# Kelly v. Secretary of Health and Human Services

> United States Court of Federal Claims · April 18, 2022

URL: https://www.frixlaw.com/law-library/cases/6332752

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** April 18, 2022
- **Precedential status:** Published
- **Opinion:** Opinion
- **Judges:** Daniel T. Horner
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/6332752

## How later opinions describe it (automated extraction)

- applying the six-part Loving test.

## Opinion text

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-1918V
Filed: March 24, 2022
PUBLISHED

Special Master Horner
DOUGLAS KELLY,

Petitioner, Shoulder Injury Related to
v. Vaccine Administration
(“SIRVA”); Influenza (“Flu”)
SECRETARY OF HEALTH AND Vaccine; Ruling on the Record
HUMAN SERVICES,

Respondent.

Leah VaSahnja Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for
petitioner.
Sarah Black Rifkin, U.S. Department of Justice, Washington, DC, for respondent.

Ruling on Entitlement 1

On December 8, 2017, petitioner, Douglas Kelly, filed a petition under the
National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012), 2 alleging that
his receipt of an influenza (“flu”) vaccination on October 26, 2016, caused a left
shoulder injury. (ECF No. 1.) For the reasons set forth below, I conclude that petitioner
is entitled to an award of compensation for a significant aggravation of a pre-existing
shoulder injury.
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

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.
2All references to “§ 300aa” below refer to the relevant section of the Vaccine Act at 42 U.S.C. § 300aa-
10-34.

1
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;
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 flu 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 provide 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

2
(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 ex rel. Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315,
1322 n.2 (Fed. Cir. 2010) (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 demonstrate: (1) a
medical theory causally connecting the vaccination and the injury; (2) a logical
sequence of cause and effect showing that the vaccination was the reason for the
injury; and (3) a showing of proximate temporal relationship between vaccination and
injury. Althen 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, 592 F.3d at 1322 n.2. Proof of medical
certainty is not required. Bunting v. Sec'y of Health & Human Servs., 931 F.2d 867, 873
(Fed. Cir. 1991). However, 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).
Here, petitioner contends that if he did not suffer a Table Injury of SIRVA, then he
nonetheless suffered a significant aggravation of a pre-existing shoulder condition.
(ECF No. 1, p. 1; ECF No. 53, p. 12-15.) The Vaccine Act defines significant
aggravation as “any change for the worse in a preexisting condition which results in
markedly greater disability, pain, or illness accompanied by substantial deterioration of
health.” § 300aa-33(4). Where a petitioner in an off-Table case is seeking to prove that
a vaccination aggravated a pre-existing injury, petitioners must establish three
additional factors. See Loving v. Sec’y of Health & Human Servs., 86 Fed. Cl. 135, 144
(Fed. Cl. 2009) (combining the first three Whitecotton factors for claims regarding
aggravation of a Table injury with the three Althen factors for off table injury claims to
create a six-part test for off-Table aggravation claims); see also W.C. v. Sec’y of Health
& Human Servs., 704 F.3d 1352, 1357 (Fed. Cir. 2013) (applying the six-part Loving
test.). The additional Loving factors require petitioners to demonstrate aggravation by
showing: (1) the vaccinee’s condition prior to the administration of the vaccine, (2) the
vaccinee’s current condition, and (3) whether the vaccinee’s current condition
constitutes a “significant aggravation” of the condition prior to the vaccination. Id.

3
II. Procedural History
This case was initially assigned to the Court’s Special Processing Unit (“SPU”)
on December 11, 2017. (ECF Nos. 1, 4.) On December 26, 2017, petitioner filed his
medical records and an initial statement of completion. (ECF Nos. 7-8.) Further
records and affidavits were filed between January 25, 2018, and July 10, 2019. 3 (ECF
Nos. 9, 12-13, 21, 31-32.) On April 9, 2019, respondent filed Rule 4(c) report
recommending against compensation. (ECF No. 26.)
This case was reassigned to my docket on October 29, 2019. (ECF No. 37.) On
October 30, 2019, I ordered petitioner to file an expert report supporting his claim. (ECF
No. 38.) Petitioner filed an expert report authored by Uma Srikumaran, M.D., on April
13, 2020. (ECF No. 41.) On October 9, 2020, respondent filed a responsive expert
report from Julie Bishop, M.D. (ECF No. 47.) Subsequently, petitioner filed Dr.
Srikumaran’s supplemental expert report on December 17, 2020. (ECF No. 49.)
On January 19, 2021, the parties filed a joint status report requesting a hearing.
(ECF No. 50.) A status conference was held on February 19, 2021, where I advised the
parties that, based on the number of SIRVA claims resolved on the record, that this
case might also be best resolved on the written record. (ECF No. 51.) The parties
agreed. (Id.) On May 5, 2021, petitioner filed a motion for a ruling on the record. (ECF
No. 53.) On June 21, 2021, respondent filed his response brief. (ECF No. 55.)
Petitioner filed his reply on July 21, 2021. (ECF No. 56.)
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

Petitioner has an extensive history of musculoskeletal problems which include
approximately 12 surgeries on his left knee (Ex. 3, p. 29), right elbow, hand, and thumb
complaints resulting in right elbow and thumb surgeries (Ex. 9, p. 5), two surgeries on
the left shoulder and two surgeries on the right shoulder prior to his vaccination (Ex. 12,
p. 3; Ex. 6, p. 2-3).

3 Respondent did also request complete physical therapy records from Comprehensive Physical Therapy,
Inc. and petitioner subsequently represented that these records are unavailable. Respondent filed a
status report questioning the documentation supporting petitioner’s representation, but at no point
thereafter specifically re-raised his request for these records and has raised no argument based on the
absence of these records. (ECF No. 33, 55.)

4
On June 4, 2015, petitioner presented to Aaron Shakespeare, PA-C, at The
Centers for Advanced Orthopedics complaining of left shoulder pain. (Ex. 5, pp. 31-32.)
Petitioner reported that he had “left shoulder pain for the last 3 years” and that “he was
reaching back to scratch his back when a friend grabbed his arm and wrenched it up.”
(Id.) At that time petitioner “had a pain in the shoulder develop.” (Id.) Petitioner tried
ultrasound and heat with therapy but described his left shoulder throbbing and feeling
weaker compared to the right. (Id.) On physical examination petitioner was tender
along his biceps, he had full range of motion with pain at flexion and abduction, and his
impingement and Speed’s signs were positive. (Id.) Petitioner was diagnosed with
bursitis-rotator cuff syndrome and biceps tendonitis and prescribed physical therapy, a
cortisone injection, and recommended NSAIDs for pain management. (Id.)

On September 9, 2015, petitioner presented to Thomas McNamara, M.D., for a
Medicare preventive visit. (Ex. 3, p. 48-52.) Dr. McNamara noted in the history of
present illness arthralgia and failed knee surgery with repeat procedures. (Id. at 49.)
He further noted that petitioner was on chronic narcotic maintenance. (Id.) There is no
mention of shoulder or elbow problems. (See id.)

On March 11, 2016, petitioner returned to PA Shakespeare complaining of
bilateral elbow, knee, and left shoulder pain. (Ex. 5, pp. 27-28.) PA Shakespeare noted
“discomfort in the left shoulder that was treated last June with a cortisone shot that gave
[petitioner] significant relief.” (Id.) Petitioner reported that the “pain is mainly at the end
range of flexion and abduction” and “lifting seems to hurt the shoulder more.” (Id.) On
physical examination petitioner had some tenderness to palpation of the incised tendon
of the left shoulder, with pain in the left lateral epicondyle, full shoulder range of motion
and strength. (Id.) Petitioner was diagnosed with shoulder bursitis and PA
Shakespeare noted rotator cuff tendonitis. (Id. at 28.) He was given a cortisone
injection and directed to physical therapy. (Id.)

On May 17, 2016, petitioner presented to Physical Medicine and Rehabilitation
specialist, Dr. Brad Rosen, for an evaluation at Rehabilitation and Sports Medicine
Associates. (Ex. 6, pp. 24-26.) On his intake form, petitioner noted past problems with
his right thumb, elbow, knees, and shoulders between 1973 and 2014—with surgery on
both shoulders in the 1980’s. (Id. at 2-3.) Petitioner complained of knee and left
shoulder pain. (Id. at 24.) Dr. Rosen noted that 35 to 40 years ago petitioner suffered
“pain up and down [the] neck,” though “ortho / MRI” showed “Ø prob[lems].” (Id.)
Petitioner reported that he has attended physical therapy for an injured left shoulder
from three years ago. (Id.) He described weakness and numbness in the shoulder
while boxing, rating the pain at 2 to 7 out of 10 in the shoulder. (Id. at 24, 26.) Dr.
Rosen suggested rehabilitation and osteopathic treatments. (Id.)

On May 20, 2016, petitioner presented to his primary care physician Seth
Garber, M.D., for “chronic conditions.” (Ex. 3, pp. 42-44.) In the history of present
illness Dr. Garber noted that petitioner had osteoarthritis of the knee (unspecified). (Id.
at 43.) There is no mention of petitioner’s shoulder or elbow problems. (See id.)

5
On June 13, 2016, petitioner returned to Dr. Rosen complaining of left shoulder
aches and numbness. (Ex. 6, pp. 22-23.) Petitioner rated his shoulder pain at a 3 to 7
out of 10. (Id.) However, petitioner reported that his shoulder condition was improving
and that he planned to continue current treatments. (Id.) On June 21, 2016, petitioner
returned to Dr. Rosen complaining of pain in his knee. (Id. at 20.) At this visit petitioner
also states that he would like to try physical therapy for his left shoulder. (Id.) On June
27, 2016, petitioner returned to Dr. Rosen complaining of knee and left shoulder pain.
(Id. at 18.) Dr. Rosen indicated that petitioner “improved since dry needling.” (Id.)
Petitioner reported that his “shoulder feels tight in the teres minor area.” (Id.) On
physical examination petitioner was tender to palpation at the infraspinatus and teres
minor (rotator cuff muscles). (Id.)

On July 19, 2016, petitioner again returned to Dr. Rosen for his knee and left
shoulder. (Ex. 6, pp. 15-17.) 4 Dr. Rosen noted that petitioner’s “shoulder [is] much
better.” (Id. at 15.) He further noted “sh[oulder] down to just a few spots – best it’s felt x
3 y[ea]rs!” (Id.) Petitioner complained of an ache and numbness in his shoulder, rating
his pain at a 3 to 6 out of 10. (Id. at 17.) Dr. Rosen ordered petitioner to return for a
follow-up in four weeks. (Id. at 15.)

On September 12, 2016, petitioner presented to Dr. Rosen again for his knee
and left shoulder, reporting that he “still had pain in the scap area, [though] [he] started
swimming two weeks ago [and it] seems like this is helping.” (Ex. 6, pp. 13-14.)
Petitioner rated his shoulder pain as ranging from 2 to 6 out of 10, but averaging 3-4
and 2-3 at the time of examination. (Id. at 14.) He further described the pain as an
ache and numbness. (Id.) On physical examination, he was noted to be tight in internal
rotation and had tenderness along the teres minor. (Id. at 13.) Petitioner’s shoulder
pain was assessed as being “improved,” and Dr. Rosen suggested a follow-up in four
weeks. (Id.)
ii. Vaccination and subsequent treatment
On October 26, 2016, petitioner received an influenza vaccination in the left
deltoid at CVS. (Exs. 1, 13.) Five days later, on October 31, 2016, petitioner presented
to Laura Nowosielski, M.D., complaining of left arm and shoulder pain and a “dull-aching
pain” since receiving the influenza vaccine the prior week. (Ex. 7, pp. 1-2.) It was noted
in his history of present illness that petitioner:
presents with a painful left arm and shoulder after receiving a[n] influenza
vaccine 4 days ago in Maryland. He has a history of bilateral shoulder
surgery and has received multiple injections in the left shoulder recently as
well as osteopathic manipulation, [his] shoulder was feeling good prior to
his injection. [Petitioner] had a sudden onset of pain with the injection in the
area[,] remains with a constant dull aching irritation. The pain causes a
decrease in his range of motion but normal grip strength. . . .

4The “overall discomfort” charts from this visit list a date of June 19, 2016 as opposed to July 19, 2016,
however based on the context and chronology of the medical records, it appears that this was an error
and that the charts do in fact apply to petitioner’s July 19, 2016 visit to Dr. Rosen.

6
(Ex. 7, p. 2.)
On physical examination petitioner had limited active range of motion in his
shoulder due to pain but normal passive range of motion. (Id.) Petitioner also had
tenderness over the left biceps. (Id.) He was assessed with “musculoskeletal pain after
flu vaccination” and a vaccine adverse reaction. (Id. at 3.) Dr. Nowosielski prescribed a
Medrol dose pack and Naproxen. (Id.)
On November 9, 2016, petitioner presented to Dr. Rosen reporting that he
“seemed to [be] get[ting] better” but “flared up after a flu shot.” (Ex. 6, p. 11.) “Now,”
petitioner described a “high / sharp pain.” (Id.) He rated his shoulder pain at a 3 to 7
out of 10 and now described it as an ache and stabbing pain. (Id. at 12.) Dr. Rosen
assessed petitioner as having a “DOA shoulder” (osteoarthritis) and myalgia after a flu
shot. (Id. at 11.) Petitioner’s plan included physical therapy and NSAIDs. (Id.)
On November 28, 2016, petitioner returned to PA Shakespeare complaining of
left shoulder pain. (Ex. 5, p. 21.) Petitioner reported “ongoing pain for quite some time
but recently had a flu shot a month ago and had significant increase in his pain.” (Id.)
Petitioner rated the pain at 3/10. (Id.) PA Shakespeare noted that petitioner had had a
cortisone shot and therapy without any significant benefit. (Id.) His range of motion
was noted to be functional with pain at the end range of motion. (Id.) Petitioner’s
radiographs showed an anchor from prior rotator cuff surgery, AC arthritis, and a
preserved joint space. (Id.) He was diagnosed with impingement syndrome of the left
shoulder and rotator cuff capsule sprain. (Ex. 5, pp. 21-22.) PA Shakespeare advised
petitioner to get a new MRI to assess for rotator cuff tear. (Id.at 22.)
On December 5, 2016, petitioner again returned to PA Shakespeare complaining
of shoulder pain “still throughout the left shoulder.” (Ex. 5, p. 19.) PA Shakespeare
noted that petitioner’s “MRI does reveal a significant tendinitis of the subscapularis with
questionable partial tear” and “significant supraspinatus and infraspinatus tendinitis.”
(Id.) Petitioner was given a cortisone injection and prescribed dedicated shoulder
physical therapy. (Id. at 20.) The plan was for petitioner to return in four months. (Id.)
On December 14, 2016, petitioner returned to his primary care physician Dr.
Garber for a preventative medicine visit. (Ex. 3, p. 36.) Dr. Garber noted in the history
of present illness that petitioner complained of receiving an influenza vaccine in the left
upper arm that resulted in “immediate pain” followed by “persistent chronic pain since
then in the area of the vaccination.” (Id. at 38.) Dr. Garber further noted that petitioner
had been seeking consultation with his orthopedists and receiving cortisone injections.
(Id.) Finally, Dr. Garber noted that petitioner was not sure of the working diagnosis or
the cause of his pain, and further noted that petitioner “did not want an eval[uation] for
this issue here.” (Id.)
On December 22, 2016, petitioner presented to Sam Sydney, M.D., with
recurring “pain in the left shoulder following a recent flu shot[.]” (Ex. 5, p. 17.) Petitioner
noted that the “pain has changed in quality from previous left shoulder pain” and that he
had minimal improvement with cortisone injections and physical therapy. (Id.) On
physical examination, Dr. Sydney noted tenderness to palpation in the biceps,
supraspinatus, and infraspinatus tendons, with 4/5 strength, functional range of motion

7
but pain at the end range, and positive impingement signs. (Id.) Petitioner’s MRI was
reviewed, and Dr. Sydney noted significant tendonitis and a questionable partial tear of
the subscapularis. (Id.) Petitioner was diagnosed with impingement syndrome and a
left rotator cuff capsule sprain and surgery was not recommended. (Id. at 18.) Dr.
Sydney recommended petitioner continue range of motion exercises to avoid
developing adhesive capsulitis. (Id.)
On March 6, 2017, petitioner returned to PA Shakespeare for a follow-up
regarding his left shoulder. (Ex. 5, p. 15.) Petitioner reported that the physical therapy
and injections had provided minimal relief. (Id.) He described a deep pain, worse with
reaching overhead and lifting, and stated that he is ready to pursue surgery. (Id.) On
physical examination, petitioner was tender to palpation over the AC joint and
supraspinatus tendon and PA Shakespeare noted shoulder discomfort with end range
of motion. (Id.) Petitioner’s MRI was reviewed, noting no full rotator cuff tears. (Ex. 5,
p. 16.) He was diagnosed with left shoulder impingement and rotator capsule sprain
and given a cortisone injection. (Id.) At this visit petitioner also complained of, and was
diagnosed with, right hand trigger finger and right ulnar nerve lesion. (Id.)
On April 20, 2017, petitioner returned to Dr. Sydney complaining of right hand
and right elbow pain. (Ex. 5, p. 13.) Petitioner noted a fall during pickleball 5 onto his
right shoulder six weeks earlier and feared “something may be torn.” (Id.) An MRI of
the right shoulder was ordered. (Id. at 14.) Dr. Sydney reviewed petitioner’s EMG /
NCV from April 17, 2017. (Id. at 13-14; Ex. 9, p. 9.) Dr. Sydney noted “results of the
right hand which reveals moderate symptomatic right medial and ulnar neuropathy” as
well as a “prior history of chronic traumatic sports injury to the right elbow.” (Ex. 5, p.
14.) Petitioner was referred to Dr. Pervaiz for consideration of his right cubital tunnel
and carpal tunnel release. (Id.)
On April 25, 2017, petitioner presented to Khurram Pervaiz, M.D., with “multiple
complaints in both arms.” (Ex. 5, p. 9.) In addition to his right elbow and hand,
petitioner complained of bilateral shoulder pain worse on the left than on the right. (Id.)
Dr. Pervaiz noted a history of bilateral shoulder surgery. (Id.) He further noted that
petitioner “had a vaccination into the left shoulder in October of last year which
aggravated his left shoulder pain.” (Id.) On physical examination, petitioner was noted
to have pain on range of motion of both shoulders, with tenderness over the AC joint,
with weakness in both rotator cuff with limited motion on the left compared to the right
(external rotation of 40 on the left and forward flexion of 90 on the left). (Id. at 10.) Dr.
Pervaiz reviewed petitioner’s left shoulder radiographs, showing an anchor from prior
surgery as well as AC joint arthritis. (Id.) Upon review of petitioner’s April 20, 2017 MRI
of the right shoulder, Dr. Pervaiz noted partial thickness tearing of the superior
subscapularis tendon along with severe long head of the biceps tendinopathy with
medial subluxation of the biceps tendon and mild glenohumeral arthritis. (Ex. 5, p. 9,
73.) Dr. Pervaiz recommended petitioner continue conservative treatment for the
shoulders because he was soon scheduled to undergo right hand and elbow surgery.

5Pickleball is a paddleball sport similar to badminton. See Pickleball, WIKIPEDIA,
https://en.wikipedia.org/wiki/Pickleball (last visited Mar. 4, 2022).

8
(Id. at 11.) Dr. Pervaiz also expressed concern that petitioner was developing adhesive
capsulitis. (Id.)
On May 19, 2017, petitioner underwent right carpal tunnel release and right
elbow ulnar nerve transposition. (Ex. 9, pp. 13-15, 33.)
On June 6, 2017, petitioner presented to Dr. Pervaiz for bilateral, but left greater
than right, shoulder pain. (Ex. 5, p. 6.) Petitioner’s history was the same as
documented on April 25, 2017. (Id. at 7.) Petitioner’s physical exam revealed the same
findings as his April 25, 2017, visit. (Id.) Dr. Pervaiz recommended an MRI on the left
shoulder. (Id. at 8.)
On June 21, 2017, petitioner presented to Dr. Pervaiz for a follow-up visit. (Ex. 5,
p. 2.) Petitioner’s shoulder history remained the same as documented on April 25 and
June 6, 2017. (See Ex. 5, pp. 2-9.) On physical examination, petitioner’s range of
motion for the left shoulder improved to 50 of external rotation and 120 of forward
elevation—compared to 40 external rotation and 90 forward elevation on April 25, 2017.
(Id.) Petitioner’s radiographs remained unchanged. (Id.) Reading petitioner’s MRI of
the left shoulder from June 7, 2017, Dr. Pervaiz noted a high-grade partial thickness
tear / tendinosis of the distal supraspinatus tendon along with a high-grade tear of the
infraspinatus tendon, along with tearing of the labrum and moderate AC joint arthritis
and biceps tenosynovitis with partial tearing of the biceps tendon with no evidence of a
full-thickness tear. (Id. at 71.) Petitioner was diagnosed with left and right shoulder
impingement syndrome, with AC joint arthritis, high-grade rotator cuff tearing, and
possible adhesive capsulitis. (Id. at 2.) Dr. Pervaiz recommended surgery involving left
shoulder arthroscopy with a distal clavicle excision, biceps tenodesis, possible rotator
cuff repair, and possible capsular release. (Id.)
On July 14, 2017, petitioner underwent left shoulder surgery. (Ex. 5, p. 67.) Dr.
Pervaiz noted that after a long history of conservative treatments, petitioner continued to
have significant discomfort. (Id. at 67-68.) Petitioner’s pre- and post-operative
diagnoses were: 1) left shoulder impingement syndrome with a type 2 acromion, 2)
severe bursitis, 3) acromioclavicular joint arthritis, 4) partial thickness bursal surface
sprain of the rotator cuff, 5) slight chondral wear in the humeral head, 6) severe
delaminated superior labral tear with instability of the biceps tendon anchor, and 7) mild
adhesive capsulitis. (Id.) In the operative description section, Dr. Pervaiz noted that
petitioner was found to have a severe tear of the superior labrum and tearing of the
proximal biceps tendon. (Id. at 67.) He further noted that the “adhesions that were
found were from the prior surgery.” (Id.) There was no evidence of a full thickness
rotator cuff tear, and Dr. Pervaiz noted that overall the rotator cuff was intact. (Id.) The
following procedures were enumerated as having been performed during surgery: 1) left
shoulder arthroscopy with extensive debridement including a capsular release, 2)
subpectoral biceps tenodesis, 3) subacromial decompression / acromioplasty, 4) distal
clavicle excision/Mumford procedure. (Id.)
On August 3, 2018, petitioner presented for a post-operative follow-up with Dr.
Pervaiz. (Ex. 10, p. 6.) Petitioner showed excellent range of motion. (Id.) Dr. Pervaiz
noted that petitioner had “similar pathology in the right shoulder as well,” and may need
right shoulder surgery in the future. (Id.)

9
On August 10, 2017, petitioner presented to Dr. Pervaiz with severe right
shoulder pain. (Ex. 10, p. 2.) Petitioner’s left shoulder was now one-month post-op and
“improving nicely.” (Id. at 4.) His records indicate that petitioner underwent right elbow
ulnar nerve transposition and a right carpal tunnel release on May 19, 2017, and that his
symptoms were improving. (Id.) During this visit petitioner received a right trigger
thumb injection. (Id.) Dr. Pervaiz decided to proceed with right shoulder surgery,
including a right shoulder arthroscopy, subacromial decompression, distal clavicle
excision, subpectoral biceps tenodesis, capsular release, debridement, and possible
rotator cuff repair. (Id.)
Also on August 10, 2017, Veronica Wilson, PT, issued a letter indicating that
petitioner was being treated for his knee at Comprehensive Physical Therapy Inc.
(“CPT”) while he was in the process of moving to Florida. 6 (Ex. 4, p. 3.) The letter
further indicated that “[n]ear the end of October, 2016, when [petitioner] came to our
office for treatment of his knee, he told us that he had a very painful shoulder following a
flu shot the previous day.” (Id.) Petitioner further indicated that “the shot was given
high in his shoulder, not in his arm.” (Id.) “Each time” petitioner attended physical
therapy at CPT “he stated that he was still having difficulties with his shoulder.” (Id.)
On September 22, 2017, petitioner underwent right shoulder surgery. (Ex. 10, p.
12.) Petitioner’s surgery revealed 1) right shoulder severe tearing of the superior
labrum as well as longitudinal tearing at the proximal biceps tendon with slight chondral
wear in the glenoid, 2) synovitis in the rotator interval, 3) slight capsular contracture /
slight adhesive capsulitis with partial thickness, 4) bursal surface slight tearing of the
rotator cuff, 5) synovitis, 6) severe bursitis, 7) type 3 acromion and 8) AC joint
osteoarthritis. (Id.) The same procedures as the left shoulder were performed on the
right: 1) right shoulder arthroscopy with extensive debridement as well as capsule
release, 2) subacromial decompression, 3) distal clavicle excision, and 4) subpectoral
biceps tenodesis. (Id.)
b. As reflected in petitioner’s affidavits
Petitioner filed an affidavit on January 25, 2018. (ECF No. 9.) Petitioner states
that he received a flu shot on October 26, 2016, that was “administered very high up” on
his left shoulder and he “immediately experienced a great deal of pain.” (Ex. 8, p. 1.)
He describes worsening pain throughout the day which “radiated down into [his]
forearm.” (Id.) The next few days petitioner describes taking morphine, hydrocodone,
and naproxen to relieve the pain (medications he was prescribed for chronic knee pain).
(Id.) On October 31, 2016, petitioner presented to Physicians Regional, where he was
prescribed a Dosepak of an anti-inflammatory drug. (Id.) Petitioner avers that Dr.
Nowosielski reported his adverse vaccine reaction. (Id.)
Petitioner states that “[o]ver the next couple weeks,” his pain and discomfort
persisted, and he continued to take morphine, hydrocodone, and naproxen. (Ex. 8, p.
6 This letter was also filed as Exhibit 16. (See Ex. 4, 16.) Petitioner also filed a letter dated June 4, 2019,

stating that petitioner was a patient at CPT intermittently over a period of years for revision of his left knee
surgery. (Ex. 15, p. 1.) The June 4th letter further indicates that petitioner complained to his physical
therapist of pain and stiffness in his left shoulder after a flu shot “in late October or early November,” and
indicating that CPT “do[es] not have any records on [petitioner’s] shoulder.” (Id.)

10
1.) He further states that he made an appointment to see his orthopedic doctor for the
pain and reduced range of motion in his shoulder. (Id.) On November 9, 2016 he
presented to Rehabilitation and Sports Medicine to begin physical therapy. (Id.) He
continued physical therapy for the next several months. (Id.) “Eventually, the pain
began to lessen,” but petitioner avers that his range of motion remained “restricted
because of [his] frozen shoulder.” (Id.)
Petitioner underwent left shoulder surgery on July 14, 2017. (Ex. 8, p. 1.) Since
the surgery, petitioner’s pain “has mostly subsided” and his range of motion “is starting
to return.” (Id.) He continued physical therapy after the surgery, including at-home
exercises. (Id.) Petitioner avers that “[b]efore the surgery, I was in constant pain.” (Id.
at 2.) Before surgery, petitioner further avers that he had difficulty reaching for objects
and was unable to lift objects overhead. (Id.) He further described difficulty dressing
and difficulty sleeping. (Id.)
Petitioner filed a supplemental affidavit on July 10, 2019. (ECF No. 31.) Therein
petitioner avers that he was “experiencing a dull pain, low in the posterior of [his] left
shoulder/upper back” prior to receiving his flu shot. (Ex. 17, p. 1.) He further avers that
he first experienced this pain in 2014, and “because it was a dull pain,” he did not visit
Dr. Sydney until June of 2015, when he received a cortisone shot in the “left shoulder
area.” (Id.) At this time, petitioner states that he continued to participate in boxing
fitness classes three times a week, in addition to strength and weight training five times
a week. (Id.) However, “[o]nce [he] received the flu shot, [he] immediately stopped”
participating in the boxing workouts and reduced his strength training. (Id.) He also
“suffered from a lack of motion in my shoulder.” (Id.)
Petitioner further stated that, prior to the flu shot in 2016, he underwent two
surgeries on his left shoulder—one orthoscopic and one open surgery. (Ex. 17, p. 1.)
However, “the pain [he] experienced after the vaccine was completely different in type
and severity.” (Id.) Lastly, regarding his medical records, petitioner avers that the
orthopedic record on November 28, 2016 which states that he had “a cortisone shot and
therapy without significant benefit” – references an earlier cortisone shot he received on
October 10, 2016 (over two weeks prior to his flu vaccination on October 26, 2016). (Id.
at 2; see Ex. 5, p. 21.) Petitioner states that that particular cortisone shot “was
administered for symptoms in [his] right elbow, not [his] shoulder.” (Ex. 17, p. 2.)
IV. Summary of Expert Opinions

a. Petitioner’s Expert, Uma Srikumaran, M.D., M.B.A., M.P.H
Dr. Srikumaran currently serves as an associate professor in the Shoulder
Division at the Johns Hopkins School of Medicine and serves as the Shoulder
Fellowship Director and Chair of Orthopaedic Surgery for the Howard County General
Hospital. (Ex. 18, p. 1.) He also serves as the Medical Director of the Johns Hopkins
Musculoskeletal Service Line in Columbia, Maryland. (Id.) Each year Dr. Srikumaran
sees approximately 2500-3000 patients for shoulder issues and performs 400-500
shoulder surgeries annually. (Id.) He has treated approximately ten to twelve patients
with shoulder dysfunction after vaccination in the past five years. (Id.)

11
Dr. Srikumaran received his medical degree from Johns Hopkins School of
Medicine in 2005. (Ex. 19, p. 1.) He completed his orthopaedic residency at Johns
Hopkins Hospital and completed a shoulder surgery fellowship at Massachusetts
General Hospital. (Id.) Dr. Srikumaran is board certified in orthopaedic surgery. (Id. at
10.) He has published numerous articles in the field of shoulder surgery, though none
specifically related to SIRVA. (Ex. 18, p. 1.) He also peer reviews journal articles for
several orthopaedic journals including The Journal of Bone & Joint Surgery,
Orthopedics, Clinical Orthopedics and Related Research, and The Journal of Shoulder
and Elbow Surgery. (Id.)
Noting that petitioner has a “complicated and extensive musculoskeletal history
including pathology involving both shoulders,” Dr. Srikumaran initially indicates that
petitioner suffered both a Shoulder Injury Related to Vaccine Administration (SIRVA)
and a significant aggravation of his pre-existing left shoulder condition. (Ex. 18, p. 2.)
However, his reports focus mainly on significant aggravation. He opines that
petitioner’s left shoulder condition was “significantly aggravated by the October 26, 2016
influenza vaccination.” (Id. at 5.) Prior to vaccination, Dr. Srikumaran notes that
petitioner’s physical therapy records show a steady improvement, from June of 2016
through September 2016. (Id. (citing Ex. 6, pp. 13-22.)) This improvement, according
to Dr. Srikumaran, establishes the state of his shoulder health prior to the vaccination.
(Ex. 18, p. 5.) He further notes that “the exacerbation that began in May of 2016 was
resolved and [petitioner] returned to a high level activity such as swimming.” (Ex. 18, p.
5.)
Dr. Srikumaran notes that petitioner consistently reported worsening pain and
function within 48 hours after vaccination, which “strongly supports a significant
aggravation claim.” (Ex. 18, p. 5.) Furthermore, he opines that the character and
quality of pain petitioner reported is distinctly different than his baseline pain. (Id.) If the
shoulder pain was simply a continuation of petitioner’s chronic shoulder problem, Dr.
Srikumaran explains, “there should be evidence in the record that the pain was similar”
prior to the vaccination and not related to the timing of vaccination. (Id.) However, he
opines that this is not the case. (Id.)
Dr. Srikumaran opines that the scientific literature also supports a theory of how
vaccinations can cause shoulder injuries. (Ex. 18, p. 5.) According to Dr. Srikumaran,
Bodor and Montalvo suggest based on two case reports that injection of vaccine antigen
into the subacromial bursa led to a “robust local immune and inflammatory response”
leading to pathology of the subacromial space, biceps tendon, glenohumeral joint, and
capsulitis. (Id. (citing Marko Bodor & Enoch Montalvo, Vaccination-related shoulder
dysfunction, 25 VACCINE 585 (2007) (Ex. 22.)) The authors further suggest a high
position of injection into the deltoid can lead to a subacromial injection rather than an
intramuscular injection. (Ex. 18, p. 5-6 (citing Bodor & Montalvo, supra, at Ex. 22.) Dr.
Srikumaran cites Atanasoff et al., which “lends further support to this causation theory”
as the authors conclude that vaccine antigen injected into synovial tissue has the
potential for inducing a prolonged immune-mediated inflammatory reaction. (Ex. 18, p.
6 (citing Sarah Atanasoff et al., Shoulder injury related to vaccine administration
(SIRVA), 28 VACCINE 8049 (2010) (Ex. 20.)) Dr. Srikumaran stresses that in Atanasoff’s
series, “all patients had a rapid onset of symptoms isolated to the area of injection.”

12
(Ex. 18, p. 6, (citing Atanasoff et al., supra, at Ex. 20).) Arias et al., in a large
systematic review, “further establish the time course of injury with a majority of patients
reporting pain within 48 hours, and many reporting a high injection location.” (Ex. 18, p.
6 (citing L.H. Martin Arias et al., Risk of bursitis and other injuries and dysfunctions of
the shoulder following vaccinations, 35 Vaccine 4870 (2017) (Ex. 21)).) Lastly, Dr.
Srikumaran cites both animal (Dumonde) and human (Trollmo) studies as supporting an
autoimmune theory. (Ex. 18, p. 6 (citing D.C. Dumonde & L.E. Glynn, The production of
arthritis in rabbits by an immunological reaction to fibrin, 43 BRIT. J. OF EXPERIMENTAL
PATHOLOGY 373 (1961) (Ex. 23); C. Trollmo et al., Intra-articular immunization induces
strong systemic immune response in humans, 82 IMMUNOLOGY 384 (1990) (Ex. 24).)
Dr. Srikumaran opines that there is logical sequence of cause and effect
demonstrating a proximate temporal relationship in petitioner’s case. (Ex. 18, p. 6.)
Again, Dr. Srikumaran suggests that petitioner’s condition prior to vaccination showed a
history of shoulder pathology in both shoulders. (Id.) However, he opines that
petitioner’s visits to Seth Garber (Ex. 3, pp. 42-43) and Bradley Rosen, D.O. (Ex. 6, pp.
13-24) clearly establishes his condition prior to vaccination. (Id.) Though petitioner had
an exacerbation of pain in May, Dr. Srikumaran insists that this pain was resolved with
conservative treatments. (Id.) Additionally, he highlights petitioner’s affidavit wherein
petitioner describes immediate pain after a “very high up” vaccination. (Id. (citing Ex. 8,
p.1).) Dr. Srikumaran stresses that petitioner consistently reported the onset of
immediate pain. (Ex. 6-7 (citing Ex. 7, p. 1; Ex. 6, p. 11; Ex. 5, pp. 9, 17-18, 21; Ex. 3,
p. 38).)
Dr. Srikumaran points to petitioner’s visit with Dr. Nowosielski on October 31,
2016, five days post-vaccination, where Dr. Nowosielski’s assessment included an
adverse reaction to vaccination. (Ex. 18, p. 7 (citing Ex. 7, p. 3).) He also highlights a
note from Dr. Rosen post-vaccination, on November 9, 2016, which noted that
petitioner’s pain as “[n]ow some high/ sharp pain.” (Ex. 6, p. 11) compared to a note
pre-vaccination, on May 17, 2016, which described petitioner’s pain as “tight” (Ex. 6, p.
25; Ex. 18, p. 7.) Dr. Srikumaran concludes that petitioner’s pre-existing left shoulder
condition was well managed with conservative measures prior to vaccine injection,
immediately worsened after the injection, failed conservative measures after injection,
was confirmed by diagnostic imaging (MRI) and surgical findings consistent with well-
known SIRVA pathologies (bursitis, capsulitis), and required surgery. All of this
evidences a significant aggravation of petitioner’s pre-existing left shoulder condition.
(Id.) Dr. Srikumaran refutes respondent’s claim that petitioner’s case represents the
natural progression of his condition. (Id.) Based on the “temporal relationship alone,”
he explains that “a chronic condition would not be expected to press so acutely.” (Id.)
Lastly, Dr. Srikumaran opines that conditions such as bursitis, capsulitis, or
inflammation can be aggravated by various triggers, and in petitioner’s case, “this
trigger was clearly the vaccination.” (Id. at 7-8.) In contrast, petitioner’s right shoulder
pain was likely triggered by a traumatic fall onto his right shoulder while playing
pickleball. (Id. at 8 (citing Ex. 5, p. 13).)

13
b. Respondent’s Expert, Julie Y Bishop, M.D.
Dr. Bishop currently serves as a professor in the department of Orthopaedic
Surgery at the Ohio State University, Wexner Medical Center, as well as Chief of the
Division of Shoulder surgery, and Vice Chair of Finance for the Orthopaedic
Department. (Ex. A, p. 1.) As a shoulder specialist, all of Dr. Bishop’s research
interests, publications, book chapters, and presentations have been on the treatment of
shoulder pathology. (Id.; Ex. B pp. 9-41.) Dr. Bishop has treated multiple patients with
SIRVA in her practice over the years and has published in this area as well. (Id.)
Dr. Bishop received her medical degree from Cornell University Medical College
in 1997. (Ex. B, p. 1.) She completed fellow training in 2003 specifically in shoulder
surgery (fellowship at Mount Sinai Hospital in New York City) and Orthopaedic sports
medicine (visiting fellowship at the University of Pittsburg Medical Center). (Ex. A, p. 1.)
She is board certified in orthopedic surgery. (Ex. B, p. 2.) Dr. Bishop is also a fellow of
the American Academy of Orthopaedic Surgeons, an active member of the American
Shoulder and Elbow Surgeons, a member of the American Orthopaedic Society for
Sports Medicine as well as an elected member of the American Orthopaedic
Association. (Ex. A, p. 1.)
Dr. Bishop opines that there is no evidence to support the conclusion that there
was a significant aggravation of petitioner’s condition due to vaccination. (Ex. A, p. 10.)
While petitioner did report an increase in pain after the vaccination, she emphasizes
that petitioner reported only one point higher on the pain scale than his previous reports
of pain for several months prior to vaccination. (Id. at 10-11.) Rather, petitioner’s
reports of pain “show the more waxing and waning nature” of the pathology in
petitioner’s left shoulder. (Id. at 11.) Dr. Bishop acknowledges that petitioner
developed a “new component,” adhesive capsulitis, in his left shoulder six months after
the vaccination. (Id.) While this certainly “added to his pain and symptoms,” Dr. Bishop
stresses that there is clear evidence presented in petitioner’s records that “the
pathology in his shoulder was degenerative and thus by definition, progressive in
nature.” (Id.) Therefore, Dr. Bishop opines, surgical intervention was the reasonable
conclusion to address petitioner’s pathology, “regardless of the vaccination.” (Id.)
Dr. Bishop observes that at the time of vaccination, petitioner was sixty-four
years old and had an extensive past musculoskeletal history that included 19 surgeries
on his left knee, bilateral shoulder surgeries and right elbow, hand and thumb
complaints (that also led to right elbow and hand surgery), culminating in a third surgery
on each of his shoulders at the conclusion of his care records. (Ex. A, p. 2.) She
further observes that petitioner had two surgeries on both his left and right shoulders
prior to his influenza vaccine, one in the 1980’s and one in 2002; he has a history of
bilateral shoulder dislocations; and he lives a vigorous lifestyle involving boxing and
weightlifting. (Id.) Shoulder dislocations likely led petitioner to undergo his surgeries in
the 1980’s, as Dr. Bishop explains, petitioner would have been in his thirties at the time
and surgery for shoulder dislocations is more prevalent in this age group. (Id. at 7.)
Petitioner also underwent rotator cuff surgery in 2002. (Id.) Dr. Bishop notes that
petitioner next presented in June 2015 with left shoulder pain, noting he injured the
shoulder three years earlier, when he was diagnosed with rotator cuff syndrome and

14
biceps tendonitis. (Ex. A, p. 7.) Nine months later, in March 2016, petitioner presented
with left shoulder pain, again with similar diagnoses. (Id.) By May of 2016, petitioner
presented again for his shoulder, this time noting that hitting the boxing bag made his
shoulder numb and feel weak. (Id.) This note, Dr. Bishop explains, is a clear indication
that “despite the pain, [petitioner] is still boxing” at this time. (Id.) Over the next four
months, Dr. Bishop observes that petitioner reported shoulder improvement, though he
still rated his pain at a 6/10. (Id.) This was down only one point from the 7/10 score
petitioner reported at his first visit. (Id.)
At the time of his surgery, Dr. Bishop observes that petitioner was found to have
chondral wear to the humeral head and was also given the diagnosis of shoulder
osteoarthritis by Dr. Rosen in his November 2016 visit post-vaccination. (Ex. A, p. 8.)
Given petitioner’s history of shoulder dislocations, Dr. Bishop asserts that there is
substantial support in the literature that shoulder dislocations lead to arthritis of the
shoulder joint. (Id.) Citing Hovelius and Saeboe, Dr. Bishop observes that in this 25-
year follow-up there was an overall incidence of shoulder arthritis in 56% of the patients
studied. (Id. (citing Lennart Hovelius & Modolv Saeboe, Neer Award 2008: Arthropathy
after primary anterior shoulder dislocation—223 shoulders prospectively followed up for
twenty-five years, 18 J. SHOULDER ELBOW SURGERY 339 (2009) (Ex. A-1).)) Moreover,
the authors found that patients who engaged in high-energy sports (like boxing), had
higher rates of arthritis. (Ex. A, p. 8 (citing Hovelius & Saeboe, supra, at Ex. A-1.)) In
fact, petitioner was found to have AC arthritis at the time of his surgery, which was
addressed with a distal clavicle excision. (Ex. A, p. 9.) Petitioner was also found to
have a type II acromion (bone spur) and subacromial impingement. (Id.) However, Dr.
Bishop opines that “an influenza vaccination would not cause these structural findings”
because these injuries are “degenerative findings related to age.” (Id. (citing Steven
Needell et al., MRI Imaging of the Rotator Cuff: Peritendinous and Bone Abnormalities
in an Asymptomatic Population, 166 AM. J. ROENTGENOLOGY 863 (1996) (Ex. A-3)).)
Dr. Bishop observes that at the time of his 2017 surgery, petitioner also suffered
from a superior labrum anterior to posterior (SLAP) injury, rotator cuff symptoms, severe
bursitis, and adhesive capsulitis. (Ex. A, pp. 9-10.) Petitioner’s SLAP injury led to
debridement of the labrum and tenodesis of the biceps during his surgery. (Id.) Dr.
Bishop explains that this finding is considered an age-related degenerative pathology,
as well as a common finding in overhead athletes and contact athletes. (Id.) Again, Dr.
Bishop stresses that an influenza vaccination would not lead to these findings, and they
are not a part of the commonly accepted shoulder pathologies for SIRVA. (Id. (citing
Sandeep Mannava et al., Prevalence of Shoulder Labral Injury in Collegiate Football
Players at the National Football League Scouting Combine, 6 ORTHOPAEDIC J. SPORT
MED. 1 (2018) (Ex. A-4); Lennard Funk & Martyn Snow, SLAP Tears of the Glenoid
Labrum in contact athletes, 17 CLINICAL J. SPORT. MED. 1 (2007) (Ex. A-5)).) Petitioner’s
MRI also confirmed a prior history of rotator cuff repair and was read as a possible
partial tear. (Ex. A, p. 9.) At the time of his 2017 surgery, petitioner’s final diagnosis
was partial thickness bursal sprain of the rotator cuff which required only debridement,
no formal repair. (Id.) Like his SLAP injury, Dr. Bishop notes that rotator cuff pathology
is an age-related degenerative finding. (Id.) In fact, petitioner underwent rotator cuff
surgery in 2002 and Dr. Bishop opines that symptoms would be expected to progress

15
over the course of 14 years post-op, especially considering petitioner’s age and history
of boxing and weight lifting. (Id.) She also notes that the healing failure rate after prior
rotator cuff repair is report as 11% to 94% in the literature. (Id. (citing Jieun Kwon et al.,
The Rotator Cuff Healing Index, 47 AM. J. SPORT MED. 173 (2019) (Ex. A-6)).) Thus, the
debridement of petitioner’s rotator cuff during his 2017 surgery was likely due to the
natural progression of this injury and not due to the influenza vaccination. (Id.) At the
time of petitioner’s surgery, Dr. Pervaiz noted “adhesions from the prior surgery” in the
operative report. (Ex. A, p. 10.) These findings from a prior surgery likely contributed to
petitioner’s severe bursitis, as Dr. Bishop explains “they are really one in the same.”
(Id.) If petitioner had bursitis triggered by an influenza vaccination, Dr. Bishop admits
that it would be difficult to differentiate it from bursitis due to the adhesions from the
prior surgery. (Id.) However, based on petitioner’s multiple pre-existing pathologies
and prior shoulder surgeries, Dr. Bishop opines that petitioner’s bursitis was not caused
by his vaccination. (Id.) Likewise, petitioner was diagnosed with mild adhesive
capsulitis at the time of surgery, though Dr. Bishop opines that this injury was also
unrelated to petitioner’s vaccination. (Ex. A, p. 10.) She also notes that adhesive
capsulitis is a disease process that is often bilateral, with a 30% chance of it occurring in
the opposite shoulder. 7 (Id. (citing Robert Tashjian, Epidemiology, Natural History, and
Indications for Treatment of Rotator Cuff Tears, 31 CLINICAL SPORTS MED. 589 (2012)
(Ex. A-8)).) Given that petitioner’s left-sided adhesive capsulitis did not present until
April 2017, or six months post-vaccination, Dr. Bishop opines that the component of
adhesive capsulitis addressed at the time of surgery was not related to the vaccination.
(Ex. A, p. 10.)
According to Dr. Bishop, petitioner’s post-operative records reveal that petitioner
did “very well after his surgery and that his [range of motion] was excellent.” (Ex. A, p.
10.) These results confirm that any component of adhesive capsulitis was resolved
after the surgery, Dr. Bishop opines. (Id.) One would not expect petitioner to suffer any
long-term dysfunction in the shoulder due to adhesive capsulitis component of the
shoulder, according to Dr. Bishop, though she notes that petitioner avers in his affidavit
that he can no longer workout using his upper body. (Id.) Most notably, petitioner
underwent a final surgery in his right shoulder, the same as the left shoulder. (Ex. A, p.
10-11.) Dr. Bishop emphasizes that the diagnoses were exactly the same, as were the
surgical interventions—providing strong evidence that the flu vaccine was not a
substantial factor in petitioner’s left shoulder pathology. (Id.)
c. Dr. Srikumaran’s Supplemental Expert Report
Dr. Srikumaran likewise agrees that many structural findings involving the
shoulder are degenerative in nature (related to age and activity). (Ex. 25, p. 1.) He
further agrees that these shoulder conditions occur in 30 to 90% of the population,
depending on the specific degenerative condition (e.g., labrum tear, AC joint arthritis,
rotator cuff tear, etc.). (Id.) Additionally, Dr. Srikumaran agrees that these findings are
not caused by vaccination. (Id.) Rotator cuff symptoms, specifically, progress
7In her report Dr. Bishop cites reference 8 (Tashjian supra, at Ex. A-8), though it appears that the
statistics she is citing actually appear in reference 9 of her report. (see Andrew Neviaser and Jo
Hannafin, Adhesive Capsulitis, A Review of Current Treatment, 38 AM. J. SPORTS MED. 2346 (2010) (Ex.
A-9) (“About 20% to 30% of those affected will developed the condition in the opposite shoulder”).)

16
regardless of vaccination. (Id.) Like Dr. Bishop, Dr. Srikumaran notes that rotator cuff
tears may worsen in severity and become symptomatic over time. (Ex. 25, p. 1.)
However, Dr. Srikumaran points to the “tight time course” post-vaccination, during which
time petitioner’s symptoms worsened, as strong support for the vaccination as the
“triggering event.” (Id.)
Dr. Srikumaran does not dispute Dr. Bishop’s summary of petitioner’s chronic
conditions, the majority of which can be asymptomatic or can wax and wane over time.
(Ex. 25, p. 1.) However, Dr. Srikumaran holds the opinion that petitioner’s vaccination
initiated inflammation “directly related to vaccine antigen being delivered to or near the
bursa or synovium of the joint,” and the inflammation then initiates pain in previously
silent, chronic degenerative condition(s). (Id. at 1-2.) The surgical procedures,
according to Dr. Srikumaran, address the underlying inflammation “by removing it.” (Id.
at 2.)
Dr. Srikumaran disagrees with Dr. Bishop’s opinions regarding petitioner’s severe
bursitis and adhesions. (Ex. 25, p. 2.) Dr. Srikumaran opines, based on his experience,
that during a second surgery adhesions are likely present from prior surgery and quite
unlikely to have bursitis (as it is replaced with scar tissue). (Id.) Regarding Dr. Bishop’s
assessment of petitioner’s pain on the 10-point pain scale, Dr. Srikumaran asserts that
similar pain scores on that scale can be experienced differently. (Id.) When assessing
pain practitioners consider many factors including severity, duration, consistency,
exacerbating and mitigating factors, and radiation. (Id.) Pain score alone, therefore, is
not a reliable way to ascertain the overall effect of pain an individual, Dr. Srikumaran
opines. (Id.)
Dr. Srikumaran suggests that there is growing acceptance of a cause-in-fact
theory, evidenced by the vaccination guidelines from the CDC and the Journal of the
American Pharmacists Association. 8 (Ex. 25, p. 5.) Dr. Srikumaran also stresses that
new research has provided epidemiologic evidence supporting the association of
subdeltoid bursitis after influenza vaccination. (Ex. 25, p. 5.) According to Dr.
Srikumaran, Hesse et al. found an increased risk of 7.78 cases per 1 million
vaccinations. (Id. (citing Elizabeth M. Hesse et al., Risk For Subdeltoid Bursitis After
Influenza Vaccination: A Population-Based Cohort Study, 173 ANNALS OF INTERAL MED.
253061 (2020) (Ex. 27).) This epidemiologic evidence can now be “added to the
growing observational clinical evidence making a strong argument for the validity of
shoulder injury related to vaccination.” (Ex. 25, p. 5 (citing Elizabeth M. Hesse et al.,
Shoulder injury related to vaccine administrations (SIRVA): petitioner claims to the
National Vaccine Injury Compensation Program, 2010-2016, 38 Vaccine 1076 (2020)
(Ex. 26).)

8 citing New Shingles Vaccine Fact Sheet for Healthcare Providers, CDC.GOV,

https://www.cdc.gov/shingles/multimedia/shingles-factsheet-
hcp.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fhcp%2Finfographics%2Fyc
ts-shingrix.html (last updated July 1, 2019); Foster & Davis, Vaccine administration: preventing serious
shoulder injuries, 53 J. AM. PHARMACISTS ASS’N 102 (2013) (not filed).

17
V. Party Positions

a. Petitioner’s contentions
Petitioner stresses that he suffered a left-sided shoulder injury meeting all four
elements demonstrating a SIRVA Table injury. (ECF No. 53, p. 7.) Alternatively,
petitioner asserts that reliable medical evidence supports a non-Table injury was
significantly aggravated by his vaccination. (Id. at 10.)
In support of his On-Table claim, petitioner stresses that his left shoulder injury, in
its present form, originated after he received the vaccine in question. (ECF No. 53, p.
8.) Any prior history of pain in petitioner’s left shoulder, he argues, does not explain the
novel symptoms that he experienced after his October 26, 2016 vaccine. (Id.) Though
petitioner did suffer left shoulder pain prior to vaccination, he asserts that his left
shoulder significantly improved prior to his October 26, 2016 vaccination. (Id. (citing Ex.
6, pp. 6, 13, 15, 18).) Furthermore, petitioner stresses that his treatment providers
consistently report his left shoulder injury as a “distinct injury, with distinct symptoms,”
which began after his influenza vaccination. (Id. at 8-9 (citing Ex. 7, pp. 1, 3; Ex. 5, pp.
17, 21; Ex. 3, p. 38).) Petitioner also stresses that his affidavits are also “entirely
consistent” with his medical records. (ECF No. 53, p. 9.) Additionally, Dr. Srikumaran
opines that petitioner’s left shoulder injury was directly attributable to his influenza
vaccination on October 26, 2016. (Id. at 10.)
In support of his causation-in-fact claim, petitioner asserts that he has
preponderantly established all six Loving prongs. (ECF No. 53, pp. 13-18.) Under
prong one, petitioner asserts that prior to administration of the vaccine petitioner was
able to participate in boxing classes, swim, and train with weights—demonstrating that
petitioner’s shoulder was in “good condition” prior to his vaccination. (Id. at 13-14 (citing
Ex. 17, p. 1; Ex. 18, p. 5., 7).) Under prong two, petitioner’s condition following
vaccination, petitioner stresses that all four of his treating physicians reported that his
left shoulder condition deteriorated. (ECF No. 53, p. 14 (citing Ex. 3, p. 38; Ex. 5, p. 17;
Ex. 7, p. 1).) Regarding prong three, citing Dr. Srikumaran’s report, petitioner argues
that his current condition is a significant aggravation of his prior condition because the
character and quality of pain he reported was distinctly different than his baseline pain.
(ECF No. 53, p. 15 (citing Ex. 18, pp. 5-8).) The medical theory that petitioner presents
under the fourth prong is that “vaccine antigen injected into synovial tissue has the
potential for inducing a prolonged immune-mediated inflammatory reaction.” (ECF No.
53, p. 16.) Finally, petitioner argues that he has met prongs five and six because all of
his treating physicians attributed his shoulder pain to his October 26, 2016 vaccination
and within a medically acceptable timeframe thereafter. (Id. at 16-17.)
In response to respondent’s contentions, petitioner stresses that his affidavits
must be given credence. (ECF No. 56, p. 4.) Petitioner claims that his affidavits directly
address the points challenged by respondent, namely, his continuation of prior shoulder
pain. (Id.) In his affidavit, petitioner avers that immediately upon receiving his influenza
vaccination he experienced new, sharp pain in the median of his left shoulder where the
shot was administered. (Id. at 4-5.) Regarding his significant aggravation claim,
petitioner stresses that a chronic condition would not be expected to progress so

18
acutely, and therefore cannot be considered a natural progression of his pre-existing
condition. (Id. at 9-10,14-15.) Therefore, petitioner argues that his current left shoulder
condition constitutes a significant aggravation of his prior condition. (Id. at 6-15.)
b. Respondent’s contentions
Respondent argues that petitioner is not entitled to compensation because he
has not met the elements for an On-Table SIRVA nor has he presented preponderant
evidence showing that his injury was significantly aggravated by his influenza
vaccination. (ECF No. 55, pp. 8, 10.)
Specifically, respondent stresses that petitioner’s extended history of shoulder
pain is well-documented in the record. (ECF No. 55, p. 9.) Respondent cites
petitioner’s prior left rotator cuff release (Ex. 3, pp. 43-45); prior left rotator cuff
tendonitis (Ex. 5, pp. 31-32); prior shoulder numbness and weakness (Ex. 6, p. 24); and
prior physical therapy (Ex. 6, pp. 5, 14). (ECF No. 55, p. 9.) Thus, respondent argues,
petitioner’s left shoulder pain was “simply a continuation of his chronic shoulder
problems that have spanned many years.” (Id.) Under Loving prongs one, two, and
three, respondent argues that petitioner’s condition was an expected clinical course, not
a significant aggravation brought on by vaccination. (Id. at 14-18.)
Respondent contends that petitioner has not established significant aggravation
of a prior shoulder injury. (ECF No. 55, p. 10.) Respondent disputes the claim that
petitioner’s shoulder was in “good condition” prior to his vaccination. (Id. at 14.) Rather,
respondent stresses that petitioner had previously undergone two left shoulder
surgeries, two right shoulder surgeries, was diagnosed with left shoulder bursitis, rotator
cuff bursitis (treated with cortisone injection), and underwent physical therapy from May
to September of 2016 where he rated his shoulder pain at a 2 to 6/10. (Id. at 14-15
(citing Ex. 5, p. 27, Ex. 6; Ex. 12, p. 3).) Respondent concedes that petitioner did
develop a new, post-vaccination diagnosis of adhesive capsulitis. (ECF No. 55, p. 16.)
However, respondent notes that this diagnosis did not appear for six months, placing it
well-outside the timeframe for vaccine-mediated causation. (Id. (citing Ex. A, p. 11).)
Respondent further stresses that petitioner suffered “essentially identical” pathology and
symptoms in his non-vaccinated right shoulder. (ECF No. 55, p. 16.)
Under prong four, respondent argues that while it is generally accepted that
vaccine administration can cause shoulder pain, petitioner has not shown how this
theory specifically applies to his case and that the medical records are inconsistent with
a vaccine-mediated injury. (ECF No. 55, p. 12.) Respondent suggests that petitioner’s
diagnoses are better classified as degenerative findings related to age. (Id.) Under
prong five, respondent asserts that petitioner’s records reflect his own subjective
assessment of his injury, and do not indicate that his treating physicians attributed
causation to his vaccination. (Id. at 13.) Moreover, even if petitioner did report an
increase in shoulder pain after his vaccination, respondent proposes that this is more
likely attributable to the waxing and waning nature of chronic shoulder pathology. (Id.)
Finally, under prong six, respondent argues that petitioner has not presented sufficient
evidence to show that any significant aggravation occurred within a medically-
appropriate timeframe following vaccination. (Id. at 14.) Instead, petitioner’s
presentation demonstrates a long history of left shoulder pain. (Id. citing Ex. A, p. 8.)

19
VI. Analysis

a. Petitioner’s Table Injury claim

In this case, petitioner’s Table Injury claim hinges on the first SIRVA QAI prong,
which requires “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.” 42 CFR §100.3(c)(10). Respondent raises no argument that petitioner’s
alleged post-vaccination pain occurred outside the specified timeframe, that his relevant
shoulder pain 9 was not limited to the shoulder in which the vaccine was administered, or
that any other condition or abnormality would explain his symptoms—as identified by
the Vaccine Injury Table. (See ECF Nos. 26, 55.) However, respondent contends that
petitioner’s post-vaccination left shoulder pain was simply a continuation of his chronic
shoulder problems. (ECF No. 55, p. 8-9.) Petitioner alleges that despite his history of
prior left shoulder pain, his shoulder had improved in the months prior to his October
2016 vaccination, and that he developed new, worsening pain post-vaccination
constituting a Table SIRVA. (ECF No. 53, pp. 7-9.)
Prior to the vaccination at issue, petitioner was still receiving physical therapy for
his left shoulder as little as six weeks before the vaccination at issue. (Ex. 6, pp. 5, 14.)
Moreover, he avers that he was still symptomatic at the time of his vaccination. (Ex. 17,
p. 1 (“[b]efore the flu shot was administered to my left shoulder, I was experiencing dull
pain, low in the posterior of my left shoulder/upper back…”).) The fact that petitioner
experienced some incomplete improvement during the months prior to his vaccination
does not in itself meet petitioner’s burden of proof on this point. Both parties’ experts
agree that the symptoms of chronic degenerative changes of the shoulder can wax and
wane. 10 Still, petitioner argues that “the medical records make clear that petitioner’s left
shoulder injury, in its present form, originated after he received the vaccine in question.
Any prior history of pain in petitioner’s left shoulder does not explain the novel
symptoms that petitioner experienced after his October 26, 2016 vaccine.” (ECF No. 53,
p. 8.) This is not persuasive.
Petitioner did report to his physician that he “feels like this pain has changed in
quality from previous left shoulder pain.” 11 (Ex. 5, p. 17.) However, even if petitioner’s
post-vaccination pain was worse, his treating physicians explicitly indicated that they
treated petitioner on the basis that his pain complaints were an exacerbation of his prior

9 Respondent does contend, however, that petitioner’s right shoulder condition is relevant to assessing
the nature of his left shoulder condition.
10
Ex A, p. 8 (Dr. Bishop indicating petitioner’s presentation of symptoms is “more consistent with the
waxing and waning nature of [petitioner’s] shoulder pain and pathology that was well documented through
the years in the records.”); Ex. 25, p. 1 (Dr. Srikumaran indicating that chronic degenerative conditions of
the shoulder can be asymptomatic or “can wax and wane over time with activity levels and treatments.”)
11
Petitioner is competent to testify as to the timing and severity of his pain, but not necessarily its cause
or medical significance. See James-Cornelius v. Sec’y of Health & Human Servs., 984 F.3d 1374, 1380
(Fed. Cir. 2021).

20
chronic shoulder pain. On November 28, 2016, Dr. Sydney recorded “ongoing pain for
quite some time but recently had a flu shot a month ago and had [a] significant increase
in his pain.” (Ex. 5, p. 21.) Later, on April 25, 2017, Dr. Pervaiz noted that petitioner
“had a vaccination into the left shoulder in October of last year which aggravated his left
shoulder pain.” (Id. at 2, 6, 9.)
In fact, petitioner’s argument that onset of post-vaccination pain constituted a
new and novel injury is flatly contradicted by his own expert’s opinion. In his motion for
a ruling on the record, petitioner focuses on the fact that Dr. Srikumaran “concludes
from his review of the medical records that petitioner’s left shoulder injury was directly
attributable to the flu vaccination he received on October 26, 2016.” (ECF No. 53, p. 10
(citing Ex. 18 at 5).) However, after describing petitioner’s clinical history, Dr.
Srikumaran explained that:
By definition, this course of events describes a significant aggravation of
Mr. Kelly’s pre-existing left shoulder condition, which typically was well
managed with conservative measures, was in good condition prior to
vaccine injection, immediately worsened after the injection, failed
conservative measures after injection, was confirmed by diagnostic (MRI
and surgical findings consistent with well known SIRVA pathologies
(bursitis, capsulitis) and required surgery after injection (over 6 months of
symptoms and decreased function). The respondent’s report claims
because Mr. Kelly had similar symptoms and pathology, as well as surgical
treatment of his right shoulder, this represents the natural progression of his
condition. This is not logical. The temporal relationship alone, with respect
to the change in Mr. Kelly’s left shoulder symptoms after injection is strong
evidence to support a significant aggravation claim; a chronic condition
would not be expected to progress so acutely and therefore cannot be
considered ‘natural progression’ of his pre-existing condition.
(Ex. 18, p. 7.)
Even if Dr. Srikumaran opines that petitioner’s vaccination was a factor in
bringing about a specific pattern of post-vaccination pain symptoms, his significant
aggravation opinion necessarily and explicitly encompasses a medical opinion that the
musculoskeletal dysfunction at the root of petitioner’s shoulder pain was the same pre-
and post-vaccination. The entire premise of a significant aggravation claim is that the
vaccine acted on a pre-existing condition. The Table SIRVA criteria does not
necessarily require a spotless prior health history of the affected shoulder. See, e.g.
O’Leary, M.D. v. Sec’y of Health & Human Servs., 18-584v, 2021 WL 3046617, at *8
(Fed. Cl. Spec. Mstr. June 24, 2021) (finding petitioner suffered a Table SIRVA despite
an “old history of trauma to his shoulder” that had previously resolved). However, given
his own expert’s assessment, petitioner’s assertion of a Table Injury for this case is
untenable.

21
b. Petitioner’s Significant Aggravation Claim

i. Petitioner’s condition prior to administration of the vaccine
(Loving prong one)

Petitioner had a long history of shoulder dysfunction, having suffered multiple
shoulder dislocations and having undergone two surgeries on the left shoulder and two
surgeries on the right shoulder. (Ex. 3, p. 29; Ex. 12, p. 3; Ex. 6, p. 2-3; Ex. 17, p.1.) A
rotator cuff release in 2002 appears to have relieved some of petitioner’s symptoms,
though contrary to petitioner’s assertions, it appears that it never fully resolved. (Ex. 3,
p. 29.) Petitioner had been diagnosed with left rotator cuff tendonitis as recently as
June 2015. (Ex. 5, pp. 31-32.) Additionally, after the date of vaccination, petitioner was
also subsequently diagnosed as having the following conditions: impingement
syndrome of the left shoulder and rotator cuff capsule sprain (Ex. 5, p. 21); significant
tendinitis of the subscapularis with a questionable partial tear and significant
supraspinatus and infraspinatus tendinitis (Id. at 19). Based on the medical records
and expert opinions, there is preponderant evidence that at least some of these
conditions were likely chronic and affected petitioner’s left shoulder prior to the
vaccination at issue. Dr. Srikumaran agrees on petitioner’s behalf that “[i]t is not
unusual to have chronic degenerative conditions of the shoulder, as by definition, these
conditions are age related and extraordinarily common. It is important to understand
that the petitioner, like most people his age, will have imaging findings of chronic
degenerative conditions such as fayed or partially torn ligaments and tendons and
osteoarthritic joints.” (Ex. 25, p. 1.)

Petitioner was experiencing reduced pain in the months leading up to his
vaccination, but there is also preponderant evidence that petitioner’s chronic shoulder
dysfunction remained symptomatic at the time of vaccination. Petitioner began
reporting improvement in June of 2016, noting in July that he felt the best he had in
three years. (Ex. 6, pp. 15-23.) However, even thereafter petitioner continued to report
ongoing shoulder pain. (Ex. 6, pp. 13-14.) Petitioner averred that he was experiencing
“dull pain, low in the posterior of my left shoulder/upper back” before his vaccination.
(Ex. 17, p. 1.) As of September 12, 2016, petitioner reported that he was swimming, but
that he still experienced average shoulder pain of between 3-4 on a pain scale. (Ex. 6,
p. 14.) However, he had only mild tightness with internal rotation. (Id. at 13.)

ii. Petitioner’s current condition/condition after administration of the
vaccine (Loving prong two)

With regard to petitioner’s post-vaccination condition, there is no evidence to
suggest that any of petitioner’s chronic shoulder conditions had fully resolved. Rather,
Dr. Srikumaran’s causal opinion is premised on three specific factual contentions
regarding petitioner’s post-vaccination condition. First, Dr. Srikumaran relies on the fact
that post-vaccination petitioner suffered an acute worsening of pain from his own prior
baseline that he opines is inconsistent with the natural progression of his degenerative
conditions. (Ex. 18, p. 7; 25, p. 2.) Second, petitioner’s subsequent surgery revealed

22
severe bursitis and adhesions that are best interpreted as developing post-vaccination.
(Id.) And, third, petitioner’s post-vaccination condition failed conservative treatment
measures. (Ex. 18, p. 7.) All three of these factual contentions are preponderantly
established on this record.

Regarding the first point, petitioner avers that after receiving his vaccination, he
“immediately experienced new, sharp pain in the median of [his] left shoulder where the
shot was administered.” (Ex. 17, p. 1.) This is corroborated by petitioner’s
contemporaneous medical records. Petitioner sought treatment five days after his
vaccination for “sudden” shoulder pain he attributed to his vaccination. (Ex. 7.) On
examination he had limited range of motion due to pain and was assessed with a
vaccine adverse reaction. (Id. at 2.) Petitioner subsequently made similar reports to Dr.
Rosen and PA Shakespeare. (Ex. 6, p. 11; Ex. 5, p. 21.) Although Dr. Rosen had
recorded only mild tightness with internal rotation prior to vaccination on September 12,
2016 (Ex. 6, p. 13), he recorded a reduction in internal rotation, external rotation, and
flexion when petitioner returned on November 9, 2016. (Id. at 11). He also recorded
end of range pain. (Id. at 11.)

There is also some inconsistency in the description of petitioner’s pain (petitioner
avers “new, sharp” pain whereas his initial treatment record records “dull-aching” pain).
(Compare Ex. 17, p. 1 and Ex. 7, p. 1.) Additionally, petitioner’s pain scale rating does
not appear to have changed significantly pre- and post-vaccination. (Compare Ex. 6, p.
14 (pain of 2-6) and Ex. 6, p. 12 (pain of 3 to 7); Ex. 5, p. 21 (pain 3 out of 10).)
However, at least some of these treatment records recorded “sharp” pain and all
identified petitioner’s pain as new or different. (Ex. 14, p. 12 (describing pain as sharp,
burning, dull, stabbing/throbbing, aching); Ex. 6, p. 11 (“Flared up after a flu shot. Now
some high/sharp pain”); Ex. 5, pp. 17-18 (pain has changed in quality from previous left
shoulder pain”); Id. at 21 (“recently had a flu shot a month ago and had significant
increase in his pain.”).)

Dr. Bishop stresses in particular petitioner’s failure to meaningfully describe an
increase in pain using the pain scale. (Ex. A, pp. 10-11.) When viewed as a whole,
however, it is clear from petitioner’s contemporaneous medical records that petitioner
complained of increased pain from the time of his vaccination forward and sought care
accordingly. The pattern with which petitioner sought care, the reported reason for
seeking that care, and the physicians’ examinations and conclusions, are more
illuminating of petitioner’s condition than his specific subjective numerical pain rating.
Petitioner sought care from a walk-in center within days of his vaccination for pain he
specifically attributed to his vaccination. (Ex. 7.) That is highly suggestive of an acute
concern. Additionally, contrary to Dr. Bishop’s assessment that petitioner’s complaints
were consistent with the waxing and waning nature of petitioner’s degenerative
conditions (Ex. A, p. 8), petitioner’s treating physicians treated these pain complaints as
a separate, post-vaccination phenomenon (Ex. 5, pp. 9, 17, 21; Ex. 3, p. 38; Ex. 6, p.
11).

23
In terms of the underlying pathology, Dr. Srikumaran relies on the adhesions and
“severe bursitis” documented in petitioner’s subsequent surgical report. (Ex. 18, pp. 7-8
(Ex. 5, p. 67).) Although petitioner’s prior MRIs taken on November 28, 2016 and June
7, 2017, did not specifically indicate bursitis, petitioner was assessed as having bursitis
in his pre-operative assessment on July 7, 2017. (Ex. 3, p. 27.) Severe bursitis was
then included as a post-operative diagnosis. (Ex. 5, p. 67.) Dr. Bishop acknowledges
this finding but suggests it should be attributed to petitioner’s adhesions from his prior
surgery and is therefore pre-existing. (Ex. A p. 10.) Dr. Srikumaran disagrees,
suggesting that if the finding were related to the prior surgery, it would more likely be
reflected as scarring rather than bursitis. 12 (Ex. 25, p. 2.)

Dr. Bishop’s interpretation of the surgical report is less persuasive. Dr. Bishop
suggests that the “adhesions from the prior surgery” are “really one in the same” as the
bursitis. (Ex. A, p. 10.) However, Dr. Pervaiz was aware of the prior surgery, noted the
post-surgical adhesions during the procedure, and still included severe bursitis as
separate, stand-alone diagnosis both pre- and post-operatively. (Ex. 5, p. 67.)
Relatedly, Dr. Pervaiz’s description of the actual course of surgery and procedures
performed does not appear to bear out Dr. Bishop’s view that the two issues were “one
in the same.” In pertinent part he notes:

Scope was first placed in the glenohumeral joint and subsequently in the
subacromial space. Inside the glenohumeral joint, I found a lot of adhesions
from his previous surgery. I released the rotator interval and the anterior
and posterior capsules, taking care to protect the rotator cuff tendons and
muscles . . . [then discussing other procedures performed] . . . I now placed
the scope in the subacromial space, where I performed a complete
bursectomy.

(Ex. 5, p. 68.)

Bursectomy is a known treatment for the type of subacromial bursitis commonly
seen in SIRVA. 13 Accordingly, Dr. Pervaiz describes two conditions in two different

12
Following the June 2015 injury petitioner suffered in his left shoulder, there are some references to
bursitis among the treating physician impressions indicated in petitioner’s treatment records prior to
vaccination. (Ex. 5, p. 31 (6/4/2015); Ex. 5, pp 27-28 (3/11/2016).) However, there is no accompanying
imaging or surgical report from that period to confirm that diagnosis. Conversely, petitioner’s subsequent
left shoulder MRIs did not confirm the presence of bursitis. (Ex. 5, pp. 75 (MRI of 11/28/2016), 71 (MRI of
6/7/2017).) To the extent that any of these records could potentially be confounding of either or both
expert opinions regarding the origin of the bursitis, neither expert discussed these records in relation to
their discussion of the “severe” bursitis they agree is documented in petitioner’s July 14, 2017, surgical
findings. (Ex. A; Exs. 18, 25.) The discussion between the experts focused exclusively on whether the
bursitis was the result of vaccination or petitioner’s prior shoulder surgery. Both experts opine that the
bursitis was present prior to either of the two MRI studies.

13 Compare, bursa, DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=7308&searchterm=bursa (last visited Mar. 11,
2022) (“a sac or saclike cavity filled with a viscid fluid and situated at places in the tissues at which friction
would otherwise develop.”), and, subacromial bursa, DORLAND’S MEDICAL DICTIONARY ONLINE,

24
anatomical locations (adhesions within glenohumeral joint and bursitis in the
subacromial space) and an additional procedure in treatment of subacromial bursitis
even after having completed the procedure he separately identified as responsive to the
adhesions he visualized as residual from the prior surgery. The report is silent as to any
link between the post-surgical adhesions and separately treated bursitis. This, coupled
with Dr. Pervaiz’s separate diagnosis of “severe” bursitis, appears more consistent with
(or at the very least remains compatible with) Dr. Srikumaran’s opinion that the bursitis
is distinguishable from the post-surgical adhesions. 14 (Ex. 25, p. 2.) And in any event,
Dr. Bishop acknowledges that “[i]f Mr. Kelly had bursitis triggered by an influenza
vaccination, it would be quite difficult to differentiate it from bursitis due to the adhesions
from the prior surgery.” (Ex. A, p. 10.) Importantly then, Dr. Bishop’s ultimate opinion
regarding the bursitis is necessarily informed at least in part by her assessment that
petitioner did not experience any change in his clinical presentation attributable to his
vaccination, a conclusion that I have separately found less persuasive based on the
contemporaneous medical records.

iii. Whether the post-vaccination condition is a “significant
aggravation” of the prior condition (Loving prong three)

As explained above, a significant aggravation is “any change for the worse in a
preexisting condition which results in markedly greater disability, pain, or illness
accompanied by substantial deterioration of health.”15 § 300aa-33(4). Here, consistent

https://www.dorlandsonline.com/dorland/definition?id=62123 (last visited Mar. 11, 2022) (“a bursa located
between the acromion and the insertion of the supraspinatus muscle, extending between the deltoid and
the greater tubercle of the humerus; usually continuous with the subdeltoid bursa.”), and, bursitis,
DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=7315&searchterm=bursitis (last visited Mar. 11,
2022) (“inflammation of a bursa, occasionally accompanied by a calcific deposit in the underlying tendon;
the most common site is the subdeltoid bursa”), and bursectomy, DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=7314&searchterm=bursectomy (last visited Mar.
11, 2022) (“excision of a bursa”); See also, Hesse et al., supra, at Ex. 26, p. 1081, Table 6 (reporting 14
bursectomies out of 476 conceded petitions for SIRVA between July 2010-December 2016).
14 Of note, Dr. Bishop stresses that petitioner’s later right shoulder surgery, which was obviously
unrelated to his left shoulder vaccination, included similar diagnoses. (Ex. A, p. 10.) And, indeed, the
same “severe bursitis” was noted during that surgery and petitioner had a bursectomy of his right
shoulder as well. (Ex. 10, p. 12.) Dr. Srikumaran noted, however, that conditions such as bursitis or
inflammation are subject to various triggers and that prior to onset of the right shoulder symptoms that led
to this right shoulder surgery, petitioner had attributed his symptoms to a fall on his right shoulder while
playing pickleball. (Ex. 18, pp. 7-8 (citing Ex. 5, p. 13).) Given that petitioner did not experience onset of
his right shoulder pain until later, and after a reported fall, it is not clear how valuable his right shoulder
findings are to evaluating his left shoulder pathology. Dr. Bishop herself appears to opine that there is in
general a causal relationship between structural shoulder dysfunction and the development of bursitis. In
this case, each shoulder has been subject to differing histories, traumas, and potential inciting events.
Thus, the fact that petitioner ultimately experienced bursitis in both shoulders does not serve as
confirmation that all of his shoulder pathology was chronic given petitioner’s own specific history.
15
There are two informative cases, Locane and Sharpe, that discuss the significant aggravation analysis
with regard to the evolution of a petitioner’s clinical course. Locane v. Sec’y of Health & Human Servs.,
685 F.3d 1375 (Fed. Cir. 2012); Sharpe v. Sec’y of Health & Human Servs., 964 F.3d 1072 (Fed. Cir.

25
with the statutory definition, the medical records show for the reasons discussed above
that petitioner’s post-vaccination condition reflects a change for the worse in petitioner’s
pre-vaccination condition inclusive of pain and disability as well as a physical
deterioration in health.

Dr. Bishop contends on respondent’s behalf that petitioner’s entire post-
vaccination clinical history is explained by the natural progression of his chronic pre-
existing degenerative shoulder condition. (Ex. A, p. 10-11.) In effect, she suggests that
a degenerative condition should be expected to continue to degenerate and so
petitioner’s ultimate outcome is not surprising. (Id. at 11.) Nor does she assess any
significance in petitioner’s own initial post-vaccination complaints of increased pain,
finding them consistent with the expected overall waxing and waning course of his pre-
existing condition. (Id. at 10-11.) She opines that petitioner’s surgical findings are more
consistent with his degenerative condition than with the type of findings typically seen in
SIRVA. (Id. at 9-11.)

Dr. Srikumaran is persuasive, however, in opining that petitioner suffered an
acute change in his condition post-vaccination. (Ex. 18, p. 5.) The medical records
clearly document that he was improving, albeit incompletely, prior to his vaccination.
This is not necessarily significant in itself for all the reasons Dr. Bishop discussed
regarding the waxing and waning nature of chronic degenerative conditions; however, it
stands in contrast to his immediate post-vaccination presentation. Petitioner promptly
and repeatedly sought care for a “sudden” increase in pain and reduced range of motion
following his vaccination. (Ex. 7, p. 2.) Importantly, his treating physicians, who were
aware of his prior history, treated his post-vaccination complaints on the basis that his
prior condition had been aggravated. (Ex. 5, pp. 9, 17, 21; Ex. 3, p. 38; Ex. 6, p. 11.)
Additionally, Dr. Srikumaran’s opinion is not limited to a change in petitioner’s subjective
complaints. He also provides a reasonable explanation of petitioner’s surgical findings

2020). The parties disagree as to the meaning and significance of these two precedents with respect the
applicable burden of proof. (ECF No. 55, pp. 10-11; ECF No. 56, pp. 6-7.) In Locane, petitioner alleged
her Crohn’s disease, an inflammatory bowel disease, was significantly aggravated by the hepatitis B
vaccine. Locane, 685 F.3d at 1377-78. The special master determined that petitioner failed to show “by
a preponderance of the evidence that she was entitled to compensation under the significant aggravation
theory because the course of her disease was not affected by the vaccination.” Id. at 1378. The Federal
Circuit found no error in the special master’s analysis. Id. at 1381-82. The Locane Court noted that
petitioner was “given ample opportunity to develop her significant aggravation claim but ‘failed to present
persuasive evidence that separates [her] problems from an expected course of Crohn's disease.’” Id. at
1382. In Sharpe, petitioner alleged L.M. had a pre-existing “seizure disorder” and the administration of
the several childhood vaccines at her six-month wellness check-up significantly aggravated L.M.’s pre-
existing condition. Sharpe, 964 F.3d at 1076-77. The special master denied petitioner’s significant
aggravation claim because L.M.’s genetic mutation, and not the vaccination, was the sole, substantial
cause of L.M.’s seizure disorder. Id. at 1080. The Circuit found that the special master’s analysis
improperly “required [p]etitioner to prove the expected outcome for a child with a DYNC1H1 gene
mutation and to show that L.M.’s current, post-vaccination condition was worse than that expected
outcome.” Id. at 1081. The Sharpe Court distinguished the special master’s decision from Locane,
explaining that in Locane “the special master did not require the petitioner to prove that her significantly
aggravated condition was not caused by her preexisting condition. Instead, the special master found that
the petitioner’s condition ‘was not affected by the vaccination.’” Id.

26
that supports the presence of post-vaccination bursitis, providing further evidence of a
physical change for the worse and deterioration of health. Even if petitioner’s
degenerative condition(s) alone could have ultimately led him to become a surgical
candidate at some point in the future, petitioner is not obligated under Sharpe (see n.
15, supra) to prove that his post-vaccination condition is worse than the expected
outcome of his pre-existing condition.
iv. Medical theory of causation (Loving prong four/Althen prong
one)

Petitioner is also required to present a persuasive medical theory of causation
demonstrating that the influenza vaccine could have significantly aggravated his
preexisting shoulder condition. Althen, 418 F.3d at 1278. It is well-established in the
Vaccine Program that compensation may be awarded for shoulder injuries on a cause-
in-fact basis. See, e.g., A.P. v. Sec'y of Health & Human Servs., No. 17-784V, 2022 WL
275785 (Fed. Cl. Spec. Mstr. Jan. 31, 2022); L.J. v. Sec'y of Health & Human Servs.,
No. 17-0059V, 2021 WL 6845593 (Fed. Cl. Spec. Mstr. Dec. 2, 2021); Tenneson v.
Sec'y of Health & Human Servs., No. 16-1664V, 2018 WL 3083140 (Fed. Cl. Spec.
Mstr. Mar. 30, 2018) rev. den., 142 Fed. Cl. 329 (2019). However, petitioner’s medical
theory must be supported by “reputable” scientific evidence and must “pertain[]
specifically to the petitioner’s case.” Moberly, 592 F.3d at 1322.
In his motion petitioner confusingly cites primarily to the Vaccine Injury Table as
support for petitioner’s medical theory with little additional argument. 16 (ECF No. 53, p.
16.) However, especially given the facts of this case, petitioner may not merely rely on
the fact that SIRVA was added to the Vaccine Injury Table to establish a medical theory
for a cause-in-fact claim. Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144,
1147-48 (Fed. Cir. 1992). 17 The government’s recognition of “SIRVA” as a vaccine-
16 Specifically, petitioner argues that “[t]he theory of how administration of an influenza vaccine can cause

SIRVA is so well accepted that the Secretary of Health and Human Services added SIRVA to the Vaccine
Injury Table in 2017.” (Id.) Still more confusing, petitioner continues that “Dr. Srikumaran discusses the
three criteria and indicates that petitioner meets all three criteria.” (Id.) It is not entirely clear what criteria
petitioner is referencing; however, as described above, the Table Injury of SIRVA is premised on four
criteria set forth in the QAI and petitioner has conspicuously failed to meet the first of the four.
17In Grant, the Federal Circuit explained the distinction between Table and non-Table claims and quoted
the legislative history of the Vaccine Act as follows:

If the petitioner sustained or had significantly aggravated an injury not listed in the Table,
he or she may petition for compensation. If the petitioner sustained or had significantly
aggravated an injury listed in the Table but not within the time period set forth in the Table,
he or she may petition for compensation. In both these cases, however, the petition must
affirmatively demonstrate that the injury or aggravation was caused by the vaccine. Simple
similarity to conditions or time periods listed in the Table is not sufficient evidence of
causation; evidence in the form of scientific studies or expert medical testimony is
necessary to demonstrate causation for such a petitioner. (Such a finding of causation is
deemed to exist for those injuries listed in the Table which occur within the time period set
forth in the Table.)

Grant, 956 F.2d at 1147-48 (quoting H.R.Rep. No. 908, 99th Cong., 2d Sess., pt. 1, at 15 (1986),
reprinted in 1988 U.S.C.C.A.N. 6344, 6356) (emphasis in Grant); see also Schick-Cowell v. Sec’y of

27
caused injury was limited by the accompanying QAI criteria. In this case, I have already
concluded for the reasons discussed above that petitioner has not met those criteria.
Thus, if petitioner’s medical theory under Althen prong one was limited to taking judicial
notice of the government’s recognition of SIRVAs as occurring in some contexts,
petitioner’s case would necessarily have to fail under Althen prong two, because the
facts of petitioner’s case do not fall within the confines of that recognition. Accord L.J.,
2018 WL 3083140 (taking judicial notice of the Table Injury of SIRVA under Althen
prong one and applying the Table SIRVA QAI as the basis for assessing Althen prong
two); Tenneson, 2018 WL 3083140 (same). To hold otherwise would be to expand the
causal presumption afforded by the Vaccine Injury Table.
In this case, however, petitioner’s presentation is not so limited given that Dr.
Srikumaran has included in his reports a discussion of relevant medical literature. Dr.
Srikumaran relies on six medical articles addressing the specific context of post-
vaccination shoulder pain. 18 (Ex. 25, pp. 2-5.) Three of those articles are closely
intertwined with respondent’s regulatory rulemaking for SIRVA. Atanasoff et al., and
Bodor and Montalvo were both cited as support for the addition of SIRVA to the Vaccine
Injury Table. Proposed Rulemaking, 2015 WL 4538923, at *45136 (citing Atanasoff et
al., supra, at Ex. 20; Bodor & Montalvo, supra, at Ex. 22.) Hesse et al. examined the
characteristics of a population of cases that were conceded by the government as
SIRVAs within this Program. (Hesse et al., supra, at Ex. 26.) A fourth study, by Hibbs
et al., examined reports of post-vaccination shoulder injuries made to the government
through the VAERS. 19 (Hibbs et al., supra, Ex. 28.)

Respondent contends that “[w]hile it is generally accepted that vaccine
administration can cause shoulder pain, petitioner has not shown how this theory
specifically applies to his case, and his medical record is inconsistent with a vaccine-
mediated injury.” (ECF No. 55, p. 12.) In total, the four studies referenced above
(Atanasoff, et al., Bodor and Montalvo, Hess, et al., and Hibbs, et al.) examine 1,711
cases of post-vaccination shoulder injuries. However, all of the studies were descriptive
analyses without comparison against background rates or controls and, importantly, all
excluded individuals with pre-existing, symptomatic shoulder conditions. To
respondent’s point, petitioner himself would have been excluded from these studies.

Health & Human Servs., 18-656V, 2022 WL 619839 (Fed. Cl. Spec. Mstr. Feb. 8, 2022); A.P., 2022 WL
275785; but see L.J., 2018 WL 3083140 (taking judicial notice of the Table Injury of SIRVA under Althen
prong one for case filed prior to inclusion of SIRVA on the Vaccine Injury Table, but decided after);
Tenneson, 2018 WL 3083140 (same).

18Two additional studies address immune reaction without specific reference to SIRVA or SIRVA-like
presentations. (Dumonde and Glynn, supra, at Ex. 23; Trollmo et al., supra, at Ex. 24.)
19 “VAERS” stands for Vaccine Adverse Event Reporting System. “VAERS is a national spontaneous
reporting (passive surveillance) system to monitor vaccine safety. It is administered by the Centers for
Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA). VAERS accepts
reports of adverse events (AEs) following vaccination from healthcare providers, patients, parents,
vaccine manufacturers, and others.” (Hibbs et al., supra, at Ex. 28, p. 1138.) The studies authors
stressed the inherent limits of the VAERS database as a passive surveillance and noted that this
constrained their ability to draw causal conclusions or assess risk. (Id. at 1141.)

28
The Atanasoff study, cited by petitioner himself as “seminal,” explains why this is
significant. (ECF No. 56, p. 7.) 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. 20, p. 8051.) 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 8052.)
Significant then is the fact of Dr. Srikumaran’s further reliance on a large-scale
study by Hesse et al., examining the risk of post-vaccination subdeltoid bursitis. 20
Instead of examining the characteristics of a population already clinically suspicious for
vaccine-caused injury, this study scoured health encounter data of nearly three million
people who received the 2016-2017 season flu vaccine and searched for incidences of
subdeltoid bursitis diagnosed within 180 days of the administration of the vaccine. 21
(Ex. 27, p. 253.) The authors ultimately concluded that they “identified a small risk for
subdeltoid bursitis with new symptom onset after injection of an influenza vaccine. This
study provides epidemiologic evidence of an association that was previously supported
by clinical evidence from case reports.” 22 (Id. at 259.)

Taken together, the literature filed in this case supports the theory that the flu
vaccine can cause bursitis which in turn can aggravate pre-existing shoulder
dysfunction as initially posited by Atanasoff et al. based on clinical suspicion.
Specifically, the Atanasoff authors explained that:

In general, chronic shoulder pain with or without reduced shoulder joint
function can be caused by a number of common conditions including

20 Significantly, petitioner had a subacromial bursectomy whereas this article cites subdeltoid bursitis.

However, the authors explain that they used the term “subdeltoid bursitis” to refer to both subdeltoid and
subacromial bursitis. (Hesse et al., supra, at Ex. 27, p. 253.) Bodor and Montalvo explained that the two
bursa are contiguous and that injection into the subdeltoid bursa can cause an inflammatory response
extending into the subacromial bursa. (Bodor & Montalvo, supra, at Ex. 22, p. 586.)
21 This study also excluded subjects that had prior shoulder dysfunction (Ex. 27, p. 255); however, it is the

design of the study, and its ability to detect risk, that is key.

22The authors also note that the Institute of Medicine previously concluded that “the evidence
convincingly supports a causal relationship between the injection of a vaccine and deltoid bursitis.”
(Hesse et al., supra, at Ex. 27, p. 253.) The Institute of Medicine (known as the National Academy of
Medicine since 2015) is the medical arm of the National Academy of Sciences. The National Academy of
Sciences (“NAS”) was created by Congress in 1863 to be an advisor to the federal government on
scientific and technical matters (see An Act to Incorporate the National Academy of Sciences, ch. 111, 12
Stat. 806 (1863)), and the Institute of Medicine is an offshoot of the NAS established in 1970 to provide
advice concerning medical issues. When it enacted the Vaccine Act in 1986, Congress directed that the
IOM conduct studies concerning potential causal relationships between vaccines and illnesses. See §
300aa–1 note.

29
impingement syndrome, rotator cuff tear, biceps tendonitis, osteoarthritis
and adhesive capsulitis. In many cases these conditions may cause no
symptoms until provoked by trauma or other events. Reilly et al reviewed a
series of shoulder ultrasound and MRI studies obtained in asymptomatic
persons past middle age and found partial or complete rotator cuff tears in
39% of those individuals. Therefore, some of the MRI findings in our case
series, such as rotator cuff tears, may have been present prior to
vaccination and became symptomatic as a result of vaccination-associated
synovial inflammation.

(Atanasoff et al., supra at Ex. 20, p. 8051.) This is further supported by the Bodor and
Montalvo case studies that specifically concluded that injection into the subdeltoid bursa
likely caused “a robust local immune and inflammatory response” and that “[g]iven that
the subdeltoid bursa is contiguous with the subacromial bursa, this led to a subacromial
bursitis, bicipital tenonitis, and inflammation of the shoulder capsule.” (Bodor &
Montalvo, supra, at Ex. 22, p. 586.) In that regard, the SIRVA medical literature as a
whole also finds significance in the presence of bursitis among these subjects.
(Atanasoff et al., supra, at Ex. 20; Arias et al., supra, at Ex. 21; Bodor & Montalvo,
supra, at Ex. 22; Hesse et al., supra, at Ex. 26; Hesse et al., supra, at Ex. 27.)

The absence of pre-existing shoulder dysfunction among study subjects was
critical to initially uncovering this phenomenon for the reasons discussed by the
Atanasoff authors, but with subsequent study confirming an epidemiologic risk of post-
vaccinal bursitis, there is no obvious reason why someone with known prior shoulder
dysfunction would not also be at the same risk and potentially affected by the same
inflammatory process. Nor has Dr. Bishop specifically offered any such opinion. Dr.
Bishop opined on behalf of respondent that petitioner’s own clinical history is not
compatible with a vaccine-related injury. She offers no opinion rebutting Dr.
Srikumaran’s theory that the flu vaccine can in general cause a significant aggravation
of a pre-existing shoulder condition via bursitis.

v. Logical sequence of cause and effect connecting the
vaccination and significant aggravation (Loving prong
five/Althen prong two)

The second Althen prong/fifth Loving prong requires proof of a logical sequence
of cause and effect showing that the vaccine was the reason for the injury, usually
supported by facts derived from a petitioner's medical records. Althen, 418 F.3d at
1278; Andreu ex re. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1375–
77 (Fed. Cir. 2009); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317,
1326 (Fed. Cir. 2006); Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, at
1148 (Fed. Cir. 1992). However, medical records and/or statements of a treating
physician do not per se bind the special master to adopt the conclusions of such an
individual, even if they must be considered and carefully evaluated. See 42 U.S.C.
§300aa-13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result,
report, or summary shall not be binding on the special master or court”); Snyder v. Sec'y

30
of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing ... that
mandates that the testimony of a treating physician is sacrosanct—that it must be
accepted in its entirety and cannot be rebutted”).

Multiple treating physicians attributed petitioner’s shoulder pain to his October
26, 2016 vaccination. On October 31, 2016, Dr. Nowosielski noted “musculoskeletal
pain after flu vaccination. History indicates sudden onset with likely or irritation of the
nerve.” (Ex. 7, p. 3.) Dr. Nowosielski further noted a “vaccine[] adverse reaction” under
the same section. (Id.) On November 9, 2016, Dr. Rosen noted that petitioner “flared
up after a flu shot, [n]ow some high sharp pain.” (Ex. 6, p. 11.) On November 28, 2016
PA Shakespeare likewise noted in the history of present illness that “[h]e has had
ongoing pain for quite some time but recently had a flu shot a month ago and had
significant increase in his pain.” (Ex. 5, p. 21.) On April 25, 2017, June 6, 2017, and
June 21, 2017, petitioner presented to Dr. Pervaiz who noted in the history of present
illness—“[h]e had a vaccination into the left shoulder in October of last year which
aggravated his left shoulder pain.” (Ex. 5, pp. 2, 6, 9.)
Respondent argues that the comments of petitioner’s treating physicians largely
memorialize petitioner’s subjective assessment of his own injury. (ECF No. 55, pp. 12-
13.) Alternatively, respondent asserts that these comments reflect the waxing and
waning nature of petitioner’s chronic shoulder pathology. (Id.) While the records from
Dr. Nowosielski, Dr. Rosen, PA Shakespeare, and Dr. Pervaiz may include subjective
reports from petitioner, I am not persuaded by respondent’s suggestion that they also
lack considered medical judgment on the part of the treating physicians. For example,
in taking petitioner’s report of post-vaccination pain, Dr. Nowosielski was careful to note
petitioner’s prior history of bilateral shoulder dysfunction. (Ex. 7, p. 2.) She also
confirmed his report of decreased range of motion by physical examination. (Id.)
Moreover, in assessing a vaccine adverse reaction, she contemplated both the
musculoskeletal pain described by petitioner as well as the possibility of a neurologic
etiology. (Id. at 3.) Dr. Rosen likewise recorded petitioner’s history, but also completed
a physical examination and included myalgia of the left shoulder “[status post] flu shot”
within his impression. (Ex. 6, p. 11.) Dr. Rosen’s assessment is particularly significant
as he was the physician that had most recently treated petitioner’s left shoulder just six
weeks prior to vaccination. (Id. at 13.) Other physicians were silent as to whether
petitioner’s vaccination played any causal role in his presentation, but none contradicted
these initial assessments. (Ex. 3, p. 38 (Dr. Garber); Ex. 5, pp. 17, 21 (Dr. Sydney).)
Nonetheless, respondent and Dr. Bishop contend that petitioner’s clinical course
is better explained by his chronic degenerative conditions. (ECF No. 55, pp. 12-13; Ex.
A, pp. 10-11.) Dr. Bishop opines that “[t]here is overwhelming evidence that the final
state of [petitioner’s] left shoulder, described at the time of his surgery, was pre-existing
and dated back to the 1980’s, which means he had 40 years of issues with his left
shoulder prior to his vaccination.” (Ex. A, p. 8.) Thus, Dr. Bishop opines that most of
the pathology addressed during petitioner’s surgery was ultimately unrelated to his
vaccination. (Id. at 8-9.) She further opines that “the natural course of the pathology in
[petitioner’s] shoulder was [progressive,] and surgical intervention was the reasonable
conclusion to address this pathology, regardless of the vaccination.” (Id. at 11.)

31
There is no question that petitioner had substantial prior shoulder dysfunction as
Dr. Bishop explains. As discussed above, however, petitioner is not obligated to prove
his condition is worse than his expected outcome. Sharpe, 964 F.3d at 1081-82.
Additionally, petitioner is not obligated to prove that his vaccination was the sole or
predominant cause of his injury. Shyface, 165 F.3d at 1352. Dr. Srikumaran is
persuasive in opining, with support from the medical records, that petitioner’s
vaccination was a but-for cause and substantial contributing factor leading to a
significant aggravation of his pre-existing shoulder dysfunction via the bursitis
demonstrated within petitioner’s surgical report.
Given the extent of petitioner’s pre-existing chronic degeneration, this represents
a close case. 23 Dr. Bishop’s competing interpretation of petitioner’s history, though
ultimately less persuasive, is also plausible. However, petitioner’s history contains none
of the confounding factual issues from the post-vaccination period that sometimes
hinder or defeat SIRVA or SIRVA-like claims (e.g., petitioner did not delay in seeking
treatment and did not waver in placing onset at the time of vaccination when speaking
with his physicians). Even with pre-existing shoulder dysfunction, petitioner’s history is
indicative of a logical sequence of cause and effect supportive of vaccine-causation for
all the reasons discussed by Dr. Srikumaran and reflected in petitioner’s
contemporaneous medical records. 24
vi. Proximate temporal relationship between vaccination and
significant aggravation (Loving prong six/Althen prong three)

The third Althen prong/sixth Loving prong requires establishing a “proximate
temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d
at 1281. That term has been equated to the phrase “medically-acceptable temporal
relationship.” Id. A petitioner must offer “preponderant proof that the onset of
symptoms occurred within a timeframe which, given the medical understanding of the
disorder's etiology, it is medically acceptable to infer causation.” de Bazan v. Sec'y of
Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008).
Petitioner stresses that the Atanasoff and Arias articles support the notion that
the strong immune mediated inflammatory reaction occurs in most, but not all patients

23 “The Vaccine Act does not contemplate full blown tort litigation in the Court of Federal Claims. The
Vaccine Act established a federal ‘compensation program’ under which awards are to be ‘made to
vaccine-injured persons quickly, easily, and with certainty and generosity.’” Knudsen v. Sec’y of Health &
Human Servs., 35 F.3d 543, 549 (Fed. Cir. 1994) (quoting H.R.Rep. No. 99–908, 99th Cong., 2d Sess.
18, reprinted in 1986 U.S.C.C.A.N. 6344). Accordingly, the Federal Circuit has suggested that this
program represents a “system created by Congress, in which close calls regarding causation are resolved
in favor of injured claimants.” Althen, 418 F.3d at 1280. I do stress that there is preponderant evidence
supporting petitioners’ claim. However, I also note that the outcome in this case is consistent with the
Federal Circuit’s guidance regarding the generous and remedial nature of this program.

24 In fact, as explained above, respondent’s only defense against petitioner’s Table SIRVA claim is his

pre-existing shoulder dysfunction with no argument advanced regarding the remaining three QAI criteria.
Obviously, this is not controlling in a cause-in-fact context, but it illustrates that petitioner’s medical history
during the post-vaccination period likely would have been suspicious for vaccine-causation (even to
respondent) but for the fact of his prior condition.

32
within 48 hours. (ECF No. 56, p. 11.; Atanasoff et al., supra, at Ex. 20; Arias et al.,
supra, at Ex. 21.) A 48-hour onset under Althen prong three has been accepted in other
cause-in-fact shoulder injury claims. See, e.g., A.P., 2022 WL 2757857; L.J., 2021 WL
6845593; Tenneson, 2018 WL 3083140.
Respondent does not argue in favor of any other understanding of what would
constitute a medically acceptable timeframe. Respondent argues only that petitioner
has not presented sufficient evidence to show that “any significant aggravation occurred
within a medically-acceptable timeframe following vaccination.” (ECF No. 55, p. 14.)
Specifically, respondent argues that petitioner experienced “roughly the same levels of
waxing and waning pain both before and after vaccination.” (Id.)
As explained above, petitioner began presenting for treatment of his post-
vaccination shoulder pain only five days after vaccination. At that time, and consistently
thereafter, he placed onset of his increased shoulder pain at or about the time of
vaccination. (Ex. 7; Ex. 6, p. 11; Ex. 5, pp. 9, 17, 21; Ex. 3, p. 38; Ex. 8; Ex. 17.) When
he first presented for care, he described “a sudden onset of pain with the injection” and
described having pain “ever since” receiving the vaccination. (Ex. 7, pp. 1-2.) There is
preponderant evidence that petitioner’s significantly aggravated shoulder pain began
within a medically-acceptable period following vaccination such that causation can be
inferred.

VII. Conclusion
For all the reasons discussed above, after weighing the evidence of record within
the context of this Program, I find by preponderant evidence that petitioner suffered a
significant aggravation of his pre-existing left shoulder injury caused-in-fact by his
October 26, 2016 flu vaccination. A separate damages order will be issued.

IT IS SO ORDERED.

s/Daniel T. Horner
Daniel T. Horner
Special Master

33

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/6332752. Public record. Not legal advice.