Camacho Keja v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 17-1511V

(Not to be published)

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

ROBIN LARA CAMACHO KEJA, *

* Chief Special Master Corcoran

*

Petitioner, *

* Filed: April 2, 2021

v. *

*

SECRETARY OF HEALTH *

AND HUMAN SERVICES, *

*

Respondent. *

*

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

Charles W. Marsar, R.J. Marzella & Associates, P.C., Harrisburg, PA, for Petitioner

Ryan Daniel Pyles, U.S. Dep’t of Justice, Washington, DC, for Respondent

ENTITLEMENT DECISION 1

On October 13, 2017, Robin Lara Camacho Keja filed a petition seeking compensation

under the National Vaccine Injury Compensation Program (the “Vaccine Program”)2 alleging that

the influenza (“flu”) vaccine that she received on October 17, 2014, caused her to develop a

number of injuries, “including Lupus, inflammatory arthritis, Serum-like Sickness, and Prurigo

1 Although not formally designated for publication, this Decision will nevertheless be posted on the United States

Court of Federal Claims’ website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This

means 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 published Decision’s inclusion of certain kinds of confidential

information. Specifically, under Vaccine Rule 18(b), each party has fourteen (14) 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 entire Decision will be

available to the public in its current form. Id.

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

100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012)) (hereinafter “Vaccine Act” or “the Act”).

All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. § 300aa.

Nodularis.” See Petition (“Pet.”) at 1. 3

The parties have agreed that the matter could best be resolved on the papers. Accordingly,

on September 30, 2020, Petitioner filed a motion requesting that the Court find entitlement in her

favor. Motion, filed Sept. 30, 2020 (ECF No. 43), and Brief in Support, filed Sept. 30, 2020 (ECF

No. 44) (“Mot.”). On November 30, 2020, Respondent filed a Response and Cross-Motion for

Ruling on the Record dismissing the claim. See Resp.’s Motion, filed Nov. 30, 2020, (ECF No.

47) (“Opp.”). Petitioner elected not file a response.

Because Petitioner was never diagnosed with the injuries she claims to have been vaccine

caused, and her expert’s theory was not persuasive and/or unsupported by other reliable evidence,

I hereby deny entitlement in this matter.

I. Medical History

Relevant Pre-Vaccination Events

Certain health problems Ms. Camacho Keja experienced pre-vaccination echo the injuries

alleged in this case. In particular, her medical history includes both issues with her lymph nodes

as well as rheumatologic-like symptoms.

On September 28, 2010, for example, Petitioner saw otolaryngologist Andrew Shorb,

M.D., following a lymph node biopsy the week prior that was benign, “consistent with a reactive

lymph node.” Ex. 18 at 17. Due to her continuing “generalized sense of fatigue and lethargy,”

however, Dr. Shorb recommended a rheumatology consultation, noting that she had seen a

rheumatologist “in the past.” Id. Almost two years later, on January 29, 2012, Petitioner was seen

by her primary care physician for acute bronchitis. Ex. 11 at 17. At that time, her “active problems”

included localized joint pain in more than one joint, exercise-induced asthma, nephrolithiasis

(kidney stones), dysmenorrhea, and “[p]arvovirus B19 [a]rthritis.” Id. Later that month, while she

was twenty-eight weeks pregnant, Petitioner had multiple joint effusions. Id. at 8.

On January 20, 2013, Petitioner was seen by Todd Curran, D.O., for an orthopedic

evaluation regarding left-sided neck pain and shoulder pain, which she characterized as chronic,

although the pain had worsened over the prior week. Ex. 2 at 262. She also reported occasional

numbness of her hands bilaterally (worse on the left side). Id. Dr. Curran’s impression was left

shoulder pain, “[p]arascapular trigger points,” and rotator cuff tendonitis, and he administered a

steroid injection to Petitioner. Id. at 263-64.

On October 26, 2013, Ms. Camacho Keja was prescribed prednisone by Certified Nurse

3

This case was originally assigned to former Special Master Millman, then transferred to Special Master Horner

upon her retirement in 2019. It was transferred a second time, to me, on July 29, 2020. See ECF Nos. 40-41.

2

Midwife (CNM) Deborah Brown at WellSpan Health, Women and Children Services. Ex. 41 at 2;

Ex. 45 at 16. Petitioner has alleged that two days later (October 28, 2013) she received a flu

vaccine. 4 Ex. 10 at 1. There are no records in the five weeks thereafter of any reaction, however.

At best, on December 6, 2013, Petitioner was seen at her primary care doctor for a “solitary skin

lesion” located on her chin of a several-week duration, but she denied the presence of any

“arthralgias, fever, headache, myalgias, sore throat and rash.” Ex. 2 at 38. At most, treaters noted

a left submandibular node on examination, and assessed her with acute lymphadenitis to be treated

with Augmentin, an antibiotic. Id. at 39-40.

Later that same month, on December 17, 2013, Ms. Camacho Keja was seen for acute

swelling of “submental” (meaning the area of the head below the chin and around the neck) lymph

nodes. Ex. 2 at 101. She reported that about two days prior to the acute swelling, she had a sore

throat that “never developed into a significant upper respiratory infection,” and that she had

“noticed a significant reduction in size of the nodule” after taking Augmentin. Id. She reported no

other head or neck symptoms at this time, and the assessment was swelling in the head and neck

and lymph node enlargement. Id. During a follow-up visit on January 9, 2014, following a course

of Augmentin and “some prednisone,” Petitioner now informed treaters that she had “noticed a

dramatic reduction [in swelling of the submental node] and [was] without other complaints or

symptoms.” Id. at 103.

On February 7, 2014, Ms. Camacho Keja went to the emergency room reporting a six-day

history of “subjective fevers, fatigue, myalgias, nausea[,] vomiting, [and] mild intermittent

diarrhea.” Ex. 2 at 55. She also complained of “mild to intermittent left lower quadrant abdominal

pain,” and reported that she had been taking Tamiflu following a telephone prescription from her

primary care physician. Id. Petitioner denied chest pain, shortness of breath, leg swelling, or rashes.

Id. The differential diagnoses were fever, viral syndrome, and gastroenteritis. Id. at 56. At a follow-

up visit on February 18, 2014, Petitioner was assessed with a cough, and the treater noted a

suspicion of bronchitis. Id. at 37. On April 11, 2014, Ms. Camacho Keja filled a prednisone

prescription from Deborah Brown, CNM. Ex. 45 at 16. No accompanying records filed in the

matter explain the reason for the prescription.

Vaccination and Subsequent History

On October 17, 2014, Petitioner received the flu vaccine at issue in this case from her

employer. See Ex. 1. Four days later, on October 21, 2014, Ms. Camacho Keja saw a primary care

doctor, Nandita Kinley, M.D., with the following history:

4Although in subsequent records Ms. Camacho Keja reported to treaters that she received a flu vaccine at this time,

proof of vaccination was not filed. Petitioner filed an affidavit dated November 19, 2018, in which she stated that she

could not recall where the alleged vaccination occurred, although she believes it may have been at York Hospital

(WellSpan), where she was employed at the time. Ex 38 at 1–2.

3

“Patient complains of lymph node enlargement. A possible swollen lymph node

that was first noticed yesterday. This is located in the left upper neck. The lymph

node is characterized as tender, firm, mobile, and enlarging in size. Related

symptoms include localized swelling, but not earache, fever, nervousness, rash,

systemic fever, toothache. [Patient] was here last week. A few days after having

received her flu vaccine, she had some “generalized lymphandenopathy.” Her[e]

now about the constellation of [symptoms] that have been ongoing for the last 6

mo[nths] at least and also with this new [lymph node]. She did have a major work

up years ago and a lymphnode [sic] excision. [Workup] was negative at that time.

[Patient] is now a single mom with a lot of stressors. She is afraid there is something

terribly wrong going on.”

Ex. 2 at 31 (emphasis in original). The plan and assessment following this appointment included

lymphadenopathy, rash, and diffuse arthralgia, and multiple diagnostic tests were ordered. Id.

A week later, on October 28, 2014, Ms. Camacho Keja was seen at Wellspan Ready Care

and reported gaining eleven and a half pounds in a week, and also that she was now experiencing

a pitting edema that was worse than when she was seen the previous day in primary care. Ex. 2 at

104. Petitioner reported being treated with prednisone the previous week for an allergic reaction

to her vaccination. Id. On November 4, 2014, Petitioner presented to primary care with complaints

of edema. Id. at 28. At the time of this appointment, Petitioner’s swelling was represented to have

been present for several weeks and primarily involved her lower extremities. Id. On exam, her

physician noted Petitioner was anxious, had 1+ pedal edema, and a firm non-tender lymph node.

Id. at 30.

On December 3, 2014, Ms. Camacho Keja again presented to primary care with complaints

of feet and ankle swelling. Ex. 2 at 25. During this appointment the treating physician, Dr. Nandita

Kinley, notes: “[t]he question is, was there an inciting event that promoted this? [Patient] had

similar [symptoms] last [year] about 1 w[ee]k after flu administration. This year, she’s had the

same [symptoms] and more, but to a worse degree. Could this be a strange, delayed allergic

[reaction] to flu? Could something autoimmune be going on?” Id. at 27. On exam, only “trace

pedal edema” was noted. Id. at 30. Petitioner was referred to rheumatology, allergy/immunology,

and dermatology. Id.

The next day (December 4th), Petitioner visited the Family Center for Allergy and Asthma

in York, Pennsylvania for further evaluation of her on-going symptoms. Ex. 2 at 106. She reported

at this appointment that after receiving the flu vaccine the year prior (2013), she suffered facial

swelling, a sense of fullness, and itching of her neck, all of which resolved following a course of

Prednisone. Id.; Ex. 40 at 2. In response, the doctor at this appointment noted her assessment as

4

“[a]ngioedema, fluid retention, reactive lymph node, in the aftermath of receiving the seasonal flu

vaccine[.]” Ex. 2 at 108. In addition, the attending physician deemed the circumstances to present

“a very complicated case. It [] certainly seems that she has some kind of underlying inflammatory

condition that may have predisposed her reaction to the influenza vaccine.” Id.

On December 23, 2014, Ms. Camacho Keja presented to Sadia Kahn, M.D., a

rheumatologist, for a consultation. Ex. 2 at 111. Dr. Khan noted in part the following:

I had seen [Petitioner] previously in 2010 when she had enlarged lymph nodes in

cervical region and excision biopsy showed reactive process. I do not find evidence

of autoimmune disease. She had mild elevation of CRP 0.86. She reports that she

was in her usual state of health until October when she received flu vaccination this

year. She developed facial swelling 24 hours after taking flu vaccine. She also

started to notice trouble swallowing smaller pills. She noticed lower extremity

edema. She felt stiff. She had similar reaction a year prior from flu vaccination.

Within few hours she developed tingling along left side of her jaw. She also

developed itching in the arm pits and neck area. She felt that her lymph nodes were

enlarged. She was seen by PCP [primary care physician]. She was started on

prednisone 40 mg daily with gradual taper. However if [sic] she then developed

worsening edema… She reports that symptoms lasted for about one to two weeks

and have resolved now…

Ex. 2 at 111 (see also Ex. 7 at 7 (same)). On December 29, 2014, Petitioner saw her primary care

provider for a cough and/or an acute infection (questioned to be either bronchitis or pneumonia).

Ex. 2 at 22-23. On January 7, 2015, Petitioner saw her primary provider for an acute cough and

four weeks of acute illness, including chest congestion, shortness of breath, body aches, headaches,

nasal congestion, chills, and malaise. Id. at 19.

On February 2, 2015, Ms. Camacho Keja presented to primary care due to concerns of

kidney stones and other ailments. Ex. 2 at 15. The assessment included pedal edema, and her treater

decided to stop Petitioner’s over-the-counter prescriptions in order to ascertain whether any

medications were exacerbating what could be an ongoing inflammatory condition. Id. at 16. On

February 10, 2015, Petitioner presented to Family Center for Allergy and Asthma for a follow-up

visit. Id. at 126. The record notes that Petitioner’s ankles were asymmetrical, possibly suggestive

of swelling. Id. The assessment indicated a “[c]oncern for angioedema, fluid retention, reactive

lymph node in the aftermath of receiving the seasonal flu vaccine, [and] possible serum sickness.”

Id.

On April 15, 2015, Ms. Camacho Keja returned to her primary care physician with edema.

Ex. 2 at 9. Treaters indicated a plan to repeat blood work and to refer to rheumatology. Id. On

5

April 28, 2015, Petitioner visited WellSpan Rheumatology. Id. at 162. Treaters explained that

Petitioner lacked the diagnostic criteria that would suggest the existence of an autoimmune

rheumatic process, but that she did have some laboratory abnormalities that did not fit into a clear

diagnostic category. Id. A musculoskeletal exam also showed “[m]ild diffuse tenderness to

palpitation of both ankles… [m]ild tenderness to palpitation of MTP joints without obvious joint

effusions.” Id.

Several months later, on August 4, 2015, Ms. Camacho Keja presented to Hershey Medical

Center (“HMC”) Rheumatology for a second opinion. Ex. 2 at 200. Treater Sowmya Surapaneni,

M.D., expressed concern regarding whether the ongoing symptoms were indicative of serum

sickness. Id. at 202. Dr. Surapaneni ordered extensive lab tests to rule out any underling

autoimmune disease. Id. Specifically, Dr. Surapaneni ordered a Serum Protein Electrophonesis

Interpretation, which revealed “[n]ormal serum protein with polyclonal distribution in the gamma

region. Serum total protein and albumin within reference limits. No evidence of monoclonal

immunoglobulin is present.” Id.

On November 24, 2015, Ms. Camacho Keja again presented to primary care with ankle

and feet swelling. Ex. 2 at 2. The next year, on February 2, 2016, Petitioner returned to HMC

Rheumatology to see Dr. Surapaneni for a follow up. Id. 246. The record from this visit notes that

Petitioner’s left knee appeared slightly swollen and warm when compared to her right knee. Id. at

247. Two days later, on February 4, 2016, Petitioner was seen in the HMC Allergy and

Immunology Clinic by Faoud Ishmael, M.D., who noted that Petitioner’s facial swelling appeared

“only directly after [her] flu vaccines, but she continued to have lots of peripheral swelling.” Id. at

242.

On February 9, 2016, Dr. Ishmael provided a message to Ms. Camacho Keja, stating: “my

overall feeling is that you had an underlying autoimmune disease that was brewing… and that it

was more the overall stimulation of the immune system from the vaccine that set this all in motion.”

Ex. 3 at 253. In addition, Dr. Ishmael wrote that “we do see a lot of cases where patients… have

flares of lupus after an infection or an immunization, and that in those cases the ‘turning on’ of the

immune system is what sets things off.” Id.

On June 16, 2016, Ms. Camacho Keja returned to HMC Rheumatology for a follow-up

with Dr. Surapaneni. Ex. 2 at 256. Dr. Surapaneni noted that “[t]here is no obvious swelling that

[he] could notice in the knees today, but there is pain with range of movements around both knees.

Id. at 257. He also noted that the “[l]eft ankle seems subtly swollen when compared to the right,

but this is better than what I have seen before… MTPs, especially the left MTPs are tender.” Id.

Almost a year later, on April 18, 2017, Ms. Camacho Keja saw Dr. Surapaneni for another

follow-up for her “inflammatory arthritis.” Ex 3 at 53. Dr. Surapaneni noted that “[a]t this point,

6

[he] is starting to wonder if the inflammatory arthritis [Petitioner] has is related to some form of

underlying spondyloarthropathy…” Id. In addition, he recorded that Petitioner reported “more

swelling and pain[,] especially in the knees, ankles, and left hip associated with stiffness in the

mornings…” Id. With regard to prior lab testing, Dr. Surapaneni noted:

[T]he blood work in the past has shown ANA to be negative including DNA Smith,

RNP, SSA, SSB, centromere, scleroderma, histo and Jo-1 antibodies which were

all negative. CRP and sed[imentation] rate were elevated back in February of 2016,

but the repeat [labs] from June 2016 were within normal limits. Ultrasound of her

ankles from November has shown diffuse nonspecific subcutaneous edema about

the ankles with no evidence of inflammatory arthritis at which point, we did

lymphoscintigraphy imaging on TOMO [on January 3, 2017 (Ex. 3 at 85)] which

did not show any abnormal lymphatic drainage.

Ex. 3 at 53. On October 3, 2017, Ms. Camacho Keja presented to urgent care for left wrist

pain, bilateral knee pain, and bilateral ankle pain that lasted for a day, specifically after falling

down and rolling her right ankle. Ex. 12 at 1. Petitioner also reported during this visit that while

walking into her garage, “her knees gave out, causing her to fall and roll her right ankle. She

remembers catching herself with her hands and landing on her right side.” Id. No medical records

after the fall of 2017 (other than pharmacy records up to 2018) were filed in this case.

II. Expert Reports

A. Dr. Thomas M. Zizic

Dr. Zizic’s expert report was the sole opinion filed on Petitioner’s behalf. Report, dated

September 21, 2018, filed as Ex. 20 (ECF No. 26) (“Zizic Rep.”). Dr. Zizic maintains that

Petitioner likely developed spondyloarthropathy, a kind of inflammatory arthritis, as a result of her

receipt of the flu vaccine. Zizic Rep. at 21.

Dr. Zizic is a physician and Associate Professor of Medicine at Johns Hopkins Hospital

and Johns Hopkins University School of Medicine in Baltimore, Maryland. See CV, filed as Ex.

21 (ECF No. 27) at 1. He received his medical degree from Johns Hopkins University School of

Medicine and served an internship and residency at John Hopkins University Hospital Center in

internal medicine. Id. Previously, Dr. Zizic was the Associate Director of the Rheumatic Disease

Unit for John Hopkins at the Good Samaritan Hospital. Zizic Rep. at 1. Dr. Zizic is a former

President of the Maryland Society of Rheumatic Disease and served on the National Committees

of the Arthritis Foundation and the Lupus Foundation. Id. at 2. Dr. Zizic has published

approximately 100 articles and abstracts in peer reviewed journals as well as several dozen

chapters in textbooks of medicine. Id. He has also conducted clinical research studies. Id.

7

Dr. Zizic opined that there is a cause-effect relationship between Petitioner’s receipt of the

flu vaccine and her subsequent development of an inflammatory arthritis, since “current scientific

knowledge delineates a highly plausible biologic mechanism for vaccination induced

autoinflammatory diseases” in susceptible individuals. Zizic Rep. at 15. As possible specific

mechanisms for such a process, Dr. Zizic described three means of autoimmune recognition of the

innate immune system: (1) the “microbial non-self;” (2) the recognition of “missing self;” and (3)

recognition of “induced or altered self.” Id. Any one of these three responses, he maintained, could

have been activated by the flu vaccine. Id.

As Dr. Zizic generally explained, autoimmune diseases are characterized by reactivity to

self-antigens, leading to chronic inflammation. Zizic Rep. at 16. The basis for the first kind of

autoimmune response, microbial non-self recognition, lies in the ability of the host to recognize

conserved products of microbial metabolism that are unique to microorganisms and are not

produced by the host. Zizic Rep. at 15. The second, recognition of “missing self,” involves

detection of markers of normal self, coupled with various inhibitory pathways that block initiation

of autoimmune responses. Id. These markers (MHC molecules)5 are commonly expressed on cell

surfaces, but can be down-regulated in an infectious process, leading the body’s innate immune

system to mistake healthy cells for infected, indiscriminately attacking both. Id. And the third,

recognition of induced self, is based on the detection of markers of abnormal self that are induced

upon infection and cellular transformation. Id. These markers tag affected cells for elimination by

the immune system. Id.

Autoimmune diseases, Dr. Zizic maintained, are characterized by “unchecked T-cell and/or

B-cell reactivity to self-antigens, leading to chronic inflammation.” Zizic Rep. at 16. 6 Certain

prototypical autoimmune diseases, such as rheumatoid arthritis and systemic lupus erythematosus,

also share a number of common features such as genetic risk factors, marked female predominance,

an association with disease-specific autoantibodies, and a positive response to T-cell or B-cell

targeted treatments (thus underscoring their autoimmune character). Id.

5 The “major histocompatibility complex” (“MHC”) is a group of genes in mammals that code for cell-surface

polymorphic glycoprotein molecules which display antigenic peptide fragments for T cell recognition, thereby aiding

in the ability of the immune system to differentiate self from non-self. Merriam-Webster’s Online Dictionary,

https://www.merriam-webster.com/dictionary/major%20histocompatibility%20complex (last visited March 18,

2021).

6

In a properly-functioning immune response, T cells coordinate defenses against pathogens by recognizing pathogen-

derived peptides and producing immune-stimulatory hormones (cytokines) to activate cells of the immune system,

and thereby control inflammation and suppress aberrant immune responses. Zizic Rep. at 16, citing P. Wright et al.,

Dendritic Cells and Regulatory T cells in Spondyloarthritis, 25(4) Current Opinion Rheumatology 440-447 (2013),

filed as Ex 25 on Sept. 24, 2018 (ECF No. 29-3) (“Wright”).

8

Dr. Zizic next discussed his proposed diagnosis for Petitioner’s constellation of symptoms.

Spondyloarthritis, he stated, is a polygenic immune-mediated inflammatory disease characterized

by inflammation of the spine and peripheral joints, as well as extra-articular manifestations such

as inflammatory bowel disease, uveitis, and psoriasis. Zizic Rep. at 19. Ankylosing spondylitis

(“AS”), a spondylarthritis variant, is characterized by inflammation of the sacroiliac joints,

peripheral inflammatory arthropathy, and the absence of rheumatoid factor. Id. Polymorphisms in

ERAP1 and ERAP2 7 could, in Dr. Zizic’s estimation, also be involved in the pathogenesis of the

autoimmune process resulting in a spondyloarthritic condition, through alterations in peptide

processing. Zizic Rep. at 20.

Finally, Dr. Zizic provided an opinion for how the flu vaccine could stimulate an

autoimmune process resulting in a spondyloarthritis. As he hypothesized, viral proteins present in

the vaccine could cause abnormal alterations in peptide processing, contributing to disease

pathogenesis. In support of this contention, Dr. Zizic referenced a Toronto study in which the

immune response to the influenza wild virus showed a change in the overall flu-peptide repertoire

in mice deficient in ERAP function. Zizic Rep. at 20 (citing F. Tsui et al., The Genetic Basis of

Ankylosing Spondylitis: New Insights into Disease Pathogenesis, 7 Application of Clinical

Genetics 105-115 (2014), filed as Ex. 29 on Sept. 24, 2018 (ECF No. 29-7) (“Tsui”). Tsui did not

involve the flu vaccine however, and no other literature was offered extending its findings to

vaccination. Zizic nevertheless concluded that it is biologically plausible that the flu vaccine could

(in a genetically susceptible host also possessing the relevant ERAP1 and/or ERAP2 mutations)

cause a similar altered peptide processing with the generation of arthritogenic peptides, resulting

in SA. Zizic Rep. at 20.

Dr. Zizic offered some literature specific to the alleged association between the flu vaccine

and Petitioner’s purported injury, although the items provided were of limited probative value. For

example, Dr. Zizic referenced a case report from 1994 (presented in the form of a letter to the

editor) to suggest that the flu vaccine has been shown to cause reactive arthritis. Zizic Rep. at 21

(citing D. Biasi et al., A case of reactive arthritis after influenza vaccination 13 Clinical

Rheumatology 645 (1994), filed as Ex. 35 on Sept. 24, 2018 (ECF No. 29-13). But reactive arthritis

is not alleged as the injury herein, and the record would not support it even if it had been. Dr. Zizic

similarly provided a 2005 case report in which a patient developed a case of reactive arthritis after

flu vaccination Id. at 21. (citing J. Asakawa et al., Reactive arthritis after influenza vaccination:

report of a case, 15:4 Clinical Rheumatology 283-285 (2005), filed as Ex. 36 (ECF No. 29-14)

7 ERAP1, or “Endoplasmic reticulum aminopeptidase 1,” is a protein which plays a central role in peptide trimming,

a step required for most HLA class I-binding peptides. See UniProt Consortium, UniProtKB - Q9NZ08

(ERAP1_HUMAN), available at https://www.uniprot.org/uniprot/Q9NZ08 (last visited March 18, 2021). Peptide

trimming is essential to customize longer precursor peptides to fit them to the correct length required for presentation

on MHC class I molecules. Id. The main function of the ERAP1 is to trim peptides within the ER (endoplasmic

reticulum) into the right length. Zizic Rep. at 20. Malfunction of ERAP1 can lead to generation of anomalous peptides

of incorrect length and sequence, which can result in misfolding (and thereafter produce aberrant downstream

outcomes). Id.

9

(“Asakawa”). However (and in addition to the fact that the injury is different), the subject in this

report was found positive for a gene variant associated with AS (discussed in more detail below)

that Ms. Camacho Keja herself has not been shown to possess. Asakawa at 283.

B. Dr. Carlos D. Rose

Dr. Rose, a board-certified rheumatologist, prepared one report for Respondent. Report,

dated March 14, 2019, filed as Ex. A (ECF No. 33-1) (“Rose Rep.”). Dr. Rose was asked to provide

an opinion on the alleged effect of the flu vaccine on Petitioner’s health, and also to respond to Dr.

Zizic. Rose Rep. at 1, at 24-28. He disputed that Petitioner’s vaccination impacted her health as

alleged, and maintained that Petitioner’s medical record did not support a finding that she more

likely than not suffered from any definable rheumatic disease. Id. at 28.

Dr. Rose obtained his medical degree from the University of Buenos Aires School of

Medicine and received a Fellows Research Award from American College of Rheumatology. Ex.

B at 4. Dr. Rose also completed a specialty fellowship in Pediatric Rheumatology at Children’s

Hospital of Philadelphia and the Alfred I. du Pont Institute in Wilmington, Delaware. Id. He served

as Professor of Pediatrics at Jefferson Medical College and Instructor of Pediatrics at University

of Pennsylvania School of Medicine. Id. Currently, Dr. Rose serves on various medical committees

and has been caring for adult and pediatric patients with rheumatic and autoimmune diseases since

1983. Id.; Rose Rep. at 1.

Dr. Rose began his report with an analysis of the contemporary medical records, starting

on October 10, 2014 (four days after Petitioner’s vaccination). See generally Rose Rep. In his

view, the two inflammatory rashes Petitioner suffered from that puzzled some doctors have no

relationship with any underlying autoimmune or rheumatic disorder. Id. at 9. He based this

conclusion on the fact that, as the record reveals, Petitioner suffered from one kind of rash,

diagnosed as Prurigo nodularis, DSAP (Disseminated superficial actinic porokeratosis, PLEVA

(Pytyriasis lichenoides varioliformis acuta) and sarcoidosis, since childhood. Id. The second rash,

located on the sole of the right foot and present for two years as of 2014, was diagnosed as bullous

tinea pedis (fungal infection), and as such could not be vaccine-caused. He therefore deemed this

evidence as not indicative of a vaccine reaction.

Dr. Rose then analyzed relevant past medical records. As he noted, Petitioner’s medical

history pre-vaccination revealed numerous concerns regarding her lymph nodes. Rose Rep. at 10.

In August of 2010, for example, Petitioner was seen for submental swelling since April of that

year, with worsening over the prior one and one-half weeks, plus fatigue and dizziness. Ex. 18 at

32. A biopsy was performed at this time, however, and a later follow-up by treaters revealed a

benign pathology consistent with a reactive lymph node, rather than a specific immunophenotypic

abnormality. Id. at 18.

10

Data from the clinical evaluation of Petitioner’s health post-vaccination was similarly, in

Dr. Rose’s view, unsupportive of Petitioner’s claim. Rose Rep. at 12. Petitioner was seen at

Wellspan Rheumatology in 2015, but physical examinations remained unrevealing, with treaters

documenting the absence of joint inflammation (synovitis) and providing an assessment that once

again ruled out rheumatic or autoimmune disease. Ex. 7 at 6. Later in 2015, a CT scan of

Petitioner’s abdomen and pelvis showed no abnormalities. Ex. 2 at 99-100. This finding was

particularly notable to Dr. Rose, because it revealed no changes to the osseous structures, meaning

that there was no fluid in the hip or involvement of the sacroiliac joints at this time—findings that

would be consistent with Petitioner’s alleged injury but which were (again) absent in the record.

Rose Rep. at 15.

Dr. Rose then addressed Petitioner’s self-reported claims to treaters of prednisone

responsiveness. Rose Rep. at 15-16. Prednisone is a synthetic glucocorticoid derived from

cortisone, administered orally as an anti-inflammatory and immunosuppressant in a wide variety

of disorders. Dorland’s Medical Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=40742&searchterm=prednisone (last

visited January 26, 2020). According to pharmacy records filed in this case, Petitioner had only

two prescriptions for prednisone, both very short in duration and occurring in 2013 and 2014. See

Ex. 41; Ex. 45. Accordingly, unless pharmacy records filed in this case were incomplete, it was

not in Dr. Rose’s view possible to confirm Petitioner’s claim of prednisone responsiveness, since

her access to this medication had not been substantiated.

Dr. Rose also highlighted the mismatch between the evidence of symptoms in the record

and Petitioner’s proposed diagnoses. Rose Rep. at 17. Records contemporary to the 2014

vaccination, plus those around the time of the purported 2013 vaccination, suggest no diagnosable

rheumatic or autoimmune disease associated with the symptoms recorded at the relevant times. Id.

The totality of Petitioner’s conditions described in late 2014 and early 2015 included fatigue,

cervical lymphadenitis, hypertension, variable degrees of lower extremity edema, joint pain, skin

rash, and slight elevation of inflammatory makers which were either long pre-existing or not

specifically suggestive of a rheumatic or autoimmune disease. Id. at 17-18. Fatigue, Dr. Rose

explains, can be caused by a multitude of factors including sleep deprivation, stress, mood

disorders, long work days, deconditioning, and inflammatory or malignant diseases among other

things. Id. at 18. And the record suggested it had been a prior issue for Petitioner, and not associated

with a possible autoimmune rheumatic condition. Id.8

8

According to the medical record, fatigue was documented as early as 2010 by Dr. Shorb as well as stress and fear,

which were repeatedly noted in the record in 2014 as ongoing for six months. Rose Rep. at 18. Petitioner reported

being under a lot of stressors as a single mother. Id. Dr. Kahn, the first rheumatologist who evaluated Petitioner in

2014, was consulted specifically to address persistent fatigue as part of a worker’s compensation filing and he did not

attribute Petitioner’s symptoms to an autoimmune or rheumatic disorder. Id.

11

Cervical adenitis was also a recurrent problem for Petitioner, but it similarly preceded her

post-vaccination symptoms. Rose Rep. at 18. And lower extremity edema, which was a confusing

symptom to many of Petitioner’s treaters, also predated vaccination, and was in fact investigated

thoroughly. Id.; Ex. 11 at 4 (noting trace pedal edema in a 2012 visit). But lower extremity edema

was not necessarily an indicator that a person suffered from a rheumatic disorder. Rose Rep. at 18.

This was especially true here, in Dr. Rose’s view, since the primary location for Petitioner’s edema

was on the lateral aspect of Petitioner’s ankle, along with the fact that it was pitting and responsive

to Lasix. Id. In Dr. Rose’s clinical experience, obese individuals 9 can experience lower extremity

edema due to chronic venous insufficiency (assuming renal or cardiac causes are ruled out). Id. As

for Petitioner’s joint pain, skin rashes, and high blood pressure, the medical record revealed that

all of these symptoms also predated vaccination. Id.

Lastly, Dr. Rose discussed vaccine causality as set forth in Dr. Zizic’s report. Rose Rep. at

23. As a general matter, Dr. Rose opined that the absence of a credibly-diagnosed injury, as well

as the obscurity of symptoms onset post-vaccination, made vaccine causality unlikely. Id. He also

proposed that Dr. Zizic’s report fell short in providing a coherent theory that would explain how

an episode of angioedema in close proximity to vaccination could evolve into spondyloarthropathy

approximately one and one-half years later. Id. at 26. In addition, Dr. Rose questioned the

purported relationship between having an underlying autoimmune disease and suffering an

abnormal response to the flu vaccine as it has been suggested in Petitioner’s case, since it was not

understood in the medical field that individuals with rheumatic diseases faced risk from this kind

of vaccination. Id. at 24. Indeed, this possibility had been investigated but rejected in patients with

established autoimmune disease diagnoses, like systemic lupus. Id.

C. Dr. Robert S. Fuijinami

Dr. Fujinami prepared one report for Respondent addressing certain points raised in Dr.

Zizic’s expert report. Report, dated May 13, 2019, filed as Ex. C (ECF No. 35-1) (“Fujinami

Rep.”). Specifically, Dr. Fujinami opined that the flu vaccine could not have caused Petitioner’s

symptoms, and he also commented on the immune-mediated mechanisms proposed by Dr. Zizic

as to causation and how they related to Petitioner’s case. Fujinami Rep. at 5-6.

Dr. Fujinami received a Ph.D. from Northwestern University in Immunology-

Microbiology. Ex. D at 1. He received post-doctoral training at The Scripps Research Institute

where he advanced to Assistant Professor investigating how viruses or infections could induce

autoimmune disease. Fujinami Rep. at 1. Currently, Dr. Fujinami is a Professor in the Department

of Pathology, Division of Immunology, at the University of Utah School of Medicine. Ex. D at 1.

9

Certain record evidence suggests Petitioner was characterized by certain treaters as obese when she complained of

such lower extremity edema. See e.g., Ex. 2 at 4 (on exam, Petitioner was “obese; tired-looking; tearful”); Ex. 2 at 11

(on exam, Petitioner was “obese; tired-looking”).

12

He is also an Adjunct Professor in the Department of Neurology at the University of Utah School

of Medicine. Id. Dr. Fujinami wrote one of the most important articles on molecular mimicry10

regularly cited by petitioners in the Vaccine Program, after his mentor, Dr. Michael Oldstone,

popularized the concept.

Dr. Fujinami began his report by addressing the lack of biological plausibility possessed

by Dr. Zizic’s proposed injury mechanisms. Dr. Zizic had proposed that Petitioner likely

developed some form of autoinflammation/autoimmune disease attributable to vaccine-induced

activation of the innate immune system in a genetically susceptible individual. Zizic Rep. at 15.

But Dr. Fujinami questioned whether any of Dr. Zizic’s three mechanisms merited any weight in

this case. Id.; Fujinami Rep. at 2.

First, Dr. Zizic’s “microbial non-self” theory was inapplicable under the circumstances

because the flu vaccine contains no products or molecules derived from gram-negative or gram-

positive bacteria. Fujinami Rep. at 1. As a result, bacterial cell wall products implicated by this

particular mechanism could not have prompted an aberrant immune response for Ms. Camacho

Keja. Id. at 2. Second, immune system activation attributable to “recognition of missing self” also

could not have prompted an autoimmune response due to receipt of the flu vaccine. As Dr.

Fujinami explained, “natural killer cells” triggered in the innate immune response are nonspecific,

and thus attack infected cells regardless of whether the cells express MHC molecules. Id. at 3.

Moreover, the flu vaccine itself is not known to decrease levels of MHC molecules on the surface

of cells, and may in fact actually increase MHC class I and class II expression (thus further

reducing the likelihood this kind of aberrant response could occur after vaccination). Id.

Third, Dr. Zizic’s proposed “recognition of induced self” mechanism, in which markers of

abnormal self that are induced upon infection and cellular transformation are detected and

attacked, does not, in Dr. Fujinami’s view, provide a credible explanation for how autoimmune

disease occurs. As he explained with the example of a wild flu virus infection, the body has the

ability to respond to an infectious process by employing phagocytic cells in an innate response to

clean up cell debris. Fujinami Rep. at 3. Thus, in response to an ongoing infectious process,

affected cells die, releasing their contents into the body, and that debris is in turn cleaned up by

phagocytic cells. But the result of this process is not the development of an autoimmune disease—

and were it otherwise, millions of individuals infected with influenza virus would go on to develop

autoimmune disease. The impact of a vaccine would be no different, Dr. Fujinami noted, observing

that unlike a wild virus, nothing in the flu vaccine can replicate in cells or cause tumors. Id.

Dr. Fujinami also addressed Dr. Zizic’s discussion of “unchecked T-cell and/or B-cell

10See R. Fujinami et al., Molecular Mimicry, Bystander Activation, or Viral Persistence: Infections and Autoimmune

Disease, 19 Clinical Microbiology Rev. 80–81 (2006).

13

reactivity to self-antigens” as a driver of autoimmunity, deeming it irrelevant to this case. Fujinami

Rep. at 3 (discussing Zizic Rep. at 16). There is no corroborative proof from this record, he

maintained, that would suggest Petitioner ever experienced unchecked T and/or B cells responses,

given the extensive clinical work ups and lab tests she underwent. Id. Had this been occurring, the

many physicians who treated Ms. Camacho Keja would most certainly have observed symptoms

reflective of such a process (i.e., inflammation or biomarkers suggestive of it) and recorded it in

the records. Id. at 3-4. Yet, as Dr. Zizic agreed in his own report, test results indicated Petitioner

“had negative ANA, ENA, antiphospholipid antibody panel” and “negative autoimmune tests.” Id.

at 4; Zizic Rep. at 8.

Dr. Fujinami also questioned Dr. Zizic’s theory that genetic polymorphisms in ERAP1 and

ERAP2 could have played a role in the pathogenesis of the autoimmune disease Petitioner is

alleged to have experienced. Fujinami Rep. at 4. As Dr. Fujinami understood it, Dr. Zizic seemed

to be hypothesizing that viral proteins present in the flu vaccine can themselves be improperly

processed due to these genetic variants, thereby going on to cause the kind of joint inflammation

common to Petitioner’s alleged spondyloarthropathy. Id. But, Dr. Fujinami deemed this as not

biologically plausible, because it mischaracterized the understood way in which the body responds

to vaccination. Id. Further, there have been no published reports demonstrating that proteins from

influenza virus can induce an autoimmune response as a result of ERAP1 and ERAP2

polymorphisms. Id.

Finally, Dr. Fujinami discussed how the timing from vaccination to what evidence arguably

established the existence of some clinical disease in this case did not support vaccine causality.

Fujinami Rep. at 4. Dr. Zizic maintained that Petitioner developed autoinflammation resulting in

spondyloarthropathy beginning within 24 hours of vaccination. Zizic Rep. 21-22. But this

timeframe was too short, given what is known about immune response to vaccination. Fujinami

Rep. at 4. The cell-mediated and humoral immune responses that are involved in autoimmune

disease pathogenesis need time to propagate/develop and cause disease following induction. Id. at

5. In support, Dr. Fujinami cited three animal studies in which an experimental autoimmune

disease was induced by injecting peptides or proteins from myelin with powerful adjuvants. Id.

Under the best of circumstances, animals such as mice immunized in this manner developed

clinical signs of disease after a week. Id. (citing A. Abbas et al., Cellular and Molecular

Immunology, Elsevier Saunders, Philadelphia, PA (2015); M. Cusick et al., Human T cell

expansion and experimental autoimmune encephalomyelitis inhibited by Lenaldekar, a small

molecule discovered in a zebrafish screen, 244 J. Neuroimmunol. 35-44 (2012); J. Libbey et al.,

The effects of diet on the severity of central nervous system disease: One part of lab-to-lab

variability, 32 Nutrition 877-883 (2016)). The flu vaccine could not likely have induced

autoimmunity in a fraction of that same timeframe. Id.

14

III. Procedural History

This case was initiated in October of 2017. On June 22, 2018, Respondent filed a Rule 4(c)

Report stating, inter alia, that after review of the petition the case was not appropriate for

compensation under the terms of the Act. ECF No. 23. On June 25, 2018, Special Master Millman

ordered that Petitioner file an expert report and supporting documents by August 24, 2018. See

Docket Entry, dated June 25, 2018. On August 20, 2018, Petitioner filed a Motion for Extension

of Time to File Petitioner’s Expert Report, which was granted. ECF No. 24. On September 21,

2019, Petitioner filed the expert report of Dr. Zizic along with supporting documentation. ECF No.

28-29.

On October 22, 2018, Respondent filed a status report requesting that Petitioner file

additional records. ECF No. 30. Respondent’s informal motion for production was granted, and

Petitioner was ordered to file the requested documents by December 6, 2018. ECF No. 31. On

November 19, 2018 Petitioner filed the requested records or submitted affidavits in respect thereto

as to why the records were unavailable. ECF No. 32.

On March 14, 2019, Respondent filed Dr. Rose’s expert report and supporting

documentation. ECF No. 33. Respondent also requested additional time to file an additional expert

report. ECF No. 34. On May 13, 2019, Respondent filed Dr. Fujinami’s expert report and

supporting documentation. ECF No. 35. Petitioner opted not to file supplement expert reports. On

June 5, 2019, this case was reassigned to Special Master Daniel Horner. On March 30, 2020,

Petitioner submitted a Consent to Change Attorney of Record, which was granted. ECF No. 39.

On July 29, 2020, this case was reassigned to me. ECF No. 40. A status conference was

held on August 4, 2020 in which I instructed the parties to file a Joint Status Report on or before

8/21/2020 regarding their preferred means of case resolution (ruling on the record or hearing), and

if the latter, proposing two mutually-acceptable days between January 1, 2021 and March 31, 2021

for hearing. See Scheduling Order, dated August 4, 2020. In reaction, on August 17, 2020, the

parties filed a Joint Status Report indicating a desire for a ruling on entitlement on the current

record. ECF No. 42. On August 18, 2020, I set deadlines for briefing. See Scheduling Order, dated

Aug. 18, 2020. On September 30, 2020, Petitioner formally moved for a Ruling on the Record and

filed a supporting brief. ECF No. 43. After an extension of time, Respondent filed his response to

Petitioner’s motion. ECF No. 47. The matter is now fully briefed and ripe for resolution.

IV. Parties’ Arguments

Petitioner asserts that she suffers from a diagnosed injury lasting at least six months after

receiving the influenza vaccination on October 17, 2014. Mot. at 15. Petitioner acknowledges that

her various symptoms have resulted in multiple speculative medical theories to explain her specific

15

injury. Id. Nonetheless, Petitioner argues that her treater’s speculations, plus Dr. Zizic’s review

and research, preponderantly establish that she suffers from a rheumatological disease known as

spondyloarthropathy. Id. at 16. Petitioner further argues that her spondyloarthropathy was caused

by her 2014 flu vaccine. Id. According to Petitioner’s expert, Dr. Zizic, the flu vaccine can cause

spondyloarthropathy in predisposed individuals through alterations in peptide processing. Id. at

18-19. Petitioner points to her development of immediate symptoms such as rash, facial edema,

pain, and weight gain as supportive of a cause and effect relationship between the flu vaccine and

her injury and differentiates the similar symptoms Petitioner suffered prior to vaccination, which

she claims were acute or attributable to pregnancy. Id. at 20. Finally, Petitioner argues in the

alternative that if I were to find that she suffered from spondyloarthropathy as a pre-existing

condition, the flu vaccine significantly aggravated the condition. Id. at 23.

Respondent, in contrast, argues that Petitioner has not preponderantly established that she

suffers from an inflammatory arthritis, however specified, or that the flu vaccine caused her alleged

injury. Opp. at 23. Respondent cites medical records establishing that Petitioner’s symptoms pre-

date vaccination, as well as Petitioner’s consistently-negative rheumatology testing as support. Id.

In addition, Respondent highlights that spondyloarthropathy was only considered as a “possible

differential diagnosis” two and a half years after vaccination, but was never confirmed by treaters.

Id. at 24 (citing Ex. 3 at 53). Next, Respondent argues that Petitioner’s theory of causation is

unreliable and unsupported by the medical literature. Id. According to Respondent, 24 hours is

much too soon for an adaptive autoimmune response to manifest as clinical disease, as Dr. Zizic

opines. Id. at 29. Further, Petitioner has failed to explain how vaccination causes that process to

begin in the first place. Id. at 30. Finally, Respondent argues that Petitioner has not established

significant aggravation of a preexisting condition because she has provided no relevant theory and

her pre-existing condition appears to be lymph node related rather than arthritic. Id. at 32.

V. Applicable 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 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §

11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed.

Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006). In

this case, Petitioner does not assert a Table claim.

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

16

of the evidence” burden of proof. Section 13(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 Enter. 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 & Hum. 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 & Hum. Servs., 165 F.3d 1344,

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

Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on 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. Sec’y of Health & Hum. 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.”

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 & Hum. 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 & Hum. 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 evidence

standard.” Andreu, 569 F.3d 1367, 1380. Accordingly, special masters must take care not to

increase the burden placed on petitioners in offering a scientific theory linking vaccine to injury.

The Federal Circuit has consistently rejected the contention that the first Althen prong can

be satisfied merely by establishing a proposed causal theory’s scientific or medical plausibility.

17

See Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also

LaLonde v. Sec’y of Health & Hum. Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014) (“[h]owever, in

the past we have made clear that simply identifying a ‘plausible’ theory of causation is insufficient

for a petitioner to meet her burden of proof.” (citing Moberly, 592 F.3d at 1322)). Rather, this

prong (like the other two) requires a preponderant showing. This naturally flows from the

overarching fact that Program petitioners always have the ultimate burden of establishing their

claim with preponderant evidence. W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1356

(Fed. Cir. 2013) (citations omitted); Tarsell v. United States, 133 Fed. Cl. 782, 793 (2017) (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; Andreu,

569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Hum. 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 (“medical records and medical opinion testimony are favored

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

‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”)

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

trustworthy evidence, since they are created contemporaneously with the treatment of the patient.

Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

Medical records and statements of a treating physician, 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 & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates

that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and

cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the

opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their

suppositions or bases. The views of treating physicians should be weighed against other, contrary

evidence also present in the record—including conflicting opinions among such individuals.

Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious

for special master to weigh competing treating physicians’ conclusions against each other), aff’d,

698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Dept. of Health & Hum. 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 opinion, 475 F. Appx. 765 (Fed. Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between

18

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 & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what

is a medically acceptable timeframe must align with the theory of how the relevant vaccine can

cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Hum.

Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand, 105 Fed. Cl. 353 (2012), aff’d

mem., 503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V,

2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. denied (Fed. Cl. Dec. 3,

2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Significant Aggravation Claims

Besides arguing that the flu vaccine directly caused her injuries, Petitioner’s brief proposes

that the same vaccine may have significantly aggravated a preexisting, if mild, autoimmune

disorder. Mot. at 23. Where a petitioner so alleges, the Althen test is expanded, and the petitioner

has additional evidentiary burdens to satisfy. See generally Loving v. Sec’y of Health & Hum.

Servs., 86 Fed. Cl. 135, 144 (2009). In Loving, the Court of Federal Claims combined the Althen

test with the test from Whitecotton v. Sec’y of Health & Hum. Services, 81 F.3d 1099, 1107 (Fed.

Cir. 1996), which related to on-Table significant aggravation cases. The resultant “significant

aggravation” test has six components, which require establishing:

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

condition (or the condition following the vaccination if that is also pertinent), (3) whether

the person’s current condition constitutes a “significant aggravation” of the person’s

condition prior to vaccination, (4) a medical theory causally connecting such a

significantly worsened condition to the vaccination, (5) a logical sequence of cause and

effect showing that the vaccination was the reason for the significant aggravation, and (6)

a showing of a proximate temporal relationship between the vaccination and the

significant aggravation.

Loving, 86 Fed. Cl. at 144; see also W.C., 704 F.3d at 1357 (holding that “the Loving case provides

the correct framework for evaluating off-table significant aggravation claims”). In effect, the last

three prongs of the Loving test correspond to the three Althen prongs.

In Sharpe v. Sec’y of Health & Hum. Servs., 964 F.3d 1072 (Fed. Cir. 2020), the Federal

Circuit further elaborated on the Loving framework. Under prong (3) of the Loving test, a petitioner

need not demonstrate an expected outcome, but merely that her current-post vaccination condition

is worse than pre-vaccination. Sharpe, 964 F.3d at 1081. And a claimant may make out a prima

19

facie case of significant aggravation overall without eliminating an associated alternative cause of

her significantly aggravated injury (although the Circuit did not alter the ability of Respondent to

so prove after the burden shifts). Id. at 1083.

C. Legal Standards Governing Factual Determinations

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 & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is

within the special master’s discretion to determine whether to afford greater weight to

contemporaneous medical records than to other evidence, such as oral testimony surrounding the

events in question that was given at a later date, provided that such determination is evidenced by

a rational determination).

Medical records 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; Doe/70 v. Sec’y of Health & Hum. Servs., 95 Fed.

Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his

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

records was rational and consistent with applicable law”), aff’d sub nom. Rickett v. Sec’y of Health

& Hum. Servs., 468 F. Appx. 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 & Hum. Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr.

Apr. 10, 2013); Cucuras v. Sec’y of Health & Hum. 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 & Hum. 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

20

where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also

Murphy v. Sec’y of Dep’t of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991) (citing United States

v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral

testimony which is in conflict with contemporaneous documents is entitled to little evidentiary

weight.”)).

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

written records, such as where records are deemed to be incomplete or inaccurate. Campbell v.

Sec’y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common

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

predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“’[w]ritten

records which are, themselves, inconsistent, should be accorded less deference than those which

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

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

be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,

1575 (Fed. Cir. 1993).

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 & Hum. 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 records and later

testimony: (1) a person’s failure to recount to the medical professional everything that happened

during the relevant time period; (2) the medical professional’s failure to document everything

reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony;

or (4) a person’s purposeful recounting of symptoms that did not exist. Lalonde v. Sec’y of Health

& Hum. Servs., 110 Fed. Cl. 184, 203–04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making

a determination regarding whether to afford greater weight to contemporaneous medical records

or other evidence, there must be evidence that this decision was the result of a rational

determination. Burns, 3 F.3d at 417.

D. 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 & Hum. Servs., 219 F.3d 1357,

1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the

factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharmaceuticals,

Inc., 509 U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328,

1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed.

21

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

& Hum. Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have

been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of

expert testimony already admitted”). The flexible use of the Daubert factors to evaluate 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.

A special master’s decision may be “based on the credibility of the experts and the relative

persuasiveness of their competing theories.” Broekelschen v. Sec’y of Health & Hum. Servs., 618

F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe, 219 F.3d at 1362). However, nothing requires the

acceptance of an expert’s conclusion “connected to existing data only by the ipse dixit of the

expert,” especially if “there is simply too great an analytical gap between the data and the opinion

proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997));

see also Isaac v. Sec’y of Health & Hum. Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed.

Cl. Spec. Mstr. July 30, 2012), mot. for rev. denied, 108 Fed. Cl. 743 (2013), aff’d, 540 F. Appx.

999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339). Weighing the relative persuasiveness of

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 (“[a]ssessments as to the reliability of expert testimony often turn on credibility

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

Cir. 2011) (“this court has unambiguously explained that special masters are expected to consider

the credibility of expert witnesses in evaluating petitions for compensation under the Vaccine

Act”).

Expert opinions based on unsupported facts may be given relatively little weight. See

Dobrydnev v. Sec’y of Health & Hum. Servs., 556 F. Appx. 976, 992–93 (Fed. Cir. 2014) (“[a]

doctor’s conclusion is only as good as the facts upon which it is based”) (citing Brooke Group Ltd.

22

v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993) (“[w]hen an expert assumes

facts that are not supported by a preponderance of the evidence, a finder of fact may properly reject

the expert’s opinion”)). Expert opinions that fail to address or are at odds with contemporaneous

medical records may therefore be less persuasive than those which correspond to such records. See

Gerami v. Sec’y of Health & Hum. Servs., No. 12-442V, 2013 WL 5998109, at *4 (Fed. Cl. Spec.

Mstr. Oct. 11, 2013), aff’d, 127 Fed. Cl. 299 (2014).

E. Consideration of Medical Literature

Petitioner has 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 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. Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016)

(“[w]e 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 & Hum. Servs., 527 F. Appx. 875, 884 (Fed. Cir. 2013) (“[f]inding

certain information not relevant does not lead to—and likely undermines—the conclusion that it

was not considered”).

F. Consideration of Comparable Special Master Decisions

In reaching a decision in this case, I have taken into account other decisions issued by

special masters (including my own) 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 such prior determinations impact my thinking on the present case.

There is no error in doing so. It is certainly correct that prior decisions from different cases

do not control the outcome herein. 11 Boatmon, 941 F.3d at 1358–59; Hanlon v. Sec’y of Health &

Hum. 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.

11

By contrast, Federal Circuit rulings concerning legal issues are generally binding on special masters in all cases.

Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121, 124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see

also Spooner v. Sec’y of Health & Hum. 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.

23

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 & Hum. 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 therefore 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. 12 Even if the

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

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

G. Evaluation of Expert Credentials and Professional Competence

It is common in Program cases for special masters to evaluate competing expert opinions

when deciding non-Table claims—and that process can be very difficult when the experts are

equally well-credentialed and qualified to provide the opinion offered. Under such circumstances,

resolution of a claimant’s success in establishing causation turns on the comparative reliability of

the scientific/medical contentions each side makes, rather than a measure of each particular

expert’s baseline qualifications against the other. See, e.g., D'Tiole v. Sec'y of Health & Hum.

Servs., No. 15-085V, 2016 WL 7664475, at *20 (Fed. Cl. Spec. Mstr. Nov. 28, 2016)

(determination that causation theory was unreliable did not arise from adequacy of Petitioner’s

expert, who was expressly deemed well-qualified to provide the opinion given), mot. for review

den’d, 132 Fed. Cl. 421 (2017), aff'd, 726 F. App'x 809 (Fed. Cir. 2018).

In other circumstances, however, weighing the probative value of an expert’s opinion fairly

takes into account that same expert’s qualifications or professional experience. This is most

obviously necessary when an expert offers an opinion that plainly exceeds his training or

individual competence. Domeny v. Sec’y of Health & Hum. Servs., No. 94-1086V, 1999 WL

12

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

receipt of 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.

24

199059, at * 15 (Fed. Cl. Spec. Mstr. Mar. 15, 1999) (dentist not qualified to offer diagnostic

opinion on whether petitioner had experienced a neuropathy), mot. for review den’d, slip op., May

25, 1999 (Fed. Cl.), aff’d, 232 F.3d 912 (Fed. Cir. 2000). But it can even be an issue with experts

who possess immense and impressive credentials, and who in prior cases may have offered reliable

opinions. See, e.g., Rolshoven v. Sec'y of Health & Hum. Servs., No. 14-439V, 2018 WL 1124737,

at *21 (Fed. Cl. Spec. Mstr. Jan. 11, 2018) (otherwise-competent expert with significant Vaccine

Program undermined his credibility in part with constant commentary about relevant legal

standards to be applied in case).

H. Determining Entitlement Via Ruling on the Record

In accordance with the parties’ agreement and my own assessment of how to best decide

this case, I am resolving Petitioner’s claim on the papers rather than via hearing. The Vaccine Act

and Rules not only contemplate but encourage special masters to decide petitions on the papers

where (in the exercise of their discretion) they conclude that doing so will properly and fairly

resolve the case. Section 12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu

of hearing has been affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d

1362, 1366 (Fed. Cir. 2020); see also Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V,

2016 WL 3456435, at *21 n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where

special masters decided case on the papers in lieu of hearing and that decision was upheld). I am

simply not required to hold a hearing in every matter, no matter the preferences of the parties.

Hovey v. Sec’y of Health & Hum. Servs., 38 Fed. Cl. 397, 402–03 (1997) (determining that special

master acted within his discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy

v. Sec’y of Health & Hum. Servs., No. 90-882V, 1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr.

19, 1991).

ANALYSIS

I. The Record Does Not Support Spondyloarthropathy as Petitioner’s Injury

It is well-recognized by Program precedent that determining the existence of an alleged

injury is often a necessary preliminary step to conducting the Althen analysis—for there can be

no vaccine injury claim without proof of injury. Broekelschen, 618 F.3d at 1346. Here, such an

analysis is required to evaluate the nature of Petitioner’s post-vaccination condition—and, in

particular, whether it factually lines up with her own contentions or her expert’s opinion.

Petitioner specifically alleges that the flu vaccine caused her to develop some kind of

spondyloarthropathy (See, e.g., Br. at 19). The spondyloarthropathies (“SpAs”) are a family of

degenerative inflammatory joint disorders, include AS, reactive arthritis, and psoriatic arthritis.

Dorland’s Illustrated Medical Dictionary 1754 (33rd ed. 2020) (“Dorland’s”). AS (which Dr.

Zizic seemed at times to embrace as a possible specific diagnosis for Petitioner) is specifically

25

“characterized by inflammatory back pain, restricted spinal mobility, peripheral arthritis,

enthesitis, and uveitis.” P.S. v. Sec’y of Health & Hum. Servs., No. 16-834V, 2020 WL 5351333,

at *20 (Fed. Cl. Spec. Mstr. May 15, 2020).

Petitioner has not, however, established that she in fact suffers from a

spondyloarthropathy. First, no treater ever so diagnosed her. At best, treaters included that

diagnosis in their differentials as a possibility, although it was never definitively embraced, and

also proposed it well after vaccination, but without adequate explanation for how her overall

clinical picture made it a reasonable diagnosis. See, e.g., Ex. 3 at 53 (spondyloarthropathy

proposed in April 2017—more than two years post-vaccination). Indeed, Petitioner’s treating

physicians appear to have struggled to determine any diagnosis for her constellation of symptoms,

and their assessments appear in some cases to have been based on Petitioner’s self-reported

history. See, e.g., Ex. 2 at 106 (Petitioner reported to her treated on December 4, 2014 “that the

first time she received the seasonal flu vaccine was last year [2013].”); Ex. 2 at 108 (On December

4, 2014, Petitioner’s treater noted, “[t]his is a very complicated case”); Ex. 3 at 53 (“[a]t this point

[April 18, 2017], I am starting to wonder if the inflammatory arthritis that she has is related to

some form of underlying spondyloarthropathy especially with this new [foot] rash…”). Their

speculation never coalesced in any meaningful way into a record-supported diagnosis that would

frame the nature of her claimed injury.

Second, the alleged diagnosis lacks preponderant record support. Testing performed on

Petitioner consistently did not display the biomarkers, specific symptoms, or kinds of

inflammation associated with an autoimmune arthritic condition. Rose Rep. at 18-20. In addition,

while the record does establish that Petitioner experienced a wide variety of post-vaccination

symptoms, and that treaters often speculated about possible diagnostic explanations for them,

they are not specific for any kind of spondyloarthropathy. Nothing about Petitioner’s persistent

lymph node issues or edema have a clear association with some kind of inflammatory arthritic

condition, nor has Petitioner shown otherwise. Rather, Petitioner’s joint swelling and edema on

ultrasound was subcutaneous—hence not related to joint inflammation. Id. at 22, 23

(subcutaneous edema is “not a component of the clinical findings in spondyloarthropathies”); Ex.

3 at 96. And the record better supports weight-related chronic venous insufficiency as a cause of

Petitioner’s edema, given its nature and location. Rose Rep. at 18-19.

At times in his report, Dr. Zizic seems to have favored AS for the SpA variant Ms.

Camacho Keja possessed, and tied it to one of his proposed mechanisms. See Zizic Rep. at 19,

21 (deeming it “biologically plausible that influenza vaccination in the genetically susceptible

host, with specific polymorphisms in ERAP1 and/or ERAP2 could result in altered peptide

processing with the generation of arthritogenic peptides resulting in ankylosing spondylitis

(spondyloarthropathy)”). But there is no record evidence Petitioner possessed the particular

26

biomarker most associated with it. The HLA-B27 biomarker 13 is found present in about 80–95

percent of patients with AS, although it is also present in six percent of the general U.S.

population (and less than five percent of Caucasians who are positive for the biomarker also have

an SpA). As a result, although a positive test for HLA-B27 alone is not diagnostic of AS, its

absence is credible evidence against the diagnosis. Godfrey v. Sec’y of Health & Hum. Servs.,

No. 10-565V, 2015 WL 10710961, at *2–3 (Fed. Cl. Spec. Mstr. Oct. 27, 2015), mot. for review

denied, slip op., Apr. 29, 2016 (ECF No. 109).

But in Petitioner’s case, lab testing for any rheumatic biomarkers was consistently

negative. See, e.g., Ex. 2 at 162 (after analysis of repeat blood work, Petitioner’s rheumatology

consult explained on April 28, 2015 that Petitioner lacked the diagnostic criteria that would

suggest the existence of an autoimmune rheumatic process); Ex. 2 at 202 (August 4, 2015 visit

with Dr. Surapaneni); Ex. 3 at 97 (“no ultrasound evidence of inflammatory arthritis”); Rose Rep.

at 19-20 (Dr. Rose explaining that higher CRP levels are normal in persons with a high BMI, like

Petitioner). And there is nothing in the record indicating that Petitioner ever tested positive for

HLA-B27—or that treaters ever thought such testing was in fact warranted.

Finally, other evidence that would support a diagnosis like AS or some other form of

spondyloarthropathy is missing from this record. For example, radiographic evidence of changes

in the sacroiliac joint is considered a diagnostic criterion for AS. P.S., 2020 WL 5351333, at *20.

But as pointed out by Dr. Rose in his expert report and discussed above, Petitioner underwent a

CT scan of the abdomen and pelvis on October 27, 2015, which showed no abnormalities. Ex. 2

at 228. And Petitioner’s osseous structures revealed no changes. Rose Rep. at 15. As Dr. Rose

persuasively proposed, such findings allowed the reasonable inference that there was no fluid on

the hip or involvement of the sacroiliac joints at this time. Id.

At best, Petitioner’s self-reported medical history and affidavits as well as the medical

record following the 2014 flu vaccination suggest that she may have suffered from a transient,

serum sickness-like reaction 14 to the flu vaccine. 15 Although there is no record evidence to

corroborate her contention, and no diagnosis of reactive arthritis either, Petitioner reports having

had a similar reaction after her receipt of the flu vaccine in 2013, describing “nonspecific

13

HLA-B27 is a genetic marker showing susceptibility to conditions such as ankylosing spondylitis. See Godfrey v.

Sec’y of Health & Hum. Servs., No. 10-565V, 2015 WL 10710961, at *5 (Fed. Cl. Spec. Mstr. Oct. 27, 2015), mot.

for review denied, slip op., Apr. 29, 2016 (ECF No. 109).

Serum sickness in association with vaccination can manifest with symptoms such as joint pain, edema, and fever.

14

Dorland’s at 1678.

15

See Hock v. Sec.’y of Health & Hum. Servs., No. 17-168V, 2020 WL 6392770, at *25 (Fed. Cl. Spec. Mstr. Sept.

30, 2020) (petitioner did not preponderantly establish he had rheumatoid arthritis beginning a day after vaccination;

his symptoms were instead far more consistent with a transient, reactive arthritis brought on by serum sickness that,

even if vaccine-induced, resolved within two months).

27

symptoms including fatigue, mild fever or rash, [and] arthralgias after flu shot.” Ex. 2 at 202.

And after a consideration of Petitioner’s history, treater Dr. Surapaneni “wondered” if she had in

fact experienced a serum sickness or serum sickness-like reaction to vaccination. Id. But this

putative reaction has not been preponderantly established to be associated with any of Petitioner’s

other symptoms or to be the precursor for a spondyloarthritis, and I conclude from the record that

if serum sickness occurred, it likely resolved well short of the six-month period required to

establish severity in Program cases. See Section 11(c)(1)(D); Watts v. Sec’y of Health & Hum.

Servs., No. 17-1494V, 2019 WL 4741748 at *3 (Fed. Cl. Spec. Mstr. Aug. 13, 2019).

As a result of the above, Petitioner’s inability to establish she in fact suffered from a

spondyloarthropathy as alleged (and as relied upon in her causation theory) is fatal overall to her

claim.

II. Petitioner Has Not Carried her Burden of Proof

In addition to not substantiating her alleged injury with preponderant evidence, Petitioner

has not met her Althen burden.

First, the “can cause” element of the Althen test was not satisfied by Dr. Zizic’s opinion.

As discussed above, Dr. Zizic’s proposed mechanisms for how the flu vaccine might propagate

an autoimmune disease were, as noted by Respondent in his brief, a “mismatch of immunological

concepts and research that have no bearing on explaining alleged vaccination causation

specifically in this case.” Opp. at 25. Thus, as Dr. Fujinami persuasively demonstrated, these

mechanisms were speculative or did not fully align with what is known by medical science about

how the immune system actually responds to vaccines. Arguments about the possibility of a

misprocessing of vaccine-containing proteins, for example, due to a genetic variant/mutation

were insufficiently linked to vaccination (and it was not even demonstrated that Ms. Camacho

Keja possessed that variant in the first place). In addition, Petitioner offered little in the way of

persuasive evidence linking the flu vaccine to any form of spondyloarthropathy, beyond case

reports (which inherently receive less weight) 16 involving reactive arthritis. Dr. Zizic’s vouching

for the concept did not gain heft from any demonstrated expertise with rheumatologic diseases

he possesses.

The second Althen prong (which looks for evidence that the vaccine at issue actually

caused the alleged injury, consistent with the proposed causal theory) has similarly not been

satisfied. As discussed above, much of Petitioner’s post-vaccination symptomology predated

vaccination or is not associated with SpA specifically. A year before the vaccination in question,

Petitioner was seen on December 6, 2013 for lymphadenitis by her primary care physician and

by otolaryngology on December 17, 2013. Ex. 2 at 38-39, 101. There was no reference to her

16

See Campbell, 97 Fed.Cl. at 668 (case reports “do not purport to establish causation definitively, and this

deficiency does indeed reduce their evidentiary value.”).

28

2013 flu shot (the occurrence of which is based entirely on Petitioner’s report) or any wider issues

proposed. Id. Then, after her October 17, 2014 flu vaccination, on October 27, 2014, Petitioner’s

primary care provider noted: “[P]atient is now worried about the constellation of [symptoms] she

is having that have been ongoing for the last 6 mo[nths] at least…” Ex. 2 at 31. Her skin

conditions were also longstanding and did not develop after vaccination. Ex. 2 at 150 (“the rash

comes and goes for years now”); 156 (ulcerating rash that had been present since childhood, as

well as eczema on her right plantar foot that had been present for about two years). No showing

was made to associate these kinds of symptoms with either the flu vaccine or the development of

a subsequent spondyloarthropathy.

There is also insufficient evidence of a systemic reaction to vaccination. The main alleged

presenting injury at Petitioner’s first medical visit after her 2014 vaccination was localized

swelling of her “left submandibular node (2 cm in size, firm, tender, mobile),” a common ailment

of Petitioner pre-vaccination. Ex. 2 at 33. The assessment was: “Lymphadenopathy.” Id. at 34.

While this is comparable to her alleged 2013 reaction, it is not consistent with the theory that the

flu vaccine caused her to experience SpA. The next day, on October 28, 2014, Petitioner went to

York Hospital emergency department with the following history: “38-year-old female presents

with left calf pain, facial swelling. Symptoms off-and-on for two weeks. Did have some swelling

prior to getting flu shot.” Ex. 43 at 2. Petitioner also reported a previous similar reaction to a 2013

flu shot and her symptoms subsided after a 5-day course of Prednisone. Id. This close-in-time

reaction Petitioner asserts was the result of the flu shot however, appears to have subsided

relatively quickly. Exam records show that by a November 4, 2014 visit, Petitioner had +1 pedal

edema (Ex. 2 at 28) and by December 3, 2014 only “trace pedal edema” was noted. Ex. 2 at 25.

The evidence in this case does not preponderate in support of the conclusion that

Petitioner’s symptoms only began after her October 17, 2014 vaccination. The most probable

explanation is that Petitioner’s issues long predated the vaccinations at issue in this case. Thus,

the flu vaccine could not have caused them.

Finally, Petitioner cannot demonstrate that the flu vaccine can cause the symptoms

Petitioner experienced within 24 hours of vaccination. Dr. Zizic’s theory, to work, depends on a

finding that the immediate, innate response to vaccination would drive a pathologic condition in

Petitioner leading to her purported spondyloarthropathy. Zizic Rep. at 21. The adaptive arm of

the immune response could not be the primary force for the proposed disease process, as Dr.

Fujinami established, since it inherently takes longer for the secondary production of B cells or

T cells implicated in that segment of an immune reaction. Fujinami Rep. at 4-6. Dr. Zizic fully

agreed (although in so doing he purported to characterize SpA as having less to do with an

adaptive response, despite its chronic character). Zizic Rep. at 19 (“[t]he lack of classic

autoimmune features leads to the hypothesis that adaptive immune responses are not of primary

importance in SpA”).

29

However, even if inflammation related to the innate immune response is clinically

relevant to spondyloarthropathy, Dr. Zizic failed to explain how vaccination causes this process

to begin in the first place, and then how it could evolve into those symptoms construed as

spondyloarthritic in nature. Rather, Dr. Zizic speculated that it was the downstream effects of

vaccination, where the vaccine somehow causes the “generation of arthritogenic peptides” that

result in disease. Zizic Rep. at 21. Again, such contentions were conclusory, scientifically

unreliable, and/or not corroborated by the actual medical record. Based on that record and the

lack of explanation and support for Dr. Zizic’s theory, it is more likely than not that Petitioner

experienced at most a transient reaction to the flu vaccine rather than the beginning of a

spondyloarthropathy.

III. Petitioner’s Significant Aggravation Claim Lacks Preponderant Support

Petitioner’s Motion for a Ruling on the Record proposes a significant aggravation claim

as an alternative basis for entitlement, based on the contention that her pre-vaccination symptoms

reflected an underlying, nascent spondyloarthropathy that the vaccine worsened. Mot at 23-25.

But Petitioner has failed to carry her burden of proving by a preponderance of the evidence that

the Loving prongs are all met, given the medical record in this case as well as deficiencies in

Petitioner’s causation theory previously discussed.

An immediate obstacle to succeeding on a significant aggravation claim in this case, as

Dr. Rose observed, is the fact that Petitioner’s pre-vaccination health issues seem to have been

dominated by symptoms distinguishable from her claimed injury. The record shows that before

October 2014, Petitioner had numerous medical complaints associated with her lymph nodes, not

rheumatic-like arthritic inflammation. Rose Rep. at 10. Thus, on August 30, 2010, Ms. Camacho

Keja was seen by an ENT specialist from York ENT Associates for submental swelling since late

April of that year which had been worsening in the previous weeks. Id. (citing Ex. 18). An indirect

laryngoscopy was negative and a biopsy of the node was obtained revealing “reactive adenitis.”

Id. Her submental lymphadenitis recurred at the end of 2013, this time preceded by a sore throat.

Id. at 11.

Then, on October 21, 2014 (eight days after vaccination), Petitioner was seen by her

primary care physician with complaints of a solitary skin lesion of concern located on the left

side of her chin, with an assessment of “[a]cute lymphadenitis on exam.” Ex. 2 at 33. Six days

later, Petitioner had a follow-up visit in which the record notes Petitioner had some “generalized

lymphandenopathy” a few days after receiving her flu vaccine,” but which was responsive to

prednisone. Id. at 38. This record also notes that Petitioner “was now worried about the

constellation of [symptoms] she is having that have been ongoing for the last 6 mo[nths] at least

and also with this new lymph node.” Id.

Such a symptoms timeline does not support a finding that the flu vaccine triggered a

noticeable worsening of a pre-existing SpA. Rather, the records indicate that Petitioner was

30

already experiencing worsening for some time prior to her 2014 vaccination – and in association

with lymph-related issues that have not in this case credibly been linked to SpA. She therefore

cannot preponderantly establish that the tempo of worsening so increased post-vaccination that

the third Loving prong is met. 17 At best, the post-vaccination reaction was merely equivalent to

the transient reaction Petitioner reported after her 2013 vaccination (assuming for sake of

argument that the record in its present form better established both the 2013 vaccination and

Petitioner’s purported reaction). It otherwise has not been preponderantly demonstrated, as

discussed above, that Petitioner had any form of spondyloarthropathy pre-2014 vaccination that

could have been worsened.

Moreover, even if (under the liberalized version of Loving that the Federal Circuit seems

to have embraced in Sharpe) I conclude generally that overall Ms. Camacho Keja was “worse”

after her 2014 vaccination (based simply on the fact that she had more reported symptoms

thereafter) such that the first three Loving prongs are deemed to have been met, prongs four to

six (which correspond to the three Althen prongs) have not been satisfied, for the reasons already

stated. In particular, insufficient preponderant evidence suggests that the flu vaccine could

worsen spondyloarthropathy, or that it did so in this case. Petitioner has not linked any transient,

lymph node-oriented issues that she might have experienced after her vaccination with her

purported spondyloarthropathy. Thus, after a thorough review of the medical records and filings,

Petitioner has not preponderantly proven that any underlying condition she suffered from,

however characterized, was significantly aggravated by the 2014 flu vaccine.

Conclusion

Despite being unable to offer a persuasive theory on causation, Petitioner’s claim has some

evidentiary basis. She may have suffered from some type of transient vaccine reaction, and her

overall health has been consistently problematic, prompting her reasonably to seek treatment.

Treaters clearly struggled to define the nature of her condition, and some ultimately speculated

that she could have some form of spondyloarthropathy. But she was never diagnosed with the

injuries she claims to have been vaccine caused, the record does not support her preferred

diagnosis, and her expert’s theory was not persuasive or sufficiently supported by independent

reliable scientific or medical evidence. As a result, I am compelled to DISMISS the claim.

17

In reaching this conclusion, I am not considering if Petitioner has shown that her overall course is comparatively

worse than what an average case of SpA would look like. Rather, I am observing, after record review, that the evidence

does not establish that her post-vaccination state was so much different from pre-vaccination to meet the requirements

of the third Loving prong—especially since her symptoms have not even been associated with spondyloarthropathy in

the first place. See, e.g., Ex. 2 at 33 (Petitioner’s primary complaint to her primary provider (Dr. Desi) on October 21,

2014, four days after vaccination, was lymph-node related, a condition for which petitioner had extensive workup in

the past; On October 27, 2014, lymphadenopathy was again the primary complaint, and at that time, petitioner reported

a “constellation of [symptoms] … that have been ongoing for the last 6 mo[nths] at least.”

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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 accordance with this decision.18

IT IS SO ORDERED.

s/Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

18

Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their

right to seek review.

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