitionType=SearchItem&

contextData=%28sc.Search%29, (last visited on April 16, 2020) (available on Westlaw).

11 The ACTH stimulation test is used to diagnose adrenal insufficiency, a condition known as Addison's disease. It is 

also used to determine if the pituitary gland is not working properly due to hypopituitarism. Deficient cortisol could 

alternately be a cause of secondary adrenal insufficiency. See ACTH Stimulation Test, Dorland’s Online, 

https://www.dorlandsonline.com/dorland/definition?id=112396&searchterm=ACTH%20stimulation%20test (last 

visited on April 22, 2020). 
9

II. Expert Reports and Other Evidence

A. Petitioner’s Expert – Dr. Laura Boylan

Dr. Boylan, a neurologist, submitted two expert reports on behalf of Petitioner. Boylan 

Rep., filed on June 11, 2018 as Ex. 31 (ECF No. 44-1); Boylan Supp. Rep., filed on February 7, 

2019 as Ex. 63 (ECF No. 70-1). Dr. Boylan opines that (1) Petitioner’s November 2013 vaccination

caused her CIDP; and (2) Petitioner’s initial symptoms of CIDP emerged in December 2013, which 

is in a medically acceptable timeframe measured from vaccination one month prior. Boylan Rep.

at 20. 

Dr. Boylan earned a B.A. in political science at Barnard College, Columbia University. 

Boylan CV at 1, filed on June 4, 2018 as Ex. 29 (ECF No. 42-1). She took pre-medical courses at

City College of New York from 1988 to 1989. Id. Then she earned her M.D. at Columbia 

University in 1994. Id. After graduating medical school she interned at St. Vincent’s Hospital in 

New York City from 1994 to 1995. Id. at 2. From 1995 to 1998 she was a neurology resident at 

The Neurological Institute, Columbia-Presbyterian Medical Center (“the Neurological Institute”) 

in New York City. Id. Following her residency, from 1998 to 2000, she completed a post-doctoral 

clinical research fellowship at the Neurological Institute. Id. From 1998 to 2000 Dr. Boylan 

completed a post-doctoral clinical research fellowship in affective disorders at New York State 

Psychiatric Institute. Id.

Dr. Boylan is board certified in neurology and is licensed to practice medicine in New York 

and Minnesota. Boylan CV at 1. She is currently an attending neurologist at Bellevue Hospital 

Center, New York City. Id. She also serves as an adjunct professor of neurology at New York 

University School of Medicine. Id. at 2. Dr. Boylan has diagnosed and treated dozens of cases of 

CIDP in her career. Boylan Rep. at 2. Although she has written and published on several medical 

topics no of them appear to be related to a demyelinating disease. See generally Boylan CV.

First Report

Dr. Boylan’s first report addresses (a) what a medically acceptable time frame is for initial 

onset of vaccine mediated CIDP; (b) how Petitioner’s December 2013 symptoms (headache, 

lightheadedness, and fatigue) were her first manifestations of CIPD; (c) whether vaccines can 

cause CIDP; and (d) why Petitioner’s other medical conditions cannot explain her December 2013

symptoms. See generally Boylan Rep. Because this Decision turns on the onset of Petitioner’s 

CIPD symptoms and whether those symptoms occurred in a medically acceptable timeframe, I 

will only discuss portions of Dr. Boylan’s reports that address this specific question - although I 

have considered all of her reports and associated literature. 

Dr. Boylan opines that “[p]ost-vaccine and post-infectious syndromes are considered to 

typically occur following a variable period of delay within 6 weeks following exposure.” Boylan 

Rep. at 3. Later, she states that “in Ms. Patel’s case I do think her initial symptoms of CIDP fell 
10

within the traditional onset of post vaccine demyelinating polyneuropathy but her course was not 

typical.” Id. at 14. She explains that CIDP has a variable course that can present with non-motor, 

non-specific symptoms. Boylan Rep. at 14–15. This can make its true onset difficult to diagnose. 

Id.

To support the contention that CIDP could manifest it non-obvious ways, Dr. Boylan

referenced a study in which 47 of 87 participants (54 percent) displayed distinct symptomatic 

features outside the typical clinical presentation of CIDP. Boylan Rep. at 14–15 (citing F. Rotta et 

al., The Spectrum of Chronic Inflammatory Demyelinating Polyneuropathy, 173 J. Neurol. Sci.

129–139 (2000), filed on Aug. 8, 2018 as Ex. 43 (ECF No. 49-2) (“Rotta”)). Four of the Rotta 

study participants (5 percent) displayed “predominant cranial nerve involvement.” Id. (citing Rotta 

at 136). In particular, “[c]ranial nerves (CNs) III, IV, and VI were affected in three patients, CN 

VII in two, and CNs IX, X, and XI in one patient each.”12 Rotta at 136. The patients also displayed 

some degree of limb weakness and one had decreased sensation in the limbs. See id. at 136–37. In 

making such points, Dr. Boylan underscored her view that the diagnosis of CIDP is “notoriously 

difficult” and that the medical/scientific understanding of the spectrum of demyelinating diseases 

is continuously changing as more understood about the disease process. Boylan Rep. at 15. 

 

12 The cranial nerves control various functions:

I. Sense of smell. See nervus olfactorius, Dorland’s Online, 

https://www.dorlandsonline.com/dorland/definition?id=92354.

II. Vision. See nervus opticus, Dorland’s Online, 

https://www.dorlandsonline.com/dorland/definition?id=92356.

III. Pupillary constriction, opening eyes, some extraocular movements. See nervus oculomotorius, 

Dorland’s Online, https://www.dorlandsonline.com/dorland/definition?id=92353.

IV. Downward, inward movement of eye. See nervus trochleasris, Dorland’s Online, 

https://www.dorlandsonline.com/dorland/definition?id=92429. 

V. Motor - temporal and masseter muscles (jaw clenching), lateral movement of jaw 

Sensory - Three divisions: (1) ophthalmic, (2) maxillary, (3) mandibular. See nervus trigeminus, 

Dorland’s Online, https://www.dorlandsonline.com/dorland/definition?id=92428.

VI. Lateral deviation of eye. See nervus abducens, Dorland’s Online, 

https://www.dorlandsonline.com/dorland/definition?id=92220.

VII. Motor - facial movements (facial expression, closing eye, closing mouth). See nervus facialis, 

Dorland’s Online, https://www.dorlandsonline.com/dorland/definition?id=92293.

VIII. Hearing (cochlear division) and balance (vestibular division). See nervus vestibulocochlearis, 

Dorland’s Online, https://www.dorlandsonline.com/dorland/definition?id=92439.

IX. Motor – pharynx. 

Sensory - posterior portions of eardrum and ear canal, pharynx, and posterior tongue, including 

taste (salty, sweet, sour, bitter). See nervus glossopharyngeus, Dorland’s Online, 

https://www.dorlandsonline.com/dorland/definition?id=92300.

X. Motor - palate, pharynx, and larynx 

Sensory - pharynx and larynx See nervus vagus, Dorland’s Online, 

https://www.dorlandsonline.com/dorland/definition?id=92435.

XI. Motor - the sternomastoid and upper portion of trapezius. See nervus accessories, Dorland’s 

Online, https://www.dorlandsonline.com/dorland/definition?id=92221.

XII. Motor – tongue. See nervus hypoglossus, Dorland’s Online, 

https://www.dorlandsonline.com/dorland/definition?id=92304. 
11

Next, Dr. Boylan opined that Petitioner’s headaches and visual problems “may have been 

directly due to problems with spinal fluid pressure caused by CIDP.” Boylan Rep. at 15. However, 

Dr. Boylan was only “able to identify two case reports of CIDP presenting with headache.” Id.

(referencing A. Altinkaya et al., Chronic Inflammatory Demyelinating Polyradiculoneuropathy 

Associated Intercranial Hypertension, 34 J. Neurol. Sci. 1027–29 (2013), filed on Aug. 8, 2018 as 

Ex. 32 (ECF No. 48-1) (“Altinkaya”); K. Morrison & P. Davies, Chronic Inflammatory 

Demyelinating Polyneuropathy Presenting with Headache and Papilledema, 39 Headache 299–

300 (1999), filed on Aug. 8, 2018 as Ex. 41 (ECF No. 48-10) (“Morrison”)). Each of these case 

reports involved a man in his mid-50s suffering from headaches, vision problems, and CIDP, and 

each acknowledged that the additional symptoms rarely were present with CIPD. See generally

Altinkaya; Morrison. In addition, both patients had papilledema13 and a high opening pressure 

when taking a lumbar puncture, and experienced improvement in their headaches when treated 

with cortisone or prednisone. Altinkaya at 1028; Morrison at 299–300. 

Dr. Boylan claims that the headaches and visual problems experienced by the subjects of 

these two case reports were comparable to what Petitioner experienced. Boylan Rep. at 15. Thus, 

in her view Petitioner’s headaches were likely attributable to abnormal CSF pressure or flow. Id.

at 15–16. Dr. Boylan did not see formal testing of visual fields in the records, however, and noted 

that testing of Petitioner’s intracranial pressure was not performed—which can be done in 

connection with a lumbar puncture. Id. In the absence of CSF pressure testing evidence, she 

speculated that: (i) Petitioner had findings of enhancement of spinal roots that is sometimes seen 

in CIDP; (ii) enhancement of spinal roots can cause an abnormal or decreased CSF flow; (iii) 

abnormal CSF flow can sometimes be mistaken for Chiari I malformations; (iv) Petitioner’s MRI 

had been interpreted as “consistent with” a Chiari I malformation; (v) the words “consistent with” 

means there are other things that could cause the same images; and (vi) therefore Petitioner likely

had abnormal CSF pressure which caused her headaches. See id. at 15–16.

Dr. Boylan did not claim to have viewed the MRI images of Petitioner’s Chari 

malformation, such that she could conclude that a mistaken diagnosis was made. See Boylan Rep. 

at 4–5, 16. In the record, only the notes and impressions of the images are available, rather than 

the images themselves. See generally Simon Med. Imaging, filed as Ex. 16 on Feb. 3, 2017 (ECF 

No. 11-3) (showing only notes and impressions of MRI images); see also id. at 5 (MRI imaging 

taken July 28, 2014, and noting mild Chiari I malformation). Dr. Boylan instead suggests that the 

doctor interpreting the images likely did not find abnormal CSF flow because he did not know of 

any abnormalities in the spinal roots when the images were taken. Boylan Rep. at 16.

Finally, Dr. Boylan concluded her first report by opining that “[i]internal inconsistency of 

records is the rule not the exception.” Boylan Rep. at 18. In this regard, she speculated from review 

 

13 Papilledema is “edema of the optic disk (papilla), most commonly due to increased intracranial pressure, malignant 

hypertension, or thrombosis of the central retinal vein.” Dorland’s Online, 

https://www.dorlandsonline.com/dorland/definition?id=36673&searchterm=papilledema (April 17, 2020).
12

of certain records of an August 2014 treatment visit that a medical student with the initials “AA” 

might have mischaracterized Petitioner’s symptoms. Id. (citing Scottsdale Healthcare at 67) (“AA 

found no weakness on Ms. Patel’s examination while other doctors were able to identify it.”). Ms. 

Patel’s primary treaters, however, were ultimately able to identify weakness on examination, and 

that “[n]eurologists are better at the exam and detailed neuromuscular exams are typically more 

sophisticated when done by neuromuscular specialists.” Id. Then, in the next paragraph of her 

report, Dr. Boylan discussed how Dr. Gorman—a neurologist—also likely missed or 

mischaracterized Petitioner’s symptoms. Id. at 18–19. She overall expressed the view that treaters 

had likely failed to recognize the full nature of Ms. Patel’s presentation as early as February 2014. 

Id. at 19.

Supplemental Report

Dr. Boylan’s supplemental report attempts to buttress her opinion that Petitioner’s 

December 2013 marked the onset of her CIDP, and in so doing ventures to explain why there is 

little record evidence of the typical CIDP symptoms before June 2014. Boylan Supp. Rep. at 1–2. 

Dr. Boylan acknowledged in her supplemental report that Petitioner’s December 2013 

symptoms (“severe fatigue, headache dizziness and chest pain”)

14 were non-specific, and thus 

could not be attributed at first glance to any particular disease or illness, and only appeared to be 

clinical indicia of CIDP on hindsight. Boylan Supp. Rep. at 2, 3. Here, such hindsight allows these 

symptoms to be understood as reflecting problems in the autonomic nervous system—and thus

characteristic of GBS, a peripheral neuropathy comparable to CIDP. Boylan Supp. Rep. at 2 (citing 

Z. Zaeem et al., Autonomic Involvement in Guillain–Barré Syndrome, Clinical Autonomic 

Research (2018), filed on May 8, 2019 as Ex. 65 (ECF No. 77-2) (“Zaeem”).

Zaeem discusses evidence of autonomic dysfunction in GBS—specifically, “blood 

pressure fluctuations, arrhythmias, vasomotor dysfunction, and gastrointestinal (GI) motility 

dysregulation.” Zaeem at 1. Zaeem concludes that autonomic dysregulation may precede the 

occurrence of neurological deficits in GBS, and that early diagnosis could hasten treatment, but it 

does not apply its findings to CIDP. Zaeem at 9. Dr. Boylan otherwise did not explain how these 

various kinds of autonomic-related symptoms generally capture what Ms. Patel was experiencing 

as early as December 2013 (which the record reveals was mainly persistent headaches). Boylan 

Supp. Rep. at 1–2.

In order to address this issue, Dr. Boylan next opined that “fatigue may be the primary,

initial presenting symptom of CIDP.” Boylan Supp. Rep. at 2 (citing S. Boukhris et al., Fatigue as 

the main Presenting Symptom of Chronic Inflammatory Demyelinating Polyradiculoneuropathy: 

A Study of 11 Cases, 10 J. Periph. Nerv. Syst. 329–37 (2006), filed on May 8, 2019 as Ex. 66 (ECF 

 

14 Dr. Boylan repeatedly states that Petitioner suffered from chest pain in addition to her other non-specific symptoms. 

See Boylan Rep. at 5; Boylan Supp. Rep. at 2. It is unclear where chest pain appears in the record, especially as one 

of Petitioner’s early symptoms. Chest pain is not mentioned in Petitioner’s affidavit or her VAERS report.
13

No. 77-3) (“Boukhris”). Boukhris studied eleven patients presenting with fatigue and some sensory 

deficits but no weakness. Boukhris at 2. Patients in this study were selected from a pool of 60 

people diagnosed with CIPD. Id. However, none of the studied patients also presented with

headaches or dizziness, as the record shows Ms. Patel first experienced, and only one reported

anything that arguably might cause such symptoms secondarily, like eye problems such as 

nystagmus.

15 Id. at 3.

Dr. Boylan’s supplemental report also included a significant qualification limiting her 

opinion. Thus, she specifically admitted that “in the absence of further information and accepting 

the premise of no relevant symptoms prior to June or July 2014 the level of medical certainty 

regarding attribution of Ms. Patel’s CIDP to her November 18th, 2013 influenza vaccination would 

be low.” Boylan Supp. Rep. at 2 (emphasis added).

B. Respondent’s Expert – Dr. Vinay Chaudhry

Dr. Chaudhry—like Dr. Boylan a neurologist—submitted two expert reports on behalf of 

Petitioner. Chaudhry Rep., filed on Nov. 16, 2018 as Ex. A (ECF No. 68-1); Chaudhry Supp. Rep., 

filed on June 17, 2019 as Ex. C (ECF No. 81-1). Dr. Chaudhry agrees that Petitioner has CIPD,

but maintains that her November 2013 flu vaccine did not cause her CIDP, which began in June 

or July 2014, and therefore not in a medically acceptable timeframe. Chaudhry Rep. at 12–13.

Dr. Chaudhry completed his undergraduate education at Delhi University in India. 

Chaudhry CV at 1, filed on November 16, 2018 as Ex. B (ECF No. 68-2). He then earned his 

bachelor of medicine and bachelor of surgery at All India Institute of Medical Sciences in New 

Delhi, India. Id. In 2009 he earned his MBA (business of medicine) at John’s Hopkins University. 

Id. After his formal education, from 1980 to 1981, he completed an internship and residency (in 

pediatric surgery) in India. Id. at 2. From 1982 through 1983 he was a house officer and senior 

house officer in internal medicine at hospitals in the United Kingdom. Id. From 1984 to 1987 he 

served as a neurology resident at the University of Tennessee Center for Health Sciences, and later 

the University of Alabama at Birmingham School of Medicine. Id. In 1987 he was the neurology 

chief resident at the University of Alabama at Birmingham School of Medicine. Id. After his 

residency he served as a clinical fellow, and later a clinical and research fellow, in the neurology 

department at Johns Hopkins University School of Medicine. Id.

Presently, Dr. Chaudhry is a neurology professor at Johns Hopkins University School of 

Medicine. Chaudhry CV at 2–3. He is licensed to practice medicine in Maryland and is board 

certified in Neurology, Neuromuscular diseases, Electrodiagnostic Medicine (Nerve Conduction 

and EMG), and Clinical Neurophysiology. Id. at 28–29. He serves as a reviewer and on the 

editorial boards of several medical journals and neurology publications. See id. He has also 

 

15 Nystagmus is “an involuntary, rapid, rhythmic movement of the eyeball, which may be horizontal, vertical, rotatory, 

or mixed.” Dorland’s Online, https://www.dorlandsonline.com/dorland/definition?id=34565 (last visited April 20, 

2020).
14

published several pieces on CIPD and peripheral neuropathies. In his clinical practice he sees 

“close to 2000 patients a year (for over 25 years) mostly related to peripheral nerve disease.” 

Chaudhry Rep. at 1. 

First Report

In his initial report, Dr. Chaudhry agreed with Dr. Boylan that Petitioner has CIDP and that 

a medically acceptable onset for “post-vaccine and post-infectious syndromes” like it would be six 

weeks. Chaudhry Rep. at 13 (internal quotations omitted). But (in addition to his view that CIDP 

is not likely vaccine-caused), he maintained that the record only supports the conclusion that Ms. 

Patel’s CIDP began more than six weeks post-vaccination—after June 2014, with fatigue or other 

nonspecific symptoms beginning before vaccination, right after the birth of her daughter in 

September 2013. See Chaudhry Rep. at 13–18. In support, he referenced a plethora of records

which place the onset of Petitioner’s acute CIDP symptoms (tingling and sensorimotor symptoms) 

in June or July 2014. See, e.g., id. at 16–17. By contrast, several records identify the start of

Petitioner’s non-specific symptoms (lightheadedness, fatigue, dizziness) in October 2013, albeit

inconsistently, as she did not report them in early 2014 at all when she first began seeking medical 

treatment after her return to the United States. See, e.g., id. at 14–15.

Dr. Chaudhry also disagreed that Petitioner’s headaches were, or could be, a presenting 

symptom of CIDP. See Chaudhry Rep. at 16. First, he questioned Dr. Boylan’s reliance on

Altinkaya and Morrison, since these case reports each documented evidence of intracranial 

hypertension, high opening CSF, and papilledema—features not found in Petitioner. See id. He 

also noted a “MRI cine flow study showed no signs of increased intraventricular pressure,”

although this finding was made in 2015 and thus long after the alleged onset periods. Id. (citing 

Simon Med. Imaging at 3). Next, Dr. Chaudhry disagreed with Dr. Boylan’s assessment that 

Petitioner had abnormal CSF flow as an explanation for her headaches. Id. (characterizing Dr. 

Boylan’s assessment as “unilateral” and “without any evidence”). Dr. Chaudhry also emphasized

that CIDP and GBS, although similar, are distinct diseases with different courses and recognized 

causes, and thus literature on one condition does not automatically apply to the other. Id. at 13–

14.

Supplemental Report

Dr. Chaudhry also submitted a supplemental report to address Dr. Boylan’s supplemental 

report, associated medical literature, and new medical records. Chaudhry Supp. Rep. at 1 

(addressing Exs. 60–66). He reiterated therein that the records show Petitioner’s symptoms started 

acutely in June 2014, and that many of her non-specific symptoms started before her vaccination 

or have alterative explanations. Id. at 3–4. 

In this additional report, Dr. Chaudhry specifically analyzed some of the new medical 

literature referenced in Dr. Boylan’s Supplemental Report. See, e.g., P. Zalewski et al., Autonomic 

Dysfunction and Chronic Disease, 128 British Medical Bulletin 61–74 (2018), filed on May 8, 
15

2019 as Ex. 64 (ECF No. 77-1) (“Zalewski”). Zalewski, he notes, is a broad review of various 

autonomic dysfunctions16 that does not mention CIDP. Chaudhry Supp. Rep. at 2. He also critiqued

Zaeem. While Dr. Chaudhry agreed that autonomic dysfunction occurs in two thirds of GBS 

patients, as Zaeem observes, Petitioner did not have GBS—and indeed the symptoms that 

prompted any treater to consider the possibility that she might have GBS or some other form of 

peripheral neuropathy did not present until June 2014, rather than “months prior” as Petitioner 

argues. Chaudhry Supp. Rep. at 2. He also distinguished Boukhris, noting that the eleven studied 

patients therein presented with fatigue rather than weakness, and were thus not comparable to 

Petitioner, who “presented with acute onset of weakness, areflexia, and high spinal fluid protein, 

all beginning in June 2014 and requiring plasma exchange treatment.” Id. And in his experience, 

when fatigue is observed in conjunction with CIDP, it is consistently present, and does not wax 

and wane (despite the overall relapsing/remitting character of CIDP). Id.

C. Other Proof

In addition to Dr. Boylan’s reports and the associated medical literature, Ms. Patel filed 

two additional items of evidence. Exhibit 19, filed in March 2018, is a VAERS17 report concerning 

Petitioner and this case. The VAERS report was completed on August 8, 2016, however—after 

the filing of this lawsuit—and thus its already diminished evidentiary value as probative of 

causation is lessened even more. 

Petitioner has also filed a letter opinion from Dr. Ortega, the treater whose EMG study 

helped confirm the CIDP diagnosis. Ortega Letter, dated April 18, 2018, filed as Ex. 25 (ECF No. 

34-1). This four-sentence letter states in conclusory fashion that Petitioner’s CIDP developed in 

December 2013 following her flu vaccination the preceding November. Id. Dr. Ortega concludes 

that “[i]t is reasonable to suspect that the flu vaccination was the precipitating factor for her CIDP.” 

Id. The basis for this opinion, however, is not elaborated upon, and is contradicted somewhat by 

certain record evidence involving contemporaneous opinions offered by Dr. Ortega. See, e.g.,

Dignity Health at 141 (Dr. Ortega observing on October 28, 2014, that there was no likely inciting 

event for Petitioner’s CIDP).

 

16 “[C]auses of autonomic dysfunction listed including multisystem atrophy, Parkinson’s disease, diabetes, familial 

dysautonomia, chronic fatigue syndrome, fibromyalgia, migraine, and irritable bowel syndrome. Other secondary 

causes due to diabetes, cardiovascular disease, multiple sclerosis, autoimmune diseases, endocrine disorders, renal 

failure, and spinal cord diseases are also noted.” Chaudhry Supp. Rep. at 2 (citing Zalewski).

17 VAERS stands for the “Vaccine Adverse Reporting System.” It is a “national early warning system to detect possible 

safety problems in U.S.-licensed vaccines. . . . VAERS accepts and analyzes reports of adverse events (possible side 

effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare 

professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse 

events that come to their attention.” About VAERS, HHS, https://vaers hhs.gov/about.html (last visited April 20, 

2020).
16

III. Procedural History

Ms. Patel filed her petition for compensation on July 19, 2016. Pet. at 1. Over the next 

several months medical records were slowly filed. By late 2017 it was unclear if Petitioner was 

going to file an expert report. See Order at 1, filed on December 12, 2017(ECF No. 23). Petitioner 

explained that she was having difficulty obtaining an expert, and if the case went forward then her 

counsel would withdraw. Id. Eventually, Petitioner decided to maintain her claim, and substituted 

in new counsel as well. Motion to Substitute Attorney, filed on Feb. 20, 2018 (ECF No. 26). 

Petitioner filed her expert report on June 11, 2018. Boylan Expert Rep. Over the next year 

both parties exchanged additional expert reports, filed associated literature, and filed additional 

medical records. See, e.g., Chaudhry Rep.; Boylan Supp. Rep.; Chaudhry Supp. Rep. On July 31, 

2019, Petitioner filed a motion for decision on the record. See Mot. For Ruling on Record (ECF 

No. 87) (“Brief”). Respondent filed a brief in response and Petitioner filed a reply brief. Response,

filed on Oct. 4, 2019 (ECF No. 90); Reply, filed on Oct. 24, 2019 (ECF No. 91). 

IV. Parties’ Respective Positions

The parties agree that post-vaccine/post-infectious syndromes can occur following a 

variable period of delay within six weeks of exposure. Brief at 28; Chaudry Rep. at 13. But they

disagree on when Petitioner’s first CIDP symptoms arose—and what constitutes CIDP symptoms 

in the first place. Petitioner argues that her symptoms began in December 2013, when she claims 

to have first experienced fatigue, dizziness, and headaches. See Brief at 22. Respondent counters 

that Petitioner’s December 2013 symptoms were not her first manifestations of CIDP, which only 

began in June 2014. Response at 12. Respondent also maintains that certain of Petitioner’s nonspecific symptoms predated vaccination. Response at 11–12.

V. Relevant Law

A. Petitioner’s Overall Burden in Vaccine Program Cases

To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that 

he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—

corresponding to one of the vaccinations in question within a statutorily prescribed period of time 

or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table 

Injury”). See Sections 11(c)(1), 13(a)(1)(A), 14(a); see also Moberly v. Sec’y of Health & Human 

Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440 

F.3d 1317, 1320 (Fed. Cir. 2006).18

 

18 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding 

authority. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings 
17

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance 

of the evidence” burden of proof. Section 13(a)(1)(a). 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, 592 F.3d at 1322 n.2; see also Snowbank Enters. v. United States, 6 Cl. Ct. 

476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard). 

Proof of medical certainty is not required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d 

867, 873 (Fed. Cir. 1991). In particular, a 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 & Human Servs., 165 F.3d 1344, 

1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. 

Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions; 

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

physician. Section 13(a)(1).

In attempting 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 & Human Services, 418 F.3d 1274, 1278 (Fed. Cir. 2005): 

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

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

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

Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners 

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 & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory 

must only be “legally probable, not medically or scientifically certain.” Id. at 549.

Petitioners may satisfy the first Althen prong without resort to medical literature, 

epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical 

theory. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378–79 (Fed. 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 essentially thorny scientific and medical 

questions, and thus 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 

 

concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121, 

124 (2003), aff’d 104 F. App’x 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13-

159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
18

evidence standard.” Id. at 1380. Accordingly, special masters must take care not to increase the 

burden placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v. 

Sec’y of Health & Human Servs., 121 Fed. Cl. 230, 245 (2015), vacated on other grounds, 844 

F.3d 1363 (Fed. Cir. 2017). 

In discussing the evidentiary standard applicable to the first Althen prong, the Federal 

Circuit has clarified that the correct standard for Althen prong one is a “reputable,” and “sound and 

reliable,” theory, not a “lower reasonable standard” See Boatmon v. Sec'y of Health & Human 

Servs., 941 F.3d 1351, 1359–60 (Fed. Cir. 2019) (internal quotations omitted); see also

Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1350 (Fed. Cir. 2010) (affirming 

special master’s determination that expert “had not provided a ‘reliable medical or scientific 

explanation’ sufficient to prove by a preponderance of the evidence a medical theory linking the 

[relevant vaccine to relevant injury].”) (emphasis added). Petitioners always have the ultimate 

burden of establishing their Vaccine Act claim overall with preponderant evidence. W.C. v. Sec’y 

of Health & Human Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted); Tarsell, 133 

Fed. Cl. at 793 (noting that Moberly “addresses the petitioner’s overall burden of proving 

causation-in-fact under the Vaccine Act” by a preponderance standard).

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; see also

Andreu, 569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Human 

Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the 

opinions and views of the injured party’s treating physicians are entitled to some weight. Andreu, 

569 F.3d at 1367; Capizzano, 440 F.3d at 1326 (“[M]edical records and medical opinion testimony 

are favored in vaccine cases, as treating physicians are likely to be in the best position to determine 

whether a ‘logical sequence of cause and effect show[s] that the vaccination was the reason for the 

injury.’” (quoting Althen, 418 F.3d at 1280)). Medical records are generally viewed as particularly 

trustworthy evidence for the “did cause” prong, since they are created contemporaneously with the 

treatment of the patient. Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. 

Cir. 1993).

Medical records and/or statements of a treating physician’s views, however, 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. Section 13(b)(1) (providing that “[a]ny such diagnosis, 

conclusion, judgment, test result, report, or summary shall not be binding on the special master or 

court”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“[T]here 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 present in the record—including conflicting opinions 
19

among such individuals. Hibbard v. Sec’y of Health & Human Servs., 100 Fed. Cl. 742, 749 (2011) 

(finding that it is not arbitrary or capricious for special masters to weigh competing treating 

physicians’ conclusions against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y 

of Dept. of Health & Human Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. 

Apr. 29, 2011), mot. for review denied, 100 Fed. Cl. 344, 356 (2011), aff’d without op., 475 F. 

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 1281. That term has been equated to the 

phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant 

proof that the onset of symptoms occurred within a timeframe which, given the medical 

understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan 

v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for 

what is a medically acceptable timeframe must also coincide with the theory of how the relevant 

vaccine can cause an injury (Althen prong one’s requirement). Id.; see also Shapiro v. Sec’y of 

Health & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand, 105 Fed. Cl. 

353 (2012), aff’d mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Human 

Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review 

denied (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 determinations in Vaccine Program cases regarding factual issues 

begins with consideration of the medical records. Section 11(c)(2). The special master is required 

to consider “all [] relevant medical and scientific evidence contained in the record,” including “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,” as well as the “results of any diagnostic or evaluative test which are contained 

in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then 

required to weigh the evidence presented, including contemporaneous medical records and 

testimony. See Burns v. Sec’y of Health & Human 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 that are created contemporaneously with the events they describe are 

presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s 

health problems). Cucuras, 993 F.2d at 1528; see also Doe/70 v. Sec’y of Health & Human Servs., 

95 Fed. Cl. 598, 608 (2010) (“Given the inconsistencies between petitioner’s testimony and his 
20

contemporaneous medical records, the special master’s decision to rely on petitioner’s medical 

records was rational and consistent with applicable law”); Rickett v. Sec’y of Health & Human 

Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption is based 

on the linked propositions that (i) sick people visit medical professionals; (ii) sick people honestly 

report their health problems to those professionals; and (iii) medical professionals record what they 

are told or observe when examining their patients in as accurate a manner as possible, so that they 

are aware of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec’y of 

Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 

2013); Cucuras v. Sec’y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993 F.2d at 

1525 (Fed. Cir. 1993) (“[I]t strains reason to conclude that petitioners would fail to accurately 

report the onset of their daughter’s symptoms.”).

Accordingly, if the medical records are clear, consistent, and complete, then they should 

be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005 

WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical 

records are generally 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 & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam, 

968 F.2d 1226 (Fed. Cir. 1992), cert. denied sub. nom. Murphy v. Sullivan, 506 U.S. 974 (1992) 

(“It has generally been held that oral testimony which is in conflict with contemporaneous 

documents is entitled to little evidentiary weight.”) (citing United States v. United States Gypsum 

Co., 333 U.S. 364, 396 (1948)).

There are, however, 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 & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“[L]ike any norm based upon 

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

the factual predicates for its application are weak or lacking.”); Lowrie, 2005 WL 6117475, at *19 

(“Written records which are, themselves, inconsistent, should be accorded less deference than 

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

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

testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Human 

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

When witness testimony is offered to overcome the presumption of accuracy afforded to 

contemporaneous medical records, such testimony must be “consistent, clear, cogent, and 

compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Human 

Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In 

determining the accuracy and completeness of medical records, the Court of Federal Claims has 

listed four possible explanations for inconsistencies between contemporaneously created medical 
21

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. La Londe v. 

Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 203–04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 

2014). In making a determination regarding whether to afford greater weight to contemporaneous 

medical records or other evidence, such as testimony at hearing, there must be evidence that this 

decision was the result of a rational determination. Burns, 3 F.3d at 417.

C. Analysis of Expert Testimony

Establishing a sound and reliable medical theory often requires a petitioner to present 

expert testimony in support of his claim. Lampe v. Sec’y of Health & Human 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 & Human Servs., 617 F.3d 1328, 1339 

(Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Human 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 they do 

when applied in other federal judicial fora (such as the district courts). Daubert factors are usually 

employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence 

that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors 

are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health 

& Human Servs., 94 Fed. Cl. 53, 66–67 (2010) (“[U]niquely 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 the 

persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88 

Fed. Cl. at 742–45. 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 in order 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.” 
22

Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing 

Lampe, 219 F.3d at 1362). But 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. 146 (1997)); see also Isaac v. Sec’y of Health & Human 

Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for 

review denied, 108 Fed. Cl. 743 (2013), aff’d, 540 Fed. App’x 999 (Fed. Cir. 2013) (citing Cedillo, 

617 F.3d at 1339). 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. Moberly, 592 F.3d at 1325–26 

(“Assessments as to the reliability of expert testimony often turn on credibility determinations . . . 

.”); see also Porter v. Sec’y of Health & Human Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) 

(“[T]his 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

Both parties filed medical and scientific literature in this case, but not every filed item 

factors into the outcome of this decision. While I have reviewed all of the medical literature 

submitted in this case, I discuss only those articles that are most relevant to my determination 

and/or are central to Petitioner’s case—just as I have not exhaustively discussed every individual 

medical record filed. See Moriarty v. Sec’y of Health & Human Servs., 844 F.3d 1322, 1328 (Fed. 

Cir. 2016) (“We generally presume that a special master considered the relevant record evidence 

even though he does not explicitly reference such evidence in his decision.”) (citation omitted); 

see also Paterek v. Sec’y of Health & Human Servs., 527 F. App’x 875, 884 (Fed. Cir. 2013) 

(“Finding certain information not relevant does not lead to—and likely undermines—the 

conclusion that it was not considered”).

E. Ruling Without Hearing or Argument

I have opted to decide this case based on written submissions and evidentiary filings, and 

the parties have acceded to my determination. The Vaccine Act and Rules not only contemplate 

but encourage special masters to decide petitions (or components of a claim) on the papers rather 

than via evidentiary hearing, where (in the exercise of their discretion) they conclude that the 

former means of adjudication will properly and fairly resolve the case. Section 12(d)(2)(D); 

Vaccine Rule 8(d). The Federal Circuit has recently affirmed this practice. Kreizenbeck v. Sec’y of 

Health & Human Servs., 945 F.3d 1362, 1365–66 (Fed. Cir. 2020). 
23

F. Consideration of Comparable Special Master Decisions

In reaching a decision in this case, I have considered other decisions issued by special 

masters involving similar injuries, vaccines, or circumstances. I also reference some of those cases 

in this Decision, in an effort to establish common themes, as well as demonstrate how prior 

determinations impact my thinking on the present case.

There is no error in doing so. It is certainly correct that prior decision in different cases do 

not control the outcome herein.19 Boatmon v. Sec’y of Health & Human Servs., 941 F.3d 1351, 

1358-59 (Fed. Cir. 2019); Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). 

Thus, the fact that another special master reasonably determined elsewhere, on the basis of facts 

not in evidence in this case, that preponderant evidence supported the conclusion that vaccine X 

caused petitioner’s injury Y does not compel me to reach the same conclusion in this case. 

Different actions present different background medical histories, different experts, and different 

items of medical literature, and therefore can reasonably result in contrary determinations.

However, it is equally the case that special masters reasonably draw upon their experience 

in resolving Vaccine Act claims. Doe v. Sec’y of Health & Human Servs., 76 Fed. Cl. 328, 338–

39 (2007) (“[o]ne reason that proceedings are more expeditious in the hands of special masters is 

that the special masters have the expertise and experience to know the type of information that is 

most probative of a claim”) (emphasis added). They would be remiss in ignoring prior cases 

presenting similar theories or factual circumstances, along with the reasoning employed in 

reaching such decisions. This is especially so given that special masters not only routinely hear 

from the same experts in comparable cases, but are also repeatedly offered the same items of 

medical literature regarding certain common causation theories. It defies reason and logic to 

obligate special masters to “reinvent the wheel”, so to speak, in each new case before them, paying 

no heed at all to how their colleagues past and present have addressed similar causation theories 

or fact patterns. It is for this reason that prior decisions can have high persuasive value—and why 

special masters often explain how a new determination relates to such past decisions.20 Even if the 

Federal Circuit does not require special masters to distinguish other relevant cases (Boatmon, 941 

 

19 By contrast, Federal Circuit rulings concerning legal issues are binding on special masters. Guillory v. Sec’y of 

Health & Human Servs., 59 Fed. Cl. 121, 124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. 

Sec’y of Health & Human Servs., No. 13-159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).

Special masters are also bound within a specific case by determinations made by judges of the Court of Federal Claims 

after a motion for review is resolved.

20 Consideration of prior determinations is a two-way street that does not only inure to the benefit of one party. Thus, 

I would likely take into account the numerous decisions finding no association between vaccination and autism when 

confronted with a new claim asserting autism as an injury, and have informed such claimants early in the life of their 

case that the claim was not viable for just that reason. But I would also deem a non-Table claim asserting GBS after 

the flu vaccine as not requiring extensive proof on Althen prong one “can cause” matters, for the simple reason that 

the Program has repeatedly litigated the issue in favor of petitioners—and I have in fact done so in this very case.
24

F.3d at 1358), it is still wise to do so.

ANALYSIS

I. Petitioner has not Established that Her CIDP Began in a Medically Acceptable 

Timeframe

Although the parties disagree on Petitioner’s overall success at meeting the Althen test in 

this case, resolution of the matter primarily turns on the third prong—and thus requires me to 

determine onset of Petitioner’s first CIDP symptoms.21 The burden of establishing onset of a 

vaccine injury is subject to the same preponderant evidence test that the overall Althen test requires. 

See de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The third 

Althen prong requires establishing a “proximate temporal relationship” between the vaccination 

and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the phrase 

“medically-acceptable temporal relationship.” Id.

A. Brief Overview of CIDP

CIDP is a chronic disease that typically appears as “symmetrically, predominantly motor 

polyradiculoneuropathy, with weakness that was both proximal and distal, associated with 

hyporeflexia or areflexia, and a relapsing or chronic progressive course.” Rotta at 3; see also 

Chaudhry Rep. at 8. Indeed, this is consistent with how previous Program cases have characterized 

CIDP. See, e.g., Blackburn v. Sec’y of Health & Human Servs., 10-410V, 2015 WL 425935, at 

*22–23 (Fed. Cl. Spec. Mstr. Jan. 9, 2015) (discussing differences between CIDP and GBS). CIDP 

has a course of at least eight weeks, some patients experience a slowly progressive disease while 

others may experience a relapsing-remitting course. R. Lewis, Chronic Inflamatory Demylinating

Polyneuropathy: Etiology, Chinical Features, and Diagnosis, UpToDate Wolters Kluwer 4 (2017) 

(“Lewis”). GBS can also present with similar symptoms but is acute and monophasic. Compare

 

21 Because the onset issue is dispositive of this case, I do not include a detailed review of Petitioner’s success in 

meeting the other two prongs. I do acknowledge that CIDP has in other cases been found to be caused by a flu vaccine, 

although such cases typically involve a much shorter onset timeframe. Daily v. Sec’y of Health & Human Servs., No. 

07-173V, 2011 WL 2174535, at *9 (Fed. Cl. Spec. Mstr. May 11, 2011); Glassberg v. Sec’y of Health & Human 

Servs., No. 07-303V, 2009 WL 4641696, at *7 (Fed. Cl. Spec. Mstr. Nov. 23, 2009) (finding that CIDP onset within 

six weeks was a medically acceptable timeframe). In addition, even if Petitioner could show that CIDP could present 

with preliminary symptoms of headache, fatigue, and dizziness, she would still need to establish under the second 

Althen prong that did happen here. See Flores v. Sec'y of Health & Human Servs., 115 Fed.Cl. 157, 166–67, aff'd, 586 

F. App’x. 588 (Fed. Cir. 2014) (upholding special master’s determination that petitioner had not satisfied Althen prong 

two when petitioner’s theory relied on the occurrence of a blood clot that could not be established). But testing and 

exams of Petitioner did not establish any connection between these earlier symptoms and her later-diagnosed CIDP, 

while some treater analyses suggested alternative explanations for Petitioner’s symptoms (sequelae from pregnancy, 

iron deficiency, Sheehan’s syndrome, etc.) that are distinguishable from CIDP. And the treater support for an earlier 

onset (such as Dr. Ortega’s letter opinion) was not itself persuasive.
25

Zaeem at 1 (discussing GBS) with Lewis at 4 (discussing CIDP). Observing a patient over time 

can distinguish which kind of peripheral neuropathy they have. Boylan Rep. at 4.

In other cases, onset two weeks after vaccination has been deemed a medically acceptable

timeframe. Kelly v. Sec’y of Health & Human Servs., 68 Fed. Cl. 84, 102 (Fed. Cl. 2005), granting 

mot. for rev., No. 02-223V, 2005 WL 1125671 (Fed. Cl. Spec. Mstr. Mar. 17, 2005) (two weeks 

between tetanus toxoid vaccination and onset of CIDP); Daily v. Sec’y of Health & Human Servs.,

No. 07-173V, 2011 WL 2174535, at *9 (Fed. Cl. Spec. Mstr. May 11, 2011) (finding that two 

weeks was an acceptable timeframe between influenza vaccination and CIDP onset). However, 

onset several months after vaccination has been deemed not to satisfy the third Althen prong. 

Strong v. Sec’y of Health & Human Servs., No. 15-1108V, 2018 WL 1125666, at *21 (Fed. Cl. 

Spec. Mstr. Jan. 12, 2012) (Four months between flu vaccine and onset of CIDP was too long).

B. Petitioner’s Headaches and Other Non-Specific Symptoms Were 

Not Initial Manifestations of Her CIDP

In this case, Petitioner’s onset arguments rely on initial presenting symptoms that are 

uncommon to CIDP, but which she reports experiencing in late 2013 or early 2014 (and thus within 

a few weeks of her receipt of the flu vaccine in November 2013). But even if it is assumed she did 

experience these symptoms at the time alleged, she has not preponderantly established that they 

are likely manifestations of her subsequently-diagnosed CIDP.

First, as Dr. Boylan admitted, headaches are rarely associated with CIDP. See Boylan Rep. 

at 15 (“I was able to identify only two cases of CIDP presenting with headache”); Altinkaya at 1; 

Morrison at 1 (“[t]o our knowledge, this is the first report of headache being a prominent and early 

symptom of this disorder.”). In fact, the filed literature in this case does not support the general 

conclusion that CIDP would ever present with headaches. See cf., Morrision at 1; Altinkaya at 1;

see, e.g., Zalewski (not mentioning GBS or CIDP). At best, there is the suggestion that some outlier 

cases featured headache as a symptom.

In addition, although Dr. Boylan identified two case reports in which headaches were a 

clinical indicia of a patient’s CIDP, these reports (which constitute a kind of evidence not naturally 

meriting significant weight to begin with)22 are not factually comparable to Ms. Patel’s 

circumstances. In particular, the studied individuals had papilledema and high-pressure CSF 

 

22 Although case reports can provide some circumstantial evidence supporting a claimant’s causation theory, they 

ultimately carry little weight—especially when only one or two case reports are submitted on an issue. See, e.g., Bast 

v. Sec’y of Health & Human Servs., No. 01-565V, 2012 WL 6858040, at *38 n.104 (Fed. Cl. Spec. Mstr. Dec. 20, 

2012) mot. for rev. denied sub nom. M.S.B. v. Sec’y of Health & Human Servs., 117 Fed. Cl. 104 (Fed. Cl. 2014) 

,aff’d, 579 F. App’x 1001 (Fed. Cir. 2014). 
26

readings. See Altinkaya at 1; Morrison at 1. But there no evidence in this case of what Petitioner’s 

CSF pressure was when tested (see Scottsdale Healthcare at 182, 188), and (as Dr. Chaudhry has 

pointed out), some subsequent imaging cast doubt on Dr. Boylan’s conclusion that Petitioner likely 

had experienced high intracranial CSF pressure. Chaudhry Rep. at 16 (citing Ex. 16 at 3 (MRI cine 

study performed in January 2015)). Petitioner was also examined twice for papilledema, without 

a positive finding. Id. at 38 (August 2014 exam); Scottsdale Healthcare II at 26 (September 2014 

exam). At most, Petitioner reported “ocular motion weakness” that had resolved prior to arriving 

to the emergency room in August 2014. Scottsdale Healthcare at 26. But cranial nerves II–XII

were examined twice and no abnormalities were mentioned. Scottsdale Healthcare at 38; 

Scottsdale Healthcare II at 26.

Dr. Boylan’s explanations for how Petitioner’s headaches might have been CIDP-related 

were otherwise unpersuasive. Thus, Dr. Boylan proposed the potential existence of deficits in 

Petitioner’s cranial nerves, but neither the fundoscopic exam (and associated negative results for 

papilledema) nor the examinations of Petitioner’s cranial nerves II–XII support such that 

conclusion.

23 See Boylan Rep. at 7–9, 15. She also failed to note the extent to which the Altinkaya 

and Morrison case reports turned on findings of papilledema and high CSF pressure. Compare id.

at 15–16 with Altinkaya at 1 (“[k]eywords headache, papilledema, chronic inflammatory 

demyelinating polyradiculopathy”) and Morrison at 1 (“[k]ey words: headache, papilledema, 

chronic inflammatory demyelinating polyradiculopathy”). And her argument that certain MRI 

images thought to be Chiari malformations could actually reflect abnormal CSF flow, thus 

explaining Petitioner’s headaches, arose largely from her speculation that Petitioner’s treaters 

erred in interpreting certain MRIs rather than from her own review of the imaging. Dr. Chaudhry

also observed inconsistency in how Dr. Boylan explained the headaches—sometimes asserting 

that high CSF pressure was to blame, other times saying they were due to low pressure. Chaudhry 

Rep. at 16; see also Boylan Rep. at 15–16. 

Petitioner has similarly not shown that her other December 2013 symptoms were likely

related to her CIDP.24 Dr. Boylan opines that symptoms of autonomic dysfunction comparable in 

respects to what Petitioner experienced have been reported to occur with or even precede CIDP. 

Boylan Supp. Rep. at 1–2 (citing Zaeem; Boukhris). However, there is a significant gap between 

Petitioner’s case and the cited literature. Zaeem, for example, involves GBS (which Petitioner 

 

23 Dr. Boylan in fact left out mention of these facts from her primary report, despite explicitly considering the August 

2014 neurologic consultation (which noted no papilledema and a normal cranial nerve exam). See Boylan Rep. at 8.

24 Some symptoms alleged in this case as evidence of Petitioner’s CIDP are not even to be found in the record. Thus, 

Dr. Boylan repeatedly states that Petitioner suffered from chest pain in addition to her other non-specific symptoms. 

See Boylan Rep. at 5; Boylan Supp. Rep. at 2. But it is unclear where chest pain appears in the record, and such a 

symptom is not mentioned in Petitioner’s affidavit or her VAERS report. 
27

unquestionably never experienced),25 and most of the autonomic-related symptoms it discusses 

were never experienced by Ms. Patel. See, e.g., Pet’r’s Aff.; VAERS Rep. By contrast, the primary

December 2013 symptoms she did report experiencing (headaches, lightheadedness, and fatigue) 

are not mentioned in this article. Compare Pet’r’s Aff., with Zaeem at 1. Thus, Dr. Boylan’s 

reliance on it is the equivalent of trying to fit a square peg into a round hole. 

Dr. Boylan’s efforts to link fatigue with CIDP are more successful—but not enough to 

meet Petitioner’s preponderant burden. Thus, Bouhkris actually discusses CIDP and fatigue—one 

of the symptoms that Petitioner reported suffered from before she presented with more classic

CIDP symptoms in June 2014. But Boukhris’s applicability to Petitioner’s case is limited. The 

article screened out patients with a history of thyroid disease and other conditions (Boukhris at 2), 

even though Petitioner had a documented history of thyroid diseases.26 In addition, although most 

of Boukhris’s subjects did not display weakness (Id. at 2), Ms. Patel’s weakness was very apparent. 

Finally, Table 1 on page 3 of Boukhris shows the primary and secondary reported symptoms of 

the study participants—none of which include lightheadedness, headache, or vision problems. See 

id. Boukhris therefore provides no more than weak support for Petitioner’s claim.

The weight to be given to any expert’s opinion is based in part on the size of the gap 

between the science and the opinion proffered. Cedillo, 617 F.3d at 1339 (quoting Joiner, 522 U.S. 

at 146). Here, the independent science does not preponderantly support Petitioner’s contention that 

headaches or fatigue would be reliably deemed common precursor symptoms of CIDP, absent 

other factors clearly not applicable to this case, or that these kinds of symptoms would commonly 

present long before the usual manifestations of such a peripheral neuropathy (symmetric 

sensorimotor weakness longer than 8 weeks duration, absent or reduced reflexes, and relapsing or 

slowly progressive course). And Dr. Boylan could not persuasively establish the contrary with her 

own arguments. Petitioner has thus not demonstrated that any of her December 2013 symptoms 

were likely related to her CIDP.

C. The Onset of Petitioner’s CIDP Most Likely Began in July 2014, and Thus Did 

Not Occur in a Medically-Acceptable Timeframe Measured from Vaccination

 

25 The admitted overlap between GBS and CIDP as peripheral neuropathies can only get Petitioner so far—for, as Dr. 

Chaudhry ultimately demonstrated, their differences are not de minimis. Chaudhry Rep. at 13–14. Of particular 

importance in this case, CIDP is chronic and relapsing, meaning that its presentation lacks the acute and sudden 

character of GBS, as well as having a different set of post-condition sequelae. Chaudhry Rep. at 12–14.

26 The reason for this exclusion is not made explicit. However, in a study about fatigue in CIDP patients, it would be 

reasonable to exclude participants from the study who have other conditions that could also cause fatigue. And one of 

hypothyroidism’s symptoms is fatigue and muscle weakness. See Hypothyroidism, Dorland’s Online, 

https://www.dorlandsonline.com/dorland/definition?id=24430 (last visited April 22, 2020) (defining hypothyroidism 

as “deficiency of thyroid activity, characterized by decrease in basal metabolic rate, fatigue, and lethargy” (emphasis 

added)).
28

Having found that Petitioner’s initial symptoms were not likely manifestations of CIDP, 

the next issue to be resolved is when Petitioner’s CIDP did most likely begin. The earliest the

symptoms normally associated with CIDP, like symmetrical tingling or numbness, appear in the 

medical record for this case is sometime in June or July 2014, when Petitioner first reported 

numbness and loss of feeling in her fingertips. See Abrazo Healthcare 2014 at 57. But all experts 

offering opinions in this case have agreed that “[p]ost-vaccine and post-infectious syndromes are 

considered to typically occur following a variable period of delay within 6-weeks following 

exposure.” Boylan Rep. at 3; Chaudhry Rep. at 13. This is consistent with what has ben found in 

other Program cases. See, e.g., Daily, 2011 WL 2174535, at *9 (finding that onset of CIDP within 

a few weeks of vaccination was a medically acceptable timeframe).

Applying that timeframe,

27 it is evident that Petitioner’s actual onset far exceeded six 

weeks from the date of her November 2013 vaccination—and thus Petitioner has not established 

that onset of her CIDP occurred in a medically-acceptable timeframe. Indeed, as noted above, Dr. 

Boylan agreed that her opinion could not be reliably advanced in the absence of a finding that 

Petitioner’s late-2013 symptoms were CIDP-related. Boylan Supp. Rep. at 2.

II. This Matter was Properly Resolved Without Hearing

In ruling on the record, I am opting against holding a hearing. The choice of how best to 

resolve this case is a matter that lies generally within my discretion, and neither party objects to 

my choice in this case, but I shall explain my reasoning nevertheless.

Prior decisions have recognized that a special master’s discretion in deciding whether to 

conduct an evidentiary hearing “is tempered by Vaccine Rule 3(b),” or the duty to afford each 

party a “full and fair opportunity to present its case.” Hovey v. Sec’y of Health & Human Servs., 

38 Fed. Cl. 397, 400–01 (citing Rule 3(b)). But that rule also includes the obligation of creation of 

a record “sufficient to allow review of the special master’s decision.” Id. at 401; see also 

Kreizenbeck, 945 F.3d at 1366. Thus, the fact that a claim is legitimately disputed, such that the 

special master must exercise his intellectual faculties in order to decide a matter, is not itself 

grounds for a trial (for if it were, trials would be required in every disputed case). Special masters 

are expressly empowered to resolve fact disputes without a hearing—although they should only so 

act if a party has been given the proper “full and fair” chance to prove their claim.

In this case, no hearing was required to resolve fairly Petitioner’s claim. I was able to 

evaluate the evidentiary strength of her expert’s theories and opinions simply based on the written 

reports, and did not require credibility determinations in weighing the medical/scientific reliability 

 

27 I do not make a determination in this case either way as to what would be a proper onset timeframe for postvaccination CIDP, based on the most likely presenting clinical symptoms. I only utilize this timeframe because it 

found expert agreement herein, and also because it finds reasoned support in other decisions.
29

of the theories espoused. The case did not otherwise turn on any fact issues (for example, the 

ultimate diagnosis or onset) that would have merited allowing live testimony, and the fact issues 

most important to my resolution (the timing of certain symptoms, and whether they constituted 

CIDP onset) could easily be determined from review of the filed medical records. Petitioner had a 

full and fair opportunity to present her claim without a live hearing.

CONCLUSION

Petitioner’s claim must be dismissed because it has not been demonstrated that the flu 

vaccine could cause CIDP more than six months after vaccination. In the absence of a timely-filed 

motion for review (see Appendix B to the Rules of the Court), the Clerk shall enter judgment in 

accord with this decision.28

IT IS SO ORDERED. 

s/Brian H. Corcoran

 Brian H. Corcoran

 Chief Special Master

 

28 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their 

right to seek review.