Kelly v. Secretary of Health and Human Services

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.

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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

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(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.

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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.)

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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.

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(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.)

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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

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