1

In the United States Court of Federal Claims 

OFFICE OF SPECIAL MASTERS

No. 18-1736V

Filed: February 24, 2023

PUBLISHED

JOYCE GRUSZKA,

 Petitioner,

v.

SECRETARY OF HEALTH AND 

HUMAN SERVICES,

 Respondent.

Michael G. McLaren, Black McLaren et al., PC, Memphis, TN, for petitioner.

Christine Becer, U.S. Department of Justice, Washington, DC, for respondent.

DECISION1

On November 8, 2018, petitioner filed a petition under the National Childhood 

Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012),2 alleging that as a result of her 

August 18, 2017, influenza vaccination, she suffered a left Shoulder Injury Related to 

Vaccine Administration (“SIRVA”). (ECF No. 1.) Respondent recommended that 

compensation be denied, arguing, inter alia, that there is not preponderant evidence 

that petitioner’s shoulder pain began within a timeframe that would support a finding of 

vaccine causation, namely 48 hours. (ECF No. 21.) In a prior Finding of Fact, I 

concluded that there is not preponderant evidence that petitioner suffered onset of new 

or significantly aggravated left shoulder pain within 48 hours of her August 18, 2017, flu 

vaccination. (ECF No. 62.) For the reasons discussed below, I now further conclude 

that petitioner is not entitled to compensation.

1 Because this finding of fact 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 EGovernment Act of 2002. See 44 U.S.C. § 3501 (2018) (Federal Management and Promotion of 

Electronic Government Services). This means the document will be available to anyone with access 

to the Internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to 

redact medical or other information the disclosure of which would constitute an unwarranted invasion of 

privacy. If the special master, upon review, agrees that the identified material fits within this definition, it 

will be redacted from public access.

2 All references to “§ 300aa” below refer to the relevant section of the Vaccine Act at 42 U.S.C. § 300aa10-34 (2018).

Special Master Horner

Shoulder Injury Related to 

Vaccine Administration 

(SIRVA); Influenza (Flu) 

Vaccine; Dismissal
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I. Applicable Statutory Scheme

Under the National Vaccine Injury Compensation Program, compensation 

awards are made to individuals who have suffered injuries after receiving vaccines. In 

general, to gain an award, a petitioner must make a number of factual demonstrations, 

including showing that an individual received a vaccination covered by the statute; 

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 aa11(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 vaccination. § 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 her 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;
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(iii) Pain and reduced range of motion are limited to the shoulder in which 

the intramuscular vaccine was administered; and

(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 show 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 show by preponderant 

evidence: (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 in order to prove causation-in-fact. 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 her assertions; rather, the petition must be supported by either medical 

records or by the opinion of a competent physician. § 300aa-13(a)(1). Once a 

petitioner has established their prima facie case, the burden then shifts to respondent to 

prove, also by preponderant evidence, that the alleged injury was caused by a factor 

unrelated to vaccination. Althen, 418 F.3d at 1278; § 300aa-13(a)(1)(B). 

Additionally, in some cases a petitioner may allege that the vaccine at issue 

“significantly aggravated” a pre-existing condition. The Vaccine Act defines a significant 

aggravation as any change for the worse in a pre-existing 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, the petitioner must establish the three 

Althen prongs along with three additional factors described in the prior Loving case. 

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 
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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. 

II. Procedural History

Petitioner filed her petition on November 8, 2018. (ECF No. 1.) This case was 

initially assigned to the Court’s Special Processing Unit (“SPU”) on November 9, 2018. 

(ECF No. 4.) On November 12, 2018, petitioner filed an affidavit, medical records, and 

a statement of completion. (ECF Nos. 6, 7.) Subsequently, petitioner filed additional 

medical records and her second affidavit. (ECF Nos. 10, 11, 13.) On November 30, 

2019, respondent filed his Rule 4 report, recommending that entitlement be denied in 

this case. (ECF No. 21.) Respondent raised the issue that “the record does not 

establish that petitioner suffered SIRVA from a vaccination within forty-eight hours and 

she had significant underlying chronic shoulder issues[.]” (Id. at 5.) Specifically, 

respondent noted that petitioner’s treating physicians had identified advanced 

osteoarthritis of the affected shoulder and petitioner had reported on multiple occasions 

during her treatment that she had a prior history of left shoulder pain from 2015. (Id. at 

4.) On December 10, 2019, this case was removed from the SPU and reassigned to my 

docket. (ECF No. 23.) 

A fact hearing was held on October 6, 2021, and I subsequently issued a Finding 

of Fact regarding onset of petitioner’s alleged shoulder pain on July 7, 2022. (ECF Nos. 

58, 62; see also Gruszka v. Sec’y of Health & Human Servs., No. 18-1736V, 2022 WL 

3024777 (Fed. Cl. Spec. Mstr. July 7, 2022).) The procedural history leading up to that 

Finding of Fact is discussed in the Finding of Fact itself. (ECF No. 62, pp. 2-3.) After 

reviewing the record as a whole, the Finding of Fact concluded that 

[T]he evidence preponderates in favor of a finding that petitioner 

experienced prior episodes of left shoulder pain and also experienced a 

gradual onset of similar left shoulder pain with an indeterminate initial onset 

occurring sometime between late August and early October of 2017. 

However, there is not preponderant evidence that onset of left shoulder 

pain, whether new or aggravated, occurred within 48 hours of her August 

18, 2017, vaccination.

(Id. at 24.)

Following issuance of the Finding of Fact a follow up status conference was held 

on August 24, 2022. (ECF No. 64.) During the call, petitioner’s counsel argued that the 

Finding of Fact did not foreclose a causation-in-fact claim. Because the parties’ experts 

had submitted their reports prior to the fact hearing and finding of fact, I afforded 

petitioner the opportunity to determine whether she would file a supplemental expert 

report accounting for the finding of fact. (Id.) However, I indicated that I felt an 

entitlement hearing to take expert testimony was unlikely to be necessary. (Id.)
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On September 20, 2022, petitioner filed a status report confirming that 

“[p]etitioner believes that her expert’s report adequately addresses the significance of 

whether it is material or not to have a sudden or gradual onset in this case. As such, 

she does not currently anticipate filing a supplemental report.” (ECF No. 65.)

Subsequently, on October 21, 2022, I issued a Scheduling Order explaining that 

based on the prior status conference and subsequent status report the case is 

presumptively ripe for resolution on the existing record. I provided the parties a short 

period of time to raise any objection, but otherwise set a briefing schedule pursuant to 

Vaccine Rule 8(d). (NON-PDF Order 10/21/2022.) Petitioner filed a Motion for a Ruling 

on the Record on December 5, 2022. (ECF No. 67.) Respondent filed his response on 

January 4, 2023, and petitioner filed a reply on January 11, 2023. (ECF Nos. 68-69.) 

In his response to petitioner’s motion, respondent noted that petitioner’s expert 

report from Dr. Srikumaran included language referencing significant aggravation even 

though petitioner’s petition and motion relied on causation-in-fact under Althen. (ECF 

No. 68, p. 8.) Respondent addressed significant aggravation “for the sake of 

completeness.” (Id. at 9.) In reply, petitioner states that “[r]espondent arguing against 

compensation because of significant aggravation issues is premature and not currently 

at issue before this Court.” (ECF No. 63, p. 2.) Petitioner further states that “[t]his 

Motion [is] seeking a ruling on cause-in-fact (not significant aggravation) based on the 

current state of the record. Should this Court find Petitioner’s record does not establish 

a pure cause-in-fact claim, Petitioner would still reserve the right to investigate and/or 

pursue a significant aggravation claim.” (Id. at 3.)

On January 13, 2023, I issued a scheduling order requiring petitioner to pursue 

any significant aggravation claim in advance of my entitlement determination or the 

claim would be waived. (ECF No. 70 (citing Vaccine Rules 8(d) and 8(f)).) Petitioner 

subsequently filed an amended petition including a significant aggravation claim and a 

supplemental brief in support of that claim. (ECF Nos. 72-73.) Respondent 

subsequently filed a status report confirming he would rely on his prior motion response 

and not provide any further response to petitioner’s supplemental filings. (ECF No. 74.) 

On February 15, 2023, I issued a follow up order confirming that the case is once again 

ripe for resolution and that a ruling on petitioner’s pending motion and supplemental 

filings would be issued. (NON-PDF Order 2/15/2023.)

In light of the above, I conclude that the parties have had a full and fair 

opportunity to develop the record of this case and that the case is ripe for resolution on 

the existing record.3 No additional evidence was filed subsequent to the July 7, 2022 

Finding of Fact. Accordingly, Sections III and IV, below, including recitation of both the 

3 Special masters “must determine that the record is comprehensive and fully developed before ruling on 

the record.” Kreizenbeck v. Sec’y of Health & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020) 

(citing Simanski v. Sec’y of Health & Human Servs., 671 F.3d 1368, 1385 (Fed. Cir. 2012); Jay v. Sec’y of 

Health & Human Servs., 998 F.2d 979, 983 (Fed. Cir. 1993.)); see also Vaccine Rule 8(d); Vaccine Rule 

3(b)(2). The parties must have a full and fair opportunity to present their case and develop a record 

sufficient for review. Id. 
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medical records and witness testimony, are repeated verbatim from the Finding of Fact. 

However, the discussion of the expert reports contained in Section V is more extensive 

than what was contained in the Finding of Fact. The Finding of Fact addressed the 

expert reports only to the extent their medical expertise helped inform the factual 

question at issue. In this decision, the expert reports are assessed in whole, including 

consideration of both the experts’ assessment of the medical records and their ultimate 

causal opinions.

III. Factual History

a. Medical Records

i. Pre-vaccination records 

Petitioner’s prior medical history is significant for bilateral knee pain, right foot / 

ankle pain, osteoarthritis, and ankylosing spondylitis. (Ex. 6, pp. 56-75, 91-149; Ex. 9, 

pp. 72-74, 76-77; Ex. 21, p. 11.) On October 21, 2015, petitioner presented to Gregory 

Kirwan, D.O., at Premier Orthopaedic & Sports Medicine Group (“Premier Ortho”), for a 

right foot assessment. (Ex. 5, p. 1.) Petitioner’s past surgical history included carpal 

tunnel release. (Id.) Petitioner was assessed with right foot pain, right ankle pain, 

cellulitis in her right lower extremity, and rheumatoid arthritis in her foot. (Id. at 4-5.) 

On March 27, 2017, petitioner presented to Mariclaire Schultz, D.C. for an initial 

exam. (Ex. 3, p. 1.) In her initial findings Dr. Schultz noted posterior right knee pain in 

extension, cervical instability with a prior cervical fracture, and bilateral ankle swelling. 

(Id.) There was no mention of shoulder or arm pain. (See id.) However, on physical 

examination, petitioner showed reduced range of motion in her shoulders bilaterally, 

and in her cervical and thoraco-lumbar regions. (Id. at 2.) Subsequently petitioner 

returned to Dr. Schultz for additional adjustments on April 3, April 10, June 5, July 18, 

and August 7, 2017. (See id. at 2-3.) 

On May 22, 2017, petitioner presented to Michael S. Rosen, M.D., complaining of 

ongoing paresthesia in her legs, left greater than right. (Ex. 6, p. 46.) She reported a 

history of diabetes. (Id.) Dr. Rosen observed that her ankylosing spondylitis was 

otherwise well managed. (Id.) He ordered an ultrasound to rule out a Baker’s cyst and 

ordered petitioner to return in 6 weeks. (Id. at 47.) 

On June 7, 2017, petitioner underwent an EMG evaluation, complaining of 

burning pain in her calves. (Ex. 6, p. 41.) Extensive EMG evaluations were completed 

in the muscles of both lower extremities, innervated by lumbar nerve roots L2 through 

S2. (Id.) Daniel Kane, M.D., indicated that the electrodiagnostic testing in conjunction 

with petitioner’s history and physical exam revealed “electrical evidence of a very mild 

generalized peripheral neuropathy.” (Id. at 41-42.) He further noted that this condition 

was both demyelinating and axonopathic, affecting both petitioner’s motor and sensory 

nerves. (Id. at 42.) However, Dr. Kane observed that “[t]here is really not a lot of 

evidence to suggest a significant lumbar radiculopathy” and while there were some 
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reinnervation potentiate noted throughout her legs, he concluded that the results were 

“really not too bad for patients 74 years old [sic].” (Id.) There was no evidence of 

lumbosacral plexopathy nor myopathy contributing to petitioner’s symptoms. (Id.) 

On July 28, 2017, petitioner presented to Nicholas Giuliani, M.D., for a follow-up 

visit, with no pain or stiffness, and no further paresthesia in her right leg. (Ex. 6, p. 38.) 

On examination Dr. Giuliani noted no synovitis, and no change in range of motion in 

petitioner’s lumbar spine. (Id. at 39.) Petitioner’s routine labs were normal, and she 

was ordered to return in four months. (Id. at 39-40.) 

ii. Vaccination and post-vaccination records 

Petitioner received an influenza vaccination in her left arm / deltoid on August 18, 

2017. (Ex. 2, p. 4.) On August 22, 2017, petitioner presented to Richard Ziegler, M.D., 

at Premier Ortho for chronic right foot pain. (Ex. 9, pp. 28-29.) In addition to right foot 

pain, petitioner complained of decreased mobility, difficulty sleeping, joint tenderness, 

limping, night pain, swelling, and weakness. (Id. at 28.) Dr. Ziegler noted that petitioner 

was previously seen for her right foot on 10/21/15 with Dr. Kirwan. (Id.) Petitioner also 

mentioned that she saw Dr. Rosen for treatment of her arthritis. (Id.) There was no 

mention of left shoulder pain. (Id. at 28-29.) 

On August 31, 2017, petitioner returned to Premier Ortho to Spencer Monaco, 

DPM, for right ankle pain. (Ex. 5, p. 14-19.) Dr. Monaco reviewed her right foot MRI 

and assessed petitioner with a mild ankle varus deformity. (Id. at 18-19.) There was no 

mention of shoulder pain. (Id. at 17-22.) Petitioner returned to Dr. Monaco again on 

September 28, 2017, complaining of right foot pain. (Id. at 20-23.) Dr. Monaco 

recommended an ankle brace and noted that petitioner was doing well with nonsurgical 

treatment. (Id.) Still, there was no mention of shoulder pain. (Id. at 23-26.) 

On October 5, 2017, petitioner returned to Dr. Schultz complaining of left 

shoulder discomfort. (Ex. 3, p. 3.) Petitioner “[r]eported just receiving flu shot in left arm 

a few weeks ago (8/18/17).” (Id.) Dr. Schultz noted decreased range of motion to 

flexion, extension, hyperabduction, adduction, internal rotation, external rotation. (Id.) 

No shoulder range of motion measurements were provided. (Id.) Dr. Schultz performed 

a deep tissue massage on petitioner’s left shoulder and adjusted her proximal humerus 

and superior / lateral scapula. (Id.) On November 2, 2017, petitioner returned to Dr. 

Schultz still experiencing pain in her shoulder. (Id. at 4.) Dr. Schultz repeated the same 

adjustments on petitioner’s left shoulder. (Id.) 

On November 28, 2017, petitioner returned to Dr. Rosen complaining of bilateral 

knee pain and “left shoulder pain for the past 2 months with abduction.” (Ex. 6, p. 35.) 

Dr. Rosen further remarked that petitioner was “doing better taking the Remicade every 

4 weeks instead of every 5 weeks. She has ankylosing spondylitis along with 

osteoarthritis.” (Id.) On physical examination, Dr. Rosen observed “[h]er upper and 

lower extremities reveal no loss of strength or motion. [Range of motion] is full.” (Id. at 

36.) Furthermore, he observed crepitation of the knees bilaterally and impingement in 
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the left shoulder, with abduction at 160 degrees. (Id.) Petitioner’s updated diagnoses 

included ankylosing spondylitis of multiple sites in the spine and primary generalized 

osteoarthritis. (Id.) Dr. Rosen ordered x-rays of the left shoulder and physical therapy, 

noting that if her pain continued, he planned to inject the left shoulder with steroids. 

(Id.) 

On December 6, 2017, petitioner presented to Jonathan Mayer, PT, DPT, at 

Excel Physical Therapy. (Ex. 4, pp. 5-17.) She presented with left shoulder pain, 

mostly in the lateral deltoid region and worse when raising her arm overhead, reaching 

in overhead cabinets, reaching behind back for dressing, bathing, groom, and 

lifting/carrying. (Id. at 13.) She described her pain as a dull ache, rated at 3/10 at best 

and 8/10 at worst. (Id.) Petitioner’s pain “began back in August and came on 

gradually.” (Id.) Mr. Mayer further indicated that she had “a similar pain in the past 

about 5 years ago of [left] shoulder that responded very well with physical therapy.” 

(Id.) On examination, petitioner’s impingement, Empty Can, Hawkin’s – Kennedy, 

Neers, painful arc, and infraspinatus tests were positive. (Id. at 14.) Mr. Mayer 

assessed petitioner with rotator cuff tendinitis and degenerative changes. (Id. at 16.) 

She completed ten physical therapy sessions.4 (Ex. 4.) 

On December 7, 2017, petitioner underwent x-rays of her left shoulder which 

revealed no fractures or dislocations, a large osteophyte overlying the inferior portion of 

the humeral head; degenerative changes and subchondral cysts in the region of the 

ureter and lesser tubercle; mild cortical irregularity overlying the lesser tubercle; no 

abnormal soft tissue calcifications; and mild degenerative changes in the 

acromioclavicular joint. (Ex. 6, p. 14.) 

On December 11, 2017, petitioner presented to Dr. Schultz for a deep tissue 

massage and left shoulder adjustment. (Ex. 3, p. 4.) Petitioner complained of shoulder 

pain on passive range of motion, especially in flexion at 80 degrees and hyperabduction 

at 80 degrees. (Id.) She noted that she could not put dishes away overhead. (Id.) Dr. 

Schultz further noted “[c]urious is there a correlation between flu shot and pain / 

[decreased range of motion].”5 (Id.) 

On February 26, 2018, petitioner presented to a rheumatologist, Nicholas 

Giuliani, M.D. (Ex. 6, p. 10-12.) She reported that she had shoulder pain for about one 

year, and that PT had helped but she still had pain on abduction. (Id.) Petitioner 

described the pain as burning, and worse with movement, better with rest. (Id.) She 

also complained of right knee pain, and previous injections in both knees. (Id.) Dr. 

4 Petitioner’s final treatment session was on January 11, 2018. (Ex. 4, pp. 57-64.) In her discharge 

summary Mr. Mayer noted that petitioner’s “shoulder was feeling much better overall. Only slight 

discomfort when reaching for heavier items.” (Id. at 62.) She demonstrated “great improvements of [left] 

shoulder ROM, strength, stability” and was discharged home with an independent home exercise 

program. (Id. at 64.) 

5 Subsequently, petitioner returned for 18 additional deep tissue and left shoulder adjustments between 

February 27, 2018, and May 14, 2019. (Ex. 3, pp. 4-9; Ex. 12.) By July 23, 2018, Dr. Schultz observed 

that petitioner “continues with shoulder exercises, but no real progress seen.” (Id. at 8.) No mention of 

petitioner’s vaccination is made in the records from the remaining visits. (See Ex. 3, Ex. 12.) 
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Giuliani remarked that her ankylosing spondylitis was otherwise doing well on 

Remicade. (Id.) On examination, petitioner had limited range of motion in the left 

shoulder with fluid in the joint. (Id.) The fluid was aspirated and showed rare white 

blood cells and crystals. (Id.) Petitioner was given a steroid injection. (Id.) 

On June 4, 2018, petitioner returned to Dr. Rosen for a follow-up for left shoulder 

pain. (Ex. 6, pp. 2-4.) Petitioner had a transient response to the bursa steroid injection 

in her left shoulder, but the pain returned. (Id.) Dr. Rosen remarked that she had 

“known osteoarthritis of both joints” and physical therapy had not been very helpful. 

(Id.) On physical examination, petitioner could abduct the left shoulder to only 60 

degrees. (Id.) Dr. Rosen noted that “[he] believe[d] the shoulder is significantly affected 

with osteoarthritis so a repair of the rotator cuff would not be practical” and referred her 

to Dr. Towsen for evaluation for a left total shoulder arthroplasty. (Id.) Dr. Rosen 

further observed petitioner’s “ankylosing spondylitis is doing well with Remicade[.]” (Id.) 

On June 18, 2018, petitioner presented to Adrienne Towsen, M.D., for a left 

shoulder evaluation. (Ex. 5, p. 24-28.) Petitioner described her symptoms as “chronic 

non-traumatic.” (Id. at 24.) Dr. Towsen noted that petitioner “had an injection of the left 

shoulder in 2015 which gave her good relief and “she notes left shoulder pain for a few 

months.” (Id.) Dr. Towsen’s assessment was primary osteoarthritis of the left shoulder. 

(Id. at 28.) Her impression was that petitioner had: 

[v]ery advanced [degenerative joint disease] in her shoulder and her [range 

of motion] is limited. This is her non-dominant arm, but she is still very 

functionally limited with this arm. Her pain is constant. She did have an 

injection a few year[s] ago which helped her for a while. We discussed 

option[s] including TSA. I think she would be a great candidate for this. She 

has done PT in the past as well, which helped a little but I think it would only 

aggravate it now. 

(Id.) Petitioner received an injection in her left shoulder and Dr. Towsen ordered her to 

follow-up as needed. (Id.) 

On October 8, 2018, petitioner returned to Dr. Rosen complaining of chronic 

shoulder pain, reporting that she saw an orthopedic surgeon and “feels she needs a 

total shoulder arthroplasty.” (Ex. 10, pp. 20-23.) In the plan portion Dr. Rosen noted no 

change to petitioner’s treatment regimen. (Id.) Subsequently petitioner continued with 

anti-inflammatory drugs and Remicade for petitioner’s ankylosing spondylitis through 

March 2019. (Id. at 5-15.) 

On January 3, 2020, petitioner presented to Charles L. Getz, M.D., at Rothman 

Orthopaedics, complaining of shoulder pain of one week. (Ex. 21, p. 284.) Petitioner 

reported that she fell onto her left shoulder getting out of a car, resulting in a dislocation. 

(Id.) Dr. Getz observed that petitioner “has had a history of left shoulder problems for 

quite sometime and had an injection about five or six years ago.” (Id.) Dr. Getz ordered 

and reviewed petitioner’s x-rays showing a reduced shoulder joint and advanced 
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osteoarthritis / rheumatoid arthritis of the left shoulder. (Id.) On physical examination, 

Dr. Getz observed active forward flexion elevation on the left to 30 degrees, neutral 

external rotation, significant crepitation through range of motion, normal internal and 

external rotation strength testing, normal deltoid strength in the left shoulder, and 

decreased active and passive range of motion in the right shoulder. (Id.) Dr. Getz 

concluded that petitioner was a candidate for shoulder replacement “based on her 

preexisting arthritis.” (Ex. 21, p. 284-85.) 

On January 22, 2020, petitioner presented to rheumatologist Michael R. 

Lattanzio, M.D., for a follow-up visit. (Ex. 20, p. 7.) Dr. Lattanzio noted that petitioner 

fell and dislocated her shoulder and was told she needs a left total shoulder 

arthroplasty. (Id.) Petitioner deferred shoulder replacement at this point. (Id.) On 

physical examination, he observed no change in her range of motion of the spine. (Id. 

at 8.) Petitioner was ordered to return in four months for a follow-up. (Id.) 

b. Letter and Testimony from Dr. Schultz 

On May 1, 2020, petitioner filed an undated letter written by Dr. Mariclaire 

Schultz. (Ex. 17.) Dr. Schultz indicates that her treatment of petitioner began in March 

2017. (Id. at 1.) During that time, she was treating petitioner for “typical age-related 

issues.” (Id.) Dr. Schultz notes that “[o]n October 5, 2017’s visit, [petitioner] complained 

of an acute pain in her left shoulder with marked decrease to her shoulder [range of 

motion] (induced pain at the end ROM especially in forward flexion and abduction near 

75 degrees; she could reach 90 degrees with my assistance.” (Id.) From that time 

forward Dr. Schultz began to adjust petitioner’s left AC joint, encouraged ADL 

modification and recommended home/aquatic exercises. (Id.) According to Dr. Schultz, 

the onset was “sudden and did not follow the typical pathway of a normal, systemic 

degenerative disease.” (Id. (emphasis in original.)) Dr. Schultz “grew pretty concerned 

upon hearing that [petitioner] had just received the [flu] shot, especially because it was 

done at a pharmacy.” (Id.) 

Dr. Schultz also testified at the fact-hearing regarding her records and petitioner’s 

treatment. (Tr. at 57-92.) Dr. Schultz testified that in her first evaluation with petitioner 

on March 27, 2017, petitioner did not have any significant injuries to her left shoulder. 

(Id. at 61.) She testified that petitioner had “limitation bilaterally, both sides of the 

shoulder, that, to me, were age-related and pretty typical. It didn’t put up a red flag for 

me.” (Id.) Petitioner was not in active pain at that visit, though Dr. Schultz testified that 

petitioner “didn’t have full range of motion, but she – it was pretty balanced on both her 

shoulder, but no pain.” (Id. at 62.) 

Dr. Schultz testified that petitioner discussed neck pain with her in her initial visit, 

on March 27, 2017, “but that was a history, just to clarify, cervical instability.” (Tr. at 66.) 

Dr. Schultz explained that petitioner would have a sore neck if she slept incorrectly, but 

nothing alarming. (Id.) In her course of treatment, Dr. Schultz testified that she spends 

about 40 minutes on every patient and she “deal[s] with the primary problem that [they] 

come in for, if [they] have one, and then [she] work[s] through, from head to toe, every 
11

single joint.” (Id.) In every visit Dr. Schultz works through range of motion exercises on 

both sides, “[s]o even though I haven’t written that down, that’s my protocol for years 

and years.” (Id. at 67.) Therefore, “if [she] had seen or felt or observed a change in 

[petitioner’s] range of motion in her shoulders, [she] would have noted that.” (Id.) Dr. 

Schultz confirmed that the lack of any notation indicates that petitioner was not 

complaining about shoulder problems. (Id.) On October 5, 2017, Dr. Schultz testified 

that petitioner presented with left shoulder discomfort, reporting that she had just 

received the flu shot in her left arm a few weeks prior. (Tr. at 68.) At that time “basically 

every single range of motion was impeded, and that’s the first time I’ve ever 

experienced that with her.” (Id.) Dr. Schultz did not recall having any discussions with 

petitioner at this visit, or her visit on November 2, 2017, about the administration of the 

vaccine. (Id. at 69-70.) In the November visit, Dr. Schultz testified “[m]aybe I thought, 

too, that, you know, it was age-related, that it was taking her a little bit longer to recover 

from it.” (Id. at 70.) However, in the November visit she also observed that petitioner’s 

active range of motion was between 80 and 90 degrees, which was “something she had 

never experienced before with me in any of her prior visits.” (Id. at 71.) Dr. Schultz

testified that this change was atypical, “when somebody would go through a typical 

degenerative process or an autoimmune disease, [her] experience over 24 years is that 

it’s more of a progressive occurrence, especially with RA...[b]ut this was more this isn’t 

getting better at all,” she noted that “it’s only on one side and it’s extreme.” (Id. at 74.) 

In her letter Dr. Schultz noted that petitioner’s diagnosis is frozen shoulder 

syndrome. (Tr. at 86; Ex. 17.) She testified that frozen shoulder syndrome is “when 

you can’t get your arm into full range of motion in almost all ranges of motion, if not all.” 

(Tr. at 86.) In contrast, she explained that “[b]ursitis and tendinitis ha[ve] more range of 

motion, per se, than a frozen shoulder would.” (Id.) With a rotator cuff tear, Dr. Schultz 

opined that “an internal and external rotation will be the greatest deficit that you’ll see.” 

(Id.) However, she acknowledged that diagnosing a rotator cuff injury is difficult without 

an MRI. (See id.) Dr. Schultz never received or viewed MR images, and petitioner 

primarily provided verbal updates on her visits with her other doctors. (Id. at 87.) 

On cross-examination, Dr. Schultz acknowledged that crepitus was not noted in 

petitioner’s records until March 27, 2018. (Tr. at 89; see Ex. 3, p. 5.)) However, based 

on her recollection, Dr. Schultz testified that petitioner’s crepitus began around 

November or December 2017. (Tr. at 89.) She also confirmed that throughout 

petitioner’s treatment, she adjusted petitioner’s neck for mechanical improvement. (Id. 

at 90.) Dr. Schultz described petitioner’s onset of pain following vaccination as sudden. 

(Tr. at 82.) However, Dr. Schutlz could not recall petitioner’s description of the onset of

her shoulder pain. (Tr. at 91.) Regarding her October 2017 visit, Dr. Schultz testified 

that she “didn’t write anything more specific as to, [] where exactly was she injected. We 

didn’t have a discussion on that, just that it was painful afterwards and [] that’s all I can 

recall.” (Id.) Dr. Schultz further testified that petitioner distinguished the pain at the top 

of her shoulder versus the pain in her arm: “[t]he initial pain was more of a – like a 

muscle pain and the – as it advanced, it became more of a deeper pain, situated around 

the AC joint. So that’s where all of my treatments were.” (Tr. at 92.) Lastly, Dr. Schultz 
12

opined that osteocytes can cause crepitus, however, it would present as a more gradual 

presentation. (Id. at 94.) 

c. Petitioner’s Affidavits and Testimony

Petitioner filed her first affidavit on November 12, 2018. (Ex. 1.) Prior to 

receiving her flu vaccination on August 18, 2017, petitioner avers that she never had 

any pain or loss of range of motion in her left shoulder, nor had she suffered any 

significant injuries or trauma to her left arm / shoulder “similar to the persistent pain 

[she] experienced after this vaccination.” (Id. at 1-2.) Petitioner contends that the pain 

began “Immediately, within 48 hours, in [her] muscle after injection.” (Id. at 2.) Over the 

next several days, petitioner described pain that “moved from [her] muscle(s) into [her] 

arm and shoulder with noticeable reductions of range in motion with certain activities.” 

(Id.) 

Petitioner filed her second affidavit on May 3, 2019. (Ex. 11.) She avers that the 

prior pain mentioned by her physical therapist in records from December 6, 2017,

referred to “neck pain that [she] experienced in 2015.” (Id. at 1.) Petitioner further 

avers that she underwent physical therapy for that pain, which helped. (Id.) The pain 

she felt in 2015 in her neck was “very different from the pain in [her] arm/shoulder now, 

which is in [her] upper arm area.” (Id.) Petitioner states that she received an injection in 

2015 for neck stiffness, which was “not related to shoulder pain at all.” (Id.) She 

describes difficulty turning her head from side to side at the time she received the 

injection in 2015. (Id.) Petitioner also underwent physical therapy beginning in 

December 2017 that was not helpful. (Ex. 11, p. 2.) In the summer of 2017, petitioner 

avers that she presented to an orthopedic specializing in foot and ankle issues for a torn 

ligament. (Id.) Though she may have mentioned her shoulder at those visits, petitioner 

stresses that the primary reason for going was for the torn ligament. (Id.) 

Petitioner filed her third affidavit on January 16, 2020. (Ex. 15.) Petitioner 

additionally avers that she has arthritis in several joints, and from time to time they flare 

up, though the pain subsides. (Id. at 1-2.) In contrast, her shoulder pain has never 

subsided, but increased. (Id.) Regarding the inconsistencies in her medical records, 

petitioner explains that when she saw her doctors, especially early on, she had not 

come to realize that her vaccination was the likely cause of her pain and in her visits, 

she gave an “approximate time frame” for the onset of her shoulder pain. (Id. at 2.) 

Looking back, she avers that “the injection site was unusually high on [her] arm.” (Id.) 

Petitioner describes constant, daily, pain and struggles with activities of daily living. (Id. 

at 2-3.) 

During the hearing, petitioner testified that she was in good health in August of 

2017. (Tr. at 11.) She has had arthritis for approximately 20 years, and she “can go 

weeks, months” without any pain, but suffers occasional flare-ups, in particular, in her 

right knee. (Id. at 12.) Petitioner also had a prior history of neck pain—“it was pain 

upon turning my head sideways[.]” (Tr. at 17-18.) She testified that she would often 

wake up with neck pain and used a special pillow to help while sleeping. (Id.) The 

references in her medical records to shoulder pain in 2015, treated with an injection, 
13

referred to injections she received “in the back along the shoulder” for her neck pain. 

(Id. (see Ex. 5, p. 28.)) She testified that she did not have any shoulder pain prior to the 

vaccination at issue. (Id. at 18-19.) Petitioner also receives Remicade infusions every 

four weeks to treat her ankylosing spondylitis. (Id. at 19.) Most recently, petitioner 

testified that she underwent back surgery on May 4th, 2021, to treat the degeneration of 

discs in her back and the nerves that were being impinged upon—which was causing 

pain in the back of her legs from her hips down to her knees. (Id. at 12-13.) 

Regarding onset, petitioner testified that her pain and dysfunction began “within a 

couple of days after the vaccine.” (Tr. at 14-15.) She described “[t]he soreness after 

the vaccination would be a tenderness...[b]ut after a couple of days that you figure you 

shouldn’t feel that anymore if you go to use that arm, and it’s a different type of pain. It’s 

not the soreness – or tenderness would be a better word. It’s painful.” (Id. at 16.) 

Unlike her neck pain, petitioner testified that “[t]he shoulder pain or the arm pain that 

I’ve had since the vaccination comes from the top of my arm down to my elbow. I call it 

arm pain; some people might call it shoulder pain.” (Id. at 20.) At her first visit postvaccination, on August 22, 2017, petitioner testified that she presented to her podiatrist 

for foot pain after a heavy weight fell on her foot. (Tr. at 21-22 (see Ex. 9, pp. 28-29)) 

At the time she was suffering shoulder pain, although she did not discuss it with her 

doctor because it was not his expertise. (Tr. at 23.) On October 5, 2017, petitioner 

complained of left shoulder pain to her chiropractor, Dr. Shultz. (Id. at 23-24 (see Ex. 3, 

p. 3.)) She waited approximately five to six weeks because she “thought it would go 

away” and didn’t realize “that it was pain from the vaccine, it was just something that I 

thought would go away.” (Tr. at 24.) Petitioner testified, though, that she associated 

the pain in her shoulder with the flu shot “within a few days” or “after like 24 hours 

[when] it didn’t feel any better, it didn’t go away.” (Id.) 

Petitioner testified that she has degenerative changes in her shoulder(s) and was 

referred to physical therapy. (Tr. at 26.) The physical therapist performed 

manipulations on petitioner’s arm in addition to home exercises. (Id.) She described 

the physical therapy as “[n]ot very good.” (Id.) Petitioner’s medical record from 

December 6, 2017, indicates that her shoulder pain “began back in August and came on 

gradually.” (Id. at 27 (citing Ex. 4, p. 13.)) She testified during the hearing that she 

described the onset as gradual “because in the fact that the pain was there, but 

gradually as [she] tried to do different things, then [she] realized the limitations.” (Id.) 

Regarding the note indicating that she suffered “similar pain in the past about five years 

ago,” petitioner testified that the pain she was experiencing was in her neck. (Id. at 28

(see Ex. 4, p. 13.)) When talking about her pain with medical providers, petitioner 

testified that when she discussed pain from the vaccination, it was in her lower arm, 

from the shoulder down (gesturing to the bicep), whereas oftentimes she referred to 

shoulder pain or preexisting shoulder pain in the top of her shoulder, it was through the 

neck (gesturing along the clavicle). (Id. at 28-29.) 

A record from February 26, 2018, indicates that petitioner suffered left shoulder 

pain for about one year, or approximately February 2017. (Tr. at 32-33 (see Ex. 6, pp. 

10-12.)) Petitioner testified that she was “not sure why it would say that. Possibly when 
14

I was giving that information, I was – my timeline was off.” (Tr. at 33.) She also testified 

that it may have had something to do “with the fact that there was a calendar year 

change[.]” (Id.) The primary reason for that visit was for her knee(s), petitioner testified. 

(Id.) When reporting to a specialist, petitioner typically discussed “[w]hatever the body 

part is that [she’s] there to talk about.” (Tr. at 36.) She described going to a doctor for 

the first time, “you’ve got paperwork to fill out before he even sees you. That’s when you 

can put down everything that is a health issue. But then when you go to see him....you 

only get to talk about the part that’s actually bothering you or hurting, whatever is 

wrong.” (Tr. at 36.) 

On cross-examination, petitioner testified that the reference to “shoulder pain for 

the past 2 months” in Dr. Rosen’s report on November 28, 2017, did not refer to the 

pain in her shoulder post-vaccination. (Tr. at 45-46.) That reference to shoulder pain, 

according to petitioner, was pain located in the “top and back part of [her] shoulder” and 

closer to her neck. (Id. at 46-47.) She explained that what “[Dr. Rosen’s] referring to 

here is the ankylosing spondylitis is in the spine but it also progresses out to the 

shoulder area.” (Id. at 47.) This pain, she testified, was also separate from the neck 

pain she experienced in 2015. (Id.) She maintained that the pain caused by her 

influenza vaccination was in her upper arm. (Id. at 47-48.) Later petitioner returned to 

Dr. Rosen, on June 4th, 2018, who noted that petitioner had osteoarthritis in her 

shoulder. (Id. at 48 (see Ex. 6, p. 3.)) Petitioner testified that she had osteoarthritis in 

her right shoulder, but not the left shoulder. (Tr. at 48.) She further testified that her 

treating doctor(s) recommended total shoulder replacement in her left shoulder, but only 

after she dislocated her shoulder after a fall in 2019. (Tr. at 26-27, 48-49; but see Ex. 6, 

p. 3 (recommending left total shoulder arthroplasty on 6/4/2018).) 

When I asked petitioner why she discussed her prior episode of shoulder / neck 

pain from 2015 – in the context of her post-vaccination shoulder pain – she testified that 

“it’s two totally different things, two totally different areas, and two totally different pains.” 

(Tr. at 54.) Again, when I asked petitioner, why then, she discussed the 2015 injury if it 

was distinct, she testified that she “[didn’t] recall doing that,” but suggested that Dr. 

Rosen “would have notes in his chart – in my chart that would be sent to him from other 

doctors.” (Id.) Lastly, she testified that, in her discussions with Dr. Schultz, petitioner

told her “about the pain and where it was and then telling [sic] her about the flu shot and 

she then concurred that that was a possibility that that’s the reason why I was still 

having the pain.” (Id. at 55.) 

IV. Witness Statements and Testimony 

a. Joesph Gruszka 

On January 16, 2020, petitioner filed a statement from her son, Joe Gruszka. 

(Ex. 13.) Mr. Gruszka indicated that he resides with petitioner, as well as his wife and 

two children. (Id.) He recalls petitioner telling him “right after she received the shot how 

much it bothered her and that it was more painful then what she remembered from 
15

previous years.” (Id.) Mr. Gruszka describes petitioner’s difficulty performing daily 

functions, including cleaning, dressing, and cooking. (Id.) 

Mr. Gruszka also testified during the fact hearing. (Tr. at 97-116.) He testified 

that petitioner had prior issues with her neck and recalled her receiving trigger point 

injections for her discomfort. (Tr. at 101.) Mr. Gruszka indicated that petitioner had no 

prior injuries or previous left shoulder problems prior to the vaccination at issue. (Id. at 

102.) He testified that after petitioner’s vaccination, he observed that the injection site 

was higher than normal, remarking that the Band-aid was higher up on petitioner’s arm 

as compared to his own vaccination he received a few months later. (Id. at 102-03.) 

Mr. Gruszka observed petitioner’s decreased range of motion and recalled pinning 

petitioner’s shirt up because her shoulder was drooping. (Id. at 104.) He testified that 

petitioner’s onset of shoulder pain was “pretty sudden,” meaning that he “notic[ed] it 

within, [] a week to, you know, also that she couldn’t do a lot of the chores, menial 

tasks.” (Id.) 

Mr. Gruszka additionally testified that he transported petitioner to some of her 

appointments. (Tr. at 98, 105.) He recalled that during petitioner’s appointments with 

Dr. Rosen, for complaints involving her foot, petitioner “sa[id] something about her 

shoulder and the vaccine and he didn’t want to discuss that. He was interested in the 

foot at that time.” (Id.) Mr. Gruszka testified that, based on his daily observations, 

petitioner’s left shoulder problems began “[l]ike the end of August of 2017.” (Id. at 108.) 

Regarding his written statement, Mr. Gruszka testified that by ”right after the shot” he 

meant that “in the week or two following, [he] noticed that those things were beginning 

to take effect.” (Id. at 110.) 

b. Cynthia Kuklinski 

On January 16, 2020, petitioner also filed a statement from her daughter, Cynthia 

Kuklinski. (Ex. 14.) Ms. Kuklinski indicated that “[t]he pain in [petitioner’s] arm started 

instantly, and she lost full use of her arm.” (Id.) She states that petitioner’s pain and 

limited use did not subside. (Id.) She also describes petitioner’s limitations which 

include (1) unable to reach her left arm higher than her wrist, (2) dressing herself is 

uncomfortable with limited use of her arm, (3) difficulty bathing herself without full use of 

both arms (4) unable to use a brush and hair dryer at the same time (5) can’t put on and 

take off a necklace and (6) unable to use a drive-thru bank or restaurant since she can’t 

accept items with her left arm through the window. (Id.) According to Ms. Kuklinski, 

petitioner’s pain and limited use of her left arm “all started with a flu vaccine.” (Id.) 

Ms. Kuklinski also testified during the fact hearing regarding petitioner’s 

shoulder dysfunction. (Tr. 120-132.) She testified that petitioner complained of 

soreness in her arm the day of her influenza vaccination, August 18, 2017, or “[i]f not, it 

was the very next day.” (Id. at 120.) Ms. Kuklinski recalled that petitioner “felt like [the 

vaccine] was administered like higher up on the arm than she had remembered in the 

past.” (Id. at 121.) She testified that in the years prior to vaccination, petitioner had no 

left shoulder problems. (Id.) Ms. Kuklinski also testified that she speaks with petitioner 
16

every week, sometimes a couple times a week. (Id.) Petitioner’s pain, she testified, did 

not subside with icing; and petitioner complained of pain that was unlike the initial 

soreness of the vaccination. (Id. at 123.) Despite the fact that petitioner had several 

doctors’ appointments in the first month to two months post-vaccination where she 

specifically did not mention shoulder pain to her medical providers, Ms. Kuklinski 

testified that petitioner was in pain during that time. (Id. at 125-26.) She testified that 

petitioner likely refrained from mentioning her shoulder pain “if it was an appointment for 

something else, she was focusing on what that appointment was for or she thought [] it 

was going to go away.” (Id. at 126.) Ms. Kuklinski did not accompany petitioner to any 

of petitioner’s doctor’s appointments in 2017. (Id.) 

V. Expert Reports 

a. Petitioner’s Expert, Uma Srikumaran, M.D.6

Citing the same literature that underlies the concept of “SIRVA,” Dr. Srikumaran 

opines that petitioner’s “needle injection of vaccine antigen inadvertently near the bursa 

or rotator cuff tendon led to a strong immune mediated inflammatory reaction, causing 

bursitis and tendinitis in her case.” (Ex. 24, pp. 13-14.) He characterizes this as a 

significant aggravation of a preexisting, but asymptomatic underlying condition. (Id. at 

14-15.)

Dr. Srikumaran indicates that “like many people of her age, [petitioner] has a 

chronic condition, osteoarthritis which was clearly asymptomatic for a long period prior 

to her vaccination.” (Ex. 24, p. 10.) Specifically, he cites a March 27, 2017, physical 

therapy visit that documents essentially normal range of motion. (Id. (citing Ex. 3, p. 2).) 

However, he further indicates that “[petitioner] consistently and reliably reports 

immediate shoulder pain after vaccination to her varied medical providers, at various 

clinical settings including office and treatment visits over a long period of time . . . .” 

(Id.) Thus, Dr. Srikumaran bases his assessment on his assumption that petitioner 

suffered shoulder pain within 48 hours of vaccination. (Id. at 11.) He also finds 

significance in the fact that no other injury or trigger is available to otherwise explain 

petitioner’s symptoms. (Id. at 12.) Dr. Srikumaran acknowledges that “[t]here can be 

many triggers to this inflammation that cause a degenerative condition to become 

6 Dr. Srikumaran 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. 24, 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.) Dr. Srikumaran received his medical degree from Johns Hopkins School of 

Medicine in 2005. (Ex. 24, 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. 26, 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.) 
17

symptomatic. However, in this case we do indeed have a trigger with a strong, reliably 

and consistently reported, temporal association.” (Id. at 13.)

Further to this, Dr. Srikumaran notes that petitioner’s post-vaccination findings on 

exam are consistent with tendonitis or bursitis while her radiographic findings indicate 

arthritis and chronic rotator cuff pathology. (Ex. 24, p. 11.) Thus, Dr. Srikumaran 

opines that 

Vaccination did not cause these degenerative conditions, but rather was the 

likely trigger that instigated inflammation in the bursal tissue leading to exam 

findings consistent with bursitis and tendonitis, and later symptoms more 

consistent with osteoarthritis. In other words, I believe the vaccination was 

the trigger that initiated inflammation in her shoulder joint, which we would 

expect to have underlying age-related degeneration, causing her 

asymptomatic state to convert to a symptomatic one. 

(Id.)

Dr. Srikumaran also opines that petitioner’s response to physical therapy is more 

consistent with bursitis or tendonitis as the cause of her shoulder pain. Noting that 

osteophytes are mechanical blocks, he suggests that physical therapy can make 

advanced arthritis worse. Importantly, however, he acknowledges that “[c]ertainly, this 

response can wax and wane over time related to treatments provided as we see in 

[petitioner’s] case as well.” (Id.) And while he opines there is an inflammatory 

component, he notes that “she continues to have symptoms consistent with 

osteoarthritis.” (Id.)

Dr. Srikumaran opines that “I do not believe it is particularly relevant whether the 

pain was sudden or gradual in onset, as both can be consistent with a SIRVA injury.” 

(Ex. 24, p. 12.) He suggests the relevant literature (Arias, et al.) allows a latency of up 

to two months post-vaccination. (Id.) Dr. Srikumaran suggests that the amount of 

antigenic material that is injected into the bursa and various risk factors in the vaccinee 

may explain the variable timeframes. (Id.) 

b. Respondent’s Expert, Paul J. Cagle, M.D.7

7 Dr. Cagle serves an as assistant professor and Associate Program Director in the Department of 

Orthopaedic Surgery at the Icahn School of Medicine at Mount Sinai. (Ex. A, p. 1.) He is a member of 

the American Shoulder and Elbow Surgeons, and a faculty member of an internationally recognized 

shoulder surgery fellowship. (Id.) His current practice focuses on the shoulder, representing 95% or 

more of the patients and pathology he treats. (Id.) Dr. Cagle conducts clinical, biomechanical, and basic 

science research. (Id.) He has presented scientific work nationally and internationally; and has published 

over twenty articles related to shoulder injuries and surgery. (Ex. B, pp. 11-12.) Dr. Cagle is a peer 

reviewer for the Journal of Orthopaedic Research, Techniques in Shoulder and Elbow Surgery, and the 

Journal of Shoulder and Elbow Surgery. ( Id. at 13.) He received his medical degree from Loyola 

University Chicago Stritch School of Medicine in 2008. (Id. at 2.) Dr. Cagle completed his orthopaedic 

residency at the University of Minnesota Academic Health center and Medical School. (Id.) He also 

completed a shoulder and elbow fellowship at Mount Sinai Hospital in New York and is board certified in 

orthopaedic surgery. (Id.) 
18

Dr. Cagle disagrees with Dr. Srikumaran’s assessment. (Ex. A.) Whereas Dr. 

Srikumaran suggested petitioner was asymptomatic pre-vaccination, Dr. Cagle stresses 

medical records from March of 2017 that show reduced range of motion (Ex. 3, p. 2) as 

well as x-ray evidence of degenerative changes captured in December of 2017 (Ex. 5, 

p. 33), and an assessment by Dr. Towsen from June 18, 2018, that recorded “chronic 

non-traumatic” shoulder pain that was “relieved by physical therapy and injections” (Ex. 

5, pp. 27-31). (Ex. A, pp. 6-7.) At that time, Dr. Towsen diagnosed primary 

osteoarthritis and recommended a total shoulder replacement. (Id. (citing Ex. 5, pp. 27-

31).) According to Dr. Cagle, petitioner demonstrated a history of degenerative 

shoulder pain dating back to 2015. (Id. at 6-7.) He indicates that “[h]aving subclinical 

symptoms that eventually cause increasing pain are a hallmark of the disease process.” 

(Id. at 6.)

Further to this, Dr. Cagle disagrees that the medical records reflect onset of 

shoulder pain within 48 hours of the vaccination at issue. (Ex. A, p. 8.) He explains that

[Petitioner] has clear and undisputed pre-existing shoulder pathology. As 

such, a failure to report an onset of pain in relation to her flu vaccine 

prevents a causal link from being drawn, and this is absolutely critical. 

Without that causal 48 hour link, the pain she experienced subsequently in 

her shoulder is easily and rationally explained by her severe shoulder 

arthritis.

(Id.)

Dr. Cagle also disagrees that petitioner’s post-vaccination physical exams are 

necessarily indicative of bursitis. (Ex. A, p. 9.) He notes that the abduction finding that 

Dr. Srikumaran cites is not demonstrably worse than it was pre-vaccination (suggesting 

it is “within interobserver variability”). (Id. (comparing Ex, p. 2, and, Ex. 6, p. 36).) 

Additionally, he charges that Dr. Srikumaran overstates the significance of osteophytes, 

which are themselves indicative of the end stages of osteoarthritis, in impeding motion. 

Thus, he disagrees with Dr. Srikumaran’s assertion that physical therapy does not help 

arthritis. (Id. at 10.)

Dr. Cagle does not go so far as to dispute Dr. Srikumaran’s general theory of 

causation, though he stresses the limitations of the underlying literature. (Ex. A, p. 10.) 

He does suggest, however, that the risk of needle overpenetration required to cause a 

SIRVA is “quite low.” (Id. at 8-9.) (For his part, Dr. Srikumaran likewise acknowledges 

that “this pathologic entity is quite rare.” (Ex. 24, p. 11.))

VI. Party Contentions

a. Petitioner’s Motion for a Ruling on the Record

For purposes of her motion, petitioner does not challenge the facts as recited in 

the Finding of Fact. (ECF No. 67, p. 2.) Petitioner stresses the following language from 
19

the Finding of Fact: “there is not preponderant evidence that onset of left shoulder pain, 

whether new or aggravated, occurred within 48 hours of [Petitioner’s] August 18, 2017, 

vaccination.” (Id. (citing ECF No. 63).) Noting that the Finding of Fact further explained 

that onset of petitioner’s shoulder pain was “gradual” and occurred “sometime between 

late August and early October of 2017,” petitioner contends that onset occurred 

between August 20 and October 14, 2017. (Id.) Petitioner further argues that the facts 

support onset within that period between three and 10 days post-vaccination. (Id. at n. 

2.) However, petitioner also contends that onset was nevertheless within two months 

regardless. (Id. at 2-3.) Thus, petitioner acknowledges that the Finding of Fact 

precludes a Table SIRVA claim but argues that onset occurring between three and 57 

days post-vaccination supports her cause-in-fact claim. (Id. at 4.)

First, petitioner argues that Dr. Srikumaran’s expert report satisfies Althen prong 

one. Specifically, she notes that he cites articles by Bodor and Montalvo, Atanasoff, et 

al., and Arias, et al., that she indicates support the proposed mechanism underlying 

“SIRVA.” (ECF No. 67, pp. 5-6.) (And, indeed, the first two of these three papers were 

cited in the respondent’s proposed rulemaking as supporting the addition of SIRVA to 

the Vaccine Injury Table (Notice Proposed Rulemaking, July 29, 2015, 80 Fed. Reg. 

45132, 2015 WL 4538923, at *45136).) Further to this, Dr. Srikumaran cites studies by 

Dumonde, et al., and Trollmo, et al., examining the immune response to antigenic 

material affecting the joints. (Id. at 6.) Further still, petitioner notes that Dr. Srikumaran 

cites a prior study by Hesse, et al., which found a statistically elevated risk of subdeltoid 

bursitis following influenza vaccination. (Id.)

With regard to Althen prong two, petitioner relies again on Dr. Srikumaran’s 

opinion. (ECF No. 67, pp. 8-9.) Specifically, Dr. Srikumaran opines that “needle 

injection of vaccine antigen inadvertently near the bursa or rotator cuff tendon led to a 

strong immune mediated inflammatory reaction, causing bursitis and tendinitis in 

[petitioner’s] case.” (Id. at 8 (quoting Ex. 24, p. 14).) Petitioner further highlights Dr. 

Srikumaran’s reliance upon his assessment of the proximate temporal relationship 

reflected in the medical records as well as on the fact that petitioner’s condition was 

asymptomatic for two years prior to vaccination. (Id.) Petitioner further stresses Dr. 

Srikumaran’s explanation of why he believes petitioner’s chronic osteoarthritis is not an 

explanation for her condition. (Id. at 9.) Petitioner urges that Dr. Srikumaran’s opinion 

is “quite probative.” (Id.)

Regarding Althen prong three, petitioner acknowledges that the Finding of Fact 

concluded that onset was outside the period recognized for a Table SIRVA but 

contends that “onsets falling outside the ‘traditional’ 48 hours are still supportive of 

causation in SIRVA cases.” (ECF No. 67, p. 10.) Petitioner stresses Dr. Srikumaran’s 

opinion that the Arias article indicates that onset of up to 2 months is medically 

appropriate and that the variability of latency is determined by a number of factors, 

including genetics, co-morbidities, tolerance to pain, and the amount of antigenic 

material errantly injected into the bursa. (Id.)

Petitioner contends that respondent has not demonstrated that petitioner’s 

osteoarthritis constitutes an alternative cause of her condition. (ECF No. 67, p. 11.)

b. Respondent’s Response
20

With regard to any Table SIRVA claim, respondent argues that petitioner’s 

history of shoulder pain dating back to 2015 constitutes a condition that would explain 

her symptoms and that the undersigned’s Finding of Fact confirms there was no onset 

of new shoulder pain within 48 hours of vaccination. (ECF No. 68, pp. 4-5.) Thus, 

petitioner is unable to satisfy two out of four SIRVA QAI criteria. 

With regard to causation-in-fact, respondent stresses his expert’s competing 

assessment that petitioner’s clinical history is consistent with her “well documented 

history of left shoulder osteoarthritis.” (ECF No. 68, p. 8.) Respondent suggests that 

petitioner’s symptoms were “classic” findings of arthritis and that even petitioner’s own 

expert, Dr. Srikumaran, factored petitioner’s preexisting condition into his overall 

opinion, noting that he described her alleged vaccine injury as a significant aggravation 

of her prior complaints. (Id. (citing Ex. 24, pp. 14-15). Moreover, respondent notes that 

petitioner’s treating orthopedist characterized her symptoms as “chronic non-traumatic.” 

(Id. at 9 (quoting Ex. 5, pp. 27-31).) Respondent further stresses Dr. Cagle’s opinion 

that petitioner had several medical appointments at which she did not report postvaccination shoulder pain. He argues that “[t]he failure to report shoulder pain 

temporally related to her vaccination in the presence of a well-documented history of 

prior shoulder pathology points to the reasonable conclusion that her left shoulder 

issues are explained by her shoulder arthritis” and that “[t]he severity of her arthritis is 

supported by two orthopedic surgeons who recommended total shoulder replacement.” 

(Id.)

Regarding the possibility that Dr. Srikumaran’s opinion has raised a claim for 

significant aggravation, respondent argues that “Dr. Cagle explains that arthritis evolves 

over time and it is part of the normal process of the disease for subclinical symptoms to 

become symptomatic. Accordingly, petitioner’s post-vaccination left shoulder symptoms 

were the ‘hallmark’ of the natural progression of arthritis, and therefore not a significant 

aggravation of her underlying condition.” (ECF No. 68, p. 11 (internal citations 

omitted).)

c. Petitioner’s Reply and Supplemental Brief Regarding Significant 

Aggravation

Petitioner contends in her reply that respondent’s arguments in response to her 

motion “muddy the waters” and ignore her cause-in-fact claim in order to focus on 

significant aggravation. (ECF No. 69, p. 2.) Petitioner stresses that respondent 

“ignores Petitioner’s expert’s direct statement that the ‘needle injection of vaccine 

antigen inadvertently near the bursa or rotator cuff tendon led to a strong immune 

mediated inflammatory reaction, causing bursitis and tendinitis.’ Nowhere does 

Petitioner’s expert limit his opinion to aggravation only, as Respondent’s Response may 

suggest.” (Id. (internal citation omitted).) Petitioner further challenges the 

persuasiveness of respondent’s expert’s opinion. Specifically, petitioner charges that 

“Respondent’s expert fails to account for the direct testimony from Petitioner in reaching 

his conclusions on causation and/or significant aggravation, looking instead at the 

medical records in a vacuum, discounting her completely asymptomatic condition 

immediately prior to vaccination.” (Id.)
21

Subsequently, in a supplemental brief, petitioner delineates a significant 

aggravation claim in the alternative. (ECF No. 73.) With regard to Loving prongs one 

through three, petitioner contends that she “had not recently exhibited clinical symptoms 

of a shoulder injury in the year or more preceding her flu vaccination” and that the prior 

fact finding in the case concluded that she experienced shoulder pain that arose postvaccination. (Id. at 3.) Thus, because there was an evolution in her condition from 

asymptomatic to clinical symptomology, she satisfies the showing of significant 

aggravation under Loving prong three. (Id.) Regarding vaccine causation of that 

significant aggravation, petitioner’s contentions regarding Loving prongs four through six 

mirror her initial contentions regarding Althen prongs one through three. Petitioner 

argues in effect that the medical theory supporting “SIRVA” necessarily also supports a 

claim for significant aggravation. Petitioner argues that her medical theory “begins with 

the simple premise that influenza vaccinations can cause SIRVA.” (Id.)

VII. Discussion

As explained above, the prior finding of fact patently precludes any Table claim 

for SIRVA insofar as it specifically confirmed that petitioner did not preponderantly 

establish onset of shoulder pain within 48 hours of onset as required by the Vaccine 

Injury Table. Gruszka v. Sec’ of Health & Human Servs., No. 18-1736V, 2022 WL 

3024777 (Fed. Cl. Spec. Mstr. July 7, 2022). Nonetheless, petitioner argues extensively 

that this same finding of fact should not preclude a claim that petitioner’s vaccine either 

caused-in-fact a shoulder injury or significantly aggravated her prior shoulder 

complaints. This decision will not repeat the entirety of the reasoning contained within 

the finding of fact, but highlighting a few aspects of the reasoning will help to explain 

why petitioner’s arguments are unpersuasive. 

As noted above, the finding of fact was not limited to the specific question of a 

48-hour onset. It concluded that: 

[T]he evidence preponderates in favor of a finding that petitioner 

experienced prior episodes of left shoulder pain and also experienced a 

gradual onset of similar left shoulder pain with an indeterminate initial onset 

occurring sometime between late August and early October of 2017. 

However, there is not preponderant evidence that onset of left shoulder 

pain, whether new or aggravated, occurred within 48 hours of her August 

18, 2017, vaccination.

Gruszka, 2022 WL 3024777 at *18. This conclusion was informed by several points

directly relevant to the instant analysis. Specifically: 

• Petitioner did not initially report shoulder pain during her medical encounters 

occurring post-vaccination (Ex. 9, pp. 28-29; Ex. 5, pp. 14-23; Ex. 3, p. 3);
22

• When she did seek care for shoulder pain, petitioner never reported her shoulder 

pain as vaccine-related to any care provider except her chiropractor who she did 

not see until two months post-vaccination (Ex. 3, p. 3); 

• Petitioner was inconsistent in reporting the timing of onset of her shoulder pain

(Ex. 6, p. 35; Ex. 6, p. 10; Ex. 5, p. 24);

• When seeking treatment, petitioner placed her pain in the context of her chronic 

complaints dating back to 2015 and described her current symptoms as similar

(Ex. 4, p. 13; Ex. 5, p. 27);

• Although petitioner’s chiropractor testified, she was ultimately unable to 

corroborate the onset of petitioner’s condition from any personal knowledge (Tr. 

91); and 

• Petitioner confirmed in her own testimony that she perceived the onset of her 

shoulder pain as gradual. (Tr. 27.)

Regardless of whether this case is addressed as a significant aggravation claim 

under the Loving test or a cause-in-fact claim under the Althen test, the dispositive 

analysis is the same. In light of all of the above, and in consideration of the record as a 

whole, petitioner has not met her burden of proof with respect to either Althen prong 

two/Loving prong five or Althen prong three/Loving prong six.8

Although Dr. Srikumaran included language in his reports that broadly accepted 

a latency of up to two months for post-vaccination shoulder pain, his actual opinion visà-vis this petitioner was based on his assumption of a 48-hour post-vaccination onset. 

(Ex. 24, p. 11.) In fact, he premised his causal opinion in part on what he characterized 

as a “strong” temporal association. (Id. at 13.) However, this is contrary to the facts as 

8 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’ of Health & Human Servs., 956 F.2d 1144, 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 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”). 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 may support her claim by 

either medical records or by the opinion of a competent physician. § 300aa-13(a)(1).
23

I have found them. Gruszka, 2022 WL 3024777, at *13-18. Accordingly, Dr. 

Srikumaran’s opinion is unpersuasive to the extent it is based in part on an unsupported 

assumption. Burns v. Sec’y of Health & Human Servs., 3 F. 3d 415 (Fed. Cir. 1993) 

(holding that “[t]he special master concluded that the expert based his opinion on facts 

not substantiated by the record. As a result, the special master properly rejected the 

testimony of petitioner's medical expert.”); see also Rickett v. Sec’y of Health & Human 

Servs., 468 Fed. Appx. 952, 958 (Fed. Cir. 2011) (holding that “it was not error for the 

Special Master to assign less weight to Dr. Bellanti's conclusion regarding challengerechallenge to the extent it hinged upon Mr. Rickett's testimony that was inconsistent 

with the medical records.”); Dobrydnev v. Sec’y of Health & Human Servs., 566 Fed. 

Appx. 976, 982–83 (Fed. Cir. 2014) (holding that the special master was correct in 

noting that “when an expert assumes facts that are not supported by a preponderance 

of the evidence, a finder of fact may properly reject the expert's opinion”) (citing Brooke 

Group Ltd. v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993)); Bushnell 

v. Sec'y of Health & Human Servs., No. 02-1648V, 2015 WL 4099824, at *12 (Fed. Cl. 

Spec. Mstr. June 12, 2015) (finding that “because Dr. Marks' opinion is based on a false 

assumption regarding the onset of J.R.B.'s condition, and the incorrect assumption of a 

“stepwise regression” after each vaccine administration, it should not be credited.”)

The only other medical professional to offer any suggestion of vaccine causation 

in this case was petitioner’s chiropractor (Dr. Schultz), who, in fact, was the only treating 

care provider that was provided a history of post-vaccination symptoms. However, as 

with Dr. Srikumaran, this opinion was based on the assumption that petitioner 

experienced a sudden onset of symptoms temporally related to her vaccination. (Tr. 

82.) But, as explained in the finding of fact, the chiropractor had no personal knowledge 

of the onset and the assumed onset is not otherwise preponderantly supported. (Id. at 

91.) This flaw in both Dr. Srikumaran’s and Dr. Schultz’s opinions defeats petitioner’s 

claim with respect to both the timing element under Althen prong three/Loving prong six 

as well as the logical sequence of cause and effect under Althen prong two/Loving

prong five, because it leaves petitioner with no reliable medical opinion supporting her 

claim based on the actual realities of onset.

Even without treating 48 hours as a bright-line in the cause-in-fact context, Dr. 

Srikumaran’s reliance on Arias, et al., to establish a two-month latency as medically 

reasonable is also unpersuasive. The Arias authors undertook a review of 67 prior 

medical articles and 13,717 reports of vaccine-related notifications from the Adverse 

Reaction Data of the Spanish Pharmacovigilance System or “FEDRA” to assemble a 

case series of 45 subjects. (L.M. Arias et al., Risk of bursitis and other injuries and 

dysfunctions of the shoulder following vaccinations, 35(37) VACCINE 4870 (2017) (Ex. 

26).) The authors assessed 37 cases from the published literature and 8 cases from 

FEDRA. Among the published cases, post-vaccination onset ranged from immediate to 

three days. (Id. at 3 (Table 2).) Among the FEDRA cases, 6 of the 8 had onset 

occurring within 7 days of vaccination. Out of all the cases reviewed by Arias, et al., 

only two cases from FEDRA had latencies beyond one-week post-vaccination. (Id. at 

3.) The Arias review is a descriptive analysis only, and thus incapable of confirming that 

the two FEDRA cases with prolonged latencies were vaccine-caused. Nor does 
24

anything in the authors’ analysis specifically endorse such a view. Instead, the authors 

conclude that 48 hours is the likely relevant onset based on the majority of cases falling 

within that timeframe. (Id. at 1 (abstract).) In contrast, a statistical analysis also cited 

by Dr. Srikumaran examined cases of bursitis occurring within 180 days of vaccination 

and used the 60 days post-vaccination period as the background rate to find a 

statistically elevated risk of bursitis occurring within 3 days post-vaccination. (Elizabeth 

M. Hesse et al., Risk for subdeltoid bursitis after influenza vaccination: a populationbased cohort study, 173 ANN. INTERN. MED. 253 (2020) (Ex. 30).) 

Petitioner’s argument that she could prevail on a cause-in-fact basis was based 

on her assertion that, despite onset being indeterminate, the period of potential onset 

identified by the finding of fact – between 3 days and 57 days post-vaccination – was 

entirely encompassed by what petitioner had established as the medically reasonable 

period of latency. In light of the above, however, this is not true. On the whole, the 

medical literature makes clear that the expected latency for a post-vaccination shoulder 

injury is within a matter of days of vaccination, not months as petitioner contends. Thus, 

petitioner is unpersuasive in suggesting that she has met her burden of proof to 

establish that her alleged injury occurred within a medically reasonable period of onset. 

As indicated by the finding of fact, there is not preponderant evidence placing the onset 

of petitioner’s shoulder pain within days of her vaccination. Rather, the finding of fact 

concluded that onset was indeterminate and possibly as late as about two months postvaccination. Gruszka, 2022 WL 3024777 at *18. Thus, even setting aside the specific 

48-hour timeframe, petitioner has not met her burden of proof under Althen prong 

three/Loving prong six.

Additionally, even accounting for Dr. Sikumaran’s broader acceptance of a 

gradual two-month onset, this is still not persuasive under the circumstances of this 

case as evidence supporting a logical sequence of cause and effect under Althen prong 

two/Loving prong five. Petitioner stresses that aspect of the finding of fact that indicated 

an onset of shoulder pain occurring sometime between late August and early October of 

2017, which petitioner argues is consistent with Dr. Srikumaran’s opinion. (ECF No. 67, 

p. 10; ECF No. 73, p. 8 (citing Ex. 24, pp. 12-15).) However, petitioner ignores those 

aspects of the finding of fact that indicated that petitioner had prior episodes of “similar”

left shoulder pain and that the shoulder pain ultimately at issue in this case was of both 

“gradual” and “indeterminate” onset. Gruszka, 2022 WL 3024777 at *18. Even before 

reaching Dr. Cagle’s competing opinion, Dr. Srikumaran acknowledges petitioner had a 

history of degenerative shoulder complaints, acknowledges that symptoms associated 

with these types of complaints can wax and wane and can be aggravated by many 

factors, and acknowledges that petitioner displayed symptoms of osteoarthritis 

subsequent to her vaccination. (Ex. 24, p. 11.) This is consistent with how both 

petitioner and her treating physicians addressed her condition on the whole. (Exs, 4-6, 

passim.) In that context, it is not persuasive for petitioner to suggest that a “gradual” 

and “indeterminate” onset of shoulder pain during the months following vaccination is 

meaningful evidence of a logical sequence of cause and effect implicating petitioner’s 

vaccination in her condition. Indeed, as noted above, the finding of fact was based in 

part on petitioner’s own inability to consistently identify the actual onset of her shoulder 
25

pain, her seeking treatment repeatedly without associating her pain to her vaccination, 

and her reports to her treating physicians that instead placed her shoulder pain in the 

context of her “chronic non-traumatic” complaints. (Ex. 5, pp. 14-28; Ex. 6, pp. 10, 35; 

Ex. 9, pp. 28-29; Ex. 3, p. 3.) Given the continuum on which petitioner’s condition 

existed pre- and post-vaccination, Dr. Srikumaran offers very little additional insight by 

citing the lack of any other specific injury or trigger to explain petitioner’s clinical 

presentation. It is far from clear that any injury or trigger would be necessary to explain 

petitioner’s condition. Nor, without more, would eliminating alternative causes support 

petitioner’s burden of proof. Walther v. Sec’y of Health & Human Servs., 485 F.3d 

1146, 1151 (Fed. Cir. 2007); Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352 

(Fed. Cir. 2006).

VIII. Conclusion

Petitioner has my sympathy for what she has endured. However, considering the 

record as a whole under the standards applicable in this program, petitioner has not 

preponderantly established that her August 18, 2017, flu vaccination resulted in a Table 

SIRVA, a cause-in-fact shoulder injury, or a significant aggravation of a pre-existing 

condition. Accordingly, petitioner is not entitled to compensation. Therefore, this case 

is dismissed.9

IT IS SO ORDERED.

s/Daniel T. Horner

Daniel T. Horner

Special Master

9 In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter 

judgment accordingly.