Small v. Secretary of Health and Human Services

REISSUED FOR PUBLICATION

DEC 2 2019

OSM

U.S. COURT OF FEDERAL CLAIMS

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 15-478V

Filed: November 1, 2019

PUBLISHED

ADINA SMALL,

Special Master Horner

Petitioner,

v. Dismissal; Ruling on the Written

Record; Influenza (flu) Vaccine;

SECRETARY OF HEALTH AND Shoulder Injury Related to Vaccine

HUMAN SERVICES, Administration; SIRVA; Injection

Injury; Direct Nerve Trauma

Respondent.

Ronald Craig Homer, Conway, Homer, P.C., Boston, MA, for petitioner.

Lynn Christina Schlie, U.S. Department of Justice, Washington, DC, for respondent.

DECISION 1

On May 11, 2015, petitioner, Adina Small, filed a petition under the National

Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012), 2 alleging that she

suffered a Shoulder Injury Related to Vaccine Administration or “SIRVA” caused-in-fact

by her February 12, 2013 influenza (“flu”) vaccination. A SIRVA is a musculoskeletal,

rather than neurological, injury manifesting as shoulder pain and reduced range of

motion. E.g. 42 C.F.R. §100.3(c)(10). Subsequently, however, although she did not

amend her petition, petitioner later submitted expert opinion indicating that petitioner’s

shoulder injury was a direct result of a nerve injury. For the reasons set forth below, I

conclude that petitioner is not entitled to an award of compensation under either theory.

1 Because this decision contains a reasoned explanation for the special master’s action in this case, it will

be posted on the United States Court of Federal Claims’ website in accordance with the E-Government

Act of 2002. See 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic

Government Services). This means the decision will be available to anyone with access to the

Internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact

medical or other information the disclosure of which would constitute an unwarranted invasion of privacy.

If the special master, upon review, agrees that the identified material fits within this definition, it will be

redacted from public access.

2Throughout this decision all references to “§ 300aa-“ refer to specific sections of the Vaccine Act at 42

U.S.C. § 300aa-10-34.

1

I. Procedural History

As noted above, petitioner commenced this action on May 11, 2015, alleging that

she suffered a SIRVA in her left shoulder that was caused-in-fact by her February 12,

2013 flu vaccination. (ECF No. 1.) Based on the allegations in the petition, the case

was assigned to the Special Processing Unit (“SPU”). (ECF No. 5.) The SPU “is

designed to expedite the processing of claims that have historically been resolved

without extensive litigation.” (Id. at 1.) Cases assigned to the SPU remain on the Chief

Special Master’s docket. 3

Initially, petitioner supported her petition with medical records marked as Exhibits

1-14 and affidavits marked Exhibits 15-17. (ECF Nos. 6-8.) A statement of completion

was filed on May 18, 2015. (ECF No. 9.)

Respondent filed a Rule 4 Report on September 15, 2015. (ECF No. 16.)

Respondent recommended against compensation, noting (1) there is no

contemporaneous medical documentation demonstrating that petitioner received the flu

vaccination in her left arm; (2) petitioner received both a vaccine covered by this

program (flu) and a non-covered vaccine (shingles) at the same time and the

vaccination record does not identify the site of either vaccination; (3) petitioner did not

report her alleged vaccine-caused shoulder pain until ten months after her vaccination

despite seeing her primary care doctor twice during that period; (4) petitioner had a

years-long history of recurring neck pain radiating to both extremities; and (5) petitioner

was diagnosed by a neurologist as having neuritis, which is not consistent with SIRVA.

(Id. at 8-9.)

Within the SPU, the Chief Special Master held a Rule 5 status conference 4 to

provide the parties with her preliminary assessment. (ECF No. 24.) The Chief Special

Master preliminarily found preponderant evidence that petitioner received her February

12, 2013 flu vaccine in her left arm and that her flu vaccine was a more likely cause of

her injury than her shingles vaccine. (Id. at 1-2.) She also noted that petitioner had

provided evidence of an extenuating circumstance that could explain petitioner’s delay

in seeking treatment. (Id. at 2.) For this reason, she felt that respondent maintained

litigative risk, suggesting an onset ruling could potentially favor petitioner. (Id.)

Nonetheless, the Chief Special Master cautioned that petitioner also maintained

litigative risk due to her diagnosis of neuritis, her history of cervical pain, and references

in her medical records to a possible lifting injury. (Id.)

3At the time this petition was filed, the Chief Special Master was Denise Vowell. (ECF Nos. 4-5.)

However, shortly after the case was filed, Nora Beth Dorsey became Chief Special Master and the case

was reassigned to her docket. (ECF No. 14.)

4 Vaccine Rule 5 provides that following respondent’s filing of his report setting forth his position regarding

entitlement (in accordance with Vaccine Rule 4), the special master may hold a status conference to “(1)

afford the parties an opportunity to address each other’s position; (2) review the materials submitted and

evaluate the parties’ respective positions; and (3) present tentative findings and conclusions.” Vaccine

Rule 5(a). Such findings are not final; rather, the conference allows the special master the opportunity to

“issue a scheduling order outlining the necessary proceedings for resolving the issues presented in the

case.” Vaccine Rule 5(b).

2

Following the Chief Special Master’s review, respondent confirmed that he

intended to continue defending the case. (ECF No. 26.) As a result, the case was

removed from the SPU and reassigned to Special Master Millman on April 27, 2016.

(ECF No. 28.)

On May 17, 2016, Special Master Millman held a status conference with the

parties in which she reviewed petitioner’s medical records and concluded that petitioner

did not suffer a SIRVA, but agreed to allow petitioner the opportunity to file an expert

report from a neurologist. (ECF Nos. 29, 31.) In a subsequent status report, however,

petitioner expressed concern that Special Master Millman’s impression of the case was

in contrast to the Chief Special Master’s prior preliminary findings which were

suggestive of a SIRVA. (ECF No. 30.)

On June 29, 2016, Special Master Millman issued an order addressing

petitioner’s concern and explaining at length why petitioner’s injury does not constitute a

SIRVA. (ECF No. 31.) Following a comprehensive review of the medical records,

Special Master Millman disagreed with the Chief Special Master’s tentative conclusion

regarding onset. (Id. at 2, 7.) She also stressed, as the Chief Special Master had

observed, that petitioner’s injury had been treated by a neurologist as a nerve injury

rather than a musculoskeletal injury. (Id. at 2-3.) She recommended that petitioner

either dismiss her claim or provide an opinion by a neurology expert supporting her

claim. (Id. at 7.)

Subsequently, on August 23, 2016, petitioner filed a letter from her treating

neurologist, Nicholas Szumski, M.D., marked as Exhibit 18. (ECF No. 33.) Dr. Szumski

indicated that petitioner experienced a nerve injury to the lateral cutaneous nerve of the

arm directly caused by her injection which led indirectly to “frozen shoulder.”5 (Ex. 18,

pp. 1-2.) Special Master Millman subsequently required a supplemental report by Dr.

Szumski which was filed as Exhibit 19 on November 11, 2016. (ECF Nos. 34, 36.)

On February 9, 2017, respondent filed a responsive expert report by neurologist

Jeffrey Allen Cohen, M.D., marked as Exhibit A. (ECF No. 42-1.) Dr. Cohen opined

that petitioner’s clinical course is not consistent with the nerve injury proposed by Dr.

Szumski, that the flu vaccination would be unlikely to cause such an injury, and that

petitioner’s course is instead consistent with her documented cervical and radicular

symptoms. (Ex. A.)

On May 8, 2017, petitioner filed a second supplemental report by Dr. Szumski

responding to Dr. Cohen’s report (ECF No. 45-1; Ex. 20) and respondent filed a further

report by Dr. Cohen on June 14, 2017 (ECF No. 48; Ex. C). Thereafter, on July 6,

2017, the parties requested a hearing. (ECF No. 49.)

5 Frozen shoulder, or adhesive capsulitis, is an orthopedic condition of the shoulder characterized by pain

and reduced range of motion. The condition can occur idiopathically, but has also been associated with

vaccination and often appears as an underlying diagnosis in SIRVA claims. See, e.g., Gurney v. Sec’y of

Health & Human Servs., No. 17-481V, 2019 WL 2298790 (Fed. Cl. Spec. Mstr. Mar. 19, 2019).

3

Over the next four months the parties attempted, but failed, to set a hearing date.

(ECF Nos. 49-51.) On November 20, 2017, Special Master Millman held a status

conference to discuss the parties’ difficulty setting a hearing date. (ECF No. 51.) The

parties reported that they “are unable to set a date for an entitlement hearing because

petitioner’s expert Dr. Szumski cannot confirm a specific date in or after July 2019.

Respondent’s counsel does not want to move forward with scheduling a hearing without

confirmation from petitioner’s expert.” (Id.) Special Master Millman warned that “[i]f the

parties do not agree on a date for a hearing, there will be no progress in moving the

case to conclusion.” (Id.)

No further action was taken in the case for ten months. On September 6, 2018,

Special Master Millman issued an order noting the parties’ failure to act in the case for

ten months and advising of her anticipated retirement. (ECF No. 52.) She informed the

parties that “[w]hen this case is transferred to another special master upon the

undersigned’s retirement, the new special master will schedule a hearing date.” (Id.)

Again, no further action was taken in the case until nine months later when it was

reassigned to me following Special Master Millman’s retirement. (ECF No. 56.) In light

of the parties’ apparent inability to timely set a hearing date, and upon my own review of

the case, I informed the parties on June 24, 2019, that in accordance with Vaccine Rule

8(d) I intended to issue a decision based on the written record without holding a hearing

and set a briefing schedule. 6 (ECF No. 57.)

On July 24, 2019, petitioner filed a brief supporting her claim. (ECF No. 58.)

Respondent filed a response on August 22, 2019, and petitioner filed her reply on

September 5, 2019. (ECF Nos. 59-60.) Accordingly, this case is now ripe for a decision

regarding entitlement.

II. Factual History

a. As reflected in medical records

i. Prior history and pattern of care

Petitioner was born April 25, 1940. (See, e.g. Ex. 1, p. 1.) At the time of the

vaccination that forms the basis of her petition, she was 72. (Id.) Petitioner’s prior

medical records before 2013 are mostly unremarkable for back or shoulder problems,

but she did treat with a number of specialists.

6 Upon review of this case and for all the reasons described herein, I determined that a hearing was not

required to resolve the issues presented by the parties. Moreover, petitioner had a full and fair

opportunity to present Dr. Szumski’s opinion by filing three expert reports that clearly explain the basis for

his opinion. (Exs. 18-20.)

4

Beginning with records in 2010, petitioner treated with urologist Dino Deconcini,

M.D. (Ex. 6.) She described “kidney pains” throughout her adult life, but in February of

2010 reported “there has been increasing right flank pain recently associated with pelvic

pressure and urinary frequency.” (Id. at 1.) Dr. Deconcini felt petitioner’s flank pain was

likely chondritis, 7 but also noted, inter alia, “[b]ack pain – seems to be more

musculoskeletal.” (Id.) Following that assessment, she did not return to Dr. Deconcini

until March of 2014. (Ex. 6, p. 7.) Petitioner also treated with a nephrologist. (Ex. 12.)

From 2011 through 2014, petitioner was followed by endocrinologist David

Aftergood, M.D., for thyroid nodules. (Ex. 7.) She treated on multiple occasions with a

dermatologist in 2011 and 2012. (Ex. 11.) Beginning in 2012, petitioner began seeing

gastroenterologist Gil Melmed, M.D. (Ex. 8.) Petitioner also followed up regularly with

her gynecologist. (Ex. 9.) None of these treatment records reflect any complaints of

neck or shoulder pain and no indication of any relevant physical examination.

Petitioner was also followed regularly by Yaron Elad, M.D. at the Cardiovascular

Medical Group of Southern California. (Ex. 2.) Notably, however, petitioner relied on

Dr. Elad for the majority of her primary care in addition to her cardiovascular treatment. 8

Although Dr. Elad saw petitioner regularly for hypertension, hyperlipidemia, and chest

pain (Ex. 2, pp. 17, 26, 29, 32, 37, 43), petitioner has an established pattern of treating

with Dr. Elad for conditions unrelated to cardiology. For example, petitioner saw Dr.

Elad multiple times in 2010 with a chief complaint of “green mucus.” (Ex. 2, pp. 39, 41.)

She has also presented on two separate occasions (in 2010 and 2015) for “cough.” (Id.

at 35, 51.)

Additionally, even when she has presented to Dr. Elad for cardiovascular issues,

petitioner has discussed other, unrelated conditions. For example, in June of 2012, she

presented with a chief complaint of hyperlipidemia, but indicated that her “[b]iggest

problem has been with abdominal pain.” (Id. at 17.) Petitioner’s records reflect only

one visit to an internist in March of 2014. (Ex. 10.) Significantly, as described in greater

detail below, Dr. Elad was the first physician to whom she described the shoulder pain

for which she seeks compensation. (Ex. 2, pp. 5-8.)

ii. Medical records immediately prior to vaccination

Approximately one month prior to her alleged injury-causing vaccination, on

January 7, 2013, petitioner presented to her rheumatologist, Dr. Silverman, with a chief

complaint of “one year history of neck pain right.” (Ex. 13, p. 1.) She also complained

of “feeling of ants on body” and “swelling of right posterior trunk.” (Id.) Past medical

7 “Chondritis” is inflammation of cartilage. Dorland’s Illustrated Medical Dictionary (“Dorland’s”), 32nd Ed.,

p. 352.

8In the petition, Dr. Elad is identified as petitioner’s cardiologist. (ECF No. 1, p. 2.) In her affidavit,

however, petitioner identified Dr. Elad as her primary care physician. (Ex. 15, p. 2.)

5

history noted “cervicalgia/neck pain” and displacement of an intervertebral disc without

myelopathy. 9

Consistent with the past medical history he recorded, Dr. Silverman assessed

petitioner as having cervicalgia and displacement of an intervertebral disc without

myelopathy. (Ex. 13, p. 2.) He recommended an x-ray and MRI of the cervical spine.

(Id.) Petitioner had the recommended x-ray performed the same day and the MRI

performed about a week later, on January 15, 2013. (Id. at 3-5.)

Petitioner’s cervical x-ray showed discogenic disease at C3-4 and C6-7 as well

as at C5-6, though to a lesser degree, characterized by decreased height of the disc

space. (Ex. 13, p. 3.) Her MRI showed similar results. (Id. at 4-5.) The impression from

the MRI was (1) “the patient has borderline developmental cervical spinal stenosis 10 and

while she only has mild changes of cervical discogenic disease at C3-C4, C4-C5, C5-

C6 and to a lesser degree C6-C7, there are mild degrees of cord effacement without

evidence of cord signal alteration. There is little CSF space present about the cord from

C3-C6;” and (2) “[r]ight C3-C4, left C4-C5, neural foraminal stenoses.” (Id. at 4.)

Notably, at the time of her MRI, petitioner’s clinical information was reported as

“[r]ecurring neck pain radiating to both upper extremities for many years. There is no

history of trauma or surgery.” (Id.)

Petitioner returned to Dr. Silverman on January 28, 2013. (Ex. 13, pp. 7-8.) Her

chief complaint was right shoulder and right lower back pain. 11 (Id.) Dr. Silverman

reviewed petitioner’s MRI and added cervical spinal stenosis, lumbago, and “tender

Right QL” 12 to petitioner’s assessment. (Id. at 8.) At that time she also underwent

testing for osteoporosis. (Id. at 10-15.)

9“Myelopathy refers to “any of various functional disturbances or pathological changes in the spinal cord,

often referring to nonspecific lesions in contrast to the inflammatory lesions of myelitis.” Dorland’s, 32nd

Ed., p. 1220. Although the chief complaint indicated a one-year history, the past medical history listed the

date of this exam (January 7, 2013) as the date of onset of these conditions. (Ex. 13, p. 1.) The source

of the history is not indicated, but prior to that, petitioner was last seen by her rheumatologist on April 6,

2011. (Id. at 23.)

10 “Stenosis” refers to an abnormal narrowing. Dorland’s, 32nd Ed., p. 1769.

11Specifically, her record indicates “right sh and right LBP.” (Ex. 3, p. 7.) “Sh” and “LBP” are common

abbreviations for “shoulder and “low back pain” respectively. See Davis, N.M., Medical Abbreviations: 32,

000 Conveniences at the Expense of Communication and Safety, 15th Ed., pp. 186, 297.

12 In light of the reference to lumbago, “QL” likely refers to quadratus lumborum, an abdominal muscle on

either side of the lower back. “Lumbago” is a nonmedical term for any pain in the lower back. See

Dorland’s, 32nd Ed., p. 1076.

6

iii. Date of vaccination (February 12, 2013)

On February 12, 2013, petitioner returned to Dr. Silverman for a further follow up.

(Ex. 13, pp. 16-17.) She also went to Rite Aid Pharmacy for vaccination. (Ex. 1.) The

time of day for petitioner’s encounter is not indicated in the records of either facility. 13

Petitioner presented to Dr. Silverman with a chief complaint of “continued neck

pain with stiffness, decreased [range of motion].” (Ex. 13, p. 16.) Petitioner was

reportedly still symptomatic despite exercises and Aspercreme. (Id.) She was placed

on Boniva for osteoporosis diagnosed at that visit. (Id.) Decreased range of motion in

the neck was confirmed on physical exam. (Id.) Petitioner declined an injection to treat

her neck pain. (Id. at 17.) Dr. Silverman recommended physical therapy and provided

muscle relaxant. (Id.)

At Rite Aid, petitioner received both a Zostavax shingles vaccination and a

Fluzone influenza vaccination. (Ex. 1, p. 2.) The influenza vaccine was administered

intramuscularly while the shingles vaccine was administered subcutaneously. (Id.) The

injection site is not listed for either vaccine. (Id.)

iv. Medical records immediately following vaccination

On February 13, 2013, the day after her vaccination, petitioner presented to Joint

Effort Medical Wellness for physical therapy. 14 (Ex. 5, pp. 16-18.) At her initial

evaluation, petitioner presented with a chief complaint of “severe pain c/s15 [and] upper

trapezius muscles and lumbosacral pain.” (Id. at 16.) She rated her cervical pain as an

“8/10” and her lumbar quadrant pain as “7/10.” (Id.) Her past medical history indicates

that she was generally healthy with hypertension under control. (Id.) In providing the

history of her present complaint, however, petitioner reported that her cervical pain

resulted from a strain she suffered lifting her husband, who was suffering Parkinson’s

disease. (Id.) Left upper extremity pain does appear among a list of four problem

areas, but it is characterized as radicular pain. (Id. at 18.) Petitioner’s vaccinations are

not discussed in her physical therapy evaluation. Thereafter, petitioner attended

physical therapy sessions through February and March of 2013 to improve cervical

spine range of motion. (Ex. 5, pp. 10-16.)

On February 21, 2013, petitioner presented to Dr. Elad for a “follow up” visit. (Ex.

2, pp. 13-16.) Petitioner was noted to be “asymptomatic from a cardiovascular point of

view,” but she discussed the abdominal discomfort she had reported at her previous

13A subsequent VAERS report (as further described in Section II(a)(vi) below), drafted by the pharmacy

more than a year after the vaccinations, indicates that they were administered at approximately 2:00pm.

(Ex. 14.)

14 This provider’s records are all handwritten and are challenging to decipher.

15 I interpret this abbreviation to refer to cervical spine. See Davis, N.M., Medical Abbreviations, 15th Ed.,

p. 94.

7

appointment with Dr. Elad in June of 2012. (Id.) Petitioner also reported back pain.

(Id.) Petitioner did not report any shoulder pain at this visit. A review of symptoms

recorded that petitioner was “negative for myalgias and joint pain” under

musculoskeletal symptoms and musculoskeletal physical exam reflected “[n]ormal

range of motion. She exhibits no edema.” (Id. at 15.) Physical exam of the neck noted

“[n]ormal range of motion. Neck supple. No JVD 16 present.” 17 (Id.)

On August 1, 2013, petitioner followed up with her endocrinologist for a recheck

of her thyroid nodules. She was asymptomatic. (Ex. 7, pp. 13-15.) There was no

mention of petitioner’s shoulder or neck conditions and no indication of any

musculoskeletal physical exam. (Id.)

Petitioner returned to Dr. Elad on August 8, 2013. (Ex. 2, pp. 9-12.) As with her

prior February 21, 2013 visit, her chief complaint for this visit was again listed as “follow

up.” (Id. at 9.) She was again noted to be asymptomatic with regard to her

cardiovascular health, but discussed the stress caused by her husband’s condition and

the fact that she had a viral infection a few weeks prior. (Id.) She was noted to be

“doing okay.” (Id.) Again, no mention is made of any shoulder pain. As at the prior

February 21, 2013 visit, a review of symptoms recorded that petitioner was “negative for

myalgias and joint pain” under musculoskeletal symptoms and musculoskeletal physical

exam reflected “[n]ormal range of motion. She exhibits no edema.” (Id. at 11.) Physical

exam of the neck noted “[n]ormal range of motion. Neck supple. No JVD present.” (Id.)

v. First report and evaluation of post-vaccination shoulder pain

On December 12, 2013, ten months after receiving her vaccinations, petitioner

returned to Dr. Elad and reported vaccine-related shoulder issues for the first time. (Ex.

2, pp. 5-8.) Similar to her prior visits, petitioner’s chief complaint was listed only as

“follow up” and she discussed a number of issues, including the passing of her husband

two and a half months prior. (Id. at 5.) Her history indicates “[g]ot two vaccines at Rite-

Aid last February and can’t raise her arm since.” (Id.) Her record still reflects a lack of

musculoskeletal concerns – i.e. the review of symptoms recorded that petitioner was

“negative for myalgias and joint pain” under musculoskeletal symptoms and

musculoskeletal physical exam reflected “[n]ormal range of motion. She exhibits no

edema.” – however, Dr. Elad recommended that petitioner seek out a neurologist for

“persistent pain, weakness in left arm.” (Id. at 7-8.) Physical exam of the neck also

noted “[n]ormal range of motion. Neck supple. No JVD present.” (Id.)

About a month and a half later, petitioner presented to neurologist Nicholas

Szumski, M.D., for the first time on January 29, 2014. (Ex. 3, pp. 2-3.) At that time,

petitioner reported “[a]bout a year ago, got her flu and shingles va[ccinations] in L[eft]

16 Especially given Dr. Elad’s specialty, this likely refers to “jugular venous distention.” See Davis, N.M.,

Medical Abbreviations, 15th Ed., p. 181.

17Of note, these reported findings regarding petitioner’s neck and musculoskeletal symptoms appear

verbatim across a number of encounters even when they appear inconsistent with Dr. Elad’s more

detailed notations.

8

shoulder at the same time and spot. Immediately had pain radiating down lateral upper

arm, which she thought was normal at the time. Hasn’t changed in the year since,

maintaining an ovoid. Advil helps somewhat, but doesn’t use it too often – just avoids

tasks.” 18 (Id. at 2.)

On general exam, Dr. Szumski observed “[t]ender to palpation along lateral

upper arm with greatest focus just below lateral edge of proximal humerus within

deltoid.” (Ex. 3, p. 3.) Dr. Szumski noted “normal bulk throughout upper extremities” as

well as “[f]ull 5/5 power demonstrated proximally and distally in upper extremities,

including the L[eft] deltoid, but pain with abduction.” (Id.) Based on the history of onset

at the time of vaccination, Dr. Szumski concluded that “[o]nset and anatomy correlate

strongly with injury to the lateral cutaneous nerve of the arm branching from the axillary

nerve within the deltoid.” (Id.) He diagnosed petitioner with “neuritis” and

recommended physical therapy. (Id.)

Petitioner returned to Joint Effort Medical Wellness for physical therapy on

February 3, 2014. (Ex. 5, p. 6.) She was evaluated for her left shoulder complaints, the

pain from which she rated as “9/10.” (Id.) She attended several physical therapy

sessions related to her left shoulder through March 3, 2014. (Id. at 1-6.)

During this period, petitioner also presented to Wells Chiropractic Group on

February 14, 2014, complaining of left deltoid and upper arm pain with limited

movement. (Ex. 4, pp. 1, 5.) She attributed her condition to the flu and shingles

vaccines she previously received at Rite Aid and rated her pain as “6” and “7” out of

“10.” (Id.) At this visit, petitioner was marked as having received both a chiropractic

adjustment and acupuncture. (Id. at 1.) A notation regarding “call back” indicates that

petitioner was contacted on February 19, 2014. (Id.) Petitioner’s response to treatment

is recorded as “complete ROM and relief of pain” and petitioner is quoted as having

stated she is “Just fine! It’s a miracle!” (Id.) Notably, however, petitioner’s physical

therapy records indicate at this time that, while she was progressing as expected,

further treatment was warranted. (Ex. 5, p. 2.) Only as of March 3, 2014, did the

physical therapist stop recommending further treatment. (Id. at 1.)

On March 10, 2014, petitioner visited an internist with a chief complaint of

“cough.” (Ex. 10, p. 1.) Petitioner made no report of her history of shoulder pain and no

findings were reported on physical examination. (Id. at 2.) A chest x-ray was

completed which showed no abnormalities. (Id. at 5.)

On March 13, 2014, petitioner returned to Dr. Szumski. (Ex. 3, pp. 1-2.) Dr.

Szumski recorded an interval history indicating that petitioner discontinued physical

therapy because it was very painful. (Id. at 1.) He recorded that the physical therapist

18 Dr. Szumski’s record indicates that petitioner also “filled out a 14-system review of systems checklist”

that is not a part of the record of this case. (Ex. 3, p. 3.) The notation indicates, however, that “[p]ertinent

positives and negatives are listed above in the history.” (Id.)

9

suspected frozen shoulder. 19 (Id.) He also noted that petitioner reported “immediate

improvement” after a single session of acupuncture. He noted that petitioner “[n]ow has

been doing better, can do her [activities of daily living].” (Id.) Upon exam, Dr. Szumski

recorded “[i]mproved L[eft] [active range of motion]. Still has focal tenderness on lateral

upper arm just below shoulder.” (Id.) Dr. Szumski’s assessment remained neuritis, but

he noted it to be “[m]arkedly improved at this point.” He noted that petitioner “[m]ay

continue acupuncture, PT when ready and needed” and recommended that petitioner

return in three months. (Id. at 2.)

vi. VAERS report

On March 13, 2014, a Rite Aid Pharmacy employee completed a Vaccine

Adverse Event Report System (“VAERS”) report regarding petitioner’s left shoulder

condition. (Ex. 14.) That document describes her condition as follows: “Left arm-pain

unbearable at time of injections. 2 months later still experiencing pain + unable to move

arm.” The form lists both the shingles and flu vaccines. (Id.)

vii. Subsequent history

On March 21, 2014, petitioner saw her urologist, Dr. Deconcini, for renal colic,

hydronephrosis, and renal cyst. (Ex. 6, pp. 2-4.) She had a renal ultrasound performed.

(Id. at 7.) No mention is made of petitioner’s shoulder.

On June 6, 2014, petitioner returned to Dr. Elad for treatment of her

hypertension. (Ex. 2, pp. 1-4.) She reported that Dr. Szumski had diagnosed her with

neuritis and that physical therapy had been no help. (Id. at 1.) She reported, however,

that acupuncture had provided immediate relief with only one treatment, though she still

had some residual pain. (Id.) Neck and musculoskeletal findings were reportedly the

same as during previous encounters. (Id. at 3.)

Petitioner returned to Dr. Elad on November 7, 2014, regarding dyslipidemia, and

on January 26, 2015, regarding a cough. (Ex. 2, pp. 47-54.) Neither of these

encounters include any notation regarding petitioner’s left shoulder pain.

On March 4, 2015, petitioner returned to Dr. Elad to discuss her cardiac risk

factors. (Ex. 2, pp. 55-58.) At that time, petitioner reported that she was experiencing

right arm pain which she associated with her flu shot. 20 (Id. at 55.) Petitioner reportedly

19 The record of petitioner’s February 3, 2014 physical therapy evaluation includes a notation that appears

to indicate “neg for frozen” under the heading of “MRI/X-ray.” (Ex. 5, p. 6.) However, it is not clear to what

imaging this notation could be referring. There are no imaging reports for petitioner’s shoulder included in

her medical records. The same record references “a moderate frozen shoulder” within the history of

complaint section. (Id.)

20 Dr. Elad’s March 4, 2015 record does not indicate to which flu vaccination petitioner is referring. (Ex. 2,

p. 55.) In her petition, petitioner asserts that this is a reference to a vaccination administered at Dr. Elad’s

office on November 7, 2014. (ECF No. 1, p. 4 (citing Ex. 2, pp. 47-50.) Although petitioner’s November

10

intended to pursue acupuncture, but Dr. Elad made no findings or recommendations

regarding her reported right shoulder pain. (Id. at 55-58.)

No further records have been filed.

b. As reflected in affidavits

i. Petitioner’s affidavit

In support of her claim, petitioner submitted an affidavit signed April 11, 2015.

(Ex. 15.) Petitioner reported having received both of her February 12, 2013

vaccinations in her left arm. (Id. at 1.) She averred that “[f]rom onset it was very painful

at the injection site. My mobility was very limited, and I moved around as if I were in a

sling even though I was not. Over the course of a few months, the pain then spread to

my entire shoulder.” (Id.)

Petitioner further indicated that “a few months” after the vaccine, she was unable

to use her arm to dress, do her hair, or prepare food. (Id. at 2.) She averred that at that

time she returned to Rite Aid to complain about the pain but was told it was normal.

(Id.) Petitioner reports that she returned to Rite Aid again in the summer of 2013, but

was again told the pain was normal and would go away. (Id.)

Petitioner’s husband died on September 17, 2013. Prior to his death, he

experienced a long battle with Parkinson’s disease, and petitioner was his caretaker.

(Ex. 15, p. 2.)

Petitioner reported that it was only at the end of 2013, at the urging of her family,

that she made an appointment with Dr. Elad to address her shoulder pain. (Id.) With

regard to her subsequent history, petitioner indicated that she became frustrated by a

lack of progress she experienced in physical therapy and, as reflected in her medical

records, felt that her acupuncture treatment was responsible for her improved condition.

(Id. at 3.) Nonetheless, as of the date of her affidavit, petitioner indicated that she still

experienced tenderness around the area of her vaccination and was still unable to lift

her arm over her head. (Id.)

ii. Additional witness affidavit

In addition to her own affidavit, petitioner also filed an affidavit by her daughter,

Tanya Kramer, signed May 11, 2015. (Ex. 17.) Ms. Kramer indicated that her mother

told her about the pain she was experiencing following her vaccinations. (Id. at 1.) She

also noted that she sees her mother often and was able to see the limitations she was

experiencing in her left arm immediately after she received the vaccinations. (Id.) Ms.

Kramer also described how difficult petitioner’s condition was on her daily life and the

7, 2014 encounter record indicates the fact of administration of a flu vaccine, it does not indicate the

location of the injection. (Ex. 2, p. 50.)

11

circumstances that led her to recommend that petitioner seek treatment from an

acupuncturist. (Id. at 2.)

III. Expert Opinions

a. Petitioner’s expert, Nicholas Szumski, M.D.

Dr. Szumski is a neurologist at Cedars-Sinai Medical Group specializing in

general neurology and movement disorders. (Ex. 18, p. 1.) He has been a treating

physician of petitioner since January 29, 2014, as well as a long-time treating physician

for her husband’s Parkinson’s disease. (Id. at 1-2.) Dr. Szumski opined that petitioner

experienced two distinct “clusters” of symptoms attributable to two separate conditions.

First, he opined that petitioner suffered an injection injury to her lateral cutaneous

nerve, branching from the axillary nerve within the deltoid. (Ex. 18, p. 1.) This resulted

in “pain at the site of injection and radiating down the lateral portion of her upper arm in

an ovoid shape ending above the left elbow.” (Id.) He indicated that the lateral

cutaneous nerve is susceptible to possible injury from an intramuscular injection and

that, with the onset of symptoms being immediate, “[t]his emergence of symptoms due

to nerve injury occurred within the medically reasonable time frame expected from the

mechanism of injury.” (Id.)

Second, Dr. Szumski described additional pain and reduced mobility developing

over a period of months as petitioner avoided significant use of her arm due to the initial

nerve pain. (Ex. 18, p. 1.) Dr. Szumski suggested that this additional pain and reduced

range of motion was reflected in petitioner’s inability to tolerate physical therapy. (Id. at

1-2.) He opined that this second cluster of symptoms constituted a “frozen shoulder,”

which he also opined occurred in a medically reasonable time frame. (Id.)

Dr. Szumski further opined that, since petitioner’s shoulder was never completely

immobilized, atrophy was not noted in petitioner’s physical findings and would not have

been expected. (Ex. 19, p. 1.) Dr. Szumski also indicated that “the direct symptoms of

her nerve injury were relatively mild compared to the indirect symptoms that developed

later and prompted medical attention.” (Id.) Dr. Szumski suggested that it is impossible

to determine when the initial, direct symptoms of nerve injury were supplanted by the

symptoms of the indirect frozen shoulder. He indicated that the frozen shoulder

symptoms, though distinct, were of insidious onset and that “[t]here was no single day

when it became clear that the primary cause of her shoulder pain was changing.” (Id. at

2.)

b. Respondent’s expert, Jeffrey Allen Cohen, M.D.

Dr. Cohen is a Professor and Chairman of Neurology at Geisel School of

Medicine at Dartmouth and the Dartmouth-Hitchcock Medical Center. (Ex. B.) He

disagrees with Dr. Szumski’s assessment of lateral cutaneous neuropathy and also

opined that petitioner’s symptoms are not a result of her vaccinations. (Ex. A, p. 1.)

12

Dr. Cohen stressed that a traumatic injection injury to the lateral cutaneous nerve

from vaccination would be extremely rare and not consistent with his clinical experience.

(Id. at 2.) But in any event, he opined that petitioner’s “clinical course is not consistent

with a nerve injury [,] i.e. a long period of time [of] 10 months before the patient saw a

physician. Nerve injuries usually improve over time, they do not worsen. The

neurological examinations are normal over time as well which would be very unusual

with worsening of a nerve injury.” (Id. at 3.) He also noted petitioner’s history of

cervical spinal stenosis, neck pain, and left arm radicular symptoms, and further

suggested that an injury to the lateral cutaneous nerve would be at the level of the

elbow, not the shoulder. (Id. at 2-3.)

c. Responsive supplemental reports

In a supplemental report, Dr. Szumski challenged Dr. Cohen’s opinion,

contending that Dr. Cohen was failing to distinguish between the lateral cutaneous

nerve of the arm, which is the superior lateral brachial cutaneous nerve, and the lateral

cutaneous nerve of the forearm, which is the lateral antebrachial cutaneous nerve. (Ex.

20, p. 1.) Dr. Szumski clarified that he has opined that petitioner suffered an injury to

the former while asserting that Dr. Cohen’s discussion of symptoms at the elbow relates

to the latter. (Id. at 4.)

Dr. Szumski noted that the rarity of the injury mechanism he proposed does not

preclude vaccine-causation. (Ex. 20, p. 1.) He contended that “referring to absence of

reports in the clinical literature may grossly underestimate the true incidence of rare

disorders” and noted that he has treated patients suffering injection-related injury to the

lateral cutaneous nerve of the forearm and to a branch of the suprascapular nerve. (Id.

at 5.)

Dr. Szumski also challenged Dr. Cohen’s assertion that neurological exams were

normal in petitioner’s case. He indicated that “[i]njuries to purely sensory branches (e.g.

the lateral cutaneous nerve of the arm) can only be tested on exam by subjective

measures, i.e. touching the areas and asking the patient, ‘does this feel normal?’, etc. A

sensory nerve could only produce objective findings, via an indirect route – if it

produced symptoms so severe that mobility was drastically limited, and disuse led to

secondary atrophy of nearby muscles.” (Ex. 20, p. 4.)

Respondent subsequently filed a supplemental report by Dr. Cohen. (Ex. C.) In

his supplemental report, Dr. Cohen stressed that “[i]t is a fact that very obscure clinical

problems commonly appear as case reports in the literature. The fact that there is not a

single case report of an injection in the shoulder causing a lateral cutaneous nerve

injury of the arm is self-evident. In the authoritative texts on peripheral nerve disorders

(Dyck Steward) an injection in the shoulder causing solely lateral cutaneous injury is

never mentioned.” (Id. at 1.) He stressed that the prior cases described by Dr. Szumski

in his own practice did not involve shoulder injections. (Id. at 1-2.) He concluded: “The

13

simple and clear fact is an injection in the shoulder does not result in a worsening and

permanent focal injury of the lateral cutaneous nerve.” (Id. at 2.)

IV. Findings of Fact

Before reaching the question of entitlement to compensation under the Althen

test discussed below, I will first address several factual points. A petitioner must prove,

by a preponderance of the evidence, the factual circumstances surrounding her claim.

§ 300aa–13(a)(1)(A). Although the previously-assigned special masters issued

tentative findings of fact during earlier stages of the case, these findings are not binding

on me. Godfrey v. Sec’y of Health & Human Servs., 2015 WL 10710961, at *9 (Fed. Cl.

Spec. Mstr. Oct. 27, 2015)(noting that “[g]enerally, special masters may change or

revisit any ruling until judgment enters, even if the case has been transferred.”); see

also Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998), aff’d, 191

F.3d 1344 (Fed. Cir. 1999) (special masters are not bound by their own or other special

masters’ decisions). Accordingly, I will explain my own findings of fact.

a. Injection site location and vaccination at issue

Of the two vaccinations petitioner received on February 12, 2013, only an injury

stemming from the influenza vaccine would be compensable in this program; however,

the injection site is not recorded for either vaccine. Accordingly, a threshold question is

whether petitioner’s vaccinations were administered in such a way that the flu vaccine

could have been the cause of her injury (i.e. was administered in her left arm) and, if so,

would have been a more likely cause of the injury than the shingles vaccine she

received at the same time.

Petitioner has averred that she received both her influenza and shingles vaccines

in her left arm on February 12, 2013. (Ex. 15, p. 1.) Additionally, although petitioner did

not immediately report her alleged shoulder condition to her physicians, once she did,

her later medical records are consistent in recording her recollection that her

vaccinations were given in her left arm, though these records are all more than ten

months post-vaccination. (Ex. 2, pp. 7-8; Ex. 3, p. 2; Ex. 4, pp. 1, 5; Ex. 14.)

Additionally, petitioner’s medical records note her to be right handed. (E.g. Ex. 3, p. 2.)

Vaccinations are often administered in the non-dominant arm.

Also significant is the fact that there is no evidence to suggest that petitioner

received either of her vaccinations in her right arm. Importantly, petitioner’s vaccination

record is silent as to the site of her injections rather than contradictory to her

recollection. (Ex. 1.) In that regard, it is also significant that petitioner returned to the

Rite Aid pharmacy where she was vaccinated and a pharmacy employee filled out a

VAERS report in which petitioner’s allegation of a left shoulder injury is recorded along

with the details of the vaccines she was administered. (Ex. 14.) If the pharmacy had a

record of petitioner’s vaccines being administered in the opposite arm, that issue likely

would have been raised in connection with completion of the form.

14

For these reasons, there is preponderant evidence that petitioner’s February 12,

2013 influenza and shingles vaccines were administered in her left shoulder. However,

since both of her vaccines were likely administered in the same shoulder, this raises the

additional question of whether one was more likely than the other to have caused a

shoulder injury via either of the above-discussed theories.

According to the SIRVA criteria, a SIRVA is limited to injuries following

intramuscular injection. See 42 C.F.R. §100.3(c)(10); see also Tenneson, Cooper,

Schoonover, infra. Likewise, both experts in this case opined that a direct nerve injury

of the type proposed by Dr. Szumski would be more likely to have been caused by an

intramuscular rather than subcutaneous injection. (Ex. 18, p. 1; Ex. A, p. 2.)

Petitioner’s influenza vaccination was intramuscularly administered and her shingles

vaccine subcutaneously administered. (Ex. 1.) Therefore, to the extent petitioner

suffered any vaccine-related injury, her flu vaccine would have been more likely than

her shingles vaccine to have caused her injury.

b. Onset and nature of shoulder pain

The next question is whether petitioner’s alleged shoulder pain arose as an

immediate consequence of her flu vaccine as alleged. There are two significant

considerations on this point – first, petitioner was actively treating for a preexisting

cervical condition at the time of her vaccinations and, second, petitioner did not report

any vaccine-related shoulder pain to her physicians until ten months after her

vaccination despite returning for regular follow-up primary care.

Medical records that are created contemporaneously with the events they

describe are presumed to be accurate and “complete” (i.e., presenting all relevant

information on a patient's health problems). Cucuras v. Sec'y of Health & Human

Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993); Doe v. Sec'y of Health & Human Servs.,

95 Fed. Cl. 598, 608 (2010) ( “[g]iven the inconsistencies between petitioner's testimony

and his contemporaneous medical records, the special master's decision to rely on

petitioner's medical records was rational and consistent with applicable law”), aff'd, 468

Fed. Appx. 952 (Fed. Cir. 2011) (non-precedential opinion). In this case the

contemporaneous medical records do not support petitioner’s allegations.

Petitioner’s medical records include suspicion of musculoskeletal back pain

dating back to 2010. (Ex. 6, p. 1.) She began a course of treatment for back and neck

pain beginning in early January 2013 and reported at that time that she had been

symptomatic for one year. (Ex. 13, p. 1.) In connection with this history, cervical spinal

stenosis was confirmed upon MRI. (Id. at 3-5.) It was specifically reported, just one

month prior to her February 12, 2013 vaccinations, that pain from this condition radiated

into both upper extremities and petitioner complained of right shoulder pain

approximately two weeks prior to vaccination. (Ex. 13, pp. 4, 7-8.) The day following

her vaccination, petitioner reported to physical therapy to treat her cervical pain. (Ex. 5,

pp. 16-18.) Consistent with the prior reports, petitioner’s assessment included left

15

radicular shoulder pain 21 as well as a number of symptoms relating to her neck and

back. (Id. at 18.) To the extent any mechanism of injury was discussed, petitioner

attributed her cervical pain to lifting her husband, whom she was caring for as his

Parkinson’s disease progressed. (Id.) In the month following her vaccination, petitioner

attended a number of physical therapy sessions for her cervical spinal stenosis. (Ex. 5,

p. 10-16.) Shoulder pain following or attributable to vaccination was never mentioned.

(Id.) She also saw her primary care physician, Dr. Elad, 22 on two occasions (February

21, 2013, and August 8, 2013) for general “follow up.” (Ex. 2, pp. 9-16.) At both of

these visits, petitioner discussed her general health and prior health complaints, but did

not mention her alleged shoulder pain. (Id.)

It was not until ten months after her vaccinations that petitioner mentioned post-

vaccination shoulder pain to any physician. (Ex. 2, pp. 5-8.) At that time, petitioner

reported to Dr. Elad that she could not raise her left arm since receiving her

vaccinations. (Id. at 5.) However, this history conflicts with petitioner’s prior medical

history as reflected in her prior treatment records and is far less contemporaneous to

the onset of her condition than her prior medical records. See, e.g. R.K. v. Sec’y of

Health & Human Servs., No. 03-632V, 2015 WL 10936123, at *76 (Fed. Cl. Spec. Mstr.

Sept. 28, 2015) (finding that more remote histories of illness did not have sufficient

indicia of reliability to be credited over conflicting contemporaneous medical records);

see also Vergara v. Sec’y of Health & Human Servs., 08-882V, 2014 WL 2795491,*4

(Fed. Cl. Spec. Mstr. May 15, 2014) (“Special Masters frequently accord more weight to

contemporaneously-recorded medical symptoms than those recorded in later medical

histories, affidavits, or trial testimony.”).

Dr. Elad advised petitioner to see a neurologist (ultimately Dr. Szumski) without

recording any relevant findings. (Ex. 2, pp. 5-8.) Based on her report of chronic pain

following vaccination, as well as physical findings of tenderness to palpation and pain

with abduction, Dr. Szumski diagnosed neuritis, relying on petitioner’s report that onset

of her shoulder pain correlated to the time of vaccination. (Ex. 3, p. 3.) Yet there is no

indication in either his medical records or any of his subsequent reports that he was

aware of, let alone considered, petitioner’s history of cervical spinal stenosis and her

treatment, contemporaneous to her vaccination, of neck and shoulder pain related to

that condition radiating into her upper extremities. 23 (Exs. 3, 18-20.) Respondent’s

21 At base, “radicular” generally means “of or pertaining to a root.” Dorland’s 32nd Ed., p. 1571. With

regard to shoulder pain, it would refer to radiculopathy, which is “disease of the nerve roots, such as from

inflammation or impingement by a tumor or bony spur.” (Id.) Cervical radiculopathy is “radiculopathy of

cervical nerve roots, often with neck or shoulder pain; compression of nerve roots is a common cause in

this area.” (Id.) In his initial report, Dr. Cohen confirmed that petitioner’s cervical condition was capable

of causing her left radicular arm pain. (Ex. A, p. 2.)

22As explained above, Dr. Elad was petitioner’s cardiologist, but he also provided her primary care. (Ex.

15, p. 2.)

23 In his final supplemental report, Dr. Szumski did briefly address Dr. Cohen’s assertion that petitioner’s

condition could have been caused by cervical arthritis, stating that “’cervical arthritis’ is such a non-

specific and common category that it is a distraction from the core question here.” (Ex. 20, p. 4.) But,

again, this statement suggests that Dr. Szumski is not taking full account of petitioner’s history, which

16

expert observed that petitioner’s cervical spinal stenosis symptoms “are identical” to the

symptoms she attributed to her vaccinations in her later reports. (Ex. A, p. 2.)

I have also considered the affidavits petitioner has submitted, but, to the extent

they conflict with the contemporaneous medical records, they are not persuasive. (Exs.

15, 17.) First, petitioner does not acknowledge her history of cervical problems or how

that was affecting her at the time of her vaccination. 24 (Ex. 15.) Second, petitioner’s

affidavit does not persuasively address her delay in seeking treatment. Petitioner is

very credible in stating that she was prioritizing her husband’s care during his end-stage

Parkinson’s disease; however, petitioner did seek primary care twice during this period

for general “follow up” and did not discuss her shoulder pain with her doctor.

Accounting for her very unfortunate family circumstance, minimization of

petitioner’s self-care is understandable, but prioritization of her husband’s care does not

explain why active medical concerns were not raised at those general follow up

appointments that did occur. This is especially significant, because petitioner has

averred that during this same period she returned to Rite Aid multiple times to challenge

their assertion that she was experiencing normal, temporary post-vaccination pain. (Ex.

15, p. 2.) Specifically, petitioner saw Dr. Elad on February 21, 2013, and made no

mention of shoulder pain. (Ex. 2, pp. 13-16.) She averred that she returned to Rite Aid

“[a] few months after the vaccine” to complain about her shoulder pain. (Ex. 15, p. 2.)

Petitioner averred that she returned to Rite Aid again “[i]n the summer of 2013” to

complain that her pain was persisting. (Id.) Petitioner saw Dr. Elad again on August 8,

2013, and again made no mention of her shoulder pain. (Ex. 2, pp. 9-12.)

Ms. Kramer’s affidavit lends some support to petitioner’s account, but lacks

sufficient specificity regarding the ten-month period immediately following petitioner’s

vaccinations to add significant weight. (Ex. 17, p .1.) Moreover, although she stressed

that “[m]y mother and I see each other often” and that she was able to immediately

observe petitioner’s post-vaccination shoulder pain, she likewise failed to address

petitioner’s preexisting cervical symptoms. (Id.)

With regard to onset of her shoulder pain, petitioner argues that I should follow a

number of decisions by the Chief Special Master addressing SIRVA claims within the

SPU. (ECF No.58, pp. 24-27.) In such decisions it has been held that neither a delay in

seeking treatment in itself, nor a failure to report symptoms to a specialist or emergency

room provider prior to later seeking treatment, is necessarily dispositive of whether a

petitioner’s shoulder pain began within 48 hours of vaccination. See Forman-Franco v.

included detailed description of petitioner’s cervical problems, including MRI imaging, as well as an

established pattern of treatment seeking to alleviate symptoms related to that condition.

24 With regard to her past medical history, petitioner indicated only that “[p]rior to receiving a flu shot, I

was [a] very health 72 year young lady. I have always tried to be physically active, and I have normal

preventative health visits with my doctors for slightly high cholesterol and blood pressure. These are well

controlled with minimal medication. I have also had growths on my thyroid, but these were non-

cancerous. I have received many flu shots in the past years without issue.” (Ex. 15, p. 1.)

17

Sec’y of Health & Human Servs., No. 15-1479V, 2018 WL 1835203 (Fed. Cl. Spec.

Mstr. Feb. 21, 2018); Tenneson v. Sec’y of Health & Human Servs., No. 16-1664V,

2018 WL 3083140 (Fed Cl. Spec. Mstr. Mar. 30, 2018), mot. rev. denied 142 Fed. Cl.

329 (2019); and Gurney v. Sec’y of Health & Human Servs., No. 17-481V, 2019 WL

2298790 (Fed. Cl. Mar. 19, 2019). 25 This case is distinguishable, however, due to the

overall length of delay in reporting vaccine-related shoulder pain, the fact of two

intervening medical encounters for general health follow up, and the presence of

contemporaneous medical records suggesting petitioner’s symptoms are attributable to

her pre-existing cervical condition.

For these reasons, when viewing the record as a whole, I do not find

preponderant evidence that petitioner had onset of post-vaccination left shoulder pain

immediately following her vaccination or within 48 hours of her vaccination. Rather, as

reflected in her contemporaneous medical records, at the time of her February 12, 2013

vaccinations, a preponderance of the evidence indicates that petitioner had preexisting

cervical spinal stenosis with pain radiating into both of her upper extremities and no

distinct onset of left shoulder pain related to vaccination. That is, petitioner’s cervical

condition more likely than not explains all of her shoulder symptoms documented during

the period from January through March of 2013. To the extent petitioner later reported

left shoulder pain that she contends was distinct from her cervical condition, there is not

preponderant evidence that such shoulder pain existed on or before August 8, 2013.

c. Adhesive capsulitis diagnosis

A further question is whether there is preponderant evidence that petitioner

experienced adhesive capsulitis as a subsequent consequence of the post-vaccination

shoulder pain she alleges. In his expert reports, Dr. Szumski relies on the presence of

adhesive capsulitis that he attributes to petitioner’s chronic disuse of her arm due to

post-vaccination shoulder pain. (Ex. 18, p. 1; Ex. 19, p. 1; Ex. 20, p. 4.)

Petitioner’s adhesive capsulitis “diagnosis” is limited to a notation by her physical

therapist during her evaluation of February 3, 2014, identifying frozen shoulder based

on pain, stiffness, and reduced mobility. (Ex. 5, p. 6.) That notation of frozen shoulder

appears in the “history of complaint” section and not in any section related to the

physical therapist’s findings or observations. (Id. at 6-7.) Notably, the physical therapist

recorded “neg for frozen” under MRI/X-Ray results. 26 (Id. at 6.) Accordingly, while

there is some evidence to suggest petitioner may have experienced symptoms

25 In her brief, petitioner stresses the Chief Special Master’s unique authority on the subject matter of

SIRVAs due to her accumulated experience in adjudicating SIRVA claims within the SPU. (ECF No. 58,

p. 23, n. 14.)

26 As noted in n. 19, supra, it is not clear to what MRI study this notation could be referring. Rather than

referring to a prior MRI study, it may be a notation indicating the lack of any MRI or X-ray support for the

frozen shoulder suspicion.

18

consistent with frozen shoulder or that frozen shoulder was suspected, the assertion

that she was “diagnosed” as having the condition overstates petitioner’s history. 27

Nonetheless, even assuming arguendo that petitioner did have adhesive

capsulitis, there is little in the record to connect it to her vaccination. By Dr. Szumski’s

reasoning, the mechanism of petitioner’s development of frozen shoulder was not

directly related to the proposed nerve injury, but merely from petitioner “voluntarily”

restricting her motion due to localized pain. He indicated that onset of the frozen

shoulder would have been insidious over months and that petitioner’s shoulder was

“never completely immobilized.” (Ex. 19, p. 1.) Yet, petitioner was not actively treating

for any neck, back or shoulder condition from March of 2013 through December of

2013. Although it is often seen in SIRVA cases, frozen shoulder can occur

idiopathically. See n. 5, supra.

Dr. Szumski’s indirect linking of petitioner’s alleged adhesive capsulitis to her

vaccination is possible only through post hoc reasoning based on his reliance on

petitioner’s reported history of identifiable left shoulder pain beginning at the time of

vaccination. However, as noted above, that history is inconsistent with, and less

reliable than, her contemporaneous medical records which show active treatment for

cervical spinal stenosis radiating to both upper extremities at the time of her vaccination.

In that regard, it is worth noting that, although petitioner demonstrated some

improvement during her earlier physical therapy related to her cervical condition, none

of petitioner’s medical records indicate that her cervical pain fully resolved.

For these reasons, assuming arguendo that petitioner did have adhesive

capsulitis, I do not find preponderant evidence that such adhesive capsulitis occurred as

a sequela to any traumatic injection injury to her lateral cutaneous nerve.

V. Discussion Regarding Entitlement

Under the National Vaccine Injury Compensation Program (the “Program”),

compensation awards are made to individuals who have suffered injuries after receiving

vaccines. To be compensated, the petitioner must establish a causal link between the

vaccination and the injury. In some cases, the petitioner may simply demonstrate the

occurrence of what has been called a “Table Injury.” That is, it may be shown that the

vaccine recipient suffered an injury of the type enumerated in the “Vaccine Injury Table,”

corresponding to the vaccination in question, within an applicable time period following

the vaccination also specified in the Table. If so, the Table Injury is presumed to have

been caused by the vaccination, and the petitioner is automatically entitled to

compensation, unless it is affirmatively shown that the injury was caused by some factor

27In his expert report, Dr. Szumski states that “[a]fter her 1/29/14 appointment, [petitioner] attempted to

work with a physical therapist to increase range of motion, reduce pain, and improve function of the left

shoulder and arm. However, by that time, she was diagnosed as having a so-called frozen shoulder . . .”

(Ex. 18, p. 1.) Dr. Szumski at no point indicated in his treatment records that he diagnosed frozen

shoulder himself, but did include in his interval history of March 13, 2014, that petitioner’s physical

therapist suspected frozen shoulder. (Ex. 3, p. 1.)

19

other than the vaccination. § 300aa-13(a)(1)(A); § 300 aa-11(c)(1)(C)(i); § 300aa-14(a);

§ 300aa-13(a)(1)(B).

In many cases, however, the vaccine recipient may have suffered an injury not of

the type covered in the Vaccine Injury Table. In such instances, an alternative means

exists to demonstrate entitlement to a Program award. That is, the petitioner may gain

an award by showing that the recipient’s injury was “caused-in-fact” by the vaccination

in question. § 300aa-13(a)(1)(B); § 300aa-11(c)(1)(C)(ii). In such a situation, of course,

the presumptions available under the Vaccine Injury Table are inoperative. The burden

is on the petitioner to introduce evidence demonstrating that the vaccination actually

caused the injury in question. Althen v. Sec’y of Health & Human Servs., 418 F.3d

1274, 1278 (Fed. Cir. 2005); Hines v. Sec’y of Health & Human Servs., 940 F.2d 1518,

1525 (Fed. Cir. 1991).

In this case, petitioner’s allegations include a theory of an injection-related nerve

trauma, first raised by her expert, as well as the claim stated in her petition that an

influenza vaccination caused her to suffer a Shoulder Injury Related to Vaccine

Administration or “SIRVA”. As of March 21, 2017, SIRVA has been included on the

Vaccine Injury Table for the flu vaccine. See National Vaccine Injury Compensation

Program: Revisions to the Vaccine Injury Table, Final Rule, 82 Fed. Reg. 6294, Jan. 19,

2017; National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury

Table, Delay of Effective Date, 82 Fed. Reg. 11321, Feb. 22, 2017 (delaying the

effective date of the final rule until March 21, 2017). However, since the filing of

petitioner’s claim predates this change to the injury table, petitioner must satisfy the

burden for establishing causation-in-fact even with regard to her SIRVA claim. See §

300aa-14(c)(4) (stating that “[a]ny modification . . . of the Vaccine Injury Table shall

apply only with respect to petitions for compensation under the Program which are filed

after the effective date of such regulation”). Thus, petitioner bears a burden of

establishing causation-in-fact under either of her proposed theories.

The showing of “causation-in-fact” must satisfy the “preponderance of the

evidence” standard, the same standard ordinarily used in tort litigation. § 300aa-

13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines, 940 F.2d at 1525. Under that

standard, the petitioner must show that it is “more probable than not” that the

vaccination was the cause of the injury. Althen, 418 F.3d at 1279. The petitioner need

not show that the vaccination was the sole cause of the injury or condition, but must

demonstrate that the vaccination was at least a “substantial factor” in causing the

condition, and was a “but for” cause. Shyface v. Sec’y of Health & Human Servs., 165

F.3d 1344, 1352 (Fed. Cir. 1999). A petitioner may not receive a Vaccine Program

award based solely on his or her assertions; rather, the petition must be supported by

either medical records or by the opinion of a competent physician. Section 13(a)(1).

In what has become the predominant framing of this burden of proof, the Althen

court described the “causation-in-fact” standard, as follows:

20

Concisely stated, Althen’s burden is to show by preponderant evidence that

the vaccination brought about her injury by providing: (1) a medical theory

causally connecting the vaccination and the injury; (2) a logical sequence

of cause and effect showing that the vaccination was the reason for the

injury; and (3) a showing of proximate temporal relationship between

vaccination and injury. If Althen satisfies this burden, she is “entitled to

recover unless the [government] shows, also by a preponderance of the

evidence, that the injury was in fact caused by factors unrelated to the

vaccine.”

Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner

need not necessarily supply evidence from medical literature supporting petitioner’s

causation contention, so long as the petitioner supplies the medical opinion of an

expert. Id. at 1279-80. The court also indicated that, in finding causation, a Program

fact-finder may rely upon “circumstantial evidence,” which the court found to be

consistent with the “system created by Congress, in which close calls regarding

causation are resolved in favor of injured claimants.” Id. at 1280.

a. Althen Prong One

Under Althen prong one, petitioner must provide a “reputable medical theory,”

demonstrating that the vaccine received can cause the type of injury alleged. Pafford v.

Sec’y of Health & Human Servs., 451 F.3d 1352, 1355–56 (Fed. Cir. 2006) (citations

omitted). To satisfy this prong, petitioner's theory must be based on a “sound and

reliable medical or scientific explanation.” Knudsen v. Sec'y of Health & Human Servs.,

35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not

medically or scientifically certain.” Id. at 549. Petitioner may satisfy the first Althen

prong without resort to medical literature, epidemiological studies, demonstration of a

specific mechanism, or a generally accepted medical theory. Andreu v. Sec'y of Health

& Human Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing Capizzano v. Sec’y of

Health & Human Servs., 440 F.3d 1317, 1325–26 (Fed. Cir. 2006)).

Petitioner’s expert asserts a mechanism whereby a direct injection trauma to

petitioner’s lateral cutaneous nerve initially caused her symptoms only for petitioner to

later develop orthopedic sequela in the form of adhesive capsulitis. Both parties’

experts agree as a general matter that traumatic nerve injuries from injection are

possible. For example, respondent’s expert noted that “[t]here are case reports of the

very rare event of axillary nerve damage from vaccinations” which do present with

shoulder and deltoid symptoms. 28 (Ex. A, p. 2.) He also agreed that traumatic injection

injuries to the lateral cutaneous nerve, though extremely rare, do occur. 29

28 Dr. Szumski opined that petitioner’s injury was to the lateral subcutaneous nerve of the arm, which he

indicated branches from the axillary nerve. (Ex. 20, p. 1.)

29Dr. Cohen opined, however, that such injuries present at the level of the elbow. (Ex. A, p. 2.) Dr.

Szumski challenged that contention, indicating that Dr. Cohen was being imprecise in failing to distinguish

between the lateral cutaneous nerve of the arm, which is the superior lateral brachial cutaneous nerve,

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Dr. Cohen’s competing contentions primarily go to petitioner’s clinical course and

whether it is consistent with Dr. Szumski’s theory. Notably, Dr. Cohen did not

challenge, or even address, Dr. Szumski’s description of adhesive capsulitis or his

opinion that it could theoretically arise as sequela to a traumatic nerve injury. As Dr.

Szumski suggested, adhesive capsulitis is known to occur as a result of long term

“favoring” or disuse of the shoulder as a pain response. See, e.g. Tenneson v. Sec’y of

Health & Human Servs., 142 Fed. Cl. 329 (2019)(noting in a prior SIRVA case that

petitioner “apparently consulted with an orthopedist who ‘felt [it] unlikely [that] this is all

related to flu shot’ but who acknowledged that [petitioner] ‘certainly could have

developed a frozen shoulder if she hasn’t moved it x 5 mo’ since the flu vaccination.”).

For these reasons, I find Dr. Szumski’s description of traumatic nerve injury

following injection leading to adhesive capsulitis to be persuasive as a general theory of

causation. However, petitioner asserts in her petition a cause-in-fact claim of a

Shoulder Injury Related to Vaccine Administration or “SIRVA.”

SIRVA is a specific concept by which some musculoskeletal injuries temporally

associated to vaccination are deemed to have been vaccine caused where they meet

certain criteria that rule out other causes. Prior cases in this program have accepted

the SIRVA concept as an acceptable medical theory sufficient to satisfy Althen prong

one based on the Secretary’s rulemaking establishing SIRVA as a Table injury and

respondent’s history of conceding causation in prior, pre-Table SIRVA claims. See, e.g.

Tenneson, 2018 WL 3083140; Cooper v. Sec’y of Health & Human Servs., No. 16-

1387V, 2018 WL 1835179 (Fed. Cl. Spec. Mstr. Jan. 18, 2018); Schoonover v. Sec’y of

Health & Human Servs., No. 16-1324V, 2019 WL 1040642 (Fed. Cl. Spec. Mstr. Jan.

30, 2019).

Because a SIRVA is a musculoskeletal rather than neurologic injury, petitioner’s

SIRVA and traumatic nerve injury theories are mutually exclusive. However, Dr.

Szumski’s failure to establish the presence of any nerve injury would still leave open the

possibility that petitioner could prevail if she can establish under Althen prongs two and

three that her injury fits within the confines of the SIRVA concept. Accordingly,

petitioner has satisfied Althen prong one under either of two alternative theories.

b. Althen Prong Two

The second Althen prong requires proof of a logical sequence of cause and

effect, usually supported by facts derived from a petitioner's medical records. Althen,

418 F.3d at 1278; Andreu, 569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v.

Sec'y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). Medical records

are generally viewed as particularly trustworthy evidence, since they are created

contemporaneously with the treatment of the patient. Cucuras, 993 F.2d at 1528.

However, medical records and/or statements of a treating physician's views do not per

and the lateral cutaneous nerve of the forearm, which is the lateral antebrachial cutaneous nerve. (Ex.

20, p. 1.) In his supplemental report, Dr. Cohen did not address that point. (Ex. C.)

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se bind the special master to adopt the conclusions of such an individual, even if they

must be considered and carefully evaluated. See Section 13(b)(1) (providing that “[a]ny

such diagnosis, conclusion, judgment, test result, report, or summary shall not be

binding on the special master or court”).

Dr. Szumski opined that petitioner experienced an immediate post-vaccination

injury directly to the lateral subcutaneous nerve. He further opined that this injury

gradually led to an adhesive capsulitis. However, the findings of fact discussed in

Section IV(b), above, are incompatible with that opinion. There is not preponderant

evidence that petitioner experienced injection-related shoulder pain immediately

following her vaccination or at any time prior to August 8, 2013. To the extent she did

experience shoulder pain during that period, it is better explained by her ongoing and

preexisting cervical condition. Moreover, Dr. Szumski’s reliance on the suspicion of

frozen shoulder by petitioner’s physical therapist is suspect and his opinion is

unpersuasive overall for failing to adequately address petitioner’s preexisting cervical

spinal stenosis which the contemporaneous medical records show to explain her

condition at and following the time of vaccination. Accordingly, Dr. Szumski’s opinion

fails to set forth a logical sequence of cause and effect explaining how petitioner’s

vaccination would have caused her injury.

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 v. Sec'y of Health &

Human Servs., 88 Fed. Cl. 706, 743 (2009); (quoting Gen. Elec. Co. v. Joiner, 522 U.S.

136, 146, 118 S. Ct. 512, 139 L.Ed.2d 508 (1997)); see also Isaac v. Sec'y of Health &

Human Servs., No. 08–601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30,

2012), mot. for review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 Fed. Appx. 999 (Fed.

Cir. 2013) (citing Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1339 (Fed.

Cir. 2010)). “When an expert assumes facts that are not supported by a preponderance

of the evidence, a finder of fact may properly reject the expert’s opinion.” Dobrydnev v.

Sec’y of Health & Human Servs., 566 Fed. Appx. 976, 982-83 (Fed. Cir. 2014) (citing

Brooke Group Ltd. v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993)).

Notably, however, Dr. Szumski is not merely an expert opining in this case, but

also a treating physician. As described above, treating physician opinions are ordinarily

accorded a degree of deference. This is because, “treating physicians are likely to be in

the best position to determine whether a ‘logical sequence of cause and effect show[s]

that the vaccination was the reason for the injury.’” Capizzano, 440 F.3d at 1326. “In

contrast to treating physicians who had observed the patient as the condition unfolded,

retained experts [are] limited to a review of the records after the fact. Consequently,

treating physicians’ opinions are often regard as ‘quite probative’ with respect to the

causation prong under Althen.” Nuttall v. Sec’y of Health & Human Servs., 122 Fed. Cl.

821, 832 (2015), aff’d 640 Fed. Appx. 996 (Fed. Cir. 2016) (citing Andreu v. Sec’y of

Health & Human Servs., 569 F.3d 1367, 1375 (Fed. Cir. 2009).).

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On the other hand, treating physician opinions are not “sacrosanct.” Snyder, 88

Fed. Cl. at 746 n.67; Accord § 300aa-13(b)(1). And, significantly, “[t]he reasoning

underlying the finding that opinions of treating physicians should be given particular

weight does not apply when, as here, the treating physician only saw the patient after

the injury and based his opinion on the same evidence as relied upon by the retained

experts.” Nuttall, 122 Fed. Cl. at 832.

In this case, petitioner did not seek out Dr. Szumski for care of her shoulder until

nearly a year after her vaccination. By that point, by Dr. Szumski’s own reasoning, her

alleged frozen shoulder symptoms had already supplanted the prior direct nerve injury

he posits. (Ex. 19, p. 2 (describing petitioner as suffering insidious onset of increased

pain and reduced functional use of her shoulder due to frozen shoulder prior to seeking

medical care).) Accordingly, Dr. Szumski never actually observed or treated the direct

nerve trauma he theorized to have caused petitioner’s injury. 30 Additionally, the

resulting adhesive capsulitis condition that he describes in his reports and that was

purportedly the primary injury present at the time of his physical examination is

orthopedic and is therefore outside his area of expertise as a neurologist.

As with expert testimony offered to establish a theory of causation, the opinions

or diagnoses of treating physicians are only as trustworthy as the reasonableness of

their suppositions or bases. The views of treating physicians should also be weighed

against other, contrary evidence also present in the record—including conflicting

opinions among such individuals. Hibbard v. Sec'y of Health & Human Servs., 100

Fed.Cl. 742, 749 (2011) (not arbitrary or capricious for special master to weigh

competing treating physicians' conclusions against each other), aff'd, 698 F.3d 1355

(Fed. Cir. 2012); Caves v. Sec'y of Health & Human Servs., 100 Fed. Cl. 119, 136

(2011), aff'd, 463 Fed. Appx. 932 (Fed. Cir. 2012); Veryzer v. Sec'y of Health & Human

Servs., No. 06–522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011),

mot. for review den'd, 100 Fed. Cl. 344, 356 (2011), aff'd without opinion, 475

Fed.Appx. 765 (Fed. Cir. 2012). As described above, Dr. Szumski’s opinions are not

persuasive in light of petitioner’s contemporaneously recorded medical history.

Alternatively, since I do not find Dr. Szumski’s opinion of a direct nerve injury

persuasive, it is appropriate to examine whether petitioner can otherwise establish a

SIRVA. In prior cases where a SIRVA has been addressed as a cause-in-fact-claim, the

Qualifications and Aids to Interpretation (“QAI”) governing the Table Injury of SIRVA

have been found to be persuasive guidance in establishing whether there is a logical

sequence of cause and effect leading to a SIRVA. Tenneson, Cooper, Schoonover,

supra. Under that standard, petitioner must satisfy the following four criteria to establish

the presence of a SIRVA:

30 As the treating neurologist for petitioner’s late husband, Dr. Szumski did know petitioner prior to

becoming her physician. (Ex. 18, p. 2.) In fact, Dr. Szumski addressed the circumstances of petitioner’s

care for her husband extensively. (Ex. 18, p. 2; Ex. 19, p. 2.) However, nothing in his records or his

reports suggests that he at any time observed petitioner’s shoulder condition or spoke to her about it prior

to becoming her treating neurologist on January 29, 2014.

24

(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; and

(ii) Pain occurs within the specified time-frame [i.e. 48 hours]; and

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

which the intramuscular vaccine was administered; and

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

patient’s symptoms (e.g. NCS/EMG or clinical evidence of

radiculopathy, brachial neuritis, mononeuropathies, or any other

neuropathy).

42 C.F.R. §100.3(c)(10); see also Tenneson, Cooper, Schoonover, supra.

Again, in light of the above fact findings, petitioner has not satisfied any of these

criteria. Specifically, as described in section IV(b) above, petitioner’s preexisting

cervical condition was noted to encompass her upper extremities bilaterally. This

explains the only specific notation of any left shoulder pain following her vaccination as

that pain was noted to be radicular. Thus, the first, third, and fourth, SIRVA criteria are

not established by preponderant evidence. That is, petitioner had a relevant history of

cervical pain and dysfunction affecting her shoulder; she had reduced range of motion

in her neck as well as her shoulder; and her cervical spinal stenosis represents an

abnormality that explains her symptoms. 31 To the extent petitioner complained in later

histories of shoulder pain she related to her vaccinations, I did not find preponderant

evidence that such pain actually existed on or prior to August 8, 2013, which is roughly

six months from the date of vaccination. Thus, the second SIRVA criterion also is not

satisfied.

Accordingly, petitioner has not satisfied Althen prong two under either of her

proposed theories.

c. Althen Prong Three

The third Althen prong requires establishing a “proximate temporal relationship”

between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term

has been equated to the phrase “medically-acceptable temporal relationship.” Id. A

petitioner must offer “preponderant proof that the onset of symptoms occurred within a

timeframe which, given the medical understanding of the disorder's etiology, it is

medically acceptable to infer causation.” Bazan v. Sec'y of Health & Human Servs., 539

F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is a medically acceptable

timeframe must also coincide with the theory of how the relevant vaccine can cause an

31As previously noted, in addition to the evidence contained in her medical records, Dr. Cohen also

opined that petitioner’s cervical condition can explain her symptoms. (Ex. A, p. 2.)

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injury (Althen prong one's requirement). Id. at 1352; Shapiro v. Sec'y of Health &

Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den'd after remand, 105 Fed. Cl.

353 (2012), aff'd mem., 503 Fed. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec'y of Health

& Human Servs., No. 11–355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013),

mot. for review den'd (Fed. Cl. Dec. 3, 2013), aff'd, 773 F.3d 1239 (Fed. Cir. 2014).

Pursuant to Dr. Szumski’s theory of direct nerve trauma, there should be an

“immediate” onset of pain. (Ex. 18, p. 1; Ex. 19, p 2.) The relevant period of onset for

shoulder pain in a typical SIRVA claim is forty-eight hours. See Tenneson, Cooper,

Schoonover, supra.

In this case, petitioner’s February 13, 2013 physical therapy evaluation

references the presence left shoulder pain. (Ex. 5, p. 18.) That record was created one

day following her vaccination. However, for the reasons discussed in section IV(b)

above, I concluded that this reference to left shoulder pain, which was characterized as

radicular shoulder pain, is explained by her ongoing and preexisting spinal condition,

which was documented to have radiated into her arms, and does not represent a report

of vaccine-caused shoulder pain. Notwithstanding petitioner’s much later reports of

shoulder pain that immediately followed her vaccination, I have found the

contemporaneous medical records, which do not support the allegation of immediate

onset, to be more credible. Accordingly, there is not preponderant evidence of shoulder

pain on or prior to August 8, 2013, about six months after petitioner’s vaccination, which

is too late to be medically appropriate under any theory proposed by petitioner.

I also note that to the extent Dr. Szumski separately opined that petitioner’s

months-long insidious onset of adhesive capsulitis occurred within a medically

appropriate timeframe (Ex. 18, p. 2), Dr. Szumski never adequately addressed the

appropriate timeframe for development of adhesive capsulitis. He stressed that

petitioner’s pain “eventually” and “gradually” increased and her function gradually

decreased “over months,” but never actually described the expected time course for the

onset of adhesive capsulitis. (Ex. 18, p. 2; Ex. 19, p. 2.) In any event, Dr. Szumski’s

description of adhesive capsulitis was as a further sequela to the direct nerve injury he

posited had an immediate onset. Insofar as petitioner has not demonstrated immediate

onset of a direct nerve injury, the timing of the onset of her alleged adhesive capsulitis is

irrelevant.

Accordingly, petitioner has not satisfied Althen prong 3 under either of her

proposed theories.

VI. Conclusion

Petitioner has my sympathy for the pain and suffering she endured during what

must have been a very difficult period in her life and I do not doubt her sincerity in

bringing this claim. However, for all the reasons discussed above, after weighing the

evidence of record within the context of this program, I cannot find by preponderant

26

evidence that petitioner’s injury was caused by her February 12, 2013 influenza

vaccination as alleged. Therefore, this case is dismissed. 32

IT IS SO ORDERED.

s/Daniel T. Horner

Daniel T. Horner

Special Master

32In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter

judgment accordingly.

27