Nicholson v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 17-1416V

Filed: September 22, 2022

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JULIE NICHOLSON, *

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* TO BE PUBLISHED

Petitioner, *

*

v. *

* Influenza (“flu”) Vaccine; Shoulder Injury

* Related to Vaccine Administration

SECRETARY OF HEALTH AND * (“SIRVA”); Dismissal Decision

HUMAN SERVICES, *

*

*

Respondent. *

*

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Isiah R. Kalinowski, Maglio Christopher & Toale, Seattle, WA, for Petitioner

Debra A. Filteau Begley, U.S. Department of Justice, Washington, DC, for Respondent

DECISION ON ENTITLEMENT 1

Oler, Special Master:

On October 3, 2017, Petitioner Julie Nicholson filed a petition for compensation under the

National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq. 2 (the “Vaccine

Act” or “Program”) alleging that she suffered from a Shoulder Injury Related to Vaccine

Administration (“SIRVA”) as a result of the influenza (“flu”) vaccine she received on October 3,

2016. Pet. at 2, ECF No. 1.

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This Decision will be posted on the United States Court of Federal Claims’ website, in accordance with

the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Decision will be available to

anyone with access to the internet. As provided in 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties

may object to the Decision’s inclusion of certain kinds of confidential information. To do so, each party

may, within 14 days, request redaction “of any information furnished by that party: (1) that is a trade secret

or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files

or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.”

Vaccine Rule 18(b). Otherwise, this Decision will be available to the public in its present form. Id.

2

National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease

of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa

(2012).

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Upon review of the evidence in this case, I find that Petitioner has failed to preponderantly

demonstrate that the vaccine she received caused her condition. The petition is accordingly

dismissed.

I. Procedural History

Petitioner filed her petition on October 3, 2017. Pet. at 1. She filed medical records in

support of her claim on October 5, 2017 (Exs. 1-10), and an affidavit on December 26, 2017. ECF

Nos. 7, 8, 11. Respondent then filed his Rule 4 Report on October 2, 2018, recommending that

entitlement be denied. Resp’t’s Rep. at 1; ECF No. 22.

Petitioner filed a second affidavit (Ex. 12) and additional medical records on February 7,

2019 (Ex. 13). ECF No. 25.

I held a status conference February 28, 2019, where I asked the parties whether a ruling

addressing the issue of onset of Petitioner’s symptoms would help to move the case forward.

Respondent indicated that it would not, since Respondent believed there were several issues

besides onset with Petitioner’s case. ECF No. 26 at 1. I asked Petitioner’s counsel if any additional

objective evidence existed that may assist in pinpointing the date of onset. Specifically, I asked

whether Petitioner had confirmed that there was no record of the phone call she allegedly made to

her doctor the day after her flu vaccination. Petitioner’s counsel stated that he would search for a

record of that phone call, or any additional evidence that may clarify the date of onset. Id. at 2.

ECF No. 26.

Petitioner filed a third affidavit (Ex. 14) and additional medical records on April 15, 2019

(Exs. 15-18).

Petitioner filed an expert report from Dr. Naveed Natanzi (Ex. 20) along with supporting

medical literature on February 20, 2020. Exs. 21-41. Respondent filed a responsive expert report

from Dr. Geoffrey Abrams (Ex. A) and supporting medical literature on July 17, 2020 (Ex. A,

Tabs 1 – 13, Ex. B). Petitioner filed a second expert report on September 15, 2020 (Ex. 43).

Respondent filed a second responsive expert report on April 30, 2021, along with supporting

medical literature.

On May 25, 2021, I held a second status conference. ECF No. 55. I informed the parties

that I believed that Petitioner was unlikely to succeed in her claim, given 1) timing, 2) prior left

shoulder pain, and 3) alternative causation. Id. at 1. Each of these issues standing alone would

make it difficult for Petitioner to prevail in this case, but when taken together, they effectively

eliminate any path for Petitioner to receive compensation. Id. Accordingly, I ordered Mr.

Kalinowski to file a status report indicating whether Petitioner would like to file a motion to

dismiss or a motion for a ruling on the record.

On June 30, 2021, Petitioner filed a motion for a ruling on the record. Pet’r’s Mot., ECF

No 57. Respondent filed his response on September 7, 2021. Resp’t’s Resp. ECF No. 59. On

September 8, 2021, my law clerk reached out to Petitioner’s counsel via email to inquire if

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Petitioner intended to file a reply brief. Counsel responded that Petitioner did not. See Informal

Communication (Remark) of September 13, 2021.

On September 21, 2021, the parties filed a joint status report indicating that the record was

complete for a ruling on the record. ECF No. 60. This matter is now ripe for an adjudication.

II. Relevant Medical Records

A. Petitioner’s Pre-Vaccination History

Petitioner was born on October 16, 1960. Ex. 1 at 1. She was diagnosed with multiple

sclerosis in 1999. Ex. 2 at 167.

Petitioner had previously received flu vaccinations on November 13, 2014 and October 13,

2015. Ex. 1 at 4. She received a Tdap vaccine on November 18, 2015. Id.

On September 26, 2012, Petitioner visited Dr. Michael Will at Lynchburg General Hospital

for several complaints, including “pain about her left arm, also some pain about the chest.” Ex. 2

at 198. X-rays taken on September 28, 2012 showed no damage to the left arm. Ex. 5 at 43. A

doppler ultrasound of her left upper arm was likewise negative. Id. Dr. Will stated that he suspected

the chest pain was “more GI in origin.” Ex. 2 at 200. Dr. Will emphasized that Petitioner needed

to be consistently taking her insulin, as her diabetes was uncontrolled and poorly managed. Id.

On September 28, 2012, while still in the hospital, Petitioner was seen by Dr. Nathan

Williams. Ex. 4 at 419. Dr. Williams noted that Petitioner was “complaining bitterly of her left

arm and shoulder hurting, which she said is the reason she came in.” Id. at 420. Dr. Williams noted

that her “range of motion is a little bit limited by pain.” Id. His notes state that the left arm pain

“sounds musculoskeletal.” Id. Dr. Williams ordered an x-ray of Petitioner’s left shoulder. Ex. 2 at

192. During the x-ray, Petitioner stated that she had been feeling “pain x 3 wks, no injury.” Id.

Petitioner was also noted to be suffering from “left arm pain and swelling.” Id. X-rays found no

evidence of an acute fracture or glenohumeral dislocation. Id. Petitioner was diagnosed with a

cervical strain after a CT scan of the C-Spine showed degenerative changes. Ex. 4 at 420.

On November 21, 2012, Petitioner “tripped on a rug while leaving Petsmart and fell

forwards to the ground.” Ex. 4 at 208. Petitioner complained of “lower back, left and right arm

pain, left and right knee pain, hip pain, and shoulder area/neck pain” after she was loaded into the

medic unit. Id. Petitioner had good PMS [pulse, motor, sensory] in all extremities, an abrasion to

her left knee, and some swelling/bruising to her right knee. Id. Petitioner’s pain was characterized

as moderate but aching. Id. at 217. X-rays of her left hand showed “a ring around the thumb that

apparently could not be removed. No fracture or other bony abnormality [was] seen. Id. at 222.

Petitioner was eventually diagnosed with a cervical strain and discharged home. Id. at 230.

On February 22, 2013, Petitioner was seen by Dr. Michael Okin for management of

diabetes. Ex. 2 at 99. Petitioner’s diabetes was eventually characterized as uncontrolled, as she did

not take her insulin consistently. Id. at 101.

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On July 16, 2013, Petitioner visited Dr. Okin in the emergency room for a follow up

regarding her back pain. Ex. 2 at 96. Her glucose value was noted to be 521 at this visit. Id.

On March 17, 2015, Petitioner was seen at Centra Lynchburg General Hospital for neck,

back, left shoulder, left hip, and right wrist pain following a motor vehicle accident. Ex. 4 at 158.

Petitioner complained of left shoulder pain radiating to her neck. Id. at 154. X-Rays were ordered

of Petitioner’s pelvis and right hip. No fracture or misalignment was found. Id. at 158, 161.

Petitioner was discharged home the same day with pain medication and was instructed not to drive.

Id. at 163.

On April 3, 2015, Petitioner presented to Dr. Michael Okin for a follow up of pain “all

over” following a motor vehicle accident on March 17, 2015. Ex. 2 at 63. Petitioner complained

of “total body aches and pains including her low back without radiation. She ha[d] knee pain as

well as upper back pain.” Id. Upon examination, Dr. Okin noted “back pain, joint pain, myalgia

and swelling of extremities.”, as well as a headache. Id. Petitioner was given an x-ray and was

noted to have “mild degenerative disc disease.” Id. at 134.

On May 4, 2015, Petitioner presented to Rehab Associates of Central Virginia. Ex. 2 at

169. She presented with complaints of lower back pain related to her motor vehicle accident

occurring on March 17, 2015. Id. Petitioner was suffering from “increased pain, decreased ROM,

and decreased BLE strength.” Id. She was noted to suffer from “functional deficits of prolonged

standing, walking, squatting, bending, and lifting.” Petitioner was noted to have “extreme”

difficulty lifting or carrying groceries. Ex. 5 at 13.

On June 9, 2015, Petitioner presented again to Rehab Associates of Central Virginia. Ex.

5 at 13. Petitioner presented “with rounded shoulder posture and noted having to change positions

frequently and holding L arm throughout entire evaluation.” Id. Physical Therapist Matthew Nolen

documented that Petitioner presented with “tenderness to touch to the PSIS [posterior superior iliac

spine] and to the Lumbar paraspinals. [Petitioner] presents tenderness to touch to the piriformis

on [both] sides, more [left] than [right].” Id. at 17. Petitioner attended a total of nine physical

therapy appointments between May 4, 2015 and June 9, 2015. 3 Id. at 16. On the same day,

Petitioner was discharged from physical therapy. Mr. Nolen’s notes indicate that Petitioner

demonstrated a “13 percent improvement” over the course of her physical therapy. Id.

On December 11, 2015, Petitioner visited the emergency department with complaints of

right foot pain for four days. Ex. 4 at 7. Petitioner reported redness, drainage, and chills. Id.

Petitioner was diagnosed with a diabetic foot ulcer and was discharged home with care

instructions. Id. at 22.

On January 4, 2016, Petitioner was seen for an MRI of her right knee and her left ribs. Ex.

5 at 2, 3. In the provider notes, Dr. Michael Rowland stated that Petitioner had “right patellar and

elbow pain, left sided rib pain.” Ex. 5 at 2. Petitioner’s rib exam showed no displaced rib fractures.

Id. at 3.

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The medical record does not appear to contain physical therapy records from any visit aside from May 4,

2015, or June 9, 2015.

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On January 21, 2016, Petitioner visited Dr. Kimberly Combs for chest pain. Petitioner

described the injury as occurring on January 12, 2016, where she “fell and hit chest, both knees

and right elbow.” Ex. 2 at 37. Petitioner was diagnosed with “decreased range of motion of the left

chest wall, difficulty taking a deep breath, hurts with palpitation, large bruise over the left breast,

painful to take a deep breath in, somewhat panting.” Id. at 40. On February 23, 2016, Petitioner

received an injection to help relieve the pain in her right elbow. Id. at 36.

On September 2, 2016, Petitioner presented to Dr. Combs with complaints of myalgia and

warts on her right hand. Ex. 2 at 24. Dr. Combs’ notes state that “the onset of myalgia has been

gradual and has been occurring for years (Worse this time [of] year, Has MS). Id. Petitioner’s pain

was described as a “moderate dull aching” located over the entire body. Id. Dr. Combs noted that

the symptoms have been associated with arthralgia. Id.

On September 9, 2016, Petitioner presented to nurse practitioner Shauntell Kline for back

pain. Ex. 2 at 19. Petitioner’s pain was described as “being located in the upper back (left side)”.

Id. It was characterized as “stabbing” and did not radiate. Petitioner’s symptoms were noted to be

aggravated by exertion. Id. Petitioner also complained of leg cramping at this visit. Id. The onset

of leg cramping was approximately one week prior. Id. Ms. Kline’s notes indicate that “there is

involvement of the left lower extremity, right lower extremity, left calf, right calf, left foot and

right foot.” Id. Upon examination, Ms. Kline noted that the “left side of back in lower rib area

[was] tender to touch” and Petitioner had “normal and symmetric movement” of all her extremities.

Id. at 22.

On October 3, 2016, Petitioner presented to Dr. Combs for a recheck of her back pain. Ex.

2 at 14. Petitioner’s pain was described as “being located in the upper back (left side)”. Id. It was

characterized as “stabbing” and did not radiate. Id. Dr. Combs noted that the pain had begun

approximately one month prior. Id. Upon examination, Petitioner was noted to have “joint pain,

joint swelling, joint stiffness and muscle spasm.” Id. at 16. Dr. Combs noted that Petitioner was

diagnosed with fibromyalgia and prescribed Lyrica. Id. at 16. Petitioner received her flu

vaccination at this visit. Id. at 17.

B. Petitioner’s Post-Vaccination History

On November 3, 2016, Petitioner presented to Dr. Peter Konieczny at CMG Neurology for

a follow up of her multiple sclerosis. Ex. 6 at 18. Petitioner complained that “I hurt, my muscles

hurt, feel like spiders are crawling on me, little tingly things.” Id. Dr. Konieczny’s notes indicate

that Petitioner had not seen a neurologist since 2011 because she “didn’t feel [as if she] needed

to.” Id. Petitioner complained of “fatigue, muscle pain, and paresthesias which have been

problematic now for 2-3 months.” Id. Upon performing a neurologic exam, Dr. Konieczny noted

that Petitioner’s shoulder shrug was “5/5 strength.” Id. at 18. A musculoskeletal exam revealed

that “strength and tone in all major muscle groups WNL for age and [d]emonstrates symmetrical

movements.” Id. Dr. Konieczny stated that “I’m not enti[r]ely sure how her symptoms of diffuse

pain and paresthesias are related to MS, if in any way. Repeat MRIs are warranted.” Id. at 19.

Petitioner was prescribed physical therapy.

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On November 16, 2016, Petitioner was seen for an MRI of her cervical spine. Ex. 6 at 23.

The MRI revealed several degenerative findings, which Dr. Konieczny characterized as “mild

diffuse atrophy.” Id. at 24.

On November 22, 2016, Petitioner presented to Dr. Kimberly Combs with complaints of

arm pain “occurring in a persistent pattern for 1 month.” Ex. 2 at 10. Petitioner described the pain

as “moderate.” Dr. Combs noted that “since 10/3/16 flu shot she has had left arm/shoulder pain.”

Id. An examination revealed that Petitioner’s pain radiated “from the le[ft] shoulder down into

forearm.” Id. at 13. Petitioner was also noted to be suffering from depression at this visit. Id.

On December 14, 2016, Petitioner was seen at OrthoVirginia by Dr. Ian Smithson. Ex. 7

at 56. Under “history of present illness”, Dr. Smithson’s notes indicate that

for the past 2 months, [Petitioner] has had shooting pain radiate from her anterior

shoulder down her forearm. She believes the flu shot stemmed her pain that she

received on 10/3/16. Pain interrupts her sleep because she likes to sleep on her left

side. Pain is also aggravated with driving and lifting items. Denies symptoms of

numbness and tingling. Does not have radicular pain in hand.

Id. Dr. Smithson noted that Petitioner suffered from both fibromyalgia and MS. Id. Upon

examination, Petitioner had no swelling, ecchymosis, erythema, or induration. Id. at 57. Her

shoulder was tender to “palpitation at [the] anterior shoulder,” and her range of motion exam

revealed she had a loss of internal and external rotation. Id. Dr. Smithson explained to Petitioner

that he did not believe her symptoms were related to her flu shot, but instead were consistent with

adhesive capsulitis. Id. at 56. Dr. Smithson noted that Petitioner was seeking information “because

she has been consulting a lawyer regarding flu shot being administered incorrectly. She was

advised for home exercise program and steroid injection. Did not wish to proceed with steroid

injection. She admitted she will not do at home exercise program but did request more information

regarding adhesive capsulitis.” Id. Petitioner was prescribed physical therapy. Id.

On January 13, 2017, Petitioner was seen by physical therapist Kristine Lee. Ex. 7 at 60.

Ms. Lee’s notes indicated that Petitioner “developed left shoulder pain [anterior] [s]houlder which

goes down arm and stiffness since getting fl[u] shot 10/3/2016…Patient feels like the pain has

gotten worse since she saw the [d]octor. Pain is 7-8/10 today during therapy with movement.” Id.

Petitioner’s current level of function was noted as “basically reports keeps the left arm at side with

walking.” Id.

Petitioner saw Ms. Lee for physical therapy again on January 17, 2017. Ex. 7 at 62.

Petitioner noted that her arm felt better “after the heat.” Id. Following the session, Petitioner was

able to let her arm “hang at side after PROM.” Id. Ms. Lee noted that Petitioner “still walks with

it adducted to side with elbow flexion.” Id.

Petitioner had another physical therapy session on January 20, 2017. Ex. 7 at 64. Petitioner

noted that “my left shoulder feels so much better after heat that I can use the arm a little. Otherwise

I have to keep it at my side.” Id. Ms. Lee noted that “Patient did better with PROM left shoulder

ER today, but still quite painful with elevation.” Id. at 65. On January 23, 2017, Ms. Lee noted

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that Petitioner was “still with pain with PROM shoulder and axilla. Needed verbal cues for correct

technique with [swiss ball] roll outs which she also does at home.” Id. at 67. On January 27, 2017,

Ms. Lee noted that Petitioner “continues to have pain with PROM and AROM left shoulder. Still

braces left arm at side with walking.” Id. at 72.

On January 31, 2017, Petitioner again presented for physical therapy with Ms. Lee. Ex. 7

at 73. Ms. Lee’s notes indicate that “Patient states she can’t pick up a coffee cup with Left UE.

The only thing that has improved since starting therapy is that she can raise [her] arm to the side a

little to put deodorant on. [She is] keeping [her] arm at [her] side all the time otherwise.” Id. Ms.

Lee’s assessment was that “Petitioner has not made progress with AROM Left shoulder since SOC.

Actually has less IR and ER. Still diffusely tender around scapula. Significant pain with all PROM.

Elbow extension has improved.” Id. at 74.

On February 3, 2017, Petitioner had her last physical therapy appointment with Ms. Lee.

Petitioner stated that her left shoulder was “feeling about the same” and that it was “still very sore

and she couldn’t use her arm for anything.” Ex. 7 at 75. Ms. Lee’s notes from February 3, 2017

indicate that she was treating Petitioner for “adhesive capsulitis of the left shoulder.” Id.

On April 21, 2017, Petitioner presented to Dr. Smithson for evaluation of left shoulder

pain. Ex. 8 at 6. Petitioner’s history indicates that “for the past 5 months, she has had shooting pain

radiate from her anterior shoulder down her forearm. She believes the flu [shot] she received on

10/3/16, incited the pain.” Id. Dr. Smithson noted that Petitioner’s range of motion had “worsened

because she has been apprehensive in working through her pain.” Id. at 9.

On June 9, 2017, Petitioner suffered a fall while carrying boxes from her living room to

her car. Ex. 10 at 13. Petitioner landed on her right hip and was unable to bear weight on her right

leg. Id. Petitioner was eventually diagnosed with fractures in her pelvis and was mostly confined

to a wheelchair. Id. at 11.

On August 30, 2017, Petitioner visited Dr. John Prahinski for pain in her right shoulder

and right pelvis. Ex. 10 at 5. Petitioner was described as being “mostly in the wheelchair” and

using a “walker in the house to get around to the refrigerator.” Id. Dr. Prahinski noted that

Petitioner had sustained a fall in early June which resulted in a sacral ala fracture and right pubic

rami fractures. Id. Dr. Prahinski diagnosed Petitioner with glenohumeral arthritis of the right

shoulder, and “unspecified chronicity” of right shoulder pain. Id. at 6. Petitioner made no mention

of left shoulder pain at this visit. Petitioner received a glenohumeral injection to her right shoulder

on September 7, 2017 to relieve her symptoms. Id. at 2.

On October 17, 2017, Petitioner visited Dr. Prahinski for a follow up on pain in her pelvis

and right shoulder. Ex. 13 at 5. Petitioner stated that her shoulder pain had improved significantly

with a glenohumeral injection. Id. at 6. Petitioner’s left shoulder was not mentioned at this visit,

and left shoulder pain was not listed in Petitioner’s problem list. Id. at 9-10.

On February 16, 2018, Petitioner visited Dr. Omar Elkhamra for pelvis pain. Ex. 13 at 11.

Petitioner complained of right sided pelvis pain and left ankle pain “for the past few months with

no inciting injury.” Id. Petitioner made no mention of either left or right shoulder pain at this visit.

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On August 17, 2018, Petitioner visited Dr. Ian Smithson for chronic left shoulder pain. Ex.

13 at 18. Petitioner reported that she believed that the flu vaccine she received on October 3, 2016

incited her pain. Id. Petitioner reported persistent pain of her left shoulder, “localized over the

anterolateral aspect of the shoulder with limited motion.” Id. Petitioner was given a glenohumeral

injection in her left shoulder. Id. X-rays of the left shoulder demonstrated a “type 1 acromion with

moderate genohumeral joint space narrowing without fracture, dislocation, or subluxation.” Id. at

26.

III. Affidavits

A. Petitioner’s First Affidavit

Petitioner submitted her first affidavit on December 26, 2017. Ex. 11. Petitioner stated that

“she mentioned to the vaccine administrator that it seemed she was injecting the vaccination too

high, but she assured me that it was in the correct location. I felt pain within two hours from the

vaccination.” Id. at 1. Petitioner further stated that “The next day I had trouble moving my left

arm. I remember taking note that it was impossible for me to use my left arm to turn my steering

wheel when driving. Soon I could hardly move my left arm because of this injury.” Id.

Petitioner also averred that she was unable to book a doctor’s appointment until

approximately one month after her vaccination. Ex. 11 at 2. At the primary care provider’s office,

Petitioner’s doctor referred her to an orthopedist for additional evaluation and treatment. Id. The

orthopedist speculated that Petitioner might be developing fibromyalgia and prescribed Lyrica as

treatment. Id.

B. Petitioner’s Second Affidavit

On February 7, 2019, Petitioner submitted a second affidavit in response to Respondent’s

Report. Ex. 12. Petitioner stated that “the place on my shoulder where [the nurse] injected the

vaccine immediately hurt.” Id. at 1. She further stated that the next day she “called the doctor’s

office where [she] had received the vaccination to complain that my left arm hurt ever since the

vaccination was administered, but was told the pain was normal, that my muscle was just sore

from the needle prick and [would] get better.” Id.

Petitioner then stated that she noticed “more pain on the morning of 4 October 2016” which

she assumed was a sore muscle from the vaccination, but the pain “got worse as that day wore on

and into the next day, 5 October.” Ex. 12 at 2. Petitioner stated that by October 5, 2016, she had

trouble “even moving [her] shoulder.” Id. Petitioner stated that “within 24 hours of the vaccination

I knew something was definitely wrong because I could not hold so much as a coffee cup with my

left hand” and that “within a few days from the vaccination…it was hard to drive because of the

difficulty in turning the steering wheel with my affected arm.” She further stated that she could

not sleep on her left side without it hurting her. Id.

Petitioner stated she was unable to book a doctor’s appointment until nearly two months

after she had received the vaccination. Ex. 12 at 2. In the interim, she was seen by a neurologist

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for her MS. Petitioner stated that she did not mention her shoulder pain at this visit because “the

problem with my shoulder was not related to my MS.” Id. Petitioner stated she was eventually

diagnosed with “frozen shoulder” by an orthopedist and referred to physical therapy, which did

not “substantially improve [her] situation.” Id. at 2-3.

Petitioner further denied suffering chronic problems in her neck, stating that she suffers

from “lower back pain at times.” Ex. 12 at 3. Petitioner stated that on June 9, 2015, she was “noted

to have ‘moderate limitation’ with tasks such as ‘lifting or carrying items like groceries’ but that

does not mean I was unable to lift or carry groceries.” Id. Petitioner noted that she “had been in a

car wreck two months earlier, which caused a lot of pain and limitations.” Id.

Petitioner also denied that her reports of pain in 2015 and 2016 were related to her left

shoulder. Ex. 12 at 3. Petitioner stated that she had never suffered from an injury to her shoulder

that would cause her ongoing pain or limitation to her range of motion, an injury or systemic

condition that would cause adhesive capsulitis, or that chronic problems in her back and neck

caused adhesive capsulitis in her shoulder. Id.

C. Petitioner’s Third Affidavit

On March 1, 2019, I issued an order instructing Petitioner to file any additional objective

evidence which may assist me in pinpointing the date of onset of Petitioner’s shoulder injury. ECF

No. 26.

In response, Petitioner filed a third affidavit on April 14, 2019. Ex. 14. Petitioner denied

ever engaging in email correspondence with her doctors, or filing a VAERS report regarding her

injury. Id. at 1. Petitioner denied undergoing chiropractic treatments, non-traditional treatments,

or psychological treatment. Id. Petitioner also stated she had been unemployed since she suffered

her injury. Id. at 2.

Petitioner also stated that she did not maintain a written journal, a calendar, or agenda at

the time of her injury. Ex. 14 at 1. She did not exercise at the time of her injury. Id. She did not

maintain telephone billing records and “did not believe telephone records would prove or disprove

the facts at issue herein.” Id. Petitioner also stated that her “financial records would not contain

useful information regarding the purchase of items that would help resolve the factual disputes in

this case.” Id. Finally, Petitioner averred that she did not post on social media regarding her injury

at any point. Id.

D. Petitioner’s Fourth Affidavit

Petitioner filed a fourth affidavit on February 20, 2020. Ex. 19, ECF No. 36. Petitioner

stated that she was standing while the vaccine was administered, and that her left arm was “lying

at rest, roughly parallel” with her torso. Id. at 1.

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IV. Expert Qualifications and Reports

A. Petitioner’s Expert: Naveed Natanzi, DO

Petitioner submitted two expert reports from Naveed Natanzi, DO. Ex. 20 (hereinafter

“First Natanzi Rep.”), Ex. 43 (hereinafter “Second Natanzi Rep.”).

Dr. Natanzi is board certified by the American Academy of Physical Medicine and

Rehabilitation and is board-eligible by the American Board of Pain Management. Ex. 21 at 1

(hereinafter “Natanzi CV”). Dr. Natanzi received a Bachelor of Arts in Biological Studies at the

University of California, Santa Barbara in 2007, and attended medical school at Western

University of Health Sciences, where he received a Doctor of Osteopathy in June 2012. Id. at 2.

Dr. Natanzi completed an internship at Downey Regional Medical Center from 2012-2013, then

completed his residency in physical medicine and rehabilitation at the University of California,

Irvine from 2013-2016. Id. at 1. Dr. Natanzi completed a fellowship at the Bodor Clinic in Napa,

California from January 2017-August 2017. Id.

From 2017-2018, Dr. Natanzi worked at the Pasadena Rehab Institute as an attending

physician specializing in interventional pain management. Natanzi CV at 1. In November 2017,

Dr. Natanzi founded the Regenerative Sports and Spine Institute, and since April 2018, Dr. Natanzi

has been a staff physician at the VA Long Beach Healthcare System. Id. Dr. Natanzi has served as

a witness in several SIRVA cases in the Program since 2017. Id.; see e.g., Taylor v. Sec’y of Health

& Hum. Servs., 2020 U.S. Claims LEXIS 2298 (Fed. Cl. Spec. Mstr. Oct. 20, 2020). He has

authored seven publications and has conducted a large double-blind research study. Id. at 3.

B. Respondent’s Expert: Dr. Geoffrey Abrams

Respondent filed two expert reports from Dr. Geoffrey D. Abrams. Ex A (hereinafter “First

Abrams Rep.”), Ex. C (hereinafter “Second Abrams Rep.”).

Dr. Abrams received a Bachelor of Arts in Human Biology with a concentration in

Neuroscience from Stanford University in 2000. Ex. B at 1 (hereinafter “Abrams CV”). He

received his medical degree from the University of California, San Diego in 2007. Id. He

completed a surgical internship at Stanford University in 2008. Id. Dr. Abrams completed his

residency at Stanford University Hospital and Clinics in 2012, and a fellowship at Rush University

Medical Center in 2013. Id.

Dr. Abrams is board certified in Orthopedic Surgery, with a subspeciality in Orthopedic

Sports Medicine. Abrams CV at 2. He is licensed to practice medicine in Illinois and California

and is a California Fluoroscopy Supervisor and Operator. Id. He holds academic appointments at

the Stanford University School of Medicine and the Veterans Administration Hospital of Palo

Alto. Id. at 1.

Dr. Abrams has published seventy-two peer-reviewed publications as well as a number of

peer-reviewed short communications. Abrams CV at 2-22. He serves as the head team physician

for several of Stanford University’s varsity teams and is an assistant team physician for the Golden

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State Warriors and the San Francisco 49ers. He has given numerous lectures on the topic of

orthopedics. Id. at 22-28.

C. Dr. Natanzi’s First Expert Report

Petitioner filed Dr. Natanzi’s first expert report on February 20, 2020. Dr. Natanzi stated

his theory of the case as follows: (1) an inadvertent overpenetration of the vaccine needle resulted

in (2) bursal rotator cuff and/or capsular penetration, which caused (3) immediate pain, limited

range of motion and discomfort. Petitioner’s vaccine then (4) interacted with naturally-occurring

antibodies from a prior vaccination, which resulted in an exaggerated, robust, and prolonged

inflammatory response resulting in (5) adhesive capsulitis and rotator cuff mediated pain. 4 First

Natanzi Rep. at 11.

Dr. Natanzi stated that “at the time of vaccination, [Petitioner’s] left arm was in a resting,

non-abducted position by her side. Both Ms. Nicholson and the injector were standing. The exact

injection location on her left deltoid muscle was not recorded.” Id. at 8.

Dr. Natanzi acknowledged that Petitioner’s medical providers do not correlate her

symptoms with her vaccination. First Natanzi Rep. at 8. He explained this by stating that “most

people are unaware that a vaccination can cause significant shoulder dysfunction, and they often

do not inherently associate adverse symptoms with a vaccination. This lack of knowledge and

understanding of SIRVA oftentimes results in discrediting vaccines as sources of post-vaccination

shoulder pain.” Id.

Based on Dr. Natanzi’s review of the medical records, he believed that Petitioner’s

shoulder pain began “immediately post vaccination and that this presentation meets the temporal

relationship requirements (onset of pain within 48 hours) of a SIRVA injury.” First Natanzi Rep.

at 9. Dr. Natanzi’s belief stems from the fact that there is no “alternative etiology for the acute

development of shoulder pain in the peri-vaccination time period.” Id.

Dr. Natanzi opined that Petitioner’s adhesive capsulitis was due to the fact that her flu

vaccination was improperly administered. First Natanzi Rep. at 9. Dr. Natanzi stated that the “risk

of adverse reactions and overpenetration is least when both the patient and administering provider

are seated and the arm is fully exposed, abducted, and flexed to 60 degrees with the hand resting

on the ipsilateral hip.” Id. Dr. Natanzi compared this optimal position with Petitioner’s vaccination,

stating that both Petitioner and the injector were standing, the vaccine was administered higher

than normal (per Petitioner’s first affidavit), and Petitioner’s arm was non-abducted at the time of

vaccination. Id. Dr. Natanzi stated that this sub-optimal vaccination procedure made it

“increasingly likely” that inadvertent overpenetration of the needle caused a SIRVA injury in

Petitioner. Id.

4

Dr. Natanzi also opined that Petitioner’s August 30, 2017 right shoulder injury was “at least in part” the

result of overcompensation, “given [Petitioner’s] left shoulder dysfunction since vaccination.” First Natanzi

Rep. at 10. Because I have found that Petitioner’s left shoulder pain was not caused by her flu vaccine, I

similarly conclude that her right shoulder dysfunction was not attributable to vaccination.

11

Dr. Natanzi then proceeded to rule out other causes of Petitioner’s shoulder pain. He noted

that in September 2012, Petitioner was seen in the emergency department for chest pain, nausea,

vomiting, and left shoulder pain. First Natanzi Rep. at 9. While in the hospital, Petitioner was

found to suffer from “mild shoulder restriction with some bicipital tenderness” and “atraumatic

left shoulder pain.” Id. Dr. Natanzi noted that following this emergency room visit, Petitioner’s

medical records did not mention left shoulder pain “for a few years.” Id. at 10. Dr. Natanzi

therefore attributed Petitioner’s shoulder pain to her “fear of having a heart attack and not a

structural shoulder injury.” Id.

Dr. Natanzi then addressed Petitioner’s March 2015 motor vehicle accident. First Natanzi

Rep. at 10. Dr. Natanzi noted that the ambulance records indicated that Petitioner experienced “left

shoulder pain that radiated to her neck” but that hospital records from the same day describe

Petitioner with hip, neck, and wrist pain, with no mention of shoulder pain; he further noted that

the medical records from April 3, 2015 describe “multiple joint complaints” but make no mention

of shoulder-specific complaints. Id. Dr. Natanzi acknowledged that Petitioner’s physical therapy

notes from June 9, 2015, stated that Petitioner “was holding her left arm and had difficulty carrying

groceries” but he noted that “there is not a description of why [Petitioner] was having this

difficulty.” Id. Furthermore, Dr. Natanzi noted that none of Petitioner’s other physical therapy

records from this time period mention shoulder pain, “which further lends likelihood to the theory

that there was no significant shoulder injury in the post-motor vehicle accident period.” 5 Id.

Finally, Dr. Natanzi stated that if Petitioner’s shoulder was a “true pain generator and limiting

factor, [Petitioner] would have made mention of it as she did with regard to her left shoulder post-

vaccination.” Id.

Given Dr. Natanzi’s interpretation of the medical records, he opined that “as a result of the

motor vehicle accident, [Petitioner] experienced multiple joint strains and whiplash, which may or

may not have involved the shoulder joint” and that Petitioner “did not experience a significant

shoulder injury and that her symptoms were likely related to a strain which is common in the

context of motor vehicle collisions.” First Natanzi Rep. at 10. Dr. Natanzi stated that Petitioner’s

post-motor vehicle collision symptoms were “markedly different in intensity, frequency, and

quality in comparison to her post-vaccination symptoms.” Id.

Finally, Dr. Natanzi discussed Petitioner’s fibromyalgia diagnosis. First Natanzi Rep. at

11. Dr. Natanzi stated that he is not convinced that Petitioner suffered from fibromyalgia, but even

if she did, fibromyalgia symptoms are typically “diffuse and present throughout the body” whereas

the symptoms experienced by Petitioner in the shoulder were “focal and isolated.” Id. As a result,

Dr. Natanzi opined that the presence or absence of fibromyalgia has “no bearing” on the fact that

Petitioner was injured by her vaccination. Id.

5

The medical records from Rehab Associates from Central Virginia do not contain any notes from the visits

between May 4, 2015 and June 9, 2015. However, notes from May 4, 2015 indicate that Petitioner had

“extreme difficulty” “lifting or carrying items like groceries.” Ex. 2 at 164. By June 9, 2015, the records

indicate that Petitioner had a “moderate limitation” “lifting or carrying items like groceries.” Id. at 163-64.

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D. Dr. Abrams’ First Expert Report

Respondent filed an expert report from Dr. Abrams on July 17, 2020, responding to

Petitioner’s expert report. First Abrams Rep.

Dr. Abrams stated that there were “a number of factors” which would preclude ascribing

Petitioner’s left shoulder pain to her vaccination, including: (1) “a history of severe and

uncontrolled diabetes, which is a well-known cause of adhesive capsulitis and shoulder pain”; (2)

“the literature reporting on adhesive capsulitis following vaccine administration almost

exclusively describes healthy patients”; (3) “the lack of any objective evidence (imaging) of a

SIRVA-related injury”; (4) “A diagnosis of arthritis of the left shoulder, also a well-known source

of waxing and waning shoulder pain”; (5) “numerous medical events and accidents associated with

left shoulder pain prior to the index vaccination”; and (6) “No report of shoulder pain until almost

two months after vaccination, including no mention of any shoulder pain during a visit with a

neurologist approximately one month following the vaccination in question.” First Abrams Rep.

at 5.

Dr. Abrams opined that, without an MRI of Petitioner’s shoulder, it was impossible to tell

if Petitioner suffered a SIRVA injury, as an MRI would show symptoms of a SIRVA such as

inflammation in the subacromial space. First Abrams Rep. at 7. He also noted that Petitioner did

not report any ongoing left shoulder pain from April 2017 to August 17, 2018, which led him to

believe that Petitioner “did not have ongoing pain at that time.” Id. at 9. Dr. Abrams opined that

this lack of ongoing pain, coupled with radiographs in August 2018 showing “moderate

osteoarthritis of the shoulder”, strongly suggested a non-SIRVA related cause of shoulder pain. Id.

Dr. Abrams stated that “There is a significant and profound effect on the petitioner’s

diagnosis of uncontrolled diabetes (and subsequent predisposition to inflammation and shoulder

pathology) on the overall pain, function, and structure of her shoulder.” He opined that because

Petitioner’s A1c values and blood sugar values were significantly elevated from May 2011 “up to

and including the day of vaccination”, Petitioner was suffering from hyperglycemia. First Abrams

Rep. at 6. Dr. Abrams stated that “diabetes is the single greatest risk factor” for the development

of adhesive capsulitis. Id.

Dr. Abrams then explained the method by which hyperglycemia causes adhesive capsulitis,

stating that “hyperglycemia permanently alters tissue macromolecules through accelerated

advanced glycation end-products (AGEs) formation.” First Abrams Rep. at 7. Dr. Abrams noted

that these AGEs have been found in cases of frozen shoulder, and that clinically, the changes

caused by AGE formation can “change the biological properties of the shoulder joint capsule to

decrease its elasticity (makes the shoulder stiff) and increase intrinsic inflammation (make it

painful). Id. Dr. Abrams conceded that case reports exist of adhesive capsulitis following vaccine

administration but stated that these injuries occur almost entirely in patients who are otherwise

healthy prior to vaccine administration and none of the reported cases include patients with a

“diagnosis of uncontrolled diabetes and prior shoulder pain.” Id.

Dr. Abrams also differentiated between an injury to the subacromial space, and an injury

to the joint capsule of an injured person’s arm, stating that adhesive capsulitis is an “inflammatory

13

condition” of the joint capsule. First Abrams Rep. at 6. Dr. Abrams stated that the American

Academy of Orthopedic Surgeons holds the position that “vaccine administration to the shoulder

cannot cause or contribute to common shoulder pathologies such as…adhesive capsulitis.” Id.

Dr. Abrams then discussed other alternative causes of Petitioner’s shoulder pain. Dr.

Abrams stated that Petitioner suffered from left shoulder arthritis, pointing to a radiograph from

December 2016 which revealed “joint space narrowing of the glenohumeral…joint

(osteoarthritis).” First Abrams Rep. at 8 (omitting internal quotations). He opined that “some of

the petitioner’s symptoms match th[ose] experienced by patients with mild to moderate arthritis of

the shoulder. Vaccines are not known to cause arthritis of the shoulder and therefore have no

etiologic factor in this condition.” Id.

Dr. Abrams also noted that Petitioner had suffered from numerous medical events and

accidents, some of which involved her left shoulder, any one of which could have led to her

shoulder pain. First Abrams Rep. at 8. This included Petitioner’s September 2012 admission to the

hospital for “nausea, vomiting, and chest pain” which included “reported left shoulder pain” and

Petitioner’s March 17, 2015 motor vehicle accident in which she complained of left shoulder pain.

Id.

Dr. Abrams then addressed Dr. Natanzi’s assertion that Petitioner’s right shoulder pain was

caused by overcompensation due to her alleged left SIRVA injury. First Abrams Rep. at 9. Dr.

Abrams disputed this assertion, noting that Petitioner “first reported right shoulder pain…on

August 25, 2017, and stated that her pain had been present for over one month. Petitioner herself

stated it was “possibly from [a] recent fall back in June.” Id. Dr. Abrams further noted that on

August 30, 2017, Petitioner saw Dr. Prahinski and made no mention of left shoulder pain or a need

to compensate for her left shoulder at this visit. Id. Dr. Abrams concluded that Petitioner’s right

shoulder pain was likely due to her use of a wheelchair and walker following a fractured hip in

June 2017, as wheelchairs and walkers place considerable stress on the shoulders. Id.

Dr. Abrams concluded his report by stating that Petitioner did not meet the criteria for a

SIRVA injury because (1) Petitioner had a history of pain and dysfunction of the affected shoulder;

(2) Petitioner’s pain did not occur within 48 hours of vaccination; and (3) Petitioner’s uncontrolled

diabetes was a much more logical explanation for Petitioner’s symptoms. First Abrams Rep. at 10.

E. Dr. Natanzi’s Second Expert Report

Petitioner submitted a rebuttal report from Dr. Natanzi on September 15, 2020. Second

Natanzi Rep.

Dr. Natanzi began his report by noting that both he and Dr. Abrams agree that Petitioner

suffers from adhesive capsulitis but disagree as to the etiology of Petitioner’s condition. Second

Natanzi Rep. at 1. He also noted that Petitioner “never experienced a sustained shoulder injury

prior to her vaccination in October 2016.” Id. at 3. He supported this statement by noting that pre-

vaccination, Petitioner logged “sparse, infrequent, and inconsistent complaints” regarding her left

shoulder, but post-vaccination, Petitioner’s complaints of shoulder pain were “sustained.” Id.

14

Dr. Natanzi conceded that those patients who suffer from “uncontrolled [diabetes mellitus]

have an increased chance of developing adhesive capsulitis.” Second Natanzi Rep. at 1. Citing

Chan, Dr. Natanzi stated that “for each unit that the HbA1c level was greater than 7, the risk of

developing [adhesive capsulitis] increased 2.7%.” Id. Using this formula, Dr. Natanzi calculated

that the chance of Petitioner developing spontaneous adhesive capsulitis was anywhere from 20-

46%. Id. He therefore concluded that “mathematically, even in light of [Petitioner’s] uncontrolled

[diabetes mellitus], it is more likely than not that [diabetes mellitus mediated adhesive capsulitis]

does not develop.” Id.

Dr. Natanzi disagreed with Dr. Abrams’ assertion that Petitioner did not develop pain

within 48 hours of her vaccination, stating that Petitioner developed pain “within hours after her

vaccination”. First Natanzi Rep. at 1. To support this point, Dr. Natanzi referred to Petitioner’s

first affidavit, in which she discussed feeling pain immediately after her shot; he also noted the

medical record from November 22, 2016, in which Petitioner stated to Dr. Combs that she had

pain in her shoulder for approximately one month. Id., see also Ex. 2 at 10. Dr. Natanzi concluded

that, based upon this timeline, Petitioner’s injury was “more in line with a SIRVA mediated injury

rather than a spontaneously occurring underlying disease”. Id.

Dr. Natanzi then addressed Dr. Abrams’ assertion that reports of SIRVA-mediated

adhesive capsulitis “are in generally healthy patients.” Second Natanzi Rep. at 2. He opined that

“this statement is not supported by the literature” (noting one patient who was described to have

underlying hypertension and chronic obstructive pulmonary disease) and that Dr. Abrams’

assertion had no relevance. Id. Dr. Natanzi opined that if adhesive capsulitis “can happen to a

healthy person without medical conditions it is even more likely to happen to someone with

multiple medical conditions.” Id.

Finally, Dr. Natanzi addressed Dr. Abrams’ alternative diagnosis of osteoarthritis. Second

Natanzi Rep. at 2. Dr Natanzi noted that both osteoarthritis and SIRVA “present with shoulder

pain and limited range of motion; therefore, they can be challenging to distinguish based on

physical exam alone. As with [adhesive capsulitis], the clinical history/context is key in

differentiating whether or not osteoarthritis could be a source of [Petitioner’s] pain.” Id. Dr.

Natanzi stated that osteoarthritis is a “degenerative issue with a development of pain that is

characteristically slow, gradual, indolent, waxing and waning, and oftentimes progressive” as

opposed to a SIRVA injury, which is “acute, sudden, and immediate.” Id. He therefore concluded

that, because Petitioner’s symptoms were “acute and severe”, the clinical picture was “much more

in line with an acute process which is exactly what SIRVA is.” Id.

Dr. Natanzi concluded his report by stating that “if one were to accept it as fact that

Petitioner’s pain began immediately (within hours) after her vaccination as she describes in her

affidavit and as described by multiple medical providers” and “given the temporal relationship of

symptoms to the accident coupled with physical exam findings of limited range of motion and pain

– a SIRVA injury is the only reasonable diagnosis.” Second Natanzi Rep. at 2.

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F. Dr. Abrams’ Second Expert Report

Respondent submitted a rebuttal expert report from Dr. Abrams on April 30, 2021. Second

Abrams Rep.

Dr. Abrams disagreed with Dr. Natanzi’s characterization of Petitioner’s risk for shoulder

pain due to her uncontrolled diabetes. Second Abrams Rep. at 1. Dr. Abrams noted that in a group

of participants with type 2 diabetes, 63% had shoulder pain or a shoulder disability. Id., citing

Shah.

Dr. Abrams also disagreed with Dr. Natanzi’s interpretation of the Chan article. Dr. Natanzi

stated that “for each unit that the HbA1c level was greater than 7, the risk of developing [adhesive

capsulitis] increased 2.7%.” Second Abrams Rep. at 1; citing Second Natanzi Rep. at 1. Dr.

Abrams stated that Dr. Natanzi failed “to recognize [that] the risk for developing adhesive

capsulitis is cumulative over time, and if one reads from the article itself…the article states that

“(f)or each unit of time (emphasis added) that HbA1c was greater than 7, there was a 3% increase

in the risk of adhesive capsulitis.” Id, citing Chan (emphasis in original). Dr. Abrams noted that

Petitioner’s blood sugar (HbA1c) was significantly elevated for at least six years prior to her

vaccination. Second Abrams Rep. at 1. Dr. Abrams opined that “because of this history of elevated

blood glucose over such a long time period, her risk of developing adhesive capsulitis was much

greater than 20-46%, as the petitioner’s expert states.” Id.

Dr. Abrams disagreed with Dr. Natanzi that adhesive capsulitis can occur in patients with

underlying conditions. Second Abrams Rep. at 2. Dr. Abrams noted that, although Dr. Natanzi

pointed to a single report of “suspected SIRVA in a patient with hypertension and chronic

pulmonary disease”, these are conditions that have no known association with shoulder pain or

pathology, “unlike diabetes, cervical pathology, [or] fibromyalgia.” Id. Dr. Abrams therefore

opined that “in patients with conditions like diabetes, or other medical diagnoses known to cause

shoulder pathology, this would be a significant confounder and calls into question the accuracy of

a SIRVA diagnosis.” Id.

Dr. Abrams also disagreed with Dr. Natanzi’s characterization of shoulder pain related to

arthritis. Second Abrams Rep. at 2. Dr. Natanzi stated that pain linked to shoulder arthritis is “slow

and gradual” rather than acute. Second Natanzi Rep. at 2. Dr. Abrams disagreed with this assertion,

stating that shoulder arthritis often presents with acute complaints, and “the most common

presentation for a person with shoulder arthritis is a statement that ‘it just started hurting one day’

and they do not recognize an inciting event.” Id.

Dr. Abrams then turned to Petitioner’s history of cervical spine disease/arthritis. Second

Abrams Rep. at 3. He noted that a CT scan in November 2012 showed “multilevel degenerative

changes” in her cervical spine and on an MRI taken “just after the vaccination in question, she was

found to have C4/5 severe left foraminal narrowing and degenerative changes.” Id., citing Ex. 4 at

217, Ex. 6 at 23. Dr. Abrams stated that cervical disease has “well known overlap with shoulder

pain, and in many cases, can be the cause of perceived shoulder pain.” Id.

16

Dr. Abrams disagreed with Dr. Natanzi that Petitioner’s shoulder pain began “within

hours” of her vaccination. Second Abrams Rep. at 3. In support of his assertion, Dr. Abrams stated

that (1) Petitioner “did not report shoulder pain until almost two months after the vaccination”; (2)

that she “had spoken to legal counsel prior to this first report of shoulder pain”; (3) her medical

visit with her neurologist on November 3, 2016 yielded no “documentation of any shoulder pain

or weakness/pain on physical exam”; (4) Petitioner described her pain to Dr. Combs on November

22, 2016 as “radiating pain”; and (5) In September 2016, Petitioner was diagnosed with

fibromyalgia, “a chronic pain condition and…another potential reason for musculoskeletal pain.”

Id.

Dr. Abrams concluded his report by restating his opinion that Petitioner’s shoulder pain

was likely not present when she was seen by her neurologist on November 3, 2016 and started at

some point after that date. Second Abrams Rep. at 4.

V. Applicable Law

A. Petitioner’s Burden in Vaccine Program Cases

Before compensation can be awarded under the Vaccine Act, a petitioner must

demonstrate, by a preponderance of evidence, all matters required under Section 11(c)(1),

including the factual circumstances surrounding his claim. § 13(a)(1)(A). In making this

determination, the special master or court should consider the record as a whole. § 13(a)(1).

Petitioner’s allegations must be supported by medical records or by medical opinion. Id.

To resolve factual issues, the special master must weigh the evidence presented, which may

include contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Hum.

Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a special master must decide what weight

to give evidence including oral testimony and contemporaneous medical records).

Contemporaneous medical records are presumed to be accurate. See Cucuras v. Sec’y of Health &

Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). To overcome the presumptive accuracy of

medical records testimony, a petitioner may present testimony which is “consistent, clear, cogent,

and compelling.” Sanchez v. Sec’y of Health & Hum. Servs., No. 11–685V, 2013 WL 1880825, at

3 (Fed. Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec’y of Health & Hum. Servs., No. 90–

2808V, 1998 WL 408611, at 5 (Fed. Cl. Spec. Mstr. June 30, 1998)).

In addition to requirements concerning the vaccination received, the duration and severity

of petitioner’s injury, and the lack of other award or settlement, a petitioner must establish that he

suffered an injury meeting the Table criteria, in which case causation is presumed, or an injury

shown to be caused-in-fact by the vaccination he received. § 11(c)(1)(C).

The most recent version of the Table identifies the vaccines covered under the Program,

the corresponding injuries, and the time period in which the particular injuries must occur after

vaccination. § 14(a). Pursuant to the Vaccine Injury Table, a SIRVA is compensable if it manifests

within 48 hours of the administration of an influenza vaccine. 42 C.F.R. § 100.3(a)(XIV)(B).

Pursuant to the Table, SIRVA is defined as:

17

shoulder pain and limited range of motion occurring after the administration of a

vaccine intended for intramuscular administration in the upper arm. These

symptoms are thought to occur as a result of unintended injection of vaccine antigen

or trauma from the needle into and around the underlying bursa of the shoulder

resulting in an inflammatory reaction. SIRVA is caused by an injury to the

musculoskeletal structures of the shoulder (e.g. tendons, ligaments, bursae, etc.).

SIRVA is not a neurological injury and abnormalities on neurological examination

or nerve conduction studies (NCS) and/or electromyographic (EMG) studies would

not support SIRVA as a diagnosis (even if the condition causing the neurological

abnormality is not known).

A vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests

all of the following:

(i) No history of pain, inflammation or dysfunction of the affected shoulder

prior to intramuscular vaccine administration that would explain the alleged

signs, symptoms, examination findings, and/or diagnostic studies occurring

after vaccine injection;

(ii) Pain occurs within the specified time-frame;

(iii) Pain and reduced range of motion are limited to the shoulder in which the

intramuscular vaccine was administered; and

(iv) No other condition or abnormality is present that would explain the patient's

symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial

neuritis, mononeuropathies, or any other neuropathy).

42 C.F.R. § 100.3.

If, however, a petitioner suffered an injury that either is not listed in the Table or did not

occur within the prescribed time frame, she must prove that the administered vaccine caused her

injury to receive Program compensation. § 11(c)(1)(C)(ii) and (iii). In such circumstances,

petitioner asserts a “non-Table or [an] off-Table” claim and to prevail, petitioner must prove her

claim by preponderant evidence. § 13(a)(1)(A).

The Federal Circuit has indicated that a petitioner “must show ‘a medical theory causally

connecting the vaccination and the injury’ to establish that the vaccine was a substantial factor in

bringing about the injury.” Shyface, 165 F.3d at 1352-53 (quoting Grant v. Sec’y of Health & Hum.

Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). The Federal Circuit added that “[t]here must be a

‘logical sequence of cause and effect showing that the vaccination was the reason for the injury.’”

Id. The Federal Circuit subsequently reiterated these requirements in a three-pronged test set forth

in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). Under this test,

a petitioner is required to show by preponderant evidence that the vaccination brought about her

injury by providing:

(1) a medical theory causally connecting the vaccination and the injury;

(2) a logical sequence of cause and effect showing that the vaccination was the

reason for the injury; and

18

(3) a showing of a proximate temporal relationship between vaccination and

injury.

Id. All three prongs of Althen must be satisfied. Id. Circumstantial evidence may be

considered, and close calls regarding causation must be resolved in favor of the petitioner. Id. at

1280.

B. Law Governing Analysis of Fact Evidence

The process for making factual determinations in Vaccine Program cases begins with

analyzing the medical records, which are required to be filed with the petition. Section 11(c)(2).

The special master is required to consider “all [] relevant medical and scientific evidence contained

in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner’s

report which is contained in the record regarding the nature, causation, and aggravation of the

petitioner’s illness, disability, injury, condition, or death,” as well as the “results of any diagnostic

or evaluative test which are contained in the record and the summaries and conclusions.” Section

13(b)(1)(A). The special master is then required to weigh the evidence presented, including

contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Hum. Servs., 3

F.3d 413, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether to

afford greater weight to contemporaneous medical records than to other evidence, such as oral

testimony surrounding the events in question that was given at a later date, provided that such

determination is evidenced by a rational determination).

Medical records created contemporaneously with the events they describe are generally

trustworthy because they “contain information supplied to or by health professionals to facilitate

diagnosis and treatment of medical conditions,” where “accuracy has an extra premium.” Kirby v.

Sec’y of Health & Hum. Servs., 997 F.3d 1378 (Fed. Cir. 2021) citing Cucuras, 993 F.2d at 1528.

This presumption is based on the linked proposition that (i) sick people visit medical professionals;

(ii) sick people honestly report their health problems to those professionals; and (iii) medical

professionals record what they are told or observe when examining their patients in as accurate a

manner as possible, so that they are aware of enough relevant facts to make appropriate treatment

decisions. Sanchez v. Sec’y of Health & Hum. Servs., No. 11-685V, 2013 WL 1880825 at *2 (Fed.

Cl. Spec. Mstr. Apr. 10, 2013) mot. for rev. denied, 142 Fed. Cl. 247, 251-52 (2019), vacated on

other grounds and remanded, 809 Fed. Appx. 843 (Fed. Cir. Apr. 7, 2020).

Accordingly, if the medical records are clear, consistent, and complete, then they should

be afforded substantial weight. Lowrie v. Sec’y of Health & Hum. Servs., No. 03-1585V, 2005 WL

6117475 at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records

are generally found to be deserving of greater evidentiary weight than oral testimony -- especially

where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also

Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam, 968 F.2d

1226 (Fed. Cir. 1992), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States

19

v. U.S. Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony

which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)).

However, there are situations in which compelling oral testimony may be more persuasive

than written records, such as where records are deemed to be incomplete or inaccurate. Campbell

v. Sec’y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common

sense and experience, this rule should not be treated as an absolute and must yield where the factual

predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475 at *19 (“[w]ritten

records which are, themselves, inconsistent, should be accorded less deference than those which

are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination

regarding a witness’s credibility is needed when determining the weight that such testimony should

be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,

1575 (Fed. Cir. 1993).

When witness testimony is offered to overcome the presumption of accuracy afforded to

contemporaneous medical records, such testimony must be “consistent, clear, cogent and

compelling.” Sanchez, 2013 WL 1880825 at *3 (citing Blutstein v. Sec’y of Health & Hum. Servs.,

No. 90-2808V, 1998 WL 408611 at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the

accuracy and completeness of medical records, the Court of Federal Claims has listed four possible

explanations for inconsistencies between contemporaneously created medical records and later

testimony: (1) a person’s failure to recount to the medical professional everything that happened

during the relevant time period; (2) the medical professional’s failure to document everything

reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony;

or (4) a person’s purposeful recounting of symptoms that did not exist. LaLonde v. Sec’y of Health

& Hum. Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making

a determination regarding whether to afford greater weight to contemporaneous medical records

or other evidence, such as testimony at hearing, there must be evidence that this decision was the

result of a rational determination. Burns, 3 F.3d at 417.

C. Analysis of Expert Testimony

Establishing a sound and reliable medical theory connecting the vaccine to the injury often

requires a petitioner to present expert testimony in support of his or her claim. Lampe v. Sec’y of

Health & Hum. Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony

is usually evaluated according to the factors for analyzing scientific reliability set forth in Daubert

v. Merrell Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Hum.

Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195

F.3d 1302, 1316 (Fed. Cir. 1999). “The Daubert factors for analyzing the reliability of testimony

are: (1) whether a theory or technique can be (and has been) tested; (2) whether the theory or

technique has been subjected to peer review and publication; (3) whether there is a known or

potential rate of error and whether there are standards for controlling the error; and (4) whether the

theory or technique enjoys general acceptance within a relevant scientific community.” Terran,

195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592-95).

The Daubert factors play a slightly different role in Vaccine Program cases than they do

when applied in other federal judicial fora. Daubert factors are employed by judges to exclude

20

evidence that is unreliable and potentially confusing to a jury. In Vaccine Program cases, these

factors are used in the weighing of the reliability of scientific evidence. Davis v. Sec’y of Health

& Hum. Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have

been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of

expert testimony already admitted”). The flexible use of the Daubert factors to evaluate

persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88

Fed. Cl. at 743. In this matter, (as in numerous other Vaccine Program cases), Daubert has not

been employed at the threshold, to determine what evidence should be admitted, but instead to

determine whether expert testimony offered is reliable and/or persuasive.

Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s

case. Where both sides offer expert testimony, a special master’s decision may be “based on the

credibility of the experts and the relative persuasiveness of their competing theories.”

Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing

Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion

“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too

great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743

(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). A “special master is entitled to

require some indicia of reliability to support the assertion of the expert witness.” Moberly, 592

F.3d at 1324. Weighing the relative persuasiveness of competing expert testimony, based on a

particular expert’s credibility, is part of the overall reliability analysis to which special masters

must subject expert testimony in Vaccine Program cases. Id. at 1325-26 (“[a]ssessments as to the

reliability of expert testimony often turn on credibility determinations”); see also Porter v. Sec’y

of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously

explained that special masters are expected to consider the credibility of expert witnesses in

evaluating petitions for compensation under the Vaccine Act”).

D. Consideration of Medical Literature

Finally, although this decision discusses some but not all of the medical literature in detail,

I have reviewed and considered all of the medical records and literature submitted in this matter.

See Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We

generally presume that a special master considered the relevant record evidence even though [s]he

does not explicitly reference such evidence in h[er] decision.”); Simanski v. Sec’y of Health &

Hum. Servs., 115 Fed. Cl. 407, 436 (2014) (“[A] Special Master is ‘not required to discuss every

piece of evidence or testimony in her decision.’” (citation omitted)), aff’d, 601 F. App’x 982 (Fed.

Cir. 2015).

21

VI. Analysis

A. Table Claim

In the instant case, Petitioner alleges that she suffered a SIRVA Table injury following her

influenza vaccination on October 3, 2016. In order to prevail on her claim, Petitioner must show

each of the following by a preponderance of the evidence:

(i) No history of pain, inflammation or dysfunction of the affected shoulder

prior to intramuscular vaccine administration that would explain the alleged

signs, symptoms, examination findings, and/or diagnostic studies occurring

after vaccine injection;

(ii) Pain occurs within the specified time-frame;

(iii) Pain and reduced range of motion are limited to the shoulder in which the

intramuscular vaccine was administered; and

(iv) No other condition or abnormality is present that would explain the patient's

symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial

neuritis, mononeuropathies, or any other neuropathy).

42 C.F.R. § 100.3.

For the reasons discussed below, I do not find that Petitioner has presented preponderant

evidence that she meets the criteria for a Table injury.

1. Petitioner’s History of Prior Left Shoulder Pain does not Explain her Post-

Vaccination Pain

Although Petitioner had a history of left shoulder pain in the years prior to her October 3,

2016 flu vaccination, there is not preponderant evidence that this prior pain explains her post-

vaccination symptoms.

On September 26, 2012, Petitioner was admitted to the hospital complaining of nausea,

vomiting, and chest pain. Ex. 2 at 190. During her hospital stay, Petitioner also complained of left

shoulder pain that she stated had been ongoing for three weeks with no known injury. Id. at 190,

192. She had a left shoulder x-ray, which was negative. Id. Left shoulder pain was included as one

of her discharge diagnoses. Id. at 191.

On March 17, 2015, Petitioner visited the ER after she was involved in a motor vehicle

accident. Ex. 4 at 159. Upon presentation, Petitioner complained of neck, back, right wrist, left

shoulder, and left hip pain. Id. She had digital x-rays performed of her pelvis and right wrist only,

suggesting that she was not experiencing sufficient left shoulder pain such that her doctor felt an

x-ray was appropriate. Id. at 161.

On June 15, 2015, Petitioner presented to physical therapy for lower back pain caused by

her MVA in March, 2015. Ex. 2 at 163. The PT Matthew Nolen added the following note to the

record: “Pt is a female with BMI of 26.6, presenting with rounded shoulder posture and noted

22

having to change positions frequently and holding L arm throughout entire evaluation.” Id. at 164.

The record does not elucidate why Petitioner was holding her left arm.

Although Petitioner’s medical records document that she was experiencing back pain in

2015 and 2016, none of these records suggest that Petitioner’s prior shoulder pain recurred. See

e.g., Ex. 2 at 19 (medical visit on September 9, 2016 where Petitioner complained of back pain).

In fact, on October 3, 2016, the day she received the allegedly causal flu vaccine, Petitioner

presented for a re-check of her back pain. Id. at 14-18. Dr. Combs performed a comprehensive

physical exam and did not document that Petitioner was experiencing left shoulder pain. See id.

This medical visit, conducted on the day Petitioner received the vaccine at issue in this case,

suggests that any shoulder pain Petitioner had experienced in the past was not affecting her as of

the date of vaccination. Accordingly, Petitioner has presented preponderant evidence in support of

the first Table injury criterion.

2. Onset of Petitioner’s Shoulder Pain was between November 4, 2016 and

November 22, 2016, more than 48 Hours after Vaccination

Petitioner received her flu vaccine on October 3, 2016. She described experiencing intense

pain in her shoulder within one day of vaccination. Petitioner averred,

Within 24 hours of the vaccination I knew something was definitely wrong because

I could not hold so much as a coffee cup with my left hand. Within a few days from

the vaccination, I could not maneuver to put on a brassiere, and it was hard to drive

because of the difficulty in turning the steering wheel with my affected arm.

Ex. 12 at 2.

Petitioner claims that she called her PCP’s office the next day to report the pain she was

experiencing. Petitioner stated, “I called that doctor’s office where I had received the vaccination

to complain that my left arm hurt ever since the vaccination was administered, but was told the

pain was normal, that my muscle was just sore from the needle prick and [would] get better.” 6 Ex.

12 at 1.

Petitioner requested copies of the office telephone records from her PCP, presumably to

corroborate her account of calling the office on October 4, 2016. Ex. 18 at 3. The request returned

the following:

Id. at 7.

6

Petitioner did not mention this phone call in her first affidavit. Instead, she averred that she “waited a

week to see if the symptoms would resolve on their own, as residual pain from vaccinations usually do.

When the pain and limitation in movement did not resolve, I called my doctor's office to schedule an

appointment.” Ex. 11 at 2.

23

During a status conference on February 28, 2019, I asked Petitioner to attempt to find any

additional objective evidence that could assist her in pinpointing the date of onset of her shoulder

pain. See Scheduling Order dated March 1, 2019. ECF No. 26. Specifically, I asked Petitioner to

look for personal phone records which would document any call she may have made to her PCP.

Id. Petitioner filed her third affidavit on April 15, 2019, although the document was executed on

February 25, 2019, three days before the status conference where I asked for the information. See

Ex. 14 at 3. In her third affidavit, Petitioner averred as follows: “I have not maintained telephone

billing records that contain listings of numbers dialed, and I do not believe telephone records would

prove or disprove the facts at issue herein.” Id. at 1. Thus, there is no evidence in the record which

corroborates Petitioner’s statement that she called her PCP the day after vaccination to complain

of left arm pain.

Petitioner’s first medical visit after vaccination was with Dr. Konieczny, her neurologist,

on November 3, 2016. The purpose of the visit was to re-establish care for her MS. Ex. 6 at 17-19.

During this visit, Petitioner indicated that she had not been to a neurologist in five years. Id. at 17.

She complained of fatigue, muscle pain, and paresthesias that had been going on for two to three

months. Id. She stated, “I hurt, my muscles hurt, feel like spiders are crawling on me, little tingly

things.” Id. There is no indication that Petitioner told Dr. Konieczny she was experiencing left

shoulder pain.

The Review of Systems section documents that Petitioner was experiencing tingling, but

was negative for any other complaint. Ex. 6 at 17.

Upon performing a neurologic exam, Dr. Konieczny noted that Petitioner’s shoulder shrug

was “5/5 strength.” Ex. 6 at 18. Dr. Konieczny further documented “Give way weakness of both

deltoids, biceps, iliopsoas”. 7 Id. Petitioner was able to complete the finger-nose-finger testing

without any documented issues. Id.

A musculoskeletal exam revealed “strength and tone in all major muscle groups WNL for

age.” Ex. 6 at 18. Dr. Konieczny described that Petitioner was experiencing “diffuse pain and

paresthesias”, and did not note any pain specific to her left shoulder. Id.

Dr. Abrams persuasively opined as follows:

7

The iliopsoas musculotendinous unit (IPMU) is comprised of the major and minor psoas muscles and the

iliacus muscle. The IPMU is commonly referred to as the iliopsoas muscle. “The iliopsoas

musculotendinous unit (IPMU) is the primary flexor of the thigh with the ability to add and extra-rotate the

coxofemoral joint. … The muscles can act separately. The iliacus muscle stabilizes the pelvis and allows a

correct hip flexion during the run; the psoas major muscle stabilizes the lumbar spine during the sitting

position and the thigh flexion in a supine position or when standing. The psoas major acts as a stabilizer of

the femoral head in the hip acetabulum in the first 15 degrees of movement. The psoas minor muscle

participates in the flexion of the trunk and can stretch the iliac fascia.” NIH, National Library of Medicine,

Anatomy, Bony Pelvis and Lower Limb, Iliopsoas Muscle, www.ncbi.nlm.nih.gov/books/NBK531508/ (last

accessed Sept. 6, 2022).

24

The petitioner did not report any left shoulder pain when she saw [] Dr. Konieczny

on November 3, 201[6]. That was just one month after the index event, and there is

no mention of any left arm symptoms. Dr. Konieczny evaluated petitioner for any

signs of MS after a long break in care for that condition, and his record shows that

he tested every extremity, including the petitioner’s upper extremity, for which she

reported no pain with exam maneuvers.

First Abrams Rep. at 10. This failure to mention left shoulder pain was despite the fact that, as

stated in her affidavit, Petitioner was experiencing so much pain that she could not hold a coffee

cup with her left hand. Ex. 12 at 2.

Petitioner conceded that she did not mention shoulder pain to Dr. Konieczny at the

November 3, 2016 visit. See Ex. 12 at 2. 8 She averred that the reason for this omission was

“because the problem with my shoulder was not related to my MS.” Ex. 12 at 2. However,

Petitioner not only failed to mention shoulder pain to Dr. Konieczny, but she also did not exhibit

any pain during the comprehensive physical exam performed by her neurologist. The fact that

Petitioner did not mention left shoulder pain during this visit with her neurologist or exhibit any

left shoulder pain during the physical exam he performed is a significant fact which suggests that

she was not experiencing left shoulder pain at the time she presented to Dr. Konieczny.

Petitioner did not mention left shoulder pain until her next medical appointment, which

was on November 22, 2016. 9 Petitioner presented to Dr. Kimberly Combs complaining of

moderate left arm/shoulder pain which began after her 10/3/16 flu vaccine. Ex. 2 at 10. An

examination revealed that Petitioner’s pain radiated “from the le[ft] shoulder down into forearm.”

Id. at 13. Dr. Combs referred Petitioner to an orthopedist. Id.

On December 14, 2016, Petitioner was seen at OrthoVirginia by Dr. Ian Smithson. Ex. 7

at 56. Under “history of present illness”, Dr. Smithson’s notes indicate that “[f]or the past 2

months, [Petitioner] has had shooting pain radiate from her anterior shoulder down her forearm.

She believes the flu shot stemmed her pain that she received on 10/3/16.” Id.

Petitioner’s shoulder was tender to “palpitation at [the] anterior shoulder,” and her range

of motion exam revealed she had a loss of internal and external rotation. Ex. 7 at 57. Dr. Smithson

explained to Petitioner that he did not believe her symptoms were related to her flu shot. Id. at 56.

He assessed her with adhesive capsulitis of the left shoulder. Id. Dr. Smithson further noted that

Petitioner was seeking information “because she has been consulting a lawyer regarding flu shot

being administered incorrectly.” Id.

8

In her brief, Petitioner also conceded that the notes from this visit “are admittedly inconsistent with

Petitioner’s account of constant and debilitating pain with reduced range of motion in her left shoulder.”

Pet’r’s Mot. at 8.

9

On November 16, 2016, Petitioner was seen for an MRI of her cervical spine. She did not mention left

shoulder pain at this appointment either. Ex. 6 at 23.

25

Petitioner returned to Dr. Konieczny on January 5, 2017. Ex. 6 at 20. The purpose of this

visit was to discuss the results of her MRI, which revealed “at least 15 white matter lesions of both

cerebral hemispheres without enhancement and no intrinsic cord signal changes… The brain MRI

was judged to be stable from prior in 2011.” Id. Accordingly, like the last visit with Dr. Konieczny,

Petitioner visited her neurologist to discuss issues surrounding her MS. However, unlike her prior

visit with Dr. Konieczny, in the review of systems section from the January 5, 2017 appointment,

Dr. Konieczny documented:

Musculoskeletal Present- Arm or Leg Pain and Arm Weakness. Not Present- Muscle Pain and

Weakness.

Id. There is no indication from this record that Petitioner’s arm or leg pain and arm weakness

involved her MS. This fact further reduces the persuasiveness of her explanation that she did not

mention shoulder pain to Dr. Konieczny on November 3 because she was seeing him for MS.

In general, contemporaneous medical records are presumed to be accurate and

complete. Cucuras v. Sec'y of Health & Hum. Servs., 933 F.2d 1525, 1528 (Fed. Cir. 1993). In

assessing when Petitioner developed pain in her left shoulder/arm, I have credited the medical

records from November 3, 2016 over those from November 22, 2016.

By the time Petitioner presented to her December 14, 2016 medical appointment with Dr.

Smithson, she was actively pursuing her vaccine claim. This point further reduces the value of this

record, as it was created in anticipation of litigation. 10 See, e.g., Sheets v. Sec'y of Health & Hum.

Servs., No. 16-1173V, 2019 WL 2296212 at *19 (Fed. Cl. Spec. Mstr. Apr. 30, 2019) (finding that

later-in-time statements whether made to treaters or prepared for purposes of litigation do not

suffice to contradict contemporaneous records); Goodgame v. Sec'y of Health & Hum. Servs., No.

17-339V, 2019 WL 4165275 at *4 (Fed. Cl. Spec. Mstr. Jul. 30, 2019) (giving little weight to

medical records prepared after a doctor’s visit that petitioner attended “at the recommendation of

her lawyer.”).

I have also considered the Kirby case in arriving at my factual determination in the case at

bar. In Kirby, a portion of the petitioner’s medical records were silent regarding the persistence of

her symptoms. The Federal Circuit held that medical records are not presumptively accurate and

complete as to all [of a] patient’s physical conditions. Kirby v. Sec’y of Health & Hum. Servs, 997

F.3d 1378, 1382-83 (Fed. Cir. 2021). The Circuit held that a reasonable fact finder could find that

petitioner’s testimony of ongoing pain did not conflict with the records which were silent about

either the existence or the nonexistence of such symptoms. Id. at 1383. The Circuit noted that the

silence in the Kirby records could be explained by the fact that petitioner had “reached maximum

medical improvement and thus exhausted all available treatment.” Id. This final point is certainly

a difference between the petitioner in Kirby and the petitioner in this case. Petitioner had never

sought treatment for left arm pain that she associated with vaccination.

Based on the particular facts of this case, I find that Petitioner’s silence about left

arm/shoulder pain on November 3, 2016 raises substantial question about whether such pain

10

I find the medical records documenting Petitioner’s later medical visits to be unpersuasive for the same

reason. See e.g., Ex. 7 at 60. Ex. 8 at 6. Ex. 13 at 18.

26

existed at that time. Petitioner first mentioned shoulder pain to a medical provider on November

22, 2016, approximately 50 days after vaccination.

Ultimately, for the reasons discussed in this decision, I find there is not preponderant

evidence to support the onset of shoulder pain within 48 hours of vaccination. Instead,

preponderant evidence supports that Petitioner developed shoulder pain sometime between

November 4 and November 21, 2016, between 32 and 49 days after her October 3, 2016 flu

vaccine.

3. Pain and Reduced Range of Motion are not Limited to the Left Shoulder

Petitioner has not presented preponderant evidence that her “pain and reduced range of

motion are limited to the shoulder in which the intramuscular vaccine was administered” as

required by the QAI for SIRVA. 42 C.F.R. § 100.3(c)(10).

The medical records consistently document that Petitioner’s pain radiated from her

shoulder down her arm. See Ex. 2 at 13 (medical visit from November 22, 2016 documenting that

Petitioner’s pain radiated “from the le[ft] shoulder down into [the] forearm.”); Ex. 7 at 56

(appointment with orthopedist who noted Petitioner “has had shooting pain radiate from her

anterior shoulder down her forearm.”); Ex. 7 at 60 (physical therapy appointment which

documented that Petitioner “developed left shoulder pain … which goes down arm.”); Ex. 8 at 6

(appointment with orthopedist who documented “for the past 5 months, [Petitioner] has had

shooting pain radiate from her anterior shoulder down her forearm.”). Because Petitioner’s pain is

not limited to her shoulder, she does not meet this element required to establish a Table injury.

4. Petitioner has Other Conditions that Explain her Symptoms

I have conducted a thorough analysis of Petitioner’s other conditions in my discussion of

the second Althen prong. Ultimately, I find there is no reason to conclude that Petitioner’s shoulder

pain is separate and distinct from these other conditions.

Although Petitioner has presented preponderant evidence that she had no history of pain,

inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration

that would explain her signs and symptoms of left shoulder pain, she has not preponderantly

demonstrated that her pain began within 48 hours of vaccine administration, that her reduced range

of motion is limited to her left shoulder, or that she has no other condition or abnormality that

would explain her symptoms. Accordingly, she has not established the elements of a Table Injury.

B. Causation in Fact

Even though Petitioner has not demonstrated that she suffered from a Table Injury, she

may still be entitled to compensation if she can establish each element of the three part Althen test.

1. Althen Prong One

Under Althen’s first prong, the causation theory must relate to the alleged injury. Petitioner

27

must provide a “reputable” medical or scientific explanation, demonstrating that the vaccines

received can cause the type of injury alleged. Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d

1352, 1355-56 (Fed. Cir. 2006). The theory must be based on a “sound and reliable medical or

scientific explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir.

1994). It must only be “legally probable, not medically or scientifically certain.” Id. at 549.

There is little question that a vaccine (to include the flu vaccine) can cause a SIRVA. The

Vaccine Injury Table indicates that a SIRVA can be presumed to be caused by the flu vaccine if

certain criteria are met. The Court of Federal Claims has noted that the existence of a Table injury

can help a petitioner to meet Althen’s first prong. See Doe 21 v. Sec'y of Health & Hum. Servs., 88

Fed. Cl. 178, 199 (2009), rev’d on other grounds, 527 Fed. Appx. 875 (Fed. Cir.

2013) (determining that a petitioner fulfilled Althen prong one, in part, because “the Table

recognizes that a vaccine containing pertussis can cause encephalopathy[ ]”). Additionally, the

Court of Federal Claims indicated that “a medical theory causally connecting” a given vaccine and

a given injury that has been “well recognized by the Office of Special Masters[ ]” can support a

petitioner’s fulfillment of the first prong. See id. Special masters have previously taken judicial

notice that the Table links SIRVA to certain vaccines and have also found that “there is a well-

established track record of awards of compensation for SIRVA being made on a cause-in-fact basis

in this program.” See, e.g., Porcello v. Sec’y of Health & Hum. Servs., No. 17-1255V, 2020 WL

4725507 at *6 (Fed. Cl. Spec. Mstr. June 22, 2020).

Dr. Natanzi opined that the overpenetration of the vaccine needle into the upper portion of

the deltoid can cause an inflammatory response leading to adhesive capsulitis. First Natanzi Rep.

at 11. This opinion is supported by the medical literature filed in this case. See e.g., Cross et al.,

Don’t aim too high: Avoiding shoulder injury related to vaccine administration, 45 AFP 5, 303-

06 (2016) (filed as Ex. 24); Bodor & Montalvo, Vaccination-related shoulder dysfunction, 25

VACCINE, 585-87 (2007) (filed as Ex. 25); Degreef & Debeer, Post-vaccination Frozen Shoulder

Syndrome. Report of 3 Cases, 112 ACTA CHIR BELG, 447-49 (2012) (filed as Ex. 28). I find this

theory to be sound and reliable. Accordingly, Petitioner has presented preponderant evidence in

support of the first Althen prong.

2. Althen Prong Two

Under Althen’s second prong, a petitioner must “prove a logical sequence of cause and

effect showing that the vaccination was the reason for the injury.” Althen, 418 F.3d at 1278. The

sequence of cause and effect must be “'logical' and legally probable, not medically or scientifically

certain.” Id. A petitioner is not required to show “epidemiologic studies, rechallenge, the presence

of pathological markers or genetic disposition, or general acceptance in the scientific or medical

communities to establish a logical sequence of cause and effect.” Id. (omitting internal citations).

Capizzano, 440 F.3d at 1325. Instead, circumstantial evidence and reliable medical opinions may

be sufficient to satisfy the second Althen prong.

The evidence in this case suggests that Petitioner’s shoulder pain was likely caused by

28

either her uncontrolled diabetes or osteoarthritis of the left shoulder. 11 The existence of these other

medical conditions reduces the persuasiveness of Petitioner’s showing that the vaccine “did cause”

her condition. See K.L. v. Sec’y of Health & Hum. Servs., 134 Fed. Cl. 579, 598 (Fed. Cl. 2017)

(“regardless of whether the burden of proof ever shifts to the respondent, the special master may

consider the evidence presented by the respondent in determining whether the petitioner has

established a prima facie case”) (internal citations omitted).

a. Diabetes Mellitus

It is uncontested that Petitioner has a significant medical history of uncontrolled diabetes.

As Dr. Abrams noted in his report, Petitioner’s A1c 12 and blood sugar values in the years prior to

vaccination were severely elevated and included the following: A1c of 15.0% on September 26,

2012 (Ex. 2 at 205); blood glucose of 521 on July 15, 2013 (Ex. 2 at 96); A1c of 10.65% on March

27, 2014 (Ex. 2 at 140); A1c of 10.6% on May 8, 2015 (Ex. 2 at 130); A1c of 10.6% on October

3, 2016 (Ex. 2 at 113). A normal A1c range is 4.50-5.70. Ex. 2 at 140.

As Dr. Abrams noted in his first expert report, “There is a significant and profound effect

of the petitioner’s diagnosis of uncontrolled diabetes (and subsequent predisposition to

inflammation and shoulder pathology) on the overall pain, function, and structure of her shoulder.”

First Abrams Rep. at 6. This position is supported by the medical literature.

Diabetes is the “single greatest risk factor” for the development of adhesive capsulitis. First

Abrams Rep. at 6; citing Jason Ramirez, Adhesive Capsulitis: Diagnosis and Management, 99 AM

FAM PHYSICIAN 5, 297-300 (2019) (filed as Ex. A, Tab 1) (hereinafter “Ramirez”); Redler &

Dennis, Treatment of Adhesive Capsulitis of the Shoulder, 27 J AM ACAD ORTHOP SURG, e544-54

(2019) (filed as Ex. A, Tab 2). The Ramirez article described a 2016 study, which concluded that

patients with diabetes “were five times more likely than the control group to have adhesive

capsulitis.” Ramirez at 297. Additionally, Shah et al., noted that 63% of a group of participants

with type 2 diabetes had shoulder pain or disability. Shah et al., Upper extremity impairments, pain

and disability in patients with diabetes mellitus, 101 PHYSIOTHERAPY 2, 147-54 (2015) (filed as

Ex. C, Tab 1).

Dr. Abrams described the biological process at play. He opined that “hyperglycemia

permanently alters tissue macromolecules through accelerated advanced glycation end-products

(AGEs) formation.” First Abrams Rep. at 7; citing Michael Brownlee, Glycation Products and the

Pathogenesis of Diabetic Complications, 15 DIABETES CARE 12, 1835-43 (1992) (filed as Ex. A,

11

I have not assessed whether Respondent has established alternate causation by preponderant evidence,

and instead have considered this evidence in so much as it reduces the strength of Petitioner’s Althen prong

two showing.

12

“The A1C test is a blood test that provides information about your average levels of blood glucose, also

called blood sugar, over the past 3 months. The A1C test can be used to diagnose type 2

diabetes and prediabetes. The A1C test is also the primary test used for diabetes management.” The A1C

Test & Diabetes, NIH, National Institute of Diabetes and Digestive and Kidney Diseases,

www.niddk.nih.gov/health-information/diagnostic-tests/a1c-test (last accessed Sept. 8, 2022).

29

Tab 6); Brownlee et al., Advanced Glycosylation End Products in Tissue and the Biochemical

Basis of Diabetic Complications, 318 N ENGL J MED. 20, 1315-21 (1988) (filed as Ex. A, Tab 7).

Dr. Abrams noted that AGEs have been found in cases of adhesive capsulitis. First Abrams Rep.

at 7; citing Hwang et al., Advanced glycation end products in idiopathic frozen shoulders, 25 J

SHOULDER ELBOW SURG. 6, 981-88 (2016) (filed as Ex. A, Tab 4). “Clinically, these factors change

the biological properties of the shoulder joint capsule to decrease its elasticity.” First Abrams Rep.

at 7; citing Wu et al., Elasticity of the Coracohumeral Ligament in Patients with Adhesive

Capsulitis of the Shoulder, 278 RADIOLOGY 2, 458-64 (2016) (filed as Ex. A, Tab 8).

In fact, Dr. Natanzi accepted this point in his expert report. He stated: “It is undeniable that

Ms. Nicholson has a history of uncontrolled DM. It is also equally undeniable that those with DM

and especially uncontrolled DM have an increased chance of developing adhesive capsulitis

(AC).” Second Natanzi Rep. at 1. 13 He went on to note that the Chan article stated that “for each

unit that the HbA1c level was greater than 7, the risk of developing AC increased 2.7%.” 14 Id. He

then concluded as follows:

Ms. Nicholson’s HbA1c in October 2016 was around 10.6%. Using this general

formula, the chance of Ms. Nicholson spontaneously developing AC related to DM

is approximately 20 – 46%. As such, mathematically, even in light of her

uncontrolled DM it is more likely than not that DM mediated AC does not develop.

In other words, just because on[e] may have DM or even uncontrolled DM - it may

increase your chance but does not guarantee development of DM mediated AC.

Id. As noted, Dr. Abrams disagreed and opined that because the risk of developing adhesive

capsulitis is cumulative over time, Petitioner’s risk was higher than 20-46%. Second Abrams Rep.

at 1-2.

Ultimately, it is clear that patients with uncontrolled diabetes have an increased risk of

developing adhesive capsulitis, and that Petitioner’s diabetes was uncontrolled for years before

she developed adhesive capsulitis. As such, a preponderance of the evidence demonstrates that

13

Petitioner also acknowledged this point in her brief. She stated: “Petitioner concedes that the prior history

of diabetes, and the worsening of symptoms from diabetes in the 18 months leading up to vaccination,

clearly do present a strong risk factor for Petitioner’s shoulder injury.” Pet’r’s Mot. at 27. Petitioner argues,

however, that this clinical picture “created a situation ripe for immune dysregulation” and that the vaccine

Petitioner received was a substantial causal factor in her development of a shoulder injury. Id. However,

this position is not persuasive. Petitioner has not presented any evidence that this happened in her case. In

fact, my findings that her pain began between 32 and 49 days after vaccination strongly suggests that this

theory is inapplicable to the specific facts of Petitioner’s case.

14

Petitioner never filed this article into the record, so I am unable to assess the merit of Dr. Natanzi’s

position. I do note that Dr. Abrams disagreed with this interpretation of the Chan article. See Second Abrams

Rep. at 1-2.

30

Petitioner’s uncontrolled diabetes is a likely explanation for her development of adhesive

capsulitis.

b. Osteoarthritis

Dr. Abrams noted that “[s]houlder arthritis in another leading cause of shoulder pain in the

general population.” First Abrams Rep. at 8; citing Millet et al., Shoulder Osteoarthritis: Diagnosis

and Management, 78 AM FAM PHYSICIAN 5, 605-11 (2008) (filed as Ex. A, Tab 10). Dr. Natanzi

acknowledged that “OA and SIRVA both present with shoulder pain and limited range of motion;

therefore, they can be challenging to distinguish based on physical exam alone.” Second Natanzi

Rep. at 2.

However, Petitioner did not only have a physical exam. Petitioner had an x-ray of her left

shoulder on December 14, 2016 which demonstrated “[j]oint space narrowing of glenohumeral

and AC joint.” Ex. 7 at 56-57. Dr. Abrams opined that these x-ray results demonstrate that

Petitioner has arthritis of the left shoulder, which he described as “a well known source of waxing

and waning shoulder pain.” First Abrams Rep. at 5. Accordingly, Petitioner’s osteoarthritis of the

left shoulder is also a condition that explains her shoulder pain.

c. Treating Physicians

I further note that none of Petitioner’s treating doctors linked her vaccination with her

shoulder pain. In fact, Dr. Smithson, Petitioner’s treating orthopedist, noted the following during

Petitioner’s December 14, 2016 medical appointment: “I advised Ms. Nicholson that I do not

believe her symptoms are related to her flu shot.” Ex. 7 at 56.

In weighing evidence, special masters are expected to consider the views of treating

doctors. Capizzano, 440 F.3d at 1326. The views of treating doctors about the appropriate

diagnosis are often persuasive because the doctors have direct experience with the patient whom

they are diagnosing. See McCulloch v. Sec’y of Health & Hum. Servs., No. 09-293V, 2015 WL

3640610, at *20 (Fed. Cl. Spec. Mstr. May 22, 2015). The fact that Dr. Smithson disavowed any

connection between Petitioner’s flu vaccine and her shoulder injury is persuasive evidence that the

vaccine did not play any role in her condition.

For these reasons, Petitioner has failed to establish the second Althen prong by

preponderant evidence.

3. Althen Prong Three

The timing prong contains two parts. First, a petitioner must establish the “timeframe for

which it is medically acceptable to infer causation” and second, she must demonstrate that the

onset of the disease occurred in this period. Shapiro v. Secʼy of Health & Hum. Servs., 101 Fed.

Cl. 532, 542-43 (2011), recons. denied after remand on other grounds, 105 Fed. Cl. 353 (2012),

aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013).

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As discussed in the analysis of her Table claim, I find that Petitioner developed shoulder

pain sometime between November 4 and November 21, 2016, between 32 and 49 days after her

October 3, 2016 flu vaccine. Petitioner has presented no persuasive evidence which suggests a

shoulder injury caused by vaccination can develop this long after vaccine administration. In fact,

her medical literature indicates onset of shoulder pain generally occurs within approximately two

days of vaccination. Significantly, Petitioner’s expert did not provide an opinion explaining how

shoulder pain could develop 32-49 days after vaccination.

Other special masters have considered this issue and have determined that a timeline

between vaccination and onset of pain such as the one in the present case does not constitute a

medically acceptable temporal interval. See, Clavio v. Sec’y of Health & Hum. Servs., No. 17-

1179V, 2022 WL 1078175 (Fed. Cl. Spec. Mstr. Feb. 16, 2022) (finding that 59 days between

vaccination and onset of shoulder pain fails to satisfy the third Althen prong); Mack v. Sec’y of

Health & Hum. Servs., No. 15-149V, 2016 WL 5746367 at *8 (Fed. Cl. Spec. Mstr. July 14, 2016)

(finding that a 42 day onset between vaccination and onset of shoulder pain is not a medically

acceptable timeframe to infer causation in a SIRVA case). C.C. v. Sec’y of Health & Hum. Servs.,

No. 17-708V, 2021 WL 2182817 at *20, 23 (Fed. Cl. Spec. Mstr. Mar. 31, 2021) (concluding that

a one week onset in a SIRVA case was not medically appropriate given the theory of causation).

For these reasons, I find that Petitioner has not presented preponderant evidence in support

of the third Althen prong.

VII. Conclusion

Upon careful evaluation of all the evidence submitted in this matter, including the medical

records, medical literature, the affidavits, as well as the experts’ opinions, I conclude that Petitioner

has not shown by preponderant evidence that she is entitled to compensation under the Vaccine

Act. Her petition is therefore DISMISSED. The clerk shall enter judgment accordingly. 15

IT IS SO ORDERED.

s/ Katherine E. Oler

Katherine E. Oler

Special Master

15

Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by each filing (either jointly

or separately) a notice renouncing their right to seek review.

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