VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-00813
Package ID: USCOURTS-cofc-1_18-vv-00813
Petitioner: James Clark
Filed: 2018-06-08
Decided: 2022-11-02
Vaccine: Hepatitis B
Vaccination date: 2017-02-21
Condition: Shoulder Injury Related to Vaccine Administration
Outcome: denied
Award amount USD: 

AI-assisted case summary:
James Clark filed a petition alleging that his Hepatitis B vaccination on February 21, 2017, caused a left shoulder injury, specifically a Shoulder Injury Related to Vaccine Administration (SIRVA). Mr. Clark had a significant history of left shoulder pain and dysfunction, including a total shoulder replacement in 2010, and ongoing issues like ankylosing spondylitis (AS), cervical spine degeneration, and limb-girdle muscular dystrophy. He claimed his shoulder pain began shortly after the vaccination, but the court found that his own contemporaneous emails and medical records indicated pain onset approximately four days after the vaccination, outside the 48-hour window required for a Table SIRVA claim. Furthermore, the court determined that Mr. Clark's pre-existing conditions, including complications from his shoulder replacement (such as glenoid loosening and fracture) and his AS, were more likely explanations for his continued shoulder pain than the vaccination. His expert, Dr. Axelrod, proposed a theory of environmentally associated autoimmune disease via molecular mimicry, but the court found this theory unpersuasive and not supported by the evidence, particularly given the immediate inflammatory nature typically associated with SIRVA. Respondent's expert, Dr. Abrams, a qualified orthopedist, provided a more convincing analysis linking Mr. Clark's symptoms to his pre-existing conditions. Ultimately, the court concluded that Mr. Clark failed to meet the criteria for a Table SIRVA and did not establish causation-in-fact. Therefore, his petition was denied.

Theory of causation field:
Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_18-vv-00813-1
Date issued/filed: 2022-11-02
Pages: 35
Docket text: PUBLIC DECISION (Originally filed: 02/07/2022) regarding 61 DECISION of Special Master. Signed by Special Master Daniel T. Horner. (mly) Service on parties made.
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Case 1:18-vv-00813-UNJ Document 69 Filed 11/02/22 Page 1 of 35
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 18-813V
Filed: February 7, 2022
PUBLISHED
Special Master Horner
JAMES CLARK,
Petitioner,
Shoulder Injury Related to
v.
Vaccine Administration
(“SIRVA”); Table Injury;
SECRETARY OF HEALTH AND
Causation-in-Fact; Hepatitis B
HUMAN SERVICES,
vaccine; Ruling on the Record
Respondent.
Caryn Fennell, Caryn S. Fennell P.C., Woodstock GA, for petitioner.
Nancy Tinch, U.S. Department of Justice, Washington, DC, for respondent.
DECISION1
On June 8, 2018, petitioner, James Clark, filed a petition under the National
Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012),2 alleging that his receipt
of a Hepatitis B vaccination on February 17, 2017, caused a left shoulder injury. (ECF
No. 1.) For the reasons set forth below, I conclude that petitioner is not entitled to an
award of compensation.
I. Applicable Statutory Scheme
Under the National Vaccine Injury Compensation Program, compensation
awards are made to individuals who have suffered injuries after receiving vaccines. In
general, to gain an award, a petitioner must make a number of factual demonstrations,
including showing that an individual received a vaccination covered by the statute;
1 Because this decision contains a reasoned explanation for the special master’s action in this case, it will
be posted on the United States Court of Federal Claims’ website in accordance with the E-Government
Act of 2002. See 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the decision will be available to anyone with access to the
Internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact
medical or other information the disclosure of which would constitute an unwarranted invasion of privacy.
If the special master, upon review, agrees that the identified material fits within this definition, it will be
redacted from public access.
2 All references to “§ 300aa” below refer to the relevant section of the Vaccine Act at 42 U.S.C. § 300aa-
10-34.
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Case 1:18-vv-00813-UNJ Document 69 Filed 11/02/22 Page 2 of 35
received it in the United States; suffered a serious, long-standing injury; and has
received no previous award or settlement on account of the injury. Finally – and the key
question in most cases under the Program – the petitioner must also establish a causal
link between the vaccination and the injury. In some cases, the petitioner may simply
demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be
shown that the vaccine recipient suffered an injury of the type enumerated in the
“Vaccine Injury Table,” corresponding to the vaccination in question, within an
applicable time period following the vaccination also specified in the Table. If so, the
Table Injury is presumed to have been caused by the vaccination, and the petitioner is
automatically entitled to compensation, unless it is affirmatively shown that the injury
was caused by some factor other than the vaccination. § 300aa-13(a)(1)(A); § 300 aa-
11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B).
As relevant here, the Vaccine Injury Table lists a Shoulder Injury Related to
Vaccine Administration or “SIRVA” as a compensable injury if it occurs within 48 hours
of administration of a Hepatitis B vaccine. § 300aa-14(a) as amended by 42 CFR §
100.3. Table Injury cases are guided by statutory “Qualifications and aids in
interpretation” (“QAIs”), which provides more detailed explanation of what should be
considered when determining whether a petitioner has actually suffered an injury listed
on the Vaccine Injury Table. 42 CFR § 100.3(c). To be considered a “Table SIRVA,”
petitioner must show that his injury fits within the following definition:
SIRVA manifests as shoulder pain and limited range of motion occurring
after the administration of a vaccine intended for intramuscular
administration in the upper arm. These symptoms are thought to occur as a
result of unintended injection of vaccine antigen or trauma from the needle
into and around the underlying bursa of the shoulder resulting in an
inflammatory reaction. SIRVA is caused by an injury to the musculoskeletal
structures of the shoulder (e.g. tendons, ligaments, bursae, etc.). SIRVA is
not a neurological injury and abnormalities on neurological examination or
nerve conduction studies (NCS) and/or electromyographic (EMG) studies
would not support SIRVA as a diagnosis . . . . A vaccine recipient shall be
considered to have suffered SIRVA if such recipient manifests all of the
following:
(i) No history of pain, inflammation or dysfunction of the affected shoulder
prior to intramuscular vaccine administration that would explain the alleged
signs, symptoms, examination findings, and/or diagnostic studies occurring
after vaccine injection;
(ii) Pain occurs within the specified time-frame;
(iii) Pain and reduced range of motion are limited to the shoulder in which
the intramuscular vaccine was administered; and
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Case 1:18-vv-00813-UNJ Document 69 Filed 11/02/22 Page 3 of 35
(iv) No other condition or abnormality is present that would explain the
patient's symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy,
brachial neuritis, mononeuropathies, or any other neuropathy).
42 CFR §100.3(c)(10).
Alternatively, if no injury falling within the Table can be shown, the petitioner may
still demonstrate entitlement to an award by showing that the vaccine recipient’s injury
or death was caused-in-fact by the vaccination in question. § 300aa-13(a)(1)(A); §
300aa-11(c)(1)(C)(ii). To so demonstrate, a petitioner must prove 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). In particular, a petitioner must provide
evidence of: (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 proximate temporal relationship between vaccination and injury.
Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005)
For both Table and Non–Table claims, Vaccine Program petitioners must
establish their claim by a “preponderance of the evidence”. § 300aa-13(a). That is, a
petitioner must present evidence sufficient to show “that the existence of a fact is more
probable than its nonexistence . . . .” Moberly ex rel. Moberly v. Sec'y of Health &
Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010). Proof of medical certainty is
not required. Bunting v. Sec'y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir.
1991). 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. § 300aa-13(a)(1). Such medical opinion must be
“sound and reliable.” Boatmon v. Sec’y of Health & Human Servs., 941 F.3d 1351,
1359-60 (Fed. Cir. 2019) (citing Knudsen v. Sec’y of Health & Human Servs., 35 F.3d
543, 548-49 (Fed. Cir. 1994)). However, petitioner may rely upon “circumstantial
evidence,” which has been found to be consistent with the “system created by
Congress, in which close calls regarding causation are resolved in favor of injured
claimants.” Althen, 418 F.3d at 1280.
II. Procedural History
This case was originally assigned to the Court’s Special Processing Unit (“SPU”)3
on June 8, 2018, after petitioner filed his petition and several medical records. (ECF
Nos. 1, 4.) After additional filings, petitioner filed a statement of completion on
November 27, 2018. (ECF Nos. 10, 15, 16.) Respondent filed his Rule 4(c) report
recommending against compensation on May 2, 2019. (ECF No. 20.)
3 On May 7, 2019, this case was reassigned to Special Master Moran. (ECF No. 22.) This case was later
reassigned to my docket on August 27, 2019. (ECF No. 29.)
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On September 5, 2019, I ordered petitioner to file an expert report supporting his
claim which he did on March 30, 2020, along with an affidavit from his wife. (ECF Nos.
30, 35, 36.) Respondent filed a responsive expert report on June 15, 2020. (ECF Nos.
39, 40.) Petitioner and respondent filed three more rounds of expert reports between
August 14, 2020 and February 1, 2021. (ECF Nos. 41-43, 46, 49.)
On September 18, 2020, after prompting, the parties advised that neither
objected to proceeding to a ruling on the written record. (ECF No. 44.) On December
15, 2020, the parties proposed a mutually agreeable briefing schedule. (ECF No. 48.)
Ultimately, on March 2, 2021, petitioner filed a motion for a ruling on the record. (ECF
No. 52.) Respondent filed a brief in response and a final expert report on June 2, 2021.
(ECF Nos. 54, 55.) Petitioner elected not to file a reply.
I have determined that the parties have had a full and fair opportunity to present
their cases and that it is appropriate to resolve this issue without a hearing. See Vaccine
Rule 8(d); Vaccine Rule 3(b)(2); Kreizenbeck v. Sec’y of Health & Human Servs., 945
F.3d 1362, 1366 (Fed. Cir. 2020) (noting that “special masters must determine that the
record is comprehensive and fully developed before ruling on the record.”).
Accordingly, this matter is now ripe for resolution.
III. Factual History
a. As reflected in the medical records
i. Pre vaccination
Prior to his vaccination, petitioner had a history of ankylosing spondylitis (“AS”),
cervical spine pathology, and limb-girdle muscular dystrophy going as far back as 2006.
(Ex. 19, p. 82.) Petitioner’s available medical records begin with a February 14, 2006
appointment with rheumatologist Dr. Jonathan Waltuck who noted that petitioner had
been diagnosed with AS in 1998, had a 2001 x-ray revealing fusion of his cervical
vertebrae, exhibited persistently elevated muscle enzyme and liver function markers,
with normal muscle biopsy and normal liver ultrasounds, and was HLA B27 positive.
(Id.) Petitioner’s primary complaint at this appointment was left shoulder pain with
increased back pain in his cervical spine. (Id.) Petitioner’s musculoskeletal exam was
unremarkable and revealed full range of motion in both shoulders, but painful range of
motion in the left. (Id. at 83.) Dr. Waltuck administered a steroid injection into
petitioner’s left shoulder and recommended he continue taking 200mg of Celebrex twice
daily and 20mg of Enbrel twice weekly. (Id. at 83-84.)
Petitioner was again seen by Dr. Waltuck on August 14, 2006. (Id. at 85-86.)
Petitioner reported significant loss of range of motion in his left shoulder, rated his pain
as 3 out of 10, and received three x-rays which revealed “bony changes of osteoarthritis
with glenohumeral osteophyte formation and subchondral cysts within the anatomic
humeral neck,” in addition to an “old cartilaginous calcification of the subcoracoid
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space,” believed to suggest “an intra-articular osteochondral body, posterior inferior
subluxation, [and] moderate glenohumeral joint space narrowing.” (Ex. 19, pp. 85-86,
134.)
Petitioner saw orthopedic surgeon Dr. Spero Karas on August 18, 2006. (Ex. 19,
pp. 31-33.) Petitioner reported frequent sharp pain in his left shoulder at a 5/10, with
weakness and stiffness lasting four weeks. (Id. at 32.) Petitioner’s left shoulder exam
revealed Hawkins and NEER positivity with AC joint tenderness. (Id. at 32-33.) He
reviewed petitioner’s previous x-rays and observed mild humeral spurring and mild
glenoid space degenerative joint disease. (Id. at 33.) He diagnosed petitioner with
shoulder degenerative disease, possible rotator cuff tear, and possible impingement
syndrome to be evaluated by MRI. (Id.)
Petitioner received an MRI of his left shoulder on August 24, 2006. (Id. at 128-
129.) The MRI revealed left shoulder osteoarthritis, supraspinatus and infraspinatus
partial tears/tendinopathy, glenoid labrum irregularity with labral ligamentous
degenerative change, and a subcoracoid osteochondral body that was about a
centimeter in diameter. (Ex. 19, pp. 128-129.) Petitioner returned to Dr. Karas for
another steroid injection on September 29, 2006 and was prescribed physical therapy.
(Id. at 29-30.)
Petitioner reported to Dr. Waltuck on February 12, 2007, complaining of
increased flare ups in his left shoulder, noting that it was stiffer and more painful both in
the morning and at night. (Id. at 87.) Petitioner reported a pain level of 6/10, and his
musculoskeletal exam revealed “some restriction to the lumbar spine movement and . . .
to forward elevation of the left shoulder.” (Id.) Dr. Waktuck prescribed the anti-
inflammatory drug Humira. (Id. at 88.) On April 18, 2007, Dr. Waltuck noted that
petitioner had been diagnosed with AS at age 40 “despite having problems since age
20.” (Id. at 89.) He recorded “3+ limitation of his left shoulder in all planes, on passive
ROM, and also on active ROM.” (Ex. 19, p. 90.) Dr. Waltuck continued petitioner’s
Humira and Celebrex prescriptions and added Percocet for pain management. (Id. at
91.) Petitioner again reported stiffness and discomfort in his back and left shoulder to
Dr. Waltuck on August 20, 2007. (Id. at 93.) His left shoulder exam revealed restriction
to forward elevation and Dr. Waltuck adjusted petitioner Humira dosage while
continuing all other prescriptions. (Id. at 94.)
The following year, petitioner was seen again by Dr. Waltuck on a February 6,
2008, for follow up with complaints of bilateral knee and shoulder pain, worse on the left
side, and left ankle and foot pain. (Id. at 95-96.) Petitioner noted that his Humira
regimen was not helping and that his pain and stiffness had increased. (Id. at 95.) Dr.
Waltuck believed that petitioner’s pain was the result of his AS, and adjusted petitioner’s
Humira dosage once again. (Ex. 19, p. 96.)
By April 8, 2008, petitioner reported to Dr. Karas that he was experiencing sharp,
throbbing pain 90% of the time which he rated as an 8/10 with clicking, weakness, and
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stiffness for the past four weeks. (Id. at 24-28.) Petitioner received an x-ray of his left
shoulder which revealed definitive degenerative joint disease, moderate glenoid
spurring that was severe in the glenoid space, and severe humeral spurring. (Id. at 26.)
Petitioner’s neck and back exams revealed painful decreased flexion, extension, lateral
bending, and rotation. (Id.) Dr. Karas administered another cortisone injection into
petitioner’s left shoulder. (Id. at 27.)
Petitioner was seen by Dr. Karas on November 20, 2008 for another follow up.
He reported his pain as sharp with some movements, but otherwise at a 6/10, aching,
intermittent, and occurring at night. (Id. at 22.) Petitioner showed slightly decreased
strength at 4/5, and pain with forward flexion, internal rotation, abduction, and external
rotation. (Ex. 19, p. 22-23.) Petitioner received another cortisone injection. (Id.)
On May 18, 2009, petitioner reported worsening joint pain, back stiffness, wrist
pain, neck pain, and finger tingling. (Id. at 97-98.) Petitioner’s exam revealed
decreased range of motion in the left shoulder and neck, and back stiffness on flexion.
(Id. at 97.) Dr. Waltuck believed that petitioner’s symptoms were consistent with
worsening AS; he prescribed Remicade infusions, recommended that petitioner
continue Celebrex and other anti-inflammatories as needed with oxycodone for pain
management. (Id.)
Dr. Karas examined petitioner at a follow-up appointment on June 4, 2009. (Id.)
He noted reduced range of motion, pain, and normal strength in petitioner’s left
shoulder. (Ex. 19, p. 20.) Petitioner was diagnosed with “definitive degenerative joint
disease of the left shoulder – glenoid space severe.” (Id. at 20.) Petitioner received
another cortisone injection at this visit. (Id.)
Petitioner was seen by Dr. Waltuck for a follow up on August 17, 2009. (Id. at
100-01.) He reported worsening of symptoms while off Humira and Remicade and
continued shoulder pain. (Id.) Dr. Waltuck increased petitioner’s Remicade dose and
scheduled a six-month follow up appointment. (Id.)
On September 8, 2009, petitioner was seen by Dr. Karas for a follow up on
“inflammatory arthritis” in his left shoulder. (Ex. 17, pp. 17-19.) Petitioner’s shoulder
exam was consistent with prior exams, and he reported that his corticosteroid injections
were providing less relief than before. (Id. at 17-18.)
Petitioner was seen again by Dr. Waltuck on October 27, 2009 and reported that
his AS had improved upon increasing his Remicade dose. (Ex. 19, pp. 102-04.)
However, he also reported continued pain in his left shoulder, with restriction with
forward elevation. (Id. at 103.) Petitioner was directed to continue Remicade and
Celebrex medications, and noted that he was to undergo shoulder surgery in early
2010. (Id.)
Petitioner underwent a total left shoulder replacement for “left inflammatory
glenohumeral arthritis secondary to ankylosing spondylitis,” on February 15, 2010. (Ex.
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5, p. 51.) Petitioner’s pre-operation imaging revealed “severe glenohumeral joint
arthritis” and “glenoid spurs.” (Id. at 52.) During the operation Dr. Karas observed
adhesions and osteophytes which he removed. (Id. at 52, 70.) Petitioner’s post-op
report noted a successful operation with no complications, petitioner was referred to
physical therapy and discharged the following day. (Id. at 52.)
Petitioner returned to Dr. Karas for a post-op follow up on February 25, 2010
where he reported “minimal, intermittent” pain of 2/10. (Ex. 19, pp. 15-16.) Petitioner’s
shoulder exam revealed passive flexion at 90 degrees without pain and passive external
rotation at 15 degrees with no pain. (Id. at 15.) Petitioner was referred to continued
physical therapy and scheduled a six-week follow up. (Id. at 16.)
Petitioner’s next appointment with Dr. Karas was on April 13, 2010. His exams
revealed improved range of motion and minimal pain. (Id. at 13-14.) Dr. Karas
recommended continued physical therapy and an eight-week follow up. (Id. at 14.)
After completing his physical therapy, petitioner saw Dr. Karas for another follow
up on June 11, 2010. (Id. at 11-12.) Petitioner again reported minimal pain and Dr.
Karas noted that petitioner had “greatly improved” since his surgery. (Id. at 11.)
Petitioner’s shoulder exam revealed active flexion at 150 degrees, passive flexion at
155 degrees, active external rotation at 30 degrees, passive external rotation at 40
degrees, internal rotation at “L3,” internal abduction at 20 degrees, and external
abduction at 70 degrees. (Ex. 19, p. 12.)
Petitioner returned to Dr. Waltuck on August 29, 2011, where he reported that he
was satisfied with his lack of pain and the range of motion that he experienced following
his shoulder surgery. (Id. at 114-15.) However, Dr. Waltuck’s exam revealed “slightly
reduced range of motion” in his left shoulder. (Id. at 115.)
On February 28, 2012, petitioner returned to Dr. Waltuck who noted that
petitioner was still taking Celebrex and Remicade. (Id. at 78-79.) Petitioner reported
that he experienced an “episode of pain in the left shoulder . . . around Christmas, but it
resolved after a week or so.” (Id.) Dr. Waltuck observed some postsurgical changes in
petitioner’s left shoulder as well. (Id. at 79.)
Petitioner was seen again by Dr. Waltuck on August 28, 2012 where he reported
he was doing well on Remicade and Celebrex. (Ex. 19, p. 70-71.) Petitioner did
however, note experiencing more stiffness than usual in the week leading up to his
Remicade infusion. (Id. at 70.) Petitioner complained of pain in the bases of his thumbs
and his exam revealed some signs of osteoarthritis. (Id. at 71.)
Petitioner next saw Dr. Waltuck on February 21, 2013. He complained of
continuing issues in his hands. (Id. at 68-69.) Dr. Waltuck noted “osteoarthritic
changes” in both of petitioner’s hands with Heberden’s nodes and squaring of the first
CMC joints. (Id. at 69.) He also noted slightly decreased range of motion in forward
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elevation of petitioner’s right shoulder. (Id.) Dr. Waltuck did not believe that petitioner’s
hand symptoms were related to an inflammatory disorder. (Ex. 19, p. 69.)
Petitioner returned to Dr. Waltuck on February 5, 2014, reporting that he was
stable in terms of his joint issues but continued to experience some minor stiffness and
discomfort in his neck and back. (Id. at 64-65.) Petitioner did, however, report a
shooting pain down his right leg which began suddenly several months prior when he
was getting into a boat. (Id. at 64.) Dr. Waltuck noted that this pain was unrelated to
petitioner’s AS and “probably nerve compression.” (Id. at 65.)
On March 20, 2014, petitioner was seen by Dr. Ernest Howard for evaluation of
his leg pain. (Ex. 12, pp. 2-4.) Petitioner complained of pain, arthralgias, weakness,
shoulder pain, hand pain, hip pain, leg pain, knee pain, and foot pain. (Id. at 3.) Dr.
Howard diagnosed petitioner with lower back pain, spinal enthesopathy, AS,
lumbar/thoracic radiculopathy, and sacroiliitis. (Id. at 4.) He recommended that
petitioner continue his medications and begin spinal stretching and exercise. (Id.)
Petitioner saw rheumatologist Dr. Roel Querubin on June 4, 2014 for evaluation
of joint and back pain. (Ex. 18, pp. 175-78.) Petitioner reported 4/10 joint pain and 6/10
spine pain. (Id. at 175.) Dr. Querubin recorded that petitioner was experiencing
numbness in both hands that worsened with sleep once or twice per month over the
past several years. (Id. at 176.) Petitioner’s neck exam revealed decreased range of
motion to anterior flexion at approximately 30 degrees, decreased bilateral rotation to
approximately 30 degrees, and decreased extension to approximately 15 degrees. (Id.
at 177.) Petitioner’s musculoskeletal exam revealed normal range of motion in upper
and lower extremities except for a decreased range of motion in left shoulder abduction
at 120 degrees and anterior flexion at 170 degrees. (Id.) Dr. Querubin’s assessment
was AS and polyarthralgia likely associated with AS. (Id. at 178.)
Petitioner saw Dr. Querubin for a follow up on September 9, 2014. (Ex. 18, pp.
162-66.) Petitioner complained of moderate finger, thumb, hand, and joint pain and
exhibited decreased range of motion in his left shoulder consistent with his June 4, 2014
exam. (Id. at 164.) Importantly, however, petitioner exhibited painful active range of
motion in his left shoulder. (Id.) Dr. Querubin also observed decreased range of motion
in petitioner’s neck consistent with his June 4 exam. (Id.)
On October 28, 2014, petitioner returned to Dr. Querubin for another follow up.
(Id. at 152-56.) This time, petitioner’s pain had decreased to a 3/10, but his shoulder
and neck exams still revealed decreased range of motion and pain consistent with what
was recorded in prior exams. (Id. at 153-55.)
Petitioner saw Dr. Querubin again on January 6, 2015 where he reported being
stable since the previous visit but rated his hand and joint pain as a 4/10 and his back
pain as a 7/10. (Ex. 18, pp. 144-48.) Petitioner’s exam once again revealed pain with
active range of motion in the left shoulder, decreased range of motion in the left
shoulder and neck, and hand numbness. (Id. at 144-46.)
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Petitioner underwent a muscle biopsy of his right quadricep muscle on February
19, 2015 which revealed mild myopathy and denervation atrophy. (Ex. 15, pp. 15-16.)
On May 5, 2015, petitioner returned to Dr. Querubin complaining of decreased
grip strength, axial spine pain radiating to the right thigh and foot rated at a 5/10. (Ex.
18, pp. 126-131.) Based on petitioner’s biopsy and elevated CPK levels, Dr. Querubin
recommended a neurology consult. (Id. at 129-30.)
Petitioner saw neurologist, Dr. Reyzelman on July 2, 2015. (Ex. 15, pp. 6-7.)
Based on petitioner’s biopsy, Dr. Reyzelman recommended petitioner be evaluated for
underlying genetic neuromuscular disease, noting differential diagnoses of “mild,
autoimmune necrotizing myopathy, an indolent muscular dystrophy, a mitochondrial
disorder with mildly abnormal eye movements or a metabolic myopathy or
channelopathy.” (Id. at 7-8.)
Petitioner followed up with Dr. Querubin on December 1, 2015. (Ex. 18, pp. 98-
102.) Dr. Querubin once again observed decreased range of motion with mild pain on
active range of motion in petitioner’s left shoulder. (Id. at 101.) Petitioner’s neck exam
also revealed reduced range of motion consistent with his previous exams. (Id.) Upon
reviewing a September 24, 2014 MRI of petitioner’s cervical spine, Dr. Querubin noted
“loss of normal lordotic curvature, reversal centered at C5-6, C5-6 mild spinal
stenosis/effacement of the cord to the left to midline . . . narrowing of the left neutral
foramen at C5-6, C6-7 . . . [and] narrowing of the right neural foramen at C4-5,” which
he believed was suggestive of impingement of the exiting nerve roots. (Id. at 102.)
Petitioner’s MRI also revealed “C2-3, left facet arthropathy with mild to moderate left
neural foraminal narrowing, prominence to the posterior ligament, which abuts the cord
[and a] facet arthropathy.” (Id.)
On December 28, 2015, petitioner reviewed the results of his genetic testing with
Amy Bradley, MMSc. (Ex. 18, pp. 94-95.) Petitioner’s genetic testing revealed two
pathogenic mutations in the ANO5 gene, suggesting an ANO5-related muscle disease.
(Id. at 94.) The test also showed petitioner to carry “one likely-pathogenic mutation in
the PLEC gene . . . associated with limb-girdle muscular dystrophy.” (Id.) Ms. Bradley
wrote that “ANO5-related muscle diseases have been estimated to be one of the most
common causes of LGMD [and that the] spectrum of ANO5-related muscle diseases is
a continuum . . . with the most common presentation being LGMD type 2L with late-
onset proximal lower limb weakness.” (Id.) She noted petitioner’s symptoms of difficult
ambulation, nonspecific exercise myalgia and/or burning sensation in his calves, and
noted that petitioner’s “disease progression is slow and ambulation is preserved until
very late in the disease course.” (Id.) She recommended a neurological evaluation to
establish a baseline muscle force measurement in order to track the progression of
petitioner’s symptoms, a CT or MRI to identify the affected muscles, and cardiac
evaluation to gauge petitioner’s increased risk for cardiomyopathies and arrhythmias.
(Id. at 95.)
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Petitioner was next seen by Dr. Querubin on June 28, 2016 where he reported
that his musculoskeletal issues had recently worsened. (Ex. 18, p. 65.) He specifically
reported increased joint pain in his hands, increased cervical and thoracic spine pain at
a 6/10, increased morning back stiffness now lasting 8-9 hours (previously lasting 4-6),
and decreased range of motion in his spine, and pain radiating to his right thigh and
foot. (Id.) Petitioner’s left shoulder and neck exams revealed the same pain and
reduced range of motion as his previous exams. (Id. at 66-67, 69.)
On November 2, 2016, petitioner reported to Dr. Querubin that his thumb and
finger pain persisted at about a 4/10, but was reduced to 0/10 and 2/10 respectively with
topical pain treatments. (Ex. 18, pp. 43-48.) He also reported that his spinal pain was a
5/10, his morning back stiffness now lasted all day, and his pain radiated from the right
thigh to the foot. (Id. at 43.) Petitioner’s shoulder and neck exams once again revealed
decreased range of motion and pain, and his spinal exam revealed decreased range of
motion and abnormal Schober’s testing. (Id. at 47-48.) Dr. Querubin also noted
hypertrophic changes in petitioner’s hands. (Id.)
Petitioner was seen by Dr. Lenhard on January 18, 2017 where he was noted to
have a history of fatty liver disease, and was administered Hepatitis A and B vaccines.
(Ex. 3, pp. 23-24.)
Petitioner returned to Dr. Querubin on February 6, 2017 where he reported
continued pain in his hands, spine, and right thigh radiating to his right foot. (Ex. 18, pp.
31-36.) Petitioner also reported mild difficulty with activities of daily living and his
physical exams continued to reveal decreased range of motion and pain in his neck,
back, and left shoulder. (Id. at 34.)
ii. Vaccination and subsequent treatment
Petitioner received a second Hepatitis B vaccination in his left deltoid on
February 21, 2017. (Ex. 2, p. 1.) Five days later, on February 26, he e-mailed Dr.
Lenhard stating that “[f]our days post immunization [he] developed significant pain in the
shoulder that received the shot[.]” (Ex. 6, p. 7.) Petitioner further wrote that “today (day
5 post) the pain is still there and is limiting my left shoulder movements but I believe the
pain is less than yesterday.” (Id.)
On March 7, 2017, petitioner e-mailed again, stating that he was still
experiencing pain with movement of his left shoulder and that he believed it may be
associated with the February 21 vaccination which he received “4 days before the pain
started.” (Ex. 6, p. 6.) Dr. Lenhard advised petitioner to see an orthopedist. (Id.)
On March 8, 2017, petitioner e-mailed Dr. Karas to ask for guidance on his
shoulder problems. (Id. at 3-4.) In his e-mail, petitioner described receiving his
vaccination on February 21, 2017, with significant pain starting on February 26. (Id. at
4.) Dr. Karas recommended that petitioner obtain an x-ray of his shoulder and receive
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future vaccinations in his gluteus. (Id.) Petitioner received a left shoulder x-ray on
March 16, 2017 which revealed mild AC joint hypertrophy. (Ex. 3, pp. 35-36.)
Petitioner next saw orthopedist Dr. Peter Symbas on March 22, 2017. (Ex. 24, p.
8.) He reported posterior left shoulder pain for over two weeks, describing the pain as
dull and ranging from 3 to 7/10. (Id.) During this visit, petitioner associated his shoulder
pain with his hepatitis vaccination. (Id.) His exam revealed “good motion of the
shoulder” in light of his total shoulder replacement, mild tenderness with range of
motion, and significantly improved pain compared to his pre-op status. (Id. at 9-10.) Dr.
Symbas reviewed petitioner’s x-rays, noting a “well-seated well-maintained total
shoulder arthroplasty.” (Id. at 10.)
Petitioner e-mailed Dr. Lenhard again on April 26, 2017, stating that at the time,
he was unable to lift a glass of water to his mouth without significant pain and asked
about receiving an MRI of his shoulder. (Ex. 6, p. 1.) Dr. Lenhard advised petitioner to
follow up with Dr. Symbas. (Id.)
On June 13, 2017, petitioner saw Dr. Querubin to follow up on his AS. (Ex. 18,
pp. 16-20.) Petitioner’s exam revealed a reduced range of motion and mild pain to
active range of motion in his left shoulder. (Id. at 19.)
Petitioner was seen by spine specialist Dr. Virlyn Bishop on June 27, 2017 with a
chief complaint of neck pain. (Ex. 8, pp. 10-12.) Petitioner’s Hawkins and Neer tests
showed no signs of impingement. (Id. at 11.) Petitioner received a cervical spine MRI
on July 10, 2017 which showed severe degenerative disc disease at multiple levels,
with the most significant being at the C5-6 level. (Id. at 1-3.)
On September 28, 2017, petitioner saw Dr. Karas, reporting post-vaccination
shoulder pain since February 2017. (Ex. 19, pp. 8-10.) Petitioner noted that the pain
was worse when sleeping on his side, and that it improved with Remicade infusions.
(Id. at 8.) Petitioner’s exam revealed no tenderness to palpation, 150-160 degree range
of motion to flexion and abduction with pain, normal external and internal range of
motion, positive Hawkins test, normal shoulder x-ray, and a small defect in the
subscapularis tendon on ultrasound. (Id. at 9.) Dr. Karas believed that petitioner
suffered from rotator cuff impingement related pain and administered another steroid
injection into petitioner’s left subacromial space. (Id. at 10.)
Petitioner saw orthopedist Dr. Anthony Grasso on February 22, 2018 for an
evaluation of cervical pain. (Ex. 20, pp. 1-3.) At this point, petitioner reported
numbness and tingling in both arms and hands. (Id. at 1.) Petitioner described his pain
as sharp and noted that it was worse when moving his neck. (Id.) Petitioner exhibited
decreased range of motion in his spine, normal range of motion in his upper extremities,
and no pain or weakness with resisted movements or range of motion. (Id. at 2.) Dr.
Grasso assessed petitioner with cervicalgia, cervical disc displacement and
degeneration, anesthesia of skin, muscle spasms, AS, and muscular dystrophy. (Id.)
He also noted that petitioner’s MRIs showed no evidence of radiculopathy or nerve root
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compression. (Id. at 3.) Dr. Grasso recommended medial branch block injection at the
C4-6 levels. (Id.) Petitioner received these injections on February 28, 2018 and again
on March 9, 2018. (Ex. 20, pp. 5-10.) Petitioner reported a 60% improvement in his
pain after receiving the medial branch block injections. (Id. at 11.)
Petitioner returned to Dr. Grasso on April 16, 2018 where he reported an 80%
improvement in his pain which he rated as a 2/10. (Id. at 17-19.) However, petitioner
complained of mid-back pain with muscle spasms which he described as “a constant
dull aching sensation with intermittent sharp exacerbations.” (Id. at 17.) Petitioner’s
exam revealed tenderness in the thoracic spine with limited range of motion and a
normal upper extremity exam. (Id. at 18.) Petitioner received a thoracic spine MRI on
April 23, 2018 which revealed mild degenerative changes and mild bulging annulus at
T2-3, T5-6, T7-8, and T11-12. (Ex. 23, pp. 1-2.)
Petitioner again saw Dr. Grasso on April 30, 2018. (Ex. 20, pp. 20-22.)
Petitioner noted that his pain was now affecting his middle back and left shoulder and
had increased to about a 3/10 that worsened with overhead activity. (Id. at 20.)
Petitioner’s exam revealed decreased range of motion in his upper extremities, pain
with internal and external rotation, and positive signs of shoulder impingement in the left
upper extremity. (Id. at 21.) Dr. Grasso diagnosed petitioner with bicipital tendinitis and
impingement syndrome of the left shoulder. (Id.) He recommended petitioner undergo
an MRI and CT scan of his left shoulder to evaluate for internal derangement. (Id.)
Petitioner received a CT scan on May 8, 2018. (Ex. 21, p. 2.) The scan revealed a
subacute to chronic-appearing nondisplaced glenoid fracture involving the articular
surface and glenoid neck, and mild cortical irregularity along the medial aspect of the
humerus neck that was thought to be a previously healed fracture. (Id.)
On May 17, 2018, petitioner returned to Dr. Grasso, reporting that his left
shoulder pain began in February of 2017 after his hepatitis vaccination. (Ex. 20, p. 23.)
Petitioner’s exam revealed a decreased range of motion in his upper extremities, pain
with internal and external rotation, and positive signs of left shoulder impingement. (Id.
at 24.)
Petitioner was seen by Dr. Symbas again on May 23, 2018. He complained of
continued left shoulder pain. (Ex. 24, pp. 5-7.) Petitioner’s exam again revealed “good”
range of motion in his shoulder, “considering he had a total shoulder arthroplasty.” (Id.
at 7.) Dr. Symbas reviewed petitioner’s CT scan and believed it showed “perhaps a
nondisplaced glenoid fracture and maybe some loosening of his glenoid.” (Id.) Dr.
Symbas referred petitioner to orthopedic surgeon Dr. James Kercher. (Id.)
Petitioner saw Dr. Kercher on June 4, 2018. (Ex. 22, pp. 7-8.) Petitioner again
noted onset of his pain in February of 2017 after receiving his hepatitis vaccination. (Id.
at 7.) Petitioner’s exam revealed 5/5 strength with pain in his supraspinatus, and
abnormal belly press, tenderness to palpation, limited motion, abnormal strength, and
tenderness to palpation in his subscapularis. (Id. at 8.) Dr. Kercher believed that
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petitioner’s CT scan suggested “osteolysis around the cement mantle though it is largely
intact [and] what appears to be a high riding humeral head suggestive of rotator cuff
rupture in addition to a weak belly press.” (Id.) Dr. Kercher suggested revision surgery
on petitioner’s shoulder, with a possible workup to evaluate for an infection, but chose to
monitor petitioner over the next six months because his prognosis was generally good.
(Id.)
On June 21, 2018, petitioner returned to Dr. Karas for a follow up on his shoulder
pain. (Ex. 21, pp. 1-4.) He reported pain of 4/10 and feeling weakest with internal and
external rotation. (Id. at 1.) Petitioner’s exam revealed no tenderness to palpation,
range of motion of 150-160 with pain for flexion and abduction, external rotation to the
SI joint on internal rotation, and 30 degrees on external rotation. (Id. at 2.) Petitioner’s
strength was 4/5 with mild pain at flexion, 4/5 with mild pain on abduction, 5/5 with mild
pain on external rotation, and 4/5 with no pain on internal rotation. (Id. at 2-3.)
Petitioner’s empty can, Neer’s, active compression, Speed’s, and O’Brien’s tests were
all normal. (Id.) His Hawkins test, however, was positive. (Id. at 3.) Dr. Karas noted
that petitioner’s CT scan showed “some nondisplaced fractures that could be from the
tunnels that were drilled during surgery.” (Ex. 21, p. 3.) He also noted that petitioner’s
glenoid component may be loose, but that it was hard to tell from the CT scan. (Id.)
After an anesthetic injection, petitioner noted that his pain remained the same but that
he had an increased range of motion. (Id.) Dr. Karas advised petitioner to continue
with his normal activities and to follow up as necessary. (Id. at 3-4.)
b. As reflected in testimony
i. Petitioner’s affidavit
Petitioner filed an affidavit with his petition on June 8, 2018. (Ex. 4.) Petitioner
states in this affidavit that he received his Hepatis B booster on February 21, 2017 at
Dr. Lenhard’s office. (Id. at 1.) He affirms that he had a successful left shoulder
replacement in 2010, and although he saw his PCP on January 18, 2017, for
hypertension and hyperlipidemia, he was not experiencing any pain or other shoulder
symptoms. (Id. at 2.) Petitioner describes his vaccination as “more painful than other
vaccinations” he received in the past, noting unusual pain when the needle was inserted
and removed. (Id.) He states that “[t]he movement of the needle felt like it was being
inserted and then removed through a rubber band and not a muscle. The onset of pain
from the injection was immediate and pain has remained to this day . . . .” (Id.)
Petitioner further affirms that he reported his pain to Dr. Lenhard on February 26, 2017
and was advised to treat with ibuprofen. (Id.) On March 7, 2017 petitioner e-mailed Dr.
Lenhard again and was referred to Dr. Symbas, an orthopedic surgeon who performed
an x-ray on petitioner’s shoulder on March 22, 2017. (Ex. 4, p. 2.) Petitioner e-mailed
Dr. Lenhard once more on April 27, 2017 and was again referred to Dr. Symbas. (Id.)
Petitioner states that he met with Dr. Karas, the surgeon who performed his
pervious shoulder replacement on September 28, 2017. (Id.) Dr. Karas performed an
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x-ray which revealed “a small defect in the subscapularis tendon and mild AC joint
arthropathy.” (Id.) Petitioner received a therapeutic corticosteroid injection into his left
subacromial joint space. (Id.)
Petitioner concludes his affidavit stating that he continues to suffer shoulder pain
on a daily basis, that he has never filed any action for his injury, and that he has never
received any award or settlement for his injury. (Id. at 3.)
ii. Louise H. Andrews’ affidavit
On March 30, 2020, petitioner’s wife, Louise H. Andrews submitted an affidavit
on his behalf. (Ex. 26.) Ms. Andrews affirms that when her husband returned home
after receiving his booster shot, “he complained that his left shoulder, which was the site
of the injection, was very painful,” and that his shoulder pain has persisted to this day,
negatively impacting his daily activities, recreation, exercise routine, and his ability to
travel, play with his grandchildren, and maintain his home. (Id. at 1-3.)
IV. Summary of Expert Opinions and Qualifications
Petitioner filed reports from allergy, immunology, and rheumatology specialist
David Axelrod, M.D., to support his claim.4 (Exs. 27, 30, 36, 43.) Respondent filed
expert reports from orthopedist Geoffery Abrams, M.D., to support his position.5 (Exs.
A, C, D.)
a. Dr. David Axelrod’s Initial Report
First, Dr. Axelrod opines that petitioner suffered a SIRVA, consistent with the
well-known Atanasoff study, which was cited as support for the creation of the SIRVA
Table Injury. (see Sarah Atanasoff et al., Shoulder Injury Related to Vaccine
Administration (SIRVA), 28 VACCINE 8049 (2010) (EX. 31).) Dr. Axelrod explains that
SIRVA occurs when “over-penetration of the needle through the upper deltoid muscle
into the shoulder bursa, with injection of the antigens (vaccine) into the bursa of
4 Dr. Axelrod received his medical degree and master’s degree in Clinical Research Design and
Biostatistics from the University of Michigan. He has worked as a basic and clinical scientist, and as a
medical professor at medical schools and private teaching hospitals. Dr. Axelrod has worked as a private
practitioner in the areas of adult rheumatology, allergy, and immunology, and has treated reactions to
medications and vaccines in this practice. He is board certified in internal medicine, allergy &
immunology, adult rheumatology, and medical laboratory immunology. (Ex. 27, p. 1.)
5 Dr. Abrams received his bachelor’s degree in human biology – neuroscience from Stanford University in
2000 and his medical degree from the University of California, San Diego in 2007. He completed his
surgical internship at Stanford University Hospital and Clinics in 2008 before serving as a Resident in the
hospital’s department of orthopedic surgery until 2012. Following his residency at Stanford, Dr. Abrams
completed a fellowship in orthopedic sports medicine at Rush University Medical Center in 2013. He is
board certified by the American Board of Orthopedic Surgery and holds medical licenses in California and
Illinois. He served as a clinical instructor at Rush University Medical Center from 2012 to 2013. He has
been an attending physician at the Veterans Administration Hospital in Palo Alto, California and an
assistant professor at Stanford University School of Medicine since 2013. Since 2016, Dr. Abrams has
served as director of the Lacon Sports Medicine Clinic at Stanford. (Ex. B, pp. 1-8.)
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individuals previously immunized or exposed to the same antigens (vaccine) results in
the development of chronic pain,” possibly related to “acute and chronic inflammation,
as a result of a memory response to the vaccine within the shoulder bursa.” (Ex. 27, p.
4) (citing Atanasoff et al., supra, at Ex. 31).) Dr. Axelrod writes that in petitioner’s case,
he had suffered shoulder pain that resulted in a left shoulder replacement in 2010, and
that petitioner did not report any shoulder pain at a rheumatologist visit on February 6,
2017. (Ex. 27, pp. 4-5.) Dr. Axelrod suggests that petitioner did not experience
subsequent shoulder pain until after his vaccination on February 21, 2017, was
previously vaccinated for Hepatitis B on three occasions, experienced pain immediately
following his vaccination which was confined to his left shoulder, and had limited range
of motion consistent with rotator cuff impingement that might be seen “with a local
immune-mediated inflammatory musculoskeletal shoulder injury.” (Id. at 5.) Dr. Axelrod
further notes that petitioner received a CT scan of his shoulder on May 8, 2018, which
revealed irregularities that were “likely an old healed fracture.” (Id.) Based on
petitioner’s presentation and course, Dr. Axelrod concludes that petitioner meets the
characteristics for a SIRVA as described in the Atanasoff study. (Id.) (citing Atanasoff et
al., supra, at Ex. 31.)
Dr. Axelrod also opines that petitioner’s injury additionally meets the criteria for
an environmentally associated autoimmune disease (“EAAD”) put forth in a study by
Miller et al. (see Frederick W. Miller et al., Criteria for Environmentally Associated
Autoimmune Diseases, 39 J. AUTOIMMUN. 253 (2012) (Ex. 47).) This criteria is met when
there is a temporal association between the injury and trigger, lack of an alternative
cause, biologic plausibility, analogy, and/or specificity. (Id.) (citing Miller et al., supra, at
Ex. 47.) Dr. Axelrod explains that studies have found that a secondary immune
response peaks between two to three days post-exposure to an antigen. (Id. at 6.)
Petitioner noted pain within four days of his vaccination, which Dr. Axelrod argues is
consistent with a “secondary (memory) adaptive immune response to his Hepatitis B
vaccination of February 21, 2017,” thus satisfying the first criteria for an EAAD. (Id.)
(citing Miller et al., supra, at Ex. 47.)
In fact, Dr. Axelrod suggests that the Atanasoff study shows SIRVA to be an
EAAD itself, noting that “the rapid onset of pain following vaccination results from a
robust and prolonged immune response within an already sensitized shoulder.”6 (Ex.
6 A study by Dumonde and Glynn showed that “immunization with human fibrin resulted in synovial
inflammation, including cells that result in antibody production.” (Ex. 27, p. 8) (citing Dudley Cohen
Dumonde & L.E. Glynn, The production of arthritis in rabbits by an immunological reaction to fibrin, 43
BRIT. J. EXPERIMENTAL PATHOLOGY 373 (1962) (Ex. 48).) Further, in a rabbit model conducted by Cooke
and Jasin, intra-articular injections of antigen resulted in synovial inflammation, “including lymphocytes
and plasma cells . . . . [showing] that antibodies produced within the synovium were specific for the
immunizing antigen.” (T. Derek Cooke & Hugo E. Jasin, The pathogenesis of chronic inflammation in
experimental antigen-induced arthritis. I. The role of antigen on the local immune response, 15(4)
ARTHRITIS & RHEUMATISM 327 (1972) (Ex. 49).) Finally, in a study by Cooke, Hurd, Ziff, and Jasin,
intraarticular injections of antigens were observed to directly stimulate specific antibodies in the synovial
tissue that participated “in the formation of complement-binding antigen-antibody complexes that
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27, p. 8) (citing Atanasoff et al., supra, at Ex. 31.) With respect to the
analogy/specificity criterion for EEAD, Dr. Axelrod cites two case reports of three
subjects all of whom developed shoulder pain after immunizations into the deltoid
muscles; however, none of these cases involved the hepatitis B vaccine. (citing Marko
Bodor & Enoch Montalvo, Vaccination-related shoulder dysfunction, 25 VACCINE 565
(2007) (Ex. 45).)
Dr. Axelrod proposes that molecular mimicry is the mechanism responsible for
petitioner’s autoimmune reaction, citing a study by Cusick et al. which suggested that
because infectious agents are the principal triggers for autoimmune disease, and
because the “vast majority of individuals exposed to infectious agents do not develop
autoimmune disease, it is likely that those who do . . . following exposure to an
infectious agent, have a defective immune system that . . . [reacts] to self-antigens or
similar antigens, to which they would otherwise be tolerant.” (Id.) (citing Matthew F.
Cusick et al., Molecular Mimicry as a Mechanism of Autoimmune Disease, 42(1) CLIN.
REV. ALLERGY & IMMUNOL. 102 (2012) (Ex. 41).) Dr. Axelrod identifies seven different
synovial and cartilage antigens that could be targets for an immune response causing
synovitis, all of which he says, “have structures that are homologous or antigenically
similar to amino acid sequences of the Hepatitis B Surface antigen . . . .”7 (Ex. 27 at 9.)
Dr. Axelrod also purports to rule-out alternative causes of petitioner’s shoulder
pain suggested by his medical history. Dr. Axelrod explains that evidence of petitioner’s
glenoid fracture was seen on MRI as early as August 24, 2006, and that an x-ray
contribute to the production and maintenance of synovial inflammation. (T. Derek Cooke et al., The
pathogenesis of chronic inflammation in experimental antigen-induced arthritis. II. Preferential localization
of antigen-antibody complexes to collagenous tissues, 135 J. EXPERIMENTAL MED. 323 (1972) (Ex. 50).)
Dr. Axelrod concedes that the Hepatitis B surface antigen is present in small amounts in the vaccine, but
argues that it is still enough to generate an immune response. (Ex. 27, p. 8.)
7 These antigens include: CILP protein, collagen alpha-1, coagulation factor XIIIB, glucose-6-phosphate
isomerase chains, PADI4 protein, Myeloperoxidase, and metalloproteinase. (Id.) (citing Jun-Ichiro
Tsuruha et al., Implication of cartilage intermediate layer protein in cartilage destruction in subsets of
patients with osteoarthritis and rheumatoid arthritis, 44 ARTHRITIS & RHEUMATOLOGY 838 (2001) (Ex. 54);
Patrik Önnerfjord et al., Quantitative proteomic analysis of eight cartilaginous tissues reveals
characteristic differences as well as similarities between subgroups, 287 J. BIOLOGICAL CHEMISTRY 18913
(2012) (EX. 55); J. Brice Weinberg et al., Extravascular fibrin formation and dissolution in synovial tissue
of patients with osteoarthritis and rheumatoid arthritis, 34 ARTHRITIS & RHEUMATOLOGY 996 (1991) (Ex.
56); Keiichi Iwanami et al., Arthritogenic T cell epitope in glucose-6-phosphate isomerase-induced
arthritis, 10 ARTHRITIS RES. & THERAPY R130 (2008) (Ex. 28); Xiaotian Chang et al., The expression of
PADI4 in synovium of rheumatoid arthritis, 29 RHEUMATOL. INT’L 1411 (2009) (Ex. 57); Sanna Turunen et
al., Rheumatoid arthritis antigens homocitrulline and citrulline are generated by local myeloperoxidase
and peptidyl arginine deiminases 2, 3 and 4 in rheumatoid nodule and synovial tissue, 18 ARTHRITIS RES.
& THERAPY 239 (2016) (Ex. 58); Shinichiro Nishimi et al., A Disintegrin and Metalloprotease 15 is
Expressed on Rheumatoid Arthritis Synovial Tissue Endothelial Cells and may Mediate Angiogenesis, 8
CELLS 32 (2019) (Ex. 29).) Dr. Axelrod explains that in the case of an immune response to amino acid
sequences of the shoulder synovium, the response and inflammation may perpetuate “long after the
vaccine disappears” thus explaining petitioner’s long-standing injury.
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following onset of petitioner’s pain did not show any evidence of a glenoid fracture nor a
loose glenoid component, and therefore, neither condition would explain petitioner’s
shoulder pain. (Id.) Regarding petitioner’s AS, Dr. Axelrod writes that petitioner was
seen by his rheumatologist around the time his pain began. During this period,
petitioner’s rheumatologist did not document any active inflammatory disease, and
continued to administer the usual dose of Remicade which suggests that petitioner’s AS
was inactive and thus, not the cause of his shoulder pain. (Id.) Finally, Dr. Axelrod
notes that petitioner’s pain was at the lateral aspects of his left shoulder, which, if
caused by disc degeneration, would be at the C3 and C4 level of the spine. (Ex. 27, p.
7.) However, Dr. Axelrod explains that no abnormalities were observed at the C3 or C4
level on petitioner’s July 10, 2017 MRI, and therefore, it is unlikely that his shoulder pain
was caused by a degenerative of displaced disc. (Id.)
Based on the preceding analysis, Dr. Axelrod concludes that petitioner’s injury
was ultimately caused by his February 21, 2017 hepatitis B vaccination.
b. Dr. Abrams’ Initial Report
Dr. Abrams indicates that petitioner’s case fails to meet the criteria for a SIRVA.
(Ex. A, p. 3.) Dr. Abrams opines that petitioner did not meet the first, second, or fourth
requirement because petitioner has a history of shoulder dysfunction predating his
vaccination, onset was outside the typical 48-hour timeframe, and petitioner’s history of
AS and/or severe cervical spine pathology would explain petitioner’s symptoms. (Id.)
Dr. Abrams notes that petitioner’s history of shoulder dysfunction was severe
enough that he received a total shoulder arthroplasty in February of 2010. (Id.) Further,
although petitioner’s pain did improve following his shoulder replacement, Dr. Abrams
notes that petitioner continued to report episodic shoulder pain up to the date of his
vaccination. (Id.) Specifically, Dr. Abrams cites reports of shoulder pain in February of
2012, June of 2014, several reports between March of 2016 and February of 2017, and
on February 6, 2017, just prior to petitioner’s vaccination. (Id. at 4-5 (citing Ex. 8, pp.
377, 642).)8 Thus, Dr. Abrams opines the first SIRVA criterion, requiring no history of
shoulder dysfunction, is not met in this case.
8 When petitioner initially filed this petition, over 800 pages of medical records from multiple medical
providers were filed collectively as Exhibit 8. During the initial status conference, the parties discussed
the need to have petitioner refile these medical records with each medical provider’s records being
separated and given an individual sequential exhibit designation. Petitioner was instructed to begin with
Exhibit 8 on the assumption that the original Exhibit 8 would be struck. (ECF No. 9.) Petitioner then filed
Exhibits 8-19 at ECF No. 10 in response to this instruction and included fourteen pages of record from Dr.
Bishop as Exhibit 8 (ECF No. 10-1); however, the original Exhibit 8 at ECF No. 1-8 was never struck. In
completing his recitation of the records, Dr. Abrams appears to have relied upon the medical records as
they were originally filed collectively as Exhibit 8 rather than the later re-filed medical records separately
marked as Exhibits 8-19. Accordingly, Dr. Abrams’s citations to Exhibit 8 refer to the documents at ECF
No. 1-8. However, apart from direct references to citations within Dr. Abrams’s reports, all references to
Exhibit 8 within this decision refer to Dr. Bishop’s records as filed at ECF No. 10-1.
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Regarding the second criterion, Dr. Abrams notes that petitioner’s own e-mail on
February 26, 2017 states that he developed significant shoulder pain “four days post
immunization . . . .” (Ex. A, p. 5.) (See Ex. 6, p. 7.) Dr. Abrams opines that not only is
such a presentation inconsistent with the SIRVA Table Injury requirements, but also
inconsistent with much of the literature on SIRVA. (Ex. A, p. 5.) He cites nine different
case reports/ studies which all reported onset of shoulder pain within, at most, 48 hours
of vaccination. (Id. at 5-6.) (citing Gail B. Cross et al., Don’t aim too high: Avoiding
shoulder injury related to vaccine administration, 45(5) AM. FAM. PHYSICIAN 303 (2016)
(Ex. A, Tab 2)).)
Regarding the fourth criterion, Dr. Abrams discusses several of petitioner’s
conditions which he views as relevant. He explains that AS is a systemic inflammatory
disease which leads to arthritis, primarily in the spine, but may affect other joints
including the shoulder. (Ex. A, p. 6) (citing R. J. H. Emery et al., The Shoulder Girdle in
Ankylosing Spondylitis, 73 J. OF BONE & JOINT SURGERY AM. 1526 (1991) (Ex. A, Tab
10); Gabriel Horta-Baas & Francisco Javier Jimenez-Balderas, Radiographic Findings of
Shoulder Involvement in Ankylosing Spondylitis, 12(5) REUMATOL. CLIN. 296 (2016) (Ex.
A, Tab 11)).) Dr. Abrams notes that “over 60%” of AS patients demonstrated enthesitis
at the rotator cuff and showed a significantly higher rotator cuff tendon pathology (42%
in AS patients) compared to the control group (15%). (Ex. A, p. 6) (citing Sanae Ali Ou
Alla et al., Ultrasound features of shoulder involvement in patients with ankylosing
spondylitis: a case-control study, 14 BMC MUSCULOSKELETAL DISORDERS 272 (2013) (Ex.
A, Tab 13).) Dr. Abrams explains that the presence of enthesitis in AS patients is
relevant because although petitioner’s shoulder replacement addressed pain associated
with cartilage loss in his shoulder, entheses would remain even after the shoulder
replacement and would likely explain petitioner’s reports of episodic pain.
Dr. Abrams also notes that even in the case of successful shoulder
replacements, complications and continued pain are not uncommon, specifically at long-
term follow up appointments. The most common reason for shoulder pain following
replacements is glenoid loosening which was observed on petitioner’s CT scan at a
December 2018 visit to Dr. Kercher along with some osteolysis around the cement
mantle of the glenoid, and a high riding humeral head suggesting a rotator cuff rupture.
(Ex. A, pp. 6-7 (citing Ex. 22, pp. 8, 10).) Dr. Abrams concludes that these findings
reasonably explain petitioner’s subsequent shoulder pain.9 Further, petitioner’s CT
9 He further clarifies that while petitioner’s expert suggests that a September 2017 x-ray showed no signs
of shoulder degeneration, this is unsurprising because CT scans reveal “a significantly more detailed view
of [bone] structures,” and that x-rays often do not “visualize subtle fractures or other pathologies of the
glenoid following shoulder arthroplasty.” (Ex. A, p. 7) (citing Thomas Gregory et al., A CT scan protocol
for the detection of radiographic loosening of the glenoid component after total shoulder arthroplasty,
85(1) ACTA ORTHOPAEDICA 91 (2014) (Ex. A, Tab 20); Thomas Gregory et al., Glenoid loosening after total
shoulder arthroplasty: an in vitro CT-scan study, 27 J. ORTHOPEDIC RES. 1589 (2009) (Ex. A, Tab 21);
Edward H. Yian et al., Radiographic and Computed Tomography Analysis of Cemented Pegged
Polyethylene Glenoid Components in Total Shoulder Replacement, 87 J. BONE AND JOINT SURG. 1928
(2005) (Ex. A, Tab 22).))
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scan revealed signs of a glenoid fracture that is “almost certainly chronic and long
standing and [present] at the time of vaccination,” and because glenoid pathology “is the
most common cause of pain following shoulder replacement,” Dr. Abrams concludes
that petitioner’s history of AS and glenoid pathology is the likely cause of his shoulder
pain. (Id.)
Dr. Abrams also addresses petitioner’s cervical spine degeneration and how that
may explain his shoulder pain. (Id.) He begins this discussion explaining that petitioner
“has significant cervical spine disease,” which can cause dysfunction and pain in the
upper extremities. (Id.) He notes that weeks prior to petitioner’s vaccination, he
reported “3rd and 5th numbness” to his rheumatologist who suspected a cervical
radiculopathy. (Id. (citing Ex. 8, p. 375).) As a result of this, petitioner underwent a
cervical spine MRI which revealed “multilevel severe degenerative disc disease.” (Ex.
A, pp. 7-8 (citing Ex. 8, p. 1).) Dr. Abrams opines that petitioner’s expert is incorrect to
suggest that “there was no abnormal positioned disc material at C3-4,” because the
dermatomal diagram used to interpret the MRI results was referring to the exiting nerve
root and not the spinal level. (Ex. A, p. 8.) In reality, petitioner’s MRI showed “indenting
of the anterior thecal sac . . . causing moderate narrowing of the bilateral neural
foramina and lateral recess with possible abutment of the bilateral exiting C5 nerve
roots.” (Id. (citing Ex. 8, p. 2).) Dr. Abrams explains that the C5 nerve root “is directly at
the lateral shoulder” and any aggravation of this nerve root would certainly cause pain
consistent with petitioner’s pain. (Ex. A, p. 8.) Further, Dr. Abrams notes that petitioner
also reported neck pain that radiated to his bilateral upper extremities which is
consistent with cervical radiculopathy. (Id.)
Dr. Abrams contends that based on Dr. Bishop’s July 27, 2017 exam, petitioner
also likely suffered from cervical spondylosis, otherwise known as cervical spine
arthritis, based on the MRI findings of disc degeneration at the C5/C6 level. (Id.) (citing
Ex. 8, p. 12.) Dr. Abrams supports this contention noting that cervical spondylosis is a
“well documented cause of neck pain,” that is often associated with neck, shoulder,
deltoid, and lateral arm pain much like petitioner reported. (Ex. A, pp. 8-9 (citing Ginger
Evans, Identifying and treating the causes of neck pain, 98 MED. CLIN. N. AM. 645 (2014)
(Ex. A, Tab 25); Nikolai Bogduk, The anatomy and pathophysiology of neck pain, 22
PHYS. MED. REHAB. CLIN. N. AM. 367 (2011) (Ex. A, Tab 26); Grant Cooper et al.,
Cervical Zygapophysical Joint Pain Maps, 8 AM. ACAD. PAIN MED. 344 (2007) (Ex. A, Tab
27); Nalini Sehgal et al., Systematic Review Of Diagnostic Utility Of Facet
(Zygapophysial) Joint Injections In Chronic Spinal Pain: An Update, 10 PAIN PHYS. J.
213 (2007) (Ex. A, Tab 28)).)
Finally, Dr. Abrams opines that petitioner had previously been diagnosed with
limb-girdle muscular dystrophy which could also explain his shoulder pain. He notes
that these diseases “are a group of disorders with wide genetic and clinical
heterogeneity, characterized by muscle pain as well as weakness of the shoulder girdle
musculature,” and that this diagnosis would also be consistent with petitioner’s pain.
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(Ex. A, p. 9 (citing Ex. 8, p. 309; Veronique Bolduc et al., Recessive Mutations in the
Putative Calcium-Activated Chloride Channel Anoctamin 5 Cause Proximal LGMD2L
and Distal MMD3 Muscular Dystrophies, 86 AM. J. HUM. GENETICS 213 (2010) (Ex. A,
Tab 29); Debbie Hicks et al., A founder mutation in Anoctamin 5 is a major cause of
limb girdle muscular dystrophy, 134 BRAIN 171 (2011) (Ex. A, Tab 30)).)
Dr. Abrams concludes his initial report by reiterating that petitioner failed to meet
the criteria for a SIRVA injury because he had complaints of shoulder pain preceding his
vaccination, did not experience onset of pain within 48 hours, and suffered from several
different conditions that would explain his symptoms.
c. Dr. Axelrod’s First Supplemental Report
Regarding the suggestion that petitioner had a history of episodic shoulder pain
after his February 2010 shoulder replacement, Dr Axelrod recounts 15 different medical
records from 2011 to 2017 where petitioner did not report left shoulder pain, all included
in an earlier section of this decision. (see Sec. II.) Dr. Axelrod also opines that the four-
day post-vaccination onset petitioner experienced is medically appropriate. (Ex. 30, p.
3.) He notes that 8% of the subjects in the Atanasoff study reported pain within four
days.10 (Id. (citing Atanasoff et al., supra, at Ex. 31).) Dr. Axelrod also contends four
days is consistent with a secondary adaptive immune response to the hepatitis B
vaccine as described by Miao et al. (Ex. 30, p. 3 (citing Hongyu Miao et al., Quantifying
the Early Immune Response and Adaptive Immune Response Kinetics in Mice Infected
with Influenza A Virus, 84(13) J. OF VIROLOGY 6687 (2010) (Ex. 38)).)
Dr. Axelrod indicates that AS is an inflammatory arthropathy with gradual onset in
the teens and twenties, (Ex. 30, p. 3 (citing Marc C. Hochberg et al., Inflammatory back
pain and The shoulder, in RHEUMATOLOGY (7th ed. 2019) (Ex. 33)), and that the medical
records in this case do not address the onset of petitioner’s AS (Ex. 30, pp. 3-4). Dr.
Axelrod cites two medical imaging records from 2006 that showed structural, but not
inflammatory disease, in petitioner’s left shoulder. (Id. at 4.) Dr. Axelrod notes that in
September of 2009, petitioner was assessed with structural arthropathy in his left
shoulder and that in 2010 he was assessed with osteoarthritis in his left shoulder,
neither of which are inflammatory conditions. (Id.) Further, Dr. Axelrod writes,
petitioner’s cervical spine MRI on July 10, 2017, was consistent with structural and not
inflammatory disease. (Id.) Although petitioner was diagnosed with AS, Dr. Axelrod
concludes that the lack of inflammatory findings in his left shoulder suggests that
petitioner’s AS was well controlled thanks to his medications and not a credible cause of
his shoulder pain. (Id.)
Dr. Axelrod explains that petitioner showed mild degenerative reduction at his C5
and C6 spinal cord, importantly, with possible impingement of the bilateral exiting C5
10 He also suggests, however, that while petitioner reported pain to his physician within 4 days, he also
described the pain as beginning on the day of his vaccination, consistent with 54% of the subjects in the
Atanasoff study. (Id.)
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and C6 nerve roots. (Id.) He concedes that the possible impingement of the bilateral
exiting C6 nerve roots could contribute to petitioner’s shoulder pain. (Ex. 30, p. 5.)
However, due to the onset of petitioner’s shoulder pain immediately following his
injection and the lack of any trauma that would aggravate petitioner’s degenerative disc
disease, Dr. Axelrod concludes that the more likely cause for petitioner’s shoulder pain
was his vaccination. (Id. at 6.)
Finally, Dr. Axelrod notes that petitioner had elevated creatine kinase, an
inconclusive muscle biopsy, and genetic testing that suggests a predisposition for limb-
girdle muscular dystrophy, but stresses that petitioner did not suffer muscle weakness.
According to Dr. Axelrod, these test results are not enough to support a clinical
diagnosis of active limb-girdle muscular dystrophy, and therefore cannot account for
petitioner’s shoulder pain. Thus, Dr. Axelrod concludes that the most likely cause of
petitioner’s shoulder injury was his February 21, 2017 hepatitis B vaccination. (Id.)
d. Dr. Abrams’s First Supplemental Report
Regarding petitioner’s history of shoulder pain, Dr. Abrams stresses that
petitioner had a rheumatology evaluation just two weeks prior to vaccination that
demonstrated mild pain with active range of motion and that petitioner’s pain could likely
be explained by the decrement in function and increased pain that is often associated
with wear and tear on shoulder replacements. (Ex. C, p. 1.) Dr. Abrams also writes that
petitioner showed “decreased (range of motion) to left shoulder abduction to 170
degrees and [stable],” and that petitioner’s “[a]ctive left shoulder range of motion mildly
reproduces pain at region.” (Id. (citing Ex. 8, p. 377).) Thus, Dr. Abrams concludes, by
Dr. Axelrod’s own admission, petitioner experienced shoulder pain prior to his
vaccination. (Ex. C, p. 1.)
Dr. Abrams also notes that while “[o]ne may argue that the quality and intensity
of shoulder pain was different before and after the injection, as the pre-existing shoulder
pain reported by the petitioner was mild,” it is “not uncommon for patients with
conditions similar to the petitioner to experience acute exacerbations and increases in
their pain levels, especially at the time frames present in this case.” (Id. at 1-2.) Dr.
Abrams stresses that this concept is “particularly relevant” considering petitioner’s
imaging results which revealed “osteolysis around the cement mantle (of the glenoid) as
well as a high riding humeral head suggestive of rotator cuff rupture.” (Id. at 2 (citing
Ex. 22, p. 8 (internal quotations omitted)).) Further, Dr. Abrams notes that petitioner’s
records reveal a “subacute to chronic appearing glenoid fracture involving the articular
surface and glenoid neck.” (Ex. C, p. 2 (citing Ex. 22, p. 10).) Dr. Abrams opines that
all of these conditions were present prior to petitioner’s vaccination and “would be
expected to cause shoulder pain,” consistent with what was documented at petitioner’s
February 2017 rheumatologist exam. (Ex. C, p. 2.)
With regard to petitioner’s theory of causation, Dr. Abrams concludes that
petitioner’s symptoms were caused by an innate immune response, and not the
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adaptive response, and thus, the Miao study does not apply to petitioner’s injury. (Ex.
C, p. 3.) Dr. Abrams notes that antibodies take many days to weeks to be produced by
the adaptive immune system, and that the innate immune system provides immediate
protection and results in things such as redness, pain, and swelling after an injury. Dr.
Abrams notes that the immune response that the Miao study describes as occurring
after five days is an adaptive, and not innate response, while SIRVA is triggered by an
innate response, explaining the relatively quick period of onset.
e. Dr. Axelrod’s Second Supplemental Report
In response to Dr. Abrams’ assertion that petitioner’s onset is inconsistent with
that of an adaptive immune response, Dr. Axelrod concedes that immediate onset of
pain as described in SIRVA is too quick to be caused by an adaptive immune response.
Worsening pain over a period of four days following the trigger, however, is consistent
with an adaptive immune response, which is what petitioner experienced. (Ex. 36, p. 2.)
Thus, Dr. Axelrod concludes on this point that even if Dr. Abrams is correct that onset of
petitioner’s pain occurred on the fourth day following his vaccination, this would still be
consistent with an adaptive immune response as described in Miao study. (Id. (citing
Miao et al., supra, at Ex. 38).)
f. Dr. Abrams’ Second Supplemental Report
Dr. Abrams clarifies his earlier discussion regarding the Miao article and the fact
that SIRVA is an innate, and not adaptive immune response. (Ex. D, p. 2.) He writes
that an adaptive immune response would not be confined to a single shoulder, but
instead spread throughout the body. Further, he writes, if SIRVA was caused by an
adaptive immune response, there would be evidence of the mechanism and timing in
the literature because patients would be primed for an adaptive immune response each
time they were vaccinated. (Id.) Instead, the literature details an immediate immune
response caused by antigenic material being injected into the subacromial space. (Id.)
In contrast, Dr. Abrams opines that petitioner’s “abrupt” onset of shoulder pain
after his vaccination “matches the clinical presentation of many patients with pain and
decreased function many years after shoulder replacement.” (Ex. D, p. 1.) Dr. Abrams
explains that he has treated many patients with clinical situations that are similar to
petitioner’s and that “[i]n a great majority . . . they state that they were doing well for
many years and then suddenly had a worsening in pain levels and/or shoulder function.”
(Id.) Dr. Abrams opines that there were numerous reasons for petitioner’s shoulder pain
noting that the radiographic findings described in his earlier reports, the pre-existing
pain reported by petitioner to his rheumatologist prior to his vaccination, and likely
loosening or tearing of the glenoid component or rotator cuff would explain the abrupt
pain that petitioner experienced. (Id.)
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g. Dr. Axelrod’s Final Supplemental Report
With regard to the suggestion that an abrupt onset of pain is more consistent with
sequelae from petitioner’s shoulder replacement, Dr. Axelrod opines that the lack of
evidence documenting any sort of issues with petitioner’s shoulder replacement, and
the fact that petitioner never reported any pain during this period, Dr. Axelrod argues
that petitioner’s pain is much more likely caused by a SIRVA.11 (Ex. 43, p. 3.) Dr.
Axelrod explains that a secondary adaptive immune response may occur within four
days, citing a study by Miller et. al., which found that the maximum antibody response to
repeat tetanus toxoid injections occurred by 4 to 6 days following booster vaccination.
(Ex. 43, p. 4 (citing John J. Miller, et al., The Speed of the Secondary Immune
Response to Tetanus Toxoid with a Review of War Reports and Observations on
Simultaneous Injection of Toxoid and Antitoxin, 3 PEDIATRICS 64 (1949) (Ex. 63)).) Thus,
Dr. Axelrod concludes, even if petitioner did not experience immediate pain, the pain
which progressed over the four-day period following his vaccination is nonetheless
consistent with a secondary adaptive immune response. (Ex. 43, p. 4.)
Dr. Axelrod disagrees that a systemic immune reaction would affect petitioner’s
entire body and not just his shoulder. (Id. at 5.) He notes that a review article by
Sparks found that rheumatoid arthritis, a systemic autoimmune disorder, may present
with single joint involvement. (Id. (citing Jeffrey A. Sparks, Rheumatoid Arthritis, 170
ANNALS OF INTERNAL MED. ITC1 (2019) (Ex. 65)).) Further, Dr. Axelrod points out,
Atanasoff et al. suggest that SIRVA “begins by the interaction of an immune response
already primed within the shoulder girdle,” and that injection of a hepatitis B vaccine into
the shoulder girdle would provoke an immune response within the joint. (Ex. 43, p. 5
(citing Atanasoff et al., supra, at Ex. 31).) Thus, he opines, a systemic immune
response “does not preclude the presence of localized symptoms.”12 (Ex. 43, p. 5.)
11 He notes that after petitioner’s shoulder replacement, petitioner showed no signs of shoulder pain until
after receiving his vaccination. (Id.) In fact, Dr. Axelrod points out, petitioner received both an x-ray and
ultrasound of his left shoulder on September 28, 2017 that both showed an intact shoulder replacement,
no fractures, good bone quality, and no signs of osteolysis, high riding humeral head, glenoid fracture,
increased motion or loosening of the glenoid component, increased tearing or inflammation of the rotator
cuff tendons, or increased propagation or stress at the glenoid fracture site. (Id. at 2.)
12 Regarding the contention that it is unlikely that petitioner’s hepatitis B vaccination caused an adaptive
immune response because there are very few cases of the injury and a large number of hepatitis B
vaccinations, Dr. Axelrod opines that there are likely a very few number of individuals who receive a
hepatitis B vaccine administered into their shoulder girdle. (Id.) A study by Rojas et al. found that
autoimmunity “represents an environmental related disorder, mediated by molecular mimicry,” and that
exposure to an antigen may cause an autoimmune disorder only in the genetically predisposed, which
would explain the small number of hepatitis B induced SIRVA cases. (Id.) (citing Manuel Rojas et al.,
Molecular mimicry and autoimmunity, 95 J. OF AUTOIMMUN. 100 (2018) (Ex. 66)).)
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h. Dr. Abrams’ Final Supplemental Report
Dr. Abrams explains that Dr. Axelrod’s reliance on studies that measure adaptive
immune responses to tetanus toxoid injections focused on a systemic reaction as
opposed to a local reaction like petitioner experienced and is therefore inapplicable to
this case. (Ex. E, p. 2.) Further, he notes that Dr. Axelrod’s reliance on the Firestein
article discussing rheumatoid arthritis presenting in a single joint is misguided because it
“has nothing to do with a local insult such as a vaccination.” (Id.) Because “the majority
of the literature regarding the mechanism of SIRVA focuses on a local inflammatory
response incited by antigenic material,” from the vaccine injected into the subacromial
space, SIRVA will necessarily occur within 48 hours or less because it will trigger an
innate immune response as opposed to an adaptive one. (Id.)
Dr. Abrams stresses that the important factor to consider in petitioner’s case is
that short term medical imaging results of a shoulder replacement are expected to be
normal at first and deteriorate over time. (Ex. E, p. 1.) Further, the main long-term
issue involved with shoulder replacement deterioration is loosening of the glenoid,
which was exhibited on petitioner’s imaging. (Id.) Dr. Abrams stresses that the
ultrasound and x-ray results provide little utility, if any, in evaluating petitioner’s shoulder
deterioration because they are not sensitive enough to reveal the pathologies involved
in these cases. (Id.) Further, petitioner’s September 2017 x-ray does not rule out mild
to moderate osteolysis nor loosening of the glenoid. (Id.) In addition to loosening of the
glenoid, petitioner’s May 2018 CT scan revealed osteolysis around the cement mantle,
both of these conditions take years to develop, and were therefore almost certainly
present prior to petitioner’s vaccination, and the more likely explanation for his pain. (Id.
at 2.)
V. Party Contentions
a. Petitioner’s Argument
Neither the petition nor petitioner’s motion for a ruling on the record is explicit in
indicating whether petitioner is seeking to prove a Table Injury or a cause-in-fact claim.
(ECF Nos. 1, 52.) However, petitioner does assert in his motion, consistent with the
assertion of a Table Injury, that onset of his shoulder pain occurred “within the normal
48 hours.” (ECF No. 52, p. 2.) Petitioner’s motion focuses primarily on two issues,
timing of onset and whether his medical history can otherwise explain his post-
vaccination shoulder pain.
Petitioner stresses that his April 26, 2017 e-mail to Dr. Lenhard shows that onset
of his shoulder pain occurred as soon as he received his hepatitis B booster shot.
Petitioner distinguishes his earlier e-mail from February 26, 2017, from the April 26 e-
mail by noting that on February 26, he wrote that his pain was significant by the fourth
day post-vaccination, while the April 26 e-mail specifically noted onset immediately
following vaccination. (ECF No. 52, p. 2.) According to petitioner, the earlier e-mail
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described the progression of his pain, while the later one described the onset. (Id.)
Petitioner argues that this report of onset is consistent with 54% of the subjects in the
Atanasoff study, and that even if I find that onset occurred four days after vaccination, it
would still be consistent with 8% of the Atanasoff subjects. (Id.) Petitioner also argues
that a four-day onset of shoulder pain would be consistent with a secondary adaptive
immune response as described in the Miao study. (Id. (citing Miao et al., supra, at Ex.
38).)
Petitioner further argues that the “[e]vidence shows no prior injury, or alternate
causation of the shoulder pain . . . .” (ECF No. 52, p. 4.) Petitioner stresses that while
he suffered chronic shoulder pain long before his vaccination, that specific instance of
pain resolved following his shoulder replacement in 2010. (Id.) He relies primarily on
several records from September 9, 2014, through February 20, 2017, a day before his
vaccination, where petitioner was examined, but did not report any left shoulder pain.
(Id. at 5-6) (see Ex. 17, p. 125; Ex. 18, pp. 31-36, 43, 47, 65, 69, 98, 101, 112, 114, 126,
129, 135, 138, 144, 146,152, 154, 162, 164.) Petitioner argues that in the years
following his shoulder replacement and leading up to his vaccination, petitioner never
reported significant left shoulder pain and only did so following his February 21, 2017
hepatitis B vaccination. (ECF No. 52, p. 7.)
Petitioner also argues that his AS was under control prior to and after his
vaccination. First, he notes that AS is an inflammatory, and not a structural condition.
(ECF No. 52, p. 7.) Next, petitioner highlights several pre-vaccination records which
involve medical imaging that showed no inflammatory process at work, or diagnoses of
structural shoulder degeneration from orthopedists. (Id. at 7-8) (see Ex. 5, p. 51; Ex.
19, pp. 17-18, 128-29, 134.) Petitioner also points out that on July 10, 2017, he
received a cervical spine MRI almost five months after his vaccination. (ECF No. 52, p.
8.) The MRI revealed some disc degeneration in addition to ligamentum flavum
thickening which petitioner argues is consistent with structural disease such as
osteoarthritis, but not inflammatory disease like AS. (Id.) Petitioner argues that this
finding in particular suggests that his AS was either nonexistent or controlled. (Id.)
Petitioner contends that his July 10, 2017 cervical spine MRI results prove that
his disc degeneration and spinal arthritis were not the cause of his shoulder pain. (Id.)
Petitioner highlights the fact that the results only showed possible abutment and
impingement of the relevant nerve roots, and that the possibility was greater on the right
side than on the left side. (Id.) Thus, petitioner argues, because he did not experience
any nerve pain on his right side, where he was more likely to experience it, it is unlikely
that his spinal condition was causing pain on his left side, where he was less likely to
experience it. (Id. at 9.) However, petitioner does note that there was possible
impingement at the C6 nerve root exit which could possibly contribute to left shoulder
pain. (ECF No. 52, p. 9.)
Petitioner also argues that although his genetic testing showed a susceptibility to
limb-girdle muscular dystrophy, he never showed any signs of weakness that would be
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consistent with such a diagnosis, and as such, it is unlikely that limb-girdle muscular
dystrophy was the cause of his shoulder pain. (Id. at 11.) Additionally, he contends the
glenoid loosening/fracture found on his May 8, 2018 CT scan could not be the cause of
his shoulder pain because on September 28, 2017, seven months after his vaccination,
an X-ray revealed no evidence of glenoid fracture or loosening. Thus, petitioner was
already experiencing left shoulder pain before his glenoid fracture/loosening. (Id. at 11-
12.)
b. Respondent’s Argument
Respondent argues that petitioner is not entitled to compensation because he
has neither met the elements for a Table SIRVA nor presented preponderant evidence
showing that his injury was caused-in-fact by his hepatitis B vaccination. (ECF No. 54,
pp. 25, 35.) Respondent argues that petitioner’s left shoulder pain goes as far back as
2006 and was caused by his AS. (Id. at 26.) He cites petitioner’s various visits to
rheumatologists who diagnosed petitioner with AS, and ultimately recommended a full
shoulder replacement. (Id. at 26-27.) Respondent stresses that the most important
records, however, arise after petitioner’s shoulder replacement where he reported
shoulder pain one year and two and a half years after his operation and as recently as
two weeks prior to his vaccination. (Id. at 27.)
Respondent also points to petitioner’s AS diagnosis, glenoid fracture and
loosening, cervical spine pathology, and limb-girdle muscular dystrophy as alternative
causes of his shoulder pain and as evidence his condition was not limited to his left
shoulder. Respondent explains that petitioner’s limb-girdle muscular dystrophy is a
genetic disorder characterized by muscle pain and weakness in the shoulder girdle,
which would also explain his pain. (ECF No. 54, p. 32.) He also argues that AS is a
systemic inflammatory disease that leads to arthritis of the spine and other joints, with
the shoulder being a “well-documented non-axial source of pain in this condition.” (Id.
at 29.) Respondent notes that when petitioner underwent his shoulder replacement, his
entheses, or rotator cuff tendon/insertion and deltoid insertion, remained in place
because they are critical for proper shoulder function. (Id.) However, respondent
continues, a main finding in AS cases is enthesitis, or inflammation of the entheses at
the rotator cuff or deltoid attachment on the acromion. (Id.) Thus, respondent
concludes, it is likely that petitioner’s AS led to enthesitis at his rotator cuff, and caused
his shoulder pain. (ECF No. 54, p. 29.)
Respondent also argues that petitioner showed signs of glenoid loosening, the
most common reason for pain following shoulder replacements which would also
explain his shoulder dysfunction. (Id.) Petitioner’s medical imaging following his
shoulder replacement revealed osteolysis of the glenoid, a high riding humeral head
suggestive of rotator cuff rupture, and subacute to chronic appearing glenoid fracture.
(Id. at 30.) According to respondent’s expert, glenoid loosening occurs at a rate of 67%
in shoulder replacements with an average follow-up date of 74-months post-op. (Id.)
Further, respondent argues, glenoid loosening and fracture take years to develop and
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therefore would be more evident in later imaging results. (Id.) Respondent concludes
then that petitioner did experience glenoid loosening and fracture which is a likely
explanation for his pain. (ECF No. 54, p. 31.)
Additionally, respondent contends that petitioner’s cervical spine pathology could
also explain his left shoulder pain. Respondent notes that as of September 24, 2014,
petitioner was observed to have “narrowing of the left neutral foramen at C5-6, C6-7
and narrowing of the right neural foramen at C4-5 such that impingement on the existing
nerve root[s] [are] suggested.” (Id.) (internal quotations omitted). Respondent also
points to petitioner’s July 7, 2017 MRI which showed “multilevel severe degenerative
disc disease, worse at the C5-6 level.” (Id.) Respondent notes that the C5 nerve root
“is directly at the lateral shoulder, one of the areas of petitioner’s reported pain,” and
that petitioner’s own expert concedes that C5 and C6 nerve root impingement could
explain petitioner’s pain. (Id. at 32.) Respondent also explains that petitioner showed
signs of cervical spine arthritis which is known to cause neck, upper extremity, and
shoulder pain. (Id.) Thus, respondent concludes, petitioner’s cervical spine disease is
also a likely explanation of his shoulder injury. (Id.)
With regard to the timing of onset, respondent contends that even if I were to
disregard petitioner’s pre-existing shoulder pain, pain reported in other areas, and
alternative causes, petitioner nonetheless failed to show that his pain began within 48-
hours of his vaccination as required by the Vaccine Injury Table. (Id. at 33.)
Respondent urges reliance on contemporaneous records wherein petitioner stated that
his pain began four days after vaccination. (Id.) Further, respondent notes that
petitioner reported this four-day onset again in an e-mail dated March 7 and March 8,
2017. (Id. at 33-34.)
Based on the foregoing respondent concludes that petitioner fails to satisfy the
elements required for a table SIRVA because he had a history of left shoulder pain
predating his vaccination, reported an onset outside the 48-hour window required by the
vaccine injury table, had pain in areas other than his left shoulder, and suffered from
various conditions that would explain his shoulder dysfunction. (Id.)
VI. Discussion
a. Petitioner has not satisfied the requirements to establish
entitlement for a Table Injury of SIRVA
As stated above, the Vaccine Act’s qualifications and aids to interpretation (QAIs)
explain that a petitioner meets the requirement for a Table SIRVA if they show by
preponderant evidence that: i) there was no history of pain, inflammation or dysfunction
of the affected shoulder that would explain the alleged signs, symptoms, examination
findings, and/or diagnostic studies occurring after vaccination; ii) that the pain occurred
within the specified time-frame (48 hours); iii) that the pain and reduced range of motion
was limited to the shoulder in which the vaccine was administered; and iv) that there is
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no other condition or abnormality that would explain the vaccinee’s symptoms. See 42
CFR §100.3(c)(10). Here, petitioner has failed to meet any of the QAI’s SIRVA criteria
and, therefore, cannot show that he has suffered a Table SIRVA.
i. Petitioner has a long history of pain and dysfunction in his left
shoulder that explains the alleged signs, symptoms,
examination findings, and/or diagnostic studies occurring after
vaccination
Petitioner’s medical records document significant shoulder pain and dysfunction
prior to his vaccination. Although a total shoulder replacement relieved much of
petitioner’s earlier severe shoulder pain, it appears, contrary to petitioner’s contention,
that it never fully resolved. Petitioner initially noted that his pain had improved, but
subsequent physical examination regularly revealed pain and reduced range of motion
up until the weeks preceding his vaccination. (See Ex. 18, pp. 31-36, 46, 65-67, 101,
144-145, 153-55, 164, 177-78; Ex. 19, pp. 11-12, 13-14, 15-16, 70, 78-79, 114-115.)
Although Dr. Axelrod stresses that during the period leading up to vaccination pain was
reported only when evoked by physical exam, petitioner’s pre- and post-vaccination
physical exams evoked similar reports of pain and reduced range of motion, suggesting
the prior history of pain and dysfunction does relate to or explain the post-vaccination
signs and exam findings, even if petitioner subjectively reported increased pain.
(Compare Ex. 18, p. 34 (rheumatologist on physical exam noting pre-vaccination
decreased left shoulder range of motion to 170 degrees and “[a]ctive left shoulder range
of motion mildly reproduces pain at region.”) and Ex. 24, p. 9 (first post-vaccination
orthopedic encounter noting “good motion of the shoulder” and “mild tenderness with
range of motion.”).)
Additionally, petitioner’s CT scan at a December 2018 visit to Dr. Kercher
showed osteolysis around the cement mantle of the glenoid, and a high riding humeral
head suggesting a rotator cuff rupture. (Ex. A, pp. 6-7) (citing Ex. 22, pp. 8, 10.)
Further, petitioner’s CT scan revealed signs of a glenoid fracture that is “almost certainly
chronic and long standing and [present] at the time of vaccination,” and because glenoid
pathology “is the most common cause of pain following shoulder replacement,” Dr.
Abrams concludes that petitioner’s history of AS and glenoid pathology is the likely
cause of his shoulder pain. (Id.) Dr. Abrams concludes that these objective findings
reasonably explain petitioner’s subsequent shoulder pain. Dr. Abrams is also
persuasive in suggesting that petitioner’s earlier ultrasound and x-ray imaging, would
not have been sensitive enough to detect these conditions. (Ex. A, p. 7.)
Dr. Abrams explains that even in the case of successful shoulder replacements,
complications and continued pain are not uncommon, specifically at long-term follow up
appointments. (Ex. A, pp. 6-7.) Dr. Abrams opines that an “abrupt” onset of worsened
shoulder pain during the period following petitioner’s vaccination also “matches the
clinical presentation of many patients with pain and decreased function many years
after shoulder replacement.” (Ex. D, p. 1.) Given his qualifications in orthopedics and
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orthopedic surgery, Dr. Abrams is better suited than Dr. Axelrod to speak to the
specifics of petitioner’s prior shoulder surgery, long term post-surgical prognosis, and
the significance of the specific imaging at issue. On the whole, Dr. Abrams is
persuasive in connecting petitioner’s prior history of shoulder pain and dysfunction to
the signs, symptoms, examination findings, and diagnostic studies, occurring after
vaccination.
ii. Petitioner’s shoulder pain arose outside the 48-hour window for
a Table SIRVA
Although petitioner experienced shoulder pain prior to his vaccination, it is clear
that he also reported pain that he attributed to his vaccination. Respondent argues that
petitioner’s post-vaccination pain did not begin until four days post-vaccination, while
petitioner argues that his pain began immediately after receiving the vaccination.
Contrary to petitioner’s contention, the evidence preponderates in favor of finding that
petitioner’s reported post-vaccination shoulder pain began roughly four days after his
vaccination.
The key pieces of evidence on this point are three e-mails that petitioner sent to
his physicians shortly after receiving his vaccination. The first e-mail was sent on
February 26, 2017. Petitioner states: “Four days post immunization I developed
significant pain in the shoulder that received the shot and today (day 5 post) the pain is
still there and is limiting my left shoulder movements but I believe the pain is less than
yesterday.” (Ex. 6, p. 7.) In the second e-mail, sent nine days later on March 7, 2017,
petitioner states in relevant part, “I am still experiencing pain upon movement of the left
shoulder (replaced 2011) that I believe may have been associated with the Hepatitis B
booster shot I received 4 days before the pain started.” (Ex. 6, p. 6.) In the third e-mail,
sent the following day on March 8, 2017, petitioner wrote: “26, February 2017 (5 days
post IM vaccination) started to have significant pain in left shoulder . . . .” (Id. at 4.)
There are several reasons for giving these notations substantial weight. First,
these are the most contemporaneous accounts of the onset of petitioner’s post-
vaccination shoulder pain. Second, this description is clearly presented in the context of
seeking treatment, meaning petitioner had an incentive to be accurate. Third, as e-mail
communications by petitioner, the description contained in the e-mails represents
petitioner’s own direct account. They are not subject to note-taking error or imprecision
in paraphrasing. Fourth, and relatedly, the three e-mails describe onset fairly
consistently and the description of onset is both precise and unambiguous. Petitioner’s
reinterpretation of the e-mails as indicating progression rather than onset of pain is not
consistent with the explicit statement in the March 7 e-mail that the vaccination occurred
four days “before the pain started.” (Ex. 6, p. 6 (emphasis added).) It was not until April
26, 2017, that petitioner later suggested in a follow up e-mail to Dr. Lenhard that his
shoulder pain began the day of the vaccination. (Ex. 6, p. 1.)
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Even setting aside the e-mail messages, petitioner’s medical records do not
preponderately establish onset within 48-hours of vaccination. Petitioner reported onset
as occurring outside of the 48-hour window during his first orthopedic assessment. He
told Dr. Symbas on March 22, 2017, that his left shoulder pain had lasted for over two
weeks. This would place onset sometime in early March, at least 10 days post
vaccination. (Ex. 24, p. 8.) Petitioner’s later medical records largely fail to detail a
specific date of onset, noting that his pain began sometime in late February, but failing
to specify when it began exactly.13 He reported to Dr. Karas on September 28, 2017,
that his pain began in late February following his Hepatitis vaccination, but did not
specify a date. (Ex. 19, pp. 8-10.) He did the same on a May 17, 2018 visit to Dr.
Grasso, and again on a June 4, 2018 visit to Dr. Kercher. (Ex. 20, p. 23; Ex. 22, p. 7.)
Petitioner’s later medical records generally place onset of his shoulder pain in late
February of 2017, while his more contemporaneous medical records place onset
specifically outside the 48-hour window at four days post-vaccination. Ultimately, the
record as a whole supports a finding that petitioner’s shoulder pain began four days
post-vaccination.
Petitioner states in his affidavit that his vaccination was “more painful” than
others he received in the past, and that “[t]he movement of the needle felt like it was
being inserted and then removed through a rubber band and not a muscle. The onset of
pain . . . was immediate . . . .” (Ex. 4, p. 2.) Petitioner’s wife also submitted an affidavit
indicating that when petitioner returned home from his medical appointment, he was
complaining of shoulder pain. (Ex. 26, p. 1.) Although witness testimony may be offered
to overcome the weight afforded to contemporaneous medical records, such testimony
must be “consistent, clear, cogent, and compelling.” Camery v. Sec’y of Health &
Human Servs., 42 Fed.Cl. 381, 391 (1998) (citing Blutstein v. Sec’y of Health & Human
Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). I
have considered the affidavit testimony available in this case; however, neither affidavit
provides any explanation, let alone a “consistent, clear, cogent, and compelling”
explanation, as to why these later written affidavits recount a history of onset that
contradicts petitioner’s contemporaneous medical records, including e-mails petitioner
himself wrote to his physicians at the time he was seeking treatment. (See Exs. 4, 25,
26.)
iii. Petitioner’s pain was not limited to his left shoulder
Petitioner’s reports of pain ultimately included his back, neck, and bilateral upper
extremities. On June 27, 2017, petitioner reported to Dr. Bishop with a chief complaint
of neck pain. (Ex. 8, pp. 10-12.) He also reported tingling and numbness in his bilateral
upper extremities on February 22, 2018. (Ex. 20, pp. 1-3.) Additionally, respondent’s
expert opines that petitioner’s shoulder pain is related to his pre-existing AS. (Ex. A, pp.
13 Medical records indicating that petitioner attributed his pain to vaccination without specifying onset do
not suffice in this case to imply onset occurring within 48 hours because petitioner’s initial e-mails to his
doctors confirm that he was willing to draw a causal connection between his vaccination and pain
beginning four days post-vaccination. (Ex. 6, pp. 6-7.)
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4, 6-8; Ex. C, p. 4; Ex. E, p. 3.) To the extent the below analysis relative to the fourth
SIRVA criterion suggests that cervical degeneration/radiculopathy and AS also
contributed to petitioner’s condition, there is consequently not preponderant evidence
that the injury at issue was limited to petitioner’s shoulder pursuant to the third SIRVA
criterion.
iv. Petitioner suffered from several other conditions that could
explain his symptoms
Petitioner suffered from several different conditions affecting his shoulder. Based
on petitioner’s medical history, Dr. Abrams is persuasive in contending that these other
conditions are more likely explanations for petitioner’s shoulder pain for all the reasons
detailed above.
First, petitioner suffered from AS even before he underwent his shoulder
operation. (Ex. 19, p. 82.) Dr. Abrams explains that because the entheses can remain
after a shoulder replacement, patients such as petitioner are still at risk for AS related
ethesitis, and because AS is a systemic, chronic disease, it would be a reasonable
explanation for petitioner’s shoulder pain.14 (Ex. A, p. 6.) Dr. Axelrod disagrees based
on the fact that petitioner’s pre-vaccination records did not evidence an inflammatory
condition while petitioner was on Remicade. (Ex. 36, p. 2.) Importantly, however,
respondent observes that petitioner’s post-vaccination shoulder pain responded to
treatment with Remicade (the treatment protocol for his AS) rather than to steroid
injections, commonly used to treat bursal inflammation. (ECF No. 54 (citing Ex. 17, p.
17; Ex. 18, p. 1; Ex. 19, p. 8).) Moreover, as discussed relative to the first SIRVA
criterion, it is also not the case that petitioner was completely asymptomatic prior to
vaccination.
Second, there is preponderant evidence that petitioner was experiencing
complications from his prior shoulder replacement, including glenoid loosening.
According to Dr. Abrams, glenoid loosening is the most common reason for pain and
corrective shoulder surgery following a shoulder replacement.15 (Ex A, p. 6.)
14 As explained above, AS is an inflammatory disease that leads to arthritis in the spine and other joints of
the body, including the shoulder. (Ex. A, p. 6) (citing Emery et al., supra, at Ex. A, Tab 10; Horta-Baas &
Jimenez-Balderas, supra at Ex. A, Tab 11.) A primary finding of AS is enthesitis, or inflammation of the
enthesis, the tissue where tendons or ligaments attach to bone; over 60% of AS patients show enthesitis
of the rotator cuff tendon. (Id.) (citing Rajesh K. Kataria & Lawrence H. Brent, Spondyloarthropathies, 69
AM. FAM. PHYSICIAN 2853 (2004) (Ex. A, Tab 12); Ali Ou Alla et al., supra, at Ex. A, Tab 13.) Further,
enthesitis of the deltoid attachment on the acromion is sometimes referred to as the “hallmark” of AS.
(Id.) (citing Robert G. W. Lambert et al., High Prevalence of Symptomatic Enthesopathy of the Shoulder in
Ankylosing Spondylitis: Deltoid Origin Involvement Constitutes a Hallmark of Disease, 51 ARTHRITIS &
RHEUMATISM 681 (2004) (Ex. A, Tab 14).)
15 Dr. Abrams cites: Nicolas Bonnevialle et al., Aseptic glenoid loosening or failure in total shoulder
arthroplasty: revision with glenoid reimplantation, 22 J. SHOULDER ELBOW SURG. 745 (2013) (Ex. A, Tab
15); Tyler J. Fox et al., Survival of the glenoid component in shoulder arthroplasty, 18 J. SHOULDER ELBOW
SURG. 859 (2009) (Ex. A, Tab 16); Barbara Melis et al., Glenoid loosening and failure in anatomical total
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Specifically, Petitioner’s medical records document “some osteolysis around the cement
mantle (of the glenoid)” and “a high riding humeral head suggestive of rotator cuff
rupture,” with the physician, Dr. Kercher, concluding that there was “some loosening of
the glenoid component that may require additional surgery.” (Ex. A, pp. 6-7; see also
Ex. 22, p. 8.) Dr. Abrams explains that glenoid fracture and loosening takes years to
develop, and therefore, it cannot be concluded that these conditions were not present at
the time of petitioner’s vaccination. He cites one study which found that glenoid
loosening occurred within two years in 20% of cases that required revision surgery after
a shoulder replacement, and another study which found that 67% of shoulder
replacements showed glenoid loosening with a mean timeframe of six years, two
months, compared to petitioner’s first radiograph which occurred seven years and
seven months after his shoulder replacement. (Ex. A, p. 7.)
Petitioner argues that his glenoid fracture wasn’t evidenced until his 2018 CT
scan and that he underwent an x-ray in September of 2017 which showed no evidence
of glenoid or rotator cuff damage and therefore it is more likely that he did not suffer
from these conditions until his 2018 CT scan. However, Dr. Abrams explains that x-rays
“often [do] not visualize subtle fractures or other pathologies of the glenoid following
shoulder arthroplasty,” and that the CT scan which did show evidence of glenoid
pathology “provides a significantly more detailed view of osseous (bone) structures.”
(Ex. A, p. 7.) Consequently, he concludes that while petitioner’s September 2017 x-ray
failed to reveal glenoid or rotator cuff damage, his 2018 CT scan suggests that he may
have been experiencing effects of his glenoid fracture in 2017.
Third, Dr. Abrams is also persuasive in identifying petitioner’s significant cervical
spine degeneration as a likely cause of his shoulder pain. Petitioner’s rheumatologist
reports that several weeks before his vaccination, petitioner complained of “3rd and 5th
numbness and suspected cervical radiculopathy.” (Id. (citing Ex. 8, p. 375).) Cervical
radiculopathy is a well-known cause of shoulder pain. (Ex. A, p. 7.) Subsequent MRIs
revealed petitioner suffered from “severe degenerative disc disease.” (Id. at 8.) (citing
Ex. 8, p. 1.) Petitioner’s expert, Dr. Axelrod, initially contended that lateral shoulder pain
cannot be attributed to the disc degeneration found on petitioner’s MRI because there
were no issues at the C3-4 level. However, Dr. Abrams points out that Dr. Axelrod
misinterpreted the results as referring to the spinal levels, when in reality it referred to
exiting nerve roots. Thus, because petitioner’s MRI revealed possible aggravation of
the C5 exiting nerve root which is “the most common cause of cervical mediated
shoulder pain,” it can be concluded that petitioner’s disc degeneration was a factor
shoulder arthroplasty: is revision with a reverse shoulder arthroplasty a reliable option?, 21 J. SHOULDER
ELBOW SURG. 342 (2012) (Ex. A, Tab 17); Lionel Neyton et al., Mid- to long-term follow-up of shoulder
arthroplasty for primary glenohumeral osteoarthritis in patients aged 60 or under, 28 J. SHOULDER ELBOW
SURG. 1666 (2019) (Ex. A, Tab 18); Patrick Vavken et al., Rates of radiolucency and loosening after total
shoulder arthroplasty with pegged or keeled glenoid components, 95 J. BONE AND JOINT SURG. 215 (2013)
(Ex. A, Tab 19)).
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contributing to his shoulder pain, especially in light of the report of numbness extending
to his fingers. (Ex. A, p. 8; Ex. 20, p. 1.)
b. Petitioner has not shown that his injury was caused-in-fact by
his hepatitis B vaccination
Although petitioner did not explicitly plead a cause-in-fact claim, his expert did
opine that if petitioner did not experience a SIRVA, he nonetheless suffered from a
more general “environmentally associated autoimmune disease,” (“EAAD”) via
molecular mimicry affecting the shoulder joint and resulting in a SIRVA-like
presentation. Absent the presence of a Table Injury, petitioner is afforded no causal
presumption. Under the Althen standard, petitioner may prove actual causation by
providing a medical theory causally connecting the vaccination and the injury, a logical
sequence of cause and effect showing that the petitioner’s specific vaccination was the
cause of his injury, and a proximate temporal relationship between the vaccination and
the injury. See Althen, 418 F.3d at 1278.
Dr. Axelrod’s medical theory is unpersuasive. He purports to marry evidence in
the medical literature examining post-vaccination shoulder injuries with evidence in the
medical literature investigating the role of the immune system in joint deterioration.
However, Dr. Axelrod stands alone in seeking to connect these two areas of inquiry.
None of the literature filed in this case supports the idea that those investigating acute
post-vaccination shoulder injuries suspected an autoimmune etiology to explain their
findings of acute shoulder pain16 whereas the literature Dr. Axelrod cites purporting to
show potential molecular mimics within joint tissue involves the separate context of
chronic conditions such as rheumatoid arthritis and osteoarthritis.17 Additionally, though
he stresses the cause of pain in SIRVA is unknown, Dr. Axelrod himself describes the
16 See, Atanasoff et al., supra, at Ex. 31; Bodor & Montalvo, supra, at Ex. 45; Ian F. Cook,
Subdeltoid/subacromial bursitis associated with influenza vaccination, 10 HUM. VACCINES &
IMMUNOTHERAPEUTICS 605 (2014) (Ex. 46).
17 See, Keiichi Iwanami et al., Arthritogenic T cell epitope in glucose-6-phosphate isomerase-induced
arthritis, 10(6) ARTHRITIS RES. & THERAPY R130 (2008) (Ex. 28); Shinichiro Nishimi et al., A Disintegrin and
Metalloprotease 15 is Expressed on Rheumatoid Arthritis Synovial Tissue Endothelial Cells and may
Mediate Angiogenesis, 8 CELLS 32 (2019) (Ex. 29); Jun-Ichiro Tsuruha et al., Implication of Cartilage
Intermediate Layer Protein in Cartilage Destruction in Subsets of Patients With Osteoarthritis and
Rheumatoid Arthritis, 44 ARTHRITIS & RHEUMATISM 838 (2001) (Ex. 54); Patrik Önnerfjord et al.,
Quantitative Proteomic Analysis of Eight Cartilaginous Tissues Reveals Characteristic Differences as well
as Similarities between Subgroups, 287 J. BIOLOGICAL CHEMISTRY 18913 (2012) (Ex. 55); J. Brice
Weinberg et al., Extravascular Fibrin Formation and Dissolution in Synovial Tissue of Patients with
Osteoarthritis and Rheumatoid Arthritis, 34 ARTHRITIS & RHEUMATISM 996 (1991) (Ex. 56); Xiaotiann Chang
et al., The expression of PADI4 in synovium of rheumatoid arthritis, 29 RHEUMATOL. INT’L. 1411 (2009)
(Ex. 57); Sanna Turunen et al., Rheumatoid arthritis antigens homocitrulline and citrulline are generated
by local myeloperoxidase and peptidyl arginine deiminases 2, 3 and 4 in rheumatoid nodule and synovial
tissue, 18 ARTHRITIS RES. & THERAPY 239 (2016) (Ex. 58).) Additionally, Dr. Axelrod himself acknowledges
that the abrupt post-vaccination onset of shoulder pain examined by Atanasoff and others is more
consistent with an inflammatory innate immune reaction rather than the type of adaptive immune
response implicated by autoimmunity and molecular mimicry. (Ex. 36, p. 2 (“Innate responses occur from
minutes to hours following an insult.”) (citing Abul K. Abbas et al., Properties and Overview of Immune
Responses and Innate Immunity, in CELLULAR AND MOLECULAR IMMUNOLOGY 1-11 (9th ed. 2018) (Ex. 42)).
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immediacy of post-vaccination onset of shoulder pain examined by Atanasoff and others
as more consistent with an inflammatory innate immune reaction rather than the type of
adaptive immune response implicated by autoimmunity and molecular mimicry. (Ex. 36,
p. 2 (explaining that “[i]nnate responses occur from minutes to hours following an insult”
and citing Abul K. Abbas et al., Properties and Overview of Immune Responses and
Innate Immunity, in CELLULAR AND MOLECULAR IMMUNOLOGY 1-11 (9th ed. 2018) (Ex.
42)). Accordingly, Dr. Axelrod’s medical theory is not sound and reliable and is
therefore insufficient to meet petitioner’s burden under Althen prong one.
Additionally, even if petitioner did provide preponderant evidence of a causal
theory to explain SIRVA-like presentations on a cause-in-fact basis, it is still unlikely that
petitioner would be able to establish a logical sequence of cause and effect in this
specific case under Althen prong two. Although the specific QAI criteria for a SIRVA
Table Injury are not controlling with respect to a cause-in-fact claim, the above analysis
with regard to petitioner’s pre-existing condition and alternative explanations for his own
shoulder symptoms remains illuminating in the cause-in-fact context and need not be
repeated.
Even with respect to causation-in-fact, petitioner relies in significant part on the
Atanasoff article to demonstrate how the proposed vaccine-caused shoulder injury can
manifest. Although some Atanasoff subjects did have MRI evidence of shoulder
dysfunction, that study purported to link vaccination and injury on the very basis that the
lack of prior shoulder symptoms along with the rapid onset of post-vaccination pain
allowed for the suspicion of an immune-mediated inflammatory state that provoked the
symptoms. (Atanasoff et al., supra, at Ex. 31, p. 3.) The Atanasoff authors stressed
that there is no diagnostic test available to assess whether shoulder dysfunction is
vaccine-caused, leaving only this type of clinical qualification to aid in identifying post-
vaccination shoulder injuries as a distinct entity. (Id. at 4.)
However, for all the reasons discussed above, petitioner’s own clinical history
both offers evidence of pre-existing, symptomatic shoulder dysfunction and affirmatively
points to other likely etiologies for petitioner’s shoulder pain and overall condition. Thus,
his presentation is incompatible with the type of circumstantial causal inference
(effectively a diagnosis of exclusion) advanced in the relevant literature by Atanasoff et
al., and Bodor and Montalvo. Alternatively, nothing in petitioner’s own medical history is
indicative of the type of autoimmune attack Dr. Axelrod hypothesizes. Nor did
petitioner’s own treating physicians suspect vaccine-causation in this case under either
scenario. Those of petitioner’s physicians that did remark on petitioner’s history of
vaccination disclaimed sufficient knowledge to render any causal conclusion. (Ex. 6,
pp. 1, 3-4.)
With regard to timing under Althen prong three, petitioner is correct that a four-
day onset period is potentially consistent with the time necessary for an adaptive
immune response to result in an autoimmune injury; however, because petitioner has
not demonstrated that his injury manifested as a consequence of an autoimmune
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response, this is of no moment. With respect to an inflammatory innate immune
response, Atanasoff observed that 93% of cases reported onset of shoulder pain
occurring within 24 hours of vaccination. (Atanasoff et al., supra, at Ex. 31, p. 2.) Bodor
and Montalvo reported two cases with onset occurring within 48 hours. (Bodor &
Montalvo et al., supra, at Ex. 45.) While Dr. Axelrod stresses that 8% of the Atanasoff
subjects experienced onset of shoulder pain within four days of vaccination rather than
within one day, 8% of the Atanasoff study group represents only one individual.
(Atanasoff et al., supra, at Ex. 31, p. 1 (noting that the study included 13 potential
cases).) The literature filed in this case does not necessarily preclude a four-day onset
period; however, without more and especially in light of the weaknesses of petitioner’s
medical theory under Althen prong one, petitioner has not preponderately established
on this record that it is a medically appropriate temporal interval for the type of injury
alleged.
VII. Conclusion
Petitioner has my sympathy for the pain he has endured and I understand why
he came to the personal conclusion that he suffered a vaccine-related injury. However,
for all the reasons discussed above, I cannot conclude that his injury was vaccine-
caused or aggravated based on the standards applicable in this Program. Accordingly,
petitioner is not entitled to compensation. Therefore, this case is dismissed.18
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
18 In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter
judgment accordingly.
35