VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_22-vv-00039
Package ID: USCOURTS-cofc-1_22-vv-00039
Petitioner: Kimberly Pendleton
Filed: 2022-01-11
Decided: 2024-12-10
Vaccine: Tdap
Vaccination date: 2019-07-31
Condition: Shoulder Injury Related to Vaccine Administration (SIRVA)
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
Petitioner Kimberly Pendleton filed a petition on January 11, 2022, alleging that the Tdap vaccine she received on July 31, 2019, at age 49, caused her to suffer from an on-Table Shoulder Injury Related to Vaccine Administration (SIRVA) or, alternatively, an off-Table shoulder injury caused-in-fact by the vaccine. Ms. Pendleton's initial symptoms began approximately 24 hours after vaccination, with right arm pain radiating to her neck and scapula. Medical records from September 3, 2019, noted pain from the cervical spine to the upper right arm with limited range of motion, and an assessment of brachial neuritis. By September 17, 2019, her symptoms included right arm pain extending down to her scapula and right arm, with weakness, and an assessment of cervical radiculopathy with possible brachial plexus injury. Physical therapy evaluations described pain radiating from the base of the neck into the right upper extremity and down to the fingers, characterized as shooting, burning, tingling, and throbbing, with significant muscle guarding in the right shoulder and limited range of motion. An EMG study on October 2, 2019, showed evidence of right median neuropathy of the wrist of mild to moderate severity, with similar findings on the left. Ms. Pendleton was discharged from physical therapy on January 20, 2020. Later medical records noted recurrent right arm pain/numbness/tingling, and ongoing lower back pain. Petitioner filed an expert report from Dr. Asif M. Ilyas, an orthopedic surgeon, who opined that Ms. Pendleton had "Right shoulder impingement/bursitis, caused by 'shoulder injury related to vaccine administration'" and that her symptoms were consistent with shoulder impingement/bursitis related to vaccination. Respondent filed an expert report from Dr. Paul J. Cagle, an orthopedic surgeon, who opined that Ms. Pendleton's case was not a demonstration of SIRVA, citing the onset of pain more than a month after vaccination, pain referenced as having a neurologic origin, lack of definitive evidence of true loss of shoulder range of motion, and symptoms frequently attributed to radiculopathy and/or neck/cervical pathology. Dr. Cagle also stated there was no objective evidence of impingement syndrome and no evidence of a shoulder injury, sustained loss of shoulder motion, or structural shoulder injury. The Special Master found that Ms. Pendleton failed to establish her off-Table claim because she did not present a medical theory explaining how the Tdap vaccine could cause impingement syndrome, thus failing the first Althen prong. For her on-Table SIRVA claim, the Special Master found that the medical records consistently indicated the injury was not confined to the shoulder, citing pain radiating to the neck, scapula, and arm, and thus she failed to meet the third SIRVA criterion. Consequently, the case was dismissed for lack of persuasive evidence. Petitioner was represented by Ying Zhou, and Respondent by Emily Hanson. The decision was issued by Special Master Christian J. Moran on December 10, 2024.

Theory of causation field:
Petitioner Kimberly Pendleton alleged that a Tdap vaccine administered on July 31, 2019, caused an on-Table Shoulder Injury Related to Vaccine Administration (SIRVA) or an off-Table shoulder injury. Petitioner's expert, Dr. Asif M. Ilyas, opined that Ms. Pendleton suffered from right shoulder impingement/bursitis caused by the vaccine administration and that her symptoms were consistent with this diagnosis. Respondent's expert, Dr. Paul J. Cagle, disagreed, stating that the medical records did not support a SIRVA diagnosis due to the delayed onset of pain, the involvement of neck and neurological symptoms, and the lack of objective shoulder injury evidence. For the off-Table claim, the Special Master found that Ms. Pendleton failed to establish the first Althen prong because Dr. Ilyas did not provide a medical theory explaining how the Tdap vaccine could cause impingement syndrome. For the on-Table SIRVA claim, the Special Master found that Ms. Pendleton failed the third criterion because medical records indicated her pain extended beyond the shoulder to the neck, scapula, and arm. The case was dismissed for lack of persuasive evidence. Petitioner was represented by Ying Zhou, and Respondent by Emily Hanson. Special Master Christian J. Moran issued the decision on December 10, 2024.

Public staged source text:

================================================================================
DOCUMENT 1: USCOURTS-cofc-1_22-vv-00039-0
Date issued/filed: 2024-12-10
Pages: 14
Docket text: PUBLIC DECISION (Originally filed: 11/14/2024) regarding 53 DECISION of Special Master Signed by Special Master Christian J. Moran. (ceo) Service on parties made.
--------------------------------------------------------------------------------
Case 1:22-vv-00039-UNJ Document 54 Filed 12/10/24 Page 1 of 14
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * *
KIMBERLY PENDLETON, *
* No. 22-39V
*
Petitioner, * Special Master Christian J. Moran
*
v. * Filed: November 14, 2024
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * *
Ying Zhou, Law Office of Ying Zhou, Philadelphia, PA, for petitioner;
Emily Hanson, United States Dep’t of Justice, Washington, D.C., for respondent.
UNPUBLISHED DECISION DENYING COMPENSATION1
Kimberly Pendleton alleges that the tetanus-diphtheria-acellular-pertussis
(“Tdap”) vaccine she received on July 31, 2019, caused her to suffer from an on-
Table Shoulder Injury Related to Vaccine Administration (“SIRVA”). Am. Pet.,
filed Oct. 4, 2024, at 4. Alternatively, Ms. Pendleton claims that her shoulder
injuries were caused-in-fact by the vaccine. Id. However, Ms. Pendleton has not
presented a theory to support her allegation that the vaccine was the cause-in-fact
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 in the website.

Case 1:22-vv-00039-UNJ Document 54 Filed 12/10/24 Page 2 of 14
of her shoulder injury. Ms. Pendleton also has not established her claim alleging
an on-Table SIRVA.
I. Medical History
Ms. Pendleton was born in 1970. Exhibit 8 at 5. On July 31, 2019, when
Ms. Pendleton was 49 years old, she visited her primary care provider (“PCP”),
Norriton Family Medicine, for an annual exam. Id. at 1. Her ongoing problem list
included obesity, foot calluses, hot flashes, IBS, perimenopausal symptoms, and
tobacco use. Id. She had no acute complaints, and there is no mention in the
record of arm pain. Id. Ms. Pendleton received the Tdap vaccination. Id. at 5.
Thirty-four days later, on September 3, 2019, Ms. Pendleton returned to her
PCP with a chief complaint of left arm pain going up her neck. Exhibit 2 at 34.
(This appears to be an error, as most other records, including further notes from
this same visit, report right arm pain). She stated that, “since the day of the shot,”
she had pain that was shooting in nature from the site of injection to the top of her
shoulder in neck. She had not had any neck, shoulder, or arm issues prior to the
vaccine. Id. Dr. Aysha Jilani recorded that Ms. Pendleton had “Pain from cervical
spine to upper right arm with range of motion limited due to pain line.” Id. She
assessed Ms. Pendleton as having brachial neuritis and started her on a trial of
baclofen, steroids, and physical therapy. If Ms. Pendleton did not respond to this
treatment, Dr. Jilani planned to refer her to a physical medicine & rehabilitation
(“PMR”) specialist for an electromyography (“EMG”) study and treatment. Id. at
35.
Ms. Pendleton returned to Dr. Jilani on September 17, 2019. Exhibit 2 at 37.
Her chief complaint was right arm pain, and she reported that her arm had not “felt
right” since her vaccination six weeks prior. Id. She had not improved with
treatment, and stated that she felt worse. She had not been able to set up a physical
therapy appointment. Ms. Pendleton described the pain as going down her
shoulder to her neck, down to the right scapula, and now completely down her
right arm. She also reported weakness in her arm. Id. Dr. Jilani’s assessment was
cervical radiculopathy with a possible brachial plexus injury. She wrote that Ms.
Pendleton needed physical therapy to prevent a frozen joint, and that she should
get a PMR evaluation for a definitive diagnosis. Id. at 38. She prescribed
cyclobenzaprine and referred her to physical therapy and a PMR evaluation. Id.
2

Case 1:22-vv-00039-UNJ Document 54 Filed 12/10/24 Page 3 of 14
On September 19, 2019, Ms. Pendleton had a physical therapy evaluation.
Exhibit 2 at 56. Ms. Pendleton recounted that she did not have pain immediately
following her vaccination, but “by the next day she was having severe [right] arm
pain.” Id. The pain worsened over time, and her symptoms were worse with
movement of her right upper extremity or neck. She had taken to holding her right
upper extremity at her chest, and she avoided turning her head to drive or talk to
people. The pain began at the base of her neck and spread into her right upper
extremity and down to her fingers and down her scapula. She described the pain
as shooting, burning, tingling, and throbbing, and pain medications did not help.
Id. Ms. Pendleton reported that she had no prior issues with her right upper
extremity or neck, but was now unable to grip, lift, carry, reach, clean, do dishes,
or cook. Id. at 57. She rated her pain as an 8 out of 10. Id.
The examination found that Ms. Pendleton’s right upper extremity active
range and passive range were limited, and that there was significant muscle
guarding in her right shoulder. Exhibit 2 at 57. Her right upper extremity strength
was within functional limits. Id. at 58. The assessment stated that her presentation
was most consistent with cervical radiculopathy, although there were “no hard
neuro[logical] signs present.” Id. at 59. It was also noted that Ms. Pendleton had
impairments in her cervical range of motion and motor control, and muscle
guarding and limited neural/soft tissue mobility throughout the cervical and
thoracic spine and right upper extremity. Her rehabilitation prognosis was fair,
and it was predicted that she would benefit from skilled physical therapy with an
eventual discharge to a home exercise program. Id.
On October 2, 2019, Ms. Pendleton had an EMG on her right arm. Exhibit 5
at 367. Ms. Pendleton recounted that after her vaccine, she had increased pain in
her right arm, fever, and difficulty moving her arm. Id. It was now better, but she
still had pain into her scapula and difficulty moving her neck and shoulder. She
also reported tingling down her arm and into her fingers, migrating from her elbow
to her hand. She reported that she sometimes had throbbing pain that could last
15-20 minutes and was worse at night in her shoulder and arm. She did not have
symptoms on her left side, and she did not have previous injuries to her arm or
neck.
The EMG study was abnormal. Exhibit 5 at 367. The impression noted
evidence of right median neuropathy of the wrist of mild to moderate severity,
with similar findings on the left.
3

Case 1:22-vv-00039-UNJ Document 54 Filed 12/10/24 Page 4 of 14
After four visits, Ms. Pendleton was discharged from physical therapy on
January 20, 2020. Exhibit 4 at 323. The reason given was: “because the patient
did not return / dropped out.” The Secretary notes that this discharge was five
months and 20 days post-vaccination. Resp’t’s Rep. at 3.
Ms. Pendleton saw Dr. Abim Esrick at her PCP office on June 16, 2020 with
a primary complaint of back pain that had started three days prior. Exhibit 2b at
403. The symptoms had started after work with no particular inciting or
aggravating event. It was located in her right lower thoracic back. She described
the pain as moderate-severe intensity, constant, and aggravated by prolonged
standing, rotation, and using the stairs. Dr. Esrick assessed her as having a spasm
of the thoracic back muscle. He and advised her to continue gabapentin and
Tylenol, to do home exercises, to take time off work/return with restrictions, and to
refrain from bending, twisting, lifting weights over 20 pounds, and standing from
more than ten minutes at a time. Id. at 404.
A follow-up appointment with Dr. Esrick took place ten days later. Exhibit
2b at 408. Ms. Pendleton’s symptoms had greatly improved, but not yet fully
resolved. She could stand for longer than ten minutes, twist, and bend, but did not
think she could lift more than 20 pounds. She was taking gabapentin and Advil
but was not doing home exercises. Id. Ms. Pendleton was advised to continue her
treatments and to return to work on light duty. Id. at 409. On July 15, 2020, Ms.
Pendleton advised Dr. Mahalakshmi Srinivasan at her PCP office that her lower
back pain had resolved a week prior, and she returned to full duty at work. Id. at
413-14.
Ms. Pendleton had another appointment with her PCP on September 5, 2020.
Exhibit 2b at 418. Her chief complaint was “recurrent right arm
pain/numbness/tingling” beginning “after a vaccine.” It was noted that she
improved after a lot of physical therapy. Gabapentin helped, but she had run out.
Id. Dr. Srinivasan assessed her as having radiculopathy and right arm pain, and
referred her to physical therapy and restarted the gabapentin. Id. at 419.
Ms. Pendleton went to Moss Rehab for physical therapy on October 7, 2020.
Exhibit 4 at 324. Her history of present illness listed a one-month history of right
neck, scapular, and upper extremity pain “that began when temperatures dropped.”
Id. at 327. It was noted that she was first seen nine months prior for the same
condition “which she states began after receiving a tetanus shot.” Id. She had no
complaints during the summer, but now her pain was worse with use of her upper
4

Case 1:22-vv-00039-UNJ Document 54 Filed 12/10/24 Page 5 of 14
right extremity. It had been diagnosed as radiculopathy. The assessment found
that she had “impairments in CT mobility, CT soft tissue pain, and mild upper limb
tension.” Id. at 329.2 The plan was for her to do one session per week for three
weeks. Id. at 330.
On October 14, 2020, Ms. Pendleton had an appointment at her PCP office
with Dr. Tejaswi Venigalla to follow-up after an ER visit for back pain. She was
in significant pain after running out of cyclobenzaprine. Exhibit 2b at 424. She
had “left” arm pain from vaccination (this appears to be an error). Id. She was
ordered to continue cyclobenzaprine for her back spasm and continue gabapentin
for her arm pain, and was referred to physical therapy. Id. at 425-26.
Ms. Pendleton returned to Moss Rehab on October 21, 2020 for another
physical therapy session. Exhibit 4 at 334. She tolerated the session well but
needed cueing to minimize guarding of her upper right extremity. Id. at 336. Her
next session was on October 29, 2020. Id. at 338. She was described as doing
well, and requiring cueing to avoid compensation and shrugging. Id. at 340.
On November 12, 2020, Ms. Pendleton had another physical therapy
session. Exhibit 4 at 342. She again tolerated the session well, and was improving
her right shoulder mobility and tolerance. Id. at 344.
Ms. Pendleton went to Dr. Srinivasan on June 23, 2021 for an employment
physical. She reported that she had not worked for two years due to long hours
and flair ups of pain in her back, but she was starting a new job soon. Exhibit 2b at
427. Her right arm pain was improving with gabapentin. Id. at 429. She was
diagnosed with pain in her right arm, but there were no abnormal findings. Her
gabapentin was refilled. Id.
On October 11, 2021, Ms. Pendleton went to her PCP office and saw Dr.
Charles Cutler for low back pain. She rated it at a 7/10, and stated that it had
started two days prior. She noted that she had pain like this “every time of this
year.” It was “shocklike,” aggravated by movement, and relieved by sitting still
and taking muscle relaxant or Tylenol. Exhibit 2b at 431. Ms. Pendleton was
prescribed more gabapentin and was referred to physical therapy. Id. at 432.
2 Given the context, “CT” may be an abbreviation for “cervicothoracic.”
5

Case 1:22-vv-00039-UNJ Document 54 Filed 12/10/24 Page 6 of 14
II. Procedural History
Ms. Pendleton filed her petition on January 11, 2022, alleging that the Tdap
vaccine she received on July 31, 2019 caused her to suffer from a form of SIRVA
known as shoulder impingement syndrome. She noted that she had previously
received a Tdap vaccination in 2013 with no incident. Ms. Pendleton stated that
“started to experience severe pain from the site of injection in her right arm to the
top of her right shoulder and neck” approximately 24 hours after receiving the
vaccine in July 2019. She described the pain as shooting in nature, limiting her
right arm’s range of motion, and putting her in moderate distress.
Along with her petition, Ms. Pendleton filed a Vocational Economic
Evaluation from Gary and Katherine Young. Exhibit 6. The Youngs interviewed
Ms. Pendleton on October 7, 2021 for the evaluation. Id. at 1. The Youngs
explain that the Social Security Administration considers age, education,
occupations, and transferable skills when adjudicating disability claims. In
combination with the Social Security Administration’s standards, the Youngs
utilized the RAPEL methodology: Rehabilitation Plan, Access to the Labor
Market, Placeability, Earnings Capacity, and Labor Force Participation. Id. at 1-2.
The Youngs reviewed Ms. Pendleton’s medical history, noting that she had
severe right arm pain following a tetanus shot, and stated that she was diagnosed
with “a shoulder impingement injury.” Exhibit 6 at 3. They opined that Ms.
Pendleton’s restrictions are permanent. Id. at 13. They noted that she was
working towards furthering her education and becoming a Licensed Practical
Nurse and then a Registered Nurse. However, the Youngs stated that she does not
have enough stamina for a full day of work, and that she has lost dexterity in her
right hand. These interfere with her aspirations. Id. The Youngs estimated past
and future wage loss between $239,219 and $787,418. Id. at 19.
The case remained pending in the Special Processing Unit (“SPU”) as the
parties entered into litigative risk settlement discussions. See Resp’t’s Status Rep.,
filed Sept. 19, 2023. After the parties reached an impasse in their settlement
negotiations, the Secretary filed his Rule 4(c) Report on January 17, 2024. The
Secretary argued that compensation should be denied, as Ms. Pendleton’s pain and
reduced range of motion were not limited to her right shoulder, and therefore she
did not satisfy the third requirement of the Qualifications and Aids to
Interpretation. Resp’t’s Rep. at 6-7. Additionally, the Secretary argued that Ms.
Pendleton did not meet the six-month severity requirement, as she did not report
any pain for ten months. Id. at 7.
6

Case 1:22-vv-00039-UNJ Document 54 Filed 12/10/24 Page 7 of 14
After reviewing the Secretary’s assessment, the Chief Special Master
commented:
Petitioner may be successful in establishing the six-month sequela
needed to satisfy the Vaccine Act’s severity requirement. More
problematic is the conflicting evidence regarding the nature and cause
of Petitioner’s symptoms, and I agree expert reports will likely be
needed in this case to pursue either a Table or causation-in-fact SIRVA.
Order, issued March 22, 2024. The Chief Special Master further noted that there
was “some evidence supporting a potential brachial neuritis Table injury,” but that
“substantial deficiencies” would need to be addressed, specifically the too-soon
onset and the lack of EMG evidence. Additionally, Ms. Pendleton maintained that
the brachial neuritis diagnosis was incorrect, and expressed no desire to pursue this
claim. Id. The Chief Special Master authorized Ms. Pendleton to retain an expert,
and the case was transferred out of SPU and reassigned to the undersigned. Id.
Ms. Pendleton filed an expert report from Dr. Asif M. Ilyas, a board-
certified orthopedic surgeon who is also certified in hand surgery. Exhibit 11 at 5.
Dr. Ilyas examined Ms. Pendleton and had the impression that she had “Right
shoulder impingement/bursitis, caused by ‘shoulder injury related to vaccine
administration.’” Id. at 4. He based this on a review of her history and medical
records, an evaluation of diagnostic studies, and on his own examination. Id. He
stated that her shoulder pain had “continued unimproved since the date of
vaccination.” Id. at 5.
The undersigned then issued a template affidavit regarding onset, which Ms.
Pendleton completed and filed on June 21, 2024. Exhibit 12. On July 22, 2024,
the Secretary filed an expert report from Dr. Paul J. Cagle, a board-certified
orthopedic surgeon with training in shoulder surgery. Exhibit A at 1.
Dr. Cagle opined that Ms. Pendleton’s case was not a demonstration of
SIRVA, stating that she did not meet the Table criteria. First, he noted that the
first evidence of shoulder pain was dated more than a month after the vaccination
and does not state that pain occurred within 48 hours. This record also references
pain in the neck with concern for a neurologic origin rather than a shoulder origin.
Exhibit A at 4. Next, Dr. Cagle stated that “there is a lack of definitive evidence
demonstrating a true loss of range of motion in the shoulder.” Id. at 5. Dr. Cagle
7

Case 1:22-vv-00039-UNJ Document 54 Filed 12/10/24 Page 8 of 14
also highlighted that Ms. Pendleton’s symptoms were frequently attributed to
radiculopathy and/or neck/cervical pathology, and that there was no attempt to
separate the shoulder from the neck symptoms. Id. Finally, Dr. Cagle saw no
evidence of an objective shoulder injury to constitute a SIRVA, noting that there
was no shoulder-specific examination or treatment. Id.
Dr. Cagle next addressed the Youngs’ vocational report. He disagreed with
their use of the term “impingement injury,” stating that the correct diagnostic term
is “impingement syndrome.” Exhibit A at 5. He saw no objective evidence of
impingement syndrome in the medical history, and believed it was unsupported.
Id. at 5-6. He agreed with the Youngs about several diagnoses—allergic rhinitis,
alopecia, elevated blood pressure, irritable bowel syndrome, low back pain,
radiculopathy, and radiculopathy of arm—but noted that these are evidence of pain
outside of the shoulder. Id. at 6. Dr. Cagle stated that he was “unaware of any
scientific reference that supports impingement syndrome being a permanent
condition,” even as he has treated thousands of patients with the diagnosis. He
saw no support for the Youngs’ statement that hand dexterity was a reason for the
limitations. Id.
Dr. Cagle noted that the first record mentioning the “impingement
syndrome” was in the October 2, 2019 EMG report, which he stated was “a very
strange place to make a diagnosis.” Exhibit A at 6. He opined that the
“impingement syndrome” came into the record after an EMG was performed when
the treating provider “wanted to suggest that the EMG was not positive for a
brachial plexus/nerve injury, and that perhaps an inflammatory pathology, such as
impingement syndrome was possible.” Id. at 6-7. The diagnosis was then
propagated through the rest of the medical records.
Finally, Dr. Cagle addressed Dr. Ilyas’s report. Dr. Cagle stated that there
was a lack of evidence to support the diagnosis of right shoulder
impingement/bursitis, as it would be very unusual for such to last for years given
that it is a treatable condition. Exhibit A at 7. He also noted that Dr. Ilyas did not
explain the “new-found change in shoulder range of motion” despite there being a
full range of motion in numerous records post-vaccination. Dr. Ilyas also did not
advance a literature-supported viable mechanism to explain how the vaccine could
have caused these symptoms for five years. Id. Dr. Cagle concluded that this is
not a demonstration of SIRVA; there is no evidence of a shoulder injury; there is
no evidence of sustained loss of shoulder motion; and there is no evidence of a
structural shoulder injury. Id. at 8.
8

Case 1:22-vv-00039-UNJ Document 54 Filed 12/10/24 Page 9 of 14
A status conference was held on August 5, 2024 to discuss the parties’
reports. Ms. Pendleton requested the opportunity to have Dr. Ilyas to file a rebuttal
report. The undersigned advised that this would be the last opportunity for Dr.
Ilyas to present a theory on causation-in-fact, and failure to do so would mean that
Ms. Pendleton could only proceed on a SIRVA claim. Order, issued Aug. 5, 2024.
The undersigned noted that Dr. Ilyas had examined Ms. Pendleton, and asked if the
Secretary wanted Dr. Cagle to examine her as well. The Secretary stated that he
was not requesting this at the time. Id.
Ms. Pendleton submitted Dr. Ilyas’s second report on October 4, 2024.
Exhibit 20. The majority of the report responds to Dr. Cagle’s report. Dr. Ilyas
reaffirmed his diagnosis and opinion. He stated that the records show that Ms.
Pendleton reported pain “since the day of the shot”. Id. at 1 (citing records from
September 3, 2019). Dr. Ilyas strongly disagreed with Dr. Cagle’s statement that
there was concern for a neurologic origin of the pain rather than a shoulder origin.
Id. at 2. He noted that the primary care physician who diagnosed Ms. Pendleton
with brachial neuritis was not an orthopedist. Furthermore, Dr. Ilyas explained
that brachial neuritis is the product of trauma to the arm or an inflammatory
process, and results in a combination of pain, numbness extending into the hand,
and isolated areas of muscular weakness. Dr. Ilyas opined that her symptomology
was inconsistent with brachial neuritis, but consistent with shoulder
impingement/bursitis related to vaccination. Id.
Dr. Ilyas also disagreed with Dr. Cagle’s opinion that there is no definitive
evidence of a true loss of range of motion in Ms. Pendleton’s shoulder. Exhibit 20
at 2. He disputed that the records indicate she ever regained a full range of motion.
He also opined that the treaters “were erroneously pursuing a neurological cause”
of the symptoms and that there was never evidence of a nerve injury. Id. at 3.
Rather, he stated that Ms. Pendleton’s reports of shoulder pain were consistent.
Dr. Ilyas maintained his diagnosis of vaccine-related shoulder
impingement/bursitis based on his exam and findings of a sore shoulder, decreased
active range of motion, positive Hawkin’s sign, and positive Neer sign. Exhibit 20
at 3. He also cited findings indicative of no radiculopathy, including lack of
numbness in the hand and arm, full range of motion in the neck, 5/5 strength in all
nerve distributions below the shoulder, and no radiation or pain distally. Id. He
affirmed that there was evidence of “impingement syndrome,” i.e., his own
examination and the lack of evidence of a neurologic problem. Id.
9

Case 1:22-vv-00039-UNJ Document 54 Filed 12/10/24 Page 10 of 14
Dr. Ilyas contested Dr. Cagle’s reliance on the medical history provided by
the Youngs, who are not medical doctors but vocational experts. Exhibit 20 at 3.
He also opined that the diagnoses were inconsistent with the complaints of
shoulder pain, and furthermore, contended that their vocational analysis “had
nothing to do with [Ms. Pendleton’s] medical diagnosis and/or injury causality.”
As to Dr. Cagle’s contention that should impingement syndrome is not
permanent, Dr. Ilyas conceded that it is reversable when treated, but noted that Ms.
Pendleton’s injury was never formally treated by an orthopedist. Exhibit 20 at 4.
He agreed that shoulder impingement syndrome does not directly impede dexterity,
but “it can cause generalized upper extremity dysfunction limiting work ability.”
Id.
Dr. Ilyas also disagreed that the EMG being used to diagnose shoulder
impingement syndrome would be “strange.” Exhibit 20 at 4. The neurologist who
mentioned the possibility would be qualified to opine on such.
Finally, Dr. Ilyas defended against Dr. Cagle’s critiques of his first report,
again citing his own examination as evidence of her shoulder
impingement/bursitis; pointing to the lack of treatment to explain the duration of
the symptoms; disputing that the records demonstrate a return to full range of
motion; and citing to two articles, which were not filed.3
Notably absent from Dr. Ilyas’s second report was an explanation of a theory
by which the Tdap vaccine could cause an impingement injury. In his conclusion,
he stated that Ms. Pendleton’s “injuries do satisfy the Althen prongs for an off-
table injury.” Exhibit 20 at 5. He stated summarily:
Althen Prong 1: A medical theory causally connecting the vaccine
and injury. The diagnosis of impingement syndrome is casually
connected to the Tdap vaccination of July 31, 2019.
3 C.T. Wood and A.M. Ilyas, Shoulder Injury Related to Vaccine Administration: Diagnosis and
Management, 4 J. Hand Surg. Glob. Online 111 (2022).
A.K. Harrison and E.L. Flatow, Subacromial impingement syndrome, 19 J. Am. Acad. Orthop.
Surg. 701 (2011).
10

Case 1:22-vv-00039-UNJ Document 54 Filed 12/10/24 Page 11 of 14
Althen Prong 2: A logical sequence of cause and effect showing the
vaccine was the reason for the injury. The clinical data I reviewed
showed clear evidence of the onset of Ms. Pendleton’s right shoulder
complaints and symptoms triggered by the Tdap vaccine of July 31,
2019.
Althen Prong 3: A showing proximate temporal relationship
between the vaccination and the injury. The record does reflect Ms.
Pendleton’s complaints of pain and discomfort in the area of the vaccine
injection in the required temporal period.
Id. at 5-6. Despite the lack of a specific theory, Ms. Pendleton amended her
petition to add a claim “for cause-in-fact shoulder injuries resulting from the
subject vaccine.” Am. Pet., filed Oct. 1, 2024.
III. Standards for Adjudication
A petitioner is required to establish her case by a preponderance of the
evidence. 42 U.S.C. § 300aa–13(1)(a). 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). Proof of
medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931
F.2d 867, 873 (Fed. Cir. 1991).
Distinguishing between “preponderant evidence” and “medical certainty” is
important because a special master should not impose an evidentiary burden that is
too high. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed.
Cir. 2009) (reversing special master's decision that petitioners were not entitled to
compensation); see also Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357
(Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed.
Cir. 1993) (disagreeing with dissenting judge's contention that the special master
confused preponderance of the evidence with medical certainty).
IV. Discussion
To receive compensation under the National Vaccine Injury Compensation
Program, petitioner must prove either (1) that she suffered a “Table Injury”—i.e.,
11

Case 1:22-vv-00039-UNJ Document 54 Filed 12/10/24 Page 12 of 14
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. Pendleton
asserts both an on-Table injury via her SIRVA claim and an off-Table shoulder
injury caused in fact by the vaccine. Am. Pet., filed Oct. 1, 2024.
A. Off-Table Claim
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).
Under the first Althen prong, a petitioner must set forth a reliable theory to
explain how a particular vaccine can cause the alleged injury; scientific certainty is
not required. Althen, 418 F.3d at 1279-80. However, petitioners must propose a
theory or mechanism, supported by a sound and reliable medical or scientific
explanation. Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed.
Cir. 1994).
Here, although Dr. Ilyas’s report summarily states that Ms. Pendleton’s
impingement syndrome “is casually connected” to her Tdap vaccination, there is
no attempt to explain how the flu vaccine would be capable of causing the injury.
The Vaccine Act does not permit a petitioner to prevail based on her claims alone,
“unsubstantiated by medical records or by medical opinion.” 42 U.S.C. § 300aa–
13(a)(1). Neither Dr. Ilyas nor the medical records explain how the vaccine could
have caused Ms. Pendleton’s impingement syndrome. Thus, Ms. Pendleton cannot
satisfy the first Althen prong. See Talbert v. Sec’y of Health & Hum. Servs., No.
18-699V, 2024 WL 1675338, at *19 (Fed. Cl. Spec. Mstr. Apr. 3, 2024).
Without a showing on each Althen element, a petitioner cannot receive
compensation; thus, when a petitioner fails to establish one Althen prong,
additional analysis is not required. Moreover, Ms. Pendleton has not set forth a
theory against which to compare the facts of her case and determine if the Tdap
vaccine actually did cause her injury. Nor is there a theory against which to
evaluate whether the onset occurred within an appropriate timeframe. As with the
first prong, Dr. Ilyas makes conclusory statements that there is “clear evidence”
12

Case 1:22-vv-00039-UNJ Document 54 Filed 12/10/24 Page 13 of 14
that the Tdap vaccine “triggered” her symptoms, and that there was an onset “in
the required temporal timeframe,” but he does not elaborate. Exhibit 20 at 5-6. In
the absence of a theory, Ms. Pendleton’s claim fails under the remaining Althen
prongs as well. Ms. Pendleton’s off-Table claim is therefore dismissed.
B. On-Table SIRVA Claim
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(c)(10)(i)-(iv).
Ms. Pendleton has had sufficient notice of potential issues with her on-Table
SIRVA claim. The Secretary argued in his Rule 4(c) Report that she did not meet
the criteria for SIRVA. Resp’t’s Rep. at 5-7. Likewise, in the Order transferring
the case out of SPU, the Chief Special Master commented that Ms. Pendleton
would likely have trouble meeting the third criterion.
While Dr. Ilyas discusses Ms. Pendleton’s range of motion in her shoulder,
he does not discuss whether the injury is confined to the shoulder. The medical
records, however, consistently indicate that the injury was not confined to Ms.
Pendleton’s shoulder. See, e.g., Exhibit 2 at 37 (pain described as going down her
shoulder to her neck, down to the right scapula, and completely down the right
arm); id. at 56 (physical therapy record of pain radiating from the base of the neck
into the scapula and fingers); Exhibit 4 at 324 (history of right neck, scapular, and
upper extremity pain); Exhibit 5 at 1 (difficulty moving neck and shoulders, pain
into scapula, and tingling from right elbow into fingers); id. at 367 (pain into
scapula and tingling migrating from elbow to fingers).
These medical records, which memorialize Ms. Pendleton’s
contemporaneous problems, are presumptively accurate. Cucuras v. Sec’y of
Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). The Youngs’ report
also discusses neck pain and a loss of dexterity in Ms. Pendleton’s right hand.
Exhibit 6 at 3, 6. Although given an opportunity through the submission of reports
from Dr. Ilyas, Ms. Pendleton has not presented a persuasive basis for finding that
her pain was limited to her shoulder. Therefore, she cannot establish that she
fulfills the regulatory definition for SIRVA. See Scott v. Sec’y of Health & Hum.
Servs., No. 20-1982V, 2024 WL 4544335, at *19-20 (Fed. Cl. Spec. Mstr. Sep. 25,
13

Case 1:22-vv-00039-UNJ Document 54 Filed 12/10/24 Page 14 of 14
2024) (the presence of neck pain / cervical radiculopathy precludes a petitioner
from satisfying the third SIRVA criterion).
Accordingly, Ms. Pendleton is not entitled to compensation for her on-Table
claim. (Given this finding regarding the third criterion, evaluating the fourth
criterion is not required. It is also not required to assess whether any shoulder
injury lasted longer than six months).
V. Conclusion
Ms. Pendleton merits admiration for her perseverance through her difficult
course of pain. However, Ms. Pendleton has not shown that the Vaccine Program
can compensate her, as she has not presented sufficient evidence for her off-Table
claim, nor has she satisfied the elements for an on-Table SIRVA claim. Thus, the
case is dismissed for lack of persuasive evidence.
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
14