# Schwarz v. Secretary of Health and Human Services

> United States Court of Federal Claims · June 4, 2024

URL: https://www.frixlaw.com/law-library/cases/10735131

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** June 4, 2024
- **Precedential status:** Unpublished
- **Opinion:** Opinion
- **Judges:** Katherine E. Oler
- **Cited by:** 0 later opinions in the Frix Law Library

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## Opinion text

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 18-619V
Filed: May 1, 2024

************************* *
*
MICHAEL SCHWARZ, *
*
Petitioner, *
*
v. *
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
Respondent. *
*
************************* *

Richard Gage, Richard Gage, P.C., Cheyenne, WY, for Petitioner
Catherine Stolar, U.S. Department of Justice, Washington, DC, for Respondent

RULING ON ENTITLEMENT1

Oler, Special Master:

On May 1, 2018, Michael Schwarz (“Petitioner”) filed a petition for compensation under
the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq.2 (the “Vaccine
Act” or “Program”). The petition alleges that Mr. Schwarz developed transverse myelitis (“TM”)
as a result of the tetanus, diphtheria, and acellular pertussis (“Tdap”) vaccine he received on May
20, 2015. Pet. at 2. After the entitlement hearing held on May 18, 2022, Petitioner clarified that

1
Because this Ruling contains a reasoned explanation for the action in this case, it must be made publicly
accessible and will be posted on the United States Court of Federal Claims’ website, and/or at
https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act
of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government
Services). This means the Ruling will be available to anyone with access to the internet. In accordance with
Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information, the
disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the
identified material fits within this definition, I will redact such material from public access.
2
National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa
(2012).

1
the Tdap vaccine caused him to develop a severe inflammatory reaction characterized by
arthralgias. Pet’r’s Post-Hearing Brief at 1; Pet’r’s Post-Hearing Reply at 3 (reiterating that “Mr.
Schwarz has arthralgias that were caused by the vaccine.”). Although several different injuries
were raised in the expert report and at the entitlement hearing, Petitioner confirmed that he was
not alleging an injury of transverse myelitis, brachial neuritis, or chronic fatigue syndrome
(“CFS”). Id.

Upon review of the evidence submitted in this case, I find that Petitioner has demonstrated
he developed arthralgias post vaccination, and that the Tdap vaccine caused this condition.
Petitioner is entitled to compensation.

I. Procedural History

Petitioner filed his petition on May 1, 2018. Pet., ECF No. 1. He filed medical records on
July 2, 2018 and August 1, 2018 followed by a statement of completion. ECF Nos. 9-12.

Respondent filed his Rule 4(c) Report on April 29, 2019 indicating that the case was not
appropriate for compensation under the Vaccine Act. Resp’t’s Rep. at 1; ECF No. 19.

Petitioner then filed additional medical records and his social security disability file. Exs.
9-14, ECF No. 21; Ex. 15, ECF No. 23. Petitioner filed an expert report from Dr. Yuval Shafrir on
March 30, 2020. Ex. 16; ECF No. 33.

On December 4, 2020, Respondent filed a responsive expert report from Dr. Michael
Wilson. Ex. A; ECF No. 41.

Petitioner then indicated that he wanted to schedule the case for an entitlement hearing.
ECF No. 45. After receiving input from the parties, I scheduled the case for a hearing to take place
on May 18-May 19, 2022. See non-PDF Scheduling Order dated August 3, 2021.

I conducted an entitlement hearing on May 18-19, 2022. Petitioner filed a post-hearing
brief on September 30, 2022. ECF No. 62. Respondent filed a response on January 30, 2023. ECF
No. 64. Petitioner filed a reply brief on March 16, 2023. ECF No. 65. The parties indicated the
record was complete on April 6, 2023. ECF No. 70. This matter is now ripe for adjudication.

II. Medical Records

On May 1, 2015, prior to Petitioner’s Tdap vaccination, Petitioner visited the Walla Walla
Clinic to establish care with Dr. Michael Wilcox, his new primary care physician (“PCP”). Ex. 1
at 9. Petitioner’s history of present illness (“HPI”) describes a five day history of a respiratory
illness with sinus congestion, purulent nasal drainage, fever, and malaise. Id. Petitioner reported
that he had a “long history of fatigue that worsened significantly over the last 4 or 5 months…
[and] some associated night sweats insomnia.” Id. Dr. Wilcox recommended an Adacel vaccine
when Petitioner recovered from his present illness. Id. at 11.

Petitioner received a Tdap vaccine at the Walla Walla Clinic on May 20, 2015. Ex. 8.
2
On May 22, 2015, Petitioner presented to the Adventist Health Walla Walla General
Hospital emergency department complaining of neck pain and stiffness that had progressively
worsened throughout the day as well as difficulty moving his right hand. Ex. 1 at 22. Petitioner
noted that his pain was radiating from his bilateral anterior chest, shoulders, and jaw, and was
exacerbated by movement. Id. The doctor diagnosed Petitioner with an acute strain of his neck
muscle. Id. at 24. Petitioner’s upper extremity reflexes were 2+ on the left and 1+ on the right. Id.
He also had tenderness to palpation over the anterior shoulder girdle and pain with arm elevation.
Id. The record documented a consult with an infectious disease doctor; the infectious disease
doctor opined: “[patient] could not have contracted tetanus from booster as it is a killed vaccine,
and it is highly unlikely [patient] contracted tetanus in absence of wound. Recommends [lumbar
puncture] to evaluate for possible meningitis and consider other sources.” Id. Petitioner’s blood
test revealed an elevated white blood cell count. Id. at 28.

The next day, on May 23, 2015, Petitioner presented to Providence St. Mary Medical
Center emergency department complaining of neck stiffness and bilateral hand weakness and pain.
Ex. 1 at 31-33. Petitioner reported onset as two days ago, that his arms were weak, and that he was
experiencing pain and stiffness in his hands. Id. Petitioner also reported ongoing fatigue problems
dating back to the beginning of spring. Id. His reflexes were 1+ in the upper extremities and 3+ in
the lower extremities. Id. at 33. Petitioner’s C-reactive protein (“CRP”) level was high; it measured
at 90.70 (reference range ≤ 3.0 mg/L). Id. at 36. His white blood count was also high at 13.8
(reference range 4.0-11.0 kK/uL). Id. at 34. The doctor noted “most likely this is an inflammatory
reaction to the tetanus shot he received” and the final impression was “polyarthralgia and bilateral
arm weakness.” Id. at 33.

Petitioner returned to his PCP Dr. Wilcox on May 26, 2015. Dr. Wilcox noted that
Petitioner was taking lorazepam for his insomnia. Ex. 1 at 39. On physical examination, Petitioner
had an erythema and swelling of his left forefinger and he noted pictures from Petitioner’s cell
phone of a migratory erythematous rash. Id. at 40. Dr. Wilcox wrote, “It appears that he is suffering
from a reaction to his Adacel vaccination. His current symptoms are reported side effects and he
has had extensive evaluation otherwise… I recommended a tapering course of prednisone…
Continue lorazepam as needed for insomnia.” Id.

Petitioner returned to Dr. Wilcox on June 5, 2015. Ex. 1 at 42-44. Dr. Wilcox assessed
Petitioner as having “arthralgia of multiple sites” and noted that he was experiencing “[c]ontinued
generalized and migratory arthralgias following a tetanus vaccination. We discussed alternative
inflammatory conditions such as palindromic rheumatism or others. His clinical course continues
to be most suggestive of a reaction to his vaccination. He initially did well on the higher dose of
prednisone…. If responding, we will set out a slower, more gradual prednisone taper.” Id. at 43.

On June 30, 2015, Petitioner was seen at Adventist Health by Dr. Cloise Moore. Ex. 1 at
45-46. Dr. Moore noted that Petitioner was being tapered from prednisone but was looking for
other treatments to hasten his recovery. Id. at 45. Dr. Moore assessed a “probable reaction to the
[Tdap]” vaccine. Id.

3
On July 9, 2015, Petitioner saw his PCP for a follow up for “arthralgias and skin
symptoms.” Ex. 1 at 47. The HPI reads:

He was evaluated back in May for fatigue and other symptoms. He then developed
much worse symptoms of arthralgias and rash following an Adacel vaccination
5/20/15. We started a slow taper of prednisone on 6/5/15, initially 60 mg daily, now
down to 15 mg 4 days ago. Arthralgias are doing relatively well. His symptoms
seem to flare when he decreases the dose of prednisone, but eventually levels out.
He described flushing and abnormal temperature sensations in his hands and groin.

Id. Petitioner complained of joint swelling, but none was observed on physical examination. Id. at
48. Under summary, Dr. Wilcox wrote:

His presentation remains complex with pre-existing symptoms and unclear clinical
picture. We could consider an underlying disorder such as seronegative
spondyloarthropathy, cryoglobulinemia, Lyme disease, Chronic fatigue syndrome
or others. Because he is currently on prednisone, testing would likely be unreliable.
We have set out a continued taper of prednisone… We will plan comprehensive
laboratory testing [in three weeks]. Consider a rheumatologic evaluation.

Id. at 49.

On July 29, 2015, Petitioner returned to Dr. Wilcox one week after completing his
prednisone taper. The medical record notes that Petitioner’s arthralgias were improving but that
there was some residual wrist discomfort. Ex. 1 at 50. Dr. Wilcox wrote, “Recommended we screen
for underlying inflammatory condition.” Id. at 52. His bloodwork was normal and was negative
for rheumatoid factor, Hepatitis C, Lyme disease, ANA antibodies,3 anti-CCP antibodies,4 and
cryoglobulin.5 Id. at 56-64. His C-reactive protein now measured ˂ 0.4 mg/dL (reference range 0.0
– 1.5). Id. at 57.

3
ANA or antinuclear antibodies: antibodies directed against nuclear antigens; ones against a variety of
different antigens are almost invariably found in systemic lupus erythematosus and are frequently found in
rheumatoid arthritis, scleroderma (systemic sclerosis), Sjögren syndrome, and mixed connective tissue
disease. Antinuclear antibodies may be detected by immunofluorescent staining. Serologic tests are also
used to determine antibody titers against specific antigens. DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=56804 (last visited April 23, 2024)
(“DORLAND’S”).
4
Anti-CCP antibody: an antibody against cyclic citrullinated peptide, seen almost exclusively in persons
with rheumatoid arthritis and indicating a severe prognosis. DORLAND’S,
https://www.dorlandsonline.com/dorland/definition?id=56787 (last visited April 23, 2024).
5
Cryoglobulin: any of numerous immunoglobulins, not present in normal serum, that undergo reversible
precipitation as serum cools. DORLAND’S, https://www.dorlandsonline.com/dorland/definition?id=11792
(last visited April 23, 2024).
4
Petitioner presented to Dr. Wilcox on August 26, 2015 with insomnia and gastrointestinal
issues. Ex. 1 at 66-70. Petitioner reported that his insomnia began after his treatment with high-
dose prednisone and since being weaned from it, the insomnia has not resolved. Id. at 66. Petitioner
said he would wake up around 4 or 5am but would not be able to go back to sleep. Id. Petitioner
was given Lunesta for his insomnia and Xifanan for his gastrointestinal issues. Id. at 70.

On September 16, 2015, Petitioner returned to Dr. Wilcox for pelvic pain. Ex. 1 at 78.
Specifically, Petitioner noted suprapubic, perineal, and genital discomfort. Id. Regarding his sleep
issues, Petitioner stated that his insomnia continued and he was able to sleep six hours with
Lunesta. Id. Petitioner underwent a pelvic CT which was unremarkable, and a lumbar MRI which
revealed spinal stenosis. Id. at 81. Dr. Wilcox recommended a urology consultation. Id.

Petitioner returned on September 28, 2015 for lower abdominal and bilateral inner thigh
paresthesias. Ex. 1 at 83. In the HPI section, Dr. John Sislow noted that Petitioner still had mild
bilateral wrist pain, unresolved lower abdominal fullness, inner thigh paresthesias, and deep
urethral pain with minimal dysuria. Id. Dr. Wilcox also wrote “Adverse reaction to immunization”
and “This may be a manifestation of his lumbar disc and nerve root disease” and recommended
either a trial of gabapentin or a neurology consult. Id. Petitioner underwent another lumbar MRI
which revealed “Congenitally short pedicles along with multifactorial degenerative changes. This
is most significant at L4-5 with moderate central stenosis, moderate right neural foraminal canal
stenosis, and mild left neural foraminal canal stenosis.” Id. at 88.

On October 7, 2015, Petitioner visited Walla Walla Naturopathic where he was prescribed
a multivitamin, vitamin C, adrenal stress herbs, and B stress comp. Ex. 6 at 1. In the HPI section,
it was noted that Petitioner had pharyngitis and took Septra6 which caused a rash to form on both
his hands. Id. at 2. Petitioner also reported the left side of his neck locking, and his right pointer
finger was inflamed the day after receiving a Tdap vaccine and he felt it felt like gout. Id.

Petitioner visited Dr. Martin Ross at the Healing Arts Partnership seeing on November 25,
2015. Ex. 4 at 18-22. Dr. Ross took a detailed history which was notable for wandering joint pain.
Id. at 18. Dr. Ross noted, “His whole body is shaking and fasciculating. Weight loss and increased
anxiety. His hands have improved [and] does not feel as much hum now has moved more proximal

6
Septra: trademark for combination preparations of trimethoprim and sulfamethoxazole. DORLAND’S
MEDICAL DICTIONARY ONLINE, https://www.dorlandsonline.com/dorland/definition?id=45431 (last
accessed April 23, 2024). Trimethoprim: an antibacterial closely related to the antimalarial pyrimethamine,
acting by inhibiting a step in bacterial folate biosynthesis and effective against various gram-negative and
gram-positive bacteria; administered orally in the prophylaxis and treatment of urinary tract infections and
the treatment of pneumocystis pneumonia. It is usually administered in combination with a sulfonamide
because the two drugs markedly potentiate each other, and in such combination (e.g., co-trimoxazole) has
additional uses including treatment of bronchitis, Shigellaenterocolitis, acute otitis media, and traveler's
diarrhea. In certain countries, it is used alone as an antimalarial. DORLAND’S MEDICAL DICTIONARY
ONLINE, https://www.dorlandsonline.com/dorland/definition?id=51090 (last accessed April 23, 2024).
Sulfamethoxazole: a sulfonamide used as an antibacterial active against various gram-negative and gram-
positive organisms, especially for the treatment of acute urinary tract infections, and as an antiprotozoal;
administered orally, usually in combination with another agent such as trimethoprim. DORLAND’S,
https://www.dorlandsonline.com/dorland/definition?id=47958 (last visited April 23, 2024).
5
now.” Id. He underwent treatment for possible Lyme disease. See generally Ex. 4. Id. at 18.
Petitioner mentioned that he began experiencing fatigue in his teen years but this worsened in the
spring of 2015. Id.

Petitioner was seen by Dr. Wilcox on December 9, 2015 for follow up. Ex. 1 at 89-92. Dr.
Wilcox informed Petitioner that if he was negative for Lyme disease, there was significant risk
and harm with his unnecessary antibiotic therapy. Id. at 91. Petitioner was re-tested for Lyme
disease on December 13, 2015 which returned negative. Id. at 93-94.

On December 10, 2015, Petitioner visited Dr. Adam Zierenberg, a physical medicine and
rehabilitation specialist, for back, abdominal, and testicular pain that began after a reaction to a
Tdap shot. Ex. 14 at 7. Petitioner informed Dr. Zierenberg that he had experienced multiple
arthralgias that were severe and lasted several weeks; the worst pain at present was in the lower
abdomen or pelvis. Id. Petitioner additionally reported that his symptoms had been worsening and
rated his pain as moderate to severe. Id.

Petitioner visited Dr. Siew Min Wong, a gastroenterologist, at the Walla Walla Clinic on
December 16, 2015 complaining of diarrhea and abdominal pain. Ex. 1 at 97-100. Dr. Wong noted
Petitioner had a history of chronic diarrhea and abdominal pain for the past 10 years but his
diarrhea reportedly became worse after he had a reaction to his Tdap vaccine. Id. at 97. Petitioner
reported that, “the prednisone improved his weakness, but his fatigue, abdominal pain, diarrhea,
and insomnia persist.” Id. Dr. Wong prescribed Dulcolax and Ondansetron HCI. Id. at 108.

Later that month, on December 30, 2015, Petitioner returned to Dr. Wilcox for insomnia,
pain, and other issues. Ex. 1 at 123. Dr. Wilcox noted that Belsomra, Petitioner’s newest insomnia
medication, worked briefly but became ineffective; he was next given extended release Ambien,
which was only effective for four hours. Id. Regarding Petitioner’s pain, Dr. Wilcox noted that he
experienced generalized abdominal pain that would become so severe it would wake him up at
night. Id. Dr. Wilcox assessed Petitioner with possible chronic fatigue syndrome but noted that his
antibiotic regime with a naturopathic doctor complicates his treatment. Id. at 125. Petitioner was
prescribed Seroquel for his insomnia and Xanax and oxycodone, to be used sparingly. Id. Petitioner
also saw Dr. Wong on the same day for a follow-up after his colonoscopy, which was
unremarkable. Id. at 127-39; see also id. at 117-18. Petitioner reported malaise, body aches,
fatigue, and vague diffuse abdominal pain. Id. at 127. Under “Review of Systems,” Dr. Wong
noted joint pain, swelling or redness of joints and muscle pain. Id. at 128. Dr. Wong summarized
stating, “patient with multiple somatic complaints, and pain out of proportion to physical exam,
with some element of neuropathic pain.” Id. at 139.

Petitioner went to the Providence St. Mary Medical Center emergency department on
January 1, 2016, reporting abdominal pain and nausea. Ex. 14 at 12. Under HPI, it was noted that
Petitioner had “significant insomnia for the last 2-3 weeks” with facial and muscle twitching, along
with two weeks of intermittent abdominal pain. Id. Petitioner reported that “his syndrome started
when he was given a tetanus injection approximately 6 months ago.” Id. He was referred to the
University of Washington neurology department. Id. at 16-17.

6
The next day, on January 2, 2016, Petitioner visited Adventist Health Walla Walla General
Hospital complaining of jaw tightness and teeth grinding. Ex. 1 at 141. Petitioner stated he could
only sleep two hours at a time, and his current problem arose at 4:00am; he came to Walla Walla
General because St. Mary’s did not see him in a timely fashion. Id. Petitioner reported that “he’s
been diagnosed as having Lyme’s disease. Lab test originally was negative [at a] FDA approved
lab but positive at a specialized Lyme’s disease testing facility.” Id. Petitioner was discharged
when his mouth and jaw moved normally. Id. at 143.

Petitioner had a follow-up with Dr. Wilcox on January 29, 2016 for his insomnia,
specifically requesting a refill of Ambien. Ex. 1 at 159. Dr. Wilcox noted

Since his last visit, he was apparently evaluated by Dr. Wilkinson in Yakima and
told that he had “a traumatic brain injury and inflamed nervous system” related to
his reaction to tetanus vaccination last summer. He is being treated with intravenous
vitamin C. Dr. Wilkins also increased his Xanax… Dr. Wilkinson apparently also
recommend the extremely high doses of melatonin. Apparently additional
laboratory testing was performed, but unfortunately we have not received any of
those results or any chart notes…. His Xanax [] works very well, calming his
abdominal symptoms, testicular pain, and other symptoms.

The patient has apparently quit his job… moved into the house of his mother-in-
law.

Apparently his antibiotic regimen has been switched for treatment of “Lyme
Disease” despite repeat normal laboratory assessments.

Id. Dr. Wilcox informed Petitioner that he was not comfortable increasing his dose of Ambien as
it exceeds the recommended dosing, especially in combination with his high dose of Xanax. Id. at
162. Dr. Wilcox also stated:

The character of his symptoms and his keen response to Xanax are suggestive of
an anxiety disorder. This may be causing or exacerbating his multitude of complex
symptoms including his insomnia. I recommended a psychology evaluation and
cognitive therapy, which he declined.

The patient’s case is obviously compromised by his many providers independently
prescribing therapies without sharing information with his PCP. He is taking no
less than 10 nutritional supplements of dubious benefit and unclear side effects.

Id. Petitioner was scheduled for a neurology consultation. Id.

Neurologist Dr. John Chaplin examined Petitioner on February 9, 2016. Ex. 1 at 165-67.
Petitioner reported that his primary symptom was a buzzing/vibrating sensation throughout his
body, which causes his inability to sleep. Id. at 165. Petitioner’s physical examination was normal.
Id. at 166. Dr. Chaplin’s impression was:

7
Michael reports chronic pain but when I ask him where he has pain he cannot even
answer this question. Clearly he has a large component of anxiety and somatization
which I believe is his primary problem. I see no evidence to support a diagnosis of
Lyme disease and he certainly does not have neurologic manifestations of Lyme
disease such [as] polyradiculopathy or peripheral neuropathy and his neurologic
exam today is pristinely normal…. One of his alternative medicine providers in Tri-
Cities has told he has an “inflamed brain” and I see no evidence to support this
contention. Mike clearly prefers an alternative medicine pathway in pursuit of a
diagnosis and treatment. However, he is exposing himself to serious risk and
potentially fatal risk with his chronic exposure to antibiotics…. This puts him at
great risk to significant harm to his gut microbiome.

Id.

On February 15, 2016, Petitioner was admitted to Swedish Medical Center in Seattle for
jaundice, elevated transaminase levels, and “medication induced liver injury.” Ex. 7 at 4.
Petitioner’s medical history upon admission was that he “has felt unwell since March 2015” when
he felt he had the flu and “yellow tongue.” Id. at 15. After receiving the Tdap vaccine, he awoke
with left cervical joint heat and could not move. Id. The nurse recorded Petitioner’s symptoms and
numerous medications from the past few months. Id. Petitioner was seen by Dr. Muktar, a
hepatologist, who ran a full hepatic workup on Petitioner to diagnose the elevated transaminase
and jaundice. Id. at 19. Petitioner was discharged on February 18, 2016 with instruction to stop all
supplements and antibiotics. Id. at 6-7. It was recommended that Petitioner see a rheumatologist.
Id. at 6.

On February 29, 2016, Petitioner traveled to Seattle to have a consultation with Dr.
Anthony Krajcer, a rheumatologist at the Polyclinic. Ex. 5 at 2. Petitioner stated he had “gout-like
symptoms” in his joints, which were helped by prednisone but he has a “general unwell feeling.”
Id. A thorough medical history was taken noting “things began to go awry in March 2015.” Id.
After vaccination, Petitioner had neck pain, right MP joint pain and deltoid discomfort, with
migratory arthralgias, some visible swelling/stiffness which [was] localized to wrists, shoulders,
knees, and ankles. Id. Regarding his present condition, it was also noted that “[Petitioner]’s not
had any concerning musculoskeletal symptoms aside from some low back stiffness and his primary
concern at this time are some vague paresthesias of the upper more so than the lower extremities
also hypersensitivity/discomfort in the perineal area/scrotal.” Id. at 3. On physical exam, Petitioner
was noted to have localized tenderness to palpation in his peripheral joints, shoulders, and knees.
Id. at 5. Dr. Krajcer’s impression was systemic inflammatory response syndrome (“SIRS”)
subsequent to a vaccination with reported migratory arthritis and spondylitis symptoms in the neck.
Id. at 11. Dr. Krajcer added there was “No clear unifying rheumatologic explanation [ ]. No evident
vasculitis or history that is suggestive of this. Most musculoskeletal migratory inflammatory
symptoms have resolved over the summer subsequent to steroid course. (Remote consideration for
reactive arthritis/spondyloarthropathy)” and “I see no indications for any anti-
inflammatory/immunosuppressive treatment.” Id. Dr. Krajcer subsequently emailed Petitioner a
message on March 11, 2016 suggesting that his SIRS “may gradually burn out” and “[t]he Tdap
vaccination is on your allergy list here and should be in any other healthcare setting.” Id. at 20.

8
Petitioner visited Dr. Daniel Drozd for an infectious diseases consultation at the Polyclinic,
pertaining to his “Lyme [disease] serologies” in March 17, 2016. Ex. 5 at 22. Dr. Drozd noted
“[Petitioner] has had a rather unbelievable and unfortunate course over the past year which at least
temporally seem[s] to have started with a reaction following a Tdap vaccine,” further adding a
review of Petitioner’s lab work was not indicative of Lyme disease, stating “I think unfortunately
that he has suffered a number of consequences, most significantly his acute livery injury that
resulted from his exposure to treatment directed at [Lyme] disease.” Id. at 30.

The next day, on March 18, 2016, Petitioner was seen by Dr. Benduan Yang, a neurologist
at the Polyclinic. Ex. 5 at 34-37. Dr. Yang noted, “Patient continues to have remarkable weakness
of the arms and legs, paresthesia, [and] muscle fasciculations,” and Petitioner denied any
significant cognitive issues. Id. at 35. Dr. Yang’s impression was “probably transverse myelitis”
after receiving tetanus booster vaccine in May 2015 but “was not confirmed by extensive imaging
and CSF study.” Id. at 36. A possible explanation was that Petitioner’s imaging was taken too soon
but Dr. Yang added, “This was probably induced by vaccine.” Id. Dr. Yang recommended a
repeated cervical spine MRI back in Walla Walla and IV steroids for residual inflammatory
changes. Id. at 37.

On October 31, 2016, Petitioner returned to his PCP, Dr. Wilcox for a follow-up. Ex. 1 at
195-97. Petitioner informed Dr. Wilcox of his traverse myelitis diagnosis. Id. at 195. Dr. Wilcox
recommended additional CT scans to make sure his liver was still recovering well. Id. at 196.

Dr. Wilcox signed vaccine exemptions for Petitioner for the annual flu and COVID
vaccines. Ex. 11 at 23, Ex. 54 at 26.

No other medical records were filed that pertain to Petitioner’s alleged injury.

III. Petitioner’s Testimony

Petitioner testified at the May 18, 2022 entitlement hearing. Mr. Schwarz works as a
physical therapist. Tr. at 6. Petitioner received a Tdap vaccine on May 20, 2015 during his 40 year-
old wellness check due to his work in the health care field. Id. at 7. Petitioner did not have an
immediate reaction to the vaccine but a few days later, on a Friday, he woke up with neck pain on
one side of his neck; he believed that he just slept poorly and went on with his day until the pain
spread across his neck. Id. at 8-9. Petitioner cancelled his patients for the day and went to the
Adventist Health emergency room after calling his doctor, who told him to do so. Id. at 9. At the
emergency room, the pain had spread from his neck to his shoulder, jaw, and chest. Id. Petitioner
underwent a lumbar puncture during this visit which was memorable because it was so painful. Id.
He was discharged with a diagnosis of neck pain. Id. at 10.

The next day, Petitioner felt his pain getting worse and went to the other emergency room
in Walla Walla, Washington, St. Mary’s Providence. Tr. at 10. He underwent more tests and was
told by the doctors that he was experiencing a reaction to the vaccine he had just received. Id.

Petitioner returned to his PCP, Dr. Wilcox later in May 2015. Tr. at 11. Dr. Wilcox
prescribed him with low dose prednisone, which helped ease his pain but was “still not cutting it.”
9
Id. He recalled attending his son’s eighth grade graduation and not being able to get up from his
chair because his hips locked up. He had to be lifted by his brother and good friend in order to
leave because his legs were not working. Id. at 11-12.

Petitioner described his pain as a 20 out of 10 in his joints and roaming from his upper
body to his lower body. Tr. at 12. Dr. Wilcox attempted to taper Petitioner off of prednisone but
his symptoms got worse. Id. Dr. Wilcox then prescribed him with high dose prednisone. Id.
Petitioner finally felt improvement; he could walk and move his joints, but not all of his pain and
stiffness were gone. Id. at 13.

Petitioner was referred to Dr. Moore for another opinion. Tr. at 13. Dr. Moore did not
change his medications but ran more tests, and believed Petitioner’s condition was caused by his
vaccination. Id.

Petitioner recalled that the summer months were still difficult. Petitioner owned his own
business so he had to do some work to pay the bills. Tr. at 14. The pain was affecting his ability to
sleep and he developed insomnia. Id. Because of his condition, his family went on their annual
summer trip without him. Id. at 15. Dr. Wilcox again tried to taper him from prednisone which
Petitioner recalled was a very long process. Id. Petitioner continued to have insomnia, fatigue, and
joint pain in his upper extremities. Id. at 15-16.

Petitioner worked until about December when he could not perform anymore. Tr. at 16.
His work days would get shorter and shorter because his pain would be unbearable. Id. He
gradually had to take whole days off to recover. Id. Petitioner stated that his wrists would be red
and swollen, his hands would get puffy, and this affected his ability to work. Id. at 17. Beyond the
pain, Petitioner also experienced brain fog. Id.

Because he was desperate to get treatment and answers, Petitioner began to seeing
naturopathic doctors. Tr. at 18. One doctor told him he had Lyme’s disease and gave him
antibiotics, which caused liver damage. Id. at 19. Petitioner was recommended to see a
rheumatologist, Dr. Krajcer, at the Polyclinic. Id. Petitioner had “very good, fond memories” of
the Polyclinic because the doctor did “full-on testing.” Id. Dr. Krajcer told him this was a vaccine
reaction and that in 26 months “it burns itself out.” Id. at 20. The doctor did not change his
treatment regimen. Id.

In early 2016, Petitioner recalled that January and February were his worst; he was airlifted
to Swedish Hospital in Seattle for treatment. Tr. at 21-22. Petitioner called his pastor to tell him
“you’re going to do my eulogy because… I never felt anything like it.” Id. at 21. He made videos
to kids and a video to his brother to tell him “how I wanted everything to go,” “because I thought…
that was it.” Id. Petitioner was not able to work and moved in with his mother-in-law because she
was a retired nurse. Id. Petitioner’s symptoms included pain, fatigue, insomnia, joint pain, and
swelling. Id. In March 2016, Petitioner was referred to Dr. Yang, a neurologist, at Swedish
Hospital because it was a bigger facility and could provide better treatment options. Id. at 22-23.
Dr. Yang similarly told Petitioner that his symptoms were part of the reaction to his Tdap vaccine.
Id.

10
Petitioner’s office manager informed him she was getting a knee replacement in July 2016
and wanted him to do her PT. Tr. at 24-25. As a result, Petitioner began setting small tasks for
himself to build up his endurance; his office manager was his first patient, whom he treated twice
per week. Id. at 25. He slowly added more patients and was working two full days each week. Id.
The more he used his hands and wrists for work, the more inflamed they would become. Id. at 26.
By 2017, Petitioner was able to get back to working four days per week but was not able to work
more. Id. Before his injury, Petitioner was very active outdoors; he was a snowboard instructor
and enjoyed hiking and camping. Id. at 27. Petitioner testified that he was able to go snowboarding
twice on his annual pass this past year. Id.

Petitioner now works as a director and sees about five patients per day, which works well
for him because that limits the work with his hands, wrists, and shoulders. Tr. at 28. Prior to his
injury, he was growing a clinic and worked long hours and felt that the growth was limitless. Id.
at 29. Petitioner reported that his symptoms today include insomnia, and wrist and hand pain if he
does too much activity. Id. Doctors have told Petitioner not to receive another Tdap vaccination.
Id. at 30.

IV. Expert Opinions and Qualifications

A. Dr. Yuval Shafrir

Dr. Shafrir authored one expert report. Ex. 16 (hereinafter “Shafrir Rep.”) and also testified
at the entitlement hearing.

This case is somewhat unusual in that I did not ultimately rely on Dr. Shafrir’s opinion
with respect to Petitioner’s correct diagnosis. As discussed in detail below, I find the opinions of
Petitioner’s treating physicians to be more persuasive in this regard. I have, however, summarized
Dr. Shafrir’s expert report and hearing testimony to lend context to my ruling.

1. Qualifications

Dr. Shafrir attended medical school at the Sackler School of Medicine at Tel Aviv
University. Ex. 17 (hereinafter “Shafrir CV”) at 1. Dr. Shafrir completed a rotating internship and
a pediatrics residency at North Shore University Hospital, which is affiliated with Cornell
University. Id. Dr. Shafrir also completed a pediatric neurology residency and fellowship at
Washington University Medical Center, and a pediatric neurophysiology and epileptology
fellowship at Miami Children’s Hospital. Id. at 2. Dr. Shafrir is board certified in pediatrics,
neurology, and clinical neurophysiology. Id. Dr. Shafrir served as a major in the U.S. Army
Medical Department at Walter Reed Army Medical Center. Id. Dr. Shafrir worked as a pediatric
neurologist at a number of institutions, and is currently at Sinai Hospital. Id. at 3. Dr. Shafrir
primarily treats patients with PANS/PANDAS. Tr. at 83-84. I recognized Dr. Shafrir as an expert
in neurology. Id. at 34-35.

2. Expert Report

Dr. Shafrir began his report by conducting an extensive summary of Petitioner’s medical
11
history. Shafrir Rep. at 1-39. He noted that although Petitioner experienced recurrent episodes of
sore throat, sinusitis, cold symptoms, and congestion, it is unlikely these complaints caused any of
Petitioner’s current problems as he had these symptoms for years before vaccination and they did
not result in the problems Petitioner experienced post-vaccination. Shafrir Rep. at 39. Dr. Shafrir
noted that Petitioner’s history of sore throat, sinusitis, cold symptoms, and congestion does suggest
some level of innate immune dysregulation. Id.

Dr. Shafrir acknowledged that “[n]o unified diagnosis was ever reached.” Shafrir Rep. at
40. He pointed out that all of Petitioner’s treating physicians agreed that “his initial symptomology
was a result of the vaccination.” Id. Dr. Shafrir stated that these opinions were reinforced by
Petitioner’s positive response to steroid treatment and his negative response when steroids were
withdrawn. Id.

Dr. Shafrir then enumerated the various diagnoses listed in Petitioner’s medical records.
Dr. Shafrir noted that although Dr. Yang diagnosed Petitioner with transverse myelitis (“TM”),
Dr. Yang was “speculating” based on Petitioner’s medical history. Shafrir Rep. at 40. Dr. Shafrir
acknowledged that “[w]e do not have solid support for this diagnosis in the contemporaneous
medical records.” Id. Dr. Shafrir stated that Dr. Wilcox diagnosed Petitioner with reactive
generalized migratory polyarthralgia, and Dr. Krajcer diagnosed him with systemic inflammatory
response syndrome (SIRS). Id.

According to Dr. Shafrir, the unifying diagnosis for Petitioner’s complex medical
presentation is chronic fatigue syndrome, “probably a specific sub type – aluminum adjuvant
induced macrophagic myofasc[i]itis.” Shafrir Rep. at 40. He then stated that the four diagnoses
(TM, SIRS, reactive generalized migratory polyarthralgia, and CFS) “were present at one time or
another, reflecting different aspects of the excessive systemic inflammation induced by the
vaccine.” Id.

Dr. Shafrir then discussed each of the four “manifestations of Mr. Schwarz’s condition.”
Shafrir Rep. at 40. He began with transverse myelitis. Dr. Shafrir noted that the correlation between
vaccines and TM has been well known for many years. Id.

Dr. Shafrir next discussed SIRS. He opined that Petitioner’s medical records do not clearly
indicate that he met the diagnostic criteria for this condition. However, Dr. Shafrir stated that
Petitioner “definitely had [a] less severe but extensive inflammatory reaction to the vaccine.”
Shafrir Rep. at 41. Dr. Shafrir highlighted that cytokine levels increase rapidly after vaccination.
Id. at 42.

Dr. Shafrir next discussed reactive arthritis. He opined as follows: “Reactive arthritis is
well described in the literature after several vaccines, including components of the DTP
vaccination.” Shafrir Rep. at 42. He noted that reactive arthritis generally occurs within one or two
days of vaccination. Id.

Dr. Shafrir stated that brachial neuritis was another “component[] of the exaggerated
inflammatory response in Mr. Schwarz.” Shafrir Rep. at 42. He noted that Petitioner’s medical
records noted decreased reflexes in the upper extremities associated with pain and weakness in
12
both arms. Id. (citing Ex. 1 at 33). Dr. Shafrir opined that “[t]his temporary abnormality in
neurological examination[] may fit the criteria for brachial neuritis as stated in the vaccine injury
table.” Shafrir Rep. at 42. Dr. Shafrir noted that if Petitioner did have brachial neuritis, this
diagnosis “cannot provide a full explanation [for] Mr. Schwarz’s severe disability.” Id. at 43.

Dr. Shafrir next turned to chronic fatigue syndrome. He opined that Petitioner’s
“presentation[] fully fit the new IOM definition for myalgic encephalomyelitis/chronic fatigue
syndrome from 2015.” Shafrir Rep. at 43. Dr. Shafrir opined that the diagnosis of chronic fatigue
syndrome is the diagnosis “most supported by the medical records.” Shafrir Rep. at 45. He stated
that each of the three Althen prongs have been met. Id. In discussing Althen prong one, Dr. Shafrir
opined that “Mr. Schwarz’s symptoms and complaints can be explained on the basis of immune
reaction causing chronic fatigue syndrome.” Id. He noted that Petitioner’s “symptoms persisted
through the activity of the adaptive immune system.” Id. The mechanisms that caused the
persistence of symptoms included “molecular mimicry, bystander activation, epitope[] spreading
and maybe even polyclonal activation.” Id.

With respect to Althen prong two, Dr. Shafrir opined as follows:

The vaccination with Adacel produced a dramatic auto inflammatory reaction
which was initially mediated by the innate immune system for inflammatory
cytokines (known to be triggered by the Adacel antigenic components and
aluminum adjuvant), producing [an] initial local reaction which was rapidly
followed by more systemic manifestations, affecting multiple body systems.

Shafrir Rep. at 45.

Dr. Shafrir opined that Petitioner’s symptoms began two days after vaccination. Shafrir
Rep. at 45. He attributed the rapid onset of Petitioner’s disease to a memory response due to the
fact that he had received previous Tdap vaccinations in the past, as well as the activation of the
innate immune system through the production of cytokines. Id.

3. Testimony

Dr. Shafrir began his testimony by interpreting a number of Petitioner’s medical records.
Dr. Shafrir discussed Petitioner’s visit with Dr. Wilcox on July 9, 2015 and the lab tests that were
run, which returned negative. Tr. at 42-43. Dr. Shafrir noted that reactive arthritis could only be
diagnosed upon physical examination, and there were no diagnostic tests for this condition. Id. at
42.

Petitioner’s appointment with Dr. Krajcer resulted in a new differential diagnosis of SIRS,
however Dr. Shafrir does not believe that Petitioner has SIRS because “he does not meet the
criteria, and there’s no place in which he did meet the criteria, but [Dr. Krajcer] tries to make [ ] a
framework to [ ] understanding it.” Tr. at 52-53. Dr. Shafrir elaborates that, “I think that Dr. Krajcer
is trying to find a way to explain so many symptoms occurring in the same person in response to
the same provocation.” Id. at 53.

13
Dr. Shafrir discussed Petitioner’s visit with Dr. Yang. Tr. at 59-60. Dr. Shafrir testified Dr.
Yang’s diagnosis did not indicate Petitioner suffered from that condition at the time of the
appointment; but instead, Dr. Yang likely gave Petitioner a diagnosis “that could have explained
his symptoms” from 2015. Id. at 59-60.

Regarding the diagnoses that Petitioner received, Dr. Shafrir opined that he had reactive
arthritis and “there is no question about it.” Tr. at 63. In the diagnostic criteria submitted by Dr.
Shafrir, the condition could have a quick recovery but could also last for months and require
prolonged treatment. Id. Reactive arthritis is associated with “sky-high” C-reactive protein levels.
Id. Dr. Shafrir did testify that some of Petitioner’s symptoms, such as his persistent paresthesias,
or sensory issues, could not be explained by reactive arthritis. Id. at 63-64.

Dr. Shafrir opined that Petitioner also suffered from chronic fatigue syndrome. Tr. at 64-
65. Although Petitioner did not experience all symptoms associated with CFS, such a cognitive
dysfunction or postural intolerance, he did experience poor sleep, GI symptoms, and irritable
bowel. Id. Dr. Shafrir clarified that while Petitioner did not have unrefreshing sleep (which is part
of the CFS diagnostic criteria), he had a sleep disorder which is part of the syndrome. Id. at 70.
Dr. Shafrir opined that Petitioner’s chronic fatigue syndrome was “definitely [an] indirect result
of the vaccination.” Id. at 68. Dr. Shafrir admitted, “in the context of the Vaccine Program, we
cannot establish temporal relationship between the onset of CFS and the vaccination.” Id. at 83.

Dr. Shafrir cited to the Kesiktas article and Maillefert article, two case report articles
involving patients who developed arthritis after vaccination. Tr. at 71-73; Kesiktas et al., A Case
of Reactive Arthritis Developed After Tetanus Vaccine, 7 IKSST DERG 3 147-49 (2015) (filed as
Ex. 43); Maillefert et al., Arthritis following combined vaccine against diphtheria, poliomyelitis,
and tetanus toxoid, 18 CLINICAL AND EXPERIMENTAL RHEUMATOLOGY 255-56 (2000) (filed as Ex.
44).

Regarding a causal mechanism, Dr. Shafrir stated that a reaction to the Tdap vaccine can
occur within 72 hours, as detailed in medical literature. Tr. at 74. He cited to the Agmon-Levin
article to explain the mechanism by which the Tdap vaccine caused Petitioner’s reactive arthritis.
Id. at 74-75; Agmon-Levin et al., Vaccines and autoimmunity, 5 NATURE REVIEWS
RHEUMATOLOGY 648-52 (2009) (filed as Ex. 53). Dr. Shafrir also mentioned cytokines and the
innate immune system are involved to cause these extremely rare occurrences. Id. at 75. Dr. Shafrir
highlighted Dr. Krajcer’s note that this was likely a cytokine reaction from the vaccine. Id. at 77.

Dr. Shafrir testified that Petitioner suffered from a systemic illness; he was bedridden for
six to eight weeks and this cannot be explained by just reactive arthritis. Tr. at 84. Dr. Shafrir
confirmed that Dr. Wilcox used the term “generalized migratory arthralgia” rather than reactive
arthritis, but stated those terms were interchangeable. Id. at 87, 89-90. Dr. Shafrir testified that
although patients with reactive arthritis generally had an asymmetric presentation, bilateral
symptoms does not rule out the diagnosis, as laid out in the Kesiktas article. Id. at 91; see also
Kesiktas at 1. Dr. Shafrir highlighted the Kaul paper as proof of a challenge-rechallenge reaction;
a patient with Reiter’s syndrome, a form of reactive arthritis, had a flare up after receiving a tetanus
vaccination. Id. at 95; Kaul et al., Recurrence of reactive arthritis after a booster dose of tetanus
toxoid, ANN RHEUM DIS. 185 (2002) (filed as Ex. 46). According to Dr. Shafrir, this demonstrates
14
an association between reactive arthritis and the Tdap vaccine, even if it does not rise to level to
“establish a causal relationship.” Id.

Dr. Shafrir reiterated that Petitioner experienced many of the symptoms associated with
chronic fatigue syndrome, such as an irritable bowel, muscle pain, genitourinary impairment, sore
throat, and sensitivity to external stimuli; but he did not have orthostatic intolerance or cognitive
impairment. Tr. at 96-97. Dr. Shafrir emphasized that many of the symptoms on the Adacel
package insert overlapped with CFS, such as body aches, muscle weakness, sore and swollen
joints. Id. at 99-100.

Dr. Shafrir admitted that beyond Petitioner’s testimony earlier in the entitlement hearing,
there was “no objective evidence in the record that he ha[d] ongoing arthritis” as of March 2016.
Tr. at 104; see also Ex. 5 at 11. Dr. Shafrir opined that despite this record, he believed Petitioner
was still experiencing musculoskeletal issues, just not to the same degree as the summer of 2015.
Id. at 106. Dr. Shafrir stated that he believed Petitioner’s reactive arthritis lasted at least four
months and possibly up until his liver failure, which was six months after vaccination. Id. at 108.

Regarding brachial neuritis, Dr. Shafrir opined that there is some evidence to support this
diagnosis as Petitioner had a difference in his reflexes and had migratory weakness in his arms
with residual paresthesias. Tr. at 110. Dr. Shafrir also noted that Petitioner’s vibration sensation
had a term, pallesthesia. Id. Given his other symptoms, Dr. Shafrir conceded there is not strong
evidence to support the diagnosis. Id. Dr. Shafrir reiterated that he believed Petitioner experienced
“reactive arthritis plus plus,” or reactive arthritis with other symptoms which were also
autoinflammatory in nature. Id. at 111.

Dr. Shafrir described how the Tdap vaccine indirectly caused Petitioner’s chronic fatigue
syndrome. He stated that the persistent elevation of cytokines can cause weight loss, cachexia,7
fatigue, lack of energy, and depression. Tr. at 112. The Agmon-Levin paper provided mechanisms
for how an antibody-mediated reaction persisted in Petitioner’s immune disease. Id. at 112-13. Dr.
Shafrir opined that Petitioner’s CFS started “the moment that his acute symptoms related to his
“arthritis plus plus” were no longer explaining his inability to function,” or four or five months
after the onset of his symptoms. Id. at 113. Dr. Shafrir testified that Petitioner did not have chronic
fatigue syndrome before his vaccination. Id. at 114.

B. Dr. Michael Wilson

Dr. Wilson authored one expert report, Ex. A (hereinafter “Wilson Rep.”) and also testified
at the entitlement hearing.

1. Qualifications

Dr. Wilson received a B.A from the University of Chicago and an M.D. from the University
of California, San Francisco (UCSF) School of Medicine. Ex. B (hereinafter “Wilson CV”) at 1.

7
Cachexia: a profound and marked state of constitutional disorder; general ill health and malnutrition.
DORLAND’S, https://www.dorlandsonline.com/dorland/definition?id=7417 (last visited April 23, 2024).
15
Dr. Wilson completed his residency in neurology at Harvard Neurology Residency Program and a
fellowship in neuro-infectious disease at Massachusetts General Hospital. Id. Dr. Wilson
subsequently completed a post-doctoral fellowship in neurovirology at Boston University and a
separate post-doctoral fellowship in metagenomics at UCSF. Id. Dr. Wilson is board certified in
neurology. Id. Dr. Wilson teaches at the UCSF School of Medicine as an associate professor of
neurology. Id. at 2. Dr. Wilson serves as an ad hoc reviewer on a number of publications including
Neurology, JAMA Neurology, the New England Journal of Medicine, International Journal of
Infectious Diseases, and Lancet Infectious Diseases. Id. at 5. Dr. Wilson has published at least 57
peer-reviewed articles and 11 book chapters. Id. at 25-31. Dr. Wilson is the principal investigator
on five different NIH grants. Tr. at 122, Wilson CV at 20-22. I recognized Dr. Wilson as an expert
in neuroimmunology. Tr. at 125.

2. Expert Report

In his expert report, Dr. Wilson addressed Dr. Shafrir’s expert report where he opined that
Petitioner developed CFS, TM, reactive generalized polyarthalgias/SIRS, and brachial neuritis as
a result of his Tdap vaccine. Wilson Rep. at 5.

Dr. Wilson first discussed transverse myelitis. He agreed with Dr. Shafrir that “we do not
have solid support for this diagnosis in the contemporaneous medical records.” Wilson Rep. at 5
(citing Shafrir Rep. at 40). Dr. Wilson opined that Petitioner “lacked many of the objective findings
of transverse myelitis.” Id. Specifically, Dr. Wilson noted that Petitioner had a normal cervical
spine MRI both at the time his symptoms began and nearly one year later. Id. Dr. Wilson stated
that although it is possible one would not see a spinal cord abnormality at the very beginning of
an episode of TM, “the inability to also see a scar on the cervical spine MRI the following year
makes it even less likely that there was ever an inflammatory lesion (or any other kind of injury)
in the spinal cord.” Id. He opined further on this issue, noting that he would expect to see “a scar
manifest as a hyperintensity on the T2-weighted MRI sequence and/or as myelomalacia (i.e.,
thinning of the spinal cord) as a result of chronic nerve damage.” Id. Dr. Wilson further noted that
Petitioner had no inflammation in the CSF. Id. In addition, “his EMG/NCS identified no muscle
or nerve abnormality that could be localized back to the nerve root or spinal cord.” Id. All these
factors suggest that Petitioner did not have TM. Id.

Dr. Wilson next addressed Chronic Fatigue Syndrome. Dr. Wilson noted that Petitioner
had been experiencing chronic fatigue since he had mono as a teenager. Wilson Rep. at 5.
Additionally, he had a ten plus year history of chronic abdominal pain and loose stools, which
worsened in the months after vaccination as a result of a drug-induced liver injury. Id. Dr. Wilson
opined: “Given that he already had these chronic symptoms before the Tdap vaccination, it is not
clear why a vaccine-induced reaction needs to be invoked to explain why he continues to have
these symptoms.” Id. Dr. Wilson further noted that a diagnosis of macrophagic myofasciitis
requires a muscle biopsy, which Petitioner did not have. Id. at 5-6.

Dr. Wilson next discussed Petitioner’s proposed diagnosis of migratory polyarthralgias and
Systemic Inflammatory Response Syndrome (SIRS). Dr. Wilson noted that systemic inflammation
with arthralgias and myalgias can occur after Tdap vaccination, however, this type of reaction lasts

16
for a period of days. Wilson Rep. at 6. To receive a diagnosis of SIRS, the following criteria must
be met:

(1) a body temperature greater than 38°C or less than 36°C; (2) a heart rate greater
than 90 beats per minute; (3) tachypnea, manifested by a respiratory rate greater
than 20 breaths per minute, or hyperventilation, as indicated by a PaCO2 of less
than 32 mm Hg; and (4) an alteration in the white blood cell count, such as a count
greater than 12,000/ cu mm, a count less than 4,000/cu mm, or the presence of more
than 10 percent immature neutrophils (“bands”).

Id. (citing Bone et al., Definitions for sepsis and organ failure and guidelines for the use of
innovative therapies in sepsis, The ACCP/SCCM Consensus Conference Committee, American
College of Chest Physicians/Society of Critical Care Medicine, 101 CHEST 6, 1644-55 (1992) (filed
as Ex. F)). Dr. Wilson opined that Petitioner did not meet these criteria. Wilson Rep. at 6. Dr.
Wilson noted that Petitioner’s repeat C-reactive protein two months after vaccination was normal
and his arthralgias had improved, “indicating that any inflammatory condition petitioner suffered
from had passed.” Id.

Dr. Wilson next discussed Dr. Shafrir’s proposed diagnosis of brachial neuritis. Dr. Wilson
opined that “it is far from clear that this diagnosis is consistent with Mr. Schwarz’s presentation.”
Wilson Rep. at 6. Dr. Wilson noted that Petitioner’s EMG/NCS “showed no evidence of prior
damage to the brachial plexus on either side.” Id. Further, Petitioner never had “individual upper
extremity muscle testing that suggested that muscle groups that localize to a particular spinal cord
level or region of the brachial plexus were weak. Rather, the notes suggest that he was generally
weak in the arms (with no grading of the severity of the weakness).” Id. Additionally, Petitioner
had intact sensory testing, which, according to Dr. Wilson, “makes it very difficult to contend that
his condition was due to brachial neuritis.” Id. Finally, Dr. Wilson opined that brachial neuritis is
a diagnosis of exclusion, yet Dr. Shafrir has proposed other conditions that explain Petitioner’s
condition. Id.

Ultimately, Dr. Wilson opined that Petitioner had “some degree of systemic inflammation
in the immediate aftermath of his vaccination that caused diffuse joint pains and stiffness.” Wilson
Rep. at 7. However, he stated that these symptoms resolved soon after vaccination. Id. He further
opined that Petitioner had fatigue and chronic abdominal complaints which preceded vaccination.
Id.

3. Testimony

Dr. Wilson testified that he did not believe Petitioner suffered from transverse myelitis. Tr.
at 126-28. Dr. Wilson agreed with Dr. Shafrir that Petitioner did not suffer from brachial neuritis.
Id. at 129-30. Finally, Dr. Wilson stated he did not believe that Petitioner suffered from SIRS. Id.
at 130.

Dr. Wilson next addressed Petitioner’s other diagnoses. He stated that CFS was a
syndrome, or a constellation of symptoms. Tr. at 130-31. Dr. Wilson believed there was not enough
information to diagnose Petitioner with CFS pursuant to the IOM diagnostic criteria and that it
17
was clear in the record that Petitioner experienced chronic fatigue many years before vaccination.
Id. at 130-31. Dr. Wilson stated he did not address macrophagic myofasciitis because Petitioner
never had a biopsy. Id. at 133-34.

Dr. Wilson addressed the differences between inflammatory diseases, autoinflammation,
and autoimmunity. An autoinflammatory disease is defined as “a group of genetic diseases
described in family, in which a number of the family members, have a gene mutation that’s critical
for innate immunity.” Tr. at 134-35. One such example is cryopyrin-associated periodic syndrome
(CAPS), where these family members experience recurrent inflammation in organ systems; but
more commonly known conditions are rheumatoid arthritis, multiple sclerosis, and lupus. Id. at
135. Dr. Wilson opined that Petitioner experienced an acute inflammatory reaction after
vaccination. Id. at 136. Petitioner experienced the hallmarks of temporally linked diffuse muscle
pain, which was steroid responsive and systemic markers of inflammation (high C-reactive protein
and elevated white blood cell count), which “are not uncommon kinds of symptoms and reactions
to have to vaccinations generally.” Id. Dr. Wilson testified that Petitioner experienced a self-
limited reaction or that his myalgias and arthralgias subsided over the weeks with prednisone. Id.
at 136-37. This was confirmed with follow-up lab tests, which showed normal inflammatory
markers after time along with improved symptomology. Id. at 137-39. Dr. Wilson stated that
rheumatologists are experts of musculoskeletal and joint exams, so there still could be
compartmentalized inflammation that would not show up in blood work but show up on
examination. Id. at 139. Petitioner never underwent an arthrocentesis to look for joint
inflammation, which would document his inflammation. Id. at 140.

Dr. Wilson defined arthralgia as pain in joints, comparable to myalgia which is muscle
pain. Tr. at 140. Just as a myelitis, or inflammation of the spinal cord, falls under a myelopathy,
or problem with the spinal cord; arthritis falls under arthralgia because joint inflammation will
include joint pain. Id. at 140-41. The medical records demonstrate Petitioner had polyarthralgias
and polymyalgias, but Dr. Wilson does not believe those were caused by acute or chronic
inflammation of the joints, or arthritis. Id. at 141.

Regarding Dr. Shafrir’s causation theory, Dr. Wilson understood it to be that Petitioner
experienced an acute reactive arthritis that was triggered by vaccination; immunosuppressive
therapies helped but inflammation lingered past the acute phase and led to a more chronic fatigue
picture, complicated by Petitioner’s many prescriptions by various providers. Tr. at 141-42. Dr.
Wilson opined that he did not believe Dr. Shafrir had explained the connection between the joint
and muscle pain with Petitioner’s fatigue symptoms, especially because Petitioner had sleep issues
after a viral infection as a teenager, well before vaccination. Id. at 142. Dr. Wilson noted that
Petitioner had been experiencing ongoing weight loss as of his emergency room visit on May 23,
2015. Id. at 144; see also Ex. 1 at 31.

Dr. Wilson testified that Petitioner’s misuse of prescription medication was a leading
suspect as the cause of Petitioner’s GI issues, such as loose stool, abdominal bloating, and liver
failure. Tr. at 145. Petitioner’s consumption of supplements did not help as the FDA does not
regulate the supplement industry. Id. Many supplements contain adulterants; there may be value
from taking supplements, but the quality concerns may override benefits. Id. at 146. Petitioner
took enough medications and supplements to suffer from liver damage, which can cause systemic
18
unwellness, and the poison from the liver damage on top of his health issues can manifest as
“unwell symptoms.” Id.

Dr. Wilson agreed that the arthralgias Petitioner experienced on July 29, 2015 were from
his vaccination. Id. at 152; see also Ex. 1 at 50. Arthralgia of multiple joints was still listed as part
of Petitioner’s active problems as of September 28, 2015, with Petitioner’s complaint of bilateral
wrist pain documented in the HPI. Tr. at 154; see also Ex. 1 at 83. Dr. Wilson agreed this was the
result of vaccination. On December 9, 2015, arthralgias is under Petitioner’s active problems list
but there was no specific mention of arthralgias in his HPI, assessment, discussion, or summary.
Tr. at 154; see also Ex. 1 at 89. Dr. Wilson stated he did not credit the various lists generated in
electronic medical records if they do not correlate with a current complaint in the HPI. Tr. at 155.

V. Applicable Law

A. Petitioner’s Burden in Vaccine Program Cases

Under the Vaccine Act, a petitioner may prevail in one of two ways. First, a petitioner may
demonstrate that she suffered a “Table” injury—i.e., an injury listed on the Vaccine Injury Table
that occurred within the time period provided in the Table. § 11(c)(1)(C)(i). “In such a case,
causation is presumed.” Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed.
Cir. 2006); see § 13(a)(1)(B). Second, where the alleged injury is not listed in the Vaccine Injury
Table, a petitioner may demonstrate that she suffered an “off-Table” injury. § 11(c)(1)(C)(ii).

For both Table and non-Table claims, Vaccine Program petitioners bear a “preponderance
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 v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1324 (Fed. Cir. 2010); see
also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or speculation
is insufficient under a preponderance standard). 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 (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 of by the opinion of a competent physician. Section 13(a)(1).

In attempting to establish entitlement to a Vaccine Program award of compensation for a
non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen v. Secretary of Health and Human Services. 418 F.3d 1274 (Fed. Cir. 2005).
Althen requires that petitioner establish by preponderant evidence that the vaccinations he received
caused her injury “by providing: (1) a medical theory causally connecting the vaccination and the
injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for

19
the injury; and (3) a showing of a proximate temporal relationship between vaccination and
injury.” Id. at 1278.

Each of the Althen prongs requires a different showing. Under Althen prong one, petitioner
must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the
type of injury alleged. Pafford, 451 F.3d at 1355-56 (citations omitted). To satisfy this prong, a
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must
only be “legally probable, not medically or scientifically certain.” Id. at 549.

Petitioner 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 complex 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.” Id. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y of
Health & Hum. Servs., 121 Fed. Cl. 230, 245 (2015) (“[p]lausibility … in many cases may be
enough to satisfy Althen prong one” (emphasis in original)), vacated on other grounds, 844 F.3d
1363 (Fed. Cir. 2017). But this does not negate or reduce a petitioner’s ultimate burden to establish
her overall entitlement to damages by preponderant evIdence. W.C. v. Sec’y of Health & Hum.
Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted).

The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion
testimony are favored in vaccine cases, as treating physicians are likely to be in the best position
to determine whether a ‘logical sequence of cause and effect show[s] that the vaccination was the
reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed
as particularly trustworthy evidence, because they are created contemporaneously with the
treatment of the patient. Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir.
1993).

However, medical records and/or statements of a treating physician’s views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully evaluated. 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 also be
weighed against other, contrary evidence also present in the record -- including conflicting
opinions among such individuals. Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742,
20
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); Caves v. Sec’y of Health &
Hum. Servs., No. 06-522V 2011 WL 1935813 at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot.
for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 Fed. App’x 765 (Fed.
Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 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 also coincide with the theory of how the relevant vaccine
can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health &
Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand on other grounds, 105
Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013). Koehn v. Sec’y of Health
& Hum. Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for
review den’d (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Law Governing Analysis of Fact Evidence

The process for making factual determinations in Vaccine Program cases begins with
analyzing the medical records, which are required to be filed with the petition. 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 413, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether to
afford greater weight to contemporaneous medical records than to other evidence, such as oral
testimony surrounding the events in question that was given at a later date, provided that such
determination is evidenced by a rational determination).

Medical records created contemporaneously with the events they describe are generally
trustworthy because they “contain information supplied to or by health professionals to facilitate
diagnosis and treatment of medical conditions,” where “accuracy has an extra premium.” Kirby v.
Sec’y of Health & Hum. Servs., 997 F.3d 1378 (Fed. Cir. 2021) citing Cucuras, 993 F.2d at 1528.
This presumption is based on the linked proposition 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) mot. for rev. denied, 142 Fed. Cl. 247, 251-52 (2019), vacated on
other grounds and remanded, 809 Fed. Appx. 843 (Fed. Cir. Apr. 7, 2020).
21
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
where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also
Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam, 968 F.2d
1226 (Fed. Cir. 1992), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States
v. U.S. Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony
which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)).

However, there are situations in which compelling oral testimony may be more persuasive
than written records, such as where records are deemed to be incomplete or inaccurate. Campbell
v. Sec’y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common
sense and experience, this rule should not be treated as an absolute and must yield where the factual
predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475 at *19 (“[w]ritten
records which are, themselves, inconsistent, should be accorded less deference than those which
are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination
regarding a witness’s credibility is needed when determining the weight that such testimony should
be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,
1575 (Fed. Cir. 1993).

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, such as testimony at hearing, there must be evidence that this decision was the
result of a rational determination. Burns, 3 F.3d at 417.

C. Analysis of Expert Testimony

Establishing a sound and reliable medical theory connecting the vaccine to the injury often
requires a petitioner to present expert testimony in support of his or her claim. Lampe v. Sec’y of
Health & Hum. Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony
is usually evaluated according to the factors for analyzing scientific reliability set forth in Daubert
v. Merrell Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Hum.
Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195
F.3d 1302, 1316 (Fed. Cir. 1999). “The Daubert factors for analyzing the reliability of testimony
22
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. Daubert factors are employed by judges to exclude
evidence that is unreliable and potentially confusing to a jury. In Vaccine Program cases, these
factors are used in the weighing of the reliability of scientific evidence. Davis v. Sec’y of Health
& Hum. Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 743. In this matter, (as in numerous other Vaccine Program cases), Daubert has not
been employed at the threshold, to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.

Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s
case. Where both sides offer expert testimony, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
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)). A “special master is entitled to
require some indicia of reliability to support the assertion of the expert witness.” Moberly, 592
F.3d at 1324. Weighing the relative persuasiveness of competing expert testimony, based on a
particular expert’s credibility, is part of the overall reliability analysis to which special masters
must subject expert testimony in Vaccine Program cases. Id. at 1325-26 (“[a]ssessments as to the
reliability of expert testimony often turn on credibility determinations”); see also Porter v. Sec’y
of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously
explained that special masters are expected to consider the credibility of expert witnesses in
evaluating petitions for compensation under the Vaccine Act”).

D. Consideration of Medical Literature

Finally, although this decision discusses some but not all of the medical literature in detail,
I have reviewed and considered all of the medical records and literature submitted in this matter.
See Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We
generally presume that a special master considered the relevant record evidence even though [s]he
does not explicitly reference such evidence in h[er] decision.”); Simanski v. Sec’y of Health &
Hum. Servs., 115 Fed. Cl. 407, 436 (2014) (“[A] Special Master is ‘not required to discuss every
piece of evidence or testimony in her decision.’” (citation omitted)), aff’d, 601 F. App’x 982 (Fed.
Cir. 2015).

23
VI. Analysis

Because Petitioner does not allege an injury listed on the Vaccine Injury Table, his claim
is classified as “off-Table.” As noted above, to prevail on an “off-Table” claim, Petitioner must
prove by preponderant evidence that he suffered an injury and that this injury was caused by the
vaccination at issue. See Capizzano, 440 F.3d at 1320.

A. Diagnosis

As a threshold matter, a petitioner must establish he suffers from the condition for which
he seeks compensation. Broekelschen, 618 F.3d at 1346. “The function of a special master is not
to ‘diagnose’ vaccine-related injuries, but instead to determine ‘based on the record as a whole and
the totality of the case, whether it has been shown by a preponderance of the evidence that a vaccine
caused the [petitioner]’s injury.’” Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1382
(Fed. Cir. 2009) (quoting Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 549 (Fed. Cir.
1994)). “Although the Vaccine Act does not require absolute precision, it does require the
petitioner to establish an injury – the Act specifically creates a claim for compensation for
‘vaccine-related injury or death.’” Stillwell v. Sec’y of Health & Hum. Servs., 118 Fed. Cl. 47, 56
(2014) (quoting 42.U.S.C. § 300aa-11(c)). Accordingly, the Federal Circuit has concluded that it
is “appropriate for the special master to first determine what injury, if any, [is] supported by the
evidence presented in the record” before applying a causation analysis pursuant to Althen v.
Secretary of Health & Human Services, 418 F.3d 1274 (Fed. Cir. 2005). Lombardi v. Sec’y of
Health & Hum. Servs., 656 F.3d 1343, 1351-53 (Fed. Cir. 2011).

Petitioner’s alleged vaccine injury has shifted throughout the course of this litigation. The
experts have discussed different potential diagnoses, including TM, brachial neuritis, CFS, SIRS,
reactive arthritis, arthralgia, and peripheral polyneuropathy. However, Petitioner’s post-hearing
brief and post-hearing reply brief eliminated many of these conditions from consideration.
Petitioner now contends that he suffers from arthralgias that resulted from a severe inflammatory
reaction caused by the Tdap vaccine. Pet’r’s Post-Hearing Brief at 1; Pet’r’s Reply Brief at 3.

Respondent asserts that Petitioner’s “non-specific inflammatory response is not a
cognizable injury.” Respt’s Brief at 29. Although Respondent does not specifically state that
arthralgia is not a cognizable injury, I will briefly analyze this issue.

In Lombardi v. Secretary of Health and Human Services, the petitioner contended that she
suffered from three different and distinct medical conditions: transverse myelitis, chronic fatigue
syndrome, and systemic lupus erythematosus. Lombardi v. Sec’y Health & Hum. Servs., 656 F.3d
1343, 1352 (Fed. Cir. 2011). Her treating physicians did not agree on a diagnosis, and even her
experts differed with one another. Id. Ultimately, the court agreed with the special master that
petitioner had not established she suffered from any of these conditions by preponderant evidence.
The Federal Circuit held that the Vaccine Act “places the burden on the petitioner to make a
showing of at least one defined and recognized injury … not merely a symptom or manifestation
of an unknown injury.” Id. at 1353.

In Lasnetski v. Secretary of Health and Human Services, the Court of Federal Claims
24
determined the special master was not arbitrary and capricious in concluding that sensory
dysesthesia8 and an “idiosyncratic severe reaction to vaccination” were not defined and recognized
injuries, but instead were descriptions of symptoms. Lasnetski v. Sec’y of Health & Hum. Servs.,
128 Fed. Cl. 242, 263-64 (2016); aff’d in non-precedential op., 696 Fed. App’x 497 (Fed. Cir.
2017). In that case, the Respondent’s expert specifically testified that sensory dysesthesia and an
idiosyncratic severe reaction to vaccination were descriptions of symptoms and not recognized
injuries. Id. at 262. No such evidence was presented in the case at bar. The Court, in addressing
Lombardi, noted that a vaccine injury cannot merely be a symptom of an unknown injury because
“a symptom or manifestation could indicate any number of different underlying injuries, each with
its own pathology, making it impossible for the court to accurately determine causation.” Id.

The case at bar is similar to Lombardi in that Petitioner’s treating physicians and her expert
discuss several different diagnoses. The different diagnoses proposed by both the treating doctors
and Dr. Shafrir reinforce the point that Petitioner’s clinical picture was less than clear. However,
in this case, unlike in Lombardi, the evidence supports a finding that Petitioner actually suffered
from several distinct conditions. For example, Dr. Wilson testified that Petitioner’s GI issues, to
include loose stool, abdominal bloating, and liver failure were likely caused by his unnecessary
prescription for antibiotics. Tr. at 145. Petitioner also suffered from fatigue after developing
mononucleosis as a teenager. Wilson Rep. at 5. Importantly, however, there is no dispute that
Petitioner suffered from arthralgia. The fact that Petitioner experienced other medical problems in
addition to arthralgia does not mean that a diagnosis of arthralgia must explain his entire clinical
picture. Further, a diagnosis of arthralgia does not frustrate the court’s ability to determine
causation. Lasnetski, 128 Fed. Cl. at 262.

Petitioner’s treating physicians repeatedly diagnosed him with arthralgia. See Ex. 1 at 33
(May 23, 2015 medical record where Petitioner is assessed with “polyarthralgia”); Ex. 1 at 40
(medical record from May 26, 2015 where Dr. Wilcox assessed Petitioner with “arthralgia of
multiple sites”); Ex. 1 at 43 (June 5, 2015 medical record where Dr. Wilcox diagnosed Petitioner
with “arthralgia of multiple sites”); Ex. 1 at 48 (July 9, 2015 medical record where Dr. Wilcox
assessed Petitioner with “arthralgia of multiple sites”); Ex. 1 at 51 (July 29, 2015 medical record
where Dr. Wilcox assessed Petitioner with “arthralgia of multiple sites”). The fact that Petitioner’s
treating physicians diagnosed arthralgia suggests that it is a medically recognized injury.

Additionally, on several occasions, these diagnoses of arthralgia were accompanied by
diagnostic code 719.49. See e.g., Ex. 1 at 40, 43, 48, 51. This code is from the ICD-9 and is for
“pain in joint, multiple sites.”9 The ICD-9, or the International Classification of Diseases is “a
complex and evolving international coding system utilized by patient care providers to identify the
condition or conditions suffered by their patients.” Koehn v. Sec’y of Health & Hum. Servs., No.
11-355V, 2013 WL 3214877, at *5 (Fed. Cl. Spec. Mstr. May 30, 2013); mot. for rev. denied, Dec.
3, 2013, aff’d, 773 F.3d 1239 (Fed. Cir. 2014). The fact that there is a specific ICD code for

8
The “distortion of any sense, especially of that of touch.” DORLAND’S, www.dorlandsonline.com/dorland/
definition?id=15186 (last visited April 22, 2024).
9
ICD-9-CM Diagnosis Code 719.49: Pain in joints, multiple sites. ICD9DATA,
http://www.icd9data.com/2015/Volume1/710-739/710-719/719/719.49.htm (last visited April 23, 2024).
25
arthralgia further suggests that it is a cognizable injury and not merely a symptom of an unknown
condition.

Based on the above, I conclude that Petitioner’s diagnosis of arthralgia is supported by the
record, and further, that it is a medically recognized injury.

B. Severity Requirement

The Vaccine Act includes a “severity requirement,” which requires a petitioner to
demonstrate that they:

(i) suffered the residual effects or complications of such illness, disability, injury,
or condition for more than 6 months after the administration of the vaccine, or (ii)
died from the administration of the vaccine, or (iii) suffered such illness, disability,
injury or condition from the vaccine which resulted in inpatient hospitalization and
surgical intervention.

§11(c)(1)(D). “‘Residual’ suggests something remaining or left behind from a vaccine injury.”
Wright v. Sec’y of Health & Hum. Servs., 22 F.4th 999, 1005 (Fed. Cir. 2022).

Respondent contends that Petitioner has not suffered from a vaccine related injury for more
than six months. Resp’t’s Brief at 37-42. Six months after vaccination is November 20, 2015. I
find the evidence supports that Petitioner continued to experience the residual effects of his
arthralgias more than six months post vaccination.

Petitioner testified that as of the date of the entitlement hearing, he still experienced joint
pain in his wrists and hands. Tr. at 29. This testimony of continuing joint pain is consistent with
the medical records detailed below.

Petitioner’s symptoms began on May 22, 2015, when he experienced neck pain and
stiffness as well as difficulty moving his right hand. Ex. 1 at 22. His symptoms continued the next
day and included neck stiffness and bilateral hand and arm weakness and pain. Ex. 1 at 31-33.
Petitioner’s CRP was elevated at 90.70 as was his white blood count. Id. at 34, 36. The doctor
noted “most likely this is an inflammatory reaction to the tetanus shot he received.” The doctor’s
final impression was “polyarthralgia” and bilateral arm weakness.” Id. at 33.

Petitioner returned to his PCP, Dr. Wilcox, on May 26, 2015. Petitioner described that he
was stiff and sore and that he was experiencing migratory swelling and arthralgias. Ex. 1 at 39. On
physical examination, Petitioner had erythema and swelling of his left forefinger. Id. at 40. Dr.
Wilcox prescribed a prednisone taper. Id.

Petitioner returned to Dr. Wilcox on June 5, 2015. Ex. 1 at 42-44. Dr. Wilcox assessed
Petitioner as having “arthralgia of multiple sites” and noted that he was experiencing “[c]ontinued
generalized and migratory arthralgias following a tetanus vaccination.” Id. at 43. Dr Wilcox
observed that Petitioner’s “clinical course continues to be most suggestive of a reaction to his
vaccination.” Id.
26
On June 30, 2015, Dr. Moore. observed that Petitioner was feeling better, but that as he
tapered from prednisone, some of his symptoms had again worsened. Ex. 1 at 45. She documented
mild synovitis in his hands. Id.

On July 29, 2015, Petitioner returned to Dr. Wilcox one week after completing his
prednisone taper. The medical record notes that Petitioner’s arthralgias were improving but that
there was some residual wrist discomfort. Ex. 1 at 50. Dr. Wilcox documented “mild redness in
the outer aspect of both wrists” on physical exam. Id. at 51.

Petitioner visited Dr. Sislow on September 28, 2015. Ex. 1 at 83. During this visit,
Petitioner complained of mild bilateral wrist pain. Id.

The medical records listed below reflect treatment conducted after November 20, 2015,
and thus are relevant to the six-month severity issue.

On December 30, 2015, Petitioner returned to Dr. Wilcox. Ex. 1 at 127. Dr. Wilcox noted
that Petitioner continued “to feel poorly.” The Review of Systems listed joint pain, swelling or
redness of joints, and muscle pain. Id. at 128.

On February 29, 2016, Petitioner visited Dr. Krajcer, a rheumatologist at the Polyclinic.
Ex. 5 at 2. On physical exam, Petitioner was noted to have localized tenderness to palpation in his
peripheral joints, shoulders, and knees. Id. at 5. Dr. Krajcer’s impression was systemic
inflammatory response syndrome (“SIRS”) subsequent to a vaccination with reported migratory
arthritis and spondylitis symptoms in the neck. Id. at 11. Dr. Krajcer subsequently emailed
Petitioner a message on March 11, 2016 suggesting that his SIRS “may gradually burn out.” Id. at
20. The statement that his inflammatory condition “may” burn out suggests that it had not yet
subsided.

On March 18, 2016, Petitioner visited Dr. Yang, a neurologist at the Polyclinic. Ex. 5 at
34-37. Dr. Yang noted that Petitioner continued to have “remarkable weakness of the arms and
legs.” Id. at 35.

Several of the medical records after November 20, 2015 demonstrate that Petitioner
continued to suffer from arthralgias or residual symptoms associated with arthralgias. These
records are consistent with his testimony at the entitlement hearing and preponderantly establish
that Petitioner suffered from the residual effects of his condition for more than six months.

C. Althen Prong One

In the context of the Program, “to establish causation, the standard of proof is
preponderance of evidence, not scientific certainty.” Langland v. Sec’y of Health & Hum. Serv.,
109 Fed. Cl. 421, 441 (2013). Petitioner’s burden under Althen’s first prong is to provide a medical
theory causally connecting the vaccination and the injury. Id. This theory must be sound and
reliable. Boatmon, 941 F.3d at 1359.

27
In his expert report, Dr. Wilson opined that “[s]ystemic inflammation with arthralgias and
myalgias are common phenomena that are associated with a wide variety of infectious triggers.
They can also occur after many vaccinations, including Tdap, but they are short-lived (days).”
Wilson Rep. at 6. Dr. Wilson cited to the Hervé article in support of this point, which described
that “[t]he mediators and products of inflammation at a localised site in the body may spill into the
circulation and can affect other body systems causing systemic side-effects.” Hervé et al., The
how’s and what’s of vaccine reactogenicity, 4 NPJ VACCINES 39, 1-11 (2019) (filed as Ex. E)
(hereinafter “Hervé”). Dr. Wilson conceded that Tdap vaccine “can cause” arthralgias, and the
Hervé article supports this opinion.10

During the entitlement hearing, Dr. Wilson testified that the Tdap vaccination caused
Petitioner’s arthralgia in July and September of 2015. See Tr. at 152-54 (In discussing the
September 28, 2015 medical record, the following exchange occurred; Q: “the arthralgia listed
under active problems, do you attribute that to the same vaccine reaction that you attributed the
July 29 note to?” A: “Yes”).

Dr. Wilson’s concession that Petitioner’s Tdap vaccine “did cause” his initial arthralgias
inherently means that he agrees the Tdap vaccine “can cause” arthralgias. Caves v. Sec’y of Dept.
of Health & Hum. Servs., 100 Fed. Cl. 119, 145 (2011) (“[A] statement that a vaccine did in fact
cause an injury presupposes that the vaccine is capable of causing that injury.”); aff’d, 463 Fed.
App’x. 932 (Fed. Cir. 2012); see also Capizzano, 440 F.3d at 1326 (stating that evidence relevant
to one Althen prong may be relevant to another Althen prong); Pankiw v. Sec’y of Health & Hum.
Servs., No. 15-1082V, 2021 WL 5578387, at *8 (Fed. Cl. Spec. Mstr. Nov. 2, 2021) (noting that a
doctor’s statement that a vaccine did cause the petitioner an injury implies that that vaccine can
cause that injury).

Accordingly, causation is conceded; Petitioner has presented preponderant evidence in
support of the first Althen prong.

D. Althen Prong Two

Under Althen’s second prong, a petitioner must “prove a logical sequence of cause and
effect showing that the vaccination was the reason for the injury.” Althen, 418 F.3d at 1278. The
sequence of cause and effect must be “'logical' and legally probable, not medically or scientifically
certain.” Id. A petitioner is not required to show “epidemiologic studies, rechallenge, the presence
of pathological markers or genetic disposition, or general acceptance in the scientific or medical
communities to establish a logical sequence of cause and effect.” Id. (omitting internal citations).
Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006). Instead,
circumstantial evidence and reliable medical opinions may be sufficient to satisfy the second
Althen prong. Isaac v. Sec’y of Health & Hum. Servs., No. 08-601V, 2012 U.S. Claims LEXIS
1023 at *75 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for rev. denied, 108 Fed. Cl. 743 (Fed. Cl.
2013); aff’d 540 Fed. App’x 999 (Fed. Cir. 2013).

10
I additionally note the Adacel package insert documents that 9.1% of adults aged 18-64 experienced sore
and swollen joints in days 0-14 after Adacel vaccination. Ex. 50 at 9. Of that number, .5% reported “severe”
symptoms. Id.
28
I first note that Petitioner’s presentation is consistent with a vaccine reaction. He
experienced weakness, joint pain, stiffness, and swelling that began two days after his Tdap
vaccination. On May 23, 2015, Petitioner’s CRP level was markedly elevated at 90.70 (reference
range ≤ 3.0 mg/L). Ex. 1 at 36. His white blood count was also high at 13.8 (reference range 4.0-
11.0 kK/uL). Id. at 34. Elevated CRP and white blood count support the existence of active
inflammation. Tr. at 38, 138.

In addition, Petitioner’s treating physicians consistently attributed his arthralgias to the
Tdap vaccination. On May 26, 2016, Dr. Wilcox diagnosed Petitioner with “arthralgia of multiple
sites” and noted “[i]t appears that he is suffering from a reaction to his Adacel vaccination. His
current symptoms are reported side effects and he has had extensive evaluation otherwise.” Ex. 1
at 40. On June 5, 2015, Dr. Wilcox again opined that “[h]is clinical course continues to be most
suggestive of a reaction to his vaccination.” Id. at 43. On June 30, 2015, Petitioner visited Dr.
Moore, who assessed him with drug toxicity and noted a “[p]robable reaction to the Tdap
[vaccine].” Id. at 45. On September 28, 2015, Dr. John Sislow noted in the medical record “[t]his
40 year old physical therapist received a tdap (Adacel) injection this past spring and had a profound
adverse reaction including diffuse joint stiffness.” Id. at 83. On February 29, 2016, Dr. Krajcer (a
rheumatologist) found that Petitioner suffered from a “[s]ystemic inflammatory response
syndrome last [M]ay subsequent to a vaccination with reported migratory arthritis, spondylitis
symptoms (neck).” Ex. 5 at 11. Dr. Krajcer messaged Petitioner on March 11, 2016 and stated, “I
suspect that this systemic inflammatory response syndrome of sorts that started after your
vaccination to Tda[p] may gradually burn out. … The Tdap [v]accination is on your allergy list
here and should be in any other healthcare setting.” Id. at 20. On February 15, 2022, Dr. Wilcox
noted that Petitioner had a “[p]revious reaction to tetanus vaccination” and noted that he should
“avoid vaccinations for now.” Ex. 54 at 11.

In weighing evidence, special masters are expected to consider the views of treating
doctors. Capizzano, 440 F.3d at 1326. The views of treating doctors are often persuasive because
the doctors have direct experience with the patient whom they are treating. See McCulloch v. Sec’y
of Health & Hum. Servs., No. 09-293V, 2015 WL 3640610, at *20 (Fed. Cl. Spec. Mstr. May 22,
2015). I find the views of Petitioner’s treating physicians to be persuasive, and help Petitioner to
establish that the vaccine “did cause” his condition.

Consistent with the opinions of Petitioner’s treating doctors, both Dr. Shafrir and Dr.
Wilson testified that Petitioner’s arthralgias were caused by his Tdap vaccination. Tr. at 68-69 (Dr.
Shafrir opining that Petitioner’s initial symptoms to include pain and inflammation was a direct
result of vaccination), Tr. at 152-54 (Dr. Wilson conceding that Petitioner’s arthralgias that he
experienced in July and September were caused by vaccination).

For the reasons articulated above, I find that Petitioner has preponderantly demonstrated
that his vaccination caused his arthralgias, and has thus established the second prong of Althen.

E. Althen Prong Three

The timing prong contains two parts. First, a petitioner must establish the “timeframe for
29
which it is medically acceptable to infer causation” and second, he must demonstrate that the onset
of the disease occurred in this period. Shapiro v. Secʼy of Health & Hum. Servs., 101 Fed. Cl. 532,
542-43 (2011), recons. denied after remand on other grounds, 105 Fed. Cl. 353 (2012), aff’d
without op., 503 F. App’x 952 (Fed. Cir. 2013).

Petitioner received his Tdap vaccine on May 20, 2015. There is no dispute that he began
to experience pain and stiffness two days later. Dr. Shafrir testified that this onset interval is
medically appropriate and implicates the vaccine as causal. Tr. at 77. Dr. Wilson agreed. He opined
as follows: “I agree with the petitioner’s expert that Mr. Schwarz had an acute inflammatory
reaction in the immediate aftermath of his vaccination associated with elevated inflammatory
markers in the blood that caused pain and discomfort in various joints, but even though there was
a temporal association between these symptoms and the vaccination, this does not prove
causation.” Wilson Rep. at 7 (emphasis added). Dr. Wilson conceded the temporal association
between vaccination and onset of arthralgias.11 Further, the Hervé article supports an onset of
symptoms consistent with an innate immune response. Two days is within this window. See
generally, Hervé; see also Tr. at 150 (Dr. Wilson testifying that the innate immune response occurs
within the first three days after vaccination). Thus, Petitioner has presented preponderant evidence
in support of the third Althen prong.

VII. Conclusion

Upon careful evaluation of all the evidence submitted in this matter, including the medical
records, the affidavits and testimony, as well as the experts’ opinions and medical literature, I
conclude that Petitioner has established entitlement to compensation. An order regarding damages
will issue shortly.

IT IS SO ORDERED.

s/ Katherine E. Oler
Katherine E. Oler
Special Master

11
Even though Dr. Wilson did not state that the temporal interval was “medically appropriate”, that is the
clear implication of his statement. Indeed if he thought the timing was not appropriate to implicate the
vaccine, he would have said so.
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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10735131. Public record. Not legal advice.