Pelelo v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-1485V
(to be published)

***************************** Chief Special Master Corcoran
*
THOMAS PELELO, *
* Filed: August 6, 2021
Petitioner, *
*
v. *
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
Respondent. *
*
*****************************

James Cook, Dutton, Daniels, Hines, Kalkhoff, Cook & Swanson, PLC, Waterloo, IA, for
Petitioner.

Catherine Stolar, U.S. Dep’t of Justice, Washington, DC, for Respondent.

ENTITLEMENT DECISION 1

On October 10, 2017, Ann Pelelo, mother of Thomas Pelelo, filed a petition on his behalf
for compensation under the National Vaccine and Injury Compensation Program (the “Vaccine
Program”). 2 (ECF No. 1) (“Petition”). The Petition alleged that Mr. Pelelo experienced Parsonage-
Turner syndrome, a/k/a brachial neuritis, after receipt of a human papillomavirus (“HPV”) vaccine
on December 29, 2015. Petition at 1. The caption was changed once Mr. Pelelo became 18 years

1
This Decision shall be posted on the Court of Federal Claims’ website in accordance with the E-Government Act of
2002, 44 U.S.C. § 3501 (2012)). This means that the Decision will be available to anyone with access to the
internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the Decision’s inclusion
of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days
within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial
or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the
disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the
whole Decision will be available to the public. Id.
2
The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the
Act”]. Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix).
old, and hence the proper petitioner/party in interest. Order, dated September 19, 2019 (ECF No.
44).

I determined that this matter could be most efficiently resolved via ruling on the record.
Based on that record and the parties’ other written submissions, I find that Petitioner has not carried
his evidentiary burden. Insufficient evidence supports the conclusion that the HPV vaccine can
cause brachial neuritis, or did so to Petitioner in this case.

I. Factual Background

Mr. Pelelo was born on August 6, 2001. Ex. 2 at 1. His prior medical history included
lumbar, right foot, and left lower extremity pain. Ex. 6 at 1-2 (December 2015 appointments with
chiropractor for lumbar and right foot pain); see also Ex. 15 at 191, 193. Petitioner received his
first dose of HPV vaccine on October 16, 2015, in his left deltoid. Ex. 2 at 1. The record does not
reveal he experienced any reaction to it, and sets forth no symptoms associated with this claim
before the next dose he received.
Vaccination and Initial Symptoms
Petitioner received his second HPV vaccine dose on December 29, 2015, again in his left
deltoid. Ex. 2 at 1; Petition at 1. Petitioner has reported awakening the morning after he received
this dose, with numbness and disability of the left arm. Id. Petitioner has also stated in another
declaration that he “attended swim practice the day after” receiving his second HPV vaccination,
but at that time “had great difficult[y] moving [his] left shoulder.” Letter, filed as Ex. 32 on Sept.
1, 2020 (ECF No. 56-1), at 1.
Less than two weeks later, on January 11, 2016, Mr. Pelelo presented to his existing
chiropractor. Ex. 6 at 3. At this time, Petitioner appears to have complained of tightness between
his shoulder blades, worse on the left side, with the “date of the condition” identified as “1/8/16 –
swim.” Id. He was referred to his pediatrician for follow-up. Id. Later that same day, Ann Pelelo
phoned Petitioner’s pediatrician’s office (as reflected in a note of the call memorialized in the
record), stating that her son could not move his arm, and was self-treating with ibuprofen but
without relief. Ex. 3 at 25-26. She also reported that Petitioner had been “evaluated by [a] swim
coach and [an] athletic trainer as well as a chiropractor and felt there was nerve damage” relating
to Petitioner’s December 29, 2015 HPV vaccine dose. Id. Petitioner was now referred to an
orthopedist. Id. at 26.
On January 12, 2016, Mr. Pelelo underwent an orthopedic assessment with Dr. Steven
Rock to evaluate his left shoulder pain, which was reported to have begun “shortly after receiving
his HPV vaccine on December 29, 201[5].” Ex. 3 at 15. The history of present illness noted that
Petitioner’s pain was “more periscapular and in the area of the upper trapezius,” with weakness
and associated difficulty “forward flexing or abducting the shoulder.” Id. The pain associated with
his symptoms made it difficult to for him to swim competitively. Id.

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 Upon examination, Petitioner displayed tenderness “over the supraspinatus, infraspinatus
and upper trapezius on the left,” with mild tenderness in the deltoid area and reduced left upper
extremity strength. Ex. 3 at 16. Dr. Rock opined that “[p]resumptively,” Petitioner had Parsonage-
Turner syndrome, “which [was] felt to be a potential autoimmune response or inflammatory
disorder [that] can occur post immunization, post illness or sometimes after injury.” Id. Dr. Rock
added, however, that specific testing—an electromyography (“EMG”) and/or nerve conduction
study (“NCS”)—could help “solidify the diagnosis.” Id. Dr. Rock prescribed a Medrol Dosepak
and ordered physical therapy. Id.
On January 19, 2016, Mr. Pelelo went back to Dr. Rock, now reporting that his pain had
not improved. Ex. 3 at 14. On exam, he revealed “no obvious scapular winging, although there
[wa]s potentially some subtle winging on the left developing.” Id. Dr. Rock referred Petitioner to
a neurologist to obtain a definitive diagnosis, and to “evaluate for any other potential possibilities.”
Id. at 15. A week later (January 28th), Mr. Pelelo saw neurologist Dr. Marsha Horwitz. Id at 8. The
history from this visit reports that Petitioner was experiencing “left shoulder numbness, pain and
unable to l[i]ft arm since 2 weeks after HPV injection,” although it also stated he has felt “a feeling
of tightness in his left shoulder the following day” after vaccination. Id. On exam, Petitioner’s left
upper extremity weakness was confirmed. Id. at 9. Dr. Horwitz’s diagnosis was “[l]eft brachial
plexopathy, autoimmune, consistent with [PTS].” Id. at 10.
Subsequent Treatment and Evaluation
On February 24, 2016, Mr. Pelelo was evaluated at the University of Iowa’s Sports
Medicine Clinic (the “Sports Medicine Clinic”). Ex. 3 at 40. The history of present illness section
of the record from this visit is consistent with Petitioner’s initial witness statement, both of which
report a reaction within a day of vaccination. Thus, this record’s history states that after the HPV
vaccine dose at issue, Petitioner had “proceeded to swim practice that night with no problems,”
but awoke the next day with numbness, and could not thereafter swim. Id. The history also noted,
however, that Petitioner’s PTS initial diagnosis had been arrived at “without an EMG.” Id. His
examination showed “severe scapular winging during forward flexion and extension indicating
serratus anterior dysfunction.” Id. at 42. He also had “[m]ild sensation loss of [his] dorsal hand
and fingers” on the left. Id.
EMG and NCS studies were performed at the Sports Medicine Clinic (now approximately
eight weeks post-vaccination), but they did not corroborate the brachial neuritis diagnosis. Rather,
they showed “no electrophysiologic evidence of either left brachial plexopathy, long thoracic
neuropathy, or other neuropathy typically involved in scapular winging.” Ex. 4 at 129. In
particular, Petitioner’s needle EMG was deemed “essentially normal.” Id. By contrast, his “left
median distal latencies were slightly prolonged” in the NCS, leading to an “incidental finding of
very mild median neuropathy at the wrist,” but his median motor and sensory studies were
otherwise normal. Id. The EMG/NCS was signed by neurologist Dr. Heather Bingham, who
certified that she was “present during the examination and concur[ed] with the findings and
interpretation of th[e] report.” Id.

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 In the subsequent months, Mr. Pelelo was extensively treated for his presumed brachial
neuritis. In March 2016, he began receiving intravenous immunoglobulin (“IVIG”) therapy, after
failing to improve with physical therapy. Ex. 3 at 47. The admission note indicated that Petitioner
had received an HPV vaccine dose on December 29, 2015, and “[t]hat night, he attended swim
practice and noted mild discomfort and weakness.” Id. Petitioner reported that “his pain gradually
ended but that he continues to have intermittent decreased sensation and tingling down his arm
and to his central three fingers.” Id. Petitioner’s treating physicians had expressed confidence in
the brachial neuritis diagnosis, even though their notes specifically acknowledged that on EMG
Petitioner had displayed “no electrophysiologic findings for left brachial plexopathy, long thoracic
neuropathy, or other neuropathy.” Id. at 47-48. Petitioner received two IVIG infusions that month.
Id. at 45.
By the end of March 2016, it appeared Mr. Pelelo had largely recovered, with resolution
of his pain and a return to his former strength. Ex. 3 at 35. At most, he displayed “slightly
diminished muscle bulk” of his left shoulder, as compared to his right, and mild scapular winging.
Id. He was now able to return to swimming, and although he continued to pursue physical therapy,
he could pursue athletic activities without pain. Ex. 5 at 4-5. As of May 2016, however, Petitioner
reported a plateauing in his recovery, with “decreased ROM and more weakness with manual
muscle testing.” Id. at 5. To gain a better understanding of the presentation, Dr. Andrew Peterson
at the Sports Medicine Clinic ordered an MRI, but the results were deemed normal. Ex. 3 at 30,
33.
Into the summer of 2016, Petitioner continued to pursue competitive sports without pain,
“but fe[lt] limited in some of the movements.” Ex. 5 at 3. Then, on July 14, 2016, Mr. Pelelo
informed his physical therapist that his left shoulder pain had worsened “over the past 7-10 days,”
although his physical therapist associated it with over-exertion and effort rather than related to
Petitioner’s earlier brachial neuritis diagnosis. Id. By the fall of 2016, Petitioner’s physical therapy
was discontinued. Id. at 2.
Subsequent evaluations revealed some persistent/lingering left shoulder pain, confirming
the sense that Mr. Pelelo’s overall condition had plateaued since May, although his range of motion
was near normal. Ex. 3 at 117-18. By early November 2016, Petitioner received a release from his
pediatrician to return to “swim team and swimming in P.E.” See Ex. 3 at 112. Thereafter, Mr.
Pelelo continued to report left shoulder pain that he said interfered with his athletic pursuits, and
he pursued chiropractic treatment from 2017 to 2019. Ex. 6 at 15 (December 23, 2016 appointment
with chiropractor reporting radiating pain from thoracic region into left shoulder); see also Ex. 19.
Records from his more recent medical history do not shed light on the claims asserted herein.

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II. Expert Reports

A. Petitioner’s expert: Alan J. Fink, M.D.

Dr. Fink, a neurologist, filed three reports. Report, dated August 14, 2018, filed as Ex.
9 (ECF No. 22-1) (“First Fink Rep.”); Report, dated December 13, 2019, filed as Ex. 22 (ECF
No. 46-1) (“Second Fink Rep.”); Report, dated August 16, 2020, filed as Ex. 36 (ECF No. 36-
001) (“Third Fink Rep.”). Dr. Fink endorsed brachial neuritis as the proper diagnosis for
Petitioner’s injury, and that the HPV vaccine had likely caused it. First Fink Rep. at 3-5.
Dr. Fink is a neurologist in private practice in Greenville, Delaware, and an examiner
for the Social Security Administration. See Ex. 10 (ECF No. 22-2) (Dr. Fink’s Curriculum
Vitae (“CV”)) at 2. He received his medical degree in 1970 from State University of New York
– Buffalo School of Medicine, and did a residency in medicine at Nassau County Medical
Center, followed by a neurology residency at Yale-New Haven Hospital. CV at 1-2. He also
held MRI-related fellowships thirty-plus years ago. Id. at 1. He has received several “best
doctor-neurology” awards from a Delaware regional magazine, and is board certified in
neurology. Id. at 2-3. He holds the position of Clinical Assistant Professor of Neurology at
Thomas Jefferson Medical College in Philadelphia, Pennsylvania. Id. at 3. Over his 47 years
of practice, Dr. Fink recalls encountering “the neurological complications of vaccines”
presenting as brachial neuritis twice, although he also treated the same condition twice where
it did not arise in connection with vaccination. First Fink Rep. at 1.
First Report
Dr. Fink began his first report with a brief review of Mr. Pelelo’s medical history
consistent with the medical record, beginning well prior to vaccination. First Fink Rep. at 1-3.
He specifically accepted the conclusion that Petitioner’s onset occurred within 24 hours of his
receipt of a second HPV vaccine dose. Id. at 3.
Dr. Fink then characterized brachial neuritis as “a condition that causes pain and
weakness of the shoulder girdle muscles and/or of the upper extremity muscles.” First Fink
Rep. at 3. He noted that “[a]utoimmune and immunizations” are an understood cause for
brachial neuritis, and maintained it was reasonable to view it as immune-mediated. J. Van Eijk
et al., Neuralgic Amyotrophy: An Update on Diagnosis, Pathophysiology, and Treatment, 53
Muscle Nerve 337-50 (2016), filed as Ex. 25 on Dec. 16, 2019 (ECF No. 46-4) (“Van Eijk”),
at 339-40. Another article Dr. Fink had offered showed that between 30 to 85 percent of all
case involving assumed immune-mediated responses occurred three to fourteen days after
vaccination, and thus somewhat acutely (although obviously less so than Petitioner avers
occurred in his case). First Fink Rep. at 3; P. Debeer et al., Brachial Plexus Neuritis Following
HPV Vaccination, 26 Vaccine 4417-19, 4418 (2008), filed as Ex. 11 on Aug. 28, 2018 (ECF
No. 22-3) (“Debeer”) (describing brachial neuritis as presenting with “sudden severe pain”).
Debeer, however, is a single-subject case report, observing one case of brachial neuritis in a

5
 19 year-old woman that manifested one month after the second HPV dose—not one day.
Debeer at 4417.
Regarding causation, Dr. Fink observed that post-vaccination brachial neuritis had
been observed in connection with a number of vaccines, and specifically noted that case reports
existed suggesting the HPV vaccine was associated with 16 incidents of brachial neuritis
(although Dr. Fink’s report provides no citation for this assertion). First Fink Rep. at 4. 3 He
proposed, however, that these occurrences were likely under-reported, since “neuritic pain is
often related to a shoulder joint problem.” Id He provided no other explanation in this report
for how the HPV vaccine might trigger or cause brachial neuritis.
Dr. Fink also provided some examples from the medical record that he maintained
supported his opinion that the HPV vaccine caused Mr. Pelelo’s brachial neuritis. He observed
that Petitioner’s treaters had made the diagnosis based on the evidence of “sudden and severe
pain followed by atrophic weakness of the shoulder muscles and dyskinesia.” First Fink Rep.
at 4-5. Mr. Pelelo also did not see a return to normal muscle function, which Dr. Fink said is
characteristic in more than half of all brachial neuritis cases. Id. at 4. And Petitioner had
experienced some recurrence as well, which also was not unusual. Id.; Van Eijk at 339.
Dr. Fink admitted that some important diagnostic criteria—in particular, Petitioner’s
MRI or EMG results—did not confirm the brachial neuritis diagnosis. First Fink Rep. at 4.
However, he discounted the importance of such findings, arguing that this was not an unusual
outcome and did not per se rule out the diagnosis. Id.
Second Fink Report
Dr. Fink’s second report responded both to challenges raised in the report of Respondent’s
expert, as well as questions posed to him directly by the special master previously presiding over
the case. First, Dr. Fink noted other aspects of the medical record that he maintained supported the
brachial neuritis diagnosis. In particular, scapular winging (which he deemed a potential result of
brachial neuritis) was observed at a May 2016 exam conducted by the University of Iowa Sports
Clinic. Second Fink Rep. at 1. Mr. Pelelo’s lack of complete recovery even as late as the fall of
2016 was also consistent with the diagnosis. Id. at 1, 4. And the kind of ongoing “prolonged
weakness” Petitioner had experienced was seen in at least a quarter of brachial neuritis cases. Id.
at 3.

More of Dr. Fink’s second report was devoted to explaining why he did not consider the
normal MRI and EMG results to be inconsistent with a brachial neuritis diagnosis. He noted
literature stating that only about six percent of brachial neuritis cases featured abnormal MRI

3
At most, one of the case reports filed in the matter states that 17 instances of “brachial plexopathy” were reported by
passive surveillance systems of reported adverse effects after the HPV vaccine. Taras et al., Brachial Neuritis
Following Quadrivalent Human Papilloma Virus (HPV) Vaccination, 6 Hand 454-456 (2011), filed as Ex. 12 on Aug.
28, 2018 (ECF No. 22-4) at 456. As discussed herein, however, that kind of data does not receive significant weight
in Program cases.

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results. Second Fink Rep. at 2; Van Eijk at 339. The same was generally true of EMGs, even
though they admittedly were often relied upon by neurologists to confirm the diagnosis. Second
Fink Rep. at 2; Van Eijk at 343. EMGs were in fact often “fraught with sampling error,” and thus
might well fail to demonstrate abnormalities demonstrated in clinical evidence, and thus optimally
two should be performed (although that did not occur here). Second Fink Rep. at 2, 3; Van Eijk at
342 (“[a] normal motor nerve conduction study examination does not exclude brachial plexitis as
a diagnosis”). Dr. Fink also observed that in Petitioner’s case, it appeared the EMG/NCS was
performed not by a neurologist but by a technician less skilled at the task. Second Fink Rep. at 3.

In response to questions raised by the special master about the likely pathophysiology of
Petitioner’s injury attributable to vaccination—a matter not explored in any detail in his the first
report—Dr. Fink proposed a multi-factored process. A genetic predisposition carried by the injured
party would, in his view, likely interact with (a) a mechanical injury to a nerve (in this case, Mr.
Pelelo swimming the day after receipt of the second HPV dose), and (b) a vaccine-instigated
immune system reaction, producing an autoimmune process. Second Fink Rep. at 3; N. van Alfen
et al., Treatment for Idiopathic and Hereditary Neuralgic Amyotrophy (Brachial Neuritis)
(Review), (3) Cochrane Database of Systematic Reviews, Art. No.: CD006976, 1-6 (2009), filed
as Ex. 28 on Dec. 16, 2019 (ECF No. 46-7) (“van Alfen I”); M. Martinez-Lavin, Hypothesis:
Human Papillomavirus Vaccination Syndrome—Small Fiber Neuropathy and Dysautonomia
Could be its Underlying Pathogenesis, 34 Clin. Rheumatol. 1165-69 (2015), flied as Ex. 26 on
Dec. 16, 2019 (ECF No. 46-5) (“Martinez-Lavin”).

Martinez-Lavin does not specifically address brachial neuritis. Rather, it puts forth the
hypothesis that small fiber neuropathy and dysautonomia (both of which it deems manifestations
of “[s]ympathetic nervous system dysfunction”) could constitute the underlying pathogenesis for
a group of rare overlapping reactions (complex regional pain syndrome, postural orthostatic
tachycardia syndrome, etc.), that often are reported in passive surveillance as adverse responses to
receipt of the HPV vaccine. Martinez-Lavin at 1165. Indeed, Martinez-Lavin notes that adverse
reactions appear to be more frequent after HPV vaccination when compared to other types of
immunizations, although the article does not flesh out a causal relationship. Id. Brachial neuritis
could, therefore, in Dr. Fink’s view plausibly reflect the same kind of “HPV syndrome.” Evidence
that the process causing brachial neuritis was likely immune-mediated was also provided by other
literature suggesting “[t]he presence of multimodal mononuclear infiltrates . . . and antiganglioside
antibodies” in the blood serum of patients with the condition. Second Fink Rep. at 3. 4

Third Fink Report

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Dr. Fink’s report cites a particular article for this assertion. Z. Simmons, Electrodiagnosis of Brachial Plexopathies
and Proximal Upper Extremity Neuropathies, 24 Phys. Med. Rehabil. Clin. N. Am. 1-20 (2013), filed as Ex. 29 on
Dec. 16, 2019 (ECF No. 46-8) (“Simmons”). Respondent filed the same article. See Ex. C. However, I cannot locate
in Simmons where the autoimmune nature of brachial neuritis is discussed. The sections of Simmons highlighted by
Petitioner do not at all deal with the subject, and the more general focus of Simmons is on the utility of the use of
EMG and NCS testing.

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 Dr. Fink’s final report, the longest of the three, endeavored to answer several additional
questions posed by the special master formerly presiding over the matter about Petitioner’s
causation theory. First, Dr. Fink discussed what he would deem a “medically acceptable” onset for
HPV vaccine-caused brachial neuritis. Third Fink Rep. at 2. Dr. Fink noted that some literature
supported an onset of 3-14 days, and hence a timeframe longer than what Petitioner alleges to have
experienced, but added that the “consensus current working opinion” is that onset occurs “acutely”
—which, in his view, supported a single-day onset. Id; M. Bromberg, Brachial Plexus Syndromes
– UpToDate (Aug. 8, 2018), https:www.uptodate.com/contents/brachial-plexus-
syndromes/print?search=…, filed as Ex. 14 on Aug. 28, 2018 (ECF No. 22-6) (“Bromberg”).
Bromberg briefly reviews the underlying anatomy, pathogenesis, and general clinical features of
brachial plexopathies, and discusses a number of specific plexopathies classified by clinical
setting. Bromberg at 1. Bromberg distinguishes between acute and insidious onset of symptoms
from brachial plexopathies. Id. at 3. However, no actual timeframe (measuring from trigger to
symptoms manifestation of brachial neuritis) is discussed in this article. Acute and insidious onset
are distinguished in terms of pain occurring in the shoulder or upper arm, versus progressive pain
and evolving weakness. Id. It is thus not self-evident from Bromberg that “acute” can be
interpreted as Dr. Fink proposes, since the term’s usage seems intended to describe degree and
temporal intensity of pain (i.e. coming on unexpectedly and severely), rather than the timeframe
from trigger to symptoms.

Second, Dr. Fink disputed that certain sports activities relevant in this case could be the
cause of brachial neuritis independent of vaccination. He felt instead that “thoracic outlet
syndrome” would be the proper diagnostic descriptor for such a sports-related injury arising from
Petitioner’s pursuits (swimming and baseball). Third Fink Rep. at 3. But in any such case, the
symptoms would be “significantly different” from what Petitioner experienced. Id. Brachial plexus
injuries do not appear associated with swimming or baseball, but instead with other kinds of
contact sports (football, rugby) or biking. Id. And they would feature secondary clinical indicia
reflective of their severity (broken bones, collapsed lungs). Id. At bottom, the kind of neurologic
symptoms characterizing Mr. Pelelo’s injury were not akin to the orthopedic-in-nature symptoms
common to a swimming injury. Id.

Dr. Fink also provided further explanation for the biological process through which he
contended the HPV vaccine would theoretically cause brachial neuritis. Third Fink Rep. at 4. He
proposed it would occur either via “direct antigenic attack” on brachial plexus nerves, or through
“focal inflammation of vessels of the nerve” resulting in axonal damage. Id; G. Chavada & H.
Willison, Autoantibodies in Immune-Mediated Neuropathies, 25(5) Current Opinions –
Neurology, 550-55, 555 (Oct. 2012), filed as Ex. 30 on Dec. 16, 2019 (ECF No. 46-9). The fact
that Petitioner had already received the HPV vaccine (two months before) had effectively “primed”
his immune system to respond more quickly after a second dose. Third Fink Rep. at 4.

Besides the above, Dr. Fink repeated his prior contentions that the absence of EMG
abnormalities in Petitioner’s case was not significant, especially since the test appeared not to have

8
been performed by a physician capable of performing the test or interpreting the results properly.
Third Fink Rep. at 4-5, 7. He also again referenced medical record evidence supporting his view
that Petitioner’s condition had persisted (despite some contrary evidence suggesting
improvement). Id. at 5-7.

B. Respondent’s expert: Peter Donofrio, M.D.

Dr. Donofrio acted as Respondent’s expert and filed three written reports. Report, dated
June 11, 2019, filed as Ex. A (ECF No. 34-1) (“First Donofrio Rep.”); Report, dated April 23,
2020, filed as Ex. L (ECF No. 51-1)(“Second Donofrio Rep.”); Report, dated December 17, 2020,
filed as Ex. P (ECF No. 60-1)(“Third Donofrio Rep.”). He contested the accuracy of Petitioner’s
diagnosis, and otherwise disputed the assertion that the HPV vaccine can cause brachial neuritis.

Dr. Donofrio is a professor of neurology and director of the MDA and ALS clinics at the
Vanderbilt University Medical Center. First Donofrio Rep. at 1; See Ex. B (ECF No. 34-2) (Dr.
Donofrio’s Curriculum Vitae (“Donofrio CV”)) at 2. He received his B.S. at the University of
Notre Dame, and then attended the Ohio State University School of Medicine for his M.D.
Donofrio CV at 2. He is board certified in neurology, internal medicine, electrodiagnostic
medicine, and neuromuscular disorders. Id. Dr. Donofrio is experienced in treating peripheral
neuropathies like GBS and CIDP, as well as brachial neuritis, and is a member of organizations
focusing on these kinds of neuropathic conditions. First Donofrio Rep. at 1. Among his
publications is a textbook on the specific topic of peripheral neuropathy. Donofrio CV at 21. He
is not an immunologist—although neither is Dr. Fink.

First Report

Dr. Donofrio’s initial report included a detailed review of Mr. Pelelo’s medical history.
First Donofrio Rep. at 1-5. He then provided an overview of brachial neuritis, deeming it an
“inflammatory condition of the nerves within the brachial plexus.” First Donofrio Rep. at 6. The
brachial plexus 5 is a “clustering of nerve fibers” whose branches form the primary nerves for the
shoulder, arms, and hands. First Donofrio Rep. at 6; Z. Simmons, Plexopathies and Proximal
Upper Extremity Neuropathies, 24 Phys. Med. Rehabil. Clin. N. Am. 1-20 (2013), filed as Ex. C
on July 23, 2019 (ECF No. 39-1) (“Simmons”). Injuries to the brachial plexus will, therefore,
inherently “produce weakness, sensory changes and commonly deep tendon reflex abnormalities.”
First Donofrio Rep. at 6. And the fact that the brachial plexus is comprised of nerve fibers also
means that injuries to it will be detectible through EMG/NCS testing. Id. This kind of condition
should also be visible to an extent on MRI, since brachial neuritis will usually lead to “neurogenic
atrophy” of the muscles served by the brachial plexus. Id.

5
Dr. Donofrio thus distinguished brachial neuritis from injuries to peripheral nerves connected to, but distal from, the
plexus. First Donofrio Rep. at 6.

9
 Brachial neuritis is understood in some cases to have an infectious origin or trauma
(whether from surgical interventions or some external accident), but is also commonly idiopathic,
meaning no triggering explanation can be identified. First Donofrio Rep. at 6, 8. Although Dr.
Donofrio admitted that case reports exist purporting to observe an association between some
vaccines and brachial neuritis, he opined that there was no reliable scientific/medical proof
connecting the two. Id. He noted in particular that the Institute on Medicine’s report regarding
proposed adverse effects of various vaccines had found no reliable link between the HPV vaccine
and brachial neuritis. Id. at 8; Institute of Medicine of the National Academies, Adverse Effects of
Vaccines: Evidence and Causality, Chronic Inflammatory Disseminated Polyneuropathy, 512-13
(Kathleen Stratton, et al.), filed as Ex. D on July 23, 2019 (ECF No. 39-2) (the “IOM Report I”).

Based on his overall review of the record, Dr. Donofrio concluded that Mr. Pelelo likely
had not experienced brachial neuritis. First Donofrio Rep. at 9. He based this conclusion on a
number of different factors. He allowed for the fact that Petitioner’s presentation, from the late
December 2015 vaccination until February 2016, was at least “suggestive of a brachial plexus
process.” First Donofrio Rep. at 6. But Dr. Donofrio deemed the negative/normal EMG and NCS
results almost dispositive of the issue, since the timing of the performance of this testing
(approximately two months after alleged onset in late December) meant they should have detected
“even subtle neurogenic abnormalities” by that time, if in fact injury to the brachial plexus had
previously occurred. Id. Indeed, Dr. Donofrio questioned later treater support for the brachial
neuritis diagnosis in the face of these normal results. Id. at 7 (discussing Ex. 3 at 47).

In highlighting the normal EMG/NCS results, Dr. Donofrio stressed his disagreement with
Dr. Fink that brachial neuritis could exist even without confirmation by such nerve testing. First
Donofrio Rep. at 7-8. He noted that medical literature filed in the case (by both sides) strongly
supported the conclusion that EMG/NCS testing were understood as critical to the diagnosis. Id.
at 8; J. Aymond et al., Neuralgic Amyotrophy, 28(12) Orthopaedic Rev. 1275-1279 (1989), filed
as Ex. F on July 23, 2019 (ECF No. 39-4); Bromberg at 3. Indeed, the more reputable studies
focusing on persons with brachial neuritis all involved individuals whose diagnosis had been
confirmed via EMG/NCS testing. See, e.g., A. Martinez-Salio et al., Neuralgia Amiotrofica:
Revision de 37 Casos, 27(159) Rev. Neurol. 823-826 (1998) (original in Spanish), filed as Ex. G
on July 23, 2019 (ECF No. 39-5). This was also true of many of the case reports filed by Petitioner
that purported to associate the HPV vaccine with brachial neuritis. See, e.g., Debeer at 4418; J.
Taras et al., Brachial Neuritis Following Quadrivalent Human Papilloma Virus (HPV)
Vaccination, 6 Hand 454-456 (2011), filed as Ex. 12 on Aug. 28, 2018 (ECF No. 22-4) (“Taras”)
at 455 (female subject’s brachial neuritis began three days after receipt of second HPV vaccine
dose; diagnosis confirmed by EMG/NCS results, although initial results were normal).

10
 Other facts gleaned from the medical record persuaded Dr. Donofrio that Petitioner’s
brachial neuritis diagnosis was not tenable. The May 2016 MRI scan of Mr. Pelelo’s left shoulder,
for example, produced normal results, and thus did not reveal the kind of denervation-related
muscle atrophy that should have been present. First Donofrio Rep. at 7; citing Ex. 3 at 32. Scapular
winging was not observed in January 2016, although it should have in Dr. Donofrio’s opinion been
evident in a case of brachial neuritis that began in late December. First Donofrio Rep. at 9.
Petitioner also showed marked improvement after treatment with IVIG and steroids (contrary to
assertions in Dr. Fink’s report), and seemed largely recovered by the end of March. First Donofrio
Rep. at 7, 9. And Dr. Donofrio noted a number of factual inconsistencies about Petitioner’s
treatment progress, noting instances where improvement of symptoms was not acknowledged in
certain records. First Donofrio Rep. at 7, citing Ex. 3 at 17-18, 30. Dr. Donofrio overall seemed to
find (although his report did not say so directly) that the totality of Petitioner’s treatment course—
looking at the record between early December 2015 (before the second HPV vaccine dose was
administered) and August 2017—revealed he suffered from a host of “musculoskeletal symptoms”
that might better explain the symptoms complained of in this case. First Donofrio Rep. at 9.

Second Report

Dr. Donofrio’s next report endeavored to answer Dr. Fink’s attacks on his initial opinion.
Dr. Donofrio devoted considerable attention to the importance of the EMG/NCS testing results.
Second Donofrio Rep. at 1-3. First, he defended the results obtained for Petitioner as trustworthy,
over Dr. Fink’s objections that a physician had not literally performed the tests on Petitioner,
emphasizing that Dr. Bingham (the neurologist who approved the results) would have well-
understood how to perform such testing and whether the results were reliable, and thus her
endorsement of the results was reasonable even if a technician had been actually responsible for
the tests. Id. at 1. Dr. Donofrio’s review of the specific records pertaining to the testing underscored
for him the reliability of the results, since the testing was thorough and involved the muscles most
likely to be abnormal in cases of scapular winging (and thus essentially undercut conclusions by
treaters about the significance of the presence of scapular winging). Id. at 1, 2-3.

Second, Dr. Donofrio reiterated points in his first report supporting the overall importance
of EMG/NCS results in diagnosing brachial neuritis. He noted that literature filed in the case stood
directly for the proposition that such testing was virtually required to confirm the diagnosis.
Second Donofrio Rep. at 2-3; Simmons at 10-11; N. van Alfen, et al., Sensory Nerve Conduction
Studies in Neuralgic Amyotrophy, 88 Am. J. Phys. Med. Rehabil. 941-946, 942 (2009), filed as
Ex. N on Apr. 28, 2020 (ECF No. 51-3) (“van Alfen II”). In response to Dr. Fink’s arguments that
literature like Van Eijk acknowledged that the diagnosis was tenable without an abnormal EMG
result, Dr. Donofrio attempted to clarify EMG as a term, noting that it “is often used to describe
only the needle examination whereas other health care providers use the term EMG to describe all
parts of the electrodiagnostic exam,” including the NCS component. Second Donofrio Rep. at 2.

11
Applying the broader understanding of the term (which Dr. Donofrio appeared to endorse), it could
not be said that a normal EMG result was common to brachial neuritis. Id. 6 In fact the relevant
literature did not actually consider in studied brachial neuritis cases whether full EMG diagnostic
tests had been performed. Id.; van Alfen II at 942.

Dr. Donofrio also defended certain record evidence as supportive of his diagnostic
contentions. He continued to embrace Petitioner’s MRI results as inconsistent with brachial
neuritis, although he agreed that an additional MRI, performed with gadolinium contrast,7 would
have helped confirm the significance of the initial findings. Second Donofrio Rep. at 3. He disputed
the importance of the fact that Petitioner had been treated with steroids or IVIG, maintaining that
their use was commonplace when neurologic injury was suspected, and hence such treatments did
not particularly corroborate the diagnosis. Id. Indeed, he deemed their alleged effectiveness as
further undermining the diagnosis, since such immunomodulating treatments are not understood
to have such a positive impact on brachial neuritis. Id. at 3-4. And he identified numerous other
discrepancies in the record that he felt did not corroborate the diagnosis, such as inconsistency in
observing scapular winging over the course of Petitioner’s treatment. Id. at 4-5.

Regarding Petitioner’s onset, Dr. Donofrio took issue with Dr. Fink’s contention that a 2-
20 day onset was reasonable, observing that (a) one of the very case reports relied upon for an
HPV vaccine-brachial neuritis association observed that this timeframe had not been confirmed
for the HPV vaccine, and (b) it was not consistent otherwise with Petitioner’s one-day onset, which
had not itself been substantiated by any reliable evidence. Second Donofrio Rep. at 5. In fact, the
timeframe for onset of any form of brachial neuritis was not in Dr. Donofrio’s view likely to be so
short, given what was known about how long it would take for an immune response to occur after
antigenic exposure. Id; Institute of Medicine of the National Academies, Adverse Effects of
Vaccines: Evidence and Causality, Evaluating Biological Mechanisms of Adverse Events, 57-58,
58 (Kathleen Stratton, et al.), filed as Ex. O on April 28, 2020 (ECF No. 51-4) (the “IOM Report
II”). Indeed, even re-exposure to the same antigen (which would inherently be faster, as was
arguably the case here, since Petitioner’s second HPV dose is alleged causal of his injury) would
not produce an immune reaction sooner than three to five days post-vaccination. Id.

6In so asserting, Dr. Donofrio also noted that Van Eijk relied on an earlier item of literature for the conclusion that an
EMG could be normal and not preclude a brachial neuritis diagnosis, but that this earlier-published item did not
consider the combination of nerve testing that Dr. Donofrio deemed to be included under the EMG heading. Second
Donofrio Rep. at 2; van Alfen at 7.
7
In some cases, a contrast material (typically gadolinium) will be injected through an intravenous line during an MRI
scan. Mayo Clinic, MRI Overview, https://www.mayoclinic.org/tests-procedures/mri/about/pac-20384768 (last visited
July 20, 2021). The contrast material enhances certain details in the imaging, and in particular can reveal the existence
of ongoing or present inflammation. Id.

12
 Third Report

Dr. Donofrio’s final report reacted to some of Dr. Fink’s responses (in his own third report)
to the special master’s questions, although he limited his commentary to diagnostic issues. He first
discussed whether it was accurate to characterize the onset of brachial neuritis after vaccination as
“acute,” questioning the reliability of one of the items of medical literature supported in behalf of
this assertion. Third Donofrio Rep. at 1. Dr. Donofrio then noted that to the extent “acute” was
meant to support the medical acceptability of a one-day onset, this contention was not consistent
with other medical literature filed by Petitioner, which supported only a longer onset timeframe.
Id; Taras at 454 (stating that in 30-85% of the cases, an antecedent event can be found 3-14 days
before the initial onset of pain). He also deemed such a short onset “highly unusual for an
immunological vaccine reaction,” adding that three days or more for a reaction was far better
supported by medical science. Third Donofrio Rep. at 4.

Next, Dr. Donofrio reviewed the distinction he drew between literature pertaining to the
common clinical features of brachial neuritis and what a young athletic person like Mr. Pelelo
might experience. Third Donofrio Rep. at 1. Although he disclaimed specialized expertise in sports
injuries, Dr. Donofrio did identify (based on some literature research he performed to respond to
the issue) a small study of 22 swimmers that did not reveal brachial plexopathy, or some other
neurologic source, to be the cause of their shoulder complaints. S. Rupp et al., Shoulder Problems
in High Level Swimmers – Impingement, Anterior Instability, Muscular Imbalance?, 16(8) J.
Sports Med. 557-565 (1995), filed as Ex. Q on Dec. 17, 2020 (ECF No. 60-2) (“Rupp”). He added
that scapular winging was not itself specific to brachial neuritis, despite Dr. Fink’s suggestions to
the contrary. Third Donofrio Rep. at 1.

Dr. Donofrio’s third report also spent additional time arguing with Dr. Fink about the
legitimacy/adequacy of Petitioner’s February 2016 EMG testing, and whether its findings were
trustworthy, as well as the greater question of whether a “normal” EMG test result was consistent
with brachial neuritis. Third Donofrio at 2. And he commented on several exhibits that (at the time
of the preparation of this final report) had been recently filed. Many of these newly-filed exhibits
were simply additional medical records or witness statements, although Dr. Donofrio did highlight
one—a case report purportedly linking the HPV vaccine to brachial neuritis—that he found
involved a different injury (proximal median nerve palsy), and that moreover had been confirmed
by an abnormal EMG. Id. at 3; Taras at 455.

III. Procedural History

After filing this action in October 2017, Petitioner began gathering documents relevant to
his claim and filing them into the record, completing the process the same month as filing. The
petition was initially assigned to the Special Processing Unit of the Office of Special Masters (the
“SPU”) based on the supposition that it might be readily settled. However, after Respondent’s Rule
4(c) Report (filed June 2018 (ECF No. 17)) revealed the intent to defend the claim, Petitioner filed

13
Dr. Fink’s first expert report that August, prompting a responsive report from Dr. Donofrio in June
2019. The matter was thereafter transferred out of SPU. ECF No. 36.

Additional expert reports were filed by both sides thereafter, with the matter subsequently
being reassigned to me in the summer of 2020. ECF No. 55. I allowed a final round of additional
expert reports to be filed, and then informed the parties of my view that the case could properly be
resolved on the papers. Petitioner’s Motion for Ruling on the Record was filed in January 2021
(ECF No. 61) (“Mot.”), and Respondent’s Opposition filed in March 2021 (ECF No. 63) (“Opp.”).
No reply was filed, and the claim is now ripe for resolution.

IV. Parties’ Respective Arguments

Petitioner offered a succinct brief arguing in favor of entitlement in this case, addressing
in succession each of the three causation prongs from Althen v. Sec’y of Health and Hum. Servs.,
418 F.3d 1274, 1278 (Fed. Cir. 2005). First, he noted the other kinds of vaccines that have been
associated with brachial neuritis, adding that case reports (some of which were filed in this matter)
have also linked the HPV vaccine to the injury. Mot. at 1. He further reiterated the potential
mechanisms outlined by Dr. Fink for how the vaccine could initiate the injury—either “direct
antigenic attack” on the brachial plexus nerves, or “a focal inflammation of vessels of the nerves”
that indirectly would cause nerve damage. Id. at 2. The fact that Petitioner had received one dose
of the HPV vaccine already also impacted his exaggerated immune reaction to the second dose.
Id.

Second, Petitioner endeavored to demonstrate how his medical history was consistent with
the vaccine causing his brachial neuritis. He recalled the one-day onset of pain and weakness,
observing this was consistent with the sudden/acute nature of brachial neuritis onset, as well as his
subsequent course. Mot. at 2-4. Finally, Petitioner devoted the remainder of his brief to defending
the time in which his onset began as medically acceptable, although in so doing he revisited Dr.
Fink’s attacks on the legitimacy of the normal EMG findings. Id. at 5-6. He otherwise maintained
that the course of his injury reflected brachial neuritis despite some evidence of improvement, and
disputed Dr. Donofrio’s points that Petitioner’s athletic endeavors could have played a role in
causation. Id. at 7-9.

Respondent’s brief was considerably longer, and included a more detailed overview of Mr.
Pelelo’s medical history. Opp. at 4-11. After a recitation of the legal standards governing a non-
Table causation claim, Respondent attempted to demonstrate why Petitioner had not carried his
burden of proof. As a general matter, Respondent contested that Petitioner had in fact been
properly diagnosed with brachial neuritis, noting that the EMG testing did not corroborate the
treaters’ clinical symptom-oriented diagnosis, and arguing that Dr. Fink’s assertion that brachial
neuritis could exist even with negative EMG findings was unreliable, especially when contrasted
with Dr. Donofrio’s more well-founded contentions. Id. at 15-20. Respondent also maintained that

14
Petitioner’s clinical course did not reflect how brachial neuritis would commonly unfold,
especially since Petitioner seemed at times to recover. Id. at 20-21.

Respondent next proposed that the three Althen prongs were unmet. Dr. Fink had not
established a reliable and reputable theory regarding the HPV vaccine’s propensity to cause
brachial neuritis, relying on limited items of literature that revealed how little was still known
about the pathogenesis of brachial neuritis. Opp. at 21-23, 26-27. Dr. Fink otherwise relied too
much on case reports or VAERS data 8 that only established a temporal relationship between the
HPV vaccine and brachial neuritis. Id. at 23-25. Petitioner also could not prove the HPV vaccine
“did cause” his brachial neuritis, relying too heavily on the temporal association alone, without
offering evidence of treater views as to vaccine causation. Id. at 27-29. And there were unrebutted
alternative explanations for Petitioner’s injury, attributable to his physical activities as a swimmer
and baseball player. Id. at 30. Finally, Respondent maintained that a 24-hour onset of vaccine-
caused brachial neuritis was not medically acceptable, noting in particular that even the
Petitioner’s most-helpful literature and case reports filed in the matter supported only an onset
more than a few days—not less than one. Id. at 31-32.

V. Applicable Law

A. Standards for Vaccine Claims

To receive compensation in the Vaccine Program, a petitioner must prove that: (1) they
suffered an injury falling within the Vaccine Injury Table (i.e., a “Table Injury”); or (2) they
suffered an injury actually caused by a vaccine (i.e., a “Non-Table Injury.) See Sections
13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; § 11(c)(1)(C)(ii)(I); see also
Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v.
Sec'y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006). In this case, Petitioner
does not assert a Table claim.

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, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.

8
“VAERS,” or the Vaccine Adverse Event Reporting System, is a passive surveillance system maintained by the
Center for Disease Control, in which anyone may file a report alleging that a vaccine caused a particular injury, illness,
or death. As discussed by other special masters, the data provided by VAERS does not illustrate a causal connection;
rather, VAERS exists to prompt further scientific investigation into potentially dangerous vaccines. See, e.g.,
Tompkins v. Sec'y of Health & Human Servs., No. 10-261V, 2013 WL 3498652, at *9 n.25 (Fed. Cl. Spec. Mstr. June
21, 2013), mot. for review denied, 117 Fed. Cl. 713 (2014). VAERS reports are informal and unverified, and should
not be confused with formal case reports in medical literature. Tompkins, 2013 WL 3498652, at *9 n.26. For these
reasons, other special masters have consistently declined to rely on VAERS data as probative with regard to vaccine
causation. See, e.g., Analla v. Sec'y of Health & Human Servs., 70 Fed. Cl. 552, 558 (2006); Ryman v. Sec'y of Health
& Human Servs., 65 Fed. Cl. 35, 39–40 (2005).

15
476, 486 (1984) (explaining that mere conjecture or speculation is insufficient under a
preponderance standard). On one hand, proof of medical certainty is not required. Bunting v. Sec'y
of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). But on the other hand, a petitioner
must demonstrate that the vaccine was “not only [the] but-for cause of the injury but also a
substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v.
Sec'y of Health & Human Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999)); Pafford v. Sec'y of
Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may not receive a
Vaccine Program award based solely on his assertions; rather, the petition must be supported by
either medical records or by the opinion of a competent physician. Section 13(a)(1).

In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non–Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen, 418 F.3d at 1278: “(1) a medical theory causally connecting the vaccination and
the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason
for the injury; and (3) a showing of proximate temporal relationship between vaccination and
injury.” Each Althen prong requires a different showing and is discussed in turn along with the
parties’ arguments and my findings.

Under Althen prong one, petitioners must provide a “reputable medical theory,”
demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at
1355–56 (citations omitted). To satisfy this prong, a petitioner's theory must be based on a “sound
and reliable medical or scientific explanation.” Knudsen v. Sec'y of Health & Human Servs., 35
F.3d 543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or
scientifically certain.” Id. at 549. However, the Federal Circuit has repeatedly stated that the first
prong requires a preponderant evidentiary showing. See Boatmon v. Sec'y of Health & Human
Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019) (“[w]e have consistently rejected theories that the
vaccine only “likely caused” the injury and reiterated that a “plausible” or “possible” causal theory
does not satisfy the standard”); see also Moberly v. Sec'y of Health & Hum. Servs., 592 F.3d 1315,
1321 (Fed. Cir. 2010); Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339, 1350
(Fed. Cir. 2010). This is consistent with the petitioner's ultimate burden to establish his overall
entitlement to damages by preponderant evidence. W.C. v. Sec'y of Health & Human Servs., 704
F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted).

Petitioners may offer individual items of evidence pertaining to the first Althen prong
without resort to medical literature, epidemiological studies, demonstration of a specific
mechanism, or a generally accepted medical theory. Andreu v. Sec'y of Health & Human Servs.,
569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing Capizzano, 440 F.3d at 1325–26). No one “type”
of evidence is required. Special masters, despite their expertise, are not empowered by statute to
conclusively resolve what are essentially thorny scientific and medical questions, and thus
scientific evidence offered to establish Althen prong one is viewed “not through the lens of the
laboratorian, but instead from the vantage point of the Vaccine Act's preponderant evidence
standard.” Andreu, 569 F.3d at 1380. However, even though “scientific certainty” is not required

16
to prevail, the individual items of proof offered for the “can cause” prong must each reflect or arise
from “reputable” or “sound and reliable” medical science. Boatmon, 941 F.3d at 1359-60.

The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner's medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec'y of Health & Human Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions
and views of the injured party's treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored
in vaccine cases, as treating physicians are likely to be in the best position to determine whether a
‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”)
(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec'y of Health & Human 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 & Human 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 & Human Servs., 100 Fed. Cl. 742,
749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians'
conclusions against each other), aff'd, 698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec'y of Dept. of
Health & Human 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, 356–57 (2011), aff'd without opinion, 475 F. App’x.
765 (Fed. Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder's etiology, it is medically acceptable to infer causation.” de Bazan v.
Sec'y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what
is a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine
can cause an injury (Althen prong one's requirement). Id. at 1352; Shapiro v. Sec'y of Health &
Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den'd after remand, 105 Fed. Cl. 353 (2012),
aff'd mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec'y of Health & Human Servs., No.

17
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 determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
to consider “all [ ] relevant medical and scientific evidence contained in the record,” including
“any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained
in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability,
injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are
contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special
master is then required to weigh the evidence presented, including contemporaneous medical
records and testimony. See Burns v. Sec'y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir.
1993) (determining that it is within the special master's discretion to determine whether to afford
greater weight to contemporaneous medical records than to other evidence, such as oral testimony
surrounding the events in question that was given at a later date, provided that such determination
is evidenced by a rational determination).

Medical records that are created contemporaneously with the events they describe are
presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient's
health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Human Servs., 95 Fed.
Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his
contemporaneous medical records, the special master's decision to rely on petitioner's medical
records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Human
Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption is based
on the linked propositions that (i) sick people visit medical professionals; (ii) sick people honestly
report their health problems to those professionals; and (iii) medical professionals record what they
are told or observe when examining their patients in as accurate a manner as possible, so that they
are aware of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec'y of
Health & Human Servs., No. 11–685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10,
2013); Cucuras v. Sec'y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at
1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to accurately
report the onset of their daughter's symptoms.”).

Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec'y of Health & Human Servs., No. 03–1585V, 2005
WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical
records are generally found to be deserving of greater evidentiary weight than oral testimony—
especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;
see also Murphy v. Sec'y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam,
968 F.2d 1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United

18
States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that
oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.”)).

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

When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent, and
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Human
Servs., No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In
determining the accuracy and completeness of medical records, the Court of Federal Claims has
listed four possible explanations for inconsistencies between contemporaneously created medical
records and later testimony: (1) a person's failure to recount to the medical professional everything
that happened during the relevant time period; (2) the medical professional's failure to document
everything reported to her or him; (3) a person's faulty recollection of the events when presenting
testimony; or (4) a person's purposeful recounting of symptoms that did not exist. La Londe v.
Sec'y of Health & Human Servs., 110 Fed. Cl. 184, 203–04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir.
2014). In making a determination regarding whether to afford greater weight to contemporaneous
medical records or other evidence, such as testimony at hearing, there must be evidence that this
decision was the result of a rational determination. Burns, 3 F.3d at 417.

C. Analysis of Expert Testimony

Establishing a sound and reliable medical theory often requires a petitioner to present
expert testimony in support of his claim. Lampe v. Sec'y of Health & Human Servs., 219 F.3d 1357,
1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the
factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579, 594–96 (1993). See Cedillo v. Sec'y of Health & Human Servs., 617 F.3d 1328, 1339
(Fed. Cir. 2010) (citing Terran v. Sec'y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir.
1999). Under Daubert, the factors for analyzing the reliability of testimony are:

(1) whether a theory or technique can be (and has been) tested; (2) whether the
theory or technique has been subjected to peer review and publication; (3) whether

19
 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).

However, in the Vaccine Program the Daubert factors play a slightly different role than
they do when applied in other federal judicial settings—e.g., the district courts. Typically, Daubert
factors are employed by judges (in the performance of their evidentiary gatekeeper roles) to
exclude evidence that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases
these factors are used in the weighing of the reliability of scientific evidence proffered. Davis v.
Sec'y of Health & Human Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the
Daubert factors have been employed also as an acceptable evidentiary-gauging tool with respect
to persuasiveness of expert testimony already admitted”). The flexible use of the Daubert factors
to evaluate the persuasiveness and reliability of expert testimony has routinely been upheld. See,
e.g., Snyder, 88 Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases),
Daubert has not been employed at the threshold, to determine what evidence should be admitted,
but instead to determine whether expert testimony offered is reliable and/or persuasive.

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, 618 F.3d at 1347 (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. 146 91997));
see also Isaac v. Sec'y of Health & Human Servs., No. 08–601V, 2012 WL 3609993, at *17 (Fed.
Cl. Spec. Mstr. July 30, 2012), mot. for review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x.
999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339). Weighing the relative persuasiveness of
competing expert testimony, based on a particular expert's credibility, is part of the overall
reliability analysis to which special masters must subject expert testimony in Vaccine Program
cases. Moberly, 592 F.3d at 1325–26 (“[a]ssessments as to the reliability of expert testimony often
turn on credibility determinations”); see also Porter v. Sec'y of Health & Human Servs., 663 F.3d
1242, 1250 (Fed. Cir. 2011) (“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

Both parties filed numerous items of medical and scientific literature in this case, but not
all such items factor into the outcome of this decision. While I have reviewed all the medical
literature submitted in this case, I discuss only those articles that are most relevant to my

20
determination and/or are central to Petitioner's case—just as I have not exhaustively discussed
every individual medical record filed. Moriarty v. Sec'y of Health & Human Servs., No. 2015–
5072, 2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 2016) (“[w]e generally presume that a special
master considered the relevant record evidence even though he does not explicitly reference such
evidence in his decision”) (citation omitted); see also Paterek v. Sec'y of Health & Human Servs.,
527 F. App’x 875, 884 (Fed. Cir. 2013) (“[f]inding certain information not relevant does not lead
to—and likely undermines—the conclusion that it was not considered”).

E. Standards for Ruling on the Record

I am resolving Petitioner’s claim on the papers rather than via hearing (and the parties have
not objected in their filings that I do so). The Vaccine Act and Rules not only contemplate but
encourage special masters to decide petitions on the papers where (in the exercise of their
discretion) they conclude that doing so will properly and fairly resolve the case. Section
12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of hearing has been
affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed. Cir.
2020); see also Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V, 2016 WL 3456435, at *21
n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided
case on the papers in lieu of hearing and that decision was upheld). I am simply not required to
hold a hearing in every matter, no matter the preferences of the parties. Hovey v. Sec’y of Health
& Hum. Servs., 38 Fed. Cl. 397, 402–03 (1997) (determining that special master acted within his
discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy v. Sec’y of Health &
Hum. Servs., No. 90-882V, 1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr. 19, 1991).

ANALYSIS

I. Overview of Brachial Neuritis

The experts in this case agree that Parsonage-Turner syndrome and brachial neuritis
interchangeably describe the same condition. See, e.g., Second Fink Rep. at 1; First Donofrio Rep.
at 6. 9 The brachial plexus is located between the spinal nerve roots and the nerves of the arm, and
is a bundle of nerves that relates to the sensory and motor function of the upper extremities.
Dorland’s Medical Dictionary 1440 (33 rd ed. 2020). It can be injured in many ways, including
trauma or infection, and such injury often leads to weakness or numbness. Donofrio First Rep. at
6. Brachial plexitis is the general term for injury to the plexus due to inflammation, while any other
kind of unexplained plexitis is commonly called PTS or brachial neuritis. Id. Brachial neuritis
often involves a finding of winged scapula due to involvement of the long thoracic nerve, and it

9 Literature filed in this case also refers to brachial neuritis as “neuralgic amyotrophy,” but recognizes the overlap in
terminology. See, e.g., Van Eijk at 337.

21
also generally involves selective weakness of the muscles of the anterior interosseous nerve. Id. It
is characterized by severe pain, muscle weakness, and atrophy. Id.

Although this case does not allege a Table claim, the requirements for the sole Table-
recognized brachial neuritis injury (after receipt of vaccines containing a tetanus component)
provide some useful insight into the contours of a vaccine-caused brachial neuritis injury. Under
the Table (42 C.F.R. § 100.3(a)(I)(B)), causation for vaccine-caused brachial neuritis is presumed
when symptoms begin within 2-28 days of the vaccination. The Table also requires corroboration
from “[n]erve conduction studies (NCS) and electromyographic (EMG) studies localizing the
injury to the brachial plexus . . . before the diagnosis can be made if weakness is limited to muscles
supplied by a single peripheral nerve…” 42 C.F.R. § 100.3(c)(6)(i-iii). Of course, a non-Table
claim is not subject to the same restrictions.

There are ample prior non-Table decisions associating vaccines containing a tetanus
component with brachial neuritis. 10 See, e.g., Devonshire v. Sec’y of Health & Human Servs., No.
99-031V, 2006 WL 2970418, at *15 (Fed. Cl. Spec. Mstr. Sept. 28, 2006) (stating that it is well
known that brachial neuritis can occur following a tetanus vaccination), aff’d, 76 Fed. Cl. 452
(2007); DeGrandchamp v. Sec’y of Health & Human Servs., No. 01-413V, 2003 WL 21439670,
at *7 (Fed. Cl. Spec. Mstr. May 15, 2003) (relying on IOM publications to find that in theory, the
tetanus toxoid in Td vaccine can cause brachial neuritis). Literature offered in this case also
supports this determination. See, e.g., J. Miller et al., Acute Brachial Plexus Neuritis: An
Uncommon Cause of Shoulder Pain, 62(9) Am. Fam. Physician. 2067-2017, 2068 (Nov. 2000),
filed as Ex. H on July 23, 2019 (ECF No. 39-6). However, I have identified no reasoned decisions
finding that the HPV vaccine specifically can cause brachial neuritis. 11

I have previously decided two non-Table cases alleging different vaccines caused brachial
neuritis, denying compensation in both—but in both instances because the claimant could not
establish onset occurred in a medically acceptable timeframe. See, e.g., Greene v. Sec’y of Health

10 Prior decisions from different cases do not control the outcome herein. Boatmon, 941 F.3d at 1358–59; Hanlon v.
Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). But special masters reasonably draw upon their experience
in resolving Vaccine Act claims. Doe v. Sec’y of Health & Hum. Servs., 76 Fed. Cl. 328, 338–39 (2007) (“[o]ne reason
that proceedings are more expeditious in the hands of special masters is that the special masters have the expertise and
experience to know the type of information that is most probative of a claim”) (emphasis added). They would therefore
be remiss in ignoring prior cases presenting similar theories or factual circumstances, along with the reasoning
employed in reaching such decisions. I therefore include this brief discussion to illustrate the framework for my
determination—which in the end arises from a balancing of the evidence offered in this case.

11 Some cases involving the HPV vaccine and brachial neuritis have resulted in settlement. See, e.g., Hessel v. Sec’y

of Health & Hum. Servs., No. 11-412V, 2012 WL 3140357 (Fed. Cl. Spec. Mstr. July 9, 2012). But they are of little
guidance herein, because settled matters are not only non-precedential but do not contained reasoned evaluations of
the science involving the capacity of the HPV vaccine to cause brachial neuritis. See Randazzo v. Sec’y of Health &
Hum. Servs., No. 18-1513V, 2021 WL 829572, at *4 (Fed. Cl. Spec. Mstr. Feb. 1, 2021) (discussing low relevance of
settled SIRVA claims in comparison to reasoned decisions).

22
& Hum. Servs., No. 11-631V, 2019 WL 4072110 (Fed. Cl. Spec. Mstr. Aug. 2, 2019) (41-day
onset after tetanus vaccine too long to be causal), mot. for rev. den’d, 146 Fed. Cl. 655 (Fed. Cl.
2020), aff’d, 841 Fed. App’x. 195 (Fed. Cir. 2020). Admittedly, Greene is mostly distinguishable,
since not only did it involve a vaccine closely associated with brachial neuritis, but an onset far
longer than relevant herein. But it stands for the proposition that even otherwise-causal vaccines
may not be found to cause injuries that occur in an unacceptable timeframe post-vaccination—
whether too short or long. See Aguayo v. Sec’y of Health & Hum. Servs., No. 12-563V, 2013 WL
441013, at *4 (Fed. Cl. Spec. Mstr. Jan. 15, 2013) (onset of GBS fourteen weeks after flu vaccine
too long to satisfy Althen prong three).

In an earlier decision—Garner v. Sec’y of Health & Human Servs., No. 15-063V, 2017
WL 1713184 (Fed. Cl. Mar. 24, 2017), mot. for review den’d, 2017 WL 3483352 (Fed. Cl. July
31, 2017)—I considered a claim that the Hepatitis A and B vaccines caused brachial neuritis. The
earliest onset possible in Garner was even longer than Greene—45 days after vaccination, based
on the first record documentation of any complaints by petitioner about arm or shoulder pain.
Garner, 2017 WL 1713184, at *1. Respondent’s expert, however, argued that the outer limit for
latency after vaccination was four weeks. Id. at *8. I found this point to be dispositive, even though
the claimant’s Althen prong one showing was persuasive. Id. at *16.

II. Petitioner Has Not Carried His Althen Burden

The experts in this case hotly contest whether Mr. Pelelo in fact likely suffered from
brachial neuritis. On this matter, there is evidence on both sides. Petitioner can point to consistent
treater support for the diagnosis, as well as symptoms that reflect the alleged injury, such as pain
and weakness of the left should and arm. See Ex. 3 at 8, 15, 40.

Respondent, however, has noted that EMG/NCS testing did not corroborate the diagnosis,
and that these results are very reliable. Dr. Fink did credibly establish that brachial neuritis could
be present even in the absence of such abnormal test results, and he offered reliable literature to
support his contention. See, e.g., Van Eijk at 339, 343-44. He also cited a case report that featured
an initially-normal EMG result before a brachial neuritis diagnosis was obtained. Taras at 454-55.
However, equally-reliable evidence suggests that the condition generally is less likely if the
diagnostic testing outcome is normal. Dr. Donofrio persuasively established (over Dr. Fink’s more
scattershot objections) that these results should be paid heed—and they undermine the diagnosis
substantially.

The context in which Petitioner experienced the injury also bears on the diagnosis. His age
and background as an athlete might provide some factual bases for his injury independent of
vaccination. Also, the course of his injury, which seemed to improve then worsen (but after a time
when his athletic pursuits intensified) provides a tantalizing suggestion for an alternative basis for
his injuries. Petitioner’s expert, Dr. Fink, stated in his second report that “a mechanical injury
(swimming) of different nerve elements,” may cause an injury of the brachial plexus. Second Fink

23
Rep. at 3. Dr. Fink backed away from this concession in his final report, however, instead asserting
that “[w]ithout specific trauma to the brachial plexus it is not possible to invoke [] repetitive motion
of the arm resulting in injury to the brachial plexus.” Third Fink Rep. at 3. Dr. Fink also noted as
an example that certain aspects of the injury such as “winging of the scapula” were “unique to
brachial plexitis.” Id. However, Dr. Donofrio rebutted this assertion and cited an article from the
International Journal of Sports Medicine where five of twenty-two swimmers with shoulder
problems had scapular winging and, in each of these instances, brachial plexopathy was “not
thought to be the cause.” Third Donofrio Rep. at 1 (citing Rupp at 1).

In many cases, evaluating the evidence offered in support of, or against, the preferred
diagnosis, in order to determine how that evidence preponderates, is critical to the case’s
resolution. Broekelshen, 618 F.3d at 1346. Here, however, I need not do so despite the attention
the issue was given by the experts—for it is clear from the record and filed submissions that two
of the three Althen prongs have not been met, even if there was not dispute as to diagnosis. I will
thus assume for sake of argument that the brachial neuritis diagnosis has preponderant support,
despite the persuasive points made by Dr. Donofrio about the reliability of this conclusion. I
address the prongs in order of their significance to my determination.

A. Althen Prong One

Petitioner’s showing on the “can cause” prong did not preponderantly support his
allegations. Indeed, it was the weakest element of his overall case, and thus is grounds for dismissal
regardless of how the other prongs are resolved. 12

It is unquestionably true that other vaccines are associated with brachial neuritis—with one
(tetanus) so persuasively linked that the Government has added a tetanus-brachial neuritis claim
to the Table. But it is an axiomatic principle in the Program that petitioners do not prevail simply
by analogizing their case to what is known about other vaccines; they must instead prove the
vaccine at issue is causal. Monzon v. Sec’y of Health & Hum. Servs., No. 17-1055V, 2021 WL
2711289, at *21 (Fed. Cl. Spec. Mstr. June 2, 2021). They also cannot bulwark a non-Table claim
by noting how close they come to meeting a comparable Table claim’s requirements. W.C. v. Sec’y
of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013); Tarsell v. United States, 133 Fed.
Cl. 782, 793 (2017). And this case does not involve a tetanus-containing vaccine in any event.

To establish that the HPV vaccine specifically can cause brachial neuritis, Petitioner mostly
relied on case reports, a type of evidence recognized in the Program to offer faint causation support.
See, e.g., Campbell v. Sec’y of Health & Hum. Servs., 97 Fed. Cl. 650, 668 (Fed. Cl. 2011) (case
reports “do not purport to establish causation definitively, and this deficiency does indeed reduce

12
Because Petitioner must meet all three Althen prongs to prevail, I need not address Petitioner’s success in
establishing the “did cause”/second prong of the Althen test. Contreras v. Sec'y of Health & Human Servs., No. 05–
626V, 2012 WL 1441315, at *1 (Fed. Cl. Spec. Mstr. Apr. 5, 2012), rev’d on other grounds, 107 Fed. Cl. 280 (Fed.
Cl. 2012).

24
their evidentiary value”). Case reports are not without any evidentiary value, but they are weak
proof of causation—a fact that is often readily acknowledged by their authors, as is true here. See,
e.g., Debeer at 4419.

Dr. Fink’s reports could not make up for the deficiency in reputable scientific or medical
support offered for the “can cause” prong. He provided no reliable scientific or medical evidence
showing that the antigens of the HPV vaccine (or for that matter the underlying wild virus it
provides immunity against) could be reliably linked to brachial neuritis, and referenced no other
medical research showing a connection. In addition, he personally possessed no demonstrated
immunologic expertise that could shed light on the issue (as reflected in the fact that most of his
expert contentions went to diagnosis rather than the crucial issue of causation). His reports
otherwise were too general in their causal assertions.

Dr. Fink also did not provide a reliable biologic mechanism for how the vaccine would
cause this injury. Although unquestionably petitioners need not prove a mechanism to prevail, it
is fair for a special master to evaluate the claimant’s success in so showing when an attempt to do
so is ventured—as here. Morgan v. Sec’y of Health & Hum. Servs., 148 Fed. Cl. 454 (Fed. Cl.
2020). But Dr. Fink’s proposed mechanisms were highly speculative. He concedes in his reports
that “the cause of post-vaccinial [sic] brachial plexitis is theoretical.” Third Fink Rep. at 4.
Nevertheless, Dr. Fink asserts that vaccinations may cause brachial neuritis “if not [through] a
direct antigenic attack by attenuated virus on brachial plexus nerves, then, a focal inflammation of
vessels of the nerve [that] causes axonal damage, with unequal severity from one nerve to another.”
Id. He goes on to suggest that autoantibodies may be involved because “autoantibodies… directed
against peripheral nerve[s] can produce a polyneuropathy.” Id. Dr. Fink’s main support for these
theories come from a single review article, however, which acknowledges its own tentative nature.
P. Seror, Neuralgic Amyotrophy. An Update, 84 Joint Bone Spine 153-58, at 156 (2017), filed as
Ex. 24 on Dec. 16, 2019 (ECF No. 46-3) (“[t]he pathophysiology of [brachial neuritis] remains
uncertain,” and mechanistic proposals for how it advances (which include an autoimmune
hypothesis) remain until now simple presumptions,” despite some evidence supporting immune-
mediation).

The proposal that brachial neuritis’s pathophysiology occurs via a generalized, innate
response to vaccination is also not helpful in this case in demonstrating causation. In some
circumstances, it may be true that a petitioner can experience a transient reaction to a vaccination,
like malaise or situs pain. But general responses that resolve short of the six-month period required
to establish the severity requirement in Program cases, and that cannot otherwise be tied to the
alleged injury, do not satisfy a petitioner’s burden. Monzon, 2021 WL 1736816 at *20. And here,
insufficient evidence has been presented that would allow me to conclude that the mere triggering
of an innate response to the HPV vaccine would be enough to evolve into brachial neuritis, absent
connective evidence providing insight into how this might occur. It cannot be assumed that the
HPV vaccine could cause brachial neuritis simply because it is a vaccine, administered prior to
injury. Speculative literature like Martinez-Lavin, that considered whether other neuropathic

25
injuries might reflect some kind of “HPV vaccine syndrome,” do not say enough about brachial
neuritis to be given significant weight.

Overall, Petitioner’s case seems mostly to rely on the fact that other vaccines have been
deemed in the Program to cause the same injury. If other vaccines can cause brachial neuritis, Dr.
Fink reasons, why not HPV as well? But the association between other vaccines, such as those
containing a tetanus component, and brachial neuritis appear more attributable to aberrant
reactions imposed by that specific component—not the general impact of vaccination. For
example, a case report cited by Dr. Fink observes that, unlike case reports of brachial neuritis
following the tetanus toxoid, “the HPV vaccine… does not contain a toxoid so it remains unclear
how it could have given rise to a neuritis[.]” Debeer at 4418 (emphasis added). Vaccines are
formulated differently to provide immunologic protections against different pathogens, so their
components usually cannot be theorized to have a “one size fits all” impact. While there are a few
injuries, like shoulder injury related to vaccine administration, or “SIRVA,” that may be caused
by a number of vaccines interchangeably, the same has not been found to be true for brachial
neuritis. 13

In this case, neither expert possessed specific immunologic expertise to “overpower” the
other simply based on personal credentials and established, well-grounded subject-matter
familiarity with the functioning of the immune system and its bearing on this kind of neurologic
injury. And I do not find this is a case where this particular issue goes against Petitioner because
of the overall strength of Respondent’s expert’s showing (although on matters relating to brachial
neuritis more generally, I do find that Dr. Donofrio’s opinion arose from more demonstrated
expertise and reliable science than Dr. Fink’s). But Dr. Fink himself lacked the kind of specific
immunologic expertise needed to breathe life into his causation theory, and his absence of
professional expertise in the topic was damaging to the theory on its own (especially since
petitioners bear the ultimate burden of proof in vaccine cases in any event). Petitioner did not carry
his burden of proof on this first prong, and that assessment can be reached simply by looking at
the evidence Dr. Fink did offer—it did not rise to a preponderant showing.

B. Althen Prong Three

Another deficiency in the evidence offered to substantiate the claim is the exceedingly
short timeframe in which Petitioner’s post-vaccination symptoms onset occurred. The record

13
Indeed, a glance at the Table illustrates the problem of broad assumptions about the scope of vaccine-associated
adverse events. For example, the Table allows claimants to seek recovery for SIRVA based on twelve different kinds
of vaccines, including HPV. See generally Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3;
§ 11(c)(1)(C)(ii)(I). But the Table includes brachial neuritis only after receipt of tetanus-containing vaccines. 42 C.F.R.
§ 100.3(a)(I)(B). This reflects Respondent’s determination that medical science supports the conclusion that many
vaccines can cause SIRVA, likely due to the common impetus for the injury (injection of antigen into the bursa
sufficient to cause localized inflammation), which is independent of their varying contents. The same has not been
found to be true of brachial neuritis.

26
establishes that Mr. Pelelo first experienced pain within 24 hours of vaccination. See, e.g., Ex. 6
at 3; Pelelo Aff. at 1. But this is far too soon for an immune-mediated case of brachial neuritis,
which the literature suggests would take several days to manifest, since the injury requires some
degree of inflammation to develop before it is felt symptomatically. See IOM Report II.

Dr. Fink maintained in response that other literature suggested that brachial neuritis onset
is felt “acutely,” but that term seems to have been employed in the relevant literature to mean
“unexpected and severe,” rather than to describe a timeframe for onset. Bromberg at 3. Indeed, the
case reports Petitioner places so much reliance upon all involve onset of more than 24 hours post-
vaccination. See, e.g., Debeer at 4417 (case report of brachial neuritis with onset one month after
second HPV vaccination); Taras at 454 (case reported of alleged brachial neuritis with onset three
days after second HPV vaccination). Thus, even if I had found that the HPV vaccine can cause
brachial neuritis, the evidence does not preponderate in favor of the determination that it would
likely manifest as quickly as it did so for Petitioner. This is especially so since Petitioner’s theory
depends on a determination that the vaccine triggered an autoimmune process, which would most
likely require some kind of adaptive immune response. Second Fink Rep. at 3. That kind of
adaptive process is understood to take several days. See Block v. Sec’y of Health & Hum. Servs.,
No. 19-969V, 2021 WL 2182730, at *1 (Fed. Cl. Spec. Mstr. Apr. 26, 2021) (time for antibody-
driven peripheral neuropathy in question takes more than three days to begin). Dr. Donofrio
credibly and persuasively established in his reports that even in the event of a speedier immune
response attributable to a prior exposure to the HPV vaccine, onset for an immune-mediated,
adaptive response (through the production of antibodies) would take more than even two days.
Donofrio Second Rep. at 5.

As noted above, Vaccine Act cases involving brachial neuritis have been dismissed where
onset was not demonstrated to be medically reasonable—most often because it was too long after
vaccination. See, e.g., Greene, 2019 WL 4072110 (41 day onset too long); Garner, 2017 WL
1713184 (45 day onset too long). Here, onset is too soon—but this equally is a basis for the
determination that the claim cannot succeed. de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d
1347, 1352 (Fed. Cir. 2008) (“we see no reason to distinguish between cases in which onset is too
soon and cases in which onset is too late; in either case, the temporal relationship is not such that
it is medically acceptable to conclude that the vaccination and the injury are causally linked”).

CONCLUSION

Other vaccines have preponderantly been demonstrated in the Vaccine Program to be
associated with the capacity to trigger brachial neuritis, and it is conceivable that science may
eventually expand that list to include the HPV vaccine. But not nearly enough was demonstrated
in this case to conclude that the HPV vaccine could also cause brachial neuritis, or in the very

27
short timeframe at issue. Accordingly, Petitioner has not met his burden of proof, and I am
compelled to dismiss this claim.

In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the
court SHALL ENTER JUDGMENT in accordance with the terms of this decision.14

IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master

14
Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices
renouncing their right to seek review.

28