VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-01283
Package ID: USCOURTS-cofc-1_20-vv-01283
Petitioner: Nadine Lynn McLee
Filed: 2020-09-28
Decided: 2023-09-20
Vaccine: influenza
Vaccination date: 2017-09-27
Condition: left shoulder injuries
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
Nadine Lynn McLee filed a petition on September 28, 2020, alleging that the trivalent influenza vaccine she received on September 27, 2017, caused her to suffer left shoulder injuries. She initially pursued an on-Table claim for Shoulder Injury Related to Vaccine Administration (SIRVA). The Special Master, Christian J. Moran, issued a ruling on May 10, 2023, finding that Ms. McLee failed to meet the criteria for an on-Table SIRVA claim. Specifically, the ruling determined that her pain did not begin within 48 hours of vaccination, as the majority of medical records indicated onset in early November 2017, over 10 weeks after the vaccination. Furthermore, the records indicated the vaccine was administered in her right deltoid, not her left, and her pain extended beyond the shoulder to her neck and hand. Consequently, her on-Table SIRVA claim was dismissed. Ms. McLee was then permitted to pursue an off-Table claim, which requires proving causation through medical evidence. A subsequent decision on September 20, 2023, addressed her off-Table claim. The decision noted that Ms. McLee had not filed a status report confirming retention of an expert by the deadline of July 12, 2023, as ordered in the May 10, 2023 ruling. The Special Master concluded that Ms. McLee had failed to present preponderant evidence supporting her off-Table claim, specifically lacking a medical theory connecting the vaccine to the injury, a logical sequence of cause and effect, or a proximate temporal relationship. The public decision does not describe the specific medical experts consulted or the exact dollar breakdowns or annuity terms, as the case was dismissed. Ms. McLee was born on May 1, 1960, making her 37 years old at the time of vaccination. Petitioner was represented pro se, and respondent was represented by Katherine C. Esposito of the United States Department of Justice.

Theory of causation field:
Nadine Lynn McLee, born May 1, 1960, received an influenza vaccine on September 27, 2017. She alleged left shoulder injuries. Her initial on-Table SIRVA claim was dismissed because the evidence did not establish that her pain began within 48 hours of vaccination (onset determined to be early November 2017), that the vaccine was administered in her left shoulder (records indicated right deltoid), or that her pain was confined to the shoulder. She was permitted to pursue an off-Table claim. The public decision of September 20, 2023, found that Ms. McLee failed to present preponderant evidence for her off-Table claim, specifically lacking a medical theory connecting the vaccination and injury, a logical sequence of cause and effect, or a proximate temporal relationship. No medical experts were named in the public decision. The case was dismissed by Special Master Christian J. Moran. Petitioner was pro se; respondent was represented by Katherine C. Esposito. The decision date was September 20, 2023.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_20-vv-01283-0
Date issued/filed: 2023-06-01
Pages: 23
Docket text: eissued date and footnote) (sw). Petitioner served via e-mail on 6/2/2023 (sw).PUBLIC ORDER/RULING (Originally filed: 05/10/2023) regarding 54 Ruling on Entitlement, Signed by Special Master Christian J. Moran. (ceo) Service on parties made. (Main Document 55 replaced on 6/2/2023 to add r
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Case 1:20-vv-01283-UNJ Document 55 Filed 06/01/23 Page 1 of 23
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Reissued for Public Availability Date: June 1, 2023
* * * * * * * * * * * * * * * * * * * * *
NADINE LYNN McLEE , *
* No. 20-1283V
*
Petitioner, * Special Master Christian J. Moran
*
v. * Filed: May 10, 2023
*
SECRETARY OF HEALTH * Entitlement; shoulder injury
AND HUMAN SERVICES, * related to vaccine administration
* (“SIRVA”); influenza (“flu”) vaccine.
Respondent. *
* * * * * * * * * * * * * * * * * * * * *
Nadine Lynn McLee, pro se, Pittsburgh, PA, for petitioner;
Katherine C. Esposito, United States Dep’t of Justice, Washington, D.C., for
respondent.
UNPUBLISHED RULING DENYING
COMPENSATION ON TABLE CLAIM12
Nadine McLee alleged that the trivalent influenza (“flu”) vaccine she
received on September 27, 2017, caused her to suffer left shoulder injuries.
Amended Pet., filed Mar. 3, 2021, at Preamble, ¶¶ 2-4. The information in the
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), the
parties have 14 days to identify and move to redact medical or other information, the disclosure
of which would constitute an unwarranted invasion of privacy. Any changes will appear in the
document posted in the website.
2 Pursuant to Vaccine Rule 18(b), this Ruling was initially filed on May 10, 2023, and the
parties were afforded 14 days to propose redactions. The parties did not propose any redactions.
Accordingly., this Ruling is reissued in its original form for posting on the Court’s website.

Case 1:20-vv-01283-UNJ Document 55 Filed 06/01/23 Page 2 of 23
record, however, does not support Ms. McLee’s allegation of a Table shoulder
injury related to vaccine administration (“SIRVA”).
Ms. McLee’s SIRVA claim suffers from three problems. First, Ms. McLee
has not shown that her injury occurred within 48 hours of vaccination. Exhibit 3 at
pdf 1, 7. Second, although Ms. McLee claims an injury to her left shoulder, the
medical records show that Ms. McLee received the flu vaccine in her right deltoid.
Exhibit 2A at pdf 1. Third, Ms. McLee has not shown that her pain was limited to
the left shoulder. CM/ECF 18-2 at pdf 19; Exhibit 8 at pdf 1. Ms. McLee has
therefore failed to establish that she meets the criteria for a SIRVA claim, and thus,
this claim is dismissed. However, Ms. McLee may proceed with her claim
alleging an off-Table shoulder injury.
I. Summary of the Evidence
A. Medical Records Before Vaccination, Including Vaccination
Ms. McLee was born on May 1, 1960. Exhibit 1 at pdf 1. She is left-hand
dominant. Exhibit 3 at pdf 1. At the time of vaccination, Ms. McLee worked full
time as a patient information coordinator at the University of Pittsburgh Medical
Center (“UPMC”) Passavant Cranberry, a job that requires frequent typing.
CM/ECF 18-2 at pdf 4; Exhibit 5 at pdf 27.
On September 27, 2017, Ms. McLee visited Dr. Farrell for a pre-operative
evaluation for a cataract surgery scheduled for October 6, 2017. CM/ECF 18 at
pdf 38. Dr. Farrell noted no issues nor any need to take special precautions with
respect to the upcoming cataract surgery. Id. at pdf 41. He discussed the cessation
of smoking with Ms. McLee and asked for a six-month follow up. Id.
During her visit with Dr. Farrell on September 27, 2017, Ms. McLee
received the flu vaccine. CM/ECF 20-2; Exhibit 2A at pdf 1. Here, there is a
dispute regarding whether Ms. McLee received her flu vaccine in her right or left
deltoid. The medical records indicate that Ms. McLee received the flu vaccine in
her right deltoid. Exhibit 2A at pdf 1.3 However, Ms. McLee later complained of
3Ms. McLee disputes the accuracy of these records and claims she received
the vaccine in her left deltoid. Exhibit 5 at pdf 32; CM/ECF 53-2 (Onset Aff.) at
pdf 3. In her motion for summary judgment, Ms. McLee asserts the discrepancies
“are based on PCP deception.” Pet’r’s Mot., filed Nov. 5, 2021, at 2. Ms. McLee
reports that “a record correction was requested,” though it apparently was not
2

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and sought treatment for left arm pain. See, e.g., Exhibit 8 at pdf 1; Exhibit 3 at
pdf 1.
B. Medical Records After Vaccination
1. Medical Records from December 9, 2017 to March 27, 2018
On December 9, 2017, approximately 10 weeks after receiving the flu
vaccine, Ms. McLee sought treatment at MedExpress Ross Township Urgent Care
for left shoulder pain. CM/ECF 18-2 at pdf 4. The doctor reported limited flexion
and extension in Ms. McLee’s left shoulder due to pain. Id. Ms. McLee denied
any injury and was diagnosed with an unspecified sprain of her left shoulder joint
and prescribed prednisone. Id. at pdf 6. The medical records from this visit
indicate that Ms. McLee was experiencing “L shoulder pain x 1 month” that was
aggravated due to frequent typing at work. Id. at pdf 4. This history implies that
Ms. McLee’s shoulder pain began around November 9, 2017.
On December 13, 2017, Ms. McLee visited the UPMC emergency room.
Exhibit 3 at pdf 1; CM/ECF 17 at pdf 14. The medical records indicate her
primary complaint was a “one month history of left arm pain accompanied by
intermittent episodes of numbness and tingling.” Exhibit 3 at pdf 1. This history
suggests the onset of pain was around November 13, 2017. Ms. McLee also stated
that she had “perceived weakness in her left hand.” Id. She denied any specific
injury and stated that her pain extended “from her trapezius along the lateral side
of her arm,” with the pain being exacerbated by any type of movement. Id. Ms.
McLee stated that she began working out with a trainer starting approximately six
weeks prior but had not done any exercises that caused the shoulder injury. Id.
She denied any trauma besides being on the computer during work. Id. at pdf 4.
She described her left arm as feeling heavy and felt a shooting pain when her left
shoulder blade, dorsal aspect of the upper left arm, and antiecubitis areas were
pressed. Id. At the time of this visit, Ms. McLee had almost finished the steroids
she was prescribed on December 9, 2017, and noted that even a high dose of the
steroid did not help her pain. Id. at pdf 1. Upon physical examination, Ms. McLee
had tenderness in her left trapezius on palpation and a slightly weaker grip on the
left side. Id. at pdf 2. Additionally, Ms. McLee experienced a significant increase
in pain on her left side while doing a shoulder shrug. Id. She was diagnosed with
granted as no corrections were provided. Id. Ms. McLee “denies responsibility for
MD’s fake assessment and documentation which disregarded [her] left arm pain.”
Id.
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intractable left cervical radicular pain and transferred to UPMC Passavant
McCandless for further evaluation and treatment. Id. at pdf 3.
Later that same day, Ms. McLee was seen by another physician at the
UPMC, Dr. Amit, for a spine consultation. Exhibit 3 at pdf 7. The medical
records state that she had progressive weakness and pain in the left upper extremity
which started in the left scapula, went across the neck and over both biceps and
triceps, with numbness in all 5 fingers on the left “over the last 1 ½ months.” Id.
This history implies that the onset of Ms. McLee’s pain would have been around
late October 2017. Ms. McLee denied symptoms in her right upper extremity. Id.
Upon musculoskeletal examination, Ms. McLee could not abduct more than 15
degrees on the left upper extremity. Id. at pdf 8. Because Ms. McLee’s condition
had not improved with oral prednisone or IV solumedrol, Dr. Amit prescribed
Robaxin for pain control. Id. at pdf 10.
On December 14, 2017, Ms. McLee reported back to the University of
Pittsburgh Medical Center with worsening pain with range of motion of the left
arm. Exhibit 3 at pdf 25. Ms. McLee was tender to palpation of the left trapezius
area and had occasional tingling and numbness in her left arm. Id.
The next day, on December 15, 2017, Ms. McLee was ordered to undergo a
brain MRI exam with and without contrast. Exhibit 3 at pdf 13. The purpose of
the exam was to rule out a stroke. Id. The impression was no acute intracranial
abnormality, meaning no acute stroke. Id. That same day, Ms. McLee told Dr.
Shtrahman, a neurologist, that she was feeling better. Id. at pdf 23. Dr. Shtrahman
diagnosed Ms. McLee with “[l]eft upper extremity pain and ‘weakness’” and noted
that the workup thus far had been unremarkable. Id. For next steps, Dr.
Shtrahman recommended an EMG and nerve conduction studies. Id. Ms. McLee
was stable for discharge. Id.
Ms. McLee saw Dr. Farrell again on January 3, 2018. Exhibit 5 at pdf 25.
The medical records show that she informed him that weakness in her left arm
“ha[d] been developing slowly since October” of 2017. Id. At the time of this
visit, Ms. McLee had no symptoms on her right side or neck. Id. Dr. Farrell noted
that there was no acute trauma or injury. Id. Ms. McLee’s left side presented with
tenderness in the left trapezius ridge and her range of motion on the left shoulder
was restricted. Id. Dr. Farrell indicated that Ms. McLee had impingement
syndrome of the left shoulder. Id. He noted that her grip strength on the left side
was maybe just a little weaker, especially considering that Ms. McLee is left-
4

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handed. Id. Dr. Farrell referred her to an orthopedist to give her a prescription for
physical therapy. Id.
On January 16, 2018, Ms. McLee visited orthopedist Dr. Gause. CM/ECF
18-2 at pdf 18. Dr. Gause’s notes state that Ms. McLee is right-hand dominant4
and presented for evaluation of the left shoulder. Id. The records indicate that Ms.
McLee reported that the onset of her pain “2 months ago on 11/20/17 after
receiving a flu shot.” Id. The records further state that her pain was “localized
somewhat diffusely about her neck traveling into the left trapezius and
anterolateral aspect of her left shoulder.” Id. Ms. McLee reported a “constant
achy pain” as well as “numbness in her fingers” and “some decreased range of
motion and weakness.” Id.
On January 24, 2018, Ms. McLee had her first visit with physical therapist
Matthew Sennott. CM/ECF 20-8 at pdf 7. The date of onset was reported as
September 18, 2017. Id. at pdf 12. Ms. McLee stated that she had “increased
muscle pain in her l[eft] shoulder following a flu shot in September 2017.” Id.
The pain, as Ms. McLee described, progressed like a toothache. Id. Mr. Sennott
noted that Ms. McLee is left-hand dominant and worked a desk job that required a
lot of time typing and writing. Id. The next day, on January 25, 2018, Ms. McLee
had an MRI performed on her left shoulder. Id. at pdf 29. There were no
significant derangements in the left shoulder. CM/ECF 28 at pdf 35.
Ms. McLee saw Dr. Esman on January 29, 2018, for left upper extremity
pain. CM/ECF 18-2 at pdf 19-20. Dr. Esman noted that Ms. McLee was left-hand
dominant and presented with a four-month history of pain in her left upper arm,
along with tingling and numbness in her forearm and fingertips. Id. This history
suggests that the onset of pain began approximately on September 29, 2017. Ms.
McLee also believed the problem started after getting her flu shot. Id. Dr. Esman
found that Ms. McLee had diffuse mild weakness throughout the left upper
extremity. Id. Nerve studies were performed, and the nerve conduction portion
was normal and showed no evidence of carpal tunnel syndrome or ulnar
neuropathy or any evidence of impairment of sensory amplitudes as would be seen
in a brachial plexus lesion. Id.
4 This appears to be incorrect because the medical records consistently
indicate that Ms. McLee is left-hand dominant. See, e.g., CM/ECF 18-2 at pdf 19;
CM/ECF 20-8 at pdf 7; Exhibit 3 at pdf 1; Exhibit 5 at pdf 25, 27.
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On February 2, 2018, Ms. McLee saw Dr. Gause again. CM/ECF 18-2 at
pdf 28-29. Dr. Gause’s notes state that Ms. McLee was bothered by diffuse neck
pain traveling into her left shoulder and arm. Id. at pdf 21. Dr. Gause concluded
that at this point, he could not find an etiology for her symptoms and recommended
that Ms. McLee follow up with her primary care physician. Id. at pdf 29.
Additionally, that same day, Ms. McLee had physical therapy with Matthew
Sennott. CM/ECF 20-8 at pdf 4. Mr. Sennott noted that Ms. McLee had continued
soreness in her left shoulder, which she said was so bad that it was numbing at
times. Id. Ms. McLee also said that typing all day at work had increased her
symptoms. Id. She was subsequently discharged from physical therapy on March
9, 2018, likely because she was too busy working to attend the sessions. CM/ECF
20-8 at pdf 17; Exhibit 8 at pdf 1.
On a follow up visit to Dr. Farrell on February 6, 2018, Ms. McLee
described her left shoulder pain as beginning in mid-September 2017. Exhibit 5 at
pdf 27. He noted that her pain continued in the same place and severity as the last
time he saw her. Id. Ms. McLee explained that her sleep was disturbed due to the
pain so she could not sleep on her back, and instead needed to sleep right laterally
recumbent. Id. However, the pain was not deep aching and Ms. McLee was not
noticing motor weakness. Id. He noted that she is left-handed and was working as
a clerical person checking inpatient stay at UPMC Passavant Cranberry and had
not missed work due to the pain. Id. Dr. Farrell explained that her range of motion
of the shoulder was limited in elevation extension, and that it would be helpful if
Ms. McLee could tolerate nerve conduction studies. Id. He suggested a referral to
Dr. Cheryl Bernstein for neurology and pain medicine and prescribed Cymbalta.
Id. at pdf 27-28.
On March 27, 2018, Ms. McLee visited UPMC Pain Medicine and saw Dr.
Bernstein. CM/ECF 28 at pdf 40. Ms. McLee’s chief complaints were arm and
hand pain, with an onset date reported as September 17, 2017. Id. at pdf 40, 52.
Dr. Bernstein diagnosed Ms. McLee with chronic pain syndrome and found that
there were no significant internal derangements in the left shoulder. Id. at pdf 40,
45. Ms. McLee was referred to an occupational therapist and a physical therapist,
as well as referred for a psychological evaluation for her chronic pain syndrome.
Id. at pdf 47.
2. Medical Records from April 6, 2018 to November 13, 2018
Ms. McLee had a follow up appointment with Dr. Farrell on April 6, 2018,
for chronic pain from the anterior shoulder distal to the hand with paresthesia
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without diagnosis. Exhibit 5 at pdf 28-29. Dr. Farrell noted that there had been no
change in pain intensity, character, or location, or pain at new sites since he last
saw Ms. McLee. Id. Additionally, Ms. McLee’s range of motion of the shoulder
was limited. Id. He referred her for another orthopedic opinion at Western
Pennsylvania Hand and Upper Extremity Center. Id.
On April 27, 2018, Ms. McLee was evaluated by Dr. Balk at the Hand and
Upper Extremity Center. Exhibit 8 at pdf 1. Ms. McLee’s primary complaints
were of left upper arm pain and stiffness and left-hand numbness, which she
attributed to a flu vaccine from September 2017. Id. She expressed that she had a
constant throbbing pain in her left upper arm that sometimes radiated to her neck.
Id. Dr. Balk noted that Ms. McLee was prescribed physical therapy but could not
attend because of a busy work schedule. Id. He recommended more physical
therapy as well as a cortisone injection, which Ms. McLee declined. Id. at pdf 3.
Additionally, Dr. Balk expressed the importance of a nerve conduction study for
Ms. McLee’s complaints of hand numbness. Id.
On May 8, 2018, Ms. McLee again visited Dr. Bernstein for arm and hand
pain. CM/ECF 28 at pdf 30. Ms. McLee was scheduled for a repeat EMG/NCS of
the left upper extremity because she could not tolerate the EMG the first time. Id.
Ms. McLee had not had much relief from her pain, mostly because she could not
attend physical therapy appointments due to her work schedule. Id. On physical
examination, Ms. McLee could not actively get past 45 degrees abduction on the
left side. Id. at pdf 34. Dr. Bernstein suggested that Ms. McLee consider a
shoulder injection, suprascapular nerve block, to improve her range of motion
without pain. Id. at pdf 36.
Ms. McLee revisited Matthew Sennott on May 10, 2018, for physical
therapy for chronic left shoulder pain. CM/ECF 20-9 at pdf 23. He noted that she
was experiencing difficulty with activities of daily living, including active shoulder
motion, dressing, and driving. Id. at pdf 28. Additionally, Ms. McLee had been
having trouble with work duties, including keyboarding, writing, and using the
phone. Id. On May 15, 2018, she returned to physical therapy and reported that
she had continued pain and was having trouble sleeping because she was unable to
find a comfortable position. Id. Ms. McLee did not tolerate the session well, and
reported increased pain with any motion at or about 90 degrees. Id. at pdf 42-43.
Ms. McLee had another session with Mr. Sennott on May 17, 2018, and reported
continued soreness and intermittently completing her home exercise program. Id.
at pdf 48. She had good tolerance to this session and completed progressions with
minimal soreness. Id. She reported for a final session on May 24, 2018, and was
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subsequently discharged with a recommendation for an independent home
program. Id. at pdf 54-56.
On August 13, 2018, Ms. McLee visited the emergency room due to
abdominal pain, nausea, and diarrhea. CM/ECF 17 at pdf 7. Additionally, Ms.
McLee noted she had chronic left arm pain for the last year since her flu shot but
had seen a specialist and was taking ibuprofen to manage the pain. Id. The doctor
also noted blood in her urine, which he treated as a urinary tract infection and
recommended she see a urologist in two weeks if the bleeding in her urine did not
subside. Id. at pdf 8. Ms. McLee was formally diagnosed with abdominal pain,
hematuria with concern for urinary tract infection, and elevated systolic blood
pressure without a history of hypertension. Id.
The next day, on August 14, 2018, Ms. McLee had a follow up visit with Dr.
Farrell. Exhibit 5 at pdf 29. He explained to her that her pain seemed like a
chronic problem and that they needed to work to try to suppress her pain. Id. at pdf
30. The medical records reflect that Ms. McLee thought her left arm was getting
weaker. Id. She noted that she had exercises that she learned from physical
therapy, but Dr. Farrell mentioned that he did not think she was doing the exercises
regularly. Id. He raised her dosage of Cymbalta and recommended she revisit Dr.
Bernstein to discuss the possibility of a nerve block. Id.
On November 23, 2018, Ms. McLee returned to Dr. Bernstein for continued
left arm pain. CM/ECF 28 at pdf 22, 26. She reported pain in her “left neck,
shoulder, and arm,” and reported that her “fingers are always numb” and “bicep is
a constant toothache.” Id. at pdf 23. Ms. McLee was to undergo a repeat EMG,
but she stated that she did not want to do so despite having continued numbness
and tingling. Id. at pdf 22, 26. Further, the records reflect that Ms. McLee did not
believe the Cymbalta was improving her pain. Id. The attending noted
neuropathic pain and recommended that Ms. McLee increase her dosage of
Cymbalta and consider nortriptyline. Id. at pdf 26.
3. Medical Records from February 19, 2019 to April 2, 2021
Ms. McLee reported for a radiology consultation on February 19, 2019, for
congestion, productive cough, and body aches for ten days. CM/ECF 28 at pdf 8.
She received a chest x-ray and was diagnosed with bronchitis. Id.; CM/ECF 18-2
at pdf 3. She was prescribed benzonatate, prednisone, ventolin, and an inhaler.
CM/ECF 18-2 at pdf 3.
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On August 13, 2019, Ms. McLee went to MedExpress because of swelling in
her right shoulder after a flu shot two years ago. CM/ECF 18-2 at pdf 10. She
reported tingling and numbness, and stated she had been careful with it since. She
also reported pain around the scapula. Id. She was diagnosed with a sprain of the
ligaments of the thoracic spine and was prescribed prednisone and
cyclobenzaprine. Id. at pdf 11.
No other relevant medical records have been filed.5
C. Affidavits6
Ms. McLee completed an onset affidavit, which was initially filed on March
30, 2022. CM/ECF 53-2 (Onset Aff.). Ms. McLee claims that her left shoulder
pain began immediately “upon needle stick” and describes the pain as “shocking,
continuous, [and] expansive.” Id. at pdf 2. She states that the part of her shoulder
that was affected was “the injection site area and beyond.” Id. She claims that she
could not lift her arm above her shoulder and felt like her arm was paralyzed. Id.
Ms. McLee claims that during her appointment on September 27, 2017, she
“immediately” informed the nurse who administered the vaccine, Kala Cinker, that
she was experiencing shoulder pain. Id. Additionally, Ms. McLee states that she
had difficulty sleeping later that night due to constant repositioning in her bed,
5 Ms. McLee filed additional materials in CM/ECF 42, including records
regarding a cataract surgery on October 6, 2017; COVID vaccination records;
records from visits to the UPP Department of Dermatology and Specialists in
Plastic Surgery of Pittsburgh regarding a mass in Ms. McLee’s upper right arm;
and records from UPMC Heart and Vascular Institute. However, CM/ECF 42 was
stricken from the record because it contained multiple filings which were not
properly labeled as exhibits. Ms. McLee was ordered to individually refile
documents in this filing with clear exhibit headings, but did not do so. See Order,
issued Aug. 19, 2022.
6 Affidavits from Ms. McLee’s children, Hannah Avva and Bradley McLee
Jr., were filed on March 30, 2022 with CM/ECF 42, but were never resubmitted
after this filing was stricken from the record. Bradley McLee Jr. stated that he
spoke to Ms. McLee the day of her September 27, 2017 vaccination, and Hannah
Avva stated that she spoke with Ms. McLee a few days after. Both stated that she
told them her pain began immediately.
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which she needed help doing. Id. She represents that her full left shoulder area
was affected, and she could not lift her arm above her shoulder. Id.
Ms. McLee also disputes the accuracy of certain medical records which state
the onset of her pain. The medical records from December 9, 2017 state that Ms.
McLee had been experiencing left arm pain for one month, and additional medical
records from December 13, 2017 state that Ms. McLee had been experiencing left
arm pain for the past one-and-a-half months; however, Ms. McLee denies this and
maintains that her entire arm was in pain since September 27, 2017. Id. at pdf 3-4.
Similarly, medical records from January 3, 2018, state that Ms. McLee’s pain had
been developing since October 2017, which she denies saying. Id. Finally, Ms.
McLee disputes the medical record from January 16, 2018, which states that she
had been experiencing left arm pain since November 20, 2017. Id. at pdf 5.
In an affidavit by Ms. McLee’s husband, Bradley McLee Sr., submitted
February 3, 2023, Mr. McLee alleges that the medical records are “erroneous” due
to “mistakes or lies” on the part of healthcare providers. CM/ECF 53-1 at pdf 2.
Specifically, Mr. McLee states that the records showed the “wrong arm”, and that
“[r]eports of non-injury, right arm, later onset of pain, PCP notes, etc. are
preposterous.” Id. at pdf 3. He refers to Ms. McLee’s “SIRVA” and describes her
“pain, loss of motion, [and] weariness.” Id.
II. Procedural History
Ms. McLee first filed her petition on September 28, 2020, alleging “injuries,
including Guillain Barre Syndrome” and “SIRVA.” An initial status conference
was held on October 29, 2020. A deadline for the Secretary’s Rule 4 report was
not set, as Ms. McLee had outstanding records to file. Ms. McLee was ordered to
continue collecting her medical records. On March 3, 2021, Ms. McLee filed more
medical records and an amended petition, again alleging “injuries, including
Guillain Barre Syndrome” and “SIRVA.” The Secretary identified more
outstanding records and Ms. McLee continued filing records through May 2021.
On June 21, 2021, the Secretary filed a status report indicating he would complete
medical review of this case by late November 2021.
On November 5, 2021, Ms. McLee moved for summary judgment,
requesting compensation for her alleged “SIRVA.” Ms. McLee disputed the
accuracy of the medical records that show that her left shoulder pain began in
October or November 2017, and instead argued that her shoulder pain began upon
vaccination. See Pet’r’s Mot., filed Nov. 5, 2021, at pdf 2-3. Ms. McLee also
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asserted that the nurse incorrectly recorded the arm in which she received the flu
vaccine, and she requested a correction of the record. Id.
The Secretary opposed Ms. McLee’s motion, arguing that Ms. McLee had
neither proven SIRVA nor that her alleged injury was caused-in-fact by the
vaccination. The Secretary recommended that compensation be denied. See
Resp’t’s Rep., at 17. Contemporaneously with his report, the Secretary moved to
dismiss this case, raising, inter alia, an issue of statute of limitations. Id. at 15.
Ms. McLee did not file a response to the Secretary’s motion.
Ms. McLee requested a status conference, which was held on January 25,
2022. During the status conference, Ms. McLee questioned the accuracy of the
medical records and mentioned that she received the COVID-19 vaccine.
Subsequently, Ms. McLee was ordered to complete an onset affidavit and file her
COVID-19 vaccination record by February 25, 2022. Order, issued Jan. 26, 2022.
After being granted an extension of time, Ms. McLee filed the additional requested
medical records on March 30, 2022. CM/ECF 42, Pet’r’s Med. Records, filed Mar.
30, 3022.
Also contained within Ms. McLee’s March 30, 2022 CM/ECF 42 filing was
a request for discovery. Id. at pdf 77. Among the inquiries, Ms. McLee requested
that the Secretary provide answers to a set of interrogatories. Id. There were also
affidavits from Ms. McLee’s son and daughter. Id. at pdf 16-19. CM/ECF 42 was
later stricken however, for failure to appropriately label the records as exhibits.
See Order, issued Apr. 11, 2022; Pet’r’s Exhibit List, filed May, 9, 2022; Order,
issued Aug. 19, 2022
The undersigned issued an order instructing both parties to file a status
report on whether a hearing would be appropriate in light of Ms. McLee’s
November 5, 2021 motion for summary judgment and the Secretary’s November
19, 2021 motion to dismiss. Order, issued July 26, 2022. After Ms. McLee’s
husband contacted chambers seeking information on her right to appeal after
electing to close the record, the undersigned ordered both parties to review Ms.
McLee’s discovery request and to file a status report on the appropriateness of
providing answers to the questions. Order, issued Aug. 19, 2022. The undersigned
also ordered respondent to review Ms. McLee’s discovery request and file a status
report on the appropriateness of providing answers to the questions. Id. at 2. Ms.
McLee was ordered to refile the non-duplicative exhibits from CM/ECF 42
individually and instructed that she may file an affidavit from her husband
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describing his observations of Ms. McLee’s vaccination by November 17, 2022.
Id.
The Secretary maintained that a hearing was not appropriate in this case.
Resp’t’s Status Rep., filed Sept. 1, 2022. The Secretary also responded to the
request for discovery, arguing that petitioner’s questions were “overly broad” and
were not appropriate for a substantive response. Resp’t’s Status Rep., filed Sept.
19, 2022. The Secretary’s counsel further noted that neither he, HHS, nor DICP
had contacted petitioner’s former doctor without disclosure. Id. at 2.
Ms. McLee did not submit a filing regarding her position on whether a
hearing was appropriate. Ms. McLee did not file an affidavit by the deadline, nor
did she refile the exhibits specified in the August 19, 2022 order. It appeared that
Ms. McLee had attempted to communicate with a person whose employment
within the Office of Special Masters had ended, and so the undersigned, sua
sponte, extended the deadline for the exhibits and affidavit to January 26, 2023.
Order, issued Dec. 28, 2022. Ms. McLee contacted chambers and the
undersigned’s law clerk the week of the deadline to inform of an intent to file these
materials, but did not file anything. Ms. McLee also did not file a status report
detailing why she failed to file these materials. The undersigned, sua sponte,
extended the deadline to February 3, 2023, reminding Ms. McLee to file through
the CM/ECF system. Order, issued Jan. 27, 2023. On February 3, 2023, Ms.
McLee filed an affidavit from her husband, and refiled her affidavit about the onset
of her symptoms. CM/ECF 53-1, 53-2.
The Secretary has not filed any materials since his September 19, 2022
status report.
Accordingly, Ms. McLee’s SIRVA claim is now ready for adjudication.
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III. Standards for Adjudication
Petitioners are required to establish their cases by a preponderance of the
evidence. 42 U.S.C. § 300aa-13(a)(1). The preponderance of the evidence
standard requires a “trier of fact to believe that the existence of a fact is more
probable than its nonexistence before [he] may find in favor of the party who has
the burden to persuade the judge of the fact’s existence.” Moberly v. Sec’y of
Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations
omitted).
The process for finding facts in the Vaccine Program begins with analyzing
the medical records, which are required to be filed with the petition. 42 U.S.C.
§ 300aa-11(c)(2). Medical records that are created contemporaneously with the
events they describe are presumed to be accurate. Cucuras v. Sec’y of Health &
Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). However, medical records
may not always list all problems a person is experiencing. See Kirby v. Sec’y of
Health & Hum. Servs., 997 F.3d 1378, 1382 (Fed. Cir. 2021).
Under the Act, a petitioner may not be given a Program award based solely
on the petitioner’s claims alone. Rather, the petition must be supported by either
medical records or by the opinion of a competent physician. 42 U.S.C. § 300aa-
13(a)(1).
Vaccine Rule 8(d) provides that a “special master may decide a case on the
basis of written submissions without conducting an evidentiary hearing.” Special
masters are required to determine whether hearings or witness testimony are
reasonable and necessary. 42 U.S.C. § 300aa-12(d)(3)(B). In doing so, special
masters must “afford[ ] each party a full and fair opportunity to present its case and
creat[e] a record sufficient to allow review of the special master’s decision.”
Vaccine Rule 3(b)(2).
Special masters have previously resolved factual disputes regarding the site
of vaccination without conducting a hearing. In Kabelitz, the petitioner argued that
affidavits supported the onset of symptoms beginning within 48 hours of vaccine
administration. See Kabelitz v. Sec’y of Health & Hum. Servs., 2022 WL 909055,
at *13 (Fed. Cl. Spec. Mstr. Feb. 17, 2022). However, respondent maintained that
the medical histories did not place the onset of symptoms within 48 hours. Id. The
special master found which arm a vaccine was administered into without a hearing
when “the parties agreed a ruling on the factual issues [wa]s necessary [and] . . .
consented to a fact ruling on the record in the absence of a hearing.” Id. The
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special master gave greater weight to the medical records, noting specifically that
the petitioner’s affidavit was created approximately one-and-a-half years after the
vaccine. Id. at *18. He ultimately found that petitioner did not provide evidence
showing more likely than not that she experienced pain within 48 hours of
receiving the vaccine. Id. at *19.
In Schmidt, the petitioner alleged a left shoulder injury; however, the
contemporaneous medical records from the date of vaccination showed that the
vaccine was administered in the right arm. Schmidt v. Sec’y of Health & Hum.
Servs., No. 17-1530V, 2021 WL 5226494, at *1 (Fed. Cl. Spec. Mstr. Oct. 7,
2021). No hearing was held since the petitioner requested a resolution through
briefing. Id. at *2. The special master stated that although “the Petitioner may
honestly believe that he received the vaccine alleged as causal in his left arm, the
record as it now stands preponderantly supports the opposite.” Id. at *11. As such,
the special master concluded that the vaccine was more likely than not
administered in petitioner’s right arm, as supported by the vaccine administration
records. Id.
In Hanna, the parties also disputed the location of petitioner’s vaccination
site under a SIRVA claim. Hanna v. Sec’y of Health & Hum. Servs., 2021 WL
3486248, at *1 (Fed. Cl. Spec. Mstr. 2021). The special master then issued an
order requesting that the parties “file a joint status report indicating whether the
parties wanted any additional opportunity to develop the record.” Id. at *2. The
parties then responded that “neither party request[ed] any further opportunity to
develop the record with regard to the site of petitioner's injection. Petitioner
request[ed] an opportunity to brief the issue of injection site before the Special
Master rules on this issue. Respondent ha[d] no objection to petitioner’s request.’”
Id. (internal citation omitted). Thereafter, the special master found it appropriate to
resolve the case without a hearing after finding that the parties “had full and fair
opportunity to present their cases.” Id. at n.3
A ruling on the record differs from adjudicating a motion for summary
judgment. Duncan v. Sec’y of Health & Hum. Servs., 153 Fed. Cl. 642, 656
(2021) (noting that “[i]n Kreizenbeck, the Federal Circuit rejected the petitioners’
argument that, in light of their objection to a ruling on the record, the special
master was obliged to either hold a hearing or resolve their case on summary
judgment . . . [and that] the language of the Vaccine Act does not ‘suggest[ ] a
consent-based limitation on a special master's authority to rule on the record.’”)
(internal citation omitted). Thus, although the parties here initially presented the
case as a motion for summary judgment (Ms. McLee) or a motion to dismiss (the
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Secretary), the July 26, 2022 order alerted the parties to a final chance to submit
their evidence and arguments. Thus, the standards for motion for summary
judgement and motion to dismiss do not govern the present adjudication.
Pursuant to these standards for determining when and whether events did or
did not happen, the undersigned finds how the evidence preponderates. In setting
forth the findings, the undersigned also cites to the primary evidence that is the
basis for the finding. The undersigned recognizes that not all evidence is entirely
consistent with these findings. See Doe 11 v. Sec’y of Health & Hum. Servs., 601
F.3d 1349, 1355 (Fed. Cir. 2010) (ruling that the special master’s fact-finding was
not arbitrary despite some contrary evidence).
IV. Analysis of SIRVA
To receive compensation under the National Vaccine Injury Compensation
Program (hereinafter “the Program”), petitioner must prove either (1) that she
suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—
corresponding to her vaccination, or (2) that she suffered an injury that was
actually caused by a vaccine. See 42 U.S.C. §§ 300aa-13(a)(1)(A) and 300aa-
11(c)(1). Ms. McLee asserts a “Table Injury” via her SIRVA claim and does not
appear to allege the injury was caused-in-fact by the vaccination. Amended Pet.,
filed Mar. 3, 2021.
A petitioner may establish causation by showing that she suffered an injury
contained in the Vaccine Injury Table corresponding to the vaccine she received
within the appropriate timeframe. 42 U.S.C. §§ 300aa-13(a)(1)(A), § 300aa-
11(c)(1)(C)(i), § 300aa-14(a), § 300aa-13(a)(1)(B). In such a case, causation is
presumed. Id. To satisfy the elements for an on-Table SIRVA claim, a petitioner
must show that (1) she had no history of shoulder pain prior to vaccination, (2) the
onset of pain occurred within 48 hours after vaccination, (3) the injury is confined
to the shoulder in which she received the vaccine, and (4) there is no evidence of
any alternative cause of her pain. 42 C.F.R. § 100.3(a), (c)(10)(i)-(iv).
For the reasons listed below, Ms. McLee has failed to demonstrate that she
suffered an on-Table SIRVA, and therefore is not entitled to compensation.
A. History of Shoulder Pain
Ms. McLee has established that she had no history of shoulder pain prior to
vaccination. The Secretary also concedes this point. The Secretary’s report avers
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that Ms. McLee’s medical history does not indicate that she experienced any upper
extremity pain prior to vaccination. Resp’t’s Rep., filed Nov. 19, 2021, at 3.
Based on the medical records submitted by Ms. McLee, the first time Ms. McLee
complained of shoulder pain to a medical professional was on December 9, 2017,
approximately ten weeks after she received the flu vaccine. CM/ECF 18-2, at pdf
4. Although Ms. McLee has satisfied one element required to prove an on-Table
SIRVA claim, other aspects of her SIRVA claim fail.
B. Onset of Pain Occurring Within 48 Hours
Under 42 C.F.R. § 100.3(c)(ii), Ms. McLee must demonstrate that her
symptoms began within 48 hours of her vaccine. See 42 C.F.R. § 100.3(a) XIV.B.
(2017) (shoulder injury from influenza vaccination). The “Qualifications and Aids
to Interpretation” (QAI) for a SIRVA-based claim also require that onset occurs
within a 48-hour time frame. 42 C.F.R. § 100.3(c)(10).
Ms. McLee offers some support for her assertion that her onset of symptoms
began around the time of her flu shot. The medical record from January 29, 2018,
indicates that Ms. McLee had a four-month history of pain, which would date back
to late September 2017.7 CM/ECF 18-2 at pdf 19. Although this one record
appears to support the onset of symptoms within the relevant timeframe of
receiving the flu vaccine, three other records state that Ms. McLee’s pain began
before the date of vaccination. The medical record of January 24, 2018 notes that
she reported increased pain in her left shoulder after the flu shot, but lists the date
of onset as September 18, 2017. CM/ECF 20-8 at pdf 12. Similarly, the record of
February 6, 2018, states that onset was “mid September,” and the record of March
27, 2018 reports that the pain started on September 17, 2017. Exhibit 5 at pdf 27;
CM/ECF 28 at pdf 50.
In contrast, the records created closest in time to Ms. McLee’s vaccination
place the onset of pain in October or November 2017. The medical records from
December 9, 2017; two records from December 13, 2017; and records from
January 16, 2018, indicate that Ms. McLee’s left shoulder pain began in late
October or November 2017. CM/ECF 18-2 at pdf 4, 18; Exhibit 3 at pdf 1, 7. The
medical record from her visit on January 3, 2018, indicates that her pain began in
7 The medical record from Ms. McLee’s April 27, 2018, appointment at the
Hand and Upper Extremity Center states that she attributes her pain to a flu shot
received in September 2017, but does not specify a timeframe for the onset of pain.
Exhibit 8 at pdf 1.
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October 2017. Exhibit 5 at pdf 25.8 Medical records with information about onset
are presented in the following chart:
8 The medical records filed with CM/ECF 42, which was stricken from the
record, were reviewed by the undersigned and do not specify a date for the onset of
pain.
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Date of Information from Reported Onset Record Citation
Record Record
12/09/2017 “L shoulder pain x 1 November 9, 2017 CM/ECF 18-2 at pdf 4
month” (implied)
12/13/2017 “one month history November 13, Ex. 3 at pdf 1
of left arm pain” 2017 (implied)
12/13/2017 “over the last 1 ½ Late October 2017 Ex. 3 at pdf 7
months”
01/03/2018 “developing slowly October 2017 Ex. 5 at pdf 25
since October”
01/16/2018 “2 months ago on November 20, CM/ECF 18-2 at pdf
11/20/17” 2017 (implied) 18
01/24/2018 “Date of Onset: September 18, CM/ECF 20-8 at pdf
9/18/17” 2017 12
01/29/2018 “four-month history September 29, CM/ECF 18-2 at pdf
of pain” 2017(implied) 19
02/06/2018 “It began in mid Mid-September Ex. 5 at pdf 27
September” 2017
03/27/2018 “When did the pain September 17, CM/ECF 28 at pdf 50
start? 9/17/2017” 2017
In Ms. McLee’s onset affidavit, initially filed on March 30, 2022, more than
four and a half years after receiving the vaccination, she disputes the accuracy of
some of these records. See CM/ECF 53-2. Ms. McLee’s and witnesses’
statements regarding onset are entitled to consideration. See Kirby v. Sec’y of
Health & Hum. Servs., 997 F.3d 1378, 1381-84 (Fed. Cir. 2021). However,
contemporaneously created medical records are presumed to be accurate and are
generally more reliable than later recollections. See Cucuras v. Sec’y of Health &
Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). Furthermore, Ms. McLee
concedes there are no nurses’ notes or medical records that confirm her
recollection. Pet’r’s Mot., at 2. Therefore, the medical records from December 9,
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2017; December 13, 2017; January 3, 2018; and January 16, 2018, are more
reliable than Ms. McLee’s and her family’s recollections over four years later.
Additionally, Ms. McLee waited over 10 weeks post-vaccination to seek medical
care for her left shoulder pain. Accordingly, Ms. McLee’s assertion that the onset
of shoulder pain began immediately after vaccination is unsupported by the
majority of the medical records. See Cucuras, 993 F.2d at 1528. Thus, I find that
Ms. McLee began experiencing shoulder pain in early November 2017. Ms.
McLee has not shown that her injury occurred within 48 hours of her September
27, 2017 vaccination.9 CM/ECF 18-2 at pdf 4.
C. Discrepancy Between Site of Vaccination and Location of
Injury
1. Site of Vaccination
The third SIRVA criteria, 42 C.F.R. § 100.3(c)(iii), requires that “[p]ain and
reduced range of motion are limited to the shoulder in which the intramuscular
vaccine was administered.” See also Dawson v. Sec'y of Health & Hum. Servs.,
No. 19-278V, 2021 WL 5774655, at *3 (Fed. Cl. Nov. 4, 2021) (“To be sure, if a
petitioner does exhibit reduced or limited range of motion under the QAI to
establish a Table SIRVA any reduced range of motion must be ‘limited to the
shoulder in which the intramuscular vaccine was administered.’” (quoting Portee v.
Sec'y of Health & Hum. Servs., No. 16-1552V, 2018 WL 5284599, at *11 (Fed.
Cl. Sept. 14, 2018))).
Ms. McLee claims that she received the flu vaccine in her left shoulder, and
immediately began to experience pain. CM/ECF 53-2 (Onset Aff.) at pdf 2.
However, her medical records indicate that she received the flu vaccine in her right
deltoid. Exhibit 2A at pdf 1. Ms. McLee disputes the accuracy of these records,
maintaining that she received the vaccine in her left deltoid. Exhibit 5 at pdf 32
(request for amendment of medical records); CM/ECF 53-2 (Onset Aff.) at pdf 3.
Although she requested a “record correction,” it was not provided. Id.
Ms. McLee’s argument that the discrepancies are due to deceptions and/or
fake assessments by her treaters is unpersuasive. Ms. McLee did not state that she
received the vaccine in her left arm until January 16, 2018, when she reported that
9 Because the regulation requires shoulder pain to start within 48 hours of
the vaccination, which was September 27, 2017, identifying a more specific date in
November is not required.
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she “developed the onset of pain [in her left shoulder] 2 months ago on 11/20/17
after receiving a flu shot.” CM/ECF 18-2 at pdf 18. This was also the first record
in which she attributed her pain to the flu vaccine. At subsequent medical and
physical therapy appointments, Ms. McLee continued to attribute the pain in her
left arm and hand to her flu vaccine. See, e.g., CM/ECF 18-20 at pdf 44 (January
24, 2018 physical therapy record stating onset of pain was following flu shot); pdf
19 (January 29, 2018 record reporting Ms. McLee’s belief that pain started after flu
shot); pdf 31 (April 27, 2018 record stating Ms. McLee attributed pain to flu shot).
However, on August 13, 2019, Ms. McLee visited MedExpress for “swelling
to right shoulder after flu shot 2 years ago,” and informed the doctor that she had
been careful with the arm since then. CM/ECF 18-2 at pdf 15; CM/ECF 28 at pdf
13-14. Her right arm was X-rayed. Id. Importantly her tuberculosis skin tests on
May 4, 2006, May 10, 2006, and April 29, 2008, have been administered in her
right arm. Exhibit 2. Ms. McLee has not persuasively shown why she deviated
this pattern for the allegedly causal flu vaccine.
Like Schmidt and Hanna, here, no hearing was held regarding the issue of
the site of the vaccination. Schmidt v. Sec’y of Health & Hum. Servs., No. 17-
1530V, 2021 WL 5226494 (Fed. Cl. Spec. Mstr. Oct. 7, 2021); Hanna v. Sec’y of
Health & Hum. Servs., 2021 WL 3486248 (Fed. Cl. Spec. Mstr. 2021).
Contemporaneously created medical records are presumed to be accurate and are
generally more reliable than later recollections. See Cucuras, 993 F.2d at 1528.
Thus, even though Ms. McLee “may honestly believe that [she] received the
vaccine alleged as causal in [her] left arm, the record as it now stands
preponderantly supports the opposite.” Schmidt, at *11. Accordingly, absent
additional medical records or physician statements noting Ms. McLee’s
vaccination occurred in her left arm, having reviewed the materials in this record,
the undersigned finds she received the flu vaccine in her right arm.
2. Confinement of Injury to Shoulder
Next, even if the vaccine was administered in the left shoulder as Ms.
McLee alleges, her pain and reduced range of motion were not limited to this
shoulder. In contrast, the medical records consistently reflect that Ms. McLee’s
left shoulder pain extended to her hand, fingers, and neck. See Exhibit 3 at pdf 7
(progressive weakness in the left upper extremity, across the neck and over both
biceps and triceps, with numbness on all five fingers on the left hand); CM/ECF
18-2 at pdf 28-29 (diffuse neck pain traveling into the left shoulder and arm);
Exhibit 8 at pdf 1 (constant throbbing pain in her left upper arm that sometimes
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radiated to her neck); Exhibit 3 at pdf 1 (perceived weakness in left hand);
CM/ECF 18-2 at pdf 19 (history of left shoulder and upper arm pain as well as
tingling and numbness in the forearm and fingertips). Thus, the medical records
show that Ms. McLee’s pain was not limited exclusively to her left shoulder.
Further, Ms. McLee states in her affidavit that her “entire left arm was in pain from
9/27/2017.” CM/ECF 53-2 (Onset Aff.) at pdf 4 (emphasis added). Therefore,
Ms. McLee has failed to establish that her injury was limited to her left shoulder.
Special masters have found that petitioners met their burden under SIRVA
when reports of pain and injury extending beyond the shoulder were limited. See,
e.g., Meagher v. Sec'y of Health & Hum. Servs., No. 18-1572V, 2023 WL
2582683, at *6 (Fed. Cl. Mar. 21, 2023) (finding that “a single notation by a
physical therapist, not a physician, documenting an isolated subjective report by
petitioner that ‘sometimes pain radiates all the way to R hand’ and that ‘over time
’” did not defeat SIRVA claim); K.P. v. Sec'y of
Health & Hum. Servs., No. 19-0065V, 2022 WL 3226776, at *7 (Fed. Cl. May 25,
2022) (finding that petitioner met SIRVA criteria where, although “at the first
medical encounter, Petitioner reported that her severe pain also involved her left
forearm and left hand,” there was “no subsequent evidence of an injury extending
beyond the shoulder.”).
However, where, as here, the records consistently note pain and injury
extending beyond the shoulder, special masters have found that petitioners did not
meet the SIRVA criteria. See, e.g., Wood v. Sec'y of Health & Hum. Servs., No.
19-0189V, 2020 WL 8368926, at *7 (Fed. Cl. Nov. 24, 2020) (finding that
petitioner failed to meet the third SIRVA criteria where the records “contain
numerous instances when Petitioner describes her pain as radiating into her chest
and/or down her arm. She also describes pain in her neck and back.”); Johnson v.
Sec'y of Health & Hum. Servs., No. 20-1008V, 2022 WL 1613647, at *2 (Fed. Cl.
Apr. 7, 2022) (“Petitioner cannot establish that he suffered a Table SIRVA injury,
given that his post-vaccination arm pain was not limited to his shoulder, but was
consistently described as including: numbness in his fingers and hands, and
paresthesia of the right upper extremity.”).
Special masters have resolved whether pain was limited to a vaccine
shoulder based upon the written record. See Johnson, 2022 WL 1613647, at *2
(finding that petitioner failed to prove SIRVA where his arm pain also included
numbness of the fingertips and paresthesia in the right upper extremity without
going to a hearing); Wood, No. 19-0189V, 2020 WL 8368926, at *7 (finding that,
based on the record and without holding a hearing, that petitioner did not meet the
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third SIRVA criteria where her pain extended beyond her shoulder); Colbert v.
Sec’y of Health & Hum. Servs., No. 18-166V, 2022 WL 2232210, at *4, *17 (Fed.
Cl. Spec. Mstr. May 27, 2022) (finding that the parties had a fair opportunity to
present their cases without a hearing and that petitioner did not satisfy the third
criteria of SIRVA where she had “voiced subjective complaints demonstrating that
she experienced pain beyond the left shoulder”).
D. No Alternate Cause of Pain
Whether Ms. McLee’s shoulder problem could have been caused by
something other than the flu vaccine is not clear. The medical records reveal that
frequent typing at work aggravated Ms. McLee’s shoulder. See CM/ECF 18-2, at
pdf 4. Physical therapy records show that Ms. McLee stated that typing at work
all day increased her symptoms. CM/EF 20-8, at pdf 4. To understand the
significance of these medical records, expert testimony about the potential
consequences to prolonged typing might have been helpful. The parties, however,
have offered no such opinion.
V. Off-Table Shoulder Injury
Thus, Ms. McLee cannot prevail on her Table claims for SIRVA. She may,
however, continue to pursue a claim for an off-Table shoulder injury. The
pleadings of pro se petitioners are held to less stringent standards than those of
petitioners represented by counsel. See Fesanco v. Sec'y of Health & Hum. Servs.,
99 Fed. Cl. 28, 32 (2011). “Indeed, it has been the tradition of this court to
examine the record to see if [a pro se] Plaintiff has a cause of action somewhere
displayed.” Id. (internal quotation marks omitted). Although Ms. McLee
predominantly references SIRVA in her filings, she alleges “injuries including
Guillain Barre Syndrome.” Am. Pet. at Preamble. Reading this broadly, Ms.
McLee has alleged off-Table shoulder injuries.
Petitioners who allege an off-Table injury bear the burden “to show by
preponderant evidence that the vaccination brought about [their] 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.” Schick-Cowell v. Sec'y of Health & Hum. Servs.,
No. 18-656V, 2022 WL 619839, at *9 (Fed. Cl. Feb. 8, 2022) (quoting Althen v.
Sec'y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005)).
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That Ms. McLee has alleged an on-Table SIRVA claim does not satisfy her
burden under the first prong; she must present a medical theory causally
connecting the vaccination and an off-Table shoulder injury. Id. See also Grant v.
Sec'y of Dep't of Health & Hum. Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). If
Ms. McLee wishes to pursue a claim for an off-Table injury, she is expected to
retain an expert to provide a report supporting her allegations and presenting a
theory of causation.
As for the second prong, while Ms. McLee’s own statements attributing her
shoulder and arm pain to the flu shot are entitled to consideration, these alone do
not support a logical sequence of cause and effect. Id. at *11. Ms. McLee will
need to present additional evidence, such as statements from treating physicians, to
satisfy her burden under this prong.
Finally, the undersigned has determined that the onset of Ms. McLee’s
injury was in early November, 2017. Ms. McLee must establish that this temporal
relationship supports her theory of causation.
If Ms. McLee wishes to continue litigating this case, she is ordered to file a
status report within 60 days through CM/ECF confirming that she has retained an
expert. If Ms. McLee does not do so, her off-Table claim will be dismissed.
VI. Conclusion
Ms. McLee has not satisfied the elements for a Table SIRVA claim. Thus,
this claim is dismissed for unpersuasive evidence. However, she should have the
opportunity to prove her off-Table claim by obtaining and offering expert support.
Accordingly, the following is ORDERED:
Ms. McLee may file a status report by Wednesday, July 12, 2023 (1)
confirming that she has retained a competent expert, (2) identifying the expert, and
(3) proposing a deadline for submitting the expert’s report.
IT IS SO ORDERED.
S/Christian J. Moran
Christian J. Moran
Special Master
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DOCUMENT 2: USCOURTS-cofc-1_20-vv-01283-1
Date issued/filed: 2023-09-20
Pages: 14
Docket text: PUBLIC DECISION (Originally filed: 08/18/2023) regarding 56 DECISION of Special Master Signed by Special Master Christian J. Moran. (ceo) Service on parties made. Petitioner served via e-mail on 9/20/2023 (sw).
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Case 1:20-vv-01283-UNJ Document 57 Filed 09/20/23 Page 1 of 14
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Reissued for Public Availability Date: September 20, 2023
* * * * * * * * * * * * * * * * * * * * *
NADINE LYNN McLEE , *
* No. 20-1283V
*
Petitioner, * Special Master Christian J. Moran
*
v. * Filed: August 18, 2023
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * *
Nadine Lynn McLee, pro se, Pittsburgh, PA, for petitioner;
Katherine C. Esposito, United States Dep’t of Justice, Washington, D.C., for
respondent.
UNPUBLISHED DECISION DENYING COMPENSATION12
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), the
parties have 14 days to identify and move to redact medical or other information, the disclosure
of which would constitute an unwarranted invasion of privacy. Any changes will appear in the
document posted on the website.
2 Pursuant to Vaccine Rule 18(b), this Decision was initially filed on August 18, 2023,
and the parties were afforded 14 days to propose redactions. The parties did not propose any
redactions. Accordingly, this Decision is reissued in its original form for posting on the Court’s
website.

Case 1:20-vv-01283-UNJ Document 57 Filed 09/20/23 Page 2 of 14
Nadine McLee alleged that the trivalent influenza (“flu”) vaccine she
received on September 27, 2017, caused her to suffer left shoulder injuries.
Amended Pet., filed Mar. 3, 2021, at Preamble, ¶¶ 2-4. Ms. McLee appears to
have alleged both an on-Table claim and off-Table claim. A previous ruling found
that she did not prevail on her on-Table claim. The present decision addresses her
off-Table claim. For the reasons explained below, she has failed to present
preponderant evidence supporting her off-Table claim. Thus, her case is
DISMISSED.
I. Summary of the Evidence3
A. Medical Records Before Vaccination, Including Vaccination
Ms. McLee was born on May 1, 1960. Exhibit 1 at pdf 1. She is left-hand
dominant. Exhibit 3 at pdf 1. At the time of vaccination, Ms. McLee worked full
time as a patient information coordinator at the University of Pittsburgh Medical
Center (“UPMC”) Passavant Cranberry, a job that requires frequent typing.
CM/ECF 18-2 at pdf 4; Exhibit 5 at pdf 27.
On September 27, 2017, Ms. McLee visited Dr. Farrell for a pre-operative
evaluation for a cataract surgery scheduled for October 6, 2017. CM/ECF 18 at
pdf 38. Dr. Farrell noted no issues nor any need to take special precautions with
respect to the upcoming cataract surgery. Id. at pdf 41. He discussed the cessation
of smoking with Ms. McLee and asked for a six-month follow up. Id.
During her visit with Dr. Farrell on September 27, 2017, Ms. McLee
received the flu vaccine. CM/ECF 20-2; Exhibit 2A at pdf 1. Here, there is a
dispute regarding whether Ms. McLee received her flu vaccine in her right or left
deltoid. The medical records indicate that Ms. McLee received the flu vaccine in
her right deltoid. Exhibit 2A at pdf 1.4 However, Ms. McLee later complained of
3 The “Summary of the Evidence” is taken from the May 10, 2023 Ruling. The evidence
is resummarized to present a complete decision. See Cottingham v. Sec’y of Health & Hum.
Servs., 971 F.3d 1337, 1345 n.2 (Fed. Cir. 2020).
4 Ms. McLee disputes the accuracy of these records and claims she received the vaccine
in her left deltoid. Exhibit 5 at pdf 32; CM/ECF 53-2 (Onset Aff.) at pdf 3. In her motion for
summary judgment, Ms. McLee asserts the discrepancies “are based on PCP deception.” Pet’r’s
Mot., filed Nov. 5, 2021, at 2. Ms. McLee reports that “a record correction was requested,”
though it apparently was not granted as no corrections were provided. Id. Ms. McLee “denies
responsibility for MD’s fake assessment and documentation which disregarded [her] left arm
pain.” Id.
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and sought treatment for left arm pain. See, e.g., Exhibit 8 at pdf 1; Exhibit 3 at
pdf 1.
B. Medical Records After Vaccination
1. Medical Records from December 9, 2017 to March 27, 2018
On December 9, 2017, approximately 10 weeks after receiving the flu
vaccine, Ms. McLee sought treatment at MedExpress Ross Township Urgent Care
for left shoulder pain. CM/ECF 18-2 at pdf 4. The doctor reported limited flexion
and extension in Ms. McLee’s left shoulder due to pain. Id. Ms. McLee denied
any injury and was diagnosed with an unspecified sprain of her left shoulder joint
and prescribed prednisone. Id. at pdf 6. The medical records from this visit
indicate that Ms. McLee was experiencing “L shoulder pain x 1 month” that was
aggravated due to frequent typing at work. Id. at pdf 4. This history implies that
Ms. McLee’s shoulder pain began around November 9, 2017.
On December 13, 2017, Ms. McLee visited the UPMC emergency room.
Exhibit 3 at pdf 1; CM/ECF 17 at pdf 14. The medical records indicate her
primary complaint was a “one month history of left arm pain accompanied by
intermittent episodes of numbness and tingling.” Exhibit 3 at pdf 1. This history
suggests the onset of pain was around November 13, 2017. Ms. McLee also stated
that she had “perceived weakness in her left hand.” Id. She denied any specific
injury and stated that her pain extended “from her trapezius along the lateral side
of her arm,” with the pain being exacerbated by any type of movement. Id. Ms.
McLee stated that she began working out with a trainer starting approximately six
weeks prior but had not done any exercises that caused the shoulder injury. Id.
She denied any trauma besides being on the computer during work. Id. at pdf 4.
She described her left arm as feeling heavy and felt a shooting pain when her left
shoulder blade, dorsal aspect of the upper left arm, and antiecubitis areas were
pressed. Id. At the time of this visit, Ms. McLee had almost finished the steroids
she was prescribed on December 9, 2017, and noted that even a high dose of the
steroid did not help her pain. Id. at pdf 1. Upon physical examination, Ms. McLee
had tenderness in her left trapezius on palpation and a slightly weaker grip on the
left side. Id. at pdf 2. Additionally, Ms. McLee experienced a significant increase
in pain on her left side while doing a shoulder shrug. Id. She was diagnosed with
intractable left cervical radicular pain and transferred to UPMC Passavant
McCandless for further evaluation and treatment. Id. at pdf 3.
3

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Later that same day, Ms. McLee was seen by another physician at the
UPMC, Dr. Amit, for a spine consultation. Exhibit 3 at pdf 7. The medical
records state that she had progressive weakness and pain in the left upper extremity
which started in the left scapula, went across the neck and over both biceps and
triceps, with numbness in all 5 fingers on the left “over the last 1 ½ months.” Id.
This history implies that the onset of Ms. McLee’s pain would have been around
late October 2017. Ms. McLee denied symptoms in her right upper extremity. Id.
Upon musculoskeletal examination, Ms. McLee could not abduct more than 15
degrees on the left upper extremity. Id. at pdf 8. Because Ms. McLee’s condition
had not improved with oral prednisone or IV solumedrol, Dr. Amit prescribed
Robaxin for pain control. Id. at pdf 10.
On December 14, 2017, Ms. McLee reported back to the University of
Pittsburgh Medical Center with worsening pain with range of motion of the left
arm. Exhibit 3 at pdf 25. Ms. McLee was tender to palpation of the left trapezius
area and had occasional tingling and numbness in her left arm. Id.
The next day, on December 15, 2017, Ms. McLee was ordered to undergo a
brain MRI exam with and without contrast. Exhibit 3 at pdf 13. The purpose of
the exam was to rule out a stroke. Id. The impression was no acute intracranial
abnormality, meaning no acute stroke. Id. That same day, Ms. McLee told Dr.
Shtrahman, a neurologist, that she was feeling better. Id. at pdf 23. Dr. Shtrahman
diagnosed Ms. McLee with “[l]eft upper extremity pain and ‘weakness’” and noted
that the workup thus far had been unremarkable. Id. For next steps, Dr.
Shtrahman recommended an EMG and nerve conduction studies. Id. Ms. McLee
was stable for discharge. Id.
Ms. McLee saw Dr. Farrell again on January 3, 2018. Exhibit 5 at pdf 25.
The medical records show that she informed him that weakness in her left arm
“ha[d] been developing slowly since October” of 2017. Id. At the time of this
visit, Ms. McLee had no symptoms on her right side or neck. Id. Dr. Farrell noted
that there was no acute trauma or injury. Id. Ms. McLee’s left side presented with
tenderness in the left trapezius ridge and her range of motion on the left shoulder
was restricted. Id. Dr. Farrell indicated that Ms. McLee had impingement
syndrome of the left shoulder. Id. He noted that her grip strength on the left side
was maybe just a little weaker, especially considering that Ms. McLee is left-
handed. Id. Dr. Farrell referred her to an orthopedist to give her a prescription for
physical therapy. Id.
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On January 16, 2018, Ms. McLee visited orthopedist Dr. Gause. CM/ECF
18-2 at pdf 18. Dr. Gause’s notes state that Ms. McLee is right-hand dominant5
and presented for evaluation of the left shoulder. Id. The records indicate that Ms.
McLee reported that the onset of her pain “2 months ago on 11/20/17 after
receiving a flu shot.” Id. The records further state that her pain was “localized
somewhat diffusely about her neck traveling into the left trapezius and
anterolateral aspect of her left shoulder.” Id. Ms. McLee reported a “constant
achy pain” as well as “numbness in her fingers” and “some decreased range of
motion and weakness.” Id.
On January 24, 2018, Ms. McLee had her first visit with physical therapist
Matthew Sennott. CM/ECF 20-8 at pdf 7. The date of onset was reported as
September 18, 2017. Id. at pdf 12. Ms. McLee stated that she had “increased
muscle pain in her l[eft] shoulder following a flu shot in September 2017.” Id.
The pain, as Ms. McLee described, progressed like a toothache. Id. Mr. Sennott
noted that Ms. McLee is left-hand dominant and worked a desk job that required a
lot of time typing and writing. Id. The next day, on January 25, 2018, Ms. McLee
had an MRI performed on her left shoulder. Id. at pdf 29. There were no
significant derangements in the left shoulder. CM/ECF 28 at pdf 35.
Ms. McLee saw Dr. Esman on January 29, 2018, for left upper extremity
pain. CM/ECF 18-2 at pdf 19-20. Dr. Esman noted that Ms. McLee was left-hand
dominant and presented with a four-month history of pain in her left upper arm,
along with tingling and numbness in her forearm and fingertips. Id. This history
suggests that the onset of pain began approximately on September 29, 2017. Ms.
McLee also believed the problem started after getting her flu shot. Id. Dr. Esman
found that Ms. McLee had diffuse mild weakness throughout the left upper
extremity. Id. Nerve studies were performed, and the nerve conduction portion
was normal and showed no evidence of carpal tunnel syndrome or ulnar
neuropathy or any evidence of impairment of sensory amplitudes as would be seen
in a brachial plexus lesion. Id.
On February 2, 2018, Ms. McLee saw Dr. Gause again. CM/ECF 18-2 at
pdf 28-29. Dr. Gause’s notes state that Ms. McLee was bothered by diffuse neck
pain traveling into her left shoulder and arm. Id. at pdf 21. Dr. Gause concluded
that at this point, he could not find an etiology for her symptoms and recommended
5 This appears to be incorrect because the medical records consistently indicate that Ms.
McLee is left-hand dominant. See, e.g., CM/ECF 18-2 at pdf 19; CM/ECF 20-8 at pdf 7; Exhibit
3 at pdf 1; Exhibit 5 at pdf 25, 27.
5

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that Ms. McLee follow up with her primary care physician. Id. at pdf 29.
Additionally, that same day, Ms. McLee had physical therapy with Matthew
Sennott. CM/ECF 20-8 at pdf 4. Mr. Sennott noted that Ms. McLee had continued
soreness in her left shoulder, which she said was so bad that it was numbing at
times. Id. Ms. McLee also said that typing all day at work had increased her
symptoms. Id. She was subsequently discharged from physical therapy on March
9, 2018, likely because she was too busy working to attend the sessions. CM/ECF
20-8 at pdf 17; Exhibit 8 at pdf 1.
On a follow up visit to Dr. Farrell on February 6, 2018, Ms. McLee
described her left shoulder pain as beginning in mid-September 2017. Exhibit 5 at
pdf 27. He noted that her pain continued in the same place and severity as the last
time he saw her. Id. Ms. McLee explained that her sleep was disturbed due to the
pain so she could not sleep on her back, and instead needed to sleep right laterally
recumbent. Id. However, the pain was not deep aching and Ms. McLee was not
noticing motor weakness. Id. He noted that she is left-handed and was working as
a clerical person checking inpatient stay at UPMC Passavant Cranberry and had
not missed work due to the pain. Id. Dr. Farrell explained that her range of motion
of the shoulder was limited in elevation extension, and that it would be helpful if
Ms. McLee could tolerate nerve conduction studies. Id. He suggested a referral to
Dr. Cheryl Bernstein for neurology and pain medicine and prescribed Cymbalta.
Id. at pdf 27-28.
On March 27, 2018, Ms. McLee visited UPMC Pain Medicine and saw Dr.
Bernstein. CM/ECF 28 at pdf 40. Ms. McLee’s chief complaints were arm and
hand pain, with an onset date reported as September 17, 2017. Id. at pdf 40, 52.
Dr. Bernstein diagnosed Ms. McLee with chronic pain syndrome and found that
there were no significant internal derangements in the left shoulder. Id. at pdf 40,
45. Ms. McLee was referred to an occupational therapist and a physical therapist,
as well as referred for a psychological evaluation for her chronic pain syndrome.
Id. at pdf 47.
2. Medical Records from April 6, 2018 to November 13, 2018
Ms. McLee had a follow up appointment with Dr. Farrell on April 6, 2018,
for chronic pain from the anterior shoulder distal to the hand with paresthesia
without diagnosis. Exhibit 5 at pdf 28-29. Dr. Farrell noted that there had been no
change in pain intensity, character, or location, or pain at new sites since he last
saw Ms. McLee. Id. Additionally, Ms. McLee’s range of motion of the shoulder
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was limited. Id. He referred her for another orthopedic opinion at Western
Pennsylvania Hand and Upper Extremity Center. Id.
On April 27, 2018, Ms. McLee was evaluated by Dr. Balk at the Hand and
Upper Extremity Center. Exhibit 8 at pdf 1. Ms. McLee’s primary complaints
were of left upper arm pain and stiffness and left-hand numbness, which she
attributed to a flu vaccine from September 2017. Id. She expressed that she had a
constant throbbing pain in her left upper arm that sometimes radiated to her neck.
Id. Dr. Balk noted that Ms. McLee was prescribed physical therapy but could not
attend because of a busy work schedule. Id. He recommended more physical
therapy as well as a cortisone injection, which Ms. McLee declined. Id. at pdf 3.
Additionally, Dr. Balk expressed the importance of a nerve conduction study for
Ms. McLee’s complaints of hand numbness. Id.
On May 8, 2018, Ms. McLee again visited Dr. Bernstein for arm and hand
pain. CM/ECF 28 at pdf 30. Ms. McLee was scheduled for a repeat EMG/NCS of
the left upper extremity because she could not tolerate the EMG the first time. Id.
Ms. McLee had not had much relief from her pain, mostly because she could not
attend physical therapy appointments due to her work schedule. Id. On physical
examination, Ms. McLee could not actively get past 45 degrees abduction on the
left side. Id. at pdf 34. Dr. Bernstein suggested that Ms. McLee consider a
shoulder injection, suprascapular nerve block, to improve her range of motion
without pain. Id. at pdf 36.
Ms. McLee revisited Matthew Sennott on May 10, 2018, for physical
therapy for chronic left shoulder pain. CM/ECF 20-9 at pdf 23. He noted that she
was experiencing difficulty with activities of daily living, including active shoulder
motion, dressing, and driving. Id. at pdf 28. Additionally, Ms. McLee had been
having trouble with work duties, including keyboarding, writing, and using the
phone. Id. On May 15, 2018, she returned to physical therapy and reported that
she had continued pain and was having trouble sleeping because she was unable to
find a comfortable position. Id. Ms. McLee did not tolerate the session well, and
reported increased pain with any motion at or about 90 degrees. Id. at pdf 42-43.
Ms. McLee had another session with Mr. Sennott on May 17, 2018, and reported
continued soreness and intermittently completing her home exercise program. Id.
at pdf 48. She had good tolerance to this session and completed progressions with
minimal soreness. Id. She reported for a final session on May 24, 2018, and was
subsequently discharged with a recommendation for an independent home
program. Id. at pdf 54-56.
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On August 13, 2018, Ms. McLee visited the emergency room due to
abdominal pain, nausea, and diarrhea. CM/ECF 17 at pdf 7. Additionally, Ms.
McLee noted she had chronic left arm pain for the last year since her flu shot but
had seen a specialist and was taking ibuprofen to manage the pain. Id. The doctor
also noted blood in her urine, which he treated as a urinary tract infection and
recommended she see a urologist in two weeks if the bleeding in her urine did not
subside. Id. at pdf 8. Ms. McLee was formally diagnosed with abdominal pain,
hematuria with concern for urinary tract infection, and elevated systolic blood
pressure without a history of hypertension. Id.
The next day, on August 14, 2018, Ms. McLee had a follow up visit with Dr.
Farrell. Exhibit 5 at pdf 29. He explained to her that her pain seemed like a
chronic problem and that they needed to work to try to suppress her pain. Id. at pdf
30. The medical records reflect that Ms. McLee thought her left arm was getting
weaker. Id. She noted that she had exercises that she learned from physical
therapy, but Dr. Farrell mentioned that he did not think she was doing the exercises
regularly. Id. He raised her dosage of Cymbalta and recommended she revisit Dr.
Bernstein to discuss the possibility of a nerve block. Id.
On November 23, 2018, Ms. McLee returned to Dr. Bernstein for continued
left arm pain. CM/ECF 28 at pdf 22, 26. She reported pain in her “left neck,
shoulder, and arm,” and reported that her “fingers are always numb” and “bicep is
a constant toothache.” Id. at pdf 23. Ms. McLee was to undergo a repeat EMG,
but she stated that she did not want to do so despite having continued numbness
and tingling. Id. at pdf 22, 26. Further, the records reflect that Ms. McLee did not
believe the Cymbalta was improving her pain. Id. The attending noted
neuropathic pain and recommended that Ms. McLee increase her dosage of
Cymbalta and consider nortriptyline. Id. at pdf 26.
3. Medical Records from February 19, 2019 to April 2, 2021
Ms. McLee reported for a radiology consultation on February 19, 2019, for
congestion, productive cough, and body aches for ten days. CM/ECF 28 at pdf 8.
She received a chest x-ray and was diagnosed with bronchitis. Id.; CM/ECF 18-2
at pdf 3. She was prescribed benzonatate, prednisone, ventolin, and an inhaler.
CM/ECF 18-2 at pdf 3.
On August 13, 2019, Ms. McLee went to MedExpress because of swelling in
her right shoulder after a flu shot two years ago. CM/ECF 18-2 at pdf 10. She
reported tingling and numbness, and stated she had been careful with it since. She
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also reported pain around the scapula. Id. She was diagnosed with a sprain of the
ligaments of the thoracic spine and was prescribed prednisone and
cyclobenzaprine. Id. at pdf 11.
No other relevant medical records have been filed.6
C. Affidavits7
Ms. McLee completed an onset affidavit, which was initially filed on March
30, 2022. CM/ECF 53-2 (Onset Aff.). Ms. McLee claims that her left shoulder
pain began immediately “upon needle stick” and describes the pain as “shocking,
continuous, [and] expansive.” Id. at pdf 2. She states that the part of her shoulder
that was affected was “the injection site area and beyond.” Id. She claims that she
could not lift her arm above her shoulder and felt like her arm was paralyzed. Id.
Ms. McLee claims that during her appointment on September 27, 2017, she
“immediately” informed the nurse who administered the vaccine, Kala Cinker, that
she was experiencing shoulder pain. Id. Additionally, Ms. McLee states that she
had difficulty sleeping later that night due to constant repositioning in her bed,
which she needed help doing. Id. She represents that her full left shoulder area
was affected, and she could not lift her arm above her shoulder. Id.
Ms. McLee also disputes the accuracy of certain medical records which state
the onset of her pain. The medical records from December 9, 2017 state that Ms.
McLee had been experiencing left arm pain for one month, and additional medical
records from December 13, 2017 state that Ms. McLee had been experiencing left
arm pain for the past one-and-a-half months; however, Ms. McLee denies this and
maintains that her entire arm was in pain since September 27, 2017. Id. at pdf 3-4.
6 Ms. McLee filed additional materials in CM/ECF 42, including records regarding a
cataract surgery on October 6, 2017; COVID vaccination records; records from visits to the UPP
Department of Dermatology and Specialists in Plastic Surgery of Pittsburgh regarding a mass in
Ms. McLee’s upper right arm; and records from UPMC Heart and Vascular Institute. However,
CM/ECF 42 was stricken from the record because it contained multiple filings which were not
properly labeled as exhibits. Ms. McLee was ordered to individually refile documents in this
filing with clear exhibit headings, but did not do so. See Order, issued Aug. 19, 2022.
7 Affidavits from Ms. McLee’s children, Hannah Avva and Bradley McLee Jr., were filed
on March 30, 2022 with CM/ECF 42, but were never resubmitted after this filing was stricken
from the record. Bradley McLee Jr. stated that he spoke to Ms. McLee the day of her September
27, 2017 vaccination, and Hannah Avva stated that she spoke with Ms. McLee a few days after.
Both stated that she told them her pain began immediately.
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Similarly, medical records from January 3, 2018, state that Ms. McLee’s pain had
been developing since October 2017, which she denies saying. Id. Finally, Ms.
McLee disputes the medical record from January 16, 2018, which states that she
had been experiencing left arm pain since November 20, 2017. Id. at pdf 5.
In an affidavit by Ms. McLee’s husband, Bradley McLee Sr., submitted
February 3, 2023, Mr. McLee alleges that the medical records are “erroneous” due
to “mistakes or lies” on the part of healthcare providers. CM/ECF 53-1 at pdf 2.
Specifically, Mr. McLee states that the records showed the “wrong arm”, and that
“[r]eports of non-injury, right arm, later onset of pain, PCP notes, etc. are
preposterous.” Id. at pdf 3. He also describes Ms. McLee’s “pain, loss of motion,
[and] weariness.” Id.
II. Procedural History
The procedural history of Ms. McLee’s case is detailed in the ruling
dismissing the Table claim. See Ruling, issued May 10, 2023, 2023 WL 3750615.
Thus, this history is provided summarily.
Ms. McLee first filed her petition on September 28, 2020, alleging “injuries,
including Guillain Barre Syndrome” and a shoulder injury related to vaccine
administration (“SIRVA”). On March 3, 2021, Ms. McLee filed an amended
petition, again alleging “injuries, including Guillain Barre Syndrome” and
“SIRVA.”8
On November 5, 2021, Ms. McLee moved for summary judgment,
requesting compensation for her alleged SIRVA. The Secretary opposed Ms.
McLee’s motion, arguing that Ms. McLee had neither proven SIRVA nor that her
alleged injury was caused-in-fact by the vaccination. Resp’t’s Rep., filed Nov. 19,
2021 at 17. The Secretary also moved to dismiss the case, raising, inter alia, an
issue of statute of limitations. Id. at 14 n.10. Ms. McLee did not file a response to
the Secretary’s motion. The undersigned issued an order instructing both parties to
file a status report on whether a hearing would be appropriate. Order, issued July
26, 2022. The Secretary stated that a hearing was not appropriate in this case.
Resp’t’s Status Rep., filed Sept. 1, 2022. Ms. McLee did not submit a filing
regarding her position on whether a hearing was appropriate.
8 Although Ms. McLee alleged she suffered from Guillain-Barré syndrome, medical
records do not persuasively show that she suffered from Guillain-Barré syndrome.
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During a status conference, Ms. McLee questioned the accuracy of the
medical records and mentioned that she received the COVID-19 vaccine.
Subsequently, Ms. McLee was ordered to complete an onset affidavit and to file
her COVID-19 vaccination record by February 25, 2022. Order, issued Jan. 26,
2022. After being granted an extension of time, Ms. McLee filed the additional
requested medical records on March 30, 2022. CM/ECF 42. This filing was later
stricken for failure to appropriately label the records as exhibits. See Order, issued
Apr. 11, 2022; Pet’r’s Exhibit List, filed May 9, 2022; Order, issued Aug. 19,
2022. Ms. McLee was ordered to refile the non-duplicative exhibits from CM/ECF
42 individually and instructed that she may file an affidavit from her husband
describing his observations of her vaccination by November 17, 2022. Id.
Ms. McLee did not file an affidavit by the deadline, nor did she refile the
exhibits specified in the August 19, 2022 order. It appeared that Ms. McLee had
attempted to communicate with a person whose employment within the Office of
Special Masters had ended, and so the undersigned, sua sponte, extended the
deadline for the exhibits and affidavit to January 26, 2023. Order, issued Dec. 28,
2022. Ms. McLee contacted chambers and the undersigned’s law clerk the week of
the deadline to inform of an intent to file these materials, but did not file anything.
Ms. McLee also did not file a status report detailing why she failed to file these
materials. The undersigned, sua sponte, extended the deadline to February 3, 2023,
reminding Ms. McLee to file through the CM/ECF system. Order, issued Jan. 27,
2023. On February 3, 2023, Ms. McLee filed an affidavit from her husband, and
refiled her affidavit about the onset of her symptoms. CM/ECF 53-1, 53-2. She did
not refile the non-duplicative materials from CM/ECF 42.
The undersigned issued a ruling dismissing Ms. McLee's on-Table claim for
unpersuasive evidence. Ruling, issued May 10, 2023, 2023 WL 3750615. The
undersigned determined that Ms. McLee established one element of a SIRVA
claim---that she had no history of shoulder pain prior to vaccination. However,
Ms. McLee’s proof on other elements was lacking. For instance, the records
created closest in time to Ms. McLee’s vaccination did not support her claim that
her shoulder pain began within 48 hours. Instead, the onset was in early November
2017. Additionally, although Ms. McLee recalled receiving the vaccine in her left
shoulder, the record supported a finding that she received the vaccine in her right
shoulder. Finally, even if the vaccine had been administered in Ms. McLee’s left
shoulder, her pain and reduced range of motion were not limited to this shoulder;
the medical records and Ms. McLee’s own statements consistently described her
pain as extending to her hand, fingers, and neck. Thus, Ms. McLee’s injury did not
meet the SIRVA criteria, and her on-Table SIRVA claim was dismissed.
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However, although Ms. McLee predominantly referenced SIRVA in her
filings, she might prevail upon other claims. The undersigned determined that Ms.
McLee had alleged off-Table shoulder injuries, and could pursue an off-Table
claim. Ms. McLee was ordered to file a status report within 60 days (by July 12,
2023) through CM/ECF confirming that she had retained an expert. The
undersigned stated that, if Ms. McLee did not comply with this order, her off-Table
claim would be dismissed.
Ms. McLee has not filed anything since the ruling was issued. Ms. McLee
appears to have attempted to email a “complaint” about the undersigned and an
“appeal of his decision” to the Secretary’s counsel on June 26, 2023. However, no
documents were attached to this email. The Secretary’s counsel informed Ms.
McLee that there were no attachments and provided instructions on how to submit
pro se filings, but Ms. McLee took no further action. Ms. McLee’s husband
contacted chambers on August 11, 2023 seeking additional information on the
procedures for a complaint and review. Neither communication indicated an intent
to file additional evidence or retain an expert.
III. Analysis
Ms. McLee’s case raises two questions. First, whether her case should be
resolved presently? And, second, if so, how does the evidence preponderate?
These are taken up in turn.
A. Now is an Appropriate Time to Resolve the Case
With some assistance from her husband, who is not an attorney, Ms. McLee
has represented herself competently. She mostly complied with orders to submit
material through the CM/ECF system.
Ms. McLee has not responded to the May 10, 2023 ruling, requiring her to
submit a status report within 60 days (or by July 12, 2023) regarding an intention
to submit an expert report. As discussed below, Ms. McLee seems unlikely to
obtain a report from an expert that would assist her. Thus, extending more time on
a sua sponte basis would appear to be only delaying an inevitable conclusion. In
addition, the informal communication from Ms. McLee’s husband suggests that
Ms. McLee wants to appeal the May 10, 2023 ruling. Under these circumstances,
Ms. McLee’s off-Table claim can be adjudicated immediately.9
9 A petitioner’s failure to comply with orders can be the basis for a dismissal for failure to
prosecute. See Tsekouras v. Sec’y of Health & Human Servs., 26 Cl. Ct. 439 (1992), aff’d, 991
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B. The Evidence Does Not Preponderate in Petitioner’s Favor
As explained to Ms. McLee in the May 10, 2023 ruling, an off-Table claim
requires a petitioner to present “(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.” Althen v. Sec'y of Health &
Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). The source of this evidence
must be “medical records” or “medical opinion.” 42 U.S.C. § 300aa–13(a)(1).
Here, Ms. McLee has not presented reliable evidence in the form of medical
record or medical opinion that could carry her burden of proof on these elements.10
This lack of evidence justifies the dismissal.
In the undersigned’s “accumulated expertise,” Ms. McLee seems unlikely to
be able to present a minimally persuasive statement from an expert supporting her
claim. See Whitecotton v. Sec’y of Health & Hum. Servs., 81 F.3d 1099, 1104
(Fed. Cir. 1996). The May 10, 2023 ruling found that the onset of Ms. McLee’s
shoulder pain was approximately six weeks after her flu vaccine. A passage of this
much time makes the flu vaccine unlikely to be causal. See Greene v. Sec’y of
Health & Hum. Servs., 146 Fed. Cl. 655, 667 (2020) (determining that the special
master was not arbitrary in determining that 41 days was not a medically
appropriate interval for brachial neuritis), aff’d, 841 F. App'x 195 (Fed. Cir. 2020).
IV. Conclusion
It is clear that Ms. McLee has a loving and supportive family who want the
best for her health and wellbeing. However, Ms. McLee has not shown that the
Vaccine Program can compensate her, as she has not satisfied the elements for an
on-Table SIRVA claim, and she has not presented sufficient evidence for her off-
Table claim. Thus, this case is dismissed for lack of persuasive evidence.
F.2d 810 (Fed. Cir. 1993) (table). However, Ms. McLee’s off-Table claim is being resolved due
to a lack of persuasive evidence, not due to a procedural misstep.
10 Although Ms. McLee asserts that the flu vaccine caused her shoulder problems, a
special master cannot award compensation based upon “the claims of a petitioner alone.” 42
U.S.C. § 300aa–13(a)(1).
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The Clerk’s Office is instructed to dismiss this case and to enter judgment in
accord with this decision unless a motion for review is filed. Information about
filing a motion for review, including the deadline for any such submission, is
available through the Vaccine Rules posted on the website for the Court of Federal
Claims.
IT IS SO ORDERED.
S/Christian J. Moran
Christian J. Moran
Special Master
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