The opinion
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 20-801V
ANA GUARDIOLA, Chief Special Master Corcoran
Petitioner,
v. Filed: September 30, 2024
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
Sean Franks Greenwood, The Greenwood Law Firm, Houston, TX, for Petitioner.
Benjamin Patrick Warder, U.S. Department of Justice, Washington, DC, for Respondent.
FACT RULING ON SITUS AND DISMISSING TABLE SIRVA CLAIM 1
On July 1, 2020, Ana Guardiola filed a Petition for compensation under the
National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq. 2 (the
“Vaccine Act”), alleging that she suffered a shoulder injury related to vaccine
administration (“SIRVA”) as a result tetanus-diphtheria-acellular pertussis (“Tdap”),
influenza (“flu”), and pneumococcal conjugate (“PCV13”) vaccines administered to her on
July 2, 2018. Pet. at 1, ECF No. 1. The Petition does not identify the site of administration
of any of the subject vaccines, and instead alleges pain in both arms following their
1
Because this Ruling 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 Ruling 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
National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2018).
receipt. 3 Id. at 1-2. The case was assigned to the Special Processing Unit of the Office of
Special Masters (the “SPU”).
For the reasons discussed below, I find it more likely than not that Petitioner
received all three vaccines in her left shoulder. However, her claim cannot meet other
Table elements, as her pain and reduced range of motion (“ROM”) were not limited to the
shoulder in which the subject vaccines were administered. Therefore, her Table SIRVA
claim is not tenable and must be dismissed (although the claim might be tenable under
an off-Table analysis). 4
I. Relevant Procedural History
Along with her Petition, Petitioner submitted an affidavit. ECF No. 1. Shortly after
initiating her claim, Petitioner filed her medical and immunization records, followed by a
statement of completion. ECF Nos. 6-7. A question was then raised regarding the validity
of the entries on Petitioner’s vaccination record from Walgreens and whether she, in fact,
received the subject flu vaccine as alleged. See ECF No. 14.
In pursuit of that issue, in March 2022, Respondent filed a status report requesting
additional outstanding records. ECF No. 27. This request for records included complete
records from Walgreens pharmacy (noting the source of the handwritten information on
the document is “unknown”), and complete records from Petitioner’s primary care
physician (“PCP”), including treatment notes from Petitioner’s July 2, 2018 visit during
which the subject PCV13 vaccination was allegedly administered. See id. Petitioner was
subsequently ordered to produce such records. ECF No. 29. In response, Petitioner filed
a status report stating that no additional records from Walgreens or her PCP exist, and
the record was therefore complete. ECF No. 30.
On July 19, 2022, Respondent filed a status report requesting to file a Rule 4(c)
Report, arguing that this case was not appropriate for compensation. ECF No. 31. That
report was filed on October 19, 2022, and in it Respondent argued that Petitioner had
failed to establish the administration site of the covered vaccinations she received on July
2, 2018. ECF No. 33. Specifically, Respondent highlighted that the Walgreens record
reflects a handwritten notation that the flu and Tdap vaccines were administered in
3
Petitioner also received a non-covered shingles (Shingrix) vaccination on July 2, 2018. Ex. 7 at 2.
Petitioner is not alleging an injury associated with that vaccination, specifically.
4
Although the parties submitted briefings on the issue of whether there was another condition or
abnormality that explains Petitioner’s post-vaccination symptoms, at this time, this Ruling is limited to a
finding of fact regarding situs and whether her pain and reduced range of motion were limited to the shoulder
in which the subject vaccinations were administered.
2
Petitioner’s left arm, and a shingles vaccine 5 in her right. Id. at 5 (citing Ex. 7 at 3).
Respondent asserted Petitioner’s vaccination records are not certified, there is no
explanation for why half of the records are handwritten when the other half is not, and
there is no corresponding treatment record to establish the site of administration of
Petitioner’s PCV13 vaccination. Id. at 6.
Respondent also argued that Petitioner’s medical records show her pain and
reduced ROM were not limited to the shoulder in which the subject vaccines were
administered. ECF No. 33 at 6-7 (citing Ex. 2 at 114-17; Ex. 3 at 55; Ex. 4 at 7-12, 18).
Finally, Respondent asserted that Petitioner’s records revealed other conditions or
abnormalities (cervical disc disease and severe osteoarthritis (“OA”) in the right
acromioclavicular (“AC”) joint) that may explain her post-vaccination shoulder symptoms.
Id. at 7 (citing Ex. 4 at 11-12, 20).
Petitioner subsequently filed a status report confirming she did not have any
additional evidence to submit in response to the arguments raised in Respondent’s Rule
4(c) Report and she filed a motion for a ruling on the record on May 25, 2023. ECF Nos.
36-37. On July 10, 2023, Respondent filed a response to Petitioner’s motion. ECF No.
38. Later that month, Petitioner filed her insurance profile from Walgreens pharmacy –
which includes documentation of Petitioner’s July 2, 2018 Tdap and Shingrix
vaccinations, without also noting proof of her receipt of a flu vaccine that day. Ex. 15 at
88. ECF No. 40. This matter is now ripe for consideration.
II. Authority
Pursuant to Vaccine Act Section 13(a)(1)(A), a petitioner must prove, by a
preponderance of the evidence, the matters required in the Petition by Vaccine Act
Section 11(c)(1). “Medical records, in general, warrant consideration as trustworthy
evidence. The records contain information supplied to or by health professionals to
facilitate diagnosis and treatment of medical conditions. With proper treatment hanging in
the balance, accuracy has an extra premium. These records are also generally
contemporaneous to the medical events.” Cucuras v. Sec’y of Health & Hum. Servs., 993
F.2d 1525, 1528 (Fed. Cir. 1993).
Accordingly, where medical records are clear, consistent, and complete, they
should be afforded substantial weight. Lowrie v. Sec’y of Health & Hum. Servs., No. 03-
1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). However, this rule
5
Respondent correctly states that the shingles (Shingrix) vaccination is not covered under the Vaccine Act
and Petitioner is not alleging an injury caused by her receipt of the shingles vaccination. Respondent’s
Report at 5, n.5.
3
does not always apply. In Lowrie, the special master wrote that “written records which
are, themselves, inconsistent, should be accorded less deference than those which are
internally consistent.” Lowrie, 2005 WL 6117475, at *19.
The Court of Federal Claims has recognized that “medical records may be
incomplete or inaccurate.” Camery v. Sec’y of Health & Hum. Servs., 42 Fed. Cl. 381,
391 (1998). The Court later outlined four possible explanations for inconsistencies
between contemporaneously created medical records and later testimony: (1) a person’s
failure to recount to the medical professional everything that happened during the relevant
time period; (2) the medical professional’s failure to document everything reported to her
or him; (3) a person’s faulty recollection of the events when presenting testimony; or (4)
a person’s purposeful recounting of symptoms that did not exist. La Londe v. Sec’y of
Health & Hum. Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1335 (Fed. Cir.
2014). The Court has also said that medical records may be outweighed by testimony
that is given later in time that is “consistent, clear, cogent, and compelling.” Camery, 42
Fed. Cl. at 391 (citing Blutstein v. Sec’y of Health & Hum. Servs., No. 90-2808, 1998 WL
408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)).
A special master may find that the first symptom or manifestation of onset of an
injury occurred “within the time period described in the Vaccine Injury Table even though
the occurrence of such symptom or manifestation was not recorded or was incorrectly
recorded as having occurred outside such period.” Section 13(b)(2). “Such a finding may
be made only upon demonstration by a preponderance of the evidence that the onset [of
the injury] . . . did in fact occur within the time period described in the Vaccine Injury
Table.” Id.
The special master is obligated to fully consider and compare the medical records,
testimony, and all other “relevant and reliable evidence contained in the record.” La
Londe, 110 Fed. Cl. at 204 (citing § 12(d)(3); Vaccine Rule 8); see also Burns v. Sec’y of
Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that it is within the special
master’s discretion to determine whether to afford greater weight to medical records or to
other evidence, such as oral testimony surrounding the events in question that was given
at a later date, provided that such determination is rational).
4
III. Relevant Factual Evidence 6
On July 2, 2018, Petitioner (then 72 years old) received the subject flu, 7 Tdap, and
PCV13 vaccines (plus a non-covered shingles vaccine). Ex. 7 at 2; Ex. 2 at 125. Petitioner
attests that she received the Tdap and flu vaccines in her left arm at Walgreens pharmacy.
Ex. 1 ¶ 2; Ex. 7 at 2. Petitioner also alleges that she received the PCV13 vaccine on the
same day at the Memorial Hermann Health System (“Memorial Hermann”). Ex. 1 ¶ 2; Ex.
2 at 125. Petitioner admits in her affidavit that she “cannot specifically recall into which
arms [she] received the shots.” Ex. 1 ¶ 2, n.1. But she began experiencing pain “in both
of [her] arms at the injection sites” immediately upon their receipt. Id. ¶ 3.
As noted above (and reproduced below), the vaccination record from Walgreens
pharmacy contains both typed and handwritten entries. The typed entries reflect
Petitioner’s immunization history and show she received Tdap and shingles vaccines on
July 2, 2018 – but without documenting a site of administration. Ex. 7 at 2. The record
also contains, however, handwritten entries noting that the subject flu and Tdap vaccines
were administered in Petitioner’s left arm, while the non-covered shingles vaccine was
administered in her right arm. Id. The Walgreens pharmacy record is reproduced below:
See id.
6
I have reviewed all of the filings submitted by both parties to date. Only those facts relevant to situs and
localization of symptoms will be discussed herein, although other facts may be included as necessary.
7
Although not explicitly contested by Respondent in his Rule 4(c) Report or response to Petitioner’s motion
for ruling on the record, there was a question early on in the pendency of this case as to whether Petitioner
received the flu vaccine at all. See, e.g., ECF No. 14. In light of Respondent’s position, this Ruling will not
otherwise determine whether Petitioner, in fact, received the vaccine (although preponderant evidence
supports the determination). See, e.g., Ex. 7 at 2.
5
Also on July 2, 2018, Petitioner presented to her PCP at Memorial Hermann for an
annual wellness visit. Ex. 10 at 91. Although treatment notes for this visit with her PCP
do not appear in the medical records, other records nevertheless show that Petitioner
received a PCV13 vaccine in her left deltoid during this visit. Ex. 2 at 125. The Memorial
Hermann vaccination record is reproduced below:
*pneumococcal 13−valent vaccine − 0.50 mL − IM (Left Deltoid)
Admin Dt/Tm: 07/02/2018 11:45 Ordered by: Herrera, Carmen Marbella MD Charted by:
Ruiz, Crissia MA Manufacturer: Wyeth Pharmaceutical Vaccines Lot Number: T85621 Exp
Dt/Tm: 03/30/2020 00:00
See id.
The next day (July 3, 2018), Petitioner went to the emergency room (“ER”)
complaining of arm and neck pain, as well as “generalized body aches.” Ex. 2 at 114-16.
Petitioner noted she received a tetanus and shingles vaccine the day before this visit. Id.
at 116. A physical examination showed “[r]ight shoulder tenderness” and normal ROM.
Id. The “final diagnostic impression” was listed as myalgias and right shoulder strain. Id.
The physician noted that her pain was “likely muscular skeletal [sic] in origin secondary
to her recent vaccine[.]” Id. Petitioner was sent home and told to use warm compresses
and over-the-counter medications to relieve her pain. Id.
On July 18, 2018, Petitioner’s PCP called her to discuss results of unrelated
laboratory work. Ex. 3 at 21. During this call, Petitioner “stated she is having pain on her
arm from vaccines she had at pharmacy.” Id. The note does not contain a description of
which arm was affected or to which vaccination or vaccinations Petitioner’s pain was
attributed. See id.
Petitioner returned to her PCP on July 26, 2018, complaining of “right shoulder
pain[,]” specifically, “neck pain that radiates down the right shoulder.” Ex. 3 at 54-55.
Petitioner reported the duration of her pain was “4 weeks.” Id. at 55. She did not provide
a description of the accident/injury that brought about such pain. See id. Petitioner
underwent an x-ray of the right shoulder, which was consistent with severe AC joint OA;
the x-ray of her cervical spine showed “mild to moderate multilevel degenerative changes
of the cervical spine.” Id. at 61-62. Petitioner was diagnosed with right shoulder pain and
cervicalgia. Id. at 56.
On August 2, 2018, Petitioner returned to the ER “[complaining of] chest pain
radiating to the bilateral arms which began earlier th[at] evening.” Ex. 4 at 6. Petitioner
6
(through her family) 8 also reported shortness of breath and that she had “recently
received injections 9 for pain[.]” Id. Petitioner was admitted.
During Petitioner’s August 3, 2018 examination, Petitioner (through her niece)
denied “any chest pain” but stated she
has had this pain in her bilateral upper extremity associated with neck pain
since she got vaccinations about 3 weeks ago at her [PCP’s] office[,] this
has been treated a few times with pain medications and injections however
no improvement[. S]he is unable to lift both of her arms at this time has
some mild numbness and tingling in bilateral upper extremity. [Petitioner] is
not sure which vaccines but tetanus was one of whom [sic] it may be
Pneumovax.
Ex. 4 at 17.
Petitioner underwent a neurology consultation on August 5, 2018, for “bilateral arm
pain and numbness.” Ex. 4 at 24. Petitioner reported she “received vaccinations for
tetanus, shingles, and one other unknown vaccination” and experienced “bony pain and
tenderness immediately upon vaccine administration in her [right] upper shoulder.” Id. at
25. She was currently experiencing “painful [right] shoulder movement.” Id. The
neurologist noted that Petitioner had “severe [OA] and probable coracoacromial joint
pathology producing some of her pain[;]” and Petitioner’s “clinical suggestion [was] of right
greater than left rotator cuff damage.” Id. at 24.
Petitioner was discharged the same day with diagnoses of atypical chest pain
(non-cardiac), right shoulder pain secondary to severe OA of the right AC joint with
supraspinatus tendinopathy, and C3-C4 cervical canal stenosis with bulging cervical disc
without myelopathy. Ex. 4 at 28-29. Petitioner was prescribed naproxen and gabapentin,
and she received a referral to orthopedics and physical therapy (“PT”). Id. at 29.
On August 16, 2018, Petitioner had her initial orthopedic evaluation. Ex. 5 at 18.
She reported a history of “bil[ateral] shoulder pain[,] 3 injections (2R, 1L) 7/2/18.” Id. She
stated that “the vaccines were given by on [sic] the arm” and she developed pain
thereafter. Id. at 19. She noted her pain is constant and burning, primarily in the lateral
8
Petitioner’s medical records contain notations that she received the services of a Spanish interpreter
during several of her medical visits. See, e.g., Ex. 3 at 23, 55.
9
Although billing records show Petitioner received a Ketorolac injection on July 30, 2018, corresponding
encounter or treatment notes for this visit cannot be located in the filed medical record. See Ex. 10 at 96.
Such treatment thus cannot be considered in determining situs or the other contested issues in this case.
7
shoulder, and worse with “attempting to lift the arm.” Id. An examination showed bilateral
tenderness to palpation, severe pain with active and passive ROM, and positive
impingement signs. Id. at 20. Petitioner was diagnosed with bilateral subacromial bursitis.
Id. She received a Kenalog injection in each shoulder. Id.
Petitioner followed up with her orthopedist two weeks later, on August 30, 2018.
Ex. 5 at 12. She reported improvement for the first three days following her steroid
injections, but her pain “returned and is now worse than before.” Id. Petitioner was
prescribed oral steroids and subsequently underwent an MRI on September 12, 2018. Id.
at 12, 24. The MRI of the left shoulder showed 1) a near-full thickness tear of the
supraspinatus tendon, 2) biceps tendinosis, 3) a tear of the posterosuperior glenoid
labrum, 4) a small glenohumeral joint effusion with synovitis, 5) moderate to severe AC
degenerative arthritis, and 6) mild subacromial subdeltoid bursitis. Id. at 24-26. The MRI
of Petitioner’s right shoulder showed 1) a tear in the supraspinatus tendon, 2) a tear in
the subscapularis tendon, 3) biceps tendinosis, 4) degenerative tearing of the labrum, 5)
mild bursitis, 6) moderate glenohumeral effusion with synovitis, 7) moderate to severe AC
degenerative arthritis, and 8) mild subacromial subdeltoid bursitis. Id. at 22-23.
On November 12, 2018, Petitioner followed up with her orthopedist to discuss her
MRI results. Ex. 5 at 9. She reported having severe pain in the bilateral shoulders. Id.
Petitioner’s physical examination was unchanged, and she was assessed with bilateral
subacromial bursitis, partial thickness rotator cuff tears, and biceps tendinosis. Id. at 10-
11. Petitioner received repeat steroid injections in each shoulder. Id.
Roughly six months later, on May 2, 2019, Petitioner returned to her orthopedist
reporting that her previous steroid injection “helped for about 2 weeks.” Ex. 5 at 5. She
stated that she “continue[d] to have a lot of pain in both shoulders, difficulty putting on her
clothes. The entire shoulder hurts.” Id. She received repeat injections in her bilateral
shoulders. Id. at 7. No additional medical record or affidavit evidence has been submitted.
IV. Findings of Fact
A. Situs
While Respondent contends that the uncertified vaccination records in this case
are insufficient to establish “which particular vaccines [Petitioner] received on July 2,
2018, or the site of those particular vaccines[,]”such arguments are unpersuasive. See
Respondent’s Report at 6; Respondent’s Response at 6.
8
Rather, the complete vaccine administration form from Walgreens pharmacy
depicts a typed entry showing Petitioner received one of the covered subject vaccines
(Tdap) on July 2, 2018. Ex. 7 at 2. Although this entry does not have a corresponding
typed situs of vaccination, it is accompanied by a handwritten entry showing that the Tdap
vaccine was administered in Petitioner’s left arm. Id. The form also shows (in a
handwritten entry) that a covered flu vaccine was likewise administered in Petitioner’s left
arm. Id. A separate record depicts a typed, computerized entry supporting receipt of
Petitioner’s PCV13 vaccine in her left arm, also. Ex. 2 at 125.
In my experience with SIRVA cases (over 2,000 within SPU since my appointment
as Chief Special Master, additional cases handled within chambers, and review of
opinions issued by other special masters), I have found it often to be the case that
information regarding the vaccine administration site is incorrect – especially information
contained in computerized records, which may feature a ‘dropdown’ menu which may not
be updated each time a separate vaccine is administered. 10 Although such records are
unquestionably the first-generated documents bearing on issues pertaining to situs, they
are not per se reliable simply because they come first – and in fact the nature of their
creation provides some basis for not accepting them at face value. But information
contained on these kinds of records reflecting specific action on the part of the vaccine
administrator (often at the very time of administration), such as a handwritten notation on
a printed form, generally warrants more significant weight. 11
Such handwritten notations can be rebutted of course, by additional, case-specific
evidence and circumstances. For instance, in one case a petitioner’s history of
vaccination and subsequent injury in the same shoulder was medically documented just
13 days post-vaccination, and consistently thereafter. That petitioner also explained that
she requested vaccination in her non-dominant arm. Rizvi v. Sec’y of Health & Hum.
Servs., No. 21-0881V, 2022 WL 2284311, at *3 (Fed. Cl. Spec. Mstr. May 13, 2022). In
another more recent matter, the petitioner’s history was medically documented 23 days
post-vaccination, and in numerous later records. And the site notation was found on “an
otherwise haphazardly-completed form (containing entries listed diagonally and not in the
allotted space)” – constituting a specific reason to doubt the record’s reliability. Toothman
10
See, e.g., Mezzacapo v. Sec’y of Health & Hum. Servs., No. 18-1977, 2021 WL 1940435, at *2 (Fed. Cl.
Spec. Mstr. Apr. 19, 2021); Desai v. Sec’y of Health & Hum. Servs., No 14-0811V, 2020 WL 4919777, at
*14 (Fed. Cl. Spec. Mstr. July 30, 2020); Rodgers v. Sec’y of Health & Hum. Servs., No. 18-0559V, 2020
WL 1870268, at *5 (Fed. Cl. Spec. Mstr. Mar. 11, 2020); Stoliker v. Sec’y of Health & Hum. Servs., No. 17-
0990V, 2018 WL 6718629, at *4 (Fed. Cl. Spec. Mstr. Nov. 9, 2018).
11
See, e.g., Schmidt v. Sec’y of Health & Hum. Servs., No. 17-1530V, 2021 WL 5226494, at *8 (Fed. Cl.
Spec. Mstr. Oct. 7, 2021); Marion v. Sec’y of Health & Hum. Servs., No. 19-0495V, 2020 WL 7054414 at
*8 (Fed. Cl. Spec. Mstr. Oct. 27, 2020).
9
v. Sec’y of Health & Hum. Servs., No. 22-0207V, 2024 WL 2698520, at *4 (Fed. Cl. Spec.
Mstr. Apr. 19, 2024).
Here, I do not find sufficient reason to doubt the entries on the relevant vaccine
administration records. Indeed, the handwritten Walgreens entries here are deserving of
appropriate weight – they clearly depict notations requiring specific action on the part of
the vaccine administrator, and the entries are not so haphazardly executed as to cast
doubt on the clarity of the record or its reliability. See Toothman, 2024 WL 2698520, at
*4. Rather, it is credible that the vaccine administrator took the time to document by-hand
each of Petitioner’s administered vaccines, along with vaccine lot numbers, expiration
dates, and site of administration. Ex. 7 at 2. In addition, the record reveals variation in the
site of administration, adding to the overall credibility of the relevant proof. For instance,
the relevant record shows that two of the three vaccinations were administered in one
arm (the left arm), while the third vaccination was administered in the other. See id. Thus,
the handwritten Walgreens vaccine administration record in this case has some facial
reliability that Respondent has not persuasively undermined.
Additionally, Respondent appears to have misidentified proof of administration of
Petitioner’s PCV13 vaccine. See Respondent’s Response at 6 (stating that the vaccine
may have been administered “based on the Medicare reimbursement records,” but the
record does not identify the site of administration or correspond to any treatment notes).
In fact, Petitioner’s medical records contain a computerized entry documenting her receipt
of this particular vaccine, and it shows said vaccination was administered in the left
deltoid. Ex. 2 at 125. I do not have any reason to doubt the accuracy of this record.
The vaccination record evidence is thus sufficient to establish situs in this case,
without looking to the contemporaneous medical records of Petitioner’s post-vaccination
treatment. (This is just as well, as Petitioner’s medical records do not contain descriptions
of which arm each subject vaccination was administered). See, e.g., Ex. 3 at 21; Ex. 4 at
17; Ex. 5 at 18. More so, her affidavit provides context for her lack of descriptions of situs
in the contemporaneous medical records – as she admittedly could not remember in
which arm or arms, she received her July 2018 vaccinations. Ex. 1 ¶ 2, n.1. I therefore
find that the subject Tdap, flu, and PCV13 vaccines were more likely than not
administered in Petitioner’s left arm. In order for Petitioner’s Table claim to succeed, she
thus needed to demonstrate that her SIRVA-consistent shoulder symptoms were located
in the left shoulder as a result of a covered vaccination.
10
B. Scope of Pain and Limited Range of Motion
The third QAI requirement for a Table SIRVA requires a petitioner’s pain and
reduced range of motion to be “limited to the shoulder in which the intramuscular vaccine
was administered.” 42 C.F.R. § 100.3(c)(10)(iii).
Respondent contests that Petitioner’s pain was limited to her shoulders, generally.
Respondent’s Response at 6. Rather, Petitioner complained of pain all over her body,
neck pain radiating to her right shoulder, and chest pain that radiated to both arms. Id. at
6-7 (citing Ex. 2 at 114-17; Ex. 3 at 55; Ex. 4 at 7-12, 18).
The record is largely consistent with Respondent’s contention. Indeed, the day
after the vaccinations, Petitioner was complaining of arm and neck pain plus “generalized
body aches” and myalgias. Ex. 2 at 114-16 (emphasis added). She did not describe left
shoulder symptoms, specifically; she instead demonstrated right shoulder findings upon
examination. See id. Later that month (July 26, 2018), Petitioner was experiencing “neck
pain that radiates down the right shoulder.” Ex. 3 at 54-55. Throughout August 2018,
Petitioner consistently reported bilateral arm pain, but often with an emphasis on the right
shoulder. See, e.g., Ex. 4 at 6, 17 (an August 2, 2018 ER note showing chest pain
radiating to the bilateral arms with neck pain); Ex. 4 at 24-25 (an August 5, 2018 neurology
note of bilateral arm pain/numbness and reporting that she experienced immediate right
shoulder pain upon vaccination and at the current time; found to have a greater pathology
in the right than left shoulders); Ex. 5 at 18 (an August 16, 2018 diagnosis of bilateral
subacromial bursitis). In addition, Petitioner’s post-vaccination diagnostic procedures and
treatment originally pertained to the opposite arm and shoulder – and presented the same
way in both arms. See, e.g., Ex. 2 at 114-16; Ex. 3 at 54-55; Ex. 4 at 24-25, 28-29.
In the Program, special masters have found that claims involving musculoskeletal
pain primarily occurring in the shoulder are valid under the Table even if there are
additional allegations of pain extending to adjacent parts of the body. K.P. v. Sec’y of
Health & Hum. Servs., No. 19-65V, 2022 WL 3226776, at *8 (Fed. Cl. Spec. Mstr. May
25, 2022) (holding that “claims involving musculoskeletal pain primarily occurring in the
shoulder are valid under the Table even if there are additional allegations of pain
extending to adjacent parts of the body”). But the third QAI criterion is intended to “guard
against compensating claims involving patterns of pain or reduced [ROM] indicative of a
contributing etiology beyond the confines of a musculoskeletal injury to the affected
shoulder.” Grossmann v. Sec’y of Health & Hum. Servs., No. 18-0013V, 2022 WL 779666,
at *15 (Fed. Cl. Spec. Mstr. Feb. 15, 2022).
11
Thus, special masters balance complaints about shoulder pain, and associated
treatment, against evidence that the overall presentation is more systemic. See, e.g.,
Cross v. Sec’y of Health & Hum. Servs., No. 19-1958V, 2023 WL 120783, at *7 (Fed. Cl.
Spec. Mstr. Jan. 6, 2023) (finding that “despite the notations of pain extending beyond
the shoulder, Petitioner’s injury is consistent with the definition of SIRVA and there is not
preponderant evidence of another etiology”); Werning v. Sec’y of Health & Hum. Servs.,
No. 18-0267V, 2020 WL 5051154, at *10 (Fed. Cl. Spec. Mstr. July 27, 2020) (finding that
a petitioner satisfied the third SIRVA QAI 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”).
Here, Petitioner did not simply experience “stray notations” of pain extending
beyond the shoulder, but whose injury was still consistent with SIRVA. See K.P., 2022
WL 3226776, at *8. Rather, there is evidence that Petitioner initially complained of
generalized body aches and myalgia. Ex. 2 at 114-16. And once Petitioner complained of
shoulder-related complaints, such complaints or manifestations were instead originally
focused on the opposite shoulder. See, e.g., Ex. 3 at 54-55, 61-62.
Additionally, Petitioner’s pain was not found to be radiating from the vaccinated left
shoulder – but rather was noted to originate in the neck and radiate to the right shoulder
or begin in the chest and radiate to the bilateral upper extremities. See Ex. 3 at 54-55;
Ex. 4 at 6, 17. Overall, the medical records do not consistently reflect a new injury
localized to the left shoulder as the primary complaint, that can be isolated from other
incidental complaints of pain elsewhere. Petitioner has therefore failed to establish this
QAI criterion and her Table claim must be dismissed.
Conclusion and Order to Show Cause
The factual finding of a left-sided vaccine administration of covered vaccinations
required Petitioner to establish that her pain was limited to that shoulder. See 42 C.F.R.
§ 100.3(c)(10)(iii) (providing that a SIRVA is limited to “the shoulder in which the
intramuscular vaccine was administered”). As she has been unable to do so, Petitioner’s
Table SIRVA claim is therefore DISMISSED.
It is therefore unnecessary to resolve whether Petitioner’s condition could be
explained by another condition or abnormality. 42 C.F.R. §§ 100.3(a), (c)(10)(iv);
Respondent’s Response at 7 (challenging this criteria).
Instead at this stage, the remaining question is whether any off-Table, causation-
in-fact claim might be feasible for a left-sided injury. But Respondent’s briefing and my
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preliminary review of the evidence has identified a potential alternative cause for the injury
discussed herein (moderate-to-severe OA of the AC joint in the bilateral shoulders). And
the overall nature of the complained-of symptoms is not in many ways consistent with an
injury that is more shoulder-oriented.
Petitioner will be afforded one brief and final opportunity to determine whether she
would like to pursue any remaining causation-in-fact claim centering on an injury in the
vaccinated shoulder/arm. However, Petitioner may not formally retain an expert, or order
any expert’s written report, without prior consultation with Respondent and the Court. Any
request for experts, when combined with this case’s age, would likely support the case’s
transfer out of SPU for further proceedings.
Petitioner’s failure to respond to this or other orders issued in this action, as well
as failure to file evidence required to support his claim, will be interpreted as a failure to
prosecute resulting in dismissal of Petitioner’s claim. Tsekouras v. Sec’y of Health & Hum.
Servs., 26 Cl. Ct. 439 (1992), aff’d, 991 F.2d 810 (Fed. Cir. 1993) (per curiam); Sapharas
v. Sec’y of Health & Hum. Servs., 35 Fed. Cl. 503 (1996); Vaccine Rule 21(b).
Accordingly, within 30 days, by no later than Wednesday, October 30, 2024,
Petitioner shall show cause why her claim should not be dismissed for insufficient
proof of causation-in-fact and otherwise stating how she wishes to proceed.
In the alternative, if Petitioner wishes to exit the Vaccine Program, counsel shall
file the appropriate motion, Stipulation, or Notice. See
http://www.uscfc.uscourts.gov/sites/default/files/autism/EXITING GUIDANCE TO PRO
SES.pdf.
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
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