VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_21-vv-00669
Package ID: USCOURTS-cofc-1_21-vv-00669
Petitioner: Ivonne Lutes
Filed: 2021-01-12
Decided: 2023-12-08
Vaccine: influenza
Vaccination date: 2019-10-16
Condition: Shoulder Injury Related to Vaccine Administration (SIRVA)
Outcome: compensated
Award amount USD: 82267

AI-assisted case summary:
On January 12, 2021, Ivonne Lutes filed a petition under the National Vaccine Injury Compensation Program, alleging that she suffered a Shoulder Injury Related to Vaccine Administration (SIRVA) in her left shoulder following an influenza vaccination received on October 16, 2019. Petitioner, who was 61 years old at the time of vaccination, presented medical records and witness statements to support her claim that the SIRVA was a Table Injury, meaning it was presumed to be caused by the vaccine. The respondent, the Secretary of Health and Human Services, initially contested entitlement, raising issues about the onset of pain and suggesting that petitioner's pre-existing diabetes might have caused the condition. Special Master Daniel T. Horner issued a ruling on entitlement on August 11, 2023, finding that petitioner had met her burden of proof for all four criteria of a Table SIRVA, including demonstrating that her pain began within 48 hours of vaccination. The Special Master concluded that the respondent failed to prove that the injury was caused by a factor unrelated to the vaccine. Consequently, entitlement to compensation was granted. A subsequent decision on December 8, 2023, awarded Ivonne Lutes a total of $82,266.95. This award comprised a lump sum payment of $76,000.00 for pain and suffering, and two lump sum payments totaling $6,266.95 to satisfy Massachusetts Medicaid liens. The checks for the liens were payable jointly to petitioner and the respective lienholders, with petitioner agreeing to endorse them for satisfaction. Petitioner was represented by Leigh Finfer of Muller Brazil, LLP, and the respondent was represented by Nina Ren of the U.S. Department of Justice. The public decision does not describe the specific onset symptoms, physical examination findings, diagnostic studies, or the mechanism of injury beyond the general definition of SIRVA. The decision also does not name any medical experts for either party.

Theory of causation field:
Petitioner Ivonne Lutes, age 61, received an influenza vaccine on October 16, 2019. She alleged a Table Injury of Shoulder Injury Related to Vaccine Administration (SIRVA) in her left shoulder. The Special Master found that petitioner met the four criteria for a Table SIRVA: no prior history of shoulder pain, pain onset within 48 hours of vaccination (this was a close question, but ultimately found to be met based on a later orthopedic record stating immediate onset after the flu shot, and other records not contradicting this), pain and reduced range of motion limited to the affected shoulder, and no other condition explaining the symptoms. The respondent argued that petitioner's diabetes was a more likely cause of her adhesive capsulitis, but the Special Master found this was not proven by preponderant evidence, as no medical opinion supported this, and a meta-analysis on diabetes and adhesive capsulitis prevalence did not establish a sole cause. Petitioner was awarded $82,266.95, consisting of $76,000.00 for pain and suffering and $6,266.95 for Massachusetts Medicaid liens. Special Master Daniel T. Horner issued the entitlement ruling on August 11, 2023, and the damages decision on December 8, 2023. Petitioner was represented by Leigh Finfer (Muller Brazil, LLP) and respondent by Nina Ren (U.S. Department of Justice).

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_21-vv-00669-0
Date issued/filed: 2023-09-06
Pages: 10
Docket text: PUBLIC ORDER/RULING (Originally filed: 8/11/2023) regarding 43 Ruling on Entitlement, Order on Motion for Ruling on the Record. Signed by Special Master Daniel T. Horner. (sh) Service on parties made.
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Case 1:21-vv-00669-UNJ Document 45 Filed 09/06/23 Page 1 of 10
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 21-669V
Filed: August 11, 2023
Special Master Horner
IVONNE LUTES,
Petitioner,
v.
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
Leigh Finfer, Muller Brazil, LLP, Dresher, PA, for petitioner.
Nina Ren, U.S. Department of Justice, Washington, DC, for respondent.
RULING ON ENTITLEMENT1
On January 12, 2021, 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 a
Table Injury of Shoulder Injury Related to Vaccine Administration (“SIRVA”) in her left
shoulder following an influenza (“flu”) vaccination she received on October 16, 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.
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Case 1:21-vv-00669-UNJ Document 45 Filed 09/06/23 Page 2 of 10
general, to gain an award, a petitioner must make a number of factual demonstrations,
including showing that an individual received a vaccination covered by the statute;
received it in the United States; suffered a serious, long-standing injury; and has
received no previous award or settlement on account of the injury. Finally – and the key
question in most cases under the Program – the petitioner must also establish a causal
link between the vaccination and the injury. In some cases, the petitioner may simply
demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be
shown that the vaccine recipient suffered an injury of the type enumerated in the
“Vaccine Injury Table,” corresponding to the vaccination in question, within an
applicable time period following the vaccination, 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 Shoulder Injury Related to
Vaccine Administration or “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
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Case 1:21-vv-00669-UNJ Document 45 Filed 09/06/23 Page 3 of 10
(iv) No other condition or abnormality is present that would explain the
patient's symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy,
brachial neuritis, mononeuropathies, or any other neuropathy).
42 CFR § 100.3(c)(10).
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); § 300aa-13(a)(1)(B).
II. Procedural History
At the time the petition was filed, petitioner also filed medical records marked as
Exhibits 1-5 and an affidavit marked as Exhibit 6. (ECF N. 1.) Further medical records
(Exs. 7, 10) were subsequently filed along with two witness statements (Exs. 8-9).
Petitioner ultimately filed a Statement of Completion on July 21, 2022. (ECF No. 30.)
The case was initially assigned to the Special Processing Unit (“SPU”) based on the
allegations of the petition. (ECF Nos. 12, 14.)
The parties initially attempted settlement, but advised as of December 14, 2022,
that they had reached an impasse. (ECF No. 34.) Respondent filed his Rule 4 Report
recommending against compensation on February 13, 2023, and the case was
reassigned to the undersigned shortly thereafter on February 23, 2023. (ECF Nos. 36-
38.) Respondent’s report raised issues with regard to onset of petitioner’s shoulder pain
as well as whether she suffered adhesive capsulitis caused by her preexisting diabetes.
(ECF No. 36, pp. 5-7.)
On February 24, 2023, I instructed the parties to advise as to whether the record
was ripe for resolution of the onset issue raised by respondent. (Scheduling Order
(Non-PDF), 2/24/2023.) The parties agreed. (ECF No. 39.) Subsequently, petitioner
filed a motion for a ruling on the record regarding all aspects of entitlement and
requesting that she be found entitled to compensation for a Table Injury of SIRVA.
(ECF No. 40.) In his response, respondent confirmed that he “agrees this case is ripe
for adjudication.” (ECF No. 41, p. 2.) However, respondent argued that the case
should be dismissed. (Id.) Petitioner filed her reply on May 25, 2023. (ECF No. 42.)
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(b)(2); Kreizenbeck v. Sec’y of Health & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir.
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Case 1:21-vv-00669-UNJ Document 45 Filed 09/06/23 Page 4 of 10
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
Petitioner received the flu vaccination at issue in this case on October 16, 2019,
at the age of sixty-one. (Ex. 1.) Her prior medical history included chronic pain
syndrome, type 2 diabetes, fibromyalgia, carpal tunnel syndrome, and low back pain.
(Exs. 2, pp. 17-24; 7, p. 131.) Petitioner was disabled. (Id. at 17.)
Petitioner’s sister, Catherine Barrios, has provided a signed statement indicating
that petitioner contacted her during the third week of October 2019 and complained that
her arm “had been very painful” since receiving the flu shot. (Ex. 8.) Thereafter, Ms.
Barrios traveled to petitioner’s home and stayed for two weeks, during which time she
observed petitioner in pain and having reduced range of motion. (Id.) Petitioner’s
niece, Eliza Barrios, states that sometime during the month of October 2019, petitioner
told her that she had been suffering pain that was more severe than she experienced
with prior vaccinations. (Ex. 9.) She indicates that approximately one week later,
petitioner came to her house, where she visualized the injection site and advised
petitioner to see a doctor. (Id.)
Petitioner first presented for care for her alleged SIRVA on December 26, 2019,
which respondent stresses was 71 days post-vaccination. (Ex. 7, p. 15.) At that time,
she saw her primary care provider, Dr. Michaels, to review her mammogram results and
also complained of pain at her vaccine injection site, which she reported as being
severe enough to interfere with her sleep. (Id.) Dr. Michaels recorded that she had
reduced range of motion in all planes. (Id. at 16.) He referred her to physical therapy.
(Id. at 17.)
Petitioner presented for a physical therapy evaluation on February 6, 2020. (Ex.
2, pp. 24-28.) The reported history indicated that her shoulder pain began “within [a]
week of having [the] flu shot.” (Id.at 26.) A separate notation indicated “[l]eft should[er]
pain sincccce [sic] October 2019 after flu shot.” (Id. at 28.) Confusingly, however, the
date of injury is specifically listed as October 6, 2019, which is prior to the date of the
subject flu vaccination. (Id. at 25.) Petitioner returned to Dr. Michaels on February 19,
2020, continuing to complain of pain and reduced range of motion. (Ex. 7, pp. 10-11.)
She was discharged from physical therapy on March 12, 2020, without accomplishing
her functional goals. (Ex. 2, p. 309.) The physical therapist recommended that
petitioner see an orthopedist. (Id. at 309-10.) Petitioner then had a virtual follow up
with Dr. Michaels wherein he referred her to orthopedics. (Ex. 7, p. 4, 6-7.)
Petitioner then presented to orthopedist Jennifer Baima, M.D., on June 1, 2020.
(Ex. 4, pp. 22, 50.) Dr. Baima recorded the following history:
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Case 1:21-vv-00669-UNJ Document 45 Filed 09/06/23 Page 5 of 10
She presents today for evaluation of severe chronic left anterolateral
shoulder pain. This started after a flu shot. She had a flu shot in October
and had onset of anterior lateral shoulder pain immediately after. That was
not unusual for her so she thought it would go away. She then had trouble
moving her arm. This persisted. The pain radiated into the back of her
head. She was sent to physical therapy. Despite compliance with a home
exercise program, she has not made any improvement.
(Id. at 50.) On physical exam, petitioner had tenderness in the subacromial bursa and
abnormal range of motion for active abduction, extension, and external rotation. (Id. at
55.) Hawkins and impingement tests were positive. (Id.) She was diagnosed with
adhesive capsulitis and an MRI of her shoulder was ordered. (Id. at 56.)
Petitioner’s subsequent MRI of June 8, 2020 was consistent with adhesive
capsulitis and also showed a partial rotator cuff tear. (Ex. 4, p. 90-91; Ex. 3, pp. 2-3.)
Dr. Baima maintained the adhesive capsulitis diagnosis after review of the MRI and
ordered a steroid injection, which petitioner received on June 18, 2020. (Ex. 4, pp. 91,
134.) Petitioner subsequently received several additional steroid injections; however,
the remaining medical records are not informative of the issues discussed in this ruling.
(Ex. 10, pp. 24-125.)
IV. Discussion
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. No history of pain, inflammation or dysfunction of the affected
shoulder
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). Petitioner notes
that she has filed medical records dating back to 2016 and that these records
demonstrate she had no prior history of shoulder pain, inflammation, or dysfunction.
(ECF No. 40, p. 10.) Respondent has not raised any argument to the contrary. (ECF
No. 41.) Based on my review of the medical records, although petitioner had other prior
pain complaints, I find petitioner has satisfied this requirement by preponderant
evidence.
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Case 1:21-vv-00669-UNJ Document 45 Filed 09/06/23 Page 6 of 10
ii. Pain occurs within 48 hours of vaccination
The second SIRVA criterion requires that the “[p]ain occurs within the specified
time-frame,” i.e., within 48 hours of vaccination. 42 CFR § 100.3(c)(10)(ii); 42 CFR §
100.3(a). This is the primary issue addressed by the parties. Based on my review of
the medical records, I find that, for the reasons discussed below, petitioner has satisfied
this requirement by preponderant evidence.
The Vaccine Act instructs that a special master may find the time period for the
first symptom or manifestation of onset required for a Table Injury is satisfied “even
though the occurrence of such symptom or manifestation was not recorded or was
incorrectly recorded as having occurred outside such period.” § 300aa-13(b)(2).
However, consistent with petitioner’s burden of proof overall, that finding must be
supported by preponderant evidence. Id.
A special master must consider the medical record as a whole and is not bound
by any particular diagnosis, conclusion, judgment, test result, report, or summary
concerning the nature, causation, and aggravation of petitioner’s injury or illness that is
contained in a medical record. § 300aa-13(b)(1). However, the Federal Circuit has held
that contemporaneous medical records are ordinarily to be given significant weight due
to the fact that “[t]he 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). Nonetheless, there is no
presumption that medical records are complete and accurate. Kirby v. Sec’y of Health
& Human Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021).
Respondent notes that petitioner waited 71 days to seek treatment when she first
presented for care on December 26, 2019. (ECF No. 41, p. 5 (citing Ex. 7, p. 15).)
Moreover, at that time, petitioner described a “months” long injury without specifying
whether her pain began within 48 hours of vaccination. (Id. at 5-6.) Petitioner stresses,
however, that this is not necessarily an unusual length of time to delay treatment of a
SIRVA. (ECF No. 40, p. 7 (citing Hanna v. Sec’y of Health & Human Servs., No. 18-
1455V, 2021 WL 3486248, at *13-14 (Fed. Cl. Spec. Mstr. July 15, 2021); Lang v. Sec’y
of Health & Human Servs., No. 17-995V, 2020 WL 7873272, at *10 (Fed. Cl. Spec.
Mstr. Dec. 11, 2020); Smallwood v. Sec’y of Health & Human Servs., No. 18-0291V,
2020 WL 2954958, at *10 (Fed. Cl. Spec. Mstr. Apr. 29, 2020)).) Additionally, petitioner
stresses that she specifically associated her symptoms to her vaccination and should
not be required to have used any specific verbiage in describing her condition to her
physicians. (Id. at 7-8.) Upon my own review of the initial treatment record, I conclude
that it is best interpreted as being effectively silent as to the particulars of onset of
petitioner’s condition, though it is consistent with petitioner’s claim in that it does
evidence treatment of a “months” long shoulder condition petitioner attributed to her
vaccination. Of note, this record is particularly terse in all respects, which would tend to
contribute to the resulting ambiguities. Without more, respondent is unpersuasive in
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implying that a two-month delay in seeking treatment is inherently suspicious, as has
been observed in the cases cited by petitioner.
Respondent also observes that when petitioner subsequently presented for her
first physical therapy appointment, she specifically reported that her pain began “within
[a] week of having [the] flu shot.” (ECF No. 41, p. 6 (quoting Ex. 3, p. 24).) This
notation certainly implies that onset was closer to one week than 48 hours. Petitioner
concedes that this notation does not necessarily support her Table claim but argues the
record should carry less weight because the records from this particular medical
provider are inconsistent and therefore less reliable. (ECF No. 40, p. 8.) Moreover,
petitioner stresses that the phrasing “within a week” does not preclude onset occurring
within 48 hours. (ECF No. 42, p. 3.) Petitioner also counters that another notation from
the same encounter record indicates that petitioner was experiencing her symptoms
“since October” and “after flu shot.” (ECF No. 42, p. 3 (citing Ex. 2, p. 27).) Petitioner is
not persuasive in suggesting that this notation of onset “after flu shot” is inconsistent
with the notation of onset “within a week” of vaccination. However, upon my review of
this record, I agree with petitioner that it is not weighty evidence with regard to onset
given its other inconsistent notations. Specifically, while one notation specifies onset
occurring “after flu shot,” the date of injury is separately specified as “10/06/19,” which
would be prior to vaccination. (Compare Ex. 2, p. 25, with Ex. 2, p. 28.) Given the
inconsistency, petitioner is persuasive in effectively arguing that the phrasing “within a
week” is itself vague and should not be overinterpreted as precluding onset within 48
hours of vaccination when the record otherwise reflects a lack of precision regarding
onset.
Petitioner also argues that her subsequent orthopedic records identify an
immediate onset. (ECF No. 42, p. 3 (citing ECF No. 41, p. 6).) Specifically, petitioner’s
June 1, 2020 encounter with Dr. Baima records that “[t]his started after a flu shot. She
had a flu shot in October and had onset of anterior lateral shoulder pain immediately
after.” (Ex. 4, p. 50.) In her reply, petitioner further stresses that, although many of the
notations in her medical records are somewhat ambiguous as to onset, not a single
medical record contradicts this history by precluding onset occurring within 48 hours of
vaccination. (ECF No. 42, p. 3.) Respondent, however, stresses that this history was
recorded over seven months post-vaccination. (ECF No. 41, p. 6.) It is not
unreasonable for respondent to suggest as a general matter that later-recorded
histories should carry less weight. Accord Anderson v. Sec’y of Health & Human
Servs., No. 20-195V, 2022 WL 17484352, at *10 (Fed. Cl. Spec. Mstr. Nov. 10, 2022)
(giving a later-reported history less weight as to injection site where prior records were
contradictory). In this case, however, review of the complete records shows Dr.
Baima’s history to be the most complete and detailed history taken throughout the entire
course of petitioner’s treatment. This is not necessarily surprising given that it is the first
instance in petitioner’s treatment history where she had a specialist evaluation.
Moreover, even as a somewhat more remote record, it is still entitled to weight as a
treatment record generated at a time when proper treatment still hung in the balance.
Cucuras, 993 F.2d at 1528. Additionally, as petitioner stresses, none of the prior
records, though much less precise, explicitly contradict this later-recorded history.
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In addition to the medical records, petitioner argues that the witness statements
from her sister, Catherine Barrios, and her niece, Eliza Barrios, are consistent with her
alleged onset, having observed petitioner’s condition during the period after her
vaccination. (ECF No. 40, pp. 9-10 (citing Exs. 8-9).) Respondent counters, however,
that the specific observations contained in the statements do not actually confirm onset
of shoulder pain within 48 hours of vaccination. (ECF No. 41, pp. 6-7.) While these
witness statements certainly do not harm petitioner’s claim, I agree with respondent that
they lack the kind of detail that could provide meaningful support for a finding that onset
of shoulder pain occurred specifically within 48 hours of vaccination.
This is a close question; however, I conclude that, in balancing all of the above,
there is preponderant evidence that petitioner’s shoulder pain began within 48 hours of
her vaccination. While petitioner’s treatment records do not explicitly confirm the
appropriate onset until well into her treatment history, onset within 48 hours of
vaccination is confirmed by medical treatment records. Though none of the other
record evidence is sufficient to confirm onset occurring within 48 hours of vaccination, it
can be read in harmony with the more specific orthopedic record.
iii. Pain and reduced range of motion are limited to the affected
shoulder
The third SIRVA criterion requires that 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). Petitioner asserts that there is no evidence that petitioner had
complaints beyond her affected shoulder. (ECF No. 40, p. 10.) Respondent has not
raised any argument to the contrary. (ECF No. 41.) Petitioner acknowledges a prior
history of bilateral hand numbness, but asserts that this is explained by her diabetic
neuropathy and predates her vaccination. (ECF No. 40, p. 10.) I also note that
petitioner did complain to Dr. Baima of head and neck pain occurring subsequent to
onset of her shoulder pain (Ex. 4, p. 50); however, there is no evidence that Dr. Baima
found any significance in these symptoms. Petitioner’s cervical neck exam was normal.
(Id. at 54.) Based on my review of the medical records, I find petitioner has satisfied
this requirement by preponderant evidence.
iv. No other condition or abnormality is present that would explain the
patient’s symptoms
Finally, 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). With regard to this requirement, respondent
argues that “[p]etitioner indisputably suffers from preexisting and disabling [diabetes
mellitus] 2, which is a more likely cause of her adhesive capsulitis.” (ECF No. 41, p. 7.)
However, respondent’s argument misconstrues the fourth SIRVA criterion. Based on
my review of the medical records, I find petitioner has satisfied this requirement by
preponderant evidence.
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Importantly, respondent is arguing that diabetes can cause adhesive capsulitis,
not that adhesive capsulitis is a feature or symptom of the diabetes itself. Therefore, it
is not the case that diabetes is a condition the presence of which explains petitioner’s
SIRVA symptoms. However, because petitioner’s adhesive capsulitis is her SIRVA, it
cannot also be some other condition that would separately explain her symptoms.3
Thus, respondent is not identifying another condition that explains petitioner’s shoulder
symptoms under SIRVA criterion four. He is asserting that the injury petitioner alleges
to be a SIRVA (adhesive capsulitis) was itself caused by a factor unrelated to
vaccination (diabetes). That argument is more properly addressed as part of
respondent’s shifted burden of proof, discussed separately below, rather than as
evidence weighing against petitioner’s prima facie showing of a Table Injury.4
b. Factor Unrelated
Once petitioner has satisfied her own prima facie burden, the burden of proof
shifts to respondent to demonstrate that her injury was caused by factors unrelated to
vaccination. § 300aa-13(a)(1)(B); Deribeaux ex rel. Deribeaux v. Sec’y of Health &
Human Servs., 717 F.3d 1363, 1367 (Fed. Cir. 2013). In order to meet his burden,
respondent must demonstrate by preponderant evidence “that a particular agent or
condition (or multiple agents/conditions) unrelated to the vaccine was in fact the sole
cause (thus excluding the vaccine as a substantial factor).” de Bazan v. Sec’y of Health
& Human Servs., 539 F.3d 1347, 1354 (Fed. Cir. Aug. 28, 2008) (emphasis omitted). As
with petitioner’s burden under Althen, respondent must show a logical sequence of
cause and effect linking the injury to the proposed factor unrelated to vaccination.
Deribeaux ex rel. Deribeaux, 717 F.3d at 1368-69. It need not be scientifically certain
but must be legally probable. Id. Conditions or other factors that are “idiopathic,
unexplained, unknown, hypothetical, or undocumentable” cannot defeat a petitioner’s
claim. § 300aa-13(a)(2); Knudsen ex rel. Knudsen v. Sec’y of Health & Human Servs.,
35 F.3d 543, 548-49 (Fed. Cir. 1994).
3 Accord Lang, 2020 WL 787372, at *13 n. 9 (observing that, in presenting a prima facie Table SIRVA
claim, “petitioner does not bear any burden of proving causation generally or to show that her shoulder
pathology can be directly related to her vaccination as causal. It would be incompatible with the very idea
of the Vaccine Injury Table to hold petitioner to a burden of proving causation to establish a Table Injury.”)
Per the QAI definition, SIRVA is an unspecified “injury to the musculoskeletal structures of the shoulder
(e.g. tendons, ligaments, bursae, etc.).” 42 CFR § 100.3(c)(10). Moreover, the QAI definition of SIRVA
was specifically drafted to encompass adhesive capsulitis among the various conditions falling under the
SIRVA umbrella. National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table,
80 Fed. Reg. 45132-01, 45136 (July 29, 2015), 2015 WL 4538923; see also Gurney v. Sec’y of Health &
Human Servs., No.17-481V, 2019 WL 2865490, at *7 (Fed. Cl. Spec. Mstr. Apr. 24, 2019) (finding that
“the timing and course of petitioner’s adhesive capsulitis remains consistent with a post-vaccination
sequela to her SIRVA as described in the [Atanasoff study] and as envisioned by the rulemaking which
created SIRVA as a Table Injury.”).
4 In the interest of completeness, I note that on this record the distinction is immaterial. Even if I
considered respondent’s proffered evidence regarding diabetes and adhesive capsulitis under QAI
criterion four, I would still find the argument unpersuasive for largely the same substantive reasons as
discussed below.
9

Case 1:21-vv-00669-UNJ Document 45 Filed 09/06/23 Page 10 of 10
In this case, respondent argues that petitioner’s preexisting diabetes is a more
likely cause of petitioner’s adhesive capsulitis. (ECF No. 41, p. 7.) However, there is
no medical opinion on this record supporting that conclusion. Petitioner’s treating
physicians never attributed her shoulder condition to her diabetes and respondent has
not presented any expert medical opinion to support his contention. Instead,
respondent cites a single meta-analysis regarding the prevalence of diabetes among
adhesive capsulitis patients and vice versa. Zreik et al., Adhesive capsulitis of the
shoulder and diabetes: a meta-analysis of prevalence, MUSCLES LIGAMENTS TENDONS J.
6(1):26-34 (Jan-Mar 2016).5 The study suggests that diabetes sufferers are five times
more likely to develop adhesive capsulitis compared to non-diabetic controls. However,
without more, demonstration of an increased prevalence of adhesive capsulitis among
diabetics does not establish a direct causal relationship or demonstrate that, among
patients with both conditions, the diabetes was the sole cause of the adhesive
capsulitis. Even if petitioner’s diabetes was a predisposing factor to development of
adhesive capsulitis, that would not preclude the vaccine from being an additional cause
precisely in the manner posited by respondent’s regulatory rulemaking with respect to
SIRVA. 42 CFR § 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”). The study cited
by respondent showed that, even with a higher prevalence, only a small minority
(13.4%) of diabetics developed adhesive capsulitis.
V. Conclusion
For all the reasons discussed above, after weighing the evidence of record within
the context of this program, I find by preponderant evidence that petitioner suffered a
Table Injury of SIRVA resulting from her October 16, 2019 flu vaccination. A separate
damages order will be issued.
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
5 Respondent did not file the article, but provided a link, last accessed February 13, 2023. (ECF No. 41,
n. 2.) That link is https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4915459, last accessed by the
undersigned on August 10, 2023.
10

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_21-vv-00669-1
Date issued/filed: 2023-12-08
Pages: 6
Docket text: PUBLIC DECISION (Originally filed: 11/13/2023) regarding 50 DECISION Stipulation/Proffer. Signed by Special Master Daniel T. Horner. (ksb) Service on parties made.
--------------------------------------------------------------------------------
Case 1:21-vv-00669-UNJ Document 54 Filed 12/08/23 Page 1 of 6
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 21-669V
Filed: November 13, 2023
IVONNE LUTES, Special Master Horner
Petitioner,
v.
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
Leigh Finfer, Muller Brazil, LLP, Dresher, PA, for petitioner.
Nina Ren, U.S. Department of Justice, Washington, DC, for respondent.
DECISION AWARDING DAMAGES1
On January 12, 2021, Ivonne Lutes, “petitioner” filed a petition for compensation
under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et
seq.2 (the “Vaccine Act”). Petitioner alleges that she suffered left shoulder injuries
related to vaccine administration (“SIRVA”), resulting from the influenza (“flu”) vaccine
she received on October 16, 2019. (ECF No. 1)
On August 11, 2023, a ruling on entitlement was issued, finding petitioner entitled
to compensation for SIRVA. On November 13, 2023, respondent filed a proffer on
award of compensation (“Proffer”) indicating petitioner should be awarded $76,000.00
for pain and suffering, and $1,469.18 and $4,797.77, representing compensation for
satisfaction of the State of Massachusetts Medical liens. (ECF No. 49, p. 2-3.) In the
Proffer, respondent represented that petitioner agrees with the proffered award. Id.
Based on the record as a whole, I find that petitioner is entitled to an award as stated in
the Proffer.
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 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755.

Case 1:21-vv-00669-UNJ Document 54 Filed 12/08/23 Page 2 of 6
Pursuant to the terms stated in the attached Proffer, I award petitioner
$82,266.95 as follows:
• a lump sum payment of $76,000.00, representing compensation for
petitioner’s pain and suffering, in the form of a check payable to petitioner.
• a lump sum payment of $1,469.18, representing compensation for
satisfaction of a state of Massachusetts Medicaid lien, in the form of a
check payable jointly to petitioner and:
Boston Medical Center HealthNet Plan
529 Main St
Suite 500
Charlestown, MA 02129
ID# B0122353100
• a lump sum payment of $4,797.77, representing compensation for
satisfaction of a state of Massachusetts Medicaid lien, in the form of a
check payable jointly to petitioner and:
The Rawlings Company
Attn: Benjamin A. Rich
PO Box 2000
La Grange, KY 40031
Reference # 123079666
Petitioner has agreed to endorse the checks to the State of Massachusetts for
satisfaction of the Medical liens. (ECF No. 49, p. 3.) These amounts represent
compensation for all damages that would be available under § 15(a).
The clerk of the court is directed to enter judgment in accordance with this
decision.3
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
3 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice
renouncing the right to seek review.
2

Case 1:21-vv-00669-UNJ Document 54 Filed 12/08/23 Page 3 of 6
IN THE UNITED STATES COURT OF FEDERAL CLAIMS
OFFICE OF SPECIAL MASTERS
IVONNE LUTES,
No. 21-669V
Petitioner, Special Master Daniel T. Horner
ECF
v.
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
PROFFER ON AWARD OF COMPENSATION
On January 12, 2021, Ivonne Lutes (“petitioner”) filed a petition for compensation under
the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34, alleging that
she suffered a Shoulder Injury Related to Vaccine Administration (“SIRVA”), as defined in the
Vaccine Injury Table, following administration of an influenza vaccine she received on October
16, 2019. Petition at 1. On April 26, 2023, petitioner filed a Motion for a Ruling on the Record
(“Motion”) arguing that she has established entitlement to compensation for a SIRVA. ECF No.
40. Respondent filed his Response to Petitioner’s Motion on May 22, 2023, recommending that
entitlement to compensation be denied. ECF No. 41. On August 11, 2023, the Court issued a
Ruling on Entitlement, finding that petitioner is entitled to compensation.1 ECF No. 43.
1 Respondent has no objection to the amount of the proffered award of damages set forth herein.
Assuming the Court issues a damages decision in conformity with this proffer, respondent
waives his right to seek review of such damages decision. However, respondent reserves his
right, pursuant to 42 U.S.C. § 300aa-12(e), to seek review of the Court’s August 11, 2023
entitlement decision.

Case 1:21-vv-00669-UNJ Document 54 Filed 12/08/23 Page 4 of 6
I. Compensation for Vaccine Injury-Related Items
A. Pain and Suffering
Based upon the evidence of record, respondent proffers that petitioner should be awarded
a lump sum of $76,000.00 for pain and suffering, in the form of a check payable to petitioner.
Petitioner agrees.
B. Medicaid Liens
Respondent proffers that petitioner should be awarded funds to satisfy the State of
Massachusetts Medicaid liens in the amounts of $1,469.18 and $4,797.77, which represents full
satisfaction of any right of subrogation, assignment, claim, lien, or cause of action the State of
Massachusetts may have against any individual as a result of any Medicaid payments the State of
Massachusetts has made to or on behalf of petitioner from the date of her eligibility for benefits
through the date of judgment in this case as a result of her alleged vaccine-related injury suffered
on or about October 16, 2019, under Title XIX of the Social Security Act.
The above amounts represent all elements of compensation to which petitioner would be
entitled under 42 U.S.C. § 300aa-15(a). Petitioner agrees.
II. Form of the Award
The parties recommend that compensation provided to petitioner should be made through
two lump sum payments described below, and request that the Special Master’s decision and the
Court’s judgment award the following: 2
A. A lump sum payment of $76,000.00 in the form of a check payable to petitioner; and
B. A lump sum payment of $1,469.18, representing compensation for satisfaction of the
State of Massachusetts Medicaid lien, in the form of a check payable jointly to
petitioner and:
2 Should petitioner die prior to entry of judgment, the parties reserve the right to move the Court
for appropriate relief. In particular, respondent would oppose any award for future medical
expenses, future pain and suffering, and future lost wages.
2

Case 1:21-vv-00669-UNJ Document 54 Filed 12/08/23 Page 5 of 6
Boston Medical Center HealthNet Plan
529 Main St
Suite 500
Charlestown, MA 02129
ID #: B0122353100
C. A lump sum payment of $4,797.77, representing compensation for satisfaction of the
State of Massachusetts Medicaid lien, in the form of a check payable jointly to
petitioner and:
The Rawlings Company
Attn: Benjamin A. Rich
PO Box 2000
La Grange, KY 40031
Reference #: 123079666
Petitioner agrees to endorse the checks to the State of Massachusetts for satisfaction of
the Medicaid liens.
Petitioner is a competent adult. Evidence of guardianship is not required in this case.
Respectfully submitted,
BRIAN M. BOYNTON
Principal Deputy Assistant Attorney General
C. SALVATORE D’ALESSIO
Director
Torts Branch, Civil Division
HEATHER L. PEARLMAN
Deputy Director
Torts Branch, Civil Division
LARA A. ENGLUND
Assistant Director
Torts Branch, Civil Division
3

Case 1:21-vv-00669-UNJ Document 54 Filed 12/08/23 Page 6 of 6
/s/ NINA Y. REN
NINA Y. REN
Trial Attorney
Torts Branch, Civil Division
U.S. Department of Justice
P.O. Box 146
Benjamin Franklin Station
Washington D.C. 20044-0146
(202) 305-3781
Nina.Ren@usdoj.gov
DATED: November 13, 2023
4