VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_21-vv-02249
Package ID: USCOURTS-cofc-1_21-vv-02249
Petitioner: Erin O’Leary
Filed: 2021-12-02
Decided: 2024-09-06
Vaccine: influenza
Vaccination date: 2020-10-27
Condition: left shoulder injury related to vaccine administration (SIRVA)
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
Erin O’Leary filed a petition alleging she suffered a left shoulder injury related to vaccine administration (SIRVA) after receiving an influenza vaccine on October 27, 2020. She claimed the injury was a Table Injury and that her pain began a few hours after vaccination. However, the medical records did not support an acute onset of pain within the required 48-hour timeframe for a Table SIRVA. Petitioner's initial medical records, from January and February 2021, described gradually increasing left shoulder pain over a couple of months, with no mention of the flu vaccine. She attributed her pain to working out and Zumba classes, and x-rays showed degenerative changes. Petitioner did not attribute her shoulder pain to the flu vaccine until August 2022, after her symptoms had resolved and after retaining counsel. The court noted that Petitioner also received COVID vaccines in the same shoulder during her physical therapy treatment. Despite being given an opportunity to supplement the record, Petitioner failed to provide sufficient evidence to establish entitlement. Consequently, the case was dismissed for failure to provide preponderant evidence.

Theory of causation field:
Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_21-vv-02249-0
Date issued/filed: 2024-09-06
Pages: 8
Docket text: PUBLIC DECISION (Originally filed: 08/05/2024) regarding 33 DECISION of Special Master Signed by Chief Special Master Brian H. Corcoran. (nh) Service on parties made.
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Case 1:21-vv-02249-UNJ Document 34 Filed 09/06/24 Page 1 of 8
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 21-2249V
ERIN O’LEARY,
Chief Special Master Corcoran
Petitioner,
v. Filed: August 5, 2024
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
Jonathan Joseph Svitak, Shannon Law Group, P.C., Woodridge, IL, for Petitioner.
Jamica Marie Littles, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION DISMISSING CASE1
On December 2, 2021, Erin O’Leary 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 a left shoulder injury related to vaccine
administration (“SIRVA”), a defined Table Injury, after receiving an influenza (“flu”)
vaccine on October 27, 2020. Petition at 1, ¶ 2, 18.
However, the record in this case contains insufficient evidence to establish the pain
onset within the timeframe required for a Table SIRVA, or even to support a causal link
between Petitioner’s left shoulder pain and the vaccination she received. See 42 C.F.R.
§ 100.3(a)XIV(B) & (c)(10)((ii) (2017) (requiring pain onset within 48 hours of vaccination);
1 Because this Decision 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 Decision 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).

Case 1:21-vv-02249-UNJ Document 34 Filed 09/06/24 Page 2 of 8
Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005) (three-
pronged test for actual causation). And despite due opportunity, Petitioner has not
provided the preponderant evidence needed to overcome these deficiencies. I therefore
DENY entitlement in this case.
I. Relevant Procedural History
Along with her petition, Ms. O’Leary filed only a declaration signed under penalty
of perjury as required by 28 U.S.C.A. § 1746. Exhibit 1. Over the subsequent 16-month
period, she filed the medical records required by the Vaccine Act, as well as supporting
signed declarations from her son and fiancée.3 Exhibits 2-12, ECF Nos. 6, 9, 14, 17, 21.
On April 4, 2023, the case was activated and assigned to the “Special Processing Unit”
(OSM’s adjudicatory system for resolution of cases deemed likely to settle). ECF No. 23.
Almost one year later, on March 15, 2024, Respondent stated that he intended to
oppose compensation. Status Report, ECF No. 27. On April 29, 2024, he filed his Rule
4(c) Report setting forth his objections. ECF No. 28. Emphasizing Petitioner’s initial
description of gradually increasing pain, report of recent exercise, and failure to mention
the flu vaccine until almost 22 months post-vaccination (eight months after the petition’s
filing), Respondent maintains Petitioner has not established the pain onset needed for a
Table SIRVA. Id. at 4-5. He also insists that Petitioner has failed to provide adequate
evidence of causation and thus, cannot prevail pursuant to a non-Table claim. Id. at 5-6.
On May 15, 2024, I issued an Order to Show Cause, allowing Petitioner a final
chance to obtain and to file the evidence needed to support her allegations. ECF No. 30.
After receiving an extension of time until July 22, 2024 (ECF No. 31), Petitioner has failed
to provide any additional evidence.
The matter is now ripe for adjudication.
II. Applicable Legal Standards
Under Section 13(a)(1)(A) of the Act, a petitioner must demonstrate, by a
preponderance of the evidence, that all requirements for a petition set forth in section
11(c)(1) have been satisfied. A petitioner may prevail on her claim if the vaccinee for
whom she seeks compensation has “sustained, or endured the significant aggravation of
any illness, disability, injury, or condition” set forth in the Vaccine Injury Table (the Table).
Section 11(c)(1)(C)(i). According to the most recent version of the Table, a SIRVA is
3 These declarations also were signed under penalty of perjury as required by 28 U.S.C.A. § 1746. Exhibits
8-9.
2

Case 1:21-vv-02249-UNJ Document 34 Filed 09/06/24 Page 3 of 8
compensable if it manifests within 48 hours of the administration of an influenza vaccine.
42 C.F.R. § 100.3(a)(XIV)(B). The specific criteria establishing a SIRVA 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) (additional requirements set forth in the Qualifications and Aids
to Interpretations (“QAI”)). If a petitioner establishes that the vaccinee has suffered a
“Table Injury,” causation is presumed.
If, however, the vaccinee suffered an injury that either is not listed in the Table or
did not occur within the prescribed time frame, petitioner must prove that the administered
vaccine caused injury to receive Program compensation on behalf of the vaccinee.
Section 11(c)(1)(C)(ii) and (iii). In such circumstances, petitioner asserts a “non-Table or
[an] off-Table” claim and to prevail, petitioner must prove her claim by preponderant
evidence. Section 13(a)(1)(A). This standard is “one of . . . simple preponderance, or
3

Case 1:21-vv-02249-UNJ Document 34 Filed 09/06/24 Page 4 of 8
‘more probable than not’ causation.” Althen, 418 F.3d at 1279-80 (referencing Hellebrand
v. Sec’y of Health & Hum. Servs., 999 F.2d 1565, 1572-73 (Fed. Cir. 1993). The Federal
Circuit has held that to establish an off-Table injury, petitioners must “prove . . . that the
vaccine was not only a but-for cause of the injury but also a substantial factor in bringing
about the injury.” Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1351 (Fed.
Cir 1999). Id. at 1352. The received vaccine, however, need not be the predominant
cause of the injury. Id. at 1351.
The Circuit Court has indicated that petitioners “must show ‘a medical theory
causally connecting the vaccination and the injury’” to establish that the vaccine was a
substantial factor in bringing about the injury. Shyface, 165 F.3d at 1352-53 (quoting
Grant v. Sec’y of Health & Hum. Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992)). The Circuit
Court added that "[t]here must be a ‘logical sequence of cause and effect showing that
the vaccination was the reason for the injury.’” Id. The Federal Circuit subsequently
reiterated these requirements in its Althen decision. See 418 F.3d at 1278. Althen
requires a petitioner
to show by preponderant evidence that the vaccination
brought about her injury by providing: (1) a medical theory
causally connecting the vaccination and the injury; (2) a
logical sequence of cause and effect showing that the
vaccination was the reason for the injury; and (3) a showing
of a proximate temporal relationship between vaccination and
injury.
Id. All three prongs of Althen must be satisfied. Id.
Finding a petitioner is entitled to compensation must not be “based on the claims
of a petitioner alone, unsubstantiated by medical records or by medical opinion.” Section
13(a)(1). Further, contemporaneous medical records are presumed to be accurate and
complete in their recording of all relevant information as to petitioner’s medical issues.
Cucuras v. Sec’y of Health & Hum. Servs., 993, F.2d 1525, 1528 (Fed. Cir. 1993).
Testimony offered after the events in questions is considered less reliable than
contemporaneous reports because the need for accurate explanation of symptoms is
more immediate. Reusser v. Sec’y of Health & Hum. Servs., 28 Fed. Cl. 516, 523 (1993).
4

Case 1:21-vv-02249-UNJ Document 34 Filed 09/06/24 Page 5 of 8
III. The Record as It Currently Stands
A. Medical Records
Prior to vaccination, Petitioner suffered from migraines, a sore throat, urinary tract
infection, and ADHD.4 Exhibit 7 at 11-48. At a primary care provider (“PCP”) appointment
for her annual physical on June 17, 2019, Petitioner reported a visit to an urgent care
clinic after injuring her left knee and right ankle during a fall. Id. at 42.
Petitioner received the flu vaccine alleged as causal intramuscularly in her left
deltoid at a CVS store on October 27, 2020. Exhibit 12 at 2. She next sought medical care
almost three months later, in early January 2021, visiting her gynecologist to discuss
contraception options. Exhibit 10 at 23. She returned twice in February 2021, for the
insertion of an intrauterine device, commonly referred to as an IUD.5 Exhibit 10 at 14-33.
There is no mention of left shoulder pain in the medical records from these visits.
On February 23, 2021, Petitioner visited her PCP, seeking to restart her ADHD
medication but now also complaining of left shoulder pain “on going [for a] couple months
[that was] not getting better.” Exhibit 7 at 57. Reporting “[n]o specific injury/trauma,”
Petitioner stated that she “just felt a gradual pain and limited romn[6] [sic],” adding that she
“[h]a[d] been working out and doing a [Z]umba class.” Id. After reviewing x-rays taken
(which showed degenerative changes),7 the PCP diagnosed Petitioner with adhesive
capsulitis and prescribed physical therapy (“PT”). Id. at 61.
At her initial PT session a few days later, on February 26, 2021, Petitioner
described progressively worsening left shoulder stiffness, soreness, and limited motion
for the last three to four months. Exhibit 4 at 75. In response to the following question on
the intake form - “How did your symptoms start?”, Petitioner wrote “gradually.” Id. at 85.
Over the subsequent four-month period, Petitioner attended 22 PT sessions.
Exhibit 4 at 7-81. Assessed as having made objective improvement but slower progress
due to a loss of insurance, she was provided a home exercise program and discharged
on June 14, 2021. Id. at 13-14. There is no mention of the flu vaccine Petitioner received
in October 2020 in any of these records.
4 ADHD stands for “attention-deficit hyperactivity disorder.” MEDICAL ABBREVIATIONS at 38 (16th ed. 2020).
5 IUD stands for “intrauterine device.” MEDICAL ABBREVIATIONS at 316.
6 ROM stands for range of motion. MEDICAL ABBREVIATIONS at 512.
7 The results of the radiology report shows “[m]ild degenerative disease of the left shoulder.” Exhibit 7 at
76-77.
5

Case 1:21-vv-02249-UNJ Document 34 Filed 09/06/24 Page 6 of 8
Petitioner next sought medical care more than a year later, visiting her PCP for an
annual physical on August 23, 2022. Exhibit 7 at 63-76. At this visit (which occurred more
than eight months after the filing of the Petition in this case), Petitioner reported that her
frozen shoulder had resolved after multiple rounds of PT and stretching. Id. at 70. For the
first time, she attributed her condition to the flu shot. Id. This record also contains entries
showing Petitioner had received COVID vaccines in her left deltoid (the shoulder at issue
herein) on March 25 and 16, 2021. Id. at 64.
B. Later Provided Evidence
In her declaration, signed on August 25, 2021, and filed with the Petition in
December 2021, Petitioner asserted that her left shoulder pain began “a few hours after
[she] received the influenza vaccine at CVS.” Exhibit 1 at ¶ 6. After attempting to treat her
condition with over-the-counter pain medication, stretching, and ice packs, she sought an
appointment with her PCP in January 2021. Id. at ¶ 7. Petitioner insisted that she informed
both her PCP and the physical therapist that her pain “started after getting the influenza
vaccine on October 27, 2020.” Id. at ¶ 8; accord. Id. at ¶ 9.
In his declaration, signed on June 15, 2022, Petitioner’s son (who lives with
Petitioner) recalled observing limitations in his mother’s range of motion and assisting her
reaching for items on October 27, 2020. Exhibit 8 at ¶ 6. He stated that Petitioner
continued to need assistance thereafter, adding that he “still observe[s] her doing routine
stretches and using a heating pad and ick packs when she needs to.” Id. at ¶ 8.
In his declaration, signed a few months later, on September 7, 2022, Petitioner’s
fiancée (who also lives with Petitioner) echoed the assertions made by her son. Compare
Exhibit 8 with Exhibit 9. He also asserted that “[a]s of today, [he] continue[d] to witness
Erin in noticeable pain and discomfort due to her left shoulder injury.” Id. at ¶ 10.
IV. Analysis
All evidence from prior to the Petition’s filing supports a gradual, rather than acute,
pain onset beginning sometime in late Fall 2020. When first seeking treatment, Petitioner
described gradual left shoulder pain beginning a couple of months earlier, placing onset
around late November 2020. Exhibit 7 at 57. Later, at her first PT session, she estimated
her pain began three to four months earlier, placing onset closer to vaccination – in late
October or November 2020. Exhibit 4 at 75. However, Petitioner again described the
onset of her pain as gradual, and (importantly) failed to mention the flu vaccine she
received. Id. at 75, 85.
6

Case 1:21-vv-02249-UNJ Document 34 Filed 09/06/24 Page 7 of 8
In fact, there is no mention of the flu vaccine in any of the medical records related
to the treatment Petitioner received. And, at her initial PCP visit, Petitioner theorized that
her shoulder pain may be due to working out and participating in Zumba classes. Exhibit
7 at 57. Furthermore, while attending PT (late February through mid-June 2021),
Petitioner received COVID vaccines in her left deltoid (in March and April). Thus, all
information provided in the contemporaneously created medical records supports a more
gradual injury, likely due to the degenerative changes seen on x-rays and overuse from
exercise.
Petitioner did not attribute her left shoulder pain to the flu vaccine she received
until she finished PT, retained Petitioner’s counsel, and began preparing her vaccine
claim. See Petition at 1; Exhibit 1.8 And she did not mention the flu vaccine as a potential
source of her pain to any medical provider until almost one year thereafter (August 23,
2022), after her symptoms had resolved. See Exhibit 7 at 70 (medical record from annual
physical on August 23, 2022).
In her declaration, Petitioner claimed that her pain began with a few hours of
vaccination, and that she attributed her symptoms to the flu vaccine when speaking to
both her PCP and physical therapist. Exhibit 1 at ¶¶ 6, 8-9. However, these later-provided
assertions run counter to the information contained in the contemporaneously created
medical records. See Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528
(Fed. Cir. 1993); Lowrie v. Sec’y of Health & Hum. Servs., No. 03-1585V, 2005 WL
6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005) (stating that medical records which
are clear, consistent, and complete should be afforded substantial weight). Even
supported by the declarations from her son and fiancée, Petitioner’s assertions are not
sufficient to counter the evidence presented by the contemporaneously created medical
records which supports a later gradual pain onset, more likely attributable to degenerative
changes and overuse while exercise.
These deficiencies were pointed out to Petitioner, and she was given the chance
to address them by supplementing the evidentiary record. She has failed to do so, and
therefore the evidence preponderates against her claim.
Conclusion
To date, and despite ample opportunity, Petitioner has failed to provide
preponderant evidence to support her allegation of a left shoulder injury that meets the
definition for a Table SIRVA or was caused by the flu vaccine she received on October
27, 2020. Petitioner was informed that failure to provide preponderant evidence to support
8 Although not filed until December 2021, the Petition is dated August 25, 2021. Petition at 1. And
Petitioner’s declaration was signed the same day, on August 25, 2021. Exhibit 1 at 3.
7

Case 1:21-vv-02249-UNJ Document 34 Filed 09/06/24 Page 8 of 8
her claim would be treated as either a failure to prosecute this claim or as an inability to
provide supporting documentation for the claim. Accordingly, this case is DISMISSED.
The Clerk of Court shall enter judgment accordingly.9
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
9 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.
8