LEE v. SECRETARY OF HEALTH AND HUMAN SERVICES

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 21-0345V
TERESA LEE,
Petitioner,
v.
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
Chief Special Master Corcoran
Filed: November 25, 2025
Jonathan Joseph Svitak, Shannon Law Group, P.C., Woodridge, IL, for Petitioner.
Joseph Douglas Leavitt, U.S. Department of Justice, Washington, DC, for Respondent.
RULING ON ENTITLEMENT1
On January 8, 2021, Teresa Lee filed a petition for compensation under the
National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the
“Vaccine Act”), which she amended on July 10, 2023. Petitioner alleges that she suffered
a shoulder injury related to vaccine administration (“SIRVA”) resulting from an influenza
(“flu”) vaccine received on September 8, 2020. Amended Petition at 1. The case was
assigned to the Special Processing Unit of the Office of Special Masters.
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 find 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).
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Respondent has argued that Petitioner is not entitled to compensation (ECF No.
34), and the parties have now fully briefed entitlement (ECF Nos. 39, 40, 41). For the
reasons set forth below, I find that record evidence preponderantly establishes that
Petitioner suffered from limited range of motion (“ROM”), experienced residual effects of
her injury for more than six months, and has satisfied the remaining requirements for
entitlement.
I. 	Relevant Factual History
A. Medical Records
Petitioner received a flu vaccine in her right arm on September 8, 2020. Ex. 15D.
Two weeks later (September 22, 2020), she attended a virtual appointment with certified
nurse practitioner (“CNP”) Lindsay Corll. Ex. 11 at 22. Petitioner stated at this time that
immediately after vaccination, she had tingling in her right fingers and upper extremity.
Id. at 27. The pain improved a day after vaccination, but worsened the day after that. Id.
She was now having “significant pain” and weakness. Id. She was assessed with adverse
effect of flu vaccine and given oral steroids. Id. at 28.
A month later (October 23, 2020), Petitioner followed up with CNP Corll. Ex. 11 at
16. She stated that the oral steroids had improved her symptoms, but they returned after
she 	completed 	the 	course. 	Id. 	She 	was 	now 	treating 	with 	over-the-counter 	anti-
inflammatory medication, but continued to have significant difficulty with ROM and
activities of daily living. Id. On examination, she had full ROM of her upper extremities
bilaterally, but with significant discomfort on the right side. Id. at 18. Petitioner was given
medication and referred to an orthopedist. Id.
Petitioner saw orthopedist Michael Miladore, M.D., on November 2, 2020. Ex. 13
at 9. She reported right shoulder pain that began two months earlier. Id. She rated her
pain seven out of ten, explaining that the pain was worse with overhead activities and
reaching behind her back. Id. On examination, she exhibited right shoulder swelling and
tenderness, but full ROM. Id. at 11. Dr. Miladore diagnosed strain of muscle, fascia, and
tendon, and recommended physical therapy (“PT”) and anti-inflammatory medication. Id.
at 12.
A week later (November 9, 2020), Petitioner underwent a PT evaluation of her right
shoulder. Ex. 4 at 6. She again rated her pain seven out of ten and reported difficulty
elevating her shoulder. Id. at 7. On examination, her right shoulder exhibited reduced
ROM in scaption and abduction compared to her left shoulder. Id. The therapist assessed
her as displaying moderate weakness and decreased ROM.
Petitioner followed up with Dr. Miladore on December 16, 2020. Ex. 13 at 19. She
had been doing PT and taking Tylenol, without improvement. Id. On examination, her
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right shoulder ROM was full, but with pain. Id. at 21. Dr. Miladore administered a steroid
injection and recommended continued PT. Id. at 22.
Petitioner was discharged from PT and given a home exercise program on January
5, 2021. Ex. 13 at 14. The record states that her treatment was discontinued because she
“decline[d] to continue care.” Id.
On February 22, 2021 – now five and a half months after vaccination – Petitioner
returned to Dr. Miladore. Ex. 13 at 15. She stated that the steroid injection helped 75%
for a week, but her symptoms then returned. Id. She rated her pain six out of ten. Id. On
examination, her right shoulder ROM was again full, but painful. Id. at 17. Dr. Miladore
recommended an MRI. Id. at 18.
Thereafter, during the remainder of 2021 and early months of 2022, Petitioner
continued to follow up with CNP Corll for other concerns, without seeking treatment for
her shoulder. Ex. 12 at 22-100. At several of these appointments she was noted to have
full ROM in her shoulders. Id. at 34, 48, 56, 73, 82, 94.
On July 29, 2022 – over a year and a half after Petitioner’s last treatment for
shoulder pain – Petitioner saw CNP Corll for other health concerns, and reported that she
continued to experience right shoulder discomfort, but did not want further evaluation. Ex.
12 at 22-23. Three months later (October 28, 2022), Petitioner saw CNP Lindsay Landis
to follow up on health concerns, adding that she had “recurrent symptoms in the right
shoulder” and planned to increase her home PT exercises and may return to her
orthopedist. Id. at 11. On examination, she had full ROM in both shoulders. Id. at 13.
Over a year later (September 25, 2023), Petitioner returned to Dr. Miladore for right
shoulder pain. Ex. 16 at 10. She rated her pain six out of ten, and reported that her pain
interfered with routine activities, and had worsened in the last two months. Id. On
examination, her right shoulder ROM was full, but painful, with positive impingement
signs. Id. at 12. Dr. Miladore administered a steroid injection and recommended PT. Id.
at 13.
The following day (September 26, 2023), Petitioner underwent a PT evaluation for
her right shoulder. Ex. 16 at 6. She related her pain to a flu vaccination in 2020, stating
that her “pain improved until a few months ago.” Id. She rated her pain six out of ten. Id.
at 7. She returned for additional PT sessions in October 2023. Id. at 3, 15.
B. Testimonial Evidence
Petitioner filed testimonial evidence in support of her claim. Exs. 1, 17. She states
that her shoulder pain persisted from February 2021 through October 2022. Ex. 17 at ¶
6. She did not seek treatment for her shoulder during this time because she “was
experiencing some unrelated health issues that required more immediate attention.” Id.
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Petitioner states that every time she saw CNP Corll, they discussed her right
shoulder, and Petitioner reported that her symptoms were still present, but she was trying
to manage them on her own. Ex. 17 at ¶ 7. She created a PT area in her basement with
PT exercise printouts and bands, and used this area two to three times a week. Id. at ¶ 5.
Eventually, her home remedies and exercises were inadequate to address her symptoms,
so she returned to her orthopedist. Id. at ¶ 8.
II. 	The Parties’ Arguments
Petitioner argues that she received consistent care from her primary care provider,
physical therapist, and orthopedist for five months and 15 days after vaccination.
Petitioner’s Motion for Ruling on the Record, filed Aug. 6, 2024, at *9 (ECF No. 39)
(“Mot.”). At her February 2021 appointment (five and a half months after the onset of her
injury), she reported a pain level of six out of ten, explaining that the December 2020
steroid injection provided one week of relief before her symptoms returned. Id. at *9-10.
She reported difficulty with overhead activities and reaching behind her back, similar to
her previous visit. Id. at *10. On examination, she exhibited tenderness over the lateral
aspect of her shoulder, painful ROM, and positive impingement signs. Id. Her orthopedist
recommended an MRI. Id.
Petitioner argues that it is highly unlikely that Dr. Miladore would recommend an
MRI if he believed her symptoms were resolved. Mot. at *10. Rather, it is much more likely
that he noted that her symptoms were unchanged from her previous visit, and considered
an MRI the next logical step for a patient who was not improving with conservative
treatment. Id.
Petitioner argues that the record demonstrates that she exhibited reduced ROM.
Mot. at *15. She emphasizes the November 2020 PT record showing that her right
shoulder active ROM was reduced by 20 degrees compared to her left shoulder. Id. The
fact that she demonstrated full ROM at some other visits “does not make the findings
during her therapy evaluation any less probative” of reduced ROM. Id.
Respondent 	argues 	that 	Petitioner 	has 	not 	satisfied 	the 	statutory 	severity
requirement. Respondent’s Response, filed Oct. 7, 2024, at *5-7 (ECF No. 40) (“Resp.”).
He asserts that other than primary care and orthopedic appointments, she attended only
one PT session and received one steroid injection in the six months after onset of her
injury. Id. at *5. At her February 2021 appointment, five and a half months after onset,
she had full ROM, although with pain. Id. at *6. Thereafter, she did not seek further
shoulder treatment for 17 months, while she continued to seek medical care for other
concerns. Id.
Respondent asserts that “the records in the instant case unambiguously establish
that petitioner’s alleged shoulder pain had resolved prior to meeting the six-month severity
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requirement.” Resp. at *7. The factual basis for this claim is not readily apparent, however,
and Respondent does not cite any facts or records in support thereof.
Respondent also argues that Petitioner “only exhibited limited ROM on four
occasions,” suggesting that this prevents her from establishing that she exhibited limited
ROM. Resp. at *8. He adds that “[a]side from these four occasions, the record
overwhelmingly demonstrates that she had full ROM bilaterally.” Id. (emphasis added).
Petitioner replies that Respondent’s analysis on severity contains contradictory
statements, and does not address Petitioner’s condition at her February 2021 orthopedic
appointment. Petitioner’s Reply, filed Oct. 21, 2024, at *2 (ECF No. 41) (“Reply”).
Petitioner emphasizes that at this appointment, she reported a pain level of six out of ten
and complained of the same difficulties as her last visit. Id. Her orthopedist recommended
an MRI, demonstrating that Petitioner’s shoulder was not “back to normal,” and “was
highly unlikely to resolve in the next two weeks.” Id. at *3.
Petitioner notes that Respondent concedes that her medical records document
limited ROM, yet still contests this criterion. Reply at *3-4. Petitioner emphasizes that the
fact that she demonstrated full ROM during some of her medical appointments does not
make the findings of limited ROM during her PT evaluation any less probative. Id.
Petitioner states that it is “unclear whether Respondent is challenging the veracity of the
November 9, 2020 physical therapy record or simply asking” that I ignore it. Id.
III. 	Legal Standards
Before compensation can be awarded under the Vaccine Act, a petitioner must
preponderantly demonstrate all matters required under Section 11(c)(1), including the
factual circumstances surrounding his or her claim. Section 13(a)(1)(A). In making this
determination, the special master or court should consider the record as a whole. Section
13(a)(1). Petitioner’s allegations must be supported by medical records or by medical
opinion. Id.
To resolve factual issues, the special master must weigh the evidence presented,
which may include contemporaneous medical records and testimony. See Burns v. Sec'y
of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a special
master 	must 	decide 	what 	weight 	to 	give 	evidence 	including 	oral 	testimony 	and
contemporaneous medical records). “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 &
Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
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To overcome the presumptive accuracy of medical records testimony, a petitioner
may present testimony which is “consistent, clear, cogent, and compelling.” Sanchez v.
Sec'y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *3 (Fed. Cl. Spec.
Mstr. Apr. 10, 2013) (citing Blutstein v. Sec'y of Health & Human Servs., No. 90-2808V,
1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). The Federal Circuit has
“reject[ed] as incorrect the presumption that medical records are accurate and complete
as to all the patient’s physical conditions.” Kirby v. Sec’y of Health & Human Servs., 997
F.3d 1378, 1383 (Fed. Cir. 2021) (explaining that a patient may not report every ailment,
or a physician may enter information incorrectly or not record everything he or she
observes).
In addition to requirements concerning the vaccination received and the lack of
other award or settlement,3 a petitioner must establish that he or she suffered an injury
meeting the Table criteria, in which case causation is presumed, or an injury shown to be
caused-in-fact by the vaccination he or she received. Section 11(c)(1)(C). The Vaccine
Act further includes a “severity requirement,” pursuant to which a petitioner demonstrate
that they:
(i) suffered the residual effects or complications of such illness, disability,
injury, or condition for more than 6 months after the administration of the
vaccine, or (ii) died from the administration of the vaccine, or (iii) suffered
such illness, disability, injury or condition from the vaccine which resulted in
inpatient hospitalization and surgical intervention.
Section 11(c)(1)(D).
“[T]he fact that a petitioner has been discharged from medical care does not
necessarily indicate that there are no remaining or residual effects from her alleged
injury.” Morine v. Sec’y of Health & Human Servs., No. 17-1013, 2019 WL 978825, at *4
(Fed. Cl. Spec. Mstr. Jan. 23, 2019); see also Herren v. Sec’y of Health & Human Servs.,
No. 13-1000V, 2014 WL 3889070, at *3 (Fed. Cl. Spec. Mstr. July 18, 2014) (“a discharge
from medical care does not necessarily indicate there are no residual effects”). “A
treatment gap . . . does not automatically mean severity cannot be established.” Law v.
Sec’y of Health & Human Servs., No. 21-0699V, 2023 WL 2641502, at *5 (Fed. Cl. Spec.
Mstr. Feb. 23, 2023) (finding severity requirement met where petitioner sought care for
under three months and had met physical therapy goals but still lacked full range of motion
and experienced difficulty with certain activities, then returned to care nearly five months
later reporting stiffness and continuing restrictions in motion); see also Peeples v. Sec’y
of Health & Human Servs., No. 20-0634V, 2022 WL 2387749 (Fed. Cl. Spec. Mstr. May
3 In summary, a petitioner must establish that he received a vaccine covered by the Program, administered
either in the United States and its territories or in another geographical area but qualifying for a limited
exception and has not filed a civil suit or collected an award or settlement for his or her injury. Section
11(c)(1)(A)(B)(E).
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26, 2022) (finding severity requirement met where the petitioner sought care for four
months, followed by fifteen-month gap); Silvestri v. Sec’y of Health & Human Servs., No.
19-1045V, 2021 WL 4205313 (Fed. Cl. Spec. Mstr. Aug. 16, 2021) (finding severity
requirement satisfied where petitioner did not seek additional treatment after the five-
month mark.
The most recent version of the Table, which can be found at 42 C.F.R. § 100.3,
identifies the vaccines covered under the Program, the corresponding injuries, and the
time period in which the particular injuries must occur after vaccination. Section 14(a).
Pursuant to the Vaccine Injury Table, a SIRVA is compensable if it manifests within 48
hours of the administration of a flu vaccine. 42 C.F. R. § 100.3(a)(XIV)(B). The criteria
establishing a SIRVA under the accompanying Qualifications and Aids to Interpretation
(“QAI”) are as follows:
Shoulder injury related to vaccine administration (SIRVA). 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 (even if the condition causing the neurological
abnormality is not known). 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).
42 C.F.R. § 100.3(c)(10).
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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.
IV. 	Ruling on Entitlement
A. Severity Requirement
The record establishes that, more likely than not, Petitioner experienced residual
effects of her injury for more than six months. She treated her shoulder pain for five and
a half months – just short of the six-month threshold – before a gap. At the February 2021
appointment, she continued to report a pain level of six out of ten, and reported that the
steroid injection received at her prior visit provided only one week of relief, and her
orthopedist recommended an MRI. And there is no affirmative evidence showing that her
shoulder pain resolved soon after this appointment.
Under these circumstances, it is more likely that Petitioner’s right shoulder pain
continued for at least two weeks afterward. In reaching this conclusion, I do not rely on
Petitioner’s 2022 and 2023 care, which may be relevant to damages.
B. Limited Range of Motion
The record also preponderantly establishes that Petitioner suffered from limited
ROM. At her November 2020 PT evaluation, her right shoulder ROM was reduced
compared to her left shoulder, and her therapist diagnosed her with decreased ROM. This
is sufficient to meet this QAI. There is no requirement that a petitioner demonstrate limited
ROM at every appointment, as Respondent appears to suggest. The fact that Petitioner’s
ROM limitations were mild and did not persist bears on damages, but does not prevent
her from meeting the QAI.
C. Factual Findings Regarding QAI Criteria for Table SIRVA and Other
Entitlement Requirements
Respondent does not contest the remaining SIRVA QAI criteria, and I find that they
are satisfied. There is no evidence that Petitioner had a pre-vaccination right shoulder
condition, or another condition or abnormality, that would explain her symptoms after
vaccination. Exs. 3, 11. Her symptoms were limited to her right shoulder (where she
received the flu vaccine). Exs. 4, 11, 13. The record also contains preponderant evidence
that the remaining requirements for entitlement are satisfied. Petitioner received a
covered vaccine in the United States (Ex. 15D), and has not previously collected an award
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or settlement of any civil action for damages for her vaccine-related injury (Ex. 1 at ¶¶ 19,
20).
Conclusion
Based on my review of the record as a whole, I find that it is more likely than not
that Petitioner suffered from limited ROM and experienced the residual effects of her
injury for more than six months. I also find that all SIRVA Table requirements are
preponderantly 	met, 	as 	are 	all 	statutory 	requirements 	for 	entitlement. 	Therefore,
Petitioner’s motion for a ruling on the record that she is entitled to compensation is
GRANTED.
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
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