Stiller v. Secretary of Health and Human Services ( 2023 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 20-1841V
Filed: November 13, 2023
Special Master Horner
KATHY STILLER,
Petitioner,
v.
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
Bridget Candace McCullough, Muller Brazil, LLP, Dresher, PA, for petitioner.
Rachelle Bishop, U.S. Department of Justice, Washington, DC, for respondent.
RULING ON ENTITLEMENT1
On December 14, 2020, petitioner filed a petition under the National Childhood
Vaccine Injury Act, 42 U.S.C. § 300aa-10, et seq. (2012),2 alleging that she suffered the
Table Injury of Shoulder Injury Related to Vaccine Administration (“SIRVA”) in her right
shoulder following tetanus diphtheria and acellular pertussis (“TDaP”) vaccination that
she received on October 11, 2019. (ECF No. 1.) For the reasons set forth below, I
conclude that petitioner is entitled to compensation for her alleged Table 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 document contains a reasoned explanation for the action taken in this case, it must be
made publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or
at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government
Act of 2002. 44 U.S.C. § 3501 note (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, upon review, I agree that the identified material fits within this definition, I will redact such material from
public access.
2 Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C.
§ 300aa-10, et seq.
1
general, to gain an award, a petitioner must make a number of factual demonstrations,
including showing that an individual received a vaccination covered by the statute;
received it in the United States; suffered a serious, long-standing injury; and has
received no previous award or settlement on account of the injury. § 300aa-11(c).
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, which is 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. See § 300aa-
13(a)(1); § 300 aa-11(c)(1)(C)(i); § 300aa-14(a).
As relevant here, the Vaccine Injury Table lists a SIRVA as a compensable injury
if it occurs within 48 hours of vaccine administration. See § 300aa-14(a), 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;
(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).
2
42 CFR § 100.3(c)(10).
Vaccine Program petitioners must establish their claim by a “preponderance of
the evidence.” § 300aa-13(a). That is, a petitioner must present evidence sufficient to
show “that the existence of a fact is more probable than its nonexistence.” Moberly ex
rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir.
2010). 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. See § 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 v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir.
2005) (citation omitted); § 300aa-13(a)(1)(B).
II. Procedural History
This case was initially assigned to the Special Processing Unit (“SPU”) on August
21, 2020. (ECF Nos. 10-11.) Petitioner filed her medical records and an affidavit in
December of 2020 and January of 2021. (ECF Nos. 1, 8; Exs. 1-6.) She subsequently
filed a supplemental affidavit marked as Exhibit 7. (ECF No. 20.) While the case was in
the SPU, the parties attempted settlement, but were unable to resolve the case. (ECF
No. 28.) Respondent filed his Rule 4 Report on August 1, 2022. (ECF No. 30.)
Respondent primarily challenged petitioner’s Table Injury claim of SIRVA on the basis
that she had preexisting right shoulder pathology and that her condition was not limited
to her right shoulder (i.e. SIRVA QAI criteria (i) and (iii)). (Id. at 6-10.) He also indicated
that an alternative cause-in-fact claim was unsupported. (Id. at 9-13.) Thereafter,
petitioner filed updated orthopedic medical records. (ECF No. 31; Ex. 8.)
While the case was still within the SPU, petitioner filed a motion for a ruling on
the record, arguing she should be found entitled to compensation for a Table SIRVA.
(ECF No. 33.) Respondent responded on November 16, 2022.3 (ECF No. 34.)
Respondent raised no objection to resolving entitlement on the existing record, but
urged that the case be dismissed. (Id.) The case was subsequently reassigned to the
undersigned on October 5, 2023, with petitioner’s motion pending. (ECF Nos. 35-36.)
On October 10, 2023, petitioner filed a joint status report on behalf of the parties
confirming that the parties continue to believe the case is ripe for a ruling on petitioner’s
motion. (ECF No. 37.)
In light of the above, I have determined that the parties have had a full and fair
opportunity to present their cases and that, given the parties’ assent, it is appropriate to
resolve entitlement on the existing record. See Vaccine Rule 8(d); Vaccine Rule
3 In his brief, respondent provides links to two online sources regarding os acomiale and impingement
syndrome respectively. (ECF No. 34, n. 4-5 (citing Thomas Youm et al., Os Acromiale: Evaluation and
Treatment, 8 AM. J. ORTHOPEDICS 382 (2005); A. E. Fongemie, D. D. Buss, & S. J. Rolnick, Management
of Shoulder Impingement Syndrome and Rotator Cuff Tears, 57 AM. ACAD. FAM. PHYSICIANS 667 (1998)).)
These links provide only the abstracts of the cited articles. I have reviewed the abstracts available by
following the links provided; however, respondent’s link citations are inadequate to place the entirety of
the cited articles into evidence.
3
3(b)(2); see also 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’s prior medical history is not informative of the issues presented by the
parties except that respondent notes that petitioner had a history of treatment for neck
and mid-back pain in February of 2017. (ECF No. 34, p. 2.)
Specifically, on February 7, 2017, petitioner presented for care for neck and mid-
back pain. (Ex. 2, p. 24.) She reported a prior history of neck pain associated with
temporomandibular joint disorder (“TMJ”) that had improved until she reinjured her neck
during a falling incident with her dog. (Id.) Her neck pain did not radiate, and she did
not have tingling, numbness, or weakness. (Id.) On exam, she had limited flexion,
extension, and rotation of the neck and bilateral tenderness of the trapezius with
spasms. (Id.) No separate shoulder exam was performed. (Id. at 24-25.) She was
diagnosed in relevant part with cervicalgia for which she was started on ibuprofen and
baclofen. (Id. at 25.) A physical therapy evaluation was also recommended. (Id. at 25.)
Petitioner subsequently sought follow up care for the same complaints at the
emergency department on February 12, 2017. (Ex. 5, p. 5.) Examination of the neck
indicated no tenderness, but mildly limited range of motion. (Id. at 9.) Again, no
separate shoulder exam was documented. (Id.) A cervical spinal x-ray was
unremarkable. (Id. at 27.) She was diagnosed with a right paracervical muscle spasm
and prescribed Naprosyn, Robaxin, and Medrol. (Id. at 8, 12.)
At her next annual physical on January 22, 2018, it is noted that petitioner was
taking baclofen “rarely” for neck pains she attributed to her TMJ. (Ex. 2, p. 19.)
Petitioner explained that by taking the baclofen only as she needed, her prescription
had lasted a full year; however, she requested a refill. (Id.) No pertinent physical
findings were documented and cervicalgia was not included in her diagnoses at this
encounter, though her baclofen was refilled for neck pain associated with her TMJ. (Id.
at 21-22.)
Petitioner returned to her primary care physician for another complete exam on
October 11, 2019. (Ex. 2, p. 13.) It is again noted that petitioner rarely uses baclofen
for neck pain associated with her TMJ. (Id. at 14, 15.) At this encounter petitioner was
administered an Adacel TDaP vaccination in her right deltoid, which is the vaccination at
issue in this case. (Id. at 15; see also Ex. 1.)
4
ii. Post-vaccination
Two weeks after vaccination, on October 25, 2019, petitioner returned to her
primary care provider with a specific complaint of “joint pain following adacel.” (Ex. 2, p.
11.) The history of present illness specifies that onset occurred “that night” after the
vaccination, but with improvement thereafter. (Id.) Petitioner complained of “pain in
bil[ateral] upper arms, worse in the right arm where she received the shot. Lift her arms
up or trying to put a bra on is painful. Feels weaker when lifting things up.” (Id.) She
denied any numbness or tingling and also denied back pain. (Id.) She had joint
stiffness, but normal range of motion in her arms. (Id.) Physical exam confirmed
normal range of motion in her cervical spine as well as “full ROM of shoulder and elbow
in all directions even though pt states that she has pain w/ mvmt.” (Id. at 12.) Petitioner
was diagnosed with “pain in the right arm” and started on a Medrol dosepak. (Id.) Her
physician suspected her symptoms were due to her TDaP vaccination given that they
started the night of the vaccination. (Id.)
On November 14, 2019, petitioner followed up with an orthopedic specialist
where she was seen by a physician’s assistant (“orthopedic PA”). (Ex. 3, p. 60.) This
time, she presented specifically for evaluation of her right shoulder for pain that she
reported started “immediately” after her TDaP vaccination. (Id. at 60-61.) Petitioner
reported that she also initially felt some pain in her left shoulder and legs. (Id. at 61.)
She denied any problem with her right shoulder prior to vaccination. (Id.) She noted
slight soreness in her neck, but denied any paresthesia down the arm. (Id.) Her
cervical spinal examination was normal with no reproduction of shoulder symptoms with
range of motion. (Id.) Examination of her right shoulder revealed no significant
tenderness of the shoulder, but did produce limited and painful range of motion with
internal rotation. (Id.) She had positive impingement and rotator cuff pain and
weakness. (Id.) Left shoulder exam revealed no abnormalities, with full and not painful
range of motion. (Id.) An x-ray of the right shoulder revealed “[o]s acromiale[4] with
degenerative changes. Otherwise normal.” (Id. at 64.) An MRI was recommended to
rule out a rotator cuff tear. (Id. at 60.) The orthopedic PA opined, “I do not feel as if the
vaccination caused this issue but may have exacerbated a pre-existing issue that was
asymptomatic prior to the injection.”5 (Id.) During this encounter petitioner also sought
an evaluation for left knee pain she was experiencing during workouts. (Id.) Petitioner
subjectively felt the pain had increased post-vaccination, but her orthopedist advised
4 The “os acromiale” is “a movable joint between the spine of the scapula and the epiphysis of the
acromion.” Os acromiale, DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=95081&searchterm=os+acromiale (last visited Nov.
7, 2023). As respondent explains, it is an anatomical variant. (ECF No. 34, pp. 11-12, n. 4.) It is often
discovered only incidentally, but when symptomatic can present similarly to subacromial impingement
syndrome.
5 It should be noted that this opinion is not actually inconsistent with a Table SIRVA.
Several prior
decisions have explained that Table SIRVA encompasses asymptomatic shoulder pathology activated by
vaccination. Grossmann v. Sec’y of Health & Human Servs., No.18-13V, 2022 WL 779666, at *16-18
(Fed. Cl. Spec. Mstr. Feb. 15, 2022); Lang v. Sec’y of Health & Human Servs., No. 17-995V, 2020 WL
7873272, at *12-14 (Fed. Cl. Spec. Mstr. Dec. 11, 2020); Gurney v. Sec’y of Health & Human Servs., No.
17-481V, 2019 WL 2865490, at *5-8 (Fed. Cl. Spec. Mstr. Apr. 24, 2019).
5
her knee pain was unrelated. (Id. at 60-61.) Regarding her right shoulder, petitioner
was diagnosed with “[w]orsening right shoulder pain following tetanus vaccination;
probable rotator cuff strain in the setting of AC joint degenerative changes and os
acromiale.” (Id. at 60.)
An MRI of petitioner’s right shoulder was completed on November 23, 2019. (Ex.
2, p. 79.) The MRI revealed the following: (1) moderate tendinosis of the supraspinatus
and infraspinatus with generalized partial thickness tearing and fraying; (2) insertional
subscapularis tendinosis with partial thickness tearing; (3) an intact biceps tendon; (4)
fraying of the posterior superior labrum; (5) moderate degenerative changes in the
acromioclavicular joint, with a type II acromion,6 moderate inflammatory changes,
unfused acromial apophysis, and os acromiale with edema at the synchondrosis; and
(6) subacromial/subdeltoid bursitis with moderate glenohumeral effusion. (Id. at 80.)
Following the MRI, petitioner followed up with the orthopedist on December 2,
2019. (Ex. 3, p. 47.) The orthopedist noted petitioner’s initial evaluation with the
orthopedic PA but did not otherwise revisit the history of onset or underlying cause of
petitioner’s complaints. (Id.) On physical exam, petitioner did not have tenderness to
palpation except over the AC joint. She had reduced range of motion, signs of
impingement, and rotator cuff weakness. (Id. at 47-48.) The orthopedist interpreted the
MRI as revealing “evidence of significant inflammation at the os acromiale and bursitis.
There is rotator cuff tendinosis. No clear evidence for fracture or rotator cuff tears
otherwise.” (Id. at 48.) Petitioner was diagnosed with both a symptomatic os acromiale
with impingement as well as bursitis. (Id. at 47.) Physical therapy was recommended.
(Id. at 48.)
Petitioner had a physical therapy evaluation on June 1, 2020. (Ex. 3, p. 41.)7
Her chief complaints were “right shoulder loss of movement, loss of strength, pain,
stiffness and tenderness.” (Id.) She reported worsening pain following her October
2019 tetanus vaccination along with significant loss of range of motion. (Id.) She also
“mention[ed] she had similar pain in left shoulder as well as leg pain/tightness.” (Id.)
She “hop[ed] to return to light weights/fitness which she is currently unable to do.” (Id.)
Upon exam, petitioner had tenderness in both shoulders, but only tested positive for
impingement in her right shoulder. (Id. at 41-43.) She had similarly reduced range of
motion in both shoulders, worse on the right. (Id. at 42.)
Petitioner attended nine physical therapy sessions between June and September
of 2020. (Ex. 3, pp. 14-40.) Respondent suggests the physical therapy included both
shoulders (ECF No. 30, p. 5); however, the record is ambiguous. Although petitioner’s
left shoulder was evaluated, her documented plan of care only ever included her right
6 The “acromion” is “the later extension of the spine of the scapula, projecting over the shoulder joint and
forming the highest point of the shoulder.” Acromion, DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=708&searchterm=acromion (last visited Nov. 7,
2023). Respondent explains that a “Type II acromion” is an anatomic variant that increases the risk of
rotator cuff impingement and tears. (ECF No. 34, p. 12, n. 5.)
7 The record is silent as to the reason for the six month gap in treatment.
6
shoulder. (Ex. 3, pp. 14-40.) In the midst of her physical therapy for her shoulder,
petitioner paused her care to pursue further treatment for her left knee. (Ex. 3, pp. 5-13,
35, 44-46; Ex. 2, p. 32-33.)
Petitioner returned to her primary care provider on October 16, 2020, for her
annual exam. (Ex. 2, p. 6.) Regarding her shoulder, petitioner reported that “[s]he had
pains in arm afterwards that persists even into today. Says her arm ‘sticks’ & she can’t
do Boot camp anymore, frustrated. Saw 2 docs at UB Ortho but wasnt [sic.] happy &
doesnt [sic.] want to go back. Still doing PT.” (Id.) A further note specifics that
petitioner “did not have previous injury to that shoulder, had been active in BOOT camp
at the time, now still unable to participate in class & frustrated.” (Id. at 9.) Petitioner was
prescribed a topical gel. (Id.)
Subsequently petitioner sought a second orthopedic opinion on November 9,
2020. (Ex. 6, p. 5.) She reported that “her symptoms began in 2019 after receiving a
tetanus vaccine, recently worsening with weight lifting exercises.” (Id.) “The pain is
continuous and described as sharp. The pain is located on the upper arm. The pain is
worse with activity, exercises including burpies, driving, raising the arm upwards. Anti-
inflammatories helps alleviate the pain. Associating symptoms include weakness and
shooting pain, pain at night.” (Id.) Exam of the cervical spine showed normal range of
motion. (Id. at 6.) She had mild tenderness over right the acromioclavicular joint,
biceps, and lateral rotator cuff insertion as well as positive Hawkins and Neers tests.
(Id.) The orthopedist also reviewed the prior MRI, concluding it showed diffuse
degenerative changes without obvious rotator cuff tearing. (Id.) He diagnosed
impingement syndrome, bursitis, and a superior glenoid labrum lesion. (Id.) Petitioner
received a subacromial cortisone injection. (Id. at 7.)
Petitioner returned to the same orthopedist for a follow up on December 14,
2020. (Ex. 6, p. 8.) She reported that “[s]he has been trying to do exercises including
planks.” (Id.) The prior subacromial cortisone injection “provided relief although
symptoms persist at a lower intensity.” (Id. at 9.) Additional treatment options, including
repeat cortisone injections and surgery, were discussed as well as “the demands of
planks/push ups/shoulder presses and recommended modification.” (Id.) Petitioner
received a second cortisone injection on January 25, 2021. (Ex. 8, p. 2.) She was also
continuing to do home exercises. (Id.) She was instructed to continue her home
exercises and to follow up on an as needed basis. (Id. at 3.) No further medical
records were filed.
b. As Reflected in Petitioner’s Affidavit
Petitioner filed two affidavits in this case. (Exs. 4, 7.) In her first affidavit
petitioner describes developing “severe deep pain in my right shoulder” on the day of
her October 11, 2019 TDaP vaccination. (Ex. 4, ¶ 4.) In her second affidavit, she
further specifies that as of the night of the vaccination “I started to feel pain in my right
upper arm where I received the injection. In the days thereafter, the pain continued to
increase and I lost my range of motion.” (Ex. 7, ¶ 3.)
7
In her second affidavit, petitioner explains that she was “fit and healthy” prior to
her vaccination and that she “had been going to bootcamp classes for three (3) years.”
(Ex. 7, ¶ 4.) She indicates that since the vaccination she has not been able to return to
the bootcamp classes. (Id. at ¶ 5.)
In both affidavits, petitioner indicates that she has ongoing limitations. In the first
affidavit she indicates that “I continue to experience pain, weakness, and limited range
of motion in my right shoulder.” (Ex. 4, ¶ 7.) In the second affidavit she states that “[t]wo
(2) years later I am still unable to use my arm at the same level I was using it prior to
receiving the TDaP vaccination and probably never will be.” (Ex. 7, ¶ 6.)
IV. Discussion
Petitioner argues that she has satisfied all four of the QAI criteria for
demonstrating that her right shoulder injury constitutes a Table SIRVA and that she
should be found entitled to compensation for that Table injury. (ECF No. 33.)
Respondent argues, however, that petitioner’s history reflects both frequent exercise
injuries and anatomic shoulder variants that predisposed her to shoulder injury. (ECF
No. 34.) He contends petitioner cannot meet either the first or third SIRVA criteria
because her condition is not limited to her right shoulder and, in any event, is due to
preexisting shoulder dysfunction. (Id.)
Because of the nature of respondent’s arguments, discussion of petitioner’s
alleged Table injury is best facilitated by taking the four SIRVA criteria out of order.
Timing of onset under the second SIRVA criterion is addressed first. Next, analysis of
the third SIRVA criterion addresses respondent’s contention that petitioner’s medical
history demonstrates that petitioner’s symptoms are best viewed as part of a pattern of
injuries and are, therefore, not confined to her shoulder. Finally, the first and fourth
criteria are examined together to address respondent’s contention that petitioner’s
condition is ultimately explained by preexisting shoulder dysfunction.
For the reasons discussed below, I conclude that petitioner has met her prima
facie burden of proof with respect to each of the four QAI criteria for establishing a
Table Injury of SIRVA. I further conclude that respondent has not met his burden of
proof with respect to whether petitioner’s condition was caused by any factor unrelated
to vaccination. Accordingly, petitioner is entitled to compensation for a Table SIRVA.
a. Petitioner’s Prima Facie Showing of a Table SIRVA
i. Pain occurs within 48 hours of vaccination (second criterion)
As an initial matter, the fact that the timing of petitioner’s shoulder pain supports
a Table SIRVA is not meaningfully disputed. The second SIRVA criterion requires that
the “[p]ain occurs within the specified time-frame,” i.e., within 48 hours of vaccination.
8
42 CFR § 100.3(c)(10)(ii); 42 CFR § 100.3(a). Petitioner explains in her motion that her
medical records establish the onset of her shoulder pain was the same day as her
vaccination. (ECF No. 33, p. 8 (citing Ex. 2, p. 11; Ex. 3, p. 62; Ex. 7, ¶ 3).) I agree.
Respondent has not raised any specific argument to the contrary. (ECF No. 34.) Thus,
petitioner has satisfied the second SIRVA criterion by preponderant evidence.
ii. Pain and reduced range of motion are limited to the affected
shoulder (third criterion)
The third SIRVA criterion requires that for a shoulder injury to constitute SIRVA
the “[p]ain and reduced range of motion are limited to the shoulder in which the
intramuscular vaccine was administered.” 42 CFR § 100.3(c)(10)(iii). Despite the fact
that petitioner suffered onset of right shoulder pain post-vaccination, respondent places
her shoulder pain in a broader context of pain complaints that he asserts is incompatible
with this SIRVA requirement. (ECF No. 34, pp. 8-10.) This is not persuasive.
Respondent argues that petitioner “consistently reported pain outside her
vaccinated shoulder.” (ECF No. 34, p. 8.) In particular, he notes that at her first post-
vaccination encounter with her primary care provider petitioner reported bilateral
shoulder pain. (Id. at 9 (citing Ex. 2, p. 11).) He further notes that petitioner
subsequently complained of neck and knee pain to the orthopedist. (Id. (citing Ex. 2, p.
40).) Later, when petitioner presented for physical therapy, she again complained of
bilateral shoulder pain as well as knee pain. (Id.) At that time reduced range of motion
in the left shoulder was confirmed. (Id. (citing Ex. 3, p. 41-42).) Thus, respondent
argues that “[e]ven if petitioner’s right shoulder injury were characterized as the focus of
her complaints and treatment, petitioner’s condition cannot be said to be “localized to
the shoulder in which the vaccine was administered.” (Id. at 10 (quoting 82 Fed. Reg.
6294-01).) Petitioner argues, however, that “there is no evidence of an injury extending
beyond petitioner’s right shoulder. While the record contains stray notations of pain in
other parts of petitioner’s body (i.e. pain in both arms and soreness in her legs),
petitioner’s injury is consistent with the definition of SIRVA and there is not
preponderant evidence of another etiology.” (ECF No. 33, p. 8.)
In interpreting the third SIRVA criterion, both parties cite the undersigned’s prior
decision in Grossman v. Secretary of Health and Human Services for the proposition
that “[i]t is clear that the gravamen of this requirement is to guard against compensating
claims involving patterns of pain or reduced range of motion indicative of a contributing
etiology beyond the confines of a musculoskeletal injury to the affected shoulder.” (ECF
Nos. 33-34 (citing 2022 WL 779666, at *15).) In Grossman, the petitioner subjectively
reported to her treating physicians that she was experiencing pain beyond the confines
of her shoulder, which prompted her treaters to initially consider the possibility of a
cervical etiology for her pain; however, they ultimately ruled out a cervical etiology and
concluded she suffered a shoulder injury. 2022 WL 779666, at *16. Examining
respondent’s response to public comment for his SIRVA rulemaking revealed that he
had explained that SIRVA is “a condition localized to the shoulder,” thus he required
pain and reduced range of motion must be limited to the affected shoulder to accurately
9
reflect that condition. (Id. at 15.) However, because the Grossmann petitioner’s
treating physicians diagnosed a shoulder injury and rejected her additional pain
complaints as diagnostically useful, they did not suggest any etiology for petitioner’s
condition beyond the confines of a musculoskeletal injury to the shoulder. (Id. at 16.)
In this case, as petitioner argues, her medical records document a distinct onset
of right shoulder pain and reduced range of motion occurring post-vaccination which
was confirmed by orthopedic exam. (Ex. 3, pp. 47-48, 60-61.) Underlying shoulder
pathology was further confirmed by MRI study. (Ex. 2, p. 79.) Ultimately, although
petitioner did once reference “slight soreness into the neck” (Ex. 3, p. 61), petitioner’s
symptoms were diagnosed by her treating orthopedist as both impingement and bursitis
of the right shoulder (Ex. 3, pp. 47-48), two conditions limited to the shoulder. Accord
Werning v. Sec'y of Health & Human Servs., No. 18-0267V, 2020 WL 5051154, at *10
(Fed. Cl. Spec. Mstr. July 27, 2020) (finding that a petitioner satisfied the third SIRVA
QIA criterion where there was a complaint of radiating pain, but the petitioner was
“diagnosed and treated solely for pain and limited range of motion to her right
shoulder.”)
Although respondent is correct that petitioner had other documented
musculoskeletal complaints, respondent has not cited any medical opinion, whether in
petitioner’s own medical history or by expert analysis, to support his contention that
petitioner’s various complaints in other parts of her body can be unified to suggest that
the pain and reduced range of motion attributable to her diagnosed right shoulder injury
in itself extended beyond her affected shoulder. Accord Rodgers v. Sec’y of Health &
Human Servs., No.18-559V, 2021 WL 4772097, at *8 (Fed Cl. Spec. Mstr. Sept. 9,
2021) (explaining that the third SIRVA criterion “does not prevent a petitioner with
simultaneous areas of pain due to unrelated conditions from also meeting the Table
SIRVA definition.”) In fact, respondent’s contention is directly contradicted by the
medical records in that petitioner was specifically advised that her knee pain was
unrelated to her shoulder complaints8 and following a cervical muscle spasm in
February 2017 her primary care physician ultimately attributed her lingering neck pain to
her TMJ. (See Ex. 2, p. 13, 19.) In any event, even if respondent were persuasive in
arguing that petitioner’s various musculoskeletal issues should all be categorized
collectively as exercise-related injuries, they would still each constitute separate injuries.
Respondent stresses the bilateral nature of the initial onset of shoulder pain.
(ECF No. 34, p. 9.) However, no medical opinion ties petitioner’s shoulder complaints
and the medical records do not establish that petitioner’s left shoulder pain followed a
8 In his motion response, respondent accurately quotes the orthopedic PA as indicating petitioner’s knee
symptoms “do not seem to be associated to her recent vaccination at all.” (ECF No. 34, p. 11 (quoting
Ex. 2, p. 39).) However, that quotation must be understood in the surrounding context. That sentence
directly follows a statement accepting that petitioner’s shoulder complaint may constitute a vaccine-
caused exacerbation of previously asymptomatic shoulder issues. (Ex. 3, p. 60.) The same record also
indicates that petitioner’s knee pain began prior to vaccination and in the context of work outs, though she
felt it worsened subsequent to vaccination. (Id. at 61.) Looking at the record as a whole, the orthopedic
PA’s clear opinion is that the onset of right shoulder pain may be vaccine related, but that petitioner’s
knee pain is a separate issue.
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similar trajectory to her right shoulder pain. Accord Montana v. Sec’y of Health &
Human Servs., No. 20-873V, 2023 WL 7338887, at *11 (Fed. Cl. Spec. Mstr. Oct. 16,
2023) (explaining that “[a]lthough respondent is correct that some of petitioner’s medical
records indicate that she presented with ‘bilateral’ shoulder pain, the medical records do
explicitly distinguish the etiology and history of the pain she experienced in each
shoulder . . . [and] there is no indication from the medical records that any of petitioner’s
treating physicians considered her right and left shoulder pain to be a part of the same
condition”). When petitioner first presented to her primary care provider, she
complained of post-vaccination bilateral shoulder soreness that was already improving.
(Ex. 2, p. 11.) By the time she first sought orthopedic care for her right shoulder, she
reported that her initial left shoulder pain had been transient and physical examination
of her left shoulder revealed no abnormality. (Ex. 3, pp. 60-61.) She did not mention
left shoulder pain again until her physical therapy evaluation in June of 2020. (Ex. 3,
pp. 41-43.) At that time petitioner had left shoulder deficits, but nothing in the record
indicates her left shoulder symptoms were continuous. (Indeed, her prior orthopedic
exam confirmed they were not.) After that, petitioner never mentioned her left shoulder
pain again despite pursuing a second orthopedic opinion regarding her right shoulder.
Accordingly, petitioner has satisfied the third SIRVA criterion by preponderant
evidence.
iii. No history of pain, inflammation or dysfunction of the affected
shoulder (first criterion) and no other condition or abnormality is
present that would explain the patient’s symptoms (fourth criterion)
In this case, the first and fourth criteria are best addressed together. The first
SIRVA criterion requires “[n]o 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)(i). The fourth SIRVA criterion requires that
“[n]o 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)(iv).
Following on from his argument with respect to the third SIRVA criterion,
respondent argues that petitioner’s presentation is due to anatomic and degenerative
shoulder dysfunction, aggravated by her exercise routine rather than her vaccination.
(ECF No. 34, pp. 11-12.) Though respondent offers this argument under the first SIRVA
criterion, it also implicitly argues that another condition is present that would explain
petitioner’s symptoms. (Id.) First, respondent stresses that petitioner’s orthopedist
opined that “I do not feel as if the vaccination caused this issue, but [it] may have
exacerbated a pre-existing issue that was asymptomatic prior to the injection.” (ECF
No. 34, p.10 (quoting Ex. 2, p. 39).) Second, respondent finds significance in the fact
that petitioner had a high intensity workout regimen. (Id. at 11.) And, third, respondent
argues that petitioner had anatomic issues, namely os acromiale and type II acromion,
that are risk factors for rotator cuff issues. (Id. at 11-12.) Thus, respondent argues that
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“it is petitioner’s shoulder anatomy that presents as subacromial impingement syndrome
and puts her at risk for rotator cuff issues, combined with her known history of frequent
exercise injuries and intense exercise demands on her joints that preponderantly
establishes petitioner had preexisting right shoulder pain, inflammation, or dysfunction
that explains her post-vaccination condition.” (Id. at 12.) Petitioner counters that
petitioner’s medical records explicitly document that she had no issues with her right
shoulder prior to vaccination and that respondent’s assessment fails to account for
onset of shoulder pain coincident to vaccination. (ECF No. 33, pp. 6-7.)
Petitioner is clearly correct that her medical records confirm that she had no prior
history of pain or inflammation of her right shoulder. In that regard, respondent
misconstrues the orthopedic PA’s opinion. Although the orthopedic PA expressed
doubt that the vaccination alone would cause petitioner’s symptoms, she confirmed any
preexisting shoulder pathology would have been asymptomatic and specifically opined
that any such pathology “may have been exacerbated” by petitioner’s vaccination. (Ex.
2, p. 39.) Thus, contrary to what respondent argues, the orthopedic PA explicitly opined
that the vaccination, not the underlying pathology, explains the presentation of signs
and symptoms. Compare, e.g., Rance v. Sec’y of Health & Human Servs., No. 18-
222V, 2023 WL 6532401, at *25 (Fed. Cl. Spec. Mstr. Sept. 11, 2023) (finding that
petitioner met SIRVA QAI criterion one where he had prior episodes of shoulder pain
two year prior to vaccination but “no indication that this was an ongoing shoulder issue
prior to vaccination”) with French v. Sec’y of Health & Human Servs., No. 20-0862V,
2023 WL 7128178, at *6 (Fed. Cl. Spec. Mstr. Sept. 27, 2023) (finding that a prior
rotator cuff repair with sequela visible on MRI defeated a Table SIRVA under criteria
one and four without necessarily being a preponderant cause).
To the extent respondent nonetheless stresses preexisting underlying
dysfunction, it is true that petitioner’s first orthopedist specifically diagnosed a
symptomatic os acriomale. (Ex. 3, p. 47.) However, respondent’s suggestion that this
entirely explains petitioner’s condition is not supported by any medical opinion. As has
been previously observed in the context of the fourth SIRVA criterion,
because SIRVA is by definition an unspecified “injury to the musculoskeletal
structures of the shoulder (e.g. tendons, ligaments, bursae, etc.)” (see 42
C.F.R. § 100.3(c)(10)), respondent does not defeat petitioner's claim simply
by noting the presence of shoulder dysfunction beyond deltoid bursitis.
Although deltoid bursitis is the specific condition that has been most clearly
associated with vaccine-related shoulder injuries, the QAI definition of
SIRVA was specifically drafted to encompass shoulder dysfunction beyond
that condition.
Lang, 2020 WL 7873272, at *12 (citing Proposed Rulemaking, 2015 WL 4538923, at
*45136). Thus, “findings consistent with impingement, rotator cuff tears, or
AC arthritis do not per se preclude a finding that a Table SIRVA exists. Rather, the
question raised by respondent's argument is whether petitioner's own clinical history
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indicates that her shoulder pathology wholly explains her symptoms independent
of vaccination.” (Id. at 13.)
Here, respondent himself acknowledges that petitioner’s anatomic variants were
merely risk factors for rotator cuff issues. (ECF No. 34, p. 12.) In that regard, the
records confirm that the orthopedic PA was already aware of petitioner’s os acromiale
and degenerative changes when she agreed based on clinical presentation that the
symptom onset may have been due to vaccination. (Ex. 3, p. 60.) Subsequently, the
orthopedist did not revisit the orthopedic PA’s opinion that petitioner’s shoulder
pathology may have been exacerbated by vaccination. Nor following the MRI did he
limit his diagnosis to impingement due to a symptomatic os acromiale. Rather, he also
separately diagnosed bursitis. (Id.) In fact, in detecting bursitis the radiologist
suspected an inflammatory etiology separate from the os acromiale. (Ex. 2, p. 80.)
There is no evidence of any inflammatory process occurring prior to vaccination and,
even as it is not absolutely required, subacromial bursitis is in effect a hallmark of
SIRVA. 42 C.F.R. § 100.3(c)(10) (explaining that SIRVA is 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.”) Neither the
medical records nor the article abstracts cited by respondent suggest that petitioner’s os
acriomiale explains her separately diagnosed bursitis.
Finally, respondent also overstates the degree to which the record implicates
petitioner’s exercise routine as a contributor to her right shoulder injury. (See ECF No.
34, p. 11.) In fact, respondent’s view is entirely speculative. Petitioner’s medical
records support her knee injury, not her shoulder injury, as related to her exercise
routine. (Ex. 3, p. 44 (petitioner “presenting now for her L knee which began bothering
her approximately one year ago following a boot camp HIIT workout.”); Ex. 3, p. 49
(indication for left knee MRI is “exercise related injury”). For the same reasons
discussed above regarding QAI criterion three, the fact that petitioner suffered a
discrete knee injury while working out is not informative of the cause of her shoulder
pain. None of petitioner’s medical records report any suspicion that her right shoulder
injury was caused by exercise. In fact, the initial orthopedic encounter wherein
petitioner reported both left knee and right shoulder pain distinguished the etiology of
the two injuries. (Ex. 3, p. 60 (noting right shoulder pain to be due to vaccine-related
exacerbation and left knee pain to be unrelated to vaccination). Several notations
express petitioner’s frustration with being unable to continue her work out routine post-
vaccination. In particular, petitioner did report beginning in late 2020 that her right
shoulder symptoms “recently worsen[ed] with weight lifting exercises . . . exercises
including burpies, driving, raising the arms upwards.” (Ex. 6, p. 5.) At that time it was
further noted that petitioner “[e]xercises regularly – up until 1 year ago because of her
shoulder.” (Id.) Her second orthopedist recommended modifying her workout. (Id. at
9.) However, this reflects that petitioner’s injury affected her exercise routine, not that
her exercise routine caused her injury.
Thus, there is no evidence that petitioner had prior history of pain or inflammation
of the affected shoulder. Nor is there medical evidence to suggest that either
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petitioner’s symptoms or the full extent of her diagnostic studies can be explained by
preexisting shoulder dysfunction. Thus, based on my review of the record as a whole, I
find petitioner has satisfied the first and fourth SIRVA criteria by preponderant evidence.
b. Factor Unrelated
Once petitioner has satisfied her own prima facie burden, respondent has the
opportunity to demonstrate, also by a preponderance of the evidence, that petitioner’s
injury was nonetheless caused by a factor unrelated to vaccination. §300aa-
13(a)(1)(B); § 300aa-13(a)(2); Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human
Servs., 717 F.3d 1363, 1367 (Fed. Cir. 2013). In this case, respondent argues that
petitioner’s injury does not meet the specific definition of SIRVA because a combination
of anatomic shoulder variants, degenerative changes, and petitioner’s high intensity
exercise regimen, confound that analysis. (ECF No. 34, pp. 10-13.) However,
respondent does not explicitly argue that he could himself meet an affirmative burden of
proof to establish these factors actually more likely than not caused petitioner’s right
shoulder injury. (See generally ECF Nos. 30, 34.) And, indeed, no medical opinion
exists on this record to support respondent’s interpretation of petitioner’s medical history
and several of his assertions are not well supported by record evidence. (See generally
Exs.1-6; 8.) Thus, even additionally considering respondent’s arguments as endorsing
factors unrelated to vaccination as the cause of petitioner’s injury, those arguments
would still fail for all the same reasons discussed above.
V. Conclusion
After weighing the evidence of record within the context of this program, I find by
preponderant evidence that petitioner suffered a Table Injury of SIRVA resulting from
her October 11, 2019 TDaP 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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